Synthetic membrane neo-pericardium facilitates total artificial heart explantation.

BACKGROUND: In the past, explantation of the Cardio West total artificial heart (TAH) has been technically challenging because of the presence of dense adhesions and extremely thickened pericardium. To prevent this, we constructed a synthetic neo-pericardium in 14 patients. METHODS: Using expanded polytetrafluoroethylene (e-PTFE) membrane, we constructed a pericardium within the pericardium, or "neo-pericardium," completely covering the Cardio West TAH separating the native atria from the native pericardium, and wrapping the ascending aorta from the outflow conduit distally for about 5 to 7 cm. RESULTS: Of the 14 patients, 9 were transplanted and could be evaluated, 3 died on device support, and 2 are currently on device support. In each case, we attained faster (by 25 minutes) and easier reentry through the sternum. Surgical planes around the aorta, over the right and left atria, and throughout the pericardial space became apparent immediately after e-PTFE membrane removal. The pericardium and related tissues although slightly thickened (<2 mm) were pliable compared with our previous 36 patients, with very thick adherent pericardium over the device and native atria. CONCLUSIONS: The plastic materials forming the ventricular housing and drivelines of the Cardio West TAH and the Dacron outflow conduits have in the past caused profound local inflammatory reactions, resulting in extremely dense adhesions and thickened adherent pericardium. Using e-PTFE membrane to fashion a complete neo-pericardium and to wrap the ascending aorta at the time of Cardio West implantation dramatically reduces adhesions and pericardial thickening and facilitates explantation.

Pentoxifylline reduces coronary leukocyte accumulation early in reperfusion after cold ischemia.

BACKGROUND: Ischemia/reperfusion injury can complicate recovery in cardiac operations. Ischemia induces endothelial dysfunction, which may contribute to leukocyte accumulation during reperfusion. Leukocyte-mediated injury may then occur. Using intravital microscopy we previously reported increased leukocyte retention in coronary capillaries and venules during early reperfusion during warm ischemia/reperfusion. In this study we investigated whether cold cardioplegic protection would limit leukocyte sequestration in coronary microvessels early in reperfusion. Pentoxifylline (PTX) has antiinflammatory effects and may limit endothelial dysfunction during ischemia/reperfusion. The effect of cardioplegia modification with PTX was also examined. METHODS: Isolated rat hearts were subjected to 90 minutes of 4 degrees C ischemia after arrest with cardioplegia. Hearts were reperfused with diluted whole blood containing fluorescent-labeled leukocytes. Leukocyte retention in coronary microvessels was observed with intravital microscopy. Three groups were studied, nonischemic control, cold ischemia, and PTX-modified cold ischemia. RESULTS: In coronary capillaries, leukocyte trapping was nearly doubled in unmodified cold ischemia versus control. PTX modification significantly reduced leukocyte accumulation. In coronary venules, greater leukocyte adhesion was observed in unmodified cold ischemia compared to nonischemic controls. PTX modification significantly reduced leukocyte adhesion. CONCLUSIONS: Cold cardioplegia did not prevent leukocyte retention in the coronary microcirculation early in reperfusion. PTX modification of cardioplegia significantly reduced leukocyte sequestration in coronary capillaries and venules. Preserving endothelial function during ischemia may limit leukocyte accumulation and ischemia/reperfusion injury after cardiac operation.

Multicenter experience with the thoratec ventricular assist device in children and adolescents.

BACKGROUND: Patient size is 1 determinant in selecting a mechanical circulatory support device. The current pulsatile ventricular assist devices (VADs) were designed primarily for average-sized adults. The flexibility of the Thoratec VAD, however, has encouraged physicians to use it in a significant number of intermediate-sized older children and adolescents. METHODS: We conducted a retrospective study in 58 children and adolescents <18 years (41 boys, 17 girls) who had been supported with the Thoratec VAD in 27 centers worldwide as of December 1999. Mean patient age was 13.8 years (range, 7 to 17 years), and mean patient weight and body surface area were 51.6 kg (range, 17 to 93 kg) and 1.5 m(2) (range, 0.7 to 2.1 m(2)), respectively. RESULTS: Thirty-five patients (60%) survived to transplantation and 6 (10%) to recovery of the native heart, respectively; 38 were discharged from the hospital (66%). In the transplanted group, post-transplantation survival was 97%. Patient age and size were not associated with significantly increased risk for death or adverse events. Fifteen patients (27%) had 18 neurologic events during support, and 6 of these were fatal. Left atrial cannulation proved a risk factor for neurologic complications. CONCLUSIONS: The Thoratec VAD has successfully been used in a large number of children and adolescents with similar morbidity and mortality results as with adults. The risk of neurologic complications may be increased, particularly in patients cannulated in the left atria.

Bridge to transplantation with a Thoratec left ventricular assist device in a 17-kg child.

A Thoratec left ventricular assist device (LVAD) was used to support a 7-year-old 17-kg boy with viral cardiomyopathy for 23 days before heart transplantation. The boy is still living more than 1 year posttransplant, and functional except for some spastic paresis of the left hand, a residual from a stroke during device support. He is the smallest person to be supported with this device. We discuss techniques for using the Thoratec in children.

Comparison of the CardioWest total artificial heart, the novacor left ventricular assist system and the thoratec ventricular assist system in bridge to transplantation.

BACKGROUND: Device selection has historically been supported by minimal comparative data. Since 1994, we have implanted 43 patients with the CardioWest Total Artificial Heart (CW), 23 with the Novacor Left Ventricular Assist System (N), and 26 with the Thoratec Ventricular Assist System (T). This experience provides a basis for our device selection criteria. METHODS: We reviewed retrospectively the results for survival, stroke, and infection in the CW, N, and T groups. Statistical methods included the Student's t-test, chi2 analysis, and Kaplan-Meier actuarial survival curves. RESULTS: The T group patients were younger and smaller sized than the CW or N group. The CW group had the highest mean central venous pressure (CVP) and lowest mean cardiac index. Survival to transplantation was 75% for CW, 57% for N, and 38% for T. Multiple organ failure postimplant caused most deaths in the CW and T groups. Right heart failure and stroke caused most N deaths. Linearized stroke rates (event/patient-month) were 0.03 for CW, 0.28 for N, and 0.08 for T. Serious infections were found in 20% of CW, 30% of N, and 8% of T patients, but linearized rates showed little difference and death from infection was rare. CONCLUSIONS: The N device should be used in "stable" patients with body surface area (BSA) greater than 1.7 m2 and with minimal right heart failure. Unstable patients with biventricular failure should receive a CW if the BSA is greater than 1.7 m2 or a T if they are smaller.

University of Arizona, Cardiac Transplantation: changing patterns in selection and outcomes.

Among 391 patients who received heart transplants at the University of Arizona since 1990, the percentage of bridge-to-transplant device patients receiving donor hearts has increased from 6.7% to 50%. Survival after transplantation in this-bridge-to transplant group and has been consistently 10-15% lower than patients who do not require a device. The result has been that our overall survival rate is beginning to fall. We have come to 2 major conclusions based on these results: First, the current UNOS system ranking candidates as Status 1A, 1B, and 2 may not identify those who are at higher risk for transplantation. It has failed to do so in our program. Rather, by grouping the potential recipients into patients with a device, Status 1 nondevice patients, and Status 2 patients, we have found a significantly lower survival rate after transplantation in the device group. This suggests that the problems shared by device patients such as being anticoagulated, having a difficult reoperation at the time of transplantation, and having increased inflammation and decreased immunity clearly place these patients in a very different risk group than other potential recipients. Second, these results lead us to believe that some high-risk device patients may not be suitable for transplantation and might be better if treated with devices as alternatives to transplantation.

The CardioWest total artificial heart as a bridge to transplantation.

The CardioWest total artificial heart (TAH), formerly known as the Jarvik-7 and then the Symbion heart, is the only TAH in current clinical use. A new study, approved by the Food and Drug Administration (FDA), was initiated in 1993 with the goal of approving this pump for commercial release. Since then, 145 CardioWest TAHs have been implanted, including 37 pumps in 36 patients at our center. Our 36 patients were studied prospectively according to the investigational device exemption protocol approved by the FDA. Clinical and hemodynamic data obtained upon patients' entry into the study identified this group as mortally ill. After receiving a CardioWest TAH, 29 of the 36 patients (81%) survived to heart transplantation, and 26 (72% of the total group and 90% of the transplant recipients) have survived for up to 7 years (average, 24 months). Multicomponent anticoagulation, based on readily available tests, and the intrinsic properties of the TAH have resulted in a low linearized stroke rate of 0.48 event per patient-year. There have been no device-related mediastinal infections. In dying patients with nonexistent or severely compromised biventricular function, the CardioWest TAH has proved safe and effective, allowing a 72% survival rate for an average of 24 months.

Diabetes enhances leukocyte accumulation in the coronary microcirculation early in reperfusion following ischemia.

BACKGROUND: Diabetic hearts are particularly vulnerable to ischemia-reperfusion injury. For leukocytes to participate in ischemia-reperfusion injury, they must first sequester in the microcirculation. The aim of this study was to determine, by direct observation, if early leukocyte deposition was increased in the diabetic coronary microcirculation early in reperfusion following myocardial ischemia. METHODS: Non-diabetic and streptozotocin (STZ)-induced diabetic rat hearts, subjected to 30 min of 37 degrees C, no-flow ischemia, were initially reperfused with blood containing labeled leukocytes. The deposition of fluorescent leukocytes in coronary capillaries and venules was directly visualized and recorded using intravital fluorescence microscopy. In addition, flow cytometry was used to measure CD11b adhesion molecule expression on polymorphonuclear (PMN) leukocytes from non-diabetic and STZ-diabetic rats. RESULTS: In the non-diabetic, control hearts, early in reperfusion, leukocytes trapped in coronary capillaries and adhered to the walls of post-capillary venules. In the diabetic hearts, leukocyte trapping in capillaries and adhesion to venules were both significantly increased (P<0.05). PMN CD11b expression was also significantly increased in the diabetic blood compared to the non-diabetic blood (P<0.05). CONCLUSIONS: Early in reperfusion following myocardial ischemia, leukocytes rapidly accumulate in greater numbers in the coronary microcirculation of the diabetic heart by both trapping in coronary capillaries and by adhering to venules. The enhanced retention of leukocytes in the diabetic coronary microcirculation increases the likelihood of inflammation-mediated reperfusion injury and may explain, in part, the poor recovery of diabetic hearts from an ischemic event.

Blood loss and transfusion requirements in patients implanted with a mechanical circulatory support device undergoing cardiac transplantation.

Patients implanted with mechanical circulatory support devices (MCSD's) are at high risk for post-operative bleeding at cardiac transplantation. However, the magnitude of the risk and transfusion requirements for MCSD patients at the time of transplantation have not been previously reported. The purpose of this study was to characterize and compare the bleeding characteristics and transfusion requirements of 3 sub-groups of cardiac transplant patients: primary (n = 45), redo (n = 26), and MCSD (n = 23) patients.

Implantation technique for the CardioWest total artificial heart.

The CardioWest total artificial heart is a pneumatically driven device that totally replaces the failing ventricles. It is currently undergoing clinical investigation as a bridge to heart transplantation in several centers throughout the world. A bilateral ventriculectomy is performed and the device is implanted. Blood flows are usually maintained at 6-8 L/min. Approximately 130 patients have undergone bridge to transplant with this device. Patient selection and excellent surgical technique are required for a successful outcome. A detailed description of the implantation technique is presented to facilitate the use of this technology.

Arizona experience with CardioWest Total Artificial Heart bridge to transplantation.

BACKGROUND: We hypothesized that bridge to transplantation with the CardioWest Total Artificial Heart would succeed in a large percentage of patients. Further, we hypothesized that this success rate would not be significantly decreased by infection or thromboembolism. METHODS: From 1993 to March 1999, 24 patients received implants with the intention of bridge to transplantation. Data were collected prospectively. Heparin, coumadin, aspirin, ticlopidine, dipyridamole, and pentoxifylline were used for anticoagulation. RESULTS: Four patients died while on device support. Nineteen of 23 patients (83%) were transplanted. All 19 survived long term. One patient remains on CardioWest Total Artificial Heart support 6 weeks after implant. There was one stroke on the day of transplantation. There was a second stroke on the day of implantation. Neither stroke caused significant residual deficits. Both were in close relationship to an operative procedure. There were no serious device-related infections. CONCLUSIONS: The CardioWest Total Artificial Heart salvaged 20 of 24 critically ill patients. Neither infections nor neurologic problems were significant. We believe it is the device of choice for decompensating patients with biventricular failure who have adequate body and heart size.

CardioWest total artificial heart: a retrospective controlled study.

The CardioWest total artificial heart (TAH) is a pneumatic device that is used as a bridge to heart transplantation and the only TAH available that totally replaces the failing ventricles. It has been utilized in selected centers in the U.S.A. with approval from the Food and Drug Administration. Strict criteria have been developed to select candidates to be bridged with the TAH. The patient must be a heart transplant candidate of age >18 and <59 years with a body surface area (BSA) > or = 1.7 m2, cardiac index (CI) <2.0 L/min/m2, and 2 inotropic agents or 1 plus an intraaortic balloon pump (IABP). A total of 24 heat transplant candidates (Group A) met the entry criteria and underwent placement of the TAH between January 1993 and July 1996. Group A consisted of 23 males; 16 patients had an IABP. The control group (Group B) consisted of 18 heart transplant candidates who met the TAH entry criteria but never received a TAH. Group B consisted of 15 males; 14 patients had an IABP. Preimplantation pulmonary vascular resistance (PVR) (Wood units), serum creatinine (mg/dl), and total bilirubin (mg/dl) were determined in both groups. The mean values for Groups A and B were, respectively, age: 47 and 47 years, BSA: 2.01 and 1.93 m2, CI: 1.5 and 1.8 L/min/m2, PVR: 2.88 and 2.47 Wood units, creatinine: 1.5 and 1.6 mg/dl, and bilirubin: 1.8 and 1.4 mg/dl. In Group A, 1 patient died on the TAH, 1 patient died after transplant, and 22 patients reached transplant and were discharged home for a survival rate of 91.7%. In Group B, 10 patients died while waiting for a heart transplant. Of the 8 patients transplanted, 7 survived and were discharged home for a survival rate of 38.9% (p = 0.0003). In summary the CardioWest TAH provided an excellent and successful method of bridging patients to heart transplantation with a reasonable risk.

Plasmapheresis during cardiopulmonary bypass: a proposed treatment for presensitized cardiac transplantation patients.

Potential thoracic organ transplantation recipients who have positive cytotoxic antibody screens as quantified panel reactive antibodies (PRA) are at risk for immediate or long-term immunologic events that may affect the donor organ. The patient population at risk includes those who are supported with cardiac assist devices, multiparous women, and individuals receiving numerous homologous blood products. We treated three highly positive PRA patients with intraoperative plasmapheresis coupled to the cardiopulmonary bypass system to remove sufficient cytotoxic antibody. Upon the availability of donor hearts of an unknown HLA type, intraoperative plasmapheresis was performed using a Cobe Spectra Plasmapheresis system coupled to a Terumo CXSX18 oxygenator system. Three plasma volume exchanges of fresh frozen plasma (FFP) were performed while the patients were on cardiopulmonary bypass. One to one and one-half plasma volume exchange plasmaphereses were performed with a declining schedule for the next 30 days post-transplantation in combination with aggressive B-cell specific immunosuppressive therapy. The three patients are NYHA functional class I and free of rejection at 6 months post-transplantation. In conclusion, intraoperative plasmapheresis is effective and safe for the patient who would not be otherwise transplanted because of markedly elevated PRAs.