Jonathan Sussman, MD is a cardiac electrophysiologist with the Gagnon Cardiovascular Institute at Morristown Medical Center in Morristown, New Jersey. In this article he discusses his experience using Catheter Robotics’ Amigo™ Remote Catheter System. Catheter Robotics, Inc. recently announced 510(k) clearance of the Amigo by the U.S. Food and Drug Administration.
Tell us about the size of your EP program at Morristown Medical Center.
Our EP program has two invasive rooms and one noninvasive room. There is an additional third room, which is a swing lab between cath and EP, but it predominantly does cath cases. We have about 12–15 lab staff. Twelve are dedicated EP staff, and the others swing between cath and EP. In addition, most of our physicians are in one group, and there are five of us who are full-time EP. There are other EPs who do some cases here as well. We perform approximately 2,000 cases a year and between 300–350 ablations per year.
When was the Amigo Remote Catheter System first implemented in your EP program?
The Amigo was available in our lab as part of the clinical trial, which took place at 13 centers and enrolled over 200 patients worldwide. Once the trial ended, the device was removed since there was no FDA approval to continue using it.
What was the learning curve like for the Amigo?
It was actually very easy. We did a handful of cases as part of the trial, and shortly into the first case, we were pretty comfortable using it.
Did Amigo integrate easily into the lab?
Yes, it was fairly simple. The Amigo attaches to the standard table, and does not take up a tremendous amount of room in the lab. The draping of the machine and integrating it sterilely was the hardest part, only because of incorporating all the different pieces of the sterile draping and the different pieces of plastic.
How did use of the Amigo change the way procedures were managed in regards to workflow?
In our case, our workflow hasn’t really changed, since we only used the Amigo during the clinical trial.
What was the controller like to operate? How is it different from using other remote navigation systems?
It was very easy to operate and has three separate degrees of control: one knob that turns to mimic flexion and extension of the catheter, one knob that mimics rotation of the catheter, and push buttons that advance and retract the catheter. It’s really very intuitive to use and was very easy to get used to. I’ve only used other remote navigation systems in simulators and animal models — I have never used them in a live patient. However, this is much more similar to maneuvering a catheter as opposed to using a different type of steering mechanism.
During procedures, were you able to get the catheter to every site you attempted? What procedures have you used the Amigo for?
Yes, we were very successful in moving the catheter to the sites attempted. As part of the study we used the Amigo for mapping prespecified points. Typically we used it during SVT ablations, but we didn’t use it for either the ablation or even the full diagnostic study. We used it in conjunction with those procedures, and as part of the study we were simply demonstrating we could use this to quickly and successfully get to prespecified points in the right ventricle, His bundle, different points within the right atrium, and the os of the coronary sinus.
What was the company like to work with?
Catheter Robotics was quite easy to work with.
Do you envision implementing an Amigo system in the future? In what other ways has your program benefited from this technology thus far?
I do. I think it’s something that is easy to add into an existing lab, it’s not prohibitively expensive to add into an existing lab, and I think it’s easy enough to use and to learn. It provides very nice catheter stability, which I think will be very useful in procedures moving forward. Some benefits to the operator were in terms of being out of the radiation field and having a little less physical stress on the operator as well. The way we had it set up, we were still in the procedure room, but even so, you can still be a little farther away from the radiation source and you certainly could set it up to be in the control room instead.
Is there anything else you’d like to add?
The way things stand now, I don’t think there are any currently in use in the U.S. at this moment – I know that there are systems in use overseas, and I think that people will be looking to investigate how they are being used overseas and build on that.