title: The safety of introducing a new generation TAVR device: one departments experience from introducing a second generation repositionable TAVR.
abstract: In the evolving field of transcatheter aortic valve replacements a new generation of valves have been introduced to clinical practice. With the complexity of the TAVR procedure and the unique aspects of each TAVR device, there is a perceived risk that changing or adding a new valve in a department could lead to a worse outcome for patients, especially during the learning phase. The objective was to study the safety aspect of introducing a second generation repositionable transcatheter valve (Boston Scientific Lotus valve besides Edwards Sapien valve) in a department.
  
  
  
  In a retrospective study, 53 patients receiving the Lotus system, and 47 patients receiving the Sapien system over a period of three years were compared for short-term outcome according to VARC-2 definitions and 1-year survival.
  
  
  
  Outcome in terms VARC-2 criteria for early safety and clinical efficacy, stroke rate, and survival at 30 days and at 1 year were similar. The Lotus valve had less paravalvular leakage, where 90% had none or trace aortic insufficiency as compared to only 48% for the Sapien system.
  
  
  
  Introduction of a new generation valve can be done with early device success and safety, and without jeopardizing the outcome for patients up to one year. We found no adverse effects by changing valve type and observed improved outcome in terms of lower PVL-rates. Both existing and new centers starting a TAVR program can benefit from the use of a new generation device.
authors.affiliation: Department of Cardiothoracic Surgery, and Cardiology, Institute of Clinical Sciences, Lund University, Skane University Hospital, SE-221 85, Lund, Sweden. henrik.bjursten@med.lu.se.
authors.forename: Henrik
authors.identifier: 0000-0001-5428-7455
authors.initials: H
authors.lastname: Bjursten
authors.affiliation: Department of Cardiothoracic Surgery, and Cardiology, Institute of Clinical Sciences, Lund University, Skane University Hospital, SE-221 85, Lund, Sweden.
authors.forename: Shahab
authors.initials: S
authors.lastname: Nozohoor
authors.affiliation: Department of Cardiothoracic Surgery, and Cardiology, Institute of Clinical Sciences, Lund University, Skane University Hospital, SE-221 85, Lund, Sweden.
authors.forename: Malin
authors.initials: M
authors.lastname: Johansson
authors.affiliation: Department of Cardiothoracic Surgery, and Cardiology, Institute of Clinical Sciences, Lund University, Skane University Hospital, SE-221 85, Lund, Sweden.
authors.forename: Igor
authors.initials: I
authors.lastname: Zindovic
authors.affiliation: Department of Cardiothoracic Surgery, and Cardiology, Institute of Clinical Sciences, Lund University, Skane University Hospital, SE-221 85, Lund, Sweden.
authors.forename: Carl-Fredrik
authors.initials: CF
authors.lastname: Appel
authors.affiliation: Department of Cardiothoracic Surgery, and Cardiology, Institute of Clinical Sciences, Lund University, Skane University Hospital, SE-221 85, Lund, Sweden.
authors.forename: Johan
authors.initials: J
authors.lastname: Sjögren
authors.affiliation: Department of Clinical Physiology, and Cardiology, Institute of Clinical Sciences, Lund University, Skane University Hospital, Lund, Sweden.
authors.forename: Magnus
authors.initials: M
authors.lastname: Dencker
authors.affiliation: Department of Cardiothoracic Surgery, and Cardiology, Institute of Clinical Sciences, Lund University, Skane University Hospital, SE-221 85, Lund, Sweden.
authors.forename: Göran
authors.initials: G
authors.lastname: Olivecrona
authors.affiliation: Department of Cardiothoracic Surgery, and Cardiology, Institute of Clinical Sciences, Lund University, Skane University Hospital, SE-221 85, Lund, Sweden.
authors.forename: Jan
authors.initials: J
authors.lastname: Harnek
authors.affiliation: Department of Cardiothoracic Surgery, and Cardiology, Institute of Clinical Sciences, Lund University, Skane University Hospital, SE-221 85, Lund, Sweden.
authors.forename: Sasha
authors.initials: S
authors.lastname: Koul
authors.affiliation: Cardiology Division, Evanston Hospital, Evanston, IL, USA.
authors.forename: Ted
authors.initials: T
authors.lastname: Feldman
authors.affiliation: Houston Methodist DeBakey Heart and Vascular Center, Houston, TX, USA.
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Reardon
authors.affiliation: Department of Cardiothoracic Surgery, and Cardiology, Institute of Clinical Sciences, Lund University, Skane University Hospital, SE-221 85, Lund, Sweden.
authors.forename: Matthias
authors.initials: M
authors.lastname: Götberg
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001021:Aortic Valve / Q000601:surgery; D001024:Aortic Valve Stenosis / Q000175:diagnosis / Q000601:surgery*; D004867:Equipment Design; D005260:Female; D006350:Heart Valve Prosthesis; D006801:Humans; D008297:Male; D011474:Prosthesis Design; D012189:Retrospective Studies; D065467:Transcatheter Aortic Valve Replacement / Q000295:instrumentation*; D016896:Treatment Outcome