Short-term outcomes after heart transplantation using donor hearts preserved with ex vivo perfusion

Figures & data

Table 1. Donor characteristics.

Characteristics	OCS (n = 9)	CCS (n = 39)	p-value
Age (years)	52 (45–57)	39 (29–51)	0.30
Age groups
<35 years	2 (22%)	15 (38%)	0.23
35–50 years	2 (22%)	11 (28%)
>50 years	5 (56%)	13 (33%)
Male sex	4 (44%)	27 (69%)	0.25
BMI (kg/m^2)	25.3 (24.1–29.4)	24.2 (21.6–27.7)	0.18
Donor/recipient BMI ratio	0.95 (0.88–1.20)	0.93 (0.85–1.09)	0.76
Donor location
Rigshospitalet	2 (22%)	22 (56%)	0.13
Other Danish hospital^a	5 (56%)	10 (26%)
Outside Denmark	2 (22%)	7 (18%)
Cause of death
Anoxia	2 (22%)	8 (21%)	0.17
Cerebrovascular event	7 (78%)	20 (51%)
Head trauma	0	11 (28%)

Data are median (interquartile range) or n (%).

^a: Aalborg university hospital, Odense university hospital or Aarhus university hospital. BMI: body mass index.

Table 2. Pre-Tx Recipient characteristics.

Characteristics	OCS (n = 9)	CCS (n = 39)	p-value
Age (years)	59 (52–62)	50 (31–58)	0.09
Age groups
<35 years	1 (11%)	15 (38%)	0.08
35–50 years	1 (11%)	6 (15%)
>50 years	7 (78%)	18 (46%)
Male sex	5 (56%)	25 (64%)	0.71
BMI (kg/m^2)	26.9 (25.5–28.7)	26.0 (23.0–28.7)	0.41
Blood group
A	3 (33%)	17 (44%)	0.02
B	3 (33%)	1 (3%)
AB	1 (11%)	2 (5%)
O	2 (22%)	19 (49%)
PRA level
0–10%	9 (100%)	35 (90%)	1
11–80%	0	4 (10%)
>80%	0	0
Left ventricle ejection fraction, LVEF (%)	20 (15–45)	15 (13–20)	0.25
mPAP (mmHg)	21 (14–23)	26 (20–35)	0.07
PVR (Wood units)	1.5 (1.1–1.5)	1.9 (1.3–2.5)	0.16
Diabetes (insulin or non-insulin)	1 (11%)	5 (13%)	1
Dyslipidaemia	3 (33%)	7 (18%)	0.37
Chronic renal insufficiency	4 (44%)	9 (23%)	0.23
Previous cardiac surgery	6 (67%)	23 (59%)	1
Mechanical circulatory support
Temporary MCS^a	0	4 (10%)	0.62
Durable LVAD	2 (22%)	13 (33%)
Primary indication for HTx
Ischemic cardiomyopathy	1 (11%)	10 (26%)	0.10
Non-ischemic cardiomyopathy^b	4 (44%)	24 (62%)
ACHD	4 (44%)	5 (13%)

^aTemporary ventricular assist device, intra-aortic balloon pump therapy, or extracorporeal membrane oxygenation.

^bDilated, hypertrophic, or restrictive cardiomyopathy.

Data are median (interquartile range) or n (%). ACHD: Adult congenital heart disease; BMI: body mass index; HTx: Heart transplantation; LVEF: Left ventricular ejection fraction; MCS: mechanical circulatory support; mPAP: mean pulmonary artery pressure; PRA: panel reactive antibodies; PVR: pulmonary vascular resistance.

Figure 1. The components of out of body time in the OCS group. Labels represent medians (interquartile range). OCS: organ care system.

Table 3. Intraoperative and in-hospital outcomes.

Variables	OCS (n = 9)	CCS (n = 39)	p-value
CPB time (min)	214 (148–277)	164 (149–174)	0.26
Surgical time (min)	399 (349–490)	370 (315–440)	0.38
Intraoperative bleeding (mL)	845 (650–1550)	922 (583–1500)	0.84
Blood transfusion requirement (mL)^a	170 (1000–1350)	1,660 (755–2455)	0.67
Duration of MV (hours)	12.3 (7.2–46.9)	10.7 (4.5–29.1)	0.47
Duration of inotropic support (hours)	68.3 (46.6–122.1)	62.5 (42.2–89.1)	0.47
Maximal vasoactive-inotropic score	14 (3–33)	13 (5–33)	0.80
Reoperation	2 (22%)	11 (28%)	1
Haemodialysis requirement	2 (22%)	9 (23%)	1
PGD
Mild	1 (11%)	7 (18%)	0.71
Moderate	2 (22%)	4 (10%)
Severe	0	0
ACR ≥2 R	1 (11%)	0	0.19
ICU stay (days)	3 (3–11)	3 (2–5)	0.59
Hospital stay (days)	24 (16–32)	18 (13–23)	0.12
30-day survival	9 (100%)	38 (97%)	1

^a = Intraoperative and first 24 h post-transplant.

Data are median (interquartile range) or n (%). ACR: acute cellular rejection; CPB: cardio-pulmonary bypass; ICU: intensive care unit; MV: mechanical ventilation; PGD: primary graft dysfunction.

Figure 2. Kaplan–meier plot of overall survival, stratified by preservation method. CCS: conventional cold storage; HTx : heart transplantation; OCS: organ care system.

Figure 3. Kaplan–meier plot of event-free survival, stratified by preservation method. CCS: conventional cold storage; HTx: heart transplantation; OCS: organ care system.

Table 4. Primary outcomes (at six-month follow-up).

Variables	OCS (n = 9)	CCS (n = 39)	p-value
ACR ≥2 R	2 (22%)	5 (13%)	0.60
Severe PGD	0	0	1
Six-month survival	100% [100–100%]	92.3% [84.3–100%]	0.40
Six-month event-free survival	77.8% [54.9–100%]	79.5% [67.8–93.2%]	0.91

Data are n (%) or percentage [95% CI]. ACR – acute cellular rejection; PGD : primary graft dysfunction.

Data availability statement

Data from this study are available upon reasonable request to the corresponding author (WHN). Public availability is restricted to respect patient privacy and ethical considerations.