Pulsatile ECM4 and VAD:: A dual use of a new device in pediatric cardiac patients

The purpose of this investigation was to present the first European clinical experience with the new MEDOS DELTASTREAM(R) DP1 used in pulsatile extracorporeal membrane oxygenation (ECMO) or ventricular assist device (VAD) options in the pediatric population. Between January 2002 and April 2006, 11 patients required ECMO and 5 patients received a left VAD (LVAD) in the San Vincenzo Hospital. Indications were postcardiotomy heart failure in 15 patients and fulminant myocarditis in one patient. ECMO was established in all patients by cannulation of the right atrium and ascending aorta. LVAD was instituted by cannulation of the left atrium and ascending aorta. The DP1, an extracorporeal rotary blood pump, was used as an ECMO and an LVAD device. The pump features a diagonal-flow impeller and can be used for both continuous and pulsatile modes of perfusion. Priming volume of the pump was approximately 30 ml, with a flow rate of up to 8 l/min. Ten patients were discharged from ECMO and four from VAD. In the ECMO group, one patient died of peritonitis while on ECMO and two patients died on days 3 and 4 after weaning because of persistent pulmonary hypertension and major neurologic complications. In the VAD group, one patient died of low output syndrome 9 days after weaning. A 12-year-old patient was successfully given transplantation on day 8 of ECMO support and discharged on day 30 after heart transplant. All other patients were discharged. Three pumps were changed for pump failure and one pump was electively replaced because of improper anticoagulation management. No other thromboembolic adverse events occurred. Our results suggest that the MEDOS DELTASTREAM DP1 pulsatile pump system can be used as an ECMO or a VAD support. The opportunity to utilize pulsatile flow in postcardiotomy cardiogenic shock significantly improved the outcomes by producing more physiologic hemodynamics and superior end organ function. Easy implantation and simple management of this device represents the major advantage.