Heart Valve Surgery: Repair and Replacement Procedures
Catheter-directed Mechanical Thrombectomy System Demonstrates Safety And Effectiveness In Patients With Pulmonary Embolism
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SCAI Scientific Sessions 2024
view moreCredit: Society for Cardiovascular Angiography & Interventions
Long Beach, Calif. – May 3, 2024 – New data from the Acute Pulmonary Embolism Extraction Trial with the AlphaVac System (APEX-AV) demonstrated that catheter-directed mechanical thrombectomy is safe and effective in patients with acute intermediate-risk pulmonary embolism (PE) with significant improvement in the right ventricle (RV) function and minimal major adverse events. The safety and efficacy results from the prospective trial were presented today as late-breaking science at the Society for Cardiovascular Angiography & Interventions (SCAI) 2024 Scientific Sessions.
Pulmonary embolism (PE), a blood clot that blocks and stops blood flow to an artery in the lung, is common and often life-threatening. PE represents the third-leading cause of cardiovascular mortality with 100,000 to 180,000 deaths per year. Catheter-directed therapies continue to evolve to address the large population of acute PE patients.
The APEX-AV trial is a prospective, single-arm, multicenter investigational device exemption trial in which patients with acute intermediate-risk PE were treated with the AlphaVac F1885 aspiration system. The primary efficacy endpoint was a change in the right ventricle-to-left ventricle (RV/LV) ratio from baseline to 48 hours post-procedure on core lab–adjudicated computed tomography angiography. The primary safety endpoint was a composite of 48 hours post-procedure major adverse events: device-related death, major bleeding, and device-related serious adverse events.
Among the 122 patients treated at 25 U.S. Sites, the average reduction in the RV/LV ratio was 0.45 with a 35.5% mean percentage reduction in the overall clot burden from the baseline at 48 hours post-procedure. Five patients had major adverse events within the 48-hour visit and no death was reported. Lastly, procedural times were short with a mean procedural time of 37.2 ± 17.7 minutes.
"Pulmonary emboli can be extremely dangerous and require effective and prompt action," said William Brent Keeling, MD, Associate Professor at the Emory School of Medicine, and lead author of the study. "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."
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About Society for Cardiovascular Angiography & Interventions (SCAI)
The Society for Cardiovascular Angiography & Interventions, established in 1978, stands as the primary nonprofit medical society dedicated to representing invasive and interventional cardiology. SCAI's mission is to guide the global interventional cardiovascular community by fostering education, advocacy, research, and upholding standards for quality patient care. For more than 40 years, SCAI has exemplified professional excellence and innovation worldwide, cultivating a reputable community of over 4,500 members committed to advancing medical science and providing life-saving care for individuals, both adults and children, affected by cardiovascular disease. For more information, visit https://scai.Org/.
For more information about the SCAI 2024 Scientific Sessions, visit https://scai.Org/scai-2024-scientific-sessions. Follow @SCAI on X (formerly Twitter) and on LinkedIn for the latest heart health news and use #SCAI2024 to follow the latest discussions.
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Arrhythmogenic Right Ventricular Dysplasia/Cardiomyopathy
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The role of infectious agents in cases of ARVD/C has been proposed due to the common finding of inflammatory infiltrates in the myocardium, suggesting that ARVD/C is a sequela of myocarditis (like dilated cardiomyopathy). A number of viruses have been identified in the hearts of patients with ARVD/C, myocarditis, or DCM. In 1986, a virus called Coxsackievirus B was identified in the hearts of patients with either myocarditis or DCM. Subsequently, it has been shown that another virus, called adenovirus, is also commonly a cause of these conditions.
It has been suggested that when the virus infects the heart, it causes the body to react against the virus, much as the body's own defense system (immune system) normally attacks a virus infection, and this causes inflammation in the heart (myocarditis). Usually the virus will be eliminated, however in some patients the immune system may not totally eliminate the virus, and in these patients, the heart muscle continues to be damaged, leading to DCM. In some people, the body's immune system attacks and damages the heart even though the virus has been eliminated: this is termed auto immune disease. It has been shown that in some patients with ARVD/C, adenovirus and Coxsackievirus may be disease-causing.
We have recently reported a study looking for evidence of virus infection of the heart in 12 patients with non-familial ARVD/C. Enteroviruses (the virus family which includes the Coxsackieviruses) were identified in seven patients and adenovirus type 5 in another two patients.
Investigations of the role of viruses in the development of ARVD/C are ongoing in the Phoebe Willingham Muzzy Pediatric Molecular Cardiology Laboratory, while viral diagnosis is provided by the John Welsh Cardiovascular Diagnostic Laboratory.
Novel Thrombectomy System Demonstrates Positive Safety And Feasibility Results In Treating Acute Pulmonary Embolism
Late-breaking data from the ENGULF trial showed that a novel dual-action thrombectomy device was effective and safe in treating acute pulmonary embolism (PE). The safety and effectiveness results were presented at the Society for Cardiovascular Angiography & Interventions (SCAI) 2024 Scientific Sessions and simultaneously published in JSCAI.
PE is a serious cardiovascular event where a blood clot causes issues with blood flow and oxygen levels in the lungs. It can be life-threatening, with up to 30% of individuals dying within one month of diagnosis. Despite recent advances in therapeutic options, PE still carries a high risk of mortality and morbidity with few FDA-cleared thrombectomy catheters available to physicians.
The ENGULF trial is a prospective, single-arm, first-in-human, safety and feasibility study evaluating a novel embolectomy catheter system for the treatment of acute PE with a steerable and expandable funnel and an internal agitator, the Hēlo PE Thrombectomy System.
Patients underwent a pre- and 48-hour post-procedural computed tomography (CT) scan. The primary efficacy outcome was the percent difference in the pre-to-post procedural right ventricle–to–left ventricle (RV/LV) ratios.
The primary and secondary safety outcomes were all-cause mortality, major life-threatening bleeding, device-related serious adverse events, pulmonary or cardiac injury, and clinical decompensation at 48 hours and 30 days post-procedure.
All 25 patients from eight centers underwent successful embolectomy. The mean RV/LV ratio was 1.53±0.27 at baseline and 1.15±0.18 at 48 hours post-procedure (23.2%±12.81% change). Of note, there were no major adverse events at 48 hours and no deaths at 30 days.
"Although more rigorous studies are needed, RV/LV ratio is the most important predictor of dysfunction and adverse outcomes in acute PE, and it is exciting to see that the RV/LV ratio reduction was just as much as other FDA-approved devices on the market without any large safety concerns in a new first-in-human device," said Tai Kobayashi, MD, Assistant Professor of Clinical Medicine at Penn Medicine, and lead author of the study.
"This technology represents the marriage between large and small-bore embolectomy, which allows for operators to travel through the heart with a smaller catheter but expand a larger funnel that matches the size of the large bore catheters—leaving a smaller footprint and lowering the risk of hemodynamic impact for the patient."
"For the field of interventional PE therapies to fully reach its promise, continued innovation is needed to optimize our procedural workflows across the wide array of patients affected by this disease," said Jay Giri MD, MPH, Director of the Cardiovascular Catheterization Laboratories at the Hospital of the University of Pennsylvania, senior author of the study, and national principal investigator of the study.
"The ENGULF trial is an important step in this process, demonstrating that a novel, purpose-built PE thrombectomy catheter can achieve excellent results even among its earliest users."
More information: "First in Human Safety and Feasibility of a Novel Catheter Thrombectomy Device for the Treatment of Pulmonary Embolism (The ENGULF Trial)" Friday, May 3, 2024; 2:26-2:33 PM PT, scai.Org/scai-2024-scientific-sessions
JSCAI (2024). DOI: 10.1016/j.Jscai.2024.102049
Citation: Novel thrombectomy system demonstrates positive safety and feasibility results in treating acute pulmonary embolism (2024, May 3) retrieved 5 May 2024 from https://medicalxpress.Com/news/2024-05-thrombectomy-positive-safety-feasibility-results.Html
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