PURPOSE: The application of a novel platform for nonfluoroscopic catheter sensor tracking within pre-recorded x-ray loops in the context of catheter ablation of atrial fibrillation (AF) demonstrated significant potential for reduction of fluoroscopy. We sought to provide the first prospective randomized comparison of fluoroscopy needs, procedure times, and complications in AF catheter ablation with or without additional use of nonfluoroscopic catheter visualization (NFCV). METHODS:Patients with AF were randomized into two groups before scheduled radiofrequency ablation: (1) using established mapping systems and fluoroscopy as needed (CONV group) or (2) with additional NFCV (NFCV group). All procedures were performed in the same lab using the same ablation catheter tip technology and the same mapping and ablation strategies. Primary endpoints were radiation time and dose. Secondary endpoints were procedural parameters, complications, and long-term success. RESULTS: A total of 80 patients (48 male patients, mean age 60 years, 46 patients with paroxysmal AF) were randomized into the two groups. Clinical parameters between both groups were similar. NFCV use reduced mean fluoroscopy time (1.9 vs. 13.2 min, p < 0.001) and mean dose (510 vs. 1549 Gycm2, p < 0.001) significantly. Procedural parameters were similar in the two groups. One conservatively treated groin complication occurred (1.3%). CONCLUSIONS: Radiation exposure can be significantly reduced by using the novel NFCV technology in addition to standard AF ablation technologies without negative effects on procedure durations, success rates, or complication rates. With the use of the technology, abandonment of lead protection for EP staff is possible following transseptal puncture.
RCT Entities:
PURPOSE: The application of a novel platform for nonfluoroscopic catheter sensor tracking within pre-recorded x-ray loops in the context of catheter ablation of atrial fibrillation (AF) demonstrated significant potential for reduction of fluoroscopy. We sought to provide the first prospective randomized comparison of fluoroscopy needs, procedure times, and complications in AF catheter ablation with or without additional use of nonfluoroscopic catheter visualization (NFCV). METHODS:Patients with AF were randomized into two groups before scheduled radiofrequency ablation: (1) using established mapping systems and fluoroscopy as needed (CONV group) or (2) with additional NFCV (NFCV group). All procedures were performed in the same lab using the same ablation catheter tip technology and the same mapping and ablation strategies. Primary endpoints were radiation time and dose. Secondary endpoints were procedural parameters, complications, and long-term success. RESULTS: A total of 80 patients (48 male patients, mean age 60 years, 46 patients with paroxysmal AF) were randomized into the two groups. Clinical parameters between both groups were similar. NFCV use reduced mean fluoroscopy time (1.9 vs. 13.2 min, p < 0.001) and mean dose (510 vs. 1549 Gycm2, p < 0.001) significantly. Procedural parameters were similar in the two groups. One conservatively treated groin complication occurred (1.3%). CONCLUSIONS: Radiation exposure can be significantly reduced by using the novel NFCV technology in addition to standard AF ablation technologies without negative effects on procedure durations, success rates, or complication rates. With the use of the technology, abandonment of lead protection for EP staff is possible following transseptal puncture.