Clinical & Industry News

Vascular Solutions Launches Minnie Support Catheter

Vascular Solutions, Inc. announced the launch of its Minnie support catheter. The new catheter is designed to provide superior guidewire support and exchange for complex interventions, with versions designed for use with 0.014”, 0.018” and 0.035” guidewires. The Minnie support catheter features a smoothly tapered distal tip to facilitate guidewire control, combined with a low crossing profile for navigating small vessels and crossing tight lesions. Its single-layer polymer design offers flexibility with exceptional tracking, while its fully embedded radiopaque markers — a unique feature that eliminates exposed metal — allow the operator to easily confirm positioning and assess lesion length. Currently available in the United States and Europe, the Minnie support catheter is packaged one unit per box. For more information, visit www. vascularsolutions.com. _______________________________

Pivotal Two-Year Results on Xience V™ Drug-Eluting Stent

Data from SPIRIT III trial demonstrate that patients treated with Xience V are less likely to have a heart attack or require a repeat intervention out to two years Data published online in Circulation from the SPIRIT III U.S. pivotal trial evaluating the Xience V™ everolimus-eluting coronary stent system demonstrated that Abbott’s Xience V outperforms the Taxus® Express²™ paclitaxel-eluting coronary stent system in reducing major adverse cardiac events (MACE) at two years. In the SPIRIT III trial of 1,002 patients, Xience V demonstrated a 45% reduction in the risk of MACE, and a 40% reduction in the risk of cardiac death or myocardial infarction (MI) at two years in patients treated with Xience V compared to those treated with Taxus. Additionally, at two years the study demonstrated a 32% reduction in the risk of target vessel failure (TVF) for Xience V compared to Taxus. These published results were first presented in May 2008 at the EuroPCR Congress in Barcelona. SPIRIT III is a prospective, multi-center, randomized, single-blind, controlled clinical trial comparing the Xience V to Taxus in 1,002 patients (669 Xience V patients, 333 Taxus patients) with either one or two de novo native coronary artery lesions. The primary endpoint of the SPIRIT III trial was in-segment late loss at eight months, wherein Xience V demonstrated superiority to Taxus with a statistically significant 50% reduction in late loss (mean, 0.14 mm for Xience V vs. 0.28 mm for Taxus). In the co-primary endpoint of TVF at nine months, Xience V demonstrated statistical non-inferiority compared to Taxus with an observed 20% reduction in TVF (7.2% for Xience V vs. 9.0% for Taxus). Additionally, in the pre-specified secondary endpoint of MACE, Xience V demonstrated a 43% reduction at nine months (4.6% for Xience V vs. 8.1% for Taxus) and a 42% reduction in MACE at one year (6.0% for Xience V vs. 10.3% for Taxus) compared to Taxus. Abbott also supplies a private-labeled Xience V to Boston Scientific called the Promus™ everolimus-eluting coronary stent system. Promus is manufactured by Abbott and supplied to Boston Scientific as part of a distribution agreement between the two companies. _______________________________

A Focus on Cath Lab Safety in 2009

New JCR course covers key lab issues Joint Commission Resources announces the release of a new DVD course, “Keeping Safety in Focus: Reducing Complications in the Cardiac Cath Lab.” JCR is a not-for-profit affiliate of The Joint Commission. This educational activity is funded in part by an unrestricted educational grant from Marine Polymer Technologies. Even with today’s technology-driven operative processes administered by highly skilled practitioners, it is not uncommon for complications to occur in the cardiac catheterization lab. The nature of these complications can sometimes be quite severe for patients. This program focuses on methods for improving patient safety in the cardiac catheterization lab, including management tools for continuous process improvement, and a step-by-step process utilizing best practices and recommended protocols to help ensure a patient’s well-being. Topics in this DVD include: The Joint Commission’s National Patient Safety Goals and requirements, which relate to the cardiac catheterization lab; identification of safety challenges facing labs; and opportunities for improvement. This DVD identifies who is responsible and accountable for safety in the lab, and shows examples of different approaches to enhancing safety based on data use and performance improvement principles. The DVD is available for $295 using item code DVD0801. To order this item, call JCR Customer Service toll-free at 877.223.6866, 8 a.m. to 8 p.m. EST, weekdays, or visit www.jcrinc.com. _______________________________

Ultrasound Delivery of Clot-Busting Drugs May Lessen Risk of Bleeding in Thrombolysis

Delivering clot-busting drugs with an ultrasound-enhanced delivery system could reduce the amount of drugs needed to break up dangerous blood clots in the legs and pelvis, according to discussions surrounding a live case demonstration at the 21st annual International Symposium on Endovascular Therapy (ISET). In a live case performed and viewed by hundreds of endovacular specialists, Constantino Peña, MD, an interventional radiologist at Baptist Cardiac & Vascular Institute in Miami, Florida, treated a 74-year-old male with a blocked leg artery. Dr. Peña delivered the drug tenecteplase (TNK) to the clot via ultrasound-accelerated catheter-directed thrombolysis, and the clot was completely dissolved upon examination 12 hours later. In a discussion of the live case, Dr. Peña indicated that the amount of TNK used to dissolve the clot was half what is typically used. Lowering the amount of drug needed to dissolve clots can significantly reduce the risk of major bleeding, according to Barry Katzen, MD, founder and medical director of Baptist Cardiac & Vascular Institute. _______________________________

Invatec Announces Worldwide Distribution Agreement with Lumen Biomedical for Newly FDA-cleared FiberNet device

Invatec announced that it has entered a worldwide distribution agreement with Lumen Biomedical, Inc. to distribute the FiberNet® Embolic Protection System (EPS). The FiberNet EPS, which received FDA clearance in November 2008, is indicated for the treatment of patients receiving endovascular intervention for carotid artery disease. The product has also received CE Mark approval for use during carotid and saphenous vein graft (SVG) procedures. The FiberNet system features a three-dimensional design composed of a matrix of fibers allowing for the entrapment of smaller particles and better overall capture efficiency. The low-profile filter is mounted on a guidewire, needing no delivery system to cross the lesion. The FiberNet EPS will treat vessels ranging from 3.5 to 7 mm and its design ensures excellent wall apposition. After the particles have been captured, the FiberNet filter is retrieved into the retrieval catheter under aspiration and removed from the patient. The FiberNet EPS was evaluated in the EPIC (Evaluating the Use of the FiberNet EPS in Carotid Artery Stenting) multi-center trial, which demonstrated the lowest stroke rates of any filter currently available in the U.S. market. As part of the trial, 237 high-surgical-risk patients with a critical carotid artery stenosis received carotid artery stenting. Overall, the 30-day stroke rate was 2.1 percent. There were no unanticipated adverse device effects. Visible debris was observed in over ninety percent of the procedures. “The FiberNet EPS has several attributes including ease of use, low profile and the ability to conform to an irregular surface in the vessel wall, that have contributed to the impressive results and safety profile we observed in the EPIC trial,” commented Dr. Subbarao Myla, medical director of cardiovascular research and endovascular intervention at Hoag Memorial Hospital in California and national principle investigator for the trial. “The device achieved the lowest stroke rate of any filter currently available.” _______________________________

Boston Scientific Submits Final Modules to FDA for Approval of Second-Generation Small Vessel and Long Lesion Stents

Positive ATLAS trial clinical data Boston Scientific Corporation has submitted to the U.S. Food and Drug Administration (FDA) the final modules of the Company’s Pre-Market Approval (PMA) applications for both its Taxus® Liberte® Atom™ and its Taxus Liberte Long™ paclitaxel-eluting coronary stent systems. If approved, the Taxus Liberte Atom stent will become the Company’s second 2.25 mm diameter drug-eluting stent (DES) available in the United States. It will then likely succeed the Taxus Express™ Atom stent, which is the Company’s first approved small stent and the only DES currently approved by the FDA to treat small vessels. The Taxus Liberte Long stent is designed to be the first 38 mm drug-eluting stent available in the U.S. The PMA submissions include clinical data from the global, multi-center Taxus ATLAS Small Vessel (SV) and Long Lesion (LL) studies, designed to compare the performance of the Taxus Liberte Atom and Taxus Liberte Long stents with Boston Scientific’s first-generation Taxus Express stent. While the second-generation Taxus Liberte stent uses identical drug dose, polymer and release kinetics as the Taxus Express stent, it features thinner struts and a uniform architecture specifically designed for drug delivery. One-year results from the Taxus ATLAS SV and LL studies were published in the December 2008 issue of the Journal of American College of Cardiology. The studies both met their primary endpoint of non-inferior, nine-month, in-segment diameter stenosis versus the Taxus Express stent control group. They reported a significant reduction in small vessel in-stent restenosis and major adverse coronary events (MACE) in patients treated with the Taxus Liberte Atom stent, and a significantly reduced rate of myocardial infarction in patients with long lesions treated with the Taxus Liberte Long stent. “In the ATLAS study, lower target lesion revascularization (TLR) rates contributed to a significantly lower rate of MACE, including heart attacks, with the Taxus Liberte Atom stent,” said Mark A. Turco, MD, Director of the Center for Cardiac and Vascular Research, Washington Adventist Hospital, and Co-Principal Investigator of the ATLAS trial. “The thinner struts of the Taxus Liberte Atom stent are designed to improve its deliverability and conformability, which is important when treating small vessels. The Taxus Liberte stent also features an advanced stent cell geometry that has been designed to allow for more consistent drug distribution.” Patients with small vessels treated with the Taxus Liberte Atom stent reported significantly lower nine-month angiographic in-segment late loss (0.16 mm vs. 0.32 mm, p=0.0146), reduced nine-month angiographic restenosis (18.5% vs. 32.7%, p=0.0219), reduced 12-month TLR (6.1% vs. 16.9%, p=0.0039), and reduced rates of stent thrombosis (0.4% vs. 1.5%, p=0.39). Patients with long lesions treated with the Taxus Liberte Long stent reported a significantly reduced 12-month rate of myocardial infarction (1.4% vs. 6.5%, p= 0.0246) as well as a trend toward fewer stent thromboses (0% vs. 0.7%, p=0.48). The Taxus Liberte Atom, Taxus Liberte Long, Taxus Element and Promus Element stents are investigational devices and are restricted under U.S. law to investigational use only. _______________________________

Study Proves That Practice Makes Perfect in PCI for Heart Attack

Patients treated by experienced doctors in experienced hospitals most likely to survive When it comes to treating heart attacks, experience matters. New research shows that patients have a much better chance of survival when both their hospital and their physician have a strong track record in treating heart attack with angioplasty and stenting. The new research, published in the February 17, 2009 issue of the Journal of the American College of Cardiology (JACC), found that the risk of dying was cut by nearly half when interventional therapy was performed by an experienced physician in a hospital with plenty of practice in providing the rapid, intense attention that heart attack patients need. “Even in this day of advanced technology and advanced training, physician and hospital volume still matter, and they matter most in high-risk patients,” said V.S. Srinivas, MBBS, an associate professor of clinical medicine at Montefiore Medical Center in New York City. Today it is widely acknowledged that primary percutaneous coronary intervention (PCI) is the safest and most effective treatment for heart attack, provided it can be accomplished quickly. As a result, many communities are establishing primary PCI programs to provide rapid, local care. This trend is raising questions, however. For example, in large cities that already have a primary PCI program, are more programs better for patients, if it means that each hospital and physician performs fewer cases? In smaller communities, can the benefit of having an experienced interventional cardiologist on staff overcome the inexperience of a fledgling primary PCI program that treats only a small number of heart attack patients each year? The new research provides unique insight into such questions. Although previous studies have looked separately at the influence of physician and hospital experience on survival after primary PCI, this is the first study to evaluate the combined effect of these two factors since stent placement came into common use. The interaction between physician and hospital experience is critically important, particularly in the case of an unforeseen complication, said James Jollis, MD, an associate professor of medicine at Duke University in Durham, NC. Dr. Jollis did not participate in the study but was invited to write an editorial in the same issue of JACC. “In most hospitals with angioplasty facilities, highly trained teams are on call 24 hours a day, 7 days a week,” Dr. Jollis said. “These teams are composed of interventional cardiologists, nurses and technologists who work in a coordinated fashion to rapidly open blocked arteries. When rare but severe complications arise, a team experienced in its recognition and treatment may be the difference between life and death.” For the study, researchers analyzed data from the New York State PCI registry, a database that all New York hospitals are required to participate in. The data came from 7,321 patients treated with primary PCI by 266 physicians at 41 medical centers between 2000 and 2002. Hospitals performing an average of more than 50 primary PCIs each year were defined as high-volume centers, while those performing 50 cases or fewer each year were defined as low-volume centers. Similarly high-volume physicians were defined as those performing more than 10 primary PCIs each year, while low-volume physicians were defined as those performing 10 or fewer cases each year. Patients who were treated at low-volume hospitals and by low-volume physicians tended to be older and sicker, and to have other characteristics that placed them at higher risk. But even when these factors were taken into account, being treated by an experienced physician in an experienced hospital was clearly associated with better survival after primary PCI. Overall, in high-volume hospitals, the risk of dying in the hospital was 42% lower when compared to low-volume hospitals. Among patients treated by high-volume physicians, the risk of in-hospital death was 34% lower overall when compared to patients treated by low-volume physicians. Researchers also examined the relationship between hospital volume and physician volume. In high-volume hospitals, the risk of in-hospital death was significantly lower among high-volume physicians when compared to low- volume physicians (3.8% vs. 6.5%, odds ratio: 0.58). In low-volume hospitals, there was a trend showing a lower risk of death among patients treated by high-volume physicians, as compared with low-volume physicians (4.8% vs. 8.4% , odds ratio: 1.44), but the difference was not statistically significant, due to the small numbers cases in this category. These findings suggest that even in the most experienced hospitals, it is important that primary PCI be performed by experienced physicians, Dr. Srinivas said. As for low-volume community hospitals, the study’s findings offer indirect guidance. “Even in high-volume hospitals, higher-volume physicians did better than lower-volume physicians. We would expect the same effect in low-volume hospitals,” Dr. Srinivas said. “Therefore, it’s all the more important that community hospitals that are developing primary PCI programs have experienced physicians.” Dr. Jollis advised outlying communities to also consider the alternatives to developing primary PCI programs, including establishing ambulance diversion plans to immediately take heart attack patients to the closest angioplasty hospital, if the travel distance is not too great. Use of clot-busting drugs is another alternative. “All hospitals, including those lacking angioplasty teams, are capable of rapidly opening coronary arteries using clot-dissolving medicines. Thus, the closest hospital is the safest and best place to proceed,” he said. _______________________________

New Appropriate Use Criteria Guide Treatment of Patients with Heart Blockage

Whether it’s appropriate to treat chest pain with medical therapy alone or prescribe medical therapy and also perform revascularization depends on several factors that vary from patient to patient. In some cases the decision is obvious; in others, it’s more nuanced. Now physicians, patients and health insurers have a practical tool for weighing each of those factors and arriving at the right treatment decision. The new document, titled “Appropriate Use Criteria for Coronary Revascularization,” appears in the February 10, 2009, issue of the Journal of the American College of Cardiology (JACC) and online at www.acc.org. The document will also be published in the January 5, 2009, online issues of Catheterization and Cardiovascular Interventions (CCI) and Circulation: Journal of the American Heart Association, and online at www.scai.org. “One of the strengths of this document is that it provides a framework for thinking about clinical scenarios and having a discussion about coronary revascularization,” said Manesh R. Patel, MD, chair of the appropriate use criteria writing group and an assistant professor of medicine at Duke University and the Duke Clinical Research Institute in Durham, NC. “These recommendations describe when coronary revascularization would be expected to improve a patient’s health status.” The new appropriate use criteria are the first to focus on cardiac treatment, rather than on diagnostic testing. They were jointly developed by the American College of Cardiology, Society for Cardiovascular Angiography and Interventions, Society of Thoracic Surgeons, American Association for Thoracic Surgery, American Heart Association, and American Society of Nuclear Cardiology. They have been endorsed by the American Society of Echocardiography, Heart Failure Society of America, and Society of Cardiovascular Computed Tomography. Appropriate use criteria differ from clinical guidelines both in their purpose and their format. While guidelines provide a comprehensive summary of evidence from clinical trials, appropriate use criteria focus on the types of patients cardiologists see in the clinic and hospital every day. Clinical studies may not have included such patients and, therefore, scientific evidence may not be readily available. Appropriate use criteria also present information in easily understood clinical scenarios that characterize patients according to four critical features: • The severity and type of symptoms; • How much cholesterol plaque has built up and in which arteries; • How much of the heart muscle, according to stress testing, is ischemic; and • Whether the patient is already taking the right heart medications in the right dosages. In developing the appropriate use criteria, a 17-member technical panel made up of general cardiologists, interventional cardiologists, cardiac surgeons, internal medicine specialists, health services researchers and others sifted through approximately 180 clinical scenarios, scoring each according to whether revascularization was appropriate, inappropriate or uncertain. “This was quite a serious undertaking,” said Peter K. Smith, MD, a cardiac surgeon member of the writing committee on behalf of The Society of Thoracic Surgeons. “The process involved extensive review and debate of the available body of evidence, and resulted in remarkable consensus between specialties.” Dr. Smith is also professor and chief of cardiothoracic surgery at Duke University. Revascularization was considered appropriate if the expected improvements in survival, symptoms, functional status and/or quality of life outweighed the possible risks. In most cases, the panel considered revascularization as either bypass surgery or percutaneous coronary intervention (PCI). Because evidence is available to support either procedure for patients with advanced coronary disease, each method of revascularization was independently rated. The panel determined that revascularization would be inappropriate in a patient who had plaque build-up in one or two arteries, experienced symptoms only during heavy exercise, had a small amount of heart muscle at risk, and was not taking medication to help control symptoms. However, they deemed revascularization appropriate if a similar patient had severe symptoms despite already taking the best available heart medication. Appropriate use criteria are not intended to diminish the importance of clinical judgment in evaluating individual patients, nor to include every possible type of patient. Instead, one of their most important uses will be in evaluating patterns of care, and in helping to reduce the large variation in rates of revascularization that has been observed throughout the country. “For physicians who look at the appropriate use criteria and conclude that 95 to 100 percent of the revascularization procedures they perform would be graded as appropriate — terrific,” said Gregory J. Dehmer, MD, a writing committee member and past president of the Society for Cardiovascular Angiography and Interventions. “But for those who find that only 60 or 70 percent of their procedures are appropriate and the rest are inappropriate, this document provides a very powerful message and gives them a benchmark for improving their practice.” Dr. Dehmer is also a professor of medicine at Texas A & M University College of Medicine and cardiology director at Scott & White Clinic, both in Temple, TX. It is also hoped that health insurers will use the appropriate use criteria in developing consistent payment and preauthorization policies and in conducting quality reviews. “In the arena of cardiovascular science, we have a fair amount of data on revascularization and its ability to improve how patients feel or long they live,” Dr. Patel said. “As a group that includes general cardiologists, interventionalists and surgeons, we’re saying: For these common clinical scenarios, here is when it’s appropriate — in most patients — to perform revascularization.” _______________________________

Houston Northwest Medical Center Is One of Two Hospitals in Texas Named A Mentor Hospital for Acute Myocardial Infarction by the Institute for Healthcare Improvement

Houston Northwest Medical Center is among an elite group of hospitals nationwide — and among only two in Texas — named by the Institute for Healthcare Improvement (IHI) as a Mentor Hospital for Acute Myocardial Infarction (AMI). IHI is an independent, not-for-profit organization with a mission of helping lead the improvement of health care throughout the world, and may be best known for its 5 Millions Lives Campaign, a nationwide initiative to protect patients from 5 million incidents of medical harm over a two-year period (December 2006-December 2008). “We are elated to be selected by the Institute for Healthcare Improvement to be a Mentor Hospital,” says Terry Kirk, RN, MSN, EdD, chief nursing officer at Houston Northwest Medical Center. “With this recent IHI Mentor Hospital designation for heart attack care, Houston Northwest Medical Center will be looked to for support, advice, clinical expertise, and tips by hospitals seeking help with their own efforts,” adds Kirk. “Hospitals that achieve this distinction by IHI are reviewed for certain AMI protocols, such as ensuring the administration of aspirin and beta-blockers on admission and discharge and ACE inhibitors as appropriate, counseling smokers to quit, and achieving commendable door-to-balloon times (D2B). Of particular note is Houston Northwest Medical Center’s D2B times. At Houston Northwest Medical Center, the average D2B time in 2008 was 60 minutes, with a Houston Northwest Medical Center record of 20 minutes.” _______________________________

SYNTAX Trial Provides Vital Information for Severe CAD Treatment

A landmark clinical trial comparing two forms of treatment for patients with severe coronary artery disease (CAD). The results were published on-line in the New England Journal of Medicine. The SYNTAX trial was a clinical research study that compared percutaneous coronary intervention (PCI) with drug-eluting stents and coronary artery bypass surgery (CABG) in patients with three-vessel and left main coronary disease. The trial results did not show any statistically significant differences between PCI and CABG in rates of death or heart attack, an excess of stroke in the CABG-treated patients, and a greater need for repeat PCI procedures in the stent-treated patients. These are better outcomes for PCI than have been seen in prior trials in less complex patients. The trial is the first randomized, controlled clinical trial to compare these two treatments in patients with left main disease and/or three-vessel disease, who are typically treated with CABG and represent a population with far more complex anatomy and advanced disease than those studied in prior drug-eluting stent (DES) clinical trials. There were 1,800 patients enrolled in the randomized arm of the trial. All patients were assessed by a multidisciplinary team including an interventional cardiologist and a cardiac surgeon. If both the cardiologist and surgeon felt that they could offer equivalent complete revascularization, patients were randomized 1:1 into one of the two treatment strategies. If either the cardiologist or surgeon felt that one or the other revascularization technique was the preferred option, due to technical considerations or co-morbidity, for example, then patients were recruited into one of two parallel, nested registries for PCI or CABG. Thus, patients in the PCI registry had been rejected for cardiac surgery. _______________________________ The International Society of Advanced Level Medical Imaging Physician Specialists Inc. have accepted the 70th Active Lifetime Member. Anyone interested in joining, please apply through the society’s secure website, https://www.ismipsi.org/. The continuing education organization held an invasive and interventional cardiology board review course at Armstrong Atlantic State University, Savannah, Georgia February 27-March 1, 2009. The society will be providing a similar meeting in conjunction with the New Cardiovascular Horizons Conference, Roosevelt Hotel, New Orleans, LA, June 18-20, 2009. Anyone who attends any of the meetings receives an annual membership as part of the registration fee. If more information is needed, please contact the Chief Operating Officer, Neil E. Holtz, by email, coo@ismipsi.org, or the Chief Executive Officer, Phyllis Williams, through her email address, ceo@ismipsi.org.

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