Clinical & Industry News

Lack of Vitamin D Could Spell Heart Trouble

Researchers issue recommendations to screen for and treat Vitamin D deficiency Vitamin D deficiency — traditionally associated with bone and muscle weakness — may also increase the risk of cardiovascular disease (CVD). A growing body of evidence links low 25-hydroxyvitamin D levels to common CVD risk factors such as hypertension, obesity and diabetes, as well as major cardiovascular events including stroke and congestive heart failure. In their review article, published in the December 9, 2008, issue of the Journal of the American College of Cardiology (JACC), the authors issue practical recommendations to screen for and treat low vitamin D levels, especially in patients with risk factors for heart disease or diabetes. “Vitamin D deficiency is an unrecognized, emerging cardiovascular risk factor, which should be screened for and treated,” said James H. O’Keefe, MD, cardiologist and director of Preventive Cardiology at the Mid America Heart Institute, Kansas City, MO. “Vitamin D is easy to assess, and supplementation is simple, safe and inexpensive.” It is estimated that up to half of U.S. adults and 30 percent of children and teenagers have vitamin D deficiency, which is defined as a 25(OH)D level of Natural organic food sources of vitamin D include salmon, sardines, cod liver oil, and vitamin D-fortified foods including milk and some cereals. Major risk factors for vitamin D deficiency include: older age, darkly pigmented skin, increased distance from the equator, winter season, smoking, obesity, renal or liver disease and certain medications. In the absence of clinical guidelines, the authors outline specific recommendations for restoring and maintaining optimal vitamin D levels in CV patients. These patients should initially be treated with 50,000 IU of vitamin D2 or D3 once weekly for 8 to 12 weeks. Maintenance therapy should be continued using one of the following strategies: 1. 50,000 IU vitamin D2 or D3every 2 weeks; 2. 1,000 to 2,000 IU vitamin D3 daily; 3. Sunlight exposure for 10 minutes for Caucasian patients (longer for people with increased skin pigmentation) between the hours of 10 am to 3 pm. Vitamin D supplements appear to be safe. In rare cases, vitamin D toxicity (causing high calcium levels and kidney stones) is possible, but only when taking in excess of 20,000 units a day. ___________________________

ev3 Inc. Receives FDA Clearance to Market EverCross and NanoCross Peripheral Angioplasty Balloons

ev3 Inc., a global endovascular device company, has received 510(k) clearance from the U.S. Food & Drug Administration (FDA) to market its EverCross 0.035” and NanoCross 0.014” peripheral angioplasty balloon catheters. ev3 expects to begin full commercialization of the EverCross and NanoCross peripheral balloon catheters globally in January 2009. The EverCross and NanoCross peripheral balloon catheters are designed to offer improved overall performance in peripheral angioplasty procedures. Among several new features, both catheters offer beveled tip profiles for lesion entry and a broad range of sizes, including the only 200 mm length .035” balloon available worldwide. The EverCross balloons also offer Rated Burst Pressures for the high pressure balloon market without compromising ease of use. ___________________________

Presence of Gum Disease May Help Dentists and Physicians Identify Risk for Cardiovascular Disease

Individuals reporting a history of periodontal disease were more likely to have increased levels of inflammation, a risk factor for heart disease, compared to those who reported no history of periodontal disease, according to an American Journal of Cardiology report. Led by investigators from Columbia University Medical Center and New York-Presbyterian Hospital, the findings suggest persons with increased levels of inflammatory markers associated with a higher risk of cardiovascular disease might be identified by asking about oral health history. This group might not be detected by traditional cardiovascular risk screening. Inflammation has been associated with cardiovascular disease and has been suggested to be a potential link between periodontal disease and cardiovascular disease. To examine whether oral health history and inflammatory markers associated with cardiovascular disease were linked, the investigators followed participants in the National Heart, Lung and Blood Institute (NHLBI) Family Intervention Trial for Heart Health (F.I.T. Heart), an ongoing national trial led by principal investigator Lori Mosca, MD, MPH, PhD, professor of medicine at Columbia University College of Physicians and Surgeons and director of preventive cardiology at NewYork-Presbyterian Hospital/Columbia University Medical Center. The NHLBI Family Intervention Trial for Heart Health aims to study family members of patients hospitalized with heart disease because they may be at increased risk themselves due to shared genetic and/or lifestyle factors. Dr. Mosca and her research team recruited family members or co-habitants of patients hospitalized for such cardiac events as a heart attack or narrowed arteries that required bypass surgery or an angioplasty procedure. Previous research has shown that family members of cardiovascular disease patients may be at increased risk for the disease due to the genes and lifestyle habits they share. In this study, 421 individuals who were blood related to and/or living with a person recently hospitalized due to cardiovascular disease were screened for traditional cardiovascular risk factors (such as elevated blood pressure and abnormal cholesterol levels), inflammatory markers associated with disease risk [high-sensitivity c-reactive protein (hsCRP) and lipoprotein-associated phospholipase A2 (Lp-PLA2)]. They were also asked standardized questions about their oral health status, including whether they had ever been diagnosed with periodontal disease, whether they had ever been treated for periodontal disease, whether they used partial or complete removable dentures, and the date of their last teeth cleaning. The oral health history was then correlated with standard markers of inflammation. Results found that among participants who did not have traditional cardiovascular disease risk factors (such as high blood pressure, high cholesterol and overweight/obese status), almost one in four were found to have a personal history of periodontal disease and higher levels of Lp-PLA2, an inflammatory marker which has been found present in inflamed rupture-prone plaque in heart arteries/valves. It is important to note that it is not possible to determine from this study that poor oral health causes cardiovascular disease risk or that any therapy based on oral health status would be effective in preventing cardiovascular disease. However, Dr. Mosca says, “Our finding is novel because it suggests the dentist and oral health exam may be the latest weapon in identifying persons at risk of cardiovascular disease, our nation’s number one killer.” “Many people don’t realize how oral health is often a predictor of one’s overall health,” says co-author John T. Grbic, DMD, MS, MMSc, professor of clinical dental medicine at the Columbia University College of Dental Medicine. “Symptoms for many life-threatening illnesses, such as diabetes and heart disease, first appear in the mouth. For this reason, it’s vitally important for people to have routine dental check-ups and have an ongoing dialogue with their dentist about their oral health. Patients may also benefit from seeing dentists affiliated with an academic medical center, where they are tapped into deep referral networks to appropriate clinicians.” ___________________________

Past Gains in Reducing Risk of Heart Disease Have Flattened; Women Especially Affected

The positive U.S. health trend documented over the past 30 years of reduction in risk for heart disease is not as strong as is widely perceived — and, in fact, the trend has flattened, according to a new analysis of national data by Mayo Clinic. This suggests that the public health challenge of curbing heart disease may be greater than is commonly thought, says Francisco Lopez-Jimenez, MD, cardiologist and lead researcher. “This study may surprise people because the data show that the risk of heart disease is not going down as we expected,” he says. “The estimated risk in our nation was coming down nicely in the 1980s. Then around 2000 it began changing — the trend lines flattened. While we had done a nice job with lowering cholesterol, blood pressure and stopping smoking, over time the improvement in these risk factors slowed and others like diabetes and obesity emerged, threatening to undo the early progress we made in reducing risk of heart disease. Most of the gains in reducing heart disease risk have been offset by the increased prevalence of diabetes and obesity.” Dr. Lopez-Jimenez presented the findings at the American Heart Association’s Scientific Sessions 2008 in New Orleans. The study is the first to suggest that not as much progress against heart disease is being made in recent years, despite the efforts by many organizations to promote healthy lifestyles, and the wide availability and lower price of many cholesterol and blood pressure-lowering drugs. “This is highly relevant to public health because most people think the risk of heart disease is going down steadily and has for the past 30 to 40 years —but our data show something different,” Dr. Lopez-Jimenez says. “The fact is that despite all the wonderful things we’ve done — all the changes in fat consumption, the promotion of exercise, the quitting smoking, treatment of high cholesterol and blood pressure — it doesn’t appear to be enough; the risk reduction we did achieve early on in the 1980s has gone flat, and we need to change that.” The researchers compared national heart disease risk factor data from three time periods to track change over time in risk reduction. The early period documented changes in risk between 1976 and 1980 and a midpoint of 1988 to 1994. The last period documented changes in risk from the midpoint to 1999 — 2004. Comparing changes from the early stage to the midpoint documented a decline in the overall risk to develop heart disease; but comparing change from the midpoint to the late period showed the trend flattening. “No one has ever compared national data this way, which is why we are the first to detect this worrisome flattening of the trend in risk factor reduction,” Dr. Lopez-Jimenez says. The data show that, in the U.S., the average age-adjusted 10-year risk of heart disease: • Decreased from 10 percent to 7.9 percent between the early period and the midpoint — a strong showing of progress in controlling risk factors during the 1980s. • Decreased only minimally in the interval from the midpoint to the last period, from 7.9 percent to 7.4 percent. This documents the flattening of the healthy trend. For women, in particular, the age-adjusted risk declined from the early period to the midpoint, but stayed flat from the midpoint to the late period, Dr. Lopez-Jimenez says. Similarly, when age groups were compared, the average predicted risk for those ages 30 to 49 stayed flat from the midpoint to the late period compared to people age 50 and above, he says. ___________________________

Carotid Endarterectomy Better Than Stenting for Artery Stenosis

With discharge data from 20 percent of all U.S. non-federal, non-acute hospitals now available from the Nationwide Inpatient Sample, researchers from the University of Massachusetts at Worcester compared the benefits of carotid endarterectomy and carotid artery stenting, as well as examined surgical outcomes and resource utilization. Several large, multi-center randomized trials in the 1990s found that carotid endarterectomy (CEA) surgery is an effective procedure for preventing stroke when the degree of stenosis is more than 60 percent; it remains the procedure of choice for patients with severe carotid artery stenosis. Carotid artery stenting (CAS) is sometimes offered to older patients or when the narrowed artery is inaccessible. Stenting also is used for individuals who are at risk for complications such as neurological conditions, prior surgery or exposure to radiation. Research has been published about CEA and CAS; however, there was no specific discharge code for CAS until 2005. With discharge data from 20 percent of all U.S. non-federal, non-acute hospitals now available from the Nationwide Inpatient Sample, researchers from the University of Massachusetts at Worcester wanted to compare the benefits of both procedures for that same year, as well as examine surgical outcomes and resource utilization associated with CAS and CEA. Researchers believe this is the first study to use this data when comparing both procedures. The complete study is available in the December 2008 issue of the Journal of Vascular Surgery®, published by the Society for Vascular Surgery. “Our primary outcome measures of interest were in-hospital mortality and postoperative stroke,” said senior author Mohammad H. Eslami, MD, division of vascular and endovascular surgery. “We also reviewed comorbidities, postoperative complications, length of hospital stay and charges, and resource utilization.” “During 2005 an estimated 135,701 patients underwent either CEA or CAS nationally and approximately 91 percent had CEA,” said Dr. Eslami. “We identified 124,000 patients who had carotid revascularization procedures. Almost all of the CAS patients had no symptoms (such as a prior TIA) for carotid artery narrowing,” said Dr. Eslami. “However, those who had CAS had a four-fold increase in mortality and an almost two-fold increase in postoperative stroke compared with those who had CEA.” Researchers said that mean charges for CAS patients were $35,100, which was significantly higher than CEA patients at $22,800. However these costs were much more pronounced when those with symptoms were evaluated, where the charges were $37,000 for CAS and $63,800 for CEA patients (who had higher odds of postoperative stroke and mortality). Dr. Eslami said that CEA has clearly significant advantages over stenting in preventing postoperative complications or death and should remain the first choice in patients who require carotid artery revascularization. “This study is not an indictment for CAS technology,” said Dr. Eslami. “I believe stenting will play an important role in carotid revascularization once the role of the procedure is better defined. Carotid stenting should be performed very cautiously and selectively and at specialized centers where both procedures are performed with great results.” Dr. Eslami added that randomized controlled trials with homogenous symptomatic and asymptomatic patient groups should be performed to define the role of CAS and determine its future applications in patients with carotid artery stenosis. The researchers explained that over time the outcome gap between CAS and CEA may grow smaller as technical improvements are made along with patient selection. ___________________________

Women Are More Likely Than Men to Die in Hospital From STEMI

Men and women have about the same adjusted in-hospital death rate for heart attack — but women are more likely to die if hospitalized for ST-elevation myocardial infarction (STEMI), according to a report in Circulation: Journal of the American Heart Association. Among patients with STEMI in a recent study, the death rate was 10.2 for women compared to 5.5 for men. Researchers said the women were older and had higher overall baseline risk profiles than men. After adjustment for these and other differences, women with STEMI had a 12 percent higher relative risk for in-hospital death compared to men. The study also found that some recommended treatments are delayed and underused in women. Researchers analyzed data from the American Heart Association’s Get With The Guidelines (GWTG) program to determine if recent efforts to improve heart attack care at hospitals had closed the gender disparity gap. They reviewed the clinical characteristics, treatments and outcomes of more than 78,000 patients diagnosed with myocardial infarction admitted to 420 hospitals between 2001 and 2006. “The finding that bears the most emphasis is that among both men and women presenting to Get With The Guidelines participating hospitals, there were no clinically meaningful differences in in-hospital survival after heart attack, once we factored in differences, such as age and other existing illnesses,” said Hani Jneid, MD, lead author of the study and assistant professor of Cardiovascular Medicine at Baylor College of Medicine in Houston, Texas. A decade ago, women had an overall higher death rate after heart attack compared with men. This suggests that these hospitals are now using high rates of evidence-based therapies shown to increase survival after heart attack. “However, the finding of persistently higher death rates among women experiencing the more severe type of heart attack (STEMI) and the persistent gender gap in certain aspects of care underscore the existing opportunities to enhance post-heart attack care among women,” Jneid said. In the study, Jneid and colleagues found that, compared to men, women were: • 14 percent less likely to receive early aspirin; • 10 percent less likely to receive beta blockers; • 25 percent less likely to receive reperfusion therapy (to restore blood flow); • 22 percent less likely to receive reperfusion therapy within 30 minutes of hospital arrival; and • 13 percent less likely to receive angioplasty within 90 minutes of hospital arrival. “We could not determine in this study to which extent these differences were due to physicians’ failures to administer optimal therapies to women vs. appropriate decision-making based on biological and other differences between men and women,” Jneid said. Furthermore, researchers found that women admitted with a STEMI were about twice as likely to die in the first 24 hours of hospitalization as men. “Although STEMI is not as common among women as it is among men, it is a concern that there is still this gap in mortality between men and women after the more severe heart attack,” said Laura Wexler, MD, co-author of the study and senior associate dean at the University of Cincinnati College of Medicine. Get With The Guidelines helps improve physicians’ awareness of proven post-heart attack therapies, said Gregg C. Fonarow, MD, chairman of the Get With The Guidelines steering committee. “As part of this effort, the American Heart Association has been collecting data from a large number of hospitals about the treatments and outcomes of therapy for heart attack victims,” said Fonarow, a professor of cardiovascular medicine at UCLA. Thus, GWTG “has not only helped improve care but also created a powerful research tool,” Fonarow said. ___________________________

Medtronic Launches Sprinter® Angioplasty Balloon Catheters on Rapid Exchange

Medtronic, Inc. announced the U.S. market launch of the Sprinter Legend (semicompliant) and the NC Sprinter (noncompliant) balloon dilatation catheters on a rapid exchange delivery system. Recently approved by the U.S. Food and Drug Administration, the Sprinter Legend balloon catheter provides innovations in balloon technology and is equipped to address difficult lesions in coronary angioplasty procedures. “The Sprinter Legend balloon catheter excels on deliverability and crossability,” said Dr. Bill Lombardi of St. Joseph Hospital in Bellingham, Wash. “Even for especially challenging coronary lesions, it has shown remarkable consistency in its ability to reach the lesion, and then cross it. Both traits are critical to clinical success.” The Sprinter Legend balloon catheter features the lowest pre-dilatation profiles on the market, making it suitable for use in challenging lesions, as well as allowing for the use of two balloons simultaneously in a 6 French guide catheter (the “kissing balloon” technique). The Sprinter Legend balloon catheter is being launched in a wide variety of sizes, covering diameters of 1.5 to 4.0 mm and lengths of 6 to 30 mm. ___________________________

FDA Approves Lumen Biomedical’s FiberNet® Embolic Protection System For Carotid Artery Stenting

Lumen Biomedical, Inc. (Plymouth, MN) announced that the U.S. Food and Drug Administration (FDA) has cleared its FiberNet® Embolic Protection System (EPS) for the treatment of patients receiving endovascular intervention for carotid artery disease. The approval follows the recent release of the EPIC Clinical Study data demonstrating the lowest stroke rates of any filter currently available on the US market. The defining attribute of the FiberNet filter lies in the 3-dimensional design, comprised of a matrix of fibers, allowing for capture efficiency (> 40 μm). The low-profile filter is mounted on a guide wire, with no delivery system needed to cross the lesion. Remote actuation deploys the fiber-based filter — treating vessels ranging from 3.5 to 7.0 mm — filling the vessel and ensuring 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 optimal filtration and ease of use of the FiberNet filter have proven to be clinically significant advancements in the carotid arena,” said Subbarao Myla, MD, U.S. Co-Principal Investigator of the EPIC trial. “The 2.1% 30-day stroke rate achieved in the EPIC trial further strengthens the parallel between technological advancements and the safety of carotid stenting.” The FiberNet EP System was evaluated in the multi-center, EPIC trial during carotid artery stenting of 237 high surgical risk patients with a critical carotid artery stenosis. Overall, the combined major adverse event rate at 30 days for all death, stroke and myocardial infarction (MI) was 3.0%. There were five strokes (4 ischemic and 1 hemorrhagic) for a 30-day stroke rate of 2.1%. There were no unanticipated adverse device effects. To learn more about Lumen Biomedical, Inc. visit the website at https://www.lumenbio.com ___________________________

Breaking the Silence After a Study Ends

While an estimated 2.3 million people in the U.S. take part in clinical trials every year, there currently exists no formal requirement to inform them of study results; an oversight that leaves participants confused, frustrated, and, in some cases, lacking information that may be important to their health. In an article published in the Archives of Neurology, researchers at the University of Rochester Medical Center (URMC) have proposed a novel and effective approach to disseminate the results of clinical trials to study volunteers. Industry, government, and academic researchers are dependent upon the willing participation of millions of individuals to fill the estimated 50,000 clinical trials conducted every year that evaluate the safety and efficacy of experimental drugs and medical devices. Researchers are only required to inform participants in instances when new information arises that may affect their willingness to continue participation. However, neither federal guidelines nor institutional review boards generally require disclosure of results at the conclusion of a study — even if the study is halted. Consequently, many research participants never learn the outcome of studies in which they volunteer. “Individuals who volunteer to participate in clinical research frequently expose themselves to risks, both known and unknown,” said URMC neurologist Ray Dorsey, MD, the report’s author. “Because of their participation, they should be informed of the results of these studies in a timely and personalized manner.” In recent years, there have been several high-profile examples in which information has been either withheld from participants (and the public), participants were not directly informed of study results, or they learned about negative study results indirectly from other sources such as the media. Despite recent federal efforts to mandate communications in instances when the product is approved, researchers are still not required to disclose results in instances when the drug or device has been tested in patients but — because of unfavorable results — abandoned before it is submitted for regulatory approval. The paper details efforts of researchers to communicate the results of a clinical trial for an experimental drug (ethyl-EPA) for Huntington’s disease. The results of the study — which showed no significant difference between the group of patients who received the drug and those who received the placebo — were also published today in the Archives of Neurology. The research was sponsored by the drug’s manufacturer, Amarin Neuroscience, and conducted by the Huntington Study Group, an international network of researchers based in Rochester. The 12 month study included 316 adults with Huntington’s disease and was conducted at 41 sites in the U.S. and Canada. Over the course of the trial, URMC and the sponsor developed a communication plan to inform participants of the study results. The goal was to directly inform participants within 48 hours of the initial public release in 2007 by the company; federal securities law requires companies to publicly disclose study results if they have a material financial impact. The plan included a mix of electronic communication and personal outreach. Information on the results was posted to the study’s website and emailed to members of the Huntington’s disease community. Additionally, study coordinators called each of the participants directly. URMC neurologist Ira Shoulson, MD, the study’s principal investigator, and the CEO of Amarin Neuroscience also held conference call which was open to all study participants and investigators during which they summarized the study results and then fielded questions. The researchers surveyed participants after the communication efforts and found that more than half (56%) learned of the results of the study within 48 hours of the initial public release by the company – the vast majority (73%) via a telephone call from the study staff. Participants reported a high level of satisfaction with the way results were communicated and had developed a strong understanding of the drugs benefits and risks. “It is critical that we treat participants as partners in research,” said Shoulson. “It is our hope that the commitment that the investigators and sponsor made to communicate the results of the clinical trial in a timely and personalized manner to research participants will set the standard for future clinical trials.” ___________________________

Study Supports Value of Advanced CT Scans to Check for Arterial Blockages

Catheterization still gold standard, but 64-row scanners now shown equally useful in diagnosis In a development that researchers say is likely to quell concerns about the value of costly computed tomography (CT) scans to diagnose coronary artery blockages, an international team led by researchers at Johns Hopkins reports solid evidence that the newer, more powerful 64-CT scans can easily and correctly identify people with major blood vessel disease and is nearly as accurate as invasive coronary angiography. Reporting in the New England Journal of Medicine, researchers at nine medical centers say the faster, 64-CT scans were 93 percent as precise as cardiac catheterization and virtually 100 percent accurate in detecting people with at least one artery dangerously clogged by the buildup of cholesterol and plaque. Comparison of CT and catheterization results also showed for the first time that they were equally useful in patients with heart attack symptoms, such as chest pain and shortness of breath, for predicting the need for cardiac bypass surgery or angioplasty to restore their blood flow. The CT scans accurately predicted 84 percent of invasive procedures performed, and catheterization predicted 82 percent. More than a quarter-million Americans undergo coronary bypass surgery each year, and another 1.2 million people undergo angioplasty. Senior study investigator and Johns Hopkins cardiologist João Lima, MD, says 64-CT scans are not a substitute for catheterization, but the scans, which take between five and 10 seconds to perform, are “an alternative diagnostic tool” physicians can use to “rule in or rule out” coronary blockages when other, more indirect tests for reduced blood flow, such as cardiac stress testing, are unclear or unsafe for a particular patient. Lima, a professor of medicine and radiology at the Johns Hopkins University School of Medicine and its Heart and Vascular Institute, says the 64-CT scans, first introduced to the United States and tested at Johns Hopkins in 2005, could reduce as much as one-fifth of the 1.3 million cardiac catheterizations performed each year nationwide that show no blockages. CT scans for heart disease, although not yet covered by many private health plans, could also serve as an alternative to cardiac stress testing, which generally cannot safely be performed on the weak and elderly because the test uses hard exercise to speed up blood flow and measure heart function. Lima says previous research had shown that older, less-powerful 16-CT scans were only a quarter to a third as precise as the newer tests, “fueling much-heated debate as to whether or not use of the technology could ever be justified. “But our latest findings weigh heavily in favor of the more advanced 64-CT scans,” he adds, citing additional study results showing that the scans could pinpoint with 91 percent certainty the precise artery blocked. At four times the strength of the more widely available 16-CT scanner, Lima says the 64-CT scans “provided our first real view of the whole picture of what is going on in the artery, precisely where the blockage is, even if it is only a partially obstructed.” Lead study investigator and interventional cardiologist Julie Miller, MD, says the advanced scanners are so good that physicians can for the first time measure blockages in blood vessels as small as 1.5 millimeters in diameter. Older 16-CT scanners, she says, are best suited for looking inside bigger arteries, those greater in diameter than 2 millimeters. Each of the 291 men and women, all over the age of 40, selected to participate in the new study were already scheduled to have cardiac catheterization to check for blocked arteries. Every participant had a 64-CT scan prior to catheterization and was then monitored through regular check-ups, starting in 2005 and set to continue through 2009, to identify who developed or did not develop any heart problems, who required subsequent bypass surgery or angioplasty, and who did not need any procedure. Researchers found that 90 percent of the patients without any major blockages were correctly diagnosed with 64-CT scans. The disadvantages of using 64-CT, Miller says, are radiation exposure and the rare potential in some people to have an allergic reaction or to develop kidney problems resulting from the contrast dyes injected into the body to enhance the images. “CT technology has come a long way in the last decade,” says Miller, the leader of angiographic research and an assistant professor at Johns Hopkins. She cites improvements that cut the average amount of radiation exposure and time required for a CT scan to less than 20 millisieverts with 16-CT scanners (which took about 12 seconds to perform), on average, to less than 15 millisieverts with 64-CT devices (at close to 6 seconds), and less than 6 millisieverts with the 320-CT (at less than a second.) She says the cost of the newer CT scans — approximately $700 — compares favorably with that of current nuclear stress testing for reduced blood flow, at nearly $1,000. Cardiac catheterization usually costs in excess of $1,500. Lima says the team’s next steps are head-to-head comparison studies using either CT or nuclear stress testing, which gauges reduced blood flow in parts of the heart to reveal clogging arteries. Included in the next analysis will be scans performed using an even more advanced scanner, the 320-CT. The latest imaging device was also tested at Johns Hopkins in 2006, and it can obtain images in less than a second, with significant reductions in radiation exposure. According to researchers, nearly 5,000 64-CT scanners are installed worldwide, but not all of the centers are equipped to perform and read cardiac CTs. Miller notes that special training and certification are required by technologists and physicians to accurately perform, read and interpret the scanned images. The American Heart Association and the American College of Cardiology Foundation in 2005 jointly established training guidelines. The CT scanner used in the study was an Aquilion 64 multidetector CT scanner, manufactured by Toshiba. Similar devices also are manufactured by Siemens, Phillips and General Electric. Toshiba also provided funding support for the study, called CORE-64, short for Coronary Artery Evaluation using 64-row Multidetector Computed Tomography. ___________________________

Number of Female Cardiologists Nearly Doubles, But Under-Representation and Discrimination Remain

Ten-year survey reveals progress and challenges amid increasing demand for cardiac care The number of female physicians in cardiology nearly doubled in the last decade, and male and female cardiologists both report a high level of job satisfaction, according to findings from a 10-year follow-up survey published in the December 16/23, 2008, issue of the Journal of the American College of Cardiology. Still, women account for less than 20 percent of all cardiologists, despite nearly equal numbers of men and women graduating from medical schools. Moreover, two-thirds of women continue to report discrimination, mostly due to competing demands of parenting and family responsibilities. “Women in cardiology continue to face the same institutional and personal roadblocks as those in other areas of medicine and science,” says Athena Poppas, MD, FACC, associate professor of medicine, Brown University Medical School, RI. “Women don’t choose to specialize as much as their male counterparts for a variety of reasons, including the intensity and length of training — at least six years for cardiology — during peak childbearing years.” As more and more Americans live with chronic heart conditions, the need to ensure a stable and competent cardiology workforce, including the recruitment of women, has become increasingly urgent. “One-third of Americans will have cardiovascular disease, so we must attract the best and the brightest — and that includes women — to keep up with demand and provide the highest level of patient care and research to help advance the field,” says Dr. Poppas, who also serves as chair of the American College of Cardiology’s Women in Cardiology Council, which commissioned the study. “We need to find ways to reduce discrimination, establish greater flexibility in work hours, and expand opportunities for mentorship to better meet the needs of women and men as they plan their careers in cardiology.” The need for greater flexibility is no longer gender-specific; both male and female doctors are striving for a better work-life balance. In fact, a similar proportion of male and female cardiologists are working less than full-time (80% vs 82%). This coincides with an overall trend toward more lifestyle-friendly areas of medicine, such as emergency departments, anesthesiology and radiology, which give physicians more control over their hours. “The perception is that cardiology is more demanding, and the hours less easy to control than other areas of medicine. Cardiology involves life-threatening emergencies, so you’re not always sure you’ll be home for dinner or make it to the school play,” she says. “But it’s incredibly rewarding and it shows. Cardiologists of both genders love what they do — nine out of 10 say they are moderately to highly satisfied.” According to the survey, women are also less likely than men to pursue interventional cardiology due, in part, to concerns about radiation exposure and pregnancy risks. One in four women reported selecting tracks to reduce their radiation risk. Female cardiologists are also more likely to have interruptions in their training or practice and, similar to other demanding professions such as law and business, they are much less likely to be married or have children than their male colleagues. The current survey of 1,110 participants, a follow up to the 1996 survey, aims to better understand the career and lifestyle needs of male and female cardiologists. This study is part of larger efforts by the American College of Cardiology (ACC) to take a critical look at why women remain under-represented in cardiology, and play a leadership role in helping to attract and retain young female medical students to the field through training, leadership and professional development. “We’re making progress, but we still have a long way to go to provide better opportunities and support for women cardiologists, and to be able to recruit more to the field,” said W. Douglas Weaver, MD, ACC’s president. “The College is committed to spearheading efforts to find creative solutions to meet the needs of our female colleagues.” ___________________________

Spectranetics Quick-Cross Extreme Product Line Receives FDA Clearance

Spectranetics Corporation announced clearance from the Food and Drug Administration for the Quick-Cross Extreme™ product line, which represents an extension of its Quick-Cross support catheters. The FDA clearance follows the recent receipt of the CE Mark in Europe and approval to market these products in Canada. The Quick-Cross Extreme product line is intended for use to guide and support a guide wire during access of the vasculature, allow for wire exchanges and provide a conduit for the delivery of saline solutions or diagnostic contrast agents. The Quick-Cross Extreme is designed to facilitate the crossing of blockages in the legs and features a braided catheter and an angled tip. The braided catheter jacket improves strength and pushability while the angled tip allows for quicker access into branched anatomy. This is an upgrade to the current Quick-Cross product line and is available for 0.035” guide wire compatibility in 65 cm, 90 cm, 135 cm, and 150 cm lengths. ___________________________

FDA Approves Boston Scientific’s Express® SD Renal Stent System

Low-profile, pre-mounted stent approved specifically for use in renal arteries The U.S. FDA has approved the Boston Scientific Corporation’s Express® SD Renal Monorail® Premounted Stent System for use as an adjunct to PTRA (percutaneous transluminal renal angioplasty) in certain lesions of the renal arteries. Two-year results from the RENAISSANCE clinical trial, which was designed to evaluate the safety and efficacy of the Express SD Renal Stent in hypertensive patients with atherosclerotic renal artery stenosis (RAS), demonstrated a statistically significant improvement in systolic blood pressure and no statistical difference in either diastolic blood pressure or serum creatinine levels from baseline through three years.1 Nine-month results demonstrated a binary restenosis rate of 21.3% (23/108), low target lesion revascularization (TLR) rates of 8.1% (9/111) and no stent thrombosis (0/100).2 The Express SD Renal Stent is designed specifically for treatment of the renal arteries by incorporating additional connections in the proximal end of the stent, which are intended to provide excellent support, especially in ostial lesions. References 1. Data on File at Boston Scientific 2. Presented by Dr. Krishna Rocha-Singh at ISET, January 2008.

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