Researchers: Off-label TAVRs yield ‘acceptable results’

Patients receiving off-label transcatheter aortic valve replacement (TAVR) are more likely to suffer adverse outcomes than other TAVR patients, according to new research. However, risk-adjusted mortality is similar between the two groups at one year post-procedure.

Off-label TAVR was defined as TAVR in patients with known bicuspid valve, moderate aortic stenosis, severe mitral or aortic regurgitation prior to the procedure or subaortic stenosis. For many of these patients, the standard of care is surgical aortic valve replacement (SAVR), but physicians may opt for TAVR if they believe it is in the patient’s best interest.

“Although we did not compare the efficacy or safety of TAVR with that of surgical AVR or medical therapy for patients with off-label indications, our findings suggest that TAVR is a therapeutic option with acceptable results at one year and may be beneficial for some of these patients who have inoperable conditions or are high-risk operative candidates,” the researchers wrote.

Lead author Ravi S. Hira, MD, of the section of cardiology at the University of Washington, and colleagues studied 23,847 patients undergoing TAVR across 328 sites in the United States. They then analyzed the rates of in-hospital mortality, and mortality and adverse cardiovascular outcomes at 30 days and one year of follow-up. Results were published in JAMA Cardiology.

Roughly 10 percent of the patients received TAVR for off-label indications and were, on average, younger but at higher risk at the time of procedure.

Adjusted risk of 30-day mortality was 27 percent higher for off-label TAVR patients than those in the on-label group. The adjusted difference at one year of follow-up wasn’t statistically significant.

In addition, the researchers found mortality rates at each stage of follow-up were highest among patients with severe mitral regurgitation.

“Certain off-label indications may have better outcomes than others, and further studies may lead to expansion of the approved indications for TAVR,” the authors wrote. “However, it is important to recognize that a TAVR is an invasive procedure associated with important rates of short- and long-term complications. Until the safety, efficacy, and cost-effectiveness of off-label TAVR is demonstrated in larger populations, the use of TAVR in untested populations should be approached cautiously.”