{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,8]],"date-time":"2026-10-08T12:28:08Z","timestamp":1791462488345,"version":"4.3.4"},"reference-count":111,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"5","content-domain":{"domain":["www.ahajournals.org"],"crossmark-restriction":true},"short-container-title":["Circ: Heart Failure"],"published-print":{"date-parts":[[2026,5]]},"abstract":"<jats:sec>\n                    <jats:title>BACKGROUND:<\/jats:title>\n                    <jats:p>Although adeno-associated virus (AAV) gene-replacement therapy is a potentially transformative therapy for severe genetic diseases, its cardiac immunotoxicity may challenge broad clinical use.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>METHODS:<\/jats:title>\n                    <jats:p>Medical Literature Analysis and Retrieval System Online, Embase, and PubMed databases were searched from January 2005 to March 2025. Studies including patients treated with AAV-replacement therapy were deemed eligible. Prespecified items (type of vector, dose, timing, and clinical significance of the adverse event) were extracted by 2 independent observers. Random-effects models were fitted using restricted maximum likelihood estimation and the method of Hartung, Knapp, Sidik, and Jonkman (International Prospective Register of Systematic Reviews [PROSPERO]. VigiBase and the US Food and Drug Administration Adverse Event Reporting System were searched for the occurrence of myocarditis with commercially available AAV-replacement drugs.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>RESULTS:<\/jats:title>\n                    <jats:p>\n                      Eighty studies including 1939 human patients were analyzed. A total of 734 adverse events were reported over 2122 patient-years of pooled observation. Seventy-one cases of myocarditis were identified. The pooled incidence rate per 100 patient-years was 8.6 (95% CI, 5.8\u201310.7;\n                      <jats:italic toggle=\"yes\">I<\/jats:italic>\n                      <jats:sup>2<\/jats:sup>\n                      =63.2%). Events occurred in patients with Duchenne muscular dystrophy, spinal muscular atrophy, and X-linked myotubular myopathy, with recombinant AAVs and adeno-associated virus serotype 8. All received an intravenous dose &gt;10\n                      <jats:sup>13<\/jats:sup>\n                      vector genomes per kilogram body weight. Myocardial injury peaked in week 1 after injection (90% [95% CI, 85.7%\u201396.2%];\n                      <jats:italic toggle=\"yes\">I<\/jats:italic>\n                      <jats:sup>2<\/jats:sup>\n                      =43.2%), whereas myocarditis occurred mostly after week 2 (55% [95% CI, 48.7%\u201365.2%];\n                      <jats:italic toggle=\"yes\">I<\/jats:italic>\n                      <jats:sup>2<\/jats:sup>\n                      =33.1%), with no cases after the first month. Most myocarditis\/myocardial injury did not have a relevant clinical impact (62, 87%), with only 8 (12%) cases having transient left ventricular dysfunction. The latter recovered during the follow-up. The only death occurred in the setting of cytokine-mediated capillary leak syndrome with cardiac dysfunction. Myocarditis occurred in relation to delandistrogene moxeparvovec (1\/16 [6%]) and onasemnogene abeparvovec (14\/217 [6%]) in the Food and Drug Administration Adverse Event Reporting System and VigiBase.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>CONCLUSIONS:<\/jats:title>\n                    <jats:p>\n                      Immune-mediated myocarditis\/myocardial injury after systemic AAV gene therapy occurred in &lt;10 per 100 patient-years (peaking at weeks 1\u20133) and was usually clinically mild, with a minority showing transient dysfunction. All events followed intravenous doses &gt;1\u00d710\n                      <jats:sup>1<\/jats:sup>\n                      <jats:sup>3<\/jats:sup>\n                      vector genomes per kilogram body weight, clustered in neuromuscular programs, and were associated with certain recombinant capsids\/serotypes. These data support intensive early cardiac monitoring, cautious dose selection, and delivery strategies to minimize systemic exposure.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>REGISTRATION:<\/jats:title>\n                    <jats:p>\n                      URL:\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/www.crd.york.ac.uk\/PROSPERO\/\">https:\/\/www.crd.york.ac.uk\/PROSPERO\/<\/jats:ext-link>\n                      ; Unique identifier: CRD420251046546).\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1161\/circheartfailure.125.013771","type":"journal-article","created":{"date-parts":[[2026,4,7]],"date-time":"2026-04-07T09:00:16Z","timestamp":1775552416000},"update-policy":"https:\/\/doi.org\/10.1161\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":2,"title":["Incidence, Timing and Clinical Significance of Immune-Mediated Myocardial Injury and Myocarditis After Gene Replacement Therapy: A Systematic Review and Meta-Analysis"],"prefix":"10.1161","volume":"19","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5819-204X","authenticated-orcid":true,"given":"Niccol\u00f2","family":"Maurizi","sequence":"first","affiliation":[{"name":"Cardiomyopathy Unit, Careggi University Hospital, Florence, Italy (N.M., A.A., I.O.)."},{"name":"Service of Cardiology, University Hospital of Lausanne (CHUV) and University of Lausanne (Unil), Switzerland (N.M.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1676-5257","authenticated-orcid":true,"given":"Enrico","family":"Ammirati","sequence":"additional","affiliation":[{"name":"De Gasperis Cardio Center, Transplant Center, Niguarda Hospital, Milano, Italy (E.A.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0000-5605-0646","authenticated-orcid":true,"given":"Elizabeth","family":"Silver","sequence":"additional","affiliation":[{"name":"Division of Cardiovascular Medicine, Department of Medicine, University of California San Diego (E.S., K.H., Q.B., E.D.A.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3293-138X","authenticated-orcid":true,"given":"Kimberly","family":"Hong","sequence":"additional","affiliation":[{"name":"Division of Cardiovascular Medicine, Department of Medicine, University of California San Diego (E.S., K.H., Q.B., E.D.A.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6070-6978","authenticated-orcid":true,"given":"Quan","family":"Bui","sequence":"additional","affiliation":[{"name":"Division of Cardiovascular Medicine, Department of Medicine, University of California San Diego (E.S., K.H., Q.B., E.D.A.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6394-9948","authenticated-orcid":true,"given":"Alessia","family":"Argir\u00f2","sequence":"additional","affiliation":[{"name":"Cardiomyopathy Unit, Careggi University Hospital, Florence, Italy (N.M., A.A., I.O.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1751-9266","authenticated-orcid":true,"given":"Iacopo","family":"Olivotto","sequence":"additional","affiliation":[{"name":"Cardiomyopathy Unit, Careggi University Hospital, Florence, Italy (N.M., A.A., I.O.)."},{"name":"Cardiology Unit, IRCCS Meyer\u2019s Children Hospital, Florence, Italy (I.O.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4765-0188","authenticated-orcid":true,"given":"Eric D.","family":"Adler","sequence":"additional","affiliation":[{"name":"Division of Cardiovascular Medicine, Department of Medicine, University of California San Diego (E.S., K.H., Q.B., E.D.A.)."}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"276","reference":[{"key":"e_1_3_3_2_2","doi-asserted-by":"publisher","DOI":"10.1038\/s41392-024-01780-w"},{"key":"e_1_3_3_3_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.ymthe.2019.12.010"},{"key":"e_1_3_3_4_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jchf.2023.09.015"},{"key":"e_1_3_3_5_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.ymthe.2021.01.016"},{"key":"e_1_3_3_6_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.ijcard.2023.131617"},{"key":"e_1_3_3_7_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.ymthe.2025.04.045"},{"key":"e_1_3_3_8_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.ymthe.2023.01.010"},{"key":"e_1_3_3_9_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.nmd.2023.09.008"},{"key":"e_1_3_3_10_2","doi-asserted-by":"publisher","DOI":"10.1001\/jama.283.15.2008"},{"key":"e_1_3_3_11_2","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pmed.1003583"},{"key":"e_1_3_3_12_2","unstructured":"Maurizi N Adler E Silver E. 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