Clinical and Industry News

Vascular Solutions Launches EXPRO Elite™ Snare Vascular Solutions, Inc. recently announced its U.S. launch of the EXPRO Elite Snare in partnership with Radius Medical Technologies. The EXPRO Elite Snare is a unique one-piece medical device designed for the retrieval and manipulation of objects located in the cardiovascular system, including coils, balloons, catheters and guidewires. The EXPRO Elite Snare features a completely integrated 0.035” profile that permits delivery through 0.035” lumens of conventional catheters and a cobalt chromium helical loop design for optimal retrieval and manipulation. The loop is encapsulated in a platinum coil to enhance visualization under fluoroscopy, is highly flexible and torqueable for atraumatic delivery, and has a longer reach than right-angle loops. Developed and manufactured by Radius Medical Technologies, in Acton, Massachusetts, the EXPRO Elite Snare comes pre-assembled and is currently available in the United States through Vascular Solutions, Inc. For more information, please visit: www.vascularsolutions.com. EXPRO Elite™ is a trademark of Radius Medical Technologies, Inc. Stopping a Killer: LUMEN 2009 Looks to Establish National Protocol for Treating Heart Attack Patients Number-One Killer of Men and Women Can Exist Unchecked by Local Municipalities It is the very early hours of the morning and you awake with a tightness in your chest. This uncomfortable pressure is making it difficult to breathe, and you feel lightheaded and nauseous. Your first instinct is to shrug off the fear that you might be having a heart attack and attribute your pain to heartburn from overindulging the night before, or even food poisoning. Yet if you continue to avoid taking your pain and symptoms seriously, your life is at risk — and the clock is ticking. According to the American College of Cardiology (ACC), the majority of deaths from ST-elevation myocardial infarction (STEMI), a heart attack caused by complete obstruction of a coronary artery, occurs within the first one to two hours after symptom onset. Yet although heart disease is the leading cause of death in the United States, there is still no protocol in place for an integrated STEMI system and national STEMI policy. LUMEN 2009: The Symposium on Optimal Treatments for Acute MI launches February 26–28, 2009 in Miami Beach to address the need for establishing protocols nationwide for the appropriate care of acute heart attack patients. In the scenario above, time is of the essence. Call 9-1-1. Do not drive or have someone drive you. Transportation by EMS is a better option than self-transport because you can be immediately evaluated and have treatment initiated by paramedics prior to arriving at the hospital, and the appropriate staff can be called in while you are still in transport. But even as skilled staff are en route to the hospital and EMS is working to save your life, in most American communities, you are not going to receive the critical care you need. For patients experiencing a heart attack, where time is absolutely critical, there is no established national protocol to treat STEMI patients, one that would ensure patients are routed to a STEMI-certified hospital equipped to not only save the life of the patient, but to make sure minimal damage is done to the heart muscle. Instead, EMS has only one guideline established by local municipalities — transport the critical care heart attack patient to the closest hospital, often a facility that lacks the equipment and expertise to save the heart attack victim. STEMI expert Dr. Sameer Mehta and many of his colleagues argue that the U.S. is well behind some of its international counterparts in establishing STEMI protocols to effectively treat these patients in ways that parallel our current national trauma system. “Level one trauma centers are designed for catastrophic events like car accidents, with emergency medical personnel assessing the immediate need of a patient at the scene and then transporting that patient to the closest trauma center equipped to handle that patient’s needs, not the closest hospital. Such patients are also often transported by helicopter to ensure quick, immediate access to quality care,” says Dr. Mehta, Lumen 2009 Program Director and author of the Textbook of STEMI Interventions. A national initiative to establish STEMI Receiving Centers within hospitals is the backbone of LUMEN 2009: The Symposium on Optimal Treatments for Acute MI. In various European countries, such as Denmark, integrated centers for STEMI care have been operational for several years. In Ottawa, Canada, a program exists under which 800,000 residents of the city have been triaged to receive angioplasty for the occluded artery. In limited areas of the United States, some integrated systems of triage and transfer for STEMI patients have been created by local emergency service operations. These include the Mayo Clinic, Minneapolis Heart Institute, SOCAL system in Southern California and RACE system in North Carolina. Yet the majority of Americans, even those in large, metropolitan cities, will not be treated successfully for their STEMI. LUMEN 2009 brings together international leaders to discuss needed protocols vital to establishing a national system to combat the number-one killer of men and women in the U.S. “Time = heart muscle,” adds Dr. Mehta, who advocates angioplasty for STEMI patients instead of thrombolytic therapy (drugs), whenever possible. “The longer the time to treatment, the greater the amount of heart muscle affected by deprivation of oxygenated blood and the likelihood that the patient will die or be unable to fully recover.” The time from the patient’s arrival at the hospital to the opening of the blocked artery, often referred to as door-to-balloon (D2B) time, should be no more than 90 minutes, as recommended by the American College of Cardiology/American Heart Associations (ACC/AHA) Clinical Guidelines for STEMI Care; any longer than 90 minutes can mean irreversible damage to the heart muscle. Of the 500,000 reported STEMI patients in the U.S. annually, only half find themselves in hospitals capable of performing immediate angioplasty. Although thrombolytics offer relief of symptoms and have the advantage of being administered early and even in the ambulance, a very high proportion of patients do not achieve complete clearing of the blockage and a majority end up also needing angioplasty. The long-term recovery of the heart muscle is better with angioplasty and the risk of stroke is reduced. “Establishing a national protocol is vital and possible. STEMI treatment is not just the domain of the interventional cardiologist; it is a matter of public health policy,” says Dr. Mehta. LUMEN 2009, the world’s premier STEMI meeting, is expected to draw international experts discussing issues related to STEMI interventions and key areas of interventional cardiology and vascular interventions. Dr. Sameer Mehta serves as the Director of LUMEN 2009. The four Co-Directors for the CME program include world experts Dr. Samin Sharma (Complex Coronary Interventions), Dr. Brahmajee Nallamothu (D2B Processes), Dr. William Hoekstra (Emergency Medicine Pathways for STEMI) and Barbara Unger, RN (STEMI Systems & Cardiovascular Nursing). The innovative CME agenda will include lectures, debates, workshops, certification courses and industry satellite programs. The meeting will be held February 26–28, 2009 at the Loews Miami Beach Hotel in Miami Beach, Florida. According to a Centers for Disease Control (CDC) study entitled “Prevalence of Heart Disease – United States,” Florida residents rank in the top 10 for the highest prevalence of heart disease. LUMEN 2009 will become the one-stop, STEMI educational rendezvous for clinical and interventional cardiologists, cardiac and vascular surgeons, emergency department staff, critical care nurses, cardiovascular laboratory technicians and nurses, paramedics, and hospital administrators who are all invested in optimal outcomes for heart attack patients. To learn more, please visit: www.LUMENami.com. LUMEN 2009 is sponsored by the North American Center for Continuing Medical Education (NACCME), a wholly-owned subsidiary of HMP Communications Holdings, LLC. NACCME provides a wide array of accredited CME offerings, with industry thought leaders participating in roundtable meetings, webcasts, symposia, conferences, seminars, podcasts and satellite programs. Merit Medical Announces Lineup of New Product Introductions Merit Medical Systems, Inc., a leading manufacturer and marketer of proprietary disposable devices used primarily in cardiology and radiology procedures, announced five new products that are scheduled to be introduced over the next several months. The Slip-Not™, a suture retention device, is scheduled to be introduced in the next two weeks. It is a patented device used for the retention of purse-string sutures following fistulagrams or other fistula procedures. A surgical version is currently under development for introduction in mid-2009. The Prelude® Short Sheath replaces a previously-purchased product that Merit has enhanced with new features and lower cost. The product is primarily used as the main access device for the treatment of dialysis grafts. The product may also be used in conjunction with the Slip-Not™. It is scheduled to be released in mid-September. The M.A.K.-NV™, an introducer set used primarily in drainage procedures, is scheduled to be introduced in mid-September. The device will complement Merit’s Resolve™ drainage catheters. The GrandStand™, a patented addition to Merit’s safety product line, is designed to help facilitate convenience and safety during interventional and diagnostic procedures. The GrandStand™ is expected to be released in the fourth quarter of 2008. The Merit HD8™ hemostasis valve is designed for use during interventional procedures that utilize guiding catheters. Its patented double seal ensures little or no blood loss, and it can be operated with one hand. The Merit HD8™ is expected to be released in the fourth quarter of 2008. TAXUS OLYMPIA Registry Shows Excellent Outcomes for High-Risk Patients Treated with Second-Generation TAXUS® Liberté® Stent Boston Scientific Corporation announced positive one-year results from the European and intercontinental launch phases of its global TAXUS OLYMPIA registry, the largest post-approval, prospective registry for a single drug-eluting stent (DES). OLYMPIA is designed to analyze real-world clinical outcomes data for Boston Scientific’s second-generation TAXUS® Liberté® Paclitaxel-Eluting Coronary Stent System in the treatment of patients with coronary artery disease. Results from the 22,000-patient study were presented by Oscar Mendiz, MD, at the European Society of Cardiology Congress in Munich, Germany. The TAXUS OLYMPIA registry employs a consecutive enrollment process and consists of diverse and high-risk patient populations, reflecting real-world usage patterns found in everyday clinical practice. One-year data were collected for a total of 22,345 patients to date in 57 countries. A large majority of patients (75%) were considered “expanded-use” cases consisting of complex lesions or complex clinical characteristics. The overall OLYMPIA population in these two phases included patients with multivessel disease (56.5%), prior percutaneous coronary intervention (27.9%), prior myocardial infarction (MI) (34.1%), multiple stents (32.3%), and medically-treated diabetes (27.0%). The one-year results demonstrated a low overall 3.8 percent rate of TAXUS Liberté stent-related composite cardiac events, including cardiac death (1.2%), MI (0.8%), and target lesion re-intervention (2.5%). The definite stent thrombosis rate was 0.8 percent after one year, which is consistent with safety data from other DES registries. In the more complex expanded-use patient population, the rates of stent-related composite cardiac events and stent thrombosis were 4.3 percent and 0.9 percent, respectively. The TAXUS Liberté stent also exhibited a high degree of procedural success at 99.7 percent. “The TAXUS OLYMPIA registry shows impressive results in the largest, prospective DES patient population ever studied for an individual stent,” said Dr. Mendiz of Fundacion Favaloro, Buenos Aires, Argentina. “The low occurrence of cardiac events and stent thrombosis is noteworthy, especially given the high degree of complex patients and lesions from real-world practice in this study.” The TAXUS Liberté stent is currently pending approval by the U.S. Food and Drug Administration and is not available for sale in the United States. VHA Inc. Launches Real-Time Monitoring Application for Hospital Cardiac Programs Powerful Tool Helps Hospitals Manage and Improve Clinical and Financial Performance in Cardiac Arena VHA Inc., the national healthcare alliance, is launching its Cardiac Performance Dashboard™, a powerful management tool that enables hospital administrators and clinicians to monitor, manage and forecast their cardiac department’s clinical, financial and operational performance in real time. The cath lab often generates a significant portion of a hospital’s cardiology revenue and expenses, so efficient management can be crucial to a hospital’s success. More than 2,000 hospitals nationwide have cardiac catheterization labs. In 2007, hospitals spent more than $21.5 billion on interventional cardiology and cardiac rhythm management devices to perform more than 1 million cath lab procedures. Wide adoption of the VHA Cardiac Performance Dashboard could support national efforts to reduce healthcare costs and improve quality in an area of healthcare that touches many families’ lives. The dashboard’s large, color-coded dials enable administrators to more rapidly detect and respond to trends and events using current information. Previously, information about interventional cardiology performance was outdated and required lengthy and time-consuming data analysis to uncover. Now, hospital administrators, medical staff and clinicians can immediately apply information about the cost of care, clinical quality measures and patient experience data — up to the last completed procedure — allowing the hospital to rapidly target areas for improvement by the hour. The Cardiac Performance Dashboard allows hospitals to monitor clinical effectiveness and operational efficiency in the cath lab, electrophysiology lab and cardiac rhythm management departments. It does not track information for cardiac surgical procedures. “We developed the Dashboard with hospitals and patients in mind,” said Joane Goodroe, senior vice president of innovation at VHA. “It is important because it saves time, reduces costs and rapidly reduces the time required to accurately interpret clinical and cost information. In addition, Dashboard users can easily compare their cardiac program’s statistics to national best practices, identify areas for improvement and monitor improvement efforts.” The tool enables hospitals to compare their cardiac programs to national benchmarks for comprehensive oversight for 49 parameters, including the following areas: • Cost per procedure; • Utilization of specific devices; • Turnaround time for cath labs between procedures; • Length of patient stay; • Infection rates; • Procedure results; • Patient profiles to measure severity; • Variation in process and supply usage by physician. Users can immediately identify areas where they can improve clinical outcomes through real-time performance alerts that identify specific factors. For example, the Dashboard would allow users to see their own detailed 24/7 door-to-balloon statistics and identify any time periods that may not meet national performance standards and determine the causes. “The Cardiac Performance Dashboard helps hospital executives make immediate, well-informed decisions that have a positive impact on the institution and its patients, since much of the detailed information collected relates directly to patient care quality,” said Goodroe. Hospitals can customize the dashboard’s metrics to best support their individual decision-making and goals. In addition, results viewed by individual physicians allow hospital staff members to precisely identify opportunities for improvement. “This innovative Dashboard application will give us detailed, current and relevant information that we can use to identify and analyze our department’s performance in many key areas,” said Tom Edwards, cardiac services director at Northeast Georgia Medical Center and Health System in Gainesville, Georgia. “We expect this will help our patients receive better care, lower our department’s costs and help our hospital remain competitive.” “The healthcare industry has been in need of a powerful tool like this for a long time. To run successful cardiac programs, it is imperative to be able to see how many cases are scheduled, the average time per case and whether volumes are up or down in real time,” said Cathy Young, RN, MBA, vice president of cardiac medicine and geriatric services at The Queen’s Medical Center in Honolulu, Hawaii. “We are a technically advanced hospital. Nobody else’s technology offered us this critical ability to link leaders to these key areas that are the engine of any heart hospital.” VHA’s Cardiac Performance Dashboard relies upon and analyzes vast amounts of information collected by VHA’s CathSource® data warehouse system and must be used in combination with it. CathSource is VHA’s proprietary data-gathering tool. It has collected detailed, real-time patient information at the point of care for nearly 3 million patient encounters nationwide. For a demonstration of the Cardiac Performance Dashboard please visit: https://www.vha.com/cardiacperformancedashboard. To learn more about VHA’s other offerings, visit www.vha.com. Mennen Medical Launches the Horizon XVu CathLab System Mennen Medical, a leading provider of patient monitoring and hemodynamic monitoring systems that also includes electrophysiology systems, announced that a new CathLab System, the Horizon XVu, was launched and is now available as part of the company’s commitment to implement an overall CathLab solution. The XVu, embedded with an ultra-modern interface and analysis system, includes network ability and efficient workflow connectivity as part of Mennen Medical’s total IT solution. The state-of-the-art software displays eight main focus areas. Combined with user-friendly windows and an intuitive graphic interface, the system enables various layouts to suit both cardiac and peripheral angiographic procedures. The CFE, Mennen Medical’s proprietary front-end vital signs monitor, is designed to work in concert with the Horizon XVu. Its exceptionally small size allows it to be rail-mounted on the procedure table for maximum space utilization. It is manufactured employing the latest technology available and is designed to operate under the demanding workload conditions existing in both cardiac and peripheral angiography environments. The CFE acquires patient vital sign data that include: electrocardiography (up to 12 leads), respiration, SpO2, NIBP, cardiac output (thermodilution method), two channels of temperature and four invasive blood pressures. Easily accessed controls on the unit allow for in-room personnel to perform functions (zero BP; cycle NIBP, etc.) without the control room’s assistance. In addition, the CFE features an Integrated EtCO2 module and six IntraCardiac channels for electrophysiology studies. Prasugrel Significantly Reduced New or Recurrent Heart Attacks in Both Acute and Longer-Term Settings Following PCI, Compared with Clopidogrel A subanalysis of the TRITON-TIMI 38 clinical trial showed that treatment with prasugrel compared with clopidogrel significantly reduced the risk of new or recurrent heart attacks (7.4 percent vs. 9.7 percent; p Expert Consensus Panel Recommendation for Incorporating Lp-PLA2 Testing into Cardiovascular Disease Risk Assessment Guidelines diaDexus, Inc. announced the release of a supplement to The American Journal of Cardiology (2008;101:12A, June) that includes an expert consensus panel recommendation to include testing for lipoprotein-associated phospholipase A2 (Lp-PLA2), a vascular-specific inflammatory marker, as an adjunct to traditional cardiovascular disease (CVD) risk assessment. These recommendations are consistent with and build on the Adult Treatment Panel III guidelines (ATP III) for the use of inflammatory markers in patients at moderate-to-high CVD risk to improve identification of those at even higher risk for heart attack and stroke who would benefit from proven therapeutic and lifestyle treatments to prevent these cardiovascular events. The six-paper supplement entitled Advances in the Detection of Rupture-Prone Plaque: The Role of Lipoprotein-Associated Phospholipase A2 in Cardiovascular Risk Assessment was authored by a consensus panel of experts in the fields of cardiology, neurology and laboratory medicine. The panel was formed to review the rapidly-emerging literature on Lp-PLA2, an enzyme implicated in the formation of rupture prone plaque. Peter H. Jones, MD, Associate Professor of Medicine and Co-Director, Baylor Lipid and Atherosclerosis Clinic, Baylor College of Medicine in Houston, Texas, and coauthor of the summary paper entitled Consensus Panel Recommendation for Incorporating Lipoprotein Associated Phospholipase A2 Testing into Cardiovascular Disease Risk Assessment Guidelines, comments, “As a highly specific biomarker for vascular inflammation, Lp-PLA2 can identify persons who are at increased risk for heart attack and/or stroke. Elevated Lp-PLA2 levels should prompt consideration of increasing the cardiovascular risk category from moderate to high, or high to very high risk, directing initiation or intensification of statin therapy to reduce LDL-cholesterol to prevent heart attacks and strokes.” The consensus panel also endorsed a simplified framework for traditional Framingham risk factor assessment in which any patient with two risk factors is recommended for Lp-PLA2 testing, given that most individuals with two risk factors are at moderate CV risk. In addition, a clinical cutpoint for Lp-PLA2 of > 200 ng/mL was recommended for considering a patient at higher risk. In the paper entitled Lp-PLA2 and Risk of Stroke, Philip Gorelick, MD, MPH, Professor and Head of Neurology, University of Illinois College of Medicine, provides a review of several prospective epidemiological studies of Lp-PLA2 and stroke risk, and states that “determining patients at high risk for stroke may be challenging because total and LDL cholesterol may not predict stroke risk very well.” The panel recommends testing Lp-PLA2 to help identify moderate-risk individuals who may be at high risk of stroke for whom more intensive lifestyle and pharmacotherapies may be indicated to reduce stroke and other major vascular events. In his paper entitled Lp-PLA2: An Independent Predictor of Coronary Events in Primary and Secondary Prevention, Jeffrey Anderson, MD, professor of medicine (cardiology), University of Utah School of Medicine reported: “Lp-PLA2 appears to be highly specific for high atherosclerotic disease activity, independent and additive to traditional risk factors and metabolic syndrome. As such, Lp-PLA2 could alert the clinician to initiate proven strategies for coronary event and stroke reduction.” Both a PDF of the supplement and a searchable text version can be found on The American Journal of Cardiology Web site at: https://www.ajconline.org/issues/contents?issue_key=S0002-9149(08)X0017-7. Medical Experts Forge Historic Cross-Specialty Ties Focusing on Safe, Low-Cost Contrast Ultrasound New International Society, ICUS, Unifies Diverse Medical Specialties to Focus on Role of Contrast Ultrasound in Improved Patient Care Worldwide Medical professionals from around the world are welcoming the formation of the International Contrast Ultrasound Society (ICUS) — the only international and cross-disciplinary professional society exclusively devoted to the field of contrast ultrasound and its role in improving patient care worldwide. The new organization was launched at the opening session of the 23rd annual international conference of contrast ultrasound specialists, “Advances in Contrast Ultrasound: Enhanced Atherosclerotic Imaging and Interventions,” in Chicago. ICUS brings together medical professionals from around the world representing the fields of cardiology, radiology, gastrointestinal medicine, vascular medicine, internal medicine, hepatology, and other specialties and basic science disciplines — all focused on improving patient care by expanding the safe and appropriate use of contrast ultrasound imaging for more accurate and reliable noninvasive diagnosis of patients with diverse, and sometimes life-threatening, abnormalities. Contrast agents are approved in more than 70 countries for use in diagnosing a wide variety of medical abnormalities. At present, four contrast agents are available for approved indications in various countries: Definity (Lantheus Medical Imaging), Levovist (Schering AG), Optison (GE Healthcare), and Sonovue (Bracco Diagnostics). Ongoing clinical trials and pending regulatory applications are aimed at expanding the uses of ultrasound contrast agents. “There is growing interest worldwide in expanding the approved uses of contrast ultrasound — not just for imaging the heart, but also for diagnosing abnormalities of the liver, carotid arteries, gastrointestinal system, kidneys, and other organ systems throughout the body,” according to Dr. Steven Feinstein, co-president of ICUS, Program Director of the Advances in Contrast Ultrasound conference, and director of echocardiography at Rush University Medical Center in Chicago. “The formation of ICUS is a truly historic development in this field,” noted Dr. Barry Goldberg, co-president of ICUS and past president of the American Institute of Ultrasound in Medicine and the World Federation of Ultrasound in Medicine and Biology. Dr. Goldberg is a professor of radiology and director of the Jefferson Ultrasound Research and Education Institute at Thomas Jefferson University Hospital in Philadelphia. “Now, for the first time ever, there is an organization that provides a forum for cross-specialty communication and collaboration among contrast ultrasound professionals worldwide,” Goldberg added. “Collaboration and inclusiveness are key to the growth of the field and, ultimately, will significantly improve patient care.” Founding ICUS board members include contrast ultrasound experts from North America, Europe, Asia and Latin America. “We consciously structured the organization to make sure that its leadership always reflects diverse medical specialties and geographic backgrounds,” Goldberg explained. “The bottom line is that ICUS will help expand the field of contrast ultrasound, which directly improves patient care,” according to Dr. Lennard Greenbaum, Secretary of ICUS, past president of the American Institute of Ultrasound in Medicine, co-director of The Hughes Center for Fetal Diagnostics at Winnie Palmer Hospital for Women & Babies in Orlando, and member of the Department of Radiology at Orlando Health. The formation of ICUS follows the recent controversial decision by the U.S. Food and Drug Administration (FDA) to impose new limitations on the use of contrast ultrasound — a decision the FDA largely reversed in May following an unprecedented groundswell of opposition from contrast ultrasound experts who marshaled new scientific data supported by prominent journal editorials and testimony relating to the life-saving potential of improved contrast ultrasound diagnoses. “Together with our colleagues from non-cardiac specialties and from allied professional societies including the American Society of Echocardiography, we were able to show the FDA that contrast ultrasound imaging is significantly safer than alternative imaging procedures, and that its use can save patients’ lives,” according to Dr. Michael Main, one of the contrast ultrasound experts who led the grassroots professional outreach to the FDA. Dr. Main is treasurer of ICUS and medical director of the Echocardiography Laboratory at the Mid-America Heart Institute in Kansas City. “With unparalleled depth of expertise focused specifically on contrast ultrasound, ICUS may serve as a valuable resource for regulatory bodies worldwide in the future,” according to Dr. Petros Nihoyannopoulos, a vice president of ICUS, president of the European Society of Echocardiography, and professor of cardiology at Imperial College School of Medicine in London. “Now, the contrast ultrasound field will have its own voice for expressing expert, principled, scientifically-based perspectives on the appropriate use and regulation of ultrasound contrast agents,” he added. The recent FDA controversy helped cardiologists appreciate “the vital importance of our colleagues in radiology, vascular imaging and related imaging fields who also are working to develop contrast ultrasound applications — for the liver, gynecological uses, whole-body scans, etc.,” according to a letter co-authored by Dr. Feinstein in the Advances in Contrast Ultrasound conference brochure. “The more we learned of their parallel universe, the more we became convinced that we needed to foster more cross-specialty dialogue and collaboration.” This year’s Advances in Contrast Ultrasound conference, for the first time, includes leading experts in non-cardiac uses of contrast ultrasound, many of whom are also ICUS board members. ICUS plans to sponsor a newsletter, educational outreach to government regulatory agencies and professional education for physicians and sonographers. ICUS also will provide leadership in contrast ultrasound research and development. The organization’s Web site is www.contrastultrasoundsociety.org.

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