Adverse Events
In the post-approval group, two (2.2%) cases of pump thrombosis were seen due to outflow graft twist, requiring an emergent pump exchange. Four (4.4%) patients had strokes, and 3 (3.3%) patients required dialysis due to renal failure. There were two (2.2%) cases of acute limb ischemia secondary to the use of IABP. 32 patients had RVF requiring inotropes >14 days (34.8%). These findings were comparable to those of the trial group (Table 3).
One statistically significant differences were observed in adverse events between the trial and the postapproval groups. Postoperative bleeding requiring re-exploration was statistically lower in the postapproval vs the trial group (10.9% vs 46.3%; p=0.01 ).