According to the first report to be released on the U.S. "commercial experience with transcatheter aortic valve replacement (TAVR)," real-world procedures are consistent with previously published randomized trial data as well as other global experience, with low rates of in-hospital mortality (5.5 percent) and procedural complication rates. The report was published Nov. 17 in the Journal of the American Medical Association.

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The U.S. Food and Drug Administration approved TAVR for the treatment of severe, symptomatic aortic stenosis and interoperable status in 2011 and later for high-risk but operable status in 2012. The study looked at all U.S. TAVR cases – 7,710 patients – from 224 participating hospitals enrolled in the STS/ACC TVT Registry from Nov. 2011 – May 2013. The authors found that device implementation success was achieved in 92 percent of cases. Further, in-hospital mortality occurred in 5.5 percent of patient (95 percent CI, 5.0 percent – 6.1 percent). Other procedural complications included stroke in 2.0 percent of patients (95 percent CI, 1.7 percent – 2.4 percent), dialysis-dependent renal failure in 1.9 percent of patients (95 percent CI, 1.6 percent – 2.2 percent), and major vascular injury in 6.4 percent of patients (95 percent CI, 5.8 percent – 6.9 percent). After 30-day follow up of 3,133 patients, the incidence of mortality was 7.6 percent, a stroke had occurred in 2.8 percent, new dialysis in 2.5 percent and reintervention in 0.5 percent.

The authors note that the findings "help address a lingering question of clinical outcomes with the first-generation TAVR device after controlled U.S. dissemination to a relatively narrow group of treatment centers." They add that the TVT Registry "has helped to address critiques of the adequacy of postmarket surveillance of high-risk medical device performance and safety."

"The large volume of data in the registry provided an excellent source to promptly examine patient characteristics and outcomes," said Michael J. Mack, MD, FACC, lead author and a member of the ACC Board Trustees. "We think that the American public can feel comfortable that this new registry is an effective means of monitoring the performance of new medical devices after they have been approved."

However, the authors caution that moving forward, even though their findings were consistent with trial research and international registry data, "long-term follow up is essential to assess continued safety and efficacy as well as patient health status.

"Transcatheter valve therapy (TVT) is the result of two transformational events," said David R. Holmes, Jr., MD, MACC, a past president of the ACC. "The first is based on the approval and now widespread use of TAVR technology in the U.S. and around the world. The second transformational event is the coming together of the ACC along with other professional societies: The Society of Thoracic Surgeons, the Society for Cardiovascular Angiography and Interventions and the American Association for Thoracic Surgery, the NCDR, data analytics and the U.S. regulatory agencies, who are all working together to optimize the outcome of patients with severe valvular heart disease. This second transformational event – the TVT Registry – promises to be an increasingly important vehicle to make sure that U.S. patients have efficient access to safe and effective new strategies of care. This first manuscript is the initial delivery of what this transformational event can accomplish."

Keywords: Vascular System Injuries, Renal Dialysis, Incidence, Registries, Stroke, Follow-Up Studies, Hospital Mortality, United States Food and Drug Administration, Heart Valve Diseases, Health Status

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