Adverse Event
Trial Group n=82 Postapproval Group n=92
p-value
Re-exploratory surgery for post-operative bleeding 38 (46.3) 10 (10.9) 0.01
Stroke 6 (7.3) 4 (4.4) 0.52
Acute limb ischemia 1 (1.2) 2 (2.2) 0.99
Gastrointestinal bleeding 17 (20.7) 12 (13) 0.22
Pump thrombosis 3 (3.7) 2 (2.2) 0.66
Driveline infection 13 (15.9) 14 (15.2) 0.99
Renal dysfunction requiring RRT 8 (9.8) 3 (3.3) 0.12
Severe RV failure requiring inotropes >14 days during initial implant hospitalization 34 (41.5) 32 (34.8) 0.36
Severe RV failure requiring RVAD during implant 4 (4.9) 3 (3.3) 0.71