John W. Holfert

A blood pump with an interatrial shunt for use as an electrohydraulic total artificial heart.

A recently designed blood pump subsystem for the completely implantable electrohydraulic total artificial heart (EHTAH) has been developed and is under evaluation. The subsystem consists of joined left and right ventricles, atrial cuffs with an interatrial shunt (IAS), and two outflow grafts. The ventricles were developed to fit within the pericardial space based on the results of anatomic fit trials. An optimized configuration for animal use, which was adaptable for human use with minimal modification, was identified. The core dimensions of the ventricles with an energy converter are approximately 10 x 11 x 7 cm. Maximum output and stroke volume are 9.2 L/min and 81 ml, respectively. The IAS is used to balance the volumetrically coupled EHTAH, and is made by forming an orifice in the common septum of the left and right atrial cuffs. Performance and durability of the IAS were examined in animal experiments for up to 9 days. The diameter of the IAS was 3.4-5.5 mm, and the left-right atrial pressure difference ranged from 2 to 10 mmHg, with 0.57-1.48 L/min of theoretically calculated shunt flow. No evidence of thrombus formation was found in or around the IAS at autopsy. The entire EHTAH system with a new blood pump is being assembled for long-term animal studies.

Electrohydraulic ventricular assist device development

A 64 ml (effective stroke volume) in vitro electrohydraulic ventricular assist device (VAD) prototype has been built. The energy converter is an axial flow pump driven by a brushless direct current (DC) motor. Systole begins as silicone oil is pumped from the volume displacement chamber (VDC) into the ventricle, displacing the flexing diaphragm separating the oil and the blood. In diastole, the motor reverses, providing active filling by pumping oil from the ventricle into the VDC. The surface mount electronic internal controller provides motor commutator, energy management, telemetry, and physiologic control functions. Energy is supplied externally by either a 12 V DC power supply or a 12 V DC rechargeable battery and is transmitted through the skin by a transcutaneous energy transformer (TET). Energy can also be supplied by a 12 V DC rechargeable internal battery. Bidirectional infrared telemetry is used to transmit information between the internal and external controllers.

In vivo long-term evaluation of the Utah electrohydraulic total artificial heart.

An electrohydraulic total artificial heart (EHTAH) has been developed and evaluated by long-term in vivo studies. The EHTAH is composed of blood pumps with an interatrial shunt (IAS), an energy converter, and electronics. The EHTAH with external electronics was implanted in four calves weighing from 81-90 kg. Two animals died on the 1st and 5th post operative days, the third animal survived for 32 days, and the fourth for 159 days. The IAS was free of thrombus at autopsy in all animals. The longest surviving animal increased in size from a pre operative weight of 81 kg to 134 kg on day 144. Cardiac output ranged from 9.3 to 10.5 L/min, whereas right and left atrial pressures increased with the calfs growth from 4-10 to 16-20 mmHg and from 8-14 to 18-22 mmHg, respectively. The animal favorably tolerated up to 3.4 km/hr of treadmill exercise, both hemodynamically and metabolically. The elevation of atrial pressures during treadmill exercise was significantly alleviated by employing an automatic control mode. It is concluded that the device has the potential to be a totally implantable system for permanent use.

Mechanical failures of the pneumatic Utah-100 and Jarvik total artificial hearts. A comparative study.

Jarvik-5 and Jarvik-7 total artificial hearts (TAHs) and Utah-100 TAHs were fabricated and implanted in calves and sheep. In the Jarvik series, 30.7% had mechanical failures (16.1% catastrophic). In the Utah-100 TAH series, 11.1% had mechanical failures (3.7% catastrophic). Failures were classified as: 1) diaphragm failures; 2) valve-holding ring failures; 3) air-leak failures; and 4) prosthetic valve failures. Marked reduction in mechanical failure for the Utah-100 TAH is attributed to progressive component redesign, material selection, and more stringent quality control criteria.