title: Safety and efficacy of valve repositioning during transcatheter aortic valve replacement with the Lotus Valve System.
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).
  
  
  BACKGROUND
  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.
  
  
  CONCLUSIONS
  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.affiliation: MonashHEART, Monash Health, Melbourne, Victoria, Australia; Monash Cardiovascular Research Centre, Monash University, Melbourne, Victoria, Australia.
authors.forename: Hashrul N Z
authors.initials: HNZ
authors.lastname: Rashid
authors.affiliation: MonashHEART, Monash Health, Melbourne, Victoria, Australia; Monash Cardiovascular Research Centre, Monash University, Melbourne, Victoria, Australia.
authors.forename: Robert
authors.initials: R
authors.lastname: Gooley
authors.affiliation: MonashHEART, Monash Health, Melbourne, Victoria, Australia.
authors.forename: Liam
authors.initials: L
authors.lastname: McCormick
authors.affiliation: MonashHEART, Monash Health, Melbourne, Victoria, Australia; Monash Cardiovascular Research Centre, Monash University, Melbourne, Victoria, Australia.
authors.forename: Sarah
authors.initials: S
authors.lastname: Zaman
authors.affiliation: MonashHEART, Monash Health, Melbourne, Victoria, Australia.
authors.forename: Satish
authors.initials: S
authors.lastname: Ramkumar
authors.affiliation: MonashHEART, Monash Health, Melbourne, Victoria, Australia.
authors.forename: Damon
authors.initials: D
authors.lastname: Jackson
authors.affiliation: MonashHEART, Monash Health, Melbourne, Victoria, Australia.
authors.forename: Ameera
authors.initials: A
authors.lastname: Amiruddin
authors.affiliation: MonashHEART, Monash Health, Melbourne, Victoria, Australia; Monash Cardiovascular Research Centre, Monash University, Melbourne, Victoria, Australia.
authors.forename: Arthur
authors.initials: A
authors.lastname: Nasis
authors.affiliation: MonashHEART, Monash Health, Melbourne, Victoria, Australia; Monash Cardiovascular Research Centre, Monash University, Melbourne, Victoria, Australia.
authors.forename: James
authors.initials: J
authors.lastname: Cameron
authors.affiliation: MonashHEART, Monash Health, Melbourne, Victoria, Australia; Monash Cardiovascular Research Centre, Monash University, Melbourne, Victoria, Australia. Electronic address: ian.meredith@myheart.id.au.
authors.forename: Ian T
authors.initials: IT
authors.lastname: Meredith
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001021:Aortic Valve / Q000601:surgery; D001024:Aortic Valve Stenosis / Q000601:surgery*; D005260:Female; D006350:Heart Valve Prosthesis; D006439:Hemodynamics; D006801:Humans; D008297:Male; D010138:Pacemaker, Artificial; D020521:Stroke / Q000209:etiology; D013997:Time Factors; D065467:Transcatheter Aortic Valve Replacement / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods; D016896:Treatment Outcome
keywords: Aortic stenosis; Lotus valve; Transcatheter aortic valve; Transcatheter aortic valve replacement