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Toxicity Drives Costly Head and Neck Cancer Readmissions

Thu, 09 Feb 2012 21:09 GMT

BY MIRIAM E. TUCKER
Elsevier Global Medical News
Breaking News

PHOENIX (EGMN) –Unplanned hospitalizations due to toxicities associated with head and neck cancer treatment were a source of substantial cost in a retrospective chart review of 141 patients treated at a single cancer center during 2007-2011.

Much of the increased cost was among patients who underwent docetaxel plus cisplatin and fluorouracil induction chemotherapy (TPF) plus chemoradiotherapy.

“In recent years, induction chemotherapy has been increasingly incorporated into multimodality regimens for selected patients with locally advanced primary squamous cell carcinoma of the head and neck (HNSCC) ... Although efficacious (N. Engl. J. Med. 2007;357:1705-15), TPF has the potential for toxicities [that] may lead to unplanned admissions during treatment. Concurrent use of chemotherapy with radiation is well documented to intensify therapeutic effect and toxicity,” Dr. Regan D. Rostorfer and his associates said in a poster.

Symptoms leading to the unplanned readmissions during induction chemotherapy (27 readmissions, 18 patients) included dehydration (in 13 of the 27 readmissions), infection (8), diarrhea (6), nausea/vomiting (5), pain (4), and mucositis (3).

A range of strategies can be used to avoid readmissions and thereby reduce these costs, including careful patient selection, use of prophylactic antimicrobials, standardized use of growth factor support, post-treatment support with outpatient intravenous fluids, integration of home health care services, early gastrostomy-tube placement, use of long-acting antiemetics during treatment, and frequent outpatient office visits during treatment, Dr. Rostorfer and his associates said.

“A number of initiatives are ongoing at our center in efforts to decrease readmission rates during combined modality treatment. Further studies are planned to assess the impact of these measures on readmission rates, and impact on costs of care,” the investigators said in their poster.

In an interview, Dr. Rostorfer said the study was initially intended to simply to gather statistics about readmission for head/neck cancer treatment-related toxicity, since there were no published data on it.

“We decided to look at data from our own institution, simply to see how frequently patients were readmitted, and the reason for readmission. More recently, costs have become an issue at almost every hospital in the country, so we decided to look at the excess costs associated with these unplanned admissions, as well.

The investigators reviewed charts for 91 randomly assigned patients with locally advanced primary HNSCC who received treatment with concurrent chemoradiotherapy, and for another 50 patients who received induction TPF chemotherapy followed by chemoradiation. The oropharynx was the most common cancer site, in 24 of the induction group (48%) and 59 of the concurrent group (65%).

A total of 19 induction patients (38%) required unplanned readmission, with 8 requiring more than one. Median length of stay for those total 27 unplanned stays was 6 days (range 1-25). In the concurrent group, 47 patients required unplanned readmission (52%), with 19 requiring more than one. That group had a total 77 unplanned readmissions, with a median stay of 7.8 days (1-65).

Total costs of admissions in the induction group were $3,368,583 for the planned admissions and $1,777,136 for the unplanned admissions. The median cost per planned hospital stay – elective admission for chemotherapy – was $32,276. In contrast, the cost per unplanned hospital stay was $42,390. For the concurrent group, which did not have planned hospitalizations, the cost per unplanned stay was $69,460, said Dr. Rostorfer, medical oncology and hematology chief fellow at MD Anderson Cancer Center Orlando, and his associates.

“Obviously this was a small, retrospective review, but the numbers can be quite alarming. We have begun to implement measures to reduce the numbers of readmission, so hopefully to reduce the cost associated with care. We will see the difference it makes.”

Dr. Rostorfer stated that he has no disclosures.

Subject Codes:
oncology; surgery; otolaryngology;

http://www.imng.com

February 09, 2012 04:09 PM EST

Regan D. Rostorfer

Otolaryngology Hospitalist Service Efficiently Fills a Need

Wed, 08 Feb 2012 21:19 GMT

BY DAMIAN MCNAMARA
Elsevier Global Medical News
Breaking News

MIAMI BEACH (EGMN) – A novel hospitalist program has optimized inpatient otolaryngology care at the University of California, San Francisco, a retrospective study reveals.

Based on its success, the program is poised to expand further this year and could become a model for other health systems, said Dr. Matthew S. Russell, an otolaryngology hospitalist at UCSF Medical Center and clinical instructor in the department of otolaryngology–head and neck surgery. “Feedback from this service has been overwhelmingly positive. I would encourage others who are interested to undertake a pilot project to see if this model is generalizable to other institutions,” he said.

A significant number of requests for otolaryngology care spurred the birth and growth of the program, which may be only one of its kind in the United States. After a pilot feasibility phase, clinicians officially launched the service in July 2009.

To measure the impact of the service on patient care and physician collaboration, Dr. Russell and his colleagues quantified their interventions between mid-2009 and December 2011.

During this period, otolaryngology hospitalists consulted on 375 new inpatients and generated 951 patient encounters. They most often evaluated general/pediatric cases (39%), laryngology concerns (29%), and rhinology issues (19%), according to a subanalysis of the first 18 months.

Respiratory failure was the most common specific diagnosis (12%) associated with a consult. They also consulted on patients with sinusitis (11%), stridor (11%), and dysphonia (8%), according to analysis of a billing database, including ICD-9 and CPT codes. Dr. Russell presented these findings at the Triological Society Combined Sections meeting, which was jointly sponsored by the Triological Society and the American College of Surgeons.

“As an otolaryngologist, I am providing mostly consultative services,” Dr. Russell said. “The types of problems I see are most commonly acute airway issues and complications of infectious processes in the head and neck. We perform a high volume of bedside procedures, and contrary to a popular assumption, the surgical volume is favorable.”

Otolaryngology hospitalists provided a total of 384 procedural or surgical interventions during the study period. Endoscopic sinonasal interventions were the most common procedure, followed by transnasal flexible laryngoscopy and operative endoscopy.

The UCSF otolaryngology hospitalists, therefore, work more like specialist consultants and less like traditional primary care hospitalists overseeing a cohort of inpatients, said Dr. Russell.

The study findings could be used to convince hospital administration of the need for this service. Improved time to consultation and surgery for many patients, for example, decreases resource utilization and shortens length of hospital stay, Dr. Russell said. “Prior to our hospitalist model, most of this care was clinically and financially invisible to the institution. We have been able to demonstrate qualitatively the benefit of our unique expertise in solving complex problems as well as mitigating risk from airway catastrophe.”

The otolaryngology hospitalists work closely with a number of other clinicians at UCSF. “The program has had a significant clinical impact in both the operating rooms and ICU,” Dr. Matt Aldrich, faculty member in the department of anesthesia and perioperative care at UCSF, said in an interview.

“On numerous occasions, Dr. Russell has been very helpful with emergency airway management,” Dr. Aldrich said. “He is also an excellent general resource for questions regarding tracheostomy management. This includes being on ‘standby’ for possible emergency tracheostomy during difficult airway management – both intubations and extubations – as well as [providing] assistance in understanding airway anatomic abnormalities during fiber-optic intubation procedures.”

“I’ve been very impressed by the speed with which he responds to our requests for help, as well as his clinical skills, knowledge, and professionalism,” Dr. Aldrich said. With only a few minutes’ notice, Dr. Russell recently came to the operating room to evaluate a patient with a pharyngeal mucosal cyst prior to placement of a transesophageal echocardiography probe, for example.

A potential limitation of the study was the use of an administrative database that likely underestimated the number of otolaryngology hospitalist interventions, Dr. Russell said. “I was a bit surprised by the volume of consultations and procedures in the consortium model data, both of which seemed low compared to my experience this year as a sole service provider. I suspect this is a limitation of how the data was collected for administrative review rather than a true phenomenon.”

UCSF is a 550-bed tertiary care and referral center. Hospitals smaller than approximately 500 beds might not be able to support a 100% full-time equivalent position for this model, he added.

But at UCSF, he is optimistic, predicting a measurably strong impact by year’s end: “This year we are on track to see over 700 unique patients with a significant bedside procedural and surgical volume,” Dr. Russell said.

Dr. Russell and Dr. Aldrich reported having no financial disclosures.

Subject Codes:
pediatrics; allergy; surgery; otolaryngology;

http://www.imng.com

February 08, 2012 04:19 PM EST

Community Hospital Offers Catheter-Directed Pulmonary Thrombolysis

Mon, 06 Feb 2012 21:53 GMT

BY SHERRY BOSCHERT
Elsevier Global Medical News
Breaking News

Few, if any, vascular specialists are aggressively treating massive or submassive pulmonary embolism with catheter-directed thrombolytic therapy at community hospitals, but it is feasible and can have good outcomes with proper planning and preparation, according to Dr. Jeffrey Y. Wang.

Catheter-directed thrombolytic therapy for massive or submassive pulmonary embolism (PE) can shorten stays in the ICU and the hospital, reduce or eliminate the need for home oxygen therapy, and help restore right heart function, he said. However, catheter-directed interventions for these patients is rare outside of academic or tertiary-care settings, probably because of a lack of randomized trials, little retrospective data, and lack of expertise, he said.

For physicians considering this treatment at their own community hospitals, Dr. Wang emphasized that preparing the hospital and protocols are as important as is technical expertise in doing the procedure. The fluoroscopy suite must be available on an emergency basis, for example.

“In our institution, we use the same protocols for call-in and transport to the cath lab as for ST-elevation myocardial infarction, which allows us to get the patient up and into the fluoroscopy suite within 30 minutes,” said Dr. Wang of Shady Grove Adventist Hospital, Rockville, Md.

Before doing his first case, he made sure that protocols were in place in the emergency department, in the ICU, and with the hospitalist team for the early detection of deep vein thrombosis and PE, notification of the appropriate staff, and posttreatment care of patients.

Systemic anticoagulation has been the mainstay of treatment for PE, but the American Heart Association and the American College of Chest Physicians have recommended more aggressive therapy for massive and submassive PEs, Dr. Wang said. Up to 60% of patients with massive PE die, data suggest, with two-thirds of the deaths occurring in the first hour of embolism formation. Within 30 days of submassive PE formation, 15%-20% of patients die secondary to pulmonary hypertension and subsequent cor pulmonale.

Approximately 30% of all 500,000 symptomatic PEs diagnosed each year in the United States lead to death. Even among inpatients who are diagnosed with a PE while in the hospital, the mortality rate is approximately 10%-15%, he said.

Until recently, there was no Food and Drug Administration–approved device for catheter-directed thrombolytic therapy. “There’s also not a purpose-built device to help you with these types of procedures,” Dr. Wang said.

At the annual meeting of the Southern Association for Vascular Surgery, he described treating nine women and three men who had a total of seven massive and five submassive PEs. Catheter-directed thrombolytic therapy was offered to patients with massive or submassive PE if they were hemodynamically unstable or had right heart dysfunction, elevated troponin levels, or pulmonary artery pressures greater than 70 mm Hg, or if they were not being weaned off intubation for oxygen within 5 days, Dr. Wang said. He excluded patients who were actively bleeding or who were not able to tolerate any systemic anticoagulation – “not even aspirin,” he said.

Recent surgery was not a disqualifying factor. “Typically those patients were orthopedic in nature, with a hip or knee replacement,” Dr. Wang said. The patient would develop a big PE, and the orthopedist would give him the green light for aggressive treatment.

All procedures were technically successful. One patient developed hemodynamically significant bradycardia, but all were off supplemental oxygen within 24 hours of the procedure, and there were no bleeding events.

One patient died 14 hours after the procedure, most likely due to a paradoxical embolism to the intestine, Dr. Wang said. The 11 surviving patients were discharged to home within 48 hours of the intervention.

His technique includes accessing the internal jugular vein to get to the pulmonary artery, placing a vena cava filter, and giving tissue plasminogen activator as the lytic agent. All patients had a spiral CT scan before going to the catheterization lab, so pulmonary angiography was not routinely performed.

He reserved mechanical (catheter) thrombectomy for some patients with massive thromboembolism. Instead of being guided by angiography, he determined the duration of mechanical thrombectomy by the patient’s blood pressure, pulse, and oxygen saturation.

“I discontinued mechanical thrombectomy once oxygen saturation was above 95%, they’re weaning off their inotropes, and the pulse rate was trending toward normal,” he said.

For some patients who developed nonsinus arrhythmias due to the wire manipulations within the heart and pulmonary arteries, he removed the wire device, waited for it to resolve, and continued. A minority of patients whose arrhythmias continued to occur during the intervention received calcium blockade or beta blockade.

Patients who received mechanical thrombectomy developed dark or bloody urine that resolved within 48 hours with hydration.

Follow-up at 2 weeks assessed general function and access sites, and patients had a repeat echocardiogram at 1 month. If they were doing well functionally and pulmonary hypertension had resolved, Dr. Wang offered to remove the vena cava filter. All but one patient accepted. All were to remain on systemic anticoagulation for 6-12 months, and patients with massive PE underwent hematologic workups.

More Studies Underway of Promising Therapy

“It amazes me that over many decades, the treatment of pulmonary embolism has remained stagnant. There have been no significant changes in the way we treat these patients. Most are treated with systemic anticoagulation and prolonged warfarin therapy,” said discussant Dr. Juan Ayerdi.

“There are many limitations to the use of systemic thrombolysis. The most important one is a high incidence of bleeding complications, about 20%-40%. Surgical thrombectomy also has limitations and is performed in a very limited number of centers, with mortality rates of about 10%-20%,” said Dr. Ayerdi of the Medical Center of Central Georgia, Macon.

“There is no question in my mind that there is a large potential benefit in treating patients with catheter-directed thrombolysis, particularly patients with massive pulmonary embolism. There’s also a potential benefit from catheter-directed thrombolysis in a large subgroup of patients with submassive pulmonary embolism. Those patients may benefit the most in terms of prevention of pulmonary hypertension,” he said.

“Many of these questions are being investigated now in a European prospective, randomized trial comparing catheter-guided pulmonary thrombolysis to chemical thrombolysis. In the Unites States, there are a couple of registries for these patients, and a randomized trial is expected to start in the near future. I encourage vascular specialists to enroll patients in these,” said Dr. Ayerdi.

Dr. Wang and Dr. Ayerdi reported having no financial disclosures.

Subject Codes:
cardiology; surgery;

http://www.imng.com

February 06, 2012 04:53 PM EST

Dr. Jeffrey Y. Wang

EDEN Trial Questions Restricting Nutrition to ALI Patients

Mon, 06 Feb 2012 16:04 GMT

BY DIANA MAHONEY
Elsevier Global Medical News
Breaking News

HOUSTON (EGMN) – Restricting the amount of initial enteral intake in mechanically ventilated patients who have acute lung injury neither reduces the duration of mechanical ventilation nor improves mortality relative to full enteral feeding, but the nutritional strategy may be slightly easier on the stomach, according to a study reported Feb. 5 at the annual meeting of the Society of Critical Care Medicine Critical Care Congress.

The importance of nutrition support in critically ill patients with acute lung injury (ALI) is well accepted as a means of maintaining gut integrity, modulating both stress and the systemic immune response, and attenuating disease severity, but conflicting data regarding the timing, formulation, and amount of enteral nutrition have contributed to uncertainty about the optimal feeding protocol, according to Dr. Todd W. Rice of Vanderbilt University Medical Center in Nashville, Tenn.

“How much nutrition we need to promote the protective benefits, we don’t know. Providing a little bit of nutrition (called trophic feeding) has been shown to decrease intestinal intolerances, compared with full-calorie feeds, but it may do so at the risk of malnutrition, worse immune function, and loss of muscle strength,” he said. Full-calorie feeding, on the other hand, may lead to more intolerances, may cause hyperglycemia and other imbalances, may increase septic complications, and may fuel the inflammatory fire, he added.

In the current study, which was published simultaneously in JAMA, Dr. Rice and colleagues in the EDEN (Early Vs. Delayed Enteral Nutrition in ALI) trial, sought to examine the relative advantages of restricting the amount of initial enteral intake in mechanically ventilated ALI patients. Specifically, the prospective, randomized, open-label trial compared the effect on clinical outcomes and survival of initial trophic enteral feeding – approximately 25% of the full target feeding – with initial full-calorie feeding for the first 6 days of mechanical ventilation in ALI patients. “We hypothesized that reduced trophic feeding during the first [6 days] would increase ventilator-free days and reduce instances of gastrointestinal intolerances compared with the conventional full enteral nutrition strategy,” he said.

The study’s primary end point was ventilator-free days through day 28; secondary end points were daily percentage of goal enteral feeding, frequency of gastrointestinal intolerances, 60-day mortality before hospital discharge with unassisted breathing, ICU- and organ failure–free days, and new infections (JAMA 2012 Feb. 5 [doi:10.1001/jama2012.137]).

The multicenter study population comprised 1,000 patients, from January 2008 through mid-April 2011, who were initiated on mechanical ventilation within 48 hours of developing ALI. Within 6 hours of randomization, enteric nutrition was initiated in 508 patients assigned to trophic nutrition and 492 assigned to full feeding, and was continued until death, extubation, or day 6, Dr. Rice explained. Per standard protocol, enteral nutrition in the full-feeding group began at 25 mL/hr and advanced to goal weights (25-30 kcal/day of nonprotein calories and 1.2-1.6 g/kg per day of protein) as quickly as possible; gastric residual volumes were checked every 6 hours while enteral feeding was increased. In the trophic group, enteral feeding was initiated at 10-20 kcal/hr and gastric residual volumes were checked every 12 hours. After 6 days, patients in the trophic group who still required mechanical ventilation were advanced to the full-energy feeding rates, he said.

Baseline characteristics of the two groups were similar, Dr. Rice noted. “The primary etiologies of lung injury in both groups of patients were pneumonia and sepsis, and the average APACHE III [Acute Physiology and Chronic Health Evaluation III] score was approximately 92. These were sick patients,” he said. For the first 6 days, the full- and trophic feeding groups received 1,300 kcal/day and 400 kcal/day, respectively.

With respect to the primary end point (28 days), the average number of ventilator-free days in both groups was similar, at 14.9 in the trophic group and 15.0 in the full-feeding group. “There were also no differences in 60-day mortality, organ failure–free days, ICU-free days, or the incidence of infection between groups,” he said. Similarly, with respect to body mass index category or lung injury severity, “there were no between-group differences in ventilator free days or survival.”

The full-feeding group did have a higher number of gastrointestinal intolerances on any one day, and statistically significant increase on days 2 and 3, but the overall percentages of intolerances were low, Dr. Rice said. There were no differences in albumin and protein levels between the groups over the first 7 days, he said.

Regarding the immediate clinical relevance of the findings, Dr. Rice stressed that the study wasn’t designed as an equivalence trial, “so I can’t tell you both feeding strategies are similar, but you can look at the results.” In fact, he said, although the study did not show a benefit other than improved gastrointestinal tolerance, his group has moved toward trophic feeds because of the ease of administration. “Our nurses love the trophic feeds. Starting at 10-20 cc/hr and running it for 6 days is a lot less hassle than worrying about trying to ramp it up and get to goals,” he said.

“Looking ahead, there are a number of places to go” with this research, Dr. Rice said. “Some of the questions we’ve thought about are what role does this play in the [total parenteral nutrition] question, and whether we need to be feeding patients at all. Initially, we thought the idea of not feeding patients would be a hard study to sell, but with these data, it may not be an unreasonable thing to look at.”

Dr. Rice disclosed no financial conflicts of interest.

Subject Codes:
top_stories; gastroenterology; pulmonology; surgery; emergency_trauma;

http://www.imng.com

February 06, 2012 11:04 AM EST

Skipping Antibiotic Guidelines Ups Trauma Surgical Infections

Fri, 03 Feb 2012 20:58 GMT

BY PATRICE WENDLING
Elsevier Global Medical News
Breaking News

LAKE BUENA VISTA, FLA. (EGMN) – Just 49.3% of patients undergoing emergency trauma laparotomy received antibiotics in accordance with the Surgical Care Improvement Project guidelines in a multicenter, retrospective analysis of 306 patients.

“Many of the non-SCIP patients received the wrong antibiotic or antibiotics for too long after their index operation,” lead author Brian M. Smith, DMD, said at the annual meeting of the Eastern Association for the Surgery of Trauma.

Moreover, compliance with the guidelines slashed surgical site infection rates from 32.9% among patients with noncompliant antibiotic management to 16.6% (P less than .001).

The Surgical Care Improvement Project (SCIP) established surgical antibiotic prophylaxis guidelines as part of a collaborative effort by the Centers for Medicare and Medicaid Services and the Centers for Disease Control and Prevention to reduce surgical complications. While these antibiotic prophylaxis guidelines have become well established in patients undergoing elective operative procedures, they have never been studied in trauma patients undergoing emergency surgery, said Dr. Smith, chair of oral and maxillofacial surgery at Temple University Hospital in Philadelphia.

He reported on an analysis involving 306 trauma patients who survived for more than 4 days after undergoing emergency laparotomy within 2 hours of admission at two level 1 trauma centers during 2007 and 2008. Patients were compared on the basis of adherence to the following SCIP guidelines: prophylactic antibiotic given, antibiotic received within 1 hour prior to incision, correct antibiotic selection, and discontinuation of antibiotic within 24 hours after surgery.

Their mean age was 32 years, 70% had penetrating wounds, 44% had enteric injuries, and 20% had preoperative hypotension.

In all, 155 patients received noncompliant perioperative antibiotic management. Of these, 55% received no prophylaxis or incorrect antibiotics, 46% received antibiotics outside of the recommended 60-minute window, and 54% received them beyond the 24-hour limit, Dr. Smith said.

“It’s important to note these because they represent simple practice maneuvers that can be changed to help improve antibiotic stewardship in our trauma patients,” he said.

The SCIP group spent significantly fewer days than the non-SCIP group in the ICU (mean 4 days vs. 7 days; P = .02) and in the hospital (mean 14 days vs. 19 days; P = .01), although no significant difference in mortality was detected (3% vs. 6%; P = .41).

Notably, Injury Severity Score was higher at admission in the non-SCIP group at 16 vs. 13 in the SCIP group (P = .03). Prehospital transfer time, which could influence the prolongation of antibiotics before surgery, was not available.

In a multivariate regression analysis that adjusted for such confounding factors as age, Injury Severity Score, shock, presence of enteric injury, transfusion requirements, damage control surgery, surgery duration, and hospital, complete adherence to the four SCIP guidelines independently decreased the risk of a surgical site infection (odds ratio, 0.448).

The non-SCIP group had significantly more enteric injuries than the SCIP group (52% vs. 35%; P = .027), and the rate of prolonged antibiotics was higher in patients with enteric injuries, compared with those without enteric injuries (38.6% vs. 19.4%; P = .001), Dr. Smith pointed out.

“This suggests the possibility that the extent of antibiotics rather than the enteric injuries themselves explained the wound infection rates in these two groups,” he said.

Discussant Dr. John Santaniello, a critical care surgeon from Loyola University Chicago, Maywood, Ill., said the authors need to further elucidate antibiotic usage in patients with enteric injuries to distinguish true SCIP prophylaxis violations from empiric treatment for contamination.

He also questioned why the authors included only four of the six SCIP measures, omitting preoperative skin preparation and intraoperative normothermia maintenance, which have been shown to reduce surgical wound infections.

Dr. Smith said missing data and difficulty in abstracting data from handwritten records kept them from analyzing these two measures.

Attendee Dr. Patrick Reilly, chief of traumatology, surgical critical care, and emergency surgery at the University of Pennsylvania in Philadelphia, questioned how SCIP compliance was defined in a damage-control patient, and asked whether the investigators have a routine way of closing the skin when the fascia can be closed in these patients.

“For a number of years, we have had a practice – we don’t really call it a practice management guideline because we don’t really have any evidence for it – where we leave the skin open if we close the fascia, at least initially, because we’ve realized a high incidence of wound infections regardless of what antibiotic regimen we use,” Dr. Reilly said.

Dr. Smith responded that they used the time from the index operation as the cut-point for SCIP compliance in the damage-control setting, but acknowledged that in many practices, patients receive another dose of antibiotics when they return to the operating room for a second look or washout.

Preliminary data on skin management in damage-control patients is being analyzed, but “we suspect, as you do at your institution, that it is probably the management of the skin in the setting of the fascial closure that may contribute to surgical site infections and are looking at a future study,” he said.

Finally, when asked how the results have changed practice at Temple University, Dr. Smith said they’d like to believe they are using only 24 hours’ worth of antibiotics in the setting of prophylaxis but lack the evidence to confirm this. He pointed out that although more than a decade has passed since the Eastern Association for the Surgery of Trauma published its own antibiotic guidelines, more than 50% of surgeons in the study were not in compliance.

“Certainly, there is always room for improvement in how we treat our patients,” he added.

Dr. Smith and Dr. Santaniello reported no conflicts of interest. Conflict of interest information for Dr. Reilly was not available.

Subject Codes:
surgery; emergency_trauma;

http://www.imng.com

February 03, 2012 03:58 PM EST

Brian M. Smith

Medicare Proposes TAVR Coverage Criteria

Fri, 03 Feb 2012 19:53 GMT

BY NASEEM S. MILLER
Elsevier Global Medical News
Breaking News

Medicare officials have released a coverage proposal for transcatheter aortic valve replacement 3 months after the procedure was approved in the United States.

The Centers for Medicare and Medicaid Services’ proposal restricts the procedure’s coverage where all of the following five criteria are met:

• The procedure meets Food and Drug Administration–approved criteria, and an FDA-approved device is used.

• Two cardiac surgeons evaluate the patient’s suitability for open valve replacement surgery.

• The procedure is performed in a facility that meets a certain level of experience. The document breaks down the criteria by centers with or without previous transcatheter aortic valve replacement (TAVR) clinical trial experience. All centers are required to participate in a prospective national TAVR study, and be committed to the Heart Team concept.

• The cardiac surgeon and interventionalist meet certain qualifications and levels of experience.

• The patient is enrolled in the prospective national registry for TAVR. The treating physician team also needs to be participating in the national registry.

The memo arrived ahead of its March 28 due date.

It also comes just days after four leading cardiovascular societies issued a document providing detailed guidance on TAVR implementation in centers across the United States.

Heart Teams, a national registry, and careful evaluation and selection of patients are also among the societies’ consensus document highlights.

In the United States, the first valve to be used for TAVR (the Edwards Lifesciences Sapien valve) was approved in November 2011. The valve is currently approved for use in inoperable patients with severe aortic stenosis. Other use of the Sapien valve is limited to clinical trials. Medtronic’s CoreValve is also in being studied in large U.S. trials.

CMS opened the national coverage determination analysis in September, before Sapien was even approved, in response to a request from the American College of Cardiology and the Society for Thoracic Surgeons to establish the criteria for national Medicare coverage of the minimally invasive valve procedure.

The CMS proposal is a step in the national coverage analysis process, in which the agency decides whether an item or service is covered by Medicare.

The CMS coverage proposal is open for comment until March 3. The agency is expected to make a final decision by May of this year.

Subject Codes:
cardiology; surgery;

http://www.imng.com

February 03, 2012 02:53 PM EST

Tinkering With Pediatric Triage Criteria Proves Thorny

Fri, 03 Feb 2012 19:21 GMT

BY PATRICE WENDLING
Elsevier Global Medical News
Breaking News

LAKE BUENA VISTA, FLA.(EGMN)–Under- and overtriage rates do not dramatically improve among injured children when additional criteria are added to those mandated for major trauma activation by the American College of Surgeons.

“Not surprisingly, as you add more criteria, your overtriage continues to increase and yet your undertriage decreases; interestingly, this [undertriage] line actually starts to flatten out after about 12 criteria are added,” Dr. Richard A. Falcone Jr. said at the annual meeting of the Eastern Association for the Surgery of Trauma.

He reported on a multicenter analysis involving 656 patients treated with the highest level of trauma resources over a 1-year period at nine level I/II pediatric trauma centers. Their mean age was 8 years and mean Injury Severity Score was 14. Mortality was 11%.

The investigators sought to prospectively evaluate the correlation between triage criteria – including the six minimum criteria mandated in 2002 by the American College of Surgeons for the highest level activation (ACS-6) at pediatric and adult trauma centers – and the need for immediate resources provided by a trauma resuscitation team.

The ACS-6 include age-specific hypotension; respiratory compromise or obstruction; transfer of patients from other hospitals who are receiving blood; gunshot wound to the chest, abdomen, or neck; Glasgow Coma Scale (GCS) score of 8 or less; and deterioration of GCS score by 2 or more points.

After meeting these basic requirements, an institution may add triage criteria at their discretion, but doing so has led to inconsistencies and overutilization of resources. It can also increase costs and affect nontrauma patient care, said Dr. Falcone, director of trauma services at Cincinnati Children’s Hospital Medical Center.

Among the nine trauma centers in the analysis, no fewer than 34 additional criteria were routinely added to the ACS-6. Two rounds of Delphi review, performed with input from all of the trauma medical directors and program managers, whittled the list down to 29 based on expert consensus, and finally to 23 criteria with at least five patients.

With the use of all 23 of these criteria, 55% of patients would have been overtriaged (meaning they had an activation criterion but did not need any of the resources), and 9% would have been undertriaged (meaning they did not meet any activation criteria, but did need resources, Dr. Falcone said.

If criteria were limited to the ACS-6, 24% of patients would have been overtriaged and 16% would have been undertriaged. In all, 53% of patients met at least one ACS criteria.

“The study nicely demonstrates that adherence to certain established criteria may be able to decrease overtriage – and thus unnecessary costly resource utilization – without a significant toll, that is, harm,” said invited discussant Dr. David T. Efron, director of trauma in the department of surgery at Johns Hopkins Hospital, Baltimore. “For obvious reasons, this is quite an attractive notion.”

In all, 45% (296) of the 656 patients used at least one high-level resource during the resuscitation. Of these 296 patients, 24% (70) used two to three resources and 8% (24) used four to seven. The most common ED resource used was intubation/reintubation in 115 patients, blood administration in 67 patients, and at least 40 mL/kg fluid bolus within a half-hour of arrival in 63 patients.

“The challenge is, which criteria do we use,” Dr. Falcone said. “I think it’s going to vary per center and what your individual resources may or may not be.”

Notably, 11 criteria utilized a high-level resource more than 50% of the time. The most common of these were gunshot wound to the abdomen, blood use prior to arrival, traumatic arrest, and poor perfusion, he said. Five of the ACS-6 were consistently ranked within the top 10 criteria, with “GCS deterioration by 2” consistently ranked lower than the other five.

Dr. Efron expressed concern that some centers had low trauma activation rates – notably, just 23 activations in 1 year – and whether this rate is sufficient to maintain a high-functioning response. Audience members also questioned whether there was any correlation between over- and undertriage rates and mortality.

Dr. Falcone acknowledged that low rates of highest-level activations can impact skill levels, and that this should be taken into account when centers consider adding elements to the ACS-6. Mortality data are available, but the analysis is not yet complete.

Dr. Falcone observed that a major challenge for appropriate trauma activation, whether at the middle or highest level, lies in the ability of prehospital providers and nonpediatric specialists to easily and accurately provide triage data.

“One of the problems that we saw was the ability to provide GCS scores, understanding age-appropriate tachycardia and/or hypotension and age-appropriate respiratory rates and signs of distress,” he said.

Dr. Falcone called for further prospective evaluation of the value of proposed revised criteria for children, patient outcomes based on level of activation, and the impact of activation criteria on health care costs.

In an online report of the study, the authors note that the average charge for the highest level trauma activation was $7,843. If only the ACS-6 criteria were used, 55 highest activation resuscitations would have been eliminated or reduced, for a potential savings of $230,000-$431,000.

The study was supported in part by the Ohio Department of Public Safety and an Institutional Clinical and Translational Science Award. Dr. Falcone and Dr. Efron reported no relevant financial conflicts of interest.

Subject Codes:
surgery; emergency_trauma;

http://www.imng.com

February 03, 2012 02:21 PM EST

Richard A. Falcone

Team-Based Geriatric Protocol Cuts Trauma Mortality

Fri, 03 Feb 2012 18:48 GMT

BY PATRICE WENDLING
Elsevier Global Medical News
Breaking News

LAKE BUENA VISTA, FLA. (EGMN) – Mortality was sharply reduced in elderly patients undergoing trauma care with an aggressive protocol marked by multidisciplinary teamwork and prompt identification of occult shock.

The survival benefit was significant even among patients older than 75 years, a group with notoriously high mortality rates, Dr. Eric Bradburn said at the annual meeting of the Eastern Association for the Surgery of Trauma.

Injured geriatric patients pose unique challenges to the trauma team because of their abnormal responses to shock and injury and frequent polypharmacy. They are also increasing in numbers with today’s active geriatric population, comprising 36% of all admissions at his own level II trauma center, said Dr. Bradburn, an acute care surgeon at Lancaster General Hospital in Hershey, Pa.

With the protocol, patients older than 65 years were screened on admission for high-risk injuries, comorbidities, and/or physiologic parameters associated with increased geriatric mortality in the literature. If one or more high-risk indicator was present, a high-risk protocol was initiated that included:

• ICU admission.

• STAT arterial blood gas (ABG).

• An ABG every 4 hours, if base deficit is –6 mmol/L or more, until base deficit is –2 mmol/L.

• STAT echocardiogram (EKG).

• Basic metabolic profile; magnesium and phosphorus tests in morning.

• Prothrombin time, partial thromboplastin time, and international normalized ratio in morning.

• Neurologic checks every hour for 24 hours.

• For unexplained hemodynamic instability, obtain a STAT EKG.

• Geriatric medicine consult.

The protocol was initiated in January 2006, with all 4,534 geriatric trauma patients admitted from 2000 to 2010 included in the analysis. Of these, 309 patients died for an overall mortality rate of 6.8%, Dr. Bradburn said.

Mortality rates increased sharply at age 75 years – consistent with the literature – from less than 4% to more than 6% and rose steadily to more than 11% by age 95 years.

In multivariate adjusted analysis of 3,902 patients with full data available, mortality significantly improved for geriatric patients on the protocol (odds ratio, 0.63), he said. The receiver operating curve was 0.86. Variables includes in the analysis were Injury Severity Score (ISS), trauma level, Revised Trauma Score (RTS), and age.

Patients on the protocol had significantly lower mortality rates regardless of whether they were 75-84 years (OR, 2.72), older than 85 years (OR, 4.62), had an Injury Severity Score of 17-25 (OR, 6.45) or ISS greater than 25 (OR, 15.93).

Furthermore, mortality was significantly lower among patients who received the full protocol even at the highest ISS categories, compared with those who did not receive the protocol or received either the protocol or the geriatric consult, “demonstrating the synergy and impact our full protocol has on this population,” Dr. Bradburn said.

“We believe the implications of this study demonstrate that an aggressive approach to the geriatric trauma patient can result in a positive outcome in this population,” he concluded.

Invited discussant Dr. Carl Schulman, a trauma and burn surgeon at the University of Miami’s Ryder Trauma Center, pointed out that geriatric consultations alone have been shown to improve mortality.

“Can you really show that your protocol added anything to this?” he asked. “Maybe all the results you have shown are from the geriatric consult alone, and this geriatric protocol is unnecessary. This would save a lot of unnecessary testing and improve the cost/benefit ratio, by simply having the geriatric consult.”

The audience also questioned what services the geriatricians provided.

Dr. Bradburn said the geriatricians assisted most with social, rehabilitative, and end-of-life issues and medication issues, but also managed some comorbidities. He said the combined approach goes beyond these issues by alerting the trauma team early on to abnormal values “rather than waiting until the reserves are tapped.” He noted that elderly trauma patients often present with occult hypotension leading to bias and that the literature is replete with data showing that not enough attention is paid to this population until it is too late.

Later, in a interview following the meeting, Dr. Bradburn explained that his trauma team managed the patients “from the bay to discharge.”

Additional input from the geriatric team included recommendations continuing/discontinuing certain medications; assisting with management of delirium; and addressing DNR status, preinjury functional assessments, as well as social and rehab needs, he said.

“They were key in addressing the polypharmacy issue removing many of those medications that might lead to falls or increased risk for delirium.”

Geriatricians’ direction on appropriate rehabilitation can boost measures such as 30-day mortality or 6-month mortality, he said. For example, in the case of an elderly fall resulting in a traumatic brain injury and extremity fractures, aggressive focused rehab to address the preexisting physical deficits that led to the fall, as well as the deficits acquired by the fall, would certainly improve the quality of life for that individual and potentially prevent additional falls.

At the meeting, Dr. Schulman also asked whether the high DNR rate of 20% could have contributed to the results. Dr. Bradburn responded that if a DNR is put into the regression model, it actually makes the results better, changing the odds ratio from 0.63 to 0.36.

Dr. Bradburn said his team had hoped to investigate functional outcomes, but that these data were not complete.

He noted that the current study is limited by its retrospective design and acknowledged that “from our data you cannot fully attribute its success solely to one part of our protocol.” Still, he said, the benefits are “clear.”

“This study lays the groundwork for a prospective multi-institutional study – in which we can potentially tease if one part of our protocol is more effective than any other.”

The protocol should be replicable beyond Lancaster General Hospital, he said. “We think the approach is unique, but believe with further study we can show this can be applied at other institutions with equivalent successes.”

Dr. Bradburn and Dr. Schulman reported no relevant conflicts of interest.

Subject Codes:
surgery; emergency_trauma; gerontology;

http://www.imng.com

February 03, 2012 01:48 PM EST

Carl Schulman

New EVAR Devices for Abdominal Aortic Aneurysm Evolving

Thu, 02 Feb 2012 16:40 GMT

BY MITCHEL L. ZOLER
Elsevier Global Medical News

MIAMI BEACH (EGMN)–Devices for endovascular repair of abdominal aortic aneurysms are evolving, with new sizing or other innovations either recently on the market or in studies.

The new products expand the scope of patients who are candidates for endovascular aneurysm repair (EVAR), and in one case bring a new approach to EVAR into the clinic.

During a session at ISET 2012, an international symposium on endovascular therapy, seven experts gave the following quick updates on what’s new in EVAR for 2012:

•Making devices smaller. Downsizing constitutes a major trend for several new EVAR devices. The Endurant device helped blaze the lower-profile path, introducing a device delivered in an 18-Fr catheter for 23- to 25-mm diameter aortic stent grafts. Endurant received Food and Drug Administration marketing approval in 2010, and results from the U.S. pivotal trial for this device appeared last year (J. Vasc. Surg. 2011;54:601-8). In the pivotal trial, the major adverse event rate after 30 days was 4%; after 1 year, the patency rate was 97%, no patients had type I endoleaks, and the rate of secondary procedures was 5%, said Dr. Dittmar Böckler, professor and medical director of vascular surgery at the University of Heidelberg (Germany). An even smaller version of the same device, Endurant II, places a 28-mm bifurcated segment of an aortic stent graft into an 18-Fr delivery catheter – reduced from 20 Fr in the existing Endurant device – and has longer limbs to maximize coverage, changes that will further “expand options” for this device, he said.

Other EVAR devices take the downsizing trend even further. The Ovation Abdominal Stent Graft System, which received FDA marketing approval last November, has a 14-Fr outer diameter. For the time being, Ovation “is the lowest-profile commercially available device, expanding the population that is suitable for EVAR,” said Dr. Horst Sievert, director of the cardiovascular center at Sankt Katharinen Hospital in Frankfurt, Germany. The FDA also made Ovation the first EVAR to be approved as a humanitarian use device (defined as an instrument aimed at a U.S. patient population that grows by fewer than 4,000 new cases annually). Ovation is approved for use in patients with iliac or femoral artery access that is less than 7 mm in diameter, and for treating an aorta with an inner neck diameter of 15.5-17.4 mm. The clinical trial results for Ovation showed “excellent short-term results,” Dr. Sievert said. In the U.S. pivotal trial with 161 patients, the major adverse event rate after 1 month was 2.5%, he noted.

The Zenith Low Profile, a third low-profile EVAR device delivered in a 16-Fr sheath, is nearing marketing approval. The FDA already has data from a U.S. pivotal trial with 120 patients, and a decision on marketing approval should come sometime this year, said Dr. Roy K. Greenberg, a vascular surgeon at the Cleveland Clinic. Although he voiced enthusiasm for lower-profile devices that allow EVAR in patients who would not be able to accommodate larger devices, he also cautioned that “as we get lower-profile devices, we need to pay more attention to iliac disease. Postimplantation residual stenosis is critical for patients with [calcified] iliac disease.”

Another issue with new devices is establishing their long-term performance. “New devices aren’t necessarily better; they’re just different. I think there are some advantages to new devices, but we don’t have a track record with respect to their long-term behavior,” Dr. Greenberg said.

Finally, the INCRAFT low-profile EVAR device starts testing in a pivotal U.S. trial in February. INCRAFT matches Ovation with a 14-F outer-diameter delivery sheath, said Dr. Robert M. Bersin, medical director of endovascular services at Swedish Medical Center in Seattle. Its track record so far comes from the first 60 patients who received the device, at six centers in Germany and Italy, he added.

•High aortic neck angles. Aside from size, the aortic-neck angle provides another opportunity to broaden the EVAR device market. The Aorfix EVAR device is highly flexible and designed to deal with aortic neck angles of 60 degrees or greater. The stent has a “unique design, because a 60-degree angle is typically an exclusion for most [EVAR] devices,” said Dr. William A. Gray, director of endovascular services at Columbia University in New York.

He reviewed the roll-in phase data from the PYTHAGORAS trial, which enrolled 62 patients with aortic neck angles smaller than 60 degrees; two-thirds of these first-phase patients had necks angled at more than 45 degrees. In the roll-in phase, “the Aorflex device has given excellent results in patients with typical anatomy,” and the results serve “as a good prelude to the high-angle cases,” he said.

The main phase of the trial, which planned to enroll up to 150 patients with high-angle aortic necks, has also finished, but those data are not yet publicly available. Lombard Medical, the company developing this device, submitted the main-phase data to the FDA, and should make the results public in the next 6 months, he said.

•Prefenestrations.Perhaps one of the more exciting new devices is the Ventana fenestrated system, an “off-the-shelf” device that comes with prefenestrations for the renal arteries that precludes the need for a custom-made device.

A current “unmet clinical need” for EVAR is a device to address patients with a short or nonexistent infrarenal neck, something that occurs in about a quarter of abdominal aortic aneurysm patients, said Dr. Daniel Clair, professor and chairman of vascular surgery at the Cleveland Clinic.

The system can potentially treat even aneurysms that include the renal arteries. The material used in the device is a multilayer polytetrafluoroethylene that forms small branches at the fenestrations that reach out into the renal arteries, and the device is delivered in a 22-Fr sheath.

Pilot studies used this system successfully on 15 patients outside the United States last year, and in February the next phase starts with another 30-50 patients scheduled for treatment both in and outside the United States, he said.

The pivotal U.S. trial (with 122 patients scheduled for treatment) also starts this year, with Dr. Clair as the principal investigator.

•Aneurysm sealing. Also in development is an EVAR-like device that’s not a stent. The Nellix system seals an aneurysm endovascularly, by deploying bags that fill with a liquid polymer that quickly solidifies to seal an aneurysm sac around a pair of stents. The system delivers the polymer at greater than blood pressure to extrude all blood from the aneurysm sac, said Dr. Lindsay Machan, a vascular surgeon at the University of British Columbia in Vancouver. This facilitates treatment of aortas with short or severely angulated necks. “The polymer anchors the devise at the bifurcation,” Dr. Machan said, producing “remarkable” stability, better than devices that rely on barbs for anchoring.

So far, operators have used the Nellix system in 47 patients in New Zealand and Latvia, the first 31 with a first-generation device and, more recently, the remaining 16 patients with a second-generation version. More than 1 year of follow-up exists for 34 patients. These cases had 100% technical success with no ruptures, no conversions to open repair, and no endoleaks (either persistent or type II), he said. Two patients needed a secondary procedure, one for renal insufficiency, the other for a type I endoleak after 15 months.

The pivotal U.S. trial is planned to start later this year. “This ‘out-of-the-box’ technology addresses many shortcomings of EVAR, and uses a simple insertion procedure that takes 20-30 minutes,” Dr. Machan said.

Dr. Böckler said that he has financial relationships with W.L. Gore, Medtronic, VASCOPS, and Siemens. Dr. Sievert said that he has financial relationships with TriVascular, W.L. Gore, and 55 other device companies. Dr. Greenberg said that he has an ownership interest in Cook Medical. Dr. Bersin said that he has financial relationships with Cordis Endovascular, W.L. Gore, Cook, and Bard. Dr. Gray said that he is a consultant to Cordis. Dr. Clair said that he has financial relationships with Endologix, ev3, Medtronic, Boston Scientific, and Covidien. Dr. Machan said that he has financial relationships with Boston Scientific, Cook, Calgary Scientific, Endologix, and Ikomed.

Subject Codes:
cardiology; surgery;

http://www.imng.com

February 02, 2012 11:40 AM EST

Horst Sievert

Pregnancy Does Not Preclude Safe DVT Treatment

Wed, 01 Feb 2012 22:24 GMT

BY MITCHEL L. ZOLER
Elsevier Global Medical News
Breaking News

MIAMI BEACH (EGMN)–Women who develop a deep vein thrombosis while pregnant can safely undergo removal of the clot without jeopardizing their pregnancy, based on a recent experience with 11 cases at one U.S. center.

“Not many vascular surgeons are willing to perform thrombectomy in pregnant women, and most physicians fear thrombolytic therapy in pregnant patients,” Dr. Anthony J. Comerota said at ISET 2012, an international symposium on endovascular therapy.

But in reality, there is no evidence that thrombolysis poses any special risk during pregnancy, in part because the drugs that are usually used – urokinase, streptokinase, or tissue plasminogen activator (TPA) – do not cross the placenta, and therefore do not exert any fibrinolytic effect on a fetus, he said. In addition, the relatively recent introduction of pharmacomechanical methods for thrombolysis have “accelerated our enthusiasm and strengthened our confidence that this is an effective and safe strategy for treating extensive DVT [deep vein thrombosis] during pregnancy,” said Dr. Comerota, a vascular surgeon and director of the Jobst Vascular Institute in Toledo, Ohio.

“Pregnancy need not be a major contraindication for successful management of extensive DVT. We need to minimize radiation, monitor the fetus, and control uterine contractions, but we should treat healthy, pregnant women [who have] a DVT the same way we treat healthy nonpregnant women” who have a DVT, he said in an interview. “The extraordinary concern for risk to the pregnancy [from clot removal] seems substantially overstated.”

Because pregnancy produces a prothrombotic state, the risk that a healthy, pregnant woman has for DVT is about sixfold higher than her risk when not pregnant. Until now, most physicians deferred endovascular or surgical management of women who develop a DVT during pregnancy, and have relied exclusively on medical treatment with heparin or low-molecular-weight heparin, a strategy that is often ineffective. “What pushed me to treat women earlier during their pregnancy was that I saw patients who did not receive therapy until after delivery, and by then the clot became more organized – a mix of collagen and scar inside the vein – -and caused severe postthrombotic disability,” Dr. Comerota said.

Recently, he treated 11 pregnant women (10 with an iliofemoral thrombosis and 1 with the clot in her superior vena cava). One woman was in the first trimester, two were in the second, and eight were in the third trimester. Three patients underwent clot removal by open surgery, with the other eight treated by endovascular methods, including six who were treated with catheter-delivered TPA and one who received urokinase via catheter. Other endovascular tools that were used as needed included ultrasound clot treatment and rheolytic thrombectomy. In all cases, these treatments successfully removed the clot. One women developed hematuria and required a transfusion following her clot removal, and another patient developed a popliteal artery pseudoaneurysm. None of the patients had a recurrent DVT; two developed mild postthrombotic symptoms.

In one case, the fetus spontaneously aborted 5 days after the procedure secondary to antiphospholipid antibody syndrome, which had also triggered the thrombosis. The other 10 cases resulted in successful pregnancies and live deliveries, one surgically and the other nine vaginally. Three of the women had successful subsequent pregnancies, Dr. Comerota said.

Dr. Comerota said that he has been a speaker for and a consultant to Covidien, a company that makes some of the devices used in these procedures.

Subject Codes:
womens_health; cardiology; surgery;

http://www.imng.com

February 01, 2012 05:24 PM EST

Anthony J. Comerota

Comorbidities Up Risk for Thyroidectomy Complications, In-Hospital Deaths

Wed, 01 Feb 2012 18:14 GMT

BY DAMIAN MCNAMARA
Elsevier Global Medical News
Breaking News

MIAMI BEACH (EGMN) –Cardiac and respiratory comorbidities were “common culprits” and present in more than half of thyroidectomy patients who died in the hospital, according to analysis of a large inpatient database.

Although overall mortality is less than 1% for thyroidectomy patients nationwide, researcher Rishi Vashishta said, “Patient comorbidities can often contribute to perioperative death and should really be considered when discussing treatment options with patients.”

Mr. Vashishta and his associates identified 11,862 patients who underwent thyroidectomy using ICD-9 codes from the Healthcare Cost Utilization Project Nationwide Inpatient Sample (NIS) database for 2009. Two-thirds of patients were white and three-fourths were female A total of 73 of these patients died during their hospitalization that year.

“We calculated the mortality rate during hospitalization to be 0.61%,” Mr. Vashishta, a medical student at George Washington University, Washington, said at the Triological Society Combined Sections meeting.

Other aims of the study were to assess thyroid surgery complications, length of stay, and total hospital charges. “There are a large number of institutional studies, but there remains a relative paucity of studies examining this procedure on a more macro and socioeconomic level,” said Mr. Vashishta.

Among the nearly 12,000 admissions, mean length of stay was 2.97 days and mean total hospital charges accrued was $39,236.

In contrast, a subgroup analysis revealed mean length of stay was 13.8 days and mean increase in total hospital charges was nearly $218,855 among patients who died during hospitalization. “Interestingly, the respiratory status in these patients was markedly worse, with a tracheostomy required in 28%, prolonged mechanical ventilation required in 43%, and endotracheal intubation in 55%,” Mr. Vashishta said at the meeting, which was jointly sponsored by the Triological Society and the American College of Surgeons.

The mean age of patients who died was 65 years, compared with a mean of 53 years for all thyroidectomy patients in the study.

Approximately 80% of all surgeries in the study were elective. The majority of patients, 55%, underwent total thyroidectomy, 32% underwent unilateral lobectomy, and the remainder had partial thyroidectomy.

When Mr. Vashishta and his colleagues assessed complications, they found hypocalcemia present in 6%, vocal cord paresis in 1.4%, and hypoparathyroidism in 0.77% of patients using bivariate analyses. The incidence of hematoma and hemorrhage were low at 1.43% and 0.67%, respectively. “Our complication rates were generally consistent with those from institutional studies published in the literature.”

“We found strong predictors of [these] complications during hospitalization included female gender; hospital location and teaching status; and type of thyroid diagnosis,” he said. “Although the majority of cases were conducted at large teaching hospitals in urban centers, no socioeconomic or regional differences were observed,” the investigators noted in their abstract but did not offer further explanation.

Admissions data showed that nontoxic nodular goiter was a diagnosis code for 36% of patients. In addition, malignant neoplasm was a code for 31% and benign neoplasm for 11%, “Graves’ disease, which we classified under acquired hypothyroidism, was much less common, around 8%,” Mr. Vashishta said. ICD-9 codes for thyrotoxicosis and thyroiditis each were noted on 8% of records.

Errors in coding and sampling are a potential limitation of this and any study based on a large administrative database, Mr. Vashishta said. For example, use of ICD-9 codes “inevitably included patients in our stratified sample admitted for some other problem who underwent incidental thyroidectomies during their hospitalization.” Furthermore, thyroidectomy is increasingly being performed as an outpatient procedure and the NIS is an inpatient database. “This effectively skewed our mean total charges and mean length of stay in the hospital upwards.”

The study was not funded by industry. Mr. Vashishta said that he had no relevant financial disclosures.

Subject Codes:
endocrinology; surgery;

http://www.imng.com

February 01, 2012 01:14 PM EST

Trauma Surgeons on Par With Neurosurgeons for Small ICHs

Wed, 01 Feb 2012 20:17 GMT

BY PATRICE WENDLING
Elsevier Global Medical News
Breaking News

LAKE BUENA VISTA, Fla. (EGMN) – Score one for the trauma surgeons. Outcomes are no different for patients with small intracranial hemorrhages managed by a trauma surgeon rather than a neurosurgeon, a new study shows.

Investigators at the JPS Health Network in Fort Worth, Tex., compared trauma activations for 124 patients before and 199 patients after a protocol was instituted at the level 1 trauma center allowing trauma surgeons to manage patients with a traumatic brain injury due to a fall resulting in a 1-cm or less intracranial hemorrhage (ICH). Patients with penetrating wounds or who were transferred to other acute care facilities were excluded from the analysis.

After the protocol was initiated, neurosurgery consults significantly decreased from 93.5% to 83.4% (P less than .01), Ms. Tiffany Littleton, trauma services research associate, and her colleagues reported at the annual meeting of the Eastern Association for the Surgery of Trauma.

No significant differences at discharge were observed pre- and postprotocol for patient age (61.5 years vs. 58 years), sex (71% male vs. 65%), race (69.4% white vs. 70.4%), Glasgow Coma Scale scores (median 14.5 vs. 15), or Injury Severity Score (both median 20).

Additionally, there were no differences in outcomes such as length of stay (median 4 days for both; P = .86), condition on discharge (P = .57), where patients were discharged to (P = .14), or Glasgow Outcome Scale (GOS) scores (P = .18), she reported.

At discharge, most patients pre- and postprotocol had moderate disability (70.2% vs. 50.3%), went home without the need for professional assistance (59.7% vs. 49.2%), and were GOS classified as “good recovery” (50% vs. 60%).

“Due to the demand placed on neurosurgeons for more severe brain injuries, these data suggest patients managed by trauma surgeons could have comparable outcomes to those managed by neurosurgeons,” the authors concluded.

The results are particularly relevant, as the literature is scant regarding the management of ICHs of 1 cm or less. Moreover, the number of trauma activations resulting from falls is expected to increase with the aging American population, the investigators noted.

Falls are the second leading cause of trauma activations, and half of fall fatalities and associated costs are related to traumatic brain injury. Falls also constitute 52% of emergency department visits for adults aged 75 years or older.

Despite the potential for turf wars when departmental duties are shifted, “neurosurgeons were delighted” with the new protocol, senior author and JPS medical director of trauma services Dr. Rajesh Gandhi said in an interview. In fact, it was two neurosurgeons who developed and initiated the protocol change.

The researchers are currently acquiring data from the National Trauma Bank to examine differences in ICH outcomes in a larger sample.

“Additionally, we want to look at the range in which trauma surgeons can effectively manage ICH, and determine the point at which neurosurgeon management results in significant differences in outcome,” said Ms. Littleton. “This can also translate to rural health care in terms of transferring these types of patients to trauma centers.”

Ms. Littleton and her coauthors reported no financial conflicts of interest. Dr. Gandhi serves as a speaker for LifeCell and KCI.

Subject Codes:
surgery; neurology; emergency_trauma;

http://www.imng.com

February 01, 2012 03:17 PM EST

Updated Criteria Revisit PCI Appropriateness Scenarios

Wed, 01 Feb 2012 17:14 GMT

BY DIANA MAHONEY
Elsevier Global Medical News
Breaking News

Percutaneous coronary intervention is an appropriate procedure for patients with two-vessel coronary artery disease with proximal left anterior descending artery and for those who have three-vessel disease with a low coronary artery disease burden, but it may not be reasonable for patients with three-vessel disease and intermediate-to-high CAD burden.

That’s according to new appropriate use criteria for coronary revascularization released Jan. 30 by the American College of Cardiology Foundation and key specialty and subspecialty societies.

In the new document – the first focused update to the original Appropriate Use Criteria (AUC) for Coronary Revascularization published in 2009 – the latter scenario is graded as “uncertain,” as is percutaneous coronary intervention (PCI) for patients with isolated left main stenosis and those with left main stenosis and additional CAD with low CAD burden. Further, the procedure is inappropriate for patients with left main stenosis and additional CAD with intermediate to high CAD burden, Dr. Manesh Patel of Duke University, Durham, N.C., and colleagues on the Appropriate Use Criteria Task Force reported (J. Am. Coll. Cardiol. 2012 Jan. 30 [doi: 10.1016/j.jacc.2011.12.001]). In the previous appropriate use document, PCI was deemed inappropriate for low burden left main disease and uncertain for low-burden three-vessel disease, they stated. Coronary artery bypass grafting (CABG), on the other hand, maintained its 2009 rating of appropriate for all six clinical scenarios, the authors wrote.

In addition to the changes to the PCI appropriateness ratings above, the updated ratings indicate that coronary revascularization of the presumed culprit artery is appropriate for acute coronary syndrome patients with unstable angina/non–ST-segment elevation MI (UA/NSTEMI) with intermediate risk features – defined as a thrombolysis in myocardial infarction (TIMI) score of 3-4 – for short-term risk of death or nonfatal MI, while it is uncertain for UA/NSTEMI patients with low-risk features (TIMI score of 2 or less) for short-term risk of death or non-fatal MI. Among asymptomatic patients without prior bypass surgery, revascularization is inappropriate for those with one or two-vessel CAD with no proximal left anterior descending artery involvement and no history of invasive testing.

The updated criteria are intended to fill in the gaps identified in the prior criteria and to take into account results of clinical trials that have been reported since the initial publication, including the Synergy Between PCI With TAXUS and Cardiac Surgery (SYNTAX) trial comparing the two revascularization procedures in patients with left main or triple-vessel CAD, the authors wrote.

For the 2009 criteria, the writing group identified 180 clinical scenarios reflecting common patient presentations in everyday cardiology practice which were then rated by an expert panel comprising interventional and noninterventional cardiologists, surgeons, internal medicine physicians, and health outcomes researchers using a modified Delphi exercise to assess whether an invasive revascularization procedure would be appropriate, inappropriate, or uncertain based on symptom status, extent of medical therapy, risk level, and coronary anatomy (J. Am. Coll. Cardiol. 2009;53:530-53).

For the updated document, the writing group reassessed the clinical scenarios and identified those warranting reevaluation, expansion, or consolidation, the authors explained. In this regard, they identified and reexamined four indications possibly affected by the results of the SYNTAX trial, splitting two of them to represent levels of disease burden, as noted above. They also identified a gap in the clinical scenarios related to lower-risk UA/NSTEMI patients and asymptomatic patients with one- or two-vessel CAD not involving the proximal left anterior descending artery in whom no noninvasive testing had been performed, and developed indications to address the omissions.

Basing appropriate use criteria on current understanding of the technical capabilities and potential patient benefits, the technical panel scored each indication on a scale from 1-9. A given procedure was considered appropriate for an indication if the median score was 7-9; uncertain if the median scores was 4-6; and inappropriate if the median score was 1-3.

Clinicians can use the updated criteria as decision support or educational tools when considering the need for revascularization, the authors wrote. “Moreover, these criteria can be used to facilitate discussion with patients and/or referring physicians about revascularization,” they stated, noting also that “facilities and payers may choose to use these criteria either prospectively in the design of protocols or pre-authorization procedures, or retrospectively for quality reports.”

Importantly, the appropriate use criteria “are intended to evaluate overall patterns of care regarding revascularization rather than adjudicating specific cases,” the authors wrote. While the criteria reflect a general assessment of when revascularization may or may not be useful for specific patient populations, “physicians and other stakeholders should continue to acknowledge the pivotal role of clinical judgment in determining whether revascularization is indicated for an individual patient.”

Dr. Patel reported having no financial disclosures. Relationships with industry of all the writing committee members are included in the AUC document.

Subject Codes:
cardiology; surgery;

http://www.imng.com

February 01, 2012 12:14 PM EST

Manesh Patel

Long-Term Mortality No Higher for Living Liver Donors

Wed, 01 Feb 2012 05:01 GMT

BY DENISE NAPOLI
Elsevier Global Medical News
Breaking News

Long-term mortality risk following live donor liver donation was nearly identical to that of matched live kidney donors as well as healthy, demographically matched controls, according to a report by Dr. Abimereki D. Muzaale and colleagues published in the February issue of Gastroenterology.

“Donor-related complications not resulting in immediate death or acute liver failure do not seem to result in decreased long-term longevity,” they wrote.

Dr. Muzaale, of Johns Hopkins University, Baltimore, followed the 4,111 patients in the United States who had donated a portion of their livers between April 1, 1994, and March 31, 2011. The donors were followed for a median of 7.6 years (Gastroenterology 2012 February [doi:10.1053/j.gastro.2011.11.015]).

Most livers (77%) were donated to a biological relative of the donor. Nonspousal, nonbiologically related donations made up 17% of the total, and spousal donations made up the remaining 6%.

“All living donors had reportedly excellent hepatic and renal function” at the time of transplant, the researchers wrote. Body mass index was greater than 30 in 15% of the donors. At some point, 22% had smoked cigarettes, and 90% of the donors were under 50 years old.

This cohort was compared with live kidney donors, who were matched to the liver donors according to year of donation, age, gender, race, education background, and BMI. Finally, liver donors also were compared with a third cohort of healthy adults, similarly matched, from the National Health and Nutrition Examination Survey III (NHANES III). None of the NHANES III patients had comorbidities that might have deemed them ineligible for liver donation, according to the authors.

All deaths were determined from the Social Security Death Master File.

Overall, the researchers found that in the first 90 days after donation, 7 living liver donors died, for a rate of 1.7 deaths per 1,000 donors (95% confidence interval, 0.7-3.5). Compared with kidney donors, this rate was higher, but not significantly higher (0.5 deaths per 1,000 donors; 95% CI, 0.1-1.8, P = .09).

“By contrast, as would be anticipated, living liver donors had a significantly higher risk of early death than matched NHANES III participants who likely did not undergo a surgical procedure in their first 90 days of follow-up (P = .008),” wrote the authors.

Among the decedents, neither donor age, recipient age, portion of liver donated, center volume at time of donor death, nor cause of death correlated with 90-day mortality.

Causes of death included anaphylaxis, multiorgan failure, infection, drug overdose and suicide, and cardiovascular and respiratory arrest.

Beyond 90 days, however, the differences in mortality decreased even more among cohorts.

For example, at 2 years, live liver donors had a cumulative mortality of 0.3%, compared with 0.2% among kidney donors and 0.3% among healthy NHANES III participants.

At 5 years, the results were similar, with all three cohorts registering a 0.4% cumulative mortality.

By 9 years, liver donors could expect a 0.9% mortality rate, compared with 1.0% among the kidney donors and 0.8% among healthy controls.

Finally, at 11 years out, the respective mortality rates were once again similar or identical among cohorts, with 1.2% for liver donors, 1.2% for kidney donors, and 1.4% for healthy controls.

The authors conceded that the study was limited by the fact that live liver donors were “meticulously screened and likely more healthy than NHANES-III participants.

“The ideal comparison group would have included healthy individuals who were cleared for donation but did not proceed to donation,” they wrote. “However, this comparison group was not available.”

Dr. Muzaale and the authors of this study stated that they had no financial disclosures. They added that the Organ Procurement and Transplantation Network is supported by the U.S. Health Resources and Services Administration.

Subject Codes:
gastroenterology; surgery;

http://www.imng.com

February 01, 2012 12:01 AM EST

Local and Regional Lung Allocation Systems Conflict

Tue, 31 Jan 2012 22:15 GMT

BY MARK S. LESNEY
Elsevier Global Medical News
Breaking News

FT. LAUDERDALE, FLA. (EGMN) –More than a decade ago, the Department of Health and Human Services issued the “Final Rule on Organ Procurement and Transplantation Network Amendments,” which was intended to ensure that “organs will be [allocated] based on medical criteria, not accidents of geography.” Despite the introduction of this final rule, disparities in waiting list outcomes are known to be significantly influenced by where the transplantation candidate lives, and lower priority candidates are receiving organs at the expense of the more severely ill.

Although all candidates are ranked based on an objective priority score known as the Lung Allocation Score (LAS), lung allocation remains a locally based system. Organs are first allocated based on geography regardless of LAS score. Therefore, organs are initially offered only to the subset of matched lung transplant candidates (based on blood group and size) within the donor’s local Donor Service Area (DSA).

As a result, if an available organ is first accepted for a candidate within the local DSA, it is never offered to potentially more-severely ill candidates at the broader regional or national level – even if the regional or national candidate has a much higher priority score. There is evidence that this is a frequent occurrence, according to research presented by Dr. Mark J. Russo at the annual meeting of the Society of Thoracic Surgeons.

Dr. Russo and his colleagues analyzed data provided by the United Network for Organ Sharing to determine the frequency with which donor lungs were allocated to local candidates when blood group– and size-matched candidates with a higher LAS existed in the same region.

Their study cohort included all locally allocated organs for double lung transplantation in the United States in the year 2009. The researchers then identified all cases in which ABO blood group– and height-matched (within 10 cm) double-lung candidates in the same region had a higher LAS than did the local candidates who actually received the lung. They also calculated the number of these events in which the LAS difference was greater than 10 and greater than 25. The number of these bypassed regional candidates who then died on the waiting list was also determined.

Among the 580 locally allocated double-lung transplants analyzed, there was a mean of 6.0 blood group – and height-matched double-lung events per transplant (3,454 total, impacting 1,193 different candidates) in the same region where candidates had a higher LAS than did the local candidate who received the organ. A total of 24% (828) of the events involved skipping over a regional candidate with an LAS greater than 10 points higher than the local recipient, with 7.2% (250) of events involving a regional candidate with an LAS greater than 25 points higher than the local recipient. Overall, 185 of the bypassed regional candidates died on the waiting list.

Dr. Russo said that although the issue of transportation is important, generally the adverse impact of an additional hour or two of ischemic time due to transportation is not clinically significant, and should not be a major factor in the decision as to local vs. regional candidates. In addition, the regional candidate is often not far from the donor, he added.

“Ideally, a suitable donor organ would be available for every lung transplant candidate who could benefit from transplantation. Unfortunately, there remains a critical scarcity of donor organs available for transplantation. Therefore, efficient allocation of organs is necessary to ensure maximum benefit from the available organs,” according to Dr. Russo, a cardiothoracic surgeon at the University of Chicago Medical Center.

“Locally-based allocation results in a high number of events in which a lung is allocated to a lower-priority candidate when an appropriately matched, higher-priority candidate exists in the same region. As a result, low-priority candidates, defined by an LAS less than 50, account for nearly 90% of lung transplant recipients, while candidates with higher LAS scores, defined by an LAS greater than 75, continue to die at extremely high rates while awaiting transplantation,” Dr. Russo stated.

Dr. Russo said further that because this study considered only double-lung candidates, did not consider the possibility of national matching, and did not allow for blood groups to be crossed, it likely significantly underestimates the frequency of these events and lives lost.

“These findings suggest that further study of organ sharing over broader geographies should be pursued to determine if it would improve [waiting] list outcomes, including higher rates of organ allocation to higher-priority candidates, improved survival on the waiting list, and greater net benefit from the organs available for transplantation,” he concluded.

Dr. Russo reported that he had no financial disclosures.

Subject Codes:
pulmonology; surgery;

http://www.imng.com

January 31, 2012 05:15 PM EST

Mark J. Russo

LVAD Support Optimal During Bridge to Transplant

Tue, 31 Jan 2012 21:00 GMT

BY MARK S. LESNEY
Elsevier Global Medical News
Breaking News

FT. LAUDERDALE, FLA. (EGMN) – Left ventricular assist devices were associated with a significant survival advantage compared with all other support pathways implemented before heart transplant in an analysis of more than 13,000 patients.

There are a variety of support pathways available to eventual heart transplant recipients, but there is little information concerning comparative outcomes of patients bridged with the various treatments. Such information could provide valuable insight for clinical decision making and organ allocation policy, according to Dr. Tara Karamlou.

A large database study was conducted using the United Network Organ Sharing Dataset to track outcomes of status 1 heart transplant recipients from 2000 to 2010. Dr. Karamlou of Seattle Children’s Hospital, and her colleagues, grouped transplant recipients based on the use of support pathways prior to transplant, including patients transitioning from one support pathway to another.

Dr. Karamlou reported her group’s results using Kaplan-Meir plots to compare time-related mortality among the different support-pathway groups. The study sought to uncover multivariable factors for time-related death using hazard regression models, she said at the annual meeting of the Society of Thoracic Surgeons.

There were six initial support pathways used in the 13,250 status 1 heart transplant patients identified in the database. These comprised inotropes (7,607); left ventricular assist devices (LVAD, 4,034); intra-aortic balloon pump (IABP, 729); biventricular assist devices (BIVAD, 521); extracorporeal circulation membrane oxygenation (ECMO, 316); and right ventricular assist devices (RVAD, 43).

“Multivariable analysis showed that LVAD use conferred a significant survival advantage compared with all other support pathways [hazard ratio, 0.71; P greater than .001],” said Dr. Karamlou. All other support treatments showed significantly increased risk of posttransplant death compared with LVAD treatment, including inotropes (HR, 1.1); RVAD (HR, 1.9); and ECMO (HR, 2.2).

There were 2,175 patients in the analysis who transitioned (either escalation or reduction) from one support pathway to another: no support to LVAD; LVAD to BIVAD; inotropes to LVAD; LVAD to inotropes; BIVAD to LVAD; and ECMO to LVAD. Among these patients, those who began with ECMO or BIVAD support followed by LVAD had improved posttransplant survival comparable to that of patients who began on LVAD and continued it throughout their course of pretransplant support.

LVAD support, especially in the setting of bridge to transplant, has clearly undergone several modifications that have made it safer and easier to implant and maintain, she added. Implantation of an LVAD in the current era, based on these findings, has survival superior to all other mechanical circulatory support pathways, and is equivalent to inotropic therapy. Additionally, in patients who are able to be weaned from biventricular support (ECMO and BIVAD therapy), LVAD implantation allows recovery of posttransplant survival to levels equivalent to primary LVAD–only therapy. This finding gives surgeons and cardiologists critical prognostic information regarding triage to pretransplant support pathways.

“Several key issues remain unresolved and, based on our results, will require further investigation. For example, the timing and clinical status of the patient surrounding both initial support and transition (either escalation or de-escalation) could not be determined from our data. In my mind, this is a crucial issue because delayed institution of mechanical support can have serious repercussions and, given the significantly increased risk of death with ECMO and BIVAD, a delay in de-escalation of therapy to LVAD could also confer an important survival disadvantage,” she said.

“Organ allocation policy development and clinical decision making might benefit by considering these results in order to maximize the societal benefits of heart transplants,” Dr. Karamlou concluded.

Dr. Karamlou reported having no financial disclosures.

Subject Codes:
cardiology; surgery;

http://www.imng.com

January 31, 2012 04:00 PM EST

Dr. Tara Karamlou

Re-Excision Rates After Breast-Conserving Surgery Vary Greatly

Tue, 31 Jan 2012 21:00 GMT

BY MARY ANN MOON
Elsevier Global Medical News
Breaking News

Rates of re-excision after initial breast-conserving surgery for invasive breast cancer vary greatly across surgeons and across medical centers, according to a report in the Feb. 1 issue of JAMA.

These variations are only partly explained by the basic clinical and demographic factors that dictate treatment decisions, such as tumor size and patient age. The remaining reasons for the profound differences in re-excision rates remain unexplained.

Nevertheless, these variations certainly are a barrier to consistent, high-quality, cost-effective care for breast cancer. “Outcomes such as local recurrence and even overall survival could be affected by variability in initial surgical care,” said Dr. Laurence E. McCahill of the Richard J. Lacks Cancer Center, Van Andel Research Institute, and department of surgery at Michigan State University, Grand Rapids, and his associates.

Noting that “currently, there are no readily identifiable quality measures that allow for meaningful comparisons of breast cancer surgical outcomes among treating surgeons and hospitals,” the investigators examined re-excision rates across four geographically diverse health systems. Their chief goal was to determine whether significant variations existed, which would in turn determine whether the re-excision rate is a meaningful measure of surgical quality.

They assessed detailed data on initial and subsequent surgeries for invasive ductal carcinoma or invasive lobular carcinoma in 2,206 women who underwent an initial breast-conserving procedure for incident cancer.

Overall, 509 patients (23%) underwent re-excision of the affected breast during 5 years of follow-up. A total of 454 women had a single re-excision, 48 had two re-excisions, and 7 had three re-excisions. Approximately 9% of the study subjects (190 women) underwent total mastectomy after the initial breast-conserving surgery.

The rate of re-excision varied greatly from one surgeon to another, ranging from 0% to 70%. This implies that patients with the same clinical presentations are likely to undergo re-excision based on who is doing their procedure, not on their clinical traits, the investigators said (JAMA 2012;307:467-75).

This study was designed to determine whether such variations exist, not the reasons why they exist. But the researchers suggested that “differences in surgical training, surgeon confidence in their operative technique in localizing tumors, utilization of intraoperative assessment of margins, and surgeon’s and pathologist’s coordination of specimen orientation and margin interpretation” may all play a role.

Surprisingly, the volume of procedures a surgeon performs did not affect his or her re-excision rate in this study, so surgical experience may not play an important role in these variations, Dr. McCahill and his colleagues added.

The rate of re-excision also varied greatly from one medical center to another, ranging from 1.7% at the center with the lowest rate to 21% at the center with the highest rate. In particular, the rate of re-excision for cases with positive margins ranged from 74% to 94%. Any variation in this statistic is surprising because positive margins are known to correlate with local recurrence and are “almost always” re-excised, the researchers said.

Again, this study was not designed to determine why re-excision rates differ so greatly between medical centers, but the investigators suggested that “institutional variation in surgeon’s training, regional variation in interpretation of the required criteria for [re-excision], or both” may account, at least in part, for the variation.

The need for re-excision in patients who have negative (pathologically clear) margins at the initial surgery is controversial, because “there is no clear consensus on the appropriate distance required for a clear margin to be deemed adequate.” So perhaps it should not be surprising that almost half of the re-excisions (242 of the 509) in this study were performed in patients who had negative margins, the researchers said.

One major limitation of this study was that some factors that greatly influence treatment decisions, including patient preferences, were not included in the data and so could not be factored into the analysis, they noted.

This study was funded by the National Institutes of Health under the American Recovery and Reinvestment Act. The authors reported no financial conflicts of interest.

Variations in Surgeons’ Attitudes and Practices

One reason for the profound variation among surgeons in re-excision rates is the lack of consensus as to what constitutes the optimal negative margin width, Dr. Monica Morrow and Dr. Steven J. Katz noted in an editorial (JAMA 2012;307:509-10).

Prospective randomized clinical trials haven’t addressed this question, and a substantial number of re-excisions (approximately half in the study by Dr. McCahill and colleagues) are performed on patients with negative margins, merely to obtain a more widely clear margin.

Moreover, some surgeons may have artificially low re-excision rates because they only offer breast-conserving surgery to patients with tumors of 1 cm or smaller, rather than those with tumors up to 4 cm in size. Other surgeons will have artificially low re-excision rates because they intentionally remove very large amounts of normal tissue during the initial lumpectomy, Dr. Morrow and Dr. Katz noted.

Dr. Morrow is at Memorial Sloan-Kettering Cancer Center, New York. Dr. Katz is in the departments of medicine and health management and policy at the University of Michigan, Ann Arbor. They reported no financial conflicts of interest.

Subject Codes:
top_stories; general_primary; oncology; womens_health; surgery;

http://www.imng.com

January 31, 2012 04:00 PM EST

Dr. Laurence E. McCahill

TAVR Gets a Detailed Road Map

Tue, 31 Jan 2012 19:23 GMT

BY NASEEM S. MILLER
Elsevier Global Medical News
Breaking News

To ensure appropriate implementation and use of transcatheter aortic valve replacement in medical centers across the United States, four leading cardiovascular organizations have pooled their knowledge and issued a consensus document.

The document comes 2 months after the Food and Drug Administration approved the first minimally invasive transcatheter aortic valve replacement (TAVR) system (J. Am. Coll. Cardiol. 2012 Jan. 31; doi:10.1016/j.jacc.2012.001).

The document reviews in detail several aspects of the procedure, including the current state of evidence, patient selection, management of complications and steps to integrating TAVR into practice.

“Our goal in crafting this expert consensus document is to provide a clear road map for the use of TAVR as it reaches patients across the United States,” Dr. Michael J. Mack, medical director of cardiovascular surgery at Baylor Health Care System, Heart Hospital Baylor Plano (Tex.), president of the Society of Thoracic Surgeons, and vice chair of the writing committee, said in a statement.

The report also recommends establishment of a national registry by cardiovascular organizations and not the industry, to create standard definitions and data specifications and to avoid the potential for conflict of interest.

In the expert consensus, the organizations also stress that the procedure’s rollout is a “key issue” in the United States. “The rollout is influenced by the societal beliefs in a free market, convenient and timely access to medical care, patient and physician expectations, as well as return on investment by companies and institutions alike,” according to the report.

What complicates the rollout, they added, is the proliferation of advanced cardiovascular facilities.

Take, for instance, Los Angeles County, which has 33 cardiovascular surgical and primary ST-elevation myocardial infarction centers. If all these centers were to offer TAVR, the result would be “the dilution of concentrated experience,” the report stated.

So, establishment of specialized centers of excellence should be a top priority, the report advised.

“As this technology is introduced into practice, detailed and agreed upon protocols are needed to ensure we achieve optimal clinical results,” Dr. David R. Holmes, professor of medicine at Mayo Clinic in Rochester, Minn., president of the American College of Cardiology, and chair of the writing committee, said in a statement.

Nearly 45,000 patients have received TAVR around the world, but the experience with the procedure in the United States lags far behind that in Europe. Five different valves are currently in widespread use across Europe. In the United States, the first valve, Edwards Sapien, was approved in 2011 for use in inoperable patients with severe aortic stenosis. Other use of the Sapien valve is limited to clinical trials. Medtronic’s CoreValve is also in being studied in large U.S. trials. The report lists several next-generation devices under investigation.

“TAVR innovation is a major advance in treating aortic stenosis and sick, elderly patients should have access to this new treatment so they can resume normal, active lives,” Dr. Mack said in a statement. “These guidelines are a coordinated effort from the cardiovascular community to help ensure the appropriate use of TAVR therapy for optimum patient safety.”

The American College of Cardiology Foundation, the American Association for Thoracic Surgery, the Society for Cardiovascular Angiography and Interventions, and the Society of Thoracic Surgeons were the main authors of the consensus document. Eight other medical and consumer groups were involved in the writing and endorsement of the document.

Dr. Mack and Dr. Holmes reported no relevant disclosures.

Subject Codes:
top_stories; cardiology; surgery;

http://www.imng.com

January 31, 2012 02:23 PM EST

The hybrid elements of transcatheter aortic valve replacement should feel the benefit of this consensus document on proper TAVR procedure.

Joint Surgery Growing Less Common in Rheumatoid Arthritis

Tue, 31 Jan 2012 16:24 GMT

BY BECKY MCCALL
Elsevier Global Medical News
Breaking News

Joint replacement surgery continues to become less common in patients with rheumatoid arthritis, probably reflecting the widespread adoption of disease modifying antirheumatic drugs, judging from findings of a population-based study published in this month’s Journal of Rheumatology.

Previous studies have found a trend for declining rates of joint surgery in patients with RA since 1985. In this study, “we examined whether the prior sex differences and use trends in reduced surgical intervention for RA persist in patients diagnosed after 1995, and evaluated the effect of RA surgery on survival in these patients,” wrote Dr. Courtney A. Shourt and her associates from the Mayo Clinic in Rochester, Minn. (J. Rheumatol. 2012 Jan. 15 [doi:10.3899/jrheum.111056]).

“The possible contribution of RA-related joint surgery to excess mortality in patients with RA is largely unexplored,” they pointed out.

A retrospective medical record review was performed using data from the Rochester Epidemiology Project (www.rochesterproject.org). The researchers reviewed records from a population-based cohort of 813 adult residents of Olmsted County, Minn., who had incident RA between Jan. 1, 1980, and Dec. 31, 2007. All cases were followed longitudinally until Dec. 31, 2008; death; or migration out of the county.

All joint surgeries were marginally associated with mortality (hazard ratio, 1.3; 95% confidence interval, 0.96-1.8; P = .09), but joint reconstructive procedures (JRPs) showed a significant association with mortality, adjusted for known RA mortality risk factors, compared with findings in patients not requiring JRP (HR, 2.8; 95% CI, 1.9-4.1; P less than .001). “The need for joint replacement surgery is still a marker of bad disease,” commented Dr. Eric L. Matteson, professor of medicine and chair of rheumatology at the Mayo Clinic, in an interview.

The proportion of patients undergoing RA-related surgeries dropped between the two time periods of 1980-94 and 1995-2007. Of the 813 Olmsted County residents in the analysis, 189 underwent at least one surgical procedure involving joints, during a mean follow up of 9.6 years. The cumulative incidence of any joint surgery at 10 years after RA incidence for the 1980-94 cohort was 27.3%, compared with 19.5% for the 1995-2007 cohort (P = 0.08), which was not statistically significant.

More aggressive use of effective DMARDs with a reduction in the progression of radiographic joint damage was suggested as a possible reason for the decline in surgical procedures. “These findings reveal that modern medical management strategy has had markedly beneficial effects on the disease course,” with less damage to the target small- and medium-size joints such as the hands, wrists, and feet than in past decades, noted Dr. Matteson, one of the report’s authors.

The greatest reduction in surgeries was seen in soft tissue procedures (synovectomy, tendon repair, tendon transfer, meniscus repair, ligament release, and/or cartilage repair). These decreased from 12% in 1980-94 to 6% in 1995-2007 at 10 years after RA incidence (P = .012).

No differences were found in the cumulative incidence of total hip arthroplasty (P = .77) or total knee arthroplasty (P = .18) between the time periods, reported the authors. Addressing the continued need for surgery on weight-bearing joints, particularly total knee and total hip arthroplasties, Dr. Matteson added, “in this respect patients are beginning to be more like people from the general population who have hip and knee replacements for osteoarthritis.”

Study coinvestigator Cynthia Crowson of the Mayo Clinic’s biostatistics division noted in an interview that “persons with RA are requiring fewer surgeries, which may indicate [that] current management strategies are leading to less disability among patients who have developed RA since 1995” compared with previous times.

The study was supported by a grant from the National Institutes of Health, and was made possible by the Rochester Epidemiology Project. The authors reported having no financial disclosures.

Subject Codes:
rheumatology; surgery;

http://www.imng.com

January 31, 2012 11:24 AM EST

Dr. Eric L. Matteson

Neurologic Improvements Possible in Neonatal ASO

Tue, 31 Jan 2012 02:05 GMT

BY MARK S. LESNEY
Elsevier Global Medical News
Breaking News

FT. LAUDERDALE, FLA.(EGMN) –The use of full-flow cardiopulmonary bypass, coupled with neurological monitoring, improved cognitive and motor outcomes in a prospective neurologic outcome study of 97 neonates with transposition of the great arteries (both single- and two-ventricle lesions) who underwent an arterial switch operation.

The cohort study, conducted by Dr. Dean B. Andropoulos and his colleagues at the Texas Children’s Hospital in Houston, examined early MRI changes and longer-term neurodevelopmental outcomes after the arterial switch operation (ASO) was performed using a cardiopulmonary bypass (CPB) protocol that avoided deep hypothermic circulatory arrest (DHCA) and low-flow CPB.

The ASO was performed by using CPB with 150-mL/kg per min flows with no low-flow CPB or DHCA; pH stat management; hematocrit 30% or higher; and hypothermia to 24° -28° C. Regional oxygen saturation greater than 50% was maintained by using near infrared spectroscopic monitoring.

Neurologic assessment was performed using brain MRI performed immediately before the operation and 7 days postoperatively. The Bayley Scales of Infant and Toddler Development, Third Edition were used at 12 and 36 months (mean score of 100).

Dextrotransposition of the great arteries was present in 31 of the 97 enrolled patients. Ten of these 31 (32%) had preoperative MRI change, and 19 of 31 (61%) showed new postoperative MRI change, with 75% showing minimal new white matter injury, he said at the annual meeting of the Society of Thoracic Surgeons.

At 2 months, Bayley Scales were performed on 17 of the patients. Their mean cognitive score was 106.5, mean motor score was 90.4, and mean language score was 89.4. Twelve patients had Bayley III testing at 36 months, with a cognitive score of 106.5, motor score of 107.4, and language score of 98.2.

“Our series demonstrates a significant incidence of pre-existing MRI changes, and 61% have new postoperative changes, but all changes in this series were mild,” said Dr. Andropoulos.

“At 12 months, the cognitive score of these children was above the population mean, but their motor and language performance was lower. By 36 months, language and motor scores had improved significantly. Thus, full-flow CPB coupled to cerebral monitoring may improve neurological outcomes.”

Because of these results, “future studies of ASO patients should include short- and long-term neurodevelopmental studies,” he said.

With greatly improved 30-day neonatal arterial switch operation mortality rates (for example, at the Texas Children’s Hospital in Houston there were no 30-day hospital mortalities for 175 ASOs since 2000), there are increasing expectations for better neurologic outcomes, according to Dr. Andropoulos, and such considerations are increasingly important.

Dr. Andropoulos reported having no financial conflicts.

Subject Codes:
cardiology; surgery;

http://www.imng.com

January 30, 2012 09:05 PM EST

Dean B. Andropoulos

Burn Size Remains Strongest Predictor of Pediatric Survival

Mon, 30 Jan 2012 23:30 GMT

BY MARY ANN MOON
Elsevier Global Medical News
Breaking News

For pediatric burn patients, the percentage of total body surface area affected remains the strongest predictor of survival, according to a report published online Jan. 31 in the Lancet.

“We have established that, in a modern pediatric burn care setting, a burn size of roughly 60% total body surface area is a crucial threshold for postburn morbidity and mortality,” wrote Dr. Robert Kraft of Shriners Hospitals for Children, Galveston, Texas, and his associates.

For decades, burn size has been the main prognostic factor for both adults and children with burn injuries. But recent improvements in burn care – including novel drug treatments, new grafting techniques and materials, and improved life-support systems and monitoring methods – have dramatically improved survival, according to the investigators. Because treatment decisions, including whether to transfer a patient to a specialized burn center, are based on the probability of survival, it was important to determine whether burn size was still predictive of major complications and mortality under current treatment conditions.

To do so, Dr. Kraft and his colleagues examined outcomes in all 952 patients admitted over a 1-year period to Galveston’s Shriners Hospital with burns involving 30% or more of their total body surface area. Most of the study patients were burned on 40%-49% of their bodies.

Burn size proved to be the strongest predictor of survival, with mortality rising significantly as burn size increased. “In patient groups with burns smaller than 60% total body surface area, there were only minor increases in mortality starting at 3% and reaching up to 7%,” the investigators wrote.

A large increase in mortality was noted when burn size reached 62% of the total body surface area. Such patients had a tenfold higher risk of death, compared with those who had smaller burns, the investigators reported (Lancet 2012 [doi:10.1016/S0140-6736(11)61345-7]).

Large burns also were associated with significant increases in multiorgan failure, infection during ICU stay, and the need for more surgeries to excise tissue. The rate of multiorgan failure was 6%-12% and the rate of sepsis was only 2%-6% for burns involving up to 59% of the body surface area. These rates ballooned as high as 27%-45% for multiorgan failure and 15%-26% for sepsis when burns involved 60% or more of the body surface area.

In addition, blood glucose and insulin levels rose significantly with burns involving 60% or more of the total body surface area, as did resting energy expenditure. Together with concomitant changes in liver structure and function, these findings reflect a massive hypermetabolic response to burn injury, Dr. Kraft and his associates reported.

Cytokine levels also differed by size of burn. With burns involving 60% or more of the body surface area, the levels of interleukin-6, -8, -10, and -13; macrophage inflammatory protein 1beta; tumor necrosis factor–alpha; granulocyte colony-stimulating factor; interferon-gamma; granulocyte-macrophage colony stimulating factor; and C-reactive protein rose substantially for an extended period of time.

Given these findings, “we recommend that pediatric patients with greater than 60% total body surface area burns be immediately transferred to a specialized burn center. Furthermore, at the burn center, patients should be treated with increased vigilance and improved therapies, in view of the increased risk of poor outcome associated with this burn size,” the researchers wrote.

After burn size, the presence of inhalation injury in addition to external burn injury was a significant predictor of mortality. Patients who sustained inhalation injury had a threefold higher risk of death than did patients with no inhalation injuries. “We recommend that the treating physician [keep] in mind that the presence of inhalation injury significantly affects postburn outcomes,” they noted.

Patient age and sex showed no association with survival, and neither did the time interval between sustaining the burn and presenting for admission.

It was noteworthy that mortality rates in this study were relatively low, even among patients who had the most extensive burns. “In our opinion, [high survival was] attributable to an improved and aggressive treatment regimen,” they added.

Important Cutoff Defined

This study shows that children with burns involving less than 62% of total body surface area can be treated successfully with standard procedures, but larger burns require the novel surgical wound management and advanced monitoring available at specialized burn centers, commented Dr. Ronald G. Tompkins, chief of the burn service at Massachusetts General Hospital and the Sumner M. Redstone Professor of Surgery at Harvard Medical School, both in Boston. .

In an editorial accompanying Dr. Kraft’s report, he said it is also important to note that overall survival in this study was quite high. Even among children with burns involving 90% of total body surface area, half survived their injuries. And even the youngest children can be expected to survive as well as older children, now that pediatric intensive care has learned to compensate for their physiological and anatomical differences (Lancet 2012 [doi:10.1016/S0140-6736(11)61626-7]). This means it is time to think beyond mere survival to survivors’ quality of life, he noted.

This study was supported by Shriners Hospitals for Children, the National Institutes of Health, the National Institute on Disability and Rehabilitation Research, the Institute for Translational Sciences, the CFI Leaders Opportunity fund, and Physicians’ Services Incorporated Foundation. The investigators reported having no financial conflicts of interest. Dr. Tompkins reported no financial conflicts of interest.

Subject Codes:
top_stories; dermatology; pediatrics; general_primary; surgery; emergency_trauma;

http://www.imng.com

January 30, 2012 06:30 PM EST

PET/CT Detects Early Recurrence of Head and Neck Cancer

Mon, 30 Jan 2012 18:14 GMT

BY MIRIAM E. TUCKER
Elsevier Global Medical News
Breaking News

PHOENIX (EGMN) – Routine use of positron emission tomography/computed tomography scans can detect locoregional recurrences of squamous cell carcinoma of the head and neck before they became clinically apparent, according to a retrospective chart review of 234 patients who had been treated with chemoradiation between 2006 and 2010.

The finding suggests that routine use of positron emission tomography/computed tomography (PET/CT) may improve the outcome of salvage therapy, said Dr. Yasir Rudha, who reported the study at the Multidisciplinary Head and Neck Symposium sponsored by the American Society for Radiation Oncology.

PET/CT was associated with a high false positive rate, which should be considered when ordering radiological exams and biopsies, but a negative posttherapy PET scan appears to be an excellent predictor of freedom from future locoregional recurrence, said Dr. Rudha of St. John Hospital/Van Elslander Cancer Center, Grosse Pointe Woods, Mich.

The technology is relatively new, and its use for routine follow-up in patients with head and neck cancer is still controversial, he acknowledged. “Only a few publications have reported the value of PET examination at a fixed time interval after the end of treatment,” he said. “PET scan is often ordered in our hospital as a routine surveillance tool following successful completion of treatment.”

The review of charts for all 234 patients identified 45 who had achieved clinical no-evidence-of-disease status at the time of posttreatment imaging. In this group, PET/CT scanning at 6-9 weeks identified 15 patients with abnormalities that required further evaluation. Of those, eight patients (53%) were proven to have malignancies based on biopsy findings: six showed occult persistent disease at the primary site, and two were diagnosed with regional lymph node recurrence and colon cancer, respectively.

In the remaining seven cases, imaging findings were shown to represent false positive results with unnecessary work-up and/or biopsy evaluation. All patients who had negative PET/CT scans remained free from locoregional relapse at the time of last follow-up.

Thus, Dr. Rudha said the true positive rate for routine PET/CT surveillance in head and neck cancer patients was estimated as 8/15, or 53%, and the false positive rate as 7/15, or 46%.

“With malignancies found in 53% of abnormal scans in this study, our research proves that PET/CT scans are valuable as routine follow-up and as a surveillance method for head and neck cancer patients ... However, since the rate of false positives was 46%, caution should be shown when ordering biopsies after abnormal scans to prevent excessive unnecessary biopsies,” he said.

During a press briefing, Dr. Rudha said that the 46% false positive rate was lower than what he and his colleagues expected. “Actually we expected the false positive ratio to be about 90%,” he said.

In an interview, he said that at his institution patients with positive PET/CT scans at 6-9 weeks postsurgery are followed in a variety of ways, depending primarily on the PET standard uptake volume (SUV). If low, the patient might undergo another PET scan at about 3 months. But if SUV is high, the patient would likely be referred for another test such as magnetic resonance imaging, ultrasound, or biopsy at the site of recurrence.

However, if the postsurgery PET/CT scan is negative, “according to this research, it gives a great indication that the patient is free from disease and the treatment is successful.”

PET/CT is being evaluated in a variety of different situations, said Dr. David Raben, professor of radiation oncology at the University of Colorado, Denver. “We’re still looking at programs that are combining PET/CT imaging with functional DCI/MRI imaging in part to help oncologists find the tumor volume and define how to plan our treatments in regard to what the target volumes are both on the ipsilateral and contralateral side of the neck,”

“In the posttreatment setting, it’s been absolutely critical for us in terms of determining who should go on to further evaluation or who could be watched carefully. For instance, a University of Maryland group has shown quite nicely that in patients who have a clinical complete response and a complete response by PET imaging, almost all those patients do not need a neck dissection (Head Neck 2010;32:46-52). ... That’s a significant savings in health care costs, whereas in the past, almost all of those patients 10-15 years ago would have gone on to a neck dissection,” he said.

The current study also offers important data, Dr. Raben continued. “I believe 6 weeks is too early. We recommend a minimum of 8 weeks, preferably 12 weeks posttreatment, to allow inflammation to subside,” he said. “That may help reduce the false positive rate. I think use of PET/CT continues to evolve, and hopefully additional functional imaging studies will help us nail down which patients need to go on to further treatment or biopsy.”

Dr. Rudha and his coauthors and Dr. Raben stated that they had no disclosures.

Subject Codes:
oncology; surgery; otolaryngology;

http://www.imng.com

January 30, 2012 01:14 PM EST

Dr. Yasir Rudha

Carotid Endarterectomy More Cost-Effective Than Stenting

Fri, 27 Jan 2012 19:03 GMT

BY SHERRY BOSCHERT
Elsevier Global Medical News
Breaking News

SCOTTSDALE, ARIZ. (EGMN) – The cost of materials makes carotid artery stenting 40% more expensive than carotid endarterectomy with no relative clinical advantage, a retrospective study of 306 cases found.

Coronary artery stenting is not cost-effective in the routine management of carotid disease, Dr. Gregory D. Crenshaw and his associates reported at the annual meeting of the Southern Association for Vascular Surgery. The study won an award as the best study presented at the meeting.

The investigators compared 30-day clinical outcomes and hospital costs for 174 patients who underwent carotid endarterectomy (CEA) and 132 who underwent carotid artery stenting (CAS) with embolic protection at a single tertiary-care institution during January 2008–September 2010. Nine other patients who underwent CAS during that time were excluded because they had additional procedures that could bias the economic analysis.

Hospital costs in 2010 dollars averaged $9,426 for CAS, 40% higher than the mean $6,734 cost of CEA, said Dr. Crenshaw, a vascular and endovascular surgery fellow at the Ochsner Clinic Foundation, New Orleans.

Supply costs drove most of the difference, with supplies for CAS procedures averaging $3,667 more than for CEA. In 2010 terms, a carotid stent in the study cost $2,100-$2,495 and an embolic protection device cost $1,594-$1,695, compared with a cost of $90-$100 for a synthetic carotid patch used with endarterectomy.

Rates of adverse events did not differ significantly between groups. Stroke, MI, or death occurred in 2.3% of patients undergoing CEA and 3.8% of patients undergoing CAS.

Analyses of subgroups found the same trends in all subgroups – higher cost but no clinical advantage with carotid artery stenting, compared with carotid endarterectomy.

The investigators assessed hospital costs (not charges) by creating relative value units (RVUs) for expenses in the categories of labor, supplies, facility or equipment, and miscellaneous. The RVUs in the study were not related to Medicare work RVU valuations. The analysis did not include professional fees. Total expenses were normalized to 2010 costs based on the medical consumer price index.

The findings support previous studies suggesting similar clinical results from the two treatments but higher costs with carotid artery stenting.

The 2,502-patient Carotid Revascularization Endarterectomy Versus Stenting (CREST) trial found rates of 6.8% for CEA and 7.2% for CAS for a composite end point of periprocedural stroke, MI, death, or an ipsilateral stroke within 4 years (N. Engl. J. Med. 2010;363:11-23). In six studies between 1998 and 2010, the cost of carotid artery stenting exceeded that of carotid endarterectomy by 5%-118%, Dr. Crenshaw said.

When there is “clinical equipoise” between two therapies, costs become increasingly important, especially in the current era of rising health care costs and the need for efficient use of health care dollars, he said.

In Dr. Crenshaw’s study, the CEA group had a higher proportion of symptomatic patients (44%) and urgent cases (13%), compared with the CAS group (34% and 10%, respectively), but these differences did not achieve statistical significance. Compared with the endarterectomy group, the stenting group had significantly higher prevalences of coronary artery disease (61% vs. 37%) and congestive heart failure (18% vs. 5%).

Hospital costs were significantly higher with carotid artery stenting than with carotid endarterectomy for symptomatic or asymptomatic patients and for elective surgeries. Higher hospital costs for urgent cases treated by stenting compared with endarterectomy did not reach statistical significance.

Higher costs for symptomatic patients compared with asymptomatic patients in each subgroup were due to longer stays in the hospital and possibly due in part to extra costs for diagnostic imaging, he said. Overall, length of hospitalization was similar between the endarterectomy and stenting groups, a mean of 2 days in each.

Although the study was limited by not including professional fees in the analysis, including professional fees likely would not have changed the conclusions, he said. Medicare reimbursement for carotid artery stenting and for carotid endarterectomy is identical (averaging $1,167 in 2011). The average Medicare reimbursement for anesthesia for carotid endarterectomy is $350-$425, which also would not have changed the results significantly.

Dr. Crenshaw said he has no relevant conflicts of interest.

Subject Codes:
cardiology; surgery;

http://www.imng.com

January 27, 2012 02:03 PM EST

Gregory D. Crenshaw

Erlotinib Dose Doubled for Smokers With Head and Neck Cancer

Fri, 27 Jan 2012 18:14 GMT

BY MIRIAM E. TUCKER
Elsevier Global Medical News
Breaking News

PHOENIX (EGMN) – Giving smokers a higher, short-course dose of erlotinib before definitive surgery for squamous cell carcinoma of the head and neck resulted in favorable responses for the first patients evaluated in a small pilot study.

Investigators gave 300 mg of erlotinib (Tarceva) to smokers daily and 150 mg daily to nonsmokers who had a waiting period of more than 14 days before scheduled surgery for head and neck cancer. Seven of the 10 patients evaluated so far had partial responses and 3 had stable disease, according to a poster presented at a head and neck cancer symposium sponsored by the American Society for Radiation Oncology.

The study was based on recent data in non–small cell lung cancer (NSCLC) patients showing that smokers metabolize erlotinib, an epidermal growth factor receptor (EGFR) inhibitor, twice as quickly as do nonsmokers (J. Clin. Oncol. 2009;27:1220-6), said lead author Dr. Mercedes Porosnicu of Wake Forest Baptist Medical Center in Winston Salem, N.C. That study established the maximum tolerated dose of erlotinib at 300 mg daily in NSCLC patients who smoke.

Dr. Poroniscu’s presentation included the case study of a smoker with a very large oral cavity tumor protruding through his lips. He was described as being in significant pain and unable to eat or chew. The first CT scan showed a tumor of at least 8 cm and there was “significant metabolic activity” on PET scan.

“At 6 days of erlotinib treatment, his tumor was obviously smaller and he could chew, eat, and talk. Metabolic activity on PET scan dropped to 44% compared to initial tumor metabolic activity,” Dr. Porosnicu said. “At the end of 14 days’ treatment, his tumor was at least 20% smaller, and he had gained 5 pounds. His surgery wasn’t delayed, and the only treatment-related toxicity was a minimal skin rash.”

A total of 12 patients have been treated to date, for an average of 18.2 days, she reported. Nine were smokers and three were nonsmokers. All patients, smokers and nonsmokers, tolerated the erlotinib dose well with no serious adverse events and no delays in the scheduled time of surgical intervention. There were no grade 3 or 4 toxicities.

Of 10 evaluable patients (including 8 smokers who received 300 mg), 7 (including 5 smokers) showed a partial response, as defined by at least a 20% reduction in maximum tumor diameter. The other three patients (all smokers) showed stable disease. Two of the 12 treated patients received shorter duration treatment but nonetheless displayed good responses.

Interestingly, all four treated female patients (including one smoker) had good responses, independent of the erlotinib dose received, Dr. Porosnicu said.

Early 18[F]-FDG PET scans taken 4-6 days after the start of neoadjuvant erlotinib showed a decrease in metabolic activity of 2% in maximum standardized uptake value (SUVmax) to 98.75% in patients with stable disease and a decrease to 48.06% in patients with partial response.

“Early changes in the PET scan uptake should be further investigated as a marker predictive of response to EGFR inhibition. This pilot trial will continue to enroll patients,” Dr. Porosnicu said.

Erlotinib is approved for indications in non–small cell lung cancer and pancreatic cancer. Head and neck cancer would be an off-label use.

Dr. Porosnicu disclosed that she received financial support for this study from Astellas Pharma.

Subject Codes:
oncology; surgery; otolaryngology;

http://www.imng.com

January 27, 2012 01:14 PM EST

Mercedes Porosnicu

Novel Approach Avoids Skin Grafts in Open Abdomens

Thu, 26 Jan 2012 16:14 GMT

BY PATRICE WENDLING
Elsevier Global Medical News
Breaking News

LAKE BUENA VISTA, FLA. (EGMN) – The use of transabdominal wall traction to close domain-loss abdomens has avoided the need for skin grafting or a planned ventral hernia, and is now part of the open abdomen protocol at Chicago’s Cook County Hospital.

Transabdominal wall traction (TAWT) uses myofascial cutaneous release via isometric traction to close abdomens in the subset of patients who, after resuscitation and diuresis, cannot be closed, Dr. Andrew Dennis explained at the annual meeting of the Eastern Association for the Surgery of Trauma. This subset of patients is increasing, largely because of the resounding success of damage control laparotomy and decompressive laparotomy.

“TAWT has revolutionized the way we manage domain-loss, open-abdomen patients, and has virtually eliminated the acceptance of planned ventral hernia,” Dr. Dennis said.

Cook County Hospital is one of the nation’s busiest trauma units, with more than 5,000 trauma patients annually. Over a 24-month period, TAWT was used in 28 damage control laparotomy patients and 1 decompressive laparotomy patient who had achieved physiologic steady state and near dry weight, but demonstrated domain loss precluding fascial closure. Their Injury Severity Scores were greater than 30 and their wounds massive at an average width of 18.3 cm (range, 9.5-30 cm) by 30.7 cm in length (range, 12-40 cm).

The technique utilizes an artificial bur (Wittmann Patch) that consists of two biocompatible polymeric sheets linked together via a meshwork of small hooks and loops. To avoid necrosis of the fascial edge, which can occur when the sheets are sewn directly to the fascia, the patch is placed into the abdomen as an underlay, noted Dr. Dennis, a surgeon at the hospital and chair of surgery at Midwestern University in Downers Grove, Ill.

The patch is secured with large braided sutures sewn through all layers of the abdominal wall at the lateral edge of the rectus muscle. Predrilled, 1-inch-wide padded aluminum bolsters are then placed cephalad to caudad over the skin of the anterior abdominal wall, which has been covered with a layer of hydrocolloid dressing for protection.

Adding the aluminum bolsters prevents skin breakdown, erosion of the sutures through the skin, and most importantly, preserves the fascial blood supply and leading fascial edge by sandwiching the abdominal wall between the patch and the bolsters. This disperses medial traction forces throughout all layers of the abdominal wall rather than focusing them on the leading edge of the fascia, as is the case during primary closure.

Domain recovery is achieved by tightening the device approximately 2-4 cm every 48 to 72 hours. When the TAWT and mid-wound distance is less than 2 cm, the system is removed and the abdomen closed primarily with interrupted absorbable suture and an inlay or underlay of bioprosthetic mesh (Gore Bio A).

“TAWT has defeated the surgical myth that domain loss is a nonrecoverable entity,” Dr. Dennis said in an interview. “By treating the muscles of the abdomen as if they are in a state of contracture and shortening, the TAWT device applies concepts learned from the physical medicine literature regarding contractures. That is, by applying constant countertraction to the muscles, in line with the fibers, we are able to lengthen the muscles and thus restore original length.” In the case of the abdomen, this restores the fascial edge to midline and allows for primary closure.

At the time of placement, TAWT decreased the initial defect in the 29 patients by 54% or an average of 9.9 cm. Primary facial closure was achieved in all patients without use of components separation or bridging biologic meshes. The patients returned to the operating room for tightening and wash out of the wound an average of 2.2 times, excluding TAWT insertion and final closure operations, the investigators said.

The average time from initial operation to TAWT placement was 9.5 days, and average time from TAWT placement to primary closure was 9.2 days.

The hospital has been using TAWT for 2 years in its acute trauma population with a near 100% success rate and has begun using it in their chronic giant ventral hernia population, Dr. Dennis said.

“We have brought those patients back, taken down their adhesions and skin grafts, applied the TAWT device in conjunction with our protocol, and subsequently closed all of them,” he said.

Dr. Dennis and his coauthors offered several pearls, including the recommendation that the minimum time for TAWT is 7-10 days, and that extubation should be attempted between tightening operations when possible. The device should be tightened to physiologic tolerance, although intraoperation total paralysis is recommended for maximal tightening.

It is critical to maintain a fenestrated plastic bowel protection barrier extending to all areas of the abdomen in all directions to prevent fusion of the abdominal wall to the viscera. “As long as the two remain independent, then successful domain recapture remains an option,” he said.

TAWT should be continued regardless of the presence of ostomy or enteral leak, which can be controlled with drains. The approach should be aborted, however, if there is no domain recovery and the mid-wound gap remains constant despite multiple attempts at tightening. The maximum number of tightenings in the study was six.

The cohort ranged in age from 16 to 59 years, and 90% were male. In all, there were 20 penetrating traumas, 8 blunt traumas, and 1 emergency surgery for perforated viscus, the authors reported. Fistula was present in four (13%) and an ileostomy or colostomy in seven (24%).

Dr. Dennis and his coauthors reported no financial conflicts of interest.

Subject Codes:
surgery;

http://www.imng.com

January 26, 2012 11:14 AM EST

New Oral Anticoagulants Troublesome in the Trauma Setting

Thu, 26 Jan 2012 14:40 GMT

BY PATRICE WENDLING
Elsevier Global Medical News
Breaking News

LAKE BUENA VISTA, FLA. (EGMN) – Patients on one of the powerful new oral anticoagulants are left without a good antidote for bleeding if they experience a traumatic injury.

The use of these agents is climbing as baby boomers age and the number of patients with atrial fibrillation continues its steady rise from 2.0 million in 1995 to a projected 4.34 million by 2030.

“If you think it’s an epidemic now, it will become even more so in the coming years,” Dr. Mark Cipolle, medical director of trauma and neurocritical care at Christiana Care Health System in Wilmington, Del., said at the annual meeting of the Eastern Association for the Surgery of Trauma.

Currently, no specific antidote is available for dabigatran (Pradaxa) or the factor Xa inhibitor rivaroxaban (Xarelto), both of which are approved for stroke prevention in nonvalvular atrial fibrillation and for deep vein thrombosis following hip or knee replacement surgery.

The oral Xa inhibitor apixaban (Eliquis) is under priority review for stroke and DVT prevention in atrial fibrillation and will likely move, sans antidote, into the marketplace later this year based on robust results from the recent ARISTOTLE trial.

Vitamin K and protamine sulfate are not expected to affect the anticoagulant activity of the new oral anticoagulants. Some centers have had anectodal success in reversing dabigatran with activated prothrombin complex concentrates (aPCCs), but this has not been widely adopted, according to Dr. Cipolle.

“Some of my colleagues in pharmacy think this may be the drug to help us reverse dabigatran ... but our blood bank hematologists aren’t thrilled about going to this because of the development of antibodies for the new agents,” he said.

The two aPCCs available in the United States are factor eight inhibitor binding activity (FEIBA) and anti-inhibitor coagulant complex, heat treated (Autoplex T); both are indicated for bypass therapy in patients with acquired inhibitors and contain the coagulation factors II, VII, IX, and X.

One of the first randomized trials to look at a specific PCC (Cofact) showed that a single bolus immediately and completely reversed the anticoagulation effect of rivaroxaban in 12 healthy volunteers who were taking 20 mg twice daily, but the PCC had no influence on the effect of dabigatran 150 mg twice daily (Circulation 2011;124:1573-9), said copanelist John Gallagher, clinical nurse specialist for the surgical/trauma ICU at the Hospital of the University of Pennsylvania in Philadelphia.

Recombinant activated factor VIIa has been widely studied in trauma, but not for this specific indication. Early research on antibody monoclonal development is showing promise, Dr. Cipolle said. A recent study described a monoclonal mouse antibody with a high and specific affinity to inhibit dabigatran in both human plasma and whole blood and in a rat in vivo model (J. Am. Coll. Cardiol. 2011;57:E1130).

The package insert for dabigatran recommends emergency dialysis as a reversal strategy, stating that about 60% of dabigatran is removed over 2-3 hours. “This [strategy] may work,” said Dr. Cipolle, observing that about 80% of dabigatran is renally excreted, compared with 66% of rivaroxaban and only 25% of apixaban.

Although not trivial, the half-lives of dabigatran (14-17 hours), rivaroxaban (9 hours), and apixaban (9-14 hours) are shorter than that of warfarin (40 hours), which means that “if you can wait and just not give them the drug, you are probably going to be okay,” he said.

Dr. Cipolle cautioned, however, that reversal of labs may not indicate loss of anticoagulant effects. Also, clotting factors and continued prolongation of anticoagulation assays do not indicate lack of effect.

“The drug industry has spent years developing a drug that we could take orally that you don’t have to measure, and all we want to do is measure it,” he said. “We would like to know just how much anticoagulant effect is present, and if our reversal strategies are working.

“A normal PTT [partial thromboplastin time] is very helpful, but other than that, the classic anticoagulation studies aren’t terribly helpful.”

This point was also referenced in a recent letter to the New England Journal of Medicine penned by two trauma surgeons and an emergency physician who treated several injured patients on dabigatran, all of whom had poor outcomes (N. Engl. J. Med. 2011;365:2039-40). Although their values for activated clotting time on rapid thromboelastography (rTEG) were grossly abnormal at the time of admission, all of the patients had normal results on conventional anticoagulation studies.

“Unfortunately, even with the aid of rTEG, supportive care is all that is available in the emergency setting,” wrote the authors, who strongly urged that hemorrhagic complications and death resulting from trauma be included as part of routine surveillance of all newly approved oral anticoagulants. The authors also argued that “the ability to perform rapid dialysis in patients with bleeding whose condition is unstable or in those with large intracranial hemorrhages will present an incredible challenge, even at level 1 trauma centers.”

Both Dr. Cipolle and Mr. Gallagher emphasized that institutions should have a protocol in place for anticoagulant reversal. The protocol should be based on evidence and practice guidelines, be transparent and modifiable, and identify specific anticoagulant agents, triggers for reversal such as intracranial hemorrhage or solid organ injury, and reversal strategies and methods for monitoring both the use of anticoagulants and reversal strategies, Mr. Gallagher said.

During a discussion of the study, attendees asked how to address anticoagulation at discharge in, for example, a 72-year-old man with early Alzheimer’s disease and a fourth admission for a fall. Dr. Cipolle replied that a recommendation would be placed in his chart based on his initial risk and that a hospitalist or cardiologist would also be called in. He observed that trauma surgeons typically overestimate the fall risk, compared with the stroke risk, and often feel that making such a recommendation may be out of their purview.

Audience member Dr. Ronald Gross, chief of trauma and emergency surgery at Baystate Medical Center in Springfield, Mass., said trauma surgeons need to play a more active role in anticoagulation. He added that physicians at his center have a conversation prior to discharge with every single fall patient about the risks and benefits of anticoagulation, and also contact their prescribing physicians.

Session moderator Dr. Lewis Kaplan, a trauma and critical care surgeon at Yale University, New Haven, Conn., said the nurse practitioners at his center call primary care physicians when trauma patients are admitted and make a follow-up call upon discharge. The trauma surgeon makes an anticoagulation recommendation at discharge, although half the time, despite the conversation, patients are back on their anticoagulants in a matter of weeks, Dr. Kaplan said.

Dr. Cipolle and Mr. Gallagher reported no conflicts of interest. Dr. Lewis serves as a consultant to Pfizer.

Subject Codes:
cardiology; surgery; emergency_trauma; gerontology;

http://www.imng.com

January 26, 2012 09:40 AM EST

Dr. Lewis Kaplan

Medicare, Medicaid, Tort Reform in Play in Florida Primary

Wed, 25 Jan 2012 20:19 GMT

BY ALICIA AULT
Elsevier Global Medical News
Breaking News

Although the Republican primaries this year have been anything but predictable, one thing is fairly certain: Health care issues will play a more prominent role in the Florida primary on Jan. 31 than they have so far.

Florida is a coveted win for the GOP contenders in part because 50 delegates are at stake, but also because the state is more diverse – racially, ethnically, and politically – than Iowa, New Hampshire, and South Carolina, where primaries have already been held. As such, it’s considered a better reflection of the general election.

With its large elderly population and hard-hit economy, social welfare programs like Social Security, Medicare, and Medicaid are very important to Florida voters.

“Medicare is certainly the third rail in Florida among the sizeable senior population, but so too is Medicaid,” said Daniel A. Smith, Ph.D., professor of political science at the University of Florida, Gainesville.

Many seniors depend on both Medicare and Medicaid for their health care needs: Medicare for basic doctor and hospital care and Medicaid for long-term care, Dr. Smith pointed out.

That means Republican candidates should consider treading lightly when they talk about Social Security, Medicare, or Medicaid, he said, noting that in 1992, Ross Perot’s presidential bid was derailed in Florida after he said he would favor having wealthier Americans pay more for Social Security and Medicare.

“Retirees aren’t interested in dismantling the welfare state,” Mr. Smith said. “Even those Floridians of means are not interested in having their benefits cut.”

Health Care Platforms

At the Republican debate in Tampa on Jan. 23, Rick Santorum went after putative front-runner Mitt Romney for creating what he called a “government-run” health care plan when Mr. Romney was governor of Massachusetts. Mr. Santorum, a former senator from Pennsylvania, called that plan “RomneyCare,” a play on the dismissive “Obamacare” moniker that Republicans have given to the Affordable Care Act.

In the past, Mr. Santorum, who at press time was polling a distant third in Florida, has supported a plan by Rep. Paul Ryan (R-Wisc.) to essentially privatize Medicare. On his official campaign website, he says his first priority as President would be to repeal the Affordable Care Act. He also has said he would encourage the purchase of health insurance across state lines, push for block grants to states for Medicaid, and bolster health savings accounts. Mr. Santorum also backs medical liability reform.

Like Mr. Santorum, Newt Gingrich is calling for more competition in health care, block grants for Medicaid, and a repeal of the ACA. But the former Speaker of the House presents a more detailed plan for health care that includes reforming the Food and Drug Administration, investing more in health research, and putting a premium on quality of care.

Mr. Gingrich and Mr. Romney have traded the lead in Florida for the last several months, with Mr. Romney leading fairly broadly before the South Carolina primary on Jan. 21. Then, just as Mr. Romney won New Hampshire, Mr. Santorum was belatedly declared the winner in Iowa. Mr. Gingrich handily beat Mr. Romney in South Carolina, 40% to 28%.

According to the University of Florida’s Dr. Smith, Mr. Romney has actively courted health care executives in Florida. But it may not be enough to fend off continued brickbats thrown at him for the Massachusetts plan. He has repeatedly disavowed the notion that the plan was the model for the Affordable Care Act. On his website he says his first priority will be a repeal of Obamacare. Mr. Romney, like the other candidates, says he supports less regulation, more competition, and medical liability reform.

Although his platform makes no overt mention of Medicare, analysis by the Center on Budget and Policy Priorities noted that, if enacted, Mr. Romney’s proposal to cap total spending and balance the budget would lead to a 17%-24% cut to Medicare by 2016.

Interestingly, the American Federation of State, County and Municipal Employees has purchased air time in Florida to attack Mr. Romney for what it calls “Medicare fraud.”

The 30-second spot says that, while Mr. Romney worked for the Damon Corp., the company defrauded Medicare. The spot then goes on to morph Mr. Romney’s face into that of Florida Governor Rick Scott’s, with the tag line, “Sound familiar?”

Gov. Scott, a Republican, was the CEO of HCA (then called Columbia/HCA) during a period when the company was found guilty of defrauding Medicare. He was forced to resign and the company paid a record fine to the government. Gov. Scott has seen his approval ratings in Florida bottom out, in part because he proposed to finance public education through reductions in Medicaid payments to hospitals.

Gov. Scott has not endorsed any of the GOP candidates. “He knows that his poll numbers are quite toxic. As a result I don’t think his endorsement behooves anyone right now,” Dr. Smith said.

The Doctors Stand Clear

Several major physicians’ organizations have so far demurred on endorsing any of the candidates. A spokesperson said that the Florida Medical Association did not feel it was appropriate to even comment on a potential endorsement, given that its membership holds a variety of views.

Dr. John A. Gross, a member of the board of the Florida Academy of Family Physicians (that state’s chapter of the American Academy of Family Physicians), said that the FAFP would not be endorsing any candidates at this time either.

The FAFP is “looking for candidates that are willing to stand up for the patient,” said Dr. Gross, who chairs the group’s government relations committee. Family physicians would be interested in candidates who support the patient-centered medical home and new models that provide high quality care.

Tort reform also is a huge issue for Florida physicians, Dr. Gross noted. In a recent poll, physicians in the state estimated that 1 of every 3 health care dollars in Florida is spent on so-called defensive medical costs. The poll was conducted by Patients for Fair Compensation, a nonprofit established by the for-profit physician staffing company Jackson Healthcare.

Dr. Gross said that medical liability reform is a priority issue for the FAFP every year.

The latest bill to address tort reform was introduced in mid-January in the Florida House and Senate.

Abortion is also a hot-button issue in Florida. The state is regarded as anti-choice by NARAL Pro-Choice America.

Mr. Santorum describes himself as strongly pro-life. Mr. Gingrich has said he supports ending federal subsidies for abortion and defunding Planned Parenthood. Mr. Romney had a much-publicized change in position, seemingly going from supporting a woman’s right to choose to being against abortion. He does not have an official stance listed on his campaign website.

This is the first in a series of articles looking at the Republican presidential primaries through the eyes of physicians. Next up: The race moves on to Minnesota and Colorado, which hold their primaries Feb. 7.

Subject Codes:
nephrology_urology; infectious; top_stories; sports; ophthalmology; gastroenterology; mental_health; diabetes; dermatology; orthopaedics; pediatrics; general_primary; oncology; endocrinology; womens_health; pain; allergy; pulmonology; cardiology; rheumatology; surgery; otolaryngology; neurology; emergency_trauma; gerontology;

http://www.imng.com

January 25, 2012 03:19 PM EST

With Florida’s large elderly population and hard-hit economy, health care issues should play a prominent role in the Republican primary on Jan. 31.

CORRECTION: New Certification for Complex Surgical Oncology

Mon, 23 Jan 2012 20:13 GMT

Elsevier Global Medical News

A story titled “New Certification for Complex Surgical Oncology,” published January 19, 2012, misidentified the organization that approved the subspecialty certification in complex general surgical oncology. The American Board of Medical Specialties approved the certification program. The program’s training requirements have not yet been approved by the Accreditation Council of Graduate Medical Education (ACGME). The role of the ACGME in administering program examinations was misstated; the American Board of Surgery will administer these exams.

Subject Codes:
oncology; surgery;

http://www.imng.com

January 23, 2012 03:13 PM EST

New Certification for Complex Surgical Oncology

Thu, 19 Jan 2012 15:30 GMT

BY FRANCES CORREA
Elsevier Global Medical News
Breaking News

A new subspecialty certification in complex general surgical oncology aims to provide surgeons with training in the diagnosis, treatment, and rehabilitation of patients with complex cancers such as sarcoma, melanoma, and esophageal malignancies – and hopefully will attract surgeons who want to focus on research.

“The idea is to build leaders in cancer research,” said Christine Shiffer, spokesperson for the American Board of Surgery (ABS). The certification program was created by the ABS and approved by the Accreditation Council for Graduate Medical Education (ACGME) in March.

Ms. Shiffer noted that the majority of oncology cases are – and will continue to be – treated by general surgeons trained in surgical oncology.

Some surgeons say the certification simply solidifies the training qualifications that surgical oncologists already have.

“Trained surgical oncologists are already available to provide care for complex general surgical oncology,” said Dr. Stephen Edge, chair of the Commission on Cancer for the American College of Surgeons (ACS). “The SSO is taking it to the next level for the future. That’s good for surgeons. That’s good for the American College of Surgeons and, most importantly, that’s good for the American public.”

Dr. Edge added that the public will benefit from the assurance that their doctor has the training and credentials to provide the best care possible.

The certification will have minimal impact on general surgeons currently treating the same conditions, said Dr. Fabrizio Michelassi, chair of the ABS Surgical Oncology Advisory Council.

“As current [Society for Surgical Oncology]–approved fellowships graduate only 50 surgical oncologists each year, the number of surgeons who will be eligible for this certificate is relatively small,” Dr. Michelassi said in a statement.

The ABS decided against grandfathering surgeons who have already completed a fellowship in surgical oncology or general surgeons who perform oncologic surgery.

Newly trained surgeons should see the new certification program as an opportunity but not a necessity, said Dr. Patricia L. Turner, a general surgeon and director of member services at ACS. However, she added that the certification could eventually carry a greater marketing advantage for new surgical oncologists. When this process is rolled out, among trainees who finish the same fellowship 1 year apart (and have identical training), one would carry the certificate and the other wouldn’t, she explained.

While program development is underway, there is still work to be done. First, the ACGME will have to approve their training requirements, which the ABS expects to see by June. Once requirements are approved, the written and oral examinations can be finalized.

Existing surgical oncology training programs can become ACGME accredited to provide the training and administer the examinations. The first examinations are expected to start in the fall of 2012, at the earliest, according to the ABS.

Subject Codes:
oncology; surgery;

http://www.imng.com

January 19, 2012 10:30 AM EST

IV Anesthetics May Speed Up Postop Recovery

Wed, 18 Jan 2012 21:03 GMT

BY MICHELE G. SULLIVAN
Elsevier Global Medical News
Breaking News

An hour of intravenous anesthetic during surgery can shave a day off the hospital stay and decrease the risk of postoperative complications for some patients, according to Dr. Marcel Durieux.

Intravenous anesthetics (for example, lidocaine) exert surprising effects on recovery from some – but not all – major abdominal surgeries. They’re associated with decreased postoperative pain, quicker return of bowel function, and a shorter length of stay. But they don’t help in all surgeries – not even in all abdominal surgeries – and the way they work is still something of a mystery, he said.

The well-documented systemic benefits of surgical epidurals got anesthesiologists thinking about intravenous agents, said Dr. Durieux, professor of anesthesiology at the University of Virginia, Charlottesville. Epidurals provide excellent postoperative pain control, but it was obvious that their effects spread much farther.

“They do much more than just help pain,” he said in an interview. “They have significant effects on surgical outcomes that can’t be explained simply by blocking sodium channels in nerves.”

Because the effects span several systems, they are probably due to systemic absorption of the anesthetic agent, he said. “If improved outcomes have little to do with blocking nerves, there is no special reason to give an anesthetic near those nerves. You should be able to give it intravenously at doses that lead to blood levels similar to what we get with an epidural.”

Researchers have been looking at the issue for more than a decade, and are now honing in on inflammation as the root of these postoperative problems.

A hyperinflammatory response to surgical trauma is probably the root of many postoperative problems, including pain and thrombosis, Dr. Durieux said. “The response develops during the case and lasts into the postoperative period. If it continues, it can lead to a lot of negative effects – increased cardiac strain, impaired respiratory function that can lead to respiratory distress syndrome, nausea and ileus, and a procoagulatory state.”

Intravenous local anesthetics seem to suppress that response before it explodes. The drugs likely target neutrophils and the two pathways in which they respond to a bodily injury: priming and activation.

In normal activation, a neutrophil senses bacteria and generates superoxide that kills the invader, leading to the normal inflammatory response seen with an illness. But a wound, including a surgical wound, primes the neutrophils for a superresponse. “Subsequently, when they encounter bacteria, they generate 10 times the amount of superoxide, actually damaging the body,” Dr. Durieux said.

In some yet-unknown way, local anesthetics appear to inhibit neutrophilic priming. “There is no other drug around that selectively blocks priming. And if you don’t prime these neutrophils during surgery, you won’t have them there 2 days after surgery causing problems. Even if the local anesthetic goes away, its beneficial effect does not.”

Recognition of this prolonged anti-inflammatory effect may eventually shape the administration of intraoperative local anesthetics. Because there is no data-driven protocol, some anesthesiologists give the drug for an hour during surgery, some continue it in the recovery room, and a few want to continue it on the surgical floor.

“This is still a matter of debate. Most of the data show that the vast majority of the benefit can be achieved by giving the drug just for the duration of the case. You can leave it on in the recovery room and turn it off when the patient is ready to go to the floor.”

Unfortunately, the agents seem rather selective in their benefit. A 2010 meta-analysis found it most effective in open and laparoscopic bowel surgeries, but unhelpful in small studies on tonsillectomy, arthroscopic surgery, or coronary artery bypass. Another 2010 study found the drugs didn’t have much effect in abdominal hysterectomy, but a 1998 study found it had good effect in prostatectomy.

“I can’t explain that,” Dr. Durieux said. “I’m impressed by the data we have but frustrated that the benefit has been shown in just a subset of surgeries.”

Although more research is necessary – and in the offing – the drugs are cheap, safe, and easy to use.

“But I’m selective in how I use it. If someone is having an open colectomy and faces prolonged painful ileus, I would consider it, for example. And for people who can’t or won’t accept an epidural, I think this is a reasonable way to go.”

He disclosed that he serves on the steering committee of a clinical trial investigating a novel system for delivering local anesthetics to surgical wounds for postoperative pain relief.

Subject Codes:
surgery;

http://www.imng.com

January 18, 2012 04:03 PM EST

Novel Antiplatelet a Bridge Between Thienopyridine and CABG

Tue, 17 Jan 2012 21:00 GMT

BY MARY ANN MOON
Elsevier Global Medical News
Breaking News

Intravenous cangrelor may prove to be a useful “bridge” in patients awaiting nonemergency CABG who must first discontinue their regular antiplatelet therapy, according to the results of the Maintenance of Platelet Inhibition With Cangrelor (BRIDGE) trialreported in the Jan. 18 issue of JAMA.

The practice of discontinuation of antiplatelet therapy is associated with significant morbidity and mortality; in patients who have coronary stents, it raises the risk of stent thrombosis that often leads to myocardial infarction and death. “Cessation of thienopyridine treatment for nearly a week before surgery, with patients not hospitalized or monitored but carrying an excess risk of major ischemic events, has been a troubling and not infrequent problem for clinicians, because it is estimated that approximately 5% of patients will require some type of surgery within the first 12 months after stent implant or [acute coronary syndrome] diagnosis,” said Dr. Dominick J. Angiolillo of the department of cardiology, University of Florida, Jacksonville, and his associates.

In this multicenter clinical trial sponsored by the drug’s maker, cangrelor “achieved and maintained target levels of platelet inhibition known to be associated with a low risk of thrombotic events compared with placebo, without a significant excess in bleeding complications,” the investigators noted.

Cangrelor is an investigational nonthienopyridine adenosine triphosphate analogue that acts as an antagonist of the P2Y12 receptor. It is characterized by “rapid, potent, predictable, and reversible platelet inhibition,” and its extremely short half-life (3-6 minutes) allows “rapid offset of effect.”

The investigators hypothesized that cangrelor would allow patients who must discontinue antiplatelet therapy prior to cardiac surgery, especially if they’re taking a P2Y12 inhibitor such as ticlopidine, clopidogrel, or prasugrel, to go off their usual drug without raising their risk for thrombotic events. They tested this hypothesis in a two-part trial.

The first part was an open-label dose-finding study involving 11 adults, which concluded that the optimal intravenous dose needed to maintain antiplatelet activity without raising bleeding risks was 0.75 mcg/kg per minute.

In the second part of the trial, 210 patients awaiting CABG at 34 medical centers around the world were randomly assigned to receive either cangrelor (106 subjects) or placebo (104 subjects) after thienopyridines were discontinued and throughout the preoperative period – that is, until 1-6 hours before surgical incision. Platelet function was assessed before, during, and after the infusion.

The mean interval between discontinuation of thienopyridines and infusion of the study drug was 29 hours, and the mean duration of the infusion was approximately 3 days.

The primary end point was the percentage of patients who showed platelet reactivity of less than 240 P2Y12 Reaction Units (PRUs) throughout the infusion of the study drug. “This level approximated the levels of platelet reactivity expected to be maintained if a thienopyridine had not been discontinued,” the investigators explained.

This end point was met by 99% of the cangrelor group but only 19% of the placebo group. It was achieved independently of patients’ usual dose of thienopyridines and independently of the length of time since thienopyridines were discontinued, Dr. Angiolillo and his colleagues said (JAMA 2012;307:265-74).

Moreover, cangrelor did not raise the rate of excessive bleeding related to CABG surgery. This safety end point occurred in 22 patients: 11.8% of the cangrelor group and 10.4% of the placebo group, a nonsignificant difference.

The number of minor bleeding events was numerically higher with cangrelor but did not reach statistical significance. Other adverse events, including dyspnea and laboratory abnormalities, also were comparable between the two groups. This favorable safety profile, even with prolonged infusion of up to 7 days, was “reassuring,” the researchers noted.

Ischemic end points prior to surgery were low in both groups, occurring in 2.8% (3 of 106) and 4.0% (4 of 101) of patients in the cangrelor and placebo groups.

“These observations support the hypothesis that intravenous cangrelor is a feasible management strategy, providing prolonged platelet P2Y12 inhibition in patients who must wait for cardiac surgery after thienopyridine discontinuation,” they said.

This study was sponsored by the Medicines Company. Dr. Angiolillo reported ties to Bristol-Myers Squibb, Sanofi-Aventis, Eli Lilly, Daiichi Sankyo, AstraZeneca, Portola, Novartis, Medicure, Accumetrics, Arena Pharmaceuticals, Merck, Evolva, and Abbott Vascular, and his associates reported ties to numerous other industry sources.

Subject Codes:
top_stories; cardiology; surgery;

http://www.imng.com

January 17, 2012 04:00 PM EST

Benchmarks Discerned for In-Hospital VTE After Hip, Knee Arthroplasty

Tue, 17 Jan 2012 21:00 GMT

BY MARY ANN MOON
Elsevier Global Medical News
Breaking News

For the first time, researchers say they have established benchmarks for the rates of in-hospital venous thromboembolism that occur after total or partial hip arthroplasty and after total or partial knee arthroplasty, according to a report Jan. 18 in JAMA.

In a meta-analysis of 47 studies that documented venous thromboembolism (VTE) event rates in nearly 45,000 patients who received recommended prophylaxis during hospitalization for knee or hip arthroplasty, investigators estimated that approximately 1 in every 100 patients undergoing knee arthroplasty and 1 in every 200 undergoing hip arthroplasty will develop symptomatic VTE before they are discharged.

“These estimates are of value to individual patients and clinicians in the consideration of risks and benefits” of the two procedures. They also are important because rates of in-hospital VTE are increasingly used as indicators of patient safety at individual medical centers, even though the expected background rates haven’t been established until now, said Jean-Marie Januel, a registered nurse with the Institute of Social and Preventive Medicine, Lausanne (Switzerland) University Hospital, and his associates.

“Large numbers of patients worldwide undergo hip and knee replacement procedures annually, and VTE is a widely acknowledged complication. Yet no estimate of symptomatic VTE risk prior to hospital discharge is available from the literature that can be conveyed to patients in the informed consent process,” they noted.

Mr. Januel and his colleagues performed a systemic search of the literature to identify studies performed between 1996 and 2011 in which subjects undergoing either hip or knee arthroplasty received VTE prophylaxis according to published guidelines, including either low-molecular-weight heparin or inhibitors of factor Xa or IIa. They found 41 randomized clinical trials and 6 observational studies to include in the meta-analysis.

A total of 22 of the studies were performed in Europe, 14 were in North America, and 11 were in other regions. The mean duration of follow-up after either surgery was 13 days.

This included 21 studies of partial or total hip arthroplasty, 20 of partial or total knee arthroplasty, and 6 studies of both procedures, with a total of 44,844 subjects.

There were 443 cases of symptomatic postoperative VTE that developed before hospital discharge: 288 in the 23,475 knee patients and 155 in the 23,475 hip patients. This included 182 cases of deep vein thrombosis in the knee patients and 93 in the hip patients, as well as 106 cases of pulmonary embolism in the knee patients and 43 in the hip patients.

The pooled incidence rates of VTE were approximately 1% after knee arthroplasty and approximately 0.5% after hip arthroplasty. This means that the background rate of VTE is approximately 1 in 100 knee patients and 1 in 200 hip patients, the investigators said (JAMA 2012;307:294-303).

When the data were broken down by type of VTE, the pooled incidence rates were 0.26% for deep vein thrombosis and 0.14% for pulmonary embolism after knee arthroplasty. The corresponding rates were 0.63% for deep vein thrombosis and 0.27% for pulmonary embolism after hip arthroplasty.

“Given that these rates are based on the results of rigorous studies, they may represent a lower incidence than actual rates observed in clinical practice, in which patients are selected less rigorously and prophylaxis is administered less assiduously,” Mr. Januel and his associates noted.

The pooled incidence rates of deep vein thrombosis were lower for both knee patients and hip patients when factor Xa or IIa inhibitors, rather than low-molecular-weight heparin, were given for prophylaxis. “However, we cannot make assertions regarding comparative efficacy among treatments, because our meta-analysis did not directly compare [these agents] as an efficacy meta-analysis would have done,” they said.

In-Hospital Not as Telling as Post-Discharge VTE Rates

The in-hospital VTE rates reported by Januel et al may be “suboptimal” for assessing both patients’ risks and a facility’s performance in patient safety, as the investigators proposed, said Dr. John A. Heit of the division of cardiovascular diseases at the Mayo Clinic, Rochester, Minn.

The period of VTE risks extends far beyond the hospital stay, with as many as 76% of VTE events occurring during the 3 months following hospital discharge. “From the perspective of the patient contemplating elective total hip replacement or total knee replacement,” the 3-month rate rather than the in-hospital rate of VTE is more important in weighing risks and benefits, he said in an editorial accompanying Mr. Januel’s report (JAMA 2012;307:306-7).

And it can be argued that this cumulative rate of VTE is also more important for the purpose of assessing a facility’s performance, Dr. Heit added.

This study was supported by Alberta Innovates Health Solutions, a government research funding agency, and the International Methodology Consortium for Coded Health Information, a collaboration of health sciences researchers to promote quality of care. Dr. Heit reported ties to Daiichi Sankyo, GTC, Ortho-McNeil-Jansen, the National Heart, Lung, and Blood Institute, the National Human Genome Research Institute, the National Institutes of Health, the Centers for Disease Control and Prevention, and the Mayo Foundation.

Subject Codes:
top_stories; cardiology; rheumatology; surgery; gerontology;

http://www.imng.com

January 17, 2012 04:00 PM EST

Local, Regional Anesthesia Surpass General for AAA EVAR

Tue, 17 Jan 2012 19:17 GMT

BY MITCHEL L. ZOLER
Elsevier Global Medical News
Breaking News

MIAMI BEACH (EGMN) – Local and regional anesthesia are better options than is general anesthesia for patients undergoing endovascular repair of an abdominal aortic aneurysm, based on findings from a registry with nearly 1,200 patients.

Both local anesthesia and regional anesthesia each surpassed general anesthesia in two periprocedural measures: significantly reducing procedure time, and significantly reducing postoperative hospitalization, Dr. Rutger A. Stokmans said at ISET 2012, an international symposium on endovascular therapy.

In addition, both local and regional anesthesia led to trends in reduced rates of major adverse events during the 30 days following surgery, although these differences did not reach statistical significance. All three anesthesia types linked with similar rates of both technical and clinical success of the aneurysm repairs. Regional anesthesia also led to a significantly lower rate of ICU admission, compared with both general and local anesthesia; local anesthesia showed no significant difference for this measure, compared with general anesthesia.

Based on these findings, local or regional anesthesia should be preferred when performing endovascular aneurysm repair (EVAR), whereas general anesthesia should usually be avoided, said Dr. Stokmans, a vascular surgeon at Catharina Hospital in Eindhoven, the Netherlands.

These findings support the most recent anesthesia recommendations of the European Society for Vascular Surgery, which in 2011 guidelines for managing abdominal aortic aneurysms (AAA) cited local anesthesia as preferred for EVAR, with regional or general anesthesia reserved for patients with contraindications for local anesthesia, he said (Euro. J. Vasc. Endovasc. Surg .2011;41[suppl. 1]:S1-S58). The most recent guidelines for AAA management from the Society for Vascular Surgery suggested using local or regional anesthesia over general anesthesia, he added (J. Vasc. Surg. 2009[suppl.]:50:S2-S49).

But despite these recommendations, the most commonly used anesthesia type worldwide for EVAR repair of AAA has been general anesthesia, followed by regional anesthesia, with local treatment used least often, according to the registry data reported by Dr. Stokmans. Among the 1,199 patients enrolled in ENGAGE (Endurant Stent Graft Natural Selection Global Postmarketing Registry) during March 2009 to December 2010 in 30 countries on five continents, 749 (62%) underwent their EVAR with general anesthesia, 325 (27%) with regional, and 125 (10%) with local anesthesia. (Percentages do not add up to 100% because of rounding.)

The registry data also showed striking regional variations in anesthesia use, with general anesthesia used on about 90% of patients in Canada, Australia, and New Zealand, and on about 70% of patients in Scandinavian countries and the United Kingdom. But in Central Europe, regional anesthesia – used on nearly 70% of EVAR patients – dominated. The only region favoring local anesthesia was South America (Argentina, Columbia, and Uruguay), where about 50% of patients received local, but more than 40% received general anesthesia, he said. The registry contained no U.S. patients, although the Endurant AAA stent graft system is marketed in the United States.

The average age of the EVAR patients in the registry was about 73 years. Those patients who underwent general anesthesia were significantly older, by an average of about 18 months, compared with those who received local or regional anesthesia.

The proportions of patients undergoing general, regional, or local anesthesia were similar in the subgroups of patients with American Society of Anesthesiologists (ASA) physical status scores of 1, 2, or 3. However, among the highest-risk patients included in the study – those with an ASA score of 4 – a significantly greater proportion of patients received general anesthesia. The multivariate models used in the analysis, therefore, were adjusted for age and for ASA score. About 42% of patients were in ASA class 2, and another 42% in class 3.

All patients were hemodynamically stable at the time of their enrollment. The maximum AAA diameter of registry patients was 6 cm, and about 88% of patients had an AAA diameter greater than 5 cm.

Average procedure times were 106 minutes in the general anesthesia patients, 95 minutes in the regional patients, and 81 minutes in the local anesthesia patients – statistically significant differences among the three groups.

The average postoperative hospitalization was 5.2 days in the general anesthesia patients, 4.3 days in the regional patients, and 3.6 days in the local anesthesia patients, differences that were statistically significant among each of the three groups.

The rate of technical surgical success was 98% in all three subgroups, and the rate of clinical success reached 97%-98% in all three groups.

The rates of major adverse events during the 30 days following surgery were 5.1% in the general anesthesia patients, 3.2% in the local patients, and 2.2% in the regional anesthesia patients. None of these differences reached statistical significance. Major adverse events included death, MI, stroke, renal failure, blood loss greater than 1 L, and bowel ischemia. No patients developed paraplegia or respiratory failure.

Postoperative ICU admission occurred for 27% of the regional anesthesia patients, 35% of the general patients, and 42% of the local anesthesia patients. The rate among the regional patients was significantly less than in the other two groups, but the difference in rates between the general and local anesthesia patients did not reach statistical significance.

The ENGAGE registry was organized and sponsored by Medtronic, which markets the Endurant stent. Dr. Stokmans and his associates received an unrestricted research grant from Medtronic. Dr. Stokmans said that he had no other disclosures.

Subject Codes:
top_stories; cardiology; surgery;

http://www.imng.com

January 17, 2012 02:17 PM EST

Rutger A. Stokmans

Weight Loss Higher After Roux-en-Y Surgery vs. Gastric Banding

Tue, 17 Jan 2012 17:51 GMT

BY MARY ANN MOON
Elsevier Global Medical News
Breaking News

Roux-en-Y gastric bypass surgery resulted in greater, more rapid, and more sustained weight loss compared with gastric banding, but also a higher number of complications in a matched-pair study published online Jan. 16 in Archives of Surgery.

The weight loss advantage achieved with Roux-en-Y leads to better correction of the comorbidities that accompany obesity, such as adverse lipid profiles and high fasting glucose levels, said Dr. Sébastein Romy of the department of visceral surgery, Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland, and his associates.

Although there are more early complications with the Roux-en-Y procedure, they are outweighed by “the much higher long-term major morbidity seen after gastric bypass, leading to a large number of major reoperations and their risks,” the investigators noted.

The sharp rise in bariatric surgeries performed in recent years in the United States has occurred predominantly in gastric banding procedures. “This is probably because gastric banding is perceived both by doctors and patients as a simple, safe, and reversible operation but also because of a huge industry-driven marketing campaign,” they said.

Which surgery is “better” has been contested. To date, among the 17 published studies comparing the two procedures, many have had important methodologic flaws such as small numbers of patients and very limited follow-up.

Dr. Romy and his colleagues performed a matched-pair analysis of patients who underwent the two procedures in 1998-2005. The study subjects, who had failed to lose weight with more conservative approaches, all had a body mass index of 40 or more, or a BMI of 35 plus at least one severe comorbidity. A total of 221 patients who underwent Roux-en-Y gastric bypass were matched for age, sex, and BMI with 221 who underwent gastric banding. Follow-up rates after 6 years were approximately 92% in both groups. The same team performed the operations at the same two hospitals.

Maximal weight loss was achieved at a mean of 18 months after Roux-en-Y gastric bypass, compared with 36 months after gastric banding. The percentage of excess weight lost was significantly higher after Roux-en-Y (78.5%) than after gastric banding (64.8%), and the mean nadir in BMI was significantly lower (26.7 vs. 29.4, respectively). After 6 years, only 5 patients (2.4%) in the Roux-en-Y group had a BMI greater than 40, compared with 21 patients (13.8%) in the gastric banding group.

As a result, significantly more patients who had Roux-en-Y surgery were rated as having excellent or acceptable results at all time points during follow-up, Dr. Romy and his associates said (Arch. Surg. 2012 Jan. 16 [doi:10.1001/archsurg.2011.1708]).

Treatment failures were defined as a weight loss of less than 25% of baseline weight or the need to reverse the surgery or convert to a different bariatric procedure. At the 3-year mark, there were no treatment failures among Roux-en-Y patients, compared with 39 treatment failures (18.2%) among gastric banding patients. After 6 years, failure rates were 2.5% and 38.9%, respectively, in Roux-en-Y and gastric banding patients.

Improvement in lipid profiles was significantly greater after Roux-en-Y than after gastric banding. Total cholesterol, LDL cholesterol, and triglyceride levels decreased after Roux-en-Y but not after gastric banding. Fasting glucose levels also were lower after Roux-en-Y (89.55 mg/dL vs. 92.79 mg/dL).

Quality of life improved in both groups, but the improvement was significantly faster and persisted for a longer time after Roux-en-Y surgery. In particular, Roux-en-Y patients had much better food tolerance, with no worsening after surgery, whereas food tolerance tended to worsen over time after gastric banding.

There were significantly more early complications after Roux-en-Y (17.2%) than after gastric banding (5.4%), which is not surprising given that Roux-en-Y is a more complex operation and requires a longer operative time and longer hospitalization. However, most of these early complications required only conservative treatment, and there was no significant difference between the two groups in early major complications, the researchers said.

In contrast, gastric banding was associated with significantly more long-term complications than was Roux-en-Y (41.6% vs. 19%) and required more than twice as many reoperations (26.7% vs. 12.7%).

“After gastric banding, functional problems like esophageal dilatation (10.4%), impairing reflux requiring (or resistant to) daily high-dose proton-pump inhibitor therapy (6.8%), or severe food intolerance (6.3%) accounted for the majority of long-term complications, together with band erosions (7.7%). Overall, band removal was necessary in 47 patients (21.3%),” they said.

“Long-term complications after Roux-en-Y gastric bypass are essentially limited to anastomotic strictures and bowel obstructions and symptomatic internal hernia.” Most strictures were not considered major complications, requiring only endoscopic dilatation. Although bowel obstruction is potentially life threatening, in most cases it doesn’t jeopardize the bypass or require reversal, Dr. Romy and his colleagues said.

No financial conflicts of interest were reported by the researchers.

Still a Few Caveats

“I personally agree” with Romy et al. that Roux-en-Y gastric bypass is the better procedure, but “before we make from this conclusion a paradigm, a few caveats remain,” Dr. Jacques Himpens said in an invited critique that accompanied Dr. Romy’s report (Arch. Surg. 2012 Jan. 16 [doi:10.1001/archsurg.2011.1855]).

A case-control study such as this one may be biased, said Dr. Himpens of the European School of Laparoscopy at Saint Pierre University Hospital, Brussels. Even though a prospective randomized trial comparing the two surgeries isn’t feasible, a prospective rather than retrospective comparison of matched patients would yield better evidence, as would a multicenter rather than a single-center study, according to Dr. Himpens.

In addition, a growing number of Roux-en-Y patients are showing neuroglycopenia and diabetes recurrence several years after surgery, which is concerning, he said.

Dr. Himpens reported being a consultant for Ethicon Endo-Surgery, Covidien, and Gore.

Subject Codes:
gastroenterology; diabetes; endocrinology; surgery;

http://www.imng.com

January 17, 2012 12:51 PM EST

CORRECTION: D-Dimer May Be Marker of VTE Risk

Fri, 13 Jan 2012 19:12 GMT

Elsevier Global Medical News

The article “D-Dimer May Be Marker of VTE Risk” (published Jan. 5, 2012) misstated D-dimer levels. The baseline median D-dimer level was 0.94 mg/L in all patients. The baseline D-dimer level was higher in patients who experienced a primary efficacy outcome event, compared with those who did not have such an event (a median of 1.98 mg/L vs. 0.92 mg/L).

Subject Codes:
cardiology; surgery;

http://www.imng.com

January 13, 2012 02:12 PM EST

Seizure Increase Not Seen Following Gastric Bypass

Wed, 11 Jan 2012 20:55 GMT

BY MIRIAM E. TUCKER
Elsevier Global Medical News
Breaking News

BALTIMORE (EGMN)–No notable increases in new-onset seizure disorder or exacerbations of a pre-existing seizure disorder were seen following gastric bypass surgery in a retrospective case series of more than 1,500 patients from the Mayo Clinic.

Reports of new-onset or exacerbated seizure disorders following Roux-en-Y surgery are often posted on epilepsy patient-oriented Web sites such as epilepsy.com, along with reports of other neurologic complications such as Wernicke-Korsakoff syndrome, polyradiculoneuropathy, myelopathy, and optic neuropathy. However, few previous studies have examined a potential connection between gastric bypass and epilepsy, Dr. Richard S. Clemmons and Gregory D. Cascino said in a poster at the annual meeting of the American Epilepsy Society.

A diagnosis of epilepsy pre-existed prior to Roux-en-Y surgery in 12 of 1,542 patients who were operated on at the Mayo Clinic between September 1997 and September 2007. Those patients were selected from a larger group of 1,776 patients because they had more than 1 year of follow-up, had undergone surgery for morbid obesity, and were aged 18 years or older. Despite evidence that gastric bypass surgery might result in decreased absorption of drugs with high proximal absorption or low pH (Am. J. Health Syst. Pharm. 2006;63:1852-7), 8 of these 12 patients had no decrease in drug levels, based on patient report or on serum testing before and after surgery. One patient who did have a low drug level was suspected of poor compliance. None of the 12 had exacerbations of their seizures.

“Based on the limited data here, there was not a decrease in serum drug levels for valproic acid, carbamazepine, or levetiracetam. ... Even patients with significant seizure risk factors did not manifest an exacerbation of seizures,” noted Dr. Clemmons and Dr. Cascino, both of whom were affiliated with the division of epilepsy in the department of neurology at the Mayo Clinic, Rochester, Minn., at the time of the study. Dr. Clemmons is currently in private practice in Denver.

Only 5 of the 1,542 patients developed new-onset epilepsy following surgery. Of those, only 3 (1.9% of the total cohort) could be considered to have unprovoked epilepsy. One of the other two patients had a history of meningoencephalitis and had just a single seizure 2 years after surgery that was possibly associated with hypoglycemia. The other one had a seizure in the setting of a stroke 3 months after surgery. None of the five developed intractable epilepsy.

About three-fourths of the patients in the study were female. Their charts were examined for evidence of seizure exacerbation post surgery, defined as an increase in seizure frequency above preoperative baseline where another cause was not identified. Patient questionnaires were used to supplement where data were lacking.

“Based on the reviewed data, there is no clear exacerbation of preexisting seizure disorder following gastric bypass ... Most patients with seizure disorder do well following Roux-en-Y,” they concluded.

Dr. Clemmons, who presented the poster at the meeting, stated that he had no financial disclosures.

Subject Codes:
gastroenterology; surgery; neurology;

http://www.imng.com

January 11, 2012 03:55 PM EST

Safety of Skin-Sparing Mastectomy Confirmed Short-Term

Tue, 10 Jan 2012 16:46 GMT

BY DIANA MAHONEY
Elsevier Global Medical News
Breaking News

SAN ANTONIO (EGMN) – Total skin-sparing mastectomy with complete preservation of the breast skin envelope was associated with favorable oncologic and ischemic outcomes in a large, high-risk cohort of women who underwent the procedure over a 10-year period in San Francisco, a study has shown.

The findings suggest that the surgery, which produces superior cosmesis and is associated with a high rate of patient satisfaction, is a reasonable option for many women facing therapeutic or prophylactic mastectomy, Dr. Anne G. Warren Peled said at the San Antonio Breast Cancer Symposium.

The total skin-sparing mastectomy (TSSM) allows preservation of the nipple-areola dermal layer when ductal tissue is removed during mastectomy. “The procedure is increasingly offered to women for both therapeutic and prophylactic indications, and when combined with immediate breast reconstruction, can produce excellent aesthetic results,” explained Dr. Warren Peled, a surgical resident at the University of California, San Francisco.

Because the oncologic safety of the procedure and the potential for higher rates of postoperative complications continue to be debated, Dr. Warren Peled and her colleagues sought to evaluate both outcomes using data collected in a prospectively maintained database. The investigators analyzed patient and tumor characteristics, treatment details, and the development of any postoperative complications, as well as local or distant recurrences, for 428 patients (mean age, 46.9 years) who underwent 657 TSSMs and immediate breast reconstruction at the UCSF Medical Center in 2001-2010.

“The mastectomy incisions included radial, lateral, periareolar, and inframammary incisions, and the areolar and nipple complex tissue was separated from the dermal layer of skin by sharp dissection with inversion of the nipple skin to ensure the removal of all of the nipple duct tissue,” Dr. Warren Peled said during a poster discussion. Of the 657 mastectomies, 412 were therapeutic procedures, and 245 (58 bilateral and 187 contralateral) were prophylactic, she said.

Most of the tumors were stage 0 (111) or stage I (135), although stage II (95), III (48), and IV (7) tumors were also observed, Dr. Warren Peled reported. Some 14 mastectomies were for recurrent cancer, she noted. In addition, 210 patients underwent neoadjuvant chemotherapy, 144 had postmastectomy radiation therapy, and 78 had adjuvant chemotherapy, she said.

With respect to nipple involvement on pathological analysis, 11 specimens had evidence of in situ cancer and 9 had evidence of invasive cancer, leading to re-excision in 7 cases, removal of the nipple-areolar complex (NAC) in 9 cases, and NAC radiation in 4 cases, said Dr. Warren Peled.

The conventional, two-stage, expander-implant method – in which a tissue expander placed under the chest muscle is implanted and gradually inflated to expand the tissue in preparation for the synthetic implant 3-6 months later – was used in 80% of the postmastectomy reconstructions, Dr. Warren Peled said. The remaining 20% of the reconstructions included either the placement of a permanent silicon implant at the time of mastectomy (4.7%) or autologous reconstruction (15.3%), she said.

A review of the oncologic outcomes in the 412 patients who underwent therapeutic mastectomies showed that, at a median follow-up of 28 months, four patients (1%) experienced local recurrence only, eight (1.9%) experienced distant recurrence only, and four experienced both local and distant recurrence (1%), Dr. Warren Peled reported. Among the local recurrences, two each were invasive (0.7%) and in situ cancer (1.8%), and among the distant recurrences, all eight (2.7) were invasive cancers. Among those with both local and distant recurrences, three (1%) and one (0.9%) were invasive and in situ, respectively, she said,

Of the 126 patients who had a minimum 36 months’ follow-up (median, 45 months), 2 patients (1.6%) had local recurrence only, one of which was invasive; 1 patient (0.8%) had distant recurrence only; and 1 (0.8%) had both, Dr. Peled said, noting that the recurrences in the latter two patients were invasive.

An assessment of ischemic complications showed 13 cases (1.9%) of partial nipple loss; 10 cases (1.5%) of complete nipple loss, and 78 cases (11.8%) of skin flap necrosis, Dr. Peled said, noting that the group’s current nipple loss rate is lower than 1%, thanks to serial improvements in surgical technique.

The findings indicate that TSSM “can be performed with low rates of nipple involvement and locoregional recurrence,” Dr. Warren Peled stated. Although the short-term findings are encouraging, the study cannot speak to the long-term oncologic safety of the procedure. “Longer term follow-up is needed to confirm the oncologic safety over time,” she said.

Dr. Warren Peled had no relevant financial conflicts to disclose.

Subject Codes:
oncology; womens_health; surgery;

http://www.imng.com

January 10, 2012 11:46 AM EST

Dabigatran Tied to Increase in Heart Attack Risk

Mon, 09 Jan 2012 21:00 GMT

BY MARY ANN MOON
Elsevier Global Medical News
Breaking News

The direct thrombin inhibitor dabigatran appears to raise the risk of myocardial infarction or acute coronary syndromes, according to a meta-analysis of seven randomized clinical trials published online Jan. 9 in the Archives of Internal Medicine.

The meta-analysis included randomized clinical trials assessing the noninferiority of dabigatran against various control treatments including adjusted-dose warfarin, enoxaparin, and placebo, in a broad spectrum of patients using the drug for a variety of indications.

“We used several meta-analytic methods and several association measures, and the results were consistent. Although the relative risk increase was 33%, the absolute risk increase was very small, at 0.27%,” said Dr. Ken Uchino and Dr. Adrian V. Hernandez, both of the Cleveland Clinic.

The mechanism by which dabigatran increases the risk of MI or acute coronary syndrome (ACS) is not yet known. It is possible that the drug doesn’t actively raise this risk, but instead lacks some protective effect that the control treatments possess, the investigators noted.

The meta-analysis covered 30,514 study subjects, including patients with atrial fibrillation who used dabigatran to prevent stroke, patients with atrial fibrillation who used it to prevent acute venous thromboembolism, patients with ACS who used it to prevent recurrent ACS, and patients undergoing joint replacement who used it to prevent deep vein thrombosis.

Overall, patients who received dabigatran were at significantly higher risk of MI or ACS than were control patients. The incidence of these events was 1.19% in those taking dabigatran, compared with 0.79% in control subjects, Dr. Uchino and Dr. Hernandez said (Arch. Intern. Med. 2012 [doi:10.1001/archinternmed.2011.1666]).

Since it is possible that dabigatran’s negative effects may increase with longer duration of use, the investigators performed a separate analysis excluding three of the seven studies that had exceptionally short (less than 1 month) exposure times. The risk of MI or ACS remained high and significant in this analysis of the data, they noted.

An important limitation of the meta-analysis is that a single large trial, with a study population of 18,113 patients, overshadowed the findings from the other 6 trials, which had populations of 515 to 2,451 patients. In addition, the large trial followed patients for a median of 2 years, while the smaller trials did so for 6 months or less.

Because of this imbalance, the large trial accounted for 59% of the meta-analysis cohort and 74% of the cardiovascular events, they said.

Overall, the findings indicate that dabigatran’s cardiovascular risks should be investigated further, “especially if [the drug] is used in populations at high risk of MI or ACS,” they added.

The “robust” finding by Dr. Uchino and Dr. Hernandez that dabigatran is associated with increased MI “is alarming and emphasizes the need for continued critical appraisal of new drugs after phase III trials,” Dr. Jeremy M. Jacobs and Dr. Jochanan Stessman wrote in remarks taken from an invited commentary that accompanied the meta-analysis (Arch. Intern. Med. 2012 [doi:10.1001/archinternmed.2011.1721]).

The researchers’ results “suggest that physicians [should] step back for a moment, take their own pulse, and retain a critical view as a powerful new drug enters clinical use on a potentially massive scale,” Dr. Jacobs of the Jerusalem Institute of Aging Research at Hadassah-Hebrew University Medical Center and Dr. Stessman of the Hebrew University–Hadassah Medical School, Jerusalem.

The findings also highlight another deeply concerning issue: “the enthusiasm – nearly to the level of euphoria – to embrace the new,” they added.

All seven studies included in the meta-analysis were sponsored by the drug manufacturer, Boehringer Ingelheim. No financial conflicts of interest were reported among the investigators for this current study.

Dr. Jacobs and Dr. Stessman reported having no financial conflicts of interest.

Subject Codes:
top_stories; cardiology; surgery; neurology;

http://www.imng.com

January 09, 2012 04:00 PM EST