A recent multicenter, single-arm, open-label study is the primary to exclusively assess bleeding complications in patients undergoing high-risk percutaneous coronary interventions (PCI) with Impella with independent adjudication via a clinical events adjudication committee and can gather meaningful real-world data based on contemporary practice. The design and rationale of the study was published online today within the Journal of the Society for Cardiovascular Angiography & Interventions (JSCAI).
Nearly one in every five patients will experience a bleeding complication during a large-bore endovascular procedure. Periprocedural bleeding is essentially the most common complication in patients undergoing PCI and is related to a significantly increased risk of mortality, morbidity, and price.
The Design and Rationale of the Protected Surveillance of PCI Under Mechanical Circulatory Support with the Saranas Early Bird Bleed Monitoring System (SAFE-MCS) study evaluates the protection of complex high-risk PCI using the Impella Heart Pump at the side of the Saranas Early Bird Bleed Monitoring System (EBBMS). The study will enroll a complete of 184 evaluable subjects at as much as 15 U.S. centers. Evaluable subjects are defined as all participants who had EBBMS placed ipsilateral to mechanical circulatory support and had post-procedure monitoring with EBBMS for at least two hours.
The Saranas EBBMS features a bleed detection array with integrated electrodes in a totally functional vascular access sheath. It’s designed to measure changes in bioimpedance to detect and monitor bleeding from vessel injury.
The first clinical endpoint is the incidence of access site-related Bleeding Academic Research Consortium (BARC) type III or V bleeding. Secondary clinical endpoints include the incidence of every Saranas EBBMS level 1, 2, and three indicators, and the incidence of all BARC type III or V bleeding.
The study authors note that along with the major clinical study, data from the SAFE-MCS study will even be used to perform an economic evaluation of the potential economic good thing about the Saranas EBBMS.
SAFE-MCS is the primary study dedicated to evaluating bleeding events post-Impella use and can bring meaningful essential insight on the rates of bleeding events during those procedures. While many of the studies on MCS devices give attention to efficacy outcomes, SAFE-MCS focuses on safety and risk mitigation, and outcomes that are very essential for patients, care givers, and the healthcare system typically.”
Dr. Philippe Généreux, MD, from Gagnon Cardiovascular Institute at Morristown Medical Center, Recent Jersey, lead creator, and co-principal investigator of the study
Généreux noted that while this study focuses on stable patients undergoing high-risk PCI, the role of early bleeding detection is much more essential in an emergency resembling cardiogenic shock, ST-elevated myocardial infarction, and through ECMO initiation.
“Timely identification of bleeding events is crucial in stopping adversarial events that may have serious consequences for patients. The information from SAFE-MCS will provide meaningful guidance on how real-time monitoring can improve clinical outcomes through a proactive approach to managing bleeding risk,” said Dr. Babar Basir, Director of Acute Mechanical Circulatory Support at Henry Ford Health System, and co-principal investigator of SAFE-MCS.
Authors note that the study is anticipated to complete enrollment by the top of 2023.
The SAFE-MCS study is funded by Saranas, Inc., with an independent clinical events adjudication committee (Cardiovascular Research Foundation) and an independent imaging core laboratory (Medical Metrics).
Source:
Society for Cardiovascular Angiography and Interventions
Journal reference:
Généreux, P., et al. (2023) Design and Rationale of the Protected Surveillance of PCI Under Mechanical Circulatory Support with the Saranas Early Bird Bleed Monitoring System (SAFE-MCS) Study. Journal of the Society for Cardiovascular Angiography & Interventions. doi.org/10.1016/j.jscai.2023.101049.