Purpose
Cryoballoon ablation (CBA) has become a standard treatment for recurrent atrial fibrillation (AF). There is need for improved CBA protocols. We aimed to demonstrate that a new protocol including minimum temperature (minT) reached could reduce procedure times and complications.
Methods
A new double factor protocol (DFP), based on the performance of one single shot per vein with variable duration, and conditional bonus shot, determined by time-to-effect (TTE) and minT, was compared with the conventional protocol (CP), with at least two shots per vein. Procedure parameters, complications, and efficacy were compared.
Results
We prospectively included 88 consecutive patients treated with the DFP. These were compared to the previous consecutive 69 patients treated with CP. All procedures were performed with 28-mm second-generation balloon. Acute pulmonary vein (PV) isolation was similar (98.6% vs. 98.9% in CP vs. DFP, p = 0.687). Procedure and ablation times favored DFP over CP (120 vs. 134 min, p = 0.003; and 1051 vs. 1475 s, p < 0.001; respectively). A composite of major and minor complications was significantly reduced in the DFP compared to the CP (18.8% vs. 6.8%, p = 0.02; respectively). Within a follow-up of 18 months, freedom from AF was 79.7% in CP and 78.4% in DFP (Log-rank 0.501). Paroxysmal AF and absence of PV potentials predicted better arrhythmia outcomes (HR 2.14 for paroxysmal vs. persistent, p = 0.031; and HR 1.61 for absence vs. presence of PV potentials, p = 0.01).
Conclusions
The novel DFP results in reduced complication rates and procedure times, with similar success rates compared with a conventional strategy.