Up to 151 days of continuous animal perfusion with trivial heparin infusion by the application of a long-term durable antithrombogenic coating to a combination of a seal-less centrifugal pump and a diffusion membrane oxygenator

Abstract

We developed a new coating material (Toyobo-National Cardiovascular Center coating) for medical devices that delivers high antithrombogenicity and long-term durability. We applied this coating to an extracorporeal membrane oxygenation (ECMO) system, including the circuit tube, cannulae, a seal-less centrifugal pump, and a diffusion membrane oxygenator, to realize prolonged cardiopulmonary support with trivial anticoagulant infusion. The oxygenator consisted of a hollow-fiber membrane made of polymethylpentene, which allows the transfer of gas by diffusion through the membrane. The centrifugal pump was free of seals and had a pivot bearing. We performed a venoarterial bypass in a goat using this ECMO system, and the system was driven for 151 days with trivial anticoagulant infusion. Plasma leakage from the oxygenator did not occur and sufficient gas-exchange performance was well maintained. In the oxygenator, thrombus formation was present around the top and the distributor of the inlet portion and was very slight in the outlet portion. In the centrifugal blood pump, there was some wear in the female pivot region and quite small amounts of thrombus formation on the edge of the shroud; the pivot wear seemed to be the cause of the hemolysis observed after 20 weeks of perfusion and which resulted in the termination of the perfusion. However, no significant amounts of thrombus were observed in other parts of the system. This ECMO system showed potential for long-term cardiopulmonary support with minimal use of systemic anticoagulants.

Left heart bypass support with the Rotaflow Centrifugal Pump® as a bridge to decision and recovery in an adult

“…Nishinaka et al [6] reported circulatory support could be continued for long periods of time (151 days) in a goat receiving low-dose anticoagulant infusion, using the Rotaflow Centrifugal Pump Ò , circuit tubes and cannulae with T-NCVC Ò coating. In this study, no thrombus formation was found in the cannulae and circuit tube, suggesting the usefulness of the T-NCVC coating Ò .…”

Veno-venous ECMO: a synopsis of nine key potential challenges, considerations, and controversies

“…A newly developed circuit allowed 151 days of ECMO in an animal model with a trivial amount of heparin [48]. The development of the T-NCVC coating system, a complex of bonded heparin and aliphatic coupling reagents, may prevent heparin from leaching into the ECMO system.…”

Contemporary extracorporeal membrane oxygenation for adult respiratory failure: life support in the new era

“…These oxygenators are currently manufactured by a number of companies including Dideco, Maquet, Medos, Novalung and Sorin. Other systems that can effectively function for months without systemic anticoagulation are in development [34]. The low blood flow resistance of these newer oxygenators facilitates the use of centrifugal pumps.…”