Study title: DOUBLE-CHOICE: Anesthesia Strategies and Self-Expanding Valve Types for TAVI

Published in Congress: ESC Congress 2025

Link: https://pubmed.ncbi.nlm.nih.gov/40878766

Prepared by: Dr. Serkan Bulguroğlu

Introduction
Transcatheter aortic valve replacement (TAVR) has become a standard treatment option for patients with severe symptomatic aortic stenosis. However, data regarding the optimal choice of anesthesia strategy (minimalist approach vs. standard approach) and self-expanding valve type (ACURATE neo2 vs. Evolut series) are limited.

Objective
The DOUBLE-CHOICE study aimed to compare anesthesia strategies and different self-expandable valve types during TAVR to evaluate which approach is more suitable in terms of safety and efficacy.

Methods
This was a 2x2 factorial, randomized, multicenter, open-label clinical study. Patients with symptomatic severe aortic stenosis, an indication for transfemoral TAVR, and suitable anatomy for both the ACURATE neo2 and Evolut valves were included. A minimalist approach of local anesthesia, no sedation, and limited invasive procedures was compared with a standard approach of local anesthesia, sedation, and more extensive invasive monitoring. The valves used were ACURATE neo2 and Evolut Pro/Pro+/FX. Primary endpoints for the comparison of anesthesia strategies were death within 30 days, vascular/bleeding complications, infections requiring antibiotics, and neurological events. Primary outcomes for the comparison of valves were death within 30 days, stroke, moderate/severe valve regurgitation, and the need for a permanent pacemaker.

Results
The minimalist approach was found to be non-inferior to standard anesthesia. The 30-day composite outcome was 22.9% with the minimalist approach and 25.8% with the standard approach. Approximately 19% of patients in the minimalist group were converted to the standard approach during the procedure (mostly due to pain, anxiety, or agitation). ACURATE neo2 demonstrated superior outcomes compared to Evolut. Specifically, the need for a permanent pacemaker was significantly higher with Evolut (26.5%) compared to 11.2% with ACURATE neo2. Moderate/severe aortic regurgitation and death/stroke rates were also lower with ACURATE neo2.

Conclusions
The minimalist anesthesia strategy was found to be similar in safety and efficacy to the standard approach and was successfully implemented in the majority of patients. ACURATE neo2 appeared superior to Evolut in short-term outcomes, specifically significantly reducing the need for pacemakers.

Commentary
The DOUBLE-CHOICE study demonstrated the safety of a minimalist anesthesia approach in TAVR and that ACURATE neo2 may have superior short-term clinical outcomes. However, the withdrawal of ACURATE neo2 from the market limits the application of these findings to clinical practice. Nevertheless, the data provide important insights into both anesthesia strategies and valve selection for future studies.