{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,29]],"date-time":"2026-10-29T22:39:39Z","timestamp":1793313579172,"version":"4.5.0"},"reference-count":30,"publisher":"Oxford University Press (OUP)","issue":"8","license":[{"start":{"date-parts":[[2022,6,1]],"date-time":"2022-06-01T00:00:00Z","timestamp":1654041600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2022,9,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Aims<\/jats:title>\n                  <jats:p>Pulsed field ablation (PFA) is a novel atrial fibrillation (AF) ablation modality that has demonstrated preferential tissue ablation, including no oesophageal damage, in first-in-human clinical trials. In the MANIFEST-PF survey, we investigated the \u2018real world\u2019 performance of the only approved PFA catheter, including acute effectiveness and safety\u2014in particular, rare oesophageal effects and other unforeseen PFA-related complications.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods and results<\/jats:title>\n                  <jats:p>This retrospective survey included all 24 clinical centres using the pentaspline PFA catheter after regulatory approval. Institution-level data were obtained on patient characteristics, procedure parameters, acute efficacy, and adverse events. With an average of 73 patients treated per centre (range 7\u2013291), full cohort included 1758 patients: mean age 61.6 years (range 19\u201392), female 34%, first-time ablation 94%, paroxysmal\/persistent AF 58\/35%. Most procedures employed deep sedation without intubation (82.1%), and 15.1% were discharged same day. Pulmonary vein isolation (PVI) was successful in 99.9% (range 98.9\u2013100%). Procedure time was 65\u2005min (38\u2013215). There were no oesophageal complications or phrenic nerve injuries persisting past hospital discharge. Major complications (1.6%) were pericardial tamponade (0.97%) and stroke (0.4%); one stroke resulted in death (0.06%). Minor complications (3.9%) were primarily vascular (3.3%), but also included transient phrenic nerve paresis (0.46%), and TIA (0.11%). Rare complications included coronary artery spasm, haemoptysis, and dry cough persistent for 6 weeks (0.06% each).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusion<\/jats:title>\n                  <jats:p>In a large cohort of unselected patients, PFA was efficacious for PVI, and expressed a safety profile consistent with preferential tissue ablation. However, the frequency of \u2018generic\u2019 catheter complications (tamponade, stroke) underscores the need for improvement.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/europace\/euac050","type":"journal-article","created":{"date-parts":[[2022,4,14]],"date-time":"2022-04-14T11:11:50Z","timestamp":1649934710000},"page":"1256-1266","source":"Crossref","is-referenced-by-count":351,"title":["Multi-national survey on the methods, efficacy, and safety on the post-approval clinical use of pulsed field ablation (MANIFEST-PF)"],"prefix":"10.1093","volume":"24","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4128-8800","authenticated-orcid":false,"given":"Emmanuel","family":"Ekanem","sequence":"first","affiliation":[{"name":"Icahn School of Medicine at Mount Sinai , New York, NY , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vivek Y","family":"Reddy","sequence":"additional","affiliation":[{"name":"Icahn School of Medicine at Mount Sinai , New York, NY , USA"},{"name":"Cardiology Department, Na Homolce Hospital, Homolka Hospital , Roentgenova 37\/2, 15030 Praha 5 Prague , Czech Republic"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Boris","family":"Schmidt","sequence":"additional","affiliation":[{"name":"MVZ CCB Frankfurt und Main-Taunus GbR , Frankfurt , Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7197-8415","authenticated-orcid":false,"given":"Tobias","family":"Reichlin","sequence":"additional","affiliation":[{"name":"Inselspital\u2014Bern University Hospital, University of Bern , Bern , Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2075-8113","authenticated-orcid":false,"given":"Kars","family":"Neven","sequence":"additional","affiliation":[{"name":"Department of Electrophysiology, Alfried Krupp Hospital , Essen , Germany"},{"name":"Department of Medicine, Witten\/Herdecke University , Witten , Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6818-6396","authenticated-orcid":false,"given":"Andreas","family":"Metzner","sequence":"additional","affiliation":[{"name":"University Heart and Vascular Center, University of Hamburg , Hamburg , Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jim","family":"Hansen","sequence":"additional","affiliation":[{"name":"Copenhagen University Hospital , Copenhagen , Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yuri","family":"Blaauw","sequence":"additional","affiliation":[{"name":"Universitair Medish Groningen , Groningen , The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Philippe","family":"Maury","sequence":"additional","affiliation":[{"name":"Department of Cardiology, University Hospital Rangueil , Toulouse , France"},{"name":"I2MC, INSERM UMR 1297 , Toulouse , France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thomas","family":"Arentz","sequence":"additional","affiliation":[{"name":"Universit\u00e4tsklinikum Freiburg , Breisgau , Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Philipp","family":"Sommer","sequence":"additional","affiliation":[{"name":"Clinic for Electrophysiology, Herz- und Diabeteszentrum NRW, Ruhr-University Bochum , Bad Oeynhausen , Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6864-3999","authenticated-orcid":false,"given":"Ante","family":"Anic","sequence":"additional","affiliation":[{"name":"Department for Cardiovascular Diseases, University Hospital Center Split , Split , Croatia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Frederic","family":"Anselme","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Rouen Hospital , Rouen , 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