Novel Technology Monitors and Lowers Bleeding Complications in Patients Undergoing Heart Procedures

Bleeding complications at the femoral access site can significantly hamper recovery, affecting the success of procedures, patient satisfaction, and overall healthcare costs. It is crucial for surgeons to quickly identify any bleeding to prevent minor bleeds from turning into serious complications. Now, a novel monitoring device offers real-time detection of bleeding during endovascular procedures, ensuring better outcomes and providing peace of mind for patients at high risk of bleeding.

The Early Bird Bleed Monitoring System (EBBMS) from Saranas, Inc. (Houston, TX, USA) is the only FDA-approved system for real-time bleed monitoring, marking a significant step forward in reducing healthcare expenses and enhancing patient care during endovascular procedures. The system employs the Bleed Detection Array to generate bioimpedance signals that track bleeding status, with simple indicators alerting surgeons to potential bleeds and signaling when intervention is necessary. Both animal studies and clinical trials have consistently shown a direct correlation between reduced bioimpedance levels and increased bleed volume. Early Bird can identify bleed progression with a statistically significant increase in volume detected at each bleed indicator level.

The "SAFE-MCS" study, a multi-center U.S. clinical trial, has assessed the safety of performing complex, high-risk percutaneous coronary interventions (PCI) with mechanical circulatory support (MCS) and monitoring with EBBMS. PCI is a non-surgical method for treating coronary artery blockages and restoring blood flow to the heart. This study, involving 203 patients from various U.S. centers, showcased EBBMS's capability to identify and mitigate bleeding complications during protected PCI. Protected PCI, which uses MCS to temporarily support the heart's pumping action, is a recognized treatment method. This pioneering study focused on bleeding complications during protected PCI, highlighting a significant decline in such complications among patients monitored with EBBMS.