title: Transfemoral aortic valve implantation with the repositionable Lotus valve compared with the balloon-expandable Edwards Sapien 3 valve.
abstract: BACKGROUND
  The rate of paravalvular aortic insufficiency (AI) with transcatheter aortic valve implantation (TAVI) with first generation devices was higher compared with surgical replacement. Residual AI after TAVI has been linked to an increased mortality rate. We compared two second generation TAVI devices - the repositionable Lotus valve with the balloon-expandable Edwards Sapien 3 valve - regarding procedural and 30 day outcome.
  
  
  RESULTS
  In 78 patients with severe aortic stenosis undergoing transfemoral TAVI we evaluated post-procedural paravalvular AI, device success and early safety according to VARC criteria. Valve size was based on a 256-multislice computed tomography. Patients were followed for 30 days. The Lotus valve (N = 26) and the Edwards Sapien 3 valve (N = 52) were implanted under fluoroscopic guidance. Baseline characteristics were similar between groups. Perimeter derived annulus diameter did not differ with 25.7 ± 1.6mm for Lotus and 25.2 ± 2.1mm for Edwards Sapien 3 patients. After TAVI aortography and transthoracic echocardiography revealed no moderate or severe AI. The rate of mild AI was 12% for Lotus and 15% for Edwards Sapien 3 (p = 0.62). There were no deaths, stroke, annulus rupture or coronary obstruction. Device success was 96% and 98% (p = 0.61), early safety according to VARC 11.5% in both groups (p = 1.0) and the need for pacemaker implantation 27% and 4% (p < 0.003), respectively.
  
  
  CONCLUSIONS
  TAVI with second-generation devices was associated with no moderate or severe AI and a low rate of mild AI. Device success was high for Lotus and Edwards Sapien 3 while the need for permanent pacemaker was significantly higher with the Lotus valve.
authors.affiliation: Dept. of Internal Medicine II - Cardiology, University of Ulm, Ulm, Germany. Electronic address: jochen.woehrle@uniklinik-ulm.de.
authors.forename: Jochen
authors.initials: J
authors.lastname: Wöhrle
authors.affiliation: Dept. of Internal Medicine II - Cardiology, University of Ulm, Ulm, Germany.
authors.forename: Birgid
authors.initials: B
authors.lastname: Gonska
authors.affiliation: Dept. of Internal Medicine II - Cardiology, University of Ulm, Ulm, Germany.
authors.forename: Christoph
authors.initials: C
authors.lastname: Rodewald
authors.affiliation: Dept. of Internal Medicine II - Cardiology, University of Ulm, Ulm, Germany.
authors.forename: Ulrike
authors.initials: U
authors.lastname: Trepte
authors.affiliation: Dept. of Internal Medicine II - Cardiology, University of Ulm, Ulm, Germany.
authors.forename: Sabrina
authors.initials: S
authors.lastname: Koch
authors.affiliation: Dept. of Internal Medicine II - Cardiology, University of Ulm, Ulm, Germany.
authors.forename: Dominik
authors.initials: D
authors.lastname: Scharnbeck
authors.affiliation: Dept. of Internal Medicine II - Cardiology, University of Ulm, Ulm, Germany.
authors.forename: Julia
authors.initials: J
authors.lastname: Seeger
authors.affiliation: Dept. of Internal Medicine II - Cardiology, University of Ulm, Ulm, Germany.
authors.forename: Sinisa
authors.initials: S
authors.lastname: Markovic
authors.affiliation: Dept. of Internal Medicine II - Cardiology, University of Ulm, Ulm, Germany.
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Rottbauer
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001021:Aortic Valve / Q000473:pathology / Q000601:surgery; D001022:Aortic Valve Insufficiency / Q000175:diagnosis / Q000601:surgery*; D001027:Aortography / Q000379:methods; D006328:Cardiac Catheterization / Q000379:methods; D002405:Catheterization, Central Venous / Q000379:methods; D057186:Comparative Effectiveness Research; D004452:Echocardiography / Q000379:methods; D005260:Female; D005268:Femoral Vein / Q000601:surgery; D005858:Germany; D006350:Heart Valve Prosthesis / Q000145:classification / Q000592:standards; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000379:methods; D006801:Humans; D008297:Male; D017063:Outcome Assessment, Health Care; D011183:Postoperative Complications / Q000175:diagnosis / Q000209:etiology; D012720:Severity of Illness Index; D065467:Transcatheter Aortic Valve Replacement / Q000009:adverse effects / Q000379:methods
keywords: Aortic stenosis; Edwards Sapien 3; Lotus; Pacemaker; Transcatheter aortic valve implantation