Peri-Interventional Anesthesia Strategies for Transcatheter Aortic Valve Implantation: A Multicenter, Randomized,...

Area of Science:

• Cardiology
• Interventional Cardiology
• Medical Devices

Background:

• Minimalist treatment strategies (MA) for transcatheter aortic valve implantation (TAVI) are increasingly adopted.
• Large randomized trials evaluating MA versus standard of care (SoC) are limited.
• The DOUBLE-CHOICE trial addresses this gap by comparing MA with SoC for transfemoral TAVI.

Purpose of the Study:

• To evaluate the safety and efficacy of a minimalist approach (MA) compared to standard of care (SoC) for transfemoral TAVI.
• To determine if MA is non-inferior to SoC based on a composite primary endpoint.
• To assess patient-reported outcomes related to anxiety and stress during the procedure.

Main Methods:

• An investigator-initiated, 2x2 factorial, open-label, randomized, multicenter, non-inferiority trial.
• 752 patients with symptomatic aortic stenosis were randomized to either MA (local anesthesia) or SoC (conscious sedation).
• The primary endpoint was a composite of mortality, vascular/bleeding complications, infections, and neurologic events at 30 days.

Main Results:

• MA was found to be non-inferior to SoC (22.9% vs. 25.8% event rates; p=0.003 for non-inferiority).
• The rate difference was 2.9% with a 95% CI of -3.4% to 9.3% (p=0.37 for difference).
• Patients in the MA group reported higher levels of intraprocedural anxiety and stress.

Conclusions:

• Minimalist approach (MA) with isolated local anesthesia is a safe and effective alternative to standard of care (SoC) for TAVI.
• MA demonstrates non-inferiority to SoC in terms of major adverse events.
• Increased patient discomfort and anxiety are potential drawbacks of the MA strategy.