Trial reportEuropace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology2025
Evaluation of a second-generation intercostal extravascular implantable cardioverter defibrillator lead with a pectoral pulse generator for sensing, defibrillation, and anti-tachycardia pacing.
Trial report in 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. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05791032 (Sub Chronic Evaluation for ATP With an Extravascular Placed ICD Lead), which is not on this map. Cited by 2 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Sub Chronic Evaluation for ATP With an Extravascular Placed ICD Lead (STEP ICD) Study
Who cites it
2 citing papers in PubMed, 1 synthesis or guideline pooled it.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors.
Funding
Abstract
aimsIntercostal 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
resultsSubjects 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.
conclusionIn 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 registrationNCT number: NCT05791032; URL: https://clinicaltrials.gov/study/NCT05791032.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.