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Purpose: To determine which donor characteristics, like previous diseases and surgeries, influence the severity of the DM/endothelial lamella preparation prior to DMEK-surgery. Patients and Methods: Retrospective cross-sectional single-center study is presented. Eight hundred and forty-six eyes with DMEK-surgery between 01/2018 and 01/2021 performed at the University Hospital Cologne, Germany, were included. Information regarding the donors' previous diseases and surgeries were provided by a large database of a cornea bank (Multi Tissue Bank Mecklenburg-Vorpommern) and merged with the Cologne DMEK database, which contains information regarding preparation characteristics of the surgeon-prepared graft directly preoperatively. Three preparation groups (easy, difficult and very difficult) were correlated to the donors' previous diseases and surgeries. The following characteristics were used for the assignment in one of the three groups: stripping difficulty, rolling and staining behavior, central and peripheral adherences, tissue fragility and DM-splitting. Results: Significant risk factors for DM-splitting were diabetes mellitus (DMel) type II, heart failure, chronic kidney disease and previous cataract surgery (p=0.022, p=0.012; p=0.047 and p<0.001 respectively). Previous DMel (especially type 2) was significantly associated with the occurrence of central adherences (p=0.009). Several cardiovascular diseases (p-values between <0.001 and p=0.038), DMel type II, chronic kidney disease and previous cataract-surgery were associated with peripheral adherences (p=0.004; p=0.020 and p<0.001 respectively). Furthermore, pseudophakic donor eyes presented a higher degree of fragility of the graft (p<0.001). Age was a significant risk factor for difficult preparation (p<0.001). The staining of the graft was poorer in donors with chronic kidney disease (p=0.037). Conclusion: Donor diabetes mellitus type 2, heart failure, previous cataract surgery, chronic kidney disease and age are associated with a difficult DMEK graft preparation. For every one-year increment in donor age, the odds of having very difficult preparation were increased by 3%. Also, chronic kidney disease predisposes to a poor tissue staining with trypan blue during preparation.
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BACKGROUND: Pulmonary involvement is the leading cause of death in systemic sclerosis (SSc) and may manifest as interstitial lung disease (ILD), pulmonary arterial hypertension (PAH), or in combination of both (ILD with pulmonary hypertension [ILD-PH]). The aim of this analysis was to determine prevalence, clinical characteristics, and survival of these different forms within the registry of the German Network for Systemic Sclerosis. RESEARCH QUESTION: Does SSc-associated ILD-PH or ILD without PH affect survival differently, and are there any risk factors that have an additional impact? STUDY DESIGN AND METHODS: Clinical data of 5,831 patients with SSc were collected in the German Network for Systemic Sclerosis registry. Kaplan-Meier estimates were used to compare overall survival in patients with SSc-associated ILD-PH and ILD without PH with patients without pulmonary involvement and those with PAH. The Cox proportional hazard model was used to analyze the influence of pulmonary involvement and other potential predictors on patient survival. RESULTS: Clinical data of 3,257 patients with a mean follow-up time of 3.45 ± 1.63 years have been included in our analysis. At baseline, ILD was present in 34.5%, whereas PH without ILD had a lower prevalence with 4.5%. At the end of follow-up, 47.6% of patients with SSc had ILD, 15.2% had ILD-PH, and 6.5% had PAH. ILD was more frequent in the diffuse cutaneous form (57.3%), whereas PAH did not differ significantly between SSc subtypes. Significant differences in baseline characteristics between PAH vs ILD-PH vs ILD without PH were found for age at diagnosis, sex, SSc subsets, antibody status, FVC, diffusing capacity of the lung for carbon monoxide, and therapy. Overall survival at 5 years was 96.4% for patients without pulmonary involvement and differed significantly between patients with ILD without PH, PAH, and being worst in patients with ILD-PH. Female sex (hazard ratio [HR], 0.3), higher BMI (HR, 0.9), and higher diffusing capacity of the lung for carbon monoxide values (HR, 0.98) were associated with a lower mortality risk. INTERPRETATION: ILD is the most prevalent pulmonary involvement in SSc, whereas the combination of ILD and PH is associated with the most detrimental survival.