A newly designed disk-lobe occluder with isogenous barbs for left atrial appendage closure: Initial multicenter experience
BackgroundAlthough the implant success rate of left atrial appendage closure (LAAC) has increased and complications have decreased over time, there are still anatomically and technically complicated cases where novel LAA occluders may simplify the procedure and thus might potentially improve the cli...
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| Format: | Article |
| Language: | English |
| Published: |
Frontiers Media S.A.
2022-09-01
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| Series: | Frontiers in Cardiovascular Medicine |
| Subjects: | |
| Online Access: | https://www.frontiersin.org/articles/10.3389/fcvm.2022.974994/full |
| _version_ | 1798025120400277504 |
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| author | Yuan Bai Xuechao Tang Xudong Xu Xianxian Zhao Yawei Xu Wei Chen Xianyang Zhu Qiguang Wang Zhihua Han Changqian Wang Lu He Yushun Zhang Xin Pan Cheng Wang Lianglong Chen Xuejiang Cen Baiming Qu Ni Zhu Sha Zhang Xinmiao Huang Yongwen Qin |
| author_facet | Yuan Bai Xuechao Tang Xudong Xu Xianxian Zhao Yawei Xu Wei Chen Xianyang Zhu Qiguang Wang Zhihua Han Changqian Wang Lu He Yushun Zhang Xin Pan Cheng Wang Lianglong Chen Xuejiang Cen Baiming Qu Ni Zhu Sha Zhang Xinmiao Huang Yongwen Qin |
| author_sort | Yuan Bai |
| collection | DOAJ |
| description | BackgroundAlthough the implant success rate of left atrial appendage closure (LAAC) has increased and complications have decreased over time, there are still anatomically and technically complicated cases where novel LAA occluders may simplify the procedure and thus might potentially improve the clinical outcome.ObjectivesThis study aimed to assess the safety and efficacy of the newly designed device with isogenous barbs in LAAC.MethodsEight centers in China participated in this prospective study from July 2016 to April 2018. Peri- and post-procedural safety and efficacy were evaluated through scheduled follow-ups and transesophageal echocardiography (TEE).ResultsA total of 175 patients with a mean age of 68.4 ± 9.2 years old, a mean CHA2DS2-VASc score of 4.7 ± 1.8, and a mean HAS-BLED score of 3.2 ± 1.3, were included. The device was successfully implanted in 173 patients (98.9%). The device size ranged from 18 to 34 mm. Clinically relevant pericardial effusion (PEF) in the perioperative period, occurred in 3 patients (1.7%). TEE follow-up was available in 167 (96.5%) patients at 12-month. During follow-up, 9 patients suffered serious adverse event: 4 death (2.3%), 1 ischemic stroke (0.6%), and 2 gastro-intestinal bleeding (1.2%) and 2 device-related thrombus (DRT) (1.2%). Estimated annual thromboembolism rate reduced by 90% and estimated annual major bleeding rate reduced by 81% after LAAC with the newly designed device.ConclusionThe newly designed device with isogenous barbs for LAAC could be performed effectively with a low incidence of adverse events and a high incidence of anatomic closure. |
| first_indexed | 2024-04-11T18:13:38Z |
| format | Article |
| id | doaj.art-dc65ddbf01e1486aaa1c4da25ff77ff5 |
| institution | Directory Open Access Journal |
| issn | 2297-055X |
| language | English |
| last_indexed | 2024-04-11T18:13:38Z |
| publishDate | 2022-09-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Cardiovascular Medicine |
| spelling | doaj.art-dc65ddbf01e1486aaa1c4da25ff77ff52022-12-22T04:10:01ZengFrontiers Media S.A.Frontiers in Cardiovascular Medicine2297-055X2022-09-01910.3389/fcvm.2022.974994974994A newly designed disk-lobe occluder with isogenous barbs for left atrial appendage closure: Initial multicenter experienceYuan Bai0Xuechao Tang1Xudong Xu2Xianxian Zhao3Yawei Xu4Wei Chen5Xianyang Zhu6Qiguang Wang7Zhihua Han8Changqian Wang9Lu He10Yushun Zhang11Xin Pan12Cheng Wang13Lianglong Chen14Xuejiang Cen15Baiming Qu16Ni Zhu17Sha Zhang18Xinmiao Huang19Yongwen Qin20Department of Cardiology, Shanghai Changhai Hospital, Navy Military Medical University, Shanghai, ChinaDepartment of Cardiology, The 960th Hospital of People’s Liberation Army, Tai’an, ChinaDepartment of Cardiology, Shanghai Changhai Hospital, Navy Military Medical University, Shanghai, ChinaDepartment of Cardiology, Shanghai Changhai Hospital, Navy Military Medical University, Shanghai, ChinaDepartment of Cardiology, Shanghai Tenth People’s Hospital, Tongji University School of Medicine, Shanghai, ChinaDepartment of Cardiology, Shanghai Tenth People’s Hospital, Tongji University School of Medicine, Shanghai, ChinaDepartment of Congenital Heart Disease, General Hospital of Northern Theater Command, Shenyang, ChinaDepartment of Congenital Heart Disease, General Hospital of Northern Theater Command, Shenyang, ChinaDepartment of Cardiology, Shanghai Ninth People’s Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, ChinaDepartment of Cardiology, Shanghai Ninth People’s Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, ChinaDepartment of Structural Heart Disease, The First Affiliated Hospital of Xi’an Jiaotong University, Xi’an, ChinaDepartment of Structural Heart Disease, The First Affiliated Hospital of Xi’an Jiaotong University, Xi’an, ChinaDepartment of Cardiology, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, ChinaDepartment of Cardiology, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, ChinaDepartment of Cardiology, Fujian Medical University Affiliated Union Hospital, Fuzhou, ChinaDepartment of Cardiology, Zhejiang Provincial People’s Hospital, Hangzhou, ChinaDepartment of Cardiology, Zhejiang Provincial People’s Hospital, Hangzhou, ChinaDepartment of Cardiology, Shanghai Changhai Hospital, Navy Military Medical University, Shanghai, ChinaDepartment of Cardiology, Shanghai Changhai Hospital, Navy Military Medical University, Shanghai, ChinaDepartment of Cardiology, Shanghai Changhai Hospital, Navy Military Medical University, Shanghai, ChinaDepartment of Cardiology, Shanghai Changhai Hospital, Navy Military Medical University, Shanghai, ChinaBackgroundAlthough the implant success rate of left atrial appendage closure (LAAC) has increased and complications have decreased over time, there are still anatomically and technically complicated cases where novel LAA occluders may simplify the procedure and thus might potentially improve the clinical outcome.ObjectivesThis study aimed to assess the safety and efficacy of the newly designed device with isogenous barbs in LAAC.MethodsEight centers in China participated in this prospective study from July 2016 to April 2018. Peri- and post-procedural safety and efficacy were evaluated through scheduled follow-ups and transesophageal echocardiography (TEE).ResultsA total of 175 patients with a mean age of 68.4 ± 9.2 years old, a mean CHA2DS2-VASc score of 4.7 ± 1.8, and a mean HAS-BLED score of 3.2 ± 1.3, were included. The device was successfully implanted in 173 patients (98.9%). The device size ranged from 18 to 34 mm. Clinically relevant pericardial effusion (PEF) in the perioperative period, occurred in 3 patients (1.7%). TEE follow-up was available in 167 (96.5%) patients at 12-month. During follow-up, 9 patients suffered serious adverse event: 4 death (2.3%), 1 ischemic stroke (0.6%), and 2 gastro-intestinal bleeding (1.2%) and 2 device-related thrombus (DRT) (1.2%). Estimated annual thromboembolism rate reduced by 90% and estimated annual major bleeding rate reduced by 81% after LAAC with the newly designed device.ConclusionThe newly designed device with isogenous barbs for LAAC could be performed effectively with a low incidence of adverse events and a high incidence of anatomic closure.https://www.frontiersin.org/articles/10.3389/fcvm.2022.974994/fullstrokeatrial fibrillationleft atrial appendagepercutaneous left atrial appendage closurecomplications |
| spellingShingle | Yuan Bai Xuechao Tang Xudong Xu Xianxian Zhao Yawei Xu Wei Chen Xianyang Zhu Qiguang Wang Zhihua Han Changqian Wang Lu He Yushun Zhang Xin Pan Cheng Wang Lianglong Chen Xuejiang Cen Baiming Qu Ni Zhu Sha Zhang Xinmiao Huang Yongwen Qin A newly designed disk-lobe occluder with isogenous barbs for left atrial appendage closure: Initial multicenter experience Frontiers in Cardiovascular Medicine stroke atrial fibrillation left atrial appendage percutaneous left atrial appendage closure complications |
| title | A newly designed disk-lobe occluder with isogenous barbs for left atrial appendage closure: Initial multicenter experience |
| title_full | A newly designed disk-lobe occluder with isogenous barbs for left atrial appendage closure: Initial multicenter experience |
| title_fullStr | A newly designed disk-lobe occluder with isogenous barbs for left atrial appendage closure: Initial multicenter experience |
| title_full_unstemmed | A newly designed disk-lobe occluder with isogenous barbs for left atrial appendage closure: Initial multicenter experience |
| title_short | A newly designed disk-lobe occluder with isogenous barbs for left atrial appendage closure: Initial multicenter experience |
| title_sort | newly designed disk lobe occluder with isogenous barbs for left atrial appendage closure initial multicenter experience |
| topic | stroke atrial fibrillation left atrial appendage percutaneous left atrial appendage closure complications |
| url | https://www.frontiersin.org/articles/10.3389/fcvm.2022.974994/full |
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