Hot Line 1: DOUBLE-CHOICE
30 Aug 2025
Hot Line ESC Congress 2025 To sedate or not to sedate during TAVI?
Explaining the two comparisons assessed in the DOUBLE-CHOICE trial, its presenter, Professor Mohamed Abdel-Wahab (Heart Center Leipzig at Leipzig University - Germany), said: “Minimalist treatment strategies for TAVI have been widely adopted due to continued procedural evolution. However, large, randomised trials comparing the minimalist approach with standard care have not been performed. Furthermore, while several head-to-head trials of different TAVI devices have been conducted, comparisons are lacking between different contemporary self-expanding devices in patients with well-defined anatomy.”
DOUBLE-CHOICE was an investigator-initiated, open-label, 2 x 2 factorial, multicentre trial conducted in Germany. Participants had severe symptomatic aortic valve stenosis with an indication for TAVI, their anatomy was considered suitable for both device types based on Heart Team consensus and transfemoral vascular access was deemed feasible. Patients were randomised to a minimalist vs. standard approach to anaesthesia care and to ACURATE neo2 vs. Evolut Pro/Pro+/Fx self-expanding valves. Patients who received the minimalist approach had isolated local anaesthesia only with no sedation, central venous lines, additional arterial lines for blood pressure monitoring or urinary catheters. In the standard anaesthesia group, patients were sedated with continuous CO2-monitoring, supplemental oxygen and catheters, arterial lines etc. according to local practices.
The 752 patients in the intention-to-treat anaesthesia comparison had a median age of 83 years and almost 60% were women. The primary endpoint was all-cause mortality, vascular and bleeding complications, infections requiring antibiotic treatment and neurologic events at 30 days.
The minimalist approach was noninferior to standard care.
The incidence of the primary endpoint was numerically lower with minimalist vs. standard care: 22.9% vs. 25.8% (rate difference 2.9%, lower boundary of the 1-sided 95% CI –2.4%, p for non-inferiority=0.003; 2-sided 95% CI –3.4 to 9.3, p for difference=0.37, p for superiority=0.18). Around 19% of patients crossed over to the standard-care group. In per-protocol and as-treated analyses, the difference in favour of the minimalist approach was more pronounced and statistically significant in the as-treated analysis.
In the device comparison, the primary endpoint was all-cause mortality, stroke, moderate or severe prosthetic valve regurgitation and permanent pacemaker implantation at 30 days. It occurred in 15.4% of patients with ACURATE neo2 valve and 30.4% with Evolut valves (rate difference 15.0%, lower boundary of the 1-sided 95% CI 10.1%, p for non-inferiority<0.001; 2-sided 95% CI 9.1 to 20.7, p for difference<0.001). The difference was predominantly driven by lower pacemaker implantation (11.2% vs. 26.5%, respectively).
Prof. Abdel-Wahab concluded: “Our results indicate that around 80% of patients can be safely managed with the minimalist approach. 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, which was conducted by highly experienced operators with careful patient selection. ACURATE neo2 valves have since been withdrawn, but reductions in pacemaker implantation indicate that aspects of their design could be used to inform future valve development.”
