58-04: Initial results of pulmonary vein isolation using the novel third-generation cryoballoon

Abstract

Introduction: A novel third-generation cryoballoon (CB3) to perform pulmonary vein isolation (PVI) has recently been released, featuring a shortened distal balloon tip when compared to the second-generation device, possibly allowing for enhanced intraablation PV signal mapping. The mechanical behavior of a cryoballoon system with a short balloon tip is unknown. Methods: We studied 95 consecutive patients who underwent CB3-PVI for paroxysmal or persistent atrial fibrillation. Target freezing time was 240 seconds. A “bonus” ablation after PVI was performed if time-to-PVI (TPVI) was > 75 seconds / not determined or if PVI required > 1 freeze. Detailed procedural data and in-hospital complications were registered in a prospective database. Results: Complete PVI using the 28 mm CB3 only was achieved in 99% of patients with 5,3 ± 1,4 balloon applications. In one patient, a single PV could not be isolated due to transient phrenic nerve palsy (PNP). Single-freeze PVI was observed in 320/369 (87%) PVs. Procedure and Fluoroscopy exposure times were 66 ± 20 and 11 ± 5 minutes, respectively. TPVI could be determined in 87% of PVs (47 ± 30 seconds). Signal noise due to ice formation on mapping electrodes occurred after 68 ± 44 seconds and did not interfere with TPVI determination. Balloon dislodgment during hockey stick maneuvers due to the short balloon tip occurred in 3/95 (3%) patients. To achieve a stable balloon position, exchange of the spiral mapping catheter with a stiff guide wire was required in 7,4% of patient. Persistent PNP occurred in 3/95 (3%) of patients. Conclusion: The CB3 offers a high TPVI determination rate, facilitating dosing schemes based on TPVI. The shortened distal tip of the CB3 requires adaptation of standard catheter maneuvers to avoid balloon dislodgment.