Impact of Operator Experience on Left Atrial Appendage Occlusion Outcomes.

IF 8 1区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

JACC. Clinical electrophysiology Pub Date : 2024-08-19 DOI:10.1016/j.jacep.2024.07.010

Tingting Zhang,Chao Gao,Jianzheng Liu,Guotao Fu,Boyu Li,Haitao Liu,Ruining Zhang,Ping Wang,Zhongping Ning,Bing Yang,Huimin Chu,Ben He,Junfeng Zhang,Ling Zhou,Yuechun Li,Yushun Zhang,Hao Hu,Yawei Xu,Jie Zeng,Jun Guo,Xi Su,Osama Soliman,Patrick W Serruys,Ling Tao,

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引用次数: 0

Abstract

BACKGROUND The relationship between long-term outcomes and operator experience for left atrial appendage occlusion (LAAO) is still unknown. OBJECTIVES This study sought to explore the association between operator LAAO experience and one-year clinical outcomes. METHODS The RECORD study (Registry to Evaluate Chinese Real-World Clinical Outcomes in Patients With AF Using the WATCHMAN Left Atrial Appendage Closure Technology; NCT03917563) was a multicenter, prospective registry that included patients with the WATCHMAN LAAO device (Boston Scientific) in China from April 1, 2019, to October 31, 2020. The current analyses included patients with solely LAAO from the registry; those who had concomitant LAAO and ablation/other procedures were excluded. The primary outcome was a composite endpoint of death, stroke, systemic embolism, and Bleeding Academic Research Consortium (BARC)-defined type 3 or 5 bleeding at 1 year. RESULTS A total of 1,547 LAAO patients and 111 operators were included. The mean ± SD CHA2DS2-VASc and HAS-BLED scores of patients were 4.0 ± 1.8 and 2.5 ± 1.1, respectively. The mean ± SD age of operators was 47.0 ± 7.2 years, 15 (13.5%) were female, and 52 (46.8%) were electrophysiologists. Utilizing maximally selected log-rank statistics, the thresholds to categorize an experienced operator were performing ≥32 LAAOs annually or ≥134 LAAOs in total. Performing ≥32 LAAOs annually is the better criterion than ≥134 LAAOs in total (absolute net reclassification index: 25.79%; P < 0.001). Compared with the ≥32 LAAO annually group, the <32 group was associated with a 1.8-fold (HRadjusted: 1.79; 95% CI: 1.16-2.78; P = 0.009) increase in the risk of the primary endpoint, and such risk in the <32 group can be reduced by ∼12% after performing each additional 5 cases (HRadjusted per 5 cases: 0.88; 95% CI: 0.78-0.99; P = 0.033). CONCLUSIONS Performing ≥32 LAAOs annually could be a threshold to categorize an experienced operator. Before reaching this threshold, the risk of death, stroke, systemic embolism, and BARC-defined type 3 or 5 bleeding decreased by 12% after every 5 cases performed.

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操作员经验对左心房阑尾闭塞术结果的影响

背景左心房阑尾闭塞术（LAAO）的长期疗效与操作者经验之间的关系尚不清楚。目的本研究旨在探讨操作者的 LAAO 经验与一年临床疗效之间的关系。方法RECORD研究（使用WATCHMAN左心房阑尾闭塞技术评估中国房颤患者真实世界临床结局的注册研究；NCT03917563）是一项多中心、前瞻性注册研究，纳入了2019年4月1日至2020年10月31日期间在中国使用WATCHMAN LAAO设备（波士顿科学公司）的患者。目前的分析包括登记中仅患有 LAAO 的患者；同时患有 LAAO 和消融术/其他手术的患者不包括在内。主要结果是1年内死亡、中风、全身性栓塞和出血学术研究联盟（BARC）定义的3型或5型出血的复合终点。结果共纳入1547名LAAO患者和111名操作者。患者的 CHA2DS2-VASc 和 HAS-BLED 评分的平均值（± SD）分别为 4.0 ± 1.8 和 2.5 ± 1.1。操作人员的平均（±SD）年龄为 47.0 ± 7.2 岁，15 人（13.5%）为女性，52 人（46.8%）为电生理学家。利用最大选择对数秩统计法，将每年进行的 LAAO ≥32 例或总共进行的 LAAO ≥134 例作为有经验操作者的阈值。每年进行的 LAAO ≥32 例是比总共进行的 LAAO ≥134 例更好的标准（绝对净重新分类指数：25.79%；P <0.001）。与每年 LAAO ≥32 例组相比，＜32 例组的主要终点风险增加了 1.8 倍（调整后 HR：1.79；95% CI：1.16-2.78；P = 0.009），而每增加 5 例，＜32 例组的主要终点风险可降低 12%（每 5 例调整后 HR：0.结论每年进行≥32例LAAO可作为划分有经验操作者的阈值。在达到这一阈值之前，每完成 5 例手术，死亡、中风、全身性栓塞和 BARC 定义的 3 型或 5 型出血的风险就会降低 12%。

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来源期刊

JACC. Clinical electrophysiology CARDIAC & CARDIOVASCULAR SYSTEMS-

CiteScore

10.30

自引率

5.70%

发文量

250

期刊介绍： JACC: Clinical Electrophysiology is one of a family of specialist journals launched by the renowned Journal of the American College of Cardiology (JACC). It encompasses all aspects of the epidemiology, pathogenesis, diagnosis and treatment of cardiac arrhythmias. Submissions of original research and state-of-the-art reviews from cardiology, cardiovascular surgery, neurology, outcomes research, and related fields are encouraged. Experimental and preclinical work that directly relates to diagnostic or therapeutic interventions are also encouraged. In general, case reports will not be considered for publication.