Pediatric assist with the Medos and Excor systems in small children.

Pediatric long-term ventricular support with paracorporeal assist devices is performed in only a few institutions. We report on our experience with two pediatric paracorporeal devices, which have been implanted in neonates, infants, and small children. Seven children with ages ranging from 2 weeks to 6 years and a body weight of 3 to 19 kg were provided with either a Medos or a BerlinHeart System. The underlying heart diseases included dilative cardiomyopathy (n = 3), endocardial fibroelastosis (n = 2), Ebstein anomaly, and status post redo aortic valve replacement (n = 1). All children were in New York Heart Association class IV and were inotrope dependent. Three children were provided with a Medos system and 4 children with a BerlinHeart Excor device. In 6 cases, left ventricular support, and in 1 case, right ventricular support was performed. All patients were stabilized with univentricular mechanical support. The perioperative course was uneventful, and end-organ function was well recovered. Reexploration for bleeding and evacuation of mediastinal blood clots was necessary in all three neonates but not in any of the older infants. Severe thromboembolic events were only noticed in the neonates. Successful bridge to transplantation was performed in 6 of the 7 patients (87.5%). Our late results have been quite encouraging, as they readily prove that pediatric long-term mechanical support is possible with a high quality of life and an acceptable low complication rate.

First clinical experience with the Incor left ventricular assist device.

BACKGROUND: The Incor (Berlin Heart AG, Germany) is a small (200 g), implantable, magnetically accentuated axial flow pump (non-pulsatile flow) designed to support the left ventricle for extended periods of time. We report on the first single-center clinical experience with this device. METHODS: The Incor was studied in 15 consecutive patients (10 men, 5 women), 24 to 59 years of age. Underlying heart disease was end-stage ischemic heart disease (n = 5), acute myocardial infarction (n = 4), dilated cardiomyopathy (n = 3), acute myocarditis (n = 2) and Chagas disease (n = 1). All patients were in New York Heart Association (NYHA) Class IV heart failure. Four patients had prior open heart surgery. Implantation via cannulation of the left ventricular apex and the ascending aorta was elective in 6 patients and on an emergency basis in 9. RESULTS: No early bleeding complications were seen, but late bleeding occurred in 4 patients. Minor cerebral thromboembolic events with transient neurologic symptoms occurred in 3 patients; severe stroke had to be treated in 1 patient. Systemic emboli were seen in 2 patients. Thrombus-related pump dysfunction was suspected in 3 patients, and managed by intensifying anti-coagulation. Five patients were successfully transplanted after a support interval of 90 to 156 days; 1 patient could be weaned from the system after 171 days. Six patients died during support, 9 to 63 days after device implantation. The remaining 3 patients are still under support, with excellent quality of life. CONCLUSIONS: The Incor is a left ventricular assist device (LVAD) with transplant and adverse event rates comparable to those of other modern ventricular support devices. Its advantages include the small pump chamber, the virtual absence of device-related infections, and the extraordinary convenience during implantation and explantation.