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Randomized Controlled Trial
. 2020 Oct 13;142(15):1437-1447.
doi: 10.1161/CIRCULATIONAHA.120.046451. Epub 2020 Aug 21.

General Versus Local Anesthesia With Conscious Sedation in Transcatheter Aortic Valve Implantation: The Randomized SOLVE-TAVI Trial

Holger Thiele  1   2 , Thomas Kurz  3   4 , Hans-Josef Feistritzer  1   2 , Georg Stachel  1   2 , Philipp Hartung  1   2 , Philipp Lurz  1   2 , Ingo Eitel  3   4 , Christoph Marquetand  3   4 , Holger Nef  5 , Oliver Doerr  5 , Ursula Vigelius-Rauch  5 , Alexander Lauten  4   6 , Ulf Landmesser  4   6 , Sascha Treskatsch  6 , Mohamed Abdel-Wahab  1   2 , Marcus Sandri  1 , David Holzhey  1   2 , Michael Borger  1   2 , Jörg Ender  1   2 , Hüseyin Ince  7 , Alper Öner  7 , Roza Meyer-Saraei  3   4 , Rainer Hambrecht  8 , Andreas Fach  8 , Thomas Augenstein  8 , Norbert Frey  4   9 , Inke R König  4   10 , Reinhard Vonthein  10 , Yvonne Rückert  2 , Anne-Kathrin Funkat  2 , Steffen Desch  1   2   4 , Astrid E Berggreen  3 , Matthias Heringlake  3 , Suzanne de Waha-Thiele  3   4 ; SOLVE-TAVI Investigators
Affiliations
Randomized Controlled Trial

General Versus Local Anesthesia With Conscious Sedation in Transcatheter Aortic Valve Implantation: The Randomized SOLVE-TAVI Trial

Holger Thiele et al. Circulation. .

Abstract

Background: In clinical practice, local anesthesia with conscious sedation (CS) is performed in roughly 50% of patients undergoing transcatheter aortic valve replacement. However, no randomized data assessing the safety and efficacy of CS versus general anesthesia (GA) are available.

Methods: The SOLVE-TAVI (Comparison of Second-Generation Self-Expandable Versus Balloon-Expandable Valves and General Versus Local Anesthesia in Transcatheter Aortic Valve Implantation) trial is a multicenter, open-label, 2×2 factorial, randomized trial of 447 patients with aortic stenosis undergoing transfemoral transcatheter aortic valve replacement comparing CS versus GA. The primary efficacy end point was powered for equivalence (equivalence margin 10% with significance level 0.05) and consisted of the composite of all-cause mortality, stroke, myocardial infarction, infection requiring antibiotic treatment, and acute kidney injury at 30 days.

Results: The primary composite end point occurred in 27.2% of CS and 26.4% of GA patients (rate difference, 0.8 [90% CI, -6.2 to 7.8]; Pequivalence=0.015). Event rates for the individual components were as follows: all-cause mortality, 3.2% versus 2.3% (rate difference, 1.0 [90% CI, -2.9 to 4.8]; Pequivalence<0.001); stroke, 2.4% versus 2.8% (rate difference, -0.4 [90% CI, -3.8 to 3.8]; Pequivalence<0.001); myocardial infarction, 0.5% versus 0.0% (rate difference, 0.5 [90% CI, -3.0 to 3.9]; Pequivalence<0.001), infection requiring antibiotics 21.1% versus 22.0% (rate difference, -0.9 [90% CI, -7.5 to 5.7]; Pequivalence=0.011); acute kidney injury, 9.0% versus 9.2% (rate difference, -0.2 [90% CI, -5.2 to 4.8]; Pequivalence=0.0005). There was a lower need for inotropes or vasopressors with CS (62.8%) versus GA (97.3%; rate difference, -34.4 [90% CI, -41.0 to -27.8]).

Conclusions: Among patients with aortic stenosis undergoing transfemoral transcatheter aortic valve replacement, use of CS compared with GA resulted in similar outcomes for the primary efficacy end point. These findings suggest that CS can be safely applied for transcatheter aortic valve replacement. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02737150.

Keywords: anesthesia; aortic valve stenosis; transcatheter aortic valve implantation; transcatheter aortic valve replacement.

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