Photopheresis for the prevention of rejection in cardiac transplantation

Mark L. Barr, Bruno M. Meiser, Howard J. Eisen, Randall F. Roberts, Ugolino Livi, Roberto Dall'Amico, Richard Dorent, Joseph G. Rogers, Branislav Radovančević, David O. Taylor, Valluvan Jeevanandam, Charles C. Marboe, Kenneth L. Franco, Hector O. Ventura, Robert E. Michler, Bartley P. Griffith, Steven W. Boyce, Bruno Reichart, Iradj Gandjbakhch

Research output: Contribution to journalArticle

231 Citations (Scopus)

Abstract

Background: Photopheresis is an immunoregulatory technique in which lymphocytes are reinfused after exposure to a photoactive compound (methoxsalen) and ultraviolet A light. We performed a preliminary study to assess the safety and efficacy of photopheresis in the prevention of acute rejection of cardiac allografts. Methods: A total of 60 consecutive eligible recipients of primary cardiac transplants were randomly assigned to standard triple-drug immunosuppressive therapy (cyclosporine, azathioprine, and prednisone) alone or in conjunction with photopheresis. The photopheresis group received a total of 24 photopheresis treatments, each pair of treatments given on two consecutive days, during the first six months after transplantation. The regimen for maintenance immunosuppression, the definition and treatment of rejection episodes, the use of prophylactic antibiotics, and the schedule for cardiac biopsies were standardized among all 12 study centers. All the cardiacbiopsy samples were graded in a blinded manner at a central pathology laboratory. Plasma from the subgroup of 34 patients (57 percent) who were enrolled at the nine U.S. centers was analyzed by polymerase-chain-reaction amplification for cytomegalovirus DNA. Results: After six months of follow-up, the mean (±SD) number of episodes of acute rejection per patient was 1.44±1.0 in the standard-therapy group, as compared with 0.91±1.0 in the photopheresis group (P=0.04). Significantly more patients in the photopheresis group had one rejection episode or none (27 of 33) than in the standard-therapy group (14 of 27), and significantly fewer patients in the photopheresis group had two or more rejection episodes (6 of 33) than in the standard-therapy group (13 of 27, P=0.02). There was no significant difference in the time to a first episode of rejection, the incidence of rejection associated with hemodynamic compromise, or survival at 6 and 12 months. Although there were no significant differences in the rates or types of infection, cytomegalovirus DNA was detected significantly less frequently in the photopheresis group than in the standard-therapy group (P=0.04). Conclusions: In this pilot study, the addition of photopheresis to triple-drug immunosuppressive therapy significantly decreased the risk of cardiac rejection without increasing the incidence of infection.

Original languageEnglish (US)
Pages (from-to)1744-1751
Number of pages8
JournalNew England Journal of Medicine
Volume339
Issue number24
DOIs
StatePublished - Dec 10 1998
Externally publishedYes

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Photopheresis
Heart Transplantation
Group Psychotherapy
Immunosuppressive Agents
Rejection (Psychology)
Methoxsalen
Drug Therapy
DNA
Incidence
Azathioprine
Cytomegalovirus Infections
Ultraviolet Rays
Prednisone
Cytomegalovirus
Immunosuppression
Cyclosporine
Allografts
Appointments and Schedules
Therapeutics
Transplantation

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Barr, M. L., Meiser, B. M., Eisen, H. J., Roberts, R. F., Livi, U., Dall'Amico, R., ... Gandjbakhch, I. (1998). Photopheresis for the prevention of rejection in cardiac transplantation. New England Journal of Medicine, 339(24), 1744-1751. https://doi.org/10.1056/NEJM199812103392404

Photopheresis for the prevention of rejection in cardiac transplantation. / Barr, Mark L.; Meiser, Bruno M.; Eisen, Howard J.; Roberts, Randall F.; Livi, Ugolino; Dall'Amico, Roberto; Dorent, Richard; Rogers, Joseph G.; Radovančević, Branislav; Taylor, David O.; Jeevanandam, Valluvan; Marboe, Charles C.; Franco, Kenneth L.; Ventura, Hector O.; Michler, Robert E.; Griffith, Bartley P.; Boyce, Steven W.; Reichart, Bruno; Gandjbakhch, Iradj.

In: New England Journal of Medicine, Vol. 339, No. 24, 10.12.1998, p. 1744-1751.

Research output: Contribution to journalArticle

Barr, ML, Meiser, BM, Eisen, HJ, Roberts, RF, Livi, U, Dall'Amico, R, Dorent, R, Rogers, JG, Radovančević, B, Taylor, DO, Jeevanandam, V, Marboe, CC, Franco, KL, Ventura, HO, Michler, RE, Griffith, BP, Boyce, SW, Reichart, B & Gandjbakhch, I 1998, 'Photopheresis for the prevention of rejection in cardiac transplantation', New England Journal of Medicine, vol. 339, no. 24, pp. 1744-1751. https://doi.org/10.1056/NEJM199812103392404
Barr ML, Meiser BM, Eisen HJ, Roberts RF, Livi U, Dall'Amico R et al. Photopheresis for the prevention of rejection in cardiac transplantation. New England Journal of Medicine. 1998 Dec 10;339(24):1744-1751. https://doi.org/10.1056/NEJM199812103392404
Barr, Mark L. ; Meiser, Bruno M. ; Eisen, Howard J. ; Roberts, Randall F. ; Livi, Ugolino ; Dall'Amico, Roberto ; Dorent, Richard ; Rogers, Joseph G. ; Radovančević, Branislav ; Taylor, David O. ; Jeevanandam, Valluvan ; Marboe, Charles C. ; Franco, Kenneth L. ; Ventura, Hector O. ; Michler, Robert E. ; Griffith, Bartley P. ; Boyce, Steven W. ; Reichart, Bruno ; Gandjbakhch, Iradj. / Photopheresis for the prevention of rejection in cardiac transplantation. In: New England Journal of Medicine. 1998 ; Vol. 339, No. 24. pp. 1744-1751.
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abstract = "Background: Photopheresis is an immunoregulatory technique in which lymphocytes are reinfused after exposure to a photoactive compound (methoxsalen) and ultraviolet A light. We performed a preliminary study to assess the safety and efficacy of photopheresis in the prevention of acute rejection of cardiac allografts. Methods: A total of 60 consecutive eligible recipients of primary cardiac transplants were randomly assigned to standard triple-drug immunosuppressive therapy (cyclosporine, azathioprine, and prednisone) alone or in conjunction with photopheresis. The photopheresis group received a total of 24 photopheresis treatments, each pair of treatments given on two consecutive days, during the first six months after transplantation. The regimen for maintenance immunosuppression, the definition and treatment of rejection episodes, the use of prophylactic antibiotics, and the schedule for cardiac biopsies were standardized among all 12 study centers. All the cardiacbiopsy samples were graded in a blinded manner at a central pathology laboratory. Plasma from the subgroup of 34 patients (57 percent) who were enrolled at the nine U.S. centers was analyzed by polymerase-chain-reaction amplification for cytomegalovirus DNA. Results: After six months of follow-up, the mean (±SD) number of episodes of acute rejection per patient was 1.44±1.0 in the standard-therapy group, as compared with 0.91±1.0 in the photopheresis group (P=0.04). Significantly more patients in the photopheresis group had one rejection episode or none (27 of 33) than in the standard-therapy group (14 of 27), and significantly fewer patients in the photopheresis group had two or more rejection episodes (6 of 33) than in the standard-therapy group (13 of 27, P=0.02). There was no significant difference in the time to a first episode of rejection, the incidence of rejection associated with hemodynamic compromise, or survival at 6 and 12 months. Although there were no significant differences in the rates or types of infection, cytomegalovirus DNA was detected significantly less frequently in the photopheresis group than in the standard-therapy group (P=0.04). Conclusions: In this pilot study, the addition of photopheresis to triple-drug immunosuppressive therapy significantly decreased the risk of cardiac rejection without increasing the incidence of infection.",
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T1 - Photopheresis for the prevention of rejection in cardiac transplantation

AU - Barr, Mark L.

AU - Meiser, Bruno M.

AU - Eisen, Howard J.

AU - Roberts, Randall F.

AU - Livi, Ugolino

AU - Dall'Amico, Roberto

AU - Dorent, Richard

AU - Rogers, Joseph G.

AU - Radovančević, Branislav

AU - Taylor, David O.

AU - Jeevanandam, Valluvan

AU - Marboe, Charles C.

AU - Franco, Kenneth L.

AU - Ventura, Hector O.

AU - Michler, Robert E.

AU - Griffith, Bartley P.

AU - Boyce, Steven W.

AU - Reichart, Bruno

AU - Gandjbakhch, Iradj

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N2 - Background: Photopheresis is an immunoregulatory technique in which lymphocytes are reinfused after exposure to a photoactive compound (methoxsalen) and ultraviolet A light. We performed a preliminary study to assess the safety and efficacy of photopheresis in the prevention of acute rejection of cardiac allografts. Methods: A total of 60 consecutive eligible recipients of primary cardiac transplants were randomly assigned to standard triple-drug immunosuppressive therapy (cyclosporine, azathioprine, and prednisone) alone or in conjunction with photopheresis. The photopheresis group received a total of 24 photopheresis treatments, each pair of treatments given on two consecutive days, during the first six months after transplantation. The regimen for maintenance immunosuppression, the definition and treatment of rejection episodes, the use of prophylactic antibiotics, and the schedule for cardiac biopsies were standardized among all 12 study centers. All the cardiacbiopsy samples were graded in a blinded manner at a central pathology laboratory. Plasma from the subgroup of 34 patients (57 percent) who were enrolled at the nine U.S. centers was analyzed by polymerase-chain-reaction amplification for cytomegalovirus DNA. Results: After six months of follow-up, the mean (±SD) number of episodes of acute rejection per patient was 1.44±1.0 in the standard-therapy group, as compared with 0.91±1.0 in the photopheresis group (P=0.04). Significantly more patients in the photopheresis group had one rejection episode or none (27 of 33) than in the standard-therapy group (14 of 27), and significantly fewer patients in the photopheresis group had two or more rejection episodes (6 of 33) than in the standard-therapy group (13 of 27, P=0.02). There was no significant difference in the time to a first episode of rejection, the incidence of rejection associated with hemodynamic compromise, or survival at 6 and 12 months. Although there were no significant differences in the rates or types of infection, cytomegalovirus DNA was detected significantly less frequently in the photopheresis group than in the standard-therapy group (P=0.04). Conclusions: In this pilot study, the addition of photopheresis to triple-drug immunosuppressive therapy significantly decreased the risk of cardiac rejection without increasing the incidence of infection.

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