A transapical-to-aorta double lumen cannula-based neonate left ventricular assist device efficiently unloads the left ventricle in neonate lambs.

Objective: We are developing a transapical-to-aorta double lumen cannula (TAA DLC) for a less-invasive/more dependable neonatal left ventricular assist device. Methods: The 18-Fr TAA DLC prototypes were bench tested and evaluated for 6 hours in neonate lambs (n = 6, 7.7-10 kg). The cardiac apex was exposed through a left anterolateral thoracotomy through the sixth intercostal space. The TAA DLC was inserted through a mattress stitch on apex, passing LV-aortic valve, into the ascending aorta with insertion/deployment guided by pressure waveform. The DLC was connected to blood pump. Cardiac output and aortic root blood flow were measured with perivascular flow sensors. Activated clotting time was maintained at 180-250 seconds. Results: The DLC pumped up to 1.8 L/min flow against 63 mm Hg drainage pressure and 145 mm Hg infusion pressure in bench testing. In all lambs, the DLC was inserted/deployed properly within 1 minute on the first attempt. Pumping flow was maintained at 1.2-1.3 L/min. Systolic arterial pressure decreased and diastolic arterial pressure/mean arterial pressure increased, indicating decreased afterload and increased perfusion pressure. Left ventricular end-diastolic pressure decreased from 13 +/- 1 mm Hg to 6 +/- 2 mm Hg, indicating decreased preload. Aortic root backward flow was 2.4% +/- 0.6% without DLC and 3.5% +/- 0.8% of cardiac output with DLC, indicating no significant DLC-induced aortic valve regurgitation. After 6 hours, free hemoglobin was <5 mg/dL with hemoglobin/platelets unchanged. No significant thrombus was found in pumps/DLCs. No trauma was found in LV, aortic valve, and aorta. Conclusions: Our TAA DLC-based neonate left ventricular assist device efficiently unloaded the LV in lambs.