{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,27]],"date-time":"2026-08-27T15:08:56Z","timestamp":1787843336519,"version":"build-2784847793"},"reference-count":14,"publisher":"Oxford University Press (OUP)","issue":"8","license":[{"start":{"date-parts":[[2021,3,17]],"date-time":"2021-03-17T00:00:00Z","timestamp":1615939200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"Cryterion Medical Inc"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2021,8,6]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Aims<\/jats:title>\n                  <jats:p>Cryoballoon pulmonary vein isolation (PVI) is a safe and effective treatment for atrial fibrillation (AF). Current limitations include incomplete vein occlusion due to balloon rigidity and inconsistent electrogram recording, which impairs identification of isolation. We aimed to evaluate the acute safety and performance of a novel cryoballoon system.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods and results<\/jats:title>\n                  <jats:p>The system includes a steerable sheath, mapping catheter, and a balloon that maintains uniform inflation pressure and size following initiation of ablation. Protocol-directed cryoablation was delivered for 180\u2009s for isolation documented in \u226460\u2009s, otherwise freeze duration was 240\u2009s. Primary endpoints were acute safety and vein isolation. Pulmonary vein isolation was confirmed at \u226530\u2009min post-isolation. Data were compared across vein locations. Thirty patients with paroxysmal AF were enrolled at two centres and underwent PVI. Pulmonary vein isolation was achieved with cryoablation only in 100% of veins (120\/120). Nadir temperature was \u221253.1\u2009\u00b1\u20095.3\u00b0C. The number of applications to achieve PVI was 1.4\u2009\u00b1\u20090.4 per vein. Of the 120 veins, 89 were isolated with a single cryothermal application (10\/30 patients required only 4 total cryoablations). There were no procedural- or device-related serious adverse events at 30\u2009days post-procedure. A subset (24\/30) of patients was followed for 1-year and 71% (17\/24) remained free of atrial arrhythmias. Six patients with arrhythmia recurrence were remapped and three had durable PVI for all four veins.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusion<\/jats:title>\n                  <jats:p>In this first human experience, the novel cryoballoon platform was safe, efficacious, and demonstrated a high proportion of successful single ablation isolation.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/europace\/euab018","type":"journal-article","created":{"date-parts":[[2021,1,10]],"date-time":"2021-01-10T08:02:25Z","timestamp":1610265745000},"page":"1237-1243","source":"Crossref","is-referenced-by-count":27,"title":["Acute safety, efficacy, and advantages of a novel cryoballoon ablation system for pulmonary vein isolation in patients with paroxysmal atrial fibrillation: initial clinical experience"],"prefix":"10.1093","volume":"23","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6864-3999","authenticated-orcid":false,"given":"Ante","family":"Anic","sequence":"first","affiliation":[{"name":"Cardiovascular Diseases, University Hospital Center Split, Spinciceva 1, 21000 Split, Croatia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nigel","family":"Lever","sequence":"additional","affiliation":[{"name":"Cardiovascular Diseases, Green Lane Cardiovascular Services, Auckland City Hospital, Auckland, New Zealand"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrew","family":"Martin","sequence":"additional","affiliation":[{"name":"Cardiovascular Diseases, Green Lane Cardiovascular Services, Auckland City Hospital, Auckland, New Zealand"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Toni","family":"Breskovic","sequence":"additional","affiliation":[{"name":"Cardiovascular Diseases, University Hospital Center Split, Spinciceva 1, 21000 Split, Croatia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Matthew S","family":"Sulkin","sequence":"additional","affiliation":[{"name":"Electrophysiology, Boston Scientific Corp., St. Paul, MN, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elizabeth","family":"Duffy","sequence":"additional","affiliation":[{"name":"Electrophysiology, Boston Scientific Corp., St. Paul, MN, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Walid I","family":"Saliba","sequence":"additional","affiliation":[{"name":"Department for Cardiovascular Diseases, Cleveland Clinic Foundation, Heart and Vascular Institute, Cleveland, OH, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mark J","family":"Niebauer","sequence":"additional","affiliation":[{"name":"Department for Cardiovascular Diseases, Cleveland Clinic Foundation, Heart and Vascular Institute, Cleveland, OH, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Oussama M","family":"Wazni","sequence":"additional","affiliation":[{"name":"Department for Cardiovascular Diseases, Cleveland Clinic Foundation, Heart and Vascular Institute, Cleveland, OH, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Niraj","family":"Varma","sequence":"additional","affiliation":[{"name":"Department for Cardiovascular Diseases, Cleveland Clinic Foundation, Heart and Vascular Institute, Cleveland, OH, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2021,3,17]]},"reference":[{"key":"2021080909024827000_euab018-B1","doi-asserted-by":"crossref","first-page":"2235","DOI":"10.1056\/NEJMoa1602014","article-title":"Cryoballoon or radiofrequency ablation for paroxysmal atrial fibrillation","volume":"374","author":"Kuck","year":"2016","journal-title":"N Engl J Med"},{"key":"2021080909024827000_euab018-B2","doi-asserted-by":"crossref","first-page":"157","DOI":"10.1093\/europace\/eux275","article-title":"2017 HRS\/EHRA\/ECAS\/APHRS\/SOLAECE expert consensus statement on catheter and surgical ablation of atrial fibrillation: executive summary","volume":"20","author":"Calkins","year":"2018","journal-title":"Europace"},{"key":"2021080909024827000_euab018-B3","doi-asserted-by":"crossref","first-page":"1658","DOI":"10.1016\/j.hrthm.2015.03.021","article-title":"Best practice guide for cryoballoon ablation in atrial fibrillation: the compilation experience of more than 3000 procedures","volume":"12","author":"Su","year":"2015","journal-title":"Heart Rhythm"},{"key":"2021080909024827000_euab018-B4","doi-asserted-by":"crossref","first-page":"1158","DOI":"10.1093\/europace\/euv452","article-title":"Incidence of real-time recordings of pulmonary vein potentials using the third-generation short-tip cryoballoon","volume":"18","author":"Chierchia","year":"2016","journal-title":"Europace"},{"key":"2021080909024827000_euab018-B5","doi-asserted-by":"crossref","first-page":"1708","DOI":"10.1093\/europace\/eus189","article-title":"Verification of pulmonary vein isolation during single transseptal cryoballoon ablation: a comparison between the classical circular mapping catheter and the inner lumen mapping catheter","volume":"14","author":"Chierchia","year":"2012","journal-title":"Europace"},{"key":"2021080909024827000_euab018-B6","doi-asserted-by":"crossref","first-page":"1348","DOI":"10.1016\/j.hrthm.2018.04.021","article-title":"Cryoballoon best practices II: practical guide to procedural monitoring and dosing during atrial fibrillation ablation from the perspective of experienced users","volume":"15","author":"Su","year":"2018","journal-title":"Heart Rhythm"},{"key":"2021080909024827000_euab018-B7","doi-asserted-by":"crossref","first-page":"1795","DOI":"10.1093\/europace\/18.suppl_1.i169b","article-title":"Procedural characteristics of pulmonary vein isolation using the novel third-generation cryoballoon","volume":"18","author":"Furnkranz","year":"2016","journal-title":"Europace"},{"key":"2021080909024827000_euab018-B8","doi-asserted-by":"crossref","first-page":"1609","DOI":"10.1093\/europace\/euw295","article-title":"2016 ESC guidelines for the management of atrial fibrillation developed in collaboration with EACTS","volume":"18","author":"Kirchhof","year":"2016","journal-title":"Europace"},{"key":"2021080909024827000_euab018-B9","doi-asserted-by":"crossref","first-page":"673","DOI":"10.1016\/j.hrthm.2014.12.026","article-title":"Single 3-minute freeze for second-generation cryoballoon ablation: one-year follow-up after pulmonary vein isolation","volume":"12","author":"Ciconte","year":"2015","journal-title":"Heart Rhythm"},{"key":"2021080909024827000_euab018-B10","doi-asserted-by":"crossref","first-page":"424","DOI":"10.1016\/j.hrthm.2015.10.033","article-title":"Procedural and biophysical indicators of durable pulmonary vein isolation during cryoballoon ablation of atrial fibrillation","volume":"13","author":"Aryana","year":"2016","journal-title":"Heart Rhythm"},{"key":"2021080909024827000_euab018-B11","doi-asserted-by":"crossref","first-page":"918","DOI":"10.1111\/jce.13927","article-title":"The fourth cryoballoon generation with a shorter tip to facilitate real-time pulmonary vein potential recording: feasibility and safety results","volume":"30","author":"Straube","year":"2019","journal-title":"J Cardiovasc Electrophysiol"},{"key":"2021080909024827000_euab018-B12","doi-asserted-by":"crossref","first-page":"639","DOI":"10.1093\/europace\/eut417","article-title":"Second-generation cryoballoon ablation for paroxysmal atrial fibrillation: 1-year follow-up","volume":"16","author":"Chierchia","year":"2014","journal-title":"Europace"},{"key":"2021080909024827000_euab018-B13","doi-asserted-by":"crossref","first-page":"492","DOI":"10.1111\/jce.12082","article-title":"Improved procedural efficacy of pulmonary vein isolation using the novel second-generation cryoballoon","volume":"24","author":"Furnkranz","year":"2013","journal-title":"J Cardiovasc Electrophysiol"},{"key":"2021080909024827000_euab018-B14","doi-asserted-by":"crossref","first-page":"1319","DOI":"10.1016\/j.hrthm.2017.06.020","article-title":"Verification of a novel atrial fibrillation cryoablation dosing algorithm guided by time-to-pulmonary vein isolation: results from the Cryo-DOSING Study (Cryoballoon-ablation DOSING Based on the Assessment of Time-to-Effect and Pulmonary Vein Isolation Guidance)","volume":"14","author":"Aryana","year":"2017","journal-title":"Heart Rhythm"}],"container-title":["EP Europace"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/academic.oup.com\/europace\/article-pdf\/23\/8\/1237\/39606039\/euab018.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"http:\/\/academic.oup.com\/europace\/article-pdf\/23\/8\/1237\/39606039\/euab018.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2021,8,9]],"date-time":"2021-08-09T09:13:13Z","timestamp":1628500393000},"score":1,"resource":{"primary":{"URL":"https:\/\/academic.oup.com\/europace\/article\/23\/8\/1237\/6174520"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,3,17]]},"references-count":14,"journal-issue":{"issue":"8","published-online":{"date-parts":[[2021,3,17]]},"published-print":{"date-parts":[[2021,8,6]]}},"URL":"https:\/\/doi.org\/10.1093\/europace\/euab018","relation":{},"ISSN":["1099-5129","1532-2092"],"issn-type":[{"value":"1099-5129","type":"print"},{"value":"1532-2092","type":"electronic"}],"subject":[],"published-other":{"date-parts":[[2021,8,1]]},"published":{"date-parts":[[2021,3,17]]}}}