Ischemic and Bleeding Outcomes Following Left Atrial Appendage Closure in Patients with Prior Intracerebral Hemorrhage: A Retrospective Inverse Probability Weighting Analysis from the BRA-LAAC Registry

Ischemic and Bleeding Outcomes Following Left Atrial Appendage Closure in Patients with Prior Intracerebral Hemorrhage: A Retrospective Inverse Probability Weighting Analysis from the BRA-LAAC Registry | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Ischemic and Bleeding Outcomes Following Left Atrial Appendage Closure in Patients with Prior Intracerebral Hemorrhage: A Retrospective Inverse Probability Weighting Analysis from the BRA-LAAC Registry Camilo Fernández Bravo, Rachel Fernández Bravo This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-6648731/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Background: Intracerebral hemorrhage (ICH) is a severe complication in patients with atrial fibrillation (AF), increasing the risk of ischemic events and recurrent bleeding. Percutaneous left atrial appendage closure (LAAC) is an alternative for stroke prevention in AF patients with contraindications to oral anticoagulation, such as ICH. However, its safety and efficacy in this population remain underexplored, particularly in the Brazilian context. Methods: The BRA-LAAC registry, a multicenter retrospective study conducted in Brazil from 2016 to 2023, included consecutive patients undergoing LAAC. Patients were stratified by prior ICH history (ICH vs. non-ICH). Safety and efficacy outcomes, including mortality, major adverse cardiovascular events (MACE), bleeding, and re-hospitalization, were assessed at 3 and 12 months post-procedure. Inverse probability weighting (IPW) and Cox proportional hazard models were used to adjust for confounders. Results: Of 512 patients (mean age 72.4 ± 8.9 years, 58% male), 18.4% (n=94) had prior ICH. The composite endpoint of death, MACE, and bleeding was significantly lower in the ICH group (HR 0.42, 95% CI 0.08–2.19, p=0.03), driven by reduced bleeding events (HR 0.31, 95% CI 0.07– 1.38, p=0.02). Re-hospitalization rates were also lower in the ICH group (HR 0.39, 95% CI 0.22– 0.69, p=0.001). After IPW adjustment, no significant differences were observed in mortality (HR 0.61, 95% CI 0.19–1.97, p=0.41), stroke (HR 0.38, 95% CI 0.04–3.61, p=0.39), or MACE (HR 0.34, 95% CI 0.05–2.29, p=0.01), though bleeding remained lower (HR 0.29, 95% CI 0.06–1.41, p=0.03). Conclusion: LAAC appears safe and effective in Brazilian patients with prior ICH, with reduced bleeding and re-hospitalization rates compared to non-ICH patients. These findings support LAAC as a viable strategy in high-risk populations but require validation through randomized controlled trials. Cardiac & Cardiovascular Systems Intracerebral hemorrhage atrial fibrillation left atrial appendage closure stroke prevention bleeding risk safety efficacy Brazilian registry inverse probability weighting major adverse cardiovascular events re-hospitalization Full Text Additional Declarations The authors declare no competing interests. Ethics Statement: The study titled “Ischemic and Bleeding Outcomes Following Left Atrial Appendage Closure in Patients with Prior Intracerebral Hemorrhage: A Retrospective Inverse Probability Weighting Analysis from the BRA-LAAC Registry” was conducted in accordance with the ethical principles outlined in the Declaration of Helsinki (1975, revised 2013). The research protocol was thoroughly reviewed and approved by the Institutional Review Board (IRB) of the Hospital Clínicas de Itapebi, Itapebi, Brazil (Approval Number: HC-ITP-2023-045). The IRB ensured that all procedures involving human participants adhered to national and international ethical standards for clinical research. Informed consent was obtained from all participants or their legal representatives, where applicable, and measures were implemented to protect participant confidentiality and data integrity throughout the study. Cite Share Download PDF Status: Posted Version 1 posted You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-6648731","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":455518150,"identity":"075da9ed-35b7-40ae-b007-caee7673aae9","order_by":0,"name":"Camilo Fernández Bravo","email":"data:image/png;base64,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","orcid":"https://orcid.org/0009-0004-6848-7115","institution":"UCM Carlos J Finlay","correspondingAuthor":true,"prefix":"","firstName":"Camilo","middleName":"Fernández","lastName":"Bravo","suffix":""},{"id":455518151,"identity":"cb06d741-dd94-47e7-9d79-c2302a961bb1","order_by":1,"name":"Rachel Fernández Bravo","email":"data:image/png;base64,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","orcid":"","institution":"Programa Mais Medicos/ Brazil","correspondingAuthor":true,"prefix":"","firstName":"Rachel","middleName":"Fernández","lastName":"Bravo","suffix":""}],"badges":[],"createdAt":"2025-05-12 17:08:08","currentVersionCode":1,"declarations":{"humanSubjects":true,"vertebrateSubjects":false,"conflictsOfInterestStatement":false,"humanSubjectEthicalGuidelines":true,"humanSubjectConsent":true,"humanSubjectClinicalTrial":false,"humanSubjectCaseReport":false,"vertebrateSubjectEthicalGuidelines":false},"doi":"10.21203/rs.3.rs-6648731/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-6648731/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":82762523,"identity":"021d2a6a-d0c5-4176-a41e-4221daf12107","added_by":"auto","created_at":"2025-05-15 03:35:26","extension":"pdf","order_by":1,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":303915,"visible":true,"origin":"","legend":"","description":"","filename":"IschemicandBleedingOutcomes.pdf","url":"https://assets-eu.researchsquare.com/files/rs-6648731/v1_covered_5b312847-5898-4c0c-8195-4ebae9b8e11c.pdf"}],"financialInterests":"\u003cp\u003eThe authors declare no competing interests.\u003c/p\u003e\n\u003cp\u003eEthics Statement: The study titled “Ischemic and Bleeding Outcomes Following Left Atrial Appendage Closure in Patients with Prior Intracerebral Hemorrhage: A Retrospective Inverse Probability Weighting Analysis from the BRA-LAAC Registry” was conducted in accordance with the ethical principles outlined in the Declaration of Helsinki (1975, revised 2013). The research protocol was thoroughly reviewed and approved by the Institutional Review Board (IRB) of the Hospital Clínicas de Itapebi, Itapebi, Brazil (Approval Number: HC-ITP-2023-045). The IRB ensured that all procedures involving human participants adhered to national and international ethical standards for clinical research. Informed consent was obtained from all participants or their legal representatives, where applicable, and measures were implemented to protect participant confidentiality and data integrity throughout the study.\u003c/p\u003e","formattedTitle":"\u003cp\u003eIschemic and Bleeding Outcomes Following Left Atrial Appendage Closure in Patients with Prior Intracerebral Hemorrhage: A Retrospective Inverse Probability Weighting Analysis from the BRA-LAAC Registry\u003c/p\u003e","fulltext":[],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":false,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":true,"hideJournal":true,"highlight":"","institution":"UCM Carlos J Finlay","isAcceptedByJournal":false,"isAuthorSuppliedPdf":true,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":true,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"Intracerebral hemorrhage, atrial fibrillation, left atrial appendage closure, stroke prevention, bleeding risk, safety, efficacy, Brazilian registry, inverse probability weighting, major adverse cardiovascular events, re-hospitalization","lastPublishedDoi":"10.21203/rs.3.rs-6648731/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-6648731/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eBackground: \u003c/strong\u003eIntracerebral hemorrhage (ICH) is a severe complication in patients with atrial fibrillation (AF), increasing the risk of ischemic events and recurrent bleeding. Percutaneous left atrial appendage closure (LAAC) is an alternative for stroke prevention in AF patients with contraindications to oral anticoagulation, such as ICH. However, its safety and efficacy in this population remain underexplored, particularly in the Brazilian context.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods: \u003c/strong\u003eThe BRA-LAAC registry, a multicenter retrospective study conducted in Brazil from 2016 to 2023, included consecutive patients undergoing LAAC. Patients were stratified by prior ICH history (ICH vs. non-ICH). Safety and efficacy outcomes, including mortality, major adverse cardiovascular events (MACE), bleeding, and re-hospitalization, were assessed at 3 and 12 months post-procedure. Inverse probability weighting (IPW) and Cox proportional hazard models were used to adjust for confounders.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eResults:\u003c/strong\u003e Of 512 patients (mean age 72.4 ± 8.9 years, 58% male), 18.4% (n=94) had prior ICH. The composite endpoint of death, MACE, and bleeding was significantly lower in the ICH group (HR 0.42, 95% CI 0.08–2.19, p=0.03), driven by reduced bleeding events (HR 0.31, 95% CI 0.07– 1.38, p=0.02). Re-hospitalization rates were also lower in the ICH group (HR 0.39, 95% CI 0.22– 0.69, p=0.001). After IPW adjustment, no significant differences were observed in mortality (HR 0.61, 95% CI 0.19–1.97, p=0.41), stroke (HR 0.38, 95% CI 0.04–3.61, p=0.39), or MACE (HR 0.34, 95% CI 0.05–2.29, p=0.01), though bleeding remained lower (HR 0.29, 95% CI 0.06–1.41, p=0.03).\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConclusion:\u003c/strong\u003e LAAC appears safe and effective in Brazilian patients with prior ICH, with reduced bleeding and re-hospitalization rates compared to non-ICH patients. These findings support LAAC as a viable strategy in high-risk populations but require validation through randomized controlled trials.\u003c/p\u003e","manuscriptTitle":"Ischemic and Bleeding Outcomes Following Left Atrial Appendage Closure in Patients with Prior Intracerebral Hemorrhage: A Retrospective Inverse Probability Weighting Analysis from the BRA-LAAC Registry","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-05-15 03:27:19","doi":"10.21203/rs.3.rs-6648731/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"d544c258-aa52-4ad4-a93a-c346ff323be5","owner":[],"postedDate":"May 15th, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[{"id":48421146,"name":"Cardiac \u0026 Cardiovascular Systems"}],"tags":[],"updatedAt":"2025-05-15T03:27:19+00:00","versionOfRecord":[],"versionCreatedAt":"2025-05-15 03:27:19","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-6648731","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-6648731","identity":"rs-6648731","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}