Arrhythmias & electrophysiologyCohort study
Evaluation of a second-generation intercostal extravascular implantable cardioverter defibrillator lead with a pectoral pulse generator for sensing, defibrillation, and anti-tachycardia pacing
- Prospective single-group pilot study
- acute and 3-month follow-up
- concomitant transvenous ICD (TV-ICD) as control
Extravascular implantable cardioverter defibrillator (EV-ICD) system followed in recording-only mode; control TV-ICD in therapy delivery mode · Devices evaluated before discharge, 2 weeks, 1, 2 and 3 months post-implant
Authors' 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.
Study context
- Population
- Subjects undergoing a TV-ICD procedure who received a concomitant second-generation intercostal EV-ICD lead system
- Participants
- 20 subjects
- Exposure
- Intercostal EV-ICD lead with left mid-axillary vs left pectoral PG
- Outcome
- Safety and performance outcomes (sensing, defibrillation of induced ventricular arrhythmias, pacing capture)
- Follow-up
- 3 months
Main finding
As reported in the abstract
| Group | Value | Patients tested |
|---|---|---|
| Left mid-axillary PG | 100% | 17 |
| Left pectoral PG | 95% | 20 |
Observational data: associations, not effects.
Further findings
Successful implantation
- Successfully implanted
- 20/20 (100%)
- Median implant time
- 9 min
Intraoperative pacing capture (integrated bipolar configuration)
- Pacing capture achieved
- 19 of 20 (95%)
- Pacing capture tolerated in all subjects; over 90% no pain after 1-month recovery
Sensing and defibrillation prior to lead removal
- Successful
- 18 of 18 (100%)
Safety
Major lead complications · mean of 82 days
- Major lead complications (lead movement; infection of both TV-ICD and EV-ICD systems)
- 2
Original publication
Summarised from the published abstract; every number is checked against it