Impact of measured versus estimated glomerular filtration rate-based screening on living kidney donor characteristics: A study of multiple cohorts.

BACKGROUND: Most transplant centers in the Netherlands use estimated glomerular filtration rate (eGFR) for evaluation of potential living kidney donors. Whereas eGFR often underestimates GFR, especially in healthy donors, measured GFR (mGFR) allows more precise kidney function assessment, and therefore holds potential to increase the living donor pool. We hypothesized that mGFR-based donor screening leads to acceptance of donors with lower pre-donation eGFR than eGFR-based screening. METHODS: In this longitudinal cohort study, we compared eGFR (CKD-EPI) before donation in one center using mGFR-based screening (mGFR-cohort, n = 250) with two centers using eGFR-based screening (eGFR-cohort1, n = 466 and eGFR-cohort2, n = 160). We also compared differences in eGFR at five years after donation. RESULTS: Donor age was similar among the cohorts (mean±standard deviation (SD) mGFR-cohort 53±10 years, eGFR-cohort1 52±13 years, P = 0.16 vs. mGFR-cohort, and eGFR-cohort2 53±9 years, P = 0.61 vs. mGFR-cohort). Estimated GFR underestimated mGFR by 10±12 mL/min/1.73m2 (mean±SD), with more underestimation in younger donors. In the overall cohorts, mean±SD pre-donation eGFR was lower in the mGFR-cohort (91±13 mL/min/1.73m2) than in eGFR-cohort1 (93±15 mL/min/1.73m2, P<0.05) and eGFR-cohort2 (94±12 mL/min/1.73m2, P<0.05). However, these differences disappeared when focusing on more recent years, which can be explained by acceptance of more older donors with lower pre-donation eGFR over time in both eGFR-cohorts. Five years post-donation, mean±SD eGFR was similar among the centers (mGFR-cohort 62±12 mL/min/1.73m2, eGFR-cohort1 61±14 mL/min/1.73m2, eGFR-cohort2 62±11 mL/min/1.73m2, P = 0.76 and 0.95 vs. mGFR-cohort respectively). In the mGFR-cohort, 38 (22%) donors were excluded from donation due to insufficient mGFR with mean±SD mGFR of 71±9 mL/min/1.73m2. CONCLUSIONS: Despite the known underestimation of mGFR by eGFR, we did not show that the routine use of mGFR in donor screening leads to inclusion of donors with a lower pre-donation eGFR. Therefore eGFR-based screening will be sufficient for the majority of the donors. Future studies should investigate whether there is a group (e.g. young donors with insufficient eGFR) that might benefit from confirmatory mGFR testing.

ABO-incompatible kidney transplantation in perspective of deceased donor transplantation and induction strategies: a propensity-matched analysis.

Kidney transplant candidates are blood group incompatible with roughly one out of three potential living donors. We compared outcomes after ABO-incompatible (ABOi) kidney transplantation with matched ABO-compatible (ABOc) living and deceased donor transplantation and analyzed different induction regimens. We performed a retrospective study with propensity matching and compared patient and death-censored graft survival after ABOi versus ABOc living donor and deceased donor kidney transplantation in a nationwide registry from 2006 till 2019. 296 ABOi were compared with 1184 center and propensity-matched ABOc living donor and 1184 deceased donor recipients (matching: recipient age, sex, blood group, and PRA). Patient survival was better compared with deceased donor [hazard ratio (HR) for death of HR 0.69 (0.49-0.96)] and non-significantly different from ABOc living donor recipients [HR 1.28 (0.90-1.81)]. Rate of graft failure was higher compared with ABOc living donor transplantation [HR 2.63 (1.72-4.01)]. Rejection occurred in 47% of 140 rituximab versus 22% of 50 rituximab/basiliximab, and 4% of 92 alemtuzumab-treated recipients (P < 0.001). ABOi kidney transplantation is superior to deceased donor transplantation. Rejection rate and graft failure are higher compared with matched ABOc living donor transplantation, underscoring the need for further studies into risk stratification and induction therapy [NTR7587, www.trialregister.nl].

Donor and Recipient Perspectives on Anonymity in Kidney Donation From Live Donors: A Multicenter Survey Study.

BACKGROUND: Maintaining anonymity is a requirement in the Netherlands and Sweden for kidney donation from live donors in the context of nondirected (or unspecified) and paired exchange (or specified indirect) donation. Despite this policy, some donors and recipients express the desire to know one another. Little empirical evidence informs the debate on anonymity. This study explored the experiences, preferences, and attitudes of donors and recipients toward anonymity. STUDY DESIGN: Retrospective observational multicenter study using both qualitative and quantitative methods. SETTING & PARTICIPANTS: 414 participants from Dutch and Swedish transplantation centers who received or donated a kidney anonymously (nondirected or paired exchange) completed a questionnaire about anonymity. Participation was a median of 31 months after surgery. FACTORS: Country of residence, donor/recipient status, transplant type, time since surgery. OUTCOMES: Experiences, preferences, and attitudes toward anonymity. RESULTS: Most participants were satisfied with their experience of anonymity before and after surgery. A minority would have liked to have met the other party before (donors, 7%; recipients, 15%) or after (donors, 22%; recipients, 31%) surgery. Significantly more recipients than donors wanted to meet the other party. Most study participants were open to meeting the other party if the desire was mutual (donors, 58%; recipients, 60%). Donors agree significantly more with the principle of anonymity before and after surgery than recipients. Donors and recipients thought that if both parties agreed, it should be permissible to meet before or after surgery. There were few associations between country or time since surgery and experiences or attitudes. The pros and cons of anonymity reported by participants were clustered into relational and emotional, ethical, and practical and logistical domains. LIMITATIONS: The relatively low response rate of recipients may have reduced generalizability. Recall bias was possible given the time lag between transplantation and data collection. CONCLUSIONS: This exploratory study illustrated that although donors and recipients were usually satisfied with anonymity, the majority viewed a strict policy on anonymity as unnecessary. These results may inform policy and education on anonymity.

Toward a conditional approach to anonymity? An explorative multicenter longitudinal study among anonymous living kidney donors and recipients.

Anonymity between living donors and recipients is a topic of discussion among transplant professionals. This longitudinal study explored living kidney donors' and patients' perspectives on anonymity. Prior to surgery (T0) and 3 months afterward (T1), participants in unspecified or specified indirect donation programs completed a questionnaire on their experiences with and attitudes toward anonymity as well as demographic and medical characteristics. Nonparametric tests were used to assess group differences and associations. Participants were content with anonymity at T0 and T1. Fourteen and 23% wanted to meet at T0 and T1, respectively. If the other party expressed the wish to meet, 50% (T0) and 55% (T1) would be willing to meet. Most participants agreed that meeting should be allowed if both parties agree. Attitude toward anonymity did not differ between donors/recipients, nor between T0/T1 and unspecified/specified indirect donation programs. This study showed that most donors and recipients who participated in anonymous donation schemes are in favor of a conditional approach to anonymity. Guidelines on how to revoke anonymity if both parties agree are needed and should include education about pros and cons of (non-) anonymity and a logistical plan on how, when, where, and by whom anonymity should be revoked.

Five-year follow-up after live donor nephrectomy - cross-sectional and longitudinal analysis of a prospective cohort within the era of extended donor eligibility criteria.

To establish the outcome of live kidney donors 5 years after donation, we investigated the risk for progressive renal function decline and quality of life (QoL). Data on estimated glomerular filtration rate (eGFR), creatinine, hypertension, QoL and survival were assessed in a prospective cohort of 190 donors, who donated between 2008 and 2010. Data were available for >90%. The mean age predonation was 52.8 ± 11.5 years, 30 donors having pre-existent hypertension. The mean follow-up was 5.1 ± 0.9 years. Eight donors had died due to non-donation-related causes. After 5 years, the mean eGFR was 60.2 (95% CI 58.7-62.7) ml/min/1.73 m2 , with a median serum creatinine of 105.1 (95% CI 102.5-107.8) µmol/l. eGFR decreased to 33.6% and was longitudinally lower among men than women and declining with age (P < 0.001), without any association on QoL. Donors with pre-existent and new-onset hypertension demonstrated no progressive decline of renal function overtime compared to nonhypertensives. No donors were found with proteinuria, microalbuminuria or at risk for end-stage renal disease. After an initial decline postdonation, renal function remained unchanged overtime. Men and ageing seem to affect renal function overtime, while decreased renal function did not affect QoL. These data support further stimulation of living kidney donation programmes as seen from the perspective of donor safety.

More than a decade after live donor nephrectomy: a prospective cohort study.

Previously reported short-term results after live kidney donation show no negative consequences for the donor. The incidence of new-onset morbidity takes years to emerge, making it highly likely that this will be missed during short-term follow-up. Therefore, evidence on long-term outcome is essential. A 10-year follow-up on renal function, hypertension, quality of life (QOL), fatigue, and survival was performed of a prospective cohort of 100 donors. After a median follow-up time of 10 years, clinical data were available for 97 donors and QOL data for 74 donors. Nine donors died during follow-up of unrelated causes to donation, and one donor was lost to follow-up. There was a significant decrease in kidney function of 12.9 ml/min (P < 0.001) at follow-up. QOL showed significant clinically relevant decreases of 10-year follow-up scores in SF-36 dimensions of physical function (P < 0.001), bodily pain (P = 0.001), and general health (P < 0.001). MFI-20 scores were significantly higher for general fatigue (P < 0.001), physical fatigue (P < 0.001), reduced activity (P = 0.019), and reduced motivation (P = 0.030). New-onset hypertension was present in 25.6% of the donors. Donor outcomes are excellent 10 years post-donation. Kidney function appears stable, and hypertension does not seem to occur more frequently compared to the general population.

Randomized controlled trial comparing hand-assisted retroperitoneoscopic versus standard laparoscopic donor nephrectomy.

BACKGROUND: Laparoscopic donor nephrectomy (LDN) has become the gold standard for live-donor nephrectomy, as it results in a short convalescence time and increased quality of life. However, intraoperative safety has been debated, as severe complications occur incidentally. Hand-assisted retroperitoneoscopic donor nephrectomy (HARP) is an alternative approach, combining the safety of hand-guided surgery with the benefits of endoscopic techniques and retroperitoneal access. We assessed the best approach to optimize donors' quality of life and safety. METHODS: In two tertiary referral centers, donors undergoing left-sided nephrectomy were randomly assigned to HARP or LDN. Primary endpoint was physical function, one of the dimensions of the Short Form-36 questionnaire on quality of life, at 1 month postoperatively. Secondary endpoints included intraoperative events and operation times. Follow-up was 1 year. RESULTS: In total, 190 donors were randomized. Physical function at 1 month follow-up did not significantly differ between groups (estimated difference, 1.79; 95% confidence interval, -4.1 to 7.68; P=0.55). HARP resulted in significantly shorter skin-to-skin time (mean, 159 vs. 188 min; P<0.001), shorter warm ischemia time (2 vs. 5 min; P<0.001) and a lower intraoperative event rate (5% vs. 11%, P=0.117). Length of stay (both 3 days; P=0.135) and postoperative complication rate (8% vs. 8%; P=1.00) were not significantly different. Potential graft-related complications did not significantly differ (6% vs. 13%; P=0.137). CONCLUSIONS: Compared with LDN, left-sided HARP leads to similar quality of life, shorter operating time, and warm ischemia time. Therefore, we recommend HARP as a valuable alternative to the laparoscopic approach for left-sided donor nephrectomy.

Quality of life of elderly live kidney donors.

BACKGROUND: Expanding the use of elderly live donors may help meet the demand for kidney transplants. The aim of this study was to quantify the effect of the surgical procedure on the quality of life (QOL) of elderly donors compared with younger donors. METHODS: Alongside three prospective studies (two randomized) running between May 2001 and October 2010, we asked 501 live donors to fill out the Short Form-36 questionnaire preoperatively and at 1, 3, 6, and 12 months postoperatively. We defined live donors 60 years or older as elderly. Between-group analyses regarding QOL were adjusted for baseline values and gender. RESULTS: One hundred thirty-five donors were older and 366 donors were younger than 60 years. The response rate was high, with 87% at 12 months postoperatively. Elderly donors less often scored as American Society of Anaesthesiology classification 1 (60% vs. 81%; P<0.001) indicating a higher rate of minor comorbidity. At 1 month postoperatively, between-group analysis showed a significant advantage in QOL in favor of the elderly group regarding the dimensions "bodily pain" (7 points; P=0.001), "role physical" (18 points; P<0.001), and "vitality" (5 points; P=0.008). At 3 months, "bodily pain" (3 points, P=0.04) and "role physical" (8 points, P=0.02) were still in favor of the older group. At 6 and 12 months, "physical function" was in favor of the younger group (3 and 5 points, respectively; P=0.04 and P<0.001). CONCLUSIONS: This study demonstrates that elderly donors recover relatively fast. The perspective of excellent postoperative QOL may help convince elderly individuals to donate.

Hand-assisted retroperitoneoscopic versus standard laparoscopic donor nephrectomy: HARP-trial.

BACKGROUND: Transplantation is the only treatment offering long-term benefit to patients with chronic kidney failure. Live donor nephrectomy is performed on healthy individuals who do not receive direct therapeutic benefit of the procedure themselves. In order to guarantee the donor's safety, it is important to optimise the surgical approach. Recently we demonstrated the benefit of laparoscopic nephrectomy experienced by the donor. However, this method is characterised by higher in hospital costs, longer operating times and it requires a well-trained surgeon. The hand-assisted retroperitoneoscopic technique may be an alternative to a complete laparoscopic, transperitoneal approach. The peritoneum remains intact and the risk of visceral injuries is reduced. Hand-assistance results in a faster procedure and a significantly reduced operating time. The feasibility of this method has been demonstrated recently, but as to date there are no data available advocating the use of one technique above the other. METHODS/DESIGN: The HARP-trial is a multi-centre randomised controlled, single-blind trial. The study compares the hand-assisted retroperitoneoscopic approach with standard laparoscopic donor nephrectomy. The objective is to determine the best approach for live donor nephrectomy to optimise donor's safety and comfort while reducing donation related costs. DISCUSSION: This study will contribute to the evidence on any benefits of hand-assisted retroperitoneoscopic versus standard laparoscopic donor nephrectomy. TRIAL REGISTRATION: Dutch Trial Register NTR1433.

Cost effectiveness of laparoscopic versus mini-incision open donor nephrectomy: a randomized study.

BACKGROUND: Cost-effectiveness remains an issue surrounding the introduction of laparoscopic donor nephrectomy (LDN). METHODS: In a randomized controlled trial the cost-effectiveness of LDN versus mini-incision open donor nephrectomy (ODN) was determined. Fifty donors were included in each group. All in-hospital costs were documented. Postoperatively, case record forms were sent to the donors during 1-year follow-up to record return-to-work and societal costs. To offset costs against quality of life, the Euroqol-5D questionnaire was administered preoperatively and 3, 7, 14, 28, 90, 180, and 365 days postoperatively. RESULTS: Mean total costs were euro6,090 (US$7,308) after LDN and euro4,818 ($5,782) after ODN (P<0.001). Disposables influenced the cost difference most. Mean productivity loss was 68 and 75 days after LDN and ODN respectively, corresponding to euro783 ($940) gained per donor after LDN. The main gain in quality of life in the LDN group was realized within 4 weeks postoperatively. LDN resulted in a mean gain of 0.03 quality-adjusted life years at mean costs of euro1,271 ($1,525) and euro488 ($586) from a healthcare perspective and a societal perspective, respectively. This implies that one additional Quality-Adjusted Life Year after LDN costs about euro16,000 ($19,200) from a societal point of view and about euro41,000 ($49,200) from a health-care perspective. Activities other than work were resumed significantly earlier after LDN (66 vs. 91 days, P=0.01). CONCLUSION: In addition to a clinically relevant donor-experienced benefit from LDN, this technique appeared, given a societal perspective, a cost-efficient procedure mainly due to less productivity losses.

Comparison of laparoscopic and mini incision open donor nephrectomy: single blind, randomised controlled clinical trial.

OBJECTIVES: To determine the best approach for live donor nephrectomy to minimise discomfort to the donor and to provide good graft function. DESIGN: Single blind, randomised controlled trial. SETTING: Two university medical centres, the Netherlands. PARTICIPANTS: 100 living kidney donors. INTERVENTIONS: Participants were randomly assigned to either laparoscopic donor nephrectomy or to mini incision muscle splitting open donor nephrectomy. MAIN OUTCOME MEASURES: The primary outcome was physical fatigue using the multidimensional fatigue inventory 20 (MFI-20). Secondary outcomes were physical function using the SF-36, hospital stay after surgery, pain, operating times, recipient graft function, and graft survival. RESULTS: Conversions did not occur. Compared with mini incision open donor nephrectomy, laparoscopic donor nephrectomy resulted in longer skin to skin time (median 221 v 164 minutes, P < 0.001), longer warm ischaemia time (6 v 3 minutes, P < 0.001), less blood loss (100 v 240 ml, P < 0.001), and a similar number of complications (intraoperatively 12% v 6%, P = 0.49, postoperatively both 6%). After laparoscopic nephrectomy, donors required less morphine (16 v 25 mg, P = 0.005) and shorter hospital stay (3 v 4 days, P = 0.003). During one year's follow-up mean physical fatigue was less (difference - 1.3, 95% confidence interval - 2.4 to - 0.1) and physical function was better (difference 6.2, 2.0 to 10.3) after laparoscopic nephrectomy. Function of the graft and graft survival rate of the recipient at one year censored for death did not differ (100% after laparoscopic nephrectomy and 98% after open nephrectomy). CONCLUSIONS: Laparoscopic donor nephrectomy results in a better quality of life compared with mini incision open donor nephrectomy but equal safety and graft function.