Atsuko Kodama1, Masanori Yamamoto1,2, Tetsuro Shimura1, Ai Kagase1, Yutaka Koyama1, Norio Tada3, Kensuke Takagi4, Motoharu Araki5, Futoshi Yamanaka6, Shinichi Shirai7, Yusuke Watanabe8, Kentaro Hayashida9. 1. Department of Cardiology, Toyohashi Heart Canter, Japan, Toyohashi. 2. Department of Cardiology, Nagoya Heart Canter, Japan, Nagoya. 3. Department of Cardiology, Sendai Kousei Hospital, Sendai, Japan. 4. Department of Cardiology, New Tokyo Hospital, Chiba, Japan. 5. Department of Cardiology, Saiseikai Yokohama City Eastern Hospital, Yokohama, Japan. 6. Department of Cardiology, Syonan Kamakura General Hospital, Kanagawa, Japan. 7. Department of Cardiology, Kokura Memorial Hospital, Kokura, Japan. 8. Department of Cardiology, Teikyo University School of Medicine, Tokyo, Japan. 9. Department of Cardiology, Keio University School of Medicine, Tokyo, Japan.
Abstract
OBJECTIVES: 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. BACKGROUNDS: 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.
OBJECTIVES: 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. BACKGROUNDS: 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.
Authors: Claudio Montalto; Andrea Raffaele Munafò; Luca Arzuffi; Francesco Soriano; Antonio Mangieri; Stefano Nava; Giovanni Luigi De Maria; Francesco Burzotta; Fabrizio D'Ascenzo; Antonio Colombo; Azeem Latib; Jacopo Andrea Oreglia; Adrian P Banning; Italo Porto; Gabriele Crimi Journal: Eur Heart J Open Date: 2022-08-18