Pre-Clinical Evaluation of a Novel, Pneumatic, Ventricular Assist Device (Medos® HIA-VAD®) under Pathophysiological Conditions

Abstract

To evaluate a new cardiac assist system, the Medos HIA-VAD, we studied the effects of mechanical unloading on regional and global myocardial dysfunction. As a model for the regional temporary contractile dysfunction we chose an anesthetized, open chest preparation in sheep. We occluded the diagonal coronary artery for 15 minutes and reperfused for 90 minutes. Hemodynamic parameters and wall thickening were monitored. Unloading with the 60-ml Medos HIA-VAD was performed either during ischemia (group II) or during reperfusion (group III). The recovery of non-uniformity indicated by post-ejection wall thickening was significantly faster (p < 0.05) in both groups if compared to the non-assisted group (group I) (all groups n = 4). Recovery of systolic wall thickening in the postischemic region in group I was only 76 +/- 12%, while it was 103 +/- 11% and 92 +/- 11% in groups II and III, respectively (p < 0.05). In a canine model of global left ventricular failure, we occluded the left anterior descending coronary artery for 20 min, and after 5 minutes of reperfusion, the circumflex artery for 45 min (group I, n = 5). After 5 min of CX occlusion in group II we performed assisted circulation for 90 min with the 10-ml (n = 5) and the 25-ml (n = 5) Medos HIA-VAD. In group I, no dog survived, in group II, all survived 4 hours of reperfusion (n = 10). Lactate at the end of the experiment was 1.1 +/- 0.9 mmol/L (10-ml, and 1.1 +/- 0.2 mmol/L (25-ml) (p > 0.05 vs. base line). We conclude that the Medos HIA-VAD is a reliable assist device that enhances myocardial recovery and allows sufficient peripheral circulation in the case of cardiogenic shock.