Table 5.
Potential Risk Factors for Occurrence of Neurological Events in Univariable and Multivariable Analyses
| Variable | With CNS Event* (n=59) | Without CNS Event* (n=145) | Univariable P Value; OR (95% CI) | Multivariable P Value; OR (95% CI) |
|---|---|---|---|---|
| Sex | 0.03* | 0.02 | ||
| Male | 24 (41) | 83 (57) | 0.51 (0.28 to 0.95) | 0.45 (0.23 to 0.86) |
| Female | 35 (59) | 62 (43) | ||
| Weight | 0.54 | |||
| <5 kg | 11 (19) | 22 (15) | 0.78 (0.35 to 1.73) | |
| ≥5 kg | 48 (81) | 123 (85) | ||
| Age, months, median (IQR) | 19.4 (6.2 to 66.5) | 18.1 (6.3 to 64.3) | 0.84 1.00 (0.99 to 1.01) | |
| Primary diagnosis | 0.08* | 0.12 | ||
| CHD | 12 (20) | 47 (32) | 0.53 (0.26 to 1.10) | 0.54 (0.25 to 1.18) |
| Non‐CHD | 47 (80) | 98 (68) | ||
| INTERMACS profile | 0.99 | |||
| 1 | 31 (52) | 76 (52) | 1.00 (0.55 to 1.84) | |
| ≥2 | 28 (48) | 69 (48) | ||
| Creatinine preimplant, dL/mL, median (IQR) | 0.4 (0.3 to 0.6) | 0.4 (0.3 to 0.7) | 0.75 0.94 (0.67 to 1.33) | |
| Bilirubin preimplant, dL/mL, median (IQR) | 1.0 (0.6 to 2.5) | 1.0 (0.5 to 1.9) | 0.30 1.00 (0.92 to 1.08) | |
| ECMO prior to implant | 28 (47) | 55 (38) | 0.21*; 1.48 (0.80 to 2.72) | 0.10; 1.73 (0.89 to 3.33) |
| Stroke prior to implant | 1 (2) | 13 (9) | 0.07*; 0.18 (0.02 to 1.67) | 0.06; 0.13 (0.02 to 1.12) |
| Met IDE entrance criteria | 35 (59) | 88 (61) | 0.86; 1.47 (0.46 to 4.66) | |
| BSA, m2, median (IQR) | 0.47 (0.33 to 0.68) | 0.50 (0.35 to 0.72) | 0.55; 0.73 (0.28 to 1.87) | |
| Device type | 0.20* | 0.38 | ||
| LVAD | 41 (70) | 87 (60) | 1.52 (0.80 to 2.90) | 1.36 (0.68 to 2.70) |
| BVAD | 18 (30) | 58 (40) | ||
| Device size | 0.52 | |||
| 10 mL | 24 (41) | 52 (36) | 1.23 (0.66 to 2.28) | |
| Other | 35 (59) | 93 (64) | ||
| Pump replacement for thrombus | 0.003* | 0.005 | ||
| None | 26 (44) | 97 (67) | 2.56 (1.38 to 4.77) | 2.58 (1.34 to 4.97) |
| ≥1 | 38 (56) | 48 (33) |
BSA indicates body surface area; BVAD, biventricular assist device; CHD, congenital heart defect; CNS, central nervous system; ECMO, extracorporeal membrane oxygenation; IDE, investigational device exemption; INTERMACS, Interagency Registry for Mechanically Assisted Circulatory Support; IQR, interquartile range; LVAD, left ventricular assist device; OR, odds ratio.
*
Values are number (percentage) except as indicated.
*
Variable included in multivariable logistic regression model.