Transcatheter aortic valve replacement (TAVR) is a standard therapy for patients with bicuspid aortic valve stenosis. However, the outcomes associated with TAVR in low-risk patients with bicuspid aortic valve stenosis are not known. This study aims to examine the efficacy, safety, and outcomes of TAVR in low-risk patients with bicuspid aortic valve stenosis.
This prospective, single-arm trial included a total of 150 low-risk patients with severe bicuspid aortic valve stenosis who underwent TAVR. All the patients underwent an attempted implant of the transcatheter aortic valve. The primary outcome of the study was the incidence of all-cause mortality or disabling stroke 30 days after the surgery.
The incidence of all-cause mortality or disabling strake was 1.3% at 30 days after undergoing TAVR. The device success rate was found to be 95.3%. The mean AV gradient at 30 days was 7.6 mm Hg, with the effective orifice area being 2.3 cm(2). A total of 22 patients (15%) underwent new permanent pacemaker implantation. No patients were found to have greater than a mild paravalvular risk.
The research concluded that in patients with low-surgical risk patients with bicuspid aortic valve stenosis, transcatheter aortic valve replacement was associated with favorable 30-day results.