title: Comparison of transcatheter aortic valve implantation with the newest-generation Sapien 3 vs. Direct Flow Medical valve in a single center cohort.
abstract: BACKGROUND
  The latest generation transcatheter heart valves including Edwards Sapien 3 (ES3) and Direct Flow Medical (DFM) were designed to allow precise implantation at the intended position and to minimize prosthesis dysfunction as well as procedural complications. Our aim was to compare short-term functional and clinical outcomes of these 2 transcatheter aortic valve systems.
  
  
  METHODS
  Of 174 patients undergoing transfemoral transcatheter aortic valve implantation (TAVI) at our institution between August 2013 and June 2015, 113 were treated with ES3 and 61 with DFM. Device success, residual aortic regurgitation and early safety endpoints were defined according to the updated VARC-2 criteria and prespecified as primary endpoints.
  
  
  RESULTS
  Patients treated with ES3 had a significantly higher rate of procedural success (ES3 94% vs. DFM 79%, p=0.005), mainly driven by lower postprocedural gradients (ES3 8.6±0.5mmHg vs. DFM 14.6±1.4mmHg by invasive recordings; p=0.00012) and no incidence of more than mild aortic regurgitation. The occurrence of safety endpoints at 30days was low and comparable in the DFM vs. ES3 group (ES3 88% vs. DFM 95% of patients without endpoints, p=0.26). No significant differences were observed in 30day mortality, stroke or the incidence of new permanent pacemaker implantation.
  
  
  CONCLUSIONS
  These single-center experience data show a higher rate of device success for ES3 treated patients, while 30day safety outcome was similar in both groups. Long-term follow-up and larger scale multicenter experience will have to assess possible effects of these observations on long-term clinical outcomes.
authors.affiliation: Department of Cardiology 1, Universitätsmedizin Mainz, Germany. Electronic address: eberhard.schulz@unimedizin-mainz.de.
authors.forename: Eberhard
authors.initials: E
authors.lastname: Schulz
authors.affiliation: Department of Cardiology 1, Universitätsmedizin Mainz, Germany; Department of Cardiology, Klinikum Frankfurt Höchst, Frankfurt am Main, Germany.
authors.forename: Alexander
authors.initials: A
authors.lastname: Jabs
authors.affiliation: Department of Cardiology 1, Universitätsmedizin Mainz, Germany.
authors.forename: Alexander
authors.initials: A
authors.lastname: Tamm
authors.affiliation: Department of Cardiology 1, Universitätsmedizin Mainz, Germany.
authors.forename: Patrick
authors.initials: P
authors.lastname: Herz
authors.affiliation: Department of Cardiology 1, Universitätsmedizin Mainz, Germany.
authors.forename: Andreas
authors.initials: A
authors.lastname: Schulz
authors.affiliation: Department of Cardiology 1, Universitätsmedizin Mainz, Germany.
authors.forename: Tommaso
authors.initials: T
authors.lastname: Gori
authors.affiliation: Department of Cardiology 1, Universitätsmedizin Mainz, Germany.
authors.forename: Stephan
authors.initials: S
authors.lastname: von Bardeleben
authors.affiliation: Department of Cardiovascular and Thoracic Surgery, Universitätsmedizin Mainz, Germany.
authors.forename: Walter
authors.initials: W
authors.lastname: Kasper-König
authors.affiliation: Department of Cardiology 1, Universitätsmedizin Mainz, Germany; Department of Cardiology, Klinikum Frankfurt Höchst, Frankfurt am Main, Germany.
authors.forename: Ulrich
authors.initials: U
authors.lastname: Hink
authors.affiliation: Department of Cardiovascular and Thoracic Surgery, Universitätsmedizin Mainz, Germany.
authors.forename: Christian-Friedrich
authors.initials: CF
authors.lastname: Vahl
authors.affiliation: Department of Cardiology 1, Universitätsmedizin Mainz, Germany.
authors.forename: Thomas
authors.initials: T
authors.lastname: Münzel
mesh_terms: D000369:Aged, 80 and over; D001021:Aortic Valve / Q000601:surgery*; D001022:Aortic Valve Insufficiency / Q000453:epidemiology / Q000209:etiology; D001024:Aortic Valve Stenosis / Q000175:diagnosis / Q000601:surgery*; D019560:Echocardiography, Three-Dimensional; D017548:Echocardiography, Transesophageal; D004562:Electrocardiography; D005260:Female; D005500:Follow-Up Studies; D005858:Germany / Q000453:epidemiology; D006350:Heart Valve Prosthesis; D006801:Humans; D015994:Incidence; D008297:Male; D061330:Multidetector Computed Tomography; D011183:Postoperative Complications / Q000453:epidemiology / Q000209:etiology; D011474:Prosthesis Design; D012189:Retrospective Studies; D013997:Time Factors; D065467:Transcatheter Aortic Valve Replacement / Q000379:methods*; D016896:Treatment Outcome
keywords: 30day safety outcome; Aortic valve stenosis; Device success; Direct Flow Medical®; Edwards Sapien 3®; Transcatheter aortic valve implantation