{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,7]],"date-time":"2026-10-07T04:01:51Z","timestamp":1791345711386,"version":"4.3.1"},"reference-count":22,"publisher":"Wiley","license":[{"start":{"date-parts":[[2026,8,19]],"date-time":"2026-08-19T00:00:00Z","timestamp":1787097600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2026,8,19]],"date-time":"2026-08-19T00:00:00Z","timestamp":1787097600000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Pacing Clinical Electrophis"],"abstract":"ABSTRACT<\/jats:title>\n \n Background<\/jats:title>\n Two pulsed field ablation (PFA) catheter systems for atrial fibrillation (AF) are widely adopted: the Affera Sphere\u20109 (Medtronic) and the Varipulse (Biosense Webster). Their comparative real\u2010world safety is unknown.<\/jats:p>\n <\/jats:sec>\n \n Methods<\/jats:title>\n We searched the FDA MAUDE database (June 27, 2026) for all reports naming either catheter since U.S. release. After excluding duplicates and non\u2010catheter components, 743 Affera and 361 Varipulse reports remained. Reports were classified by FDA Event Type (device\u2010 vs. patient\u2010related) and complication status, with complications grouped by organ system. Proportions were compared with chi\u2010square or Fisher exact tests in R 4.3.3.<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n Neurologic events were far more frequent among Varipulse reports (44.3\u00a0%\u00a0vs. 14.8%;\n P<\/jats:italic>\n \u00a0<\u00a00.001), driven by stroke (38.0%\u00a0vs. 9.7%;\n P\u00a0<\/jats:italic>\n <\u00a00.001). Cardiovascular events predominated among Affera reports (43.2%\u00a0vs. 29.1%;\n P<\/jats:italic>\n \u00a0<\u00a00.001), including ventricular fibrillation (52\u00a0vs. 1), heart block (8.7%\u00a0vs. 1.4%; P\u00a0<\u00a00.001), and hypotension (5.5%\u00a0vs. 0.8%;\n P<\/jats:italic>\n <0.001); effusion\/tamponade was more frequent with Varipulse (15.2%\u00a0vs. 9.0%;\n P<\/jats:italic>\n = 0.003). Complication\u2010free reports were more frequent with Affera (35.3%\u00a0vs. 21.1%;\n P<\/jats:italic>\n \u00a0<\u00a00.001). Deaths did not differ (2.6%\u00a0vs 1.4%;\n P<\/jats:italic>\n = 0.30).\n <\/jats:p>\n <\/jats:sec>\n \n Conclusions<\/jats:title>\n These PFA systems show distinct reported safety signatures: neurologic\/stroke\u2010predominant for Varipulse and cardiovascular\/arrhythmic (ventricular fibrillation, heart block) for Affera. Because MAUDE lacks procedural denominators, these proportions describe reported events, not incidence. Prospective, patient\u2010level studies are needed to establish causation.<\/jats:p>\n <\/jats:sec>","DOI":"10.1111\/pace.70396","type":"journal-article","created":{"date-parts":[[2026,8,20]],"date-time":"2026-08-20T03:55:16Z","timestamp":1787198116000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Real\u2010World Safety of Two Pulsed Field Ablation Catheters for Atrial Fibrillation: A MAUDE Analysis"],"prefix":"10.1111","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5015-0814","authenticated-orcid":false,"given":"Sami J.","family":"Shoura","sequence":"first","affiliation":[{"name":"Department of Cardiology University of Illinois College of Medicine at Peoria Peoria Illinois USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9635-7658","authenticated-orcid":false,"given":"Shreyas","family":"Singireddy","sequence":"additional","affiliation":[{"name":"Department of Cardiology University of Illinois College of Medicine at Peoria Peoria Illinois USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5121-4346","authenticated-orcid":false,"given":"Kyle","family":"Coombes","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine University of Illinois College of Medicine at Peoria Peoria Illinois USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ragavendar","family":"Saravanabavanandan","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine University of Illinois College of Medicine at Peoria Peoria Illinois USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0007-2062-1014","authenticated-orcid":false,"given":"Skylar","family":"Murphy","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine University of Illinois College of Medicine at Peoria Peoria Illinois USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0006-8498-3498","authenticated-orcid":false,"given":"Abdul\u2010Rahim","family":"Shilbayeh","sequence":"additional","affiliation":[{"name":"Adult Hospitalist Service OSF Saint Francis Medical Center Peoria Illinois USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0005-6087-0635","authenticated-orcid":false,"given":"Chetan","family":"Bhardwaj","sequence":"additional","affiliation":[{"name":"Division of Advanced Heart Failure OSF HealthCare Peoria Illinois USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Siddharth","family":"Shah","sequence":"additional","affiliation":[{"name":"Division of Cardiac Electrophysiology OSF HealthCare Peoria Illinois USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,8,19]]},"reference":[{"key":"e_1_2_13_2_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2019422"},{"key":"e_1_2_13_3_1","doi-asserted-by":"publisher","DOI":"10.1093\/eurheartj\/ehae176"},{"key":"e_1_2_13_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2023.08.017"},{"key":"e_1_2_13_5_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2307291"},{"key":"e_1_2_13_6_1","doi-asserted-by":"publisher","DOI":"10.1093\/europace\/euae038"},{"key":"e_1_2_13_7_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41591\u2010024\u201003022\u20106"},{"key":"e_1_2_13_8_1","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.124.070333"},{"key":"e_1_2_13_9_1","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCEP.123.012667"},{"key":"e_1_2_13_10_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.hrthm.2024.09.060"},{"key":"e_1_2_13_11_1","doi-asserted-by":"publisher","DOI":"10.1111\/jce.70367"},{"key":"e_1_2_13_12_1","doi-asserted-by":"publisher","DOI":"10.1007\/s10840\u2010024\u201001935\u20103"},{"key":"e_1_2_13_13_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.hrthm.2024.10.063"},{"key":"e_1_2_13_14_1","article-title":"Ablation Catheter Correction: Biosense Webster Updates Use Instructions for Varipulse due to High Rate of Stroke or Transient Ischemic Attack","author":"U. 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Food and Drug Administration","year":"2025","journal-title":"FDA Medical Device Recalls and Early Alerts;"},{"key":"e_1_2_13_15_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacep.2025.12.018"},{"key":"e_1_2_13_16_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaccas.2025.106739"},{"key":"e_1_2_13_17_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacep.2021.08.016"},{"key":"e_1_2_13_18_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacep.2022.11.027"},{"key":"e_1_2_13_19_1","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.122.061497"},{"key":"e_1_2_13_20_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacep.2023.12.008"},{"key":"e_1_2_13_21_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41591\u2010024\u201003114\u20103"},{"key":"e_1_2_13_22_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.hrthm.2025.02.006"},{"key":"e_1_2_13_23_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.hrthm.2026.04.001"}],"container-title":["Pacing and Clinical Electrophysiology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/pace.70396","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/pace.70396","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/pace.70396","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,8,20]],"date-time":"2026-08-20T03:55:17Z","timestamp":1787198117000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/pace.70396"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,8,19]]},"references-count":22,"alternative-id":["10.1111\/pace.70396"],"URL":"https:\/\/doi.org\/10.1111\/pace.70396","archive":["Portico"],"relation":{},"ISSN":["0147-8389","1540-8159"],"issn-type":[{"value":"0147-8389","type":"print"},{"value":"1540-8159","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,8,19]]},"assertion":[{"value":"2026-06-30","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-08-08","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-08-19","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"pace.70396"}}