Electroanatomical mapping improves procedural outcomes of cryoballoon pulmonary vein isolation (the Achieve Plus study)

Background Validation of pulmonary vein (PV) isolation (PVI) using only the Achieve catheter following cryoballoon ablation (CBA) is imperfect since pulmonary vein potentials (PVP) can be recorded in only 50-85% of the veins and residual PVP are found in up to 4.3-7.6% of the isolated veins in remapping studies. Objective To study if addition of electroanatomical mapping to Achieve catheter-guided CBA is superior for PVI. Methods One hundred patients were randomized between Achieve catheter-guided CBA (control group; N = 50) and Achieve catheter-guided CBA with additional EnSite voltage maps performed pre- and post-CBA (Achieve Plus group; N = 50). Confirmation of PVI was done by circular mapping catheter (CMC) and EnSite mapping by a second blinded operator. Results Despite apparent PVI in all PVs after CBA, incomplete PVI was present in 0 out of 50 patients (0%) and 0 out of 204 PVs in the Achieve Plus group versus 6 patients out of 50 (12%; P = 0.012) and 6 out of 203 PVs (3%; P = 0.013) in the control group. All 6 non-isolated PVs could be successfully isolated by additional cryoapplications. Procedure time was longer in the Achieve Plus group (75.76 +/- 21.65 vs 66.06 +/- 16.83 min; P = 0.014) with equal fluoroscopy times (14.85 +/- 6.41 vs 14.33 +/- 8.55; P = 0.732). Conclusion The addition of electroanatomical EnSite mapping to the Achieve catheter improves the PVI rate of CBA and could be considered for future use.