Feasibility of Coronary Alignment in TAVI with Balloon-Expandable Valves: Insights from a COMPARE-TAVI 1 Substudy

Background Coronary alignment may be an important prerequisite for redo-TAVI and may be achieved with ballon-expandable valves (BEV) by intentional orientation of neo-commissures during crimping. Aims To evaluate whether coronary alignment is possible during implantation of BEVs and to assess the risk of coronary obstruction limiting the feasibility of redo-TAVI. Methods On post-TAVI CT scans available in 375 patients enrolled in the COMPARE-TAVI 1 study, we assessed coronary alignment defined by neo-commissure-to-coronary-angles and assessed coverage of coronary ostia by the THV frame and valve-to-aorta distance. Patients were randomized to treatment with Sapien 3 (Group A) or Myval (Group B) with random orientation of neo-commissures during valve crimping (Period 1), or Sapien 3 (Group C) or Myval Octacor (Group D)(Period 2), where intentional orientation of neo-commissures during crimping was attempted according to pre-TAVI CT-scan. Results Left main alignment or mild misalignment occurred in 50%, 51%, 47% and 55% of patients in groups A, B, C and D, p=0.33, and right coronary alignment or mild misalignment occurred in 52%, 62%, 54% and 53%, p=0.53. The proportion of patients considered feasible for redo-TAVI defined as a) no coronary coverage by the THV frame, b) coronary coverage but VTA≥2 mm, or c) coronary coverage and VTA<2 mm but coronary alignment optimal or only mild misalignment, was 81%, 78%, 80%, 87% in groups A, B, C and D, p=0.33. Conclusions Crimping BEV neo-commissures at predefined angles did not increase coronary alignment, however, the majority of patients treated with BEVs were still considered eligible for redo-TAVI.