title: Comparison of vascular closure devices for access site closure after transfemoral aortic valve implantation.
abstract: BACKGROUND
  The majority of transcatheter aortic valve implantation (TAVI) procedures are currently performed by percutaneous transfemoral approach. The potential contribution of the type of vascular closure device to the incidence of vascular complications is not clear.
  
  
  OBJECTIVE
  To compare the efficacy of a Prostar XL- vs. Perclose ProGlide-based vascular closure strategy.
  
  
  METHODS
  The ClOsure device iN TRansfemoral aOrtic vaLve implantation (CONTROL) multi-center study included 3138 consecutive percutaneous transfemoral TAVI patients, categorized according to vascular closure strategy: Prostar XL- (Prostar group) vs. Perclose ProGlide-based vascular closure strategy (ProGlide group). Propensity-score matching was used to assemble a cohort of patients with similar baseline characteristics.
  
  
  RESULTS
  Propensity matching identified 944 well-matched patients (472 patient pairs). Composite primary end point of major vascular complications or in-hospital mortality occurred more frequently in Prostar group when compared with ProGlide group (9.5 vs. 5.1%, P = 0.016), and was driven by higher rates of major vascular complication (7.4 vs. 1.9%, P < 0.001) in the Prostar group. However, in-hospital mortality was similar between groups (4.9 vs. 3.5%, P = 0.2). Femoral artery stenosis occurred less frequently in the Prostar group (3.4 vs. 0.5%, P = 0.004), but overall, Prostar use was associated with higher rates of major bleeding (16.7 vs. 3.2%, P < 0.001), acute kidney injury (17.6 vs. 4.4%, P < 0.001) and with longer hospital stay (median 6 vs. 5 days, P = 0.007).
  
  
  CONCLUSIONS
  Prostar XL-based vascular closure in transfemoral TAVI procedures is associated with higher major vascular complication rates when compared with ProGlide; however, in-hospital mortality is similar with both devices.
authors: Leviev Heart Center, Sheba Medical Center, Tel Hashomer, Sackler Faculty of Medicine, Tel Aviv University, Ramat Gan, Israel ibarbash@gmail.com.
authors: Israel M
authors: IM
authors: Barbash
authors: Division of Cardiology, Ferrarotto Hospital, University of Catania, Catania, Italy.
authors: Marco
authors: M
authors: Barbanti
authors: Department of Cardiology, St Paul's Hospital, University of British Columbia, Vancouver, BC, Canada.
authors: John
authors: J
authors: Webb
authors: Groupe CardioVasculaire Interventionnel, Clinique Pasteur, Toulouse, France.
authors: Javier
authors: J
authors: Molina-Martin De Nicolas
authors: Cedars-Sinai Medical Center, Cedars-Sinai Heart Institute, Los Angeles, CA, USA.
authors: Yigal
authors: Y
authors: Abramowitz
authors: Interventional Cardiology Unit, EMO-GVM Centro Cuore Columbus & San Raffaele Scientific Institute, Milan, Italy.
authors: Azeem
authors: A
authors: Latib
authors: Department of Cardiology, Bichat-Claude-Bernard Hospital, Assistance Publique-Hôpitaux de Paris, Université Paris VII, Paris, France.
authors: Caroline
authors: C
authors: Nguyen
authors: Department of Cardiovascular Surgery, University Heart Center, Hamburg, Germany.
authors: Florian
authors: F
authors: Deuschl
authors: Leviev Heart Center, Sheba Medical Center, Tel Hashomer, Sackler Faculty of Medicine, Tel Aviv University, Ramat Gan, Israel.
authors: Amit
authors: A
authors: Segev
authors: Clinic for Cardiovascular Surgery, German Heart Centre, Munich, Germany.
authors: Konstantinos
authors: K
authors: Sideris
authors: Division of Cardiology, Ferrarotto Hospital, University of Catania, Catania, Italy.
authors: Sergio
authors: S
authors: Buccheri
authors: Department of Cardiology, St Paul's Hospital, University of British Columbia, Vancouver, BC, Canada.
authors: Matheus
authors: M
authors: Simonato
authors: Groupe CardioVasculaire Interventionnel, Clinique Pasteur, Toulouse, France.
authors: Francesco Della
authors: FD
authors: Rosa
authors: Division of Cardiology, Ferrarotto Hospital, University of Catania, Catania, Italy.
authors: Corrado
authors: C
authors: Tamburino
authors: Cedars-Sinai Medical Center, Cedars-Sinai Heart Institute, Los Angeles, CA, USA.
authors: Hasan
authors: H
authors: Jilaihawi
authors: Interventional Cardiology Unit, EMO-GVM Centro Cuore Columbus & San Raffaele Scientific Institute, Milan, Italy.
authors: Tadashi
authors: T
authors: Miyazaki
authors: Department of Cardiology, Bichat-Claude-Bernard Hospital, Assistance Publique-Hôpitaux de Paris, Université Paris VII, Paris, France.
authors: Dominique
authors: D
authors: Himbert
authors: Department of Cardiovascular Surgery, University Heart Center, Hamburg, Germany.
authors: Niklas
authors: N
authors: Schofer
authors: Leviev Heart Center, Sheba Medical Center, Tel Hashomer, Sackler Faculty of Medicine, Tel Aviv University, Ramat Gan, Israel.
authors: Victor
authors: V
authors: Guetta
authors: Clinic for Cardiovascular Surgery, German Heart Centre, Munich, Germany.
authors: Sabine
authors: S
authors: Bleiziffer
authors: Groupe CardioVasculaire Interventionnel, Clinique Pasteur, Toulouse, France.
authors: Didier
authors: D
authors: Tchetche
authors: Division of Cardiology, Ferrarotto Hospital, University of Catania, Catania, Italy.
authors: Sebastiano
authors: S
authors: Immè
authors: Cedars-Sinai Medical Center, Cedars-Sinai Heart Institute, Los Angeles, CA, USA.
authors: Raj R
authors: RR
authors: Makkar
authors: Department of Cardiology, Bichat-Claude-Bernard Hospital, Assistance Publique-Hôpitaux de Paris, Université Paris VII, Paris, France.
authors: Alec
authors: A
authors: Vahanian
authors: Department of Cardiovascular Surgery, University Heart Center, Hamburg, Germany.
authors: Hendrik
authors: H
authors: Treede
authors: Clinic for Cardiovascular Surgery, German Heart Centre, Munich, Germany.
authors: Rüdiger
authors: R
authors: Lange
authors: Interventional Cardiology Unit, EMO-GVM Centro Cuore Columbus & San Raffaele Scientific Institute, Milan, Italy.
authors: Antonio
authors: A
authors: Colombo
authors: Department of Cardiology, St Paul's Hospital, University of British Columbia, Vancouver, BC, Canada.
authors: Danny
authors: D
authors: Dvir
mesh_terms: D058186:Acute Kidney Injury / Q000209:etiology; D000368:Aged; D000369:Aged, 80 and over; D001024:Aortic Valve Stenosis / Q000601:surgery*; D002309:Cardiology / Q000592:standards; D002983:Clinical Competence / Q000592:standards; D003251:Constriction, Pathologic / Q000209:etiology; D005260:Female; D005263:Femoral Artery; D006801:Humans; D059032:Learning Curve; D008297:Male; D009203:Myocardial Infarction / Q000209:etiology; D019106:Postoperative Hemorrhage / Q000209:etiology; D020521:Stroke / Q000209:etiology; D065467:Transcatheter Aortic Valve Replacement / Q000009:adverse effects* / Q000295:instrumentation; D065506:Vascular Closure Devices / Q000009:adverse effects*; D014652:Vascular Diseases / Q000209:etiology*
keywords: Aortic stenosis; Transcatheter aortic valve replacement; Vascular closure device; Vascular complication