Arrhythmias & electrophysiology
Dual-chamber leadless pacemaker implant procedural outcomes: Insights from the AVEIR DR i2i study
Authors' conclusion
In a pivotal investigational study, implantation of a dual-chamber LP system was successful in 99% of patients. Advanced implant experience was accompanied by improvements in procedural outcomes including reduced procedural times (introducer sheath insertion to removal, dual-chamber procedure, ventricular LP and atrial LP procedures, and fluoroscopy) and improved freedom from complications.
Study context
- Population
- Patients undergoing de novo percutaneous implantation of a dual-chamber leadless pacemaker (AVEIR DR) systempatients, implanted by 126 physicians
- Participants
- 452 patients
- Comparison
- 1-4 vs 9+ dual-chamber leadless pacemaker (LP) implant procedures
- Outcome
- Successful implantation of de novo dual-chamber LPs
Main finding
As reported in the abstract
Successfully implanted
446 of 452 patients
99%
Further findings
Mean procedural duration metrics
- Introducer sheath insertion-to-removal time
- 90±37 minutes
- Dual-chamber procedure duration
- 74±32 minutes
- Right ventricular LP procedure duration
- 26±17 minutes
- Right atrial LP procedure duration
- 42±24 minutes
- Fluoroscopy duration
- 20±13 minutes
- Reductions in duration metrics between initial and advanced implant experience
- 19%-36% (P<.05)
Safety
Freedom from complications, initial vs advanced implant experience
- Freedom from complications, initial vs advanced implant experience: P<.05
Procedural complications · within 30 days of implantation
- Procedural complications
- 62
- Patients with complications
- 50 of 452 patients (11.1%)
- Complication free
- 88.9%
- Cardiac arrhythmias (atrial fibrillation/flutter or complete atrioventricular block)
- 16 of 452 [3.5%]
Original publication
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