Off-Label Use of TAVR Evaluated in TVT Registry

June 26, 2017—An investigation of trends and outcomes of off-label use of transcatheter aortic valve replacement (TAVR) procedures found that approximately one in 10 patients in the United States have received TAVR for an off-label indication. After adjustment, 1-year mortality was similar in these patients to that in patients who received TAVR for an on-label indication. These results reinforce the need for additional research on the efficacy of off-label TAVR use, concluded the investigators.

Ravi S. Hira, MD, et al published insights from the National Cardiovascular Date Registry Society for Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry online in Journal of the American Medical Association (JAMA): Cardiology.

The Transcatheter Valve Therapy registry is composed of patients receiving commercially funded TAVR in the United States. This study assessed a total of 23,847 patients from 328 sites performing TAVR between November 9, 2011 and September 30, 2014. Off-label TAVR was defined as TAVR in patients with known bicuspid valve, moderate aortic stenosis, severe mitral regurgitation, severe aortic regurgitation, or subaortic stenosis. Data were linked with the Centers for Medicare & Medicaid Services for 15,397 patients to evaluate 30-day and 1-year outcomes.

As summarized in JAMA: Cardiology, among the 23,847 patients in the study (11,876 women and 11,971 men; median age, 84 years [interquartile range, 78–88 years]), off-label TAVR was used in 2,272 patients (9.5%).

In-hospital mortality was higher among patients receiving off-label TAVR than those receiving on-label TAVR (6.3% vs 4.7%; P < .001), as was 30-day mortality (8.5% vs 6.1%; P < .001) and 1-year mortality (25.6% vs 22.1%; P = .001). Adjusted 30-day mortality was higher in the off-label group (hazard ratio, 1.27; 95% confidence interval, 1.04–1.55; P = .02), while adjusted 1-year mortality was similar in the two groups (hazard ratio, 1.11; 95% confidence interval, 0.98–1.25; P = .11).

The median rate of off-label TAVR use per hospital was 6.8% (range, 0%–34.7%; interquartile range, 3.4%–12.1%), with hospitals in the highest tertile of off-label use associated with increased 30-day adverse cardiovascular events compared with the lowest tertile. However, this difference was not observed in adjusted 30-day or 1-year outcomes, reported the investigators in JAMA: Cardiology.