{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,7,30]],"date-time":"2025-07-30T11:56:42Z","timestamp":1753876602314,"version":"3.41.2"},"reference-count":24,"publisher":"Oxford University Press (OUP)","issue":"4","license":[{"start":{"date-parts":[[2025,3,25]],"date-time":"2025-03-25T00:00:00Z","timestamp":1742860800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100004374","name":"Medtronic Inc.","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004374","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2025,3,28]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Aims<\/jats:title>\n                  <jats:p>The Lead EvaluAtion for Defibrillation and Reliability (LEADR) trial evaluated the small-diameter (4.7 Fr), integrated bipolar OmniaSecure defibrillation lead. As previously reported, the trial exceeded primary safety and efficacy objective thresholds, demonstrating favourable performance and zero fractures through \u223c12 months follow-up, with patients in ongoing follow-up. Longer-term follow-up of the LEADR trial with emphasis on the sensing and detection capabilities of the OmniaSecure lead is reported here.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods and results<\/jats:title>\n                  <jats:p>Patients with indications for de novo implantable cardioverter-defibrillators\/cardiac resynchronisation therapy defibrillators were implanted with the OmniaSecure lead in standard right ventricle (RV) locations and followed at pre-specified intervals along with CareLink\u2122 remote monitoring transmissions, where available. Throughout follow-up, the lead was evaluated for safety, efficacy, and reliability along with sensing and detection performance. There were 643\/657 (97.9%) patients successfully implanted with the OmniaSecure lead with mean follow-up of 18.2 \u00b1 5.5 months. There was a 96.9% freedom from major study lead-related complications at 24 months. Inappropriate shock rate was 2.7 and 3.8% at 12 and 24 months, respectively. At 24 months, 17.6% of patients received appropriate therapies (shock and\/or ATP) with a 76.5% ATP efficacy. There have been zero fractures during follow-up along with chronically stable pacing capture threshold, pacing impedance, and R-wave amplitudes. There were four patients with an adverse event related to PWOS (0.6%), none of which was associated with inappropriate shock. There were four patients with an adverse event related to TWOS (0.6%), of which three patients were associated with inappropriate shock (0.5%). Oversensing was resolved predominantly by programming the RV sensitivity to less sensitive settings. During VF induction at implant, 97.6% (120\/123) of patients showed appropriate VF episode detection at the least sensitive setting of 1.2\u2005mV, with the remaining having detection at more sensitive settings. In follow-up, 670 VT\/VF episodes were appropriately detected and treated in 94 patients with a variety of RV sensitivities and no reports of under-detected episodes. Moreover, a virtual sensitivity analysis also showed no under-detection across different RV sensitivity programming.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusion<\/jats:title>\n                  <jats:p>Chronic sensing performance of the OmniaSecure defibrillation lead demonstrated R-wave stability with a low rate of P-wave and T-wave oversensing, resolved predominantly by adjusting RV sensitivity. Further, VT\/VF detection was successful and was not impacted when programmed to less sensitive settings. The OmniaSecure lead shows robust sensing and detection performance and programmability in ongoing follow-up.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/europace\/euaf062","type":"journal-article","created":{"date-parts":[[2025,3,29]],"date-time":"2025-03-29T05:03:59Z","timestamp":1743224639000},"source":"Crossref","is-referenced-by-count":0,"title":["Sensing and detection performance of the novel, small-diameter OmniaSecure defibrillation lead: in-depth analysis from the LEADR trial"],"prefix":"10.1093","volume":"27","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3803-8429","authenticated-orcid":false,"given":"Prashanthan","family":"Sanders","sequence":"first","affiliation":[{"name":"Centre for Heart Rhythm Disorders, University of Adelaide and Royal Adelaide Hospital , Adelaide, South Australia ,","place":["Australia"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4276-2391","authenticated-orcid":false,"given":"Pamela K","family":"Mason","sequence":"additional","affiliation":[{"name":"Electrophysiology Laboratory, University of Virginia , Charlottesville, VA ,","place":["USA"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0002-4592-7734","authenticated-orcid":false,"given":"Bert","family":"Hansky","sequence":"additional","affiliation":[{"name":"Klink f\u00fcr Kardiologie und Internistische Intensivmedizin, St\u00e4dtische Kliniken , Bielefeld ,","place":["Germany"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1144-5000","authenticated-orcid":false,"given":"Paolo","family":"De Filippo","sequence":"additional","affiliation":[{"name":"Cardiac Electrophysiology and Pacing, ASST Papa Giovanni XXIII , Bergamo ,","place":["Italy"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Maully J","family":"Shah","sequence":"additional","affiliation":[{"name":"Cardiac Center, The Children\u2019s Hospital , Philadelphia, PA ,","place":["USA"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Darius P","family":"Sholevar","sequence":"additional","affiliation":[{"name":"Cardiology Group, Virtua Health , Cherry Hill, NJ ,","place":["USA"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0001-3754-6555","authenticated-orcid":false,"given":"John S","family":"Zakaib","sequence":"additional","affiliation":[{"name":"Heart Rhythm Center, Minneapolis Heart Institute Foundation , Minneapolis, MN ,","place":["USA"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2012-0486","authenticated-orcid":false,"given":"Francois","family":"Philippon","sequence":"additional","affiliation":[{"name":"Institut Universitaire de Cardiologie et de Pneumologie de Qu\u00e9bec, Laval University , Qu\u00e9bec City, Qu\u00e9bec ,","place":["Canada"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0000-4081-1033","authenticated-orcid":false,"given":"Bernice","family":"Tsang","sequence":"additional","affiliation":[{"name":"Cardiac Program, Southlake Regional Health Centre , Newmarket, Ontario ,","place":["Canada"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rajeev K","family":"Pathak","sequence":"additional","affiliation":[{"name":"Cardiac Electrophysiology & Pacing, Canberra Heart Rhythm Centre and Australian National University , Garran, ACT ,","place":["Australia"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9772-0308","authenticated-orcid":false,"given":"Travis D","family":"Richardson","sequence":"additional","affiliation":[{"name":"Divsion of Cardiovascular Medicine, Vanderbilt University Medical Center , Nashville, TN ,","place":["USA"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Meir","family":"Friedman","sequence":"additional","affiliation":[{"name":"Heart & Vascular Institute Wellness Center, Hartford Hospital , Hartford, CT ,","place":["USA"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8608-7247","authenticated-orcid":false,"given":"Robert D","family":"Schaller","sequence":"additional","affiliation":[{"name":"Cardiac Arrhythmia Program, Hospital of the University of Pennsylvania , Philadelphia, PA ,","place":["USA"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6988-3487","authenticated-orcid":false,"given":"Ignasi","family":"Anguera","sequence":"additional","affiliation":[{"name":"Unidad de Arritmias y Electrofisiologia, Hospital Universitari Bellvitge , Barcelona 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