Women in cardiology leadership of randomized clinical trials and participation of women in late-breaking clinical trials: Has the COVID-19 pandemic changed a thing or not exactly

Introduction: Despite considerable developments made in the representation of women in cardiology (WIC) recently, there still remain substantial disparities in the representation of women participants in clinical trials, as well as women physicians and scientists in clinical trial leadership. Under-representation of women in Randomized Clinical Trials (RCTs) remains the bane of the modern medicine, impeding the development of sexspecific guidelines in cardiovascular diseases. Female leadership in clinical trials has been shown to enhance the inclusion of women as trial participants. Furthermore, while the COVID-19 pandemic has impacted women in academia, there is no data thus far reporting the impact of the pandemic in terms of presenters and leadership of late-breaking clinical trials (LBCT) in cardiology during this period. Purpose(s): We aimed to determine inclusion of WIC in LBCTs leadership and their correlation to inclusion of women in reported RCTs. Method(s): In our comprehensive analysis, we included all LBCTs presented at major international cardiovascular meetings reported over the period of January 2020 to February 2022. Data were derived from the original presentation at the meeting and/or simultaneous/ subsequent publication of manuscript. Sex of the presenter (woman or man), was assessed by either original videos of the presentation at the meeting, or based on pronoun use in the biographies derived from institutional profiles. The presence or absence of reporting of sex distribution of study participants were also recorded from original presentation at the meeting and/or published manuscript. Proportion of women included in each trial was sourced from either original publication or calculated from any similar data shown during the presentations. Result(s): A total of 400 of RCTs from 19 meetings were included with a total of 400 presenters/principal investigators recorded - 32 (8%) women and 368 (92%) men. There were no significant differences between 2020 and 2021 [15 (7.2%) women in 2021 vs. 17 (19.3%) in 2020 (P=0.446)]. Proportions of women included in RCTs with WIC (37.3%) vs. non-WIC (38.7%) presenters were comparable (p=0.559), while 45% of RCTs didn't report sex distribution of participants. Except for 2 meetings (CRT 2020 and 2022), all others were virtual. Conclusion(s): WIC representation as RCTs presenters was significantly low, despite the opportunity of virtual attendance afforded during the COVID-19 pandemic. Modest inclusion of women irrespective of sex of RCT leadership emphasizes multi-level problems that require more actionable solutions: I.e. implicit bias training started as early as medical school, continuing education on necessity for diversity, equity and inclusion, patient and public involvement, and comprehensive guidance on trial design, such that future RCT participants reflect the populations intended to treat. (Figure Presented).

Women’s health in Serbia – past, present, and future

Cardiovascular and reproductive health of women have been going hand in hand since the dawn of time, however, their links have been poorly studied and once the basis of their connections started to be established in late 20th century, it depended on local regional abilities and the level of progressive thinking to afford comprehensive women’s care beyond the “bikini medicine”. Further research identified different associations rendering more conditions sex-specific and launching therefore a slow, yet initial turn around in clinical trials’ concept as the majority of global cardiovascular guidelines rely on the results of research conducted on a very modest percentage of women and even less on the women of color. Currently, the concept of women’s heart centers varies depending on the local demographics’ guided needs, available logistics driven by budgeting and societal support of a broad-minded thinking environment, free of bias for everyone: from young adults questioning their gender identity, via women of reproductive age both struggling to conceive or keep working part time when healthy and line of work permits it during pregnancy, up to aging and the elderly. Using “Investigate-Educate-Advocate-Legislate” as the four pillars of advancing cardiovascular care of women, we aimed to sum-marize standing of women’s health in Serbia, present ongoing projects and propose actionable solutions for the future. © 2021, Serbia Medical Society. All rights reserved.

Implications of left ventricular function on short-term outcomes in COVID-19 patients with myocardial injury

Background/Introduction: Myocardial injury is a complication of coronavirus disease 2019 (COVID-19). Purpose: We sought to describe a large multi-centre experience of COVID-19 patients with myocardial injury, examining the prognostic role left ventricular function plays on short-term outcomes. Methods: We included adult COVID-19 patients admitted to our health system with evidence of myocardial injury and who underwent a transthoracic echocardiogram (TTE) during index admission. Patients were dichotomized into those with reduced ejection fraction (EF;<50%) and preserved EF (>50%). Results: Across our 11-hospital system, 5032 adult patients were admitted with COVID-19 from March-September 2020. Of these, 235 had evidence of myocardial injury (troponin >1 ng/mL). Included were 134 patients who underwent TTE, of whom 43.3% (n=58) had reduced EF and 56.7% (n=76) preserved EF (Figure 1). A subset of 6 patients had newly reduced EF, with 5 demonstrating evidence of stress cardiomyopathy and subsequently dying. Overall, mortality was high in those with reduced EF and preserved EF (in-hospital: 34.5% vs. 28.9%;p=0.494;6 months: 63.6% vs. 50.0%;p=0.167;Kaplan-Meier estimates: p=0.2886). Readmissions were frequent in both groups (30 days: 22.2% vs. 26.0%;p=0.162;6 months: 52.0% vs. 54.5%;p=0.839) (Figure 2). Conclusions: Many COVID-19 patients admitted with evidence of myocardial injury did not undergo TTE. For those who did, short-term mortality was high. Patients who survived hospitalisation had frequent readmissions. In patients with newly reduced EF, most had evidence of stress cardiomyopathy and expired. Larger studies are needed to fully evaluate the prognosis of COVID-19 patients with evidence of myocardial injury and left ventricular dysfunction.

The evolution of management and outcomes of patients with myocardial injury during the COVID-19 pandemic

Background: Cardiac involvement in coronavirus disease 2019 (COVID- 19) has been established. This is manifested by troponin elevation, and associated with worse prognosis as compared with patients without myocardial injury. Purpose: We sought to evaluate if the outcomes of these patients has improved as experience accumulated during the pandemic. Methods: We analyzed COVID-19-positive patients with the evidence of myocardial injury (defined as troponin elevation) who presented to our large US healthcare system in the northeast region during the Early Phase of the pandemic (March 1-June 30, 2020) and compared their characteristics and outcomes to the COVID-19-positive patients with the presence of troponin elevation in the Current Phase of the pandemic (October 1, 2020-January 31, 2021). Results: The cohort included 788 COVID-19-positive admitted patients for whom troponin was elevated, 167 during the Early Phase and 621 during the Current Phase. The cohort's mean age was 70.2±14.9 years;54.3% were men (Figure 1). Maximum troponin-I in the Early Phase was 13.46±34.72 versus 11.21±20.57 in the Current Phase (p=0.553) In-hospital mortality was significantly higher (50.3%) in the Early Phase group compared to the Current Phase group (24.6%;p<0.001). Similarly, the incidence of intensive care unit admission (77.8% versus 46.1%;p<0.044) and requirement for mechanical ventilation (61.7% versus 28%;p<0.001) were higher in the Early Phase (Figure 2). In addition, 6% of those in the Early Phase underwent coronary angiography compared to 2.3% in the Current Phase (p=0.013). Finally, 3% of Early Phase and 0.8% of Current Phase patients underwent percutaneous coronary intervention (p=0.025). Conclusions: Treatment outcomes have significantly improved since the beginning of the pandemic in COVID-19-positive patients with troponin elevation. This may be attributed to awareness, severity of the disease, improvements in therapies and provider experience.

The Impact of Ejection Fraction on COVID-19 Patients With Myocardial Injury

Background: Coronavirus disease 2019 (COVID-19) has demonstrated deleterious effects on the cardiovascular system, which is associated with worse outcomes. Myocardial injury in COVID-19 is common and, coupled with a reduction in ejection fraction (EF), is concerning for myocarditis. We sought to investigate the outcomes of COVID-19 patients with evidence of myocardial injury and a reduced ejection fraction. Methods: This was a retrospective observational study in which we screened COVID-19-positive patients who presented to the MedStar Health system (11 hospitals in Washington, DC, and Maryland) since the beginning of the COVID-19 pandemic (March-September 2020). We compared patients with a positive troponin (defined as >1.0 ng/mL) and reduced EF (<50%) to those with preserved EF (>50%) examining inpatient outcomes. Results: There were 3386 COVID-19-positive patients admitted to the MedStar system from March through September 2020 in whom a troponin was drawn. Of these, 195 patients had a positive troponin, of whom 105 had a transthoracic echocardiogram (TTE) during admission. There were 41 COVID-19-positive patients with a positive troponin and a reduced EF and 64 COVID-19-positive patients with a positive troponin and a preserved EF (32.4% vs. 60.2%;p=0.0001). Patients with a reduced EF saw higher maximum troponins during their admission (28.1 ng/mL vs. 5.6 ng/mL;p=0.0104), but similar rates of requiring intubation (58.5% vs. 57.8%;p=1.0000), intensive-care-unit length of stay (ICU LOS) (9.4 days vs. 12.1 days;p=0.2978) and inpatient mortality (36.6% vs. 31.3%;p=0.6721). Conclusions: COVID-19 patients with evidence of myocardial injury and reduced EF have higher troponin elevations compared to those with preserved EF but demonstrate similar dismal inpatient outcomes regardless of EF with higher rates of requiring intubation, prolonged ICU LOS, and an inpatient mortality >30%.

Update on the north american covid-19 myocardial infarction (NACMI) registry

Background: The Coronavirus 2019 (COVID-19) pandemic has impacted ST-segment elevation myocardial infarction (STEMI) care, including timely access to primary percutaneous coronary intervention (PPCI). The goal of The North American COVID-19 and STEMI (NACMI) registry is to describe demographic characteristics, management strategies and outcomes of COVID-19 patients with STEMI. Methods: A prospective, ongoing observational registry was created under the guidance of 3 societies. STEMI patients with confirmed COVID + or suspected (person under investigation or PUI) COVID-19 infection were included. A group of age and sex matched STEMI patients (matched to COVID + in a 2:1 ratio) treated in the pre-COVID era (2015-2019) serves as the control group for comparison of treatment strategies and outcomes. The primary outcome was a composite of in-hospital death, stroke, recurrent myocardial infarction or repeat unplanned revascularization. Results: Current enrollment numbers is comprised of 1,507 patients NACMI (301 COVID +, 604 PUIs and 602 controls). COVID + patients were more likely to have minority ethnicity and have diabetes and undergo medical therapy as primary perfusion therapy (all p <0.001 relative to PUI). Among COVID + patients who received angiography, 71% received PPCI and 23% had no culprit vessels identified on angiography (both p <0.001 relative to controls). The primary outcome occurred in 36% of COVID +, 13% of PUI and 5% of control patients (p<0.001 relative to controls). For the Late Breaking presentation, we will update the numbers of enrolment, present new insights into the ethnic differences, explore patient characteristics in those with no culprit disease and hope to present preliminary results from the EKG and angiographic core lab. Conclusions: COVID + patients with STEMI represent a high-risk group of patients with unique demographic and clinical characteristics and high in-hospital cardiac events.