AIMS: Reduction of radiation exposure using a sensor-based non-fluoroscopic catheter tracking (NFCT) system (MediGuide™, St Jude Medical, Inc.) was recently demonstrated by retrospective comparisons. We aimed to prospectively compare the effects of using NFCT vs. standard fluoroscopy on procedural parameters in patients undergoing radiofrequency ablation of typical atrial flutter. METHODS AND RESULTS: We prospectively randomized 40 patients undergoing cavotricuspid isthmus ablation for typical atrial flutter to either NFCT (n = 20) orconventional fluoroscopy (CONV, n = 20). Procedural parameters such as fluoroscopy time, radiation dose, and procedure duration, as well as periprocedural complications were compared. There were no statistically significant differences in baseline characteristics between the two groups. Bidirectional isthmus block was achieved in all patients. Fluoroscopy time was significantly reduced in the NFCT group {0.3 [inter-quartile range (IQR) 0.2; 0.48] min} when compared with CONV [5.7 (IQR 4.2; 11.5) min] (P < 0.001). This resulted in a significant reduction in radiation dose in patients randomized to NFCT [17.4 (IQR 11; 206.6) cGy cm(2)] vs. the CONV group [418.4 (IQR 277; 812.2) cGy cm(2)] (P < 0.001). There were no significant differences in procedure duration between the NFCT group [49.5 (IQR 37; 65) min] when compared with the CONV group [33.5 (IQR 26.3; 55.5) min] (P = 0.053). No adverse events were recorded. Freedom from atrial flutter at 6 months of follow-up was 19/20 (95%) in the NFCT and 18/20 (90%) in the CONV group (n.s.). CONCLUSION: In this first prospective randomized study, by comparing NFCT with standard fluoroscopy in patients undergoing radiofrequency ablation of typical atrial flutter, NFCT significantly reduced both radiation dose and fluoroscopy time with no effects on procedural duration. These findings support the incorporation of NFCT in routine clinical use. Published on behalf of the European Society of Cardiology. All rights reserved.
RCT Entities:
AIMS: Reduction of radiation exposure using a sensor-based non-fluoroscopic catheter tracking (NFCT) system (MediGuide™, St Jude Medical, Inc.) was recently demonstrated by retrospective comparisons. We aimed to prospectively compare the effects of using NFCT vs. standard fluoroscopy on procedural parameters in patients undergoing radiofrequency ablation of typical atrial flutter. METHODS AND RESULTS: We prospectively randomized 40 patients undergoing cavotricuspid isthmus ablation for typical atrial flutter to either NFCT (n = 20) or conventional fluoroscopy (CONV, n = 20). Procedural parameters such as fluoroscopy time, radiation dose, and procedure duration, as well as periprocedural complications were compared. There were no statistically significant differences in baseline characteristics between the two groups. Bidirectional isthmus block was achieved in all patients. Fluoroscopy time was significantly reduced in the NFCT group {0.3 [inter-quartile range (IQR) 0.2; 0.48] min} when compared with CONV [5.7 (IQR 4.2; 11.5) min] (P < 0.001). This resulted in a significant reduction in radiation dose in patients randomized to NFCT [17.4 (IQR 11; 206.6) cGy cm(2)] vs. the CONV group [418.4 (IQR 277; 812.2) cGy cm(2)] (P < 0.001). There were no significant differences in procedure duration between the NFCT group [49.5 (IQR 37; 65) min] when compared with the CONV group [33.5 (IQR 26.3; 55.5) min] (P = 0.053). No adverse events were recorded. Freedom from atrial flutter at 6 months of follow-up was 19/20 (95%) in the NFCT and 18/20 (90%) in the CONV group (n.s.). CONCLUSION: In this first prospective randomized study, by comparing NFCT with standard fluoroscopy in patients undergoing radiofrequency ablation of typical atrial flutter, NFCT significantly reduced both radiation dose and fluoroscopy time with no effects on procedural duration. These findings support the incorporation of NFCT in routine clinical use. Published on behalf of the European Society of Cardiology. All rights reserved.
Authors: Karol Deutsch; Janusz Śledź; Mariusz Mazij; Bartosz Ludwik; Michał Labus; Dariusz Karbarz; Bernadetta Pasicka; Michał Chrabąszcz; Arkadiusz Śledź; Monika Klank-Szafran; Laura Vitali-Sendoz; Tomasz Kameczura; Jerzy Śpikowski; Piotr Stec; Marek Ujda; Sebastian Stec Journal: Medicine (Baltimore) Date: 2017-06 Impact factor: 1.889