Guidelines for Living Donor Kidney Transplantation

1 Guidelines forLiving Donor Kidney TransplantationUnited Kingdom British Transplantation SocietyMarch 2018 BTS/RA Living Donor Kidney Transplantation Guidelines 2018 Fourth EditionBTS/RA Living Donor Kidney Transplantation Guidelines 2018 2 CONTENTS 1 INTRODUCTION AND OBJECTIVES 5 Introduction 5 Scope of the Guidelines 6 Process of Writing and Methodology 6 Editorial Committee 7 Contributing Authors 7 Disclaimer 10 Declarations of Interest 11 Grading of Recommendations 11 Abbreviations 12 2 LEGAL FRAMEWORK 15 The Human Tissue Act 2004 15 The Human Tissue Authority (HTA) 16 The European Union Organ Donation Directive 16 Consent for the Removal of Organs from Living donors 17 Types of Living Kidney Donation Permitted by the Legislation 17 Requirements for Transplants involving a Living Donor 19 Prohibition of Commercial Dealings in Human Material 20 Reimbursement of Expenses 21 Exceptional Circumstances 21 The Human Tissue (Scotland) Act 2006 22 3 ETHICS 26 Ethics 26 Key Ethical Principles in Living Donor Transplantation 26 The Recipient Perspective 27 The Donor Perspective 28 The Transplant Team Perspective 29 Expanding the Living Donor Pool 30 The Child or Young Person as a Living Donor 30 The British Transplantation Society (BTS)

2 Ethics Committee 30 4 SUPPORTING AND INFORMING THE POTENTIAL Donor 32 Confidentiality 33 Informing the Potential Donor 34 Informed Consent for Living Kidney Donation 35 Donor Identity 39 Patient Advocacy 40 Independent Translators 42 Psychological Issues 42 Death and Transplant Failure 45 5 Donor EVALUATION 48 Introduction 48 Donor Evaluation: Summary 52 ABO Blood Grouping and Crossmatch Testing 58 Medical Assessment 59 Assessment of Renal Function 66 BTS/RA Living Donor Kidney Transplantation Guidelines 2018 3 Donor Age 79 Donor Obesity 85 Hypertension in the Donor 90 Diabetes Mellitus 98 Cardiovascular Evaluation 105 Proteinuria 110 Non-Visible Haematuria 116 Pyuria 123 Infection in the Prospective Donor 125 Nephrolithiasis 139 Haematological Disease 146 Familial Renal Disease 151 Donor Malignancy 159 6 SURGERY.

3 TECHNICAL ASPECTS, Donor RISK AND PERI-OPERATIVE CARE 171 Introduction 172 Assessment of Renal Anatomy 173 Peri-Operative Mortality 176 Peri-Operative Morbidity 177 Long-Term Mortality 178 Pre-operative Care and Preparation 179 Donor Nephrectomy 181 7 HISTOCOMPATIBILITY TESTING FOR Living Donor Kidney Transplantation 191 Assessment of Donor -Recipient HLA Mismatch Status 193 Identification and Characterisation of Alloantibodies 194 Pre-transplant Donor -Recipient Crossmatch Test 196 Selection of Suitable Donor -Recipient Pairs 198 Antibody Incompatible Living Donor Transplantation 199 8 EXPANDING THE Donor POOL 202 Paired/Pooled Living Donation 203 Altruistic Donation (Directed and Non-directed) 210 Antibody Incompatible Donation 219 Appendix: Mental Health Assessment of Altruistic Kidney donors 222 9 LOGISTICAL CONSIDERATIONS 235 Reimbursement of Living Donor Expenses 235 donors who are Non-UK Residents 237 Prisoners as Living donors 238 Appendix.

4 Template Letter for Potential Overseas donors 243 10 Donor FOLLOW-UP AND LONG-TERM OUTCOME 247 Long-Term Outcome Following Living Kidney Donation 248 Arrangements for Follow-up 251 The Unsuitable Donor 255 Pregnancy following Kidney Donation 256 BTS/RA Living Donor Kidney Transplantation Guidelines 2018 4 11 RECIPIENT OUTCOME AFTER Living Donor Kidney Transplantation IN ADULTS 260 Living versus Deceased Donor Transplantation 261 Extended Criteria Living donors 261 Transplantation versus Dialysis 262 High Risk Recipients 263 12 RECURRENT RENAL DISEASE 267 Introduction 268 Diabetic Nephropathy 269 Primary Focal Segmental Glomerulosclerosis 269 IgA Nephropathy 270 Membranous Nephropathy 271 Amyloidosis 272 Systemic Lupus Erythematosus 273 ANCA Associated Systemic Vasculitis 273 Goodpasture s Disease 274 Alport Syndrome 274 Mesangiocapillary glomerulonephritis 275 Haemolytic Uraemic Syndrome 277 Primary Hyperoxaluria 278 Cystinosis 279 13 Living Donor Kidney Transplantation IN CHILDREN 284 Introduction 284 Donor Selection 285 Recipient Considerations 286 Surgery 287 14 APPENDIX 291 Conflicts of Interest 291 Search Strategies 292 BTS/RA Living Donor Kidney Transplantation Guidelines 2018 5 1 INTRODUCTION AND OBJECTIVES Introduction Kidney Transplantation from a Living Donor , when available, is the treatment of choice for most patients with end stage renal disease.

5 Offering optimum patient and graft survival and reduced time on the national transplant waiting list. Living Donor Transplantation also offers a proportion of complex recipients the opportunity to benefit from a transplant that they might otherwise not have received from the deceased Donor waiting list; or, through the UK Living Kidney Sharing Schemes (UKLKSS), a better quality or better matched Kidney than might otherwise have been available. For all these reasons, and the opportunity to expand the Kidney Donor pool, Living Kidney donation has been actively promoted in the UK over the last 20 years. At the time of writing, approximately 1 in 3 Kidney transplants performed in the UK are from Living donors . The latest national statistics show that there were 998 Living Kidney Donor transplants in the UK in 2016-17 (1). Of 926 adult Donor transplants, 484 were related, 442 were unrelated, 18 were HLA incompatible, 65 were ABO incompatible, 109 were paired/pooled, and 81 were altruistic Donor transplants.

6 36% of the patients transplanted from Living donors were transplanted pre-emptively, without a need for dialysis (1). The expansion of the UKLKSS has represented a significant change in practice since the last edition of this guideline, not least by reducing the need for HLA- and ABO-incompatible Transplantation . In parallel, increasing confidence in the safety of Living Kidney donation has permitted the expansion of the potential Donor pool; to date, the oldest Living Kidney Donor in the UK was aged 85. Nonetheless, it must be recognised that Living Kidney donation carries some risk. The welfare of the Donor remains paramount, and vigilance in Donor care and management is essential to ensure that appropriate safeguards are in place to protect individuals and to inspire public confidence. These Guidelines are intended to act as a resource for the transplant community, and to underpin best practice in Living Donor Kidney Transplantation .

7 BTS/RA Living Donor Kidney Transplantation Guidelines 2018 6 Scope of the Guidelines This guidance relates only to Living Donor Kidney Transplantation and reflects a growing body of evidence, incorporating aspects of clinical practice that are relevant to both adult and paediatric settings. These include the ethical and medico-legal aspects of Donor selection, medical and pre-operative Donor evaluation, identification of high risk donors , the management of complications, and expected outcome. Scenarios that present an increased level of risk to the potential recipient, such as antibody incompatible Transplantation , recurrent disease and Transplantation in the context of other co-morbidities, are also included. Guidance is provided on the most appropriate investigations to be considered to assist clinical decision-making, and the best surgical approaches when faced with different clinical scenarios.

8 Process of Writing and Methodology The original UK Guidelines for Living Donor Kidney Transplantation were commissioned by the British Transplantation Society (BTS) and the Renal Association (RA) as part of a wider initiative to develop Best Practice guidance for clinicians involved in Transplantation . Initially published in 2000 (2) and revised in 2005 (3) and 2011 (4), the Guidelines have achieved international repute. This fourth edition has used the framework of previous editions but has been significantly updated in the light of new data and changing practice. It has been produced with wide representation from UK colleagues and professional bodies involved in both Donor and recipient management and in consultation with patient representatives. In updating these Guidelines , areas of interest were identified with input from clinicians and patient representatives.

9 A systematic review of the relevant literature and synthesis of the available evidence was undertaken by selected relevant clinical experts. This was followed by peer group appraisal and expert review. Draft proposals were amended by the editorial committee and the appropriate levels of evidence added to recommendations. Wider consultation with the transplant community was undertaken by e-mail. The penultimate draft of the document was placed on the BTS website in January 2018 for a six week period of open consultation, to which professional groups, patients and other authorities were actively encouraged to contribute. The final document was posted in March 2018. BTS/RA Living Donor Kidney Transplantation Guidelines 2018 7 Where available, these Guidelines are based on published evidence, and the evidence and recommendations have been graded for strength except where the published studies are descriptive.

10 With a handful of exceptions, conference presentations have not been included and the publication cut-off date for evidence was July 2017. It is anticipated that these Guidelines will next be revised in 2023. Editorial Committee Dr Peter A Andrews MD FRCP Consultant Nephrologist & Clinical Lead for Transplantation , SW Thames Renal & Transplantation Unit, St Helier Hospital, Surrey Reader in Renal Medicine, University of London Chair of BTS Standards Committee Ms Lisa Burnapp RN MA Consultant Nurse, Living Donor Kidney Transplantation , Guy s & St Thomas NHS Foundation Trust, London Lead Nurse - Living Donation, Organ Donation and Transplantation , NHS Blood and Transplant (NHSBT) Contributing Authors Dr Peter Andrews MD FRCP, Consultant Nephrologist & Reader in Renal Medicine, SW Thames Renal & Transplantation Unit, St Helier Hospital, Surrey Dr Richard Baker PhD FRCP, Consultant Nephrologist, St.