Procedural characteristics of pulmonary vein isolation using the novel third-generation cryoballoon

Europace. 2016 Dec;18(12):1795-1800. doi: 10.1093/europace/euw012. Epub 2016 Mar 2.

Abstract

Aim: A novel third-generation cryoballoon (CB3) to perform pulmonary vein isolation (PVI) has recently been released, featuring a shortened distal balloon tip when compared with the second-generation (CB2), possibly allowing for enhanced intra-ablation pulmonary vein (PV) signal mapping. We aimed to investigate procedural efficacy and safety of the CB3 as compared to the CB2.

Methods and results: We studied 472 consecutive patients who underwent CB-PVI for paroxysmal or persistent atrial fibrillation (CB3: 49 patients; CB2: 423 patients). Detailed procedural data and in-hospital complications were registered in a prospective database. Complete PVI using the CB only was achieved in 98% of patients in each group. Single-freeze PVI was observed in 84/88% (CB2/CB3, P = n.s.) of the PVs. Time-to-PVI (TPVI) was 49 ± 32 (CB2) and 45 ± 27 s (CB3) (P = n.s.). Time-to-PVI determination rate was higher in the CB3 group (89.5 vs. 82.6%, P = 0.016). Signal noise due to ice formation on mapping electrodes occurred after 70 ± 46 s using CB3 and did not interfere with TPVI determination. Exchange of the spiral mapping catheter with a guide wire was more frequently required in the CB3 group (8.2 vs. 0.7% patients, P < 0.001). Balloon dislodgement during hockey stick manoeuvres occurred in 6.1% patients of the CB3 group only (P = 0.001). Complication rates were not different between the groups.

Conclusion: The CB3 offers a higher TPVI determination rate, facilitating dosing schemes based on TPVI, with equally high single-freeze efficacy compared with the CB2. The shortened distal tip of the CB3 requires adaptation of standard catheter manoeuvers to avoid balloon dislodgement.

Keywords: Ablation; Arrhythmia; Atrial fibrillation; Cryoballoon; Electrophysiology.

Publication types

  • Comparative Study

MeSH terms

  • Aged
  • Atrial Fibrillation / surgery*
  • Catheter Ablation*
  • Cryosurgery / adverse effects
  • Cryosurgery / instrumentation*
  • Databases, Factual
  • Female
  • Fluoroscopy
  • Humans
  • Male
  • Middle Aged
  • Prospective Studies
  • Pulmonary Veins / surgery*
  • Recurrence
  • Time Factors
  • Treatment Outcome
  • United States