Impact of commissural alignment on the hemodynamic performance of supra-annular self-expandable transcatheter aortic valves
Authors: Amat-Santos Ignacio J. , Gómez Javier , Pinon Pablo , Nombela-Franco Luis , Moreno Raúl , Munoz-García Antonio J. , Redondo Alfredo , Gómez-Menchero Antonio , Blasco-Turrión Sara , Fernandez Jorge Salgado , Tirado-Conte Gabrsiela , Vera-Vera Silvio , Alonso-Briales Juan H. , Trillo Ramiro , Freire Santiago Camacho , Sánchez-Luna Juan Pablo , Gonzalez-García Jose Carlos , Marengo Giorgio , Aristizabal Christian , Gutiérrez-García Hipólito , Serrador-Frutos Ana , Revilla Ana , Baladrón Carlos , Carrasco-Moraleja Manuel , Gómez-Salvador Itziar , Román J. Alberto San 
Published: May 2023

Background

Impact of commissural alignment (CA) strategies with self-expandable supra-annular transcatheter aortic valves (TAVR) has not been investigated yet.

Methods

Multicentric ambispective study including patients who underwent self-expandable TAVR in 7 centers with the Evolut Pro/Pro+ (EP)(Medtronic, USA) and Acurate neo2 (AN2)(Boston Scientific, USA). Comparison of those with CA attempt vs. those with no CA attempt was performed. The degree of commissural misalignment (CMA) was assessed by computed tomography/angiography and 1-year transvalvular gradients/regurgitation evaluated by echocardiography. A matched comparison according to annular dimensions/eccentricity, prosthesis size/type, and baseline left ventricular function and gradients was performed.

Results

A total of 557 patients, mean age 80.7±6.6 years, 61.4% men, and STS score of 4.3±3.1% were analyzed. A CA technique was attempted in 215 patients (38.6%), including 113 patients with AN2 and 102 patients with EP. None/mild CMA was found in 158 (73.5% vs. 43.6% if no CA attempted, p<0.001) with no differences between devices (AN2:75.2%; EP:71.6%, p=0.545). Patients with moderate/severe CMA had a greater aortic peak gradient (22.3±8.7 vs. 19.7±8.5, p=0.001), significantly greater progression of both peak (p=0.002) and mean gradients (p=0.001) after matching, and higher rate of central aortic regurgitation (1.2% vs. 0.4%, p=0.005) at 1-year, but not a greater proportion of patients with mean gradient ≥10mmHg.

Conclusions

The use of CA strategies significantly reduced the rate of CMA for the self-expandable TAVR devices ACN2 and EP which was associated to lower transvalvular gradients and intra-prosthetic regurgitation progression at 1-year although no criteria of structural deterioration were met at this follow up.Clinicaltrials.org:NCT05097183

CONDENSED ABSTRACT

Commissural alignment (CA) strategies with Evolut Pro and Acurate neo2 TAVR devices were similarly successful in ¾ of the patients, representing a significant increase compared to traditional implantation. Patients with moderate/severe commissural misalignment (CMA) had a significantly greater progression of both peak and mean gradients and higher rate of new central aortic regurgitation at 1-year, but not a greater proportion of patients with mean gradient above 10mmHg. Hence, even at only 1-year of follow up and despite the lack of formal structural deterioration criteria, some hints suggest a more rapid deterioration if moderate/severe CMA is present after supra-annular TAVR.