Living donor liver transplant candidate and donor selection and engagement: Meeting report from the living donor liver transplant consensus conference.

INTRODUCTION: Living donor liver transplantation (LDLT) is a promising option for mitigating the deceased donor organ shortage and reducing waitlist mortality. Despite excellent outcomes and data supporting expanding candidate indications for LDLT, broader uptake throughout the United States has yet to occur. METHODS: In response to this, the American Society of Transplantation hosted a virtual consensus conference (October 18-19, 2021), bringing together relevant experts with the aim of identifying barriers to broader implementation and making recommendations regarding strategies to address these barriers. In this report, we summarize the findings relevant to the selection and engagement of both the LDLT candidate and living donor. Utilizing a modified Delphi approach, barrier and strategy statements were developed, refined, and voted on for overall barrier importance and potential impact and feasibility of the strategy to address said barrier. RESULTS: Barriers identified fell into three general categories: 1) awareness, acceptance, and engagement across patients (potential candidates and donors), providers, and institutions, 2) data gaps and lack of standardization in candidate and donor selection, and 3) data gaps regarding post-living liver donation outcomes and resource needs. CONCLUSIONS: Strategies to address barriers included efforts toward education and engagement across populations, rigorous and collaborative research, and institutional commitment and resources.

The utility of thrombophilia and hematologic screening in live liver donation.

BACKGROUND: Most centers perform some degree of hematologic screening, including thrombophilia testing, on prospective live liver donors. The nature and extent of such screens are not standardized, and there is limited evidence regarding hematologic risk stratification. METHODS AND RESULTS: We present an experience of hematologic screening among prospective liver donors. Five-hundred-eightyfour patients were screened for liver donation between 1/2013 and 1/2020, of whom 156 (27%) proceeded to donor hepatectomy. Thirty-three of 428 (8%) declined patients were excluded for hematologic indications. Hematologic indications were the 2nd most frequent medical indications for exclusion (trailing only hepatologic indications). The most common reason for hematologic exclusion was concern regarding thrombophilia. Nevertheless, 21 patients with evidence of possible thrombophilia proceeded to donor hepatectomy, and none incurred hematologic complications. Similarly, seven patients with screening findings concerning for increased bleeding risk (most often thrombocytopenia) underwent donor hepatectomy without hematologic complication. Three of 156 (2%) of patients who underwent donor hepatectomy incurred a hematologic complication (all thrombotic, none fatal). None of these patients had any evident hematologic risk factor on screening. CONCLUSION: This study underscores the difficulty of hematologic risk stratification among prospective living donors, however, suggests that some patients with relatively mild risk factors may be safe for donation.

Evaluation and care of international living kidney donor candidates: Strategies for addressing common considerations and challenges.

End-stage kidney disease patients in the United States may have family members or friends who are not US citizens or residents but are willing to serve as their living kidney donor in the United States ("international donors"). In July 2017, the American Society for Transplantation (AST) Live Donor Community of Practice (LDCOP) convened a multidisciplinary workgroup of experts in living donation care, including coordinators, social workers, donor advocates, administrators, and physicians, to evaluate educational gaps related to the evaluation and care of international donors. The evaluation of international living donor candidates is a resource-intensive process that raises key considerations for assessing risk of exploitation/inducement and addressing communication barriers, logistics barriers, and access to care in their home country. Through consensus-building discussions, we developed recommendations related to: (a) establishing program guidelines for international donor candidate evaluation and selection; (b) initial screening; (c) logistics planning; (d) comprehensive evaluation; and (e) postdonation care and follow-up. These recommendations are not intended to direct formal policy, but rather as guidance to help programs more efficiently and effectively structure and execute evaluations and care coordination. We also offer recommendations for research and advocacy to optimize the care of this unique group of living donors.

Care of international living kidney donor candidates in the United States: A survey of contemporary experience, practice, and challenges.

The evaluation and care of non-US citizen, non-US residents who wish to come to the United States to serve as international living kidney donors (ILKDs) can pose unique challenges. We surveyed US transplant programs to better understand practices related to ILKD care. We distributed the survey by email and professional society list-servs (Fall 2018, assessing 2017 experience). Eighty-five programs responded (36.8% program response rate), of which 80 considered ILKD candidates. Only 18 programs had written protocols for ILKD evaluation. Programs had a median of 3 (range: 0,75) ILKD candidates who initiated contact during the year, from origin countries spanning 6 continents. Fewer (median: 1, range: 0,25) were approved for donation. Program-reported reasons for not completing ILKD evaluations included visa barriers (58.6%), inability to complete evaluation (34.3%), concerns regarding follow-up (31.4%) or other healthcare access (28.6%), and financial impacts (21.4%). Programs that did not evaluate ILKDs reported similar concerns. Staff time required to evaluate ILKDs was estimated as 1.5-to-3-times (47.9%) or >3-times (32.9%) that needed for domestic candidates. Among programs accepting ILKDs, on average 55% reported successful completion of 1-year follow-up. ILKD evaluation is a resource-intensive process with variable outcomes. Planning and commitment are necessary to care for this unique candidate group.

Is obesity a contraindication for kidney donation?

INTRODUCTION: To enlarge the donor pool, kidney donors with obesity have been considered. We hypothesized that it is safe for patients with obesity to serve as living kidney donors. METHODS: In this single-center retrospective analysis, we examined the effect of obesity (body mass index (BMI) of 30-35 kg/m2) on glomerular filtration rate (GFR) and creatinine in patients undergoing laparoscopic donor nephrectomy. Other outcomes included intraoperative, 30-, and 90-day complications. We examined the trajectory between patients with obesity versus patients without obesity over time using mixed effects models for the outcomes of creatinine in mg/dL and GFR in mL/min/1.73 m2. RESULTS: Among donors with obesity versus donors without obesity, there were no significant differences in demographics or comorbidities. Baseline creatinine in donors with obesity was significantly greater than that of donors without obesity (p = 0.02). Operative time was significantly longer in donors with obesity versus without obesity (p = 0.03). There was no significant difference in 30-day morbidity between donors with obesity versus without obesity (6.52 vs. 3.57%, respectively; p = 0.38). The rate of graft complications was 8.7% in donors with obesity versus 7.1% in donors without obesity (p = 1.0). 90-day complications were infrequent, and not significant different between the groups. At 6, 12, and 24-month postoperative follow-up, the mean creatinine level in patients with obesity was not significantly different from that of patients without obesity (1.23 vs. 1.31, 1.23 vs. 1.26, and 1.17 vs. 1.19 at 6, 12, and 24 months, respectively). Mean GFR was also not significantly different at 6, 12, and, 24 months. CONCLUSION: Postoperative creatinine and GFR changes were not significantly different in patients with obesity versus without obesity after laparoscopic donor nephrectomy. These findings suggest that carefully screened living kidney donors with obesity do not experience decreased postoperative renal function.

Impact of the OPTN transmissible diseases policy and US PHS increased risk donor guidelines on living donor candidates.

Donor-derived human immunodeficiency virus (HIV), hepatitis C virus (HCV), and hepatitis B virus (HBV) transmissions in transplantation have led to policies mandating assessment of donor behavioral history, and disclosure of donor increased risk (IR) status to recipients. Organ Procurement Transplantation Network (OPTN) policy safeguards were promulgated in the context of deceased donation, with its narrow time window for organ utilization and uncertainty about donor history. These policies have been applied to living donation without substantive data on risk of disease transmission in living donor transplantation. Unlike for deceased donors, the OPTN does not collect data on living donor IR status. Given the feasibility of thorough living donor evaluation via already-mandated lab tests and clinical assessments, living donor IR assessment and associated disclosures may have limited benefit in improving recipient informed consent. Applying the current IR policy to living donors may also introduce unintended consequences to donors and recipients, causing donors psychological harm, delays in donation to avoid IR status disclosure, and potential withdrawal from donation. We suggest strategies that reduce risk of harm to donor candidates while maintaining policy compliance, and review additional approaches for evaluating risk of disease transmission in living donor candidates. Data on the risk of disease transmission by living donors are needed to inform policy modification.

Multicenter investigation of the reliability and validity of the live donor assessment tool as an enhancement to the psychosocial evaluation of living donors.

The live donor assessment tool (LDAT) is the first psychosocial assessment tool developed to standardize live donor psychosocial evaluations. A multicenter study was conducted to explore reliability and validity of the LDAT and determine its ability to enhance the psychosocial evaluation beyond its center of origin. Four transplant programs participated, each with their own team of evaluators and unique demographics. Liver and kidney living donors (LDs) undergoing both standard psychosocial evaluation and LDAT from June 2015 to September 2016 were studied. LDAT interrater reliability, associations between LDAT scores and psychosocial evaluation outcome, and psychosocial outcomes postdonation were tested. 386 LD evaluations were compared and had a mean LDAT score of 67.34 ± 7.57. In 140 LDs with two LDATs by different observers, the interrater scores correlated (r = 0.63). LDAT scores at each center and overall stratified to the conventional grouping of psychosocial risk level. LDAT scores of 131 subjects who proceeded with donation were expectedly lower in LDs requiring postdonation counseling (t = -2.78, P = .01). The LDAT had good reliability between raters and predicted outcome of the psychosocial evaluation across centers. It can be used to standardize language among clinicians to communicate psychosocial risk of LD candidates and assist teams when anticipating postdonation psychosocial needs.

Longterm Impact of Living Liver Donation: A Self-Report of the Donation Experience.

Outcomes for adult-to-adult living liver donors (LDs) are largely based on short-term data drawn from single-center studies. The aim of this study was to determine how living liver donation (LLD) impacts self-reported quality-of-life (QOL) up to 6 years after donation in a sample of residents from New York State. New York transplant programs are state-mandated to track LDs as part of a quality assurance and patient safety effort. Donor-reported QOL within 1 year of donation and longitudinal data over a 10-year period were analyzed. Self-reported surveys include the following domains: employment, finances, health/life insurance, activities of daily living, physical/emotional health, donor experience, relationships, and LD opinions. There were 220 LDs in New York (2004-2013) who completed a survey over the 10-year period with many donors completing surveys at several points in time. Overall, longterm LDs remain as comfortable about LLD as they were during the first year after donation (95%). The majority of LDs reported feeling as well as before LLD (72%). At 1 year after donation, 60% of subjects self-reported medical problems, and 30% reported emotional issues. However, the majority reported that they would willingly donate again. In conclusion, LDs remain satisfied with their decision to donate over time. A minority of LDs report longterm medical and emotional issues. The conclusions provide information for educational interventions to improve informed choice to those considering donation.

Increasing living donation by implementing the Kidney Coach Program.

Candidates for living donor kidney transplantation (LDKT) find it difficult to discuss living donation with people in their social network, and there is a lack of useful interventions to train them. The Kidney Coach Program (KCP) was developed to equip individuals (advocates for candidates and candidate themselves) with the tools needed to find potential donors. The purpose of this pilot study is to evaluate the effects of the KCP on increasing the number of people considering living donation. METHODS: Candidates for the KCP were recruited. Data were collected on the number of live donor inquiries in the coach group compared to listed patients (historical controls). RESULTS: Over a 12-month period, 20 transplant candidates enrolled in the KCP were compared to 50 controls. Eighty percent of the participants in the KCP had at least one donor inquiry compared to 38% of controls (P = 0.001). Significantly, more Caucasian candidates participated in the KCP compared to other racial groups. CONCLUSIONS: The KCP can be an effective method to increase awareness of a patient's need for LDKT. Existing clinical staff successfully implemented the program. Transplant programs should provide training to candidates and their supports on effective ways to find a living donor.

A Prospective Study of the Reliability and Validity of the Live Donor Assessment Tool.

BACKGROUND: The psychosocial evaluation is an important part of the live organ donor evaluation process, yet this is not standardized across institutions. OBJECTIVE: This study was designed to prospectively test the reliability and validity of a semistructured psychosocial evaluation tool that was recently developed and reported in the literature (the Live Donor Assessment Tool [LDAT]). METHODS: A total of 248 live donor candidates who presented for evaluation were invited to participate in a study that involved the LDAT being scored as part of the standard psychosocial evaluation process; 222 provided informed consent. Evaluations were conducted by staff experienced with psychosocial evaluation of living donors and trained in the use of the LDAT. Furthermore, 123 donor candidates were evaluated twice, as per routine standard of care, and had 2 LDATs administered. Reliability of the LDAT was assessed by calculating the internal consistency of the LDAT items and inter-rater reliability. Validity was assessed by comparing LDAT scores across the risk-group categories (the traditional outcome designation of the psychosocial evaluation) and in 86 eventual donors, associations between LDAT scores, and indicators of psychosocial outcomes post-donation. RESULTS: The LDAT was found to have good internal consistency, strong inter-rater reliability, and showed signs of validity: LDAT scores differentiated the traditional risk-group categories, and a significant association between LDAT score and treatment adherence post-donation was revealed. CONCLUSIONS: The LDAT demonstrated good reliability and validity, but future research on the LDAT and the ability to implement the LDAT across institutions is warranted.

Upper midline incision for living donor right hepatectomy.

BACKGROUND: Living donor liver transplantation is a viable option to increase access to transplantation and techniques to limit the operative incision is one way to increase donation by decreasing donor morbidity. We describe our experience with a limited upper midline incision (UMI) for living donor right hepatectomy. STUDY DESIGN: Prospective data were collected on 58 consecutive living liver donors who underwent right hepatectomy via a UMI. RESULTS: Donor median age was 32 years, with median body mass index of 24.6. The mean incision length was 11.7 cm. Ten liver grafts included middle hepatic vein. The mean graft volume by preoperative imaging was 940 cc. The mean operative time was 407 minutes; cellsaver was utilized in 35 patients with median of 1 unit. Mean peak aspartate transaminase (AST) and alanine transaminase (ALT) were 492 and 469, and peak bilirubin and international normalized ratio (INR) were 3.3 and 1.8. The average length of stay was 6 days. There were 10 Clavien grade I and 11 Clavien grade II complications. Three patients developed an incisional hernia requiring surgical repair. CONCLUSION: Living liver donor hepatectomy can be safely performed through a UMI. This approach consolidates the steps of liver mobilization, hilar dissection, and parenchymal transection in a single-exposure technique, with incision comparable to the laparoscopic-assisted modality.

Comparison of Single-Port Robotic Donor Nephrectomy and Laparoscopic Donor Nephrectomy.

Purpose: To compare the intra- and postoperative outcomes of single-port robotic donor nephrectomies (SP RDNs) and laparoscopic donor nephrectomies (LDNs). Materials and Methods: We retrospectively reviewed our institutional database for patients who received LDN or SP RDN between September 2020 and December 2022. Donor baseline characteristics, intraoperative outcomes, postoperative outcomes, and recipient renal function were extracted and compared between LDN and SP RDN. SP RDN learning curve analysis based on operative time and graft extraction time was performed using cumulative sum analysis. Results: One hundred forty-four patients underwent LDN and 32 patients underwent SP RDN. LDN and SP RDN had similar operative times (LDN: 190.3 ± 28.0 minutes, SP RDN: 194.5 ± 35.1 minutes, p = 0.3253). SP RDN patients had significantly greater extraction times (LDN: 83.2 ± 40.3 seconds, SP RDN: 204.1 ± 52.2 seconds, p < 0.0001) and warm ischemia times (LDN: 145.1 ± 61.7 seconds, SP RDN: 275.4 ± 65.6 seconds, p < 0.0001). There were no differences in patient subjective pain scores, inpatient opioid usage, or Clavien-Dindo II+ complications. Short- and medium-term postoperative donor and recipient renal function were also similar between the groups. SP RDN graft extraction time and total operative time learning curves were achieved at case 27 and 13, respectively. Conclusion: SP RDN is a safe and feasible alternative to LDN that minimizes postoperative abdominal incisional scars and has a short learning curve. Future randomized prospective clinical trials are needed to confirm the findings of this study and to identify other potential benefits and drawbacks of SP RDNs.

Outcomes of Living Kidney Donor Candidate Evaluations in the Living Donor Collective Pilot Registry.

BACKGROUND: Gaps in our knowledge of long-term outcomes affect decision making for potential living kidney donors. METHODS: The Scientific Registry of Transplant Recipients was asked to determine the feasibility of a candidate registry. RESULTS: Ten living kidney donor programs evaluated 2107 consecutive kidney donor candidates; 2099 of 2107 (99.6%) completed evaluations, 1578 of 2099 (75.2%) had a decision, and 790 of 1578 (50.1%) were approved to donate as of March 12, 2020. By logistic regression, candidates most likely to be approved were married or had attended college or technical school; those least likely to be approved had ≥1 of the following characteristics: Black race, history of cigarette smoking, and higher blood pressure, higher triglycerides, or higher urine albumin-to-creatinine ratios. Reasons for 617 candidates not being approved included medical issues other than chronic kidney disease risk (25.3%), chronic kidney disease risk (18.5%), candidate withdrawal (15.2%), recipient reason (13.6%), anatomical risk to the recipient (10.3%), noneconomic psychosocial (10.3%), economic (0.5%), and other reasons (6.4%). CONCLUSIONS: These results suggest that a comprehensive living donor registry is both feasible and necessary to assess long-term outcomes that may inform decision making for future living donor candidates. There may be socioeconomic barriers to donation that require more granular identification so that active measures can address inequities. Some candidates who did not donate may be suitable controls for discerning the appropriateness of acceptance decisions and the long-term outcomes attributable to donation. We anticipate that these issues will be better identified with modifications to the data collection and expansion of the registry to all centers over the next several years.

A peer-based intervention to educate liver transplant candidates about living donor liver transplantation.

The number of liver donors has not measurably increased since 2004 and has begun to decrease. Although many waitlisted patients may be suitable candidates to receive a living donor graft, they are often reticent to discuss living donation with close friends and family, partly because of a lack of knowledge about donor health and quality of life outcomes after donation. The objective of this study was to test the effectiveness of an educational intervention that uses testimonials and self-report data from living donors in New York State. The study had an independent sample pretest (n = 437) and posttest (n = 338) design with posttest, between-subjects comparison for intervention exposure. All waitlisted patients at 5 liver transplant centers in New York were provided a peer-based educational brochure and DVD either by mail or at the clinic. The outcome measures were liver candidates' knowledge and self-efficacy to discuss living donation with family and friends. The number and proportion of individuals who presented to centers for living liver donation evaluation were also measured. Liver transplant candidates' self-efficacy to discuss living donation and their knowledge increased from the pretest period to the posttest period. Those exposed to the peer-based intervention reported significantly greater knowledge, a greater likelihood of discussing donation, and increased self-efficacy in comparison with those not exposed to the intervention. The results did not differ by age, length of time on the waiting list, education, or ethnicity. In comparison with the preintervention period, living donation increased 42%, and the number of individuals who presented for donation evaluation increased by 74%.

Quality improvement in the care of live liver donors: implementation of the Designated Donor Nurse Program.

Publications on living donor liver transplant have focused on the medical aspects of donor selection, postoperative management, surgical procedures, and outcomes, but little attention has been given to the nursing implications for care of live liver donors during their inpatient stay. Donor advocates from various disciplines are involved during the initial education and evaluation, but most care after surgery is delivered by an inpatient medical team and bedside nursing staff who are not as familiar with the donor and concepts related to donor advocacy. In an effort to improve the overall donor experience and provide safe, high-quality care to patients undergoing elective partial hepatectomy, our academic medical center began a quality improvement project focused on improving the inpatient stay. Inpatient nursing standards and policies and procedures were developed to ensure that consistent care is delivered. However, the infrequency of living donor liver transplantation makes it nearly impossible to have all transplant program staff on a nursing unit be "experts" on donor care. Therefore, our center determined that, similar to the Independent Donor Advocacy Team, a transplant program needs live donor champions on the nursing unit to mirror the goals of the team. To that end, we developed the concept of the Designated Donor Nurse to care for and advocate for live liver donors during the inpatient stay and also to serve as a resource to their colleagues.

Digital imaging of extended criteria donor livers to facilitate placement and utilization.

The disparity between organ supply and demand has necessitated more aggressive use of livers from extended criteria donors. Organ sharing between donor service areas and transplant centers in other regions is common. Confidence in the graft quality is greatly improved with a digital image taken in conjunction with the recovery surgeon's report and biopsy data. Three cases in which digital images of various levels of quality allowed the recipient's surgery to proceed, minimized the cold ischemia time, and yielded excellent outcomes are described. Another case in which a picture was not available and the liver was discarded after importation is also presented for comparison.

Robotic-assisted vs. laparoscopic donor nephrectomy: a retrospective comparison of perioperative course and postoperative outcome after 1 year.

Safety is of utmost importance in live donor nephrectomies. In this study, we describe our initial experience with robot-assisted laparoscopic donor nephrectomy (RDN) in comparison with the standard laparoscopic donor nephrectomy (LDN). We retrospectively reviewed 95 patients who either underwent RDN or LDN performed by a single surgeon from 2011 to 2016 at a tertiary institution. Donor perioperative course and postoperative outcome along with recipient outcomes were compared. Of the 95 cases, 73 were classified as LDN and 22 were classified as RDN. There were no significant differences between the two groups in age, sex, BMI, race, and ASA status. Operative times (p < 0.001) were longer in the RDN group, but eventually approached LDN times. Warm ischemia (p = 0.002) and extraction times (p = 0.05) were also longer in the RDN cohort. The donor length of hospital stay, complication rates, and postoperative change in eGFR from baseline were similar in both cohorts up to 1 year. Recipient outcomes, including delayed graft function, graft failure, and renal function up to 1 year, were also comparable. In this study, we compared the longest postoperative course so far in both donors and recipients between RDN and LDN. Up to 1 year, RDN does not negatively impact outcomes. Proficiency with RDN also quickly improved to match LDN, making it a suitable procedure for newer surgeons.

Selection and Postoperative Care of the Living Donor.

Live organ donors typically consult their primary care providers when considering live donation and then return for follow-up after surgery and for ongoing primary care. Live liver and kidney transplants are performed routinely as a method to shorten the waiting time for a recipient, provide a healthy organ for transplant, and increase recipient survival. Careful medical and psychosocial evaluation of the potential donor is imperative to minimize harm. This evaluation must be performed by an experienced live donor medical team. Routine health care with careful attention to weight maintenance, cardiovascular health, and prevention of diabetes and hypertension is paramount.