Fehmi Keçe

Advances in Atrial Fibrillation Ablation Devices 51 2 2.7.4 Stroke/TIA Cryoballoon ablation has been associatedwith a lower risk for thrombus formation compared to RFCA (126). In line with this data is the observed lower incidence of silent cerebral embolism compared to irrigated RFCA and PVAC (51, 52, 127). However, in a randomized study comparing laserballoon (n=33), cryoballoon (n=33) and irrigated RFCA (n=33), the incidence of asymptomatic cerebral lesions was not significantly different (24%, 18% and 24%, respectively) (116). For PVAC, a higher rate of micro-embolic signals and asymptomatic cerebral embolism has been observed compared to cryoballoon or RFCA (51, 53, 56). However, the incidence of symptomatic cerebral events (stroke/TIA) is similar (0.3vs.0.2%). 2.7.5 Phrenic nerve palsy and oesophageal/vagal nerve injury The incidence of PNP is significantly higher with the cryoballoon compared to RF, occurring in 3.9% of the ablations (264 of 6772 cases; range 0-15%), with permanent paralysis in <1% (table 1-2). Similar, laserballoon ablations are complicated by PNP in 5.8% of patients (111). In contrast, the reported risk for oesophageal injury is lower with cryoballoon compared to RFCA (128). 2.7.6 Pulmonary vein stenosis In a clinical trial comparing laserballoon vs. RFCA, the incidence of PV stenosis was lower (0vs.3%) (111). In a study comparing the laserballoon with RFCA and cryoballoon, only mild stenosis was seen in 18, 10 and 3.6% of the PVs, respectively (129). 2.7.7 Groin complications and bleeding Based on the published data summarized in table 1 and 2, there were no significant differences in groin related complications between cryoballoon ablation and RFCA: total reported cases for cryoballoon are 139 (1.8%) vs. 179 (1.8%) for RFCA. 2.7.8 Patient characteristics related to complications The majority of patients included in ablation studies are male (130). Bleeding complications (groin-related) after catheter ablation were reported in 2.1% of female patients (total 3265 patients, n=518 females) undergoing AF ablation. These numbers exceed those reported in males (n=27; 0.9%) (130). Both female gender and higher age have been associated with major adverse events (29). In a large nationwide survey, significant predictors for complications were female gender, high burden of comorbidity and low ablation volume of the hospital (< 50 procedures/per year) (131). In addition, patient with diabetes mellitus are at risk specifically for thrombotic or haemorrhagic complications (132).