WHY THIS STUDY?

Balloon-expandable (BE) and self-expanding (SE) transcatheter heart valve (THV) have different technical features that may impact on outcomes of patients with raphe-type bicuspid aortic valve (BAV) stenosis undergoing TAVR. To investigate short- and mid-term outcomes of TAVR with current-generation BE-THV versus SE-THV for raphe-type 1 BAV stenosis.

HOW WAS IT EXECUTED?

The AD HOC is an observational, retrospective, multicenter, investigator-driven registry. Consecutive patients with raphe-type 1 BAV stenosis undergoing TAVR with BE-THV or SE-THV at 23 high-volume centers were included. Clinical and echocardiographic outcomes were assessed in-hospital, at 30 days and at the last available follow-up. A 1:1 propensity-score matching (PSM) analysis was performed to account for differences of baseline clinical (age, body mass index, sex, diabetes mellitus, coronary artery disease, atrial fibrillation, chronic obstructive pulmonary disease, Society of Thoracic Surgeons Predicted Risk of Mortality and estimated glomerular filtration rate), echocardiographic (left ventricular ejection fraction, aortic valve area, degree of aortic regurgitation and degree of mitral regurgitation), computed tomography (raphe localization, annulus area, virtual raphe ring perimeter, degree of leaflets, raphe, non-fused cusp and annular/LVOT calcifications) and procedural (THV size ? annular or supra-annular) data. Endpoints were addressed according VARC-3 criteria.

WHAT WERE THE ESSENTIAL RESULTS?

Between the 1st January 2016 and the 30th June 2023, 943 patients were included. PSM resulted in 327 pairs. VARC-3 technical success was similar between BE- and SE-THV (95.7% vs 94.5%; OR 1.30, 95%CI 0.64-2.67; p=0.47). Compared to SE-THV, BE-THV was associated with a higher occurrence of patient-prosthesis mismatch (PPM) (any PPM: 29.9% vs 15.4%, OR 2.34, 95%CI 1.59-3.45, p<0.001; severe PPM: 4.4% vs 0.6%, OR 7.28, 95%CI 1.64-32.28, p=0.009) but with a lower incidence of new permanent pacemaker implantation (9.6% vs 17.7%, OR 0.49, 95%CI 0.31-0.78, p=0.004) and more-than-mild paravalvular regurgitation (0.3% vs 6.1%, OR 0.05, 95%CI 0.01-0.35, p=0.003), both post-procedural and at 30 days. At a median follow-up of 1.26 years, BE-THV had a similar rate of death, stroke/transient ischemic attack, or hospitalization for heart failure compared with SE-THV (VARC-3 clinical efficacy: 85.0% vs 81.9%; HR 0.90, 95%CI 0.61-1.35; p=0.619).

WHY IT IS IMPORTANT?

This is the largest population with stenotic raphe-type 1 BAV treated with current-generation THVs. BE- and SE-THV resulted in a similarly high rate of technical success. BE-THV is associated with a higher occurrence of patient-prosthesis mismatch but with a lower incidence of new pacemaker implantation and more-than-mild paravalvular regurgitation. Mid-term clinical efficacy is encouraging and is comparable between BE- and SE-THV.

PLEASE LIST THE DEVICE(S)/TECHNOLOGY(IES) INVOLVED IN THIS TRIAL

Sapien 3/3Ultra (Edwards Lifesciences) Evolut R/Pro/Pro+ (Medtronic) Portico/Navitor (Abbott) Acurate Neo/Neo2 (Boston Scientific) MyVal (Meril) Venus A plus (Venus Medtech) TaurusOne Valve (Peijia Medical) Prizvalve (Shanghai NewMed Medical Co.)