Emerging Evidence Supports Minimalist Technique in Transcatheter Aortic Valve Replacement

Recent research presented at ESC Congress 2025 highlights the viability of a minimalist approach to transcatheter aortic valve implantation (TAVI). This technique, which omits sedation and relies solely on local anesthesia, was found to be noninferior to the conventional approach concerning 30-day outcomes. TAVI is increasingly preferred over surgical valve replacement, especially for patients with severe aortic stenosis, as it has demonstrated significant growth due to expanding indications and an aging population.

The study, named DOUBLE-CHOICE, was a robust, multicenter, randomized trial conducted across ten German centers. It evaluated two key aspects of TAVI: anesthesia methods (minimalist vs. standard) and valve device types (ACURATE neo2 vs. Evolut Pro/Pro+/Fx). Patients eligible for the trial had severe symptomatic aortic stenosis suitable for transfemoral access and were assigned either the minimalist approach—characterized by local anesthesia without sedation, devoid of central venous and urinary catheters—or traditional sedation protocols.

The primary endpoints assessed at 30 days included composite measures such as mortality, vascular complications, bleeding, infections, stroke, and prosthetic valve regurgitation. Results showed a trend favoring the minimalist approach, with a 22.9% event rate compared to 25.8% in the standard care group, demonstrating noninferiority. Notably, around 19% of patients initially in the minimalist group crossed over to standard care due to discomfort, but further analysis confirmed the safety and effectiveness of the minimalist protocol.

Furthermore, device comparison revealed that the ACURATE neo2 valve resulted in fewer adverse events, particularly a lower incidence of pacemaker implantation (11.2% vs. 26.5%), outperforming the Evolut device. This suggests that design features of ACURATE neo2 may inform future valve development.

Lead researcher Professor Mohamed Abdel-Wahab emphasized that about 80% of patients could be safely managed with the minimalist approach, which could simplify procedures, reduce resource utilization, and improve patient comfort. Ongoing analyses are expected to identify specific patient subgroups most suitable for this strategy.

Overall, these findings reinforce the trend towards less invasive TAVI procedures and highlight potential improvements in device design, contributing to better patient outcomes and procedural efficiency.