Indian Transplant Newsletter Vol. V Issue NO.: 17/18 (Feb-Jun-Oct 2004)
Print ISSN 0972 - 1568

Summary of the report of the Amsterdam forum on the care of the live Kidney donor

Indian Transplant Newsletter.
Vol. V Issue NO.: 17/18 (Feb-Jun-Oct 2004)
Print ISSN 0972 - 1568
Print PDF


DATA AND MEDICAL GUIDELINES

Kidney transplant physicians and surgeons met in Amsterdam,the Netherlands,from April 1-4,2004 for an international Forum on the care of the Live Kidney Donor.Forum participants included over 100 experts and leaders in transplantation,representing over 40 countries from around the world, including Sweden,Israel,turkey,Saudi Arabia Pakistan,India and China;and participants from all of the continents including Africa,asia,Australia,Europe,North and South America.

The objective of the forum was to develop an international standard of care with a position statement of the transplantation society regarding the responsibility of the community for the live kidney donor.The position statement was adopted by the council of the Transplantation society and published in transplantation (August 27,2004)


PREAMBLE

This report of the Amsterdam forum ids derived from evidencebased recommendation; it is not a document of mandatory regulation. Medical judgement influences the decision to accept an individual as live kidney donor when there is a borderline clinical situation.

 

THE MISSION OF THE AMSTERDAM FORUM

Abdallah Daar (Canada) presented the mission statement of the Amsterdam forum emphasizing the concern of the participants for thye welfare of the live donor.Specific objectives of the forum included the development of an international standard of care for the live donor; the development of a position statement regarding the responsibility of the transplant community for the live kidney donor;and the forging of an alliance with the world health organization to implement these standards. The intent of the forum leaders was for conference participants to become subsequent emissaries of these standards within their geographical sphere of influence around the world.

 

ALLIANCE WITH THE WORLD HEALTH ORGANISATION

Carl Groth (Transplantation Society) and Luc Noel world health organization provided a background report regarding the involvement of the transplantation society with the world health organization(WHO) and the role of the Amsterdam Forum as a conditinnum of the Madrid WHO conference on organ donation and transplantation in October 2003.

 

What is known regarding the sentinel events of live kidney donors:

Forum participants were charged with outlining what is known,and not known,about the sentinel events regarding living donors in the current era(death,dialysis and need for a kidney transplant) ,and to develop recommendations for the collection of data to omprove the care of potential and actual living donors.

In Iran,with over 15,000 live kidney donors, the perioperative mortality rate of live kidney donation was of 15,000 (0.2%).

In united states, between 1/1/1999 and 7/1/2001.10,828 living  donor nephrectomies were carried out: 52.3% open,20.7% hand-assisted laparoscopic nephrectomies (LN), and 27% non hand- assisted LN. Two donors (0.02%) died from  surgical complications and one is in a persistent vegetative state (all after LN).Reoperations was necessary in 22 (0.4%) open,23 (1.0%) hand assisted LN , and 21 (0.9%) non-hand assisted LN cases (p =0.001). complications not requiring reoperation were reported for 19 (0.3) open, 22(1.0%) hand –assisted LN, and 24 (0.8%) non-hand assisted LN cases (p = 0.02). Readmission rate was higher for LN (1.6% vs. open (0.6) donors (p< 0.001), almost entirely as a result of an increase in gastrointestinal complications in LN donors.

 

Pregnancy after live kidney  donation:

Annika tibell and Anders Hartmann from Norway concluded that donors nephrectomy is not detrimental to the prenatal course or outcome of future pregnancies. There are no data to suggest that hyperfiltration associated with the combination  of unilateral nephrectomy and pregnancy leads to significant hypertension,change in glomerular filtration rate.It was recommended however to delay pregnancy until at least 2 months after nephrectomy to access renal compensation prior to conception: including blood pressure, GFR ,and microalbuminuria.

 

Fifty years of live kidney donation

Fifty years have elapsed since the first  successful kidney transplant from a live donor .Forum participants agreed that prior to donation, the live kidney donor must receive appropriate informed consent, and be capable of understanding the information presented in that process  to make a voluntary decision.All donors should have standard tests performed to assure donor safety. These include blood and urine screening tests, chest X ray, EKG, cardiac stress test, radiographic assessment of the kidney and vessels. A complete listing of tests is appended by Andrew Bradley (UK).

As in the general population, based upon age and other medical risk factors (for example hypertension, proteinuria, hyperlipidemia, impaired glucose tolerance test), kidney donors should undergo regular  long term followup of body weight, blood pressure, blood sugar, serum creatinine and urinalysis. Abnormalities should be treated promptly by either the local medical physician or the transplant nephrologist.

Forum participants discussed the evaluation of various medical issues in the potential donor, such as donor hypertension , body mass index , dyslipidemia , renal function, malihnancy , and a history or current presence of infectious diseases such as tuberculosis or hepatitis.

 

 Donor hypertension

The  following consensus guidelines regarding hypertensive donors were adopted following discussion by Greg Obrador (mexico, M.K. Mani (India) and Ian Dittmer (New Zealand):

  1. Patients with a blood pressure (BP) >140/90 by ambulatory blood pressure monitoring (ABPM) are generally not acceptable as donors;
  2. BP should preferably be measured by ABPM, particularly among older donors (>50 years) and / or those with high office BP readings.
  3. Some patients with easily controlled hypertension, who meet other defined criteria, e.g. > 50 years of age, glomerular filtration rate.
  4. Donors with hypertension should be followed with nephrologists.

 

 

Obesity:

The following consensus guidelines were adopted regarding obesity:

  1. Patients with a BMI>35 kg/m2 should be discourged from donating,especially when other co-morbid conditions are present.
  2. Obese patients shold be encouraged to lose weight prior to kidney donation and should be advised not to donate if they have other associated co-morbid condition:
  3. Obese patients should be informed of both acute and long- term risks, especially when other co-morbid conditions are present;
  4. Healthy lifestyle education should be available to all living donors.

 Dyslipidemia:

Dyslipidemia should be included along with other risk factorin donor risk assessment, but dyslipidemia alone does not exclude kidney donation.

Acceptable donor renal failure

The following consensus guidelines was adopted regarding acceptable renal failure function:  a GFR<80ml/min or 2SD below  normal(based on age, gender, and BSA ) generally preclude donation. Kidneys from live donors with GFR=80mL/min are associated with relative risk of graft loss of 2.28 compared to those with greater prenephrectomy GFR.

Urine analysis for protein and blood

The discussion was initiated  by M.K Mani (india) and yuesvanrenterghem(Belgium). laboratories vary as to normal values of quantitated urine protein, but a consensus was reached to conclude that a 24 hour urine protein of > 300 mg is a contraindication to donation. 

With regard to microalbuminuria determination it was concluded that while it may a more reliable marker of renel disease, its value as an international standard of evaluation for kidney donors has not been determined. 

Patients with persistent microscopic hematuria should not be considered for kidney donation unless urine cytology and a complete urologic work-up are performed. If urolorogical malignancy and stone disease are excluded, a kidney biopsy may be indicated to rule out glomeruler pathology such as LgA nephropathy.

Diabetes and Live Kidney Donation

Individuals with a history of diabetes or fasting blood glucose 120 mg/dl (7.0 mmol/l) on at least 2 occations (or 2 hr glucose with OGTT >200 mg/dl (11.1 mmol/l) should not donate.

STONE DISEASE :

An asymptomatic potential donor with history of a single stone may be suitable for kidney donation if:

1. No hypercalcuria, hyperuricemia, or metabolic acidos

2. No cystinuria or hyperoxaluria

3. No urinary tract infection

4. If multiple stones or nephrocalcinosis not evident on CT.

Asymptomatic potential donor with current single stone may be suitable if :

The donor meets the criteria shown previously for single stone formers and current stone less than 1.5 cm in size, or potentially removable during the transplant.

Stone formers who should not donate are those with :

a) nephrocalcinosis on X-ray or bilateral stone disease and; 

b) stone types that have high rate of recurrence rates, and are difficult to prevent, for example;

i) Cystine stones that have a high rate of recurrence and a need for urologic procedures in the donor;

ii) Struvite stones of infection stones that are difficult to eradicate and thus not feasible to transplant them into an immunosuppressed patient;

iii) Stones associated with inherited or other systemicdicorders, such as primary or enteric hyperoxaluria, distal renal tubular acidosis, and sarcoid, because of the probability of a high rate of recurrence and the risk of renal insufficiently;

iv) Stones in the setting of inflammatory bowel disease with an increased risk of stones particularly after bowel resection also increased risk of renal insufficiency;V

v) Recurrence while on appropriate treatment (i.e.failed therapy).

HISTORY OF DONOR MALIGNANCY

A prior history of the following mallignancies usually excludes live kidney donation:

 Melanoma, testicular cancer, renal cell carcinoma, choriocarcinoma, hematological malignancy, bronchail cancer, breasr cancer and monoclonal gammopathy.

A prior of malignancy may only be acceptable for donation if :

1) Prior treatment of the malignancy does not decrease renal reserve or place the donor at increased risk for ESRD;

2) Prior treatment of malignancy does not increase the operative risk of nephrectomy.

A prior history of malignancy usually excludes live kidney donation but may be acceptable if :

 1) The specific cancer is curable and the potential transmission of the cancer reasonably be excluded. Examples include: colon cancer A >5 years servival, non-melanoma skin cancer, carcinoma in situ of the cervix.

2) Consent to receive a renal transplant must include a discussion with the donor and the recipient that transmission of malignant cannot be completely excluded.

SCREENING FOR INFECTIOUS DISEASE

Donor screening is essential to prevent transmissible infectious disease through live kidney transplantation.

HIV :

The detection of a positive Human Immunodeficiency Virus (HIV) by an ELISA assay in a potential kidney donor should be confirmed by a western b;ot analysis. A positive result rules out aa invidual from being a live kidney donor.

CMV and EBV:

Essam Elsawy (Egypt) screens for CMV lgM to evaluate recent infection, because CMV reactive lgG is detected in more than 90% positive of his donors. If the CMV lgM is positive, a PCR for CMV is performed. If the PCR is positive, he excludes live kidney donation until PCR bcomes negative. If the CMV lgM is positive and PCR is negative they proceed with transplantation. 

BILL HARMON (U.S.A) Suggested that a living donor (for example a parent) who is either CMV or EBV positive is still acceptable for a recipient who is CMV or EVB negative.

Hepatitis C Virus :

If the donor has normal liver function tests and the serology test (reactive antibody determination by ELISA) for HCV is negative, there is no contraindication for donation. However, if the serology test is positive for HCV, Essam Elsawy recommended that the recipient HCV, the potential positive HCV donor should be exclued. If the potential recipient is also positive for HCV, the potential donor should be assessed by PCR for HCV. If the potential donor is PCR positive, the potential donor should be excluded because the potential donor may have chronic hepatitis (and is not well). If the potential donor is negative by PCR, the potential donor may nor necessarily be excluded because the likelihood transmission of HCV through the kidney is remote. 

Hepatitis B Virus

The detection of hepatitis B surface antigen is a potential donor generally excludes the individual from live kidney donation. However, Stephen Munn reported that in New Zealand, some of the live kidney donors have been HBV core antibody positive. A core positive rsult indicates a recent exposure to the HBV; a surface antibody positive result indicates that months may have elapsed since the hepatitis infection. The ELISA core antibosy test can distinguish between lgM, a delay in the consideration of the potential donor was recommended to determine whether HBV infection may be progressing. A PCR quantition of HBV DNA should be performed as appropriate care of the donor. Otherwise, by the New Zealand practice, if the potential donor is PCR negative for HBV, kidneys may be transplanted safely from either an HBV surface antibody positive donor or a donor who is HBV core antibody (lgG) positive into recipients who either have successfully recovered from hepatitis B infection or been immunized against hepatitis B.

TUBERCULOSIS

From Essam Elsawy : Active Mycobacterium tuberculosis infection is contraindication for donation.

From Enrique Ona : In the Philippines, many potential live kdney donors may have evidence of previous infection, revealed by a primary complex of fibrosis in the lung apex on chest x-ray. The donors are treated (as are most of the recipients) with prophylactic INH, for about 4 months. Thus, a past history of tuberculosis in a potential donor who has received adequate would, however, require a more specific and extensive examination of the urinary tract and the kidneys prior to donation. 

From M.K.Mani : Urinary culture for tuberculosis is not done routinely as it is a poor screening tool; the potential donor is usually assessed for pyuria and anatimical radiographic abnormalities of the urinary tract and kidneys, despite a normal chest x-ray. Mahen Bhandari concurred to report in his experience that genitourinary tuberculosis may exist without chest x-ray evidence. 

Malaria:

Potential live kidney donors who either reside or have traveled to endemic areas should be screened for Plasmodium falciparum.

Urinary Tract Infections:

The donor urine should be sterile prior to donation. Pyuria and hematuria at the proposed time of donation is a contraindication to donation. Asymptomatic bacteruria should be treated pre donation.

Live Unrelated Donors:

The current available data from the U.K. and the U.S. suggest no restriction to live kidney donation based upon the absence of an HLA match. An unrelated donor transplant is equally successful to the outcome achieved by a genetically-related family member such as a parent, child, or sibling, who is not HLA identical to the recipient. Such exchanes have occurred in the United States and in Korea, but are considered illeal in Australia. 

The Gender Imbalance:

International experience revels that approximately 65% of live kidney donors have been women and approximately 65% of recipients are men. 

In living kidney transplants there may be an unethical component of coercion and family/social pressures brought to bear upon the woman. The role of the doctor, who is the mandatory intermediary in the situation of donor consent, cannot be overlooked.

PERSPECTIVE REGARDING MINORS AS DONORS

Participants agreed that minors less than 18 years of age should not be used as living kidney donors.

Risk Estimation for Donor Candidates with Medical Abnormalities :

R.Steiner (U.S.A) suggested that kidney donor candidates be presented a defensible and quantitative estimate of medical risk. This risk assessment applies not only to "normal" donors but to donors with isolated medical abnormalities (IMAs), such as hematuria, low grade proteinuria, hypertension, stone disease, and borderline normal GFR.

The estimate of any IMA risk can be determined by the following formula developed by R.Steiner: Yearly risk for risk factor A = (yearly incidence of ESRD A) / (prevalence of risk factor A). The risk over the next "n" years is (n) x the yearly risk. The yearly risk for ESRD for "medical condition A" that is assumed to be the only cause of "ESRD A" (e.g., hypertension and hypertensive ESRD) is the yearly incidence of "ESRD A" in the general population devided by the prevalence of "condition A".

Predicting the effect of nephrectomy is alsp a problem for "normal" donors, as some "normal" donors will develop diabetic nephropathy or other forms of ESRD after donation later in life. Even though their risks for ESRD are often lower, "normal" donors also need to know their risks, for the same reasons that apply to donors with IMAs.  

DETERMINING EQUIPOISE IN THE RISK-BENEFIT ANALYSIS

Thomas Gutmann (Germany) Suggested the folloeing: "In developing international standards of care for the live kidney donor and standards of medical suitability, the risk-benefit ratio of any proposed living donor transplant should be determined notonly by medical facts, but ultimately by personal value the one most affected by the outcome - i.e. the prospective donor him/herself. After appropriate information has been given to the patients, the question of whether it is 'worth it' and the risks 'acceptable' to the particular donor can only be based on the character and values of that person and their actual relationship with the intended recipient".

PRE, PERI, AND POST OPERATIVE ISSUES

Cardiovascular risk:

The clinical predictors of an increased perioperative cardiovascular risk (for non-cardiac surgery) by the American College of Cardiology / American Hospital Association standards fall into three categories: major, intermediate and minor. All major predictor (unstable coronary syndromes, decompensated heart failure, significant arrythmias and severe valvular disease) are contraindications to live kidney donation. Most of the intermediate predictors (mild angina, previous myocardial infarction, compensated or prior heart failure, diabetes mellitus) are also contraindications to donation, although a history of a myocardial infarction many years prior to the possible donation may not be an absolute contraindication. Minor predictors (older age, abnormal ECG, rhythm other or uncontrolled hypertension) warrant individual consideration.

Most potential donors will need only an ECG prior to surgery.

SMOKING CASSATION AND ALCOHOL ABSTINENCE

Forum Statement

1) Smoing cessation at least 4 weeks prior to donation is advised based on recommendations for patients undersoing elective surgical procedures.

2) Cessation of alcohol abuse defined by DSM-3: 60 gm of alcohol/day sustained over _>6 months should be avoided for a minimum of 4 weeks ro decrease the known risk of postoperative morbidity. 

3) All potential donors should have a health promoting dialogue with the anesthesiologist or health professional, which focuse on alcohol and smoking cessation in the context of other risk factors.

Pulmonary issues :

Patients with chronic pulmonary disease, who are at risk of the development end-stage pulmonary disease, should not be candidates for living kidney donation. Patients with asthma who are well controlled and with a peak flow measurement of greater than 80% predicted, could be considered on an individual basis for live kidney donation. 

Venous thromboembolism:

Factor V-Leiden, a variant of the coagulation protein Factor V, is associated with venous thrombosis especially in oral contraceptive users. Factor V-Leiden is the most common hereditary blod coagulation disorder, present in 3-8% of a healthy white population. Jonas Wadstrom (Sweden) suggested that potential living kidney donors should be evaluated by a comprehensive coagulation profile to include PT,PTT, antithrombin 3, protein S and protein C, Activated protein C (APC) resistence, as well as a PT- prothrombin mutation, cardiolipin antibodies and lupus anticoagulants. APC resistance is due to an inherited disorder of the factor V molecule (usually Factor V-Leiden) and is again associated with venos thromboembolism.

However, there was no consensus on this issue. Mark Stegall (U.S.A) recommmended that a history of venous thromboemboloism be ascertained prior to an in-depth coagulation work-up. Unless the history rveals a medical concern that necessitates a comprehensive coagulation profile, doing these tests is not necessary as they are considered expensive and are not likely to yeild consequential information. 

ROUTINE SCREENING INVESTIGATIONS FOR THE POTENTIAL LIVING KIDNEY DONOR

Urinalysis:

Dipstick for protein, blood and glucose; Microscopy, Culture and sensitivity  Measurement of protein excretion rate

Assessment of renal function: Estimation / measurement of GFR

Blood tests:

Haematological profile:.

Complete blood count  

Haemoglobinopathy (where indicated)      

Coagulation screen (PT and APTT)

G6PD deficiency (where indicated)

Biochemical profile:

Creatinine, urea, and electrocytes

Liver tests

Urate Fasting plasma glucose

Glucose tolerance test (if fasting plasma glucose > 6-7 mmol/l)

Blood lipids

Thyroid function tests (if indicated)

Bone profile

Pregnancy test (if indicated)

PSA (if indicated )

Virology and infection screen:

Hepatitis B and C

Toxoplasma Syphilis

HIV and HTLV

Malaria (where indicated)

CMV

Trypanozome cruzi (where indicated)

Epstein-Barr virus

Schistosomiasis (where indicated)

HHV8 (where indicated)

Strongyloides (where indicated)

Typhoid (where indicated)

Brucellosis (where indicated)

Cardiorespiratory system:

Chest X-ray EKG;

stress test and echocardiography (where indicated)

Assessment of renal anatomy

Appropriate imaging investigations should allow confirmation of the presence of two kidneys of normal size and enable abnormalities of the collecting system and calcification or stone disease in the renal tract to be detected. They must also delineate the anatomy of the renal vasculature Mr. Sunil Shroff (India) quoting a study from his centre, said that the non-invasive method using either MR Angiogram or CT angiogram was preferable to conventional angiogram to delineate the renal vascular tree as it was not only quicker but also had lesser morbidity and the results were similar.

(The Indian representatives included – Drs. M. K. Mani, M. Bhandari, Chacko, G. Abraham & S. Shroff)  


To cite : Shroff S, Navin S. Summary of the report of the Amsterdam forum on the care of the live Kidney donor. Indian Transplant Newsletter Vol. V Issue NO.: 17/18 (Feb-Jun-Oct 2004).
Available at:
https://www.itnnews.co.in/indian-transplant-newsletter/issue17/18/SUMMARY-OF-THE-REPORT-OF-THE-AMSTERDAM-FOURM-ON-THE-CARE-OF-THE-LIVE-KIDNEY-DONOR-228.htm

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