Minimalist treatment strategies for transcatheter aortic valve implantation (TAVI) are becoming more common, but have been supported by limited data from large randomised trials.² The DOUBLE-CHOICE trial was designed to evaluate the safety and efficacy of a minimalist approach (MA) using isolated local anaesthesia compared with the standard of care (SoC) with conscious sedation for transfemoral TAVI.¹

This investigator-initiated, 2×2 factorial, open-label, randomised, multicenter, noninferiority trial (DOUBLE-CHOICE) was conducted at 10 sites in Germany. The study enrolled 752 patients with symptomatic aortic stenosis who were undergoing transfemoral TAVI.

The cohort had a median age of 83 years, 58.5% were women, and the median Society of Thoracic Surgeons (STS) risk score was 4.6%. Patients were randomly assigned to either the MA group (n=377), which involved isolated local anaesthesia, or the SoC group (n=375), which used conscious sedation.

The primary endpoint was a 30-day composite of all-cause mortality, vascular and bleeding complications, infection requiring antibiotic therapy, and neurological events. The trial aimed to establish the noninferiority of the MA compared to the SoC.

The trial successfully met its primary endpoint for noninferiority. The composite primary endpoint occurred in 22.9% of patients in the MA group compared to 25.8% in the SoC group (rate difference, 2.9%; P for noninferiority=0.003). There was no significant difference between the groups in terms of superiority (P for difference=0.37).

Notably, patient-reported anxiety and stress levels during the procedure were found to be higher in the MA group compared to the SoC group.

The findings from the DOUBLE-CHOICE trial support the safety and efficacy of a minimalist approach for TAVI. The investigators concluded that the “MA including isolated local anesthesia was noninferior to the SoC with conscious sedation, highlighting the safety and efficacy of the MA for transcatheter aortic valve implantation.”¹

However, they also noted an important consideration for clinical practice, stating that “the burden of intraprocedural pain and discomfort is potentially higher in the MA group.”¹ This suggests that while clinically noninferior in terms of major outcomes, patient experience and comfort may differ between the two anaesthetic strategies.

References

1. Feistritzer HJ, Ender J, Lauten P, et al. Peri-Interventional Anesthesia Strategies for Transcatheter Aortic Valve Implantation: A Multicenter, Randomized, Controlled, Noninferiority Trial. Circulation. 2025;152(22):1526-1537. https://doi.org/10.1161/CIRCULATIONAHA.125.076557

2. Thiele H, Kurz T, Feistritzer HJ, et al; SOLVE-TAVI Investigators. General versus local anesthesia with conscious sedation in transcatheter aortic valve implantation: the randomized SOLVE-TAVI trial. Circulation. 2020;142:1437–1447. https://doi.org/10.1161/CIRCULATIONAHA.120.046451

This study was funded by the Dr Rolf M. Schwiete Foundation and the German Heart Research Foundation.

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