Complications of pulmonary vein isolation in atrial fibrillation: predictors and comparison between four different ablation techniques: Results from the MIddelheim PVI-registry.

Aims To define predictors of complications of pulmonary vein isolation (PVI) and compare safety between different ablation techniques. Methods and results One thousand patients with atrial fibrillation (AF) (age 60 +/- 10, 72% males, CHA(2)DS(2)-VASc score 1 +/- 1) underwent PVI using various techniques: conventional PVI (CPVI) using mapping with irrigated point-per-point RF ablation (n = 576), multi-electrode RF ablation with the pulmonary vein ablation catheter (PVAC) (n = 272) or high density mesh ablator (HDMA) (n = 59) and cryoballoon (CB) ablation (n= 93). A complication was defined as any procedure-related adverse event resulting in permanent injury or death, requiring intervention or treatment, or prolonging/requiring hospitalization for >48h. A total of 105 (10.5%) complications occurred in 101 (10.1%) patients. No periprocedural death occurred. Most frequent complications were vascular complications (4%) and pericarditis (3.1%). Seven patients experienced permanent deficit due to PV stenosis (n = 3, 1 CPVI, 2 PVAC) (n = 3) and phrenic nerve palsy (PNP) (n = 4, 3 CPVI, 1 PVAC). Independent predictors of complications were female sex [odds ratio (OR) = 1.73; 95% confidence interval (CI) 1.08-2.79; P=0.023], CHA(2)DS(2)-VASc score (OR = 1.24; 95% CI 1.01-1.52; P = 0.039), and ablation technique (P=0.006) in multivariable-adjusted analysis. Among the different techniques, CB (P= 0.047) and PVAC ablation (P=0.003) had lowest overall complication rates. Complication profile (type/severity) differed between techniques (association between CB and PNP. CPVI and pericardial injury, PVAC and transient ischaemic attack/PV stenosis). Conclusion Overall complication rate of PVI with various techniques is 10.5%. Permanent deficit occurred only after PVAC and CPVI in 0.7% of patients. Female sex and a higher CHA(2)DS(2)-VASc score increase, while PVAC and CB-PVI decrease, overall risk. Differences in overall safety and individual complication profile make selection of the ablation technique in relation to clinical risk profile possible.