Clinical Impact of Residual Leaks Following Left Atrial Appendage Occlusion: Insights From the NCDR LAAO Registry.

Clinical Impact of Residual Leaks Following Left Atrial Appendage Occlusion: Insights From the NCDR LAAO Registry.
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DOI:
10.1016/j.jacep.2022.03.001
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发表时间:
2022-06
影响因子:
7
通讯作者:
Holmes, David R.
Holmes, David R.
中科院分区:
医学1区
文献类型:
--
作者:
Alkhouli, Mohamad;Du, Chengan;Killu, Ammar;Simard, Trevor;Noseworthy, Peter A.;Friedman, Paul A.;Curtis, Jeptha P.;V. Freeman, James;Holmes, David R.

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关于左心耳封堵术[LAAO]后器械周围残余泄漏影响的数据有限。探索器械周围泄漏与不良临床事件的相关性。我们查询了NCDR-LAAO登记研究,以确定2016年1月1日至2019年12月31日期间接受LAAO的患者。根据45+/-14天超声心动图的泄漏大小对患者进行分类:(0 mm,无泄漏; >0- 5 mm,小泄漏; > 5 mm,大泄漏)。共纳入51,333例患者,其中37,696例(73.4%)无泄漏,13,258例(25.8%)有小泄漏,379例(0.7%)有大泄漏。在45天时,大剂量组与小剂量组或无泄漏组相比,接受华法林治疗的患者比例更高(分别为44.9%与34.4%和32.4%,p<0.001)。在6个月和12个月时,抗凝剂使用减少,但在大渗漏患者中仍然更频繁。血栓栓塞事件在所有组中均不常见。然而,与无渗漏的患者相比,有少量渗漏的患者发生卒中/TIA/全身性栓塞的几率略高(调整后风险比[aHR] 1.152,95%CI 1.025-1.294)、大出血(HR 1.11,95%CI 1.029-1.120)和任何重大不良事件(HR 1.102,95%CI 1.048-1.160)。大泄漏患者与小泄漏或无泄漏患者之间的不良事件无显著差异。LAAO术后的小泄漏(0- 5 mm)与血栓栓塞和出血事件的发生率适度较高相关;大泄漏(> 5 mm)与不良事件无关,尽管这些患者中维持抗凝治疗的比例较高。具有改进密封的较新器械可能会缓解与残留泄漏相关的事件。我们查询了NCDR LAAO登记研究,以比较根据45天TEE时残余漏大小分层的LAAO术后临床结局。37,696例(73.4%)无器械周围泄漏,13,258例(25.8%)有少量泄漏,379例(0.7%)有大量泄漏。与无泄漏相比,有小泄漏的患者发生卒中/短暂性脑缺血发作/全身栓塞(aHR 1.152,95%CI 1.025-1.294)、大出血(HR 1.11,95%CI 1.029-1.120)和任何重大不良事件(HR 1.102,95%CI 1.048-1.160)的几率略高。大泄漏与较高的不良事件无关,尽管这些患者中有较高比例在45天、6个月和1年时维持抗凝治疗。
Data on the impact of residual peri-device leak following left atrial appendage occlusion [LAAO] are limited. to explore the association of peri-device leak with adverse clinical events. We queried the NCDR-LAAO Registry to identify patients undergoing LAAO between January-1st, 2016, and December-31st, 2019. Patients were classified according to leak size on 45+/−14 days echocardiography: (0mm, no leak; >0–5mm, small leak; >5mm, large leak). A total of 51,333 patients were included, of whom 37,696 (73.4%) had no leak, 13,258 (25.8%) had small leaks, and 379 (0.7%) had large leaks. The proportion of patients on warfarin at 45-day was higher in the large vs. small or no leak cohort (44.9% vs. 34.4% and 32.4%, respectively, p<0.001). At 6- and 12-month, anticoagulant utilization decreased but remained more frequent in patients with large leaks. Thromboembolic events were uncommon in all groups. However, compared with patients with no leak, those with small leaks had slightly higher odds of stroke/TIA/systemic embolization (adjusted hazard ratio [aHR] 1.152, 95%CI 1.025–1.294), major bleeding (HR 1.11, 95%CI 1.029–1.120), and any major adverse events (HR 1.102, 95%CI 1.048–1.160). There were no significant differences in adverse events between patients with large leaks and patients with small or no leaks. Small (0–5mm) leaks after LAAO were associated with modestly higher incidences of thromboembolic and bleeding events; large leaks (>5mm) were not associated with adverse events although higher proportions of these patients were maintained on anticoagulation. Newer devices with improved seal might mitigate the events associated with residual leaks. We queried the NCDR LAAO Registry to compare post-LAAO clinical outcomes stratified by the size of residual leak at 45-day TEE. Peri-device leak was absent in 37,696 (73.4%), small in 13,258 (25.8%), and large in 379 (0.7%). Compared with no leak, patients with small leaks had slightly higher odds of stroke/transient ischemic attacks/systemic embolization (aHR 1.152, 95%CI 1.025–1.294), major bleeding (HR 1.11, 95%CI 1.029–1.120), and any major adverse events (HR 1.102, 95%CI 1.048–1.160). Large leaks were not associated with higher adverse events although a higher proportion of those patients were maintained on anticoagulation at 45-day, 6-month, and 1-year.
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