Steven W. Etoch

The AbioCor implantable replacement heart

The AbioCor implantable replacement heart (IRH) is the first available totally implantable artificial heart. We recently initiated a multicenter trial of this device in patients with severe, irreversible biventricular failure. Patients who were not candidates for other therapies, including transplantation, were evaluated. All candidates were adults with inotrope-dependent biventricular failure, whose 30-day predicted mortality was higher than 70%. A three-dimensional computerized fit study predicted fit of the AbioCor thoracic unit in all recipients. At operation, the internal battery controller and transcutaneous energy transfer unit were placed. The AbioCor thoracic unit was placed in an orthotopic position after incision of the ventricals. There were 2 intraoperative deaths (due to intraoperative bleeding or aprotinin reaction). Four late deaths were recorded, 1 from multisystem organ failure and 3 cerebrovascular accidents. Autopsy revealed thrombus on the atrial struts of the 3 patients with cerebrovascular accident. Blood pumps and valves were clean on all patients. Significant morbidity was observed, primarily related to preexisting severity of illness. However, 3 patients recovered to the point of being able to take multiple trips outside of the hospital. Two patients were discharged from the hospital, with 1 patient being discharged home for more than 7 months. No significant device malfunctions or multi-system organ failure device-related infections were noted. The AbioCor IRH may be effective therapy for patients with end-stage heart failure. Many milestones have been achieved in the initial trial in humans, including the successful discharge of a patient to home and no significant device malfunctions. The occurrence of stroke is likely related to the presence of thrombus on the atrial struts and may be decreased as these atrial struts have been removed for future clinical implants.

Current status of the AbioCor implantable replacement heart

BACKGROUND The AbioCor implantable replacement heart (IRH) has been developed as an alternative to transplant (ie, destination therapy). We report our experience with the AbioCor IRH in a bovine model at the University of Louisville. METHODS Male Holstein cows were used (85 to 115 kg). The internal controller, battery, and secondary transcutaneous energy transfer coil were implanted in the right flank. After cardiopulmonary bypass, the thoracic unit was implanted orthotopically. After removal of air and weaning from cardiopulmonary bypass, the AbioCor was connected to internal components and energy transfer through transcutaneous energy transfer coils was achieved. RESULTS Nineteen animals underwent implantation of the AbioCor IRH for a proposed 30-day duration. There were 6 deaths, none related to device malfunction. All animals demonstrated normal hemodynamics with normal pressures in the aorta, pulmonary artery, left atrium, and right atrium. There was no significant hemolysis and all animals demonstrated normal end organ function. The internal battery allowed for brief periods of untethered mobility. CONCLUSIONS The AbioCor IRH has resulted in normal hemodynamics and normal end organ function without evidence of hemolysis in a bovine model.

Results after partial left ventriculectomy versus heart transplantation for idiopathic cardiomyopathy

OBJECTIVE Partial left ventriculectomy has been introduced as an alternative surgical therapy to heart transplantation. We performed a single-center, retrospective analysis of all patients with idiopathic dilated cardiomyopathy who underwent partial left ventriculectomy or heart transplantation or who were listed for transplantation to determine operative mortality rate, 12-month survival, freedom from death on the heart transplantation waiting list, and freedom from death or need for relisting for heart transplantation. METHODS Patients who had partial left ventriculectomy (October 1996 to April 1998) were retrospectively compared with patients who were listed for heart transplantation (January 1995 to April 1998). Survival was assessed after the surgical procedure (partial left ventriculectomy vs heart transplantation) and from time of listing for heart transplantation to assess the additional impact of waiting list deaths. Freedom from death or relisting for heart transplantation was also compared. RESULTS There was no difference in age or United Network for Organ Sharing status between the 2 groups. Twenty-nine patients with idiopathic dilated cardiomyopathy were listed for heart transplantation; 17 patients underwent transplantation, 6 patients died while on the waiting list, and 6 patients remain listed. One patient died after heart transplantation, and 1 patient required relisting. Sixteen patients had partial left ventriculectomy; 10 patients are in improved condition, 2 patients died (1 death early from sepsis and 1 death from progressive heart failure), and 4 patients required relisting for heart transplantation. Operative survival was 94% after partial left ventriculectomy and 94% after heart transplantation (P =.92). Postoperative 12-month Kaplan-Meier survival was 86% after partial left ventriculectomy and 93% after heart transplantation (P =.90). Twelve-month Kaplan-Meier survival after listing for heart transplantation was 75% due to death while on the waiting list (P =.76). Freedom from death or need for relisting for heart transplantation was 56% after partial left ventriculectomy and 86% after transplantation (P =.063). CONCLUSION Operative and 12-month survival after partial left ventriculectomy and heart transplantation were comparable. However, despite their initial improvement, many patients who underwent partial left ventriculectomy required relisting for transplantation. Although partial left ventriculectomy is associated with acceptable operative and 12-month survival, it may prove to serve better as a bridge to transplantation in patients with idiopathic dilated cardiomyopathy rather than definitive therapy, given the number of patients who required relisting for transplantation.

Hemodynamic and pressure-volume responses to continuous and pulsatile ventricular assist in an adult mock circulation

This study investigated the hemodynamic and left ventricular (LV) pressure–volume loop responses to continuous versus pulsatile assist techniques at 50% and 100% bypass flow rates during simulated ventricular pathophysiologic states (normal, failing, recovery) with Starling response behavior in an adult mock circulation. The rationale for this approach was the desire to conduct a preliminary investigation in a well controlled environment that cannot be as easily produced in an animal model or clinical setting. Continuous and pulsatile flow ventricular assist devices (VADs) were connected to ventricular apical and aortic root return cannulae. The mock circulation was instrumented with a pressure–volume conductance catheter for simultaneous measurement of aortic root pressure and LV pressure and volume; a left atrial pressure catheter; a distal aortic pressure catheter; and aortic root, aortic distal, VAD output, and coronary flow probes. Filling pressures (mean left atrial and LV end diastolic) were reduced with each assist technique; continuous assist reduced filling pressures by 50% more than pulsatile. This reduction, however, was at the expense of a higher mean distal aortic pressure and lower diastolic to systolic coronary artery flow ratio. At full bypass flow (100%) for both assist devices, there was a pronounced effect on hemodynamic parameters, whereas the lesser bypass flow (50%) had only a slight influence. Hemodynamic responses to continuous and pulsatile assist during simulated heart failure differed from normal and recovery states. These findings suggest the potential for differences in endocardial perfusion between assist techniques that may warrant further investigation in an in vivo model, the need for controlling the amount of bypass flow, and the importance in considering the choice of in vivo model.

Initial experience with the AbioCor implantable replacement heart at the University of Louisville.

Potential benefits of heart transplantation are limited by the severe donor organ shortage. The AbioCor implantable replacement heart has been developed as a potential alternative to heart transplantation. We report our initial experience with the AbioCor in a bovine model. A right thoracotomy was performed for access to the heart and great vessels. After initiation of cardiopulmonary bypass, excision of the native ventricles was followed by orthotopic placement of the IRH and complete implantation of the transcutaneous energy transfer coil, controller, and battery pack. Invasive monitoring of IVC, SVC, carotid artery, pulmonary artery, and left atrial (LA) pressures was performed in all animals. Twelve calves have undergone implantation of the AbioCor. There were three early deaths, one from bleeding, one from respiratory failure, and one from neurodysfunction from low flow during CPB. Nine animals have had a normal recovery and survived a mean of 24.5 days (range, 4–48 days). All the animals have demonstrated excellent hemodynamics with the maintenance of normal pressures in the LA, SVC, IVC, pulmonary artery, and aorta. Adjustment of the right-sided internal hydraulic fluid shunt has allowed for control of right-left balance and, thereby, manipulation of left and right side filling pressures. Late morbidity has consisted of neck wound infection and sepsis, pneumonia, and bleeding. Successful orthotopic implantation of all components of the AbioCor has been achieved in a bovine model. This device has demonstrated restoration of normal hemodynamics and excellent function of the atrial hydraulic shunt to achieve right-left balance.

Intermediate-Term Results After Partial Left Ventriculectomy for End-Stage Dilated Cardiomyopathy: Is There A Survival Benefit?

Background: The mortality of congestive heart failure remains high despite advances in medical therapy. Partial left ventriculectomy (PLV) has been advocated as a surgical alternative for select patients with dilated cardiomyopathy. Methods: A prospective clinical trial of PLV for patients with end‐stage idiopathic dilated cardiomyopathy was performed. Inclusion criteria were left ventricular end‐diastolic diameter (LVEDD) greater than 7 cm, refractory New York Heart Association (NYHA) Class IV symptoms, and severely depressed exercise oxygen consumption. Results: Twenty patients underwent PLV with mean follow‐up of 21.1 months. Sixteen were male; mean age was 50.1 years ± 12.0 years (range 25–67 years). Left ventricle (LV) ejection fraction improved after surgery from 14.1%± 4.7% to 24.1%± 3.1% (p < 0.05, t‐test) and this improvement persisted up to 3 years after operation. LVEDD and NYHA Class also were notably improved. There were two early deaths for an operative mortality of 10% (2 of 20 patients). Nine patients after initial improvement in clinical status and LV function developed worsening congestive heart failure (CHF). Six of the 9 ultimately died of complications secondary to CHF. One‐, 2‐, and 3‐year survival rates were 84%, 64%, and 40%, respectively, by Kaplan‐Meier analysis. The other three patients required listing for transplantation because of recurrent NYHA Class IV symptoms. Freedom from death or the need for listing for transplantation at 1, 2, and 3 years was 65%, 53%, and 33%, respectively. The remaining nine patients all had improvement in their NYHA classification. Conclusions: PLV can be performed with acceptable early and intermediate term mortality; survival compares favorably to reports of similar groups of patients treated with medical therapy alone.

Blood lactic acid levels after artificial heart implantation.

The aim of this study is to investigate blood lactic acid levels after the placement of the AbioCor implantable replacement heart to determine whether circulatory support with the AbioCor device results in adequate tissue perfusion. Tissue perfusion may not be adequate during cardiac surgery, especially with the use of cardiopulmonary bypass (CPB). Inadequate perfusion is usually associated with anaerobic metabolism, metabolic acidosis, and lactate accumulation.Ten calves had implantation of the AbioCor by means of a right thoracotomy. Standard cardiopulmonary bypass was performed during surgery. Lactic acid levels and blood gas analyses were measured. All animals were monitored for pressures in the aorta, pulmonary artery, and left and right atria. The output of the AbioCor was calculated based on beat rate and stroke volume.All animals were rapidly weaned off cardiopulmonary bypass to full AbioCor support and had normal hemodynamics with normal filling pressures. The lactic acid levels were elevated after surgery, peaked at 8 to 12 hours, and then gradually decreased to the normal range 24 hours after surgery. There was a positive relationship between lactate levels, oxygen consumption, and extraction rate, that is, the lactic acid levels were higher in the presence of increased oxygen consumption and increased oxygen extraction rate. There was a negative relationship between lactate levels and oxygen delivery, and arterial and venous oxygen content, that is, the lactic acid levels were higher when oxygen delivery and arterial and venous oxygen contents were low.The pathophysiology of lactic acidosis is uncertain, but is most likely due to inadequate perfusion during cardiopulmonary bypass, and lactate washout after adequate perfusion has been established. The return to aerobic metabolism with clearance of lactate demonstrates that the AbioCor is able to provide complete circulatory support with normal tissue perfusion.