Highlight
The DOUBLE-CHOICE trial compared isolated local anesthesia (minimalist approach, MA) with conscious sedation (standard of care, SoC) in transfemoral transcatheter aortic valve implantation (TAVI).
MA was found to be non-inferior to SoC for a composite safety endpoint including mortality, vascular and bleeding complications, infections, and neurologic events at 30 days.
Patients receiving MA reported higher procedural anxiety and stress, suggesting a trade-off between safety/effectiveness and patient comfort.
Study Background and Disease Burden
Aortic stenosis (AS) is a common and life-threatening valvular heart disease in elderly populations, causing significant morbidity and mortality. Transcatheter aortic valve implantation (TAVI) has emerged as an effective, less invasive treatment alternative to surgical valve replacement, especially suited for patients at intermediate or high surgical risk.
With advances in procedural techniques and devices, minimalist strategies for peri-interventional management aimed at reducing invasiveness, procedural time, and resource utilization have gained traction in TAVI practice. Anesthesia and sedation approaches have evolved from general anesthesia to conscious sedation, and more recently to isolated local anesthesia, to enhance patient recovery and reduce complications.
Despite widespread adoption of minimalist anesthesia strategies for TAVI, robust evidence from large randomized controlled trials comparing isolated local anesthesia to conscious sedation was lacking. The DOUBLE-CHOICE trial was designed to fill this evidence gap by investigating the safety and efficacy of these two anesthesia strategies in transfemoral TAVI.
Study Design
This investigator-initiated, open-label, randomized, controlled, 2×2 factorial, multicenter, non-inferiority trial enrolled 752 patients with symptomatic aortic stenosis across 10 German sites between July 2022 and January 2025.
Eligible patients undergoing transfemoral TAVI were randomized to minimalist anesthesia (isolated local anesthesia at the access site) or standard care (conscious sedation). The primary endpoint was a composite of all-cause mortality, vascular and bleeding complications, infections requiring antibiotics, and neurologic events within 30 days post-procedure.
Non-inferiority was assessed in the intention-to-treat population with a prespecified absolute non-inferiority margin of -6% and a one-sided alpha of 0.05.
Key inclusion criteria included symptomatic severe AS; exclusion criteria were not detailed in the summary but typically include contra-indications to TAVI or anesthesia strategies.
Key Findings
A total of 752 patients (377 MA, 375 SoC) were randomized. The median age was 83 years, with 58.5% female participants and a median STS risk score of 4.6%, indicating an intermediate surgical risk cohort.
The primary composite endpoint occurred in 22.9% of the MA group and 25.8% of the SoC group, resulting in a rate difference of 2.9%. The lower boundary of the one-sided 95% confidence interval was -2.4%, meeting the criterion for non-inferiority with a p-value of 0.003. The difference was not statistically significant for superiority (p=0.37), indicating comparable safety profiles between the two anesthesia approaches.
Secondary safety endpoints such as individual components of the primary endpoint (mortality, vascular/bleeding complications, infections, neurologic events) showed no significant differences, supporting the comparable efficacy and safety of MA.
Importantly, patient-reported anxiety and intraprocedural stress levels were higher in the MA group, highlighting potentially greater discomfort with isolated local anesthesia versus conscious sedation. This suggests a trade-off between minimizing anesthesia and patient experience.
No excess adverse events related to localized anesthesia were reported, confirming its feasibility in routine clinical practice.
Expert Commentary
The DOUBLE-CHOICE trial makes a significant contribution by providing randomized evidence supporting the safety of a minimalist anesthesia strategy in TAVI.
This aligns with recent trends favoring streamlined TAVI pathways aimed at reducing procedure complexity, resource consumption, and hospital stay.
However, the increased anxiety and discomfort signals raise important considerations regarding patient selection and peri-procedural support. Management strategies such as anxiolytic premedication or enhanced patient counseling might mitigate these issues.
While the trial was conducted at high-volume German centers with experienced operators, generalizability to lower volume settings and other healthcare systems may require cautious interpretation.
The open-label design and the inability to blind patients or caregivers to anesthesia strategy are intrinsic limitations but unlikely to affect hard clinical endpoints.
Future research should explore tailored anesthesia approaches balancing patient comfort with procedural efficiency and safety and evaluate quality-of-life outcomes, long-term durability of minimalist approaches, and cost-effectiveness analyses.
Conclusion
The DOUBLE-CHOICE trial establishes that isolated local anesthesia is a safe, effective minimalist anesthesia strategy that is non-inferior to conscious sedation for transfemoral TAVI in intermediate-risk elderly patients.
While it offers procedural advantages, clinicians should be mindful of the trade-off with increased patient intraprocedural anxiety and tailor peri-interventional care accordingly.
This evidence supports wider adoption of minimalist anesthesia protocols in well-selected TAVI populations, offering a foundation for protocol standardization and optimization to improve patient outcomes and procedural efficiency.
References
Feistritzer HJ, Ender J, Lauten P, et al. Peri-interventional Anesthesia Strategies for Transcatheter Aortic Valve Implantation: A Multicenter, Randomized, Controlled, Non-inferiority Trial. Circulation. 2025 Aug 29. doi: 10.1161/CIRCULATIONAHA.125.076557. Epub ahead of print. PMID: 40878766.
Leon MB, Smith CR, Mack M, et al. Transcatheter Aortic-Valve Implantation for Aortic Stenosis in Patients Who Cannot Undergo Surgery. N Engl J Med. 2010;363(17):1597–1607.
Thiele H, Kurz T, Feistritzer HJ. Minimalistic TAVI in 2020: Where do we stand? EuroIntervention. 2020;16(7):544-547.