Transapical left ventricular bypass with local heparinization for prolonged circulatory support

Area of Science:

• Cardiovascular Surgery
• Biomedical Engineering
• Medical Devices

Background:

• Severe heart disease necessitates advanced circulatory support strategies.
• Current ventricular assist devices face challenges in long-term efficacy and biocompatibility.
• Minimally invasive bypass techniques are crucial for improving patient outcomes.

Purpose of the Study:

• To evaluate the efficacy and safety of a novel transapical ventricular bypass system.
• To assess the performance of a vinyl sheet device for prolonged left ventricular unloading.
• To investigate the application of this bypass system in both animal models and critically ill human patients.

Main Methods:

• A custom vinyl sheet device incorporating a Pall filter, pressure monitoring, and heparinization lines was utilized.
• Transapical left ventricular bypass was performed in 36 calves and 11 human patients.
• Blood was returned to the abdominal aorta, ascending aorta, or carotid artery.
• Anticoagulation strategies included local heparinization followed by oral anticoagulation.

Main Results:

• Calves undergoing left ventricular bypass (n=31) and biventricular bypass (n=5) survived scheduled periods up to 7 weeks, with exceptions due to air embolism and infection.
• The anticoagulation regimen effectively prevented bleeding and thromboembolism in animal subjects.
• Eleven critically ill patients with severe heart disease received circulatory support for up to 172 hours.
• Four patients recovered, and three were successfully weaned from bypass, with later survival noted in some.

Conclusions:

• The transapical ventricular bypass system demonstrates feasibility and potential for prolonged hemodynamic support.
• The employed anticoagulation strategy appears effective in managing bleeding and thrombotic risks.
• This approach offers a viable option for managing severe heart failure, warranting further clinical investigation.