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加拿大高敏患者项目报告:1000例肾移植的故事

Canadian Highly Sensitized Patient Program Report: A 1000 Kidney Transplants Story.

作者信息

Shamseddin M Khaled, Paraskevas Steven, Mainra Rahul, Maru Kyle, Piggott Bailey, Jagusic Darlene, Yetzer Kathy, Gunaratnam Lakshman, Ribic Christine, Kim Joseph, Singh Sunita, Hoar Stephanie, Prasad G V Ramesh, Masse Melanie, Houde Isabelle, Khalili Myriam, West Kenneth, Liwski Rob, Martin Sean, Gogan Nessa, Karpinski Martin, Monroy-Cuadros Mauricio, Gourishankar Sita, Johnston Olwyn, Lan James, Nguen Christopher, Gill John, Pâquet Michel

机构信息

Division of Nephrology, Department of Medicine, Queen's University, ON, Canada.

Department of Surgery, McGill University, Montreal, QC, Canada.

出版信息

Can J Kidney Health Dis. 2024 Dec 24;11:20543581241306811. doi: 10.1177/20543581241306811. eCollection 2024.

Abstract

PURPOSE

Highly sensitized patients (HSPs) with kidney failure have limited access to kidney transplantation and poorer post-transplant outcomes. Prioritizing HSPs in kidney allocation systems and expanding the pool of deceased donors available to them has helped to reduce their wait times for transplant and enhanced post-transplant outcomes. The Canadian HSP Program was established by Canadian Blood Services in collaboration with provincial organ donation and transplantation programs throughout the country to increase transplant opportunities for transplant candidates needing very specific matches from deceased kidney donors. Highly sensitized patients in the Canadian Program are defined by a calculated panel-reactive antibody (cPRA) ≥95%. In this report, we describe the evolution and trajectory of the Canadian HSP Program and evaluate the national impact on the first 1000 kidney transplant cases.

SOURCE OF INFORMATION

To allocate deceased donor kidney organs nationally to HSPs and report on the Canadian HSP Program's performance, Canadian Blood Services developed a national database registry known as the Canadian Transplant Registry (CTR) and an online reporting tool known as the Canadian HSP Program Data Dashboard.

METHODS

The CTR, which collects HSPs' data for the purpose of matching potential donors to HSPs and as part of required national quality, safety, and efficiency performance measurements, was retrospectively reviewed. Due to the nature of using deidentified aggregate registry data, a patient consent form was not required. A Research Ethical Board (REB) application was also waived.

KEY FINDINGS

In this article, we describe the historical development, initial deployment, and evolution of the Canadian HSP Program with a primary aim to increase the rate of deceased donor kidney transplantation. A secondary aim was to evaluate the national impact of the Canadian HSP Program on the first 1000 kidney transplant cases. Transplant candidates who have participated in the Canadian HSP Program and recipients who received transplants were predominantly females (average age 50 years, female 62%) with blood group O (47% of candidates, 42% of transplants). Seventy percent of all active transplant candidates enrolled in the HSP Program were in the hardest to match group (cPRA ≥99%), and only 22% of the transplant candidates with cPRA of 100% have received a transplant to date through the Program. The average times from first participation in the Canadian HSP Program to transplantation for cPRA ≥99% transplant recipients were significantly longer than for cPRA 95% to 98% recipients averaging 22 months versus 6 months, respectively. By the end of June 2024, the Canadian HSP Program had facilitated 1000 transplants, 613 of which were from interprovincial matches. The average (SD) cold ischemic time (CIT) was 14.5 (5.9) hours, with interprovincial transplants exhibiting significantly longer CITs compared with intraprovincial transplants, averaging an additional 4.7 hours.

LIMITATIONS

Our study limitations include first that it is a retrospective registry data analysis with no available short- and long-term clinical outcomes data at this point (patient and graft survival). Second, given the nature of registry data, not all relevant data may have been captured and reporting may not be complete for all patients.

IMPLICATIONS

Examination of CTR registry data showed the Canadian HSP Program had a meaningful impact in enabling 1000 HSPs to access transplantation opportunities that may otherwise be unavailable to them.

摘要

目的

肾衰竭的高敏患者(HSPs)获得肾移植的机会有限,移植后的预后较差。在肾脏分配系统中优先考虑HSPs,并扩大可供他们使用的已故捐赠者库,有助于减少他们的移植等待时间,并改善移植后的预后。加拿大血液服务中心与全国各省的器官捐赠和移植项目合作,设立了加拿大HSP项目,以增加需要与已故肾脏捐赠者进行非常特殊匹配的移植候选人的移植机会。加拿大项目中的高敏患者定义为计算得出的群体反应性抗体(cPRA)≥95%。在本报告中,我们描述了加拿大HSP项目的发展历程和轨迹,并评估了其对前1000例肾移植病例的全国性影响。

信息来源

为了在全国范围内将已故捐赠者的肾脏器官分配给HSPs,并报告加拿大HSP项目的表现,加拿大血液服务中心开发了一个名为加拿大移植登记处(CTR)的全国性数据库登记系统,以及一个名为加拿大HSP项目数据仪表板的在线报告工具。

方法

对CTR进行回顾性审查,该登记处收集HSPs的数据,目的是将潜在捐赠者与HSPs进行匹配,并作为国家所需的质量、安全和效率绩效衡量的一部分。由于使用的是去识别化的汇总登记数据,因此不需要患者同意书。研究伦理委员会(REB)的申请也被豁免。

主要发现

在本文中,我们描述了加拿大HSP项目的历史发展、初步部署和演变,主要目的是提高已故捐赠者肾移植的比例。次要目的是评估加拿大HSP项目对前1000例肾移植病例的全国性影响。参与加拿大HSP项目的移植候选人和接受移植的受者主要为女性(平均年龄50岁,女性占62%),血型为O型(候选者占47%,移植者占42%)。所有参加HSP项目的活跃移植候选人中,70%属于最难匹配的群体(cPRA≥99%),到目前为止,cPRA为100%的移植候选人中只有22%通过该项目接受了移植。cPRA≥99%的移植受者从首次参加加拿大HSP项目到移植的平均时间明显长于cPRA为95%至98%的受者,分别平均为22个月和6个月。到2024年6月底,加拿大HSP项目促成了1000例移植,其中613例来自省际匹配。平均(标准差)冷缺血时间(CIT)为14.5(5.9)小时,省际移植的CIT明显长于省内移植,平均多出4.7小时。

局限性

我们研究的局限性首先在于这是一项回顾性登记数据分析,目前没有可用的短期和长期临床结果数据(患者和移植物存活情况)。其次,鉴于登记数据的性质,并非所有相关数据都可能被收集到,而且可能并非所有患者的报告都完整。

启示

对CTR登记数据的审查表明,加拿大HSP项目对使1000名HSPs获得移植机会产生了有意义的影响,否则他们可能无法获得这些机会。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cea5/11672600/c3f812f25ea7/10.1177_20543581241306811-fig1.jpg

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