Researchers from Children’s Hospital Colorado have had success using a fused fluoroscopic and echocardiographic imaging (FFEI) system in children with congenital heart disease, a patient population that typically has not used the system.
Between January 2013 and February 2015, operators performed 26 procedures in 25 children who ranged in age from 5 to 26. When the primary operators were asked to rate the anatomic quality of the FFEI system, 20 procedures were graded as “excellent,” six were graded as “good” and none were graded as “poor.”
In addition, 21 of the procedures were deemed as “superior” to transesophageal echocardiography (TEE), while five of the procedures were said to have had no added benefit when using the FFEI system compared with TEE.
Pei-Ni Jone, MD, director of 3D echocardiography at Children’s Hospital Colorado, was scheduled to present a poster with the findings on June 15 at the American Society of Echocardiography scientific sessions in Boston.
“Where I think the real benefit of this is going to come in is with the much more complex procedures,” Thomas E. Fagan, MD, director of the cardiovascular catheter laboratory at Children’s Hospital Colorado and one of the study’s authors, told Cardiovascular Business. “We’re really looking at the best bang for the buck here with the more complex (procedures), but thankfully the more complex isn’t as frequent. We’re learning all this off what we have as the more common and sometimes the more straightforward procedures. But if we can show an added benefit even with those, hopefully we will say that this is a technology that’s going to help everybody for a lot of procedures.”
Jone said no other pediatric centers in the U.S. are using the FFEI system, which fuses real-time 3D echocardiography images and fluoroscopy images. When performing procedures, interventionalists said the most important advantage of the system was it allowed clear 3D visualization of anatomy facilitated catheter manipulation and the ability to view three screens simultaneously.
For now, its use at Children’s Hospital Colorado is limited to children who are at least 16 kg, which is approximately 35 pounds. Smaller children cannot accept the 3D echo probe in their esophagus because the probe is too large, according to Fagan. He added that they consider using the system when procedures are performed inside the heart and in the vessels near the heart.
The FFEI system includes the Philips EchoNavigator live image-guidance tool, which received 510(k) clearance from the FDA in March 2013. Researchers have asked Philips, the manufacturer of the probe, to develop a smaller pediatric 3D probe so the system can be used in smaller children.
“That’s something that’s been asked of echocardiographic companies for a long time,” Fagan said. “A lot of it is physical limitations with the physics behind how you create these images. Hopefully this will be another area that helps motivate everybody to push in that realm.”
Fagan said the researchers plan on conducting a study that compares using the system and FFEI system with not using the system. They will also assess the optimal radiation dose and procedure time and create a more objective grading system.
“The next step is to become much more objective about this now that we’re defining which lesions work well, which ones don’t,” Fagan said. “We can highlight some of those lesions and concentrate on those, especially the more frequent ones, and then take those patients and randomize them and use the system on them and not others and really start to define more objectively the benefits of this technology.”