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Journal of Interventional Cardiac Electrophysiology

Published in:

01-03-2018

Randomized controlled trial of Amigo® robotically controlled versus manually controlled ablation of the cavo-tricuspid isthmus using a contact force ablation catheter

Authors: Kurt S. Hoffmayer, Felix Krainski, Sanjay Shah, Jessica Hunter, Maylene Alegre, Jonathan C. Hsu, Gregory K. Feld

Published in: Journal of Interventional Cardiac Electrophysiology | Issue 2/2018

Abstract

Background

Radiofrequency catheter ablation (RFCA) of the cavo-tricuspid isthmus (CTI) is a common treatment for atrial flutter (AFL). However, achieving bi-directional CTI conduction block may be difficult, partly due to catheter instability.

Objective

To evaluate the safety and efficacy of the Amigo® Remote Catheter System (RCS) compared to manual catheter manipulation, during CTI ablation for AFL.

Methods

Fifty patients (pts) were prospectively randomized to robotically (25 pts) versus manually (25 pts) controlled catheter manipulation during CTI ablation, using a force-contact sensing, irrigated ablation catheter. The primary outcome was recurrence of CTI conduction after a 30-min waiting period. Secondary outcomes included total ablation, procedure, and fluoroscopy times, contact force measurement, and catheter stability.

Results

Recurrence of CTI conduction 30 min after ablation was less with robotically (0/25) versus manually (6/25) controlled ablation (p = 0.023). Total ablation and procedure times to achieve persistent CTI block (6.7 ± 3 vs. 7.4 ± 2.5 min and 14.9 ± 7.5 vs. 15.2 ± 7 min, respectively) were not significantly different (p = 0.35 and p = 0.91, respectively). There was a non-significant trend toward a greater force time integral (FTI in gm/s) with robotically versus manually controlled CTI ablation (571 ± 278 vs. 471 ± 179, p = 0.13). Fluoroscopy time was longer with robotically versus manually controlled CTI ablation (6.8 ± 4.4 min vs. 3.8 ± 2.3 min, p = 0.0027). There were no complications in either group.

Conclusion

Robotically controlled CTI ablation resulted in fewer acute recurrences of CTI conduction compared to manually controlled CTI ablation, and a trend toward higher FTI. The longer fluoroscopy time during robotically controlled ablation was likely due to a steep learning curve.

Trial registration

Clinicaltrials.gov Identifier: NCT02467179

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Title: Randomized controlled trial of Amigo® robotically controlled versus manually controlled ablation of the cavo-tricuspid isthmus using a contact force ablation catheter
Authors: Kurt S. Hoffmayer
Felix Krainski
Sanjay Shah
Jessica Hunter
Maylene Alegre
Jonathan C. Hsu
Gregory K. Feld
Publication date: 01-03-2018
Publisher: Springer US
Published in: Journal of Interventional Cardiac Electrophysiology / Issue 2/2018
Print ISSN: 1383-875X
Electronic ISSN: 1572-8595
DOI: https://doi.org/10.1007/s10840-018-0319-1

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