Balloon Aortic Valvuloplasty Prior to Self‐Expanding TAVI: The BAVSE‐TAVI Registry

BACKGROUND: Direct transcatheter aortic valve implantation (TAVI) approach is feasible and safe compared to predilatation-TAVI. Certain clinical and computerized tomography (CT)-based characteristics might indicate the need for balloon aortic valvuloplasty (BAV) before TAVI, especially with self-expanding valves. AIMS: We aimed to identify patients who require predilatation before TAVI. METHODS AND RESULTS: We performed a retrospective, single-center study between 2020 and 2024, enrolling 315 patients (predilatation = 158 vs. direct = 157) aged 81 ± 6 years, 43.5% male, with EuroSCORE II of 3.7 ± 2.9. The rate of predilatation increased over the study period and was performed more often in patients with higher velocity and pressure gradients on echocardiography, higher aortic valve calcium score on CT, bicuspid morphology, bigger aortic annulus anatomy, severe aortic cusp calcification, tortuous descending aorta (bend > 60°), and horizontal ascending aorta (angle > 50°). Direct implantation was performed more frequently in patients with permanent pacemaker, ischemic heart disease, concomitant significant aortic regurgitation, or alternative-access TAVI. Regression analysis demonstrated that only the horizontal aorta was an independent predictor of predilatation (p = 0.037). The rates of valve recapture, embolization, contrast use, procedure duration, hospital stay, inpatient death, stroke, significant paravalvular leak on postprocedural echocardiography, and new pacemaker implantation were not different between the groups. The rate of BARC ≥ 3 bleeding, mainly due to access-site complications, was more frequent with direct-TAVI compared to predilatation (6.4% vs. 0.6%; p = 0.005). CONCLUSIONS: Both predilatation and direct-TAVI approaches can be safely performed in routine practice. Upfront selection of either approach based on the patient characteristics, echocardiography gradients, and CT anatomical features is recommended.