Donor, Recipient, and Operative Factors Associated With Increased Endothelial Cell Loss in the Cornea Preservation Time Study

• Published in: JAMA ophthalmology Vol. 137; no. 2; p. 185
• Main Authors: Lass, Jonathan H, Benetz, Beth Ann, Patel, Sanjay V, Szczotka-Flynn, Loretta B, O'Brien, Robert, Ayala, Allison R, Maguire, Maureen G, Daoud, Yassine J, Greiner, Mark A, Hannush, Sadeer B, Lee, W Barry, Mauger, Thomas F, Menegay, Harry J, Mifflin, Mark D, Raizman, Michael B, Rose-Nussbaumer, Jennifer, Schultze, Robert L, Schmidt, Gregory A, Sugar, Alan, Terry, Mark A, Verdier, David D
• Format: Journal Article
• Language: English
• Published: United States 01.02.2019
• Subjects: Adolescent; Adult; Aged; Aged, 80 and over; Cell Count; Child; Cornea; Corneal Edema - surgery; Corneal Endothelial Cell Loss - diagnosis; Descemet Stripping Endothelial Keratoplasty; Double-Blind Method; Endothelium, Corneal - pathology; Female; Fuchs' Endothelial Dystrophy - surgery; Graft Survival - physiology; Humans; Male; Middle Aged; Organ Preservation - methods; Prospective Studies; Risk Factors; Time and Motion Studies; Tissue Donors; Transplant Recipients
• ISSN: 2168-6173
• DOI: 10.1001/jamaophthalmol.2018.5669

Determining factors associated with endothelial cell loss after Descemet stripping automated endothelial keratoplasty (DSAEK) could improve long-term graft survival. To evaluate the associations of donor, recipient, and operative factors with endothelial cell density (ECD) 3 years after DSAEK in the Cornea Preservation Time Study. This cohort study was a secondary analysis of data collected in a multicenter, double-masked, randomized clinical trial. Forty US clinical sites with 70 surgeons participated, with donor corneas provided by 23 US eye banks. Individuals undergoing DSAEK for Fuchs dystrophy or pseudophakic/aphakic corneal edema were included. The DSAEK procedure, with random assignment of a donor cornea with a preservation time of 0 to 7 days or 8 to 14 days. Endothelial cell density at 3 years as determined by a reading center from eye bank and clinical specular or confocal central endothelial images. The study included 1090 participants (median age, 70 years) with 1330 affected eyes (240 bilateral cases [22.0%]), who underwent DSAEK for Fuchs dystrophy (1255 eyes [94.4%]) or pseudophakic/aphakic corneal edema (PACE) (75 eyes [5.6%]). Of these, 801 eyes (60.2%) belonged to women and 1207 (90.8%) to white individuals. A total of 749 participants (913 eyes; 164 [21.9%] bilateral cases) had functioning grafts with acceptable endothelial images preoperatively and at 3 years postoperatively and were included in this analysis. Factors associated with a lower ECD at 3 years (estimated effect with 99% CI) in the final multivariable model included donors with diabetes (-103 [-196 to -9] cells/mm2), lower screening ECD (-234 [-331 to -137] per 500 cells/mm2), recipient diagnosis of PACE (-257 [-483 to -31] in cells/mm2), and operative complications (-324 [-516 to -133] in cells/mm2). Endothelial cell loss (ECL) from a preoperative measurement to a 3-year postoperative measurement was 47% (99% CI, 42%-52%) for participants receiving tissue from donors with diabetes vs 43% (99% CI, 39%-48%) without diabetes; it was 53% (99% CI, 44%-62%) for participants diagnosed with PACE vs 44% (99% CI, 39%-49%) for those diagnosed with Fuchs dystrophy, and 55% (99% CI, 48%-63%) in participants who experienced operative complications vs 44% (99% CI, 39%-48%) in those who did not. No other donor, recipient, or operative factors were significantly associated with 3-year ECD. Donor diabetes, lower screening ECD, a PACE diagnosis in the recipient, and operative complications were associated with lower ECD at 3 years after DSAEK surgery and may be associated with long-term graft success. While causation cannot be inferred, further studies on the association of donor diabetes and PACE in recipients with lower 3-year ECD warrant further study.