Routine use of a 3D mapping system in the ablation of supraventricular arrhythmias with as low as reasonably achievable X-ray exposure (AALARA): protocol for a prospective, observational, multicentre, multinational, open-label registry study.

INTRODUCTION: The reduction of fluoroscopic exposure during catheter ablation of supraventricular arrhythmias is widely adopted by experienced electrophysiology physicians with a relatively short learning curve and is becoming standard of care in many parts of the world. While observational studies in the USA and some parts of Western Europe have evaluated the minimal fluoroscopic approach, there are scarce real-world data for this technique and generalisability of outcome in other economic regions. METHODS AND ANALYSIS: The arrhythmias with as low as reasonably achievable X-ray exposure study is a prospective, observational, multicentre and multinational open-label registry study. Up to 700 patients undergoing catheter ablation for right-sided supraventricular arrhythmias (according to national guidelines) will be enrolled for the routine use of the EnSite Precision 3D mapping system. Participating sites are distributed in 13 countries from Central Eastern Europe, North and South Africa, the Middle East and the CIS (Commonwealth of Independent States), with different levels of expertise using minimal fluoroscopic exposure techniques. After electrophysiological procedure, patients will be followed up for 6 months either in-clinic or via telephone interview. Patients will be asked to complete a study questionnaire at enrolment and 6 months after the invasive procedure to assess quality of life changes secondary to the procedure. The study's primary objective is to describe ionising radiation exposure during catheter ablation when the EnSite Precision 3D mapping system is used in supraventricular tachycardia ablation. The study's secondary objective is to assess the safety and efficacy of this method. Furthermore, fluoroscopy timing, total procedure time, success rate and complications will be reported. ETHICS AND DISSEMINATION: The study was approved by the ethics committee at Mohammed Bin Khalifa Specialist Cardiac Centre (BDF/R&REC/2020-504) and the medical ethics committees of all participating sites. Participants will be required to provide informed consent before enrolment in the study. The study results will be published and presented at conferences. TRIAL REGISTRATION NUMBER: NCT04716270.

Comparison of robotic and manual persistent AF ablation using catheter contact force sensing: an international multicenter registry study.

BACKGROUND: Catheter-based contact force sensing (CFS) technology gives detailed information regarding contact between the catheter tip and myocardium. This may result in more effective ablation procedures. The primary objective of this study was comparison of remote robotic navigation (RRN) and Manual CFS ablation. The secondary objective was to compare CFS with non-CFS ablation for both navigation modes. METHODS: Prospective registries of consecutive cases undergoing their first ablation for persistent atrial fibrillation (AF) from six hospitals in the United Kingdom and South Africa were analyzed: 50 Manual/CFS and 50 RRN/CFS cases were included. Historical control non-CFS ablation patients were matched by propensity score, giving a total 200 patient cohort. RESULTS: RRN/CFS was associated with improved single procedure 1-year success rates (64% vs 36%, P = 0.01) and shorter fluoroscopy times (41% reduction, P < 0.0005) than Manual/CFS ablation, without any difference in procedure times (P = 0.8). The mean contact force was higher in RRN/CFS than Manual/CFS cases (16 [15-18 g] vs 13 [12-15 g], respectively, P = 0.003). Compared with non-CFS historical controls, CFS cases had higher 1-year success rates for RRN (64% vs 36%, P = 0.01), but not Manual ablation (36% vs 38%, P = 1). Procedure times were reduced for CFS cases (20%, P < 0.005 both navigation modes), as were fluoroscopy times (Manual: 43%, RRN 83%, P < 0.005 for both). There were no differences in rates of major or minor complications for either comparison (P > 0.5). CONCLUSIONS: A combination of RRN and CFS is associated with improved success rates at 1 year and fluoroscopy times for persistent AF ablation, compared with Manual ablation and non-CFS RRN ablation.

Robotically assisted ventricular tachycardia substrate modification ablation with the novel Lynx(TM) integrated sheath and RF ablation catheter.

Catheter ablation of ventricular tachycardia (VT) is demanding and time consuming. Robotically controlled catheter ablation reduces operator fatigue and exposure to X-rays, and provides greater precision and stability of the catheter. A new flexible, integrated robotic sheath and ablation catheter has recently been introduced (Lynx(TM)) and used in atrial ablation procedures. We describe the first VT substrate modification ablation in the world with the Lynx(TM) robotic radio frequency ablation catheter.

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.

Robotically controlled ablation for atrial fibrillation: the first real-world experience in Africa with the Hansen robotic system.

BACKGROUND: We report the first single-centre experience in Africa with the Sensei X robotic navigation system in an unselected subset of patients with atrial fibrillation (AF). METHODS: Data were recorded prospectively of all consecutive patients who underwent robotically assisted catheter ablation therapy using the Sensei X robotic navigation system at the Christiaan Barnard Memorial Hospital, Cape Town, South Africa, from July 2009 to July 2010. Outcomes were defined at one and nine months. RESULTS: A total of 95 patients were included: 63% had only AF and 37% had AF plus atrial flutter. AF was of the persistent type in 81% of patients. The mean procedure, fluoroscopy and ablation times were 220.6 ± 89.6 min, 31.0 ± 20.4 min, and 61.3 ± 28.1 min, respectively. Both fluoroscopy and procedure times were significantly longer for the first 19 patients compared with the remaining 76 patients (43.5 ± 22.7 vs 27.8 ± 18.5 min and 274.7 ± 90.2 vs 207.1 ± 84.7 min, respectively, p = 0.002). The procedural endpoint of the study was successfully achieved in all patients. After one attempt, 27% were discharged from hospital off anti-arrhythmic drugs (AADs). At a median of nine months' follow up, 74% were AF-free off AADs, and 11% were AF-free on AADs, yielding a total freedom from AF of 84% without any redo procedures. Freedom from relapse after 1.12 procedures was 88%. CONCLUSION: The Sensei X robotic navigation system offers a safe and effective approach for the treatment of AF. There was a learning curve with regard to fluoroscopy and procedure time, after which point reduction in radiation exposure and operator strain, as well as improvement in procedure throughputs were even more pronounced.