Safety and efficacy of valve repositioning during transcatheter aortic valve replacement with the Lotus Valve System

Abstract

ObjectiveTo determine the safety and efficacy of valve repositioning following transcatheter aortic valve replacement (TAVR) with the Lotus Valve System (Boston Scientific, Marlborough, MA, USA). IntroductionTAVR is a well-established treatment for severe aortic stenosis. The Lotus Valve System is fully repositionable and retrievable. Valve repositioning has the potential to minimize TAVR-related complications caused by valve malposition; however, the effect on adverse event rates such as stroke is unknown. MethodsConsecutive patients with severe aortic stenosis treated with the Lotus Valve System (n=125) were prospectively recruited. Patients who did not require valve repositioning (Group A) were compared to patients who required one or more valve repositions (Group B). The primary end-point was 30-day occurrence of major adverse cardiovascular and cerebrovascular events (MACCE). Secondary end-points included each component of the primary end-point, new pacemaker insertion, and procedural or 30-day major adverse events, defined according to VARC-2 definitions. ResultsValve repositioning was utilized in 60.8% (76/125) of patients including 17.1% (13/76) who required full valve resheathing. The most frequent indications for valve repositioning were altering the depth and angulation of initial implantation (69.7%), reducing paravalvular regurgitation (13.2%), and attempt to correct new or worsened heart block (7.9%). Baseline characteristics were similar in both groups. The primary end-point occurred in 12.2% and 6.6% of Group A and B, respectively (p=0.10). Thirty-day new pacemaker implantation was 34.1% and 18.8% in Group A and B, respectively (p=0.06). The secondary end-point measures were not significantly different between the groups. ConclusionRepositioning facilitated correct anatomical positioning of all devices leading to optimal prosthesis hemodynamics and a trend to lower pacemaker rate without increased risk of MACCE.