At 1 year after transcatheter aortic valve replacement (TAVR), patients treated with contemporary balloon-expandable valves (BEVs) and self-expanding valves (SEVs) showed similar rates of all-cause mortality, significant paravalvular leak and permanent pacemaker implantation, but patients treated with BEVs showed a higher rate of stroke, according to study results presented Friday at the TCT Connect virtual conference.
As TAVR develops, improvements in the design and delivery of BEVs and SEVs continue to enhance its safety and applicability across all risk groups. Ongoing clinical trials aim to examine the safety and efficacy of additional valves for the treatment of severe symptomatic aortic stenosis (AS). As the number of U.S. Food and Drug Administration-approved valves increases, data on direct comparisons between valves remain sparse. Registry data on local anesthesia (LA) with moderate sedation in TAVR suggest lower mortality, morbidity and shorter length of stay, but prospective data are lacking.
The SOLVE-TAVI (Self-Expandable vs Balloon-Expandable Valves and General vs Local Anesthesia in Patients Undergoing Transcatheter Aortic Valve Implantation) trial was a multicenter, randomized, 2x2 factorial designed trial that enrolled 447 high-risk patients with severe symptomatic AS (mean Society of Thoracic Surgeons score 7.7%), randomly assigning patients to receive either the third-generation SAPIEN 3 BEV (Edwards Lifesciences) or the second-generation CoreValve Evolut R SEV (Medtronic). Additionally, patients were randomized to general anesthesia (GA) versus LA.
Hans-Josef Feistritzer, MD, PhD, of Heart Center Leipzig, Germany, presented 1-year results from the SOLVE-TAVI trial on Friday at TCT Connect.
Of the patients enrolled, 219 were randomized to receive a BEV and 219 received an SEV. Although most baseline clinical characteristics were similar between the BEV and SEV cohorts, patients in the BEV arm appeared to have more hypertension and chronic kidney disease and were more likely to be current smokers.
When comparing patients who received an SEV to those who received a BEV at 1 year, patients in both groups demonstrated similar all-cause mortality (17.6% vs. 17.0%; p=0.88), moderate or severe paravalvular leak (7.0% vs. 4.5%; p=0.35) and permanent pacemaker implantation (24.7% vs. 20.2%; p=0.25). Patients receiving a BEV had a higher stroke rate at 1 year (6.9% vs. 1.0%; p=0.002). Gradients were lower at 1 year in patients receiving SEVs (mean 6 mmHg vs. 10 mmHg; p<0.001). There were no significant differences in all-cause mortality, stroke, myocardial infarction or acute kidney injury when comparing the two anesthesia strategies.
This trial helps shed some light on the direct comparison of the third-generation BEV and the second-generation SEV in high-risk patients undergoing TAVR. Future studies will be needed in lower-risk patients using truly contemporary valves, such as the fourth-generation SAPIEN 3 Ultra and the third-generation CoreValve Evolut PRO.
This study was funded by the German Heart Research Foundation.