Thrombotic outcomes in patients in a large clinical enterprise following COVID-19 vaccination.

Vaccination against COVID-19 reduces infection-related mortality. Unfortunately, reports of vaccine-induced immune thrombotic thrombocytopenia (VITT) in individuals administered adenovirus-vector-based vaccines (ChAdOx1 nCoV-19 and Ad26.COV2.S) have spurred side effect concerns. To address vaccine hesitancy related to this, it is essential to determine the incidence of VITT (defined by a 50% decrease in platelet count and positive anti-PF4 immunoassay within 4-28 days after vaccination) among patients administered two doses of an mRNA-based COVID-19 vaccination. We identified a retrospective cohort of 223,345 patients in the Cleveland Clinic Enterprise administered a COVID-19 vaccine at any location in Northeast Ohio and Florida from 12/4/2020 to 6/6/2021. 97.3% of these patients received an mRNA-based vaccination. Patients with: (1) a serial complete blood count both before and after vaccination and (2) a decrease in platelet count of ≥ 50% were selected for chart review. The primary outcome was the incidence of thrombotic events, including venous thromboembolism (VTE) and arterial thrombosis, 4-28 days post vaccination. Of 74 cohort patients with acute thrombosis, 72 (97.3%) demonstrated clear etiologies, such as active malignancy. Of two patients with unprovoked thrombosis, only one had findings concerning for VITT, with a strongly positive anti-PF4 antibody assay. In this large, multi-state, retrospective cohort, of 223,345 patients (97.2% of whom received the mRNA-based mRNA-1273 or BNT162b2 vaccines), we detected a single case that was concerning for VITT in a patient who received an mRNA vaccine. The overwhelming majority of patients with a thrombotic event 4-28 days following vaccination demonstrated clear etiologies.

Low-Dose Naltrexone Use in Postural Orthostatic Tachycardia Syndrome: A Case Series.

Introduction In recent years, low-dose naltrexone has emerged as a novel off-label therapy for many chronic conditions including postural orthostatic tachycardia syndrome (POTS), however, there is little evidence for its efficacy. Methods In this institutional review board (IRB)-approved case series, the charts of six tilt table-confirmed patients with POTS who underwent a trial of low-dose naltrexone (LDN) at our institution were reviewed. Medical history, subjective description of symptom severity, the continuation of therapy, tolerability, and scores on patient-reported outcome measures (Patient-Reported Outcomes Measurement Information System {PROMIS} Fatigue, PROMIS physical and mental health, Generalized Anxiety Disorder Assessment {GAD}-7, Patient Health Questionnaire {PHQ}-9, and Composite Autonomic Symptom Score {COMPASS}) were collected at therapy initiation and six to 12 months after the start of LDN. Results Three out of six reviewed patients reported an improvement in their POTS after the initiation of LDN. Two patients discontinued the therapy due to a lack of perceived benefit. No side effects or adverse outcomes were reported. The patient-reported outcome measures of PROMIS Fatigue, PROMIS physical and mental health, GAD-7, PHQ-9, and COMPASS showed inconsistent changes over the course of therapy, with some patients showing improvement or stability and others showing worsening. The small sample size and incomplete response rate did not allow for extensive statistical analysis. Conclusion As seen in its use in other conditions, LDN appears to have a favorable safety and side effect profile in patients with POTS but has little evidence for efficacy. Although some patients noted benefit, patient-reported outcome measures show a variable response profile. High-quality randomized controlled trials are needed to determine if the treatment is efficacious and should be used outside of a trial basis.

Isolated Gastrocnemius Recession for Progressive Collapsing Foot Deformity.

INTRODUCTION: Progressive collapsing foot deformity (PCFD) is frequently associated with a gastrocnemius contracture. Surgical treatment of PCFD often includes a gastrocnemius recession in addition to other corrective procedures, which typically requires a period of restricted weight bearing postoperatively. Isolated gastrocnemius recession may allow passive correction of the deformity, improve orthotic fit, and obviate the need for full reconstruction and restricted weight bearing. The goal of this study was to evaluate patient-reported outcomes after an isolated gastrocnemius recession for flexible PCFD in patients anticipated to have difficulty with postoperative restricted weight bearing. METHODS: A total of 47 patients met the inclusion criteria: isolated gastrocnemius recession for flexible PCFD, no previous ipsilateral surgery, and more than 6 months of follow-up. Of 47 eligible patients, 29 (31 feet) participated. Available preoperative and postoperative patient-reported outcomes were gathered, including the Foot and Ankle Ability Measure Activities of Daily Living, visual analog scale, and the Patient-Reported Outcome Measurement Information System Physical Function Short Form 10a. In addition, patients were asked about satisfaction, willingness to undergo the procedure again, and whether orthotics provided better relief. RESULTS: At a mean of 5.1 (range, 0.6 to 9.0) years postoperatively, median Foot and Ankle Ability Measure Activities of Daily Living was 82.1, mean Patient-Reported Outcome Measurement Information System Physical Function Short Form 10a was 44.2, and median visual analog scale was 10 (of 100). Sixty-nine percent of patients were either satisfied or very satisfied, 69% would undergo the procedure again, and 62% reported improved relief with use of orthotics postoperatively. Among the 47 eligible patients, there were 5 (11%) subsequent flatfoot reconstructions. CONCLUSIONS: Isolated gastrocnemius recession for the management of flexible PCFD can be effective as this procedure demonstrated good outcomes scores with high procedural satisfaction and 11% of patients proceeding to subsequent flatfoot reconstruction. This alternative approach may be of particular value for patients anticipated to have difficulty with postoperative weight-bearing restrictions. LEVEL OF EVIDENCE: :IV.

Snapping Plantaris Tendon: A Rare Case in a Competitive Dancer.

Pathology associated with the plantaris includes rupture of the tendon and an association with mid-substance Achilles tendinopathy in some patients. There have only been two previous case reports in the literature in English language describing snapping of the plantaris tendon. We present a case report of a 15-year-old female competitive dancer who described pain and an audible popping at the medial margin of the Achilles tendon while squatting. Physical examination revealed visible and audible popping of the plantaris, and ultrasonography confirmed the diagnosis. After symptoms persisted despite nonsurgical treatment with physical therapy, the patient underwent an open plantaris tenotomy. By 8 weeks after surgery, she had resumed dancing. Twenty-three months after her operation, she reported an excellent outcome and full recovery with no limitations to her physical activity. She reported having no pain, a Foot and Ankle Ability Measure Activities of Daily Living Subscale score of 100, and a Foot and Ankle Ability Measure Sports Subscale score of 100. This case demonstrates a successful course of treatment for this uncommon pathology within the context of a competitive dancer.

Correlation Between Patient-Reported Outcome Measures and Health Insurance Provider Types in Patients with Hip Osteoarthritis.

BACKGROUND: Patient-reported outcome measures (PROMs) are frequently utilized to assess patient perceptions of health and function. Numerous factors influence self-reported physical and mental health outcome scores. The purpose of this study was to examine if an association exists between insurance payer type and baseline PROM scores in patients diagnosed with hip osteoarthritis. METHODS: We retrospectively reviewed the baseline PROM scores of 5,974 patients diagnosed with hip osteoarthritis according to the International Classification of Diseases, Tenth Revision (ICD-10) code within our institutional database from 2015 to 2020. We examined Hip disability and Osteoarthritis Outcome Score-Physical Function Short-form (HOOS-PS), Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Short Form 10a (PF10a), PROMIS Global-Mental, and PROMIS Global-Physical scores. Descriptive analyses, analysis of variance (ANOVA), analysis of covariance (ANCOVA), and post hoc analyses were utilized to assess variations in PROM scores across insurance type. RESULTS: The mean age (and standard deviation) of the study population was 63.5 ± 12.2 years, and 55.7% of patients were female. The Medicaid cohort had a comparatively higher percentage of Black, Hispanic, and non-English-speaking patients and a lower median household income. The Charlson Comorbidity Index was highest in the Medicare and Medicaid insurance cohorts. Patients utilizing commercial insurance consistently demonstrated the highest baseline PROMs, and patients utilizing Medicaid consistently demonstrated the lowest baseline PROMs. Subsequent analyses found significantly poorer mean scores for the Medicaid cohort for all 4 PROMs when compared with the commercial insurance and Medicare cohorts. These score differences exceeded the minimal clinically important differences (MCIDs). For the PROMIS Global-Mental subscore, a significantly lower mean score was observed for the Workers' Compensation and motor vehicle insurance cohort when compared with the commercial insurance and Medicare cohort. This difference also exceeded the MCID. CONCLUSIONS: PROM scores in patients with hip osteoarthritis varied among those with different insurance types. Variations in certain demographic and health indices are potential drivers of these observed baseline PROM differences. For patients with hip osteoarthritis, the use of PROMs for research, clinical, or quality-linked payment metrics should acknowledge baseline variation between patients with different insurance types. LEVEL OF EVIDENCE: Prognostic Level IV. See Instructions for Authors for a complete description of levels of evidence.