Arrhythmias & electrophysiologyCohort study

Incidence of phrenic nerve injury during pulmonary vein isolation using different cryoballoons: data from a large prospective ablation registry

EuropacePublished

  • Prospective observational registry study
  • multicentre
  • 19 centres
  • consecutive patients

Authors' conclusion

Our study demonstrated a significantly higher incidence of right PNI and lower touch-up rate for the POLARx-CB than AFA-CB in the real-world clinical practice.

Study context

Population
Consecutive atrial fibrillation (AF) patients undergoing pulmonary vein isolation (PVI) by cryoballoon, 19 centres, January 2022–October 2023
Participants
2,555 patients
Exposure
POLARx-CB vs AFA-CB for PVI
  • POLARx-CBn = 1,197
  • AFA-CBn = 1,358reference
Outcome
Acute procedural efficacy (touch-up ablation) and safety (right phrenic nerve injury)

Main finding

As reported in the abstract

Touch-up ablation

P = 0.002

Touch-up ablation overall
299(11.7%)

Observational data: associations, not effects.

Further findings

OutcomeP value
Touch-up ablation, PAF vs non-PAF · 8.8% vs 17.2%P < 0.001

Touch-up ablation, PAF vs non-PAF

Touch-up rate similar between the two cryoballoons in non-PAF patients

Safety

Right phrenic nerve injury · right PNI

P < 0.001

Symptomatic PNI

P < 0.001

PNI during RSPV ablation

P < 0.001

Right phrenic nerve injury — Right phrenic nerve injury (PNI) overall
64(2.5%)
Right phrenic nerve injury — Symptomatic PNI overall
22(0.9%)
Right phrenic nerve injury — PNI during right superior PV (RSPV) ablation overall
39(1.5%)

Right phrenic nerve injury

No significant difference during RIPV ablation
PNI recovered more quickly with AFA-CB than POLARx-CB

Original publication

Incidence of phrenic nerve injury during pulmonary vein isolation using different cryoballoons: data from a large prospective ablation registry. Europace. Published 8 April 2024. doi:10.1093/europace/euae092

Summarised from the published abstract; every number is checked against it