title: Comparative data of single versus double proglide vascular preclose technique after percutaneous transfemoral transcatheter aortic valve implantation from the optimized catheter valvular intervention (OCEAN-TAVI) japanese multicenter registry.
abstract: OBJECTIVE
  This study aimed to assess the feasibility of percutaneous arterial access site closure after percutaneous transfemoral transcatheter aortic valve implantation (TF-TAVI) using single versus double Perclose ProGlide devices.
  
  
  BACKGROUND
  Although suturing with the preclose technique has been widely adopted during TF-TAVI, the optimal vascular closure strategy is still under debate.
  
  
  METHODS
  Data from 279 patients who underwent TF-TAVI, obtained from the Optimized CathEter vAlvular iNtervention (OCEAN-TAVI) Japanese multicenter registry. Technical, procedural, and clinical outcomes were compared between the single ProGlide group (n = 99) and double ProGlide group (n = 180). They were also analyzed by propensity adjusted matching model (single [n = 69] vs. double [n = 69]). All patients were treated through a 16-Fr to 20-Fr eSheath. Technical success of the closure device was defined as hemostasis not requiring alternative invasive treatment. Access site-related vascular complications, bleedings, and other procedural complications were defined according to the Valvular Academic Research Consortium-2 (VARC-2) criteria.
  
  
  RESULTS
  The rates of technical success and access site-related vascular complications were similar in the 2 groups (94.9% vs. 91.6%, p = 0.44; 5.0% vs. 7.7%, p = 0.54, respectively). The prevalence of bleeding complications did not differ between the 2 groups (1.0% vs. 3.3%, p = 0.43). Thirty-day mortality rate also showed no difference between the 2 groups (2.0% vs. 1.1%, p = 0.95), although these events were not associated with access site failure. These results were not attenuated in the propensity matching model.
  
  
  CONCLUSIONS
  Vascular closure with a single ProGlide in TF-TAVI could achieve equivalent, acceptable rates of technical success and procedural complications compared with the double ProGlide technique. © 2016 Wiley Periodicals, Inc.
authors: Department of Cardiology, Toyohashi Heart Canter, Japan, Toyohashi.
authors: Atsuko
authors: A
authors: Kodama
authors: Department of Cardiology, Toyohashi Heart Canter, Japan, Toyohashi.|Department of Cardiology, Nagoya Heart Canter, Japan, Nagoya.
authors: Masanori
authors: M
authors: Yamamoto
authors: Department of Cardiology, Toyohashi Heart Canter, Japan, Toyohashi.
authors: Tetsuro
authors: T
authors: Shimura
authors: Department of Cardiology, Toyohashi Heart Canter, Japan, Toyohashi.
authors: Ai
authors: A
authors: Kagase
authors: Department of Cardiology, Toyohashi Heart Canter, Japan, Toyohashi.
authors: Yutaka
authors: Y
authors: Koyama
authors: Department of Cardiology, Sendai Kousei Hospital, Sendai, Japan.
authors: Norio
authors: N
authors: Tada
authors: Department of Cardiology, New Tokyo Hospital, Chiba, Japan.
authors: Kensuke
authors: K
authors: Takagi
authors: Department of Cardiology, Saiseikai Yokohama City Eastern Hospital, Yokohama, Japan.
authors: Motoharu
authors: M
authors: Araki
authors: Department of Cardiology, Syonan Kamakura General Hospital, Kanagawa, Japan.
authors: Futoshi
authors: F
authors: Yamanaka
authors: Department of Cardiology, Kokura Memorial Hospital, Kokura, Japan.
authors: Shinichi
authors: S
authors: Shirai
authors: Department of Cardiology, Teikyo University School of Medicine, Tokyo, Japan.
authors: Yusuke
authors: Y
authors: Watanabe
authors: Department of Cardiology, Keio University School of Medicine, Tokyo, Japan.
authors: Kentaro
authors: K
authors: Hayashida
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001024:Aortic Valve Stenosis / Q000000981:diagnostic imaging / Q000601:surgery*; D002406:Catheterization, Peripheral / Q000009:adverse effects; D016009:Chi-Square Distribution; D004867:Equipment Design; D005240:Feasibility Studies; D005260:Female; D005263:Femoral Artery / Q000000981:diagnostic imaging; D006470:Hemorrhage / Q000209:etiology / Q000517:prevention & control*; D006489:Hemostatic Techniques / Q000009:adverse effects / Q000295:instrumentation*; D006801:Humans; D007564:Japan; D016015:Logistic Models; D008297:Male; D057216:Propensity Score; D011677:Punctures; D012042:Registries; D012189:Retrospective Studies; D013997:Time Factors; D065467:Transcatheter Aortic Valve Replacement / Q000009:adverse effects; D016896:Treatment Outcome; D065506:Vascular Closure Devices
keywords: AOD; SHDI; TVI; aortic disease; structural heart disease intervention; transcatheter valve implantation