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Войти в исследования Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology · 2025
Evaluation of a second-generation intercostal extravascular implantable cardioverter defibrillator lead with a pectoral pulse generator for sensing, defibrillation, and anti-tachycardia pacing.
Оценочное исследованиеСтатьяКлиническое исследованиеНазвание и аннотация: Перевод в очереди
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Doshi Shephal K, Knops Reinoud E, Ebner Adrian, Husby Michael, Marcovecchio Alan, Sanghera Rick, Scheck Don, Burke Martin C
Аннотация
AIMS: 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).
METHODS AND RESULTS: 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 'recording-only' mode and the control TV-ICD system in 'therapy delivery' 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 min). 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.
CONCLUSION: 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.
CLINICAL TRIAL REGISTRATION: NCT number: NCT05791032; URL: https://clinicaltrials.gov/study/NCT05791032.
METHODS AND RESULTS: 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 'recording-only' mode and the control TV-ICD system in 'therapy delivery' 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 min). 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.
CONCLUSION: 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.
CLINICAL TRIAL REGISTRATION: NCT number: NCT05791032; URL: https://clinicaltrials.gov/study/NCT05791032.