title: Impact of suture mediated femoral access site closure with the Prostar XL compared to the ProGlide system on outcome in transfemoral aortic valve implantation.
abstract: BACKGROUND
  Management of femoral access site is an important issue in transfemoral transcatheter aortic valve implantation (TAVI) and crucial for acute and long-term outcome. Data on vascular closure devices in this setting are limited. We evaluated safety and efficacy of the Prostar XL compared to the ProGlide suture-based vascular closure device.
  
  
  RESULTS
  We enrolled 585 patients undergoing percutaneous transfemoral transcatheter aortic valve implantation (TAVI). Outcomes were defined according to Valve academic research consortium (VARC)-2 criteria. In 237 (40.5%) patients femoral access site closure was performed using the Prostar and in 348 patients (59.6%) using the ProGlide vascular closure device. There was no significant difference in patient baseline characteristics including single and dual antiplatelet therapies. Sheath outer diameter was significantly larger in the ProGlide compared with the Prostar group (7.7±1.5 vs. 7.9±0.5mm; p=0.001). Closure device failure according to VARC-2 criteria was significantly more frequent with the Prostar versus ProGlide device (19% vs. 4.6%; p<0.01). Need for surgical repair (11.8% vs. 0%, p<0.01), major (12.2% vs. 2.3%, p<0.01) and minor (17.3% vs. 5.7%, p<0.01) vascular complications and bleeding complications (5.5% vs. 2.0%, p=0.02) occurred significantly more often with the Prostar device compared with the ProGlide system. In addition, in-hospital mortality was higher with Prostar compared with ProGlide (5.9% vs. 2.0%; p=0.01).
  
  
  CONCLUSIONS
  Femoral access site closure with the ProGlide device compared with the Prostar device in transfemoral aortic valve implantation was associated with significantly lower rates of closure device failure, minor and major bleedings and a significantly lower in-hospital mortality.
  
  
  BACKGROUND
  clinicaltrials.govNCT02162069.
authors: Department of Internal Medicine II, Cardiology, University of Ulm, Ulm, Germany.
authors: Julia
authors: J
authors: Seeger
authors: Department of Internal Medicine II, Cardiology, University of Ulm, Ulm, Germany.
authors: Birgid
authors: B
authors: Gonska
authors: Department of Internal Medicine II, Cardiology, University of Ulm, Ulm, Germany.
authors: Christoph
authors: C
authors: Rodewald
authors: Department of Internal Medicine II, Cardiology, University of Ulm, Ulm, Germany.
authors: Wolfgang
authors: W
authors: Rottbauer
authors: Department of Internal Medicine II, Cardiology, University of Ulm, Ulm, Germany. Electronic address: jochen.woehrle@uniklinik-ulm.de.
authors: Jochen
authors: J
authors: Wöhrle
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001024:Aortic Valve Stenosis / Q000000981:diagnostic imaging* / Q000503:physiopathology / Q000601:surgery*; D005260:Female; D005263:Femoral Artery / Q000000981:diagnostic imaging* / Q000601:surgery*; D006801:Humans; D008297:Male; D011446:Prospective Studies; D065467:Transcatheter Aortic Valve Replacement / Q000295:instrumentation* / Q000379:methods*; D016896:Treatment Outcome
keywords: Aortic valve; Transcatheter aortic valve implantation; Vascular closure device