Net Clinical Benefit of Left Atrial Appendage Occlusion After Intracerebral Hemorrhage in Atrial Fibrillation: A Focused Review and Benchmark-Adjusted Secondary Analysis

Background/Objectives: Atrial fibrillation (AF) after intracerebral hemorrhage (ICH) creates a therapeutic conflict: withholding oral anticoagulation may increase ischemic stroke risk, whereas resumption of anticoagulation may increase recurrent ICH. Left atrial appendage occlusion (LAAO) offers a nonpharmacologic alternative, but isolated stroke or bleeding rates do not describe the overall benefit–harm balance. This focused review examines net clinical benefit (NCB) as a decision framework for LAAO after ICH and presents a secondary benchmark-adjusted analysis derived from our prior systemaatic review and meta-analysis. Methods: Thirteen endocardial LAAO cohorts with complete data for ischemic stroke, recurrent ICH, major bleeding, and all-cause death contributed to the analysis. The component event data and prespecified severity weights were carried forward from the prior meta-analysis; the external benchmark comparison, study-level benchmark-adjusted NCB synthesis, and benchmark-sensitivity analyses were not part of that report and constitute the distinct secondary analysis presented here. Results: Prespecified external benchmark rates were 8.0, 2.0, 3.0, and 6.0 events per 100 patient-years, respectively. Unweighted and severity-weighted NCB were evaluated using both pooled-rate and study-level Hartung–Knapp random-effects approaches. Study-level pooled NCB was 12.20 events per 100 patient-years (95% CI, 8.61–15.79; I2 = 96%), and weighted NCB was 14.39 (95% CI, 8.84–19.94; I2 = 94%). Additional two-component analyses using PRESTIGE-AF reference rates yielded unweighted NCB estimates of 5.65 and 2.06 events per 100 patient-years for no-OAC and DOAC comparator scenarios, respectively. Excluding all-cause mortality from the original model yielded an unweighted NCB of 8.41. These exploratory results highlight the sensitivity of NCB estimates to comparator selection and endpoint composition. Conclusions: Contemporary randomized evidence, including PRESTIGE-AF, CLOSURE-AF, and CHAMPION-AF, reinforces that benefit–harm balance is population-, comparator-, endpoint-, and time-horizon-dependent. Accordingly, these NCB estimates should be interpreted as decision-analytic and hypothesis-generating rather than causal treatment effects. ICH-specific randomized comparisons remain essential.

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Journal
Journal of Clinical Medicine
Published
2026-11-05
DOI
https://doi.org/10.3390/jcm15218612
Primary Topic
Atrial Fibrillation Management and Outcomes
Type
article
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article

Net Clinical Benefit of Left Atrial Appendage Occlusion After Intracerebral Hemorrhage in Atrial Fibrillation: A Focused Review and Benchmark-Adjusted Secondary Analysis

IOANNIS A. PARASKEVAIDIS, Basel Ramlawi, Serge Sicouri, Christos Kourek et al.
Journal of Clinical Medicine
Atrial Fibrillation Management and Outcomes
article

Net Clinical Benefit of Left Atrial Appendage Occlusion After Intracerebral Hemorrhage in Atrial Fibrillation: A Focused Review and Benchmark-Adjusted Secondary Analysis

IOANNIS A. PARASKEVAIDIS, Basel Ramlawi, Serge Sicouri, Christos Kourek, Dimitrios E. Magouliotis, Αlexandros Briasoulis, Andrew V. Xanthopoulos
article en

Abstract

Background/Objectives: Atrial fibrillation (AF) after intracerebral hemorrhage (ICH) creates a therapeutic conflict: withholding oral anticoagulation may increase ischemic stroke risk, whereas resumption of anticoagulation may increase recurrent ICH. Left atrial appendage occlusion (LAAO) offers a nonpharmacologic alternative, but isolated stroke or bleeding rates do not describe the overall benefit–harm balance. This focused review examines net clinical benefit (NCB) as a decision framework for LAAO after ICH and presents a secondary benchmark-adjusted analysis derived from our prior systemaatic review and meta-analysis. Methods: Thirteen endocardial LAAO cohorts with complete data for ischemic stroke, recurrent ICH, major bleeding, and all-cause death contributed to the analysis. The component event data and prespecified severity weights were carried forward from the prior meta-analysis; the external benchmark comparison, study-level benchmark-adjusted NCB synthesis, and benchmark-sensitivity analyses were not part of that report and constitute the distinct secondary analysis presented here. Results: Prespecified external benchmark rates were 8.0, 2.0, 3.0, and 6.0 events per 100 patient-years, respectively. Unweighted and severity-weighted NCB were evaluated using both pooled-rate and study-level Hartung–Knapp random-effects approaches. Study-level pooled NCB was 12.20 events per 100 patient-years (95% CI, 8.61–15.79; I2 = 96%), and weighted NCB was 14.39 (95% CI, 8.84–19.94; I2 = 94%). Additional two-component analyses using PRESTIGE-AF reference rates yielded unweighted NCB estimates of 5.65 and 2.06 events per 100 patient-years for no-OAC and DOAC comparator scenarios, respectively. Excluding all-cause mortality from the original model yielded an unweighted NCB of 8.41. These exploratory results highlight the sensitivity of NCB estimates to comparator selection and endpoint composition. Conclusions: Contemporary randomized evidence, including PRESTIGE-AF, CLOSURE-AF, and CHAMPION-AF, reinforces that benefit–harm balance is population-, comparator-, endpoint-, and time-horizon-dependent. Accordingly, these NCB estimates should be interpreted as decision-analytic and hypothesis-generating rather than causal treatment effects. ICH-specific randomized comparisons remain essential.

Journal of Clinical MedicineVol. 15(21)
Lankenau Institute for Medical Research (US), National and Kapodistrian University of Athens (GR), Lankenau Medical Center (US), University Hospital of Larissa (GR)
Openalex Percentile: Top 12%
Atrial Fibrillation Management and Outcomes
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