CMS Broadens Access to TAVR, Plus Other Cardiology Updates

CMS updated its national coverage determination for transcatheter aortic valve replacement (TAVR), removing the evidence development requirement for symptomatic severe aortic stenosis and adding coverage for asymptomatic cases under evidence development. The update also includes other changes. Additionally, the FDA granted de novo authorization to an ECG analyzer for detecting STEMI, and other studies on troponins and PCI in nonagenarians were reported.

The CMS decision removes a significant reimbursement barrier for patients with symptomatic severe aortic stenosis, who previously had to be enrolled in clinical studies to qualify for TAVR coverage. Asymptomatic patients now gain access to the procedure, though their cases remain tied to evidence development, meaning ongoing data collection will continue for that subgroup.

The FDA's de novo authorization for the Queen of Hearts ECG analyzer adds a new diagnostic option for detecting STEMI and STEMI equivalents in suspected heart attack patients. Separately, point-of-care troponin testing combined with the HEART score helped emergency services identify non-ST-elevation acute coronary syndrome, and a Dutch high-volume center reported that carefully selected nonagenarians could undergo PCI safely.