The Centers for Medicare & Medicaid Services (CMS; Baltimore) recently asked the Heart Rhythm Society (HRS; Washington) to lead a working group to make recommendation for a national implantable cardioverter defibrillator (ICD) registry. Late in September, CMS posted a draft national coverage determination to expand coverage of ICDs. The decision was based on new research showing that the devices can benefit a wider population of patients than first indicated in original trials, CMS said. As part of the draft coverage decision, CMS proposed a national registry be implemented for primary prevention ICD therapy, and the working group's task will be to provide recommendations to develop a national registry to follow Medicare/Medicaid patients receiving an ICD for that indication.

Medical registries often are used to monitor medical conditions and outcomes after the implementation of prevention and treatment programs. "This is a new process for CMS and for us, so we are really putting this together without a lot of precedent," Stephen Hammill, MD, president of the Heart Rhythm Society, told Cardiovascular Device Update. "We have people on the group who have a great deal of experience with large registries, NIH [National Institutes of Health] registries and large national studies."

Group members also include representatives from Guidant (Indianapolis); Medtronic (Minneapolis); St. Jude Medical (St. Paul, Minnesota); the American College of Cardiology (Bethesda, Maryland); American Heart Association (Dallas); Heart Failure Society of America (also St. Paul); Duke Clinical Research Institute (Durham, North Carolina); University of Pittsburgh Epidemiology Data Center (Pittsburgh); and Indiana University Krannert Institute of Cardiology (also Indianapolis). Hammill said CMS would have a non-voting group member present to help with questions. "CMS wants a pretty quick turnaround, at least with our initial suggestions," he said.

Meetings were scheduled for October and November. The presentation and submission of recommendations to CMS is expected by late this month. "We will define what the main questions are that can be answered by a national registry," Hammill explained. "We'll look at the type of data that should be entered. We want enough data points to make the information useful, but not unmanageable." Topics the group will address include the feasibility of mandatory national registry, the design of such registry, patient and device data elements collected, registry management and funding.

According to CMS, evidence-based guidelines that doctors currently use to decide who should receive an ICD are based on broad patient characteristics, meaning that some patients who receive ICDs are less likely to benefit than others. Because the risk of life-threatening arrhythmias is still relatively low in many patients, most individuals will never require cardioversion or defibrillation from their device. If more precise characteristics can be identified to better predict which patients are likely to benefit from these devices – or which will not – patients and doctors could make better decisions and perhaps avoid unnecessary procedures and potentially inappropriate shocks without the guarantee of any benefit, CMS said following its decision to extend coverage. CMS hopes a national data registry can help fill that "critical" information gap, in addition to gathering long-term safety and effectiveness data on the device for the covered indications.

Clinical trials have limited follow-up times and do not provide adequate long-term data. "These devices are implanted for life, making it important to have data over longer periods of time," CMS said in a statement. "Data from registries are important in demonstrating that new technologies have acceptable long-term benefits and safety profiles, especially for low-risk populations."

CMS' previous national coverage determination provided coverage of ICDs as a primary prevention of sudden cardiac death in certain patients with ischemic cardiomyopathy. The updated decision expands coverage to more patients with ischemic cardiomyopathy and adds a large group of beneficiaries with nonischemic cardiomyopathy. The agency said both groups benefit from ICD with relative reductions in mortality of about 20%, and an absolute reduction in mortality of 6%-7%. This means that both groups have a significant number of patients who will never receive active therapy from the ICD, and may have been able to avoid having the implant if there were more precise measures for predicting which patients would most likely require a cardioversion.

Data currently available from completed clinical trials do not provide more precise methods for identifying patients at relatively low or high risk of sudden cardiac death, according to CMS. The agency said that to conduct studies that accurately identify the patients who are most likely to benefit and those who are unlikely to benefit requires collection of data on all patients.

In other coverage news, CMS also recently issued a final national coverage determination expanding coverage of percutaneous transluminal angioplasty (PTA) of the carotid artery with stenting to Medicare-eligible participants of a large FDA-mandated post-approval study for a newly approved carotid stent. CMS posted the draft decision one day after the FDA approved the first carotid artery stenting system, and this final CMS decision comes just five weeks after the FDA approval. CMS said that comments received in response to the earlier draft decision were "overwhelmingly positive." CMS believes that carotid stenting in the setting of an FDA post-approval study reasonably assures patient protection through quality monitoring, and can provide Medicare beneficiaries the opportunity to receive the benefits of carotid stents.

Prior to the decision last month, CMS only covered PTA of the carotid artery concurrent with stent placement in clinical trials being conducted prior to FDA approval. FDA approval of the carotid stenting system means that it is no longer investigational for the approved use. The new coverage decision enables Medicare to pay for carotid stenting performed for these FDA post-approval studies. CMS said it also is evaluating a separate request for a broader coverage expansion of PTA of the carotid artery concurrent with stent placement for patients at high risk for carotid endarterectomy.

PCI growing in New York

Percutaneous coronary interventions (PCI) have become more common and significantly more successful in New York State, said researchers at New York Presbyterian Hospital-Weill Cornell Medical Center (New York). The rate of emergent coronary artery bypass grafting (CABG) for failed PCIs decreased by more than 84%, from 1.6% in 1994-1995, to about 0.25% in 2000-2001. The decline in emergent bypass rates correlates with an increase in coronary stent usage over the same time period. In 1994-1995, only 17% of all percutaneous coronary interventions involved stents. That number increased to 44% in 1996-1997 and rose to almost 80% in 2000-2001. The low rates of emergent bypass in the current "stent era" also raise the question of whether on-site cardiothoracic surgical backup is necessary for institutions performing PCIs.

"These improvements reflect numerous dramatic advances in interventional cardiology in recent years, as well as the commitment of New York State hospitals to provide improved cardiac care," said Atul Sharma, MD, lead investigator and interventional cardiology fellow at New York Presbyterian. He called the decline in emergent CABG "likely due to more frequent use of coronary stents, new adjuvant pharmacotherapies and improved operator techniques and equipment."

In 1991, in an effort to better track trends in coronary intervention, the state's department of health collaborated with all state hospitals with privileges to perform angioplasty to create the Angioplasty Reporting System. The registry systematically obtains all angioplasty procedure results, generates a clinical outcomes database and provides access to information for physicians, hospitals and the public. The data are gathered at each hospital site that performs PCIs, and random site audits provide quality control and assurance.

New York Presbyterian Hospital researchers examined the registry data from 1994-1995, 1996-1997 and 2000-2001, comparing baseline characteristics and in-hospital outcomes in patients who underwent emergent CABG for failed angioplasty. Multiple PCIs performed on the same patient during a single hospital admission were collapsed into single-case records. A total of 40,265 people underwent PCI in New York State during 1994-1995, of whom 658 (1.6%) underwent emergent CABG for failed PCI. In 1996-1997, 430 of 55,170 PCI patients (0.78%) underwent emergent CABG surgery, compared to 202 of 82,140 patients (0.25%) during 2000-2001. Compared to their counterparts from 1994-1997, patients undergoing emergent CABG in 2000-2001 were generally older and more likely to have high blood pressure, multi-vessel coronary artery disease, a history of multiple heart attacks and more frequent prior bypass surgeries.

Although rates of emergent CABG have declined over time, morbidity and mortality associated with emergent bypass have increased, according to the study. Between 1994-1995 and 2000-2001, there was nearly a two-fold increase in mortality (11.9% in 2000-2001 vs. 6.1% in 1994-1995), as well as a significant rise in post-bypass stroke rates among patients who underwent emergent bypass in 2000-2001, compared to those bypassed in 1994-1995. Sharma attributed these increases to patient demographic changes, "which tended to be older and have more co-morbidities than during earlier periods. The data suggest that the few patients who fail PCI in the current era represent a very high-risk patient cohort."

AHRQ: Prehypertension needs elimination

Prehypertension – an elevation in blood pressure that is a risk factor for heart attack, heart failure, stroke and kidney disease – is estimated to be responsible for 9.1% of U.S. deaths, 6.5% of nursing home stays and 3.4% of hospital stays each year for people ages 25 to 74, according to new research that was funded by the Agency for Healthcare Research and Quality (Washington). AHRQ's study estimated that as many as two-thirds of people between the ages of 45 and 64, and 80% of people between the ages of 65 and 74, might have prehypertension or residual hypertension. The researchers found that, per 10,000 adults between the ages of 25 and 74, prehypertension and residual hypertension together account for almost 14% of deaths, nearly 10% of nursing home admissions, and 4.7% percent of hospital admissions.

The researchers found that women between 65 and 74 would benefit most if prehypertension and residual hypertension were eliminated. Hospital admission rates among women could drop by almost 150 admissions per 10,000 women in this age group. Men also show substantial reductions in risk. Hospital admission rates could drop by 85 admissions per 10,000 for men ages 45 to 64 and by 62 admissions per 10,000 for men 65 to 74. "Prehypertension is a significant health problem and requires treatment with diet, exercise and smoking cessation," said Carolyn Clancy, MD, director of AHRQ. "This research clearly shows that we need to continue improving preventive services and encouraging Americans to adopt healthier lifestyles."

Cystatin C seen as key heart attack marker

A biomarker called cystatin C, which measures kidney function, predicts which people are less likely to survive a heart attack, according to research recently published in Circulation, the journal of the American Heart Association. In the study, patients with the highest levels of cystatin C in their blood after they had a type of heart attack called non-ST-elevation acute coronary syndrome, had "a more than 55% cumulative probability of death versus about a 7% probability of death among patients with lowest levels of cystatin C," said lead author Tomas Jernberg, MD, PhD, an associate professor at Uppsala Research Center (Uppsala, Sweden). The study is being called the first to demonstrate that cystatin C can be used as a quick and early predictor of death, he said.

Cystatin C is a cysteine protease inhibitor filtered through the kidneys and circulated in the blood. Kidney function is one of several factors used to determine which heart attack patients need aggressive treatment to reduce the risk of death or a non-fatal second heart attack.