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