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From August 1979 through August 1991, 91 patients were supported with centrifugal mechanical ventricular assist. Major indications for its use were postcardiotomy ventricular failure (79) or as a bridge to cardiac transplantation (12). In postcardiotomy use (0.2% of all cardiac procedures), there were 54 male (68.4%) and 25 female patients (31.6%) with a mean age of 54.8 years and a mean duration of use of 3.56 days (range, 1 hour to 19 days). Forty-nine patients (62%) were successfully weaned, and 20 (25.3%) were hospital survivors. In 57 patients the device was inserted to wean from cardiopulmonary bypass, whereas in 22 it was employed later in the postoperative period because of low cardiac output or sudden arrest. Thirty-four (59.6%) of the 57 patients in the former group were weaned, and 15 (26.3%) were discharged, results similar to those in the latter group with 15 (68.2%) weaned and 5 (22.7%) discharged. Morbidity associated with use of centrifugal blood pumps included bleeding (87.3%; mean transfusion requirement, 53.2 units), renal failure (46.8%), cerebrovascular accident (12.7%), thromboembolism (12.7%), and hepatic insufficiency (12.7%). After a mean follow-up of 45.4 months (range, 2 to 142 months), 7 patients had died (35% late mortality), 1 patient is in functional class IV, and all others are in functional class I or II. Lower survival was associated with biventricular failure and renal failure but not with age or sex of the patient.
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PMID:Postcardiotomy centrifugal mechanical ventricular support. 144 87

A right ventricular assist device (VAD) based on the principle of counterpulsation has been developed at our institution. The device is a valveless, pneumatically actuated, 40 cc, sac-type pump, with a single inlet-outlet port. For right ventricular support, the "Uniport" pump is anastamosed end-to-side to the pulmonary artery. In previous experimental trials, the device has been shown to impart minimal trauma to blood components. In this study, biventricular failure was induced in eight Holstein calves by normothermic ischemia during cardiopulmonary bypass. A Pierce-Donachy left VAD (LVAD) was used for left ventricular support following the ischemic insult. Hemodynamic measurements were obtained throughout the study, and each animal served as its own control. A significant increase in post injury cardiac output (33.5 +/- 11.4%) was obtained with use of the Uniport and LVAD, as compared to use of the LVAD alone (p less than or equal to 0.005). Other hemodynamic parameters of right heart failure, including right atrial pressure (RAP), pulmonary artery pressure (PAP), and left atrial pressure (LAP) were not significantly affected. These data suggest that the Uniport right ventricular assist device significantly improves cardiac output in this model of moderate right ventricular failure. Additional studies are required, however, to optimize pump stroke volume, and to further define the performance envelope of the device.
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PMID:Hemodynamic effects of a new right ventricular assist device. 225 37

Several devices are currently available for bridging to cardiac transplantation, but the efficacy of each has not been established. From September 1983 to March 1988 we supported 17 transplant candidates with mechanical assist devices. Extracorporeal membrane oxygenation (ECMO) was used to bridge two patients, external ventricular assist devices (VADs) were used in 11 patients, internal left ventricular assist systems (LVAS) were used in three patients, and implantable prosthetic replacement ventricles (TAH) were used in one patient. The 14 men and three women, aged 24 to 59 years (mean 46 years), suffered cardiogenic shock caused by ischemic (13 patients), postpartum (two patients), viral (one patient), and drug-induced (one patient) cardiomyopathy. Five patients with isolated left ventricular failure (LVF) received only left VADs, three patients with severe LVF and moderate right ventricular failure received LVAS, and nine patients with severe biventricular failure received ECMO (two patients), biventricular assist devices (six patients), and TAH (one patient). Patients were supported for periods of 1/2 to 90 days (mean 22) with flows of 2.15 to 3.39 L/min/m2. Ten patients underwent transplantation (eight of whom were discharged) and seven patients died without transplants. The two patients who received ECMO died 1 and 30 days after transplantation, in part as a result of ECMO complications. Seven patients were denied transplants because of renal failure (five patients), infection (five patients), bleeding (four patients), and cerebrovascular accident (two patients). The seven survivors were supported with VADs (five patients) or LVAS (two patients). Three had driveline infections, two had bleeding complications, two developed mediastinitis, and one each had hemolysis, cerebrovascular accident, and mechanical failure.(ABSTRACT TRUNCATED AT 250 WORDS)
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PMID:Bridging to heart transplantation with circulatory support devices. 265 15

The results of a gated radionuclide cardiac study are reported in a patient with biventricular failure and tricuspid insufficiency demonstrated by clinical evaluation, M-mode and 2-D sector echocardiography, and cardia catheterization. The processed gated radionuclide cardiac study showed a left ventricular/right ventricular stroke volume ratio of 0.5; expansion of the hepatic blood pool demonstrated by hepatic time activity curve and calculation of an "'expansion fraction"; and synchronous changes of count rate of the atrial and hepatic regions detected by phase analysis (similar phase shifts).
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PMID:Tricuspid insufficiency detected by equilibrium gated radionuclide study. 729 85

The number of octogenarian patients undergoing an open heart procedure in our unit is the fastest increasing group of patients. Between June 1985 and July 1994 112 octogenarians (mean age 81.7 years, 60 males, 52 females) underwent cardiac operations. The postoperative course was uneventful in 90 patients (80.4%). The perioperative mortality rate was 8.9% (10 patients). Mortality was lowest in the group receiving aortic valve replacement, with one death out of 30 patients (3.3%). The cause of death was left- or biventricular heart failure in more than half of the fatalities. Postoperative complications included: AV-block III (n = 1), postoperative bleeding (n = 2), unstable sternum (n = 3), acute cholecystitis (n = 1), low cardiac output syndrome (n = 1), stroke (n = 1), pneumothorax (n = 2) and urinary tract infections (n = 1). We consider open heart procedures in octogenarians, despite a mortality rate of 8.9%, as justified. According to the severity and course of clinical symptoms and the type of surgery required, selection of patients for operation should be decided on at an early stage of the disease. Not only life expectancy increases, but there is also a significant increase in life quality for these patients.
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PMID:[Heart surgery in the elderly]. 857 51

Left dominant biventricular failure is a common type of heart failure after cardiac surgery. We developed a biventricular bypass (BVB) system for treatment of postcardiotomy ventricular failure, and we previously reported that the clinical results of the BVB system were superior to those obtained with venoarterial bypass (VAB). The purpose of this study was to evaluate the effect of the BVB system on left ventricular (LV) performance in comparison to that of VAB by means of the LV pressure-volume relationship (PVR). Eight adult mongrel dogs (14-21 kg) underwent VAB with right atrial and aortic cannulation. Left atrial cannulation was added for BVB, and both atrial drainage tubes were joined with a Y-shaped connector. The bypass flow was maintained at half of the baseline cardiac output (0.7-1.0 L/min), and the hemodynamic parameters were monitored. A high fidelity microtip catheter and a conductance catheter were used to evaluate LV function. The slope of the LV end-systolic pressure-volume relation (Emax), the slope of the LV end-systolic pressure-stroke-volume relation (Ea), the LV stroke work (SW), LV potential energy (PE), LV pressure-volume area (PVA), the slope of the SW end-diastolic volume relation (PRSW), and an index of the LV energizing charge (ratio of PE/PVA) were assessed during transient occlusion of the inferior vena cava. LV contractility (Emax) showed no significant change during each experiment. Standardized LV work (PRSW) was reduced by BVB in comparison to the baseline and in comparison to VAB. The rate of LV energy charge (PE/PVA) significantly increased only during BVB. These results suggested that the BVB system might be an effective circulatory support for reducing LV work and improving the LV energizing charge in patients with severe heart failure after cardiac operation.
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PMID:Effect of a balanced biventricular bypass system on left ventricular energies. 975 70

The immediate transition from positive pressure mechanical ventilation to spontaneous ventilation may generate significant cardiopulmonary hemodynamic alterations based on the mode of weaning selected, particularly in individuals with preexisting cardiac dysfunction. The purpose of this study was to compare hemodynamic responses associated with the initial transition to 3 modes of ventilator weaning (spontaneous ventilation/T-piece, pressure support [PS], and continuous positive airway pressure [CPAP]). Right ventricular hemodynamic responses were evaluated with a thermodilution pulmonary artery catheter; while left ventricular hemodynamic responses were measured by a transducer-tipped Millar catheter and conductance catheter. Two groups of canines were studied. Group 1: normal biventricular function (n = 10) and group 2: propranolol-induced biventricular failure (n = 10). Dependent variables were measured at baseline on controlled mechanical ventilation (MV) and following the initial transition to each of 3 randomized spontaneous ventilatory conditions: T-piece, PS 5 cmH2O, and CPAP 5 cmH2O. Both groups significantly increased cardiac output in response to T-piece. Right ventricular stroke work was also significantly increased with T-piece and CPAP in both groups of subjects. Left ventricular response depended on baseline ventricular function. Baseline ventricular function influenced hemodynamic response to the immediate transition from mechanical to spontaneous ventilation. There were also differential hemodynamic responses based on the ventilatory mode. Consideration of baseline cardiac function may be an important factor in the selection of an appropriate mode of spontaneous ventilation following controlled MV.
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PMID:A comparison of hemodynamic changes during the transition from mechanical ventilation to T-piece, pressure support, and continuous positive airway pressure in canines. 1123 4

The CardioWest TAH was created and initially tested at the same time as the Thoratec, Novacor, and HeartMate devices. It was designed as a permanent artificial heart and was the first-ever mechanical circulatory device to be used as destination therapy. Twenty years have passed since that early experience. Pneumatic technology is still current and being developed as in existing or new implantable Thoratec VADs the pneumatic HeartMate, and the Abiomed BVS 5000 pumps. Portable pneumatic drivers have been available since 1982, and in recent times have allowed discharge to home of substantial numbers of patients, thus reducing the length of hospital stays and making mechanical device support less expensive to society and more tolerable to patients. Within months, a portable driver for the CardioWest will be available. The documented benefits of the CardioWest TAH include rescue of: critically ill patients with advanced heart failure; patients with biventricular failure especially those with significant right heart failure, elevated pulmonary vascular resistance, or pulmonary edema; patients with renal or hepatic failure secondary to low cardiac output; patients with massive myocardial damage such as those with post-\infarction VSD or irreversible cardiac graft rejection; patients with mechanical valves or native valve disease; and patients with intractable arrhythmias and heart failure. High device outputs with restoration of normal filling pressures result in high perfusion pressures that have led to dramatic recoveries, convalescence, and return to levels of activity compatible with normal life. The average device output with the CardioWest TAH is higher than any other approved or investigational device. The reason for this resides in design simplicity this device has the shortest and largest inflow pathway. Stroke, in the authors' own series, is rare with a linearized rate of 0.068 events per patient year. If the experiences of La Pitie and the University of Arizona are combined, there has been one stroke in 25 patient years (0.04 events/patient year). Serious infections have been rare (12% of patients). No clinical mediastinitis has occurred. Drivelines have healed in tightly and never caused an "ascending" infection. There has not been a case of device endocarditis. Using a broad definition of bleeding, including takeback reoperation for bleeding, bleeding more than 8 units in the first postoperative 24 hours or 5 units over any other 48-hour period, a 25% to 36% incidence has been documented. No cases of fatal exsanguination have resulted, as there have been with the HeartMate. The incidence of bleeding as an adverse event is about 17% lower than the rate reported for the HeartMate VE LVAD, and it is about the same as that reported for Novacor and for Thoratec. Implantation of this device is relatively easy and often done (with attending help) by the authors' residents. If one follows the guidelines for fitting the device, and takes the recommended advice for implantation, hemostasis is excellent and restoration of immediate cardiac function with high flows is nearly automatic. Use of a neopericardium of 0.1 mm EPTFE at the time of implantation assures atraumatic and relatively quick re-entry for transplantation and prevents the normal inflammatory mediastinal reaction that might be desirable in a destination application. In selected patients the CardioWest TAH is the device of choice for bridge to transplantation. When a portable driver becomes available, out of hospital management of CardioWest TAH patients will be feasible and consideration of use of this device for longer term applications, (e.g., "destination therapy,") will be reasonable. A wearable driver, even smaller than a portable, will improve quality of life and expand the patient population that may be therapeutically served with this system. In short, the CardioWest TAH has come nearly full circle. It was first used as a destination device. It has since been used as a bridge to transplantation in nearly 200 patients as the Jarvik-7/Symbion TAH and, since 1993, in over 225 patients as CardioWest. The results have improved with time. Thromboembolism and infection rates have been competitive with currently available devices. Device reliability and durability have been excellent. Survival rates have been very high in a group of perhaps the sickest patients to be supported with any pulsatile device. Pneumatic technology has improved with portability and miniaturization, and there is reason to believe that it will become even better. Application of modern manufacturing techniques to this very simple device raises the possibility of significant manufacturing cost reduction, in an era of prohibitive cost for other devices. All of this establishes the CardioWest as a valuable device for any program that is seriously interested in end-stage heart disease and a likely device for permanent use in appropriately selected patients.
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PMID:Total artificial hearts: bridge to transplantation. 1279 49

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.
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PMID:The AbioCor implantable replacement heart. 1282 Jul 41

Children with heart failure unresponsive to medical therapy are left with few options for survival. Pulsatile paracorporeal ventricular assist devices are life-saving options for such patients, allowing for bridge to transplantation or cardiac recovery. From March 1997 to July 2004, 12 patients underwent implantation of Thoratec biventricular assist devices (BVADs) for refractory heart failure. Mean age was 14.9 (range 7-20) and mean BSA was 1.7 (range 1.1-1.9). Indications for support included end-stage cardiomyopathy (n=10), myocarditis (n=1), and postcardiotomy heart failure (n=1). Preimplant variables included 50% of patients requiring mechanical ventilation (mean 4.2 days), hyperbilirubinemia in 58%, and acute renal failure in 50%. Mean duration of support was 64.5 (range 2-175) days. Overall survival was 83%, with nine patients successfully bridged to transplantation (75%). One patient exhibited recovery allowing for device explantation, and two patients died while on BVADs. Complications included bleeding requiring reoperation in 25% (n=3), stroke in 8% (n=1), driveline infections in 17% (n=2), and device malfunction in one patient. Pulsatile paracorporeal BVADs can be used successfully in children and adolescents with heart failure. These results warrant consideration of using available miniaturized technology in the United States for the support of smaller children with intractable biventricular failure.
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PMID:Pulsatile paracorporeal assist devices in children and adolescents with biventricular failure. 1632 2


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