SOLVE-TAVI after 12-month followup: self-expanding vs. balloon expandable and general vs. local anesthesia

The ambitious SOLVE-TAVI (soon to be published in JACC) is aimed at answering to of the most important questions we make when facing a TAVR procedure: What valve do we choose, a self-expanding or a balloon expandable? And once we have chosen our device, do we proceed with general anesthesia or conscious sedation? 

The SOLVE-TAVI had already shown no major differences at 30 days between devices or sedation strategies. At present, after one year, we look forward to these results. 

Using a 2 × 2 factorial design, 447 intermediate to high-risk patients with severe, symptomatic aortic stenosis were randomly assigned to transfemoral TAVR using the self-expanding Evolut R vs. the balloon expandable Sapien 3.  Following the 2 x 2 design, patients were randomized to general anesthesia vs. conscious sedation at the same time. 

When comparing devices, the combined end point rate (all-cause mortality, stroke, moderate to severe paravalvular leak and need of permanent pacemaker implantation) resulted similar between prosthesis at one year (38.3% vs 40.4%, HR 0.94, CI 95% 0.7 to 1.26; p=0.66).

As regards sedation, outcomes were as disappointing: general anesthesia resulted similar to conscious sedation when it came to the combined end point of all-cause mortality, stroke, MI and acute kidney injury (25.7% vs 23.8%, HR 1.09, CI 95% 0.76 to 1.57; p=0.63).

Read also: TCT 2018 | SOLVE-TAVI: Self-Expandable vs. Balloon-Expandable Valves and General vs. Local Anesthesia in One Study.

Probablemente, para la enorme mayoría de los pacientes la elección de la válvula o el tipo de anestesia todavía pase por la experiencia de cada operador y equipo. Sin embargo, existen diferencias sutiles de subgrupos que pueden inclinar la balanza hacia una u otra válvula como también al tipo de anestesia.

Conclusión

En pacientes de riesgo intermedio o alto que reciben TAVI transfemoral no se observaron diferencias al año entre las actuales generaciones de la válvula autoexpandible y la válvula balón expandible. Los tipos de anestesia tampoco mostraron diferencias significativas en el mismo período de tiempo.

Título original: Impact of Anesthesia Strategy and Valve Type on Clinical Outcomes After Transcatheter Aortic Valve Replacement.

Referencia: Hans-Josef Feistritzer et al. J Am Coll Cardiol. 2021 May, 77 (17) 2204–2215.

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