US County-Level Variation in Preterm Birth Rates, 2007-2019.

Importance: Preterm birth is a leading cause of preventable neonatal morbidity and mortality. Preterm birth rates at the national level may mask important geographic variation in rates and trends at the county level. Objective: To estimate age-standardized preterm birth rates by US county from 2007 to 2019. Design, Setting, and Participants: This serial cross-sectional study used data from the National Center for Health Statistics composed of all live births in the US between 2007 and 2019. Data analyses were performed between March 22, 2022, and September 29, 2022. Main Outcomes and Measures: Age-standardized preterm birth (<37 weeks' gestation) and secondarily early preterm birth (<34 weeks' gestation) rates by county and year calculated with a validated small area estimation model (hierarchical bayesian spatiotemporal model) and percent change in preterm birth rates using log-linear regression models. Results: Between 2007 and 2019, there were 51 044 482 live births in 2383 counties. In 2007, the national age-standardized preterm birth rate was 12.6 (95% CI, 12.6-12.7) per 100 live births. Preterm birth rates varied significantly among counties, with an absolute difference between the 90th and 10th percentile counties of 6.4 (95% CI, 6.2-6.7). The gap between the highest and lowest counties for preterm births was 20.7 per 100 live births in 2007. Several counties in the Southeast consistently had the highest preterm birth rates compared with counties in California and New England, which had the lowest preterm birth rates. Although there was no statistically significant change in preterm birth rates between 2007 and 2019 at the national level (percent change, -5.0%; 95% CI, -10.7% to 0.9%), increases occurred in 15.4% (95% CI, 14.1%-16.9%) of counties. The absolute and relative geographic inequalities were similar across all maternal age groups. Higher quartile of the Social Vulnerability Index was associated with higher preterm birth rates (quartile 4 vs quartile 1 risk ratio, 1.34; 95% CI, 1.31-1.36), which persisted across the study period. Similar patterns were observed for early preterm birth rates. Conclusions and Relevance: In this serial cross-sectional study of county-level preterm and early preterm birth rates, substantial geographic disparities were observed, which were associated with place-based social disadvantage. Stability in aggregated rates of preterm birth at the national level masked increases in nearly 1 in 6 counties between 2007 and 2019.

Characteristics of Clinical Trial Sites for Novel Transcatheter Mitral and Tricuspid Valvular Therapies.

Importance: Racial and ethnic minority and socioeconomically disadvantaged patients have been underrepresented in randomized clinical trials. Efforts have focused on enhancing inclusion of minority groups at sites participating at clinical trials; however, there may be differences in the patient populations of the sites that participate in clinical trials. Objective: To identify any differences in the racial, ethnic, and socioeconomic composition of patient populations among candidate sites in the US that did vs did not participate in trials for novel transcatheter therapies. Design, Setting, and Participants: This cross-sectional analysis used Medicare Provider Claims from 2019 for patients admitted to hospitals in the US. All clinical trials for transcatheter mitral and tricuspid valve therapies and the hospitals participating in each of the trials were identified using ClinicalTrials.gov. Hospitals with active cardiac surgical programs that did not participate in the trials were also identified. Data analysis was performed between July 2021 and July 2022. Exposures: Multivariable linear regression models were used to identify differences in racial, ethnic, and socioeconomic characteristics among patients undergoing cardiac surgery or transcatheter aortic valve replacement at trial vs nontrial hospitals. Main Outcome and Measures: The main outcome of the study was participation in a clinical trial for novel transcatheter mitral or tricuspid valve therapies. Results: A total of 1050 hospitals with cardiac surgery programs were identified, of which 121 (11.5%) participated in trials for transcatheter mitral or tricuspid therapies. Patients treated in trial hospitals had a higher median zip code-based household income (difference of $5261; 95% CI, $2986-$7537), a lower Distressed Communities Index score (difference of 5.37; 95% CI, 2.59-8.15), and no significant difference in the proportion of patients dual eligible for Medicaid (difference of 0.86; 95% CI, -2.38 to 0.66). After adjusting for each of the socioeconomic indicators separately, there was less than 1% difference in the proportion of Black and Hispanic patients cared for at hospitals participating vs not participating in clinical trials. Conclusions and Relevance: In this cohort study among candidate hospitals for clinical trials for transcatheter mitral or tricuspid valve therapies, trial hospitals took care of a more socioeconomically advantaged population than nontrial hospitals, with a similar proportion of Black and Hispanic patients. These data suggest that site selection efforts may improve enrollment of socioeconomically disadvantaged patients but may not improve the enrollment of Black and Hispanic patients.

Best Practices for Designing Informative Trials Including Women.

PURPOSE OF REVIEW: Despite mandates from funding agencies and professional societies to broaden inclusivity in medical research, women remain underrepresented in cardiovascular clinical trials. This lack of representation limits the generalizability of the findings and results in uncertainty about the safety and efficacy of many cardiovascular therapies in female patients. RECENT FINDINGS: Several barriers impact women's participation in clinical trials, including enrollment criteria, common misconceptions, access to tertiary care, and women representation in clinical trial leadership. This short review discusses these barriers and suggests potential solutions to increase women's participation in clinical trials and improve their cardiovascular health.

Becoming a Parent During Cardiovascular Training.

BACKGROUND: Specialty training in cardiovascular diseases is consistently perceived to have adverse job conditions and interfere with family life. There is a dearth of universal workforce support for trainees who become parents during training. OBJECTIVES: This study sought to identify parental policies across cardiovascular training programs internationally. METHODS: An Internet-based international survey study available from August 2020 to October 2020 was sent via social media. The survey was administered 1 time and anonymously. Participants shared experiences regarding parental benefits/policies and perception of barriers for trainees. Participants were divided into 3 groups: training program directors, trainees pregnant during cardiology fellowship, and trainees not pregnant during training. RESULTS: A total of 417 replies were received from physicians, including 47 responses (11.3%) from training program directors, 146 responses (35%) from current or former trainees pregnant during cardiology training, and 224 responses (53.7%) from current or former trainees that were not pregnant during cardiology training. Among trainees, 280 (67.1%) were parents during training. Family benefits and policies were not uniformly available across institutions, and knowledge regarding the existence of such policies was low. Average parental leave ranged from 1 to 2 months in the United States compared with >4 months outside the United States, and in all countries, paternity leave was uncommon (only 11 participants [2.6%]). Coverage during family leave was primarily provided by peers (n = 184 [44.1%]), and 168 (91.3%) were without additional monetary or time compensation. CONCLUSIONS: This is the first international survey evaluating and comparing parental benefits and policies among cardiovascular training programs. There is great variability among institutions, highlighting disparities in real-world experiences.

Impact of prior oral anticoagulant use and outcomes on patients from secondary analysis in the AUGUSTUS trial.

OBJECTIVE: Managing antithrombotic therapy in patients with atrial fibrillation (AF) and an acute coronary syndrome (ACS) and/or percutaneous coronary intervention (PCI) is challenging and can be affected by prior oral anticoagulant (OAC) treatment. We examined the relationship between prior OAC use and outcomes in the AUGUSTUS trial. METHODS: This prespecified secondary analysis is from AUGUSTUS, an open-label, 2-by-2 factorial, RCT to evaluate the safety of apixaban versus vitamin K antagonist (VKA) and aspirin versus placebo in patients with AF and ACS and/or PCI. The primary endpoint, major or clinically relevant non-major bleeding and clinical outcomes were compared in patients receiving (n=2262) or not receiving (n=2352) an OAC prior to enrolment. RESULTS: Patients with prior OAC use had more comorbidities, higher CHA2DS2-VASC and HAS-BLED scores, and were more likely enrolled following elective PCI. There was no difference in major or clinically relevant non-major bleeding with or without prior OAC (30 days: 5.1% vs 5.9% (adjusted HR (aHR) 0.82, 95% CI 0.63 to 1.06); 180 days: 13.5% vs 13.5% (aHR 0.98, 95% CI 0.83 to 1.16)). Patients with prior OAC use had a lower risk of death or ischaemic events (30 days: 1.7% vs 2.8% (aHR 0.61, 95% CI 0.41 to 0.92); 180 days: 5.4% vs 7.6% (aHR 0.70, 95% CI 0.55 to 0.88)). No interactions between randomised treatment (apixaban vs VKA, aspirin vs placebo) and prior OAC status were observed for outcomes, apart from apixaban (vs VKA) being associated with a lower risk of myocardial infarction with prior OAC use (180 days: 2.0% vs 3.7% (aHR 0.56, 95% CI 0.33 to 0.91(). CONCLUSIONS: In AUGUSTUS, prior OAC use was associated with fewer ischaemic events but not more bleeding. In patients with AF and ACS and/or undergoing PCI, clinicians can be assured that the trial results can be applied to patients regardless of their prior OAC status. TRIAL REGISTRATION NUMBER: NCT02415400.

Gender Differences in Medicare Payments Among Cardiologists.

Importance: Women cardiologists receive lower salaries than men; however, it is unknown whether US Centers for Medicare & Medicaid Services (CMS) reimbursement also differs by gender and contributes to the lower salaries. Objective: To determine whether gender differences exist in the reimbursements, charges, and reimbursement per charge from CMS. Design, Setting, and Participants: This cross-sectional analysis used the CMS database to obtain 2016 reimbursement data for US cardiologists. These included reimbursements to cardiologists, charges submitted, and unique billing codes. Gender differences in reimbursement for evaluation and management and procedural charges from both inpatient and outpatient settings were also assessed. Analysis took place between April 2019 and December 2020. Main Outcomes and Measures: Outcomes included median CMS payments received and median charges submitted in the inpatient and outpatient settings in 2016. Results: In 2016, 17 524 cardiologists (2312 women [13%] and 15 212 men [87%]) received CMS payments in the inpatient setting, and 16 929 cardiologists (2151 women [13%] and 14 778 men [87%]) received CMS payments in the outpatient setting. Men received higher median payments in the inpatient (median [interquartile range], $62 897 [$30 904-$104 267] vs $45 288 [$21 371-$73 191]; P < .001) and outpatient (median [interquartile range], $91 053 [$34 820-$196 165] vs $51 975 [$15 622-$120 175]; P < .001) practice settings. Men submitted more median charges in the inpatient (median [interquartile range], 1190 [569-2093] charges vs 959 [569-2093] charges; P < .001) and outpatient settings (median [interquartile range], 1685 [644-3328] charges vs 870 [273-1988] charges; P < .001). In a multivariable-adjusted linear regression analysis, women received less CMS payments compared with men (log-scale ß = -0.06; 95% CI, -0.11 to -0.02) after adjustment for number of charges, number of unique billing codes, complexity of patient panel, years since graduation of physicians, and physician subspecialty. Payment by billing codes, both inpatient and outpatient, did not differ by gender. Conclusions and Relevance: There may be potential differences in CMS payments between men and women cardiologists, which appear to stem from gender differences in the number and types of charges submitted. The mechanisms behind these differences merit further research, both to understand why such gender differences exist and also to facilitate reductions in pay disparities.

Sex-Based Differences in Bleeding Risk After Percutaneous Coronary Intervention and Implications for the Academic Research Consortium High Bleeding Risk Criteria.

Background Female sex was not included among the high bleeding risk (HBR) criteria by the Academic Research Consortium (ARC) as it remains unclear whether it constitutes an HBR condition after percutaneous coronary intervention. We investigated whether female sex associates with HBR and assessed the performance of ARC HBR criteria separately in women and men. Methods and Results Among all consecutive patients undergoing percutaneous coronary intervention between 2009 and 2018, bleeding occurrences up to 1 year were prospectively collected and centrally adjudicated. All but one of the originally defined ARC HBR criteria were assessed, and the ARC HBR score generated accordingly. Among 16 821 patients, 25.6% were women. Compared with men, women were older and had lower creatinine clearance and hemoglobin values. After adjustment, female sex was independently associated with access-site (adjusted hazard ratio, 2.14; 95% CI, 1.22-3.74; P=0.008) but not with overall or non-access-site 1-year Bleeding Academic Research Consortium 3 or 5 bleeding. This association remained consistent when the femoral but not the radial approach was chosen. The ARC HBR score discrimination, using the original criteria, was lower among women than men (c-index 0.644 versus 0.688; P=0.048), whereas a revised ARC HBR score, in which age, creatinine clearance, and hemoglobin were modeled as continuous rather than dichotomized variables, performed similarly in both sexes. Conclusions Female sex is an independent predictor for access-site bleeding but not for overall bleeding events at 1 year after percutaneous coronary intervention. The ARC HBR framework shows an overall good performance in both sexes, yet is lower in women than men, attributable to dichotomization of age, creatinine clearance, and hemoglobin values, which are differently distributed between sexes. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT02241291.

Impact of Chronic Kidney Disease on Revascularization and Outcomes in Patients with ST-Elevation Myocardial Infarction.

Chronic kidney disease (CKD) in patients with ST-elevation myocardial infarction (STEMI) is associated with worse outcomes. We assessed the impact of CKD on guideline directed coronary revascularization and outcomes among STEMI patients. The Nationwide Inpatient Sample dataset from 2012-2014 was used to identify patients with STEMI using International Classification of Diseases, Ninth Revision, Clinical Modification codes. Patients were categorized as non-CKD, CKD without dialysis, and CKD with dialysis (CKD-HD). Outcomes were revascularization, death and acute renal failure requiring dialysis (ARFD). A total of 534,845 were included (88.9% non-CKD; 9.6% CKD without dialysis, and 1.5% CKD-HD). PCI was performed in 77.4% non-CKD, 56.2% CKD without dialysis, and 48% CKD-HD patients (p < 0.0001). In-hospital mortality and ARFD were significantly higher in CKD patients (16.5% and 40.6%) compared with non-CKD patients (7.12% and 7.17%) (p < 0.0001). In-hospital mortality was significantly lower in patients treated revascularization compared with patients treated medically (non-CKD: adjusted odds ratio (aOR) 0.280, p < 0.0001; CKD without dialysis: aOR 0.39, p < 0.0001; CKD-HD: aOR 0.48, p < 0.0001). CKD was associated with higher length of hospital stay and cost (5.86 ± 13.97, 7.57 ± 26.06 and 3.99 ± 11.09 days; p < 0.0001; $25,696 ± $63,024, $35,666 ± $104,940 and $23,264 ± $49,712; p < 0.0001 in non-CKD, CKD without dialysis and CKD-HD patients respectively). In conclusion, CKD patients with STEMI receive significantly less PCI compared with patients without CKD. Coronary revascularization for STEMI in CKD patients was associated with lower mortality compared to medical management. The presence of CKD in patients with STEMI is associated with higher mortality and ARFD, prolonged hospital stay and higher hospital cost.

The Lancet women and cardiovascular disease Commission: reducing the global burden by 2030.

Cardiovascular disease is the leading cause of death in women. Decades of grassroots campaigns have helped to raise awareness about the impact of cardiovascular disease in women, and positive changes affecting women and their health have gained momentum. Despite these efforts, there has been stagnation in the overall reduction of cardiovascular disease burden for women in the past decade. Cardiovascular disease in women remains understudied, under-recognised, underdiagnosed, and undertreated. This Commission summarises existing evidence and identifies knowledge gaps in research, prevention, treatment, and access to care for women. Recommendations from an international team of experts and leaders in the field have been generated with a clear focus to reduce the global burden of cardiovascular disease in women by 2030. This Commission represents the first effort of its kind to connect stakeholders, to ignite global awareness of sex-related and gender-related disparities in cardiovascular disease, and to provide a springboard for future research.

Design and rationale of the XIENCE short DAPT clinical program: An assessment of the safety of 3-month and 1-month DAPT in patients at high bleeding risk undergoing PCI with an everolimus-eluting stent.

Dual antiplatelet therapy (DAPT) is key for the prevention of recurrent ischemic events after percutaneous coronary intervention (PCI); however, it increases the risk of bleeding complications. While new generation drug-eluting stents have been shown superior to bare-metal stents after a short DAPT course, the optimal DAPT duration in patients at high bleeding risk (HBR) remains to be determined. TRIAL DESIGN: The XIENCE Short DAPT program consists of three prospective, single-arm studies (XIENCE 90, XIENCE 28 Global and XIENCE 28 USA) investigating 3- or 1-month DAPT durations in HBR patients undergoing PCI with the XIENCE stent. The XIENCE 90 study is being conducted in the US and enrolled 2047 subjects who discontinued DAPT at 3 months if they were free from myocardial infarction (MI), repeat coronary revascularization, stroke, or stent thrombosis. The XIENCE 28 program includes the USA study, enrolling 642 patients in US and Canada, and the Global study, enrolling 963 patients in Europe and Asia. In XIENCE 28, patients were to discontinue DAPT at 1 month post-PCI if event-free. The primary hypothesis for both XIENCE 90 and XIENCE 28 is that a short DAPT regimen will be non-inferior to a conventional DAPT duration with respect to the composite of all-cause death or MI. Patients enrolled in the prospective multicenter post-market XIENCE V USA study will be used as historical control group in a stratified propensity-adjusted analysis. CONCLUSIONS: The XIENCE Short DAPT Program will provide insights into the safety and efficacy of 2 abbreviated DAPT regimens of 3- and 1-month duration in a large cohort of HBR patients undergoing PCI with the XIENCE stent.

Reducing the cost of managing patients with atrial fibrillation undergoing percutaneous coronary intervention with stenting.

Patients undergoing percutaneous coronary intervention (PCI) have an increased risk of both ischemic events and bleeding complications resulting from antithrombotic therapy. These events are particularly common in patients with a concomitant indication for oral anticoagulation, such as those with atrial fibrillation, and are associated with a substantial healthcare resource burden. Advances in procedural aspects of PCI have led to marked improvements in outcomes and a consequent reduction in the costs resulting from PCI-associated complications. Furthermore, recent randomized clinical trials have investigated the optimal antithrombotic strategy in the specific case of patients with atrial fibrillation undergoing PCI, leading to a shift toward the tailoring of antithrombotic therapy according to the patient's individual stroke and bleeding risks. Here we review these recent advances, with a particular focus on the improvements in antithrombotic strategies offered by the non-vitamin K antagonist oral anticoagulants.

Lipid Management in Patients Presenting With Acute Coronary Syndromes: A Review.

Despite many improvements in its prevention and management, acute coronary syndrome (ACS) remains a major cause of morbidity and mortality in the developed world. Lipid management is an important part of secondary prevention after ACS, but many patients currently remain undertreated and do not attain guideline-recommended levels of low-density lipoprotein cholesterol reduction. This review details the current state of evidence on lipid management in patients presenting with ACS, provides directions for identification of patients who may benefit from early escalation of lipid-lowering therapy, and discusses novel lipid-lowering medication that is currently under investigation in clinical trials. Moreover, a treatment algorithm aimed at attaining guideline-recommended low-density lipoprotein cholesterol levels is proposed. Despite important advances in the initial treatment and secondary prevention of ACS, ≈20% of ACS survivors experience a subsequent ischemic cardiovascular event within 24 months, and 5-year mortality ranges from 19% to 22%. Knowledge of the current state of evidence-based lipid management after ACS is of paramount importance to improve outcomes after ACS.

The urgent need for integrated science to fight COVID-19 pandemic and beyond.

The COVID-19 pandemic has become the leading societal concern. The pandemic has shown that the public health concern is not only a medical problem, but also affects society as a whole; so, it has also become the leading scientific concern. We discuss in this treatise the importance of bringing the world's scientists together to find effective solutions for controlling the pandemic. By applying novel research frameworks, interdisciplinary collaboration promises to manage the pandemic's consequences and prevent recurrences of similar pandemics.

Gender differences in industry payments among cardiologists.

BACKGROUND: There is a wage gap among men and women practicing cardiology. Differences in industry funding can be both a consequence of and a contributor to gender differences in salaries. We sought to determine whether gender differences exist in the distribution, types, and amounts of industry payments among men and women in cardiology. METHODS: In this cross-sectional analysis, we used the Centers for Medicare & Medicaid Services Open Payment program database to obtain 2016 industry payment data for US cardiologists. We also used UK Disclosure data to obtain 2016 industry payments to UK cardiologists. Outcomes included the proportions of male and female cardiologists receiving industry funding and the mean industry payment amounts received by male and female cardiologists. Where possible, we also assessed 2014 and 2015 data in both locations. RESULTS: Of the 22,848 practicing Centers for Medicare & Medicaid Services US cardiologists in 2016, 20,037 (88%) were men and 2,811 (12%) were women. Proportionally more men than women received industry payments in 2016 (78.0% vs 68.5%, respectively; P < .001). Men received higher overall mean industry payments than women ($6,193.25 vs. $2,501.55, P < .001). Results were similar in 2014 and 2015. Among UK cardiologists, more men (24.4%) than women (13.5%) received industry payments in 2016 (P < .001). However, although the difference in overall industry payments was numerically larger among men compared to women, this did not achieve statistical significance (£2,348.31 vs £1,501.37, respectively, P = .35). CONCLUSIONS: Industry payments to cardiologists are common, and there are gender differences in these payments on both sides of the Atlantic.

Trends and Outcomes of Intravascular Imaging-guided Percutaneous Coronary Intervention in the United States.

INTRODUCTION: Intravascular imaging-guided percutaneous coronary intervention (PCI) has shown to improve outcomes in randomized controlled trials. However, there are little real-world data about intravascular imaging utilization during PCI and its outcomes in the United States. METHODS: We conducted an observational analysis on the use of intravascular imaging (Intravascular Ultrasound or Optical Coherence Tomography)-guided PCI in 2,425,036 patients undergoing PCI between January 2010 and December 2014 from the Nationwide Inpatient Sample database. Utilizing propensity score matching, 83,988 matched pairs were identified. The primary outcome was in-hospital mortality. The secondary outcomes included cardiogenic shock and acute kidney injury. RESULTS: Among the 2,425,036 patients, 161,808 (6.7%) underwent imaging-guided PCI. Use of imaging-guidance increased from 6% in 2010 to 6.6% in 2014 (Ptrend < 0.001). The in-hospital mortality was significantly different between imaging-guided PCI and angiography-guided PCI [1.0% vs. 1.5%; adjusted OR: 0.67; 95% confidence interval (CI): 0.54-0.83, P < 0.001]. The rates of cardiogenic shock (2.5% vs. 3.1%; adjusted OR: 0.78; 95% CI: 0.66-0.93; P = 0.005) were significantly lower in imaging-guided PCI group and acute kidney injury rates (7.0% vs. 7.1%; adjusted OR: 0.99; 95% CI: 0.89-1.12; P = 0.919) were not significantly different. CONCLUSIONS: Imaging-guided PCI is associated with lower in-hospital mortality. Yet, a small proportion of patients undergoing PCI have imaging-guidance.

Aortic Valve Stenosis Treatment Disparities in the Underserved: JACC Council Perspectives.

Underserved minorities make up a disproportionately small subset of patients in the United States undergoing transcatheter and surgical aortic valve replacement for aortic stenosis. The reasons for these treatment gaps include differences in disease prevalence and patient, health care system, and disease-related factors. This has major implications not only for minority patients, but also for other groups who face similar challenges in accessing state-of-the-art care for structural heart disease. The authors propose the following key strategies to address these treatment disparities: 1) implementation of measure-based quality improvement programs; 2) effective culturally competent communication and team-based care; 3) improving patient health care access, education, and effective diagnosis; and 4) changing the research paradigm that creates an innovation pipeline for patients. Only a concerted effort from all stakeholders will achieve equitable and broad application of this and other novel structural heart disease treatment modalities in the future.