Two new devices for advanced pulmonary embolism thrombolysis show promise
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Key takeaways:
- Two new thrombectomy devices showed good safety and efficacy in the treatment of intermediate-risk pulmonary embolism.
- Results of the APEX-AV and ENGULF trials were presented at the SCAI Scientific Sessions.
Two catheter-directed thrombectomy devices demonstrated efficacy and safety in the treatment of acute intermediate-risk pulmonary embolism, speakers reported.
The results of the investigational device exemption APEX-AV trial and the first-in-human ENGULF trial were presented at the Society for Cardiovascular Angiography and Interventions Scientific Sessions.
The APEX-AV trial
For the prospective, multicenter, single-arm APEX-AV trial, William Brent Keeling, MD, associate professor at the Emory School of Medicine, and colleagues evaluated the safety and efficacy of a mechanical aspiration thrombectomy system (AlphaVac F1885, AngioDynamics) in a cohort of 122 patients with acute intermediate-risk PE. Participants were enrolled from October 2022 to December 2023.
The system features a 33 French opening and an 18 French cannula, a manual aspiration handle and a closed waste system for clot and blood disposal.
In April, the mechanical aspiration thrombectomy system received FDA 510(k) clearance for the expanded indication to treat pulmonary embolism.
For inclusion in the trial, patients were required to be hemodynamically stable with no vasopressor requirement; heart rate of 130 bpm or less; systolic BP or 90 mm Hg or more; and right ventricle-to-left ventricle (RV/LV) ratio of 0.9 or more.
The primary efficacy endpoints were change in RV/LV ratio and post-procedure adverse events at 48 hours.
Keeling reported an average reduction in RV/LV ratio of 0.45, or 29.1%, at 48 hours.
Major adverse events were reported in 4.1% of the cohort, none resulting in death.
Keeling also reported:
- a mean reduction in clot burden of 35.5%;
- a mean reduction in pulmonary artery pressure of 7.7 mm Hg in those with pulmonary hypertension (P < .001);
- a mean reduction in pulmonary artery pressure of 2.8 mm Hg in those with normal pulmonary artery pressure (P = .003); and
- a mean procedure time of 37.2 minutes.
Five patients experienced major adverse events, including five major bleeding events, within 48 hours; however, none required thrombolytics and no deaths were reported.
One patient had symptomatic PE recurrence within 30 days.
“Pulmonary emboli can be extremely dangerous and require effective and prompt action,” Keeling said in a press release. “Catheter-directed mechanical thrombectomy using a new aspiration system can achieve excellent thrombus removal with a wonderful safety profile, thus enabling more tools in our armamentarium for the treatment of acute PE.”
The ENGULF trial
For the prospective, single-arm, first-in-human ENGULF trial, Taisei Kobayashi, MD, director of the cath lab at the Corporal Michael J. Crescenz Veterans Affairs Medical Center and assistant professor of clinical medicine (cardiovascular medicine) at Penn Medicine, and colleagues evaluated the safety and feasibility of a novel thrombectomy catheter system (Hlo PE, Endovascular Engineering) for the treatment of acute PE in 28 patients.
“Mechanical thrombectomy is now a primary strategy for the treatment of pulmonary embolism, with three devices that have achieved PE indications,” Kobayashi said during a press conference. “Despite this, there continues to be challenges with clot removal, which include things like possible vascular injury, hemodynamic instability and inordinate blood loss with large-bore catheters; incomplete or ineffective clot removal with small and moderate bore catheters; and catheter corking and challenges with removing organized or fibrotic chronic clots remains a continuing problem with small- and moderate-bore catheters.This is a novel catheter trying to address both of those problems.”
The novel system features a steerable and expandable funnel with an internal spinning agitator to break down clots. It features a 16 French catheter tipped with a funnel that expands out to 24 French.
The primary efficacy outcome was the percent change in RV/LV ratio after thrombectomy with the device. The primary and secondary safety outcomes were all-cause mortality, major bleeding, device-related serious adverse events, pulmonary or cardiac injury and clinical decompensation at 48 hours and 30 days.
The mean RV/LV ratio decreased from 1.53 at baseline to 1.15 at 48 hours, translating to a 23.2% mean reduction, according to the presentation.
Kobayashi also stated that on angiography of targeted pulmonary arteries, they observed an 80% reduction in thrombus burden.
Overall, two patients experienced device-related serious adverse events, both with post-procedural anemia requiring transfusion. Neither meet criteria for major life-threatening bleeding by Valve Academic Research Consortium-2 (VARC-2) criteria, according to the presentation.
“When you take a look at the efficacy of this particular device in comparison to others that have gone before it and are already FDA-approved, including Penumbra and the Inari device, we’re looking at similar drops in RV/LV ratio, about 23%,” Kobayashi said during the press conference. “Of course, this is a first-in-human study, and so a prospective IDE trial is currently underway.”
The results of the ENGULF trial were simultaneously published in the Journal of the Society for Cardiovascular Angiography and Interventions.
References:
- AngioDynamics receives 510(k) clearance for AlphaVac F18 system in treatment of PE. https://investors.angiodynamics.com/news-releases/news-release-details/angiodynamics-receives-510k-clearance-alphavac-f1885-system. Published April 4, 2024. Accessed May 5, 2024.
- Catheter-directed mechanical thrombectomy system demonstrates safety and effectiveness in patients with pulmonary embolism. https://scai.org/catheter-directed-mechanical-thrombectomy-system-demonstrates-safety-and-effectiveness-patients. Published May 3, 2024. Accessed May 9, 2024.
- Kobayashi T, et al. Featured clinical research part 2. Presented at: Society for Cardiovascular Angiography and Interventions Scientific Sessions; May 2-4, 2024; Long Beach, California.
- Kobayashi T, et al. J Soc Cardiovasc Angiogr Interv. 2024;doi:10.1016/j.jscai.2024.101877.
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Keeling WB, et al. Featured clinical research part 2. Presented at: Society for Cardiovascular Angiography and Interventions Scientific Sessions; May 2-4, 2024; Long Beach, California.
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