Schweizerischer Nationalfonds zur Förderung der Wissenschaftlichen Forschung, Basel Cardiovascular Research Foundation, and B Braun Medical AG.

Aims Transcatheter aortic valve implantation (TAVI) has emerged as established treatment option in patients with symptomatic aortic stenosis. Technical developments in valve design have addressed previous limitations such as suboptimal deployment, conduction disturbances, and paravalvular leakage. However, there are only limited data available for the comparison of newer generation self-expandable valve (SEV) and balloon-expandable valve (BEV). Methods and results SOLVE-TAVI is a multicentre, open-label, 2 × 2 factorial, randomized trial of 447 patients with aortic stenosis undergoing transfemoral TAVI comparing SEV (Evolut R, Medtronic Inc., Minneapolis, MN, USA) with BEV (Sapien 3, Edwards Lifesciences, Irvine, CA, USA). The primary efficacy composite endpoint of all-cause mortality, stroke, moderate/severe prosthetic valve regurgitation, and permanent pacemaker implantation at 30 days was powered for equivalence (equivalence margin 10% with significance level 0.05). The primary composite endpoint occurred in 28.4% of SEV patients and 26.1% of BEV patients meeting the prespecified criteria of equivalence [rate difference −2.39 (90% confidence interval, CI −9.45 to 4.66); Pequivalence = 0.04]. Event rates for the individual components were as follows: all-cause mortality 3.2% vs. 2.3% [rate difference −0.93 (90% CI −4.78 to 2.92); Pequivalence < 0.001], stroke 0.5% vs. 4.7% [rate difference 4.20 (90% CI 0.12 to 8.27); Pequivalence = 0.003], moderate/severe paravalvular leak 3.4% vs. 1.5% [rate difference −1.89 (90% CI −5.86 to 2.08); Pequivalence = 0.0001], and permanent pacemaker implantation 23.0% vs. 19.2% [rate difference −3.85 (90% CI −10.41 to 2.72) in SEV vs. BEV patients; Pequivalence = 0.06]. Conclusion In patients with aortic stenosis undergoing transfemoral TAVI, newer generation SEV and BEV are equivalent for the primary valve-related efficacy endpoint. These findings support the safe application of these newer generation percutaneous valves in the majority of patients with some specific preferences based on individual valve anatomy.

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Background: In clinical practice, local anesthesia with conscious sedation (CS) is performed in roughly 50% of patients undergoing transcatheter aortic valve replacement (TAVR). However, no randomized data assessing the safety and efficacy of CS versus general anesthesia (GA) are available. Methods: SOLVE-TAVI is a multicenter, open-label, 2x2 factorial, randomized trial of 447 patients with aortic stenosis undergoing transfemoral TAVR comparing CS versus GA. The primary efficacy endpoint 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 endpoint occurred in 27.2% of CS and 26.4% of GA patients (rate difference 0.8 [90%CI -6.2 to 7.8]; P equivalence =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]; P equivalence <0.001), stroke 2.4% versus 2.8% (rate difference -0.4 [90%CI -3.8 to 3.8]; P equivalence <0.001), myocardial infarction 0.5% versus 0.0% (rate difference 0.5 [90%CI -3.0 to 3.9]; P equivalence <0.001), infection requiring antibiotics 21.1% versus 22.0% (rate difference -0.9 [90%CI -7.5 to 5.7]; P equivalence =0.011), acute kidney injury 9.0% versus 9.2% (rate difference - 0.2 [90%CI -5.2 to 4.8]; P equivalence =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 TAVR, use of CS compared with GA resulted in similar outcomes for the primary efficacy endpoint. These findings suggest that CS can be safely applied for TAVR. Clinical Trial Registration: URL: https://clinicaltrials.gov Unique Identifier: NCT02737150

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