Frequency, Outcomes of Off-Label TAVR Procedures in the U.S.

Increased 30-day adverse cardiovascular events for hospitals in highest tertile of off-label use
Increased 30-day adverse cardiovascular events for hospitals in highest tertile of off-label use

HealthDay News — Adjusted one-year mortality is similar for individuals undergoing transcatheter aortic valve replacement (TAVR) for on-label or off-label indications, according to a study published online June 21 in JAMA Cardiology.

Ravi S. Hira, MD, from the University of Washington in Seattle, and colleagues examined patterns and adverse outcomes of off-label use of TAVR, defined as TAVR in patients with known bicuspid valve, moderate aortic stenosis, severe mitral regurgitation, severe aortic regurgitation, or subaortic stenosis, in U.S. clinical practice. 

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Off-label TAVR was used in 2,272 (9.5%) of the 23,847 patients in the study. The researchers found that patients receiving off-label TAVR had higher in-hospital mortality (6.3 versus 4.7%; P<0.001), 30-day mortality (8.5 versus 6.1%; P<0.001), and one-year mortality (25.6 versus 22.1%; P=0.001), compared to those receiving on-label TAVR. The off-label group had higher adjusted 30-day mortality (hazard ratio, 1.27; 95% confidence interval, 1.04 to 1.55; P=0.02), while adjusted one-year mortality was similar between the groups (hazard ratio, 1.11; 95% confidence interval, 0.98 to 1.25; P=0.11). Per hospital, the median rate of off-label TAVR use was 6.8%, with increased 30-day adverse cardiovascular events for hospitals in the highest tertile of off-label use versus the lowest tertile.

"These results reinforce the need for additional research on the efficacy of off-label TAVR use," the authors write.

Several authors disclosed financial ties to the pharmaceutical industry.

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