What Is Going on With Catheter-Based Pulmonary Embolism Devices in the Real World?

LONG BEACH, Calif. — Big Data may provide some answers to the many questions surrounding advanced catheter-based pulmonary embolism (PE) therapies, a buzzing field that otherwise has little evidence from real-world practice due in part to the lack of a national registry.

In an exploratory analysis of de-identified electronic health records (EHRs), investigators found 435,296 patients with a PE diagnosis from January 2018 through May 2023, of whom 0.48% were logged as having received advanced therapy with either the mechanical thrombectomy FlowTriever or EKOS ultrasound-guided catheter-directed thrombolysis system.

Interrogating disparities of care, researchers found Black people (0.37% vs 0.50% for non-Blacks, P<0.0001) and women (0.41% vs 0.55% for men, P<0.0001) disproportionately less likely to undergo such advanced therapy, reported Sahil Parikh, MD, of Columbia University Irving Medical Center in New York City at the Society for Cardiovascular Angiography & Interventions (SCAI) annual meeting.

Safety events also suggested disproportionately more major bleeding within 7 days when advanced PE therapies were applied to white versus Black patients (13.9% vs 9.3%, P=0.028) and women versus men (16.6% vs 11.1%, P=0.003). No such differences were detected for in-hospital mortality and stroke.

Parikh cautioned that these were hypothesis-generating analyses, as his group did not adjust for PE risk stratification.

Nevertheless, he stressed the value of a Big-Data approach for real-time monitoring of clinical decision-making. “Both novel and established therapies can benefit from similar evaluation techniques to work toward equitable and patient-centric care,” he said.

The Truveta Data Platform was the source of data for the study, which was an offshoot of the REAL-PE report from October 2023. With artificial intelligence coming for chart record analysis on this tool, there will be opportunities for more granularity, the goal being to better understand who patients were and why they got the treatments they got, Parikh suggested.

For now, he said, the field of PE intervention currently lacks class I indications for procedures, mandated national registries, and designated centers of excellence.

Session panelist William Keeling, MD, of Emory University in Atlanta, suggested not immediately trying to mitigate the observed disparities in PE care — if they are real disparities at all.

“We don’t know who we should be intervening on” in the first place, he said, urging more work on “who actually benefits” from the advanced PE therapies.

The available PE devices have all gone through the same 510(k) path to regulatory approval. In this less stringent type of device marketing application, the sponsor is asked to show the device is “substantially equivalent” to another device already on the market.

“The bar of entry into the space is low,” Keeling said. “I think that’s good for patients, but I think postmarket registries and analyses of these catheters, especially when it comes to safety and efficacy, are going to be of utmost importance.”

At the SCAI session, Keeling presented data from the APEX-AV study on the AlphaVac F18⁸⁵, the latest mechanical thrombectomy device given 510(k) by the FDA for PE. Based on the results of this study, the device seems to offer comparable safety and efficacy to predicate devices on the market.

Just after this presentation, Tai Kobayashi, MD, of the Hospital of the University of Pennsylvania in Philadelphia, discussed yet another catheter-based device in development: The Helo PE system had promising early feasibility data in 25 patients. Helo was designed to marry aspiration technology with an in-catheter agitator that dislodges clot material.

Parikh suggested that all the devices that make it to the market will have to show their relative value some way. He predicted that comparative effectiveness data will emerge, as the predicate devices are already being compared in randomized controlled studies.

Keeling said he disagreed on these trials being the next step.

“We should be intervening on more people,” he said. As the pool of patients grows, “those catheters will find their role for certain indications, patients, operator preference, and whatnot … The next thing to do is grow the space.”