The COVID-19 pandemic has profoundly affected health care delivery. In addition to the significant morbidity and mortality associated with acute illness from COVID-19, the indirect impact has been far-reaching, including substantial disruptions in chronic disease care. As a result of pandemic disruptions in health care, vulnerable and minority populations have faced health inequalities. The aim of this review was to investigate how the COVID-19 pandemic has impacted vulnerable populations with limb-threatening peripheral artery disease and diabetic foot infections.
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Shipra Arya;
Olamide Alabi;
P Goodney;
J Mao;
J Columbo;
B Suckow;
M Schermerhorn;
M Malas;
B Brooke;
A Hoel;
S Scali;
E Spangler;
A Beck;
B Gladders;
K Moore;
X Zheng;
J Eldrup-Jorgensen;
A Sedrakyan
Objective: To evaluate long term outcomes (reintervention and late rupture of abdominal aortic aneurysm) of aortic endografts in real world practice using linked registry claims data. Design: Observational surveillance study. Setting: 282 centers in the Vascular Quality Initiative Registry linked to United States Medicare claims (2003-18). Participants: 20 489 patients treated with four device types used for endovascular abdominal aortic aneurysm repair (EVAR): 40.6% (n=8310) received the Excluder (Gore), 32.2% (n=6606) the Endurant (Medtronic), 16.0% (n=3281) the Zenith (Cook Medical), and 11.2% (n=2292) the AFX (Endologix). Given modifications to AFX in late 2014, patients who received the AFX device were categorized into two groups: the early AFX group (n=942) and late AFX group (n=1350) and compared with patients who received the other devices, using propensity matched Cox models. Main outcome measures: Reintervention and rupture of abdominal aortic aneurysm post-EVAR; all patients (100%) had complete follow-up via the registry or claims based outcome assessment, or both. Results: Median age was 76 years (interquartile range (IQR) 70-82 years), 80.0% (16 386/20 489) of patients were men, and median follow-up was 2.3 years (IQR 0.9-4.1 years). Crude five year reintervention rates were significantly higher for patients who received the early AFX device compared with the other devices: 14.9% (95% confidence interval 13.7% to 16.2%) for Excluder, 19.5% (18.1% to 21.1%) for Endurant, 16.7% (15.0% to 18.6%) for Zenith, and early 27.0% (23.7% to 30.6%) for the early AFX. The risk of reintervention for patients who received the early AFX device was higher compared with the other devices in propensity matched Cox models (hazard ratio 1.61, 95% confidence interval 1.29 to 2.02) and analyses using a surgeon level instrumental variable of >33% AFX grafts used in their practice (1.75, 1.19 to 2.59). The linked registry claims surveillance data identified the increased risk of reintervention with the early AFX device as early as mid-2013, well before the first regulatory warnings were issued in the US in 2017. Conclusions: The linked registry claims surveillance data identified a device specific risk in long term reintervention after EVAR of abdominal aortic aneurysm. Device manufacturers and regulators can leverage linked data sources to actively monitor long term outcomes in real world practice after cardiovascular interventions.
Patients with coronavirus disease 2019 (COVID-19) seem to be at high risk for venous thromboembolism (VTE) development, but there is a paucity of data exploring both the natural history of COVID-19–associated VTE and the risk for poor outcomes after VTE development. This investigation aims to explore the relationship between COVID-19–associated VTE development and mortality. A prospectively maintained registry of patients older than 18 years admitted for COVID-19–related illnesses within an academic health care network between March and September 2020 was reviewed. Codes from the tenth revision of the International Classification of Diseases for VTE were collected. The charts of those patients with a code for VTE were manually reviewed to confirm VTE diagnosis. There were 2,552 patients admitted with COVID-19–related illnesses. One hundred and twenty-six patients (4.9%) developed a VTE. A disproportionate percentage of patients of Black race developed a VTE (70.9% VTE v 57.8% non-VTE; P = .012). A higher proportion of patients with VTE expired during their index hospitalization (22.8% VTE v 8.4% non-VTE; P < .001). On multivariable logistic regression analysis, VTE was independently associated with mortality (odds ratio = 3.17; 95% confidence interval, 1.9–5.2; P < .001). Hispanic/Latinx ethnicity was associated with decreased mortality (odds ratio = 0.45; 95% confidence interval, 0.21–1.00; P = .049). Hospitalized patients of Black race with COVID-19 were more prone to VTE development, and patients with COVID-19 who developed in-hospital VTE had roughly nearly threefold higher odds of mortality. Further emphasis should be placed on optimizing COVID-19 anticoagulation protocols to reduce mortality in this high-risk cohort.
Since the onset of the COVID-19 pandemic, a concentrated research effort has been undertaken to elucidate risk factors underlying viral infection, severe illness, and death. Recent studies have investigated the association between blood type and COVID-19 infection. This article aims to comprehensively review current literature and better understand the impact of blood type on viral susceptibility and outcomes.
Coronavirus disease 2019 (COVID-19), caused by severe acute respiratory syndrome coronavirus 2, is a pandemic with more than 32 million cases and more than 500,000 deaths nationwide. With the significant health consequences seen secondary to COVID-19, health care disparities have been further exacerbated. Mechanisms that have been proposed to account for the increased disparity seen during the COVID-19 pandemic are multifactorial. This review of the literature outlines the unique barriers to health and disparities that are associated with vulnerable communities who have been most impacted by the COVID-19 pandemic in the United States.
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Lindsey E. Scierka;
Carlos Mena-Hurtado;
Mehdi H. Shishehbor;
John A. Spertus;
Sameer Nagpal;
Trissa Babrowski;
Matthew C. Bunte;
Amani Politano;
Misty Humphries;
Jayer Chung;
Lee Kirksey;
Olamide Alabi;
Peter Soukas;
Sahil Parikh;
Rumi Faizer;
Robert Fitridge;
Jeremy Provance;
Gaelle Romain;
Neil McMillan;
Nancy Stone;
Kate Scott;
Christine Fuss;
Christina M. Pacheco;
Kensey Gosch;
Avis Harper-Brooks;
Kim G. Smolderen
Background: Critical limb ischemia (CLI), the most severe form of peripheral artery disease, is associated with pain, poor wound healing, high rates of amputation, and mortality (>20% at 1 year). Little is known about the processes of care, patients’ preferences, or outcomes, as seen from patients’ perspectives. The SCOPE-CLI study was co-designed with patients to holistically document patient characteristics, treatment preferences, patterns of care, and patient-centered outcomes for CLI. Methods: This 11-center prospective observational registry will enroll and interview 816 patients from multispecialty, interdisciplinary vascular centers in the United States and Australia. Patients will be followed up at 1, 2, 6, and 12 months regarding their psychosocial factors and health status. Hospitalizations, interventions, and outcomes will be captured for 12 months with vital status extending to 5 years. Pilot data were collected between January and July of 2021 from 3 centers. Results: A total of 70 patients have been enrolled. The mean age was 68.4 ± 11.3 years, 31.4% were female, and 20.0% were African American. Conclusions: SCOPE-CLI is uniquely co-designed with patients who have CLI to capture the care experiences, treatment preferences, and health status outcomes of this vulnerable population and will provide much needed information to understand and address gaps in the quality of CLI care and outcomes. ClinicalTrials.gov identifier (NCT Number): NCT04710563 https://clinicaltrials.gov/ct2/show/NCT04710563.
On March 17, 2020, Emory University School of Medicine temporarily suspended student–patient contact to minimize the risk of exposure to coronavirus disease 2019, representing an unprecedented disruption to medical education. In response, virtual electives were expeditiously created to supplement existing curricula and keep students on track for their scheduled graduation dates. The Emory University School of Medicine Department of Surgery faculty and students created the ViSEG (virtual surgical education group) to design virtual electives in eight surgical specialties for third-year medical students. All students, including those not previously enrolled in a surgical clerkship, were encouraged to enroll. Seven students chose the virtual vascular surgery elective.
Background: Lower extremity peripheral arterial disease (PAD) is a public health problem and many patients with PAD experience claudication despite adequate medical and/or surgical management. Mobilization of endogenous progenitor cells using Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) is a novel therapeutic option that has shown promising results in experimental models and phase I/IIA clinical trials. The GPAD-3 trial will study the effect of two successive administrations of GM-CSF at 3-month interval for improving claudication among patients with lower extremity PAD. Methods: We plan to recruit 176 patients in this ongoing randomized, double-blind, placebo-controlled Phase IIB trial. After screening for inclusion and exclusion criteria, eligible subjects undergo a 4-week screening phase where they perform subcutaneous placebo injections thrice weekly and walk at least three times a day until they develop claudication. After the screening phase, eligible subjects undergo baseline testing and are randomized 2:1 to receive 500 μg/day of GM-CSF subcutaneously thrice weekly for three weeks or placebo injections. After 3 months, follow-up endpoint testing is performed and subjects in the GM-CSF group receive the second administration of the drug for three weeks while subjects in placebo group receive matching placebo injections. All participants undergo endpoint testing at six-month and nine-month follow-up. The primary endpoint is change in 6-min walk distance between baseline and 6-month follow-up. Conclusion: GPAD-3 explores a novel approach to address the need for alternative therapies that can alleviate symptoms among patients with lower extremity PAD. If successful, this study will pave the way for a pivotal Phase III trial.