Impact of valve type and anesthesia strategy for TAVI – 5-Year results of the SOLVE-TAVI study

Published in congress: EuroPCR 2024

Link: https://www.pcronline.com/Cases-resources-images/Resources/Course-videos-slides/2024/EuroPCR/Late-breaking-trials-TAVI-head-to-head

Dr. Ayşe Nur Özkaya İbiş

Introduction:
Transcatheter aortic valve implantation (TAVI) is being developed as a standard strategy for symptomatic patients with severe aortic stenosis. Observation of device-related problems such as permanent pacemaker implantation, paravalvular leak, and vascular complications has driven the technical development of transcatheter aortic valves (TAVs) over time. There is increasing evidence for direct comparisons of TAVs (CHOICE, REPRISE III, SCOPE I, SCOPE II, PORTICO IDE, SMART). In clinical practice, TAVI is increasingly performed with conscious sedation (CS) and local anesthesia or local anesthesia alone. Studies have shown that patients who undergo TAVI with local anesthesia have lower mortality and morbidity rates, shorter procedure times, and shorter intensive care unit and hospital stays than those who undergo general anesthesia (GA). However, the effect of anesthesia strategy on long-term clinical outcomes is still unknown.

Objective:
This study aims to investigate the long-term clinical outcomes of self-expandable and balloon-expandable valves, and the anesthesia procedures used during TAVI in patients undergoing the procedure.

Methods:
The SOLVE-TAVI study was a multicenter, open-label, 2x2 factorial design, randomized trial conducted at seven centers in Germany from April 2016 to April 2018. Patients undergoing TAVI were randomized to valve strategy (self expandable valve [Evolut-R] vs. balloon expandable valve [Sapien 3]) and anesthesia procedure (GA vs. CS). The primary end points for valve strategy comparison were all-cause death, stroke, moderate or severe prosthetic valve failure, and permanent pacemaker implantation. Primary endpoints for anesthesia strategy comparison included all-cause death, stroke, myocardial infarction, infection requiring antibiotic therapy, and acute kidney injury. Patients were followed at discharge for 30 days, 6 months, 12 months, 24 months and 60 months, and superiority between groups was tested. The five-year results of the research are presented in this report.

Results:
A total of 447 TAVR patients were randomized 1:1, 225 in the GA group and 222 in the CS group. Follow-up data were available for 438 patients with a mean age of 81.6 years. In the valve strategy comparison, there was no significant difference in the primary composite endpoints between the Evolut R and SAPIEN 3 groups (140 [67.7%] vs. 131 [63.4%]; p=0.34). However, the stroke rate was significantly higher in the Sapien 3 group [19 (15.5%) vs. 4 (4.8%); p=0.001]. In the anesthesia strategy comparison, there was no significant difference in the primary composite endpoints between the CS and GA groups (102 [53.6%] vs. 128 [64.1%]; p=0.06). However, all-cause mortality was lower in the CS group (81 [41.5%] vs. 110 [54.3%]; p=0.02).

Conclusion:
This study shows that there is no significant difference in the five-year rates of all-cause death, stroke, moderate or severe prosthetic valve failure, and permanent pacemaker implantation between self-expandable and balloon-expandable valves in TAVI procedures. The five-year stroke rate was higher in the group receiving the balloon-expandable Sapien 3 valve. The use of conscious sedation during TAVI procedures leads to similar five-year composite primary endpoint results compared with general anesthesia, with lower all-cause mortality in the CS group.

Commentary:
Five-year follow-up results from the SOLVE-TAVI study show no significant difference in composite outcomes between self-expandable and balloon-expandable valves in patients with severe symptomatic aortic stenosis at moderate to high surgical risk. These results are consistent with previously published 30-day and one-year results; while the rate of stroke remained higher in the balloon-expandable valve group, this contradicts other studies. While most previous randomized studies showed no variation in stroke risk by valve type, the CENTER study showed a higher procedural stroke rate with self-expandable valves. The increased stroke rate in the balloon-expandable valve group after 30 days in this study may be related to procedure-related predilatations that potentially influence valve selection in high-risk patients.

Conscious sedation with local anesthesia is increasingly utilized in TAVI procedures. No significant difference was observed between GA and CS groups, but all-cause mortality at five years was lower in the CS group. The higher need for inotropes and the occurrence of complications requiring GA in the early results may explain the continued higher mortality in the GA group at five years. However, the composite outcome suggests that both anesthesia strategies are viable in clinical practice. Ultimately, patient factors, preferences, and the experience of the center and operator should play a crucial role in determining the optimal anesthesia and valve type.