Safety and feasibility of transradial aortic valve valvuloplasty (TRAV study)

Abstract

Introduction: The importance of balloon aortic valvuloplasty (BAV) in the transcatheter aortic valve implantation (TAVI) era emerged in the past decades, but the access site related complication rate remained significant. Aim: To establish the safety and technical success of transradial balloon aortic valvuloplasty (trBAV). The secondary objective was to determine the effectiveness and appropriate role of trBAV. Material and methods: Between 2017 and 2019, 36 consecutive patients with symptomatic aortic stenosis (AoS) were treated with trBAV in this prospective, single-center study. During the procedure, the efficacy and the aortic valve insufficiency were controlled by hemodynamic measurements and later by echocardiography. The primary end-points were technical success and major adverse events (MAE). Secondary end-points were the access site complication rate, hemodynamic and clinical result of the intervention, procedure-related factors, crossover rate to the femoral access site and hospitalization duration. Results: Clinical and technical success was achieved in all cases. Invasively measured peak-to-peak gradient decreased from 76.8 ±27.2 to 54.7 ±21.1 mm Hg (p = 0.001), and the aortic-valve area increased from 0.69 ±0.2 to 0.91 ±0.3 cm2 (p = 0.001). No major adverse cardiac or cerebrovascular events or vascular complications (according to VARC 2 criteria) occurred during the procedures. The perioperative death rate was 2.7% (n = 1). Conclusions: According to our study, radial artery access is a safe and effective option for balloon aortic valvuloplasty in patients with severe aortic valve stenosis.