Research Spotlight

Alsharidah, S., Ayed, M., Ameen, R.M., Alhuraish, F., Rouheldeen, N.A., Alshammari, F.R., Embaireeg, A., Almelahi, M., Adel, M., Dawoud, M.E., Aljasmi, M.A., Alshammari, N., Alsaeedi, A., Al-Adsani, W., Arian, H., Awad, H., Alenezi, H.A., Alzafiri, A., Gouda, E.F., Almehanna, M., Alqahtani, S., Alshammari, A. and Askar, M.Z. (2021). “COVID-19 convalescent plasma treatment of moderate and severe cases of SARS-CoV-2 infection: A multicenter interventional study.” Int J Infect Dis 103: 439-446.

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OBJECTIVE: To study the effectiveness of COVID-19 convalescent plasma (CCP) therapy for patients with moderate and severe COVID-19 disease. METHODS: This non-randomized prospective cohort study was conducted from May 21 to June 30, 2020, at four major tertiary hospitals in Kuwait. CCP was administered to 135 patients. The control group comprised 233 patients who received standard treatment. All patients (N = 368, median age 54 [range 15-82]) had laboratory-confirmed SARS-CoV-2 infection and either moderate or severe COVID-19 disease. RESULTS: CCP treatment was associated with a higher rate of clinical improvement in patients with moderate or severe disease. Among those with moderate COVID-19 disease, time to clinical improvement was 7 days in the CCP group, versus 8 days in the control group (p = 0·006). For severe COVID-19 disease, time to clinical improvement was 7 days in the CCP group, versus 15.5 days in the control group (p = 0·003). In the adjusted analysis, patients with moderate disease treated with CCP had a significantly lower 30-day mortality rate. Compared to the control group, oxygen saturation improved within 3 days of CCP transfusion, and lymphocyte counts improved from day 7 in patients with moderate COVID-19 disease and day 11 in patients with severe disease. C-reactive protein levels declined throughout the first 14 days after CCP transfusion. None of the CCP patients developed a serious transfusion reaction. CONCLUSIONS: The data show that administration of CCP is a safe treatment option for patients with COVID-19 disease with a favorable outcome in the rate of, and time to, clinical improvement.

Shaefi, S., Brenner, S.K., Gupta, S., O’Gara, B.P., Krajewski, M.L., Charytan, D.M., Chaudhry, S., Mirza, S.H., Peev, V., Anderson, M., Bansal, A., Hayek, S.S., Srivastava, A., Mathews, K.S., Johns, T.S., Leonberg-Yoo, A., Green, A., Arunthamakun, J., Wille, K.M., Shaukat, T., Singh, H., Admon, A.J., Semler, M.W., Hernán, M.A., Mueller, A.L., Wang, W. and Leaf, D.E. (2021). “Extracorporeal membrane oxygenation in patients with severe respiratory failure from COVID-19.” Intensive Care Med 47(2): 208-221.

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PURPOSE: Limited data are available on venovenous extracorporeal membrane oxygenation (ECMO) in patients with severe hypoxemic respiratory failure from coronavirus disease 2019 (COVID-19). METHODS: We examined the clinical features and outcomes of 190 patients treated with ECMO within 14 days of ICU admission, using data from a multicenter cohort study of 5122 critically ill adults with COVID-19 admitted to 68 hospitals across the United States. To estimate the effect of ECMO on mortality, we emulated a target trial of ECMO receipt versus no ECMO receipt within 7 days of ICU admission among mechanically ventilated patients with severe hypoxemia (PaO(2)/FiO(2) < 100). Patients were followed until hospital discharge, death, or a minimum of 60 days. We adjusted for confounding using a multivariable Cox model. RESULTS: Among the 190 patients treated with ECMO, the median age was 49 years (IQR 41-58), 137 (72.1%) were men, and the median PaO(2)/FiO(2) prior to ECMO initiation was 72 (IQR 61-90). At 60 days, 63 patients (33.2%) had died, 94 (49.5%) were discharged, and 33 (17.4%) remained hospitalized. Among the 1297 patients eligible for the target trial emulation, 45 of the 130 (34.6%) who received ECMO died, and 553 of the 1167 (47.4%) who did not receive ECMO died. In the primary analysis, patients who received ECMO had lower mortality than those who did not (HR 0.55; 95% CI 0.41-0.74). Results were similar in a secondary analysis limited to patients with PaO(2)/FiO(2) < 80 (HR 0.55; 95% CI 0.40-0.77). CONCLUSION: In select patients with severe respiratory failure from COVID-19, ECMO may reduce mortality.

Wolk, C.B., Alter, C.L., Kishton, R., Rado, J., Atlas, J.A., Press, M.J., Jordan, N., Grant, M., Livesey, C., Rosenthal, L.J. and Smith, J.D. (2021). “Improving Payment for Collaborative Mental Health Care in Primary Care.” Med Care Jan 7. [Epub ahead of print].

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BACKGROUND: There is strong evidence supporting implementation of the Collaborative Care Model within primary care. Fee-for-service payment codes, published by Current Procedural Terminology in 2018, have made collaborative care separately reimbursable for the first time. These codes (ie, 99492-99494) reimburse for time spent per month by any member of the care team engaged in Collaborative Care, including behavioral care managers, primary care providers, and consulting psychiatrists. Time-based billing for these codes presents challenges for providers delivering Collaborative Care services. OBJECTIVES: Based on experience from multiple health care organizations, we reflect on these challenges and provide suggestions for implementation and future refinement of the codes. CONCLUSIONS: Further refinements to the codes are encouraged, including moving from a calendar month to a 30-day reimbursement cycle. In addition, we recommend payers adopt the new code proposed by the Centers for Medicare and Medicaid Services to account for smaller increments of time.

Moreyra, A.E., Cosgrove, N.M., Zinonos, S., Yang, Y., Cabrera, J., Pepe, R.J., Alam, A., Kostis, J.B., Lee, L. and Kostis, W.J. (2021). “Constrictive Pericarditis after Open Heart Surgery: A 20-Year Case Controlled Study.” Int J Cardiol Jan 6;S0167-5273(20)34338-2. [Epub ahead of print].

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BACKGROUND: Constrictive pericarditis is a rare complication of open heart surgery (OHS), but little is known regarding the etiologic determinants, and prognostic factors. The purpose of this study was to investigate clinical predictors and long term prognosis of post-operative constrictive pericarditis (CP). METHODS: Using the Myocardial Infarction Data Acquisition System database, we analyzed records of 142,837 patients who were admitted for OHS in New Jersey hospitals between 1995 and 2015. Ninety-one patients were hospitalized with CP 30 days or longer after discharge from OHS. Differences in proportions were analyzed using Chi square tests. Controls were matched to cases for demographics, surgical procedure type, history of OHS, and propensity score. Cox proportional hazard models were used to evaluate the risk of all-cause death. Log-rank tests and Cox models were used to assess differences in the Kaplan-Meier survival curves with and without adjustments for comorbidities. RESULTS: Patients with CP were more likely to have history of valve disease (VD, p < 0.001), atrial fibrillation (AF, p = 0.024) renal disease (CKD, p = 0.028), hemodialysis (HD, p = 0.008), previous OHS (p < 0.001). Patients with CP compared to matched controls had a higher 7-year mortality (p < 0.001). This difference became statistically significant at 1-year after surgery. CONCLUSION: CP is a rare complication of OHS that occurs more frequently in patients with VD, AF, CKD, HD, multiple OHS, and it is associated with an unfavorable long-term prognosis. Given the large number of OHS performed every year, the results highlight the need for clinicians to recognize and properly manage this complication of OHS.

Agarwal, A., Johannesson, L., Findeis, S.K., Punar, M., Askar, M., Ma, T.W., Pinto, K., Demetris, A.J. and Testa, G. (2021). “Clinicopathologic Analysis of Uterine Allografts Including Proposed Scoring of Ischemia-reperfusion Injury and T Cell-mediated Rejection-Dallas UtErus Transplant Study: A Pilot Study.” Transplantation Jan 20. [Epub ahead of print.].

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BACKGROUND: Uterus transplantation (UTx) enables pregnancy in infertile women. This study describes the histopathological changes of ischemia reperfusion injury and mostly acute T cell-mediated rejection (TCMR) in UTx and proposes modification toward a working formulation grading system with associated treatments. METHODS: Protocol and indication biopsies from 11 living and 2 deceased donor UTx recipients were analyzed. Serving as a control were 49 age-matched nontransplanted uteri. All posttransplant histopathological specimens were evaluated in a blinded fashion by 3 pathologists. Response to treatment was assessed by follow-up biopsies. Serial serum donor-specific antibody (DSA) responses were also recorded. RESULTS: Changes attributed to ischemia reperfusion resolved within 2 weeks of UTx in most of the patients. For TCMR grading, perivascular inflammation, focal capillary disruption, and interstitial hemorrhage were added to interface inflammation, intercellular edema, stromal inflammation, and epithelial apoptotic bodies. Of the 173 protocol biopsies, 98 were classified as negative for TCMR; 34, indeterminate-borderline; 35, mild; 3, moderate; and 3, severe, 1 of which occurred in a DSA-positive recipient and also showed microvascular injury. Corticosteroids successfully treated all moderate to severe TCMR episodes. Mild TCMR was treated by increasing existing baseline immunosuppression. Indeterminate-borderline episodes were not treated. Neither ischemia reperfusion injury nor TCMR with DSA adversely affected embryo transfer. CONCLUSION: Relying on a modified histopathological grading system, we developed a treatment strategy resulting in resolution of TCMR and successful pregnancies.