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    <title>Vascular Device Forum</title>
    
    
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    <updated>2010-05-24T01:07:00-07:00</updated>
    <subtitle>Vascular Device Forum (VDF) provides a convenient medium for the discussion of various peripheral and coronary medical devices. We encourage visitors to provide personal comments to make this a very interactive and informative daily experience. 

"Usually fact, Sometimes Opinion, Always Informative"</subtitle>
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        <link rel="alternate" type="text/html" href="http://www.vasculardeviceforum.com/my_weblog/2010/05/although-underappreciated-by-most-people-except-vascular-proceduralists-management-of-vascular-access-sites-is-the-most-impo.html" />
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        <published>2010-05-24T01:07:00-07:00</published>
        <updated>2010-05-24T01:07:00-07:00</updated>
        <summary>Although, underappreciated by most people except vascular proceduralists-management of vascular access sites is the most important part of any percutaneous intervention. The reliable and consistently successful management of vascular access sites significantly reduces the morbidity associated with complex high volume...</summary>
        <author>
            <name>lee kirksey</name>
        </author>
        
        
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<div xmlns="http://www.w3.org/1999/xhtml"><p>Although, underappreciated by most people except vascular proceduralists-management of vascular access sites is the most important part of any percutaneous intervention. The reliable and consistently successful management of vascular access sites significantly reduces the morbidity associated with complex high volume work. Endovascular Today has a very detailed article describing the currently available products<a href="http://blog.vascularsurgeryexpertwitness.com/.a/6a0120a832abe4970b0133ee4d21aa970b-pi" style="DISPLAY: inline"><img alt="1255" border="0" class="asset asset-image at-xid-6a0120a832abe4970b0133ee4d21aa970b " src="http://blog.vascularsurgeryexpertwitness.com/.a/6a0120a832abe4970b0133ee4d21aa970b-800wi" title="1255" /></a> <br /></p>
<p>This is the eighth year that I have had the privilege of writing the annual Overview of Vascular Closure in <em>Endovascular Today</em>. There were a number of developments in the past year, including new device approvals and changes in existing closure platforms. Vascular closure continues to grow toward the eventual billion- dollar mark, as an ever-expanding range of endovascular procedures drives the need for more efficient closure at the end of procedures. In addition, a changing reimbursement landscape, with slowly increasing adoption of outpatient interventions in the United States, will likely drive vascular closure device (VCD) use (as well as increasing transradial interventions). Although the intellectual property space is narrowing, a number of creative concepts are being explored, some of which will be covered in this edition of our annual overview.</p>
<p><a href="http://vascularsurgeryexpertwitness.com" /> </p>
<p>I will review the existing technologies, discuss new devices receiving US Food and Drug Administration (FDA) clearance, and touch on some not-yet-ready for market platforms. I continue to find it useful, for both new readers as well as those familiar with the classification system, to show the various technologies classified by category (Figures 1 through 7); this time, I have included FDA-approved devices as well as some in various stages of development. This classification system, first introduced in <em>Endovascular Today</em>, provides a conceptual framework to allow comparison of VCDs and to anticipate the potential strengths and weaknesses of each device. I will review select items from the past year’s medical literature and will expound on fluoroscopy-guided access (see <em>What Should Fluoroscopic Guidance Really Entail?</em>).</p>
<p><a href="http://www.bmctoday.net/evtoday/2010/05/article.asp?f=overview-of-vascular-closure">Source</a></p></div>
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    </entry>
    <entry>
        <title>What is the role of atherectomy, angioplasty and stenting in SFA-Perspectives</title>
        <link rel="alternate" type="text/html" href="http://www.vasculardeviceforum.com/my_weblog/2010/05/what-is-the-role-of-atherectomy-angioplasty-and-stenting-in-sfaperspectives.html" />
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        <published>2010-05-03T09:43:00-07:00</published>
        <updated>2010-05-03T09:43:00-07:00</updated>
        <summary>From Endovascular Today, Dr Garcia shares his frank perspectives on the state of treatments for the SFA: What level of symptoms dictates that a patient should undergo vascular intervention for superficial femoral artery (SFA) disease? The answer may be elusive...</summary>
        <author>
            <name>lee kirksey</name>
        </author>
        
        
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<div xmlns="http://www.w3.org/1999/xhtml"><p><strong>From Endovascular Today, Dr Garcia shares his frank perspectives on the state of treatments for the SFA: </strong></p>
<p><strong>What level of symptoms dictates that a patient should  undergo vascular intervention for superficial femoral  artery (SFA) disease?</strong><br />  The answer may be elusive in some patients.   The typical  response is that revascularization is necessary when  lifestyle-limiting claudication occurs. This limitation, however,  takes several forms, which to one  person may not be critical, but to another  may be significant. For example, a  grandparent with limited mobility would  be happy to ambulate enough to follow  his or her grandchildren through the  course of a day, which may only necessitate  walking 200 to 500 feet at any one  time. But this distance may not be  enough for a golfer, for example, who can  only walk two holes instead of his or her  usual nine or 18.</p>
<p><strong>With all of the device options available for treating   SFA  disease, how do you decide which platform is best for a  particular patient?</strong><br />  The SFA remains a very difficult location to   determine the  best endovascular treatment method based on current evidence.  If we look at all of the currently available devices, we  can generally place them into several key categories: medical  therapy, balloon angioplasty, stent placement (open or  graft), and atheroablative technology (excisional, laser, or  rotational). All patients, regardless of lesion status, should  receive best medical therapy and include an exercise program  (when appropriate), hypertension control, and  lipid/diabetes control. To me, the data, although not crystal  clear, have suggested that for short focal lesions (TASC A) in  this territory, percutaneous transluminal angioplasty (PTA)  is a very good start, with acceptable patency rates of 70% or  higher. Other forms of revascularization&amp;mdashlstenting or the  atheroablative technologies—have equally good results, but  the general costs of the atheroablative technologies make  this approach for these lesions less attractive unless proven  to be more cost effective.</p>
<p>For longer or more complex TASC B or C lesions,  ABSOLUTE and the subsequent DURABILITY trials suggest  stenting to be far better in the first year than angioplasty  alone (63% vs 37%, respectively). However, the benefit of  this approach quickly dwindles in the second year such that the   endoprosthesis benefit is nearly lost, although still with  a higher primary patency rate compared with angioplasty  alone, demonstrated in the 2-year ABSOLUTE data (54% vs  33%, respectively). For longer lesions, the use of covered  stent technologies has not translated to improved primary  patency rates at the end of the first year, as shown in  VIBRANT (53%). Further, the alternative  atheroablative therapies have a poor primary  patency rate in the first year at nearly  40% to 50% at this length; the benefit  through the second year is similar to that  of stents and provides some evidence that  a nonstenting approach may afford a longterm  clinical and anatomic benefit comparable  to stents.</p>
<p>No device to date has shown great utility  in long total occlusions and calcified  arteries (TASC D) in the SFA. Currently,  there are no compelling data in this patient  subset to the point that no trial (with the exception of  VIBRANT) has enrolled this type of patient with highly difficult  long occlusions or stenoses, and no trial likely will. We  have very little data on calcified lesions. What is the best  way to treat these lesions? Should we use PTA alone or  does this lesion subset require changes in arterial compliance  through rotational atherectomy devices to then placate  the artery to then balloon or stent? These data are  early in their formulations, and no definitive conclusions  can be drawn as of yet on their usefulness or applications  in these specific locations.</p>
<p><strong>How would you summarize   your own approach to the  various lesion types?</strong><br />  For TASC A lesions, I perform PTA first,   with provisional  stenting second. Atheroablative treatment is acceptable,  although the costs may be prohibitive. For TASC B and C, I  perform stenting primarily with the understanding that I  will have a 50/50 chance that the stent is patent at the end  of 2 years. Patients need to be aware of and understand this  possibility. Atheroablative technologies may provide primary  patency rates in the same ballpark as stents at the  end of 2 years and thus may be an attractive approach in  this patient group for both clinical and anatomic patency.  For TASC D lesions, I suggest starting with stenting. If this fails at   the end of 6 to 12 months, it is time to consider surgical  revascularization.</p>
<p>What remains unclear is in which   lesions, if any, drug-eluting  balloons or drug-eluting stents will play a role in the SFA.  The THUNDER trial and the early registry data from Zilver  PTX (Cook Medical, Bloomington, IN) seem to show us that  in the future, revascularization in the SFA will incorporate  these antirestenotic technologies in some form. However,  the expectation is high that they will provide a great benefit  in this very difficult territory.</p>
<p><strong>What is one of the most   important techniques or strategy  adjustments you have made since your initial experiences  using atherectomy in the SFA?</strong><br />  Early in our experience, we   believed that atherectomy was  a sound alternative to stenting given the extremely dynamic  nature of the SFA; leaving an endoprosthesis behind was less  attractive. I would still argue that the clinical benefit of  atheroablative technologies is very good. However, clinical  benefit and durability are not the same, with the primary  patency rates of atherectomy in longer lesions or multilevel  disease being near or below 50%.My biggest adjustment  has been that we treat longer lesions, TASC C, or the totally  occluded, TASC D, arteries with stenting rather than  atherectomy with the understanding that we will likely be  returning to retreat in 12 months and perform surgical  revascularization in 2 to 3 years.</p>
<p><strong>What is the current   focus of your research in the SFA?</strong><br />  My principal research focus   has been technologic development  in the SFA—searching for the “perfect” combination  therapy to obtain the best primary patency rate and  durable clinical benefit in patients with claudication or limb  ischemia.</p>
<p>DEFINITIVE LE is a   registry trial evaluating SilverHawk  atherectomy (ev3 Inc., Plymouth, MN) in a real-world registry.  This trial, in which I serve with Jim McKinsey, MD, of  New York, as global principal investigators, will be the  largest peripheral trial ever completed to date, evaluating  800 patients with peripheral arterial disease. The protocol  includes patients with infrainguinal disease and will treat  patients with claudication as well as critical limb ischemia.  Patients with diabetes will be evaluated regarding their outcomes  with SilverHawk, and we will also perform plaque  analysis in a subgroup to further define some proteonomic  signals in the treatment of our patients with peripheral vascular  disease. Primary endpoints will be primary patency  rate of the lesions at 12 months, followed further for the  claudicant group, and limb salvage rates for the critical limb  ischemia patients. The trial is currently enrolling and will  likely be completed in late 2010.</p>
<p>SUPERB is   a stent registry evaluating the Supera stent  (Idev Technologies Inc., Webster, TX) in an objective performance  criteria-driven evaluation of the stent for  infrainguinal disease. This trial, for which I serve as a conational  principal investigator with Ken Rosenfield, MD, of  Boston, will seek US Food and Drug Administration  approval for the stent in the SFA. This unique stent with  an interwoven nitinol design allows unusually high flexibility  without any significant compromise of radial  strength. This design allows for the unique vessel forces of  the SFA to be relatively unchanged despite the stent presence  but still allows significant radial force to scaffold the  artery where needed. This trial is currently enrolling and  should be completed in 2010.</p>
<p>I also serve as the Data and Safety Monitoring Board  chairman for other trials and serve on the steering committees  of several other trials.</p>
<p><strong>What are the most significant   unanswered clinical questions  that future trials and studies must seek to address?</strong><br />  Unfortunately,   it remains the same issue that Andreas  Grüntzig raised after his PTA result in 1978: PTA may be  useful if we can show scientifically that it is superior to surgery.  Unfortunately, the data as we know it in the SFA territory  are exceedingly poor. In lieu of “getting an indication”  for the SFA by enrolling short lesions or the patient subset  in which we know the technology performs well, we need  to see the data in real-world patients with long SFA lesions  and occlusions to know the best evidence-based approach  for our patients. We need to be able to effectively discuss  with them all of these issues and understand their expectations  for any and all outcomes to make the best decision  available.</p>
<p><a href="http://www.bmctoday.net/evtoday/2010/04/article.asp?f=an-interview-with-lawrence-a-garcia-md" title="Interview from EV Today">Source</a></p></div>
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    </entry>
    <entry>
        <title>Alternatives to office based laser and radiofrequency ablation of incompetent veins</title>
        <link rel="alternate" type="text/html" href="http://www.vasculardeviceforum.com/my_weblog/2010/05/alternatives-to-office-based-laser-and-radiofrequency-ablation-of-incompetent-veins.html" />
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        <published>2010-05-01T09:38:46-07:00</published>
        <updated>2010-05-01T09:38:46-07:00</updated>
        <summary>The technology for varicose vein treatment continues to evolve. Currently most physicians use some form of laser or radiofrequency ablation for saphenous vein incompetence associated with insufficiency signs. Another alternative is now being investigated: April 21, 2010—Vascular Insights LLC (Madison,...</summary>
        <author>
            <name>lee kirksey</name>
        </author>
        
        
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<p>The technology for varicose vein treatment continues to evolve. Currently most physicians use some form of laser or radiofrequency ablation for saphenous vein incompetence associated with insufficiency signs. Another alternative is now being investigated:</p>
<br />
<p>April 21, 2010—Vascular Insights LLC (Madison, CT) announced results from the initial clinical trial of its ClariVein catheter for the treatment for varicose veins. The device combines mechanical and chemical modalities to accomplish vein treatment in an in-office setting. Vascular Insights has received 510(k) clearance from the US Food and Drug Administration to market ClariVein for infusion of physician-specified agents in the peripheral vasculature. Principal investigator Steve Elias, MD, stated, “Results were excellent. The initial success rate is equal to that from radiofrequency or laser treatment of great saphenous vein disease.”</p>
<p>According to the company, 30 patients with an average age of 55 years were part of this first-in-man trial. Most patients had symptomatic varicose veins, with some having more advanced vein disease such as swelling and skin changes. Mean vein diameter was 8.1 mm. Treatment for each vein averaged 5 minutes and overall procedure time was 14 minutes.</p>
<p>At 6-month follow-up, 29 of the 30 veins treated were successfully closed. The only vein that did not respond was that of the first patient. Subsequent to the trial, 22 other patients had the ClariVein procedure, all of which were successful.</p>
<p>“The main advantage of this new technique in comparison to older endovenous therapies is that it does not require tumescent anesthesia infusion, saving significant time and decreasing patient discomfort,” commented Dr. Elias. “In addition, a generator is not required, and therefore capital and maintenance cost is reduced. This in-office procedure takes about 15 minutes to perform and patients resume normal activity that day, including exercise.”</p>
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    </entry>
    <entry>
        <title>Keeping patients safe in a culture of fear from NY Times</title>
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        <id>tag:typepad.com,2003:post-6a00e54ed1b996883301310fd9a8fa970c</id>
        <published>2010-03-24T18:31:03-07:00</published>
        <updated>2010-03-24T18:31:03-07:00</updated>
        <summary>One afternoon during my training, I watched as one of my closest friends, another surgery resident, was led into the office of the department chief. A week earlier she had been on call when a patient developed a rapid and...</summary>
        <author>
            <name>lee kirksey</name>
        </author>
        <category scheme="http://www.sixapart.com/ns/types#category" term="Medical Malpractice" />
        
        
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<div xmlns="http://www.w3.org/1999/xhtml"><p>One afternoon during my training, I watched as one of my closest friends, another surgery resident, was led into the office of the department chief. A week earlier she had been on call when a patient developed a rapid and irregular heart rhythm. He became unconscious and would have soon died if my friend had not stepped in and resuscitated him. 
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<p>Her intervention, I thought, really proved her mettle. </p>
<p>But there had been a misunderstanding that night about the timing of one of the medications administered. Questions turned into a heated discussion between my friend and a nurse, and what should have been cause for celebration quickly turned into a blistering debate. The next morning, my friend found herself the subject of an “incident report,” a form that hospital workers can use to report accidents. The nurse believed my friend had committed malpractice by ordering the medication too quickly, despite her saving the patient’s life. </p>
<p>“It doesn’t matter if I’m right or wrong,” my friend told me after learning of the report. “That incident report will be a permanent mark on my record.” </p>
<p>I could not argue with her; she was expressing what all of us doctors-in-training believed to be true. While we often talked about errors among ourselves, dissecting the events with great precision, we also went out of our way to avoid any formal documentation of mistakes we had seen. For it seemed that once these mishaps were discussed in department meetings or written up, the narratives called out for someone who could be held accountable. Incident reports, described to us on our first day on the job as a tool for decreasing errors and increasing transparency, became a way for others in the hospital “to hang the residents out to dry.” </p>
<p>Even now, my heart skips a beat when I hear the words “incident report.” </p>
<p>But over the last decade, <a class="meta-classifier" href="http://topics.nytimes.com/top/news/health/diseasesconditionsandhealthtopics/hospitals/index.html?inline=nyt-classifier" title="Recent and archival health news about hospitals."><font color="#004276">hospitals</font></a> have increasingly made patient safety a priority. Incorporating the lessons learned in high-risk industries like aviation and nuclear energy, medical centers across the country have begun promoting protocols, procedures and checklists to prevent health care errors. </p>
<p>Chief among these initiatives has been a push for greater disclosure and transparency — and less fear. We should talk about our errors. We should, if necessary, bring up the topic with one another. We should say we’re sorry. And we should write up incident reports. All of this, doctors have been assured, will improve safety while decreasing blame and the risk of malpractice lawsuits. </p>
<p>But a recent study indicates that current doctors-in-training may still be hesitant to document errors. Last month, <a href="http://www.ingentaconnect.com/content/jcaho/jcjqs/2010/00000036/00000001/art00007" title="The Joint Commission report."><font color="#004276">The Joint Commission Journal on Quality and Patient Safety reported</font></a> that the majority of residents have never written up an incident report. And according to <a href="http://www.npsf.org/download/LLI-Unmet-Needs-Report.pdf" title="Lucian Leape report (PDF)."><font color="#004276">a paper issued this week</font></a> from a committee of leading experts in medical education and health care working with the Lucian Leape Institute of the National Patient Safety Foundation, young doctors are still going out into practice with little education or training in patient safety. </p>
<p>Changing a health care culture that undermines some of the most important principles of error reduction — trust, teamwork and communication — has proved to be much more difficult than a safety checklist would lead one to assume. </p>
<p>“Young doctors are being educated in a toxic culture,” said Dr. Lucian L. Leape, a leading patient safety expert at the Harvard School of Public Health who was chairman of the report’s committee. “The current environment is hierarchical, stressful for the individual, driven by the fee-for-service payment system and humiliating, all of which works against improving patient safety.” To ensure safer health care, doctors-in-training need time to reflect on their actions, a sense of community with colleagues and other health care workers, and the support to engage freely in disclosing errors. </p>
<p>Remarkably, <a class="meta-classifier" href="http://topics.nytimes.com/top/news/health/diseasesconditionsandhealthtopics/medical_schools/index.html?inline=nyt-classifier" title="Recent and archival health news about medical schools."><font color="#004276">medical schools</font></a> and clinical training programs have long neglected patient safety in their required curriculum, but in the last few years, several institutions have tried to do so, with varying degrees of success. Many have had difficulty finding financial support, supportive leadership and experienced physician-teachers with formal training in patient safety. </p>
<p>And without appropriate expertise and leadership, institutions are at risk of overlooking even the obvious. In the study of residents and incident reports, for example, researchers found that hospital administrators and educators had told most of the trainees about the importance of patient safety. “But the residents were not aware of the procedure for filling out incident reports or even where they could find the forms,” said Rangaraj Ramanujam, an associate professor of management at the Owen Graduate School of Management at <a class="meta-org" href="http://topics.nytimes.com/top/reference/timestopics/organizations/v/vanderbilt_university/index.html?inline=nyt-org" title="More articles about Vanderbilt University"><font color="#004276">Vanderbilt University</font></a> in Nashville and senior author of the study. “It seems procedural and mundane, but in terms of shaping behavior, this kind of basic information is pretty important.” </p>
<p>The reward for institutions that have managed to make patient safety education a priority has been dramatic for both students and patients. Six years ago, the <a class="meta-org" href="http://topics.nytimes.com/top/reference/timestopics/organizations/u/university_of_illinois/index.html?inline=nyt-org" title="More articles about University of Illinois"><font color="#004276">University of Illinois</font></a> at Chicago College of Medicine instituted an extensive patient safety education program that involved a series of required workshops and lectures for medical students beginning in their first year. Graduates have since gone on to take leading roles in patient safety at other hospital systems and academic medical centers. More recently, the university has begun incorporating safety education into their residency programs. Residents at the medical center, who once feared incident reports and filed none, now submit over 100 a month. </p>
<p>“We are a much safer hospital now,” said Dr. David Mayer, co-executive director of the medical school’s Institute for Patient Safety Excellence. “We have been fortunate enough to have incredible leadership in the medical center that has allowed us to move forward with this. No one would ask twice about</p>
<p><a href="http://www.nytimes.com/2010/03/11/health/11chen.html" title="ny times">read more</a></p></div></div>
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    </entry>
    <entry>
        <title>Proposed medicare paycuts threaten cardiology and other vascular specialties</title>
        <link rel="alternate" type="text/html" href="http://www.vasculardeviceforum.com/my_weblog/2010/03/proposed-medicare-paycuts-threaten-cardiology-and-other-vascular-specialties.html" />
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        <id>tag:typepad.com,2003:post-6a00e54ed1b99688330120a95791eb970b</id>
        <published>2010-03-19T17:36:29-07:00</published>
        <updated>2010-03-19T17:36:29-07:00</updated>
        <summary>As Healthcare Reform legislation awaits approval, CMS cuts loom large over cardiology and other vascular specialties. No tort reform in the legislation and impending cuts suggests more of the same for physicians. CMS Proposes Major Payment Cuts for Cardiology The...</summary>
        <author>
            <name>lee kirksey</name>
        </author>
        <category scheme="http://www.sixapart.com/ns/types#category" term="Current Affairs" />
        
        
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<div xmlns="http://www.w3.org/1999/xhtml"><h2 align="left"><strong style="FONT-SIZE: 13px">As Healthcare Reform legislation awaits approval, CMS cuts loom large over cardiology and other vascular specialties. No tort reform in the legislation and impending cuts suggests more of the same for physicians.</strong></h2>
<h2 align="center"><strong>CMS Proposes Major Payment Cuts for Cardiology</strong><span size="3" style="font-family: Arial, Helvetica, sans-serif;"><br /></span></h2>
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<p>The Centers for Medicare and Medicaid Services (CMS) today released its proposed 2010 Medicare Physician Fee Schedule, which includes policy proposals that would significantly reduce payments for cardiovascular-related services. CMS projects that the proposed changes would reduce total Medicare payments to cardiology by 11 percent. The projected payment cut would result from the following policy proposals: <br /></p>
<p><strong>Practice Expense</strong>: CMS has proposed incorporating the results of the American Medical Association’s Physician Practice Information Survey into its formula for calculating practice expense relative value units (RVUs). If implemented, this proposal alone would decrease total Medicare payments to cardiology by 10 percent. However, with the exception of evaluation and management services, nearly all services that cardiologists perform would see cuts ranging from 10 percent to more than 40 percent for individual services. A few key examples: </p>
<ul>
<li>Transthoracic echo with spectral and color flow Doppler (93306): 42 percent cut 
<li>Left heart catheterization (93510-26): 24 percent cut 
<li>EKG: 21 percent cut 
<li>Level 4 established patient office visit (99214): 11 percent increase </li>
</li></li></li></ul>
<p><strong>Equipment utilization</strong>: CMS proposes adopting the Medicare Payment Advisory Commission’s (MedPAC) recommendation to change the agency’s formula for calculating the per-procedure cost of medical equipment worth more than $1 million. The proposal would assume that all equipment with an acquisition cost greater than $1 million is used 90 percent of the time an office is open, thus driving down the practice expense RVUs for services using that equipment. Within cardiology, cardiac MR, cardiac CT, and non-hospital cardiac catheterization services would see payment cuts as a result of this change.<br /><br /><strong>Malpractice</strong>: CMS proposes to update the malpractice RVUs with data from a new survey of specialty-level malpractice premiums. In addition, CMS has proposed a new method for determining malpractice RVUs for technical component services. The proposed new malpractice RVUs would reduce cardiology payments by 1 percent.</p>
<p><a href="http://www.acc.org/advocacy/advoc_issues/cmspaymentcut.cfm" title="cms cardiology cuts">Read complete article</a></p></div>
</content>



    </entry>
    <entry>
        <title>Randomized Prospective study shows benefit of Bards Flair</title>
        <link rel="alternate" type="text/html" href="http://www.vasculardeviceforum.com/my_weblog/2010/03/randomized-prospective-study-shows-benefit-of-bards-flair.html" />
        <link rel="replies" type="text/html" href="http://www.vasculardeviceforum.com/my_weblog/2010/03/randomized-prospective-study-shows-benefit-of-bards-flair.html" thr:count="0" />
        <id>tag:typepad.com,2003:post-6a00e54ed1b996883301310faaba3c970c</id>
        <published>2010-03-16T12:41:24-07:00</published>
        <updated>2010-03-16T12:41:24-07:00</updated>
        <summary>A recently published article in the NEJM in which Haskal et al compared POBA in hemodialysis access grafts versus Bard's Flair stent graft in a prospective, randomized fashion showed a statistically significant patency benefit as well as freedom from restenosis...</summary>
        <author>
            <name>lee kirksey</name>
        </author>
        
        
<content type="xhtml" xml:lang="en-US" xml:base="http://www.vasculardeviceforum.com/my_weblog/">
<div xmlns="http://www.w3.org/1999/xhtml"><p><a href="http://www.vasculardeviceforum.com/.a/6a00e54ed1b996883301310faab707970c-pi" style="DISPLAY: inline"><img alt="20852_1" border="0" class="asset asset-image at-xid-6a00e54ed1b996883301310faab707970c " src="http://www.vasculardeviceforum.com/.a/6a00e54ed1b996883301310faab707970c-800wi" title="20852_1" /></a> <br /> A recently published article in the NEJM in which Haskal et al compared POBA in hemodialysis access grafts versus Bard's Flair stent graft in a prospective, randomized fashion showed a statistically significant patency benefit as well as freedom from restenosis for the covered graft from Bard. Although this study looked at short term results and it is unlcear what the severity of recurrence will be for the covered stent device-the study makes a compelling argument that POBA for HD grafts is losing favor.</p>
<p>6 month patency 51% vs 23% in stent graft vs POBA</p>
<p>binary restenosis greater in POBA group vs stent graft 78% 28% respectively</p></div>
</content>



    </entry>
    <entry>
        <title>Long awaited CREST data suggest equivalence between stenting and surgery</title>
        <link rel="alternate" type="text/html" href="http://www.vasculardeviceforum.com/my_weblog/2010/03/long-awaited-crest-data-suggest-equivalence-between-stenting-and-surgery.html" />
        <link rel="replies" type="text/html" href="http://www.vasculardeviceforum.com/my_weblog/2010/03/long-awaited-crest-data-suggest-equivalence-between-stenting-and-surgery.html" thr:count="0" />
        <id>tag:typepad.com,2003:post-6a00e54ed1b99688330120a8e81b29970b</id>
        <published>2010-03-01T13:36:55-08:00</published>
        <updated>2010-03-01T13:36:55-08:00</updated>
        <summary>February 26, 2010—Long-awaited results from the CREST (Carotid Revascularization Endarterectomy versus Stenting Trial) study were presented today for the first time at the American Stroke Association’s Annual International Stroke Conference 2010, which convened on February 24–26 in San Antonio, Texas....</summary>
        <author>
            <name>lee kirksey</name>
        </author>
        <category scheme="http://www.sixapart.com/ns/types#category" term="Carotid Angioplasty and Stenting (CAS)" />
        
        
<content type="xhtml" xml:lang="en-US" xml:base="http://www.vasculardeviceforum.com/my_weblog/">
<div xmlns="http://www.w3.org/1999/xhtml"><p>February 26, 2010—Long-awaited results from the <a href="http://www.clinicaltrials.gov/ct2/show/NCT00004732">CREST</a> (Carotid Revascularization Endarterectomy versus Stenting Trial) study were presented today for the first time at the <a href="http://strokeconference.americanheart.org/portal/strokeconference/sc/">American Stroke Association’s Annual International Stroke Conference 2010</a>, which convened on February 24–26 in San Antonio, Texas. The CREST Executive Committee met recently to take a first look at this very large data set and prepared the manuscript of the outcome results that was presented.</p>
<p>CREST is comparing stent-assisted carotid angioplasty (CAS) to carotid endarterectomy (CEA) for the treatment of carotid artery stenosis to prevent recurrent strokes in those patients who have had a transient ischemic attack (TIA) or a mild stroke within the previous 6 months (symptomatic) and in those patients who have not had any symptoms within the previous 6 months (asymptomatic). The study is sponsored by the <a href="http://www.umdnj.edu/crestweb/">University of Medicine and Dentistry of New Jersey</a> in collaboration with the US National Institute of Neurological Disorders and Stroke (NINDS). Thomas G. Brott, MD, is the principal investigator for CREST.</p>
<p>Enrollment in the CREST study commenced in December 2000 with an anticipated total enrollment of 2,500 patients and a completion date of December 2011 for collection of data for primary outcome measure. The investigators now report that the current data encompass 2,502 patients enrolled at more than 100 centers in North America. More than 80% of the participants had an artery blockage &gt; 70%.</p>
<p><a href="http://www.bmctoday.net/evtoday/2010/02/article.asp?f=crest-data-show-equivalence-between-cas-and-cea" title="CREST data from EV Today">Read more</a></p></div>
</content>



    </entry>
    <entry>
        <title>President Obama struggles with personal addiction</title>
        <link rel="alternate" type="text/html" href="http://www.vasculardeviceforum.com/my_weblog/2010/03/president-obama-struggles-with-personal-addiction.html" />
        <link rel="replies" type="text/html" href="http://www.vasculardeviceforum.com/my_weblog/2010/03/president-obama-struggles-with-personal-addiction.html" thr:count="0" />
        <id>tag:typepad.com,2003:post-6a00e54ed1b99688330120a8e80c34970b</id>
        <published>2010-03-01T13:25:36-08:00</published>
        <updated>2010-03-01T13:25:36-08:00</updated>
        <summary>There is no doubt that the tobacco is one of the most addictive agents known to man, responsible for millions of cumulative deaths, illnessess and cases of disability. The broad antismoking campaign including significant tax increases ("sin tax") have made...</summary>
        <author>
            <name>lee kirksey</name>
        </author>
        
        
<content type="xhtml" xml:lang="en-US" xml:base="http://www.vasculardeviceforum.com/my_weblog/">
<div xmlns="http://www.w3.org/1999/xhtml"><p>
<p>There is no doubt that the tobacco is one of the most addictive agents known to man, responsible for millions of cumulative deaths, illnessess and cases of disability. The broad antismoking campaign including significant tax increases ("sin tax") have made some progress in this effort. However, we still have a long way to go. It seems that President Obama also suffers from hyperlipidemia. This is not really vascular device stuff but it may be if the First lady doesn't take some corrective action. We wish the President the best of luck in his personal battle</p>
<div class="off" jquery1267477995755="6" style="FONT-SIZE: 12px; FLOAT: right; MARGIN: auto auto auto 5px; WIDTH: 232px; LINE-HEIGHT: 12px">
<div class="blog-captioned-photo0" jquery1267477995755="5">
<div class="photo-container" jquery1267477995755="4" style="CLEAR: both; PADDING-RIGHT: 0px; PADDING-LEFT: 0px; PADDING-BOTTOM: 0px; PADDING-TOP: 0px; POSITION: relative; HEIGHT: 213px"><span jquery1267477995755="3"><a href="http://i.usatoday.net/communitymanager/_photos/the-oval/2010/02/28/obama-thumbsx-large.jpg" jquery1267477995755="2" target="_blank"><img alt="" credit="By J. Scott Applewhite, AP" cutline="President Obama after his physical Sunday." height="211" src="http://i.usatoday.net/communitymanager/_photos/the-oval/2010/02/28/obama-thumbsx-inset-community.jpg" style="BORDER-RIGHT: #666 1px solid; BORDER-TOP: #666 1px solid; FLOAT: none; MARGIN: 0px; BORDER-LEFT: #666 1px solid; BORDER-BOTTOM: #666 1px solid" width="230" /></a></span> 
<div class="legend" style="FONT-SIZE: 10px; Z-INDEX: 20; FILTER: alpha(opacity=70); LEFT: 0px; VISIBILITY: hidden; WIDTH: 232px; COLOR: #fff; BOTTOM: 1px; POSITION: absolute; BACKGROUND-COLOR: #000; opacity: 0.7; moz-opacity: 0.7">
<div class="wording" style="MARGIN: 5px; FONT-FAMILY: Arial,Helvetica,sans-serif">President Obama after his physical Sunday.</div></div></div>
<div class="controls">
<div class="label" style="FLOAT: left; WIDTH: 100px"><a href="javascript:void(0)" jquery1267477995755="7" style="PADDING-RIGHT: 0px; PADDING-LEFT: 11px; FONT-SIZE: 10px; BACKGROUND: url(http://i.usatoday.net/_common/_images/caption0.gif) no-repeat left 50%; PADDING-BOTTOM: 0px; COLOR: #666; PADDING-TOP: 0px"><font color="#666666">CAPTION</font></a></div>
<div class="credit" style="FONT-SIZE: 10px; FLOAT: left; WIDTH: 132px; COLOR: #666; TEXT-ALIGN: right">By J. Scott Applewhite, AP</div></div></div></div>It seems President Obama, reformed cigarette smoker, is having trouble completely kicking the habit.
<p />
<p>
<p>Echoing Obama's comments on the tobacco topic in June, spokesman Robert Gibbs said the president still occasionally "falls of the wagon," just like others who have struggled to quit smoking for good.</p>
<p>"The president continues to chew nicotine gum," Gibbs noted. He added that he doesn't know where in the White House the president might go away to sneak a smoke.</p>
<p>"I don't doubt that he would tell you that he wishes once and for all he could wipe away that struggle," Gibbs said. "I know he works on it each and every day."</p>
<p>While Obama sailed through his physical yesterday with high marks, the medical report citing ongoing efforts at smoking "cessation."</p>
<p>The report also cited a spike in Obama's bad cholesterol, meaning Obama will have to cut down on his share of sweets -- no easy task when living in a house with its own pastry chef.</p>
<p>"Look," Gibbs said, "those guys make good desserts over there."</p>
<p>Just because Obama is thin -- 6-1, 180 pounds -- doesn't mean always eats as well as he should, the spokesman added.</p>
<p>By the way, here is the full transcript of what Obama said in June about smoking.</p>
<blockquote>
<p>Q: How many cigarettes a day do you now smoke? Do you smoke alone or in the presence of other people? And do you believe the new law would help you to quit? If so, why?</p>
<p>THE PRESIDENT: Well, first of all, the new law that was put in place is not about me, it's about the next generation of kids coming up. So I think it's fair, Margaret, to just say that you just think it's neat to ask me about my smoking, as opposed to it being relevant to my new law. (Laughter.) But that's fine, I understand. It's an interesting human -- it's an interesting human interest story.</p>
<p>But I've said before that, as a former smoker, I constantly struggle with it. Have I fallen off the wagon sometimes? Yes. Am I a daily smoker, a constant smoker? No. I don't do it in front of my kids, I don't do it in front of my family, and I would say that I am 95 percent cured, but there are times where -- (laughter) -- there are times where I mess up.</p>
<p>And, I mean, I've said this before. I get this question about once every month or so, and I don't know what to tell you, other than the fact that, like folks who go to AA, once you've gone down this path, then it's something you continually struggle with, which is precisely why the legislation we signed was so important, because what we don't want is kids going down that path in the first place. Okay?</p></blockquote>
<p><em>(Posted by David Jackson)</em></p></p></p></div>
</content>



    </entry>
    <entry>
        <title>Risk Of Dialysis Access Failure Reduced By Combination Of Aspirin And Anti-Clotting Drug</title>
        <link rel="alternate" type="text/html" href="http://www.vasculardeviceforum.com/my_weblog/2010/02/risk-of-dialysis-access-failure-reduced-by-combination-of-aspirin-and-anti-clotting-drug.html" />
        <link rel="replies" type="text/html" href="http://www.vasculardeviceforum.com/my_weblog/2010/02/risk-of-dialysis-access-failure-reduced-by-combination-of-aspirin-and-anti-clotting-drug.html" thr:count="0" />
        <id>tag:typepad.com,2003:post-6a00e54ed1b996883301310f3b50e3970c</id>
        <published>2010-02-25T14:01:59-08:00</published>
        <updated>2010-02-25T14:01:59-08:00</updated>
        <summary>For the first time, a combination of aspirin and the anti-platelet drug dipyridamole has been shown to significantly reduce blockages and extend the useful life of new artery-vein access grafts used for hemodialysis, according to a study by the Dialysis...</summary>
        <author>
            <name>lee kirksey</name>
        </author>
        <category scheme="http://www.sixapart.com/ns/types#category" term="Access Management" />
        
        
<content type="xhtml" xml:lang="en-US" xml:base="http://www.vasculardeviceforum.com/my_weblog/">
<div xmlns="http://www.w3.org/1999/xhtml">For the first time, a combination of aspirin and the anti-platelet drug dipyridamole has been shown to significantly reduce blockages and extend the useful life of new artery-vein access grafts used for hemodialysis, according to a study by the Dialysis Access Consortium (DAC). The study, supported by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), part of the National Institutes of Health, will be published in the May 21, 2009, <em>New England Journal of Medicine</em>. <br /><br />Artery-vein access grafts, called arteriovenous (AV) grafts, fail most often due to narrowing of blood vessels (stenosis) at the graft site and subsequent clotting, which block the flow of blood. A blocked graft cannot be used for dialysis and is a major cause of worsening health in dialysis patients. <br /><br />The DAC trial found that the combination treatment decreased the rate of loss of primary unassisted graft patency - the useful life of a graft before it becomes blocked the first time - by 18 percent and the rate of developing significant stenosis by 28 percent, compared to placebo. Previous smaller clinical trials of anti-clotting therapies failed to show that these drugs improve AV graft patency or that they could be used safely in dialysis patients. <br /><br />"This drug combination provides a modest but important new therapy to keep AV grafts in good working order so patients can get the dialysis they need," said NIDDK Director Griffin P. Rodgers, M.D. "But clearly more research is needed to extend the useful life of AV grafts." <br /><br />A total of 649 participants with new AV grafts were recruited for the trial at 13 clinical sites in the United States and were randomly assigned to treatment with dipyridamole plus aspirin or to a placebo. The trial took place over a period of five years. <br /><br />"Our trial results show that we now have a drug therapy that significantly prolongs the viability of AV grafts," said Bradley S. Dixon, M.D., of the University of Iowa College of Medicine, Iowa City, and lead author of the study. "This is an important step forward as we proceed to develop therapies to improve dialysis patients' quality of life." <br /><br />According to the 2008 U.S. Renal Data System Annual Data Report, more than half a million patients have kidney failure, 70 percent of whom are on dialysis. Costs for kidney failure are more than $30 billion. Annual costs of vascular access-related procedures in the United States have been estimated to exceed $1 billion. <br /><br />Boehringer Ingelheim Pharmaceuticals, Inc. provided the study drugs and placebo at no cost and provided additional funding as well. The company was not involved in the design of the study, the analysis of data, or the preparation of the manuscript. <br /><br />Source: <br />Arthur Stone <br />NIH/National Institute of Diabetes and Digestive and Kidney Diseases</div>
</content>



    </entry>
    <entry>
        <title>Angiogenesis using stem cells shows promise</title>
        <link rel="alternate" type="text/html" href="http://www.vasculardeviceforum.com/my_weblog/2010/02/angiogenesis-using-stem-cells-shows-promise.html" />
        <link rel="replies" type="text/html" href="http://www.vasculardeviceforum.com/my_weblog/2010/02/angiogenesis-using-stem-cells-shows-promise.html" thr:count="0" />
        <id>tag:typepad.com,2003:post-6a00e54ed1b99688330120a8b48947970b</id>
        <published>2010-02-19T11:21:00-08:00</published>
        <updated>2010-02-19T11:21:00-08:00</updated>
        <summary>Historically there has been lots of promise about angiogenesis agents however not much to show in terms of practical benefits in a clinically meaningful way. the Dept of Surgery at Grant Medical Center in Columbus Ohio presented their work in...</summary>
        <author>
            <name>lee kirksey</name>
        </author>
        
        
<content type="xhtml" xml:lang="en-US" xml:base="http://www.vasculardeviceforum.com/my_weblog/">
<div xmlns="http://www.w3.org/1999/xhtml"><p>Historically there has been lots of promise about angiogenesis agents however not much to show in terms of practical benefits in a clinically meaningful way. the Dept of Surgery at Grant Medical Center in Columbus Ohio presented their work in a recent JVS Here is an exerpt from EV Today</p>
<p>ADULT STEM CELLS FOR ANGIOGENESIS SHOW PROMISE IN TREATING SEVERE PAD</p>
<p>February 11, 2010—Grant Medical Center in Columbus, Ohio announced that results of a clinical trial documenting the outcomes of nine patients who received transplants of adult stem cells were published by Randall W. Franz, MD, et al in the <a href="http://www.jvascsurg.org/article/S0741-5214(09)01606-1/abstract"><em>Journal of Vascular Surgery</em></a> (2009;50:1378–1390). Few options other than amputation exist for some patients with peripheral arterial disease (PAD) and severe anatomical limitations, the investigators noted.</p>
<p>In this prospective study, the investigators presented short-term results of dual-intramuscular and intra-arterial autologous bone marrow mononuclear cell (BM-MNC) implantation for treating patients with severe PAD for whom amputation was considered the only viable treatment option. Baseline 2-week and 3-month evaluations were </p>
<p><a href="http://bmctoday.net/evtoday/2010/02/article.asp?f=adult-stem-cells-for-angiogenesis-show-promise-in-treating-severe-pad">see full story</a></p></div>
</content>



    </entry>
 
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