Patrick Campbell

An original version of this article was published by sister publication HCPLive.

While more is still being learned about the impact of 

 on cardiometabolic health, new research suggests use of anticoagulants could improve survival in hospitalized COVID-19 patients.

Using data from the Mount Sinai COVID Informatics Center, results of the study, which included more than 2500 patients with confirmed COVID-19 infections, indicated patients receiving anticoagulants had a lower rate of in-hospital mortality than those not receiving anticoagulants—with the difference becoming more apparent in cases requiring invasive mechanical ventilation.

“This research demonstrates anticoagulants taken orally, subcutaneously, or intravenously may play a major role in caring for COVID-19 patients, and these may prevent possible deadly events associated with coronavirus, including heart attack, stroke, and pulmonary embolism,” said investigator Valentin Fuster, MD, PhD, Director of Mount Sinai Heart and Physician-in-Chief of the Mount Sinai Hospital, in a statement.

With new research demonstrating an increased risk of thromboembolic events in COVID-19 patients and the impact of anticoagulation on disease management still unclear, Fuster and a team of colleagues sought to assess the association of in-hospital anticoagulant use on survival in hospitalized patients. Investigators used Cox proportional hazards models to assess treatment-dose systemic AC, including oral, subcutaneous, or intravenous forms, on in-hospital mortality.

Of note, the investigators’ analysis accounted for confounding factors including age, sex, ethnicity, body mass index, history of hypertension, heart failure, atrial fibrillation, type 2 diabetes, anticoagulant use before admission, and admission date. Additionally, anticoagulant treatment duration was used as a covariate to adjust for length of stay and initiation of anticoagulants.

For the analysis, investigators used a cohort of 2773 patients hospitalized within the Mount Sinai Health System between March 14-April 11, 2020 with laboratory-confirmed COVID-19. For the cohort, median hospitalization duration was 5 (3-8) days, median time from admission to anticoagulant initiation was 2 (0-5) days, and median duration of anticoagulant treatment was 3 (2-7) days.

Results indicated an in-hospital mortality rate of 22.5% for patients treated with anticoagulants compared to 22.8% in patients who did not receive them—median survival for these groups was 21 days and 14, respectively. Results also demonstrated patients receiving anticoagulants were more likely to require invasive mechanical ventilation than those not receiving anticoagulants (29.8% vs 8.1%; 

Investigators highlighted significantly increased baseline prothrombin time, activated partial thromboplastin time, lactate dehydrogenase, ferritin, C-reactive protein, and D-dimer values in patients who received in-hospital anticoagulation, but none of these differences were observed in patients who required mechanical ventilation.

Among the 395 individuals requiring mechanical ventilation, patients receiving anticoagulants had an in-hospital mortality rate of 29.1% and a median survival of 21 days compared to 62.7% and 9 days, respectively, in patients not receiving anticoagulants. Results of the investigators’ multivariate proportional hazards model indicated longer duration of anticoagulant therapy was associated with reduced risk of mortality (aHR 0.86; 95% CI, 0.82-0.89; 

When examining the impact of anticoagulation on risk of bleeding events in these patients, investigators found 1.9% of patients not receiving anticoagulants experienced major bleeding compared to 3.0% of those receiving anticoagulants 

 = .02). Among those receiving anticoagulants who experienced bleeding, 63% experienced the event after starting therapy and 37% had events before starting anticoagulation.

Investigators noted the observational nature of their study and caution against overinterpretation without considering its limitations.

“Using anticoagulants should be considered when patients get admitted to the ER and have tested positive for COVID-19 to possibly improve outcomes. However, each case should be evaluated on an individualized basis to account for potential bleeding risk,” said Fuster in the aforementioned statement.

This study, “Association of Treatment Dose Anticoagulation with In-Hospital Survival Among Hospitalized Patients with COVID-19,” was published in the 

Journal of the American College of Cardiology.

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New data from a New York City-based hospital shows patients on blood thinners had a lower mortality risk due to COVID-19.

Anticoagulants Linked to Improved COVID-19 Survival Rate

Wuhan University Study Details Cardiac Injury, Mortality in COVID-19 Patients

, was originally published on HCPLive.com

 is providing more information on the link between cardiac injury and mortality among patients hospitalized with coronavirus disease 2019 (COVID-19).

The analysis includes data from more than 400 patients who were hospitalized at the Renmin Hospital of Wuhan University in Wuhan, China. 

Authored by Congxin Huang, MD, PhD, director of the Cardiovascular Research Institute at Wuhan University, and team of physicians from the hospital, the analysis revealed nearly 1 in 5 patients hospitalized with COVID-19 had a cardiac injury occur, and patients with cardiac injury had a three-fold increased risk of mortality.

To more clearly define the incidence and significance of cardiac injury in patients with COVID-19, investigators designed a retrospective cohort study of hospitalized patients with laboratory-confirmed COVID-19 between January 20 and February 10, 2020—with a follow-up period lasting until February 15.

Of note, the Renmin Hospital was assigned to treat severe cases in the Hubei Province by the Wuhan government and all cases were diagnosed according to World Health Organization (WHO) standards.

Initially, 1004 patients were identified from the medical record systems. After excluding cases that were not confirmed, those without available medical information and duplicated records, and patients missing values for high-sensitivity troponin I (hs-TNI) and creatinine kinase—myocardial band (CK-MB), the study cohort contained 416 cases. Investigators defined cardiac injury as blood levels of cardiac biomarkers above the 99th-percentile upper reference limit.

The mean age of patients was 64 (21-95) years, 211 were female, and 82 (19.7%) had cardiac injury. The most common symptom among the entire study cohort was fever (80.3%). Other common symptoms included cough (34.6%), shortness of breath (28.1%), fatigue (13.2%), and sputum production (5.5%).

In regard to common comorbidities, 30.5% of patients had hypertension and 14.4% had been previously diagnosed with diabetes. Additionally, 10.6% of patients had coronary heart disease (CHD), 5.3% had cerebrovascular disease, and 4.7% had chronic heart failure.

Analysis indicated patients with cardiac injury were more likely to require noninvasive (46.3% vs 3.9%; 

 <.001) and invasive mechanical ventilation (22.0% vs 4.2%; 

 <.001) during hospitalization. Patients with cardiac injury also had a greater risk for complications than those without, including acute respiratory distress syndrome (58.5% vs 14.7%; P <.001), acute kidney injury (8.5% vs 0.3%; 

 <.001), electrolyte disturbances (15.9% vs 5.1%; 

=.003), hypoproteinemia (13.4% vs 16 4.8%; 

=.01), and coagulation disorders (7.3% vs 1.8%; 

More than half of the patients (51.2%) who suffered cardiac injury died compared to just 4.5% of patients without cardiac injury (

 <.001). A Cox regression model indicated patients with cardiac injury were at a greater risk of mortality during the time from symptom onset (HR, 4.26 [95% CI, 1.92-9.49]) and from admission to endpoint (HR, 3.41 [95% CI, 1.62-7.16]).

Comparison of characteristics between patients with and without cardiac injury indicated patients with cardiac injury were older (74 [34- 95] years vs 60 [21-90] years; 

 <.001) and more likely to have chest pain (13.4% vs 0.9%; 

 <.001). Other differences included an increase in prevalence of hypertension (59.8% vs 23.4%), diabetes (24.4% vs 12.0%), CHD (29.3% vs 6.0%), cerebrovascular disease (15.9% vs 2.7%), chronic heart failure (14.6% vs 1.5%), chronic obstructive pulmonary disease (7.3% vs 1.8%), and cancer (8.5% vs 0.6%) in patients with cardiac injury (all 

Patients with cardiac injury had a higher proportion of multiple mottling and ground-glass opacity according to chest radiography results (64.6% vs 4.5%). Laboratory results indicated patients with cardiac had higher leukocyte counts (median interquartile range (IQR), 9400 [6900-13 800] vs 5500 [4200-7400] cells/μL) and levels of C-reactive protein (10.2 [6.4-17.0] vs 3.7 [1.0-7.3] mg/dL), procalcitonin (0.27 [0.10-1.22] vs 0.06 [0.03-0.10] ng/mL), CK-MB (3.2 [1.8-6.2] vs 0.9 [0.6-1.3] ng/mL), myohemoglobin (128 [68-305] vs 39 [27-65] μg/L), hs-TNI (0.19 [0.08-1.12] vs <.006 [<.006-.009] μg/L), N-terminal pro-B-type natriuretic peptide (1689 [698-3327] vs 139 [51-335] pg/mL), aspartate aminotransferase (40 [27-60] vs 29 [21-40] U/L), and creatinine (1.15 [0.72-1.92] vs 0.64 [0.54-0.78] mg/dL).

Investigators noted multiple limitations within their study. Limitations included logistic limitations such as inability to collect data ECG and other data, many with and without cardiac injury may not have reached clinical endpoints due to the ongoing nature of the study, and data from other centers and larger populations are necessary if the findings of the study are to be confirmed.

A new study is providing more information on the link between cardiac injury and mortality among patients hospitalized with COVID-19.

What is the Association Between Cardiac Injury and Mortality Among COVID-19 Patients?

 on cardiovascular health is an urgent question for clinicians around the world during this global pandemic.

offers an overview of available data on COVID-19 and cardiovascular health. The study team examined the impact on heart transplantation as well as potential treatments.

The study, authored by Nir Uriel, MD, MSc, and a team of colleagues, contains information from more than 60 articles to provide clinicians and cardiologists a much-needed outline of the disease and how its impact on those with cardiovascular disease (CVD) differs from those without.

Existing information suggests cardiovascular diseases are a common comorbidity among patients with COVID-19—as was seen with SARS and MERS&mdash;and 5 sets of data provided were referenced in support of this. Of note, an analysis of 8 studies including more than 45,000 infected patients found the most prevalent comorbidities were hypertension (17±7%, 95% CI, 14-22%), diabetes mellitus (8±6%, 95% CI 6-11%), and cardiovascular diseases (5±4%, 95% CI 4-7%). Another study, which analyzed 1099 infected patients, found hypertension was present in 36% of patients that died or required intubation.

An analysis of 138 hospitalized patients with COVID-19 indicated hypertension was present in 31% of patients and 58% that required placement in an intensive care unit (ICU) while CVD was presented in 15% overall and 25% that required ICU. This same study is referenced in the next section of the article, which examines COVID-19 and myocardial injury. In this analysis, elevated high sensitivity Troponin I (hs-cTnI) or new ECG or echocardiographic abnormalities were presented in 7.2% of the cohort and 22% of those requiring ICU.

Uriel and colleagues note available data suggest 2 apparent patterns of myocardial injury associated with COVID-19. The first, indicates a rise in hs-cTnI—as well as D-dimer, ferritin, IL-6, and lactate dehydrogenase&mdash;suggest this is more indicative of a cytokine storm or secondary hemophagocytic lymphohistiocytosis rather isolated myocardial injury. The second, which occurs in patients with predominantly cardiac symptoms, is more indicative of potential viral myocarditis or stress cardiomyopathy&mdash;they reference 3 reports to evidence this point.

The investigators briefly touch on the role of ACE inhibitors and ARBs in the disease and go on to point out most major cardiology organizations advise against adding or stopping these therapies given the lack of evidence currently available. They also touch on heart transplantation and COVID-19, explaining available data appears to indicate it remains safe even during the pandemic.

A survey in Wuhan found the risk of infection with SARS-CoV-2 did not increase if routine preventive measures were used. Additionally, Uriel and colleagues note recommendations from major societies include avoiding donors with known or suspected COVID-19 and if a donor had COVID-19, they should be COVID-19 free as assessed by RT-PCR for at least 14 days.

The portion of Uriel and colleagues’ work that outlines potential treatments includes more than half-a-dozen therapies, including chloroquine and hydroxychloroquine. In regard to these therapies, investigators note the therapy blocks SARS-CoV-2 cell entry 

 at concentrations comparable to that achieved with treatment for rheumatoid arthritis and trials are still ongoing.

Other treatments that have been examined or could, at least in theory, provide some form of benefit referenced in this section include remdesevir, camostat mesylate, lopinavir/ritonavir, tocilizumab, sarilumab, and recombinant human ACE2 (APN01). At multiple points throughout the section highlighting treatments, Uriel and colleagues note none of these treatments have proven clinical efficacy to date.

Uriel and colleagues also point out that research into the mechanisms behind many of the aforementioned associations requires further investigation and many other questions surrounding COVID-19 and its impact on cardiovascular health remain unanswered.

“COVID-19, caused by SARS-CoV-2, is a global pandemic evolving in real time,” Uriel and colleagues wrote.

The impact of COVID-19 on cardiovascular health is an urgent question for clinicians around the world during this global pandemic.

Study Provides Overview of COVID-19 and Cardiovascular Health

Shingles Vaccine Could Reduce Stroke Risk

The findings from a study conducted by experts with the US Centers for Disease Control and Prevention (CDC) indicate that the shingles vaccine could reduce an individual's risk of stroke.

The results were presented at the American Stroke Association’s International Stroke Conference (ISC) and suggest that the Zoster Vaccine Live not only reduced the risk for shingles but also reduced stroke risk by 16% in older adults.

"Our study results may encourage people ages 50 and older to follow the recommendation and get vaccinated against shingles,” Quanhe Yang, PhD, lead investigator and senior scientist at the CDC, said in a statement. “You are reducing the risk of shingles, and at the same time you may be reducing your risk of stroke."

While previous research has linked herpes zoster to an increased risk of stroke in older patients, no studies had established a definitive link between the Zoster Vaccine Live and the risk of stroke in this population group. To perform such as assessment, Yang and a team of CDC colleagues performed a retrospective analysis using the Medicare health records of more than 1.3 million Medicare fee-for-service beneficiaries.

For inclusion in the analysis, patients were required to be 66 years of age or older, have no stroke history, and must have received the Zoster Live Vaccine between 2008 and 2014. A total of 1,382,051 individuals were identified for inclusion and investigators proceeded to match this cohort with 1,382,051 controls to control for age, gender, race, medications, and comorbidities.

Cox proportional hazards models were used to examine the association between the vaccine and a composite endpoint of fatal and nonfatal incident stroke outcomes. Additional analyses were performed examining the effectiveness of the vaccine and stroke reduction stratified by different age groups.

During follow-up, which had a median length of 3.9 years, a total of 42,267 stroke events occurred over 5,890,113 person-years among those who received the vaccine. Of the 42,267 events, 33,510 were acute ischemic strokes and 4318 were hemorrhagic strokes.

Among matched controls, 48,139 total stroke events occurred over 5,693,943 person-years. Of the 48,139 events, 39,334 were acute ischemic strokes and 4713 were hemorrhagic strokes.

When comparing the groups, lower incidence rates per 1000 person-years were observed among those who received the Zoster Live Vaccine than those who did not for all stroke events(7.18 vs 8.45), acute ischemic stroke (5.40 vs 6.53), and for hemorrhagic stroke (0.73 vs 0.82)(P <.001 for difference). Results of the Cox proportional hazards models indicated receiving the vaccine decreased risk of stroke by 16%, risk of ischemic stroke by approximately 18%, and risk of hemorrhagic stroke by 12%.

Of note, results indicate the beneficial impact on stroke risk appeared to be greater in patients 79 years of age and younger than in the older patients examined. Additionally, investigators pointed out the study examined a time period when the Zoster Vaccine Live was the only shingles vaccine available.

This study, “Herpes Zoster Vaccine Live And Risk For Stroke Among Medicare Beneficiaries: Population Based Matched Cohort Study,” will be presented at ISC 2020 in Los Angeles, CA.

A new study found that the Zoster Vaccine Live not only reduced the risk for shingles but also reduced stroke risk by 16% in older adults.

Can a Shingles Vaccine Reduce Stroke Risk in Older Adults?

President Donald Trump has announced his intent to appoint Stephen Hahn, MD, as the next commissioner of the US Food and Drug Administration (FDA), according to a 

Hahn is the chief medical executive at the University of Texas M.D. Anderson Cancer Center, and a professor in the Department of Radiation Oncology at the University of Texas M.D. Anderson Cancer Center.

The president is required to appoint a permanent replacement or a new interim commissioner by November 1. Hahn will fill the vacancy left by Scott Gottlieb, MD, who 

 from his role as commissioner in April, and take over the role currently held by 

Hahn’s appointment, which would first need to be approved by the US Senate, would appear to be the Texas-based doctor’s first entrance into the public arena in decades. 

Hahn began to emerge as a frontrunner for the position in September, after reports he had met with Trump about the job. In the past, Hahn has served as the chairman of the radiation oncology department at the University of Pennsylvania and as a Commander at the National Cancer Institute, part of the United States Public Health Service.

 Sharpless will immediately return to his previous role as the director of the National Cancer Institute. Until Hahn's position is confirmed, Brett Giroir, MD, of the Department of Health and Human Services, will serve as acting FDA Commissioner. Meanwhile, Gottlieb, who announced his resignation in March and stepped away from office in April, now sits on the board of Pfizer and Aetion Inc.

Once confirmed, Hahn will join an exclusive club as he becomes the FDA’s 24th commissioner and face lofty challenges as the administration attempts to navigate through issues including a historic fight against e-cigarette use in American youths, the growing opioid epidemic, and reports of mysterious vaping illnesses.

Reports from the Washington Post and New York Times noted Hahn has a history of donating to political parties. Specifically, Hahn donated $1000 to the New Pioneers PAC, a Republican committee, in 2017 and for donating smaller denominations to Mitt Romney in 2012 and Rep. John Murtha in 2008.

While Sharpless’s term as acting commissioner expires on November 1, he is expected to maintain the role until Hahn’s appointment is confirmed by the Senate, which could take several weeks or months.

*Editor’s note: This is a breaking news story and will be updated as more information becomes available.

The article titled "Stephen Hahn, MD, Expected to be Named FDA Commissioner" originally appeared on 

Until Hahn's position is confirmed, Brett Giroir, MD, of the Department of Health and Human Services, will serve as acting FDA Commissioner.

Trump Announces Intent to Nominate Stephen Hahn, MD, as New FDA Commissioner

According to a recent study from the University of Michigan, two-thirds of pneumonia patients receive an excessive amount of antibiotic therapy.&#8232;&#8232;

The examination of 43 hospitals in the Michigan Hospital Medicine Safety Consortium also revealed that antibiotics prescribed at discharge from the hospital accounted for 93.2% of the excess duration. &#8232;&#8232;

"Antibiotic stewardship, which includes choosing the right drug and the right duration for each patient, has become a part of most hospitals," said lead author Valerie Vaughn, MD, MSc, assistant professor of internal medicine at the University of Michigan. "But these results show us that we need to pay more attention to stewardship at discharge.”&#8232;

To examine the predictors and outcomes associated with excess duration of antibiotic treatment, investigators conducted a retrospective cohort study on 6481 general care medical patients from 43 hospitals that were discharged between Jan. 2017 and April 2018.

The primary outcome of the study was the rate of excess antibiotic treatment duration, which was defined as excess days per 30-day period. Investigators calculated excess days by subtracting each patient’s shortest effective treatment duration from the actual duration. Negative binomial generalized estimating equations were used to calculate rate ratios in order to assess predictors of 30-day rates of excess duration. &#8232;&#8232;

Patient outcomes were assessed 30 days through medical records and telephone calls. Outcomes were also evaluated using logic generalized estimating equations to adjust for patient characteristics and probability of treatment.

After analyses, investigators found that 4747 (73.2%) patients had community-acquired pneumonia (CAP) and 1734 (26.8%) had health care-associated pneumonia. Two-thirds (4391 of 6481) of patients received antibiotics for longer than the shortest effective duration consistent with guidelines (71.8% [3410 of 4747] for CAP and 56.6% [981 of 1734] for HCAP).

Investigators also found that antibiotics charged at discharge accounted for 49.5% of totals with antibiotic therapy and 93.2% of excess days. Investigators noted that 99.6% of patients had an expected duration of 5 of fewer days, yet the most common duration prescribed at discharge was 5 days.

Additionally, the analyses revealed that each excess day of treatment was associated with a 5% increase in the odds of antibiotic-associated adverse events reported by patients after discharge.

"We have a perfect opportunity to really improve antibiotic use for many patients. If we can improve just one moment in time -- that prescription patients get as they leave the hospital -- we can eliminate nearly all unnecessarily prolonged treatment," Vaugh said.

In a related editorial, Brad Spellberg, MD, of the University of Southern California Medical Center, and Louis Rice, MD, of the Warren Alpert Medical School of Brown University, wrote that the current study highlights the need to adjust practice accordingly for the best interest of patients. &#8232;

“To live up to the expectations that our patients have for us and that we have for one another, we must overcome inertia and tradition and change practice when compelling evidence becomes available,” wrote Spellberg and Rice. “After dozens of RCTs and more than a decade since the initial clarion call to move to short-course therapy, it is time to adapt clinical practice for diseases that have been studied and adopt the mantra ‘shorter is better’.”

This study, titled “Excess Antibiotic Treatment Duration and Adverse Events in Patients Hospitalized With Pneumonia,” was published in the 

The study found that two-thirds of patients receive excess antibiotic treatment and that every excess day increased a patient's risk of adverse events by 5%.

Patrick Campbell

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