Machine perfusion in abdominal organ transplantation: Current use in the Netherlands

doi:10.5500/wjt.v10.i1.15

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World Journal of Transplantation

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World J Transplant. Jan 18, 2020; 10(1): 15-28
Published online Jan 18, 2020. doi: 10.5500/wjt.v10.i1.15

Table 1 Outcomes from meta-analyses or large studies comparing donation after circulatory death to donation after brain death outcomes in abdominal organ transplantation

	DCD	DBD	P value
Kidney[56]
PNF (%)	3.2	2.6	0.06
DGF (%)	48.5	24.9	< 0.001^a
1-yr eGFR¹	47.4 (35.6-61.2)	48.7 (37.3-61.1)	0.69
5-yr graft survival (%)	76.8	78.1	0.60
5-yr patient survival (%)	86.5	89.4	< 0.001^a
Liver[57]
Biliary complications (%)	26	16	< 0.001^a
Ischemic cholangiopathy (%)	16	3	< 0.001^a
3-yr graft survival (%)	73	74	0.01^a
3-yr patient survival (%)	82	88	0.04^a
Pancreas[7]
Graft survival	HR 0.98 (0.74-1.31)	Reference value	0.92
Patient survival	HR 1.31 (0.62-2.78)	Reference value	0.47
Graft thrombosis	OR 1.67 (1.04-2.67)	Reference value	0.006^a

¹Data is presented as median and interquartile range.

^aStatistically significant. DBD: Donation after brain death; DCD: Donation after circulatory death; DGF: Delayed graft function; eGFR: Estimated glomerular filtration rate; HR: Hazard ratio; OR: Odds ratio; PNF: Primary non function.

Table 2 Clinical studies published about kidney transplant outcomes after abdominal regional perfusion

						Graft survival, %			Patient survival, %
Study	n	DCD type	Rejection, %	DGF, %	PNF, %	1	3	5	1	3	5
HRP
Valero et al[35], 2000	8	II	-	75	0	-	-	-	-	-	-
Koyama et al[58], 2002	46	III/IV	-	87	6.5	88.3	-	-	-	-	-
Lee et al[34], 2005	31	II/III/IV	35.5	41.9	0	100	-	88.4	100	-	100
Sánchez-Fructuoso et al[59], 2006	320	I/II	4.4	60.9	4.4	87.4	-	82.1	95	-	90
Farney et al[33], 2011	25	III	16	21	0	88	88	-	-	-	-
NRP
Valero et al[35], 2000	8	II	-	12.5	0	-	-	-	-	-	-
Magliocca et al[37], 2005	24	III	0	8.3	0	-	-	-	-	-	-
Reznik et al[60], 2011	20	II	10	70	10	-	-	-	-	-	-
Hessheimer et al[61], 2015	158	II	-	65	9	88	-	-	-	-	-
Oniscu et al[42], 2014	32	III	-	40	6	87.5	-	-	96.8	-	-
Butler et al[43], 2014	14¹	III	-	18.2	9.1	-	-	-	-	-	-
Rojas-Peña et al[62], 2014	29²	III	-	31	3.5	-	-	-	-	-	-
Demiselle et al[63], 2016	19	II	-	53	5.3	94	-	-	100	-	-
Miñambres et al[36], 2017	37	III	-	27	5	91.8	-	-	-	-	-

¹Fourteen kidneys were transplanted in 11 recipients. Therefore, clinical outcomes are calculated in the 11 recipients;

²Outcomes were only mentioned from their own center. DCD: Donation after circulatory death; DGF: Delayed graft function; HRP: Hypothermic regional perfusion; NRP: Normothermic regional perfusion; PNF: Primary non function.

Table 3 Clinical studies published about liver transplant outcomes after normothermic regional perfusion

							Graft survival, %			Patient survival, %
Study	n	DCD type	Rejection, %	BC, %	IC, %	PNF, %	1	3	5	1	3	5
Otero et al[64], 2004	14	II	22	-	28	28	43	-	-	71	-	-
Fondevila et al[41], 2007	10	II	-	10	-	10	50	-	-	70	-	-
Jiménez-Galanes et al[65], 2009	20	II	-	-	5	10	80	-	-	85	-	-
Fondevila et al[66], 2012	34	II	-	12	8	4.3	-	-	-	-	-	-
Oniscu et al[42], 2014	11	III	-	18.2	0	9.1	87.5	-	-	96.8	-	-
Butler et al[43], 2014	3	III	-	-	0	-	-	-	-	-	-	-
Rojas-Peña et al[62], 2014	13	III	-	-	14.3	14.3	85.7	-	-	-	-	-
Hessheimer et al[61], 2015	42	II	-	-		10	73	-	-	-	-	-
De Carlis et al[67], 2016	7	II/III	14.3	14.3	0	0	-	-	-	-	-	-
Miñambres et al[36], 2017	11	III	-	0	0	9.1	90.9	-	-	-	-	-
Hessheimer et al[40], 2019	95	III	-	8	2	2	88	88	-	93	93	-

BC: Biliary complications; DCD: Donation after circulatory death; IC: Ischemic cholangiopathy; NRP: Normothermic regional perfusion; PNF: Primary non function.

Table 4 Currently ongoing clinical trials concerning ex vivo machine perfusion in kidney transplantation

Name of study	Registration number	Design	PI	n	Primary outcome	Intervention	Included donors	Results
Unknown	ISRCTN91315246	Non-randomized	Cambridge	90	Graft function	1 h NMP	Discarded kidneys	November 2019
COPE-POMP	ISRCTN63852508	RCT	COPE Essen	262	Graft survival 1y	Short period HMP vs SCS only	ECD-DBD	July 2019
COPE-COMPARE	ISRCTN32967929	RCT	COPE Leuven	162	Kidney graft function 1 y	HMP with oxygen vs HMP without oxygen	DCD III	↓ risk BPAR ↑ 1-y eGFR[44]
PIO	NCT03031067	Case control	Bologna	20	Graft function	2 h HMP vs SCS	ECD -DBD	February 2018
PREDICTION	NCT02055950	Case control	Bergamo	60	Kidney function	HMP vs SCS	ECD-DBD	Augustus 2018
Unknown	NCT03837197	RCT	Bologna	260	DGF	2 h oxygenated HMP vs SCS	ECD-DBD	December 2021
IMPULSION	NCT01170910	RCT	Lyon	162	DGF	6-8 h HMP vs SCS	ECD	August 2016
Machine perfusion trial	ISRCTN83876362	RCT	COPE Groningen	654	DGF	Non-oxygenated HMP vs SCS	DCD III and DBD	↓ risk of DGF (OR 0.57) ↓ risk of graft failure (HR 0.52) ↑ allograft survival (94 vs 90%, P = 0.04)[27]
Unknown	ISRCTN15821205	RCT	Cambridge	400	DGF	1 h pre-transplant NMP vs SCS	DCD III and IV	January 2021

BPAR: Biopsy proven acute rejection; COPE: Consortium for Organ Preservation in Europe; DBD: Donation after brain death; DCD: Donation after circulatory death; DGF: Delayed graft function; ECD: Expanded criteria donor; eGFR: Estimated glomerular filtration rate; HMP: Hypothermic machine perfusion; HR: Hazard ratio; NMP: Normothermic machine perfusion; OR: Odds ratio; PI: Principal investigator; RCT: Randomized controlled trial; SCS: Static cold storage.

Table 5 Currently ongoing clinical trials concerning ex vivo machine perfusion in liver transplantation

Name of study		Design	PI	n	Primary outcome	Intervention	Included donors	Results
DHOPE DCD	NCT02584283	RCT	Groningen	156	% NAS	2 h end-ischemic DHOPE	DCD III	October 2019
HOPE	NCT01317342	RCT	Zürich	170	Postoperative complications	1-2 h HOPE	DBD	July 2019
HOPE ECD-DBD	NCT03124641	RCT	Aachen	46	Peak ALT	1-2 h HOPE	ECD-DBD	June 2019
DHOPE-COR-NMP	NTR5972	Non-randomized	Groningen	16	Graft survival	DHOPE, gradually rewarming, NMP	Discarded livers (DCD and DBD)	11 livers transplanted 100% patient/graft survival, 9.1% ischemic cholangiopathy[48]
PIO	NCT03031067	Case control	Bologna	20	Graft function	2 h HOPE	ECD livers	February 2018
VITTAL	NCT02740608	Non-randomized	Birmingham	22	Patient survival	4 h NMP	Discarded livers (DCD and DBD)	March 2020
Liver WP2	ISRCTN39731134	RCT	Oxford COPE	220	Peak AST	Minimally 4 h NMP	All deceased donors	49.4% ↓ peak AST[47]
CORNET	ISRCTN94691167	RCT	Essen	40	Peak AST	1,5 h COR until 20 degrees (dual perfusion)	ECD	February 2021
DHOPE	NTR4493	Case control	Groningen	10	Graft survival 6 mo	At least 2 h of DHOPE	DCD III	↑ graft survival (P = 0.052) ↓peak ALT (P = 0.006) ↓bilirubin (P = 0.044)[46]
Unknown	NCT03837197	RCT	Bologna	260	Early allograft dysfunction	Minimally 1 hour of HOPE	ECD-DBD	December 2021

ALT: Alanine aminotransferase; AST: Aspartate transaminase; COR: Controlled oxygenated rewarming; COPE: Consortium for Organ Preservation in Europe; DBD: Donation after brain death; DCD: Donation after circulatory death; DHOPE: Dual hypothermic oxygenated perfusion; DCD: Donation after circulatory death; ECD: Expanded criteria donor; HOPE: Hypothermic oxygenated perfusion; NAS: Non-anastomotic strictures; NMP: Normothermic machine perfusion; PI: Principal investigator; RCT: Randomized controlled trial

Citation: Rijkse E, IJzermans JN, Minnee RC. Machine perfusion in abdominal organ transplantation: Current use in the Netherlands. World J Transplant 2020; 10(1): 15-28
URL: https://www.wjgnet.com/2220-3230/full/v10/i1/15.htm
DOI: https://dx.doi.org/10.5500/wjt.v10.i1.15