A multicenter, randomized, controlled trial of Celsior for flush and hypothermic storage of cardiac allografts

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Original article: cardiovascular

A multicenter, randomized, controlled trial of Celsior for flush and hypothermic storage of cardiac allografts

J. David Vega, MD^a, John L. Ochsner, MD^b, Valluvan Jeevanandam, MD^c, David C. McGiffin, MD^d, Kenneth R. McCurry, MD^e, Robert M. Mentzer, Jr, MD^f, James C. Stringham, MD^g, Richard N. Pierson, III, MD^h, O.H. Frazier, MDⁱ, Alan H. Menkis, MD^j, Edward D. Staples, MD^k, Dennis L. Modry, MD^l, Robert W. Emery, MD^m, William Piccione, Jr, MDⁿ, Michel Carrier, MD^o, Paul J. Hendry, MD^p, Salim Aziz, MD^q, Satoshi Furukawa, MD^c, Si M. Pham, MD^e

^a Emory University Hospital, Atlanta, Georgia, USA
^b Alton Ochsner Medical Foundation, New Orleans, Louisiana, USA
^c Temple University Hospital, Philadelphia, Pennsylvania, USA
^d University of Alabama at Birmingham, Birmingham, Alabama, USA
^e University of Pittsburgh, Pittsburgh, Pennsylvania, USA
^f University of Kentucky, Lexington, Kentucky, USA
^g University of Utah, Salt Lake City, Utah, USA
^h Vanderbilt University Medical Center, Nashville, Tennessee, USA
ⁱ Texas Heart Institute, Houston, Texas, USA
^j University Hospital–London, London, Ontario, Canada
^k University of Florida, Gainesville, Florida, USA
^l University of Alberta Hospitals, Edmonton, Alberta, Canada
^m Minneapolis Heart Institute, Minneapolis, Minnesota, USA
ⁿ Rush Presbyterian–St. Luke’s, Chicago, Illinois, USA
^o Montreal Heart Institute, Montreal, Quebec, Canada
^p University of Ottawa Heart Institute, Ottawa, Ontario, Canada
^q University of Colorado, Denver, Colorado, USA

Accepted for publication January 13, 2001.

Address reprint requests to Dr Vega, The Emory Clinic, A2216, 1365 Clifton Rd NE, Atlanta, GA 30322
e-mail: david_vega{at}emory.org

Background. A multicenter, randomized, controlled, open-labeltrial was conducted to evaluate the safety and efficacy of Celsiorwhen used for flush and hypothermic storage of donor heartsbefore transplantation.

Methods. Heart transplant recipients were randomized to oneof two treatment groups in which donor hearts were flushed andstored in either Celsior or conventional preservation solution(s)(control). Study subjects were followed for 30 days after transplantation.

Results. A total of 131 heart transplant recipients were enrolled(Celsior, n = 64; control, n = 67). The treatment groups wereevenly distributed in donor and recipient base line characteristics.Graft loss rate was lower in the Celsior group on day 7 (3%versus 9%) and on day 30 (6% versus 13%), but the differencewas not statistically significant based on 95% confidence intervalanalysis. No significant difference was measured between theCelsior and control groups in 7-day patient survival (97% versus94%) and the proportion of patients with one or more adverseevents (Celsior, 88%; control 87%) or serious adverse events(Celsior, 38%; control, 46%). Significantly fewer patients inthe Celsior group developed at least one cardiac-related seriousadverse event (13% versus 25%).

Conclusions. Celsior was demonstrated to be as safe and effectiveas conventional solutions for flush and cold storage of cardiacallografts before transplantation.

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