A minimalist approach to transcatheter aortic valve implantation (TAVI) using local anesthesia without sedation, was noninferior to the standard approach for the composite primary outcome of cardiovascular events and complications at 30 days, according to results from the DOUBLE-CHOICE Trial presented at ESC Congress 2025. The trial also compared the ACURATE neo2 vs. Evolut Pro/Pro+/Fx self-expanding valves, looking at all-cause mortality, stroke, moderate or severe prosthetic valve regurgitation and permanent pacemaker implantation at 30 days.

DOUBLE-CHOICE, which was conducted at 10 centers in Germany, included patients with severe symptomatic aortic valve stenosis and an indication for TAVI. All patients had anatomy considered suitable for both device types based on heart team consensus. Of the 752 patients in the intention-to-treat anesthesia comparison, the median age was 83 years and roughly 60% were women.

Researchers randomized participants to a minimalist vs. standard approach to anesthesia care (n=752), as well as one of the two valves (n=855). Patients in the minimalist group received isolated local anesthesia with no sedation, central venous lines, additional arterial lines for blood pressure monitoring or urinary catheters. Patients in the standard care group had continuous CO2-monitoring, supplemental oxygen and the use of central venous catheters.

The primary combined endpoint at 30 days occurred in numerically fewer patients receiving minimalist anesthesia, compared with those assigned to standard care (22.9% vs. 25.8%, respectively). According to the study investigators, "in per-protocol and as-treated analyses, the difference in favor of the minimalist approach was more pronounced and statistically significant in the as-treated analysis." They also noted that approximately 19% of patients in the minimalist group crossed over to the standard-care group, primarily due to pain or discomfort.

In terms of device comparison, the primary combined endpoint at 30 days occurred in 15.4% of the patients with ACURATE neo2 valve and 30.4% with Evolut valves. However, ACURATE neo2 valves have since been withdrawn.

"Our results indicate that around 80% of patients can be safely managed with the minimalist approach," said Mohamed Abdel-Wahab, MD, in presenting the findings. "Further analyses may help to better inform in which subgroups the minimalist approach is most or least suitable. Regarding devices, we found that ACURATE neo2 valves were superior to Evolut valves in our trial. […] ACURATE neo2 valves have since been withdrawn, but reductions in pacemaker implantation observed with these devices indicate that aspects of their design could be used to inform future valve development."