Pugazhendhi Vijayaraman, Xingbin Liu, Russell Denman, Edward J Schloss, Zachary I Whinnett, Jordana Kron, Marek Jastrzębski, John S Zakaib, Walter P Abhayaratna, François Philippon, Muhammad R Afzal, Parash Pokharel, James Burrell, Jocelyn Tanner, Tessa Geelen, Megan L Platner, Kiah Butler, Pamela K Mason, George H Crossley
{"title":"用于左束分支区域放置的新型除颤导线的安全性和性能：LEADR LBBAP临床试验的主要结果","authors":"Pugazhendhi Vijayaraman, Xingbin Liu, Russell Denman, Edward J Schloss, Zachary I Whinnett, Jordana Kron, Marek Jastrzębski, John S Zakaib, Walter P Abhayaratna, François Philippon, Muhammad R Afzal, Parash Pokharel, James Burrell, Jocelyn Tanner, Tessa Geelen, Megan L Platner, Kiah Butler, Pamela K Mason, George H Crossley","doi":"10.1016/j.hrthm.2025.10.028","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Right ventricular placement of the OmniaSecure defibrillation lead has demonstrated high defibrillation success and low occurrence of lead-related major complications. With the advent of left bundle branch area pacing (LBBAP) as a physiological pacing option, use of the OmniaSecure lead may be a viable alternative for LBBAP in the ICD population.</p><p><strong>Objective: </strong>To understand the defibrillation efficacy at implant and safety of the OmniaSecure lead for LBBAP.</p><p><strong>Methods: </strong>The global LEADR LBBAP trial enrolled patients indicated for de novo implantation of a primary or secondary prevention ICD or CRT-D. Per study protocol, LBBAP includes ECG characterization of LBBP and deep septal pacing. The primary efficacy objective was defibrillation efficacy at implant exceeding a pre-specified threshold of 88% in ≥160 patients. The primary safety endpoint was to demonstrate the OmniaSecure lead-related major complication rate at 3 months post-implant.</p><p><strong>Results: </strong>A total of 307 patients underwent an LBBAP implant attempt (age: 64.9±12.2 years; 28.7% female; BMI: 28.4±6.1kg/m<sup>2</sup>). A total of 293 patients were successfully implanted per protocol (95.4%). The primary efficacy objective was met with 100% of patients defibrillated to protocol. The observed freedom from OmniaSecure lead-related major complications at 3 months was 97.9% (CI: 95.8-100%). There were zero study lead fractures, no oversensing adverse events and stable electrical parameters through 2.6±2.5 months follow-up.</p><p><strong>Conclusions: </strong>These results demonstrate implantation of OmniaSecure lead when intended for LBBAP results in high defibrillation success at implant, stable short-term electrical parameters, and a low rate of OmniaSecure lead-related major complications at 3 months.</p><p><strong>Clinical trial registration number: </strong>NCT04863664.</p>","PeriodicalId":12886,"journal":{"name":"Heart rhythm","volume":" ","pages":""},"PeriodicalIF":5.7000,"publicationDate":"2025-10-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Safety and performance of a novel defibrillation lead for left bundle branch area placement: primary results of the LEADR LBBAP clinical trial.\",\"authors\":\"Pugazhendhi Vijayaraman, Xingbin Liu, Russell Denman, Edward J Schloss, Zachary I Whinnett, Jordana Kron, Marek Jastrzębski, John S Zakaib, Walter P Abhayaratna, François Philippon, Muhammad R Afzal, Parash Pokharel, James Burrell, Jocelyn Tanner, Tessa Geelen, Megan L Platner, Kiah Butler, Pamela K Mason, George H Crossley\",\"doi\":\"10.1016/j.hrthm.2025.10.028\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Right ventricular placement of the OmniaSecure defibrillation lead has demonstrated high defibrillation success and low occurrence of lead-related major complications. With the advent of left bundle branch area pacing (LBBAP) as a physiological pacing option, use of the OmniaSecure lead may be a viable alternative for LBBAP in the ICD population.</p><p><strong>Objective: </strong>To understand the defibrillation efficacy at implant and safety of the OmniaSecure lead for LBBAP.</p><p><strong>Methods: </strong>The global LEADR LBBAP trial enrolled patients indicated for de novo implantation of a primary or secondary prevention ICD or CRT-D. Per study protocol, LBBAP includes ECG characterization of LBBP and deep septal pacing. The primary efficacy objective was defibrillation efficacy at implant exceeding a pre-specified threshold of 88% in ≥160 patients. The primary safety endpoint was to demonstrate the OmniaSecure lead-related major complication rate at 3 months post-implant.</p><p><strong>Results: </strong>A total of 307 patients underwent an LBBAP implant attempt (age: 64.9±12.2 years; 28.7% female; BMI: 28.4±6.1kg/m<sup>2</sup>). A total of 293 patients were successfully implanted per protocol (95.4%). The primary efficacy objective was met with 100% of patients defibrillated to protocol. The observed freedom from OmniaSecure lead-related major complications at 3 months was 97.9% (CI: 95.8-100%). There were zero study lead fractures, no oversensing adverse events and stable electrical parameters through 2.6±2.5 months follow-up.</p><p><strong>Conclusions: </strong>These results demonstrate implantation of OmniaSecure lead when intended for LBBAP results in high defibrillation success at implant, stable short-term electrical parameters, and a low rate of OmniaSecure lead-related major complications at 3 months.</p><p><strong>Clinical trial registration number: </strong>NCT04863664.</p>\",\"PeriodicalId\":12886,\"journal\":{\"name\":\"Heart rhythm\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":5.7000,\"publicationDate\":\"2025-10-17\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Heart rhythm\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1016/j.hrthm.2025.10.028\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"CARDIAC & CARDIOVASCULAR SYSTEMS\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Heart rhythm","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1016/j.hrthm.2025.10.028","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"CARDIAC & CARDIOVASCULAR SYSTEMS","Score":null,"Total":0}
Safety and performance of a novel defibrillation lead for left bundle branch area placement: primary results of the LEADR LBBAP clinical trial.
Background: Right ventricular placement of the OmniaSecure defibrillation lead has demonstrated high defibrillation success and low occurrence of lead-related major complications. With the advent of left bundle branch area pacing (LBBAP) as a physiological pacing option, use of the OmniaSecure lead may be a viable alternative for LBBAP in the ICD population.
Objective: To understand the defibrillation efficacy at implant and safety of the OmniaSecure lead for LBBAP.
Methods: The global LEADR LBBAP trial enrolled patients indicated for de novo implantation of a primary or secondary prevention ICD or CRT-D. Per study protocol, LBBAP includes ECG characterization of LBBP and deep septal pacing. The primary efficacy objective was defibrillation efficacy at implant exceeding a pre-specified threshold of 88% in ≥160 patients. The primary safety endpoint was to demonstrate the OmniaSecure lead-related major complication rate at 3 months post-implant.
Results: A total of 307 patients underwent an LBBAP implant attempt (age: 64.9±12.2 years; 28.7% female; BMI: 28.4±6.1kg/m2). A total of 293 patients were successfully implanted per protocol (95.4%). The primary efficacy objective was met with 100% of patients defibrillated to protocol. The observed freedom from OmniaSecure lead-related major complications at 3 months was 97.9% (CI: 95.8-100%). There were zero study lead fractures, no oversensing adverse events and stable electrical parameters through 2.6±2.5 months follow-up.
Conclusions: These results demonstrate implantation of OmniaSecure lead when intended for LBBAP results in high defibrillation success at implant, stable short-term electrical parameters, and a low rate of OmniaSecure lead-related major complications at 3 months.
期刊介绍：
HeartRhythm, the official Journal of the Heart Rhythm Society and the Cardiac Electrophysiology Society, is a unique journal for fundamental discovery and clinical applicability.
HeartRhythm integrates the entire cardiac electrophysiology (EP) community from basic and clinical academic researchers, private practitioners, engineers, allied professionals, industry, and trainees, all of whom are vital and interdependent members of our EP community.
The Heart Rhythm Society is the international leader in science, education, and advocacy for cardiac arrhythmia professionals and patients, and the primary information resource on heart rhythm disorders. Its mission is to improve the care of patients by promoting research, education, and optimal health care policies and standards.
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