{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,22]],"date-time":"2026-10-22T03:38:38Z","timestamp":1792640318136,"version":"4.5.0"},"reference-count":32,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"4","license":[{"start":{"date-parts":[[2025,1,28]],"date-time":"2025-01-28T00:00:00Z","timestamp":1738022400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["www.ahajournals.org"],"crossmark-restriction":true},"short-container-title":["Circulation"],"published-print":{"date-parts":[[2025,1,28]]},"abstract":"<jats:sec>\n                    <jats:title>BACKGROUND:<\/jats:title>\n                    <jats:p>Substernal lead placement of the extravascular implantable cardioverter defibrillator (EV ICD) permits both defibrillation at thresholds similar to those seen with transvenous implantable cardioverter defibrillators and effective anti-tachycardia pacing (ATP) while avoiding the vasculature and associated complications. The global Pivotal study has shown the EV ICD system to be safe and effective through 6 months, but long-term experience has yet to be published. Our aim was to report the performance and safety of the EV ICD system throughout the study.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>METHODS:<\/jats:title>\n                    <jats:p>The EV ICD Pivotal study was a prospective, global, single-arm, premarket clinical study. Individuals with a Class I or IIa indication for a single-chamber implantable cardioverter defibrillator per guidelines were enrolled. Freedom from major system- or procedure-related complications and appropriate and inappropriate therapy rates were assessed through 3 years with the Kaplan-Meier method. ATP success was calculated from simple proportions.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>RESULTS:<\/jats:title>\n                    <jats:p>\n                      An implantation was attempted in 316 patients (25.3% female; 53.8\u00b113.1 years of age; 81.6% primary prevention; left ventricular ejection fraction, 38.9\u00b115.4%). Of 299 patients with a successful implantation, 24 experienced 82 spontaneous arrhythmic episodes that were appropriately treated with ATP only (38, 46.3%), shock only (34, 41.5%), or both (10, 12.2%) for a Kaplan-Meier\u2013estimated rate of first any appropriate therapy of 9.2% at 3 years. ATP was successful in 77.1% (37\/48) of episodes, and ATP use significantly increased from discharge to last follow-up visit (\n                      <jats:italic>P<\/jats:italic>\n                      &lt;0.0001). Shock therapy was successful in 100% (27\/27) of discrete, spontaneous ventricular arrhythmias. The inappropriate shock rates at 1 and 3 years were 9.8% and 17.5%, respectively, with P-wave oversensing the predominant cause. No major intraprocedural complications were reported, and the estimated freedom from system- or procedure-related major complications was 91.9% at 1 year and 89.0% at 3 years. The most common major complications were lead dislodgement (10 events; n=9 patients, 2.8%), postoperative wound or device pocket infection (n=8, 2.5%), and device inappropriate shock delivery (n=4, 1.3%). Twenty-four system revisions were performed as a result of major complications related to the EV ICD system or procedure.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>CONCLUSIONS:<\/jats:title>\n                    <jats:p>From implantation to study completion, the EV ICD Pivotal study demonstrated that a single integrated system with an extravascular lead placed in the substernal space maintains high ATP success, effective defibrillation, and a consistent safety profile.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>REGISTRATION:<\/jats:title>\n                    <jats:p>\n                      URL:\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/www.clinicaltrials.gov\">https:\/\/www.clinicaltrials.gov<\/jats:ext-link>\n                      ; Unique identifier: NCT04060680.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1161\/circulationaha.124.071795","type":"journal-article","created":{"date-parts":[[2024,9,27]],"date-time":"2024-09-27T02:18:23Z","timestamp":1727403503000},"page":"322-332","update-policy":"https:\/\/doi.org\/10.1161\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":94,"title":["Performance and Safety of the Extravascular Implantable Cardioverter Defibrillator Through Long-Term Follow-Up: Final Results From the Pivotal Study"],"prefix":"10.1161","volume":"151","clinical-trial-number":[{"clinical-trial-number":"nct04060680","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5052-2948","authenticated-orcid":true,"given":"Paul","family":"Friedman","sequence":"first","affiliation":[{"name":"Mayo Clinic, Rochester, MN (P.F.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Francis","family":"Murgatroyd","sequence":"additional","affiliation":[{"name":"King\u2019s College Hospital, London, UK (F.M.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4591-4220","authenticated-orcid":true,"given":"Lucas V.A.","family":"Boersma","sequence":"additional","affiliation":[{"name":"Cardiology Department of St. Antonius Hospital Nieuwegein, Netherlands (L.V.A.B.)."},{"name":"Amsterdam University Medical Centers Netherlands (L.V.A.B., R.E.K.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jaimie","family":"Manlucu","sequence":"additional","affiliation":[{"name":"London Health Sciences Centre, ON, Canada (J.M.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2129-0401","authenticated-orcid":true,"given":"Bradley P.","family":"Knight","sequence":"additional","affiliation":[{"name":"Northwestern University, Evanston, IL (B.P.K.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nicolas","family":"Cl\u00e9menty","sequence":"additional","affiliation":[{"name":"Clinique du Millenaire, Montpellier, France (N.C.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4399-5568","authenticated-orcid":true,"given":"Christophe","family":"Leclercq","sequence":"additional","affiliation":[{"name":"CHU de Rennes-H\u00f4pital Pontchaillou, France (C.L.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anish","family":"Amin","sequence":"additional","affiliation":[{"name":"Riverside Methodist Hospital, Columbus, OH (A.A.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6514-0723","authenticated-orcid":true,"given":"B\u00e9la","family":"Merkely","sequence":"additional","affiliation":[{"name":"Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0473-1826","authenticated-orcid":true,"given":"Ulrika Maria","family":"Birgersdotter-Green","sequence":"additional","affiliation":[{"name":"University of California San Diego, San Diego (U.M.B.-G.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3356-4836","authenticated-orcid":true,"given":"Joseph Yat Sun","family":"Chan","sequence":"additional","affiliation":[{"name":"Prince of Wales Hospital, Chinese University of Hong Kong, China (J.Y.S.C.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4590-8584","authenticated-orcid":true,"given":"Mauro","family":"Biffi","sequence":"additional","affiliation":[{"name":"Policlinico Sant\u2019 Orsola\u2013Malpighi, Bologna, Italy (M.B.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0772-3573","authenticated-orcid":true,"given":"Reinoud Elwin","family":"Knops","sequence":"additional","affiliation":[{"name":"Amsterdam University Medical Centers Netherlands (L.V.A.B., R.E.K.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gregory","family":"Engel","sequence":"additional","affiliation":[{"name":"Palo Alto Medical Foundation, Redwood City, CA (G.E.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3843-8609","authenticated-orcid":true,"given":"Ignacio","family":"Mu\u00f1oz 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