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Women are under-represented as leaders of cardiovascular randomized controlled trials, representing 1 in 10 lead authors of cardiovascular trials published in high-impact journals. Although the proportion of cardiovascular specialists who are women has increased in recent years, the proportion of cardiovascular clinical trialists who are women has not. This gap, underpinned by systemic sexism, has not been adequately addressed. The benefits of diverse randomized controlled trial leadership extend to patients and professionals. In this position statement, we present strategies adopted by some organizations to end gender inequality in research leadership. We offer an actionable roadmap for early-career researchers, scientists, academic institutions, professional societies, trial sponsors, and journals to follow, with the goal of harnessing the strength of women and under-represented groups as research leaders and facilitating a just culture in the cardiovascular clinical trial enterprise.

The WiSE system is a novel, leadless endocardial system that can provide cardiac resynchronization therapy in patients who cannot be treated with a conventional epicardial left ventricular lead. Safety and efficacy were being evaluated in the pivotal, randomized, double-blind SOLVE-CRT Trial (Stimulation of the Left Ventricular Endocardium for Cardiac Resynchronization Therapy.) The trial was initiated in 2018; however, patient enrollment was significantly impacted by the COVID-19 pandemic necessitating a change in design. This article describes the revised trial and the scientific rationale for the specific changes in the protocol.

The specialty of cardio-obstetrics has emerged in response to the rising rates of maternal morbidity and mortality related to cardiovascular disease (CVD) during pregnancy. Women of childbearing age with or at risk for CVD should receive appropriate counseling regarding maternal and fetal risks of pregnancy, medical optimization, and contraception advice. A multidisciplinary cardio-obstetrics team should ensure appropriate monitoring during pregnancy, plan for labor and delivery, and ensure close follow-up during the postpartum period when CVD complications remain common. The hemodynamic changes throughout pregnancy and during labor and delivery should be considered with respect to the individual cardiac disease of the patient. The fourth trimester refers to the 12 weeks after delivery and is a key time to address contraception, mental health, cardiovascular risk factors, and identify any potential postpartum complications. Women with adverse pregnancy outcomes are at increased risk of long-term CVD and should receive appropriate education and longitudinal follow-up.

Heart failure (HF) patients experience a high burden of symptoms and functional limitations, and morbidity and mortality remain high despite successful therapies. The majority of HF drugs in the United States are approved for reducing hospitalization and mortality, while only a few have indications for improving quality of life, physical function, or symptoms. Patient-reported outcomes that directly measure patient's perception of health status (symptoms, physical function, or quality of life) are potentially approvable endpoints in drug development. This paper summarizes the history of endpoints used for HF drug approvals in the United States and reviews endpoints that measure symptoms, physical function, or quality of life in HF patients.

Background. Despite demonstrated efficacy, patient decision aids (DAs) are rarely used in clinical practice in the absence of coverage mandates. Deciding whether to pursue a left ventricular assist device (LVAD) is a major, preference-sensitive decision—ideal for exploring implementation of a DA. Methods. We conducted a type II effectiveness-implementation hybrid trial at 6 LVAD programs using a stepped-wedge cluster-randomized design. Using the RE-AIM framework, we collected both quantitative and qualitative outcomes, including a checklist collected by study staff for each enrolled patient regarding DA use and interviews with LVAD program clinicians preintervention, 6 months postintervention, and at the conclusion of the study. Results. From June 2015 to January 2017, 248 patients and their caregivers were enrolled. A total of 69 interviews were conducted with 48 clinicians at 3 time points. The DA reached 95% of eligible patients. Adoption was 100%, as all sites approached agreed to participate in the trial. Interviews revealed several themes related to the implementation of the DA: clinicians had a strong desire to ensure patients were informed and embraced the DA. Despite this, they reported communication challenges among their team that impeded implementation. Five of the 6 sites have maintained use of the DA following the trial; 1 site reported concerns about decreased procedural volume with use of the DA as a reason for discontinuation. Conclusions. In this hybrid trial, a DA for patients considering LVADs and their caregivers demonstrated high reach. Adoption and implementation were facilitated by a strong desire to ensure that patients were well informed. Future dissemination research and practice should attend to concerns about procedure volume and coverage mandates and facilitate ongoing communication at sites using the DA.

BACKGROUND. The residual lifetime risk (RLR) of developing heart failure (HF) may have changed over time due to the increasing population burden of hypertension, obesity, and diabetes, greater survival after myocardial infarction (MI), and a greater lifespan. OBJECTIVE. We assessed changes in the RLR for HF in two 25-year epochs (1965-1989; 1990-2014). METHODS. We compared the RLR of HF at age 50 (adjusting for competing risk of death) in the two epochs in Framingham Study participants overall, and in the following strata: sex, body mass index (BMI), blood pressure (BP), and diabetes. RESULTS: Mean life expectancy increased from 75.9 to 82.1 years in women and 72.5 to 78.1 years in men. We observed 624 HF events over 111,351 person-observations in epoch 1, and 875 HF events over 128,903 person-observations in epoch 2. The mean age at onset of HF increased across the epochs by 6.6 (women) to 7.7 (men) years. The RLR of HF at age 50 increased across epochs from 18.86 to 22.55 percent (absolute increase 3.69, 95% CI 0.90-6.49, p=0.01) in women, and from 19.19 to 25.25 percent (absolute increase 6.06, 95% CI 3.08-9.04, p

Heart failure (HF) continues to be a major contributor of morbidity and mortality for men and women alike, yet how the predisposition for, course and management of HF differ between men and women remains underexplored. Sex differences in traditional risk factors as well as sex-specific risk factors influence the prevalence and manifestation of HF in unique ways. The pathophysiology of HF differs between men and women and may explain sex-specific differences in clinical presentation and diagnosis. This in turn, contributes to variation in response to both pharmacologic and device/surgical therapy. This review examines sex-specific differences in HF spanning prevalence, risk factors, pathophysiology, presentation, and therapies with a specific focus on highlighting gaps in knowledge with calls to action for future research efforts.

Heart failure (HF) is a leading cause of morbidity and mortality in pregnant women in the United States. Although peripartum cardiomyopathy is the most common diagnosis for pregnant women with HF, women with preexisting cardiomyopathies and systolic dysfunction are also at risk as the hemodynamic demands of pregnancy can lead to decompensation, arrhythmia, and rarely death. The differential diagnosis of HF in pregnancy is broad and includes Takotsubo or stress cardiomyopathy, exacerbation of a preexisting cardiomyopathy, such as familial cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, or left ventricular noncompaction. This review will explore the implications of pregnancy in women with preexisting cardiomyopathies and de novo HF, risk assessment and preconception planning, decisions about contraception, the safety of HF medications and implantable cardioverter-defibrillators during pregnancy, pregnancy in women with left ventricular assist devices and following heart transplantation.

Left ventricular (LV) endocardial pacing is a promising method to deliver cardiac resynchronization therapy (CRT). WiSE-CRT is a wireless LV endocardial pacing system, and delivers ultrasonic energy to an LV electrode.The purpose of this study was to present short-term outcomes with the WiSE-CRT system in centers with no prior implanting experience.Data were prospectively collected from 19 centers where WiSE-CRT systems were implanted during the roll-in phase of the SOLVE-CRT trial. Patients were followed at 1, 3, and 6 months, including transthoracic echo (TTE) at 6 months.The WiSE-CRT was successfully implanted in all 31 attempted cases, and 30 patients completed the 6-month follow-up. One patient underwent heart transplantation 1 month after implantation, and was excluded. Fourteen (46.7%) patients demonstrated ≥1 NYHA class improvement. TTE data were available in 29 patients. LV ejection fraction, LV end-systolic volume, and LV end-diastolic volume improved from 28.3% ± 6.7% to 33.5% ± 6.9% (P.001), 134.9 ± 51.3 mL to 111.1 ± 40.3 mL (P = .0004), and 185.4 ± 58.8 mL to 164.9 ± 50.6 mL (P = .0017), respectively. There were 3 (9.7%) device-related type 1 complications: 1 insufficient LV pacing, 1 embolization of an unanchored LV electrode, and 1 skin infection.We demonstrated a high success rate of LV endocardial electrode placement in centers with no prior implanting experience. Favorable clinical responses in heart failure symptoms and significant LV reverse remodeling were noted.

Shared decision making with patients in advanced heart failure is critical when making decisions on therapies such as left ventricular assist device implantation and cardiac transplantation. We describe a case wherein the risks of coronavirus disease-2019 affected the decision of a patient regarding proceeding with cardiac transplantation. (Level of Difficulty: Beginner.).

Regardless of the cause, the failure of cardiology to attract women when the gender ratio of medical undergraduates is approximately balanced indicates that a substantial proportion of the talent pool is being lost to other specialties. If this is not corrected, it will prove increasingly difficult

BackgroundThe rates of readmission for serious cardiovascular events among patients admitted with a diagnosis of non-specific chest pain are unknown.MethodsA national retrospective cohort study in the United States was undertaken to evaluate the rates, trends and predictors of readmission for serious cardiovascular events (acute coronary syndrome (ACS), pulmonary embolism (PE) and aortic dissection (AD)) after an inpatient episode with a primary diagnosis of non-specific chest pain.ResultsAmong 1,172,430 patients with an index diagnosis of non-specific chest pain between 2010 and 2014, 2.4% were readmitted with an ACS, 0.4% with a PE and 0.06% with an AD within 6 months of discharge. Predictors of ACS readmissions were diabetes (OR 1.49 95% CI 1.17–1.32), coronary artery disease (OR 2.29 95% CI 2.15–2.44), previous percutaneous coronary intervention (OR 1.65 95% CI 1.56–1.75), previous CABG (OR 1.52 95% CI 1.43–1.61) and discharge against medical advice (OR 1.94 95% CI 1.78–2.12). Female patients (OR 0.82 95% CI 0.78–0.86) and patients in whom a coronary angiogram was undertaken (OR 0.48 95% CI 0.45–0.52) were less likely to be readmitted for ACS. For PE, predictors of readmission were pulmonary circulatory disorder (OR 2.20 95% CI 1.09–4.43), anemia (OR 1.62 95% CI 1.40–1.86) and cancer (OR 4.15 95% CI 3.43–5.02). Peripheral vascular disease (OR 8.63 95% CI 5.47–13.60), renal failure (OR 2.08 95% CI 1.34–3.24) were predictors of AD.ConclusionsNon-specific chest pain may not be a benign condition as readmissions for serious cardiovascular events occur in 3% of patients within 180 days. Research is needed to define measures that may mitigate readmissions among these patients.

Background In a conference 2018, Senator Kelleher said she concurred with the statement describing ADMA “…. as a paradigm shift…a major, major culture shift which has yet to work through our societal systems….”(1) In 2016, a senior and manager speech and language therapist (SLT) won the Dementia Elevator Innovation Award with the project “Empowering Persons with Dementia to Become More Active Participants in Decision Making Related to Their Present and Future Needs”. The IASLT Position Statement on the role of the speech and language therapist (SLT) in assessing Capacity and Facilitating Understanding to Support Decision Making for Adults with Communication Disabilities 2017 names training others in assisted decision making as a key SLT role. Talking Mats (TM) (2) may help address some training issues outlined. TM is discussed in NICE-Capacity Guidelines 2018. The Phase 1 project outlined recommends progression to Phase 2. Methods In 2018, the senior SLT trained SLTs working professionally with people with dementia across different service settings. They made a prior commitment to attend and complete the course and to trial TM with people with dementia. Results The Phase 1 report Dec 18 contains 16 brief case studies. Some initial findings: Facilitates strengths rather than deficits.Helpful for assisted decision-making when listeners are trained.Pictures help maintain attention and aid comprehension.Pictorial record of photographed TM viewed very positively, particularly for meetings.Video recording sessions, with consent, greatly enhances reflective practice.It helped address the unmet needs of one person with dementia who presented with responsive behaviour. Conclusion Talking Mats was strongly endorsed by all participants. Recommendations in Phase 1 report 2018 included progressing to Phase 2 i.e. training the six SLTs to become TM trainers and commence cascading through the system. We are currently awaiting funding approval.

Objectives: This study sought to determine clinician and scientist involvement in heart failure (HF) clinical research and to describe the challenges of conducting clinical trials in the Un...

Objectives This study aims to characterize caregivers of patients considering destination therapy left ventricular assist device (DT-LVAD) and evaluate the effectiveness of a shared decision-making (SDM) intervention. Background Caregivers play an integral role in the care of patients with chronic illness. At the extreme, pursuing a DT-LVAD is a major preference-sensitive decision that requires high-level caregiver engagement. Yet, little is known about caregivers of patients considering DT-LVAD, and there is a paucity of research on the involvement of caregivers in medical decision-making. Methods A 6-center, stepped-wedge trial was conducted. After varying time in usual care (control), sites were transitioned to an SDM intervention consisting of staff education and pamphlet and video decision aids (DAs). The primary outcome was decision quality, measured by knowledge and values-choice concordance. Results From 2015 to 2017, 182 caregivers of patients considering DT-LVAD were enrolled (control group, n = 111; intervention group, n = 71). The median age was 61 years, 86.5% were female, and 75.8% were spouses. Caregiver knowledge (0% to 100%) improved from baseline to post-education in both groups: in the control group it improved from 64.2% to 73.3%; in the intervention group it improved from 62.6% to 76.4% (adjusted difference of difference: 4.8%; p = 0.08). At 1 month, correlation between stated values and caregiver-reported treatment choice was stronger in the intervention group (difference in Kendall’s tau: 0.36, 95% confidence interval: 0.04 to 0.71; p = 0.03). Caregivers reported decisional conflict (0 to 100) at baseline (control group: 19.0 ± 2.1; intervention group: 21.4 ± 2.6), which decreased post-education more in the control group (control group: 9.0 ± 1.9, intervention group: 18.8 ± 2.4; p = 0.009). Caregivers in the control group were more likely to “definitely recommend” the educational materials than those in the intervention group (93.5% vs. 74.5%, respectively; p = 0.004). Conclusions An SDM intervention improved concordance between caregiver values and treatment choice for their loved ones but did not significantly impact knowledge. Caregivers found the DAs less acceptable than more biased educational materials and exposure to DAs led to higher conflict initially. These findings highlight the complexity of SDM involving caregivers of patients with chronic illness. (PCORI-1310-06998 Trial of a Decision Support Intervention for Patients and Caregivers Offered Destination Therapy Heart Assist Device [DECIDE-LVAD]; NCT02344576 )

There is growing evidence that rural and racial disparities and social determinants of health (SDOH) impact adverse pregnancy outcomes (APOs) and overall maternal mortality in the United States. These APOs, such as preeclampsia, preterm birth, and intrauterine growth restriction, are in-turn associated with increased risk of future cardiovascular disease (CVD) later in life. Importantly, SDOH such as socioeconomic disadvantages, poor health literacy, transportation barriers, lack of access to adequate health care, food insecurity, and psychosocial stressors have cascading effects on APOs and downstream cardiovascular health. These SDOH are also deeply intertwined with and compounded by existing racial and rural disparities. Pregnancy thus provides a unique opportunity to identify at-risk women from a social determinants perspective, and provide early interventions to optimize long-term CVD and mitigate cardiovascular health disparities. Addressing the challenges posed by these disparities requires a multi-pronged approach and involves national, regional, and individual level solutions. Eliminating disparities will necessitate a nationwide obligation to ensure health care equity via enhanced health insurance coverage, resource investment, and public and clinician accountability.

Discrimination and emotional and sexual harassment create a hostile work environment (HWE). The global prevalence of HWE in cardiology is unknown, as is its impact.This study sought to evaluate emotional harassment, discrimination, and sexual harassment experienced by cardiologists and its impact on professional satisfaction and patient interactions worldwide.The American College of Cardiology surveyed cardiologists from Africa, Asia, the Caribbean, Eastern Europe, the European Union, the Middle East, Oceana, and North, Central, and South America. Demographics, practice information, and HWE were tabulated and compared, and their impact was assessed. The p values were calculated using the chi-square, Fisher exact, and Mann-Whitney U tests. Univariate and multivariate logistic regression analysis determined the association of characteristics with HWE and its subtypes.Of 5,931 cardiologists (77% men; 23% women), 44% reported HWE. Higher rates were found among women (68% vs. 37%; odds ratio [OR]: 3.58 vs. men), Blacks (53% vs. 43%; OR: 1.46 vs. Whites), and North Americans (54% vs. 38%; OR: 1.90 vs. South Americans). Components of HWE included emotional harassment (29%; n = 1,743), discrimination (30%; n = 1,750), and sexual harassment (4%; n = 221), and they were more prevalent among women: emotional harassment (43% vs. 26%), discrimination (56% vs. 22%), and sexual harassment (12% vs. 1%). Gender was the most frequent cause of discrimination (44%), followed by age (37%), race (24%), religion (15%), and sexual orientation (5%). HWE adversely affected professional activities with colleagues (75%) and patients (53%). Multivariate analysis showed that women (OR: 3.39; 95% confidence interval: 2.97 to 3.86; p 0.001) and cardiologists early in their career (OR: 1.27; 95% confidence interval: 1.14 to 1.43; p 0.001) had the highest odds of experiencing HWE.There is a high global prevalence of HWE in cardiology, including discrimination, emotional harassment, and sexual harassment. HWE has an adverse effect on professional and patient interactions, thus confirming concerns about well-being and optimizing patient care. Institutions and practices should prioritize combating HWE.

The specialty of cardio-obstetrics has emerged in response to the rising rates of maternal morbidity and mortality related to cardiovascular disease (CVD) during pregnancy. Women of childbearing age with or at risk for CVD should receive appropriate counseling regarding maternal and fetal risks of pregnancy, medical optimization, and contraception advice. A multidisciplinary cardio-obstetrics team should ensure appropriate monitoring during pregnancy, plan for labor and delivery, and ensure close follow-up during the postpartum period when CVD complications remain common. The hemodynamic changes throughout pregnancy and during labor and delivery should be considered with respect to the individual cardiac disease of the patient. The fourth trimester refers to the 12 weeks after delivery and is a key time to address contraception, mental health, cardiovascular risk factors, and identify any potential postpartum complications. Women with adverse pregnancy outcomes are at increased risk of long-term CVD and should receive appropriate education and longitudinal follow-up.

Introduction: Improvement in social functioning is an important goal for advanced heart failure (HF) patients (pts) who receive left ventricular assist devices (LVADs). Self-reported social functioning and its association with clinical change is understudied. Methods: Adult HF pts who received LVADs at nine U.S. sites completed two measures of social functioning prior to, and 3-6 months after, surgery. Patient-Reported Outcomes Measurement Information System (PROMIS) measures were: Ability to Participate in Social Roles and Activities (Ability) and Satisfaction with Social Roles and Activities (Satisfaction). PROMIS uses T-scores standardized to a U.S. general population (mean=50; standard deviation, SD=10); higher scores represent better outcomes. New York Heart Association (NYHA) Functional Classification was assigned at both times by treating clinicians; change was subsequently categorized as Better, Same or Worse NYHA. Linear mixed effects models and least-squares means were estimated for Ability and Satisfaction. Results: Pts ( n =107) were primarily male (78%) and non-Hispanic White (68%); mean age (SD)=54 (12.5) years; 74% were NYHA Class IV prior to surgery and only 18% were NYHA IV at follow-up. NYHA was better for the majority ( n =75, 70%); 24% ( n =26) were the same, and 6% ( n =6) were worse. Mean Ability and Satisfaction were lower than the general population mean of 50 at both time points (Figure). Ability improved for the NYHA Better ( p p =0.030) groups, and nominally decreased for the Worse group ( p =0.800). Satisfaction improved for the Better ( p p >0.300). Conclusions: Self-reported social functioning measures were responsive to clinician-rated clinical change. Understanding these relationships may guide clinicians in providing targeted health-related quality of life therapies to improve social functioning.

This quality improvement study describes representation of women within leadership committees of clinical trials and in lead authorship positions of ensuing cardiovascular trial publications.