Transcatheter aortic valve replacement (TAVR) appears to be safe in patients at low risk for surgical mortality who have bicuspid aortic stenosis, according to late-breaking trial results presented Monday at Cardiovascular Research Technologies (CRT) 2020 in National Harbor, Maryland.
Ron Waksman, MD, of MedStar Washington Hospital Center, and colleagues reported on results from 61 patients with bicuspid aortic valves who enrolled in the bicuspid arm of the Low-Risk TAVR (LRT) trial.
The top-line LRT results, which were published in 2018, showed zero mortality and zero disabling stroke at 30 days.
The results presented Monday and published simultaneously online in JACC: Cardiovascular Interventions were the first to examine TAVR in low-surgical-risk patients with severe bicuspid aortic stenosis, who were not included in the results of either the main LRT study or the randomized cohorts of the two pivotal low-risk trials published in 2019. One of the pivotal trials randomized low-risk patients to undergo TAVR with the balloon-expandable Sapien 3 valve (Edwards Lifesciences) or surgical aortic valve replacement (SAVR), and the other randomized these patients to undergo TAVR using a self-expanding valve (CoreValve, Evolut R or Evolut Pro; Medtronic) or SAVR.
The 61 low-risk bicuspid patients in the LRT trial underwent TAVR at 7 U.S. centers from 2016 to 2019. As with the trial’s main tricuspid arm, the bicuspid patients had zero mortality and zero disabling stroke at 30 days post-TAVR. The permanent pacemaker implantation rate was 13.1%, and only one patient had moderate paravalvular leak at 30 days.
The study also shows that subclinical leaflet thrombosis was observed in a minority of patients at 30 days but that it did not appear to be associated with clinical events.
The U.S. Food and Drug Administration approved TAVR in low-surgical risk patients in August 2019 after results from the pivotal and LRT trials were published showing that the procedure is safe in this patient population.
The LRT trial is funded by the MedStar Health Research Institute, Washington, D.C.