Fehmi Keçe

Advances in Atrial Fibrillation Ablation Devices 41 2 2.4.3 Complications The reported incidence of complications is low and not significantly different between the first and second-generation cryoballoons (79, 82-96). Specifically, the reduction in ablation time was not associated with lower complication rates (table 2). Cardiac tamponade occurred in 0.7% (47 of 6672 procedures) and was similar for first and the second-generation balloons (table 2). The incidence of phrenic and vagal nerve damage is however, of concern. In a series of 66 patients, asymptomatic gastroparesis was reported in 9%, transient PNP in 8% and symptomatic inappropriate sinus tachycardia in 1% (97). The reported incidence of PNP ranged between 2-28% for the first-generation and between 1-16% for the second-generation cryoballoon (table 2). An association between cryoballoon use and any oesophageal injury has been reported in up to 17% (98, 99). However, atrial- oesophageal fistulae are rare and have only been case-reported (100-102). Stroke and transient ischemic attacks are reported in 0.3-0.5% of patients (table 2). Of importance, the risk for PVS is also low. In a recent study, 0.4% of the patients showed an only mild (25-50%) PVS (103).