Over the past 30 years, deaths from cardiovascular diseases have increased by 60%. There is a growing need for cardiovascular innovation with a focus on patient outcomes, whether that’s through advancements in technology, the use of digital therapeutics, or the research and development of revolutionary devices.
“Constant innovation is required to address the danger of cardiovascular disease, as we’re seeing a growing number of patients in need. At the SCAI 2025 Scientific Sessions, leading researchers show promising data on how novel treatment devices can reduce the risk of serious cardiovascular outcomes,” said SCAI President James B. Hermiller, MD, MSCAI.
pVAD System Shown to be Safe and Effective PE Treatment in High-Risk Patients Undergoing PCI
Percutaneous ventricular assist devices (pVADs) help increase blood flow for those undergoing severe cardiovascular conditions. Due to the immediate cardiac support and less invasiveness pVADs provide, they are often used in patients with high-risk percutaneous coronary intervention (HRPCI) who also have advanced coronary artery disease, complex comorbidities, and left ventricular dysfunction – a patient group vulnerable to serious cardiac complications and even death.
The small access, high flow (5.5 L/min) Supira System pVAD is designed to provide temporary (≤4 hours) hemodynamic, or blood flow, support in HRPCI. A prospective, single-arm, multicenter early feasibility study was conducted at four sites in the United States to examine the safety and efficacy of pVAD system in HRPCI. Results showed HRPCI with the pVAD system was associated with favorable safety and performance. The primary feasibility endpoint is successful initiation and maintenance of hemodynamic support without sustained hypotension (low blood pressure). The primary safety endpoint is the rate of composite major device-related adverse events from device insertion through removal.
15 patients (mean age of 72 years, 74% male) were treated between Nov. 2024 and Jan. 2025 with ongoing data collection at 30- and 90-day post-procedure follow-up. PCI was successfully completed for all participants with one major device-related adverse event (arrhythmia) that resolved by the end of the procedure.
“pVAD systems are an emerging therapy to provide safer options for patients whose clinical features post high risk for complex PCI. The potential of this therapy can also extend to other patient populations such as those with cardiogenic shock and advanced heart failure in whom circulatory support can improve outcome,” said David Kandzari, MD, FACC, MSCAI; Chief, Piedmont Heart Institute and Cardiovascular Services in Atlanta, Ga. and lead author of the study.
These findings encourage further clinical study evaluating the lower profile, high-flow pVAD systems compared to current-generation devices.
Aspiration-Based Thrombectomy System Reduces Clot Blockage by Nearly 36% in Patients with Pulmonary Embolism
Often caused by a blood clot, pulmonary embolism (PE) is associated with significant morbidity and mortality. About one in 1,000 people worldwide experience pulmonary embolism, with up to 20% of people diagnosed with acute PE dying in the next 90 days. Thrombectomy is a common procedure used to remove blood clots, especially for more severe cases of PE and higher-risk patients. The AVENTUS thrombectomy system is an aspiration-based system integrating mechanical thrombectomy with inline blood filtration and reinfusion designed for efficient clot removal, minimal blood-loss and enhanced ease-of-use.
The prospective, multi-center, pivotal study aimed to evaluate the safety, efficacy, and performance of the thrombectomy system in acute intermediate-risk PE patients. To measure the device’s performance, the primary efficacy endpoint was a measurement of the ventricle function or flow as the core laboratory-adjudicated change in right ventricular to left ventricular (RV/LV) ratio from baseline to 48 hours post-procedure. The primary safety endpoint was a composite rate of device-related major adverse events (MAEs) within 48 hours.
The pivotal trial demonstrates that the thrombectomy system is a safe, and effective treatment for acute intermediate-risk PE, significantly reducing RV/LV ratio and an improvement in functional outcomes by 30 days with no device-related MAEs. A total of 120 patients (mean age 59, 55.8% male) underwent PE thrombectomy with the device. There was a mean reduction of 27% (0.47) in RV/LV ratio at 48 hours with a decrease in clot burden of 35.9% based on Refined Modified Miller score. No device-related MAEs were observed within and through 30 days. The distance completed in a six-minute walk test increased by 36% at 30 days compared to 48 hours post-procedure. In 88.2% of patients, two passes through the heart or less were required with the device (60.8% of patients had one pass).
“This thrombectomy system provides unique advantages for both patients and physicians. The device was associated with a significant reduction in clot burden and improvement in heart function. The low number of passes through the heart without removal or repositioning of the device highlights the intuitive design, even for novice users,” said Jun Li, MD, FSCAI, FACC, University Hospitals Harrington Heart & Vascular Institute in Cleveland, Ohio and Case Western Reserve University School of Medicine in Cleveland, Ohio, and lead author of the study. “This technology may encourage broader adoption in community hospitals, improving access to life-saving treatment in underserved areas.”
Ongoing clinical trials are studying the use of device-based therapies for intermediate-risk PE patients against medical therapy alone for quality of life and functional improvement. The 30-day improvements in quality of life and walking distance shown in the AVENTUS trial will add to the growing body of evidence for large-bore thrombectomy in a short-term basis.
This abstract is published in SCAI’s official journal, JSCAI, here with an additional feature article here.
Carotid Stent System Safe and Durable for Treatment of Carotid Artery Stenosis in High-Risk Patients
Carotid artery stenosis (CAS) increases the risk of strokes by up to 15%. A common procedure for CAS is carotid endarterectomy (CEA), a surgical procedure used to remove plaque buildup and restore normal blood flow.
The PERFORMANCE II study is a prospective, multicenter, single-arm, open-label study to evaluate the safety and effectiveness of the Neuroguard IEP® 3-in-1 Carotid Stent System with Integrated Embolic Protection for the treatment of CAS in subjects at elevated risk for adverse events following CEA. 305 patients were enrolled at 32 sites in the United States and Europe. The primary endpoint was the 30-day rate of a major adverse event (MAE), defined as death, all stroke, myocardial infarction (MI) within 30 days of the index procedure, or ipsilateral stroke (a stroke occurring on the same side as the procedure) through 12 months of the procedure.
The study demonstrated procedural safety and long-term durability of the stent system in high-surgical-risk patients. The 30-day stroke rate was 1.3%, the death/stroke rate was 1.6%, and the death/stroke/MI rate was 2.3%. The rate of 30-day all stroke plus ipsilateral stroke through one year was 1.8%, all of which were minor. There were no major strokes, stent thromboses, or neurological deaths through two years. The rate of in-stent restenosis (ISR, or re-narrowing of an artery within the stent itself) at one year was 3.65% and 3.85% at two years. There were no clinically driven repeat procedures at one year, and 1 (0.36%) at two years.
“In the PERFORMANCE 2 study performed in patients with obstructive carotid artery disease and at high risk for carotid endarterectomy, carotid stenting with the Neuroguard stent system was safe and effective, with low stroke rates and excellent durability and patency at 2 years. These findings offer an excellent treatment strategy for these patients with significant cardiovascular risk,” said D. Chris Metzger, MD, FSCAI, leading enroller and presenting author of the study.
Ongoing follow-up of the carotid stent cohort is anticipated, with results reported at three years.
Session Details:
“Safety and Feasibility of the Supira System in High-Risk Percutaneous Coronary Interventions: 30-Day Results from the US SUPPORT I Early Feasibility Study (EFS)”
Friday, May 2, 2025 11:14-11:22 AM ET
Walter E. Washington Convention Center, Hall D, Theater 4
“A Prospective Study of the Next Generation AVENTUS Thrombectomy System: Advancing Thrombectomy and Autologous Blood Reinfusion for Pulmonary Embolism”
Friday, May 2, 2025 11:47-11:55 AM ET
Walter E. Washington Convention Center, Hall D, Theater 4
“The PERFORMANCE II Trial: A Prospective Multicenter Single Arm Investigation of the Neuroguard IEP® 3-in-1 Carotid Stent System with Integrated Embolic Protection. Stent Durability and Patency at 2 years”
Friday, May 2, 2025 11:58 AM - 12:06 PM ET
Walter E. Washington Convention Center, Hall D, Theater 4
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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 5,000 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 2025 Scientific Sessions, visit https://scai.org/scai-2025-scientific-sessions. Follow @SCAI on X for the latest heart health news and use #SCAI2025 to follow the latest discussions.
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