Citations

Objective: To evaluate access, clinical outcomes, engagement, and satisfaction associated with an advanced musculoskeletal virtual care model. Design: Retrospective cohort study of adults with musculoskeletal complaints referred to advanced orthopedic virtual physical therapy by Physical Medicine and Rehabilitation providers between July 2024 and April 2025. Outcomes included access to care, patient-reported outcome measures, pain intensity, plan-of-care completion, and patient satisfaction. Results: Of 137 referred patients, 86 (62.8%) completed evaluations; 70.9% of those (n=61) completed full care episodes — exceeding national completion benchmarks (71% vs. 43%). Among completers, 96% achieved Minimal Clinically Important Differences. Functional improvements were significant: Oswestry Disability Index −32.4, Neck Disability Index −29.5, Lower Extremity Functional Scale +26.6 (all P <.001). Pain decreased from 6.1 to 0.9 (−85%). Average care required 5.6 visits versus national benchmarks of 6–10. Patient satisfaction was exceptional (Net Promoter Score=100). Conclusion: Among patients who completed a full episode of care, this advanced virtual musculoskeletal model was associated with substantial functional improvement, pain reduction, and high satisfaction while requiring fewer visits than national averages. Because outcome analyses were limited to completers, these findings may not represent all referred patients. Prospective controlled studies are needed to evaluate effectiveness and scalability.

BACKGROUND: The Harmony transcatheter pulmonary valve (TPV) is designed to treat severe pulmonary regurgitation in the native or surgically repaired right ventricular (RV) outflow tract. Early outcomes after TPV replacement with the Harmony valve have been positive, but longer-term data are limited. METHODS: The study included patients who received a commercially available TPV22 or TPV25 device as part of the nonrandomized, prospective Native Outflow Tract Early Feasibility Study, Harmony Pivotal Trial, and Continued Access Study. Patients completed at least 3 years of follow-up, and outcomes to 5 years were reported when available. RESULTS: Eighty-nine patients were catheterized, and 86 were successfully implanted with a Harmony TPV. Median duration of follow-up was 5 (range 0–6) years in the TPV22 group and 3 (1–4) years in the TPV25 group. At 3 years, all patients with a TPV22 and 96% of those with a TPV25 had ≤mild pulmonary regurgitation. By magnetic resonance imaging, significant improvements from preimplant to 2 years were observed in RV end-diastolic volume index, RV to left ventricular end-diastolic volume ratio, and effective RV stroke volume (all P <0.001). SF-36 quality-of-life scores improved after Harmony implantation and were sustained over 3 years. Early cases of ventricular tachycardia resolved, and there were no new arrhythmias. Adverse events up to 5 years included 3 deaths unrelated to the device or procedure, 2 cases of endocarditis that were treated (1 medically, 1 transcatheter debulking of a vegetation) and resolved, 6 patients with RV outflow tract obstruction or thrombosis resulting in valve-in valve procedures, and 1 major stent fracture resulting in surgical explant. CONCLUSIONS: At 3 to 5 years, Harmony TPV replacement resulted in sustained valve competence, beneficial cardiac remodeling, and improved quality of life. Continued monitoring is needed to assess long-term outcomes and valve performance. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT01762124; NCT02979587.

Abstract Background Invasive fungal infections have been described throughout the COVID-19 pandemic. Cryptococcal disease after infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has been reported in several isolated case reports and 1 larger case series. We sought to describe cryptococcal infections following SARS-CoV-2 through establishing a database to investigate underlying risk factors, disease manifestations, and outcomes. Methods We created a crowdsourced call for cases solicited through the Mycoses Study Group Education and Research Consortium, the Centers for Disease Control and Prevention Emerging Infectious Diseases Network, and infectious diseases Twitter groups. Data were collected in a web-based and secure REDCap survey without personal identifiers. Results Sixty-nine cases were identified and submitted by 29 separate institutional sites. Cryptococcosis was diagnosed a median of 22 days (interquartile range, 9–42 days) after SARS-CoV-2 infection. Mortality among those with available follow-up was 72% (26/36) for the immunocompetent group and 48% (15/31) for the immunocompromised group (likelihood ratio, 4.01; P = .045). We observed a correlation between disease manifestation (central nervous system infection, proven/probable disseminated disease, and respiratory) and mortality (P = .002). Conclusions The mortality rate of 59% for patients with cryptococcosis following SARS-CoV-2 is higher than that of modern Cryptococcus cohorts. There was an association between immunocompromised status and cryptococcal disease manifestations as well as mortality. Moreover, our series emphasizes the need for clinical and laboratory assessment of opportunistic infections beyond 30 days when concerning symptoms develop.

Abstract Background In patients with ulcerative colitis (UC), risks of infection and malignancies increase with age. Tofacitinib is an oral, small molecule Janus kinase inhibitor for the treatment of UC. This analysis assessed age as a risk factor for adverse events of special interest (AESI) in the tofacitinib UC clinical program. Methods Data were from phase 2 and 3 induction studies, a phase 3 maintenance study, and an open-label, long-term extension study. Efficacy and/or safety outcomes were analyzed in the Induction, Maintenance, and Overall Cohorts (patients who received ≥ 1 dose of tofacitinib), stratified by age. The effects of baseline demographic and disease-related factors on AESI incidence were assessed by Cox proportional-hazards regression analysis. Results In the Overall Cohort (1157 patients with ≤ 6.8 years’ tofacitinib treatment), age was a statistically significant predictor of herpes zoster (HZ), malignancies excluding nonmelanoma skin cancer (NMSC), and NMSC. Other statistically significant predictors included prior tumor necrosis factor inhibitor failure for HZ, NMSC, and opportunistic infection events, and prior duration of UC for malignancies excluding NMSC. In the Induction and Maintenance Cohorts, a higher proportion of tofacitinib-treated than placebo-treated patients (numerical difference) achieved the efficacy endpoints (endoscopic improvement, clinical remission, clinical response) across all age groups. Conclusions Older individuals receiving tofacitinib as induction and maintenance therapy to treat UC may have an increased risk of HZ, malignancies (excluding NMSC), and NMSC versus similarly treated younger patients, consistent with findings from the general population. Across all age groups, tofacitinib demonstrated greater efficacy than placebo as an induction and maintenance therapy. ClinicalTrials.gov Registration Numbers NCT00787202; NCT01465763; NCT01458951; NCT01458574; NCT01470612.

Background: Acute myocarditis is an inflammatory condition that may herald the onset of dilated cardiomyopathy (DCM) or arrhythmogenic cardiomyopathy (ACM). We investigated the frequency and clinical consequences of DCM and ACM genetic variants in a population-based cohort of patients with acute myocarditis. Methods: This was a population-based cohort of 336 consecutive patients with acute myocarditis enrolled in London and Maastricht. All participants underwent targeted DNA sequencing for well-characterized cardiomyopathy-associated genes with comparison to healthy controls (n=1053) sequenced on the same platform. Case ascertainment in England was assessed against national hospital admission data. The primary outcome was all-cause mortality. Results: Variants that would be considered pathogenic if found in a patient with DCM or ACM were identified in 8% of myocarditis cases compared with <1% of healthy controls ( P =0.0097). In the London cohort (n=230; median age, 33 years; 84% men), patients were representative of national myocarditis admissions (median age, 32 years; 71% men; 66% case ascertainment), and there was enrichment of rare truncating variants (tv) in ACM-associated genes (3.1% of cases versus 0.4% of controls; odds ratio, 8.2; P =0.001). This was driven predominantly by DSP -tv in patients with normal LV ejection fraction and ventricular arrhythmia. In Maastricht (n=106; median age, 54 years; 61% men), there was enrichment of rare truncating variants in DCM-associated genes, particularly TTN -tv, found in 7% (all with left ventricular ejection fraction <50%) compared with 1% in controls (odds ratio, 3.6; P =0.0116). Across both cohorts over a median of 5.0 years (interquartile range, 3.9–7.8 years), all-cause mortality was 5.4%. Two-thirds of deaths were cardiovascular, attributable to worsening heart failure (92%) or sudden cardiac death (8%). The 5-year mortality risk was 3.3% in genotype-negative patients versus 11.1% for genotype-positive patients ( P adjusted =0.08). Conclusions: We identified DCM- or ACM-associated genetic variants in 8% of patients with acute myocarditis. This was dominated by the identification of DSP -tv in those with normal left ventricular ejection fraction and TTN -tv in those with reduced left ventricular ejection fraction. Despite differences between cohorts, these variants have clinical implications for treatment, risk stratification, and family screening. Genetic counseling and testing should be considered in patients with acute myocarditis to help reassure the majority while improving the management of those with an underlying genetic variant.

AbstractInternational Statistical Classification of Disease and Related Health Problems, 10th Revision codes (ICD‐10) are used to characterize cohort comorbidities. Recent literature does not demonstrate standardized extraction methods. Objective: Compare COVID‐19 cohort manual‐chart‐review and ICD‐10‐based comorbidity data; characterize the accuracy of different methods of extracting ICD‐10‐code‐based comorbidity, including the temporal accuracy with respect to critical time points such as day of admission. Design: Retrospective cross‐sectional study. Measurements: ICD‐10‐based‐data performance characteristics relative to manual‐chart‐review. Results: Discharge billing diagnoses had a sensitivity of 0.82 (95% confidence interval [CI]: 0.79–0.85; comorbidity range: 0.35–0.96). The past medical history table had a sensitivity of 0.72 (95% CI: 0.69–0.76; range: 0.44–0.87). The active problem list had a sensitivity of 0.67 (95% CI: 0.63–0.71; range: 0.47–0.71). On day of admission, the active problem list had a sensitivity of 0.58 (95% CI: 0.54–0.63; range: 0.30–0.68)and past medical history table had a sensitivity of 0.48 (95% CI: 0.43–0.53; range: 0.30–0.56). Conclusions and Relevance: ICD‐10‐based comorbidity data performance varies depending on comorbidity, data source, and time of retrieval; there are notable opportunities for improvement. Future researchers should clearly outline comorbidity data source and validate against manual‐chart‐review.

AbstractCOVID‐19 has disproportionately affected low‐income communities and people of color. Previous studies demonstrated that race/ethnicity and socioeconomic status (SES) are not independently correlated with COVID‐19 mortality. The purpose of our study is to determine the effect of race/ethnicity and SES on COVID‐19 30‐day mortality in a diverse, Philadelphian population. This is a retrospective cohort study in a single‐center tertiary care hospital in Philadelphia, PA. The study includes adult patients hospitalized with polymerase‐chain‐reaction‐confirmed COVID‐19 between March 1, 2020 and June 6, 2020. The primary outcome was a composite of COVID‐19 death or hospice discharge within 30 days of discharge. The secondary outcome was intensive care unit (ICU) admission. The study included 426 patients: 16.7% died, 3.3% were discharged to hospice, and 20.0% were admitted to the ICU. Using multivariable analysis, race/ethnicity was not associated with the primary nor secondary outcome. In Model 4, age greater than 75 (odds ratio [OR]: 11.01; 95% confidence interval [CI]: 1.96–61.97) and renal disease (OR: 2.78; 95% CI: 1.31–5.90) were associated with higher odds of the composite primary outcome. Living in a “very‐low‐income area” (OR: 0.29; 95% CI: 0.12–0.71) and body mass index (BMI) 30–35 (OR: 0.24; 95% CI: 0.08–0.69) were associated with lower odds of the primary outcome. When controlling for demographics, SES, and comorbidities, race/ethnicity was not independently associated with the composite primary outcome. Very‐low SES, as extrapolated from census‐tract‐level income data, was associated with lower odds of the composite primary outcome.

AbstractObjectiveWe compared 5‐year outcomes of transcatheter pulmonary valve (TPV) replacement with the Melody TPV in the post‐approval study (PAS) and the investigational device exemption (IDE) trial.BackgroundAs a condition of approval of the Melody TPV after the IDE trial, the Food and Drug Administration required that a PAS be conducted to evaluate outcomes of TPV replacement in a “real‐world” environment. The 5‐year outcomes of the PAS have not been published, and the IDE and PAS trials have not been compared.MethodsThe cohorts comprised all patients catheterized and implanted at 5 IDE sites and 10 PAS sites. Differences in trial protocols were detailed. Time‐related outcomes and valve‐related adverse events were compared between the two trials with Kaplan–Meier curves and log‐rank testing.Results167 patients (median age, 19 years) were catheterized and 150 underwent TPV replacement in the IDE trial; 121 were catheterized (median age, 17 years) and 100 implanted in the PAS. Freedom from hemodynamic dysfunction (p = .61) or any reintervention (p = .74) over time did not differ between trials. Freedom from stent fracture (p = .003) and transcatheter reintervention (p = .010) were longer in PAS, whereas freedom from explant (p = .020) and TPV endocarditis (p = .007) were shorter. Clinically important adverse events (AEs) were reported in 14% of PAS and 7.2% of IDE patients (p = .056); the incidence of any particular event was low in both.ConclusionsHemodynamic and time‐related outcomes in the PAS and IDE trials were generally similar, confirming the effectiveness of the Melody TPV with real‐world providers. There were few significant complications and limited power to identify important differences in AEs. The lack of major differences in outcomes between the two studies questions the usefulness of mandated costly post‐approval studies as part of the regulatory process for Class III medical devices.