Extracorporeal membrane oxygenation (ECMO) was used in the treatment of 100 newborn infants with respiratory failure in three phases: Phase I (50 moribund patients to determine safety, efficacy, and risks); Phase II (30 high risk patients to compare ECMO to conventional ventilation); and Phase III (20 moderate to high risk patients, the current protocol). Seventy-two patients survived including 54% in Phase I, 90% in Phase II, and 90% in Phase III. The major complication was intracranial bleeding, which occurred in 89% of premature infants (less than 35 weeks) and 15% of full-term infants. Best survival results were in persistent fetal circulation (10, 10 survived), followed by congenital diaphragmatic hernia (9, 7 survived), meconium aspiration (44, 37 survived), respiratory distress syndrome (26, 13 survived), and sepsis (8, 3 survived). There were seven late deaths; in follow-up, 63% are normal or near normal, 17% had moderate to severe central nervous system dysfunction, and 8% had severe pulmonary dysfunction. ECMO is now used in several neonatal centers as the treatment of choice for full-term infants with respiratory failure that is unresponsive to conventional management. The success of this technique establishes prolonged extracorporeal circulation as a definitive means of treatment in reversible vital organ failure.

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A polymethylpentene (PMP) fiber gas exchange device was evaluated in healthy sheep (35-42 kg) to characterize its performance and potential use in clinical extracorporeal life support (ECLS). Five PMP devices (1.3 m2) were compared with five silicone rubber membrane lung (SRML) devices (1.5 m2) that were supported on venovenous ECLS for 72 hours. The two device groups were compared for differences in gas exchange, device pressure gradient, hematology, blood biochemistry, and pathology. The results showed superiority in the PMP devices in both oxygen and CO2 exchange when compared at similar blood flow rates. Platelet consumption and the device pressure gradient were significantly less when using the PMP device. The device pressure gradient across the PMP devices was < 20 mm Hg as compared with > 150 mm Hg for the SRML devices at all blood flow rates. Changes in plasma hemoglobin levels, leukocyte counts, blood chemistry results, and pathologic findings were not significantly different between the two device groups. Plasma leakage or device failure did not occur in any of the test devices. These data support the use of the PMP device for extended circulatory support. Patients may fare better because of improved preservation of platelets, and the low resistance may allow for wider use of centrifugal-style pumps or the use of the device in a pumpless arteriovenous mode.

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The purpose of this study was to describe the hemolytic effects of both negative pressure and an air-blood interface independently and in combination in an in-vitro static blood model. Samples of fresh ovine or human blood (5 mL) were subjected to a bubbling air interface (0–100 mL/min) or negative pressure (0–600 mmHg) separately, or in combination, for controlled periods of time, and analyzed for hemolysis. Neither negative pressure nor an air interface alone increased hemolysis. However, when air and negative pressure were combined, hemolysis increased as a function of negative pressure, the air interface, and time. Moreover, when blood samples were exposed to air prior to initiating the test, hemolysis was 4–5 times greater than samples not pre-exposed to air. When these experiments were repeated using freshly drawn human blood the same phenomena were observed, but the hemolysis was significantly higher than that observed in sheep blood. In this model, hemolysis is caused by combined air and negative pressure and is unrelated to either factor alone.

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Lower extremity ischemia is common when the femoral artery is used for veno-arterial extracorporeal membrane oxygenation (VA ECMO). We describe a new technique to reperfuse the extremity. The ipsilateral posterior tibial artery is exposed via a small incision behind the medial malleolus. The vessel is cannulated in a retrograde fashion and connected to the arterial limb of the ECMO circuit. Thirty-six patients received a posterior tibial reperfusion cannula: average flow was 155.8 ml/min and increased over the initial 24 hours. Fifty-eight percent received the posterior tibial cannula within 6 hours of ECMO initiation and none sustained permanent lower extremity injury. Of the remaining 42%, three required amputation or developed permanent neurologic injury. Overall survival was 41%. Cannulation of the posterior tibial artery is a simple technique to reperfuse the lower extremity during VA ECMO. The cannula should be inserted within 6 hours of ECMO initiation to avoid irreversible ischemic damage.