Dr. Jacob Dutcher, chief medical officer at EchoPixel and interventional cardiologist at CentraCare, had the honor of presenting at the prestigious Transcatheter Cardiovascular Therapeutics (TCT) conference, which was held in San Francisco October 23 to 26.
One of the world's foremost educational forums specializing in interventional cardiovascular medicine, the event attracts thousands of attendees from around the world to present and discuss the latest evidence-based research. As such, it was an ideal opportunity for EchoPixel to share the important work it has been doing at CentraCare, one of the largest health systems in Minnesota. By leveraging EchoPixel’s pre-planning True3D and its Holographic Therapy Guidance (HTG) softwares, Dr. Dutcher has accomplished many “firsts” over the years in successfully conducting WATCHMAN implants using a real-time holographic digital twin of a patient.
First study illuminates suggested new guidance on post-procedure imaging
The EchoPixel team submitted two abstracts, both of which were accepted for presentation. The first covered a CT observational study for a post-WATCHMAN implant, designed to help inform best practices for CT imaging after the procedure.
In the study that took place at CentraCare, 204 patients who underwent a WATCHMAN implant from October 2020 through December 2022 had a post-procedural CT using EchoPixel 3D technology to analyze the results of the implant. In one group, images were done prior to 90 days after the implant, with the second group’s images occurring 90 days after the implant. “The results were quite similar, with the only difference being that in the second group, we picked up on more device-related thrombus, which makes sense because it takes a while for a clot to potentially develop around the area where the device has been implanted,” explained Dr. Dutcher.
Therefore, these results indicate a recommendation for later imaging to detect device-related thrombi, which could potentially cause problems if undetected.
In addition, the team compared its CT results with more extensive studies conducted with transesophageal echocardiogram (TEE), which found a 23% increase in detecting device-related outcomes with CT. “This finding—that CT appears to be a much more sensitive tool to device-related outcomes than TEE—is crucial for U.S. providers to be aware of. It could actually be a practice-changing event, pointing to CTs as the standard imaging post-implant, rather than TEE, given how much more we’re able to observe,” Dr. Dutcher says.
Second study confirms better outcomes for WATCHMAN implants using HTG
The second presentation, which will be ready for publication soon, was based on the inaugural experience of using EchoPixel’s Holographic Therapy Guidance (HTG) for WATCHMAN implants. The hypothesis of the study, which included 69 patients, was that HTG guidance would allow for more ideal placement of the WATCHMAN device and ultimately better outcomes. The team was delighted the study confirmed that indeed HTG guidance provided a much greater likelihood of achieving ideal placement. “What we were looking for is to have a device that's either at the true ostium of the left atrial appendage (LAA) or very proximal in the appendage,” says Dr. Dutcher, adding that they were trying to avoid a deep implant, which has been associated with less-positive outcomes. In addition, it’s preferable to have the device flat, or flush, to the ostium, rather than tilted. “We expected that would provide a greater likelihood of having a better seal and no leak around the device, which is exactly what we found.”
The study yielded impressive outcomes: Nearly 98.6% of the implants were positioned either at the ostium or in the extremely proximal segment of the appendage, and 95.7% of the devices exhibited no tilt. Particularly noteworthy was the minimal leak rate at 10.1%, with only one patient (1.4%) experiencing a leak exceeding three millimeters. This contrasts with previously reported data, where the leak rate is estimated to be approximately 17%, which translates to a 40% relative risk reduction in leak compared to all prior published trials, which is very impressive.
An additional consideration is that these studies were done using the EchoPixel 3D CT imaging tool, which, as explained above, is much more sensitive than TEE. “It’s very impressive that even though we used a more sensitive imaging tool, we still saw tremendously less leak,” says Dr. Dutcher “I think this is going to lead to quite a bit of enthusiasm to explore HTG at other hospitals and through other trials.”
Dr. Dutcher also noted that the tilt concept hasn’t been a factor that was measured in other studies, which further gives HGT an edge in creating better outcomes on something that hadn’t previously been considered. “We think this trial and the subsequent paper will further help define the standards that should be more universally adopted by other institutions.”