SOLVE-TAVI: Self-Expandable vs. Balloon-Expandable Valves Yield Similar Outcomes

Two different types of prosthetic aortic valves yielded similar rates of mortality, valve regurgitation, and need for subsequent pacemaker implantation, according to results from the SOLVE-TAVI study presented at Transcatheter Cardiovascular Therapeutics (TCT) 2020.

“Transcatheter Aortic Valve Replacement (TAVR) is developing as standard strategy for symptomatic patients with severe aortic stenosis at high to immediate and now also low risk,” the authors said in a presentation. “Aortic valve replacement device design led to relevant technical and clinical improvements. There is limited evidence for direct valve comparison in particular for latest-generation valve designs.”

The randomized, 2X2 factorial study included 447 patients with severe, symptomatic aortic stenosis who were randomly assigned to either transfemoral transcatheter aortic valve implantation (TAVI) using a balloon-expandable valve (BEV) self-expandable valve (SEV) and also to general anesthesia. The endpoint of interest was a composite of all-cause mortality, stroke, moderate or severe PVL, and permanent pacemaker implantation at 30 days.

According to the results, rates of all-cause death, cardiovascular death, moderate or severe prosthetic valve regurgitation, and permanent pacemaker implantation were similar between intervention groups. Rates of stroke were higher in the BEV-treated patients, and mean aortic gradients were 10 mm Hg in BEV patients compared with 6 mm Hg in SEV patients.

“In symptomatic patients with severe aortic stenosis undergoing TAVR, newer generation SEV compared to BEV resulted in similar rates of the composite endpoint of all-cause death, stroke, moderate/severe PVL, and permanent pacemaker implantation,” the authors concluded in a presentation. “[There were] higher stroke rates in BEV-treated patients, similar time-related safety according to the VARC-2 criteria, and lower aortic gradients in SEV.”

Feistritzer HJ. SOLVE-TAVI:A 2×2 Randomized Trial of Self-Expandable vs Balloon-Expandable Valves and General vs Local Anesthesia in Patients Undergoing Transcatheter Aortic Valve Implantation 1-year Results . Presented at TCT 2020.