Logistics and Strategy of Multiorgan Procurement Involving Total Face Allograft

The face is the latest body structure to be added to the field of transplantation and the learning curve is ongoing. In the scenario of multiorgan recovery, the face is a nonvital ‘organ’ structure compared with other life‐saving organs. To date, the face has been the first ‘organ’ to be procured in a multiorgan procurement. A technique for simultaneous recovery of the whole face, heart, lungs, liver, pancreas and kidneys is described. Thirty professionals participated in the procedure, of whom 13 were surgeons. No tracheotomy was performed. A mask of the donor's face was made from a mold impression. Duration of the procedure from skin incision to the end of surgery was 7.3 h. The face was perfused with Wisconsin solution through a cannula inserted into the aortic arch between the origin of the brachiocephalic arterial trunk and the left subclavian artery. Blood requirements consisted of 4 units of packed red blood cells. After the procedure, the mask was placed on the donor's face. All recovered grafts functioned immediately. In summary, simultaneous multiorgan procurement including the whole face is feasible, effective and saves time without jeopardizing life‐saving organs and without the need for tracheotomy.     

The Nondirected Living Donor Program: A Model for Cooperative Donation, Recovery and Allocation of Living Donor Kidneys

We describe an altruistic nondirected (ND) and live donor/deceased donor list exchange (LE) donor program administered by an organ procurement organization (OPO) in the Washington, DC area. Screening eliminated 25 donors (17 NE; 8 LE) from the 97 donor applications (62 ND; 35 LE) completed. Twenty-one donors (16 ND; 5 LE) failed to follow through with the psychiatric evaluation, which eliminated 13 donors (9 ND; 4 LE). Two donors dropped out and 12 (9 ND; 3 LE) were medically unsuitable after final clinical evaluation. Twenty donor procedures were performed (10 ND; 10 LE) with four pending (2 ND; 2 LE). This resulted in a modest 3-5% increase in the OPO-procured kidney organ pool. The average cold ischemia time of the grafts not transported between transplant centers was 205 +/- 66 min compared with 243 +/- 48 min for transported grafts. With no documented adverse outcomes, donors had a hospital stay of length 2.9 days and at home recuperation of 12.3 days. Three- and 6-month creatinines were 1.44 +/- 1.36 and 1.68 +/- 0.61 for grafts not transported between transplant centers, and 1.6 +/- 0.27 and 1.6 +/- 0.44 for transported grafts. An OPO-administered altruistic donor program can serve as a model for cooperative donation, recovery and allocation of living donor kidneys.     

Evidence‐based development of liver allocation: a review

Liver transplantation has undergone a rapid evolution from a high‐risk experimental procedure to a mainstream therapy for thousands of patients with a wide range of hepatic diseases. Its increasing success has been accompanied by progressive imbalance between organ donor supply and the patients who might benefit. Where demand outstrips supply in transplantation, a system of organ allocation is inevitably required to make the wisest use of the available, but scarce, organs. Early attempts to rationally allocate donor livers were particularly hampered by lack of available and suitable data, leading to imperfect solutions that created or exacerbated inequities in the system. The advent and maturation of evidence‐based predictors of waiting list mortality risk led to more objective criteria for liver allocation, aided by the increasing availability of data on large numbers of patients. Until now, the vast majority of allocation systems for liver transplantation have relied on estimation of waiting list mortality. Evidence‐based allocation systems that incorporate measures of post‐transplant outcomes are conceptually attractive and these transplant benefit‐based allocation systems have been developed, modeled, and subjected to computer simulation. Future implementations of benefit‐based liver allocation await continued refinement and additional debate in the transplant community.     

The Influence of End‐of‐Life Care on Organ Donor Potential

Many patients with acute devastating brain injury die outside intensive care units and could go unrecognized as potential organ donors. We conducted a prospective observational study in seven hospitals in the Netherlands to define the number of unrecognized potential organ donors outside intensive care units, and to identify the effect that end‐of‐life care has on organ donor potential. Records of all patients who died between January 2013 and March 2014 were reviewed. Patients were included if they died within 72 h after hospital admission outside the intensive care unit due to devastating brain injury, and fulfilled the criteria for organ donation. Physicians of included patients were interviewed using a standardized questionnaire regarding logistics and medical decisions related to end‐of‐life care. Of the 5170 patients screened, we found 72 additional potential organ donors outside intensive care units. Initiation of end‐of‐life care in acute settings and lack of knowledge and experience in organ donation practices outside intensive care units can result in under‐recognition of potential donors equivalent to 11–34% of the total pool of organ donors. Collaboration with the intensive care unit and adjusting the end‐of‐life path in these patients is required to increase the likelihood of organ donation.     

Professionalization of surgical abdominal organ recovery leading to an increase in pancreatic allografts accepted for transplantation in the Netherlands: a serial analysis

Professional abdominal organ recovery with certification has been mandatory in the Netherlands since 2010. This study analyses the effects of certification (January 2010–September 2015) on pancreas transplantation and compares it to an era before certification (February 2002–May 2008) for surgical injuries and the number of pancreases transplanted. A total of 264 cases were analysed. Eighty‐four recovered pancreases (31.8%) with surgically injuries were encountered. Forty‐six of those were surgically salvaged for transplantation, resulting in a total of 226 (85.6%) being transplanted. It was found that certified surgeons recovered grafts from older donors (36.8 vs. 33.3; P = 0.021), more often from donation after circulatory death (DCD) donors (18% vs. 0%; P < 0.001) and had less surgical injuries (21.6% vs. 41.0%; P < 0.001). Certification (OR: 0.285; P < 0.001) and surgeons from a pancreas transplant centre (OR: 0.420; P = 0.002) were independent risk factors for surgical organ injury. Predictors for proceeding to the actual pancreas transplantation were a recovering surgeon from a pancreas transplantation centre (OR: 3.230; P = 0.003), certification (OR: 3.750; P = 0.004), donation after brain death (DBD) (OR: 8.313; P = 0.002) and donor body mass index (BMI) (OR: 0.851; P = 0.023). It is concluded that certification in abdominal organ recovery will limit the number of surgical injuries in pancreas grafts which will translate in more pancreases available for transplantation.     

Intensivist‐Led Management of Brain‐Dead Donors Is Associated with an Increase in Organ Recovery for Transplantation

The disparity between the number of patients in need of organ transplantation and the number of available organs is steadily rising. We hypothesized that intensivist‐led management of brain dead donors would increase the number of organs recovered for transplantation. We retrospectively analyzed data from all consented adult brain dead patients in the year before (n = 35) and after (n = 43) implementation of an intensivist‐led donor management program. Donor characteristics before and after implementation were similar. After implementation of the organ donor support team, the overall number of organs recovered for transplantation increased significantly (66 out of 210 potentially available organs vs. 113 out of 258 potentially available organs, p = 0.008). This was largely due to an increase in the number of lungs (8 out of 70 potentially available lungs vs. 21 out of 86 potentially available lungs; p = 0.039) and kidneys (31 out of 70 potentially available kidneys vs. 52 out of 86 potentially available kidneys; p = 0.044) recovered for transplantation. The number of hearts and livers recovered for transplantation did not change significantly. Institution of an intensivist‐led organ donor support team may be a new and viable strategy to increase the number of organs available for transplantations.     

Defining the Tipping Point in Surgical Performance for Laparoscopic Donor Nephrectomy Among Transplant Surgery Fellows: A Risk‐Adjusted Cumulative Summation Learning Curve Analysis

The United Network for Organ Sharing recommends that fellowship‐trained surgeons participate in 15 laparoscopic donor nephrectomy (LDN) procedures to be considered proficient. The American Society of Transplant Surgeons (ASTS) mandates 12 LDNs during an abdominal transplant surgery fellowship. We performed a retrospective intraoperative case analysis to create a risk‐adjusted cumulative summation (RACUSUM) model to assess the learning curve of novice transplant surgery fellows (TSFs). Between January 2000 and December 2014, 30 novice TSFs participated in the organ procurement rotation of our ASTS‐approved abdominal transplant surgery fellowship. Measures of surgical performance included intraoperative time, estimated blood loss, and incidence of intraoperative complications. The performance of senior TSFs was used to benchmark novice TSF performance. Scores were tabulated in a learning curve model, adjusting for case complexity and prior TSF case volume. Rates of adverse surgical events were significantly higher for novice TSFs than for senior TSFs. In univariable analysis, multiple renal arteries, high BMI, prior abdominal surgery, male donor, and nephrolithiasis were correlated with higher incidence of adverse surgical events. Based on the RACUSUM model, high intraoperative time is mitigated after 28 procedures, incidence of intraoperative complications tends to diminish after 24 procedures, and improvement in estimated blood loss did not remain consistent. TSFs exhibit a tipping point in LDN performance by 24–28 cases and proficiency by 35–38 cases.     

Kidney Transplantation From a Donor With Sickle Cell Disease

In the United States, >100 000 patients are waiting for a kidney transplant. Given the paucity of organs available for transplant, expansion of eligibility criteria for deceased donation is of substantial interest. Sickle cell disease (SCD) is viewed as a contraindication to kidney donation, perhaps because SCD substantially alters renal structure and function and thus has the potential to adversely affect multiple physiological processes of the kidney. To our knowledge, transplantation from a donor with SCD has never been described in the literature. In this paper, we report the successful transplantation of two kidneys from a 37‐year‐old woman with SCD who died from an intracranial hemorrhage. Nearly 4 mo after transplant, both recipients are doing well and are off dialysis. The extent to which kidneys from donors with SCD can be safely transplanted with acceptable outcomes is unknown; however, this report should provide support for the careful expansion of kidneys from donors with SCD without evidence of renal dysfunction and with normal tissue architecture on preimplantation biopsies.     

Organ Procurement Organization Compliance with 21 CFR 1271: A Challenge for Allogeneic Pancreatic Islet Cell Transplantation Programs

In order to protect tissue recipients, the Food and Drug Administration drafted Title 21, Section 1271 of the Code of Federal Regulations 1271 (21 CFR 1271) to address infectious disease risk. These regulations apply to tissues but not vascularized organs. Pancreatic islet cells are regulated under 21 CFR 1271. These regulations require qualification of suppliers of critical materials and services with regard to 21 CFR 1271 compliance. As part of supplier qualification, all organ procurement organizations (OPOs) in the United States were sent a questionnaire covering the key components of these regulations. Of the 57 OPOs, 29 (51%) were in compliance based upon survey results. Twelve (21%) were not compliant in one or more areas. All indicated plans to become compliant. The remaining 15 (27%) either failed or refused to complete the survey, some indicating 21 CFR 1271 did not apply to OPOs. Using 2006 data, OPOs compliant with 21 CFR 1271 recovered 50% of the organs procured in the United States. These findings represent a challenge for allogeneic islet cell transplant programs whose raw material must comply with 21 CFR 1271. OPOs should work toward understanding and complying with 21 CFR 1271. Regulatory agencies should work toward enhancing safety of the pancreas supply by facilitating compliance through harmonization of requirements.     

First‐in‐man controlled rewarming and normothermic perfusion with cell‐free solution of a kidney prior to transplantation

Cold preservation sensitizes organ grafts to exacerbation of tissue injury upon reperfusion. This reperfusion injury is not fully explained by the mere re‐introduction of oxygen but rather is pertinent to the immediate rise in metabolic turnover associated with the abrupt restoration of normothermia. Here we report the first clinical case of gradual resumption of graft temperature upon ex vivo machine perfusion from hypothermia up to normothermic conditions using cell‐free buffer as a perfusate. A kidney graft from an extended criteria donor was put on the machine after 12.5 hours of cold storage. During ex vivo perfusion, perfusion pressure and temperature were gradually elevated from 30 mm Hg and 8°C to 75 mm Hg and 35°C, respectively. Perfusate consisted of diluted Steen solution, oxygenated with 100% oxygen. Final flow rates at 35°C were 850 mL/min. The kidney was transplanted without complications and showed good immediate function. Serum creatinine fell from preoperative 720 µmol/L to 506 µmol/L during the first 24 hours after transplantation. Clearance after 1 week was 43.1 mL/min. Controlled oxygenated rewarming prior to transplantation can be performed up to normothermia without blood components or artificial oxygen carriers and may represent a promising tool to mitigate cold‐induced reperfusion injury or to evaluate graft performance.     

Survival Benefit From Kidney Transplantation Using Kidneys From Deceased Donors Aged ≥75 Years: A Time‐Dependent Analysis

Patients with end‐stage renal disease have longer survival after kidney transplantation than they would by remaining on dialysis; however, outcome with kidneys from donors aged ≥75 years and the survival of recipients of these organs compared with their dialysis counterparts with the same probability of obtaining an organ is unknown. In a longitudinal mortality study, 2040 patients on dialysis were placed on a waiting list, and 389 of them received a first transplant from a deceased donor aged ≥75 years. The adjusted risk of death and survival were calculated by non–proportional hazards analysis with being transplanted as a time‐dependent effect. Projected years of life since placement on the waiting list was almost twofold higher for transplanted patients. Nonproportional adjusted risk of death after transplantation was 0.44 (95% confidence interval [CI] 0.61–0.32; p < 0.001) in comparison with those that remained on dialysis. Stratifying by age, adjusted hazard ratios for death were 0.17 (95% CI 0.47–0.06; p = 0.001) for those aged <65 years, 0.56 (95% CI 0.92–0.34; p = 0.022) for those aged 65–69 years and 0.82 (95% CI 1.28–0.52; p = 0.389) for those aged ≥70 years. Although kidney transplantation from elderly deceased donors is associated with reduced graft survival, transplanted patients have lower mortality than those remaining on dialysis.     

APOL1‐Associated End‐Stage Renal Disease in a Living Kidney Transplant Donor

Homozygosity for apolipoprotein‐L1 (APOL1) risk variants has emerged as an important predictor of renal disease in individuals of African descent over the past several years. Additionally, these risk variants may be important predictors of renal allograft failure when present in a living or deceased donor. Currently, there is no universal recommendation for screening of potential donors. We present a case of end‐stage renal disease with focal segmental glomerulosclerosis in a living donor 7 years following donor nephrectomy. Genetic assessment revealed homozygosity for the G1 high‐risk APOL1 variant.