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The development of an implantable, portable, electrically powered left ventricular assist device.

The development of the portable, electrically powered LVAD was a complex process that began in the early 1970s with the left ventricular assist project sponsored by the National Institutes of Health. The problems that DeBakey outlined in 1971 that challenged widespread clinical use of a ventricular assist device have today largely been solved by the TCI portable, electrically powered LVAD. The cost of LVAD implantation and maintenance, although still considerable, is less than the cost of caring for a patient in an intensive care unit for 75 days (the median waiting time in 1992 for a UNOS Status I candidate [UNOS, personal communication, 1994]) and comparable with the cost of other devices in use, such as the internal defibrillator. Although the implantation of the LVAD still requires a major operation, it is now a commonly performed procedure in transplant centers that use LVADs, and the level of operative risk is considered acceptable. The operation to implant an LVAD is usually performed in patients for whom death is imminent, and the potential benefit to such patients is high in relation to the risk of the surgical procedure. DeBakey feared that textured blood-contacting surfaces might not be suitable over long periods, but this has not been the case.(ABSTRACT TRUNCATED AT 250 WORDS)

Animals↗

Extracorporeal life support as a post left ventricular assist device implant supplement.

Extracorporeal life support (ECLS) is indicated following left ventricular assist device (LVAD) implant for right heart failure or pulmonary dysfunction. From December 1991 to December 1996, 100 patients were supported with the implantable HeartMate LVAD. Of these, 12 patients were supported with ECLS post LVAD implant. Pre-operatively, 10 patients (83%) were on an intra-aortic balloon pump, 9 patients (75%) were intubated, and 8 patients (67%) required ECLS bridge to LVAD implant. Six patients (50%) were men, and patient age ranged from 28 to 63 years (mean 46 +/- 10 years). Duration of ECLS averaged 3 +/- 2 days (range, 1-9 days). Eight patients (67%) required a right ventricular assist device (RVAD) with an ECLS circuit, three patients (25%) required peripheral veno-venous ECLS, and one patient peripheral veno-arterial ECLS. Forty-five percent supported with ECLS post LVAD survived to transplant compared with the 81% supported with LVAD only. Early in this experience, three patients had RVAD support only and all three patients died. RVAD support (with or without ECLS) was 11% overall and declined from 14% in the first 50 patients to 8% in the second 50. ECLS post LVAD is relatively uncommon and its use is associated with reduced survival, but helps salvage these critically ill patients.

Adult↗

Altered humoral control of circulating volume during artificial circulation.

UNLABELLED: Plasma atrial natriuretic polypeptide (ANP) levels and plasma renin activity (PRA) were measured in six left ventricular assist device (LVAD) goats, four single artificial heart (SAH) goats, i.e., LVAD animals with fibrillated hearts, and 3 total artificial heart (TAH) calves. During the 4 week experiment, the ANP levels in the SAH goats increased to 516 pg/ml from the control value of 61.8 pg/ml because of an elevated CVP of 13-21 mmHg, while those of the LVAD goats were near the lower limit of the control values. The TAH calves had slightly decreased ANP levels at 23-46 pg/ml after the third postoperative week, which did not increase after the steep increase in CVP induced by the changes in the driving conditions. The PRA levels were 10-50 times higher than control in the SAH goats and a TAH calf whose CVP rose to 19 mmHg, although the cardiac output was within normal limits. IN CONCLUSION: 1) The secretion of ANP secondary to alteration in CVP was preserved in the LVAD recipients and enhanced diuresis, while it was compromised in the TAH cases. 2) The PRA levels in cases with elevated CVPs were high enough to suppress diuresis.

Animals↗

A complete mock circulation loop for the evaluation of left, right, and biventricular assist devices.

A new mock circulation loop was developed to replicate the necessary features of the systemic and pulmonic circulatory systems, including pulsatile left and right ventricles coupled with vascular compliances and resistances. A brief description of the mock loop construction is provided before results are presented confirming the recreation of perfusion rates and pressures found in the natural systemic and pulmonic vascular trees for a normal and failing heart at rest. This rig provides the ability to evaluate the hemodynamic effect of left, right, and biventricular assist devices in vitro. The small and compact mock circulation rig has the potential to reduce device evaluation costs by simulating the natural circulatory system, thus providing valuable device performance feedback prior to expensive in vivo animal trials.

Blood Circulation↗

Power output of pericardium-lined skeletal muscle ventricles, left ventricular apex to aorta configuration: up to eight months in circulation.

OBJECTIVE: The purpose of this experiment was to evaluate the potential for a skeletal muscle ventricle connected to the circulation between the left ventricle and the aorta to provide effective, long-term cardiac assist. METHODS: Skeletal muscle ventricles were constructed from the latissimus muscle in 10 dogs. After conditioning, the skeletal muscle ventricles were connected to the left ventricle and the aorta with 2 valved conduits. The skeletal muscle ventricle was programmed to contract during diastole. RESULTS: At time of implantation, skeletal muscle ventricles stimulated at 33 Hz and in a 1:2 ratio with the heart significantly decreased left ventricular work by 56% (P <.01) and at 50 Hz by 65% (P <.01). At a 1:2 ratio, the power output of the skeletal muscle ventricles was 59% of left ventricular power output at 33 Hz (P <. 01) and 93% at 50 Hz (P <.01). Animals survived 7, 11, 16, 17, 72, 99, 115, 214, and 249 days. Three deaths were directly related to the skeletal muscle ventricle. One animal is alive at 228 days. In the animal that survived 249 days, skeletal muscle ventricle power output at 8 months with a 33 Hz stimulation frequency and a 1:2 contraction ratio was 57% of left ventricular power output and 82% at 50 Hz. At a 1:1 ratio, skeletal muscle ventricle power output was 97% and 173% of the left ventricle at 33 and 50 Hz, respectively. CONCLUSIONS: Left ventricular assist with a skeletal muscle ventricle connected between the left ventricle and the aorta is the most hemodynamically effective configuration we have tested and can maintain significant power output up to 8 months.

Animals↗

[Successful post-bypass extracorporeal circulatory assistance with the centrifugal pump].

Patients with reduced left ventricular function do have an increased risk of inability to be weaned off bypass after open heart surgery despite maximal pharmacologic support and intraaortic balloon counter-pulsation. Centrifugal pumps used for extracorporeal circulatory assist can maintain a patient in low cardiac output up to days without anticoagulation. We used a centrifugal pump in 3 patients: as a left ventricular assist device (LVAD) in 2 patients and right ventricular assist device (RVAD) in 1 patient. One LVAD-patient became a long-term survivor after 20 h of assist, another was bridged successfully to an open heart procedure for 2 h after papillary muscle rupture. One RVAD patient died on the operating table due to massive tracheal bleeding probably caused by pulmonary hypertension.

Assisted Circulation↗