Outcomes of Immunosuppression Reduction During Covid-19 Infection in Heart Transplant Patients

Reduction in immunosuppression (IS) is universally recommended in the setting of infection, but its effect on outcomes in the setting of COVID-19 has not been established. The purpose of this study is to characterize the impact of IS reduction strategies on disease severity and outcomes of COVID infection in heart transplant patients (HTPs). This was a single center, retrospective review of HTPs with COVID infection managed inpatient or outpatient, examined in cohorts by approach to IS reduction. Demographics, severity at diagnosis and peak based on NIH Classification of COVID Illness Severity, and secondary clinical outcomes were collected (Table 1). The primary outcome was the difference in COVID severity score after IS regimen changes at time of diagnosis. Descriptive statistics, ANOVA, independent t-tests, and chi square analyses were used to evaluate baseline characteristics, primary outcome, and secondary outcomes. Data was collected for 110 patients with 113 COVID infections between March 2020 and June 2022. Patients were on average 54 years old, 75% white, 15% Hispanic ethnicity, and 5 years post HT at the time of their infection. Approaches to IS changes were antimetabolite (antiM) reduction (62%), all IS reduced (6%), or no change (32%). There was a significant difference in clinical severity from diagnosis to peak across all groups (p = 0.004), contributed largely by the All IS Reduced group with significantly higher peak severity (p = 0.002) leading to drastic IS reductions. In a sub-analysis to compare the protocolized approach of antiM reduction to no change in IS, no difference was noted in mortality, superimposed infections, or treated graft rejection (Table 1). Change in severity of infection over time is noted by variant in Figure 1. As COVID vaccination and therapeutic agents evolve, drastic IS modifications may not be necessary if baseline infection is mild. However, reduced duration IS reduction did not lead to more treated graft rejection. [ABSTRACT FROM AUTHOR] Copyright of Journal of Heart & Lung Transplantation is the property of Elsevier B.V. and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Case Series of New-Onset CNS Immunological Disorders Temporally Associated with mRNAbased COVID-19 Vaccines

Objective: To present a single-health system retrospective analysis of post-mRNA-based COVID-19 vaccination CNS autoimmunity conducted in the greater New York City area. Background: There have been rare reports associating mRNA-based COVID-19 vaccines with central nervous system (CNS) inflammation. We report a case series of five patients with newonset neurological disorders of immunological origin temporally associated with these vaccines. Design/Methods: Case-series. Results: Five cases of post-vaccination CNS disorders of immune origin were observed within two weeks of inoculation with either the first or second dose of mRNA-based COVID-19 vaccines (Moderna = 3, Pfizer = 2). This includes: Fatal ADEM (n = 1), new-onset NMO (n = 2), new-onset fulminant MS (n = 1), and meningoencephalitis (n = 1). The age of our patients ranged from 27 to 81, and three were female. None of the patients had pre-existing neurological illnesses and one had a pre-existing autoimmune condition (immune thrombocytopenia purpura). New-onset focal neurological symptoms were present in all five patients, including quadriparesis, numbness, diplopia, and encephalopathy. CSF pleocytosis was present in all patients, and three had elevated protein. All but one patient (meningoencephalitis) had contrastenhancing lesions involving either the cerebrum or spinal cord. Both NMO patients had longitudinally extensive transverse lesions involving the central thoracic cord. Aquaporin-4 serum antibody was present in one NMO patients and aquaporin-4 CSF antibody present in the other. All but one patient (fatal ADEM) clinically improved with pulse steroids or plasmapheresis. Conclusions: These are among the emerging cases of CNS immunological events temporally associated with mRNA-based COVID-19 vaccines. These findings should be interpreted with great caution as they neither prove a link nor imply a potential long-term increased risk in postvaccination CNS autoimmunity. Larger prospective studies are needed. The mRNA-based SARS-CoV-2 vaccines should continue to be strongly encouraged given their high efficacy in overcoming this pandemic.

Pharmacist Expansion to Tele-Health Visits in Heart Transplant Clinic

Purpose: During the COVID-19 pandemic, inpatient cardiothoracic transplant pharmacists expanded clinical services to include remote telehealth visits to increase patient access to pharmacy services and streamline visits for providers. Pharmacist visit activities included adherence and medication access assessments, adverse effect assessment and management, chart reviews, and medication reconciliation. Methods: A single center retrospective chart review of 80 heart transplant recipients transplanted between January 2020 and December 2020 was completed. From July 2020 - March 2021, pharmacists called patients within the first year of transplant prior to scheduled provider clinic visits. Patients were not called if they had been called within the prior 4 weeks. Activities from clinic visits before and after pharmacist involvement were compared at 1 month, 3 months, 6 months, and 12 months post-transplant. The goal of this analysis was to describe the number and types of interventions made by the pharmacist. Results: A total of 100 patients and 272 clinic visits were analyzed, baseline clinical characteristics did not differ in the two cohorts. Pharmacists performed 233 tele-health visits which resulted in 394 interventions from July 2020 - March 2021, summarized in Figure 1. The most common interventions included adverse effect management (34%) and renal dose adjustment (17.8%). An analysis of outpatient visits before and after pharmacist involvement found no significant difference in reported adherence, appropriate renal dosing of medications or reported neurotoxicity (Table 1). Conclusion: Close to 400 interventions were made by our transplant pharmacy team through tele-health visits over a period of 8 months. Use of pre-visit pharmacist tele-health assessments allowed for expansion of clinical pharmacy services while facilitating more focused provider clinic visits. more consistency in clinic may yield improved post-pharmacist outcomes, though further analysis is warranted.

Impact analysis of virtual transplant ambulatory pharmacist during COVID-19

Purpose: During the COVID-19 pandemic, transplant centers were challenged to meet the demand for new telemedicine strategies. High-risk immunocompromised patients, such as lung transplant recipients (LTR) require close follow-up due to their medical complexity and need for frequent medication changes. The pandemic significantly limited the ability of lung transplant providers (LTP) to safely conduct face-to-face clinic visits. Transplant pharmacists, previously unable to provide medication management visits for all patients due to time and space restraints of clinic, were now able to conduct virtual telehealth visits to assist LTP in the transition to telemedicine. Methods: A retrospective chart review of telephone encounters from cardiothoracic pharmacists (CTRx) at our center from March to September 2020 was completed. LTR scheduled for clinic visits with LTP were called prior to the visit by CTRx who conducted chart reviews, medication reconciliations, adherence assessments, and medication access assistance. Clinical recommendations were then communicated directly to the LTP and documented in patient electronic medical records. The primary outcome was the number of pharmacist-driven clinical interventions made during COVID-19 virtual lung transplant visits. Secondary endpoints included the total number of medication discrepancies, average number of interventions, and average number of discrepancies found per visit. Results: From March to September 2020 the CTRx conducted 385 virtual visits on 157 LTR with an average of 23.4 minutes spent per visit. There were 864 total interventions made by CTRx and a total of 778 medication discrepancies identified. An average of 2.8 interventions were sent to LTP per visit. The most common interventions made were medication education (20.8%), adherence counseling (19.5%), update on adherence level (20.4%), and reinforcement of social distancing and COVID-19 precautions (17.1%). There was an average number of 2.5 medication discrepancies identified out from an average of 22.6 medications reconciled per visit. (Table 1) Conclusions: Implementation of CTRx telehealth visits has potential for increased patient access to pharmacy care, improved accuracy of medication lists and increased collaboration with LTP given the flexibility that telemedicine provides. Further investigation is needed to determine the significance of CTRx clinical interventions on clinical patient outcomes.