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Observed versus Expected Ischemic and Bleeding Events Following Left Atrial Appendage Occlusion.

ABSTRACT: Data on the efficacy of left atrial appendage occlusion (LAAO) in clinical practice are limited. We performed a systematic review and meta-analysis of observational studies that reported observed versus expected rates of ischemic strokes and/or major bleeding following LAAO. Our primary end points were the pooled relative risk reduction (RRR) in ischemic stroke and major bleeding with corresponding 95% confidence intervals compared with what was expected by the CHA2DS2-VASc and HASBLED scores, respectively. Twenty-nine studies including 11,071 patients (age 74.0 ± 8.7 years, 60% males) met the inclusion criteria. The mean CHA2DS2-VASc score was 4.22 ± 1.48, and the mean HASBLED score was 3.04 ± 1.16. During 19,567 patient-year follow-up, 290 of 11,071 patients (2.62%) suffered an acute ischemic stroke. This represented a 73.6% (95% confidence interval 68.9-78.2%) RRR in ischemic strokes compared with what was expected based on the CHA2DS2-VASc score. A total of 26 studies reported observed versus expected major bleeding (10,056 patients; age 74.0 ± 8.7, 60% males). During 16,967 patient-year follow-up, 404 of 10,056 patients (4.0%) suffered a major bleeding event. This represented a 55% (95% confidence interval 44.2% to -65.9%) RRR in major bleeding compared with what was expected based on the HASBLED score. These estimates were consistent across subgroups stratified according to age, CHADS2VASc, HASBLED scores and type of LAAO device used. In conclusion, LAAO is associated with a favorable observed/expected ratio with regards to ischemic stroke and major bleeding in clinical practice. Future clinical trials remain essential to further assess the efficacy of LAAO via a direct comparison with oral anticoagulation.

SUBMITTER: Busu T

PROVIDER: S-EPMC7453959 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundLeft atrial appendage occlusion (LAAO) to prevent stroke in patients with atrial fibrillation has been evaluated in 2 randomized trials; post-approval clinical data are limited.ObjectivesThe purpose of this study was to describe the National Cardiovascular Data Registry (NCDR) LAAO Registry and present patient, hospital, and physician characteristics and in-hospital adverse event rates for Watchman procedures in the United States during its first 3 years.MethodsThe authors describe the LAAO Registry structure and governance, the outcome adjudication processes, and the data quality and collection processes. They characterize the patient population, performing hospitals, and in-hospital adverse event rates.ResultsA total of 38,158 procedures from 495 hospitals performed by 1,318 physicians in the United States were included between January 2016 and December 2018. The mean patient age was 76.1 ± 8.1 years, the mean CHA2DS2-VASc (congestive heart failure, hypertension, 65 years of age and older, diabetes mellitus, previous stroke or transient ischemic attack, vascular disease, 65 to 74 years of age, female) score was 4.6 ± 1.5, and the mean HAS-BLED (hypertension, abnormal renal/liver function, stroke, bleeding history or predisposition, labile international normalized ratio, elderly, drugs/alcohol concomitantly) score was 3.0 ± 1.1. The median annual number of LAAO procedures performed for hospitals was 30 (interquartile range: 18 to 44) and for physicians was 12 (interquartile range: 8 to 20). Procedures were canceled or aborted in 7% of cases; among cases in which a device was deployed, 98.1% were implanted with <5-mm leak. Major in-hospital adverse events occurred in 2.16% of patients; the most common complications were pericardial effusion requiring intervention (1.39%) and major bleeding (1.25%), whereas stroke (0.17%) and death (0.19%) were rare.ConclusionsThe LAAO Registry has enrolled >38,000 patients implanted with the device. Patients were generally older with more comorbidities than those enrolled in the pivotal trials; however, major in-hospital adverse event rates were lower than reported in those trials.

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Observed versus Expected Ischemic and Bleeding Events Following Left Atrial Appendage Occlusion.

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