Report From the 2022 Mary Tyler Moore Vision Initiative Diabetic Retinal Disease Clinical Endpoints Workshop.

The Mary Tyler Moore Vision Initiative Diabetic Retinal Disease (DRD) Clinical Endpoints Workshop was held on October 22, 2022 to accelerate progress toward establishment of useful clinical and research endpoints and development of new therapeutics that have important relevance across the full spectrum of DRD pathology. More than 90 patient representatives, clinicians, scientists, funding and regulatory agencies, diagnostic, therapeutic and biotech industry representatives discussed the needs for new diagnostic and therapeutic approaches to prevent and restore retinal neurovascular unit integrity. Phase I of the MTM Vision Initiative plans, notably updating the DRD staging system and severity scale, establishing a human ocular biorepository and resource, and clinical endpoints and biomarker development and validation, was emphasized.

Survival in Differentiated Thyroid Cancer: Comparing the AJCC Cancer Staging Seventh and Eighth Editions.

BACKGROUND: The American Joint Committee on Cancer Cancer Staging System for differentiated thyroid cancer has been recently revised. The purpose of this study was to compare survival prognostication between the seventh and eighth editions. MATERIALS AND METHODS: We retrospectively reviewed 2579 differentiated thyroid cancer patients who underwent surgery at MD Anderson Cancer Center between 2000 and 2015. Disease-specific survival (DSS) and overall survival were estimated using the Kaplan-Meier method and compared using log rank test. The effect of potential predictor was estimated using Cox proportional hazards model. Power of survival prediction was estimated using Harrell's C concordance index (C-index), and predictive capacities for DSS were estimated using proportion of variance explained (PVE). RESULTS: Revision of tumor-node-metastasis (TNM) categories, age cutoff, and stage reassignment in the 8th edition caused reclassification of overall stage compared with the seventh edition. The proportion of patients in stage I and II increased from 62% to 83% and 5% to 12%, respectively, while the proportion of patients in stage III and IV decreased from 20% to 2% and 14% to 3%, respectively. Ten-year DSS for stages I-IV based on the seventh edition were 100%, 97.5%, 98.3%, and 82.6%, respectively, while 10-year DSS for the corresponding stage in the eighth edition were 99.8%, 88.3%, 72.4%, and 71.9%, respectively. In multivariate analysis for both seventh edition (C-index 0.94, PVE 4.6%) and eighth edition (C-index 0.94, PVE 4.8%), the factors predictive of worse outcome for DSS were older age, advanced tumor size category, and distant metastasis while cervical lymph node metastases did not predict worse survival. For the eighth edition, patients <55 years of age with stage II disease had significantly worse DSS (p < 0.001) than patients ≥55 years with stage II disease but appeared to be similar to patients ≥55 years with stage III (p = 0.742) and IV disease (p = 0.566). Patients ≥55 years old with T3a and T3b disease had 10-year DSS of 67% and 92%, respectively (p = 0.390). CONCLUSION: The AJCC eighth edition is similar to the seventh edition in disease-specific survival prediction. Potential modifications that may improve disease-specific survival prediction in future renditions include reconsideration of T3b tumor category and upstaging classification of patients <55 years of age with distant metastases.

The burden of preserved ejection fraction heart failure in a real-world Swedish patient population.

OBJECTIVES: To evaluate resource use and associated costs in patients with a diagnosis of heart failure with preserved ejection fraction (HF-PEF) in Sweden. METHODS: This retrospective study identified real-world patients with an ICD-10 diagnosis code for heart failure (I50) for the period between July 1, 2005 and December 31, 2006 from electronic medical records of primary care centers in Uppsala County Council, and in the Swedish patient registry data. Patients were categorized as having HF-PEF (left ventricle ejection fraction [LVEF] > 50%) during the index period. The study assessed medication utilization, outpatient visits, hospitalizations, and associated healthcare costs, as well as the incidence rates and time to all-cause and heart failure mortality following the index period. RESULTS: The study included 137 HF-PEF patients with a mean age of 77.1 (SD = 9.1) years. Over 50% of HF-PEF patients were female and hypertensive. Nearly all patients received ≥ 1 medication post-index. Patients had an average of 1.5 heart failure related hospitalizations per follow-up year. The average annual per patient cost for the management of a HF-PEF patient was found in Sweden to be Swedish Krona (SEK) 108,246 (EURO [EUR] 11,344). Hospitalizations contributed to more than 80% of the total cost. All-cause mortality over the 18-month study period was 25.5%, and more than 50% of these deaths occurred within 1 year of index. LIMITATIONS: Due to the limitations of registry data, it is not possible to confirm the HF diagnosis, and therefore the accuracy of registry records must be assumed. Other factors such as short follow-up time, the study-mandated LVEF assessment, and a lack of drug duration data may also have an impact on the study results. CONCLUSIONS: All-cause mortality was high in the HF-PEF population, with more than half of patients dying within 1 year of study follow-up. Study results also indicate that 60% of HF-PEF patients have ≥ 1 hospitalization during follow-up. Hospitalizations, especially heart failure related admissions, represent a substantial proportion of the total healthcare burden of patients with HF-PEF in Sweden.

Nasolacrimal duct obstruction associated with radioactive iodine therapy for thyroid carcinoma.

A 50-year-old woman presented with a 5-year history of unilateral epiphora that began shortly after 131I therapy for thyroid carcinoma. A recent recombinant human thyroid-stimulating hormone (Thyrogen) scan had shown a focus of uptake adjacent to the right eye that was initially thought to be a possible metastasis. Probing and irrigation revealed complete blockage of the right nasolacrimal duct. The patient underwent a right dacryocystorhinostomy (DCR) and biopsy of the lacrimal sac. Histopathologic examination of the lacrimal sac and nasal mucosa revealed foreign-body reaction and fibrosis with no malignant cells. A repeat Thyrogen scan after DCR showed no residual focus of activity in the nose or near the lacrimal sac and confirmed reestablishment of lacrimal drainage on the right side. This case demonstrates that 131I therapy for thyroid carcinoma can be associated with nasolacrimal duct obstruction. The appearance of a focus of uptake near the lacrimal sac on Thyrogen scanning in a patient with a history of thyroid carcinoma may not be due to a new focus of metastasis and may indeed be due to pooling of 131I in the lacrimal sac due to nasolacrimal duct blockage.