title: Repositionable Versus Balloon-Expandable Devices for Transcatheter Aortic Valve Implantation in Patients With Aortic Stenosis.
abstract: The safety and effectiveness of the fully repositionable LOTUS valve system as compared with the balloon-expandable Edwards SAPIEN 3 prosthesis for the treatment of aortic stenosis has not been evaluated to date.
  
  
  
  All patients undergoing transcatheter aortic valve implantation with the Edwards SAPIEN 3 or the LOTUS valve system were included into the Swiss Transcatheter Aortic Valve Implantation Registry. An adjusted analysis was performed to compare the early clinical safety outcome according to the Valve Academic Research Consortium-2 definition. Between February 2014 and September 2015, 140 and 815 patients were treated with the LOTUS and the Edwards SAPIEN 3 valve, respectively. There was no difference in crude and adjusted analyses of the early safety outcome between patients treated with LOTUS (14.3%) and those treated with Edwards SAPIEN 3 (14.6%) (crude hazard ratio, 0.97; 95% CI, 0.61-1.56 [P=0.915]; adjusted hazard ratio, 1.03; 95% CI, 0.64-1.67 [P=0.909]). More than mild aortic regurgitation was <2% for both devices. A total of 34.3% of patients treated with LOTUS and 14.1% of patients treated with Edwards SAPIEN 3 required a permanent pacemaker (HR, 2.76; 95% CI, 1.97-3.87 [P<0.001]).
  
  
  
  The repositionable LOTUS valve system and the balloon-expandable Edwards SAPIEN 3 prosthesis appeared comparable in regard to the Valve Academic Research Consortium-2 early safety outcome, and the rates of more than mild aortic regurgitation were exceedingly low for both devices. The need for new permanent pacemaker implantation was more frequent among patients treated with the LOTUS valve.
authors.affiliation: Department of Cardiology, Swiss Cardiovascular Center, University Hospital, Bern, Switzerland.
authors.forename: Thomas
authors.initials: T
authors.lastname: Pilgrim
authors.affiliation: Department of Cardiology, Swiss Cardiovascular Center, University Hospital, Bern, Switzerland.
authors.forename: Stefan
authors.initials: S
authors.lastname: Stortecky
authors.affiliation: Department of Cardiology and Cardiovascular Surgery, University Hospital Zurich, Zurich, Switzerland.
authors.forename: Fabian
authors.initials: F
authors.lastname: Nietlispach
authors.affiliation: Institute of Social and Preventive Medicine and Clinical Trials Unit, Bern University Hospital, Bern, Switzerland.
authors.forename: Dik
authors.initials: D
authors.lastname: Heg
authors.affiliation: Department of Cardiology, Triemlispital, Zurich, Switzerland.
authors.forename: David
authors.initials: D
authors.lastname: Tueller
authors.affiliation: Department of Cardiology, Kantonsspital, Luzern, Switzerland.
authors.forename: Stefan
authors.initials: S
authors.lastname: Toggweiler
authors.affiliation: Department of Cardiovascular Surgery, University Hospital, Lausanne, Switzerland.|Cardiac Surgery Unit, Cardiocentro Ticino Foundation, Lugano, Switzerland.
authors.forename: Enrico
authors.initials: E
authors.lastname: Ferrari
authors.affiliation: Division of Cardiology, University Hospital, Geneva, Switzerland.
authors.forename: Stéphane
authors.initials: S
authors.lastname: Noble
authors.affiliation: Department of Cardiology and Cardiovascular Surgery, University Hospital Zurich, Zurich, Switzerland.
authors.forename: Francesco
authors.initials: F
authors.lastname: Maisano
authors.affiliation: Department of Cardiology, University Hospital, Basel, Switzerland.
authors.forename: Raban
authors.initials: R
authors.lastname: Jeger
authors.affiliation: Division of Cardiology, University Hospital, Geneva, Switzerland.
authors.forename: Marco
authors.initials: M
authors.lastname: Roffi
authors.affiliation: Department of Cardiovascular Surgery, Hirslanden Klinik, Zurich, Switzerland.
authors.forename: Jürg
authors.initials: J
authors.lastname: Grünenfelder
authors.affiliation: Department of Cardiovascular Surgery, Swiss Cardiovascular Center, University Hospital, Bern, Switzerland.
authors.forename: Christoph
authors.initials: C
authors.lastname: Huber
authors.affiliation: Department of Cardiology, Swiss Cardiovascular Center, University Hospital, Bern, Switzerland peter.wenaweser@insel.ch.|Department of Cardiology, Klinik im Park, Zurich, Switzerland.
authors.forename: Peter
authors.initials: P
authors.lastname: Wenaweser
authors.affiliation: Department of Cardiology, Swiss Cardiovascular Center, University Hospital, Bern, Switzerland.
authors.forename: Stephan
authors.initials: S
authors.lastname: Windecker
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001022:Aortic Valve Insufficiency / Q000453:epidemiology; D001024:Aortic Valve Stenosis / Q000601:surgery*; D015331:Cohort Studies; D005260:Female; D006350:Heart Valve Prosthesis; D006801:Humans; D008297:Male; D011183:Postoperative Complications / Q000453:epidemiology; D016016:Proportional Hazards Models; D011446:Prospective Studies; D011474:Prosthesis Design; D012042:Registries; D013557:Switzerland / Q000453:epidemiology; D065467:Transcatheter Aortic Valve Replacement / Q000295:instrumentation*
keywords: aortic valve regurgitation; newer‐generation devices; permanent pacemaker; transcatheter aortic valve replacement