Publications by authors named "Steven P Dunn"

58 Publications

Comprehensive Adult Medical Eye Evaluation Preferred Practice Pattern®.

Ophthalmology 2021 Jan 12;128(1):P1-P29. Epub 2020 Nov 12.

Departments of Ophthalmology & Visual Sciences, and Epidemiology, University of Michigan, Ann Arbor, Michigan.

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http://dx.doi.org/10.1016/j.ophtha.2020.10.024DOI Listing
January 2021

A giant mystery in giant cell myocarditis: navigating diagnosis, immunosuppression, and mechanical circulatory support.

ESC Heart Fail 2020 02 24;7(1):315-319. Epub 2019 Dec 24.

Division of Cardiology, University of California San Francisco, San Francisco, CA, USA.

Giant cell myocarditis is a rare but often devastating diagnosis. Advances in cardiac imaging and mechanical circulatory support have led to earlier and more frequent diagnoses and successful management. This disease state has wide variation in acuity of presentation, and consequently, optimal treatment ranging from intensity and type of immunosuppression to mechanical circulatory support is not well defined. The following case describes the management of a patient with an unusual presentation of giant cell myocarditis over a 10 year course of advanced heart failure therapies and immunomodulatory support. This case highlights emerging concepts in the management of giant cell myocarditis including sub-acute presentations, challenges in diagnosis, and treatment modalities in the modern era.
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http://dx.doi.org/10.1002/ehf2.12564DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7083393PMC
February 2020

Evaluation of cardiomyopathy in acute myeloid leukemia patients treated with anthracyclines.

J Oncol Pharm Pract 2020 Apr 9;26(3):680-687. Epub 2019 Sep 9.

Department of Medicine, Division of Hematology/Oncology, University of Virginia, Charlottesville, VA, USA.

Background: Acute myeloid leukemia patients receive anthracycline-containing induction chemotherapy. Anthracyclines cause cardiotoxicity; however, there is a paucity of data reflecting the risk of cardiotoxicity in the acute myeloid leukemia population, and risk factors for development of reduced left ventricular ejection fraction are not well established in this population.

Methods: A retrospective cohort study of adult acute myeloid leukemia patients receiving anthracycline-containing induction chemotherapy between March 2011 and August 2017 was performed. Baseline and all additional cardiac monitoring within one year of induction were collected. Home medications and new medication initiation were determined via the electronic health record and new outpatient prescriptions.

Results: Of 97 evaluable patients, 25 (25.8%) developed reduced left ventricular ejection fraction and 18 (18.6%) experienced clinical heart failure within one year of induction. The median difference from baseline to lowest left ventricular ejection fraction was -5.0 percentage points, with a range of +10.0 to -52.5. The median time to onset of reduced left ventricular ejection fraction was 27 days, at a median cumulative anthracycline dose of 270 mg/m. No patient-specific or medication-specific factors were significantly associated with the risk of developing reduced left ventricular ejection fraction. Of 14 patients started on medical management for reduced left ventricular ejection fraction, 10 (71%) responded to therapy.

Conclusions: In this retrospective analysis, we observed that acute myeloid leukemia patients experienced reduced left ventricular ejection fraction more quickly and at lower doses than previously reported in the solid tumor population. Reduced left ventricular ejection fraction was at least partially reversible in most patients started on medical management. Although no factors were significantly associated with decreased cardiomyopathy risk, future assessment of cardioprotective medications may be warranted.
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http://dx.doi.org/10.1177/1078155219873014DOI Listing
April 2020

Antithrombin supplementation in adult patients receiving extracorporeal membrane oxygenation.

Perfusion 2020 01 19;35(1):66-72. Epub 2019 Jun 19.

Department of Pharmacy Services, University of Virginia Health System, Charlottesville, VA, USA.

Introduction: Extracorporeal membrane oxygenation is associated with an increased risk of thrombosis and hemorrhage. Acquired antithrombin deficiency often occurs in patients receiving extracorporeal membrane oxygenation, necessitating supplementation to restore adequate anticoagulation. Criteria for antithrombin supplementation in adult extracorporeal membrane oxygenation patients are not well defined.

Methods: In this retrospective observational study, adult patients receiving antithrombin supplementation while supported on extracorporeal membrane oxygenation were evaluated. Antithrombin was supplemented when anti-Xa levels were subtherapeutic with unfractionated heparin infusion rates of 15-20 units/kg/h and measured antithrombin activity <50%. Patients were evaluated for changes in degree of anticoagulation and signs of bleeding 24 hours pre- and post-antithrombin supplementation.

Results: A total of 14 patients received antithrombin supplementation while on extracorporeal membrane oxygenation. The median percentage of time therapeutic anti-Xa levels were maintained was 0% (0-43%) and 40% (9-84%) in the pre-antithrombin and post-antithrombin groups, respectively (p = 0.13). No difference was observed in the number of patients attaining a single therapeutic anti-Xa level (pre-antithrombin = 6, post-antithrombin = 13; p = 0.37) or unfractionated heparin infusion rate (pre-antithrombin = 7.35 (1.95-10.71) units/kg/h, post-antithrombin = 6.81 (3.45-12.58) units/kg/h; p = 0.33). Thirteen patients (92%) achieved an antithrombin activity at goal following supplementation. Antithrombin activity was maintained within goal range 52% of the time during the replacement period. Four bleeding events occurred pre-antithrombin and 10 events post-antithrombin administration (p = 0.26) with significantly more platelets administered post-antithrombin (pre-antithrombin = 0.5 units, post-antithrombin = 4.5 units; p = 0.01).

Conclusion: Therapeutic anticoagulation occurred more frequently following antithrombin supplementation; however, this difference was not statistically significant. More bleeding events occurred following antithrombin supplementation while observing an increase in platelet transfusions.
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http://dx.doi.org/10.1177/0267659119856229DOI Listing
January 2020

Prelamellar Dissection Donor Corneal Thickness Is Associated With Descemet Stripping Automated Endothelial Keratoplasty Operative Complications in the Cornea Preservation Time Study.

Cornea 2019 Sep;38(9):1069-1076

Case Western Reserve University, Department of Ophthalmology and Visual Sciences and University Hospitals Eye Institute, Cleveland, OH.

Purpose: To identify donor and recipient factors, including eye bank tissue observations, predictive of operative complications in the Cornea Preservation Time Study.

Methods: One thousand three hundred thirty study eyes undergoing Descemet stripping automated endothelial keratoplasty for Fuchs dystrophy or pseudophakic/aphakic corneal edema were randomized to receive a donor cornea with preservation time (PT) of 0 to 7 days (N = 675) or 8 to 14 days (N = 655). Donor factors included demographics, prelamellar corneal and postlamellar lenticule dissection thickness, central endothelial cell density, and tissue processing time. Recipient factors included demographics, intraocular pressure, and glaucoma medications or surgery (trabeculectomy, laser trabeculoplasty). Eye bank observations included donor tissue folds, pleomorphism/polymegethism, and endothelial cell abnormalities. Possible tissue-related operative complications were recorded including difficult donor lenticule unfolding and positioning. Multivariable logistic regression with backward selection was used to identify statistically significant (P < 0.01) associations between factors and operative complications.

Results: The only factor predictive of operative complications [58 (4.4%) of 1330 surgeries] was prelamellar dissection donor corneal thickness (P = 0.002). For every 50 μm of donor corneal thickness prior to lamellar dissection, operative complication odds increased by 40% (odds ratio [99% confidence interval (CI)]: 1.40 [1.06-1.83]) adjusting for PT and whether the epithelium was on or off. The estimated mean prelamellar dissection donor corneal thickness for PT 0 to 7 days was 537 μm (99% CI: 516 μm-558 μm) compared with 567 μm (99% CI: 546 μm-588 μm) for PT 8 to 14 days (P < 0.001).

Conclusions: Thicker donor tissue (prelamellar dissection) is associated with operative complications and should be considered in tissue selection for Descemet stripping automated endothelial keratoplasty lenticule preparation.
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http://dx.doi.org/10.1097/ICO.0000000000002040DOI Listing
September 2019

Methylprednisolone Acetate (Depo-Medrol) Injection during Cataract Surgery Causing Retinal Necrosis.

Ophthalmology 2019 09 28;126(9):1332-1333. Epub 2019 Mar 28.

Department of Ophthalmology, Henry Ford Hospital, Wayne State University, Detroit, Michigan; Retina Consultants of Michigan, Southfield, Michigan. Electronic address:

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http://dx.doi.org/10.1016/j.ophtha.2019.03.034DOI Listing
September 2019

Effect of Graft Attachment Status and Intraocular Pressure on Descemet Stripping Automated Endothelial Keratoplasty Outcomes in the Cornea Preservation Time Study.

Am J Ophthalmol 2019 07 6;203:78-88. Epub 2019 Mar 6.

Case Western Reserve University Department of Ophthalmology and Visual Sciences, University Hospitals Eye Institute, and the Cornea Image Analysis Reading Center, Cleveland, Ohio, USA. Electronic address:

Purpose: To examine the association of donor, recipient, and operative factors on graft dislocation after Descemet stripping automated endothelial keratoplasty (DSAEK) in the Cornea Preservation Time Study (CPTS) as well as the effects of graft dislocation and elevated IOP on graft success and endothelial cell density (ECD) 3 years postoperatively.

Design: Cohort study within a multi-center, double-masked, randomized clinical trial.

Methods: 1090 individuals (1330 study eyes), median age 70 years, undergoing DSAEK for Fuchs endothelial corneal dystrophy (94% of eyes) or pseudophakic or aphakic corneal edema (6% of eyes). Recipient eyes receiving donor corneal tissue randomized by preservation time (PT) of 0-7 days (N = 675) or 8-14 days (N = 655) were monitored for early or late graft failure through 3 years. Donor, recipient, operative, and postoperative parameters were recorded including graft dislocation (GD), partial detachment, and pre- and post-operative IOP. Pre- and postoperative central donor ECD were determined by a central image analysis reading center. Proportional hazards, mixed effects, and logistic regression models estimated risk ratios and (99% confidence intervals).

Results: Three independent predictive factors for GD were identified: a history of donor diabetes (odds ratio [OR]: 2.29 [1.30, 4.02]), increased pre-lamellar dissection central corneal thickness (OR: 1.13 [1.01, 1.27] per 25µ increase), and operative complications (OR: 2.97 [1.24, 7.11]). Among 104 (8%) eyes with GD, 30 (28.9%) developed primary donor or early failure and 5 (4.8%) developed late failure vs. 15 (1.2%; P < .001) and 29 (2.4%; P = .04), respectively, of 1226 eyes without GD. 24 (2%) of 1330 study eyes had early acutely elevated postoperative IOP that was associated with a higher risk of graft failure through 3 years (hazard ratio: 3.42 [1.01, 11.53]), but not with a lower mean 3-year ECD (mean difference 61 (-479, 601) cells/mm, P = .77). History of elevated postoperative IOP beyond 1 month was not significantly associated with 3-year graft success or ECD.

Conclusions: Donor diabetes, increased donor corneal thickness, and intraoperative complications were associated with an increased risk of GD. Early acutely elevated postoperative IOP and GD significantly increased the risk for graft failure following DSAEK.
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http://dx.doi.org/10.1016/j.ajo.2019.02.029DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6612575PMC
July 2019

Postoperative Endothelial Cell Density Is Associated with Late Endothelial Graft Failure after Descemet Stripping Automated Endothelial Keratoplasty.

Ophthalmology 2019 08 18;126(8):1076-1083. Epub 2019 Feb 18.

Verdier Eye Center, Grand Rapids, Michigan.

Purpose: To determine whether preoperative endothelial cell density (ECD) and postoperative ECD after Descemet stripping automated endothelial keratoplasty (DSAEK) are associated with late endothelial graft failure (LEGF) in the Cornea Preservation Time Study (CPTS).

Design: Cohort study within a multicenter, randomized clinical trial.

Participants: A total of 1007 individuals (1223 study eyes), mean age 70 years, undergoing DSAEK for Fuchs' dystrophy (94% of eyes) or pseudophakic or aphakic corneal edema (PACE) (6% of eyes) and followed for up to 5 years.

Methods: Central ECD was determined by a central image analysis reading center. Preoperative ECD was determined for 1209 eyes that did not fail and 14 eyes that experienced LEGF. The ECD at 6 and 12 months after DSAEK, the change in ECD from preoperative to 6 and 12 months, surgeon-reported operative complications, and postoperative graft dislocation were investigated for an association with LEGFs unrelated to other postoperative events. Univariable and multivariable Cox proportional hazards regression models were used to assess associations.

Main Outcome Measures: Late endothelial graft failure and its associations with pre- and postoperative ECD and operative complications.

Results: The cumulative probability of LEGF was 1.3% (95% confidence interval [CI], 0.8%-2.4%). Median (interquartile range [IQR]) preoperative ECDs were similar for eyes with LEGF (2523; 2367-3161) cells/mm) and eyes without failure (2727; 2508-2973) cells/mm) (P = 0.34). The ECD at 6 months was associated with LEGF (P < 0.001) in time-to-event analyses, whereas preoperative ECD was not (P = 0.55). The cumulative incidence (95% CI) of LEGF was 6.5% (3.0%, 14.0%) for 97 grafts with a 6-month ECD less than 1200 cells/mm, 0.3% (0.0%, 2.4%) for 310 grafts with a 6-month ECD between 1200 and 2000 cells/mm, and 0.6% (0.1%, 2.7%) for 589 grafts with a 6-month ECD greater than 2000 cells/mm. In multivariable analyses, ECD at 6 months and operative complications were both associated with LEGF (P = 0.002 and P = 0.01, respectively), whereas graft dislocation was not (P = 0.61).

Conclusions: In eyes undergoing DSAEK, preoperative ECD is unrelated to LEGF, whereas lower ECD at 6 months is associated with LEGF. Early endothelial cell loss after DSAEK and intraoperative complications should be minimized to improve graft survival.
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http://dx.doi.org/10.1016/j.ophtha.2019.02.011DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6646077PMC
August 2019

Identifying Core Content for Electrocardiogram Instruction in Doctor of Pharmacy Curricula.

Am J Pharm Educ 2018 12;82(10):7009

Virginia Commonwealth University School of Pharmacy, Richmond, Virginia.

Minimum competencies for diagnostic tools, such as the electrocardiogram, are not well-defined in current standards or publications. The electrocardiogram has significant pharmacotherapeutic implications that pharmacists should have an adequate understanding of. This commentary highlights the importance of pharmacists' understanding of key elements of the electrocardiogram and drafts a set of recommended minimum competencies for graduating pharmacy students.
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http://dx.doi.org/10.5688/ajpe7009DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6325467PMC
December 2018

Blepharitis Preferred Practice Pattern®.

Ophthalmology 2019 01 23;126(1):P56-P93. Epub 2018 Oct 23.

Departments of Cornea and External Diseases, Scripps Clinic Torrey Pines, La Jolla, California.

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http://dx.doi.org/10.1016/j.ophtha.2018.10.019DOI Listing
January 2019

Bacterial Keratitis Preferred Practice Pattern®.

Ophthalmology 2019 01 23;126(1):P1-P55. Epub 2018 Oct 23.

Departments of Cornea and External Diseases, Scripps Clinic Torrey Pines, La Jolla, California.

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http://dx.doi.org/10.1016/j.ophtha.2018.10.018DOI Listing
January 2019

Dry Eye Syndrome Preferred Practice Pattern®.

Ophthalmology 2019 01 23;126(1):P286-P334. Epub 2018 Oct 23.

Departments of Cornea and External Diseases, Scripps Clinic Torrey Pines, La Jolla, California.

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http://dx.doi.org/10.1016/j.ophtha.2018.10.023DOI Listing
January 2019

Conjunctivitis Preferred Practice Pattern®.

Ophthalmology 2019 01 23;126(1):P94-P169. Epub 2018 Oct 23.

Michigan Cornea Consultants, P.C., Southfield, MI.

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http://dx.doi.org/10.1016/j.ophtha.2018.10.020DOI Listing
January 2019

Corneal Edema and Opacification Preferred Practice Pattern®.

Ophthalmology 2019 01 23;126(1):P216-P285. Epub 2018 Oct 23.

Michigan Cornea Consultants, P.C., Southfield, MI.

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http://dx.doi.org/10.1016/j.ophtha.2018.10.022DOI Listing
January 2019

Corneal Ectasia Preferred Practice Pattern®.

Ophthalmology 2019 01 23;126(1):P170-P215. Epub 2018 Oct 23.

Michigan Cornea Consultants, P.C., Southfield, MI.

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http://dx.doi.org/10.1016/j.ophtha.2018.10.021DOI Listing
January 2019

Factors Associated With Graft Rejection in the Cornea Preservation Time Study.

Am J Ophthalmol 2018 12 9;196:197-207. Epub 2018 Oct 9.

Case Western Reserve University Department of Ophthalmology and Visual Sciences and University Hospitals Eye Institute, Cleveland, Ohio, USA.

Purpose: To identify factors related to graft rejection following Descemet stripping automated endothelial keratoplasty (DSAEK) in the Cornea Preservation Time Study (CPTS).

Design: Cohort study within a multicenter randomized clinical trial.

Methods: A total of 1330 eyes of 1090 subjects undergoing DSAEK were randomized to receive a donor cornea with preservation time (PT) of 0-7 days (n = 675) or 8-14 days (n = 655) and followed for 3 years. Central endothelial cell density (ECD) was determined by a central image analysis reading center. Multivariable Cox models adjusted for PT, recipient diagnosis, and surgeon effect were used to identify factors associated with rejection.

Results: Cumulative probability of definite graft rejection was 3.6% (99% confidence interval 2.5%-5.3%). Younger recipient age was associated with graft rejection (P < .001; hazard ratio: 0.53 [0.33, 0.83] per decade). PT, donor-recipient sex mismatch, recipient diagnosis, recipient race, graft size, discontinuation of topical corticosteroids and immune-modulators, prior immunizations within 3 months, and prior glaucoma surgery were not associated with rejection (P > .01). Among clear grafts with an ECD measurement at baseline and 3 years (n = 913), endothelial cell loss (ECL) was greater in eyes that experienced a rejection episode (n = 27) than in those that did not (n = 886) (48% vs 38%, P = .03). Twelve of 44 eyes (27%) with definite graft rejection subsequently failed, comprising 15% of the 79 failures in the CPTS.

Conclusions: Graft rejection is uncommon after DSAEK and more likely with younger age, in a study cohort mostly > 50 years old. Rejection increases ECL, but it is not a leading cause of DSAEK failure.
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http://dx.doi.org/10.1016/j.ajo.2018.10.005DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6258266PMC
December 2018

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

Ophthalmology 2018 11 9;125(11):1700-1709. Epub 2018 Aug 9.

Department of Ophthalmology and Visual Sciences, Case Western Reserve University and University Hospitals Eye Institute, Cleveland, Ohio. Electronic address:

Purpose: To associate donor, recipient, and operative factors with graft success 3 years after Descemet stripping automated endothelial keratoplasty (DSAEK) in the Cornea Preservation Time Study (CPTS).

Design: Cohort study within a multicenter, double-masked, randomized clinical trial.

Participants: One thousand ninety individuals (1330 study eyes) with a median age of 70 years undergoing DSAEK for Fuchs endothelial corneal dystrophy (94% of eyes) or pseudophakic or aphakic corneal edema (PACE; 6% of eyes).

Methods: Eyes undergoing DSAEK were randomized to receive a donor cornea with preservation time (PT) of 0 to 7 days (n = 675) or 8 to 14 days (n = 655). Donor, recipient, and operative parameters were recorded prospectively. Graft failure was defined as regraft for any reason, a graft that failed to clear by 8 weeks after surgery, or an initially clear graft that became and remained cloudy for 90 days. Failure in the first 8 weeks was classified further as primary donor failure or early failure, in the absence or presence of operative complications, respectively. Proportional hazards and logistic regression models were used to estimate risk ratios (RR) and 99% confidence intervals (CIs) for graft failure.

Main Outcome Measures: Graft success at 3 years.

Results: One thousand two hundred fifty-one of 1330 grafts (94%) remained clear at 3 years and were considered successful. After adjusting for PT, tissue from donors with diabetes (RR, 2.35; 99% CI, 1.03-5.33) and operative complications (RR, 4.21; 99% CI, 1.42-12.47) were associated with increased risk for primary or early failure. Preoperative diagnosis of PACE (RR, 3.59; 99% CI, 1.05-12.24) was associated with increased risk for late failure by 3 years after surgery compared with Fuchs dystrophy. Graft success showed little variation among other factors evaluated, including donor age (RR, 1.19 per decade; 99% CI, 0.91-1.56 per decade), preoperative donor endothelial cell density (RR, 1.10 per 500 cells; 99% CI, 0.74-1.63 per 500 cells), graft diameter (RR, 1.22 per 1 mm; 99% CI, 0.39-3.76 per 1 mm), and injector use for graft insertion (RR, 0.92; 99% CI, 0.40-2.10).

Conclusions: Descemet stripping automated endothelial keratoplasty success in the early and entire postoperative period is more likely when the donor did not have diabetes and was without operative complications and in the long-term postoperative period in recipients with Fuchs dystrophy compared with those with PACE. Mechanisms whereby diabetic donors and PACE recipients reduce the rate of graft success after DSAEK warrant further study.
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http://dx.doi.org/10.1016/j.ophtha.2018.08.002DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6196643PMC
November 2018

Corneal Endothelial Cell Loss 3 Years After Successful Descemet Stripping Automated Endothelial Keratoplasty in the Cornea Preservation Time Study: A Randomized Clinical Trial.

JAMA Ophthalmol 2017 12;135(12):1394-1400

Jaeb Center for Health Research, Tampa, Florida

Importance: Demonstrating that endothelial cell loss following Descemet stripping automated endothelial keratoplasty (DSAEK) is independent of donor cornea preservation time (PT) could increase the pool of corneal tissue available for keratoplasty.

Objective: To determine whether endothelial cell loss 3 years after successful DSAEK is related to PT.

Design, Setting, And Participants: A multicenter, double-masked, randomized clinical trial included 40 clinical sites (70 surgeons) in the United States, with donor corneas provided by 23 US eye banks. A total of 945 eyes of 769 participants were included in the Cornea Preservation Time Study that had not experienced graft failure 3 years after DSAEK, performed primarily for Fuchs endothelial corneal dystrophy (96% of the cohort). The study was conducted from April 16, 2012, to June 5, 2017.

Interventions: DSAEK with random assignment of a donor cornea with PT of 0 to 7 days (0-7d PT) or 8 to 14 days (8-14d PT).

Main Outcomes And Measures: Endothelial cell density (ECD) at 3 years determined by a central image analysis reading center from clinical specular or confocal central endothelial images.

Results: Nine hundred forty-five eyes of 769 participants (median age, 70 years [range, 42-90 years], 60.8% women, 93.0% white) in the Cornea Preservation Time Study that had not experienced graft failure 3 years after DSAEK were included. At the initial eye bank tissue screening, mean (SD) central ECD was 2746 (297) cells/mm2 in the 0-7d PT group (n = 485) and 2723 (284) cells/mm2 in the 8-14d PT group (n = 460). At 3 years, the mean (SD) ECD decreased from baseline by 37% (21%) in the 0-7d PT group and 40% (22%) in the 8-14d PT group to 1722 (626) cells/mm2 and 1642 (631) cells/mm2, respectively (mean difference, 73 cells/mm2; 95% CI, 8-138 cells/mm2; P = .03). When analyzed as a continuous variable (days), longer PT was associated with lower ECD (mean difference by days, 15 cells/mm2; 95% CI, 4-26 cells/mm2; P = .006). Endothelial cell loss (ECL) was comparable from 4 to 13 days’ PT (n = 878; 36%-43% when tabulated by day). Available extension study ECD results at 4 years mirrored those at 3 years in the 203 eyes in the 0-7d PT group (mean [SD] ECD, 1620 [673] cells/mm2 and mean [SD] ECL, 41% [23%]) and 209 eyes in the 8-14d PT group (mean [SD] ECD, 1537 [683] cells/mm2 and mean [SD] ECL, 44% [23%]) (mean difference, 112 cells/mm2; 95% CI, 5-219 cells/mm2; P = .04).

Conclusions And Relevance: Although ECL 3 years after Descemet stripping automated endothelial keratoplasty is greater with longer PT, the effect of PT on ECL is comparable from 4 to 13 days’ PT.
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http://dx.doi.org/10.1001/jamaophthalmol.2017.4970DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6583548PMC
December 2017

Effect of Cornea Preservation Time on Success of Descemet Stripping Automated Endothelial Keratoplasty: A Randomized Clinical Trial.

JAMA Ophthalmol 2017 12;135(12):1401-1409

Department of Ophthalmology and Visual Sciences, Case Western Reserve University, Cleveland, Ohio

Importance: Demonstrating that success of Descemet stripping automated endothelial keratoplasty is similar across donor cornea preservation times (PTs) could increase the donor pool.

Objective: To determine whether the 3-year rate of graft success using corneal donor tissue preserved 8 to 14 days is noninferior to that of donor tissue preserved 7 days or less.

Design, Setting, And Participants: A multicenter, double-masked, randomized noninferiority clinical trial was conducted from April 16, 2012, to June 5, 2017, at 40 clinical sites (70 surgeons) in the United States, with donor corneas provided by 23 US eye banks. A total of 1090 individuals (1330 study eyes) underwent Descemet stripping automated endothelial keratoplasty (1255 eyes [94.4%] for Fuchs endothelial corneal dystrophy).

Interventions: Descemet stripping automated endothelial keratoplasty with random assignment of a donor cornea with a PT of 7 days or less (0-7d PT) or 8 to 14 days (8-14d PT).

Main Outcomes And Measures: Graft success at 3 years.

Results: Of the 1090 participants (1330 study eyes; 60.2% women and 39.8% men; median age at enrollment, 70 years [range, 42-90 years]), the 3-year cumulative probability of graft success was 95.3% (95% CI, 93.6%-96.9%) in the 0-7d PT group and 92.1% (95% CI, 89.9%-94.2%) in the 8-14d PT group (difference, 3.2%). The upper limit of the 1-sided 95% CI on the difference was 5.4%, exceeding the prespecified noninferiority limit of 4%. The difference was mostly owing to more primary donor failures in the 8-14d PT group, with the conditional probability of failure after the first month being 2.4% in the 0-7d PT group and 3.1% in the 8-14d PT group. In preplanned secondary analyses, longer PT was associated with a lower rate of graft success (unadjusted hazard ratio for graft failure per additional day of PT, 1.10; 95% CI, 1.03-1.18; P = .008 [PT analyzed as days]), with success rates of 96.5% (95% CI, 92.3%-98.4%) for PT of 4 days or less, 94.9% (95% CI, 92.5%-96.6%) for PT of 5 to 7 days, 93.8% (95% CI, 91.0%-95.8%) for PT of 8 to 11 days, and 89.3% (95% CI, 84.4%-92.7%) for PT of 12 to 14 days (P = .01 [PT analyzed as categorical variable]).

Conclusions And Relevance: The 3-year success rate in eyes undergoing Descemet stripping automated endothelial keratoplasty was high irrespective of PT. However, the study was unable to conclude that the success rate with donor corneas preserved 8 to 14 days was similar to that of corneas preserved 7 days or less with respect to the prespecified noninferiority limit. Although longer PT was associated with a lower success rate, the difference in rates was small when PT was less than 12 days.
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http://dx.doi.org/10.1001/jamaophthalmol.2017.4989DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6583547PMC
December 2017

: A Validated Scoring System for Early Stratification of Neurologic Outcome After Out-of-Hospital Cardiac Arrest Treated With Targeted Temperature Management.

J Am Heart Assoc 2017 May 20;6(5). Epub 2017 May 20.

Department of Cardiovascular Medicine, University of Virginia, Charlottesville, VA

Background: Out-of-hospital cardiac arrest (OHCA) results in significant morbidity and mortality, primarily from neurologic injury. Predicting neurologic outcome early post-OHCA remains difficult in patients receiving targeted temperature management.

Methods And Results: Retrospective analysis was performed on consecutive OHCA patients receiving targeted temperature management (32-34°C) for 24 hours at a tertiary-care center from 2008 to 2012 (development cohort, n=122). The primary outcome was favorable neurologic outcome at hospital discharge, defined as cerebral performance category 1 to 2 (poor 3-5). Patient demographics, pre-OHCA diagnoses, and initial laboratory studies post-resuscitation were compared between favorable and poor neurologic outcomes with multivariable logistic regression used to develop a simple scoring system (). The score ranges 0 to 5 using equally weighted variables: (): coronary artery disease, known pre-OHCA; (): glucose ≥200 mg/dL; (): rhythm of arrest not ventricular tachycardia/fibrillation; (): age >45; (): arterial pH ≤7.0. A validation cohort (n=344) included subsequent patients from the initial site (n=72) and an external quaternary-care health system (n=272) from 2012 to 2014. The c-statistic for predicting neurologic outcome was 0.82 (0.74-0.90, <0.001) in the development cohort and 0.81 (0.76-0.87, <0.001) in the validation cohort. When subdivided by score, similar rates of favorable neurologic outcome were seen in both cohorts, 70% each for low (0-1, n=60), 22% versus 19% for medium (2-3, n=307), and 0% versus 2% for high (4-5, n=99) scores in the development and validation cohorts, respectively.

Conclusions: stratifies neurologic outcomes following OHCA in patients receiving targeted temperature management (32-34°C) using objective data available at hospital presentation, identifying patient subsets with disproportionally favorable ( ≤1) and poor ( ≥4) prognoses.
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http://dx.doi.org/10.1161/JAHA.116.003821DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5524053PMC
May 2017

Epithelial Ingrowth Following Endothelial Keratoplasty.

Cornea 2016 Apr;35(4):465-70

*Private Practice, Mumbai, India; †Wills Eye Hospital, Philadelphia, PA; ‡Michigan Cornea Consultants, Southfield, MI; §Department of Ophthalmology, Upstate Medical University, Syracuse, NY; ¶Department of Ophthalmology, University of Illinois at Chicago (UIC); ‖Department of Ophthalmology, Rush Medical College, Chicago, IL; and **Department of Ophthalmology, Northwestern University, Feinberg School of Medicine, Chicago, IL.

Purpose: To present a large case series of epithelial ingrowth or implantation following endothelial keratoplasty (EK) with the purpose of identifying the common causes as well as the various clinical presentations. We aim to determine the typical clinical course and the most effective treatment for this rare but serious complication.

Methods: This is a retrospective study of 13 patients who developed epithelial ingrowth or implantation post-EK. Slit lamp photographs were independently examined along with other diagnostic imaging and histopathology to confirm the diagnosis. Patient medical records including operative reports were reviewed to determine the number of surgeries that occurred before EK and details of surgical technique, for example, whether venting incisions were performed. Records from follow-up visits were reviewed to determine the natural progression and management of these cases. The literature was reviewed and a meta-analysis was performed.

Results: The patients were divided into 5 groups according to the type of epithelial presentation. Eight patients had involvement within the interface away from the visual axis. One patient had ingrowth in the interface within the visual axis, 2 had retrocorneal involvement, and 1 had anterior chamber involvement. One had both retrocorneal and anterior chamber involvement. Venting incisions were performed in 8 patients, but only 1 had ingrowth related to the venting incision. Nine patients were observed without evidence of significant progression. Four patients had surgical treatment to remove the epithelium.

Conclusions: Epithelial ingrowth or implantation occurs most commonly within the interface away from the visual axis and typically does not progress. The presentation of a homogeneous gray-white interface opacity is characteristic. Ingrowth can result from venting incisions, but rarely does. Other causes are eccentric trephination or loose donor or host epithelium being dragged into the eye at the time of surgery.
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http://dx.doi.org/10.1097/ICO.0000000000000775DOI Listing
April 2016

Effectiveness of Pharmacist-Led Amiodarone Monitoring Services on Improving Adherence to Amiodarone Monitoring Recommendations: A Systematic Review.

Pharmacotherapy 2016 Feb 5;36(2):230-6. Epub 2016 Feb 5.

Virginia Commonwealth University, Richmond, Virginia.

Amiodarone remains the mostly frequently used antiarrhythmic in clinical practice and is most often used to maintain normal sinus rhythm in patients with atrial fibrillation who have failed a rate control strategy. Amiodarone has superior efficacy over other antiarrhythmics, a lower risk of torsade de pointes, and a better cardiovascular safety profile in patients with structural heart disease. However, amiodarone is associated with notable noncardiac toxicities affecting the thyroid, lungs, eyes, liver, and central nervous system. Since 2000, clinicians have been advised to follow amiodarone monitoring guidelines provided by the Heart Rhythm Society. Adherence to these recommendations in clinical practice, however, is suboptimal. Pharmacists play a major role in ensuring the safe and effective use of medications, particularly high-risk medications such as amiodarone. This qualitative review details the evidence supporting the role of pharmacist-led amiodarone monitoring services (AMS) in improving adherence to amiodarone monitoring guidelines and identifying adverse effects. Five studies were identified, and, overall, these programs had a favorable impact on improving adherence to guideline-recommended monitoring standards for amiodarone. The available evidence is limited by the significant variations in study designs and outcome definitions, lack of patient randomization, and limited generalizability. Nevertheless, available studies suggest that pharmacist-led AMS may improve adherence to recommended monitoring guidelines and identification of amiodarone-related adverse effects. Further study is warranted to demonstrate whether these services impact the overall quality of care provided to patients receiving amiodarone, which may justify broader implementation.
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http://dx.doi.org/10.1002/phar.1697DOI Listing
February 2016

The role of the clinical pharmacist in the care of patients with cardiovascular disease.

J Am Coll Cardiol 2015 Nov;66(19):2129-2139

St. Vincent Heart Center, Indianapolis, Indiana.

Team-based cardiovascular care, including the use of clinical pharmacists, can efficiently deliver high-quality care. This Joint Council Perspectives paper from the Cardiovascular Team and Prevention Councils of the American College of Cardiology provides background information on the clinical pharmacist's role, training, certification, and potential utilization in a variety of practice models. Selected systematic reviews and meta-analyses, highlighting the benefit of clinical pharmacy services, are summarized. Clinical pharmacists have a substantial effect in a wide variety of roles in inpatient and ambulatory settings, largely through optimization of drug use, avoidance of adverse drug events, and transitional care activities focusing on medication reconciliation and patient education. Expansion of clinical pharmacy services is often impeded by policy, legislation, and compensation barriers. Multidisciplinary organizations, including the American College of Cardiology, should support efforts to overcome these barriers, allowing pharmacists to deliver high-quality patient care to the full extent of their education and training.
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http://dx.doi.org/10.1016/j.jacc.2015.09.025DOI Listing
November 2015

Cornea preservation time study: methods and potential impact on the cornea donor pool in the United States.

Cornea 2015 Jun;34(6):601-8

*Department of Ophthalmology and Visual Sciences, Case Western Reserve University and University Hospitals Eye Institute, Cleveland, OH; †Jaeb Center for Health Research, Tampa, FL; ‡Jules Stein Eye Institute, University of California, Los Angeles, Los Angeles, CA; §Eye Associates Northwest, Seattle, WA; ¶Michigan Cornea Consultants, PC, Southfield, MI; ‖Cornea Associates of Texas, Dallas, TX; **Mid Atlantic Cornea Consultants, Baltimore, MD; ††Central Pennsylvania Eye Center, Hershey, PA; ‡‡Midwest Eye-Banks, Ann Arbor, MI; §§Devers Eye Institute, Portland, OR; and ¶¶Verdier Eye Center, Grand Rapids, MI.

Purpose: The aim of this study was to describe the aims, methods, donor and recipient cohort characteristics, and potential impact of the Cornea Preservation Time Study (CPTS).

Methods: The CPTS is a randomized clinical trial conducted at 40 clinical sites (70 surgeons) designed to assess the effect of donor cornea preservation time (PT) on graft survival 3 years after Descemet stripping automated endothelial keratoplasty (DSAEK). Eyes undergoing surgery for Fuchs endothelial corneal dystrophy or pseudophakic/aphakic corneal edema were randomized to receive donor corneas stored ≤7 days or 8 to 14 days. Donor and patient characteristics, tissue preparation and surgical parameters, recipient and donor corneal stroma clarity, central corneal thickness, intraocular pressure, complications, and a reading center-determined central endothelial cell density were collected. Surveys were conducted to evaluate pre-CPTS PT practices.

Results: The 1330 CPTS donors were: 49% >60 years old, 27% diabetic, had a median eye bank-determined screening endothelial cell density of 2688 cells/mm, and 74% eye bank prepared for DSAEK. A total of 1090 recipients (1330 eyes including 240 bilateral cases) had: median age of 70 years, were 60% female, 90% white, 18% diabetic, 52% phakic, and 94% had Fuchs endothelial corneal dystrophy. Before the CPTS, 19 eye banks provided PT data on 20,852 corneas domestically placed for DSAEK in 2010 to 2011; 96% were preserved ≤7 days. Of 305 American Academy of Ophthalmology members responding to a pre-CPTS survey, 233 (76%) set their maximum PT preference at 8 days or less.

Conclusions: The CPTS will increase understanding of factors related to DSAEK success and, if noninferiority of longer PT is shown, will have great potential to extend the available pool of endothelial keratoplasty donors.Clinical Trial Registration-URL: http://www.clinicaltrials.gov. Unique identifier: NCT01537393.
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http://dx.doi.org/10.1097/ICO.0000000000000417DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4426012PMC
June 2015

Thymosin β4 significantly improves signs and symptoms of severe dry eye in a phase 2 randomized trial.

Cornea 2015 May;34(5):491-6

Departments of *Ophthalmology, and †Anatomy and Cell Biology, Kresge Eye Institute, Wayne State University, School of Medicine, Detroit, MI; ‡Michigan Cornea Consultants, Southfield, MI; and §Kresge Eye Institute, Detroit, MI.

Purpose: Standard therapies for severe dry eye are limited and fail to resolve the problem. The purpose of this study was to evaluate the safety and efficacy of Thymosin β4 eye drops (RGN-259) as a novel therapy for severe dry eye disease (including that associated with graft vs. host disease).

Methods: A small, multicenter, randomized, double-masked, placebo-controlled 56-day phase 2 clinical trial including a 28-day follow-up at 2 US sites. Nine patients with severe dry eye were treated with either RGN-259 (0.1%) or vehicle control 6 times daily over a period of 28 days. Dry eye sign and symptom assessments, such as ocular discomfort (using the OSDI questionnaire) and corneal fluorescein staining (using the NEI workshop grading system), were evaluated at various time points.

Results: Statistically significant differences in both symptom and sign assessments, were seen at various time points throughout the study. Of particular note at day 56, the RGN-259-treated group (12 eyes) had 35.1% reduction of ocular discomfort compared with vehicle control (6 eyes) (P = 0.0141), and 59.1% reduction of total corneal fluorescein staining compared with vehicle control (P = 0.0108). Other improvements seen in the RGN-259-treated patients included tear film breakup time and increased tear volume production.

Conclusions: In this small trial, RGN-259 eye drops were safe and well tolerated and met key efficacy objectives with statistically significant symptom and sign improvements, compared with vehicle control, at various time intervals, including 28-days posttreatment. CLINICAL TRIAL REGISTRATION--URL: http://www.clinicaltrials.gov. Unique identifier: NCT01393132.
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http://dx.doi.org/10.1097/ICO.0000000000000379DOI Listing
May 2015

Angioedema related to Angiotensin inhibitors.

J Pharm Pract 2014 Oct 14;27(5):461-5. Epub 2014 Aug 14.

University of Kentucky HealthCare, Gill Heart Institute, UK College of Pharmacy, Lexington, KY, USA

Angiotensin inhibitors have been extensively evaluated in clinical trials and have demonstrated significant reductions in morbidity and mortality following myocardial infarction and stroke, as well as in patients with heart failure or who are at risk of cardiovascular disease. Further, both angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs) are frequently prescribed for the treatment of hypertension and to preserve renal function in patients with diabetes mellitus and chronic kidney disease. Angioedema is a known, but rare, adverse effect of ACEIs and ARBs. Therefore, it is important for clinicians to have a thorough understanding of risks and benefits of prescribing these medications, particularly in patients with a history of angioedema. This review describes the literature evaluating the incidence and cross-reactivity of angioedema with ACEIs and ARBs in order to provide guidance for clinical decision making.
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http://dx.doi.org/10.1177/0897190014546101DOI Listing
October 2014

Corneal graft rejection 10 years after penetrating keratoplasty in the cornea donor study.

Cornea 2014 Oct;33(10):1003-9

*Michigan Cornea Consultants and Department of Ophthalmology, Oakland University/William Beaumont School of Medicine, Southfield-Rochester, MI; †Jaeb Center for Health Research, Tampa, FL; ‡Inland Eye Institute, Colton, CA; §Cincinnati Eye Institute and Department of Ophthalmology, University of Cincinnati, Cincinnati, OH; ¶Case Western Reserve University and University Hospitals Eye Institute, Cleveland, OH; ‖Eye Health Vision Center, Tufts University School of Medicine, Harvard Medical School, Boston, MA; **University of California Davis, Sacramento, CA; ††WK Kellogg Eye Center, the University of Michigan, Ann Arbor, MI; ‡‡Corneal Associates, PC, Wills Eye Hospital, Philadelphia, PA; and §§The Johns Hopkins University School of Medicine, Baltimore, MD.

Purpose: The aim of this study was to assess the effect of donor and recipient factors on corneal allograft rejection and evaluate whether a rejection event was associated with graft failure.

Methods: One thousand ninety subjects undergoing penetrating keratoplasty for a moderate risk condition (principally Fuchs dystrophy or pseudophakic corneal edema) were followed for up to 12 years. Associations of baseline recipient and donor factors with the occurrence of a rejection event were assessed in univariate and multivariate proportional hazards models.

Results: Among 651 eyes with a surviving graft at 5 years, the 10-year graft failure (±99% confidence interval) rates were 12% ± 4% among eyes with no rejection events in the first 5 years, 17% ± 12% in eyes with at least 1 probable, but no definite rejection event, and 22% ± 20% in eyes with at least 1 definite rejection event. The only baseline factor significantly associated with a higher risk of definite graft rejection was a preoperative history of glaucoma, particularly when previous glaucoma surgery had been performed and glaucoma medications were being used at the time of transplant (10-year incidence 35% ± 23% compared with 14% ± 4% in eyes with no history of glaucoma/intraocular pressure treatment, P = 0.008).

Conclusions: Patients who experienced a definite rejection event frequently developed graft failure raising important questions as to how we might change acute and long-term corneal graft management. Multivariate analysis indicated that previous use of glaucoma medications and glaucoma filtering surgery was a significant risk factor related to a definite rejection event.
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http://dx.doi.org/10.1097/ICO.0000000000000212DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4653080PMC
October 2014

Review of clinical practice guidelines for the management of LDL-related risk.

J Am Coll Cardiol 2014 Jul;64(2):196-206

Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.

Managing risk related to low-density lipoprotein (LDL) is vital in therapy for patients at risk for atherosclerotic cardiovascular disease (ASCVD) events given its important etiologic role in atherogenesis. Despite decades of research showing reduction of ASCVD risk with multiple approaches to lowering of LDL cholesterol, there continue to be significant gaps in care with inadequate numbers of patients receiving standard of care lipid-lowering therapy. Confusion regarding implementation of the multiple published clinical practice guidelines has been identified as one contributor to suboptimal management of LDL-related risk. This review summarizes the current guidelines for reduction of LDL-related cardiovascular risk provided by a number of major professional societies, which have broad applicability to diverse populations worldwide. Statements have varied in the process and methodology of development of recommendations, the grading system for level and strength of evidence, the inclusion or exclusion of expert opinion, the suggested ASCVD risk assessment tool, the lipoproteins recommended for risk assessment, and the lipoprotein targets of therapy. The similarities and differences among important guidelines in the United States and internationally are discussed, with recommendations for future strategies to improve consistency in approaches to LDL-related ASCVD risk and to reduce gaps in implementation of evidence-based therapies.
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http://dx.doi.org/10.1016/j.jacc.2014.05.015DOI Listing
July 2014

Distinguishing anemia and iron deficiency of heart failure: signal for severity of disease or unmet therapeutic need?

Pharmacotherapy 2014 Jul 28;34(7):719-32. Epub 2014 Mar 28.

Department of Pharmacy, TriStar Centennial Medical Center, Nashville, Tennessee.

Despite advances in the management of heart failure (HF), quality of life and other outcomes remain suboptimal for many patients. Anemia and iron deficiency are comorbidities associated with adverse outcomes, although their pathophysiology in the setting of HF is not entirely understood. Anemia and iron deficiency may exist independently and may be a consequence of the systemic inflammatory state characterized by chronic HF. However, it is unclear whether serum hemoglobin concentrations and other hematologic parameters serve as markers for the severity of disease or represent novel therapeutic targets. Research in this area has focused primarily on therapies known to be effective for these conditions in other chronic disease states with similar pathophysiologic features (e.g., end-stage renal disease). Despite its many practical advantages, minimal evidence exists to support the use of oral iron supplementation in this setting. In contrast, intravenous iron has been the subject of several recent investigations, demonstrating improvements in both surrogate and clinical end points, although benefits seem to be the most substantial in patients with concomitant anemia. Erythropoietin-stimulating agents demonstrated early promise in retrospective analyses and small prospective trials, but their benefit was outweighed by a lack of improvement in clinical outcomes and an excess number of thromboembolic events in the largest trial of patients with anemia and HF to date. For acute symptomatic anemia, blood transfusion may be considered, although few trials have included patients with HF, and caution must be exerted in those who are hemodynamically unstable. Based on the currently available evidence, treatment of iron deficiency appears to confer benefit in patients with HF, whereas strategies aimed at improving hemoglobin alone do not. Included is a review of the pathophysiology of these conditions in the setting of HF, clinical trials evaluating pharmacologic therapy, and recommendations for management.
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http://dx.doi.org/10.1002/phar.1412DOI Listing
July 2014

The effect of donor age on penetrating keratoplasty for endothelial disease: graft survival after 10 years in the Cornea Donor Study.

Ophthalmology 2013 Dec;120(12):2419-2427

Jaeb Center for Health Research, Tampa, Florida.

Objective: To determine whether the 10-year success rate of penetrating keratoplasty for corneal endothelial disorders is associated with donor age.

Design: Multicenter, prospective, double-masked clinical trial.

Participants: A total of 1090 participants undergoing penetrating keratoplasty at 80 sites for Fuchs' dystrophy (62%), pseudophakic/aphakic corneal edema (34%), or another corneal endothelial disorder (4%) and followed for up to 12 years.

Methods: Forty-three eye banks provided corneas from donors aged 12 to 75 years, using a randomized approach to assign donor corneas to study participants without respect to recipient factors. Surgery and postoperative care were performed according to the surgeons' usual routines.

Main Outcome Measures: Graft failure defined as a regraft or, in the absence of a regraft, a cloudy cornea that was sufficiently opaque to compromise vision for 3 consecutive months.

Results: In the primary analysis, the 10-year success rate was 77% for 707 corneas from donors aged 12 to 65 years compared with 71% for 383 donors aged 66 to 75 years (difference, +6%; 95% confidence interval, -1 to +12; P = 0.11). When analyzed as a continuous variable, higher donor age was associated with lower graft success beyond the first 5 years (P<0.001). Exploring this association further, we observed that the 10-year success rate was relatively constant for donors aged 34 to 71 years (75%). The success rate was higher for 80 donors aged 12 to 33 years (96%) and lower for 130 donors aged 72 to 75 years (62%). The relative decrease in the success rate with donor ages 72 to 75 years was not observed until after year 6.

Conclusions: Although the primary analysis did not show a significant difference in 10-year success rates comparing donor ages 12 to 65 years and 66 to 75 years, there was evidence of a donor age effect at the extremes of the age range. Because we observed a fairly constant 10-year success rate for donors aged 34 to 71 years, which account for approximately 75% of corneas in the United States available for transplant, the Cornea Donor Study results indicate that donor age is not an important factor in most penetrating keratoplasties for endothelial disease.
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http://dx.doi.org/10.1016/j.ophtha.2013.08.026DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3885822PMC
December 2013