SOLVE-TAVI: Study Compares SEVs vs. BEVs and General vs. Local Anesthesia in TAVR Patients

Findings from the SOLVE-TAVI trial presented Oct. 16 during TCT 2020 suggest symptomatic patients with severe aortic stenosis undergoing transfemoral TAVR with newer generation self-expandable valves (SEV) had similar rates of all-cause death, stroke, moderate/severe paravalvular leakage, and permanent pacemaker implantation at one year, compared with those receiving balloon-expandable valves (BEV).

The 2x2 factorial designed trial randomized patients to either the CoreValve Evolut R (SEV group; N=219) or the Edwards Sapien 3 (BEV group; N=219), as well as to local anesthesia or general anesthesia. The median patient age in both groups was approximately 81 and there were no significant differences in baseline characteristics across both groups.

While overall results showed no significant differences in the composite endpoint, researchers did observe a higher rate of stroke in the BEV patient group (6.9% vs. 1.0%, respectively). Similarly, there were no significant differences between those patients receiving local anesthesia with conscious sedation and those receiving general anesthesia. Like the two valve groups, there was also no significant difference in time-related safety according to the VARC-2 criteria between the anesthesia groups.

According to Hans-Josef Feistritzer, MD, PhD, et al., approximately half of routine TAVRs are performed using general or local anesthesia with conscious sedation, and registry data suggest local anesthesia may lead to better outcomes, along with shorter hospital stays and procedure times. This is one of the first studies to look at the impact of anesthesia strategy on clinical outcomes during extended follow-up, they said.

Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Valvular Heart Disease, Aortic Surgery, Cardiac Surgery and VHD, Interventions and Structural Heart Disease

Keywords: TCT20, Transcatheter Cardiovascular Therapeutics, Percutaneous Coronary Intervention, Aortic Valve Stenosis, Transcatheter Aortic Valve Replacement, Heart Valve Prosthesis


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