March 3, 2020
Device Outcomes Compared for TAVR in Patients With Bicuspid or Tricuspid Aortic Valve Disease
March 3, 2020—Outcomes for current- and next-generation transcatheter aortic valve replacement (TAVR) devices used to treat patients with bicuspid aortic valve (AV) or tricuspid AV stenosis were compared in a study by Sharif A. Halim, MD, et al published online in Circulation.
Investigators aimed to compare device success, procedural outcomes, post-TAVR valve performance, and in-hospital clinical outcomes (ie, mortality, stroke, major bleeding) according to AV morphology (bicuspid vs tricuspid). Data were gathered from the Society of Thoracic Surgeons (STS)/American College of Cardiology Transcatheter Valve Therapy registry for a date range between November 2011 through November 2018.
According to the researchers, the results were stratified by older valve prostheses or current valve prostheses (Sapien 3 [Edwards Lifesciences] and Evolut R [Medtronic]).
A total of 170,959 eligible procedures at 593 sites were included. There were 5,412 (3.2%) TAVR procedures performed in patients with bicuspid AV stenosis, including 3,705 that were completed with a current-generation device. Patients with a bicuspid AV were younger, with a lower STS Predicted Risk of Operative Mortality score compared with patients who had tricuspid AVs.
When comparing older-generation devices with current-generation devices in patients with bicuspid AV stenosis, device success increased (93.5% vs 96.3%; P = .001) and the incidence of 2+ aortic insufficiency declined (14% vs 2.7%; P < .001) with the use of current-generation devices. Additionally, device success was only slightly lower in the bicuspid AV than the tricuspid AV groups (96.3% vs 97.4%, respectively; P = .07). A slightly higher incidence of residual moderate or severe aortic insufficiency was observed within the bicuspid AV group (2.7% vs 2.1%; P < .001).
Medicare administrative claims were used to determine mortality and stroke incidences out to 1 year among the eligible patients (aged ≥ 65 years). A lower 1-year adjusted risk of mortality (hazard ratio [HR], 0.88; 95% confidence interval [CI], 0.78–0.99) was found for bicuspid versus tricuspid AV patients in the Medicare-linked cohort, while no difference was observed in the 1-year adjusted risk of stroke (HR, 1.14; 95% CI, 0.94–1.39).
The authors concluded that when using current-generation devices, procedural, postprocedural, and 1-year outcomes for TAVR were comparable for patients treated for bicuspid AV versus tricuspid AV disease.