Clinical and Industry News

Clinical and Industry News

Episode of Rapid, Irregular Heart Rhythm Before or After Cardiac Catheterization Associated With Increased Risk of Death Within 3 Months

Certain heart attack patients who experience a rapid, abnormal heart rhythm before or after a coronary artery intervention or stent placement have a significantly higher risk of death within 90 days of the procedure, according to a study in the May 6 issue of JAMA. The incidence and outcomes of sustained ventricular tachycardia or fibrillation (VT/VF) on patients with ST-elevation myocardial infarction (STEMI) undergoing a percutaneous coronary intervention (PCI) have not been well understood. Rajendra H. Mehta, MD, MS, of the Duke Clinical Research Institute, Durham, NC, and colleagues evaluated the association of VT/VF and its timing with the risk of death at 30 and 90 days in 5,745 patients with STEMI undergoing PCI at 296 hospitals in 17 countries. The patients were categorized into four groups: 1) No VT/VF; 2) VT/VF any time; 3) Early VT/VF, before the end of cardiac catheterization; and 4) Late VT/VF, after the end of cardiac catheterization. Of the patients in the trial, VT/VF occurred in 5.7 percent. The majority of VT/VF episodes (90 percent) occurred within 48 hours, and 64 percent occurred before the end of catheterization. The rate of death was significantly higher in patients with any VT/VF compared with those without it (90-day death, 23.2 percent vs. 3.6 percent). Clinical outcomes were particularly worse among patients with late VT/VF, although even those with early VT/VF had a significantly higher event rate compared with those without any VT/VF (90-day mortality for early VT/VF, 17.2 percent; and for late VT/VF, 33.3 percent; vs. 3.6 percent for patients with no VT/VF). After adjusting for various factors, the risk of death at 90 days was more than three times higher for patients with any VT/VF; more than two times higher for early VT/VF; and the risk of death at 90 days was about 5.5 times greater for patients with late VT/VF. Among the factors associated with early VT/VF included lower systolic blood pressure, higher body weight and higher heart rate; factors related to late VT/VF included lower systolic blood pressure, higher heart rate and lack of beta-blockers on admission. “Our analysis identified patients who may benefit from closer surveillance in the intensive care or telemetry unit after the [PCI] procedure because of the risk for late VT/VF. In contrast, because of very low risk for late VT/VF in patients with complete reperfusion, our findings suggest that close monitoring for late VT/VF may not be necessary and these patients may be candidates for early discharge. Because currently the majority of patients with STEMI worldwide are routinely monitored for longer than 72 hours, our findings have the potential to decrease resource use without compromising patient safety when a risk-based strategy of monitoring or early discharge is followed. However, this finding also needs confirmation in future studies,” the authors write. Source: JAMA. 2009;301[17]:1779-1789. __________________________

Abiomed receives FDA 510(k) Clearance for Impella® 5.0 and Impella® LD

Abiomed, Inc, a provider of heart support technologies for revascularization, heart recovery and cost-effective patient care, announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Impella® 5.0 and Impella® LD Circulatory Support Devices. This 510(k) clearance designates Impella 5.0 and Impella LD to provide circulatory support for periods of up to six hours. Similar to the Impella 2.5, which received 510(k) clearance on June 2, 2008 for partial circulatory support for periods of up to six hours, the Impella 5.0 and Impella LD devices are minimally invasive catheter-based pumps, designed to provide temporary circulatory support and reduce the workload of the heart muscle. The pump is approximately the size of a pencil with a small 9 Fr catheter, which drives up to five liters of blood flow per minute, a flow rate typically adequate to fully support the average adult. “Formerly, only patients with a grave prognosis received aggressive circulatory support due to the invasiveness and potential complications associated with conventional surgery devices,” said Anson Cheung, MD, Surgical Director of Heart Transplantation at St. Paul’s Hospital in Vancouver, British Columbia. “The availability of the Impella 5.0 and Impella LD has reduced our threshold to implanting patients with a temporary circulatory support device and offers a potential benefit to reduce the likelihood of escalating therapy, such as implantable devices or heart transplantation. We have already seen patient success from Impella 5.0 and LD in providing the therapeutic benefit of ventricular unloading, which helps to interrupt the progression of heart muscle damage and potentially repair reversible damage.” For additional information, visit __________________________

The American Society of Hypertension Launches Education Program for Hypertension Accreditation

The American Society of Hypertension, Inc. (ASH) has launched a new educational initiative in hypertension and related cardiovascular disease — the ASH Hypertension Accreditation Program — to enhance the level of education of allied health professionals and pharmaceutical sales representatives. While this program will be tailored to meet the educational needs of each of the intended target groups, it is designed to improve all participants’ understanding of hypertension and related cardiovascular disease, improve the flow of information and create partnerships with healthcare providers that seek to improve patient outcomes. To inaugurate this initiative, ASH will offer the training first to pharmaceutical sales representatives to provide them with an even greater understanding of the underlying science of hypertension and cardiovascular disease. The program is based on ASH’s Clinical Hypertension Review Course for physicians, which emphasizes state-of-the-art scientific principles and evidence-based clinical practice. Daiichi Sankyo, Inc. collaborated with ASH on the training concept and will be the first pharmaceutical company to have its sales force considered for the ASH Hypertension Accreditation Program. The ASH Hypertension Accreditation Program, which is set to begin in June 2009, will be led by members of ASH. The curriculum content focuses on the science behind hypertension and cardiovascular disease and will examine mechanisms that regulate blood flow, pathways to heart disease and organ involvement, as well as social and economic disparities that affect diagnosis, treatment, control and compliance. The American Society of Hypertension (ASH) is the largest U.S. professional organization of scientific investigators and healthcare professionals committed to eliminating hypertension and its consequences. For more information, visit __________________________

Vascular Solutions Launches VSI Tru-Torque™ guidewires and Amplatz SST™ guidewires

Vascular Solutions, Inc. recently launched the VSI Tru-Torque line of guidewires, a complete line of highly torqueable 0.035” guidewires that facilitate catheter placement during diagnostic angiography and interventional procedures. The VSI Tru-Torque guidewires feature an excellent torque response for steerability, PTFE coating for enhanced device tracking and radiopaque tip for enhanced visibility. Each VSI Tru-Torque guidewire comes packaged with a torque device. The VSI Tru-Torque guidewires can be accurately controlled to facilitate navigation through tortuous vessels and adjoining side branches. They are available in standard, floppy and modified J tip configurations, and are currently available in the United States. Vascular Solutions, Inc. also recently launched the Amplatz SST line of guidewires, a line of 0.035” and 0.038” guidewires designed for extra support during catheter placement in diagnostic angiography and interventional procedures. Amplatz SST guidewires have an inner-core construction which provides added strength for increased support, a radiopaque tip for enhanced visibility and PTFE coating for enhanced device tracking. The Amplatz SST guidewire is available in straight and modified J configurations and in 0.035” and 0.038” diameters. Amplatz SST guidewires are currently available in the United States. For more information, visit __________________________

Heart Disease Patients Carrying Extra Pounds Do Better, Live Longer

Weight of Evidence Still Points to Purposeful Weight Loss, Further Research Needed Being overweight or obese is a leading contributor to cardiovascular disease (CVD) and associated risk factors; however, in patients with established CVD, obesity appears to play a protective role. In fact, data suggest obese patients with heart disease do better and tend to live longer than leaner patients with the same severity of disease, according to a review article published in the May 26, 2009, issue of the Journal of the American College of Cardiology. “Obese patients with heart disease respond well to treatment and have paradoxically better outcomes and survival than thinner patients,” said Carl Lavie, MD, FACC, medical director of Cardiac Rehabilitation and Prevention, Ochsner Medical Center, New Orleans, LA and lead author of the article. “Although these patients have a more favorable short- and long-term prognosis, we don’t yet understand the mechanisms for why this might be the case.” The obesity paradox in patients with CVD, which was first noticed earlier this decade, is complex. It is likely due to a combination of obesity’s impact on fat cells and other metabolic processes (e.g., insulin resistance, glucose metabolism, metabolic syndrome), as well as other consequences of being obese. Dr. Lavie speculates that excess weight may be somewhat protective because these patients have more reserves to fight disease than thinner patients. Another explanation might be that obese patients present with problems earlier due to physical deconditioning (being out of shape) and other non-cardiovascular symptoms and, therefore, have the opportunity to be diagnosed with milder disease. Although obese patients appear to experience fewer cardiovascular events and have better survival rates, Dr. Lavie is quick to caution that patients with heart disease shouldn’t incorrectly assume that gaining weight is the answer. “Obesity is often what’s causing high blood pressure, blockages in arteries, and increased risk of sudden death in the first place. Such excess weight has adverse effects on all of the major cardiovascular risk factors and has increased the prevalence of heart disease,” he said. “Taken together, most studies are supportive of purposeful weight loss for preventing and treating cardiovascular disease.” Health-promoting behaviors to stay active and lose weight can also confer benefits beyond initial heart disease. For example, patients who are overweight or obese are at heightened risk of diabetes, which can further complicate treatment and outcomes. Patients who make sustained lifestyle changes, including regular exercise and some weight reduction through a reduction in calories, cut their risk of developing diabetes by roughly 60 percent. “Obesity is skyrocketing in America and if this continues, we may see an unfortunate reversal to what has been a steady increase in life expectancy,” says Dr. Lavie. “We need more research: first to prevent obesity in the first place; second, to intervene early enough so that patients who are overweight or obese won’t develop heart disease; and then to better understand why these patients have a better prognosis once they have heart disease. Perhaps this information could lead to benefits for all patients, including patients with heart disease who aren‘t overweight or obese.” According to authors, obesity may soon overtake tobacco use as the leading cause of preventable death in the United States if current trends continue. Nearly 7 out of 10 adults are classified as overweight or obese. In adults, overweight is defined as a body mass index (BMI) 25 to 29.9 kg/m2 and obesity as BMI ≥30 kg/m2. Other indices that have been used less commonly, but possibly with more predictive power include body fatness, waist circumference (WC), waist-to-hip ratio (WHR), and weight-to-height ratio. “Clinicians should emphasize to patients the importance of achieving and maintaining a healthy weight, as well as benefits that can be obtained from restricting their intake of calories and getting regular exercise of 30 to 40 minutes on most, if not all, days,” said Dr. Lavie. __________________________

Small Promotional Items from Drug Companies May Influence Medical Students’ Attitudes

Exposure to small promotional items from pharmaceutical companies, such as clipboards and notepads, appears to influence medical students’ unconscious attitudes toward the marketed product, according to a report in the May 11 issue of Archives of Internal Medicine, one of the JAMA/Archives journals. Students whose medical school restricts marketing practices had less favorable attitudes toward the product following exposure to the items, while those at a school with no such limitations responded more favorably. “Discussions about the influence of pharmaceutical promotion on physicians often focus on gifts and payments of relatively large economic value,” the authors write as background information in the article. “The underlying assumption is that smaller gifts are unlikely to exert influence on prescribing decisions.” However, marketing and psychological research suggests that even trivial items can sway attitudes and behaviors. David Grande, MD, MPA, of the University of Pennsylvania, Philadelphia, and colleagues conducted a randomized controlled experiment involving 352 third- and fourth-year medical students. Of these, 154 were enrolled at the University of Pennsylvania School of Medicine (Penn), which has a policy prohibiting most gifts, meals and samples from drug companies. The other 198 attended the University of Miami Miller School of Medicine (Miami), which permits these marketing practices. One hundred and eighty-one of the participants were randomly assigned to be unknowingly exposed to small branded promotional items for the cholesterol-lowering medication Lipitor, including a clipboard and notepad used when they signed in to study appointments. The other 171 students received no such priming. All of the participants completed a test of implicit attitudes toward Lipitor (one of the most heavily promoted brand-name statins in the United States) and Zocor (which is available generically and considered to be equally effective). The test involved matching the brands to attributes of the brands (such as pleasant and unpleasant) in a computerized image- and word-association test. Differences in reaction times help reveal unconscious attitudes. The students also reported their explicit (conscious) attitudes toward both drugs by completing a questionnaire about safety, superiority, efficacy and convenience. “Overall, students in both class years and both schools demonstrated implicit attitudes favoring Lipitor over Zocor as reflected by the positive values even among control students,” the authors write. “However, there were significant differences between the exposed and control groups among fourth-year medical students at Penn and Miami.” Fourth-year students at Miami demonstrated stronger preferences toward Lipitor after exposure to promotional items, whereas fourth-year students at Penn exhibited the opposite response, with those in the exposure group showing weaker preferences toward Lipitor than the control group. There were no differences between the control and exposure groups among third-year students. This could be because fourth-year students have more clinical experience and have formed attitudes toward treatment options that can be primed with branded promotional items, the authors note. “Our results provide evidence that subtle branding exposures are important and influential, as the psychology and marketing literature would suggest,” they conclude. “Our findings are particularly notable because they are attributable to simple exposure to promotional items independent of other effects attributable to the social relationships associated with gifts. Our study also suggests that institutional policies, by way of their influence on student attitudes toward marketing, could lead to different responses to branded promotional items.” Source: Arch Intern Med 2009;169[9]:887-893;829-831. Editorial: The Time Has Come to Adopt Policies Restricting Drug Marketing. “The powerful influence by drug companies on physicians and medicine has drawn increasing public attention,” writes Philip Greenland, MD, of the Feinberg School of Medicine, Northwestern University, Chicago, in an accompanying editorial. “Grande et al in this issue of the Archives present interesting data on the effects of more restrictive institutional policies, such as those enforced at the University of Pennsylvania,” Dr. Greenland writes. “The authors concluded that institutional policies can reverse the effects of drug marketing tactics, and the data suggest that adopting these more restrictive policies will reverse longstanding adverse trends on physicians’ prescribing habits.” “As others have outlined, it is time to act and adopt restrictive policies,” he concludes. “It is imperative that the profession police itself, or it is inevitable that government will step in and create a policing structure that will be punitive and require expensive oversight. Why are most of us still waiting? The evidence is clear, and the path is defined. It is time to act.” __________________________

SCAAR Registry Provides Reassurance on Drug-Eluting Stent Safety

A statement from the European Society of Cardiology A study published in The New England Journal of Medicine (May 7, 2009),1 analyses the outcomes of 47,967 patients entered into the Swedish Coronary Angiography and Angioplasty Registry (SCAAR) between 2003 and 2006. Commenting on the results, interventional cardiology specialist, Professor Franz Eberli from the University Hospital Zurich (Switzerland) and official spokesperson for the European Society of Cardiology, said: “To appreciate the significance of this paper you need to bear in mind the huge impact that data from the previous analysis of the SCAAR registry had when it was presented at the ESC in Barcelona in 2006, and published in the New England Journal of Medicine in 2007.2 The initial paper, which showed that patients receiving drug eluting stents (DES) in Sweden between 2003 and 2004 had increased late mortality over those receiving bare metal stents (BMS), created a huge firestorm. The immediate impact was a decrease in the use of DES and a lot of scrutiny on safety, and the move for safety, cost effectiveness and durability of stents to be considered over efficacy,” said Professor Eberli. “This latest paper, looking at the same patient cohort, with the results extended to include all patients in Sweden receiving a stent between 2003 and 2006, (for whom there is more than one year of follow-up) found no increased risk of death between the two groups. The conclusions are similar to many of the trials and registries already published in this area, and significant principally because they refute the previous findings of the SCAAR registry. The latest SCAAR data provides a lot of reassurance on the safety of DES,” he said, adding that the study was probably the largest registry yet on stents with the longest follow up. Exploring possible reasons for the differences between the two SCAAR publications, Professor Eric Eeckhout, official spokesperson for the European Society of Cardiology, from the University Hospital of Lausanne, Switzerland, said: “The difference in outcome is likely to be a reflection of the way in which cardiology practice has evolved over time, leading to greater optimization of the results of stenting. Significant changes include use of higher balloon pressures and the increased use of dual anti-platelet therapy.” He added that the field of DES was continually evolving, and that new devices with the potential to improve safety were arriving in the market. “For me, this paper shows that there should now be no real concerns about the safety of DES and that the emphasis should shift back to considering the relative efficacy of BMS and DES.” Dr. Steen Dalby Kristensen, from Aarhus University Hospital, Denmark, and Vice-President of the European Society of Cardiology, highlighted the inherent problems of registries, where there are dangers of inclusion bias. “To draw definitive conclusions about the safety of drug-eluting stents, what is really needed, is a large scale randomized controlled long term trial. Unfortunately there are challenges in getting public funding for such trials, which may also prove difficult to perform in countries that already have high uptakes of DES.” He added that data from the SCAAR registry suggesting that 39 patients would need to be treated with DES to prevent one case of restenosis, and that 10 patients in the higher risk groups would need to be treated to prevent one case, made a strong argument of the cost effectiveness of drug eluting stents. “What also needs to be remembered is that preventing restenosis also has an enormous influence on the patient's quality of life,” he said. References 1. James SK, Stenestrand U, Lindback J et al. Long-Term Safety and Efficacy of Drug-Eluting Versus Bare-Metal Stents in Sweden. N Engl J Med 2009; 360: 1933-45. 2. Lagerqvist B, James SK, Stenestrand U, et al. Long-Term Outcomes with Drug-Eluting Stents Versus Bare-Metal Stents in Sweden. N Engl J Med 2007; 356: 1009-19. __________________________

Preventing Enzyme Seen in ‘Snot’ May Help Treat Heart Disease

Controlling the green stuff in snot could help treat heart disease, reveals Professor Michael Davies from the Faculty of Medicine and the Heart Research Institute at the University of Sydney, Sydney, Australia. In an exciting discovery, researchers from The University of Sydney, the Free Radical Centre at the Heart Research Institute (HRI), and the Queensland University of Technology have found agents that could stop the progression of heart disease by preventing damage by an enzyme also found in snot. “It might sound disgusting, but the same goop that makes snot green gets dumped in our arteries during heart disease,” said Professor Davies. Snot appears green due to the presence of the enzyme, myeloperoxidase. Myeloperoxidase is normally called into action by our immune systems to kill off bacteria. It does this by making the powerful oxidant hypochlorous acid — the main ingredient in household bleach. “Although hypochlorous acid is a vital component of the body’s defense system against bacteria, it is also highly reactive and can damage tissues when produced in the wrong place, at the wrong time or at excessive levels,” said Professor Davies. “This has been shown to contribute to a number of diseases such as atherosclerosis, asthma, rheumatoid arthritis and some cancers.” “Because of the common occurrence and far-reaching medical consequences of these diseases, we wanted to find a safe way of controlling myeloperoxidase,” he said. The team has developed antioxidant compounds called nitroxides that are very effective at preventing myeloperoxidase from producing hypochlorous acid. There is now considerable hope that the discovery will lead to a new drug to treat heart disease and other inflammatory diseases. The group’s work will be published in the upcoming edition of the international scientific journal Biochemical Journal. __________________________

Less Than One in Five Heart Problems are Diagnosed Before Symptoms Appear

Clinicians are missing golden opportunities to identify heart disease before patients start displaying symptoms, according to a study of 13,877 people published in the May issue of the International Journal of Clinical Practice. Researchers from Oregon, Maryland and Delaware found that just over 11% of the respondents had been diagnosed with heart disease. However, only 19% of those individuals — who had been involved in the ongoing study for two years — said that their heart disease was picked up during routine screening. More than half of the diabetic patients with heart disease who took part in the study (54%) reported that their heart disease was diagnosed when they became symptomatic and a further 22% said it was picked up while they were being treated for other health issues. The figures were lower for individuals without diabetes. Just under half (48%) were diagnosed with heart disease when they became symptomatic and 15% were picked up during treatment for other conditions. “Our study showed that not enough patients with heart disease are being picked up during routine screening or treatment for conditions like diabetes, which are commonly associated with heart problems,” says lead author Dr. Sandra J. Lewis from the Northwest Cardiovascular Institute in Portland, Oregon. “The majority of those who took part in the study were not diagnosed until they started displaying symptoms.” “Many individuals do not show symptoms and go undiagnosed until the disease is in an advanced state, often when they have actually had a heart attack,” explains Dr. Lewis. “That is why it is so important to diagnose CHD before patients experience their first crisis, by looking at major risk factors such as smoking, having high blood cholesterol, having high blood pressure, being overweight, being physically inactive or just getting older. “Guidelines recommend that all adults over the age of 20 should receive risk factor screening from their family doctor every two to five years. There are more specific guidelines for patients with type 2 diabetes as their risk of a heart attack is twice as high as the general population.” The analysis from the SHIELD study (Study to Help Improve Early evaluation and management of risk factor Leading to Diabetes) was performed to see if ongoing recommendations for improved screening in the U.S. were resulting in more patients being diagnosed with heart disease before they became symptomatic. It forms part of the larger SHIELD survey of 211,097 U.S. households who responded to a national questionnaire. More than 18,400 people who had participated in the baseline and first follow-up SHIELD surveys, and had diabetes or one of the five cardiometabolic risk factors, were sent questionnaires and 13,877 (75%) responded. Of these, 1,573 (11% of the total) had been diagnosed with heart disease. Just under two-thirds had heart disease on its own (62%). They were predominantly male (59%) and white (91%) with an average age of 67. The remaining 38% had heart disease and type 2 diabetes. They were slightly more likely to be women (50.7%), 88% were white and their average age was 69. The average time since diagnosis was 11.7 years in CHD patients without diabetes and 10.7 years in individuals with diabetes and CHD. Almost a third of the non diabetes group (31%) and 36% of the diabetes group had been diagnosed since 2001, when a number of consensus statements and guidelines on screening and prevention were published. “Despite increased knowledge and awareness of the risk factors for CHD, many individuals are not diagnosed with heart disease until they are symptomatic,” concludes co-author Dr Kathleen Fox from Strategic Healthcare Solutions in Monkton, Maryland. “The fact that only a small percentage of the SHIELD respondents were diagnosed through screening indicates that there is a missed opportunity to diagnose heart disease during earlier, less severe stages of the disease. “As blood pressure and weight are evaluated when most patients visit their family doctor, medical providers already have information about two key modifiable risk factors. “Our study demonstrates the need for improved targeted education aimed at both patients and doctors to reduce heart disease before symptoms occur.”