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Zhao, Mingzhong, Hou, Cody R., Xiong, Xiaolin, Post, Felix, Herold, Nora and Yu, Jiangtao (2021). Safety and effectiveness of left atrial appendage closure in patients with non-valvular atrial fibrillation and prior major bleeding. Expert Rev. Med. Devices, 18 (12). S. 1209 - 1218. ABINGDON: TAYLOR & FRANCIS LTD. ISSN 1745-2422

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Abstract

Objectives To investigate safety and effectiveness of left atrial appendage closure (LAAC) in atrial fibrillation patients with prior major bleeding. Methods A total of 377 consecutive patients scheduled for LAAC with Watchman device were divided into bleeding group (n = 137) and non-bleeding group (n = 240). Data were compared between groups. Results The bleeding group had more patients >= 75 years old (P = 0.044), higher CHA(2)DS(2)-VASc (P = 0.029) and HAS-BLED scores (P = 0.001) than the non-bleeding group. During the long-term follow-up, except for thromboembolism event (P = 0.031), the incidences of major bleeding , all-cause death , co-primary efficacy events , and the cumulative survival ratio after adjustment of confounding factors were comparable. The observed thromboembolism rate was reduced by 86.3% (P = 0.0002) and 55.1% (P = 0.0293) and the observed major bleeding rate was decreased by 61.9% (P = 0.0393) and 35.7% (P = 0.2426) compared with expected risks in bleeding and non-bleeding groups, respectively. The risk reduction in thromboembolism and major bleeding were significantly greater in bleeding group versus non-bleeding group (all P < 0.0001). Conclusions Among patients with prior bleeding, LAAC is a safe and effective alternative to anticoagulation therapy and seems to emerge as a higher efficacy in risk reduction of thromboembolism and major bleeding compared to those without prior bleeding.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Zhao, Mingzhong UNSPECIFIED UNSPECIFIED UNSPECIFIED Hou, Cody R. UNSPECIFIED UNSPECIFIED UNSPECIFIED Xiong, Xiaolin UNSPECIFIED UNSPECIFIED UNSPECIFIED Post, Felix UNSPECIFIED UNSPECIFIED UNSPECIFIED Herold, Nora UNSPECIFIED UNSPECIFIED UNSPECIFIED Yu, Jiangtao UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-586536
DOI:	10.1080/17434440.2021.2011718
Journal or Publication Title:	Expert Rev. Med. Devices
Volume:	18
Number:	12
Page Range:	S. 1209 - 1218
Date:	2021
Publisher:	TAYLOR & FRANCIS LTD
Place of Publication:	ABINGDON
ISSN:	1745-2422
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language STROKE; WARFARIN; RISK; OUTCOMES; DEVICE Multiple languages Engineering, Biomedical Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/58653