Impact of commissural alignment on the hemodynamic performance of supra-annular self-expandable transcatheter aortic valves

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][1] ### Competing Interest Statement The authors have declared no competing interest. ### Funding Statement This investigation received funding resources from the Sociedad Española de Cardiología (SEC) with the grant number: SEC/FEC-INV-CLI 21/023, a FIS grant Nr PI21/01188 (Instituto de Salud Carlos III, Madrid, Spain), and from Gerencia Regional de Salud de Castilla y León (GRS 2455/A/21) ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: CEIM Valladolid Este (Spain) I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes Data are available for other investigators for further research under request. [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT05097183&atom=%2Fmedrxiv%2Fearly%2F2023%2F05%2F28%2F2023.05.23.23290422.atom