Arrhythmias & electrophysiology
Predictors of Success for Pulmonary Vein Isolation With Pulsed-field Ablation Using a Variable-loop Catheter With 3D Mapping Integration: Complete 12-month Outcomes From inspIRE
Authors' conclusion
The inspIRE study confirms the safety and effectiveness of pulmonary vein isolation using the novel 3-dimensional mapping integrated circular loop catheter. An optimal number of PFA applications (≥48 total or ≥12 per vein) resulted in an improved 1-year success rate of ≈80%.
Study context
- Population
- Drug-refractory paroxysmal AF
- Participants
- 186 participants
- Outcome
- Acute pulmonary vein isolation plus freedom from any atrial arrhythmia
- Follow-up
- 12 months
Methodological detailsprospective, multicentre, Follow-up: 24-hour Holter at 3, 6 and 12 months plus remote rhythm monitoring (weekly 3–5 months, monthly 6–12 months, and for symptoms)
- Prospective
- Multicentre
- Follow-up: 24-hour Holter at 3, 6 and 12 months plus remote rhythm monitoring (weekly 3–5 months, monthly 6–12 months, and for symptoms)
Main finding
As reported in the abstract
PEE achieved
75.6%
95% CI 69.5%–81.8%
Observational data: associations, not effects.
Further findings
Freedom from symptomatic recurrence (clinical success)
- Freedom from symptomatic recurrence
- 81.7% (95% CI, 76.1%-87.2%)
Freedom from all and symptomatic recurrence, simulated standard real-world monitoring (no protocol-driven remote monitoring)
- Freedom from all recurrence
- 85.8% (95% CI, 80.8%-90.9%)
- Freedom from symptomatic recurrence
- 94.0% (95% CI, 90.6%-97.5%)
Independent predictors of PEE success (multivariate)
- LVEF ≥60%, adjusted OR
- 0.30
- ≥48 PFA applications, adjusted OR
- 0.28
PEE success by PFA applications per vein
- ≥12 PFA applications per vein
- 79.2%
- Fewer PFA applications
- 57.1%
Safety
Primary adverse event rate
- Primary adverse event rate
- 0%
- Previously reported
Serious procedure-related AE
- Serious procedure-related AE (urinary retention)
- 1
Original publication
Summarised from the published abstract; every number is checked against it