Arrhythmias & electrophysiology
Dual energy for pulmonary vein isolation using focal ablation technology integrated with a three-dimensional mapping system: SmartfIRE 12-month results
Authors' conclusion
The 12-month follow-up of the SmartfIRE study demonstrated the effectiveness, safety, and healthcare benefits of ablation using the DE STSF platform.
Study context
- Population
- Patients with symptomatic paroxysmal AF undergoing pulmonary vein isolation136 per-protocol
- Participants
- 149 patients
- Outcome
- Freedom from documented symptomatic and asymptomatic atrial arrhythmia on or off antiarrhythmic therapy, including acute procedural failures
- Follow-up
- 12 months
Main finding
As reported in the abstract
Freedom from symptomatic and asymptomatic atrial arrhythmia
71.5%
Freedom from atrial arrhythmia, standard-of-care monitoring only
84.2%
Further findings
Clinical success (freedom from symptomatic arrhythmia) and single procedural success · 12 months
- Clinical success (freedom from symptomatic arrhythmia)
- 86.4%
- Single procedural success
- 81.0%
- n = 136
Overall AFEQT score change vs baseline · 12 months
- Median increase in overall AFEQT score vs baseline (points)
- 26.9
CV hospitalization rate, 12 months before vs after ablation
- Before ablation
- 20.1
- After ablation
- 11.9%
Class I/III and antiarrhythmic drug (AAD) use · 6-12 months postablation
- Baseline
- 60.3%
- 6-12 months postablation
- 23.9%
Freedom from atrial arrhythmia recurrence by adherence to recommended inter-tag distance and pulsed field (PF)/radiofrequency (RF) index (post hoc) · 12 months
- High adherence (n = 47)
- 86.9%
- Remaining patients (n = 88)
- 64.0%
- Post hoc analysis
Safety
- Device- and/or procedure-related serious adverse events (SAEs) (5/140 patients)
- 3.6%
- Cardiac tamponade
- 2
- Pulmonary vein stenosis
- 2
- Anaphylactic shock
- 1
- Safety population (n = 140)
Original publication
Summarised from the published abstract; every number is checked against it