Abstract 11735: Periprocedural Cerebral Ischemic Events With TAVI Performed Without Prior Balloon Dilatation of the Aortic Valve: A Randomized Prospective Study

Abstract

Introduction: Balloon aortic valvuloplasty (BAV) is considered as an essential part of Transcatheter Aortic Valve Implantation (TAVI) procedure, but cerebral embolization may occur during this step. Hypothesis: We assessed the hypothesis that TAVI performed without prior BAV may be associated with decrease of risk of periprocedural cerebral ischemia assessed using diffusion-weighted (DW) magnetic resonance imaging (MRI). Methods: In this prospective monocentric study we randomized consecutive patients who underwent TAVI with the new generation balloon expandable SAPIEN 3 prosthesis. Group 1 (n=14) included patients with BAV performed prior implantation of the prosthesis and group 2 (n=14) patients with direct implantation of the valve. Periprocedural cerebral ischemia was assessed blindly by neurological testing and serial cerebral DW MRI at baseline and within 3 days after TAVI. Results: On the 28 patients included, mean age was 83 years (78-86),18 were of female gender (64.3%) and mean logistic Euroscore II was 8.4 (6.3-10.6) without significant differences between the 2 groups. Implantation of the valve was successful in all patients. Considering the total population, preexisting silent ischemic brain abnormalities were observed in 11 patients (39.3%) and microbleeds in 14 patients (50 %). New foci of restricted diffusion, mainly lacunar, and new microbleeds were found on cerebral DW MRI in respectively 13 (46.4%) and 6 (21%) patients after the procedure without significant difference between the 2 groups (table 1). There were neither apparent impairments of neurocognitive function or neurological events during the in-hospital stay in the 2 groups. In conclusion: Direct implantation of new generation balloon expandable prosthesis appears feasible but is not associated with reduction of periprocedural ischemic cerebral events . These results argue for embolization occurring during positioning of the valve rather than during balloon valvuloplasty.