TTS2022 Awards--Congratulations

 Today at TTS2022, prizes will be awarded.  One that I know is very well deserved, is to Dr. Vivek Kute, for his extraordinary achievements in kidney transplantation in India. Congratulations to all the prize winners.

I've followed Dr. Kute's work over the years in multiple posts.

Kidney exchange in India: progress, then Covid

 Here's a paper reporting, among other things, a long kidney exchange cycle in India.  But Covid has put a temporary halt to all that.

Paired Kidney Exchange in India: Future Potential and Challenges Based on the Experience at a Single Center  by Kute, Vivek B. MD, DM, FASN, FRCP1; Patel, Himanshu V. MD, DNB1; Modi, Pranjal R. MS, DNB2; Rizvi, Syed J. MS, MCh2; Engineer, Divyesh P. MD, DM1; Banerjee, Subho MD, DM1; Butala, Bina P. MD3; Gandhi, Shruti MD4; Patel, Ansy H. MBBS5; Mishra, Vineet V. MS  Transplantation: May 2021 - Volume 105 - Issue 5 - p 929-932  doi: 10.1097/TP.0000000000003421

But now Covid is taking a toll. Dr. Kute writes in an email that transplantation has been on hold in Gujarat since April. He says "we had cumulative 225 kidney transplant recipients with PCR confirmed COVID-19 in our single center. Over all mortality in transplants population 10% and much higher in dialysis."

Here's hoping that vaccine production ramps up and Covid falls away in India and the rest of the world soon.

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I have quite a number of posts following the work of Dr. Kute and his colleagues in Ahmedabad.

Non-Simultaneous Kidney Exchange Cycles in India: new design, in Transplant International by Kute and Rees et al.

 Perhaps the biggest part of the ongoing design of kidney exchange around the world involves adapting to constantly changing local conditions in patient and donor populations, and the prevailing laws, regulations and medical situation.  In India, where non-directed donation is illegal (except in Kerala), this means that some patients can be transplanted only if long exchange cycles are possible.  In most of the world, the requirement that the surgeries in a cycle be performed simultaneously has prevented this.

The paper below, organized by two of the world's most innovative transplant doctors, Vivek Kute and Mike Rees (first and last authors, in the medical manner), demonstrates a path forward in India. The paper reports 17 very carefully arranged and conducted non-simultaneous (and non-anonymous) kidney exchange cycles, accomplishing 67 transplants. These were performed at the  Trivedi Institute of Transplantation Sciences  (using our software:).

Vivek B. Kute, Himanshu V. Patel, Pranjal R. Modi, Sayyad J. Rizvi, Pankaj R. Shah, Divyesh P Engineer, Subho Banerjee, Hari Shankar Meshram, Bina P. Butala, Manisha P. Modi, Shruti Gandhi, Ansy H. Patel, Vineet V. Mishra, Alvin E. Roth, Jonathan E. Kopke, Michael A. Rees, “Non-simultaneous kidney exchange cycles in resource-restricted countries without non-directed donation,” Transplant International, February 2021.

Abstract: Recent reports suggest that bridge-donor reneging is rare (1.5%) in non-simultaneous kidney exchange chains. However, in developing countries, the non-directed donors who would be needed to initiate chains are unavailable, and furthermore, limited surgical space and resources restrain the feasibility of simultaneous kidney exchange cycles. Therefore, the aim of this study was to evaluate the bridge-donor reneging rate during non-simultaneous kidney exchange cycles (NSKEC) in a prospective single-center cohort study (n=67). We describe the protocol used to prepare co-registered donor-recipient pairs for non-simultaneous surgeries, in an effort to minimize the reneging rate. In addition, in order to protect any recipients who might be left vulnerable by this arrangement, we proposed the use of standard criteria deceased-donor kidneys to rectify the injustice in the event of any bridge-donor reneging.  We report 17 successful NSKEC resulting in 67 living-donor kidney transplants (LDKT) using  23 bridge-donors without donor renege  and  no intervening pairs became unavailable. We propose that NSKEC could increase LDKT, especially for difficult-to-match sensitized pairs (25 of our 67 pairs) in countries with limited transplantation resources. Our study confirms that NSKEC can be safely performed with careful patient-donor selection and non-anonymous kidney exchanges.

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Some previous posts:

Saturday, February 1, 2020

Long kidney exchange in Ahmedabad, India

Wednesday, May 22, 2019

Kidney exchange in India: the legal framework

Tuesday, May 21, 2019

Robot-assisted kidney transplantation in Ahmedabad, India.

Long kidney exchange in Ahmedabad, India

Vivek Kute writes with the news:
IKDRC completes India’s longest cross-transplant chain

"Institute of Kidney Diseases and Research Center, Institute of Transplantation Sciences (IKDRC-ITS) Ahmedabad, India is pleased to share the news of an exciting milestone for the patients with end stage renal disease with incompatible living kidney donors. Our transplant team has completed longest Kidney Exchange transplant chain in India as well as Asia involving 10 donor-recipients pairs over 5 days in January 2020. Two kidney transplant surgeries were performed each on 4, 6 and 7 January, 3 transplants on 8 January and last kidney transplant was completed on 22 January 2020.
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". The success of this program can be attributed to the selflessness of the more than 500 family members who have stepped forward to be living organ donors. Dr Vivek Kute Professor of Nephrology maintains the single center registry of incompatible pairs. Dr Vivek Kute  and his team is greatful to Prof. Michael Rees and Prof. Alvin Roth for providing the Alliance for Paired Donations software for computer allocation at free of cost. Transplant team members are Dr Vineet Mishra, Dr Pranjal Modi, Dr Himanshu Patel, Dr Jamal Rizvi, Dr Vivek Kute, Dr Bina Butala and others."

Kidney exchange in India: the legal framework

Last week in Ahmedabad I had a chance to interact with Dr. Vivek Kute and his colleagues at the Trivedi Institute, to better understand the setting of their innovative kidney exchange program.  The legal framework is of course a big part of that environment.

Here's India's Transplantation of Human Organs and Tissues Act (THOA), 2014 (scroll down for the English language version).

As in other places, much of the law is shaped by  repugnance towards kidney sales. To this end, the law requires that an Authorisation Committee approve donation from someone who is not a "near relative," in the immediate nuclear family.

"Authorisation Committee.
(3) When the proposed donor and the recipient are not near relatives, the Authorisation Committee shall,- 
(i)evaluate that there is no commercial transaction between the recipient and the donor and that no payment has been made to the donor or promised to be made to the donor or any other person; 
(ii)prepare an explanation of the link between them and the circumstances which led to the offer being made;"

In the case of kidney exchange, only a near relative may serve as the intended donor (i.e. no uncles, aunts, cousins, etc.).

"(4)Cases of swap donation referred to under subsection (3A) of section 9 of the Act shall be approved by Authorisation Committee of hospital or district or State in which transplantation is proposed to be done and the donation of organs shall be permissible only from near relatives of the swap recipients."

The present law also does not allow nondirected donors.
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Here are some related earlier posts:

Tuesday, May 21, 2019 Robot-assisted kidney transplantation in Ahmedabad, India.

Monday, July 2, 2018

Kidney exchange in all its aspects: a view from India

Monday, May 14, 2018

Kidney Exchange in India: current conditions and recommendations for the future

Kidney exchange in all its aspects: a view from India

Here's a survey that sees kidney exchange, and all the advances that have been made in how to use it to facilitate more transplants, as a force for making medicine more inclusive around the world.

Kidney exchange transplantation current status, an update and future perspectives
Vivek B Kute, Narayan Prasad, Pankaj R Shah, Pranjal R Modi
World J Transplant. Jun 28, 2018; 8(3): 52-60
Published online Jun 28, 2018. doi: 10.5500/wjt.v8.i3.52

Abstract: "Kidney exchange transplantation is well established modality to increase living donor kidney transplantation. Reasons for joining kidney exchange programs are ABO blood group incompatibility, immunological incompatibility (positive cross match or donor specific antibody), human leukocyte antigen (HLA) incompatibility (poor HLA matching), chronological incompatibility and financial incompatibility. Kidney exchange transplantation has evolved from the traditional simultaneous anonymous 2-way kidney exchange to more complex ways such as 3-way exchange, 4-way exchange, n-way exchange,compatible pair, non-simultaneous kidney exchange,non-simultaneous extended altruistic donor, never ending altruistic donor, kidney exchange combined with desensitization, kidney exchange combined with ABO incompatible kidney transplantation, acceptable mismatch transplant, use of A2 donor to O patients, living donor-deceased donor list exchange, domino chain, non-anonymous kidney exchange, single center, multicenter, regional, National, International and Global kidney exchange. Here we discuss recent advances in kidney exchanges such as International kidney exchange transplantation in a global environment, three categories of advanced donation program, deceased donors as a source of chain initiating kidneys, donor renege myth or reality, pros and cons of anonymity in developed world and (non-) anonymity in developing world, pros and cons of donor travel vs kidney transport, algorithm for management of incompatible donor-recipient pairs and pros and cons of Global kidney exchange. The participating transplant teams and donor-recipient pairs should make the decision by consensus about kidney donor travel vs kidney transport and anonymity vs non-anonymity in allocation as per local resources and logistics. Future of organ transplantation in resource-limited setting will be liver vs kidney exchange, a legitimate hope or utopia?"

An interesting section of the paper discusses different practices regarding anonymity in kidney exchange centers in different countries:

"PROS AND CONS OF ANONYMITY IN DEVELOPED WORLD AND (NON-) ANONYMITY IN DEVELOPING WORLD

There is disparity on standard practice of kidney exchange in developed and developing World in term of (non-) anonymity. There is variable practice on anonymity before and after surgery in different countries.

Conditional approach[38]: When the donor-recipient pairs give consent for meeting after surgery, they are allowed to meet each other after surgery in some countries such as the United States of America[39] and the United Kingdom[40]. In other countries, such as the Netherlands and Sweden[41], anonymity is absolute. Anonymity protects patients, donors and transplant hospital/ administration against the risks of revoking anonymity and prevents further commercialization of organs, and breach of patient donor privacy. An Ethical, Legal and Psychosocial Aspects of Organ Transplantation (ELPAT), a subsection of the European Society for Organ Transplantation reported that a conditional approach to anonymity should be possible after surgery[42]. Pronk et al[38] showed that most donor-recipient pairs who participated in anonymous donation process are in favour 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.

Non-anonymous allocation[11,12]: Donor-recipient pairs are allowed to meet each other before allocation of donor for surgery and even after surgery. They can share medical reports of exchange donors before surgery and kidney transplant and donor surgery outcome after surgery. Donor-recipient pairs do not choose their match but donor-recipient pairs may decline a match or can withdraw from participation in the kidney exchange program at any time, for any reason. Non-anonymous allocation has the potential of commercialization of organs in case of compatible donor-recipient pairs along with breach in privacy of donor-recipient pairs. Kute et al[11,12] reported that donor-recipient pairs are willing for non-anonymous allocation process in single center study of 300 kidney exchange transplants in India. They reported that non-anonymity is more helpful in manual allocation in absence of computer software allocation which also increases trust between patients, donors and transplant hospital/administration and legal team. More long term prospective studies are required to explore the donor and recipient perspective on anonymity in living kidney donation in different socio-economic regions and countries."

Regarding Global Kidney Exchange they conclude:

"Global kidney exchange appears to provide life-saving kidney transplantation to poor donor-recipient pairs from developing countries that otherwise could die due to economic constrain[50-53]."

And here's their conclusion:

CONCLUSION

"Kidney exchange transplantation has increased living donor kidney transplantation for end stage renal disease patients with chronological incompatibility and financial incompatibility. The participating transplant teams and donor-recipient pairs should make the decision by consensus about kidney donor travel vs kidney transport and anonymity vs non-anonymity in allocation as per local resources and logistics. There is need of uniform algorithm for management of incompatible donor-recipient pairs."

Kidney Exchange in India: current conditions and recommendations for the future

The Indian Society of Organ Transplantation has published guidelines for expanding kidney exchange in India:

Kute VB, Agarwal SK, Sahay M, Kumar A, Rathi M, Prasad N, Sharma RK, Gupta KL, Shroff S, Saxena SK, Shah PR, Modi PR, Billa V, Tripathi LK, Raju S, Bhadauria DS, Jeloka TK, Agarwal D, Krishna A, Perumalla R, Jain M, Guleria S, Rees MA. Kidney-paired donation to increase living donor kidney transplantation in India: Guidelines of Indian Society of Organ Transplantation – 2017. Indian J Nephrol 2018;28:1-9

Here's the summary of their recommendations:

"Evidence-based recommendations, suggestions, and expert consensus statements in this document aim to expand KPD and may serve as a model for other developing countries. For these guidelines, all reference articles in the English literature related to KPD transplantation in India from MEDLINE (PubMed from 2000 to 2017) database were included and reviewed.

We recommend that each potential DRP should be educated, encouraged, and counseled about KPD transplant in an easy-to-understand format as early as possible in the process of chronic kidney disease (CKD) care.

We recommend that all the transplant team members including transplant coordinator in addition to other regular training should also be trained for counseling about risk, benefits of KPD, nonexchange options, consent process, financial screening of DRP, data entry-related issues of KPD, and overall support for KPD.

We recommend that a standard written informed consent should be obtained from each DRP. We suggest that DRP should be given information about expected waiting time before transplantation, and every attempt should be made to reduce waiting time, particularly for hard-to-match pairs with the innovative ways in KPD matching.

We suggest that easy-to-match pairs (A donor and B recipient and vice versa) and sensitized pairs should be encouraged for KPD over ABO-incompatible kidney transplantation (ABOiKT) and desensitization protocol.

We recommend that all types of KPD should be practiced only after legal permission as per the existing transplant law.

We suggest that three-way exchange has optimum quality and quantity of matching.

We suggest that potential KPD transplant centers should study the key elements of success of other successful KPD program.

We suggest that computerized algorithms should be encouraged over manual allocation.

We recommend that all patients should be screened for pretransplant immunological risk, occult infections, and other risk factors to prevent and reduce posttransplant unequal outcome due to patient-related factors.

We suggest that the age difference between KPD donors should not be the key issue in allocation and better immunological match may counteract the effect of higher donor–recipient age difference.

We recommend that participating transplant teams should make the decision by consensus about kidney donor travel versus kidney transport as per local resources and logistics, though donor travel rather than kidney transport is likely to be simple.

We suggest that transplant surgery should be performed at the place where patient is evaluated, admitted, and willing to do posttransplant follow-up and simultaneous rather than sequential surgery should be preferred.

We recommend that the formation of KPD registry is one of the principal strategies to improve the quality of matching and number of KPD.

We suggest that DRP needs to be cognizant of transcultural, language, and legal barriers in national program when patients and their donors may belong to different regions or states of India."


And here's the introductory summary of the background in India:

The Indian CKD registry in 2010 reported that at the time of enrolment in registry, 61% of end-stage renal disease (ESRD) patients were not on any form of renal replacement therapy (RRT), while 32% were on hemodialysis, 5% on peritoneal dialysis, and only 2% were being worked up for kidney transplantation.^[1] There is a gross disparity between supply and demand of the transplant organs across the world, including India. All efforts are to be made to increase the supply of quality organs to the waiting transplant recipients. KPD is one such process for increasing supply of organs to patients waiting for transplant. ABO-compatible living donor kidney transplant (LDKT) is the ideal and cost-effective RRT modality for ESRD patients in resource-limited developing country such as India, where morbidity and mortality on long-term dialysis is unacceptably high. Access to RRT is mainly prevented by paucity of facilities and affordability. Up to 80% of kidney donors are living donors, while DDKT programs are still evolving in most parts of India.

KPD transplant enables two incompatible DRP to receive more compatible kidneys. In this, a living kidney donor who is otherwise incompatible with the recipient exchanges kidneys with another DRP. KPD can be performed at any transplant center that is doing kidney transplantation without the need of extra facilities as required for ABOiKT and transplant with desensitization protocol.

Kidney exchange in India

Right now, kidney exchange in India is all done in single transplant center programs. Here's an article advocating inter-hospital exchange to increase accesss to transplantation.

Kidney-paired donation to increase living donor kidney transplantation in India: Guidelines of Indian Society of Organ Transplantation – 2017
Kute VB, Agarwal SK, Sahay M, Kumar A, Rathi M, Prasad N, Sharma RK, Gupta KL, Shroff S, Saxena SK, Shah PR, Modi PR, Billa V, Tripathi LK, Raju S, Bhadauria DS, Jeloka TK, Agarwal D, Krishna A, Perumalla R, Jain M, Guleria S, Rees MA
Indian Journal of Nephrology, 2018  |  Volume : 28  |  Issue : 1  |  Page : 1-9

"Conclusion: KPD transplant is legal, cost-effective, rapidly expanding modality with good long-term outcome, and being implemented in several centers in India with the potential to increase LDKT by 25%. KPD transplant should be encouraged over ABOiKT and desensitization protocol. The quality of matching and number of KPD will be superior in national program versus single-center program due to large donor pool. Transplant team members, stakeholder, and policy-makers should work together to expand KPD.

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These are recommendation on KPD transplantation after the Indian Society of Organ Transplantation (ISOT) midterm meeting organized at Chennai on March 18, 2017, and 1-day Workshop organized at Hotel Pullman, Aerocity, New Delhi, on April 29, 2017, under the Aegis of ISOT and participation of NOTT organization to discuss various issues related to expanding KPD and starting the National KPD program. Transplant surgeons, physicians, and other stakeholders from major centers across the country participated and had a robust discussion on the related issues."

Global kidney exchange debated in the October issue of American Journal of Transplantation

The October issue of the AJT starts off with a news report, and ends with six letters to the editor (3 of which are replies by us to the letters and to the editorial that was published along with our original article in the March 2017 issue).

The AJT Report

1.     You have free access to this content

Global Kidney Exchange: Overcoming the Barrier of Poverty (pages 2499–2500)

Lara C. Pullen

Version of Record online: 28 SEP 2017 | DOI: 10.1111/ajt.14469

This month's installment of “The AJT Report” debates the benefits, ethics and sustainability of Global Kidney Exchange. We also look at efforts to shore kidney paired donation implementation in the United States.

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Letters to the Editor

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Kidney Paired-Donation Program Versus Global Kidney Exchange in India (pages 2740–2741)

V. Kute, R. M. Jindal and N. Prasad

Version of Record online: 22 MAY 2017 | DOI: 10.1111/ajt.14324

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Comment: Kidney Exchange to Overcome Financial Barriers to Kidney Transplantation (page 2742)

L. S. Baines and R. M. Jindal

Version of Record online: 15 MAY 2017 | DOI: 10.1111/ajt.14325

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Global kidney exchange: Financially incompatible pairs are not transplantable compatible pairs (pages 2743–2744)

M. A. Rees, S. R. Paloyo, A. E. Roth, K. D. Krawiec, O. Ekwenna, C. L. Marsh, A. J. Wenig and T. B. Dunn

Version of Record online: 1 SEP 2017 | DOI: 10.1111/ajt.14451

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Opposition to irresponsible global kidney exchange (pages 2745–2746)

Francis L. Delmonico and Nancy L. Ascher

Version of Record online: 2 SEP 2017 | DOI: 10.1111/ajt.14473

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People should not be banned from transplantation only because of their country of origin (pages 2747–2748)

Alvin E. Roth, Kimberly D. Krawiec, Siegfredo Paloyo, Obi Ekwenna, Christopher L. Marsh, Alexandra J. Wenig, Ty B. Dunn and Michael A. Rees

Version of Record online: 13 SEP 2017 | DOI: 10.1111/ajt.14485

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Open dialogue between professionals with different opinions builds the best policy (page 2749)

Ignazio R. Marino, Alvin E. Roth, Michael A. Rees and Cataldo Doria

Version of Record online: 11 SEP 2017 | DOI: 10.1111/ajt.14484

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A transplant center in India has done 300 kidney exchange transplants

Here's the article, whose first author is Dr. Vivek Kute, of the Faculty of Nephrology and Transplantation, Institute of Kidney Diseases and Research Center and Dr. H L Trivedi Institute of Transplantation Sciences ,
(IKDRC-ITS) Ahmedabad , India

Transpl Int. 2017 Mar 20. doi: 10.1111/tri.12956. [Epub ahead of print]

Impact of Single-Centre Kidney Paired Donation Transplantation to Increase the Donor Pool in India.

Kute VB1, Patel HV1, Shah PR1, Modi PR2, Shah VR3, Rizvi SJ2, Pal BC2, Shah PS1, Modi MP3, Butala BP3, Wakhare PS1, Varyani UT1, Shinde SG1, Ghodela VA1, Kasat GS1, Patil MV1, Patel JC1, Kumar DP1, Trivedi VB4, Patel MH4, Trivedi HL1.

Author information

Abstract

In a living donor kidney transplantation (LDKT) dominated transplant programme, kidney paired donation (KPD) may be a cost-effective and valid alternative strategy to increase LDKT in countries with limited resources where deceased donation kidney transplantation (DDKT) is in the initial stages. Here, we report our experience of 300 single-centre KPD transplantations to increase LDKT in India. Between January 2000 and July 2016, 3616 LDKT and 561 DDKT were performed at our transplantation centre, 300 (8.3%) using KPD. The reasons for joining KPD among transplanted patients were ABO incompatibility (n=222), positive cross match (n=59) and better matching (n=19). A total of 124 two-way (n=248), 14 three-way (n=42), one 4-way (n=4) and one 6-way exchange (n=6) yielded 300 KPD transplants. Death-censored graft and patient survival were 96% (n=288) and 83.3% (n=250), respectively. The mean serum creatinine was 1.3 mg/dl at a follow-up of 3±3 years. We credit the success of our KPD programme to maintaining a registry of incompatible pairs, counselling on KPD, a high-volume LDKT programme and teamwork. KPD is legal, cost effective and rapidly growing for facilitating LDKT with incompatible donors. This study provides large-scale evidence for the expansion of single-centre LDKT via KPD when national programmes do not exist. This article is protected by copyright. All rights reserved.

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Here's a related recent article by Dr. Kute:

World J Transplant. 2017 Feb 24;7(1):64-69. doi: 10.5500/wjt.v7.i1.64.

International kidney paired donation transplantations to increase kidney transplant of O group and highly sensitized patient: First report from India.

Kute VB1, Patel HV1, Shah PR1, Modi PR1, Shah VR1, Rizvi SJ1, Pal BC1, Shah PS1, Wakhare PS1, Shinde SG1, Ghodela VA1, Varyani UT1, Patel MH1, Trivedi VB1, Trivedi HL1.

Author information

Abstract

AIM:

To report the first international living related two way kidney paired donation (KPD) transplantation from India which occurred on 17th February 2015 after legal permission from authorization committee.

METHODS:

Donor recipient pairs were from Portugal and India who were highly sensitized and ABO incompatible with their spouse respectively. The two donor recipient pairs had negative lymphocyte cross-matching, flow cross-match and donor specific antibody in two way kidney exchange with the intended KPD donor. Local KPD options were fully explored for Indian patient prior to embarking on international KPD.

RESULTS:

Both pairs underwent simultaneous uneventful kidney transplant surgeries and creatinine was 1 mg/dL on tacrolimus based immunosuppression at 11 mo follow up. The uniqueness of these transplantations was that they are first international KPD transplantations in our center.

CONCLUSION:

International KPD will increases quality and quantity of living donor kidney transplantation. This could be an important step to solving the kidney shortage with additional benefit of reduced costs, improved quality and increased access for difficult to match incompatible pairs like O blood group patient with non-O donor and sensitized patient. To the best of our knowledge this is first international KPD transplantation from India.

More on starting kidney exchange chains with deceased donor kidneys

Here's a forthcoming letter to the editor in the American Journal of Transplantation: We need to take the next step, by Marc L. Melcher, John P. Roberts, Alan B. Leichtman, Alvin E. Roth, and Michael A. Rees

It replies to another letter: A potential solution to make best use of living donor- deceased donor list exchange by VB Kute, HV Patel, PR Shah, PR Modi, VR Shah, HL Trivedi

which was prompted by our earlier article: Melcher, Marc L., John P. Roberts, Alan B. Leichtman, Alvin E. Roth, and Michael A. Rees, “Utilization of Deceased Donor Kidneys to Initiate Living Donor Chains,” American Journal of Transplantation, 16, 5, May 2016, 1367–1370.


Here's a post about that earlier article:

Using deceased donor kidneys to start living donor kidney exchange chains

and here's a post about the followup we hope to do:

White House Organ Summit--video and links. Deceased donor chains planned at Walter Reed