The HeartSaver left ventricular assist device: an update.

BACKGROUND: Ventricular assist devices have been shown to be effective as bridges to transplantation and recovery for patients with end-stage heart failure. Current technology has been limited because of the need for percutaneous connections with controllers. The HeartSaver ventricular assist device (VAD) (World Heart Corporation, Ottawa, Ontario, Canada) was developed with the intention of having a completely implantable, portable VAD system. The system consists of an electrohydraulic blood pump, internal and external battery power, and a transcutaneous energy transfer and telemetry unit that allows for power transmission through the skin. Control of the device may be achieved locally or remotely through a variety of communication systems. METHODS: The device has been modified with the Series II preclinical version being available for in vitro (mock loop) and in vivo (bovine model) testing. RESULTS: Seventeen Series II devices have been functional on mock loops or other testing trials for an accumulated 900 days of operation. There have been eight acute experiments using a bovine model to test various components as they have become available from manufacturing. Mean pump output was 10.4 +/- 1.1 L/min in full-fill/full-eject mode. Changes in the last 24 months include (1) cannula redesign for better port alignment and integration of tissue valves; (2) battery redesign to convert to new lithium-ion cells; (3) optimized infrared information and electromagnetic inductance energy transmission through various skin thicknesses and pigmentation; and (4) improved reliability of internal and external controller hardware and software. CONCLUSIONS: Modifications have been required to optimize the HeartSaver VAD's performance. The final HeartSaver VAD design will be produced in the near future to allow for formal in vitro and in vivo testing before clinical implantation.

Circulatory support for cardiogenic shock due to acute myocardial infarction: a Canadian experience.

BACKGROUND: Cardiogenic shock due to acute myocardial infarction (AMI) is associated with high mortality. Circulatory support devices may be used to assist these patients while they await cardiac transplantation. METHODS AND RESULTS: From 1986 to 1997, 25 patients in cardiogenic shock complicating AMI within 3.6+/-0.7 days of the event were supported with artificial hearts. Of the 25 patients, 21 were men with a mean age of 48.4 +/- 1.8 years. The age range was 26 to 62 years. Patients were considered for a device when the following criteria were met: cardiac index less than 1.8 L/min/m2, wedge pressure greater than 20 mmHg despite one or two inotropes and/or intra-aortic balloon support. They received either a CardioWest total artificial heart (n=13), a Thoratec biventricular assist device (n=6) or left ventricular assist device (LVAD) (n=6). Three patients were not considered transplant candidates and died while on the devices (two with multiorgan failure and one found to have a bronchogenic carcinoma after implant), with 22 undergoing cardiac transplantation within 8.6+/-2.2 days of device implant. Six patients died in hospital after the transplants (27.3% mortality). Complications included bleeding or tamponade in seven (28%), pneumonia in six (24%) and right ventricular failure in three LVAD patients (12%). Post-transplant actuarial one-, two- and five-year survival rates were 71.4%, 71.4% and 51%, respectively. CONCLUSIONS: Circulatory support devices offer a means to maintain organ perfusion in patients who develop cardiogenic shock due to AMI. Patients can then undergo transplantation with a reasonable expectation for survival when the alternative is death. Eventually the availability of permanent support devices may obviate the need for transplant in these patients.

Multi-purpose mechanical circulatory device.

A mechanical circulatory assist device for long term use outside the hospital setting has been developed. The device can be used for left, right or bi-ventricular support, and several of the developed technologies are applicable for total artificial hearts and non-pulsatile flow systems. The totally implantable device is principally designed for left ventricular support with implantation in the left hemithorax. The system utilizes transcutaneous energy and information transfer sub-systems, and has no percutaneous connections. In vitro durability testing has been conducted for periods from 1-4 years. Bovine experiments have been conducted with sustained circulation for periods form 1.5 to 96 hours. The in vitro and in vivo evaluation to date has demonstrated that the system can function effectively as a totally implantable ventricular assist device. The transcutaneous energy and information transfer sub-systems provided the ability to power, monitor and control the device, without the need for percutaneous connections. Design optimization and chronic in vivo evaluation is planned.

Cardiac transplantation after mechanical circulatory support: a Canadian perspective.

BACKGROUND: To assess the relative efficacy of cardiac transplantation after mechanical circulatory support with a variety of support systems, we analyzed our consecutive series of patients who had and did not have mechanical support before transplantation. METHODS: A review of 209 patients undergoing cardiac transplantation from 1984 to May 1995 was performed. Group 1 consisted of 110 patients who were maintained on oral medications while awaiting transplantation, and group 2 consisted of 60 patients who required intravenous inotropic support. Group 3 included 39 patients who had transplantation after mechanical circulatory support for cardiogenic shock. The indication for device implantation was acute onset of cardiogenic shock in 38 patients and deterioration while awaiting transplantation in 1 patient. The support systems were an intraaortic balloon pump in 13 (subgroup 3A), a ventricular assist device in 7 (subgroup 3B), and a total artificial heart in 19 patients (subgroup 3C). RESULTS: After transplantation, infection was more common in group 3 (56%) than in group 1 (28%) or group 2 (32%) (p = 0.005). Survival to discharge was lower for group 3 (71.7%) than for group 1 (90.9%) or 2 (88.3%) (p = 0.009). For mechanically supported patients, survival to discharge was 84.6% in subgroup 3A, 71.4% in subgroup 3B, and 63.1% in subgroup 3C (p = not significant). CONCLUSIONS: Transplantation after mechanical support offers acceptable results in this group of patients for whom the only alternative is certain death. Patient selection and perioperative management remain the challenge to improving these results.

Totally implantable intrathoracic ventricular assist device.

BACKGROUND: A totally implantable, intrathoracic electrohydraulic ventricular assist device (EVAD) is being developed for permanent use or as a bridge to transplantation. METHODS: The blood pump with 70-mL nominal stroke volume, volume displacement chamber, reversible turbine, internal electronics and infrared diaphragm position sensor are combined in one compact unit (unified system). The size and geometry are based on human anatomic measurements and fluid dynamic studies. A transcutaneous energy transfer powers the system and recharges the implantable nickel-cadmium battery pack. Autotuning circuitry optimizes energy transfer efficiency over a range of transcutaneous energy transfer coil spacings and misalignments. An infrared diaphragm position sensor detects end-systole and diastole points. RESULTS: In vitro and acute in vivo tests have demonstrated flow rates greater than 6 L/min. The transcutaneous energy transfer system demonstrated power transfer efficiencies of 60% to 80% for power demands from 5 to 60 W. Thirteen systems are currently undergoing durability testing; one has run for more than 750 days failure-free. The system recently sustained circulation in an acute calf implantation for 96 hours. CONCLUSIONS: Results of the in vitro and in vivo testing to date have demonstrated that the developed system can function effectively as a totally implantable ventricular assist device. Chronic in vivo evaluation is planned.