Arrhythmias & electrophysiology
Dual energy for pulmonary vein isolation using dual-energy focal ablation technology integrated with a three-dimensional mapping system: SmartfIRE 3-month results
Authors' conclusion
A DE focal CF catheter with 3D mapping integration showed a 100% acute success rate with an acceptable safety profile in the treatment of paroxysmal AF. Prespecified 3-month remapping showed notable PVI durability.
Study context
- Population
- Drug-refractory, symptomatic paroxysmal atrial fibrillation (AF) undergoing pulmonary vein isolation (PVI)137 per-protocol
- Participants
- 149 participants
- Outcome
- Acute procedural success (effectiveness); rate of primary adverse events (safety)
- Follow-up
- PAEs within 7 days of the procedure
Methodological detailsprespecified imaging, endoscopy and remapping subsets, Enrolment February–June 2023, 140 had catheter inserted (safety analysis set)
- Prespecified imaging, endoscopy and remapping subsets
- Enrolment February–June 2023
- 140 had catheter inserted (safety analysis set)
Main finding
As reported in the abstract
Dual-energy (DE) focal contact force (CF) catheter
100%
Observational data: associations, not effects.
Further findings
First-pass isolation
- Patients with first-pass isolation
- 89.1%
- Veins with first-pass isolation
- 96.8%
Procedure and fluoroscopy times
- Median (Q1/Q3) total procedure time, min
- 108.0 (91.0/126.0)
- Median (Q1/Q3) fluoroscopy time, min
- 4.2 (2.3/7.7)
- n = 137
Cavotricuspid isthmus ablation
- Successfully performed
- 12 patients
- Pulsed field (PF) only
- 6
- Radiofrequency (RF) only
- 5
- RF/PF
- 1
PVI durability at remapping (Day 75 ± 15; subset n = 30)
- Treated pulmonary vein (PVs) durably isolated
- 100/115 (87%)
- Patients with all PVs durably isolated
- 18/30 (60.0%)
- Prespecified subset
Safety
Primary adverse events (primary safety endpoint) · within 7 days of the procedure
- PAE rate
- 4.4% (6/137 patients)
- PV stenoses
- 2
- Cardiac tamponades/perforations
- 2
- Stroke
- 1
- Pericarditis
- 1
Coronary artery spasm
- No coronary artery spasm reported
Oesophageal lesion (EE subset, 72 h) · 72 h post-procedure
- Oesophageal lesions
- 0/31, 0%
- Prespecified subset
Cerebral microemboli lesions (neurological assessment (NA) subset, n = 30) · discharge
- Microemboli lesions
- 2/30, 6.7%
- Symptomatic
- 1
- Silent cerebral lesion
- 3.3%
- Both resolved at follow-up
Severe PV narrowing >70% (computed tomography (CT)/magnetic resonance angiogram (MRA) subset, n = 30) · 3 months post-procedure
- Patients
- 2/30, 6.7%
- Vein level
- 2/128, 1.6%
- 1 dilatation and stenting, 1 asymptomatic; both associated with high index values and small inter-tag distance
Original publication
Summarised from the published abstract; every number is checked against it