UMass chief peers down the lens of an if-not radiation-free complex aortic procedural future, then one in which the methods of today will look positively quaint.
“I say this a lot,” says Andres Schanzer, MD, “but I think there is a time within the next five or 10 years when we’ll be talking to medical students and they will say to us, kind of confused, ‘What do you mean you stepped on a pedal the entire time you were doing one of these cases.’”
The University of Massachusetts (UMass), Worcester, chief of vascular surgery is reflecting on the advance of imaging technologies designed to dramatically reduce exposure to radiation, particularly during lengthy complex aortic endovascular aneurysm repair procedures. Several modalities, loosely grouped together under the banner of “radiation-free,” have emerged in this space in recent years. The “radiation-free” tag represents a lofty goal. Or “a very high bar,” Schanzer says, explaining: “I think what we have all come to realize as we have explored these new technologies is that hopefully we can get closer and closer to that goal. But certainly, within the short term, we are not going to get to a complete radiation-free repair.”
Short of that high bar, significant strides forward have been made. And now, those advances have given way to a randomized controlled trial (RCT) designed to test one of these technologies. Playing on the radiation-free moniker, the RadFree unblinded, multicenter, international study places LumiGuide (Philips), powered by Fiber Optic RealShape (FORS), in a head-to-head with conventional X-ray in a bid to firmly establish that it requires less average fluoroscopy time. Several patients have already been randomized, with the first receiving treatment using LumiGuide recently carried out by Darren Schneider, MD, at the University of Pennsylvania in Philadelphia.
Schanzer is a principal investigator in this 11-site RCT. He has been on the radiation-busting trail for some time. His UMass team was involved in some of the earliest cases of FORS in the U.S., reporting a 75% decrease in fluoroscopy use while carrying out a fenestrated endovascular aneurysm repair (FEVAR) of a thoracoabdominal aortic aneurysm (TAAA).
In the period since the technology first received Food and Drug Administration (FDA) approval in 2020, they have been at the center of studies probing its safety and effectiveness, Schanzer details. “We’ve had the opportunity to be involved in several institutional studies looking at our own data and some multicenter studies with other collaborators from the U.S. and around the world, and what we have learned in these early experiences is that use of LumiGuide seems to decrease radiation time, decrease radiation dose, and the hope is that by doing a randomized controlled trial we can definitively show whether or not there is a benefit associated with using this technology.”
The rationale is beyond question. The sheer length of a FEVAR or branched EVAR (BEVAR) can expose care teams to extensive amounts of radiation. Initial concerns around radiation exposure rightly focused on the patient, Schanzer continues. But, all things considered, patients might expect to undergo one or perhaps two procedures. So thoughts soon turned to the fact that providers might take part in several over the course of any given week.
“If you think about it, it’s crazy that we’re standing right up against an image intensifier that is emitting radiation for procedures that can be several hours long, and we’re taking that radiation and exposing the entire care team to it, day in and day out,” says Schanzer. “So, this is a complete paradigm shift, and it has the potential to really be transformative if the results bear out and show that there is a significant reduction in radiation time and dose. Moreover, I’m sure that, as we continue to iterate on the generations of this technology, it will be able to be used for more and more steps of the procedure. It will be an adjunct to radiation use, but I think that we could potentially cut the dose of radiation more than in half by embracing technologies like this.”
The UMass team has completed more than 100 cases using LumiGuide’s FORS technology. Schanzer believes the UMass data and that accumulated elsewhere in the U.S. and in Europe suggests wider use, but only an RCT like RadFree can provide the sort of robust evidence needed to do so. “The initial investigators that started using and testing LumiGuide have been working with Philips for several years now, and really pushing that we need level-1 data to support a larger, broad rollout of this technology,” Schanzer says.
Such technologies tackle some of the most radiation-intensive steps in complex aortic procedures. “There are certainly many technologies that have come along that have helped decrease the radiation necessary with the more modern, hybrid room setups,” Schanzer continues. “But even as we practice good radiation safety behavior, there still is a significant amount of radiation used for these complex procedures. Where we are with this technology is we can now take a lot of the radiation-intense steps and decrease the use of radiation, and eliminate it for several of these steps.” A case in point: cannulation of the vessels during FEVAR. “This is something that can be done entirely—safely and effectively—using LumiGuide,” he adds.
SVS vice presidency
Schanzer’s contributions to driving the vascular field forward—he is also a key player in the trail-blazing U.S. Aortic Research Consortium, which investigates complex aortic repairs through individual investigational device exemption (IDE) studies—continue apace at a time when he is also rising in the Society for Vascular Surgery (SVS) having recently been elected SVS vice president. His rise into the presidential line of succession arrives at a relatively young age, when he is still comfortably positioned as an active clinician. He described his selection by the membership as a privilege, arriving when “a lot of new diverse stakeholders are getting engaged with the SVS.”
Going forward, Schanzer hopes to bring a novel perspective to further the Society’s “outstanding leadership” over the years. “I am still a very active clinician, a very active investigator and take a lot of pride in my vascular division at UMass,” he says. “In some ways, that brings a perspective to SVS leadership that I hope is very relatable and very generalizable to many members of the SVS. I’m not at the stage of my career where I am winding down taking care of patients, or not really doing much of my own clinical or research work anymore. Hopefully that will allow me to better understand the needs of many of our active members in the field. It’s an honor to serve in this role and I will continue to work as hard as I possibly can to continue to move the field forward for all of our members.”
