{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,22]],"date-time":"2026-10-22T03:38:39Z","timestamp":1792640319322,"version":"4.5.0"},"reference-count":30,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"8","content-domain":{"domain":["www.ahajournals.org"],"crossmark-restriction":true},"short-container-title":["Circ: Arrhythmia and Electrophysiology"],"published-print":{"date-parts":[[2023,8]]},"abstract":"<jats:sec>\n                    <jats:title>BACKGROUND:<\/jats:title>\n                    <jats:p>This study assessed safety and feasibility of a novel extravascular implantable cardioverter defibrillator (ICD) lead when inserted anteriorly through a rib space and connected to various commercially available ICD pulse generators (PGs) placed in either a left mid-axillary or left pectoral pocket. Currently available or investigational, extravascular-ICDs include a subcutaneous or subxiphoid lead connected to customized extravascular-ICD PGs.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>METHODS:<\/jats:title>\n                    <jats:p>This novel extravascular-ICD (AtaCor Medical Inc, San Clemente, CA) employs a unique intercostal implant technique and is designed to function with commercial DF-4 ICD PGs. In this nonrandomized, single-center, acute study, 36 de novo or replacement ICD (transvenous ICD) patients enrolled to receive a concomitant extravascular-ICD lead inserted through an intercostal space along the left parasternal margin. extravascular-ICD leads were connected to DF-4 compatible ICD PGs positioned in either a left mid-axillary or pectoral pocket for acute sensing and defibrillation testing. Defibrillation testing started at 30 Joules (J) and stepped up or down in 5 to 10 joule increments depending on the success and limitations of the generator used.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>RESULTS:<\/jats:title>\n                    <jats:p>Successful acute defibrillation using \u226435 J was noted in 100% of left mid-axillary PG subjects (n=27, mean 16.3\u00b18.6 J) and 83% of left pectoral PG subjects (n=6, mean 21.0\u00b18.4 J). Furthermore, 24 of 27 (89%) of patients tested with a left, mid-axillary intermuscular PG had successful VF conversion with defibrillation energies at least 10 J below the maximum delivered output of the device. All evaluable episodes (n=93) were automatically sensed, detected, and shocked. No serious device-related intraoperative adverse events were observed.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>CONCLUSIONS:<\/jats:title>\n                    <jats:p>This first-in-human study documented the safe and reliable placement of a novel extravascular ICD lead with effective sensing and defibrillation of induced ventricular fibrillation using commercial DF-4 ICD PGs.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1161\/circep.123.011922","type":"journal-article","created":{"date-parts":[[2023,7,24]],"date-time":"2023-07-24T05:01:02Z","timestamp":1690174862000},"page":"421-432","update-policy":"https:\/\/doi.org\/10.1161\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":12,"title":["Initial Experience With Intercostal Insertion of an Extravascular ICD Lead Compatible With Existing Pulse Generators"],"prefix":"10.1161","volume":"16","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0522-6466","authenticated-orcid":true,"given":"Martin C.","family":"Burke","sequence":"first","affiliation":[{"name":"CorVita Science Foundation, Chicago, IL (M.C.B.)."},{"name":"Department of Clinical and Experimental Cardiology, Amsterdam UMC, Academic Medical Center, the Netherlands (M.C.B., R.E.K., S.P.)."},{"name":"AtaCor Medical, Inc., San Clemente, CA (M.C.B., M.H., A.M., M.O., R.S., D.S.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0772-3573","authenticated-orcid":true,"given":"Reinoud E.","family":"Knops","sequence":"additional","affiliation":[{"name":"Department of Clinical and Experimental Cardiology, Amsterdam UMC, Academic Medical Center, the Netherlands (M.C.B., R.E.K., S.P.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5638-4993","authenticated-orcid":true,"given":"Vivek","family":"Reddy","sequence":"additional","affiliation":[{"name":"Mount Sinai Medical School, New York (V.R.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Johan","family":"Aasbo","sequence":"additional","affiliation":[{"name":"Lexington Cardiology and Baptist Health, KY (J.A.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0283-3933","authenticated-orcid":true,"given":"Michael","family":"Husby","sequence":"additional","affiliation":[{"name":"AtaCor Medical, Inc., San Clemente, CA (M.C.B., M.H., A.M., M.O., R.S., D.S.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0573-1630","authenticated-orcid":true,"given":"Alan","family":"Marcovecchio","sequence":"additional","affiliation":[{"name":"AtaCor Medical, Inc., San Clemente, CA (M.C.B., M.H., A.M., M.O., R.S., D.S.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mark","family":"O\u2019Connor","sequence":"additional","affiliation":[{"name":"AtaCor Medical, Inc., San Clemente, CA (M.C.B., M.H., A.M., M.O., R.S., D.S.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0376-2695","authenticated-orcid":true,"given":"Rick","family":"Sanghera","sequence":"additional","affiliation":[{"name":"AtaCor Medical, Inc., San Clemente, CA (M.C.B., M.H., A.M., M.O., R.S., D.S.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Don","family":"Scheck","sequence":"additional","affiliation":[{"name":"AtaCor Medical, Inc., San Clemente, CA (M.C.B., M.H., A.M., M.O., R.S., 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