Arrhythmias & electrophysiology
Paroxysmal Atrial Fibrillation Ablation Using a Novel Variable-Loop Biphasic Pulsed Field Ablation Catheter Integrated With a 3-Dimensional Mapping System: 1-Year Outcomes of the Multicenter inspIRE Study
Authors' conclusion
The inspIRE trial confirmed the safety and effectiveness of the novel mapping-integrated PFA system.
Study context
- Population
- Drug-refractory paroxysmal AF undergoing pulmonary vein (PV) isolation with a mapping-integrated biphasic pulsed field ablation (PFA) system with a variable-loop circular catheter; 13 centres in Europe/Canada
- Participants
- 226 participants
- Exposure
- Wave I vs Wave II
- Wave In = 40
- Wave IIn = 186
- Outcome
- Primary effectiveness: confirmed PV isolation with freedom from documented atrial arrhythmia; primary safety: incidence of early-onset primary adverse events
- Follow-up
- 12 months
Methodological detailsmulticenter, prespecified interim analysis, Wave I (initial safety) and Wave II (pivotal phase)
- Multicenter
- Prespecified interim analysis
- Wave I (initial safety) and Wave II (pivotal phase)
Main finding
As reported in the abstract
Primary effectiveness (Wave II, Kaplan-Meier)
Wave II
70.9%
Observational data: associations, not effects.
Further findings
Acute PV isolation
- Entrance block
- 100%
- PV isolation without acute reconnection (targeted veins)
- 97.1%
Freedom from symptomatic AF/atrial flutter/atrial tachycardia recurrence and from repeat ablation (Wave II) · 12 months
- Freedom from symptomatic AF/atrial flutter/atrial tachycardia recurrence
- 78.9%
- Freedom from repeat ablation
- 92.3%
Procedure times
- Total procedure time
- 70.1±27.7 minutes
- Transpired PFA time
- 26.7±14.0 minutes
Safety
- Primary adverse events (Wave II)
- 0 · events
- Esophageal thermal lesions and PV stenosis (Wave I)
- 0 · events
Silent cerebral lesions on MRI (Wave I, 39 with MRI)
- First 6 subjects
- 4 of 6
- After workflow enhancements (incl. 10-second pause between PFA applications)
- 4 of 33
Original publication
Paroxysmal Atrial Fibrillation Ablation Using a Novel Variable-Loop Biphasic Pulsed Field Ablation Catheter Integrated With a 3-Dimensional Mapping System: 1-Year Outcomes of the Multicenter inspIRE Study. Circ Arrhythm Electrophysiol. Published 3 February 2023. doi:10.
Summarised from the published abstract; every number is checked against it