Clinical and Industry News

Tryton Medical Completes Enrollment Phase of First-in-Man Study 30 Patients With Coronary Bifurcation Lesions Treated Using Company’s Side-Branch Stent Tryton Medical, Inc., a developer of stents designed to treat bifurcation lesions, announced it completed the enrollment phase of the Tryton First-in-Man (FIM) Study. The multi-center clinical trial evaluated the safety of Tryton’s Side-Branch Stent in the treatment of coronary bifurcation lesions. The Study was performed at the: HELIOS Heart Center/Siegburg, Germany (Prof. Eberhard Grube); Thoraxcenter Rotterdam (Prof. Patrick Serruys) and at the Institut Cardiovasculaire Paris Sud, France (Marie-Claude Morice, MD). The Tryton Side-Branch Stent allowed us to successfully treat a group of patients with challenging bifurcation lesions with an easy-to-use system. The ability to address the side-branch definitively with a Tryton without interfering with treatment of the main vessel is one of the fundamental strengths of this approach. It is unclear how we could have treated these patients without Tryton, said Professor Eberhard Grube, HELIOS Heart Center/ Siegburg, Germany. This technology has the capacity to redefine the treatment of bifurcation lesions and resolve a frequent dilemma of the interventional cardiologist, said Professor Serruys, Head of the Department of Interventional Cardiology, Thoraxcenter, Erasmus Medical Center, Rotterdam, Netherlands. We are very pleased with how the Tryton Side-Branch Stent performed in this Study and how quickly the sites were able to incorporate a ‘save-the-side-branch’ strategy into their routine, said H. Richard Davis, Chief Technical Officer, Tryton Medical, Inc. This approach permitted interventional cardiologists to address complex bifurcation lesions using their choice of Guide (6 French), guide wire, pre-dilation strategy and main vessel sent. The Study should provide the necessary clinical data to support a CE mark, Davis added. Every year, over half a million bifurcation coronary lesions are sub-optimally treated as no commercially available optimized solution exists for treating bifurcation lesions. As a result, cardiologists are forced to use a provisional strategy which avoids the deployment of a second stent, leaving the side branch vulnerable to thrombosis and restenosis. Tryton’s stent uses standard equipment and techniques compatible with 5 and 6 Fr guiding catheters. The following case study is provided courtesy of Drs. Müller and Grube (HELIOS Heart Center/ Siegburg Germany): A 72-year-old woman with stable angina underwent elective cardiac catheterization followed by Tryton bifurcation stenting. Baseline angiogram (left panel) demonstrates a high grade lesion (yellow arrow) in the left anterior descending coronary artery involving the origin of the first diagonal branch. This lesion was definitively treated via a 6 Fr guide catheter with placement of a Tryton Side-Branch in the diagonal branch and a Cypher Select in the main vessel. The final angiogram (right panel) demonstrates a successful angiographic result. Updated AHA Guidelines Advise Focusing on Women’s Lifetime Heart Risk Definitive Answers on HRT, Aspirin, Supplements Healthcare professionals should focus on women’s lifetime heart disease risk, not just short-term risk, according to updated American Heart Association guidelines. The 2007 Guidelines for Preventing Cardiovascular Disease in Women, published in a special women’s health issue of Circulation: Journal of the American Heart Association, also include new directions for using aspirin, hormone therapy and vitamin and mineral supplements in heart disease and stroke prevention in women. The updated guidelines emphasize the lifetime risk of women, not just the more short-term focus of the 2004 guidelines, said Lori Mosca, MD, PhD, director of preventive cardiology at New York-Presbyterian Hospital and chair of the American Heart Association expert panel that wrote the guidelines. We took a long-term view of heart disease prevention because the lifetime risk of dying of cardiovascular disease (CVD) is nearly one in three for women. This underscores the importance of healthy lifestyles in women of all ages to reduce the long-term risk of heart and blood vessel diseases. The guidelines include a new paradigm for risk assessment based on risk factors and family history, as well as the Framingham risk score. (First published in 1998, the Framingham risk score estimates the risk of developing coronary heart disease within 10 years.) The new guidelines include expanded recommendations on lifestyle factors such as physical activity, nutrition and smoking cessation, as well as more in-depth recommendations on drug treatments for blood pressure and cholesterol control. Furthermore, guidelines on hormone and aspirin therapy and antioxidant and folic acid supplements are revised based on recently published data. Since the last guidelines were developed, more definitive clinical trials became available to suggest that healthcare providers should consider aspirin in women to prevent stroke, Mosca said. In addition, providers should not use menopausal therapies such as hormone replacement therapy (HRT) or selective estrogen receptor modulators (SERMs) such as raloxifene or tamoxifene to prevent heart disease because they have been shown to be ineffective in protecting the heart and may increase the risk of stroke. A recent American Heart Association survey showed that women are confused about methods to prevent heart disease including the role of aspirin, hormones and dietary supplements. The new guidelines reinforce that unregulated dietary supplements are not a method proven to prevent heart disease. For example, recent studies have shown that folic acid is ineffective to protect the heart despite widespread use by patients and physicians hoping for a heart benefit, Mosca said. These recent findings emphasize the importance of using well-conducted clinical trial data to develop national recommendations to help patients and their doctors use best practices to prevent heart disease practices based on data rather than myth or wishful thinking. CVD is the largest single cause of mortality among women, accounting for 38 percent of all deaths among females. The public health impact of CVD in women is not solely related to mortality, as advances in science and medicine allow many women to survive heart disease. For example, in the United States 42.1 million (36.6 percent) women live with CVD and the population at risk is even larger. In fact, nearly all women are at risk for CVD, underscoring the importance of a heart-healthy lifestyle in everyone, the authors wrote. Some women are at significant risk of future heart attack or stroke because they already have CVD and/or multiple risk factors. These women are candidates for more aggressive preventive therapy and we define them as high risk. Physicians can easily identify high-risk women, but tools to determine other levels of risk are limited, Mosca said. The authors have aligned their recommendations with treatments proven to work and give strong advice for what not to do, as well. Therefore, we have more aggressive recommendations for high-risk women, and strongly emphasize lifestyle strategies to reduce risk in all women, she said. Medicine is still an art but these guidelines are meant to guide healthcare professionals on the best science available. Highlights of the changes include: Recommended lifestyle changes to help manage blood pressure include weight control, increased physical activity, alcohol moderation, sodium restriction, and an emphasis on eating fresh fruits, vegetables and low-fat dairy products. Besides advising women to quit smoking, the 2007 guidelines recommend counseling, nicotine replacement or other forms of smoking cessation therapy. Physical activity recommendations for women who need to lose weight fast or sustain weight loss have been added a minimum of 60-90 minutes of moderate-intensity activity (e.g., brisk walking) on most, and preferably all, days of the week. The guidelines now encourage all women to reduce saturated fats intake to less than 7 percent of calories if possible. Specific guidance on omega-3 fatty acid intake and supplementation recommends eating oily fish at least twice a week, and consider taking a capsule supplement of 850-1000 mg of EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid) in women with heart disease, two to four grams for women with high triglycerides. Hormone replacement therapy and selective estrogen receptor modulators (SERMs) are not recommended to prevent heart disease in women. Antioxidant supplements (such as vitamin E, C and beta-carotene) should not be used for primary or secondary prevention of CVD. Folic acid should not be used to prevent CVD a change from the 2004 guidelines that did recommend it be considered for use in certain high-risk women. Routine low-dose aspirin therapy may be considered in women age 65 or older regardless of CVD risk status, if benefits are likely to outweigh other risks. (Previous guidelines did not recommend aspirin in lower risk or healthy women.) The upper dosage of aspirin for high-risk women increases to 325 mg per day rather than 162 mg. This brings the women’s guidelines up to date with other recently published guidelines. Consider reducing LDL cholesterol to less than 70 mg/dL in very high-risk women with heart disease (which may require a combination of cholesterol-lowering drugs). This 2007 update provides the most current clinical recommendations for preventing CVD in women 20 and older and are based on a systematic search of the highest quality science interpreted by experts in the fields of cardiology, epidemiology, family medicine, gynecology, internal medicine, neurology, nursing, public health, statistics and surgery. The authors note that these guidelines cover the primary and secondary prevention of chronic atherosclerotic vascular diseases. Recommendations for managing vascular disease before or after cardiac procedures or post-hospital and valvular heart disease are covered in other American Heart Association guidelines. Philips Cardiovascular Technology Earns Prestigious KLAS Awards for Second Consecutive Year Philips CALYSTO solution is named KLAS Specialty Niche Category Leader for Cardiology Hemodynamics and Best in KLAS for Cardiology PACS Royal Philips Electronics was recently recognized in the 2006 Top 20 Year-End Best in KLAS Awards report. KLAS, an independent research firm specializing in monitoring and reporting performance of healthcare information technology vendors, announced that the Philips CALYSTO technology was named the KLAS Specialty Niche Category Leader for Cardiology Hemodynamics. In addition, this Philips solution achieved Best in KLAS for Cardiology PACS (Picture Archiving and Communication System). The CALYSTO solution earned both of these prestigious awards in the 2005 KLAS Top 20 report. Philips’ KLAS ratings are published in the 2006 Top 20 Year-End Best in KLAS report. This report reflects the summary of Healthcare Information Technology (HIT) product and service performance data collected over the past 13 months (October 15, 2005 - November 15, 2006) as reported by integrated delivery networks (IDNs), clinics and inpatient facilities. The professional services section reflects data collected over the past 18 months (May 15, 2005 - November 15, 2006). Each vendor’s product or service has been categorized into a market segment where like products and services are subsequently compared and ranked against one another. In addition, an exclusive Top 20 ranking is provided that involves vendor products from the 14 software market segments with the broadest operational impact. For services, overall rankings are provided for firms in five key categories. To learn more about the 2006 Top 20 Year-End Best in KLAS report, visit www.healthcomputing.com. FDA Approves Possis Spiroflex® Catheter For Coronary Thrombus Removal Possis Medical, Inc. a developer, manufacturer and distributor of medical devices used in endovascular procedures, announced that it has received approval from the U.S. Food and Drug Administration (FDA) to market its AngioJet® Spiroflex® rapid exchange catheter to remove thrombus from coronary arteries. The Spiroflex catheter, Possis’ most flexible and maneuverable rapid exchange catheter, is specifically designed for thrombectomy in small vessels such as coronary arteries. Sharing the same technology, the AngioJet SpiroflexVG catheter is approved for use in larger peripheral vessels. FDA approval for use in saphenous vein bypass grafts in the heart and larger native coronary vessels is pending. The Spiroflex catheter allows physicians to remove coronary thrombus. With its rapid exchange design platform, polymer-clad spiral-cut shaft technology, enhanced soft tip, and patented Cross-Stream® technology, the Spiroflex catheter offers: Increased trackability inside the vessel; Improved crossing in difficult anatomy; 360-degree thrombus removal. The Spiroflex catheter is now approved for sale in the United States and in overseas markets for both peripheral and coronary use. Researchers Attempt to Determine Optimal Timing for Administration of Platelet-Inhibiting Drugs for Treatment of Patients with Acute Coronary Syndromes Clinicians should carefully weigh the risks and benefits of when to administer platelet glycoprotein IIb/IIIa (Gp IIb/IIIa) inhibitors for patients with acute coronary syndromes undergoing invasive treatment, according to a study in the February 14 issue of the Journal of the American Medical Association. In patients with acute coronary syndromes (ACS; unstable angina or non-ST-segment elevation myocardial infarction [MI]), an early invasive strategy, consisting of angiography with subsequent triage to either percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) surgery or medical management, results in reduced rates of death and MI compared with conservative care, the authors note. Furthermore, the upstream use of platelet glycoprotein IIb/IIIa (Gp IIb/IIIa) inhibitors (tirofiban or eptifibatide) prior to angiography in patients with ACS further reduces the occurrence of death and MI at 30 days, although at the expense of increased major and minor bleeding complications. Current guidelines recommend the use of Gp IIb/IIIa inhibitors in certain patients with ACS undergoing an invasive strategy, either administered upstream prior to angiography in all patients or initiated in the catheterization laboratory selectively to patients undergoing PCI. Gregg W. Stone, MD, from Columbia University Medical Center, New York, and colleagues performed the Acute Catheterization and Urgent Intervention Triage Strategy (ACUITY) Timing trial, a large-scale, randomized trial examining the optimal use strategy of Gp IIb/IIIa inhibitors in 9,207 patients with moderate- and high-risk ACS undergoing an early, invasive treatment strategy at 450 medical centers in 17 countries between Aug. 23, 2003, and Dec. 5, 2005. Patients were randomly assigned to receive either routine upstream (n = 4,605) or deferred selective (n = 4,602) Gp IIb/IIIa inhibitor administration. Glycoprotein IIb/IIIa inhibitors were used more frequently (98.3 percent vs. 55.7 percent, respectively) and for a significantly longer duration (median [midpoint], 18.3 vs. 13.1 hours) in patients in the upstream group compared with the deferred group, the researchers report. Composite ischemia (death, MI or unplanned revascularization) at 30 days occurred in 7.9 percent of patients assigned to deferred use compared with 7.1 percent of patients assigned to upstream administration (relative risk 1.12 [a non-significant trend toward a 12 percent increase]); as such, the criterion for noninferiority was not met. The authors add, … routine upstream compared with deferred selective Gp IIb/IIIa inhibitor use resulted in fewer unplanned revascularization events for ischemia, with no significant differences in the rates of death or MI. In contrast, deferred use compared with routine upstream use resulted in significantly few major bleeding (4.9 percent vs. 6.1 percent) and minor bleeding events. The 30-day rates of net clinical outcomes (composite ischemia and major bleeding) were nearly identical between the two strategies. Deferring the routine upstream use of Gp IIb/IIIa inhibitors for selective administration in the cardiac catheterization laboratory only to patients undergoing PCI resulted in a numerical increase in composite ischemia that, while not statistically significant, did not meet the criterion for noninferiority. This was offset by a significant reduction in major bleeding, minor bleeding and blood transfusions. Given emerging data regarding alternative anticoagulant strategies in ACS and evolving understanding of the relative importance of bleeding and ischemic events, clinicians should carefully weigh the risks and benefits of adjunctive pharmacologic strategies in individual patients, the authors conclude. Editorial: Optimal Timing Questions, Answers and More Questions. The ACUITY Timing Trial reported by Stone and colleagues in this issue of JAMA is a good example of a clinical investigation that can provide evidence for clinical practice as well as a factual framework that addresses several clinical and research issues, write Kenneth W. Mahaffey, MD and Robert A. Harrington, MD, from Duke Clinical Research Institute, Durham, NC, in a related editorial. In the ACUITY Timing Trial, clinical care decisions were left to the discretion of the treating physicians. This is a common and preferred approach that allows for the testing of research questions in a setting reflective of routine practice, but its use does produce some limitations. In ACUITY, the use of antithrombin therapy was open-label and, in the nonbivalirudin group, the physician had the choice to use unfractionated heparin or low-molecular-weight heparin. In addition, the decision about which Gp IIb/IIIa inhibitor to use upstream or during PCI was left to the discretion of the treating physician. Moreover, two-thirds of patients were already receiving some antithrombin therapy prior to randomization, and nearly 10 percent of patients were being treated with a Gp IIb/IIIa inhibitor prior to randomization. Much remains to be learned about optimum care of patients with ACS, and the findings from the ACUITY Timing Trial provide valuable insights for future investigators seeking answers to critical questions of clinical practice. Source: JAMA 2007; 297:591-602, 636-638. Low Health Literacy Puts Patients at Risk: The Joint Commission Sets Forth Solutions to National Problem Far too often, ordinary citizens are placed at risk for unsafe care because important health care information is communicated using medical jargon and unclear language that exceed their literacy skills, according to a call to action released today by The Joint Commission in its newest public policy white paper, ‘What Did the Doctor Say?:’ Improving Health Literacy to Protect Patient Safety. The paper frames the existing communications gap between patients and caregivers as a series of challenges involving literacy, language, and culture, and suggests multiple steps that need to be taken to narrow or even close this gap. Effective communication is a cornerstone of patient safety, says Dennis S. O’Leary, MD, president, The Joint Commission. If patients lack basic understanding of their conditions and the whats and whys of the treatments prescribed, therapeutic goals can never be realized, and patients may instead be placed in harm’s way. The detailed solutions developed by a special Joint Commission Expert Roundtable focus on making effective communications a priority in protecting the safety of patients; addressing patient communications needs across the spectrum of care; and pursuing public policy changes that promote better communications between health care practitioners and patients. Failure to provide patients with information about their care in ways that they can understand, The Joint Commission report warns, will continue to undermine other efforts to improve patient safety. Breakdowns in communication between patients and caregivers can significantly impair the ability of physicians to diagnose and treat medical problems, says Ronald M. Davis, MD, chair of The Joint Commission Expert Roundtable on Health Literacy and director of the Center for Health Promotion and Disease Prevention at Henry Ford Health System, Detroit. Everyone who has a role in health care specifically including practitioners, employers, and regulators must work together to pursue strategies for improving communications with patients that will result in safer, more effective care. What is clear to you is clear to you, says Toni Cordell, Expert Panel member and nationally known speaker on the topic of health literacy, who struggles with dyslexia. Every patient should be a full partner in his or her medical decisions. This requires crystal-clear communication that is done with compassion and mutual respect, she says. The Joint Commission already promotes the involvement of patients in their care through its ongoing Speak Up educational campaigns. In addition, expectations regarding patient engagement and involvement in care decisions are stipulated in Joint Commission accreditation standards and its National Patient Safety Goals. But health literacy problems, which often go unrecognized and unaddressed by health care practitioners, undermine the ability of health care organizations to comply with the intents of the accreditation standards and safety goals that seek to protect the safety of patients. The Joint Commission report on strategies for addressing health literacy and protecting patient safety contains 35 specific recommendations that cover a wide range of important improvement opportunities including, among others: Sensitization, education and training of clinicians and health care organization leaders and staff regarding health literacy issues and patient-centered communications. Development of patient-friendly navigational aids in health care facilities. Enhanced training and use of interpreters for patients. Re-design of informed consent forms and the informed consent process. Development of insurance enrollment forms and benefits explanations that are client-centered. Use of established patient communication methods such as teach back. Expanded adaptation and use of adult learning centers to meet patient health literacy needs. Development of patient self-management skills. Health care organization assessment of the literacy levels and language needs of the communities they serve. Design of public health interventions that are audience-centered and can be communicated in the context of the lives of the target population. Integration of the patient communication priority into emerging physician pay-for-performance programs. Provision of medical liability insurance discounts for physicians who apply patient-centered communication techniques. A complete copy of The Joint Commission white paper, ‘What Did the Doctor Say?:’ Improving Health Literacy to Protect Patient Safety is available at www.jointcommission.org. The report is part of a continuing series of white papers on key public policy issues that impact patient safety and health care quality. Certification Board for Radiology Practitioner Assistants (RPAs) News Discrimination Concerns The CBRPA would like to inform all RPAs and RPA students that very helpful information has been obtained for those facing discrimination issues that are preventing them from working as RPAs. Please contact Dr. Jane via email for counsel on how to address this situation at jvan1074 (at) comcast. net. CBRPA Intellectual Property Copyright The CBRPA is proud to announce that all written works produced by CBRPA have been granted a copyright. Copyrighted CBRPA materials include, but are not limited to, the Scope of Practice, the Standards of Practice, content specifications, clinical competency lists and criteria, policies, all tests, testing data and materials, including the test bank. The CBRPA Board of Directors has overseen the development of these materials since their inception. The principle person responsible for directing the development of these items is the Executive Director of CBRPA, Jane Van Valkenburg, PhD, RPA/RA (CBRPA). As the principle person involved in the development of the materials, Dr. Van Valkenburg has graciously assigned ownership of her intellectual property to the CBRPA. Because Dr. Van Valkenburg was employed by Weber State University, it is important to note that the types of materials developed, known as intellectual property, fall under the American Association of University Professors Statement of Copyright, which states, It has been the prevailing academic practice to treat the faculty member as the copyright owner of works that are created independently and at the faculty member’s own initiative... References accessed 2/14/07 AAUP Statement on Copyright, https://www.aaup2.org/statments/Redbook/Specopyr.htm Who Owns Intellectual Property? https://aaup.org/AAUP/issuesd/DE/sampleIP.htm Merger Summit Meetings While the Summit meetings are ongoing, a confidentiality agreement signed by the CBRPA participants will be honored to prevent undue influence from various sources on the negotiating process. At the Denver ASRT meeting, CBRPA representatives stated, prior to any summit meeting, that the conditions of any merger must include the following three (3) items: a grandfathering of all RPAs, a broad scope of practice and a signed legal agreement by all organizations. CBRPA will negotiate in good faith for a merger while preserving the values and integrity of the advanced level of practice for technologists. Researchers Find Predictor of Mortality in Cardiac Patients Researchers at State University of New York (SUNY) Downstate Medical Center in Brooklyn have determined that low levels of a protein in the blood is a predictor of cardiac death in patients with coronary artery disease. In a group of men undergoing coronary angiography, low baseline levels of RANTES (Regulated upon Activation, Normal T-cell Expressed, and Secreted), also known as CCL5, were shown to be an independent predictor of cardiac mortality. RANTES is a chemokine produced by a variety of cell types including blood platelets that has been implicated in atherosclerosis. Chemokines are naturally occuring human proteins that signal white blood cells to move in a specific direction, such as to an infection site. Erdal Cavusoglu, MD, assistant professor of medicine at SUNY Downstate, and colleagues measured baseline RANTES levels in 389 male patients at a Veterans Affairs Medical Center. The patients were followed prospectively for the occurrence of cardiac mortality and myocardial infarction. Results showed that patients with the lowest level of RANTES had the lowest survival rate, and those with the highest levels had the highest survival rates. This was also true for the diabetic subset of patients in the study. The authors propose several potential explanations for this somewhat paradoxical observation, including potential upregulation of the RANTES receptor, the CCR5 receptor, which is known for its proatherosclerotic properties. Alternatively, lower levels of RANTES may simply reflect greater deposition of RANTES on atherosclerotic arteries with less circulating levels available for measurement by routine ELISA testing. The research was published by Arteriosclerosis, Thrombosis, and Vascular Biology online at https://atvb.ahajournals.org. Researchers from the Bronx Veterans Affairs Medical Center and the University of Michigan at Ann Arbor also contributed to the study. Additional information may be obtained from Dr. Cavusoglu at ECavusoglu (at) aol. com. Meeting Update Selected News from the International Symposium on Endovascular Therapy (ISET) January 28-February 1, 2007; Hollywood, Florida The International Symposium on Endovascular Therapy (ISET) is attended by more than 1,200 physicians, scientists and industry professionals from around the world, as well as several hundred industry representatives. The meeting pioneered the use of live cases to promote the multidisciplinary treatment of vascular disease. ISET is presented by the Baptist Cardiac & Vascular Institute, Miami. Ultrasound-enhanced Clot Buster Gets Patients Out of Hospital Faster Thomas McNamara, MD, University of California at Los Angeles, presented data on 111 patients treated for blood clots in pelvic or leg arteries with ultrasound-enhanced delivery of clot-busting drugs. The ultrasound-enhanced system dissolved the clot quicker than standard delivery of clot-busting drugs: 18.5 hours vs. 24.4 hours. The end result is patients typically leave the hospital a day earlier after ultrasound-enhanced delivery of clot-busting drugs vs. standard delivery. The device enhances delivery of the drugs via tiny rice-sized ultrasound transducers situated on a wire that is advanced to the site of the clot. The transducers emit high-frequency, low-energy ultrasound waves that loosen up the fibers of the clot, as well as force the drug into the clot so that it dissolves faster. CoreValve Trial Update Eberhard Grube, MD (Heart Center Siegburg, Germany), reported the experience of high-risk patients unsuitable for surgery who underwent percutaneous aortic valve replacement (PAVR) as an alternative to palliative medical therapy for severe aortic stenosis. Drawing data from 39 procedures performed successfully, Dr. Grube found that PAVR with the self-expandable CoreValve prosthesis (21 French version and even more the new 18 French version) is feasible and safe; successful procedures result in marked hemodynamic and clinical improvement, which was sustained at 15 months. In the first generation, the approach involved general anesthesia, surgical peripheral arterial access and femoral vein-femoral artery cardiopulmonary bypass; when the 18 French prosthesis is used, there is no more need for surgical preparations, cardiopulmonary bypass or general anesthesia. PAVR is on its way to becoming a stent-like procedure, according to Dr. Grube. Prevention of Restenosis with Paclitaxel-Coated Balloons Gunnar Tepe, MD (University of Tuebingen, Germany), reports research suggesting that paclitaxel-coated balloons could significantly reduce the rate of restenosis after percutaneous transluminal angioplasty (PTA) in the superficial femoral artery (SFA) and in the popliteal artery. Data includes outcomes of 102 patients enrolled to receive treatment of stenosis or occlusion of the SFA and/or popliteal artery with either a bare or coated balloon. The primary efficacy endpoint of the study was the late lumen loss of the target lesion, directly post-intervention and at a six-month follow-up. Most Failures in Carotid Artery Stenting are Preventable Juan Carlos Parodi, MD, University of Miami, presented data from Washington University on 213 cases of carotid artery stenting (CAS) that resulted in five strokes (2.3 %), all ischemic and minor. Expanding on the details of each case, Dr. Parodi reported that the strokes might have been prevented had attending physicians: avoided crossing catheters over severe lesions; chosen cerebral protection devices (CPDs) and stents according to anatomy and plaque morphology; and selected appropriate anticoagulation agents and different styles of catheters.

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