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

Andreas Rillig, Boris Schmidt, Luigi Di Biase, Tina Lin, Leonie Scholz, Christian H. Heeger, Andreas Metzner, Daniel Steven, Peter Wohlmuth, Stephan Willems, Chintan Trivedi, Joseph G. Galllinghouse, Andrea Natale, Feifan Ouyang, Karl Heinz Kuck, Roland Richard Tilz

Research output: Contribution to journalArticle

9 Citations (Scopus)

Abstract

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).

Original languageEnglish (US)
JournalJACC: Clinical Electrophysiology
DOIs
StateAccepted/In press - 2017

Fingerprint

Catheter Ablation
Robotics
Atrial Fibrillation
Pulmonary Veins
Therapeutics
Multicenter Studies
Patient Navigation
Ablation Techniques
Recurrence
Anti-Arrhythmia Agents
Fluoroscopy
Incidence
Fistula
Cardiac Arrhythmias
Safety

Keywords

  • Atrial fibrillation
  • Catheter ablation
  • Randomized trial
  • Robotic navigation

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Physiology (medical)

Cite this

Manual Versus Robotic Catheter Ablation for the Treatment of Atrial Fibrillation. The Man and Machine Trial. / Rillig, Andreas; Schmidt, Boris; Di Biase, Luigi; Lin, Tina; Scholz, Leonie; Heeger, Christian H.; Metzner, Andreas; Steven, Daniel; Wohlmuth, Peter; Willems, Stephan; Trivedi, Chintan; Galllinghouse, Joseph G.; Natale, Andrea; Ouyang, Feifan; Kuck, Karl Heinz; Tilz, Roland Richard.

In: JACC: Clinical Electrophysiology, 2017.

Research output: Contribution to journalArticle

Rillig, A, Schmidt, B, Di Biase, L, Lin, T, Scholz, L, Heeger, CH, Metzner, A, Steven, D, Wohlmuth, P, Willems, S, Trivedi, C, Galllinghouse, JG, Natale, A, Ouyang, F, Kuck, KH & Tilz, RR 2017, 'Manual Versus Robotic Catheter Ablation for the Treatment of Atrial Fibrillation. The Man and Machine Trial', JACC: Clinical Electrophysiology. https://doi.org/10.1016/j.jacep.2017.01.024
Rillig, Andreas ; Schmidt, Boris ; Di Biase, Luigi ; Lin, Tina ; Scholz, Leonie ; Heeger, Christian H. ; Metzner, Andreas ; Steven, Daniel ; Wohlmuth, Peter ; Willems, Stephan ; Trivedi, Chintan ; Galllinghouse, Joseph G. ; Natale, Andrea ; Ouyang, Feifan ; Kuck, Karl Heinz ; Tilz, Roland Richard. / Manual Versus Robotic Catheter Ablation for the Treatment of Atrial Fibrillation. The Man and Machine Trial. In: JACC: Clinical Electrophysiology. 2017.
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abstract = "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).",
keywords = "Atrial fibrillation, Catheter ablation, Randomized trial, Robotic navigation",
author = "Andreas Rillig and Boris Schmidt and {Di Biase}, Luigi and Tina Lin and Leonie Scholz and Heeger, {Christian H.} and Andreas Metzner and Daniel Steven and Peter Wohlmuth and Stephan Willems and Chintan Trivedi and Galllinghouse, {Joseph G.} and Andrea Natale and Feifan Ouyang and Kuck, {Karl Heinz} and Tilz, {Roland Richard}",
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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

PY - 2017

Y1 - 2017

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 - Atrial fibrillation

KW - Catheter ablation

KW - Randomized trial

KW - Robotic navigation

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