{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,23]],"date-time":"2026-10-23T20:04:48Z","timestamp":1792785888798,"version":"4.5.0"},"reference-count":29,"publisher":"Oxford University Press (OUP)","issue":"3","license":[{"start":{"date-parts":[[2025,3,3]],"date-time":"2025-03-03T00:00:00Z","timestamp":1740960000000},"content-version":"vor","delay-in-days":2,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"AtaCor Medical, Inc"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2025,3,5]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Aims<\/jats:title>\n                    <jats:p>Intercostal extravascular implantable cardioverter defibrillator (EV-ICD) leads may work better in contact with the pericardium thereby directing pacing and defibrillation energy towards excitable myocytes. We report 3-month safety and performance outcomes with a second-generation intercostal EV-ICD lead paired with standard, commercially available ICD pulse generators (PGs).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and results<\/jats:title>\n                    <jats:p>Subjects undergoing a transvenous ICD (TV-ICD) procedure received a concomitant intercostal EV-ICD lead system. The intercostal EV-ICD lead was connected sequentially to a PG in a left pectoral and then a left mid-axillary location. Extravascular ICD lead assessment included sensing and defibrillation of induced ventricular arrhythmias and pacing capture. The intercostal EV-ICD system was followed in a \u2018recording-only\u2019 mode and the control TV-ICD system in \u2018therapy delivery\u2019 mode to compare stored events. Devices were evaluated prior to hospital discharge, 2 weeks, 1 month, 2 months, and 3 months post-implant. Defibrillation testing was repeated prior to lead removal; 20\/20 (100%) were successfully implanted (median implant time of 9\u2005min). Two major lead complications were reported over a mean of 82 days: (i) lead movement and (ii) infection of both the TV-ICD and EV-ICD systems. Intraoperative pacing capture was achieved with the integrated bipolar configuration in 19 of 20 (95%) subjects. Pacing capture with the EV-ICD system was tolerated in all subjects, with over 90% feeling no pain after a 1-month recovery from the procedure. Induced VF episodes were sensed in all subjects and defibrillated successfully in 17 of 17 patients (100%) with a left mid-axillary PG and 19 of 20 patients (95%) with a left pectoral PG. Sensing and defibrillation were successful in 18 of 18 (100%) tested prior to lead removal.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>In this pilot experience with a second-generation intercostal EV-ICD lead implantation, sensing and defibrillation of induced VF were successful when paired with a standard ICD PG from either a left mid-axillary or pectoral pocket.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Clinical trial registration<\/jats:title>\n                    <jats:p>NCT number: NCT05791032; URL: https:\/\/clinicaltrials.gov\/study\/NCT05791032<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/europace\/euaf044","type":"journal-article","created":{"date-parts":[[2025,2,28]],"date-time":"2025-02-28T15:18:44Z","timestamp":1740755924000},"source":"Crossref","is-referenced-by-count":6,"title":["Evaluation of a second-generation intercostal extravascular implantable cardioverter defibrillator lead with a pectoral pulse generator for sensing, defibrillation, and anti-tachycardia pacing"],"prefix":"10.1093","volume":"27","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-8567-0211","authenticated-orcid":false,"given":"Shephal K","family":"Doshi","sequence":"first","affiliation":[{"name":"Department of Electrophysiology, Pacific Heart Institute , Santa Monica, CA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0772-3573","authenticated-orcid":false,"given":"Reinoud E","family":"Knops","sequence":"additional","affiliation":[{"name":"Department of Clinical and Experimental Cardiology, Amsterdam UMC, Academic Medical Center , Meibergdreef 9, Amsterdam ,","place":["The Netherlands"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Adrian","family":"Ebner","sequence":"additional","affiliation":[{"name":"Cardiovascular Department, Sanatorio Italiano , Asunci\u00f3n ,","place":["Paraguay"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0283-3933","authenticated-orcid":false,"given":"Michael","family":"Husby","sequence":"additional","affiliation":[{"name":"Research and Development Department, AtaCor Medical, Inc. , 905 Calle Amenecer #360, San Clemente, CA 92673, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0573-1630","authenticated-orcid":false,"given":"Alan","family":"Marcovecchio","sequence":"additional","affiliation":[{"name":"Research and Development Department, AtaCor Medical, Inc. , 905 Calle Amenecer #360, San Clemente, CA 92673, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0376-2695","authenticated-orcid":false,"given":"Rick","family":"Sanghera","sequence":"additional","affiliation":[{"name":"Research and Development Department, AtaCor Medical, Inc. , 905 Calle Amenecer #360, San Clemente, CA 92673, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Don","family":"Scheck","sequence":"additional","affiliation":[{"name":"Research and Development Department, AtaCor Medical, Inc. , 905 Calle Amenecer #360, San Clemente, CA 92673, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0522-6466","authenticated-orcid":false,"given":"Martin C","family":"Burke","sequence":"additional","affiliation":[{"name":"Department of Clinical and Experimental Cardiology, Amsterdam UMC, Academic Medical Center , Meibergdreef 9, Amsterdam ,","place":["The Netherlands"]},{"name":"Research and Development Department, AtaCor Medical, Inc. , 905 Calle Amenecer #360, San Clemente, CA 92673, USA"},{"name":"Childers Electrocardiology Lab, CorVita Science Foundation , 1006 S Michigan Ave, Suite 500, Chicago, IL 60605 ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2025,3,3]]},"reference":[{"key":"2025032208565931500_euaf044-B1","doi-asserted-by":"crossref","first-page":"e73","DOI":"10.1016\/j.hrthm.2017.10.036","article-title":"2017 AHA\/ACC\/HRS guideline for management of patients with ventricular arrhythmias and the prevention of sudden cardiac death: executive summary: a report of the American College of Cardiology\/American Heart Association task force on clinical practice guidelines and the Heart Rhythm Society","volume":"15","author":"Al-Khatib","year":"2018","journal-title":"Heart Rhythm"},{"key":"2025032208565931500_euaf044-B2","doi-asserted-by":"crossref","first-page":"900","DOI":"10.1001\/jamacardio.2016.2782","article-title":"Trends and in-hospital outcomes associated with adoption of the subcutaneous implantable cardioverter defibrillator in the United States","volume":"1","author":"Friedman","year":"2016","journal-title":"JAMA Cardiol"},{"key":"2025032208565931500_euaf044-B3","doi-asserted-by":"crossref","first-page":"e000198","DOI":"10.1136\/openhrt-2014-000198","article-title":"A systematic review of ICD complications in randomised controlled trials versus registries: is our \u2018real-world\u2019 data an underestimation?","volume":"2","author":"Ezzat","year":"2015","journal-title":"Open Heart"},{"key":"2025032208565931500_euaf044-B4","doi-asserted-by":"crossref","first-page":"240","DOI":"10.1161\/CIRCEP.108.777888","article-title":"Patient and implanting physician factors associated with mortality and complications after implantable cardioverter-defibrillator implantation, 2002\u20132005","volume":"1","author":"Al-Khatib","year":"2008","journal-title":"Circ Arrhythm Electrophysiol"},{"key":"2025032208565931500_euaf044-B5","doi-asserted-by":"crossref","first-page":"926","DOI":"10.1111\/j.1540-8159.2005.00195.x","article-title":"Complications of implantable cardioverter defibrillator therapy in 440 consecutive patients","volume":"28","author":"Alter","year":"2005","journal-title":"Pacing Clin Electrophysiol"},{"key":"2025032208565931500_euaf044-B6","doi-asserted-by":"crossref","first-page":"582","DOI":"10.1161\/CIRCOUTCOMES.113.000299","article-title":"Cardiac perforation from implantable cardioverter-defibrillator lead placement: insights from the national cardiovascular data registry","volume":"6","author":"Hsu","year":"2013","journal-title":"Circ Cardiovasc Qual Outcomes"},{"key":"2025032208565931500_euaf044-B7","doi-asserted-by":"crossref","first-page":"1186","DOI":"10.1093\/eurheartj\/eht511","article-title":"Complications after cardiac implantable electronic device implantations: an analysis of a complete, nationwide cohort in Denmark","volume":"35","author":"Kirkfeldt","year":"2014","journal-title":"Eur Heart J"},{"key":"2025032208565931500_euaf044-B8","doi-asserted-by":"crossref","first-page":"83","DOI":"10.17219\/acem\/42317","article-title":"Venous stenosis and occlusion in the presence of endocardial leads","volume":"25","author":"Boczar","year":"2016","journal-title":"Adv Clin Exp Med"},{"key":"2025032208565931500_euaf044-B9","doi-asserted-by":"crossref","first-page":"1027","DOI":"10.1111\/pace.14266","article-title":"Long-term incidence of upper extremity venous obstruction in implantable cardioverter defibrillator patients","volume":"44","author":"Horlbeck","year":"2021","journal-title":"Pacing Clin Electrophysiol"},{"key":"2025032208565931500_euaf044-B10","doi-asserted-by":"crossref","first-page":"2474","DOI":"10.1161\/CIRCULATIONAHA.106.663807","article-title":"Annual rate of transvenous defibrillation lead defects in implantable cardioverter-defibrillators over a period of &gt;10 years","volume":"115","author":"Kleemann","year":"2007","journal-title":"Circulation"},{"key":"2025032208565931500_euaf044-B11","doi-asserted-by":"crossref","first-page":"2461","DOI":"10.1161\/CIRCULATIONAHA.107.698597","article-title":"Transvenous implantable cardioverter-defibrillator leads: the weakest link","volume":"115","author":"Maisel","year":"2007","journal-title":"Circulation"},{"key":"2025032208565931500_euaf044-B12","doi-asserted-by":"crossref","first-page":"iv20","DOI":"10.1093\/europace\/euab016","article-title":"Therapy and outcomes of cardiac implantable electronic devices infections","volume":"23","author":"Perrin","year":"2021","journal-title":"Europace"},{"key":"2025032208565931500_euaf044-B13","doi-asserted-by":"crossref","first-page":"1490","DOI":"10.1093\/europace\/euu147","article-title":"Risk factors for 1-year mortality among patients with cardiac implantable electronic device infection undergoing transvenous lead extraction: the impact of the infection type and the presence of vegetation on survival","volume":"16","author":"Tarakji","year":"2014","journal-title":"Europace"},{"key":"2025032208565931500_euaf044-B14","doi-asserted-by":"crossref","first-page":"1622","DOI":"10.2215\/CJN.07920520","article-title":"Trends in use and in-hospital outcomes of subcutaneous implantable cardioverter defibrillators in patients undergoing long-term dialysis","volume":"15","author":"Pun","year":"2020","journal-title":"Clin J Am Soc Nephrol"},{"key":"2025032208565931500_euaf044-B15","doi-asserted-by":"crossref","first-page":"189","DOI":"10.1007\/s00392-014-0764-5","article-title":"Substernal lead implantation: a novel option to manage DFT failure in S-ICD patients","volume":"104","author":"Guenther","year":"2015","journal-title":"Clin Res Cardiol"},{"key":"2025032208565931500_euaf044-B16","doi-asserted-by":"crossref","first-page":"181","DOI":"10.1093\/europace\/euab178","article-title":"Non-traditional implantable cardioverter-defibrillator configurations and insertion techniques: a review of contemporary options","volume":"24","author":"Tonko","year":"2022","journal-title":"Europace"},{"key":"2025032208565931500_euaf044-B17","doi-asserted-by":"crossref","first-page":"249","DOI":"10.1016\/j.pcad.2019.04.003","article-title":"Evolution of extravascular implantable defibrillator technologies","volume":"62","author":"Pfenniger","year":"2019","journal-title":"Prog Cardiovasc Dis"},{"key":"2025032208565931500_euaf044-B18","doi-asserted-by":"crossref","first-page":"520","DOI":"10.1007\/s00059-021-05077-4","article-title":"Non-transvenous ICD therapy: current status and beyond","volume":"46","author":"van Dijk","year":"2021","journal-title":"Herz"},{"key":"2025032208565931500_euaf044-B19","doi-asserted-by":"crossref","first-page":"72","DOI":"10.1007\/s11886-018-1021-8","article-title":"An overview of clinical outcomes in transvenous and subcutaneous ICD patients","volume":"20","author":"Baalman","year":"2018","journal-title":"Curr Cardiol Rep"},{"key":"2025032208565931500_euaf044-B20","doi-asserted-by":"crossref","first-page":"526","DOI":"10.1056\/NEJMoa1915932","article-title":"Subcutaneous or transvenous defibrillator therapy","volume":"383","author":"Knops","year":"2020","journal-title":"N Engl J Med"},{"key":"2025032208565931500_euaf044-B21","first-page":"1525","article-title":"First-in-human chronic implant experience of the substernal extravascular implantable cardioverter-defibrillator","volume":"6","author":"Crozier","year":"2020","journal-title":"J Am Coll Cardiol EP"},{"key":"2025032208565931500_euaf044-B22","doi-asserted-by":"crossref","first-page":"1292","DOI":"10.1056\/NEJMoa2206485","article-title":"Efficacy and safety of an extravascular implantable cardioverter\u2013defibrillator","volume":"387","author":"Friedman","year":"2022","journal-title":"N Engl J Med"},{"key":"2025032208565931500_euaf044-B23","doi-asserted-by":"crossref","first-page":"euad301","DOI":"10.1093\/europace\/euad301","article-title":"Three-year chronic follow-up from the pilot study of a substernal extravascular implantable cardioverter-defibrillator","volume":"25","author":"Crozier","year":"2023","journal-title":"Europace"},{"key":"2025032208565931500_euaf044-B24","doi-asserted-by":"crossref","first-page":"421","DOI":"10.1161\/CIRCEP.123.011922","article-title":"A initial experience with intercostal insertion of an extravascular ICD lead compatible with existing pulse generators","volume":"16","author":"Burke","year":"2023","journal-title":"Circ Arrhythm Electrophysiol"},{"key":"2025032208565931500_euaf044-B25","doi-asserted-by":"crossref","first-page":"830","DOI":"10.1016\/j.jacc.2017.06.040","article-title":"Implant and midterm outcomes of the subcutaneous implantable cardioverter-defibrillator registry: the EFFORTLESS study","volume":"70","author":"Boersma","year":"2017","journal-title":"J Am Coll Cardiol"},{"key":"2025032208565931500_euaf044-B26","doi-asserted-by":"crossref","first-page":"905","DOI":"10.1016\/j.jacep.2016.12.026","article-title":"Novel extravascular defibrillation configuration with a coil in the substernal space: the ASD clinical study","volume":"3","author":"Chan","year":"2017","journal-title":"JACC Clin Electrophysiol"},{"key":"2025032208565931500_euaf044-B27","doi-asserted-by":"crossref","first-page":"186","DOI":"10.1016\/j.jacep.2018.11.003","article-title":"Therapy from a novel substernal lead: the ASD2 study","volume":"5","author":"Boersma","year":"2019","journal-title":"JACC Clin Electrophysiol"},{"key":"2025032208565931500_euaf044-B28","doi-asserted-by":"crossref","first-page":"322","DOI":"10.1161\/CIRCULATIONAHA.124.071795","article-title":"Performance and safety of the extravascularr implantable cardioverter defibrillator through long term follow-up: final results from the pivotal study","volume":"151","author":"Friedman","year":"2024","journal-title":"Circulation"},{"key":"2025032208565931500_euaf044-B29","doi-asserted-by":"crossref","first-page":"euae225","DOI":"10.1093\/europace\/euae225","article-title":"Comprehensive analysis of substernal lead removal: experience from EV-ICD pilot, pivotal and continued access studies","volume":"26","author":"Sagi","year":"2024","journal-title":"Europace"}],"container-title":["Europace"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/academic.oup.com\/europace\/advance-article-pdf\/doi\/10.1093\/europace\/euaf044\/62216123\/euaf044.pdf","content-type":"application\/pdf","content-version":"am","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/europace\/article-pdf\/27\/3\/euaf044\/62216123\/euaf044.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/europace\/article-pdf\/27\/3\/euaf044\/62216123\/euaf044.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,3,23]],"date-time":"2025-03-23T07:21:35Z","timestamp":1742714495000},"score":1,"resource":{"primary":{"URL":"https:\/\/academic.oup.com\/europace\/article\/doi\/10.1093\/europace\/euaf044\/8047336"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,3]]},"references-count":29,"journal-issue":{"issue":"3","published-print":{"date-parts":[[2025,3,5]]}},"URL":"https:\/\/doi.org\/10.1093\/europace\/euaf044","relation":{},"ISSN":["1099-5129","1532-2092"],"issn-type":[{"value":"1099-5129","type":"print"},{"value":"1532-2092","type":"electronic"}],"subject":[],"published-other":{"date-parts":[[2025,3]]},"published":{"date-parts":[[2025,3]]},"article-number":"euaf044"}}