Fehmi Keçe

Chapter 2 48 2.6 Laserballoon 2.6.1 Historical overview The first-generation laserballoon (Endoscopic ablation system, Cardiofocus Inc. Marlborough, Massachusetts, USA) was available in three diameters (20, 25 and 30 mm). It consists of a delivery sheath with an endoscope and arc generator inside a balloon. With the endoscope, the intra-cardiac anatomy and adequate tissue contact can be visualised real-time. The arc generator delivers laser energy to perform PVI (110). Similar to other balloon-based devices, superior caval vein pacing and oesophageal temperature monitoring (39 °C cut off) is recommended to minimize the risk for PNP and oesophageal injury. After ablation, PV isolation needs to be evaluated with a separate spiral catheter. In the next-generation balloon (HeartLight, Cardiofocus, Inc., Marlborough, Massachusetts, USA), the arc of the laser was decreased from 90-150 to 30 degrees to improve safety. In addition, the balloon material was modified allowing variable sizing and deformation to prevent mismatch between the balloon size and the PV diameter (111). Based on data from 9 studies, including 1021 patients the efficacy of the HeartLight balloon procedure ranged between 58-88% at 1-1.5 year follow (off AAD) (112). A more compliant laserballoon is currently being developed (HeartLight Excalibur Balloon™, Cardiofocus Inc.). 2.6.2 Procedure time The first-generation laserballoon was initially constructed as a two-operator device for positioning the balloon and directing the laser ablation (113). The second-generation laserballoon can be used by a single-operator. In addition, energy delivery has been modified leading to a shorter procedural duration from 334 min during first use (110) to 133-236 min in the improved laserballoon (112, 114). 2.6.3 Complications A paper providing pooled data of 8 small studies (total 308 patients) reported PNP in 2.3% and cardiac tamponade in 1.9% of the patients (113). In a multi-center study including 200 patients with paroxysmal AF, similar complications rates were observed (2% cardiac tamponade and 2.5% PNP (115). However, in a recent multicenter prospective study 1 patient out of 68 showed PNP and 1 patients developed a stroke (both 1.5%) (114). Of concern, the incidence of asymptomatic cerebral embolism with the laserballoon was 24%, but not significantly higher (p=0.8) than for cryoballoon (18%) and irrigated RFCA (24%) in a randomized study (116). In a clinical trial comparing laserballoon with irrigated