Applications of the pulsatile flow versatile ECLS: in vivo studies

Area of Science:

• Cardiovascular Engineering
• Biomedical Devices
• Critical Care Medicine

Background:

• Twin-Pulse Life Support (T-PLS) is the first commercial pulsatile Extra Corporeal Life Support (ECLS) device.
• Its dual sac structure minimizes membrane oxygenator inlet pressure and hemolysis.
• Various models were tested to validate T-PLS for ECLS and its advantages.

Purpose of the Study:

• To evaluate the efficacy and safety of the T-PLS device in different clinical scenarios.
• To compare T-PLS performance against conventional devices like Biopump.
• To assess T-PLS's potential as an alternative to standard cardiopulmonary bypass and resuscitation methods.

Main Methods:

• Comparative analysis in partial cardiopulmonary bypass (CPB) models (swine) using T-PLS, Biopump, and a single pulsatile pump.
• Evaluation in a total CPB model (bovine) with induced cardiac arrest.
• Assessment in emergency cardiac arrest (canine) and Acute Respiratory Distress Syndrome (ARDS) models (canine).

Main Results:

• T-PLS demonstrated significantly lower inlet pressure (max ~250 mmHg) and comparable hemolysis levels to centrifugal pumps, unlike single pulsatile pumps (700-800 mmHg).
• In total CPB, T-PLS maintained physiological pulsatile flow (26-43 mmHg pulse pressure, 40-60 bpm).
• Successful resuscitation was achieved in emergency cardiac arrest models, and adequate oxygenation (PO2 258 mmHg) was maintained in ARDS models.

Conclusions:

• T-PLS shows promise as a portable pulsatile ECLS device for CPB and as an alternative CPR device.
• Its pulsatile flow effectively delivers oxygenated blood without overloading the heart, particularly beneficial for ARDS patients.
• The T-PLS device offers a potentially safer and more effective solution for critical circulatory support.