Yohsuke Honda1, Masahiro Yamawaki2, Takahide Nakano2, Kenji Makino2, Yoshiaki Ito2, Fumiaki Yashima3, Norio Tada4, Toru Naganuma5, Futoshi Yamanaka6, Kazuki Mizutani7, Minoru Tabata8, Hiroshi Ueno9, Kensuke Takagi10, Yusuke Watanabe11, Masanori Yamamoto12, Shinichi Shirai13, Kentaro Hayashida14. 1. Department of Cardiology, Saiseikai Yokohama City Eastern Hospital, Yokohama, Japan. Electronic address: rum-tum-tugger.1218@hotmail.co.jp. 2. Department of Cardiology, Saiseikai Yokohama City Eastern Hospital, Yokohama, Japan. 3. Department of Cardiology, Saiseikai Utsunomiya Hospital, Tochigi, Japan; Department of Cardiology, Keio University School of Medicine, Tokyo, Japan. 4. Department of Cardiology, Sendai Kosei Hospital, Sendai, Japan. 5. Department of Cardiology, New Tokyo Hospital, Chiba, Japan. 6. Department of Cardiology, Shonan Kamakura General Hospital, Kanagawa, Japan. 7. Department of Cardiovascular Medicine, Osaka City University Graduate School of Medicine, Osaka, Japan. 8. Department of Cardiovascular Surgery, Tokyo Bay Urayasu-Ichikawa Medical Center, Chiba, Japan. 9. Department of Cardiology, Toyama University Hospital, Toyama, Japan. 10. Department of Cardiology, Ogaki Municipal Hospital, Gifu, Japan. 11. Department of Cardiology, Teikyo University School of Medicine, Tokyo, Japan. 12. Department of Cardiology, Toyohashi Heart Center, Toyohashi, Japan; Department of Cardiology, Nagoya Heart Center, Nagoya, Japan. 13. Department of Cardiology, Kokura Memorial Hospital, Kokura, Japan. 14. Department of Cardiology, Keio University School of Medicine, Tokyo, Japan.
Abstract
BACKGROUND: Access-site complications during transfemoral transcatheter aortic valve implantation (TF-TAVI) cause serious issues in the future, if unresolved, but the best strategies to manage these complications remains unclear. This study aimed to comprehensively assess access-site complications during percutaneous TF-TAVI in terms of their management. METHODS: Using the prospective, multicentre, observational registry OCEAN (Optimized Transcatheter Valvular Intervention), 1497 patients who underwent percutaneous TF-TAVI between October 2013 and May 2017 were identified. The incidence, predictors, temporal changes, and prognosis of access-site complications along with its treatment strategy and re-intervention rate were evaluated. RESULTS: Access-site complications occurred in 105 patients (7.0%) and was predicted with lower body-mass-index (OR, 0.94; 95% CI; 0.89-0.99; p = 0.03) and higher sheath-to-femoral-artery-ratio (OR, 1.12; 95% CI, 1.03-1.24; p < 0.002). The incidence of access-site complications declined over time, irrespective of the increasing number of percutaneous TF-TAVI cases. Access-site complications were treated by conservative therapy (n = 19, 18%), interventional procedures (n = 42, 40%), rescue surgical repair (SR) (n = 10, 10%), and primary SR (n = 34, 32%). The severity of complications differed but the re-intervention rate was similar among 4 groups (p = 0.46). Re-intervention was not needed, except for a case of common femoral artery stenosis/occlusion induced by ProGlide. The need for all SRs decreased annually. Access-site complications were not associated with 30 days- and 1 year-survival rate. CONCLUSIONS: The incidence of access-site complications was not low but has declined annually. Access-site complications are not related to worse outcomes after successful management. Interventional procedure is acceptable as the first-line strategy to treat access-site complications.
BACKGROUND: Access-site complications during transfemoral transcatheter aortic valve implantation (TF-TAVI) cause serious issues in the future, if unresolved, but the best strategies to manage these complications remains unclear. This study aimed to comprehensively assess access-site complications during percutaneous TF-TAVI in terms of their management. METHODS: Using the prospective, multicentre, observational registry OCEAN (Optimized Transcatheter Valvular Intervention), 1497 patients who underwent percutaneous TF-TAVI between October 2013 and May 2017 were identified. The incidence, predictors, temporal changes, and prognosis of access-site complications along with its treatment strategy and re-intervention rate were evaluated. RESULTS: Access-site complications occurred in 105 patients (7.0%) and was predicted with lower body-mass-index (OR, 0.94; 95% CI; 0.89-0.99; p = 0.03) and higher sheath-to-femoral-artery-ratio (OR, 1.12; 95% CI, 1.03-1.24; p < 0.002). The incidence of access-site complications declined over time, irrespective of the increasing number of percutaneous TF-TAVI cases. Access-site complications were treated by conservative therapy (n = 19, 18%), interventional procedures (n = 42, 40%), rescue surgical repair (SR) (n = 10, 10%), and primary SR (n = 34, 32%). The severity of complications differed but the re-intervention rate was similar among 4 groups (p = 0.46). Re-intervention was not needed, except for a case of common femoral artery stenosis/occlusion induced by ProGlide. The need for all SRs decreased annually. Access-site complications were not associated with 30 days- and 1 year-survival rate. CONCLUSIONS: The incidence of access-site complications was not low but has declined annually. Access-site complications are not related to worse outcomes after successful management. Interventional procedure is acceptable as the first-line strategy to treat access-site complications.