Arrhythmias & electrophysiologyRandomised controlled trial
Sequential hybrid ablation vs. surgical CryoMaze alone for treatment of atrial fibrillation: results of multicentre randomized controlled trial
- Randomised controlled trial
- multicentre
Authors' conclusion
Pre-emptively performed catheter ablation after the CryoMaze procedure was safe and associated with higher freedom from AF/AT and improved clinical outcomes.
Study context
- Population
- Patients with non-paroxysmal atrial fibrillation (AF) undergoing CABG and/or valve repair/replacement with mandatory concomitant CryoMaze
- Participants
- 113 vs 116
- Comparison
- Sequential hybrid ablation vs CryoMaze alone
- Hybridn = 113
- Surgeryn = 116reference
- Primary endpoint
- Efficacy: first recurrence of AF/AT without class I or III antiarrhythmic drugs (implantable cardiac monitors); clinical: composite of hospitalization for arrhythmia recurrence, worsening HF, cardioembolic event or major bleeding
- Follow-up
- Median 715 (IQR 528-1072) days
Primary result
As reported in the abstract
Primary efficacy (AF/AT recurrence off class I/III antiarrhythmics) and primary clinical endpoint · median follow-up 715 days
Hybrid Group (HG)
41.1%
Primary efficacy endpoint · Primary clinical endpoint 19.9%
HG vs SurgeryHazard ratio (95% CI)P value
primary efficacy endpoint; 41.1% vs. 67.4% (Surgery Group)
0.38(0.26–0.57)
P < 0.001primary clinical endpoint; 19.9% vs. 40.1% (Surgery Group)
0.51(0.29–0.86)
P = 0.012Further findings
All-cause mortality
- Trial groups did not differ in all-cause mortality (10.6% vs. 8.6%)
- HR = 1.17, 95%CI: 0.51-2.71, P = 0.71
Safety
Major complications of catheter ablation
- Major complications of catheter ablation (infrequent)
- 1.9%
Original publication
Sequential hybrid ablation vs. surgical CryoMaze alone for treatment of atrial fibrillation: results of multicentre randomized controlled trial. Europace. Published 2 February 2024. doi:10.1093/europace/euae040
Summarised from the published abstract; every number is checked against it