How does the methodological clinical evaluation impact organ donation? Experience from 4 Organ Procurement Organizations (OPO)

INTRODUCTION: The lack of a clear and reproducible methodology for evaluating potential organ donors, which ensures traceability in the process, can compromise the number of utilized organ donors and the transplantation quality. METHODOLOGY: We developed a reproducible and safe method for the evaluation and validation of Potential Organ Donors (PD) based on 2 principles:1) Updated knowledge of absolute contraindications for organ donation and, 2) Decision making supported by 3 questions. The first principle was absolute contraindications. They were categorized into 4 groups: A) Serologies, B) Tumors, C) Infections, and D) Biological risk for transmission of infectious diseases and cancer. The second principle was the decision-making questions: A) What is the cause of death? B) Are there absolute contraindications to organ donation? and, C) Are there relative contraindications to organ donation? Each PD was subjected to the same methodology. The questions were answered after knowing the PD's clinical file. The PD was valid only if the set of answers adhered to an established matrix respecting different guidelines. The same physician evaluated each PD in all OPO. We applied in 4 different OPO, 3 of them in the State of São Paulo/Brazil and one in the United Arab Emirates, in different periods, including the SARS-COV 2 pandemic. RESULTS: OPO­SCSP, before the methodology (2007): 62 utilized donors, 205 transplants. After the methodology has been started (2008/2009/2010): 117, 154, 186 utilized donors and 348, 533, 487 transplants, respectively. 2) OPO-BTU, before the methodology (2009): 9 utilized donors and 19 transplants. After the methodology has been started (2010/2011/2012): 17, 36, 49 utilized donors and 38, 90, 143 transplants, respectively. 3) OPO-IDPC, before the methodology (2017): 93 utilized donors and 202 transplants. After the methodology has been started (2018/2019/2020): 107, 177, 187 utilized donors and 219, 395, 356 transplants, respectively. 4) UAE OPO, before the methodology (2020): 9 utilized donors and 35 transplants. After the methodology has been started (2021/2022): 39, 55 utilized donors and 147, 203 transplants, respectively. The percentage increase after the beginning of the methodology, considering the last year evaluated: 1) OPO-SCSP: 195% (Utilized donors) and 137% (Transplants); 2) OPO-BTU: 444% (Utilized donors) and 652% (Transplants); C) OPO-IDPC: 101% (Utilized Donors) and 76% (Transplants); 4) OPO-EOTC (United Arab Emirates): 511% (Utilized donors) and 480% (Transplants). CONCLUSION: The methodology used demonstrates that it can directly contribute to increasing the percentage of effective donors and transplants. The increase in donors ranged from 101% to 444%. The percentage growth of transplantation ranged from 76% to 652%. Indirectly, an increase the referrals was observed, motivated by frequent contact with OPO members and ICU professionals.

Outcomes of lung transplantation at a Canadian center using donors declined in the United States.

OBJECTIVES: Donor lungs from the United States can be offered by US organ procurement organizations to Canada if no American centers accept them. The purpose of this study is to evaluate outcomes of patients undergoing transplant at a single center in Canada using declined lungs from the United States and to compare these outcomes to patients receiving lungs from Canadian donors. METHODS: A single-center retrospective review of recipients receiving lung transplantation between January 2009 and October 2019 was performed. An Organ Procurement and Transplantation Network standard transplant analysis and research-limited dataset as of August 17, 2021, was provided by the United Network for Organ Sharing. De-identified patient-level data were extracted from the standard transplant analysis and research file to identify lung offers made by US organ procurement organizations, declined by US lung centers, and transplanted by the University Health Network within the study time frame. We divided the analysis into 2 groups: recipients receiving donor lungs from Canada and recipients receiving donor lungs from the United States. Donor and recipient characteristics between the 2 groups were compared. Primary end point was proportional survival over a 10-year period. Secondary end points included 30-day mortality, intensive care unit and hospital length of stay, severe primary graft dysfunction, and incidence of chronic lung allograft dysfunction. RESULTS: During the study period, 1424 lung transplants were performed at our center. Of these, 124 (8.7%) were performed using donors from the United States. The incidence of transplants using US donors increased from 5% (5 out of 102) in 2009 to 15% (30 out of 200) in 2018. US donors were younger (aged 41 vs 47 years; P = .004), less likely to be from donors after cardiac death (9.6% vs 20%; P = .008), had higher use of ex vivo lung perfusion (EVLP, 46% vs 27%; P = .0002), and higher incidence of positive nucleic acid test for hepatitis C (16% vs 0.7%; P = .0001). Although the incidence of EVLP utilization was higher in the US lungs versus Canada lungs, more than half of US lungs (54%) proceeded directly to transplantation. Similar short- and long-term outcomes were observed between the 2 groups, including overall survival (hazard ratio, 1.12; 95% CI, 0.85-1.47; P = .40) CONCLUSIONS: Lung transplantation using donor lungs declined by multiple centers in the United States resulted in similar short- and long-term outcomes compared with donor lungs offered in Canada.

Ex Situ Perfusion of Human Limb Allografts for 24 Hours.

BACKGROUND: Vascularized composite allografts, particularly hand and forearm, have limited ischemic tolerance after procurement. In bilateral hand transplantations, this demands a 2 team approach and expedited transfer of the allograft, limiting the recovery to a small geographic area. Ex situ perfusion may be an alternative allograft preservation method to extend allograft survival time. This is a short report of 5 human limbs maintained for 24 hours with ex situ perfusion. METHODS: Upper limbs were procured from brain-dead organ donors. Following recovery, the brachial artery was cannulated and flushed with 10 000 U of heparin. The limb was then attached to a custom-made, near-normothermic (30-33°C) ex situ perfusion system composed of a pump, reservoir, and oxygenator. Perfusate was plasma-based with a hemoglobin concentration of 4 to 6 g/dL. RESULTS: Average warm ischemia time was 76 minutes. Perfusion was maintained at an average systolic pressure of 93 ± 2 mm Hg, flow 310 ± 20 mL/min, and vascular resistance 153 ± 16 mm Hg/L per minute. Average oxygen consumption was 1.1 ± 0.2 mL/kg per minute. Neuromuscular electrical stimulation continually displayed contraction until the end of perfusion, and histology showed no myocyte injury. CONCLUSIONS: Human limb allografts appeared viable after 24 hours of near-normothermic ex situ perfusion. Although these results are early and need validation with transplantation, this technology has promise for extending allograft storage times.

Early pancreas transplant outcomes with histidine-tryptophan-ketoglutarate preservation: a multicenter study.

Little is known about the use of histidine-tryptophan-ketoglutarate (HTK) preservation solution for pancreas preservation. We compared early pancreas graft outcomes at four pancreas transplant programs within the state of Michigan in 2002 and 2003 (University of Wisconsin [UW] era) with those in 2004 (HTK era). The primary endpoint was early graft loss. The UW group (n=41) and the HTK group (n=36) had similar outcomes with respect to: technical graft loss (9.8% vs. 8.3%, P=NS), 90-day graft function (90.2% vs. 86.1%, P=NS), and rate of pancreatic leak/abscess (12.2% vs. 11.1%, P=NS). There were also no significant differences in postoperative amylase and lipase levels between the two groups. The HTK group did have significantly more acute rejection within the first 180 days (25.0% vs. 9.8%, P<0.05). HTK is a suitable substitute for UW in the preservation of pancreas allografts.

Quantifying organ donation rates by donation service area.

Previous measures of OPO performance based on population counts have been deemed inadequate, and the need for new methods has been widely accepted. This article explains recent developments in OPO performance evaluation methodology, including those developed by the SRTR. As a replacement for the previously established measure of OPO performance--donors per million population--using eligible deaths as a national metric has yielded promising results for understanding variations in donation rates among the donation service areas assigned to each OPO. A major improvement uses "notifiable deaths" as a denominator describing a standardized maximal pool of potential donors. Notifiable deaths are defined as in-hospital deaths among ages 70 years and under, excluding certain diagnosis codes related to infections, cancers, etc. A most proximal denominator for determining donation rates is "eligible deaths," which includes only those deaths meeting the criteria for organ donation upon initial assessment. Neither measure is based on the population of a geographic unit, but on restricted upper limits of deaths that could be potential donors in any one locale (e.g., hospital or OPO). The inherent strengths and weaknesses of metrics such as donors per eligible deaths, donors per notifiable deaths, and number of organs per donor are discussed in detail.