Madrid, Spain – 29 August 2025: A minimalist approach to transcatheter aortic valve implantation (TAVI), without sedation, was noninferior to the standard approach for the primary outcome at 30 days, according to late-breaking research presented in a Hot Line session today at ESC Congress 2025.1
Used in the treatment of severe aortic stenosis, TAVI has been refined over the years such that these procedures now outnumber surgical aortic valve replacement, with further increases expected due to expanding indications and the ageing population.2
Explaining the two comparisons assessed in the DOUBLE-CHOICE trial, its presenter, Professor Mohamed Abdel-Wahab from the Heart Center Leipzig at Leipzig University, Germany, said: “Minimalist treatment strategies for TAVI – such as using local anaesthesia without sedation – have been widely adopted due to continued procedural evolution. However, large, randomised trials comparing the minimalist approach with the standard of 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, randomised trial conducted at 10 centres in Germany. Included patients 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 the use of central venous catheters, additional arterial lines and urinary catheters was according to local practices.
For the anaesthesia comparison, the primary combined endpoint at 30 days was all-cause mortality, vascular and bleeding complications, infections requiring antibiotic treatment and neurologic events. For the device comparison, the primary combined endpoint at 30 days was all-cause mortality, stroke, moderate or severe prosthetic valve regurgitation and permanent pacemaker implantation.
The 752 patients in the intention-to-treat anaesthesia comparison had a median age of 83 years and almost 60% were women. The primary combined endpoint at 30 days occurred in numerically fewer patients with minimalist vs. standard care: 22.9% vs. 25.8% (rate difference 2.9%, lower boundary of the 1-sided 95% confidence interval [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, mostly due to pain or discomfort. 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.
Across 855 patients in the device comparison, the primary combined endpoint at 30 days 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 in the primary endpoint with ACURATE neo2 valves over Evolut valves was predominantly driven by lower pacemaker implantation (11.2% vs. 26.5%, respectively).
Professor 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 observed with these devices indicate that aspects of their design could be used to inform future valve development.”
ENDS
Notes to editor
Funding: The trial was supported by the Dr. Rolf M. Schwiete Stiftung and the German Heart Research Foundation.
Disclosures: Professor Abdel-Wahab reports that his hospital receives speaker’s honoraria and/or consultancy fees on his behalf from Boston Scientific, Medtronic and Edwards Lifesciences.
References and notes:
1‘DOUBLE-CHOICE: Anaesthesia strategies and self-expanding valve types for TAVI’ presented during HOT LINE 1 on 29 August 2025 at 11:45 to 11:55 in Madrid (Main Auditorium).
2Rosseel L, Mylotte D, Cosyns B, et al. Contemporary European practice in transcatheter aortic valve implantation: results from the 2022 European TAVI Pathway Registry. Front Cardiovasc Med. 2023;10:1227217.
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