{"id":1833,"date":"2023-05-15T15:28:32","date_gmt":"2023-05-15T07:28:32","guid":{"rendered":"https:\/\/transnovo.com\/?p=1833"},"modified":"2023-06-02T13:50:28","modified_gmt":"2023-06-02T05:50:28","slug":"%e4%bd%8e%e6%b8%a9%e6%9c%ba%e6%a2%b0%e7%81%8c%e6%b3%a8%e8%bf%98%e6%98%af%e4%ba%9a%e4%bd%8e%e6%b8%a9%e6%b2%bb%e7%96%97dbd%e4%be%9b%e4%bd%93%ef%bc%9f2023%e5%b9%b4nejm%e9%87%8d%e7%a3%85%ef%bc%9a%e4%b8%80","status":"publish","type":"post","link":"https:\/\/transnovo.com\/en\/news\/%e4%bd%8e%e6%b8%a9%e6%9c%ba%e6%a2%b0%e7%81%8c%e6%b3%a8%e8%bf%98%e6%98%af%e4%ba%9a%e4%bd%8e%e6%b8%a9%e6%b2%bb%e7%96%97dbd%e4%be%9b%e4%bd%93%ef%bc%9f2023%e5%b9%b4nejm%e9%87%8d%e7%a3%85%ef%bc%9a%e4%b8%80\/","title":{"rendered":"Hypothermic Mechanical Perfusion or Subcritical Treatment for DBD Donors?NEJM 2023 Heavyweight: a Large-Scale, Multicenter, Randomized Controlled Study"},"content":{"rendered":"
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Preface<\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

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Currently, hypothermic mechanical perfusion (HMP) is commonly used for organ preservation, repair, and evaluation prior to donor kidney transplantation, but some argue that this method raises clinical operational requirements, increases preoperative medical costs, and has little relevance in the use of mechanical perfusion in relatively good quality brain dead (DBD) donor kidneys. Subcooling, also known as targeted temperature management, is commonly used to protect neurological function in patients with cardiac arrest, stroke, and asphyxia, and the protective effect on the patient's kidney is unclear.<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n

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In 2015, Niemann et al. published an article in NEJM comparing the effects of subcooling (34-35\u00b0C) compared to normothermia (36.5-37.5\u00b0C) on the postoperative effects of treating donors with DBD donor kidney transplantation. The results of the study suggest that the incidence of postoperative DGF can be significantly reduced by subcold treatment of the donor + static cold preservation of the donor kidney compared to conventional CS[1]<\/sup>.2019 paper by same team at Clinical Transplantation demonstrates that subfreezing therapy can help patients reduce their medical costs<\/span>[2]<\/sup>.<\/span><\/span><\/p>\n

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In February 2023, Niemann's team again published a study in NEJM comparing the effects of three different modalities of subcryotherapy compared to HMP and subcryotherapy combined with HMP on DBD donor kidney transplantation<\/span>[3]<\/sup>. The results suggest that<\/span>The incidence of postoperative DGF was significantly lower in patients in the HMP group compared with the subhypothermia-only treatment group, and was not significantly different from the combined treatment group<\/span><\/strong>. The following is a detailed description of the research protocol and results of the article.<\/span><\/span><\/p>\n

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Research Program<\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n

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A total of 725 DBD donors from 6 U.S. organ acquisition centers were included, and the donor kidneys were required to meet the mechanical perfusion criteria of 6 OPOs. Four of the OPOs had perfusion criteria of poor donor quality (including ECD donor kidney, high KDPI score, etc.), and the remaining two OPOs had no special perfusion criteria and perfusion was available for all donor kidneys.<\/span><\/p>\n

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The remaining donor enrollment criteria are as follows:<\/span><\/strong><\/span>1) Hemodynamically stable (low-dose boosters only and mean arterial pressure > 60 mmHg);<\/span>2) Absence of coagulation and electrolyte disturbances.<\/span>The main exclusion criteria include:<\/span><\/strong>DCD donor kidney, donor ESRD or history of dialysis during hospitalization.<\/span><\/p>\n

The donor kidney was randomly divided into sub-cold group, HMP group and sub-cold combined with HMP group.<\/span>Two midterm analyses were performed in this study, the first assessing the efficacy of the subcritical group compared to the other two groups, followed by discontinuing the enrollment of patients in the subcritical group and making corrections to the number of people to be included in the study.<\/span>A second comparison of the efficacy between the two groups was made between HMP and combination therapy.<\/span><\/p>\n

Donor body temperature control via Arctic Sun, Bair Hugger and other devices.After completion of organ acquisition, the kidneys were preserved by static cold storage in the subcryogenic group, and the kidneys were preserved by LifePort cryo-mechanical perfusion in the HMP and combined treatment groups.<\/span><\/strong>The primary study endpoint was the incidence of postoperative DGF (defined as the need for dialysis at 1 week postoperatively), and the secondary study endpoint was graft survival at 1 year postoperatively.<\/span><\/p>\n

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Figure 1. Brief flow chart of the study<\/strong><\/span><\/p>\n

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Study results<\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n

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The final transplantation was performed in 1348 recipients (1349 donor kidneys and 1 recipient in the HMP group who underwent double kidney transplantation). Of these, 359 recipients were in the subcritical group, 510 in the HMP group, and 479 in the combined treatment group. There were no statistical differences in the baseline clinical characteristics of the recipients between the three groups, and the CIT was 16.7\u00b18.3h, 19.3\u00b18.3h, and 19.1\u00b18.0h in the subhypothermia group, HMP group, and combined treatment group, respectively.<\/span><\/p>\n

A total of 109 patients (30%) in the subcryogenic group developed DGF postoperatively, with a significantly higher incidence of DGF than in the HMP group (19%) and the combination therapy group (22%). After correcting for confounding factors, the risk of postoperative DGF was 1.72 times higher in recipients treated with subcryogenic therapy only than in recipients with donor kidneys preserved by mechanical perfusion (95% CI, 1.35 to 2.17). There was no significant difference in graft survival between the three groups of patients at 1 year postoperatively (Table 1).<\/span><\/p>\n

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Table 1: Study primary and secondary endpoint outcomes<\/strong><\/section>\n<\/section>\n
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Summary<\/p>\n<\/section>\n<\/section>\n<\/section>\n

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As the proportion of DBD donors continues to increase, more high-quality clinical studies are needed to support the preservation strategies for this donor organ segment. In this study, a large prospective multicenter clinical trial demonstrated that cryo-mechanical perfusion has a significant clinical benefit in preserving DBD donor kidneys and reducing the incidence of postoperative DGF.<\/p>\n<\/section>\n<\/section>\n<\/section>\n

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To read the original article, please scan the QR code below:<\/span><\/strong><\/p>\n

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Reference:<\/p>\n

[1] Niemann CU, Feiner J, Swain S, et al. Therapeutic Hypothermia in Deceased Organ Donors and Kidney-Graft Function. N Engl J Med. 2015;373(5):405-414.<\/p>\n

[2] Axelrod DA, Malinoski D, Patel MS, et al. Modeling the economic benefit of targeted mild hypothermia in deceased donor kidney transplantation. clin Transplant. 2019;33(7):e13626.<\/p>\n

[3] Malinoski D, Saunders C, Swain S, et al. Hypothermia or Machine Perfusion in Kidney Donors. N Engl J Med. 2023;388(5):418-426.<\/p>\n

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Jianfeng Medicine, focus on transplant industry<\/p>\n<\/section>\n<\/section>\n<\/section>\n

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