Industry News

May-08

India Overwhelmed by Heart Disease
By 2010, India will carry 60 percent of the world’s heart disease burden, nearly four times more than its share of the global population, according to a recent study. Adding to the burden is a higher incidence of the types of heart disease resulting in serious illness and mortality, and the fact that these conditions strike at an earlier age, says the study.
Death rates are especially high among the country’s poorest residents, unable to get to hospital quickly in an emergency, or to afford routine treatments and surgery.
Ischemic heart disease is the leading cause of mortality in the world, accounting for 7.1 million deaths in 2001. More than 80 percent of these were in developing countries.
Researchers have long known that south Asia has the highest level of acute coronary syndromes in the world, but little statistical data was available about treatment and health outcomes.
A team of researchers led by Denis Xavier of St. John’s National Academy of Health Sciences in Bangalore, India gathered data on nearly 21,000 coronary patients admitted to 89 hospitals across 50 cities across the country. They found that of 20,468 patients given a definite diagnosis, 60 percent showed evidence of a heart attack, compared with 40 percent in developing countries. With a average age of 60, these Indian patients were also younger by three to six years than their counterparts in richer nations.
The risk factors are the same as elsewhere, but the gap between India and developed nations have more specific causes, the study found. One was simply the time needed for patients suffering an acute heart problem to get medical attention. On average, it took 300 minutes to reach a hospital in India, twice as long as in rich nations.
“Few patients used an ambulance to reach the hospital. Most used private or public transport” due to financial constraints, the authors note.
Poverty also prevented most patients in India — where 75 percent of health care expenses are paid out-of-pocket — from obtaining routine treatments in hospital, much less preventative surgery.
Many of these findings were expected, but had never before been quantified.
“This registry is a major milestone, since it provides the first comprehensive view of the epidemic of acute coronary syndrome in India and helps to identify opportunities for improvement in care,” notes cardiologist Kim Eagle in a commentary, also published in The Lancet.
“As the Indian economy grows, there is a possibility to further increases in cardiovascular disease before we see a decline similar to that being witnessed in developed countries,” he warned.
By 2020, ischemic heart disease is expected to have increased over three decades by 137 percent for men and 120 percent for women in poorer nations, compared with 30 to 60 percent in rich economies, according to The Lancet.

 

Piedmont Hospital Rated Best in Atlanta for Overall Cardiac Care and Cardiac Surgery

Piedmont Hospital has been recognized as Best in Atlanta for Overall Cardiac Care and Cardiac Surgery for 2008, according to The Tenth Annual HealthGrades Hospital Quality in America Study.
The HealthGrades® study identifies key trends in the quality of care provided by approximately 5,000 hospitals nationwide. HealthGrades researchers analyzed Medicare discharges from every U.S. hospital between 2004 and 2006. Risk-adjusted mortality and complication rates were calculated, and hospitals were assigned a one-star (poor), three-star (as expected), or five-star (best) quality rating for 28 diagnoses and procedures from heart failure to hip replacement to pneumonia.
“We are extremely proud of this recognition earned by a dedicated team of professionals, who aim tirelessly to attain the greatest clinical outcomes and patient safety standards. To win such high honors by an independent study is a testament to the physicians, nurses and entire team of cardiac professionals at Piedmont,” said Robert W. Maynard, president and CEO of Piedmont Hospital.
Piedmont Hospital is the only metro Atlanta hospital to attain both the Cardiac Care and the Cardiac Surgery Excellence Awards and one of only 108 hospitals in the country to earn the distinction. Overall cardiac care includes performance in numerous cardiovascular services, including care for patients with heart attack, atrial fibrillation, coronary artery bypass graft surgery (CABG), valve surgery, interventional cardiology, and heart failure. Earlier in the year, Piedmont Hospital was the recipient of HealthGrades 2007 Distinguished Hospital for Patient Safety Award™, for the second consecutive year. The award ranked Piedmont among the top five percent nationally for patient safety outcomes.
The Piedmont Heart Institute is the first integrated cardiovascular healthcare delivery program affiliated with a community health system in greater Atlanta. For more information, visit www.piedmont.org.

 

Long-Term Financial Benefits of Drug-Eluting Stents: Report Available

Each year in the United States alone, almost 1 million people with coronary artery disease are treated with a percutaneous coronary procedure (PCI); worldwide the number is about 2.1 million. According to a new report by Kalorama Information, Major World Markets for Stents and the Economics of Drug-Eluting Technology, the current market for coronary stents in the seven major world healthcare markets is $4.9 billion.
The market effects of drug-eluting stents (DES) began in 2003. Today they represent 69.2% of the total coronary stent market, expected to grow at a rate of about 4.6%.
“Though drug-eluting stents cost 3 to 4 times as much as bare metal stents, when one examines their cost-effectiveness, the case is clear,” notes Kalorama analyst Kenneth Krul. “They remain an exciting innovation that will be a major part of cardiovascular intervention technologies over the next ten years, and it should become increasingly evident that DES use does in fact result in reduced long-term healthcare costs and improved economic outcomes.”
The report can be purchased directly from Kalorama Information by visiting http://www.kaloramainformation.com/Major-Stents-Economics-1646598/.

 

Everolimus-Eluting Stent Shows Promise for Improving Outcomes in Patients With Coronary Artery Disease
For patients who underwent angioplasty, the use of stents releasing the drug everolimus reduced the rate of restenosis and significantly reduced the risk of major cardiac events, compared to paclitaxel-releasing stents, according to a study in the April 23/30 issue of JAMA.
Gregg W. Stone, MD, of Columbia University Medical Center and the Cardiovascular Research Foundation, New York, and colleagues conducted the SPIRIT III trial to evaluate the everolimus-releasing stent in comparison to the paclitaxel-releasing stent in 1,002 patients with coronary artery disease. Patients were randomized 2:1 to receive the everolimus-releasing stent (n = 669) or the paclitaxel-releasing stent (n = 333). Angiographic follow-up was prespecified at 8 months in 564 patients and completed in 436 patients. Clinical follow-up was performed at 1, 6, 9, and 12 months.
The researchers found that angiographic in-segment late loss was significantly less in the everolimus-releasing stent group compared with the paclitaxel group. At 9 months, everolimus stents, compared with paclitaxel stents, were noninferior for the outcome of target vessel failure (47 of 657 patients [7.2 percent] vs. 29 of 321 [9.0 percent], respectively. Use of the everolimus stent compared with the paclitaxel stent resulted in a 44-percent reduction (4.6 percent vs. 8.1 percent) at 9 months in the composite of major adverse cardiac events (cardiac death, heart attack, or target vessel revascularization), and a 42 percent reduction in the composite of major adverse cardiac events at 1 year (6.0 percent vs. 10.3 percent). This was due to fewer heart attacks and target lesion revascularization procedures.
“This large-scale, prospective, randomized, single-blind, controlled study demonstrates that an everolimus-eluting stent compared with a widely used paclitaxel-eluting stent results in a significant reduction in angiographic in-segment late loss at 8 months, with noninferior 9-month rates of ischemia-driven target vessel failure,” the authors write.
In an accompanying editorial, Manesh R. Patel, MD, of Duke University, Durham, NC, and David R. Holmes, Jr., MD, of Mayo Clinic, Rochester, Minn., write that the results of the SPIRIT III trial are promising.
“These data are encouraging and would qualify as demonstrating biological plausibility and mechanistic effect at the level of a phase 2 study,” they write. “What happens next with the everolimus-eluting stent is critical. The current data from the SPIRIT III trial are analogous to the initial comparisons of drug-eluting vs. bare-metal stents. Restenosis is reduced with the everolimus stent, potentially with a clinical reduction in target lesion revascularization and myocardial infarction. The clinical effect in a broad population of patients who may be clinically exposed following device approval is unknown. Furthermore, clinical efficacy without any mandated angiographic analysis and long-term safety remain important unanswered clinical issues. Postmarketing approval registries, although complex and expensive to perform optimally, may not address both these concerns.”
“Physicians must continue to be judicious stewards of the interventional toolbox so that patients continue to allow them the privilege of performing procedures intended to improve their health.”

 

Heart Researchers Report Modest Progress in Including More Women in Studies
A review of three and one-half decades of clinical cardiology trials shows that while an increasing number of women are being included in clinical trials, their numbers are still so low in some areas of research that it’s questionable whether study conclusions can be legitimately applied to women.
The researchers, led by Dr. Chiara Melloni, a research cardiologist at the Duke Clinical Research Institute, examined the numbers of women included in 156 randomized clinical trials cited by the 2007 American Heart Association Guidelines for Cardiovascular Disease Prevention in Women.
They found that overall, women comprised 30.6 percent of the total number of participants enrolled, with the number growing significantly during the past 36 years.
In 1970, women comprised only 9 percent of those registered in the prevention trials. In 2006, that figure rose to 42.4 percent, although researchers say the latter figure reflects a striking increase in the number of single-sex trials.
The researchers found that location of the trials appeared to play a role in participation: More women were enrolled in clinical trials in the U.S. (45 percent) compared to those abroad (26 percent).
Clinical conditions appeared to make a difference, too, with the highest number of women found in trials for hypertension (41 percent), diabetes (39 percent), and stroke (37 percent), and lowest for trials related to heart failure (29 percent), coronary artery disease (24 percent), and high cholesterol (17 percent).
The funding source for the studies did not seem to have any influence on the numbers of women involved. Women comprised about 30 percent of all participants enrolled in both government and privately-funded trials.
“It’s heartening to note some gain in the numbers of women taking part in cardiovascular disease prevention trials, but we are still seeing substantial deficits in female representation in many areas of research,” says Dr. Kristin Newby, a cardiologist at Duke and senior author of the study. “The results of this study tell us that efforts to change that picture are not robust enough to make a difference and that we still have a lot of work to do to ensure that we can generate evidence-based, sex-specific treatment recommendations when they are appropriate.”

 

Off-Hours Acute Myocardial Infarction Patient Less Likely to Get Angioplasty
Compared to heart attack patients who arrive at hospitals during weeknights, weekends and holidays, those who arrive during regular hours tend to receive faster and more comprehensive care, says a U.S. study. However, those differences don’t affect in-hospital death rates of heart attack patients, said the authors of the study, which was published in the April 22 issue of Circulation. Of the 62,814 heart attack patients included in the study, 54 percent arrived during off-hours. They were 7 percent less likely than patients who arrived during regular hours to undergo primary percutaneous coronary intervention (PCI) and 6 percent less likely to undergo PCI or coronary artery bypass graft (CABG) surgery.
Dr. Hani Jneid, an interventional cardiology physician-in-training at the Massachusetts General Hospital in Boston, said, “In our study, the average time from when the patient entered the hospital to when he or she received angioplasty was 110 minutes during off-hours compared with 85 minutes during regular hours.”
Jneid and colleagues also found that patients who arrived in off-hours were 66 percent less likely to achieve the 90-minute window for primary angioplasty recommended by the American Heart Association and the American College of Cardiology.
Despite the differences, death rates were similar for both groups of patients — 7.1 percent for patients arriving during off-hours and 7.2 percent for those arriving during regular hours.
“It is interesting to note that the observed delays in primary PCI did not translate into measurable differences in in-hospital outcome,” Jneid said. “This seems to run counter to previous study findings. Future studies should not only strive to confirm or disprove these results but also examine variables that might affect the interplay of care and outcome with arrival time.”

 

Knowing Physician’s Financial Interests Doesn’t Deter Clinical Trial Participants
A patient’s willingness to participate in a clinical trial may be unaffected by the disclosure of a researcher’s financial interests in the study, unless the amount of money a researcher stands to earn depends on the results of the trial, according to a new study by researchers at the Duke Clinical Research Institute, Wake Forest University, and the Johns Hopkins Berman Institute of Bioethics.
“We found that the patients we surveyed rated most types of financial disclosures less important in influencing their decisions to participate than other factors, like the risks and benefits of the proposed treatment,” said Kevin Weinfurt, PhD, deputy director of the DCRI’s Center for Clinical and Genetic Economics, and lead investigator on the study. “We also found that some patients are savvy enough to distinguish between different types of financial relationships, and they have different reactions based on these distinctions.” The researchers published their findings in the April 2, 2008 online edition of the Journal of General Internal Medicine. The study was funded by the National Heart, Lung and Blood Institute.
More than 3,600 diabetes and asthma patients were surveyed for this study, and the researchers asked each to answer questions related to their willingness to participate in a hypothetical clinical trial. Each electronic survey contained one of five financial disclosure statements.
“The disclosure statements ranged from the generic — the doctor running the trial might benefit financially from the study — to the more specific — dealing with per capita payments, and ownership of equity on the part of the researcher or the institution,” Weinfurt said. “We found that none of the disclosures significantly affected subjects’ willingness to participate with the exception of ownership of equity on the part of the researcher.”
This disclosure stated that the study leader could gain or lose money depending on the outcome of the study, Weinfurt said. Nearly 30 percent of respondents presented with this disclosure were unwilling to participate in the trial, as compared to 25 percent of respondents presented with a generic disclosure, and 20 percent of those who were told the investigator received payments from industry to cover the cost of running the study.
“It’s likely that patients felt ownership of equity could influence the researcher’s behavior in the trial, which might jeopardize the patients’ rights and welfare,” he said.
In addition to their willingness to participate in the trial, the subjects’ reactions to the financial disclosures were also assessed as they related to level of surprise, confidence in the quality of the science, and trust of the researcher and the institution.
“Interestingly, we found that trust seemed to be the most affected, although it didn’t necessarily correlate with their willingness to participate,” Weinfurt said. “One-third of the respondents said the financial disclosures made them less trusting of the researcher or the institution, but further studies will be needed to really tease out the implications of this.”
The relationships between researchers and industry are becoming more complex, Weinfurt said, leading to greater interest and visibility for this issue as it relates to patients.
“The Department of Health and Human Services, among other organizations, has issued a call to the scientific and medical communities to consider whether disclosing financial relationships between investigators and industry during the consent process would help protect the rights and welfare of patients. Our data can help answer this question,” Weinfurt said. This study is one of several projects conducted as part of the Conflict of Interest Notification Study (COINS), led by Jeremy Sugarman, MD, a professor of bioethics and medicine at the Johns Hopkins Berman Institute of Bioethics and senior author of the study.

 

Low Vitamin D Levels Associated With An Increased Risk of Peripheral Arterial Disease
Low levels of vitamin D may be associated with an increased risk for peripheral arterial disease (PAD), researchers reported at the American Heart Association’s Arteriosclerosis, Thrombosis and Vascular Biology Annual Conference 2008.
Results of the study will also be simultaneously published in Arteriosclerosis, Thrombosis, and Vascular Biology: Journal of the American Heart Association.
PAD affects about 8 million Americans and is associated with significant disease and death, according to the American Heart Association’s Heart Disease and Stroke Statistics — 2008 Update.
Vitamin D, or 25-hydroxyl vitamin D, is converted by the body to a hormone that makes bones stronger. Severe vitamin D deficiency can cause diseases such as rickets in children. Scientists are only beginning to explore the relationship between 25-hydroxyl vitamin D and cardiovascular disease.
“In animals, vitamin D has anti-inflammatory activity,” said Michal Melamed, MD, MHS, lead author of the study and assistant professor of Medicine and Epidemiology and Population Health at Albert Einstein College of Medicine in New York City.
“In addition, in mice, vitamin D is a regulator of one of the hormone systems that affects blood pressure. The cells in the blood vessels in the body have receptors for vitamin D, so vitamin D may have direct effects on the vessels, although this has not been fully worked out.”
To study whether there is a relationship of vitamin D with PAD, Melamed and colleagues analyzed data from a national survey measuring vitamin D levels in 4,839 U.S. adults. Researchers in that survey had also documented ankle-brachial index.
“We also measured other risk factors for peripheral arterial disease such as cholesterol levels, diabetes, blood pressure and inflammatory markers such as C-reactive protein,” Melamed said.
The researchers found that higher levels of vitamin D correlated with a lower prevalence of PAD. In the participants with the highest vitamin D levels — more than 29.2 nanogram per milliliter (ng/mL) — only 3.7 percent had PAD. Among those with the lowest levels — less than 17.8 ng/mL — 8.1 percent had PAD.
“After adjusting for age, sex, race and co-existing health problems, we found adults in the lowest vitamin D group had a 64 percent higher prevalence of PAD compared to those with the highest vitamin D levels,” Melamed said. “For each 10 ng/mL lower vitamin D level, there was a 29 percent higher risk of peripheral arterial disease.”
This does not mean that vitamin D is having a protective effect itself, although this is one hypothesis. It is also possible that higher vitamin D levels may be a marker of other health practices, e.g., eating a healthier diet or engaging in more physical activity, which could be related to sun exposure, though not necessarily, researchers said.
The findings need to be addressed in a large randomized clinical trial of vitamin D supplementation, Melamed said. This could be done with natural sources from food.
“Other vitamins have been thought to help prevent cardiovascular disease, such as vitamin E, which did not pan out after being tested in a randomized clinical trial,” Melamed said.
“Therefore, we would not recommend people start taking vitamin D supplements without talking to their doctors. However, we recommend eating a balanced diet. People obtain vitamin D either through exposure to the sun or from foods, especially fish and fortified milk and other fortified foods.”

FDA Grants Market Clearance for the LipiScan Coronary Imaging System
A Novel Spectroscopy System for the Identification of Lipid Core-Containing Plaques of Interest in the Coronary Arteries
InfraReDx, Inc. announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its catheter-based LipiScan Coronary Imaging System. The LipiScan device uses near-infrared spectroscopy to identify lipid core-containing plaques of interest in the coronary arteries in patients already undergoing cardiac catheterization. Such plaques, which cannot be detected by commonly used tests such as a treadmill examination and even coronary angiography, are suspected to be the cause of most sudden cardiac deaths and non-fatal heart attacks.
The availability of this tool culminates a decade-long biomedical engineering effort to create an instrument that could perform spectroscopy in the arteries of patients with coronary artery disease. The identification of the chemical composition of coronary plaques is expected to be of value to cardiologists in the selection of medical, stenting or surgical therapy for coronary lesions. The device is also expected to be of value to the pharmaceutical industry as a means to assess the effect of novel anti-atherosclerotic agents on lipid core plaque burden.
“The LipiScan System has been validated in tissue samples and a clinical study and has been cleared by the FDA for use in patients,” says James E. Muller, MD, cardiologist, co-founder, President and CEO of InfraReDx, Inc.
Dr. Muller noted that the creation of this device was greatly aided by the support and expertise of Sanderling Ventures of San Mateo, California. “Robert McNeil, PhD, Chairman of the Board of InfraReDx, and Timothy Mills, PhD, InfraReDx Board member are managing directors of Sanderling and both have extensive experience in medical device development,” said Dr. Muller. “Sanderling was a seed investor in Advanced Cardiovascular Systems, a company that pioneered development of balloon angioplasty and was acquired by Guidant.”
“While angioplasty and stenting were major advances, stenting has not been capable of preventing heart attacks due to the difficulty in identifying lesions likely to rupture and cause thrombosis. With the development of the LipiScan Coronary Imaging System, Sanderling is again contributing to a major step forward in providing a useful tool with which interventional cardiologists may improve the care of cardiac patients.”
“There is a real unmet medical need to identify lipid core-containing plaques of interest in the coronary arteries, which before now we could not do,” says James Goldstein, MD, Director of Research and Education at William Beaumont Hospital in Royal Oak, Michigan, who is also an investigator in the SPECTACL clinical trial for the device and a consultant for InfraReDx. “The ability to detect lipid core-containing plaques of interest may go a long way in providing information to help prevent heart attacks in the near future.”
Near-infrared (NIR) spectroscopy is commonly used to measure the chemical composition of unknown substances. The LipiScan Coronary Imaging System utilizes advanced optical technology, much of it developed for telecom uses, to deliver and retrieve NIR light from coronary plaques. The light reflected back at different wavelengths is analyzed to detect the chemical composition of the coronary plaques. At the completion of the catheter pullback, the LipiScan console instantly displays the scan results on a “chemogram,” a digital color-coded map of the location and intensity of lipid core-containing plaques of interest in the artery. A Lipid Core Burden Index is also reported, which is a measure of the total amount of lipid core-containing plaques of interest in the coronary artery. The LipiScan catheter interrogates each artery in less than 2 minutes and does not require the interruption of the flow of blood.
The SPECTACL clinical trial documented the similarity of near-infrared spectra obtained from 106 patients undergoing coronary angiography compared to spectra obtained in autopsy specimens in which the gold-standard of histology was available. For more information, visit the InfraReDx website at http://www.infraredx.com.

 

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