Using the Society of Thoracic Surgeons (STS)/American College of Cardiology (ACC) Transcatheter Valve Therapies Registry, researchers evaluated 3,168 propensity-matched pairs of patients at low surgical risk who underwent TAVR for bicuspid versus tricuspid aortic stenosis from 2015 to 2020.
They found no significant differences between the bicuspid and tricuspid groups in terms of procedural success or complications, valve hemodynamics, or death at 30 days (0.9% vs. 0.8%; hazard ratio, 1.18; 95% confidence interval, 0.68 to 2.03) or one year (4.6% vs. 6.6%; HR, 0.75; 95% CI, 0.55 to 1.02).
There were also no significant differences in stroke at 30 days (1.4% vs. 1.2%; HR, 1.14; 95% CI, 0.73 to 1.78) or one year (2.0% vs. 2.1%; HR, 1.03; 95% CI, 0.69 to 1.53).
"There are limited data on outcomes of TAVR for bicuspid aortic stenosis in patients at low surgical risk," Dr. Raj Makkar with Cedars-Sinai Heart Institute, in Los Angeles, and colleagues note in JAMA.
They caution that due to the potential for selection bias and absence of a control group treated surgically for bicuspid aortic stenosis, "randomized trials are needed to adequately assess the efficacy and safety of transcatheter aortic valve replacement for bicuspid aortic stenosis in patients at low surgical risk."
The authors of a linked editorial say the findings from this study may have implications for clinical practice.
"Clearly, TAVR is possible in patients with bicuspid aortic valve, although presumably only patients with otherwise favorable annular, valve, and aortic anatomy were offered this approach," write Dr. Catherine Otto of the University of Washington, in Seattle, and Dr. David Newby of the University of Edinburgh, in the U.K.
They note that patients with bicuspid aortic-valve develop severe aortic stenosis about 10 years earlier than patients with a trileaflet valve.
"In the overall cohorts reported by Makkar and colleagues, patients with bicuspid aortic valve were 7.2 years younger than those with a trileaflet aortic valve. Therefore, questions regarding longevity of transcatheter bioprosthetic valves become increasingly important, with this study reporting only one-year outcomes and with robust data extending to only about five years available in the published literature," the editorial writers caution.
Dr. Otto and Dr. Newby say, "Additional evidence is needed to understand the precise implications of TAVR longevity. The majority of long-term data are based on studies that involved older populations with higher surgical risk. Therefore, physicians need to be mindful of these issues when considering patients for TAVR. More robust long-term durability data are needed for patients with either bicuspid or trileaflet aortic valve disease, but particularly for those with bicuspid aortic valve."
SOURCE: https://bit.ly/3hPhX32 and https://bit.ly/2Z93ete JAMA, online September 21, 2021.
By Reuters Staff
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