Pulsatile ECMO in Neonates and Infants: First European Clinical Experience with a New Device

Objective: This study presents the first European clinical experience with the Medos DeltaStream DP1, a new pulsatile flow pump, in neonates and infants.

Methods: Between January 2002 and December 2004, 420 patients at our institution underwent congenital heart surgery on cardiopulmonary bypass. During this period, 10 patients required extracorporeal membrane oxygenation (ECMO) support for acute postcardiotomy heart failure. Seven patients (median age 7 days, range 1-70 days), were supported by a nonpulsatile Biomedicus centrifugal pump, whereas three patients (aged 1 month, 1 year, and 12 years) were supported by a pulsatile Medos DP1. The DP1 is an extracorporeal rotary blood pump. The pump features a diagonal-flow impeller, and can be used for both continuous and pulsatile output. Special characteristics include a small priming volume of approximately 30 ml and a high pumping capacity. A temperature sensor and speed sensors are integrated in the pump. The pump has a delivery rate of up to 8 l/min and a speed range of 100-10,000.

Results: Overall mortality was 40% (4 of 10 patients), and all four deaths were in the nonpulsatile Biomedicus group. In the nonpulsatile group, the median support duration was 95 hours with a range of 48-140 hours. Two patients assisted with the pulsatile pump system were successfully weaned after 36 and 53 hours, respectively; the 12-year-old patient was successfully transplanted on the eighth postimplant day and discharged from the hospital on the 32nd posttransplant day. Although this preliminary experience doesn’t allow for statistical analysis, clinically it was possible to observe a better performance in pulsatile flow recipients with faster lactate recovery, reduced need for inotropic support, reduced assistance duration in bridge-to-recovery settings, and smoother intensive care management.

Conclusion: ECMO for postcardiotomy heart failure in neonates and infants still carries high mortality and morbidity rates. Pulsatile flow with the Medos DeltaStream DP1 pump system improves results by producing more physiologic hemodynamics, reducing the duration of support in the case of bridge to recovery, and improving end-organ function.