Differences in Frame Geometry Between Balloon-expandable and Self-expanding Transcatheter Heart Valves and Association With Aortic Regurgitation.

ABSTRACT

INTRODUCTION AND OBJECTIVES: Patient- and procedure-related factors are known to be associated with aortic regurgitation after transcatheter aortic valve implantation. Nevertheless, this entity may also be caused by a specific device-host interaction due to the biomechanical properties of the valves, independently of clinical factors. We sought to elucidate the role of frame geometry in the occurrence of aortic regurgitation after Medtronic CoreValve and Edwards SAPIEN valve implantation. METHODS: We conducted an observational study encompassing 134 patients undergoing transcatheter aortic valve implantation with the Medtronic CoreValve and Edwards SAPIEN valve. Frame analysis was performed at 3 predefined levels of both valves by rotational angiography using dedicated motion compensation software. A distinction was made between patients with no-to-mild and moderate-to-severe aortic regurgitation by echocardiography. RESULTS: Baseline characteristics were similar between the 2 valves. Despite greater use of predilation in the CoreValve (95.2% vs 82.0%; P=.012), more oversizing (perimeter, 114±7% vs 103±7%; P<.001), and the same depth of implantation (noncoronary sinus, 7±4 vs 8±2mm; left coronary sinus, 8±4 vs 8±2mm), it was less expanded and more eccentric than the Edwards SAPIEN (83±7% vs 92±4%; P<.001 and 82±8% vs 95±3%; P<.001, respectively) and when eccentricity was adjusted for the patient's annulus eccentricity (4±13% vs 21±11%; P<.001). Eccentricity and adjusted eccentricity were associated with moderate-to-severe aortic regurgitation. CONCLUSIONS: Independently of patient- and procedure-related factors, there is a device-specific device-host interaction that explains aortic regurgitation after transcatheter aortic valve implantation.