Table 2 Patients outcomes.

From: A nonrandomized open-label phase 2 trial of nonischemic heart preservation for human heart transplantation

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)

  1. Data are n (%) or median (IQR).
  2. 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.
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