{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,7]],"date-time":"2026-07-07T21:01:24Z","timestamp":1783458084385,"version":"3.55.0"},"reference-count":9,"publisher":"Wiley","issue":"9","license":[{"start":{"date-parts":[[2024,7,8]],"date-time":"2024-07-08T00:00:00Z","timestamp":1720396800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Cardiovasc electrophysiol"],"published-print":{"date-parts":[[2024,9]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Introduction<\/jats:title><jats:p>The QDOT MICRO<jats:sup>TM<\/jats:sup> Ablation Catheter is a next\u2010generation ablation catheter that allows for high\u2010power ablation up to 90 watts.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>We aimed to assess AE associated with the QDOT MICRO<jats:sup>TM<\/jats:sup> catheter using the MAUDE database. A MAUDE database search was conducted on May 25, 2024, to capture all AEs (since FDA approval) associated with this ablation catheter.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>A total of 302 AEs from November 23, 2022, to April 30, 2024, were reported including 148 (49%) catheter\u2010related issues and 154 (51%) clinical complications. Among the catheter\u2010related issues, physical catheter damage (74.3%, <jats:italic>n<\/jats:italic>\u2009=\u2009110) was most common, followed by communication or display issue (10.8%, <jats:italic>n<\/jats:italic>\u2009=\u200916), irrigation issue (9.5%, <jats:italic>n<\/jats:italic>\u2009=\u200914), signal issue or artifact (3.4%, <jats:italic>n<\/jats:italic>\u2009=\u20095), and inaccurate temperature measurement (2.0%, <jats:italic>n<\/jats:italic>\u2009=\u20093). Regarding clinical complications, the most common AE was pericardial effusion (43.5%, <jats:italic>n<\/jats:italic>\u2009=\u200967), followed by char formation (11.7%, <jats:italic>n<\/jats:italic>\u2009=\u200918), catheter thrombosis (7.1%, <jats:italic>n<\/jats:italic>\u2009=\u200911), stroke (7.1%, <jats:italic>n<\/jats:italic>\u2009=\u200911), pericarditis (7.1%, <jats:italic>n<\/jats:italic>\u2009=\u200911), esophageal complications (6.5%, <jats:italic>n<\/jats:italic>\u2009=\u200910), phrenic nerve palsy (3.9%, <jats:italic>n<\/jats:italic>\u2009=\u20096), cardiac arrest (3.9%, <jats:italic>n<\/jats:italic>\u2009=\u20096), significant AV block (3.9%, <jats:italic>n<\/jats:italic>\u2009=\u20096), pulmonary vein stenosis (3.2%, <jats:italic>n<\/jats:italic>\u2009=\u20095), coronary artery spasm (1.3%, <jats:italic>n<\/jats:italic>\u2009=\u20092), and pulmonary embolism (0.6%, <jats:italic>n<\/jats:italic>\u2009=\u20091). There were 11 deaths (five related to esophageal complications, five related to cardiac arrest, and one related to pericardial effusion with cardiac tamponade).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>As high\u2010power ablation strategy with novel ablation catheters is becoming more widely utilized, operators must be aware of potential catheter\u2010related issues and clinical complications that may arise. More data are needed to further evaluate risks of these complications to improve the catheter's safety and efficacy.<\/jats:p><\/jats:sec>","DOI":"10.1111\/jce.16363","type":"journal-article","created":{"date-parts":[[2024,7,9]],"date-time":"2024-07-09T05:26:21Z","timestamp":1720502781000},"page":"1874-1877","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":5,"title":["Catheter\u2010related and clinical complications associated with QDOT MICRO<sup>TM<\/sup> Ablation Catheter"],"prefix":"10.1111","volume":"35","author":[{"given":"Jakrin","family":"Kewcharoen","sequence":"first","affiliation":[{"name":"Division of Cardiology, Cardiac Arrhythmia Service Loma Linda University Health Loma Linda California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1345-0719","authenticated-orcid":false,"given":"Kuldeep","family":"Shah","sequence":"additional","affiliation":[{"name":"Division of Cardiology, Cardiac Arrhythmia Service MercyOne Siouxland Heart and Vascular Center Sioux City Iowa USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7734-8660","authenticated-orcid":false,"given":"Rahul","family":"Bhardwaj","sequence":"additional","affiliation":[{"name":"Division of Cardiology, Cardiac Arrhythmia Service Loma Linda University Health Loma Linda California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mohit K.","family":"Turagam","sequence":"additional","affiliation":[{"name":"Helmsley Electrophysiology Center Icahn School of Medicine at Mount Sinai New York New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tahmeed","family":"Contractor","sequence":"additional","affiliation":[{"name":"Division of Cardiology, Cardiac Arrhythmia Service Loma Linda University Health Loma Linda California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ravi","family":"Mandapati","sequence":"additional","affiliation":[{"name":"Division of Cardiology, Cardiac Arrhythmia Service Loma Linda University Health Loma Linda California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1492-2693","authenticated-orcid":false,"given":"Dhanunjaya","family":"Lakkireddy","sequence":"additional","affiliation":[{"name":"Kansas City Heart Rhythm Institute and Research Foundation Kansas City Missouri USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6857-7418","authenticated-orcid":false,"given":"Jalaj","family":"Garg","sequence":"additional","affiliation":[{"name":"Division of Cardiology, Cardiac Arrhythmia Service Loma Linda University Health Loma Linda California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2024,7,8]]},"reference":[{"key":"e_1_2_3_2_1","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCEP.121.009899"},{"key":"e_1_2_3_3_1","doi-asserted-by":"publisher","DOI":"10.1007\/s10840-023-01633-6"},{"key":"e_1_2_3_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacep.2022.10.019"},{"key":"e_1_2_3_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacep.2017.11.018"},{"key":"e_1_2_3_6_1","doi-asserted-by":"publisher","DOI":"10.1111\/jce.15433"},{"key":"e_1_2_3_7_1","doi-asserted-by":"publisher","DOI":"10.1097\/HCO.0000000000000348"},{"key":"e_1_2_3_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2023.03.418"},{"key":"e_1_2_3_9_1","doi-asserted-by":"publisher","DOI":"10.1093\/europace\/euad296"},{"key":"e_1_2_3_10_1","doi-asserted-by":"publisher","DOI":"10.1111\/jce.15932"}],"container-title":["Journal of Cardiovascular Electrophysiology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/jce.16363","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,11,19]],"date-time":"2024-11-19T11:52:19Z","timestamp":1732017139000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/jce.16363"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,7,8]]},"references-count":9,"journal-issue":{"issue":"9","published-print":{"date-parts":[[2024,9]]}},"alternative-id":["10.1111\/jce.16363"],"URL":"https:\/\/doi.org\/10.1111\/jce.16363","archive":["Portico"],"relation":{},"ISSN":["1045-3873","1540-8167"],"issn-type":[{"value":"1045-3873","type":"print"},{"value":"1540-8167","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,7,8]]},"assertion":[{"value":"2024-03-21","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication 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