Pediatric Ventricular Assist Device Research Articles

Pulsatile Pediatric Ventricular Assist Devices: Current Results for Bridge to Transplantation

While pulsatile ventricular assist devices have gained widespread use in adult patients awaiting heart transplantation, only very limited experience with these devices exists in the pediatric population. In the past mostly non-pulsatile systems such as ECMO have been used to support pediatric patients with heart failure for very limited periods of time. Only recently have miniaturized pulsatile devices became available. This article describes the technical characteristics of these devices which have been implanted at the Deutsches Herzzentrum Berlin since 1992. The Berlin Heart assist device has since been used in 34 children between the ages of 6 days and 16 years. We report our strategy in patient selection, perioperative care and subsequent heart transplantation. The current literature on mechanical circulatory support in children is reviewed. Copyright 1999 by W.B. Saunders Company

Circulatory support with pneumatic paracorporeal ventricular assist device in infants and children

Background. Mechanical circulatory support in intractable heart failure in children has been limited to centrifugal pumps and extracorporeal membrane oxygenation: Since 1990 small adult-size pulsatile air-driven ventricular assist devices “Berlin Heart” (VAD) and, since 1992 miniaturized pediatric VAD (12, 15, 25, 30 mL pumps), have been used in our institution. Since 1994 the blood-contacting surfaces of the device system have been heparin-coated. In this report the experiences with VAD support in 28 children are presented. Methods. In 28 children—ages between 6 days and 16 years—the Berlin Heart VAD has been applied for periods of between 12 hours and 98 days (mean, 16.9 days) aiming at keeping the patient alive and allowing for recovery from shock sequelae until later transplantation or myocardial recovery. There were three groups. Group I: with primary intention of “bridge-to-transplantation” in various forms of cardiomyopathy (n = 13) or chronic stages of congenital heart disease (n = 5). Group II: “Rescue” in intractable heart failure early after corrective surgery for congenital heart disease (n = 4) or in early graft failure after a heart transplantation (n = 1). Group III: “Acute myocarditis” (n = 5) aiming at either myocardial recovery or transplantation. Twelve were brought to the operating room under cardiac massage and 25 had been on the respirator for more than 24 hours. Results. Twelve patients died on the system from sequelae of profound shock—multiorgan failure, sepsis, loss of peripheral circulatory resistance—or from hemorrhagic complications (n = 4) or brain death (n = 1). Thirteen patients (groups I and III) were transplanted after support periods of between 3 and 98 days with 7 long-term survivors living now up to 7.5 years (mean, 4.4 years). Three patients (groups II and III) were weaned from the system with two long-term survivors (both in group III). There were no patients in group II who survived and the “rescue” indication has been discarded for VAD since 1992. Such patients are since treated by extracorporeal membrane oxygenation (ECMO) in our institution. Out of the 8 patients placed on VAD during 1996 and 1997, 7 were successfully supported until transplantation or weaning. Thirteen patients were extubated and mobilized on the system. Whereas with the earlier systems thrombi in the blood pumps were seen in 15 instances and 2 patients suffered from thromboembolic complications, no thrombotic events occurred with the heparin-coated systems. Conclusions. After accumulating clinical experience and several technical improvements since 1990 the use of the pediatric Berlin Heart VAD has matured into a reliable and safe system to keep patients with otherwise intractable heart failure alive until complete myocardial recovery is reached or transplantation becomes feasible. Whereas heart failure early after cardiac operation is now primarily treated by ECMO, acute myocarditis appears to be a promising precondition for complete cardiac recovery during VAD support.

Evaluation of a Pulsatile Pediatric Ventricular Assist Device in an Acute Right Heart Failure Model

The development of pulsatile ventricular assist devices for children has been limited mainly by size constraints. The purpose of this study was to evaluate the MEDOS trileaflet-valved, pulsatile, pediatric right ventricular assist device (stroke volume = 9 mL) in a neonatal lamb model of acute right ventricular failure. Right ventricular failure was induced in ten 3-week-old lambs (8.6 kg) by right ventriculotomy and disruption of the tricuspid valve. Control group 1 (n = 5) had no mechanical support whereas experimental group 2 (n = 5) had right ventricular assist device support for 6 hours. The following hemodynamic parameters were measured in all animals: heart rate and right atrial, pulmonary arterial, left atrial, and systemic arterial pressures. Cardiac output was measured by an electromagnetic flow probe placed on the pulmonary artery. All results are expressed as mean +/- standard deviation and analyzed by Student's t test. A p value less than 0.05 was considered statistically significant. Base-line measurements were not significantly different between groups and included systemic arterial pressure, 80.6 +/- 12.7 mm Hg; right atrial pressure, 4.6 +/- 1.6 mm Hg; mean pulmonary arterial pressure, 15.6 +/- 4.2 mm Hg; left atrial pressure, 4.8 +/- 0.8 mm Hg; and cardiac output, 1.4 +/- 0.2 L/min. Right ventricular injury produced hemodynamics compatible with right ventricular failure in both groups: mean systemic arterial pressure, 38.8 +/- 10.4 mm Hg; right atrial pressure, 16.8 +/- 2.3 mm Hg; left atrial pressure, 1.4 +/- 0.5 mm Hg; and cardiac output, 0.6 +/- 0.1 L/min. All group 1 animals died at a mean of 71.4 +/- 9.4 minutes after the operation. All group 2 animals survived the duration of study. Hemodynamic parameters were recorded at 2, 4, and 6 hours on and off pump, and were significantly improved at all time points: mean systemic arterial pressure, 68.0 +/- 13.0 mm Hg; right atrial pressure, 8.2 +/- 2.3 mm Hg; left atrial pressure, 6.4 +/- 2.1 mm Hg; and cardiac output, 1.0 +/- 0.2 L/min. The results demonstrate the successful creation of a right ventricular failure model and its salvage by a miniaturized, pulsatile right ventricular assist device. The small size of this device makes its use possible even in small neonates.

Pierce-Donachy pediatric VAD: Progress in development

Despite the successful use of ventricular assist devices in adults over the past 15 years, relatively little has been done to develop similar devices for pediatric patients. Consequently, no such device is currently available. A review of clinical data suggests that the majority of patients in need of a pediatric ventricular assist device, either for postcardiotomy cardiogenic shock or as a bridge to cardiac transplantation, are neonates weighing 3 to 5 kg. Attempts to "scale down" an adult blood pump to make an appropriate device for these patients have been difficult due to the lack of sufficiently small, commercially available valves and the tendency for thrombus to develop in these small pumps. We report on progress in the development of the Pierce-Donachy pediatric ventricular assist device, which incorporates 10-mm-diameter bileaflet valve prototypes. Particle image velocimetry is used to quantify the velocity field inside the pump. Particle image velocimetry velocity maps demonstrate the complexity of the flow patterns in these pumps and suggest that improved flow patterns may result from the use of valves with improved hemodynamic performance. Animal tests to determine whether improved flow patterns and better "washing" of the pump's blood-contacting surfaces will reduce thrombus formation are underway.

A Pediatric Ventricular Assist Device: Its Development and Experimental Evaluation of Hemodynamic Effects on Postoperative Heart Failure of Congenital Heart Diseases

To evaluate the effectiveness of a pediatric ventricular assist device (VAD), hemodynamic effects of the VAD were investigated experimentally in two types of postoperative profound heart failure models of congenital heart disease. In the model I Fontan or modified Fontan operation model, right ventricular pump function was excluded surgically and a shunt between the right atrium and the pulmonary artery was constructed in four dogs. With a VAD between the left atrium and the aorta, pressure gradient across the lung and the cardiac output increased. Right ventricular failure was induced surgically and high pulmonary vascular resistance was made by injection of glass beads in five dogs in model II. Cardiac output increased and the right atrial pressure decreased when a VAD between the right atrium and the pulmonary arterial trunk was activated. In conclusion, the VAD will become a promising modality to manage pediatric profound heart failure cases.

Experimental evaluation and clinical application of a pediatric ventricular assist device.

A pneumatic pediatric ventricular assist device (VAD) with a stroke volume of 20 ml has been developed to treat post-operative heart failure (HF), and maintain transplant candidates. The polyurethane VAD has two #21 Bjork-Shiley valves and the internal diameter of the cannula is either 6 or 8 mm. Hemodynamic effects of a left ventricular assist device (LVAD) on a HF after Fontan's procedure model, and those of a right ventricular assist device (RVAD) on right HF with pulmonary hypertension model, were investigated in acute experiments with four and five dogs, respectively. In the former, the pressure gradient across the lung and cardiac output (CO) increased with an LVAD; right atrial pressure decreased and CO increased with an RVAD in the latter. The pump was implanted as an LVAD in 8 young goats, 9-22 kg in weight, for 4-10 weeks and favorable in vivo performance was demonstrated. The VAD system was applied as an LVAD to two postcardiotomy patients, a 12 kg boy with a ventricular septal defect, and a 13 kg boy with an endocardial cushion defect. In these cases, CO was well maintained at the level of 2.5-4.1 L/min/m2 for three and seven days, respectively, and the pump was removed. In conclusion, this VAD will become a promising circulatory support system for pediatric uses.

Experimental Evaluation and Clinical Application of a Pediatric Ventricular Assist Device

Experimental Evaluation and Clinical Application of a Pediatric Ventricular Assist Device