Table 2.
Patients outcomes.
| Primary outcome | NIHP (n = 6) | SCS (n = 25) | RR/ES (95% CI) |
| Survival free of event within 180 days | 6 (100%) | 18 (72%) | 1.4 (1.1–1.8) |
| First event that resulted in failure to reach the primary end point | |||
| PGD within 24 h | 0 | 2 (8%) | – |
| ECMO within 7 days | 0 | 1 (4%) | – |
| ACR ≥ 2R within 180 days | 0 | 3 (12%) | – |
| Death within 180 days | 0 | 1 (4%) | – |
| Secondary outcomes | NIHP (n = 6) | SCS (n = 25) | RR/ES (95% CI) |
| Immediate graft function | |||
| Reperfusion time (minutes) | 91 (83–95) | 89 (77–107) | 0.14 (−0.75 to 1.03) |
| Inotropic score at 6 h post transplantation | 21 (9–24) | 30 (20–54) | −0.55 (−1.5 to 0.40) |
| LVEF < 40% within 24 h | 0 | 2 (9%) | − |
| RVEF < 40% within 24 h | 1 (17%) | 6 (27%) | 0.61 (0.090–4.1) |
| I/R-tissue injury | |||
| cTnI > 0.02 ng/mL at end of preservation | 1 (20%) | 15 (100%) | 0.20 (0.035–1.2) |
| CK-MB > 4.3 ng/mL at end of preservation | 0 | 6 (33%) | – |
| CK-MB 6 ± 2 h after ending preservation (ng/mL) | 76 (54–101) | 138 (72–198) | −1.18 (−2.2 to 0.10) |
| CK-MB 12 ± 4 h after ending preservation (ng/mL) | 38 (30–67) | 53 (41–77) | −0.84 (−1.8 to 0.16) |
| CK-MB 24 ± 6 h after ending preservation (ng/mL) | 16 (10–24) | 15 (12–38) | −0.41 (−1.3 to 0.51) |
| Renal function | |||
| Minimum creatinine clearance within 7 days | 33 (31–40) | 44 (34–59) | −0.83 (−1.8 to 0.18) |
| CRRT within 7 days | 3 (50%) | 4 (16%) | 3.1 (0.94–10) |
| Liver function | |||
| ASAT within 48 h (μkat/L) | 1.6 (1.4–2.1) | 2.6 (2.2–3.6) | −1.3 (−2.3 to −0.19) |
| ALAT within 48 h (μkat/L) | 0.4 (0.3–0.5) | 0.6 (0.4–0.8) | −1.0 (−2.0 to −0.067) |
| Time on ventilator (hours) | 32 (22–54) | 39 (22–52) | −0.19 (−1.1 to 0.71) |
| Acute rejection (ACR ≥ 1R) within 180 days | 2 (33%) | 15 (63%) | 0.56 (0.17–1.8) |
| Duration of ICU stays (days) | 7.0 (5.4–17) | 6.0 (5.1–11) | 0.062 (−0.81 to 0.95) |
Data are n (%) or median (IQR).
ACR acute cellular rejection, ALAT alanine transaminase, ASAT aspartate aminotransferase, cTnI cardiac troponin I, CK-MB creatinine kinase-muscle/brain, CRRT continuous renal replacement therapy, ECMO extracorporeal membrane oxygenation, ES effect size, ICU intensive care unit, IQR interquartile range, I/R ischemia and reperfusion, LVEF left ventricular ejection fraction, NIHP nonischemic heart preservation, RR relative risk, RVEF, right ventricular ejection fraction, SCS static cold storage.