Impact of Peridevice Leak on Clinical Outcomes After Left Atrial Appendage Closure: The OCEAN‐LAAC Registry
Background The impact of peridevice leak (PDL) at device implantation on clinical outcomes after percutaneous left atrial appendage closure (LAAC) is unknown. This study aimed to investigate the association between PDL and clinical outcomes after LAAC. Methods Using data from the OCEAN‐LAAC (Optimiz...
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Wiley
2025-08-01
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| Series: | Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease |
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| Online Access: | https://www.ahajournals.org/doi/10.1161/JAHA.125.044422 |
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| author | Tetsuya Saito Hikaru Tsuruta Akiyoshi Kajino Juri Iwata Shingo Sakata Toshinobu Ryuzaki Mitsuru Sago Shuhei Tanaka Ryuki Chatani Daisuke Hachinohe Toru Naganuma Yohei Ohno Tomoyuki Tani Hideharu Okamatsu Kazuki Mizutani Yusuke Watanabe Masaki Izumo Mike Saji Shingo Mizuno Hiroshi Ueno Shunsuke Kubo Shinichi Shirai Masaki Nakashima Masahiko Asami Masanori Yamamoto Masaki Ieda Kentaro Hayashida |
| author_facet | Tetsuya Saito Hikaru Tsuruta Akiyoshi Kajino Juri Iwata Shingo Sakata Toshinobu Ryuzaki Mitsuru Sago Shuhei Tanaka Ryuki Chatani Daisuke Hachinohe Toru Naganuma Yohei Ohno Tomoyuki Tani Hideharu Okamatsu Kazuki Mizutani Yusuke Watanabe Masaki Izumo Mike Saji Shingo Mizuno Hiroshi Ueno Shunsuke Kubo Shinichi Shirai Masaki Nakashima Masahiko Asami Masanori Yamamoto Masaki Ieda Kentaro Hayashida |
| author_sort | Tetsuya Saito |
| collection | DOAJ |
| description | Background The impact of peridevice leak (PDL) at device implantation on clinical outcomes after percutaneous left atrial appendage closure (LAAC) is unknown. This study aimed to investigate the association between PDL and clinical outcomes after LAAC. Methods Using data from the OCEAN‐LAAC (Optimized Catheter Valvular Intervention‐Left Atrial Appendage Closure) Japanese multicenter registry, we examined 1397 patients who underwent LAAC between September 2019 and December 2022. The primary outcome was transient ischemic attack, ischemic stroke, or systemic embolism within 2 years of LAAC. Clinical outcomes were compared between patients with and without PDL at device implantation using Fine and Gray multivariable regression analyses and propensity score matching. Additional analyses were performed by categorizing PDL into 2 groups: ≤3 mm and >3 mm but ≤5 mm. Results Of 1397 patients who underwent LAAC, 84 (6.0%) had PDL, of whom 73 (86.9%) had ≤3 mm PDL. Patients with PDL had a larger left atrium and higher CHADS2 scores than those without PDL. Multivariable analyses showed that PDL was significantly associated with a higher risk of transient ischemic attack, ischemic stroke, or systemic embolism (adjusted subdistribution hazard ratio [sHR], 4.25 [95% CI, 1.91–9.44]; P<0.001). Even PDL ≤3 mm was independently associated with an increased risk compared with no PDL (adjusted sHR, 3.53 [95% CI, 1.37–9.04]; P=0.016). Propensity score matching analyses revealed consistent findings. Conclusions PDL was associated with a higher risk of transient ischemic attack, ischemic stroke, or systemic embolism, even PDL ≤3 mm. Therefore, it may be necessary to aim for no PDL as much as possible. |
| format | Article |
| id | doaj-art-7ddc3af8d3e24dc8aba16f5548e7d5c1 |
| institution | Kabale University |
| issn | 2047-9980 |
| language | English |
| publishDate | 2025-08-01 |
| publisher | Wiley |
| record_format | Article |
| series | Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease |
| spelling | doaj-art-7ddc3af8d3e24dc8aba16f5548e7d5c12025-08-20T07:25:10ZengWileyJournal of the American Heart Association: Cardiovascular and Cerebrovascular Disease2047-99802025-08-01141610.1161/JAHA.125.044422Impact of Peridevice Leak on Clinical Outcomes After Left Atrial Appendage Closure: The OCEAN‐LAAC RegistryTetsuya Saito0Hikaru Tsuruta1Akiyoshi Kajino2Juri Iwata3Shingo Sakata4Toshinobu Ryuzaki5Mitsuru Sago6Shuhei Tanaka7Ryuki Chatani8Daisuke Hachinohe9Toru Naganuma10Yohei Ohno11Tomoyuki Tani12Hideharu Okamatsu13Kazuki Mizutani14Yusuke Watanabe15Masaki Izumo16Mike Saji17Shingo Mizuno18Hiroshi Ueno19Shunsuke Kubo20Shinichi Shirai21Masaki Nakashima22Masahiko Asami23Masanori Yamamoto24Masaki Ieda25Kentaro Hayashida26Department of Cardiology Keio University School of Medicine Tokyo JapanDepartment of Cardiology Keio University School of Medicine Tokyo JapanDepartment of Cardiology Keio University School of Medicine Tokyo JapanDepartment of Cardiology Keio University School of Medicine Tokyo JapanDepartment of Cardiology Keio University School of Medicine Tokyo JapanDepartment of Cardiology Keio University School of Medicine Tokyo JapanDepartment of Cardiology Toyohashi Heart Center Toyohashi JapanSecond Department of Internal Medicine Toyama University Hospital Toyama JapanDepartment of Cardiology Kurashiki Central Hospital Kurashiki JapanDepartment of Cardiology Sapporo Higashi Tokushukai Hospital Sapporo JapanDepartment of Cardiology New Tokyo Hospital Chiba JapanDepartment of Cardiology Tokai University School of Medicine Isehara JapanDepartment of Cardiology Sapporo East Tokushukai Hospital Sapporo JapanDivision of Cardiology Saiseikai Kumamoto Hospital Cardiovascular Center Kumamoto JapanDivision of Cardiology, Department of Medicine Kinki University Faculty of Medicine Osaka JapanDepartment of Cardiology Teikyo University School of Medicine Tokyo JapanDivision of Cardiology St. Marianna University School of Medicine Hospital Kawasaki JapanDepartment of Cardiology Sakakibara Heart Institute Tokyo JapanDepartment of Cardiology Shonan Kamakura General Hospital Kamakura Kanagawa JapanDepartment of Cardiology National Cerebral and Cardiovascular Center Suita JapanDepartment of Cardiology Kurashiki Central Hospital Kurashiki JapanDivision of Cardiology Kokura Memorial Hospital Kitakyushu JapanDepartment of Cardiology Sendai Kosei Hospital Sendai JapanDivision of Cardiology Mitsui Memorial Hospital Tokyo JapanDepartment of Cardiology Toyohashi Heart Center Toyohashi JapanDepartment of Cardiology Keio University School of Medicine Tokyo JapanDepartment of Cardiology Keio University School of Medicine Tokyo JapanBackground The impact of peridevice leak (PDL) at device implantation on clinical outcomes after percutaneous left atrial appendage closure (LAAC) is unknown. This study aimed to investigate the association between PDL and clinical outcomes after LAAC. Methods Using data from the OCEAN‐LAAC (Optimized Catheter Valvular Intervention‐Left Atrial Appendage Closure) Japanese multicenter registry, we examined 1397 patients who underwent LAAC between September 2019 and December 2022. The primary outcome was transient ischemic attack, ischemic stroke, or systemic embolism within 2 years of LAAC. Clinical outcomes were compared between patients with and without PDL at device implantation using Fine and Gray multivariable regression analyses and propensity score matching. Additional analyses were performed by categorizing PDL into 2 groups: ≤3 mm and >3 mm but ≤5 mm. Results Of 1397 patients who underwent LAAC, 84 (6.0%) had PDL, of whom 73 (86.9%) had ≤3 mm PDL. Patients with PDL had a larger left atrium and higher CHADS2 scores than those without PDL. Multivariable analyses showed that PDL was significantly associated with a higher risk of transient ischemic attack, ischemic stroke, or systemic embolism (adjusted subdistribution hazard ratio [sHR], 4.25 [95% CI, 1.91–9.44]; P<0.001). Even PDL ≤3 mm was independently associated with an increased risk compared with no PDL (adjusted sHR, 3.53 [95% CI, 1.37–9.04]; P=0.016). Propensity score matching analyses revealed consistent findings. Conclusions PDL was associated with a higher risk of transient ischemic attack, ischemic stroke, or systemic embolism, even PDL ≤3 mm. Therefore, it may be necessary to aim for no PDL as much as possible.https://www.ahajournals.org/doi/10.1161/JAHA.125.044422atrial fibrillationpercutaneous left atrial appendage closurepropensity score matching |
| spellingShingle | Tetsuya Saito Hikaru Tsuruta Akiyoshi Kajino Juri Iwata Shingo Sakata Toshinobu Ryuzaki Mitsuru Sago Shuhei Tanaka Ryuki Chatani Daisuke Hachinohe Toru Naganuma Yohei Ohno Tomoyuki Tani Hideharu Okamatsu Kazuki Mizutani Yusuke Watanabe Masaki Izumo Mike Saji Shingo Mizuno Hiroshi Ueno Shunsuke Kubo Shinichi Shirai Masaki Nakashima Masahiko Asami Masanori Yamamoto Masaki Ieda Kentaro Hayashida Impact of Peridevice Leak on Clinical Outcomes After Left Atrial Appendage Closure: The OCEAN‐LAAC Registry Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease atrial fibrillation percutaneous left atrial appendage closure propensity score matching |
| title | Impact of Peridevice Leak on Clinical Outcomes After Left Atrial Appendage Closure: The OCEAN‐LAAC Registry |
| title_full | Impact of Peridevice Leak on Clinical Outcomes After Left Atrial Appendage Closure: The OCEAN‐LAAC Registry |
| title_fullStr | Impact of Peridevice Leak on Clinical Outcomes After Left Atrial Appendage Closure: The OCEAN‐LAAC Registry |
| title_full_unstemmed | Impact of Peridevice Leak on Clinical Outcomes After Left Atrial Appendage Closure: The OCEAN‐LAAC Registry |
| title_short | Impact of Peridevice Leak on Clinical Outcomes After Left Atrial Appendage Closure: The OCEAN‐LAAC Registry |
| title_sort | impact of peridevice leak on clinical outcomes after left atrial appendage closure the ocean laac registry |
| topic | atrial fibrillation percutaneous left atrial appendage closure propensity score matching |
| url | https://www.ahajournals.org/doi/10.1161/JAHA.125.044422 |
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