Utilization of 3D mapping systems in interventional electrophysiology and its impact on procedure time and fluoroscopy-Insights from the "Go for Zero Fluoroscopy" project.

AIM: The implementation of 3D mapping systems plays an important role in interventional electrophysiology (EP) in recent years. The aim of the present study was to evaluate use of 3D mapping systems regarding fluoroscopy and procedure duration. METHOD: In the "Go for Zero Fluoroscopy" project 25 European centers provided data of consecutive EP procedures. Data on use of 3D mapping systems as well as utilization of contact force catheters and multipolar mapping catheters were associated with fluoroscopy time, dose area product (DAP), and procedure duration. RESULT: A 3D mapping system was used in 966 (54%) cases. Use of 3D mapping for atrioventricular nodal reentry tachycardia (AVNRT) was associated with reduced fluoroscopy time (p < 0.001), DAP (p = 0.04) but increased procedure time (p = 0.029). Moreover, fluoroscopy time (p < 0.001) and DAP (p = 0.005) were significantly lower in the 3D mapping group in ablation of typical atrial flutter. However, the procedure time (p < 0.001) increased. Use of 3D mapping in the ablation of accessory pathway (AP) was associated with reduced fluoroscopy time (p < 0.001) and DAP (p < 0.001) with no significant increase in procedure time (p = 0.066). In the case of atrial fibrillation, a 3D mapping system was used in 485 patients (75.8%). Additional use of a contact force catheter was associated with lower fluoroscopy time (p < 0.001) and DAP (p < 0.001). Use of a multipolar mapping catheter was associated with lower fluoroscopy time (p = 0.002). The implementation of 3D mapping systems in the ablation of ventricular tachycardias resulted in a significant increase in the procedure time (p = 0.001) without significant differences regarding the DAP (p = 0.773) and fluoroscopy time (p = 0.249). CONCLUSION: Use of 3D mapping systems in ablation of supraventricular tachycardias is associated with lower radiation exposure. Nevertheless, the procedure time often increases, except in the case of ablation for AP. Use of contact force catheters and multipolar mapping catheters is associated with yet lower radiation exposure values. Prospective randomized studies are needed to further elucidate potential benefit of these technological tools.

Temperature-Controlled Catheter Ablation for Paroxysmal Atrial Fibrillation: the QDOT-MICRO Workflow Sttudy.

BACKGROUND: A novel QDOT MICRO (Biosense Webster, Inc., Irvine, CA) catheter with optimized temperature control and microelectrodes was designed to incorporate real-time temperature sensing with contact force detection and microelectrodes to streamline ablation workflow. The QDOT-MICRO feasibility study evaluated the workflow, performance, and safety of temperature-controlled catheter ablation in patients with symptomatic paroxysmal atrial fibrillation with conventional ablation setting. METHODS: This was a non-randomized, single-arm, first-in-human study. The primary outcome was pulmonary vein isolation (PVI), confirmed by entrance block after adenosine and/or isoproterenol challenge. Safety outcomes included incidences of early-onset primary adverse events (AEs) and serious adverse device effects (SADEs). Device performance was evaluated via physician survey. RESULTS: All evaluated patients (n = 42) displayed 100% PVI. Two primary AEs (4.8%) were reported: 1 pericarditis and 1 vascular pseudoaneurysm. An additional SADE of localized infection was reported in 1 patient. No stroke, patient deaths, or other unanticipated AEs were reported. Average power delivered was 32.1±4.1 W, with a mean temperature of 40.8°C±1.6°C. Mean procedure (including 20-minute wait), fluoroscopy, and radiofrequency application times were 129.8, 6.7, and 34.0 minutes, respectively. On device performance, physicians reported overall satisfactory performance with the new catheter, with highest scores for satisfaction and usefulness of the temperature indicator. CONCLUSIONS: Initial clinical experience with the novel catheter showed 100% acute PVI success and acceptable safety and device performance in temperature-controlled ablation mode. There were no deaths, stroke, or unanticipated AEs. Fluoroscopy and procedural times were short and similar or better than reported for prior generation catheters.

Comparative effectiveness of catheter ablation devices in the treatment of atrial fibrillation: a network meta-analysis.

Atrial fibrillation (AF) ablation is most commonly performed using radiofrequency (RF) and cryoballoon (CB) catheters. Ablation Index is a novel lesion-quality marker associated with improved outcomes in RF ablation. Due to lack of direct comparative evidence between the latest generations of technologies, there is uncertainty regarding the best treatment option. Aim: To conduct a network meta-analysis to evaluate the comparative effectiveness of RF with Ablation Index to other catheter ablation devices in the treatment of AF. Methods: Searches for randomized and nonrandomized prospective comparative studies of ablation catheters were conducted in multiple databases. The outcome of interest was 12-month freedom from atrial arrhythmias after a single ablation procedure. Studies were grouped as high-, low- and unclear-quality based on study design and balanced baseline patient characteristics. Bayesian hierarchical network meta-analysis was conducted and results presented as relative risk ratios with 95% credible intervals (CrIs). Results: 12 studies evaluating five different catheter ablation devices were included. Radiofrequency ablation with Ablation Index was associated with statistically significantly greater probability of 12-month freedom from atrial arrhythmias than Arctic Front (relative risk: 1.77; 95% CrI: 1.21-2.87), Arctic Front Advance™ (1.41; 1.06-2.47), THERMOCOOL™ (1.34; 1.17-1.48) and THERMOCOOL SMARTTOUCH™ (1.09; 1-1.3). Results were robust in multiple sensitivity analyses. Conclusion: Radiofrequency catheter with Ablation Index is superior to currently available options for 12-month freedom from atrial arrhythmias after AF ablation. This study provides decision-makers with robust, pooled, comparative evidence of the latest ablation technologies.

Safety and Long-Term Success of Persistent Atrial Fibrillation Ablation Using THERMOCOOL SMARTTOUCH® Catheter: Real-World Experience.

BACKGROUND: To investigate the real-world clinical experience of persistent atrial fibrillation (persAF) ablation using the THERMOCOOL SMARTTOUCH® catheter with contact force (CF)-sensing ability in a prospective, multicenter registry. METHODS: Patients with persAF (excluding long-standing persAF) undergoing ablation were enrolled. Primary adverse events (AEs), 12-month success, quality of life (QoL), and correlation of success with CF were assessed. RESULTS: Overall, 150 patients with persAF (age 61.6 ± 9.4 years; 76.0% male; 90.7% Caucasian; left ventricular ejection fraction 56.9% ± 10.3%; left atrial diameter 41.5 ± 7.9 mm) underwent catheter insertion (safety cohort); 142 met eligibility criteria and were ablated (evaluable cohort). Confirmation of entrance block for all targeted pulmonary veins was achieved in 99.3% of patients. The primary AE rate was 4.0% (6/150), and 12-month success was 63.1% (95% confidence interval: 54.2%-71.4%). A non-significant trend towards higher success was observed in patients with isoproterenol/adenosine challenge vs. those without (73.1% vs. 60.2%, respectively; P=0.065). Investigators stayed within their pre-selected CF working range (catheter-tissue contact stability) 79.7% ± 12.7% of the time. When investigators stayed within the CF range ≥80% vs. <80% of the time, ablation success was 69.2% vs. 58.5%, respectively (P=0.285). QoL improved significantly at 6 months and was sustained through the 12-month follow-up (P<0.0001). CONCLUSIONS: Symptom control in a real-world setting of persAF ablation using the THERMOCOOL SMARTTOUCH® catheter was 63.1%, with significant improvements in QoL, and trended non-significantly towards increased success in patients receiving isoproterenol/adenosine challenge and when investigators stayed within their pre-selected CF range ≥80% of the time.