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 ).