Hodge, David O.

Purpose: The goal of this study was to compare outcomes of Descemet stripping endothelial keratoplasty (DSEK) in eyes with glaucoma and abnormal anatomy to eyes with Fuchs endothelial corneal dystrophy (FECD). Methods: In a retrospective interventional series of all cases of DSEK between April 1, 2006, and November 30, 2015, recipient diagnosis, preoperative glaucoma status, concurrent surgical procedures, and graft outcomes were recorded. Graft survival, risk of rejection, and subsequent glaucoma surgery were estimated by using Kaplan–Meier analysis with risk factors determined by proportional hazard models. Results: Of 703 DSEKs in 666 eyes (509 subjects), the main recipient diagnoses were FECD (n = 496), pseudophakic corneal edema (n = 112), and failed graft (n = 83). Glaucoma was present in 150 cases before DSEK. Overall graft survival was 85%, 75%, and 71% at 5, 10, and 12 years, respectively, and for FECD without glaucoma was 95%, 89%, and 87% at 5, 10, and 12 years, respectively. Independent risk factors for graft failure included recipient diagnoses of pseudophakic corneal edema (HR = 8.3, P < 0.001), failed graft (HR = 6.4, P < 0.001), and preoperative medical glaucoma (HR = 7.1, P < 0.001) or surgical glaucoma (HR = 12.3, P < 0.001). Preoperative glaucoma treated by previous surgery resulted in graft survival of 28% at 10 years. Preoperative glaucoma was associated with an increased risk of graft rejection (HR = 6.8, P < 0.001) and subsequent glaucoma surgery (HR > 17.4, P < 0.001). Conclusions: Preoperative glaucoma increases the risk of graft failure, graft rejection, and needing subsequent glaucoma surgery in the first decade after DSEK. With previous glaucoma surgery, DSEK graft survival was more favorable compared with published reports of Descemet membrane endothelial keratoplasty.

Background: There are good data to support using a single high-sensitivity cardiac troponin T (hs-cTnT) below the limit of detection of 5 ng/L to exclude acute myocardial infarction. Per the US Food and Drug Administration, hs-cTnT can only report to the limit of quantitation of 6 ng/L, a threshold for which there are limited data. Our goal was to determine whether a single hs-cTnT below the limit of quantitation of 6 ng/L is a safe strategy to identify patients at low risk for acute myocardial injury and infarction. Methods: The efficacy (proportion identified as low risk based on baseline hs-cTnT<6 ng/L) of identifying low-risk patients was examined in a multicenter (n=22 sites) US cohort study of emergency department patients undergoing at least 1 hs-cTnT (CV Data Mart Biomarker cohort). We then determined the performance of a single hs-cTnT<6 ng/L (biomarker alone) to exclude acute myocardial injury (subsequent hs-cTnT >99th percentile in those with an initial hs-cTnT<6 ng/L). The clinically intended rule-out strategy combining a nonischemic ECG with a baseline hs-cTnT<6 ng/L was subsequently tested in an adjudicated cohort in which the diagnostic performance for ruling out acute myocardial infarction and safety (myocardial infarction or death at 30 days) were evaluated. Results: A total of 85 610 patients were evaluated in the CV Data Mart Biomarker cohort, among which 24 646 (29%) had a baseline hs-cTnT<6 ng/L. Women were more likely than men to have hs-cTnT<6 ng/L (38% versus 20%, P <0.0001). Among 11 962 patients with baseline hs-cTnT<6 ng/L and serial measurements, only 1.2% developed acute myocardial injury, resulting in a negative predictive value of 98.8% (95% CI, 98.6–99.0) and sensitivity of 99.6% (95% CI, 99.5–99.6). In the adjudicated cohort, a nonischemic ECG with hs-cTnT<6 ng/L identified 33% of patients (610/1849) as low risk and resulted in a negative predictive value and sensitivity of 100% and a 30-day rate of 0.2% for myocardial infarction or death. Conclusions: A single hs-cTnT below the limit of quantitation of 6 ng/L is a safe and rapid method to identify a substantial number of patients at very low risk for acute myocardial injury and infarction.

AbstractBackgroundLike other chronic, inflammatory skin disorders, hidradenitis suppurativa (HS) is increasingly recognized to be associated with various medical disorders.ObjectiveUsing the Rochester Epidemiology Project (REP), we sought to conduct the first American population‐based study examining the association between HS and various comorbid conditions.MethodsFrom the REP database, we identified patients diagnosed with HS from 2003 through 2018 who were residents of Olmsted County, Minnesota, USA, along with age‐ and gender‐matched controls. The frequency of a wide variety of comorbid conditions was compared between the groups.ResultsA total of 1160 patients with HS were identified during the study period. Compared with age‐ and gender‐matched controls, patients with HS had a significantly higher frequency of several medical conditions, including depression, anxiety, hyperlipidemia, acne conglobata, dissecting cellulitis, pilonidal cysts, polycystic ovary syndrome, diabetes, chronic kidney disease, psoriasis, atopic dermatitis, obesity, and disordered substance use, among others.LimitationsOur study was limited by its retrospective design.ConclusionsProviders caring for patients with HS should consider these results, along with those of similar studies, and obtain a thorough history, comprehensive physical examination, and, potentially, laboratory testing and referral to other specialists.

Background: Left ventricular hypertrophy (LVH) is considered a marker of stage B heart failure according to the ACC/AHA classification. Current guidelines recommend beta-blocker (BB) therapy for treatment but randomized control trials suggest that Angiotensin Receptor Blocker (ARB) therapy may be superior. Purpose: To compare survival among cohorts of LVH patients classified according to use of BB, ARB or neither (NONE) class of medications. Methods: A retrospective analysis of hypertension patients seen in the outpatient clinics was done. LVH was defined using the most stringent electrocardiogram (ECG) criteria whereas patients with minimal and moderate voltage criteria were excluded. Using hypertension medications from the year 2009 outpatient visits notes, 869 LVH patients were classified into BB (604), ARB (115) and NONE (150) cohort groups. Cox proportional hazard models were built. Results: Survival at 5 years was 85.2% with 17 deaths and 98 censored patients, (unadjusted hazard ratio HR 0.53, p=0.03) in the ARB cohort and 75.5 % with 148 deaths, 456 censored patients (HR 0.91, p=0.61) in the BB group compared to 74.0% in the NONE cohort with 39 deaths and 111 censored patients. After adjusting for age, sex, atrial fibrillation/flutter, heart failure, chronic kidney disease (CKD), coronary artery disease (CAD), acute myocardial infarction, stroke, obesity, diabetes, sleep apnea and pulmonary hypertension, HR was 0.40, p=0.006 for ARB and HR=0.80, p=0.278 for BB compared to the NONE group. At baseline, there was no significant difference in age, sex, and the prevalence in heart failure, stroke, obesity, sleep apnea, and pulmonary hypertension in all three groups although the BB group had significantly highest prevalence of atrial fibrillation/flutter, CAD, CKD and the lowest prevalence of diabetes. Conclusion: There was a significant mortality reduction benefit to hypertension patients with ECG diagnosed LVH treated with ARB which was not seen in similar patients on BB when compared to those treated with none of both medication classes. This effect persisted even after adjusting for cardiovascular comorbidities.

Abstract Background: There is an urgent need to improve clinical trial (CT) enrollment of breast cancer (BC) patients (pts), especially from unrepresented minorities. In this regard, our study aims to better understand the characteristics and factors associated with CT enrollment to inform strategies to enhance CT accrual rates. Method: We included 1,308,767 female pts from the National Cancer Data Base diagnosed from 2010 to 2017 with known ER, PR, and HER2 status. Demographic, socioeconomic, Charlson-Deyo Score (CDS) and BC specific data were compared between CT versus non-CT enrolled pts for initial therapy. Comparisons were assessed by Chi-square test. Logistic regression was utilized to determine associations between characteristics and CT enrollment. Odds ratios (OR) and p-values are reported for each group. Results: A total of 1797 pts (0.14%) were enrolled in CT for initial BC therapy. Focusing on the CT group, majority of pts were non-Hispanic White (W;(78.2%), followed by non-Hispanic black (AA;12.2%); Hispanic (H; 5.6%); and non-Hispanic Asian (A; 4%). Most pts (29.3%) were in 50-59 age quartile. TNBC pts formed 22% of CT pts and non-TNBC were 78%. Most pts were from academic centers (54%), followed by comprehensive community cancer (CCC; 23.5%), community cancer (3.9%) and integrated network cancer (INC; 5.6%) programs. Most had private insurance (70%) versus government insurance (27%) and others (3%). Stage IV pts were only 10% of the CT group while most pts (41%) had Stage II BC. CDS of 0 was noted in 90% pts while 1.3% pts had CDS of 2 or more. Most CT pts traveled &lt; 50 miles from treatment center (88.5%), and only 1.2% CT pts traveled 200 or more miles. Most CT pts resided in areas with highest literacy rate (30%) while 15% were from areas with lowest literacy rate. In multivariable model, non-white pts were less likely than Whites to be enrolled in CT (OR 0.81, p&lt;0.05). The odds of CT enrollment in 40-49, 50-59 and 60-69 age quartiles were 3.5, 2.7 and 2.3 times respectively that of pts 70 years or older (p&lt;0.001). TNBC pts were 1.9 times more likely to be enrolled in CT than non-TNBC pts (p&lt;0.001). Academic center pts were 3 times more likely (p&lt;0.001) while INC program pts were less likely than CCC pts to be enrolled (OR 0.7, p=0.006). Pts with government insurance and other insurance were less likely to enroll in CT (OR 0.74, and 0.55, p &lt;0.001 and p=0.003, respectively) compared to private insurance. The odds of a patient with stage II, III, IV BC enrolling in CT was about 2, 3.5 and 4 times higher than a stage I pt (p -&lt;0.001). Pts with CDS 1 (OR 0.8, p=0.025) or 2 or more (OR 0.5, p=0.002) were less likely than CDS 0 pts to be enrolled. Pts who traveled 50-99 or 100-199 miles from the treatment center conducting CT, were 1.9 (p&lt;0.001) and 1.5 times (p&lt;0.05) more likely to be enrolled while those with &gt; 200 miles were less likely (OR 0.75, p=0.442). The group of pts who belonged to a residential area with the highest literacy rate (&lt;6.3% of no high school diploma) were 1.4 times more likely to accrue in CT (p&lt;0.001) than those with high school diploma rate between 6.3 and 10.8%. Compared to metro areas, pts from rural areas were less likely to be enrolled (OR 0.5, p=0.04) as was a lower median income &lt; $40,227 (OR 0.77, p= 0.016).Conclusion: CT enrollment is poor for initial therapy of BC treatment. We identify several modifiable factors including sociodemographics which are associated with BC pts not getting treated on CT. There are other factors that are non-modifiable, e.g., disease stage but may point to the need for more CT development in these areas. Addressing these disparities would lead to improved CT enrollment and overall advancement in BC management landscape. Citation Format: Pooja P Advani, Aaron Spaulding, Alexander Hochwald, Mizba Baksh, David Hodge, Saranya Chumsri, Shanada Monestime, Sikander Ailawadhi. Clinical trial enrollment for initial therapy of breast cancer: Exploring factors associated with poor accrual and significant disparities [abstract]. In: Proceedings of the 2021 San Antonio Breast Cancer Symposium; 2021 Dec 7-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2022;82(4 Suppl):Abstract nr P2-11-15.

Précis: For patients with glaucoma, metabolic syndrome was associated with higher intraocular pressure and greater central corneal thickness. Patients with metabolic syndrome were more likely to have ocular hypertension. Purpose: The purpose of this study was to determine whether glaucomatous optic neuropathy, also known as glaucoma, and ocular hypertension are more likely to occur in patients with metabolic syndrome. Patients and Methods: Patients in Olmsted County, MN, were identified as having metabolic syndrome based on diagnosis codes, laboratory values, and/or medication use to meet 3 or more of the 5 standard criteria for diagnosing metabolic syndrome: systemic hypertension, hyperglycemia, hypertriglyceridemia, reduced high-density lipoprotein cholesterol, and central adiposity defined by increased body mass index. Patients with glaucoma, including primary open angle, low tension, pigment dispersion, and pseudoexfoliation, were identified using diagnostic codes. The charts of patients with glaucoma were individually reviewed to collect visual acuity, intraocular pressure, cup to disc ratio, central corneal thickness, visual field mean deviation, retinal nerve fiber layer thickness, and treatment of intraocular pressure. Patients with ocular hypertension were separately identified and similarly evaluated. Results: For patients with glaucoma, those with metabolic syndrome had higher intraocular pressure and greater central corneal thickness compared with those without metabolic syndrome. After adjustment for central corneal thickness, there was no longer a significant difference in intraocular pressure between groups. Metabolic syndrome was also associated with the diagnosis of ocular hypertension, and although central corneal thickness trended higher in patients with metabolic syndrome, it did not attain statistical significance. Conclusion: In Olmsted County, though metabolic syndrome was associated with ocular hypertension and higher intraocular pressure in patients with glaucoma, the results were likely related to a thicker central corneal in this patient population.

Abstract Background: Reduced or low-dose direct oral anticoagulants (DOACs) have been studied in randomized control trials for the extended prevention of venous thromboembolism (VTE) after 6 months of treatment at the therapeutic doses. The real-world effectiveness as well as utilization of this approach in clinical practice compared to continuing at therapeutic doses is unknown. Aims: Evaluate the efficacy of reduced-dose DOACs compared to standard therapeutic anticoagulation in patients with extended anticoagulation. Methods: Consecutive patients with VTE were identified using the Mayo Clinic VTE Registry from March 1st , 2013 to December 31st, 2020. Patients were followed prospectively for outcomes of VTE recurrence, death, major bleeding and clinically relevant non major bleeding (CRNMB) either in person or by survey. Type of anticoagulation and dose changes were recorded, and progressing to a low dose was treated as an endpoint. In the models relating it to the outcome, it was treated as a time-dependent covariate in the cox models. After completing standard anticoagulation treatment for 3 months with any anticoagulant, patients continuing anticoagulation were divided into two groups: standard therapeutic anticoagulation (any drug) vs those who transitioned to rivaroxaban 10 mg daily or apixaban 2.5mg twice daily any time after 3 months. Patients with recurrent VTE, major or CRNMB during the first 3 months were excluded from further analysis. Results: 219 patients (153 on Apixaban and 66 on Rivaroxaban) were identified in the low dose DOAC and 2521 in the standard anticoagulation group. The mean age was 60.7 years, mean weight was 93.2 Kg and 55.9% were males (Table 1). Patients on low dose DOACs were about the same age and weight compared to standard anticoagulation group. Among all diagnosis categories, patients with active cancer were less likely to be prescribed low dose DOACs (HR 0.56; 95%CI 0.42-0.73; P&lt;0.001), while low dose DOACs prescription was more likely in patients with pulmonary embolism (HR 1.45; 95%CI 1.11-1.89; P=0.007). The median months to start a low dose DOAC after completing the 3 months was 3.1 months with standard deviation of 6.6 months and interquartile range 2.8 months. There was no statistically significant association in the likelihood of going to a low dose group in relation to VTE recurrence (HR 1.36; 95%CI 0.42-4.45; P=0.61) or major bleeding (HR 0.59; 95%CI 0.08-4.37; P=0.61). However, transitioning to low dose DOAC was associated with reduced mortality (HR 0.53; 95%CI 0.35-0.80; P=0.003). Also, patients on low dose DOACs were more likely to have a CRNMB (HR 2.76; 95%CI 1.15-6.62; P=0.02). Conclusion: In this study of patients continuing anticoagulation past 3 months for an initial acute venous thromboembolic event, transitioning to low dose DOACs was not associated with any statistically significant association with VTE recurrence or major bleeding. However, mortality was lower and CRNMB was higher in this unadjusted analysis. Our results show that physicians are not always waiting until 6 months to transition to low doses and low doses are being utilized in cancer patients. Further research is needed to better understand the higher risk for CRNMB identified in this group. Figure 1 Figure 1. Disclosures No relevant conflicts of interest to declare.