OBJECTIVES:Circumferential pulmonary vein isolation (CPVI) using irrigated radiofrequency is the most frequently used ablation technique for the treatment of atrial fibrillation worldwide. BACKGROUND: To date, no large randomized multicenter trials have evaluated the efficacy and safety of CPVI using robotic navigation (RN) systems compared with the current gold standard of manual ablation (MN). METHODS: In this prospective, international multicenter noninferiority trial, 258 patients with paroxysmal or persistent atrial fibrillation were randomized for CPVI using either RN (RN group, n = 131) or manual ablation (MN group, n = 127). In all patients, CPVI was performed using irrigated radiofrequency ablation in combination with a 3-dimensional mapping system. The primary endpoint was the absence of atrial arrhythmia recurrence on or off antiarrhythmic drugs during a 12-month follow-up period. Secondary endpoints were the evaluation of periprocedural complications and procedural data such as procedure time, fluoroscopy time, and incidence of esophageal injury. RESULTS: Baseline characteristics were comparable between the RN group and MN group. Procedure time was significantly shorter in the MN group (129.3 ± 43.1 min vs. 140.9 ± 36.5 min; p = 0.026). 247 patients completed the 12-month follow-up (RN group, n = 123; MN group, n = 124). Recurrence rate was comparable between the RN and MN groups (n = 29 of 123 [23.6%] vs. 25 of 124 [20.2%]). The incidence of procedure-related major complications did not differ significantly between ablation arms (RN group, n = 8 [6.1%] vs. MN group, n = 6 [4.7%]; p = 0.62). One patient from the RN group developed a fatal atrioesophageal fistula. CONCLUSIONS: This study demonstrated that robotic ablation is noninferior to the current gold standard of manual ablation for CPVI with respect to success and complication rates. Procedure times were significantly longer in the RN group. (Alster Man and Machine: Comparison of Manual and Mechanical Remote Robotic Catheter Ablation for Drug-Refractory Atrial Fibrillation; NCT00982475).
RCT Entities:
OBJECTIVES: Circumferential pulmonary vein isolation (CPVI) using irrigated radiofrequency is the most frequently used ablation technique for the treatment of atrial fibrillation worldwide. BACKGROUND: To date, no large randomized multicenter trials have evaluated the efficacy and safety of CPVI using robotic navigation (RN) systems compared with the current gold standard of manual ablation (MN). METHODS: In this prospective, international multicenter noninferiority trial, 258 patients with paroxysmal or persistent atrial fibrillation were randomized for CPVI using either RN (RN group, n = 131) or manual ablation (MN group, n = 127). In all patients, CPVI was performed using irrigated radiofrequency ablation in combination with a 3-dimensional mapping system. The primary endpoint was the absence of atrial arrhythmia recurrence on or off antiarrhythmic drugs during a 12-month follow-up period. Secondary endpoints were the evaluation of periprocedural complications and procedural data such as procedure time, fluoroscopy time, and incidence of esophageal injury. RESULTS: Baseline characteristics were comparable between the RN group and MN group. Procedure time was significantly shorter in the MN group (129.3 ± 43.1 min vs. 140.9 ± 36.5 min; p = 0.026). 247 patients completed the 12-month follow-up (RN group, n = 123; MN group, n = 124). Recurrence rate was comparable between the RN and MN groups (n = 29 of 123 [23.6%] vs. 25 of 124 [20.2%]). The incidence of procedure-related major complications did not differ significantly between ablation arms (RN group, n = 8 [6.1%] vs. MN group, n = 6 [4.7%]; p = 0.62). One patient from the RN group developed a fatal atrioesophageal fistula. CONCLUSIONS: This study demonstrated that robotic ablation is noninferior to the current gold standard of manual ablation for CPVI with respect to success and complication rates. Procedure times were significantly longer in the RN group. (Alster Man and Machine: Comparison of Manual and Mechanical Remote Robotic Catheter Ablation for Drug-Refractory Atrial Fibrillation; NCT00982475).
Authors: Thomas Fink; Andreas Metzner; Stephan Willems; Lars Eckardt; Hüseyin Ince; Johannes Brachmann; Stefan G Spitzer; Thomas Deneke; Claus Schmitt; Matthias Hochadel; Jochen Senges; Andreas Rillig Journal: Clin Res Cardiol Date: 2019-04-05 Impact factor: 5.460
Authors: Laura Rottner; Barbara Bellmann; Tina Lin; Bruno Reissmann; Tobias Tönnis; Ruben Schleberger; Moritz Nies; Christiane Jungen; Leon Dinshaw; Niklas Klatt; Jannis Dickow; Paula Münkler; Christian Meyer; Andreas Metzner; Andreas Rillig Journal: Cardiol Ther Date: 2020-01-02