Fehmi Keçe

Chapter 2 50 2.7 Comparison of ablation devices 2.7.1 Ablation technology and efficacy Outcome after cryoballoon ablation vs. point-by point RFCA has been well studied, also in randomized trials: a recent meta-analysis of 10 studies (total of 6473 patients; 3 randomized trials) showed similar efficacy (118). Data comparing other single-shot techniques with RFCA are limited. Smaller studies suggest no significant differences in efficacy. A randomized multi-center clinical trial comparing the laserballoon with RFCA (178 vs. 175 patients) reported a 61 vs. 62% AF free survival at 1 year (off AAD) (111). Also in another multi-center prospective trial comparing laserballoon (n=68) with RFCA (n=66) there was no difference in outcome (71 vs. 69%, p=0.40) at 1-year follow-up (off AAD)(114). In a study comparing laserballoon with cryoballoon (n=140) the efficacy at 1 year off AAD was comparable between the 2 techniques (73.vs.63%) (119). 2.7.2 Ablation technology and procedural time The reported procedure times for cryoballoon ablation are significantly shorter compared to point-by-point RFCA (118) (table 1-2). Similar, procedural time using multi-electrode ablation catheters (PVAC) are shorter if compared to point-by-point RFCA, while the efficacy was similar (120, 121). Although in an early study longer procedural times were reported for laserballoon ablation compared to cryoballoon ablation and point-by-point RFCA (116), a recent study demonstrated similar procedural duration (laserballoon 144 minutes, cryoballoon 136 minutes) (119). This was also applicable when comparing laserballoon with RFCA (128 vs. 135 min)(114). 2.7.3 Pericardial Effusion/Cardiac Tamponade Radiofrequency ablation, compared to balloon-based devices is associated with an increased risk for cardiac tamponade (1.5vs.0.1%) (122). This risk was higher in PVI plus additional lesions sets compared to PVI only (0.8vs.0.1%, p=0.024) (122). For CF catheters, the reported incidences are higher (2.5-8%)(123-125). Based on published data (table 1, table 2), the estimated incidence of pericardial effusion/cardiac tamponade is approximately 1.9% (144 of 9793; range 1-12%) for point-by-point RFCA and 0.7% (47 of 6772; range 0-8%) for the cryoballoon.