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Irrigated tip catheter added to magnetic navigation platform
New catheter may bring the remote magnetic navigation system up to standard of care.
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A remotely operated magnetic-tipped irrigated ablation catheter has cleared a procedural hurdle and received FDA approval for use with a magnetic navigation system.
The irrigated tip catheter (NaviStar RMT ThermoCool, Biosense Webster) was designed for use with the magnetic system (Niobe, Stereotaxis Inc.) to create an open-loop ablation system capable of being operated from a remote workstation.
Integrated platforms
Both technologies function together within an integrated system controlled primarily by computer. The system operates by using the powerful electromagnets of the Niobe platform that pull the magnetic tip of the NaviStar catheter into place. The catheter travels through the vessels along a premapped route programmed into a computer by the electrophysiologists.
What makes the NaviStar catheter unique is the irrigation-cooled tip that emits a saline solution during the ablation process. There are currently no fully automated ablation systems that support an open-loop irrigated catheter.
“What is great about today’s technology is the addition of irrigation,” David Burkhardt, MD, former electrophysiologist at the Cleveland Clinic and chief medical officer of Stereotaxis, told Cardiology Today. “There are several ports on the tip of the catheter that send saline out, which cools the tip of the catheter but allows you to effectively deliver heat, energy and destruction into the tissue with a much-reduced incidence of carbon and thrombus at the tip of the catheter. So you get bigger lesions that are also more likely to be safer and are less likely to have these complications.”
Although the irrigated catheter technology has been used in the electrophysiology community for several years, the capacity to use it with the Stereotaxis system was only recently developed and then approved by the FDA. Stereotaxis is approved for use with a suite of nonirrigated catheters, and the addition of the first irrigated catheter to the suite may provide the benefits of irrigated ablation systems within the Stereotaxis platform.
“This particular magnetic catheter is the first magnetic-irrigated tip, so it gives you the current standard of care in left atrial and ventricular ablation that is also compatible with the magnetic system,” Burkhardt said. “For the average practice, this takes all of the benefits of the magnetic system, including the safety and the ease of the procedure, and it brings it up to today’s technology.”
Scant clinical data
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Source: Biosense Webster |
According to a press release, the preliminary data suggested an acute success rate of 90%, and a 95% acute success rate in centers that performed more than 20 of the ablation procedures. One practitioner shared an anecdote of a patient who had suffered with chronic AF for more than seven years with many aggressive attempts to convert. After using the integrated Stereotaxis system with the irrigated-tip catheter, he was successfully converted and had not suffered a relapse since the procedure.
“There are no studies for the magnetic catheter yet, since it was just approved in Europe and just recently approved in the United States,” Burkhardt said. “There have been multiple other studies on manual-irrigated tip catheters, including basic scientific studies, clinical studies in terms of AF and many others.”
Although the preliminary performance of the irrigated catheter with the Niobe system is promising, some believe that more data are needed to truly assess the system’s effect.
“With the approval of a magnetic-irrigated catheter, Stereotaxis is now just catching up to an ablation platform that is commonly used in manual, and not Stereotaxis based procedures,” Uday N. Kumar, MD, adjunct clinical instructor of medicine at the Stanford University School of Medicine, told Cardiology Today. “The question still remains: Will the use of this catheter in combination with the Stereotaxis system result in the same or better short- and long-term outcomes compared with non-Stereotaxis based procedures?”
Implications
The new catheter really does not offer any new therapy that was not previously available and the addition of the irrigated catheter to the Niobe system’s suite of catheters does not change the standard of care.
“When AF ablation was starting, we were using regular 4 and 8 mm tip ablation catheters,” Kumar said. “With time, additional data suggested that the use of irrigated tip catheters could potentially result in more efficacious procedures. This eventually translated into the irrigated tip, becoming the standard of care in some centers. Since only regular ablation catheters were approved for the Stereotaxis system at the time, some users complained that there were frequent AF recurrences due to uneven efficacy when performing AF ablation with the Stereotaxis system. This may have led to a reversion back to manual procedures using irrigated catheters in some centers. Thus, with the approval of a magnetic irrigated catheter, Stereotaxis is not necessarily providing anything new, from a standard-of-care perspective, outside of merging an already accepted and commonly used ablative energy platform with their magnetic system.”
Despite the relative light data set for the integrated irrigated catheter system, the system’s advocates believe the approval of their combined use will still add a much-needed tool to the electrophysiologist’s armamentarium.
“Most people in this business are using the irrigated tip for the best combination of efficacy and safety, at least from the perspective of preventing a stroke or other neurologic event during the procedure,” John M. Miller, MD, professor of medicine at Indiana University School of Medicine, told Cardiology Today. “With most of the country and the world using the irrigated tip catheter, we were stuck with the 8 mm electrode. Now, using the same irrigated tip technology combined with the Stereotaxis platform, we have the capability to be very precise and very effective with the magnetic navigation. Coupled with our top-of-the-line ablation tool, I think this technology is going to be a major splash.” - by Eric Raible
Dr. Miller is a paid consultant for Stereotaxis Inc.
For more information:
- To learn more about the Biosense Webster NaviStar ThermoCool magnetic irrigated tip catheter, visit www.biosensewebster.com/products/navigation.
- To learn more about the Stereotaxis Niobe magnetic navigation system, visit www.stereotaxis.com/Products-Technology.