Clinical and Industry News for October 2007

Few Americans Aware of Dangerous Peripheral Arterial Disease Three out of four people aren't aware of peripheral arterial disease (PAD), affecting approximately 8 million Americans, according to a new study published in Circulation: Journal of the American Heart Association. In a cross-sectional, population-based telephone survey of 2,501 adults over age 50, researchers found that public awareness of PAD (25 percent) is markedly lower than for other cardiovascular diseases such as stroke (74 percent), coronary artery disease (67 percent) and heart failure (67 percent). Yet, the risk for PAD is equal to or greater than the risk for these conditions. Survey respondents were much more aware of relatively rare diseases that affect far fewer people, including Lou Gehrig's Disease (36 percent), multiple sclerosis (42 percent) and cystic fibrosis (29 percent). Few Americans know that having PAD significantly increases the risk for heart attack, stroke, amputation and death, the survey showed. Only one in four adults who were familiar with PAD associate the disease with an increased risk of heart attack; only 28 percent associate PAD with an increased risk of stroke; and only 14 percent link PAD with either amputation or death. Every day that PAD is undetected and untreated, we permit preventable heart attacks, strokes and death to occur, said Alan T. Hirsch, MD, chair of the National Peripheral Arterial Disease Coalition, professor of epidemiology and community health at the University of Minnesota School of Public Health, and director of the vascular medicine program at the Minneapolis Heart Institute. PAD affects both women and men and can strike adults of any age. The risk of PAD is increased in people over age 50, particularly in smokers and former smokers, and in people with diabetes, high blood pressure, abnormal cholesterol, a personal history of heart disease or stroke, and in African Americans. Awareness of PAD was low in all sub-groups studied, including African Americans. The risk of PAD in African Americans is twice what it is in other ethnic groups, and like other high-risk groups, African Americans should be a major focus of educational efforts about PAD, said Michael H. Criqui, MD, MPH, co-author and professor of family and preventive medicine at the University of California-San Diego. The study also found that most Americans do not know the causes or risk factors of PAD. Cigarette smoking and diabetes contribute to the development and progression of PAD, a fact unknown even by many survey respondents who reported familiarity with the disease. Further, more than half of those familiar with PAD do not know that high blood pressure and high blood cholesterol are also risk factors. The survey also found that almost half of adults familiar with PAD first became aware of the disease through the media broadcast or cable television (26 percent), a magazine (15 percent), newspaper (5 percent), the Internet (3 percent) or radio (0.7 percent). Only 19 percent of adults reported first hearing about PAD from a healthcare provider, and about 17 percent first heard about PAD from a family member or friend. The Peripheral Arterial Disease Coalition funded the study through grants from the Bristol-Myers Squibb/Sanofi Aventis Partnership and Cordis Endovascular, a division of Cordis Corporation. Note: The American Heart Association is a member of the National Peripheral Arterial Disease Coalition, an alliance of more than 50 leading health organizations, vascular professional societies and government agencies united to raise public and health awareness about PAD. For more information on the risk factors, symptoms and treatment of PAD, visit americanheart.org/pad and padcoalition.org. Stem Cells From Testes Produce Wide Range of Tissue Types U.S. researchers say they've successfully reprogrammed adult stem cells from the testes of male mice into a wide variety of cell types, including functional blood vessels, contractile cardiac tissue, and brain cells. If the same can be done with adult testes stem cells from humans, they may offer a source of new therapies to treat men with health problems such as heart disease, vascular diseases, diabetes, stroke, Parkinson's, Alzheimer's, and even cancer, the researchers said. The study, by Howard Hughes Medical Institute scientists, is published in the Sept. 20 issue of the journal Nature. Only a small subset of adult testes cells have the ability to develop into multiple cell types. Until now, scientists haven't had the means to identify and isolate these stem cells. In this new study, the researchers reported that they had identified a novel cell surface marker called GPR125 that's expressed on a unique set of cells within adult testes spermatogonial stem and progenitor cells (SPCs). Using GPR125, the scientists were able to identify and harvest a large number of SPCs from adult mouse testes. In the lab, the team propagated and reprogrammed the SPCs to become stem cells that could differentiate into a variety of cell types. It appears that these specialized GPR125-positive spermatogonial cells could be an easily obtained and manipulated source of stem cells with a similar capability to form new tissues that we see in embryonic stem cells, study author Shahin Rafii, of Weill Cornell Medical College in New York City, said. For male patients, this could someday mean a readily available source of stem cells that gets around ethical issues linked to embryonic stem cells. It also avoids issues linked to tissue transplant rejection, since these autologous cells come from the patient's own body, Rafii said. AHRQ And FDA Collaborate In Largest Study Ever Of Possible Heart Risks With ADHD Medications Two U.S. Department of Health and Human Services agencies will collaborate in the most comprehensive study to date of prescription medications used to treat attention deficit hyperactivity disorder (ADHD) and the potential for increased risk of heart attack, stroke or other cardiovascular problems. Researchers supported by the Agency for Healthcare Research and Quality and the U.S. Food and Drug Administration will examine the clinical data of about 500,000 children and adults who have taken medications used to treat ADHD to determine whether those drugs increase cardiovascular risks. Because medications used to treat ADHD can increase heart rate and blood pressure, there are concerns about the drugs' potential to increase cardiac risks. It is also thought these risks may be different for adults and children, but more evidence is needed about the long-term effects of using ADHD medications. The planned analysis follows an FDA-sponsored preliminary study that compiled information from large health care databases on prescription drug use, inpatient care, outpatient treatment, and health outcomes, including death. Based on that effort, researchers identified people who took ADHD drugs during a 7-year period ending in 2005. AHRQ, which sponsors research on clinical effectiveness and safety, will team with FDA to complete the analysis of the data. Case reports have described adverse cardiovascular events in adult and pediatric patients with certain underlying risk factors who receive drug treatment for ADHD, but it is unknown whether or not these events are causally related to treatment, said Gerald Dal Pan, MD, director of FDA's Office of Surveillance and Epidemiology. "The goal of this study is to develop better information on this question." The study will be coordinated by Vanderbilt University researchers on contract through AHRQ's Effective Health Care program. Data analysis will be performed by researchers at Vanderbilt, Kaiser Permanente of California, the HMO Research Network and i3 Drug Safety, as well as from FDA and AHRQ. The analysis will include all drugs currently marketed for treating ADHD. The study will analyze the risks of all the drugs as a whole, and risks of the drugs grouped by class. The analysis will take about two years to complete. Results are expected to be important not only to patients, their families and health care providers, but also to government insurance programs. Medicaid, Medicare, and the State Children's Health Insurance Program provide reimbursement for drugs prescribed for ADHD. This information could also be used to inform product labeling, which is used by health care providers when making treatment decisions. ADHD is a behavioral disorder that, in many patients, causes hyperactivity, and may have a significant impact on school performance and social functioning. According to the National Institute of Mental Health, ADHD affects approximately 3 percent to 5 percent of school-age children and about 4 percent of adults. Use of ADHD drugs has increased in recent years among children and adults. A recent AHRQ analysis of medication expenditures found three ADHD drugs, Concerta, Strattera, and Adderall, ranked among the top five drugs prescribed for children ages 17 years and younger. About $1.3 billion was spent on those drugs in 2004, the study estimated. Adult use is also believed to be increasing. In May 2006, based on a review of anecdotal reports of heart attack, stroke and sudden death among patients taking usual doses of ADHD medications, the FDA asked drug manufacturers to revise product labeling to reflect concerns about possible adverse events. AGA Medical Corporation Receives FDA and CE Mark Approvals for the Amplatzer Vascular Plug II AGA Medical Corporation has received U.S. Food and Drug Administration (FDA) and European CE Mark approvals for the Amplatzer Vascular Plug II. It is designed to embolize blood vessel and blood vessel malformations in the peripheral vasculature. The Amplatzer Vascular Plug II is a self-expandable nitinol mesh occlusion device and is designed to be introduced in a minimally invasive fashion through a catheter. The delivery cable that comes pre-attached uses the Amplatzer user interface to enable the physician to more precisely position the device in the targeted blood vessel. Once positioned, the cable is unscrewed and the device is released. The vascular plug II is designed with multiple lobes to facilitate rapid clotting. I have used the new Amplatzer Vascular Plug and I found it to be very easy to use and very effective in causing a quick and complete occlusion, said Dr. James F. Benenati, Medical Director of the Peripheral Vascular Lab at the Baptist Cardiac & Vascular Institute in Miami, Florida. Deployment is easy, radio-opacity is excellent and occlusion is complete and rapid. The Vascular Plug II comes in sizes ranging from 3 mm to 22 mm. A single Vascular Plug II is generally required to occlude the targeted vessel. Appropriate Hospital Discharge System Can Prevent Future Cardiac Events Improving how healthcare providers follow proven protocols could reduce the risks of subsequent heart problems for heart disease patients, according to a study reported in a cardiovascular surgery supplement of Circulation: Journal of the American Heart Association. A study of the American Heart Association’s Get With The Guidelines^SM(GWTG) database found significant differences in how hospitals carry out many of the association’s secondary prevention recommendations. Specifically, patients who received percutaneous catheter intervention (PCI) were more likely to get the proven measures that could significantly reduce their risks for later heart attack, as compared to patients who underwent coronary artery bypass graft surgery (CABG) or no intervention at all. GWTG is an evidence-based, hospital quality improvement program that helps ensure patients receive quality care during treatment and discharge based on specific guidelines that will reduce the risk of secondary cardiac events, said Loren F. Hiratzka, MD, lead author of the study and co-author of the 2006 GWTG update. The program empowers providers to consistently treat heart and stroke patients according to the most up-to-date guidelines. Hiratzka said a key part of GWTG is the education healthcare providers give when a patient is discharged from the hospital after a heart attack or other cardiac event. The guidelines call for patients to receive specific instructions, counseling and medication recommendations all of which can reduce the progression of atherosclerosis. Most hospitals that implement GWTG realize measurable results, including improved patient outcomes. The scientific evidence shows us that, when used appropriately and consistently, these performance measures can save lives, Hiratzka said. The challenge is to ensure that hospitals are providing this care for every patient, every time. Researchers conducted a study of the GWTG database to determine to what degree hospitalized patients with coronary artery disease were receiving the appropriate medications and advice at discharge. They divided that data of 119,106 hospitalized patients into three groups: those who received CABG (14,118); those who received PCI (58,702), which included balloon angioplasty and stenting to open blocked arteries; and those who didn’t receive either intervention (46,286). Surprisingly, researchers found that CABG patients were less likely than PCI patients to receive all of GWTG’s recommended measures, even when taking into account the exclusion of certain patients for which the measures wouldn’t be medically appropriate. CABG patients are in the hospital for several days after the operation, during which time we have multiple opportunities to stress to them the Get With The Guidelines prevention measures, said Hiratzka, chair of the American Heart Association’s Council of Cardiovascular Surgery and Anesthesia and medical director of cardiac surgery, TriHealth, Inc., Cincinnati, Ohio. Some PCI patients tend to be in the hospital for less than 24 hours; even then, healthcare providers have opportunities before and after the procedure to meet with patients and their families to review these topics. Get With The Guidelines performance measures include: prescribing angiotensin-converting enzyme (ACE) inhibitors, when appropriate; recommending that patients take aspirin; prescribing appropriate beta blockers for blood pressure and heart rate control; giving smoking cessation advice if patients are smokers; and prescribing statins and other kinds of cholesterol-lowering medications. The study found these measures were provided as follows for patients without exclusions or contraindications for each group: ACE (angiotensin-converting enzyme) inhibitors - PCI patients - 74 percent - CABG patients- 57.3 percent - No intervention patients - 66.3 percent Aspirin therapy - PCI patients - 99.4 percent - CABG patients - 97.1 percent - No intervention patients- 94.5 percent Beta blockers - PCI patients - 91 percent - CABG patients - 90.8 percent - No intervention patients -88.2 percent Smoking cessation counseling - PCI patients - 84.8 percent - CABG patients- 82.4 percent - No intervention patients - 73.9 percent Lipid drugs - PCI patients - 89.2 percent - CABG patients - 77.4 percent - No intervention patients - 72.3 percent Those patients who did receive all of the recommended performance measures were more often PCI patients 71.5 percent of those patients received all the measures, while 65.1 percent of all CABG patients received all of the measures and 62.1 percent of the no-intervention group of patients received all the measures. Even though these numbers are better than they have been, they are not as good as they could be in any of the groups in particular the group at highest risk, the surgical patients, said Hiratzka. Though there were limitations to this study, it suggests that we need to improve our systems of care so that they are better geared to making sure that all heart disease patients are getting the information, guidance and treatment they need to prevent future cardiac events. Note: Get With The Guidelines (GWTG) is the American Heart Association and American Stroke Association’s evidenced-based quality improvement program that helps hospitals align their care for coronary artery disease, stroke and heart failure patients with the latest scientific guidelines. For more information, visit www.americanheart.org/ getwiththeguidelines. Severe Heart Attack Damage Limited By Hydrogen Sulfide, Study Shows Administering hydrogen sulfide (H2S) directly into the heart during a simulated heart attack significantly reduces the tissue and cell damage often seen in oxygen-starved organs, according to a new study from researchers at the University of Alabama at Birmingham. H2S boosts post-heart-attack function by helping to minimize reperfusion injury, an unwanted side effect of restoring blood flow swiftly to hearts suffering from low oxygen, the study authors said. In testing on mice, the H2S injection led to a 72 percent reduction in the amount of severe heart-tissue death after restoring normal oxygen and blood flow to mice hearts. The 72 percent reduction compares to a much larger average amount of tissue death in untreated mice hearts after the same 30 minutes of oxygen deprivation. Findings on the protective qualities of H2S have broad implications for improving human survival after cardiac arrest, heart transplant and trauma in general, said David Kraus, PhD, a UAB associate professor in the Departments of Environmental Health Sciences and Biology and co-author on the new study. One of the most damaging biological stresses on the heart and other organs from trauma or transplantation is the rapid change in oxygen levels, Kraus said. First there’s a drop, which elicits a dramatic cellular adjustment to survive low oxygen, and then a rapid rise caused by resuscitation. H2S as an internal bodily signal appears to serve as an important protective mechanism during the stress of low oxygen availability, he said. The UAB researchers worked with a team led by David Lefer, PhD from the Albert Einstein College of Medicine in Bronx, NY. The tests were done by injecting H2S directly into the hearts of mice who had been anesthetized for surgery, and whose left ventricular artery had been clamped for 30 minutes to simulate a heart attack. In addition to a decrease in heart-tissue death, H2S-treated mice hearts showed a 35 percent drop in blood-protein levels that signal myocardial damage, and a 26 percent drop in heart-tissue markers of inflammation when compared to un-treated mice hearts. Furthermore, by isolating mitochondria from the H2S-treated mice, the authors confirmed that heart-cell functional integrity had been preserved. Recent reports from other researchers demonstrate that inhaled H2S can induce a fully reversible suspended animation state in animals. Kraus said it follows that H2S could be used to place organs into "suspended animation" before surgery or during medical transport until normal oxygen and blood flow is restored. Also, by augmenting internal H2S production in the body, perhaps through diet, people may reduce their risks of cardiovascular disease, chronic oxidative cell damage and other illnesses, Kraus said. H2S is normally considered a toxic, flammable gas that is responsible for the foul odor of rotten eggs. But in the UAB study it was carefully formulated into a low concentration saline-type solution. The study was published Sept. 18 in the online Early Edition of the journal Proceedings of the National Academy of Sciences. FDA Clears Hand-Held Injector for Angiographic Imaging Pinyons Medical Technology, Inc. announced it has received U.S. Food and Drug Administration (FDA) clearance to market the PowrSyringe Injector. The PowrSyringe Injector is a one-piece disposable hand-held device that adds ergonomic and mechanical advantages to a high-pressure syringe. In angiography, the Injector can increase injection speed without sacrificing user control and tactile feedback. Shawn Fojtik, Pinyons Chief Executive Officer, said, Increasing angiographic injection speed may improve image quality, enable clinicians to use smaller catheters, reduce contrast, and make it easier to inject. Improving patient care with simple cost-effective devices is our company goal. According to Pinyons, the PowrSyringe does not require costly new capital equipment. An abstract on the first in-vivo use of the PowrSyringe was presented at the New Cardiovascular Horizons Meeting on September 5, 2007, reporting faster injection speeds than control syringes. Previous studies with electronic power injectors conclude that increasing angiographic injection speeds can reduce contrast usage per procedure and save institutions thousands of dollars in contrast media expense. Reducing contrast media is also associated with a reduction in contrast induced nephropathy (CIN) and acute renal failure. The company is planning further study to determine how the PowrSyringe can be used to improve image quality, reduce contrast usage, reduce patient complications, and improve care. The PowrSyringe Injector’s indication for use is to inject and withdraw fluids from the body including use in angiography. PowrSyringes may be useful in cardiac catheterization, interventional radiology, vascular surgery, orthopedics, spine, ear nose and throat, and general hospital use where viscous fluids are injected through small devices to diagnose, treat, or enable other medical devices. Pinyons plans to market a family of PowrSyringe devices for angiography, viscous fluid delivery, balloon catheter inflation, discography, vertebroplasty, biopsy, and aspiration. The PowrSyringe Injector is expected to be available for commercial sale in early 2008. U.S. and foreign patents are issued and pending on the PowrSyringe Injector, Monitor, and Aspirator. Pinyons Medical Technology, Inc. has offices in Park City, Utah and Hallandale Beach, Florida. See www.pinyonsmedical.com for more information. Cordis Corporation Introduces Fire Star Rx PTCA and Dura Star Rx PTCA Dilatation Catheters Cordis Corporation announced the introduction in the U.S. of the Fire Star Rx PTCA Dilatation Catheter and the Dura Star Rx PTCA Dilatation Catheter. Both balloons, indicated for expansion in the narrowed area of a coronary artery or bypass graft, will be offered to catheterization laboratories and interventional cardiologists starting on Oct. 15. The U.S. FDA approved the commercialization of these products in late August. The Fire Star Balloon features the lowest pre-dilatation profile in the market. It is equipped to enable interventional cardiologists to easily guide the catheter through tortuous arteries and to cross complex blockages. The Dura Star Balloon facilitates the post-delivery expansion of stents in coronary arteries and is also suitable for tackling tortuous arteries and complex blockages. It has been designed to provide controlled and even expansion of the balloon to the correct diameter, which may help reduce the potential for artery damage to the patient. With its low pre-dilatation profile, the Fire Star Balloon is also suitable for use in highly stenosed lesions and bifurcations. In addition, the Fire Star Balloon offers a controlled expansion for accurate dilatation of arteries, which may help reduce the potential for artery damage. It also has a soft and tapered tip to facilitate crossing stent struts and challenging lesions, while its shaft construction helps to reduce the risk of kinking. The device is finished with a lubricating coating and is available in various lengths and diameters ranging from 10 mm to 30 mm and from 1.5 mm to 3.5 mm, respectively. The Dura Star Balloon is suited for use with both drug-eluting and bare-metal balloon-expandable stents. Its short and soft tip facilitates crossing stent struts and complex lesions. Designed to reduce the risk of kinking and equipped with a lubricating coating, the Dura Star Balloon provides easy delivery to the site of a lesion, especially in challenging cases. The balloon is available in various lengths from 10 to 30 mm and from 2.25 to 4.0 mm in diameter. Young Women Less Attentive to Heart Risks Than Men Young women with a family history of heart disease may be less careful about following a healthy lifestyle than their male counterparts, a study has found. It's well known that people with a parent or sibling who suffered a heart attack at a relatively young age are themselves at higher-than-average risk, so it is especially important for them to maintain a heart-healthy lifestyle. The new study, published in the American Heart Journal, found that younger women may be less likely than men to heed this advice. Some of them are getting the message, senior study author Dr. Amit Khera said, but not nearly as much as men. Heart disease was once widely thought of as a man’s disease. Although this is changing, some women even those with a family history of early heart problems still underestimate their risk, according to Khera, an assistant professor of internal medicine at the University of Texas Southwestern Medical Center in Dallas. For their study, Khera and his colleagues looked at more than 2,400 men and women between the ages of 30 and 50, of whom 265 had a family history of premature heart disease. This was defined as having a father or brother who suffered a heart attack before the age of 50, or a mother or sister who suffered one before age 55. Among women, the researchers found, those with a family history were more likely than other women to have multiple other risk factors for heart disease such as smoking, excess weight and high blood pressure. Just about half (49 percent) had at least two heart risk factors, versus 39 percent of women with no family history of early heart disease. Much narrower differences were seen among men, however. What’s more, men with a family history tended to be more physically active than other men their age. In contrast, their female counterparts were just as likely to sedentary as women without a family history of heart problems. Part of the problem, Khera noted, may be that health providers are not as likely to ask women about their family history of heart disease, or to counsel them on ways to cut heart disease risk. It's important for all women to be aware of their family history, and to know that premature heart disease whether in a male or female relative is relevant to them, according to Khera. No matter how young they are, he said, women with a family history should be taking steps to protect their hearts, through diet, exercise and not smoking. They should also see their doctors for routine medical screenings, including blood pressure and cholesterol measurements, he advised. Abbott Initiates Clinical Study to Evaluate Use of RX Herculink® Elite Renal Stent System for the Treatment of Renal Artery Stenosis HERCULES Trial Aims to Treat Renal Artery Obstructions and Lower Blood Pressure in Patients Not Responding to Medication Abbott today announced enrollment of the first patient in HERCULES (Herculink Elite Cobalt Chromium Renal Stent Trial to Demonstrate Efficacy and Safety), a U.S. clinical trial designed to evaluate the safety and effectiveness of the investigational RX Herculink® Elite Renal Stent System to treat patients with renal artery stenosis (RAS), a condition characterized by fatty plaque buildup in the kidney arteries that can lead to high blood pressure. The first implant was performed by Joaquin Martinez de Arraras, MD, FACC, president of Amarillo Heart Clinical Research Institute, Inc. in Amarillo, Texas. Many patients with high blood pressure and renal artery stenosis do not respond as well to medication alone as they may to medication plus stenting, said Dr. Martinez de Arraras. The goal of the HERCULES trial is to evaluate whether renal artery stenting may reduce vessel renarrowing, thereby potentially reducing other risk factors for cardiovascular disease, such as high blood pressure. To qualify for the HERCULES study, patients must have uncontrolled hypertension that is not responding to treatment with at least two blood pressure medications, and must have at least 60 percent stenosis or blockage in a renal artery as measured by visual X-ray angiography. About the HERCULES Trial. Abbott is conducting the HERCULES trial to seek U.S. Food and Drug Administration approval for use of the RX Herculink Elite Renal Stent System in the treatment of renal artery stenosis. The HERCULES trial will enroll up to 202 patients at approximately 50 sites across the United States. The primary endpoint of the study is binary restenosis at nine months, a measure of vessel renarrowing. Secondary endpoints in the trial will measure changes in blood pressure and the use of hypertensive medication at nine months. Additional analyses in patient follow-up visits out to 36 months will measure major adverse events in patients such as death, surgical removal of the kidney, or embolic events resulting in kidney damage, as well as target lesion revascularization (TLR). The RX Herculink Elite Renal Stent System is an .014-inch rapid-exchange (single-operator) renal stent system made of cobalt chromium. First-In-Man Reported for the Stentys Bifurcated DES Stentys’ bifurcated stent was successfully implanted into a 56-year-old male patient at the HELIOS Klinikum Siegburg in Siegburg, Germany. Stentys has developed a next-generation dedicated drug-eluting stent (DES) for treatment of blocked coronary artery bifurcations. The stent-opening for the side branch can be created anywhere in the stent after implantation in the vessel. This first-in-man medical milestone took routine interventional time to complete; the patient was released from the ICU within hours of the Stentys implantation and was discharged from the hospital shortly after the procedure. The Stentys platform offers great promise in treating blocked coronary artery bifurcations as simply and effectively as a conventional stenting procedure, said Eberhard Grube, MD, Chief of Cardiology and Angiology at HELIOS Klinikum Siegburg and a consulting professor of medicine at Stanford University.

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