The Centers for Medicaid & Medicare Services in early May issued a decision not to expand the patient pool which will be reimbursed for carotid artery stenting (CAS) procedures, expansion of CAS issued in a proposed National Coverage Decision in February.

The current proposal covers those at high risk for the surgical procedure to open carotid arteries, called carotid endarterectomy (CEA) in FDA Category B Investigational Device Exemption (IDE) trials, in FDA-approved post approval studies or in accordance with the Medicare clinical trial policy.

The proposed expansion would have covered asymptomatic patients under age 80, at high risk for surgery and have 80% or greater carotid artery stenosis, and eligible for coverage outside of a post-market study or clinical trial, as long as the procedure was performed using the FDA-approved CAS systems and embolic protection devices in a facility approved by CMS.

Several medical device makers have U.S. regulatory approval for carotid stenting, including Abbott Laboratories (Abbott Park, Illinois), Boston Scientific (Natick, Massachusetts), Johnson & Johnson (New Brunswick, New Jersey), ev3 (Plymouth, Minnesota) and C.R. Bard (Murray Hill, New Jersey). .

Abbott, which markets two carotid stents, Xact and Acculink, had made a formal request to CMS to revise and expand the coverage policy and provided the agency with the data on which to make the expansion decision.

Don McLeod, a spokesperson for CMS, told CDU: "We had been asked by the manufacturer to cover the approved application. But we decided not to do the changes".

The decision puts a damper on what all the players in this sector had been looking forward to as a way of expanding its sales.

Abbott had predicted that the expanded reimbursement would create 50%-75% market growth, or up to $50 million-$75 million on an annual basis.

The carotid stent market is currently valued at about $100 million in the U.S.

The decision not to expand coverage maintains the patient pool for the procedure at about 150,000 to 200,000 patients in the U.S., with the CAS market in the U.S. valued at about $100 million.

In deciding not to move ahead with the expanded coverage, the agency cited the opposition of medical groups — not unexpectedly, those representing specialists who perform the open procedure.

Study from Canada links genes to increased risk of heart disease

Canadian scientists have released a report saying that they have found a piece of DNA in the human genome that increases some people's risk of getting heart disease by up to 40%, regardless of other factors such as cholesterol, high blood pressure and diabetes.

The study, conducted at the University of Ottawa Heart Institute (UOHI), is published in Science, available in the Science Express online edition.

The research was led by Dr Ruth McPherson, Director of UOHI's Lipid Clinic and Lipid Research Laboratory in collaboration with Dr Jonathan Cohen of the University of Texas Southwestern Medical School. They hope their discovery will one day lead to a genetic test to identify people at high risk as well as help other scientists better understand the biology of heart disease.

The researchers compared the DNA of 1,300 people with heart disease to the DNA of 1,500 healthy people and looked for differences in their genes. The participants were part of the Ottowa Heart Study, considered to be the first to scan the human genome for heart disease genes using half a million genetic markers.

The results showed that:

• A region on chromosone 9 was strongly linked to premature heart disease.
• About 25% of participants carried the variant and that those carrying the variant had a 30%-40% increased risk of heart disease compared to those who did not.
• This increased risk was regardless of other known risks linked to cholesterol, blood pressure, diabetes and smoking.

To confirm their findings the Canadian team collaborated with researchers working on other large scale genome-wide association (GWA) projects in the U.S. and Denmark, bringing the overall number of participant to more than 23,000 Canadians, Americans and Danes.

The other studies had participants enrolled in the Copenhagen City Heart study, the Atherosclerosis Risk in Communities (ARIC) in the U.S., and the Dallas Heart Study. All three studies confirmed that this same stretch of DNA was significantly linked to coronary heart disease.

McPherson said that the genetic variant "has a very strong effect on heart disease risk that isn't related to other factors that we already know about. To put this into perspective, of the groups studied in Ottawa, about 33% of people with early onset heart disease had this genetic variant versus 24% of healthy elderly people."

Speculating on their findings the researchers said they believed the finding could push forward a predictive medicine approach to heart disease — specifically , that since the gene variant does not work through blood pressure, cholesterol and the other known risk factors there is some new pathway, such as a code for a protein that directly promotes atherosclerosis.

Howard Hughes research: no link between genes, atherosclerosis

The Canadian study would appear to contradict the findings of a somewhat earlier research report

A research group led by Thomas Morgan, MD, of the department of genetics at the Howard Hughes Medical Institute (Chevy Chase, Maryland), wrote in the April 11 edition of the Journal of the American Medical Association that while several studies have suggested "a genetic basis for atherosclerotic heart disease and acute coronary syndrome" [ACS] most of the data behind those claims have not been validated in studies of "large, well-characterized patient populations."

Matching 811 patients who presented with ACS between 2001 and 2003 at two centers in Kansas City, Missouri, with 650 controls with no history, the researchers checked their genomes "for 85 variants in 70 genes" to evaluate whether these variations were truly predictive of ACS. The two groups "had similar age, sex and body mass index distributions," but the family history of coronary artery disease or infarction was 2.7 times higher in the men in study group than in the controls.

The ratio for women in the study group to women in the controls was 2.0. For both sexes, those who had a history of a disease were more likely to smoke or have Type 2 diabetes, although they apparently were "less likely to consume at least one alcoholic drink per month."

Higher cholesterol levels were seen in the study women than in the controls, but the two groups of men exhibited no such difference. Roughly 36% of the study subject had undergone at least one revascularization, but none of those enrolled as controls had.

The authors stated that of the 85 genetic variants they examined, only one, "the -455 promoter variant in beta-fibrinogen, was [even] nominally statistically significant," and that tests for several of the genes they tested "can already be ordered clinically for indicates that explicitly include possible ACS risk."

The findings of this study argue against the outcomes of "several high-profile studies," including those for two haplotypes, or groups of genes. As an alternate approach, the article recommends an effort to "screen the entire genome [of an unspecified number of subjects] in an unbiased way," and it pointed out that the cost of such tests is dropping as "the field is moving rapidly toward a comprehensive, genome-wide approach."

Study: ICD found effective in 'primary prevention' of heart disease

Researchers at the School of Medicine of the University of Pennsylvania (Philadelphia) have issued a study saying that implantable cardioverter-defibrillators (ICDs) not only help patients with heart problems live longer but also support patients in a way that they have active lives. Further, the study found most patients living with ICDs enjoy a quality of life consistent with average Americans their age and have a high level of satisfaction with the device, offsetting longstanding perceptions that the technology extends but seriously impairs patients' lives.

While the finding that ICDs have a life-saving ability is not unusual, the researchers point out that the study is the first to analyze quality-of-life and cost in "primary prevention" ICD patients — that is, patients with no prior history of abnormal heart rhythms, but whose heart disease may increase their risk of sudden cardiac death. It is also among the first to verify the effectiveness of ICDs in patients who were not enrolled in clinical trials.

Peter Groeneveld, MD, assistant professor of General Internal Medicine and his co-authors report their findings in the April 2007 issue of the journal Pacing and Clinical Electrophysiology.

"While the lifesaving benefits of ICDs have been well documented over the last decade, little was known about the experience of patients in the real world post implantation. This study looked at a population that better represents current device recipients, which in turn, means that physicians can now communicate a more accurate description about life with the device to patients," said Groeneveld.

The researchers administered a patient survey to better understand quality of life benefits, for both primary prevention and "secondary prevention" ICD patients, i.e., patients who have already experienced a cardiac event.

Among the key findings:

• Patients living with an ICD report high levels of emotional, physical and functional well-being, and are satisfied and able to adapt to living with the device.
• When analyzed against a control population, their experiences are comparable to average Americans of the same age.
• Driving, lifting heavy objects and sexual activity were the most common lifestyle concerns voiced by ICD patients during the quality of life survey, suggesting that physicians should routinely address these issues with patients when communicating expectations of living with the device and throughout long-term care.

According to Groeneveld, the quality of life benefits emerge from advances in ICD technology over the last decade resulting in smaller, more easily programmed devices which can more accurately respond to the needs of the individual patient.

The research was supported by an ugrant from The Institute for Health Technology Studies (InHealth; Washington), non-profit organization that supports analysis of the economic, social, and health effects of patient access to medical innovations.

Study: radiation for breast cancer does not increase risk of heart disease

According to a study released today in the International Journal of Radiation Oncology*Biology *Physics, the journal of American Society for Therapeutic Radiology and Oncology (Fairfax, Virginia), elderly women who receive radiation therapy for early-stage breast cancer appear to have no increased risk of a heart attack after taking pre-existing cardiac risk factors into account. Pre-existing cardiac risk factors such as diabetes, hypertension and hyperlipidemia do not potentiate the effects of radiation on the heart.

Using the Surveillance, Epidemiology and End-Results (SEER) database, researchers conducted a retrospective study of female Medicare recipients aged 65 and older who were diagnosed with breast cancer from 1992 to 2000. Researchers then reviewed the records of more than 48,000 breast cancer patients. Of those women, 19,897 had lumpectomies (42%) and 26,534 has mastectomies (55%).

Of all the patients in the study, 21,502 (45%) received radiation therapy and 4,151 (9%) received both radiation and chemotherapy. Patients with pre-existing heart disease were less likely to receive radiation.

After adjusting for pre-existing heart problems as well as other health and socioeconomic factors such as age, race, marital status, income, rural vs. urban living and receipt of chemotherapy, doctors found that women who received radiation were not at an increased risk of having heart attacks. As would be expected, heart attacks were more likely to be found among individuals already at higher risk for heart disease, such as women of increased age, African-American ethnicity and those with more co-morbid conditions.

"Women with breast cancer are naturally concerned about the side effects of their treatments, including radiation therapy. This study provides them and their physicians with some peace of mind knowing that the benefits of radiation appear to outweigh the cardiac risks," said John Doyle, Dr.P.H., lead author on the study and an adjunct assistant professor of Health Policy and Management and Epidemiology at the Mailman School of Public Health of Columbia University (New York).

Contrast-enhanced MRI used to target brain veins

Neuroradiologists at the University of Cincinnati (UC; Cincinnati, Ohio) said they believe a brain imaging approach that combines standard MRI scans with specialized contrast-enhanced techniques could lead to more effective diagnoses in patients with difficult-to-detect blood clots in veins of the brain.

James Leach, MD, reports the findings in the April issue of the American Journal of Neuroradiology. The researchers said this is the first study to correlate the clinical importance of data gleaned from standard MRI scans and detailed contrast-enhanced imaging techniques in patients with chronic thrombosis in veins of the brain.

"Detailed contrast-enhanced techniques produce more defined distinctions between abnormal and normal veins in the membrane around the brain," said Leach, a neuroradiologist and associate professor at UC and principal investigator of the study."

Researchers say these techniques — known as contrast-enhanced MR venography — produce more clearly defined pictures of difficult-to-detect abnormal flow areas within vessels of the brain which may serve as important warning signs of blocked blood flow that require medical intervention.

The enhanced imaging tools can also help identify areas where flow has been partially reestablished after a vessel blockage has occurred. The researchers used the contrast-enhanced techniques, in combination with MRI, to evaluate a small subgroup of patients with features consistent with what is called partially recanalized chronic dural sinus thrombosis, a condition in the membrane surrounding the brain where blood flow has been partially reestablished in a previously blocked vessel.