title: One-year outcomes with two suture-mediated closure devices to achieve access-site haemostasis following transfemoral transcatheter aortic valve implantation.
abstract: OBJECTIVE
  In the current study we assess the impact of two different access-site suture-mediated closure devices (SMCD), ProGlide and Prostar, on vascular and bleeding complications after transfemoral transcatheter aortic valve implantation (TAVI), as well as on long-term mortality.
  
  
  RESULTS
  From 2008 to 2013, 1,022 patients underwent transfemoral TAVI in two German centres using ProGlide (n=506) and Prostar (n=516) SMCD to close the access site. The primary outcome was the incidence of peri-TAVI major vascular complications according to Valve Academic Research Consortium-2 (VARC-2) definitions. Secondary outcomes were the incidence of bleeding complications and mortality. Compared to the Prostar SMCD group, patients in the ProGlide SMCD group less frequently experienced VARC-2 major vascular complications (7.5% vs. 15.9%, p<0.001), closure device failure (0.8% vs. 2.3%, p=0.04), any bleeding (BARC: 36.8% vs. 53.9%, p<0.001; VARC-2: 30.8% vs. 34.9%, p=0.59). Furthermore, one-year mortality was significantly lower in the ProGlide SMCD group, 14.8% vs. 19.5% in the Prostar SMCD group, log-rank p=0.04. However, VARC-2 major vascular complications but not ProGlide use were identified as an independent predictor of one-year mortality (adjusted odds ratio 1.54, 95% CI: 1.01-2.34 and 1.01, 95% CI: 0.65-1.55, respectively).
  
  
  CONCLUSIONS
  In this analysis, the use of ProGlide SMCD was associated with a reduced risk of vascular and bleeding complications following TAVI compared to Prostar SMCD usage. However, major vascular complications but not ProGlide use did independently predict long-term mortality.
authors.affiliation: Cardiology Department, Munich University Clinic, Ludwig-Maximilians University, Munich, Germany.
authors.forename: Julinda
authors.initials: J
authors.lastname: Mehilli
authors.forename: David
authors.initials: D
authors.lastname: Jochheim
authors.forename: Mohamed
authors.initials: M
authors.lastname: Abdel-Wahab
authors.forename: Konstantinos D
authors.initials: KD
authors.lastname: Rizas
authors.forename: Hans
authors.initials: H
authors.lastname: Theiss
authors.forename: Nina
authors.initials: N
authors.lastname: Spenkuch
authors.forename: Magda
authors.initials: M
authors.lastname: Zadrozny
authors.forename: Moritz
authors.initials: M
authors.lastname: Baquet
authors.forename: Mohamed
authors.initials: M
authors.lastname: El-Mawardy
authors.forename: Takao
authors.initials: T
authors.lastname: Sato
authors.forename: Philipp
authors.initials: P
authors.lastname: Lange
authors.forename: Christian
authors.initials: C
authors.lastname: Kuppatt
authors.forename: Martin
authors.initials: M
authors.lastname: Greif
authors.forename: Jörg
authors.initials: J
authors.lastname: Hausleiter
authors.forename: Axel
authors.initials: A
authors.lastname: Bauer
authors.forename: Florian
authors.initials: F
authors.lastname: Schwarz
authors.forename: Maximilian
authors.initials: M
authors.lastname: Pichlmaier
authors.forename: Christian
authors.initials: C
authors.lastname: Hagl
authors.forename: Gert
authors.initials: G
authors.lastname: Richardt
authors.forename: Steffen
authors.initials: S
authors.lastname: Massberg
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001021:Aortic Valve / Q000601:surgery*; D001024:Aortic Valve Stenosis / Q000601:surgery*; D006328:Cardiac Catheterization / Q000295:instrumentation*; D019918:Heart Valve Prosthesis Implantation / Q000295:instrumentation* / Q000379:methods; D006470:Hemorrhage / Q000150:complications; D006489:Hemostatic Techniques / Q000295:instrumentation*; D006801:Humans; D008297:Male; D008875:Middle Aged; D065467:Transcatheter Aortic Valve Replacement / Q000295:instrumentation*; D016896:Treatment Outcome