News In Brief

A nationwide registry to collect data on transcatheter aortic heart valve replacements was launched Dec. 1 by the Society of Thoracic Surgeons and the American College of Cardiology. The two groups jointly developed the tool, dubbed the “TVT Registry,” to track real-world outcomes with the procedure in conjunction with FDA’s first-of-a-kind approval last month of Edwards Lifesciences’ Sapien valve. Edwards will employ the registry to meet certain post-market study requirements tied to the FDA approval, which targets use of the device in patients who are too sick, frail or high risk for conventional open-heart valve surgery. It is also highly likely that CMS will require hospitals to enter patient data in the registry as a condition of Medicare coverage once it finalizes a pending national coverage determination for the procedure. (See Also see "CMS Jumps Out Ahead Of FDA With Transcatheter Valve Coverage Analysis" - Medtech Insight, 3 October, 2011..) STS and ACC say the TVT Registry will be linked to the Social Security Death Master File and Medicare databases to track long-term outcomes. In addition, hospitals participating in the registry will receive quarterly reports comparing an institution’s procedure performance with national outcomes.