Safety and feasibility of balloon aortic valvuloplasty in non-TAVI centers: The "BAV for life" experience.

Abstract

To evaluate the safety and the feasibility of balloon aortic valvuloplasty (BAV) procedure made by trained operators in centers not performing transcatheter aortic valve implantation (TAVI). BAV is a valuable therapeutic tool for patients with symptomatic severe aortic valve stenosis (AS) at prohibitive risk for TAVI or surgery. Consecutive high-risk AS patients underwent BAV in five non-TAVI centers, where BAV operators had completed a 6-month training period in high-volume TAVI centers (Group A). All clinical, echocardiographic, and procedural data were prospectively collected and compared with data of patients treated in TAVI center (Group B). Between June 2016 and June 2017, 55 patients (83.9 ± 7.0 years) were enrolled: 25 in Group A and 30 in Group B. After BAV, a substantial reduction of the peak-to-peak aortic valve gradient was obtained in both groups (-35.3 ± 15.2 vs -28.8 ± 13.9 mmHg, P =0.25). No major bleeding or vascular complications occurred. In-hospital death was observed in three patients of Group A and two patients of Group B (P =0.493). The mean follow-up time was 303 ± 188 days; no patients were lost. The 1-year survival free from overall death (Group A 75.8% vs Group B 68.8%; P =0.682) and heart failure rehospitalization (Group A 73.0% vs Group B 66.8%; P =0.687) was similar in the two groups. At multivariable analysis, low left ventricular (LV) ejection fraction (HR: 0.943; P = 0.011) and cardiogenic shock (HR: 5.128; P = 0.002) at admission were independent predictors of mortality. BAV is a safe and effective procedure that can be performed by trained operators in centers not performing TAVI.