Arrhythmias & electrophysiologyCohort study
STAR Apollo™ Map-Guided Redo Ablation for Recurrent Persistent Atrial Fibrillation after Prior Pulmonary Vein Isolation: Procedural Feasibility, Safety, and Twelve-Month Rhythm Outcomes from a Prospective Multicenter Study (NCT05826665)
- prospective, multicenter, observational study
Authors' conclusion
In conclusion, in recurrent persistent AF after prior PVI, STAR Apollo-guided redo ablation was feasible and safe, added a modest mapping step, and was associated with sinus rhythm and symptom improvement in most patients at 12 months. Designed as a feasibility and safety study, and being single arm, these data cannot establish the incremental efficacy of STAR guidance; the encouraging rhythm outcomes are hypothesis generating and support a randomized comparison with PV re-isolation alone.
Study context
- Population
- Patients with persistent atrial fibrillation (AF) recurring after 1 prior pulmonary vein isolation (PVI) (prior extrapulmonary vein ablation excluded) who underwent pulmonary vein re-isolation, STAR Apollo mapping, and operator-directed adjunctive ablationpatients (of 64 enrolled) in whom a STAR map was obtained, the 14 without a STAR map, because they were not in AF during the procedure, were excluded
- Participants
- 50 patients
Main finding
As reported in the abstract
STAR Apollo-guided redo ablation
92.0%
46 of 50 of 50
Observational data: associations, not effects.
Further findings
| Outcome | Values |
|---|---|
| ESAs identified per patient | STAR Apollo-guided redo ablation median 3 (range as printed 2–3) |
| Procedure time | STAR Apollo-guided redo ablation Added by STAR mapping 16 (13-21) · Total procedure time 125 (91-166) |
| Restoration of sinus rhythm in the laboratory | STAR Apollo-guided redo ablation Restored without cardioversion 23 of 50 (46.0% · AF terminated during ablation 19/50 [38.0%] · Terminated spontaneously 4/50 [8.0%] · Required cardioversion 26 of 50 (52.0%) · Not restored in the laboratory 1 of 50 (2.0%) |
| Adjunctive lines | STAR Apollo-guided redo ablation Roof line 30 of 50 (60.0%) · Mitral isthmus line 11 of 50 (22.0%) |
| Sinus rhythm among the 40 patients assessed at 12 months | STAR Apollo-guided redo ablation 82.5% |
| Symptom class improved to European Heart Rhythm Association I · 12 months | STAR Apollo-guided redo ablation 76.7% |
| Freedom from AF (Kaplan-Meier, single procedure; recurrence, repeat ablation, or cardioversion counted as failure) · 6 and 12 months | STAR Apollo-guided redo ablation 6 months 95.3% (95% confidence interval [CI]: 82.5-98.8) · 12 months 75.3% (95% CI: 59.0-85.9) |
| Baseline characteristics | STAR Apollo-guided redo ablation Age 68.8 ± 8.7 years · Male 35 (70.0%) · Body mass index 31.3 ± 5.5 kg/m² |
- Sinus rhythm among the 40 patients assessed at 12 months: of the 40 patients assessed at 12 months
Safety
| Outcome | Values |
|---|---|
| Procedural complication (pericardial effusion) | STAR Apollo-guided redo ablation 2.0% |
Original publication
Summarised from the published abstract; every number is checked against it