Ann Thorac Surg 2006;81:1116-1118
© 2006 The Society of Thoracic Surgeons
Case report
Successful Bridge to Transplant Using the Berlin Heart Left Ventricular Assist Device in a 3-Month-Old Infant
Gansevoort H. Dunnington, Jr, MD,
Justin Sleasman,
Abdulaziz Alkhaldi, MD,
Marc P. Pelletier, MD
*
,
Bruce A. Reitz, MD,
Robert C. Robbins, MD
Department of Cardiothoracic Surgery, Stanford University, Stanford, California
Accepted for publication January 17, 2005.
* Address correspondence to Dr Pelletier, Stanford University, Room 318, 2500 Grant Rd, Mountain View, CA 94040 (Email: marcp{at}stanford.edu).
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Abstract
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The EXCOR Berlin Heart (Berlin Heart, Berlin, Germany) was successfully used as a pediatric left ventricular assist device as a bridge to cardiac transplantation. The pneumatically driven paracorporeal device successfully supported a 7 kg patient for 53 days until a suitable heart was obtained for transplantation.
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Introduction
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Ventricular assist devices (VADs) can be invaluable tools for the management of refractory heart failure. Only recently has the technology evolved for small pediatric patients to benefit from this therapeutic modality.
A 2-week-old infant was admitted to an outside hospital for congestive heart failure, and a diagnosis of idiopathic dilated cardiomyopathy was established. He rapidly had cardiogenic shock develop, requiring support with extracorporeal membrane oxygenation. After 9 days of extracorporeal membrane oxygenation support, the patient improved and was discharged home on a comprehensive heart failure medical regimen, including an angiotensin converting enzyme inhibitor, digoxin, and diuretics. Being unable to tolerate oral feedings, the patient's nutrition was maintained with continuous nasojejunal feeding. He was seen in consultation at our institution for further evaluation and consideration of cardiac transplantation. Clinically the patient remained relatively asymptomatic; however his echocardiogram revealed poor ventricular function, global left ventricular dilatation, an ejection fraction of 25%, and a fractional shortening of 9%, consistent with a diagnosis of a dilated idiopathic cardiomyopathy.
While awaiting transplant listing, the patient was admitted to our center at 2 months of age after planned surgical gastrostomy tube placement at an outside hospital, which led to respiratory failure. He became hypercapneic and lethargic, leading to intubation and mechanical ventilation. Inotropic support was also required with dopamine and milrinone to assist his failing heart. After more than 2 weeks of unsuccessful attempts to wean the inotropes, he was placed on the cardiac transplant list.
After 1 month in the hospital and after several bouts of ventricular tachycardia, a decision was made to proceed with left VAD support. At 3 months of age, the patient received a 10 mL stroke volume Berlin Heart left VAD. The use and implantation of the paracorporeal pneumatic pump was approved by the Food and Drug Aministration on terms of "Compassionate Use." The device was implanted by a previously described technique [1], with the inflow cannula placed in the left ventricular apex and the outflow cannula inserted into the ascending aorta. The procedure required 77 minutes of cardiopulmonary bypass time without cardioplegic arrest. With a body surface area of 0.32 m2, the left VAD was set and maintained at an output of 100 strokes per minute. The patient's renal function remained well preserved with a blood urea nitrogen of 24 mg/dL and a creatinine of 0.40 mg/dL. Six days after implantation of the device, the patient required drainage of a pericardial effusion. The patient's coagulation parameters were closely monitored and his activated clotting time was kept between 160 to 200 seconds, maintained by a heparin drip. In addition, the patient was maintained on aspirin 40 mg/day. Despite some ongoing bleeding, on postoperative day 9, a small clot was noted in the left VAD chamber at the outflow valve commissures. Within 3 days of this observation, the patient lost most movement in his left arm. A head computed tomographic scan did not reveal ischemic changes or active bleeding; however, the thrombus within the device did appear smaller than previously observed. After several hours, the symptoms resolved and the patient was able to freely move his left arm. An electroencephalogram was normal without seizure activity. Cranial ultrasounds were performed every other day until transplantation to monitor for intracranial bleeding. Three weeks after surgery, the patient had a fever and mottling develop, along with positive blood cultures for Enterococcus faecalis and Staphylococcus aureus. The appropriate antibiotics were started with resolution of the physical findings. On postoperative day 21 the patient was successfully extubated. A fixed gaze was noted on postoperative day 22, which led to a repeat head computed tomography. Again the computed tomographic scan was negative for hemorrhagic or ischemic infarct, and subsequently the symptoms resolved. These continuous neurologic issues led to the addition of Clopidogrel (Bristol-Myers Squibb, New York, NY) to the anticoagulation regimen. There were no further neurological events with this anticoagulation regimen.
After 53 days of left VAD support, a donor heart became available and was implanted. Pathologic examination of the native heart was consistent with dilated cardiomyopathy and endocardial fibrosis. The patient was weaned from inotropes by postoperative day 3. A postoperative echocardiogram demonstrated normal biventricular function with a fractional shortening of 39%. The patient was ultimately discharged on posttransplant day 13 in excellent clinical condition.
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Comment
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Until recently, the options for supporting small pediatric patients with heart failure have been very limited, especially in the United States. The introduction of the Berlin Heart VAD adds a valuable tool to the armamentarium of cardiac surgery. Although it has been used in Europe for several years, the experience in North America has been extremely limited. This case represents the smallest child in the United States to be bridged to transplantation by a Berlin Heart.
The Berlin Heart is a paracorporeal pneumatically driven blood pump, consisting of inflow and outflow cannulae connected to a pump with blood and air chambers separated by a polyurethane membrane. Three-leaflet polyurethane valves prevent blood reflux, and all blood-contacting surfaces are coated with heparin (Carmeda, Texas). The pump is driven by an electropneumatic mechanism controlled by a drive unit called the IKUS 2000 (Berlin Heart, Berlin, Germany). The pump is currently available in several stroke volumes, including 10, 25, 30, 50, 60, and 80 mL.
Stiller and colleagues [2] have reported their results with the Berlin Heart and have had good success in bridging to both recovery and to transplant. Of the 18 patients who were bridged to transplant by Berlin Heart VADs, there were only 4 early deaths and 2 late deaths, which compared similarly with those patients who received either elective or emergency heart transplants. The Berlin Heart is a pulsatile VAD that can support all sizes of pediatric patients, unlike currently available pulsatile VADs in the United States.
As the Berlin Heart is a paracorporeal device, it does not yet act as a portable support system. Nevertheless, the patient was not only able to be extubated and well maintained on this VAD (Fig 1), but he was also physically active prior to transplantation. His organ systems were well preserved, and he was in excellent homeostasis when a donor heart became available for transplantation.
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Fig 1. Extubated patient with Berlin Heart ventricular assist device in place (printed with permission by family).
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One difficult aspect of this case was the occurrence of two transient ischemic attacks that resulted in temporary left hemiparesis on one occasion and a fixed gaze on another. As the head computed tomography scans failed to reveal any apparent infarct or bleed, and the electroencephalogram was negative for seizures, we could only assume these events were secondary to emboli. With the addition of Clopidogrel (Bristol-Myers Squibb) to the anticoagulation regimen, no further events were observed. A similar experience using this agent has been reported [3]. At the time of transplantation, there was some fibrin deposit adherent to the outflow valve of the device (Fig 2). Although it is believed that apical cannulation reduces the incidence of neurologic events associated with pediatric VADs [4], this case is a reminder of the continued risk of this complication despite "adequate" anticoagulation.
Although the Food and Drug Adminstration has not yet fully approved the use of the Berlin Heart in the United States, this case, along with previously published reports from the European experience, demonstrate the efficacy and value of this device in managing end-stage pediatric cardiac failure. Because of this device, this patient is the smallest child to be bridged to transplantation in the United States. The only other option at this time for a child of this size is a nonpulsatile VAD or extracorporeal membrane oxygenation, which might not have been as effective for his long period of time on the cardiac transplant waiting list.
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References
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- Hetzer R, Matthias L, Potapov E, et al. Circulatory support with pneumatic paracorporeal ventricular assist device in infants and children Ann Thorac Surg 1998;66:1498-1505.[Abstract/Free Full Text]
- Stiller B, Hetzer R, Weng Y, et al. Heart transplantation in children after mechanical circulatory support with pulsatile pneumatic assist device J Heart Lung Transpl 2003;22:1201-1208.[Medline]
- Fries D, Innerhofer P, Streif W, et al. Coagulation monitoring and management of anticoagulation during cardiac assist device support Ann Thorac Surg 2003;76:1593-1597.[Abstract/Free Full Text]
- Reinhartz O, Stiller B, Eilers R, Farrar DJ. Current Clinical Status of Pulsatile Pediatric Circulatory Support ASAIO 2002;48:455-459.[Medline]
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The Hemostatic History of a 15-Month-Old Child Implanted with a Berlin Heart Left Ventricular Assist Device
Anesth. Analg.,
March 1, 2007;
104(3):
538 - 540.
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Abstract
Introduction
