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Peer-reviewedCC BY 4.0Journal of Clinical Medicine

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

  • Christos Kourek1
  • Serge Sicouri1
  • Alexandros Briasoulis2
  • Dimitrios E. Magouliotis1
  • Andrew Xanthopoulos3
  • Ioannis Paraskevaidis4
  • Basel Ramlawi1,5
5 affiliations
  1. 1Department of Cardiac Surgery Research, Lankenau Institute for Medical Research, Wynnewood, PA 19096, USA
  2. 2Amyloidosis Center of Excellence, Department of Therapeutics, National and Kapodistrian University of Athens, 11528 Athens, Greece
  3. 3Department of Cardiology, University Hospital of Larissa, 41334 Larissa, Greece
  4. 4Medical School of Athens, National and Kapodistrian University of Athens, 11527 Athens, Greece
  5. 5Department of Cardiac Surgery, Lankenau Medical Center, Wynnewood, PA 19096, USA
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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.

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Cite

BibTeXRIS
BibTeX
@article{kourek2026clinical,
  title = {{Net Clinical Benefit of Left Atrial Appendage Occlusion After Intracerebral Hemorrhage in Atrial Fibrillation: A Focused Review and Benchmark-Adjusted Secondary Analysis}},
  author = {Christos Kourek and Serge Sicouri and Alexandros Briasoulis and Dimitrios E. Magouliotis and Andrew Xanthopoulos and Ioannis Paraskevaidis and Basel Ramlawi},
  journal = {Journal of Clinical Medicine},
  year = {2026},
  month = nov,
  doi = {10.3390/jcm15218612},
  url = {https://www.mdpi.com/2077-0383/15/21/8612},
  note = {CC BY 4.0},
}
RIS
TY  - JOUR
TI  - Net Clinical Benefit of Left Atrial Appendage Occlusion After Intracerebral Hemorrhage in Atrial Fibrillation: A Focused Review and Benchmark-Adjusted Secondary Analysis
AU  - Christos Kourek
AU  - Serge Sicouri
AU  - Alexandros Briasoulis
AU  - Dimitrios E. Magouliotis
AU  - Andrew Xanthopoulos
AU  - Ioannis Paraskevaidis
AU  - Basel Ramlawi
PY  - 2026
DA  - 2026/11/05
JO  - Journal of Clinical Medicine
DO  - 10.3390/jcm15218612
UR  - https://www.mdpi.com/2077-0383/15/21/8612
AB  - 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.
SN  - 2077-0383
ER  -