Donor, Recipient, and Operative Factors Associated with Graft Success in the Cornea Preservation Time Study

Terry, Mark A.; Aldave, Anthony J.; Szczotka-Flynn, Loretta; Liang, Wendi; Ayala, Allison R.; Maguire, Maureen G.; Croasdale, Christopher R.; Daoud, Yassine J.; Dunn, Steven P.; Hoover, Caroline; Macsai, Marian S.; Mauger, Thomas F.; Pramanik, Sudeep; Rosenwasser, George O. D.; Rose‐Nussbaumer, Jennifer; Stulting, R. Doyle; Sugar, Alan; Tu, Elmer Y.; Verdier, David D.; Yoo, Sonia H.; Lass, Jonathan H.

doi:10.1016/j.ophtha.2018.08.002

Cited by 75 publications

(126 citation statements)

References 50 publications

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“…Recipient diagnosis was the main recipient factor that affected ECL at 3 years. Endothelial cell loss was greater for participants with PACE compared with participants with FECD, paralleling our graft survival findings 11 and others. 6 The differing percentage of ECL at 3 years by recipient diagnosis in the CPTS (53% for participants with PACE vs 44% for participants with FECD) could be explained by peripheral host corneal endothelial health, with higher ECL associated with diminished peripheral ECD in individuals with PACE.…”

Section: Recipient Factors Diagnosissupporting

confidence: 90%

“…i There are 5 eyes for which complete air fill duration values were missing. donor and graft failure after DSAEK, particularly primary or early failures, 11 unlike previous studies of PK, 12,13 DSAEK, 29 and DMEK, 28 which did not find a deleterious effect. These studies were also limited by less rigorous historical diabetes characterization.…”

Section: Donor Factorscontrasting

confidence: 77%

“…8 We have recently defined and assessed multiple donor, recipient, and operative factors influencing graft success in the CPTS. 11 These same parameters were assessed in this analysis. In brief, donor information was gathered and reported by the 23 Eye Bank Association of America-accredited eye banks in the CPTS.…”

Section: Methodsmentioning

confidence: 99%

“…The CPTS did not find an association of recipient diabetes with greater ECL nor failure. 11 Previously, recipient diabetes had been associated with worse PK survival 38 and greater ECL after DMEK. 28…”

Section: Diabetesmentioning

confidence: 99%

“…10 In this study, we evaluate other donor factors, as well as recipient and operative factors, associated with endothelial cell density (ECD) during the first 3 years after DSAEK, complementing a recent study examining the association of these factors with graft success. 11…”

mentioning

confidence: 99%

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

et al. 2019

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; for the Cornea Preservation Time Study Group IMPORTANCE Determining factors associated with endothelial cell loss after Descemet stripping automated endothelial keratoplasty (DSAEK) could improve long-term graft survival. OBJECTIVE 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. DESIGN, SETTING, AND PARTICIPANTS 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. INTERVENTIONS The DSAEK procedure, with random assignment of a donor cornea with a preservation time of 0 to 7 days or 8 to 14 days. MAIN OUTCOMES AND MEASURES Endothelial cell density at 3 years as determined by a reading center from eye bank and clinical specular or confocal central endothelial images. RESULTS 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/mm 2), lower screening ECD (−234 [−331 to −137] per 500 cells/mm 2), recipient diagnosis of PACE (−257 [−483 to −31] in cells/mm 2), and operative complications (−324 [−516 to −133] in cells/mm 2). 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. CONCLUSIONS AND RELEVANCE 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.

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Section: Recipient Factors Diagnosissupporting

confidence: 90%

Section: Donor Factorscontrasting

confidence: 77%

Section: Methodsmentioning

confidence: 99%

Section: Diabetesmentioning

confidence: 99%

mentioning

confidence: 99%

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

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A Machine Learning Model With Survival Statistics to Identify Predictors of Descemet Stripping Automated Endothelial Keratoplasty Graft Failure

Hallak

2021

JAMA Ophthalmol

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Descemet stripping automated endothelial keratoplasty (DSAEK) is a predominant surgical method of endothelial keratoplasty for treating corneal endothelial dysfunction. 1 Prediction, variable selection, and determining factors associated with graft failure may lead to improved clinical decisionmaking guidelines and surgical outcomes of DSAEK. Survival data allow for time-to-event analysis, which can be defined as death, onset of disease, or the success or failure of procedures. The traditional statistical methods used to analyze survival data include Kaplan-Meier analysis for estimating the survival function, the log-rank test for 2-group comparisons, and the Cox proportional hazards regression model to determine associations between risk factors and the probability of survival. 2 More recently, machine learning techniques have been used to expand our ability in including high-dimensional data with multiple features for predictions and variable selection. In this issue of JAMA Ophthalmology, O'Brien et al 3 use data from the Cornea Preservation Time Study to apply a random survival forest (RSF), an ensemble tree method for analysis of right-censored survival data, as a method to select important variables that predict graft failure after DSAEK.For censored survival data, Cox proportional hazards regression models are known for their ease of use and interpretability in determining associations between factors, such as sociodemographic, clinical, and environmental factors, and time to event. However, the proportional hazards assumption can restrict the application of this model. Cox proportional hazards regression and logistic regression were used in a previous study to determine factors associated with DSAEK graft success using the same data from the Cornea Preservation Time Study. 4 Donor diabetes status and intraoperative complications were associated with graft success in the early and entire postoperative period, whereas preoperative diagnosis (Fuchs dystrophy compared with pseudophakic or aphakic corneal edema) was associated with long-term postoperative graft success. What differentiates this study 3 is the use of a machine learning model with survival statistics, an RSF, to incorporate 67 predictive donor, recipient, eye bank, and intraoperative variables and rank their importance in predicting graft failure. Survival trees and RSF models are approaches for prediction and feature selection when the proportional hazards assumption is violated and when there is a need to include multiple variables for exploratory analysis. The notable finding in the study by O'Brien et al 3 is that, with the RSF, intraoperative complications were ranked as one of the most important predictors of graft failure after DSAEK. Specifically, the authors were further able to identify that donor lenticule flipping on insertion and difficulty unfolding, as well as positioning donor tissue without use of the positioning hook, were the most informative variables for predicting graft failure.

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Random Survival Forests Analysis of Intraoperative Complications as Predictors of Descemet Stripping Automated Endothelial Keratoplasty Graft Failure in the Cornea Preservation Time Study

et al. 2021

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for the Cornea Preservation Time Study (CPTS) Group IMPORTANCE A new analytic method can evaluate factors of interest associated with graft failure after Descemet stripping automated endothelial keratoplasty (DSAEK) or more generally in any ophthalmic surgical setting with a time-to-event outcome. OBJECTIVE To reanalyze types of intraoperative complications associated with DSAEK graft failure in the Cornea Preservation Time Study using random survival forests. DESIGN, SETTING, AND PARTICIPANTS This cohort study, initially conceived in April 2019, used a prediction model to conduct a post hoc 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. The study included 1090 participants, representing 1330 eyes, undergoing DSAEK for Fuchs dystrophy (1255 eyes [94.4%]) or pseudophakic or aphakic corneal edema (75 eyes [5.6%]). Enrollment occurred

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Donor, Recipient, and Operative Factors Associated with Graft Success in the Cornea Preservation Time Study

Cited by 75 publications

References 50 publications

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

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

A Machine Learning Model With Survival Statistics to Identify Predictors of Descemet Stripping Automated Endothelial Keratoplasty Graft Failure

Random Survival Forests Analysis of Intraoperative Complications as Predictors of Descemet Stripping Automated Endothelial Keratoplasty Graft Failure in the Cornea Preservation Time Study

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