Impact of Peridevice Leak on Clinical Outcomes After Left Atrial Appendage Closure: The OCEAN‐LAAC Registry

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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Main Authors: 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
Format: Article
Language:English
Published: Wiley 2025-08-01
Series:Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease
Subjects:
atrial fibrillation
percutaneous left atrial appendage closure
propensity score matching
Online Access:https://www.ahajournals.org/doi/10.1161/JAHA.125.044422
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Summary: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.
ISSN:2047-9980

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