Calves implanted with the LionHeart left ventricular assist device during the Food and Drug Administration Investigational Device Exemption (IDE) trial had fewer renal infarctions than calves implanted after this trial (post-IDE). Since a decrease in renal infarctions indicates a favorable outcome, we compared nine IDE with 16 post-IDE implantations. Renal infarct severity was graded (0 to 4) on the basis of necropsy reports, histopathology reports, and photographs. Implants were compared for duration of support, anticoagulation, device flow, percent fill, device rate, free plasma hemoglobin, fibrinogen, platelet count, nonsteroidal anti-inflammatory drug use, inlet cannula shape, and outlet graft-to-graft anastomosis technique. IDE calves had lower renal pathology scores (1.8 vs. 2.8, p = 0.03), mean device percent fill (88.5% vs. 94.0%, p = 1 × 10), and median free plasma hemoglobin (2.6 vs. 4.4 mg/dL, p = 0.01). IDE animals also had a higher mean device rate (108 vs. 98 bpm, p = 0.04), received low-molecular-weight dextran in the early postoperative period, began oral warfarin earlier, had straighter inlet cannulae, and had factory-sewn outlet graft-to-graft anastomoses. Duration of support did not predict severity of renal infarction, and there were no differences in device flow, international normalized ratio, platelet count, or nonsteroidal anti-inflammatory drug use. These results could assist future implantations.
All Science Journal Classification (ASJC) codes
- Biomedical Engineering