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The Centers for Medicare and Medicaid Services for its beneficiaries but only as part of FDA-approved studies.
The draft of the agency's national coverage determination for the devices noted a number of criteria for these studies, including addressing peri-procedural and post-procedural complications, long-term outcomes, and potential differences among patient subgroups with a particular emphasis on underrepresented populations.
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Heart Monitoring Algorithm
Among the late-breaking clinical trials presented at the American Heart Association meeting this week was the , which reported that an algorithm uploaded to existing implanted cardiac resynchronization therapy-defibrillator devices to monitor heart sounds, thoracic impedance, physical activity, respiration, and heart rate predicted heart failure events.
The algorithm had a sensitivity of 70% with an unexplained alert rate of 1.47 per year, meeting both minimum performance criteria designated in the trial. The alerts of impending heart failure decompensation averaged about a month prior to events that occurred, which the presenter suggested would leave opportunity for action.
However, study discussant Mary Norine Walsh, MD, of St. Vincent Heart Center in Indianapolis, noted that there are many strategies to predict hospitalization, ranging from risk calculators to telemonitoring, and encouraged the investigators to involve patients in the process going forward.
Past AHA president Clyde Yancy, MD, of Northwestern University in Chicago, noted that algorithms like these will have to demonstrate that they perform better than those existing strategies.
"Everyone keeps looking for technology solutions to decompensated heart failure but we have to be very careful here," he told ľֱ.
Rheumatoid Arthritis Risks
Cardiovascular risk for rheumatoid arthritis patients is double that of the general population and on par with the heart risk conferred by type 2 diabetes, a study reported at the American College of Rheumatology meeting in Washington, D.C.
"We need better implementation programs for screening and treating cardiovascular risks," the presenter said. "There's accumulating evidence that anti-rheumatic treatment, particularly with biologics, decrease cardiovascular risk. However, our current strategy of tapering or stopping biologics might expose patients to increased risk. This should be addressed in future studies."
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Statins for Liver Disease
Analysis of Danish nationwide databases showed 40% to 55% lower mortality risk with statin use among adults with alcoholic cirrhosis.
The observational findings reported at the American Association for the Study of Liver Diseases in Boston are significant given how few options there are for the disease and the little impact on life expectancy seen with available treatments for decompensated cirrhosis, the researchers said.
"In this country, there is general aversion by practitioners to administer statins to anyone with even a whiff of liver disease," commented Raymond Chung, MD, of Massachusetts General Hospital in Boston. The early days when liver test monitoring was required has left the "very common fear that if a patient has chronic liver disease, the deck is stacked against him in terms of risk."
"But it has been shown time after time that is not the case," Chung added, "...indeed, there appear to be benefits for those patients with the use of statins."
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