Leaders in Pharmaceutical Business Intelligence (LPBI) Group

• Off-label transcatheter aortic valve replacement (TAVR) was associated with higher in-hospital, 30-day, and 1-year mortality rates compared with on-label TAVR use, but after adjustment, 1-year mortality was similar in the two groups.
• Note that approximately one in 10 TAVR patients in the United States have received the procedure for an off-label indication.

Three-quarters of off-label indications were deemed so due to presence of severe aortic or mitral regurgitation or both; one-fifth were off-label because of bicuspid valves.

Successful device implantation was slightly less likely with off-label TAVR (92.9% versus 93.0%, P=0.02). But in-hospital outcomes were the bigger issue for off- versus on-label TAVR:

• Mortality (6.3% versus 4.7%, P<0.001)
• Cardiac arrest (6.6% versus 4.8%, P<0.001)
• Transient ischemic attack (0.5% versus 0.2%, P=0.007)
• Moderate-to-severe perivalvular leaks (12.4% versus 7.6%, P<0.001)

Mortality was most likely for patients with severe mitral regurgitation as the only off-label indication for TAVR. The authors suggested this is owing to secondary mitral regurgitation caused by left ventricular dilatation.