Dr. Peter Weiss is a cardiac electrophysiologist and a University of Arizona associate professor of medicine at Banner-University Medical Center Phoenix. [Photo courtesy of the University of Arizona]
In addition to his medical practice and work with Stereotaxis, Weiss is a founding member and former president of the Society for Cardiac Robotic Navigation (SCRN) and a University of Arizona associate professor of medicine at Banner-University Medical Center Phoenix, where he’s the director of ventricular arrhythmia management and robotics.
We asked Weiss three questions ahead of the latest Stereotaxis milestone to help device developers better understand the needs of electrophysiologists (EPs) and their patients. The following has been lightly edited for length and clarity.
MDO: What unmet needs does the Stereotaxis MAGiC ablation catheter solve for EPs?
The Stereotaxis MAGiC catheter is used with Stereotaxis robotic magnetic navigation systems for cardiac ablation. [Image courtesy of Stereotaxis]
MDO: What are the challenges that remain for EPs even after this latest system?
Weiss: “There are several ongoing challenges that continue to impact the care of EP patients.
“First, the ability to integrate technologies across platforms and the time it takes for regulatory approvals to support this. A specific example in this case might be the approval of a new radiofrequency (RF) ablation catheter, with the potential for rapid technical evolution allowing for pulsed field applications as well. How will this play out in the current regulatory environment?
“Second, continued access to what we describe as an ‘open EP ecosystem.’ Many of us support the concept that having a broad range of choices when applying available technologies to the care of patients is always best. To a greater or lesser extent, many of the strategic technology companies dominating our field have moved towards closed ecosystems that limit this choice. With the rapid evolution of EP technology, allowing for potential interoperability would allow us to choose the best tools for each patient in each case.
“Third, I am incredibly excited about the future of robotics in endovascular procedures, including but not limited to EP. Robotics has had marked impact on areas such as soft tissue surgery and orthopedics. With the advent of robotic platforms with smaller footprint, smaller capital expense, more versatile compatibility with other lab systems such as fluoroscopy, a widening landscape of disposables, and even the potential for clinically relevant remote procedures, it seems that we are nearing an important tipping point in the application of robotics in the care of patients who may benefit from endovascular procedures including EP, peripheral and neuro interventions, and invasive cardiology.”
MDO: Can you offer your perspective on the latest findings around pulsed-field ablation (PFA) safety (for example, this and this) and what we still have yet to learn on topics like microbubbles?
Weiss: “PFA is in its early postmarket period. It is no surprise that associated complications are coming to the surface and beginning to be explored in the medical literature. To date, reports of phrenic nerve palsy, hemolysis, coronary spasm, and microbubbles have been the main examples.
“The discussion is complex, as PFA delivery is highly variable depending on a variety of factors such as energy totals, waveforms, and delivery system form factors. This is quite different than thermal ablation platforms which are much more uniform in their biophysics. Due to this, future research in these areas will need to focus on PFA as a whole, but also each system according to its unique attributes.
“Key to determining longer term risks and benefits of each system would be rigorous post marketing registries, as is being put in place through Heart Rhythm Society with its new initiative to develop an industry wide, state of the art platform for collecting real-world data on PFA. Our hope is that PFA continues its evolution as a transformative approach to arrhythmia care, but that our enthusiasm as a field for its efficiency and apparent effectiveness/safety profile is tempered with appropriate caution and skeptical analysis.”
Related: Do PFA microbubbles matter? We asked Abbott’s top doc in electrophysiology and Talking PFA safety with Boston Scientific’s Dr. Brad Sutton
