Quantifying the risk of incompatible kidney transplantation: A multicenter study

B. J. Orandi; J. M. Garonzik-Wang; A. B. Massie; A. A. Zachary; J. R. Montgomery; K. J. Van Arendonk; M. D. Stegall; S. C. Jordan; J. Oberholzer; T. B. Dunn; L. E. Ratner; S. Kapur; R. P. Pelletier; J. P. Roberts; M. L. Melcher; P. Singh; D. L. Sudan; M. P. Posner; J. M. El-Amm; R. Shapiro; M. Cooper; G. S. Lipkowitz; M. A. Rees; C. L. Marsh; B. R. Sankari; D. A. Gerber; P. W. Nelson; J. Wellen; A. Bozorgzadeh; A. O. Gaber; R. A. Montgomery; D. L. Segev

doi:10.1111/ajt.12786

Quantifying the risk of incompatible kidney transplantation: A multicenter study

B. J. Orandi, J. M. Garonzik-Wang, A. B. Massie, A. A. Zachary, J. R. Montgomery, K. J. Van Arendonk, M. D. Stegall, S. C. Jordan, J. Oberholzer, T. B. Dunn, L. E. Ratner, S. Kapur, R. P. Pelletier, J. P. Roberts, M. L. Melcher, P. Singh, D. L. Sudan, M. P. Posner, J. M. El-Amm, R. ShapiroM. Cooper, G. S. Lipkowitz, M. A. Rees, C. L. Marsh, B. R. Sankari, D. A. Gerber, P. W. Nelson, J. Wellen, A. Bozorgzadeh, A. O. Gaber, R. A. Montgomery, D. L. Segev

Surgery

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Abstract

Incompatible live donor kidney transplantation (ILDKT) offers a survival advantage over dialysis to patients with anti-HLA donor-specific antibody (DSA). Program-specific reports (PSRs) fail to account for ILDKT, placing this practice at regulatory risk. We collected DSA data, categorized as positive Luminex, negative flow crossmatch (PLNF) (n-=-185), positive flow, negative cytotoxic crossmatch (PFNC) (n-=-536) or positive cytotoxic crossmatch (PCC) (n-=-304), from 22 centers. We tested associations between DSA, graft loss and mortality after adjusting for PSR model factors, using 9669 compatible patients as a comparison. PLNF patients had similar graft loss; however, PFNC (adjusted hazard ratio [aHR]-=-1.64, 95% confidence interval [CI]: 1.15-2.23, p-=-0.007) and PCC (aHR-=-5.01, 95% CI: 3.71-6.77, p-<-0.001) were associated with increased graft loss in the first year. PLNF patients had similar mortality; however, PFNC (aHR-=-2.04; 95% CI: 1.28-3.26; p-=-0.003) and PCC (aHR-=-4.59; 95% CI: 2.98-7.07; p-<-0.001) were associated with increased mortality. We simulated Centers for Medicare & Medicaid Services flagging to examine ILDKT's effect on the risk of being flagged. Compared to equal-quality centers performing no ILDKT, centers performing 5%, 10% or 20% PFNC had a 1.19-, 1.33- and 1.73-fold higher odds of being flagged. Centers performing 5%, 10% or 20% PCC had a 2.22-, 4.09- and 10.72-fold higher odds. Failure to account for ILDKT's increased risk places centers providing this life-saving treatment in jeopardy of regulatory intervention. In this 22-center study of HLA-incompatible live donor kidney transplants (ILDKT), the authors demonstrate the increased risk of graft loss and death associated with increasing anti-HLA donor-specific antibody strength, and they quantify the significantly increased risk of flagging for regulatory scrutiny by the Centers for Medicare & Medicaid Studies that is incurred by centers that perform ILDKT. See editorial by Cole and Tinckam on page 1475.

Original language	English (US)
Pages (from-to)	1573-1580
Number of pages	8
Journal	American Journal of Transplantation
Volume	14
Issue number	7
DOIs	https://doi.org/10.1111/ajt.12786
State	Published - Jul 2014

Keywords

Alloantibody
Scientific Registry for Transplant Recipients (SRTR)
clinical research
graft survival
health services and outcomes research
kidney transplantation
law
legislation
living donor
nephrology
practice
simulation

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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Orandi, B. J., Garonzik-Wang, J. M., Massie, A. B., Zachary, A. A., Montgomery, J. R., Van Arendonk, K. J., Stegall, M. D., Jordan, S. C., Oberholzer, J., Dunn, T. B., Ratner, L. E., Kapur, S., Pelletier, R. P., Roberts, J. P., Melcher, M. L., Singh, P., Sudan, D. L., Posner, M. P., El-Amm, J. M., ... Segev, D. L. (2014). Quantifying the risk of incompatible kidney transplantation: A multicenter study. American Journal of Transplantation, 14(7), 1573-1580. https://doi.org/10.1111/ajt.12786

Orandi, BJ, Garonzik-Wang, JM, Massie, AB, Zachary, AA, Montgomery, JR, Van Arendonk, KJ, Stegall, MD, Jordan, SC, Oberholzer, J, Dunn, TB, Ratner, LE, Kapur, S, Pelletier, RP, Roberts, JP, Melcher, ML, Singh, P, Sudan, DL, Posner, MP, El-Amm, JM, Shapiro, R, Cooper, M, Lipkowitz, GS, Rees, MA, Marsh, CL, Sankari, BR, Gerber, DA, Nelson, PW, Wellen, J, Bozorgzadeh, A, Gaber, AO, Montgomery, RA & Segev, DL 2014, 'Quantifying the risk of incompatible kidney transplantation: A multicenter study', American Journal of Transplantation, vol. 14, no. 7, pp. 1573-1580. https://doi.org/10.1111/ajt.12786

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abstract = "Incompatible live donor kidney transplantation (ILDKT) offers a survival advantage over dialysis to patients with anti-HLA donor-specific antibody (DSA). Program-specific reports (PSRs) fail to account for ILDKT, placing this practice at regulatory risk. We collected DSA data, categorized as positive Luminex, negative flow crossmatch (PLNF) (n-=-185), positive flow, negative cytotoxic crossmatch (PFNC) (n-=-536) or positive cytotoxic crossmatch (PCC) (n-=-304), from 22 centers. We tested associations between DSA, graft loss and mortality after adjusting for PSR model factors, using 9669 compatible patients as a comparison. PLNF patients had similar graft loss; however, PFNC (adjusted hazard ratio [aHR]-=-1.64, 95% confidence interval [CI]: 1.15-2.23, p-=-0.007) and PCC (aHR-=-5.01, 95% CI: 3.71-6.77, p-<-0.001) were associated with increased graft loss in the first year. PLNF patients had similar mortality; however, PFNC (aHR-=-2.04; 95% CI: 1.28-3.26; p-=-0.003) and PCC (aHR-=-4.59; 95% CI: 2.98-7.07; p-<-0.001) were associated with increased mortality. We simulated Centers for Medicare & Medicaid Services flagging to examine ILDKT's effect on the risk of being flagged. Compared to equal-quality centers performing no ILDKT, centers performing 5%, 10% or 20% PFNC had a 1.19-, 1.33- and 1.73-fold higher odds of being flagged. Centers performing 5%, 10% or 20% PCC had a 2.22-, 4.09- and 10.72-fold higher odds. Failure to account for ILDKT's increased risk places centers providing this life-saving treatment in jeopardy of regulatory intervention. In this 22-center study of HLA-incompatible live donor kidney transplants (ILDKT), the authors demonstrate the increased risk of graft loss and death associated with increasing anti-HLA donor-specific antibody strength, and they quantify the significantly increased risk of flagging for regulatory scrutiny by the Centers for Medicare & Medicaid Studies that is incurred by centers that perform ILDKT. See editorial by Cole and Tinckam on page 1475.",

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year = "2014",

month = jul,

doi = "10.1111/ajt.12786",

language = "English (US)",

volume = "14",

pages = "1573--1580",

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T1 - Quantifying the risk of incompatible kidney transplantation

T2 - A multicenter study

AU - Orandi, B. J.

AU - Garonzik-Wang, J. M.

AU - Massie, A. B.

AU - Zachary, A. A.

AU - Montgomery, J. R.

AU - Van Arendonk, K. J.

AU - Stegall, M. D.

AU - Jordan, S. C.

AU - Oberholzer, J.

AU - Dunn, T. B.

AU - Ratner, L. E.

AU - Kapur, S.

AU - Pelletier, R. P.

AU - Roberts, J. P.

AU - Melcher, M. L.

AU - Singh, P.

AU - Sudan, D. L.

AU - Posner, M. P.

AU - El-Amm, J. M.

AU - Shapiro, R.

AU - Cooper, M.

AU - Lipkowitz, G. S.

AU - Rees, M. A.

AU - Marsh, C. L.

AU - Sankari, B. R.

AU - Gerber, D. A.

AU - Nelson, P. W.

AU - Wellen, J.

AU - Bozorgzadeh, A.

AU - Gaber, A. O.

AU - Montgomery, R. A.

AU - Segev, D. L.

PY - 2014/7

Y1 - 2014/7

N2 - Incompatible live donor kidney transplantation (ILDKT) offers a survival advantage over dialysis to patients with anti-HLA donor-specific antibody (DSA). Program-specific reports (PSRs) fail to account for ILDKT, placing this practice at regulatory risk. We collected DSA data, categorized as positive Luminex, negative flow crossmatch (PLNF) (n-=-185), positive flow, negative cytotoxic crossmatch (PFNC) (n-=-536) or positive cytotoxic crossmatch (PCC) (n-=-304), from 22 centers. We tested associations between DSA, graft loss and mortality after adjusting for PSR model factors, using 9669 compatible patients as a comparison. PLNF patients had similar graft loss; however, PFNC (adjusted hazard ratio [aHR]-=-1.64, 95% confidence interval [CI]: 1.15-2.23, p-=-0.007) and PCC (aHR-=-5.01, 95% CI: 3.71-6.77, p-<-0.001) were associated with increased graft loss in the first year. PLNF patients had similar mortality; however, PFNC (aHR-=-2.04; 95% CI: 1.28-3.26; p-=-0.003) and PCC (aHR-=-4.59; 95% CI: 2.98-7.07; p-<-0.001) were associated with increased mortality. We simulated Centers for Medicare & Medicaid Services flagging to examine ILDKT's effect on the risk of being flagged. Compared to equal-quality centers performing no ILDKT, centers performing 5%, 10% or 20% PFNC had a 1.19-, 1.33- and 1.73-fold higher odds of being flagged. Centers performing 5%, 10% or 20% PCC had a 2.22-, 4.09- and 10.72-fold higher odds. Failure to account for ILDKT's increased risk places centers providing this life-saving treatment in jeopardy of regulatory intervention. In this 22-center study of HLA-incompatible live donor kidney transplants (ILDKT), the authors demonstrate the increased risk of graft loss and death associated with increasing anti-HLA donor-specific antibody strength, and they quantify the significantly increased risk of flagging for regulatory scrutiny by the Centers for Medicare & Medicaid Studies that is incurred by centers that perform ILDKT. See editorial by Cole and Tinckam on page 1475.

AB - Incompatible live donor kidney transplantation (ILDKT) offers a survival advantage over dialysis to patients with anti-HLA donor-specific antibody (DSA). Program-specific reports (PSRs) fail to account for ILDKT, placing this practice at regulatory risk. We collected DSA data, categorized as positive Luminex, negative flow crossmatch (PLNF) (n-=-185), positive flow, negative cytotoxic crossmatch (PFNC) (n-=-536) or positive cytotoxic crossmatch (PCC) (n-=-304), from 22 centers. We tested associations between DSA, graft loss and mortality after adjusting for PSR model factors, using 9669 compatible patients as a comparison. PLNF patients had similar graft loss; however, PFNC (adjusted hazard ratio [aHR]-=-1.64, 95% confidence interval [CI]: 1.15-2.23, p-=-0.007) and PCC (aHR-=-5.01, 95% CI: 3.71-6.77, p-<-0.001) were associated with increased graft loss in the first year. PLNF patients had similar mortality; however, PFNC (aHR-=-2.04; 95% CI: 1.28-3.26; p-=-0.003) and PCC (aHR-=-4.59; 95% CI: 2.98-7.07; p-<-0.001) were associated with increased mortality. We simulated Centers for Medicare & Medicaid Services flagging to examine ILDKT's effect on the risk of being flagged. Compared to equal-quality centers performing no ILDKT, centers performing 5%, 10% or 20% PFNC had a 1.19-, 1.33- and 1.73-fold higher odds of being flagged. Centers performing 5%, 10% or 20% PCC had a 2.22-, 4.09- and 10.72-fold higher odds. Failure to account for ILDKT's increased risk places centers providing this life-saving treatment in jeopardy of regulatory intervention. In this 22-center study of HLA-incompatible live donor kidney transplants (ILDKT), the authors demonstrate the increased risk of graft loss and death associated with increasing anti-HLA donor-specific antibody strength, and they quantify the significantly increased risk of flagging for regulatory scrutiny by the Centers for Medicare & Medicaid Studies that is incurred by centers that perform ILDKT. See editorial by Cole and Tinckam on page 1475.

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KW - Scientific Registry for Transplant Recipients (SRTR)

KW - clinical research

KW - graft survival

KW - health services and outcomes research

KW - kidney transplantation

KW - law

KW - legislation

KW - living donor

KW - nephrology

KW - practice

KW - simulation

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ER -

Quantifying the risk of incompatible kidney transplantation: A multicenter study

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UN SDGs

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