title: Initial Single-Center Experience With the Fully Repositionable Transfemoral Lotus Aortic Valve System.
abstract: BACKGROUND
  Transcatheter aortic valve replacement (TAVR) has become the standard therapy for patients with severe symptomatic aortic stenosis and unacceptable high risk for surgical aortic valve replacement. Several different devices for TAVR have been introduced so far, each of them with unique features.
  
  
  OBJECTIVE
  To analyze our first real-world experience with the second- generation, mechanically expanded, fully repositionable transfemoral Lotus TAVR device (Boston Scientific).
  
  
  RESULTS
  Between August 2014 and January 2016, a total of 298 patients were scheduled for transfemoral TAVR at our institution. Among them, 145 patients received a CoreValve/CoreValve Evolut R device (Medtronic), 90 patients received a Sapien 3 device (Edwards Lifesciences), and 63 patients were scheduled for Lotus TAVR device implantation based on access vessel size and annulus diameter. Of the 63 subsequent patients scheduled, 62 were successfully implanted. Short-term Valve Academic Research Consortium (VARC)-2 results at 30 days showed a 6.4% all-cause mortality, a 3.2% major stroke rate, a 36.5% new permanent pacemaker rate and 1.6% major vascular complications. Of note was the near absence of significant residual aortic regurgitation in the presence of a favorable hemodynamic profile even in patients with difficult anatomy.
  
  
  CONCLUSIONS
  Our first real-time experience with the fully repositionable Lotus TAVR system mimics the results of early clinical studies like REPRISE II. Further next-generation modifications in combination with gaining experience with this new device will likely reduce the need for new permanent pacemaker implantation and vascular complications in the future.
authors.forename: Kai-Uwe
authors.initials: KU
authors.lastname: Jarr
authors.forename: Florian
authors.initials: F
authors.lastname: Leuschner
authors.forename: Benjamin
authors.initials: B
authors.lastname: Meder
authors.forename: Hugo A
authors.initials: HA
authors.lastname: Katus
authors.forename: Raffi
authors.initials: R
authors.lastname: Bekeredjian
authors.affiliation: Department of Cardiology, Angiology & Pulmology, Heidelberg University Hospital, Im Neuenheimer Feld 410, 69120 Heidelberg, Germany. e.chorianopoulos@med.uni-heidelberg.de.
authors.forename: Emmanuel
authors.initials: E
authors.lastname: Chorianopoulos
mesh_terms: D000369:Aged, 80 and over; D001021:Aortic Valve / Q000000981:diagnostic imaging / Q000601:surgery*; D001022:Aortic Valve Insufficiency / Q000175:diagnosis / Q000601:surgery*; D001024:Aortic Valve Stenosis / Q000175:diagnosis / Q000601:surgery*; D004452:Echocardiography; D004867:Equipment Design; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D011474:Prosthesis Design; D012189:Retrospective Studies; D065467:Transcatheter Aortic Valve Replacement / Q000295:instrumentation*; D016896:Treatment Outcome; D065506:Vascular Closure Devices