Song Zhang, Sihuai Xiong, Sha Zhang, Keyu Chen, Hua Wang, Ke Li, Xudong Xu, Xianxian Zhao, Ni Zhu, Xinmiao Huang, Yongwen Qin, Zhifu Guo, Yuan Bai
{"title":"WATCHMAN与LACbes®装置经皮左心耳闭合：单中心倾向匹配研究","authors":"Song Zhang, Sihuai Xiong, Sha Zhang, Keyu Chen, Hua Wang, Ke Li, Xudong Xu, Xianxian Zhao, Ni Zhu, Xinmiao Huang, Yongwen Qin, Zhifu Guo, Yuan Bai","doi":"10.1186/s12872-024-04383-z","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Different left atrial appendage closure (LAAC) devices have been introduced into the clinical setting. A new dual-seal mechanism LACbes® occluder with isogenous barbs for LAAC has been designed to facilitate easier delivery and improve safety. The purpose of this study is to compare the clinical outcomes of the WATCHMAN with those of the LACbes® device for LAAC.</p><p><strong>Methods: </strong>Consecutive patients with atrial fibrillation (AF) who had undergone LAAC performed using a WATCHMAN or LACbes® device from June 2016 to February 2022 were included. The primary efficacy endpoint included ischemic stroke, cardiovascular/unexplained death and device-related thrombus, while the primary safety endpoint included major peri-procedural complications and major bleeding events during clinical follow-ups. 1:1 propensity score matching (PSM) was performed.</p><p><strong>Results: </strong>After PSM, 184 patients were included in each group. The mean CHA<sub>2</sub>DS<sub>2</sub>-VASc score was 3.1 ± 1.5 (LACbes®) vs. 3.1 ± 1.4 (WATCHMAN), and the HAS-BLED score was 2.7 ± 1.1 vs. 2.7 ± 1.0. At a mean follow-up of 2.5 ± 1.5 vs. 2.4 ± 0.9 years, the defined three endpoints were comparable between the two groups. The occurrence of all-cause stroke was lower in 5/452 (1.8%) with LACbes® vs. 16/433 (3.7%) with WATCHMAN occluders (HR, 0.40, 95% confidence interval (CI), 0.18-0.89, P = 0.023), and the incidence of any bleeding was higher in the WATCHMAN group (41/433, 9.5% vs. 8/452, 1.8%; HR, 0.19, 95% CI, 0.11-0.33).</p><p><strong>Conclusion: </strong>The LACbes® occluder exhibited comparable safety and efficacy of stroke prevention for AF when compared with the WATCHMAN device.</p>","PeriodicalId":9195,"journal":{"name":"BMC Cardiovascular Disorders","volume":"25 1","pages":"18"},"PeriodicalIF":2.0000,"publicationDate":"2025-01-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11724465/pdf/","citationCount":"0","resultStr":"{\"title\":\"WATCHMAN versus LACbes® device for percutaneous left atrial appendage closure: a single-center, propensity-matched study.\",\"authors\":\"Song Zhang, Sihuai Xiong, Sha Zhang, Keyu Chen, Hua Wang, Ke Li, Xudong Xu, Xianxian Zhao, Ni Zhu, Xinmiao Huang, Yongwen Qin, Zhifu Guo, Yuan Bai\",\"doi\":\"10.1186/s12872-024-04383-z\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Different left atrial appendage closure (LAAC) devices have been introduced into the clinical setting. A new dual-seal mechanism LACbes® occluder with isogenous barbs for LAAC has been designed to facilitate easier delivery and improve safety. The purpose of this study is to compare the clinical outcomes of the WATCHMAN with those of the LACbes® device for LAAC.</p><p><strong>Methods: </strong>Consecutive patients with atrial fibrillation (AF) who had undergone LAAC performed using a WATCHMAN or LACbes® device from June 2016 to February 2022 were included. The primary efficacy endpoint included ischemic stroke, cardiovascular/unexplained death and device-related thrombus, while the primary safety endpoint included major peri-procedural complications and major bleeding events during clinical follow-ups. 1:1 propensity score matching (PSM) was performed.</p><p><strong>Results: </strong>After PSM, 184 patients were included in each group. The mean CHA<sub>2</sub>DS<sub>2</sub>-VASc score was 3.1 ± 1.5 (LACbes®) vs. 3.1 ± 1.4 (WATCHMAN), and the HAS-BLED score was 2.7 ± 1.1 vs. 2.7 ± 1.0. At a mean follow-up of 2.5 ± 1.5 vs. 2.4 ± 0.9 years, the defined three endpoints were comparable between the two groups. The occurrence of all-cause stroke was lower in 5/452 (1.8%) with LACbes® vs. 16/433 (3.7%) with WATCHMAN occluders (HR, 0.40, 95% confidence interval (CI), 0.18-0.89, P = 0.023), and the incidence of any bleeding was higher in the WATCHMAN group (41/433, 9.5% vs. 8/452, 1.8%; HR, 0.19, 95% CI, 0.11-0.33).</p><p><strong>Conclusion: </strong>The LACbes® occluder exhibited comparable safety and efficacy of stroke prevention for AF when compared with the WATCHMAN device.</p>\",\"PeriodicalId\":9195,\"journal\":{\"name\":\"BMC Cardiovascular Disorders\",\"volume\":\"25 1\",\"pages\":\"18\"},\"PeriodicalIF\":2.0000,\"publicationDate\":\"2025-01-11\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11724465/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"BMC Cardiovascular Disorders\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1186/s12872-024-04383-z\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"CARDIAC & CARDIOVASCULAR SYSTEMS\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"BMC Cardiovascular Disorders","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1186/s12872-024-04383-z","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"CARDIAC & CARDIOVASCULAR SYSTEMS","Score":null,"Total":0}
WATCHMAN versus LACbes® device for percutaneous left atrial appendage closure: a single-center, propensity-matched study.
Background: Different left atrial appendage closure (LAAC) devices have been introduced into the clinical setting. A new dual-seal mechanism LACbes® occluder with isogenous barbs for LAAC has been designed to facilitate easier delivery and improve safety. The purpose of this study is to compare the clinical outcomes of the WATCHMAN with those of the LACbes® device for LAAC.
Methods: Consecutive patients with atrial fibrillation (AF) who had undergone LAAC performed using a WATCHMAN or LACbes® device from June 2016 to February 2022 were included. The primary efficacy endpoint included ischemic stroke, cardiovascular/unexplained death and device-related thrombus, while the primary safety endpoint included major peri-procedural complications and major bleeding events during clinical follow-ups. 1:1 propensity score matching (PSM) was performed.
Results: After PSM, 184 patients were included in each group. The mean CHA2DS2-VASc score was 3.1 ± 1.5 (LACbes®) vs. 3.1 ± 1.4 (WATCHMAN), and the HAS-BLED score was 2.7 ± 1.1 vs. 2.7 ± 1.0. At a mean follow-up of 2.5 ± 1.5 vs. 2.4 ± 0.9 years, the defined three endpoints were comparable between the two groups. The occurrence of all-cause stroke was lower in 5/452 (1.8%) with LACbes® vs. 16/433 (3.7%) with WATCHMAN occluders (HR, 0.40, 95% confidence interval (CI), 0.18-0.89, P = 0.023), and the incidence of any bleeding was higher in the WATCHMAN group (41/433, 9.5% vs. 8/452, 1.8%; HR, 0.19, 95% CI, 0.11-0.33).
Conclusion: The LACbes® occluder exhibited comparable safety and efficacy of stroke prevention for AF when compared with the WATCHMAN device.
期刊介绍：
BMC Cardiovascular Disorders is an open access, peer-reviewed journal that considers articles on all aspects of the prevention, diagnosis and management of disorders of the heart and circulatory system, as well as related molecular and cell biology, genetics, pathophysiology, epidemiology, and controlled trials.
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