Manual Versus Robotic Catheter Ablation for the Treatment of Atrial Fibrillation: The Man and Machine Trial

TY - JOUR

T1 - Manual Versus Robotic Catheter Ablation for the Treatment of Atrial Fibrillation: The Man and Machine Trial

AU - Rillig, Andreas

AU - Schmidt, Boris

AU - Di Biase, Luigi

AU - Lin, Tina

AU - Scholz, Leonie

AU - Heeger, Christian H

AU - Metzner, Andreas

AU - Steven, Daniel

AU - Wohlmuth, Peter

AU - Willems, Stephan

AU - Trivedi, Chintan

AU - Galllinghouse, Joseph G

AU - Natale, Andrea

AU - Ouyang, Feifan

AU - Kuck, Karl-Heinz

AU - Tilz, Roland Richard

N1 - Copyright © 2017 American College of Cardiology Foundation. All rights reserved.

PY - 2017/8

Y1 - 2017/8

N2 - 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).

AB - 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).

KW - Aged

KW - Atrial Fibrillation/surgery

KW - Catheter Ablation/adverse effects

KW - Female

KW - Humans

KW - Male

KW - Middle Aged

KW - Operative Time

KW - Robotic Surgical Procedures/adverse effects

U2 - 10.1016/j.jacep.2017.01.024

DO - 10.1016/j.jacep.2017.01.024

M3 - SCORING: Journal article

C2 - 29759785

VL - 3

SP - 875

EP - 883

JO - JACC-CLIN ELECTROPHY

JF - JACC-CLIN ELECTROPHY

SN - 2405-500X

IS - 8

ER -