Association of Cardiovascular Medications with Adverse Outcomes in a Matched Analysis of a National Cohort of Patients with COVID-19

BACKGROUND The use of statins, angiotensin-converting enzyme inhibitors (ACEIs)/angiotensin II receptor blockers (ARBs), and anticoagulants may be associated with fewer adverse outcomes in COVID-19 patients. METHODS Nested within a cohort of 800,913 patients diagnosed with COVID-19 between 4/1/20 and 6/24/21 from the Optum COVID-19 database, three case-control studies were conducted. Cases—defined as persons who: a) were hospitalized within 30 days of COVID-19 diagnosis (n=88,405);b) were admitted to the intensive care unit [ICU]/received mechanical ventilation during COVID-19 hospitalization (n=22,147);c) died during COVID-19 hospitalization (n=2,300)—were matched 1:1 using demographic/clinical factors with controls randomly selected from a pool of patients who did not experience the case definition/event. Medication use was based on prescription ≤90 days before COVID-19 diagnosis. RESULTS Statin use was associated with decreased risk of hospitalization (adjusted odds ratio [aOR], 0.72;95% CI, 0.69, 0.75) and ICU admission/mechanical ventilation (aOR, 0.90;95% CI, 0.84, 0.97). ACEI/ARB use was associated with decreased risk of hospitalization (aOR, 0.67;95% CI, 0.65, 0.70), ICU admission/mechanical ventilation (aOR, 0.92;95% CI, 0.86, 0.99) and death (aOR, 0.60;95% CI, 0.47, 0.78). Anticoagulant use was associated with decreased risk of hospitalization (aOR, 0.94;95% CI, 0.89, 0.99) and death (aOR, 0.56;95% CI, 0.41, 0.77). Interaction effects—in the model predicting hospitalization—were statistically significant for: statins and ACEI/ARBs (p<.0001), statins and anticoagulants (p=.003), ACEI/ARBs and anticoagulants (p<.0001). An interaction effect—in the model predicting ventilator use/ICU—was statistically significant for statins and ACEI/ARBs (p=.002). CONCLUSIONS Statins, ACEI/ARBs, and anticoagulants were associated with decreased risks of the adverse outcomes under study. These findings may provide clinically relevant information regarding potential treatment for patients with COVID-19.

Atypical Cells on Transbronchial Biopsies of Peripheral Pulmonary Lesions: How Should We Interpret the Result?

SESSION TITLE: Lung Nodule Biopsy: Yield and Accuracy SESSION TYPE: Original Investigations PRESENTED ON: 10/16/2022 10:30 am - 11:30 am PURPOSE: Atypia is common on biopsy specimens of peripheral pulmonary lesions (PPLs) and may result from inflammation or inadequate sampling of a malignancy. The significance of atypical cells on PPLs biopsies has not been well described. In addition, recent studies of navigational bronchoscopy have variably considered atypia on biopsies as diagnostic. METHOD(S): We analyzed a prospective database of consecutive PPLs sampled via navigational bronchoscopy at our institution (IRB: 212187). Search terms "atypia" and "atypical" were applied to pathology reports generated by these procedures. Manual inspection ensured atypia was present in the PPL itself. Definitive PPL diagnosis was established during a two-year routine clinical follow-up. Bronchoscopy diagnostic yield was defined as histopathological findings which readily explained a nodule (malignancy, organizing pneumonia, frank purulence, granulomatous inflammation) and permitted management of the patient without an immediate additional diagnostic intervention. Atypia was considered nonspecific and, therefore, nondiagnostic. RESULT(S): From 11/2017 to 4/2019, 461 biopsied PPLs were identified. Eleven cases, none exhibited atypia, lacked complete two-year follow-up, and were excluded. Ultimately, 274 of 450 (61%) analyzed PPLs were malignant. Diagnostic biopsies were obtained in 331 (73.5%) cases. Atypical cells were present in 33 PPLs (7% of overall cohort, 28% of the 119 nondiagnostic cases). Two-thirds (22 of 33) were eventually determined to be malignant. Lung adenocarcinoma was the most common ultimate malignant diagnosis (10 cases). Most benign PPLs with atypia regressed on follow-up imaging without further pathological data (5 cases). Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of atypia for an eventual diagnosis of malignancy among the 223 PPLs not diagnosed as malignant at index bronchoscopy were 46% (95% CI 31-61%), 94% (89-97%), 92% (85-96%), and 53% (46-60%), respectively, with positive likelihood ratio (+LR) of 7.3 (3.8-14). CONCLUSION(S): The presence of atypical cells was a common finding, found in 28% of PPLs without a specific diagnosis after bronchoscopy. Two-thirds of PPLs with atypia were ultimately malignant, with a high PPV (92%) for malignant diagnosis in this cohort with an overall prevalence of malignancy of 61%. CLINICAL IMPLICATIONS: Atypia not diagnostic of malignancy in bronchoscopic biopsy specimens is a nonspecific finding, which may be due to inadequate sampling of a malignant PPL or inflammation. However, the high PPV and +LR of atypia for ultimate malignant PPL diagnosis suggest that in populations with a similar prevalence of malignancy and/or in the clinical context of a high pre-test probability of malignancy, atypical findings might prompt repeat biopsy or definitive PPL management (resection or ablation). DISCLOSURES: No relevant relationships by Robert Lentz No relevant relationships by Kaele Leonard No relevant relationships by See-Wei Low PI ofan investigator-initiated study relationship with Medtronic Please note: >$100000 by Fabien Maldonado, value=Grant/Research Support PI on investigator-initiated relationship with Erbe Please note: $5001 - $20000 by Fabien Maldonado, value=Grant/Research Support Consulting relationship with Medtronic Please note: $5001 - $20000 by Fabien Maldonado, value=Honoraria co-I industry-sponsored trial relationship with Lung Therapeutics Please note: $5001 - $20000 by Fabien Maldonado, value=Grant/Research Support Board of director member relationship with AABIP Please note: $1-$1000 by Fabien Maldonado, value=Travel Consultant relationship with Medtronic/Covidien Please note: $1001 - $5000 by Otis Rickman, value=Consulting fee No relevant relationships by Briana Swanner Copyright © 2022 American College of Chest Physicians

Diagnostic Yield Vs Diagnostic Accuracy for Lung Nodule Biopsy Evaluation: Evidence Supporting a Pragmatic End Point for Future Studies

SESSION TITLE: Lung Nodule Biopsy: Yield and Accuracy SESSION TYPE: Original Investigations PRESENTED ON: 10/16/2022 10:30 am - 11:30 am PURPOSE: A variety of endpoints have been used to evaluate the diagnostic performance of navigational bronchoscopy for sampling peripheral pulmonary lesions (PPLs), including diagnostic yield (rate of biopsies with a specific diagnosis that facilitates clinical decisions) and diagnostic accuracy (yield plus a follow-up to assess for false negative/positive initial results). There is also significant variation in what non-malignant findings are considered diagnostic, especially regarding nonspecific inflammatory changes. We hypothesized a diagnostic yield definition excluding nonspecific findings as diagnostic would lead to few false negative PPL biopsies. METHOD(S): Our center maintains a prospective cohort of consecutive PPLs targeted via navigational bronchoscopy. Diagnostic yield was defined as specific findings readily explaining the presence of a PPL (malignancy, organizing pneumonia, granulomatous inflammation, frank purulence, other specific finding) permitting management without immediate additional diagnostic intervention. "Other specific finding" required pulmonologist and lung pathologist agreement. All other findings were considered non-diagnostic. RESULT(S): A total of 450 PPLs biopsied 2017-2019 with complete two-year follow-up were included in the analysis. Ultimately, 274 of 450 (60.9%) PPLs were determined to be malignant. Diagnostic biopsies were obtained in 331 cases (73.6%). There was a single false-positive among 228 malignant biopsies (0.4%, carcinoid tumor on cytopathology, alveolar adenoma on resection surgical pathology). Among 223 PPLs without malignant diagnosis at initial bronchoscopy, 48 were later determined to be malignant. Most (n=39) exhibited nonspecific abnormalities on initial pathology. Two of 104 specific benign biopsies were false negative (1.9%). Both demonstrated organizing pneumonia on initial pathology but re-biopsy months after index bronchoscopy revealed Hodgkin's lymphoma and metastatic renal cell carcinoma, respectively. The sensitivity, specificity, and positive predictive value of specific benign findings for an ultimately benign nodule were 58% (95% CI, 51-66%), 95% (86-99%), and 90% (70-97%). The sensitivity, specificity, and positive predictive value of nonspecific benign findings for an ultimately benign PPL diagnosis were 32% (95% CI, 25-39%), 19% (9-33%), and 20% (16-24%). CONCLUSION(S): A definition of diagnostic yield excluding nonspecific benign findings had low false positive/negative rates. If bronchoscopy is not diagnostic of malignancy, a specific benign finding was highly predictive of an ultimately benign PPL, while nonspecific findings poorly predicted benignity. CLINICAL IMPLICATIONS: This definition of diagnostic yield could be used as the primary outcome in future studies, permitting distribution of reliable diagnostic results without requiring years of follow-up. DISCLOSURES: No relevant relationships by Joyce Johnson No relevant relationships by Robert Lentz No relevant relationships by Kaele Leonard No relevant relationships by See-Wei Low PI ofan investigator-initiated study relationship with Medtronic Please note: >$100000 by Fabien Maldonado, value=Grant/Research Support PI on investigator-initiated relationship with Erbe Please note: $5001 - $20000 by Fabien Maldonado, value=Grant/Research Support Consulting relationship with Medtronic Please note: $5001 - $20000 by Fabien Maldonado, value=Honoraria co-I industry-sponsored trial relationship with Lung Therapeutics Please note: $5001 - $20000 by Fabien Maldonado, value=Grant/Research Support Board of director member relationship with AABIP Please note: $1-$1000 by Fabien Maldonado, value=Travel Consultant relationship with Medtronic/Covidien Please note: $1001 - $5000 by Otis Rickman, value=Consulting fee No relevant relationships by Briana Swanner Copyright © 2022 American College of Chest Physicians

Platform Incorporating Patient Navigation, Preparative Guidelines, and Hospital at Home May Improve COVID-19 Outcomes for Patients with Myeloid Malignancies

Background: Patients (pts) with malignancies are at increased risk of morbidity and mortality from COVID-19. Among these pts, some of the higher case fatality ratios (CFR) reported are among pts with myeloid malignancies, ranging from 37 to 50% (Mehta V, Cancer Discov 2020;Ferrara F, Leukemia 2020). Levine Cancer Institute (LCI) has a robust hematologic malignancy and cellular therapy program that serves many pts with myeloid malignancies, seeing nearly 100 new diagnoses of acute myeloid leukemia per year. A strategy to mitigate risks associated with COVID-19 was established at LCI in partnership with Atrium Health's (AH) Hospital at Home (HAH). HAH was a system wide platform using telemedicine and home health services to assess and monitor COVID-19 + pts at high risk of complications. To augment HAH for our medically complex cancer pts, a virtual health navigation process involving expertise from across LCI, including a specialized nurse navigation team, was developed to rapidly identify LCI pts + for SARS-CoV-2, monitor them under physician supervision, and escalate care as needed with AH HAH. Along with the navigation platform, data-driven guidelines for detecting, monitoring, and managing LCI pts + for SARS-CoV-2 were swiftly employed across the extensive LCI network. Herein we report on the outcomes for LCI pts with myeloid malignancies + for SARS-CoV-2 and outline the employed risk mitigation strategies and their potential impact on these outcomes. Methods: An automated daily list of LCI pts + for SARS-CoV-2 was provided by AH Information Services. Each pt's chart was reviewed by a nurse navigator for hematologic or oncologic diagnosis, outpatient or inpatient status, and COVID-19 symptoms. Pts without a cancer diagnosis were not assigned a navigator. If hospitalized, a pt was not assigned a navigator;following discharge, if enrolled in HAH, a navigator was assigned. In collaboration with HAH, an algorithm for directing care was utilized (Figure 1). A diagnosis-specific navigator contacted and screened the pt with an assessment tool, which scored pts for surveillance and treatment needs (Table 1). Documentation was forwarded to the primary hematologist/oncologist. Comprehensive guidelines for testing, scheduling, management of + pts, research, and process changes were created, disseminated, and actively updated through LCI's EAPathways. For outcome analysis for pts with myeloid malignancies, pt vital status was updated through data cutoff (7/3/21). Results: From inception on 3/20/20 to 12/2/20, 974 LCI patients were identified as SARS-CoV-2 + and reviewed for nurse navigation. Of the 974 pts, including pts with benign and malignant diagnoses, 488 were navigated. Among all SARS-CoV-2 + LCI pts, 145 (15%) had a hematologic malignancy, including 37 (4%) pts with myeloid malignancies. Characteristics are shown in Table 2. Of the 37 pts, 18 (49%) were navigated. 70% with myeloid malignancies were on active treatment at the time of + test. Nearly 50% of those on active treatment were navigated. 46% were hospitalized with COVID-19, with this being the main reason for no assigned navigator. 24% of hospitalized pts were eventually assigned a navigator. Only 3 pts had undergone allogeneic stem cell transplantation (allo-SCT) with a median time from transplant to detection of SARS-CoV-2 of 9 months (range, 7-23). 2 out of 3 cases post allo-SCT were asymptomatic. No pt died from COVID-19 following allo-SCT. Among the navigated pts with myeloid malignancies, there was no death related to COVID-19. 4 pts, all of whom were hospitalized, died from COVID-19 (N=2, myelodysplastic syndrome with 1 on azacitidine;N=2, myeloproliferative neoplasm, both on hydrea). A CFR of 11% was demonstrated for LCI pts with myeloid malignancies. Conclusions: A multidisciplinary response strategy liaising between AH HAH and LCI followed, assessed, and assisted cancer pts + for SARS-CoV-2. With our embedded nurse navigation team's specialized attention along with enhanced physician oversight and close collaboration with AH HAH, opportunities f r care escalation or adjustments in cancer-focused care were promptly identified. In this setting, among the high-risk population of pts with myeloid malignancies, a lower CFR than has been reported was observed. A virtual navigation platform with HAH capabilities is a feasible, safe, and effective way to monitor and care for this high-risk population. [Formula presented] Disclosures: Moyo: Seattle Genetics: Consultancy. Chai: Cardinal Health: Membership on an entity's Board of Directors or advisory committees. Avalos: JUNO: Membership on an entity's Board of Directors or advisory committees. Grunwald: Amgen: Consultancy;Agios: Consultancy;Astellas: Consultancy;Daiichi Sankyo: Consultancy;Stemline: Consultancy;Bristol Myers Squibb: Consultancy;PRIME: Other;Trovagene: Consultancy;Blueprint Medicines: Consultancy;AbbVie: Consultancy;Med Learning Group: Other;Pfizer: Consultancy;Sierra Oncology: Consultancy;Janssen: Research Funding;Incyte: Consultancy, Research Funding;Gilead: Consultancy;MDEdge: Other;PER: Other;Cardinal Health: Consultancy;Karius: Consultancy. Copelan: Amgen: Consultancy.

Patient navigation plus hospital at home to improve COVID-19 outcomes for cancer patients

Background: Reports suggested cancer patients were at greater risk for increased morbidity and mortality from COVID-19. A process to mitigate these risks was established at Levine Cancer Institute (LCI) in partnership with Atrium Health's (AH) Hospital at Home (HAH) initiative. This virtual health navigation process employed expertise from the departments of Hematologic Oncology and Blood Disorders, Oncology, and Supportive Oncology, including a specialized nurse navigation team, to rapidly identify COVID-19 positive LCI patients, monitor them under physician supervision, and escalate care as needed with AH HAH program. Methods: AH Information Services created an automated list of LCI COVID-19 positive patients with a daily database. Each patient was reviewed by a nurse navigator. Review included hematologic or oncologic diagnosis, outpatient or inpatient status, and any COVID-19 symptoms. Once a malignant diagnosis was confirmed, a diagnosis-specific navigator contacted and screened the patient with a COVID assessment tool. Documentation was forwarded to the primary oncologist/hematologist. The tool scored patients for surveillance and treatment needs. A score of 0-2 prompted phone assessment every 48-72 hours, and score of 3-5 required every 24-48 hour calls with physician involvement when appropriate. If score of ≥6, care was escalated to LCI nurse/physician for admission to AH acute care HAH or conventional inpatient admission. Results: From inception on 3/20/2020 to data review date of 12/2/2020, 974 LCI patients were identified as COVID-19 positive and reviewed for nurse navigation (Table). Of the 974, 488 were navigated. Given limited resources, patients with benign conditions were not assigned a navigator, though a similar process was created for sickle cell disease. Of the 974, 75 are now deceased. Only 25 are deceased among the 488 navigated. Conclusions: The COVID-19 pandemic presented unprecedented circumstances to our patients and their clinicians. LCI expeditiously put policies and procedures in place to mitigate the intersection of COVID-19 and cancer. The multidisciplinary response strategy liaising between AH HAH and LCI followed, assessed, and assisted LCI COVID19 positive patients. With our embedded nurse navigation team's specialized attention along with enhanced physician oversight and close collaboration with AH HAH, opportunities for care escalation or adjustments in cancerfocused care were promptly identified. Analysis is ongoing to elucidate the lower mortality rate observed among navigated patients.

Attitudes and Perceptions Toward Virtual Health in Eye Care During Coronavirus Disease 2019.

Purpose: To evaluate attitudes and perceptions toward virtual health (VH) and its usage among eye care providers before, during, and after the coronavirus disease 2019 (COVID-19) pandemic. Materials and Methods: In April and May 2020, an online survey comprised of questions regarding past and current VH practices, as well as plans for future use was distributed among eye care providers nationwide. Results: Of the 117 eye care providers who completed the survey, 96.6% were not using VH before the COVID-19 pandemic. In contrast, 77.4% reported using VH during the pandemic. The majority of visits were for red eye (64.4%, n = 56) and ocular surface complaints (58.6%, n = 51). Examination components tested virtually varied, but most respondents felt these were at least "somewhat reliable." Almost half of respondents (45%) felt it was "very easy" or "somewhat easy" to implement VH and the majority (53.8%, n = 43) were able to get it up and running in under a week. The majority felt the transition to VH was positive (57.5%), however, only 50.4% (n = 53) of those providers planned to use VH regularly once able to see patients safely in clinic again. Conclusions: While the majority of U.S. eye care providers who responded were not using VH before the COVID-19 pandemic, just months into the U.S. outbreak, 77.4% were using VH in their daily practice. In general, providers used these platforms for urgent examinations, adnexal disease, and postoperative care most often. The majority felt the transition was a positive one, however, only half planned to continue regular use of VH once the pandemic ended.

Mobilization and Physical Therapy in ECMO patients with Coronavirus-2019

During the coronavirus-2019 (COVID-19) pandemic, ECMO has been utilized extensively around the world as a rescue therapy for severe acute respiratory distress syndrome (ARDS). Although mobilization has been used in other ECMO settings, guidelines on the use of ECMO for COVID-19 patients have recommended against it due to concerns for cannula dislodgment, hemodynamic instability, resource utilization, personal protective equipment (PPE) use, and infection control. Our institution had robust experience with mobilization and therefore we aimed to continue our usual practice mobilization of patients with ARDS on ECMO. To date, we have mobilized 14/18 (77%) patients with severe ARDS due to COVID-19. All patients had dual cannula configuration with a femoral drainage cannula and right internal jugular reinfusion cannula. Mobilization was limited to the patient's room due to minimize staff exposure to SARs-CoV-2. Maximal activity was limited to standing and marching in place. The ECMO mobilization team typically included 1-2 physical therapists, a nurse ECMO specialist, a respiratory therapist and the bedside ICU nurse. Most sessions also included an occupational therapist who would work with the patient once sitting at the side of the bed. We were able to show that physical therapy and mobilization of ECMO patients with COVID-19 is feasible and safe for both the patient and healthcare staff with appropriate PPE utilization. However, we acknowledge that scarce resources (i.e. staff or PPE) may limit mobilization at some centers.