Worldwide experience with the robotic navigation system in catheter ablation of atrial fibrillation: methodology, efficacy and safety.

INTRODUCTION: The Hansen Robotic system has been utilized in ablation procedures for atrial fibrillation (AF). However, because of the lack of tactile feedback and the rigidity of the robotic sheath, this approach could result in higher risk of complications. This worldwide survey reports a multicenter experience on the methodology, efficacy, and safety of the Hansen system in AF ablations. METHODS AND RESULTS: A questionnaire addressing questions on patient's demographics, procedural parameters, ablation success rate and safety information was sent to all centers where more than 50 robotic AF ablation cases have been performed. From June 2007 to December 2009, 1,728 procedures were performed at 12 centers utilizing the Hansen robotic navigation technology. The overall complication rate was 4.7% and the success rate was 67.1% after 18 ± 4 months of follow-up. In 5 low volume centers there appeared to be a learning curve of about 50 cases (complication rate 11.2% for the first 50 cases vs 3.7% for the 51-100 cases; P = 0.044) and a trend showing a decrease of complication rate with increasing case volume. However, in the remaining 7 centers no learning curve was present and the complication rate was stable over time (3.7% for the first 50 cases vs 3.6% for the 51st case thereafter; P = 0.942). CONCLUSION: The Hansen robotic system can be used for AF ablation safely. In low volume centers, there appeared to be a learning curve of the first 50 cases after which the complication rate decreased. With a higher case volume, the success rate increased.

Oesophageal temperature monitoring and incidence of oesophageal lesions after pulmonary vein isolation using a remote robotic navigation system.

AIMS: Oesophageal lesions (EL), a potential complication after pulmonary vein isolation (PVI), have been described recently. A new remote robotic navigation system (RNS; Hansen Medical) provides enhanced catheter stability along with more effective lesion placement. The aim of this prospective study was to evaluate temperature monitoring and incidence of EL when using RNS with an irrigated tip radiofrequency catheter for PVI. METHODS AND RESULTS: Circumferential PVI using RNS was performed in 73 patients (pts) with paroxysmal (n = 46, 63%) and persistent atrial fibrillation. An oesophageal temperature probe was placed in 58 (79.5%) pts and was integrated in the 3D-map (NavX). Power was limited to 25 W at the posterior wall, and in the case of an increase in temperature power was limited to 20 W. Endoscopy was performed in 42 pts within 24 h after PVI. In 44 of 58 (75.9%) pts, a significant rise in temperature (>39 degrees C) was observed. In 6 of 42 (14.3%) pts, an EL was found during endoscopy. In patients with EL, the body mass index (BMI) was significantly lower than in pts without EL (24.1 +/- 2.0 vs. 29.0 +/- 5.8, P = 0.047). The BMI of all patients with EL was <26, whereas all patients without EL had a BMI above 26. The EL showed brisk healing after re-endoscopy within 2 weeks in all pts. CONCLUSION: In patients undergoing PVI using the RNS, the incidence of EL is 14.3% when using power settings comparable to settings used in manual ablation. Patients with lower BMI (<26) are at higher risk for EL.