Clinical and Industry News

Five-year Fractional Flow Reserve Data Confirms Benefit of Stenting Deferral Radi PressureWire® System Provides Definitive Information About Which Lesions To Stent And Those Which May Be Deferred Patients treated based on fractional flow reserve (FFR) results achieve long term outcomes equal, or superior to, patients who undergo stenting solely based on angiographic evidence, according to the results of a study published in the May 29 issue of the Journal of the American College of Cardiology. The authors report the five-year follow-up results of the DEFER study, which investigated the appropriateness of stenting a coronary stenosis that appears to be angiographically significant but is not restricting blood flow enough to cause symptoms. Dr. Nico Pijls, the study's principal investigator, said, From the DEFER study and other recent publications, it has become clear that the key issue in deciding which lesions should be stented is knowledge about whether a stenosis is responsible for ischemia. Current guidelines state that evidence must exist demonstrating that a stenosis is actually causing ischemia before it would be considered for percutaneous coronary intervention (PCI). This study concludes that stenting any lesion with an FFR of 0.75 or more (blood flow through the narrowed area of the artery that is at least 75 percent of normal) does not relieve any symptoms or prevent future cardiac events. Given the absence of patient benefit, the potential risks of heart attack or restenosis associated with the PCI procedure itself, and the high cost of PCI, using FFR technology to determine with certainty which lesions are significant and which can safely be left alone would seem to be warranted in every cath lab, said Morton Kern, MD, Associate Chief, Division of Cardiology, University of California, Irvine. The study results show the practice of stenting an intermediate lesion merely because it visually appears to be significant is of questionable value. Study Design. This prospective, randomized study involved 325 patients with stable chest pain scheduled for elective PCI of a single stenosis deemed significant based on visual assessment of an angiogram. Prior to any physiologic testing being performed, 167 patients were randomly selected to have PCI deferred (DEFER group); the remaining 158 were assigned to have PCI performed (the PERFORM group). FFR was then obtained on all patients using the Radi PressureWire®. All patients who had an FFR less than 0.75 in the suspected vessel were treated with a bare metal stent (the REFERENCE group), regardless of their initial randomization. A total of 144 patients received stents (FFR 0.75 and stenting is deferred. Stenting these patients does not improve outcomes. After five-years of follow-up, there were no statistical differences between the DEFER (FFR>0.75, no stent) and PERFORM (FFR>0.75 with stent) groups in terms of event-free survival (79% vs. 73%) and freedom from chest pain (67% vs. 57%). Importantly the composite rates of cardiac death and acute myocardial infarction yielded 3.3% vs. 7.9%. In addition, the use of medicines to manage chest pain and high blood lipids was identical (92% vs. 92%) in the two groups. Conversely, cardiac events after 5 years were significantly (p=0.03) higher in the REFERENCE (FFRAbout FFR. FFR expresses maximum achievable blood flow in a coronary artery with abnormal stenosis as a fraction of normal maximum blood flow in the absence of a stenosis. It is calculated using an interventional guidewire with a specially designed sensor built into it. Using the well-established value of 0.75, FFR is 100% specific in identifying which lesions are actually causing flow restriction and can be treated. FFR also documents the exact percentage of the reduction in flow associated with each lesion. The PressureWire® system (Radi Medical Systems, Wilmington, MA) consists of the sensing guidewire and a proprietary monitor which calculate Fractional Flow Reserve(FFR) in coronary arteries. Assessment of FFR with the newest version, PressureWire® Certus, provides physicians with valuable information on which to form clinical decisions on coronary vascular evaluation. Florida Hospital College Salutes the Online Radiologic Sciences Program Graduates Florida Hospital College of Health Sciences (FHCHS) proudly acknowledges the hard work and effort of the class of 2007 who graduated on April 29 from the online Bachelor of Science in Radiologic Sciences program. The 185 students in this graduating class completed their degrees from several regions of the United States. Some make their home as close as Orlando; others live as far away as California. However, over the past two years they have come together online with a common goal - to earn their Bachelor of Science in Radiologic Sciences degree. The FHCHS online Radiologic Sciences program has more than 700 students currently enrolled. Many of the graduates have developed close relationships with their classmates through the online program even though they are spread throughout the country. The graduation ceremony in Orlando will be the first opportunity many of the graduates have to meet their colleagues face-to-face. Some of the graduates share their thoughts about their experiences in the program: Shelley Donnelly of Merced, CA is a part-time instructor and lab assistant for the Radiology program at Merced Community College: "I have really enjoyed my learning experience at FHCHS," said Ms. Donnelly. "When I began the program, online learning was very new to me, but I truly enjoyed it and feel like my education was just as good, if not better than going to on-campus classes. I feel a sense of camaraderie with my fellow students in the program. Most, if not all, were very helpful in every aspect of learning; whether it was just a note of support, help in studying, or pitching in to help transcribe notes and PowerPoint presentations." Jennifer Altiveros is a radiologic technologist residing in Seacaucus, NJ: "For those in the program, stick with it - all the hard work will pay off. For those still thinking about going back to school, it's never too late," said Ms. Altiveros. "I am amazed at the options that have opened for me. This program is getting recognition, slowly but surely. There are healthcare companies out there waiting to recruit students who graduate from this program. FHCHS does a great job by including requirements necessary to take the advanced certification exams within the course materials." Florida Hospital College of Health Sciences online Bachelor of Science in Radiologic Sciences can be completed in as little as 18 months. Students interested in more information about the BS in Radiologic Sciences distance education program can contact a Florida Hospital College Enrollment Advisor at 877-471-1454 or visit the program web site, www.onlineradiology.fhchs.edu. Most Young Women Don't Recognize Heart Attack Warning Signs Most women 55 years and younger who have heart attacks don't recognize warning signs, researchers reported at the American Heart Association's 8th Scientific Forum on Quality of Care and Outcomes Research in Cardiovascular Disease and Stroke. Women younger than 55 years represent less than 5 percent of all hospitalized heart disease patients, but because so many heart attacks occur in the United States each year, even this small percentage affects a large number of people. Young women with heart disease account for about 40,000 hospitalizations each year. Diseases of the heart in young women account for about 16,000 deaths annually, ranking it among the leading causes of death in this group, according to authors. The number of young women who die from coronary heart disease each year is roughly comparable to the number of women who die of breast cancer in this age group, said Judith Lichtman, PhD, lead author of the study. Studies have shown that young women with heart disease are twice as likely to die in the hospital as similarly aged men. While these statistics are startling, relatively little is known about the clinical presentation, care or outcomes of young women with heart disease. In a pilot study, Lichtman and colleagues studied 24 women (55 and younger) who had heart attacks and were admitted to one of two Connecticut hospitals. The researchers asked them about their symptoms before the heart attack and whether they recognized or understood that they were at risk for heart disease. Nearly 90 percent of the women in the study had the typical heart attack symptom of chest pain, with 7.4 being the average rating of their chest pain on a scale of one to 10 (with 10 being the most painful). This means that they were experiencing significant chest pain, said Lichtman, an assistant professor in the Department of Epidemiology and Public Health at Yale School of Medicine in New Haven, Conn. Researchers said they were surprised that only 42 percent, or four in 10, of the women who came into the hospital thought something was wrong with their hearts. Many of them told us that they thought they had indigestion or heartburn, Lichtman said. The women also reported other less typical symptoms: 58 percent said they had pain in the jaw or shoulder 38 percent reported sweating 29 percent experienced nausea 29 percent reported shortness of breath 21 percent said they had indigestion or heartburn 8 percent felt weakness or fatigue Only about half of the women went to an emergency room within the first hour of their symptoms. When we asked the women why they delayed going to the hospital, half of those who waited more than an hour said they were afraid their symptoms weren't real; about 42 percent attributed their symptoms to something else; about 17 percent said they were embarrassed by their symptoms; and 8 percent admitted that they feared the symptoms or experienced denial that it could be heart disease, Lichtman said. The researchers also found that about 88 percent of the women had a family history (a parent or sibling) with heart disease. Even though 71 percent said their health was fair/poor, less than half considered themselves at risk for heart disease. The researchers said doctors may be failing to link many young women's symptoms to heart disease. Prior to their heart attacks, 38 percent saw their primary providers for some or all of their symptoms; yet, only 56 percent of those women said their doctors told them their symptoms were heart-related. It seems that many young women are not connecting their symptoms with heart disease, even more are simply unaware of the possibility that they are at risk for a heart attack, Lichtman said. We have to get the messages across to young women that they are at risk for a heart attack, they might experience not only typical but also atypical symptoms, and they need to be aware of their own risk factors, including family history. Prevention and modification of risk factors is important for young women. Clinical Trial Coordinators Need More Financial Conflict-of-Interest Training Medical professionals conducting clinical trials should be provided more information about financial conflicts of interest before they talk to patients about participating in the trials. That is one of the main conclusions of a new survey by researchers from Duke University Medical Center and Johns Hopkins University. Their study found that 41 percent of the clinical trial coordinators surveyed had experience disclosing financial aspects of the trial to potential participants, and 28 percent of the coordinators had been asked by participants about potential financial conflicts. Financial interests can include such things as corporate support for the costs of the trial and its personnel, a researcher's consulting contract with a company that has a vested interest in a trial and an investigator's ownership of stock in a sponsoring company. Clinical trial coordinators usually conduct most of the informed consent process by explaining to potential participants such details of the study as possible health benefits and risks. But more frequently now, the talk also includes financial conflicts of interest when they are relevant to the particular trial. "We found that coordinators who had more experience discussing financial matters felt more comfortable in discussing them with potential clinical trial participants," said Joelle Friedman, who presented the results of the latest survey April 22, 2007, during the annual meeting of the Association of Clinical Research Professionals in Seattle. Jeremy Sugarman, MD, of Johns Hopkins Berman Institute of Bioethics, also participated in the presentation. "When we asked the coordinators what they felt were the major barriers to providing financial information to patients, 76 percent cited lack of information about the financial aspects of the trial and 26 percent said they didn't think the patient would understand the disclosure," Friedman continued. The survey was part of the ongoing Conflict of Interest Notification Study (COINS), a five-year, $3 million project funded by the National Heart, Lung, and Blood Institute of the National Institutes of Health. The study is a collaboration among Duke University Medical Center, Johns Hopkins and Wake Forest University. The goal of the project is to analyze all aspects of financial disclosure to potential research participants and provide data and recommendations to help medical institutions and government agencies develop guidelines for such disclosures. "That more than three-quarters of the coordinators did not feel that they had enough information about possible financial conflicts of interest is high," Kevin Weinfurt, PhD, deputy director of the Center for Clinical and Genetic Economics at the Duke Clinical Research Institute said. "It is the responsibility of the clinical trial's principal investigator to ensure the coordinators are thoroughly educated on all aspects of the trial." Of those coordinators who said they were uncomfortable answering questions about financial interests, 58 percent said it was because of a lack of knowledge. The researchers also found that 13 percent of the coordinators who felt uncomfortable disclosing financial information thought that the information was a private matter for the investigator. "These findings are important because they underscore the importance of on-the-job experience and how coordinators new to their positions might benefit from additional education and training," Weinfurt said. The researchers surveyed 300 coordinators who were attending the 2006 international conference of the Association of Clinical Research Professionals. The full report of this study will be published in the journal Clinical Trials. Earlier COINS projects have looked at official institutional policies involving conflicts of interest in research and how potential study participants view these conflicts, as well as the reluctance of some researchers and officials to disclose financial interests to potential participants in the trials. Study Finds Longer Clopidogrel Rx Reduces Risk of Heart Attack, Death With Both Drug-Eluting and Bare Metal Stents A study showing that diabetic patients who are treated with long-term anti-clotting therapy are less likely to have a heart attack or die more than a year after stenting has been named among the best research papers presented at the 30th Annual Scientific Sessions of the Society for Cardiovascular Angiography and Interventions (SCAI), May 9-12, 2007. The study found that regardless of whether a drug-eluting or bare metal stent was utilized, diabetic patients were more likely to enjoy continued good health if treatment with clopidogrel was continued for more than 6 months post-stenting. The new study suggests that physicians may need to tailor antiplatelet therapy to the special needs of patients with diabetes. Diabetics are among the highest-risk groups undergoing coronary interventions, said Somjot S Brar, MD, a cardiologist at Kaiser Permanente Medical Center in Los Angeles. It is very common for these patients to have diffuse coronary artery disease. In patients who do not have diabetes, cardiologists typically prescribe a combination of aspirin and clopidogrel for about 1 month after placement of a bare metal stent, to prevent thrombosis, in the stent during healing. With drug-eluting stents, it is now common to extend the length of treatment with antiplatelet medication to a full year, based on evidence that these devices are more prone to very late thrombosis than was once believed. The ideal length of clopidogrel therapy remains unknown, however, particularly in patients with diabetes. In the study presented during the SCAI Annual Scientific Sessions, Dr. Brar and his colleagues identified 671 diabetic patients who had a stenting procedure and remained healthy during the first 6 months of follow-up. Patients were then divided into 4 groups, depending on whether they had been treated with a bare metal or drug-eluting stent, and whether they were continuing to take clopidogrel for longer than 6 months. One year later, diabetic patients who were treated with a drug-eluting stent were less likely to have suffered a heart attack or died if they continued taking clopidogrel than if they discontinued the medication (2.2 percent versus 5.5 percent, respectively; p=0.07). More surprising was the finding that even with bare metal stents, long-term clopidogrel therapy significantly reduced the risk of death or heart attack (3.5 percent versus 12.2 percent, p=0.01). Among patients who discontinued clopidogrel after 6 months, the difference in the combined rate of death or heart attack for drug-eluting and bare metal stents was not statistically significant. Dr. Brar speculated that in diabetic patients, long-term clopidogrel therapy may be helpful regardless of the type of stent because it prevents blood clots from forming on inflamed plaques throughout the diseased coronary arteries, not just on the stent itself. As for when it is safe to stop clopidogrel in diabetic patients, the study recorded the lowest rate of death or heart attack among those who continued therapy for up to 1 year. After that, the antiplatelet medication did not further reduce risk. Regardless of the type of stent, clopidogrel should be continued for more than 6 months-and perhaps for as long as 1 year-in diabetic patients, whenever possible, Dr. Brar said. Transmitting ECGs to Cardiologists by Smart Phone Cuts Treatment Time in Half Imagine paramedics mobilizing a team of cardiologists and nurses within minutes of arriving at the home of a person who is having a heart attack, simply by pressing a button that sends an electrocardiogram (ECG) over a wireless network. That's exactly what's being done at a Newark, NJ, medical center, and it's dramatically improving the quality of care, according to a study honored as the best abstract presented at the 30th Annual Scientific Sessions of the Society for Cardiovascular Angiography and Interventions (SCAI), May 9-12, 2007. The wireless system, which enables on-call cardiologists to view full ECGs on smart phones, has cut in half the time it takes to begin the treatment of heart attack with catheter-based techniques such as angioplasty and stenting. We have found a way to receive electrocardiograms from home, from another hospital, from our cars-anywhere we are, said Vivek N. Dhruva, DO, academic chief fellow in the Division of Cardiology at the University of Medicine and Dentistry of New Jersey (UMDNJ)-New Jersey Medical School, who presented the paper. In only 4 months, we went from being in the bottom 10 percent of hospitals in the time to treatment of heart attack to being in the top 10 percent of hospitals. Door-to-balloon time has become a recognized marker of the quality of care delivered to heart attack patients. Current guidelines have set a goal of no more than 90 minutes, a deadline that many hospitals struggle to meet. At UMDNJ, for example, it took an average of 61 minutes in 2005 just to notify a cardiologist that a patient with a heart attack had arrived at the emergency room. Coupled with the assignment of on-call cardiologists to more than one hospital and the catheterization laboratory's 5 pm closing time, it was virtually impossible to begin catheter-based treatment within 90 minutes. In fact, the average door-to-intervention time-an alternative term used in this study to reflect the full range of catheter techniques available to interventional cardiologists-was nearly 146 minutes in 2005. Under the guidance of Marc Klapholz, MD, director of the Division of Cardiology at UMDNJ, the wireless system went live in June 2006. It enables paramedics to use Bluetooth technology to send an ECG not just to the emergency room but also to a receiving station in the cath lab. From there the electrocardiogram is automatically converted to a PDF file and forwarded via the hospital intranet to several e-mail addresses set up just for that purpose. The on-call cardiologist receives a text message with instructions to download the electrocardiogram for viewing on a smart phone. The file also includes the phone number of the paramedic who initiated transmission of the electrocardiogram, so the cardiologist can immediately be in contact with the ambulance crew. Patients who are clearly having a heart attack are whisked directly to the cath lab. Using the wireless system, cardiologists are now notified an average of 15 minutes before the patient even arrives at the hospital. From June to December 2006, the average door-to-intervention time fell to 80 minutes. Today, it is lower still, averaging just 73 minutes. Establishing the wireless system took 6-8 months of planning and involved staff from cardiology, the emergency department, and emergency medical services. Representatives from administration, admitting, information technology, and telecommunications played a key role as well, Dr. Klapholz said. We had a commitment from multiple stakeholders within the institution to make this a priority, he said. Everyone was on-board and that's why we were successful. World's Largest Drug-Eluting Stent Registry Completes European and Intercontinental Enrollment Phases More than 23,000 patients now enrolled in TAXUS OLYMPIA registry Boston Scientific Corporation announced that it has completed enrollment in the European and Intercontinental phases (II and III) of its TAXUS OLYMPIA registry, bringing the total number of current patients to more than 23,000. The registry is designed to evaluate the safety and performance of the Company's second-generation drug-eluting coronary stent (DES), TAXUS® Liberte, in a real-world setting. OLYMPIA is the world's largest DES registry and plans to enroll at least 27,000 patients treated for complex coronary lesions at more than 400 centers worldwide. "The size of the OLYMPIA registry is truly unprecedented in the DES field and will yield invaluable real-world information to the benefit of interventional cardiologists and those patients who suffer from cardiovascular disease," said Martyn Thomas, MD, FRCP, Director of Invasive Cardiology, Kings College Hospital, London, and one of the coordinating investigators of the registry. "We expect the results from this registry to remain consistent with the safety and efficacy results we've seen in previous clinical trials featuring the TAXUS stent system in complex patients with complex lesions." The multi-center, prospective, observational OLYMPIA registry will evaluate a variety of safety and performance measures, including the rate of repeat procedures (target lesion revascularization, or TLR) and major adverse cardiac events. Additionally, sub-analyses on complex patient groups such as diabetics, patients with multi-vessel disease, in-stent restenosis or a prior history of heart attack will be performed. The OLYMPIA registry is enrolling patients in multiple phases, corresponding to the commercial introduction of the TAXUS Liberte stent system in different regions of the world. The initial, transitional phase enrolled 529 patients from a limited number of international markets in which TAXUS Liberte was commercially available. The Phase I enrollment consisted of diverse and high-risk populations (including 50 percent diabetics, 49 percent multi-vessel disease, 40 percent small vessels, and 48 percent complex lesions defined as B2/C), reflecting complex usage patterns in "real-world" clinical practices. Twelve-month results from OLYMPIA Phase I were announced at the 2006 Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium in Washington, D.C. The results demonstrated an overall TAXUS Liberte stent-related cardiac event rate of 3.7 percent, including myocardial infarction (1.4 percent), and TAXUS Liberte stent-related re-intervention of the target vessel (1.9 percent), with an overall cardiac death rate of 1.5 percent. The next and final phase of the registry (IV) will enroll U.S. patients, following regulatory approval. Data collected for the OLYMPIA registry are being uniformly reported through a web-based data capture system, and all major clinical events are regularly reviewed and adjudicated by an independent Clinical Event Committee of interventional cardiologists or an Independent Medical Reviewer. The TAXUS Liberte coronary stent system is the second generation to Boston Scientific's market-leading paclitaxel-eluting coronary stent system, TAXUS® Express2. TAXUS Liberte is pending PMA approval and is not available for sale in the U.S. Toshiba's CorE 64 Multi-Center Study Completes Enrollment Largest International Multi-Center 64-Slice CT Trial; Benefits of Findings Evidenced By Use In Two Ancillary Studies Presented at ACC Toshiba America Medical Systems, Inc. announced the completion of enrollment for 400 patients in its CorE 64 (Coronary Evaluation on 64) study taking place across seven countries, the largest trial ever initiated evaluating the use of 64-slice CT technology. The trial's enrollment completion signifies that the study of all patient participants has finished, resulting in the most statistically reliable data available to date. Toshiba's CorE 64 trial investigates the use of multi-slice CT as the primary diagnostic tool for detecting cardiovascular diseases and disorders, as compared to cardiac catheterization. Data collected to date from CorE 64 indicates CT holds a favorable place as a diagnostic alternative to cardiac catheterization and has the potential to change the delivery of healthcare. We expect CorE 64 findings to impact the overall reimbursement guidelines for multi-slice CT, resulting in greater patient access to these exams and to have significant economic benefits for 64-slice CT, explained Toshihiro Rifu, senior fellow, Toshiba Medical Systems Corporation. Additional benefits from this study are already evidenced by the use of CorE 64's preliminary data in two ancillary studies by Johns Hopkins University presented at American College of Cardiology (ACC) annual meeting. The CorE 64 multi-center study participants include nine sites across seven countries. According to Toshiba's senior director of CT, Doug Ryan, the CorE 64 clinical trial utilizes a different approach when compared to previous studies on the topic. This is attributed in large part to the study's unique design, which calls for an international, multi-center approach, bypassing limitations associated with previous studies that focus on one geographic area or utilize smaller patient populations. CorE 64 is the first trial that evaluates all of its 400 study participants who are between 50 and 70 percent stenotic, resulting in statistically significant data, noted Ryan. For more information about CorE 64, please visit www.medical.toshiba.com. CV Administrators at Academic Medical Centers Report Highest Average Compensation Cardiovascular administrators employed by academic medical centers enjoyed the highest average compensation in 2006; those with community teaching hospitals had the highest median compensation, according to Tyler & Company (www.tylerandco.com), an healthcare executive search firm. According to the new compensation survey, conducted in cooperation with the American Academy of Medical Administrators (AAMA) and its specialty group, the American College of Cardiovascular Administrators (ACCA), compensation of cardiovascular administrators by facility type showed a wide variance, from a low of $56K to a high of $207K. Community hospital CV administrators reported a $105K average compensation, $100K median. Those with community teaching hospitals report $116K average, $115K median. Academic medical center CV administrators indicate $120K average, $108K median compensation. There were insufficient responses from freestanding heart hospitals, health systems or physician practice staff to draw effective comparisons. Seventy percent of respondents were bonus eligible. Of those, 72% received a percentage of base; 29% received a flat amount based on other criteria. Reimbursement issues headed the list of cardiovascular administrators' top 10 concerns for 2007, according to survey results. In order of response, here are the leading issues concerning cardiovascular professionals: 1. Reimbursement 2. Staff Recruitment and Retention 3. Technology 4. Cost Management 5. Competition/Market Share 6. Volumes/Growth 7. Physician Relationships 8. Quality 9. Regulations 10. Pay for Performance

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