Hashrul N Z Rashid1, Robert Gooley1, Liam McCormick2, Sarah Zaman1, Satish Ramkumar2, Damon Jackson2, Ameera Amiruddin2, Arthur Nasis1, James Cameron1, Ian T Meredith3. 1. MonashHEART, Monash Health, Melbourne, Victoria, Australia; Monash Cardiovascular Research Centre, Monash University, Melbourne, Victoria, Australia. 2. MonashHEART, Monash Health, Melbourne, Victoria, Australia. 3. MonashHEART, Monash Health, Melbourne, Victoria, Australia; Monash Cardiovascular Research Centre, Monash University, Melbourne, Victoria, Australia. Electronic address: ian.meredith@myheart.id.au.
Abstract
OBJECTIVE: To determine the safety and efficacy of valve repositioning following transcatheter aortic valve replacement (TAVR) with the Lotus Valve System (Boston Scientific, Marlborough, MA, USA). INTRODUCTION: TAVR 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. METHODS: Consecutive 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. RESULTS: Valve 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. CONCLUSION: Repositioning facilitated correct anatomical positioning of all devices leading to optimal prosthesis hemodynamics and a trend to lower pacemaker rate without increased risk of MACCE.
OBJECTIVE: To determine the safety and efficacy of valve repositioning following transcatheter aortic valve replacement (TAVR) with the Lotus Valve System (Boston Scientific, Marlborough, MA, USA). INTRODUCTION: TAVR 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. METHODS: Consecutive 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. RESULTS: Valve 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. CONCLUSION: Repositioning facilitated correct anatomical positioning of all devices leading to optimal prosthesis hemodynamics and a trend to lower pacemaker rate without increased risk of MACCE.
Authors: Francesco Moroni; Lorenzo Azzalini; Lars Sondergaard; Guilherme F Attizzani; Santiago García; Hani Jneid; Mamas A Mamas; Rodrigo Bagur Journal: J Am Heart Assoc Date: 2022-06-14 Impact factor: 6.106