Achieving equitable access to incretin-based therapies in cardiovascular care.

The role of incretin-based therapies, including glucagon-like peptide-1 receptor agonists (GLP1RAs) and dual GLP-1/glucose-dependent insulinotropic polypeptide (GIP) receptor agonists, in the management of type 2 diabetes mellitus (T2DM) and obesity has been increasingly recognized, along with significant cardiovascular (CV) benefits. Despite the clinical efficacy of incretin-based therapies, high costs, suboptimal access, limited insurance coverage, and therapeutic inertia present substantial barriers to widespread adoption. Overcoming these obstacles is essential for the equitable initiation, access, and utilization of incretin-based therapies. Clinicians must make targeted efforts to ensure health equity in the use of these and other advanced therapies.

Public health and system approach in eliminating disparities in hypertensive disorders and cardiovascular outcomes in non-Hispanic Black women across the pregnancy life course.

Hypertension is one of the leading risk factors for cardiovascular disease. The ACC/AHA/Multisociety hypertension guideline covered all aspects of the recommendations for optimal blood pressure diagnosis and management to improve cardiovascular outcomes. Despite this, there remains a growing prevalence of hypertension within the United States, largely in non-Hispanic Black women at earlier stages of their life course. This highlights the evident racial disparities, but offers a targeted opportunity for improved outcomes. With hypertension increasingly seen in the antenatal and immediate postpartum period, and obstetrics societies weighing in on the need to alter pharmacotherapy initiation goals, national initiatives have purposefully targeted pregnant and postpartum women in an effort to improve outcomes. This same energy must also re-focus health care efforts across the entire health continuum. Public health and system strategies are in place to do so, with the strongest enforcing initiatives as early as childhood with a greater focus on primordial prevention.

Tackling the Disproportionate Burden of Resistant Hypertension in US Black Adults.

PURPOSE OF REVIEW: Elevated blood pressure is the leading modifiable risk factor for cardiovascular morbidity and mortality in the US. Older individuals, Black adults, and those with comorbidities such as chronic kidney disease, have higher levels of uncontrolled and resistant hypertension. This review focuses on resistant hypertension, specifically in the US Black population, including potential benefits and limitations of current and investigational agents to address the disparate toll. RECENT FINDINGS: There is a necessity to implement public health measures, including early screening, detection, and evidence-based hypertension treatment with lifestyle, approved and investigational agents. The evidence highlights the importance of implementing feasible and cost-effective public health measures to advocate for early screening, detection, and appropriate treatment of hypertension. A team-based approach involving physicians, advanced practice nurses, physician assistants, pharmacists, social workers, and clinic staff to implement proven approaches and the delivery of care within trusted community settings may mitigate existing disparities.

Asundexian versus Apixaban in Patients with Atrial Fibrillation.

BACKGROUND: Stroke prevention with direct-acting oral anticoagulant agents in patients with atrial fibrillation confers a risk of bleeding and limits their use. Asundexian, an activated factor XI (XIa) inhibitor, is an oral anticoagulant that may prevent strokes with less bleeding. METHODS: In a phase 3, international, double-blind trial, we randomly assigned high-risk patients with atrial fibrillation in a 1:1 ratio to receive asundexian at a dose of 50 mg once daily or standard-dose apixaban. The primary efficacy objective was to determine whether asundexian is at least noninferior to apixaban for the prevention of stroke or systemic embolism. The primary safety objective was to determine whether asundexian is superior to apixaban with respect to major bleeding events. RESULTS: A total of 14,810 randomly assigned patients were included in the intention-to-treat population. The mean (±SD) age of the patients was 73.9±7.7 years, 35.2% were women, 18.6% had chronic kidney disease, 18.2% had a previous stroke or transient ischemic attack, 16.8% had received oral anticoagulants for no more than 6 weeks, and the mean CHA2DS2-VASc score (range, 0 to 9, with higher scores indicating a greater risk of stroke) was 4.3±1.3. The trial was stopped prematurely at the recommendation of the independent data monitoring committee. Stroke or systemic embolism occurred in 98 patients (1.3%) assigned to receive asundexian and in 26 (0.4%) assigned to receive apixaban (hazard ratio, 3.79; 95% confidence interval [CI], 2.46 to 5.83). Major bleeding occurred in 17 patients (0.2%) who received asundexian and in 53 (0.7%) who received apixaban (hazard ratio, 0.32; 95% CI, 0.18 to 0.55). The incidence of any adverse event appeared to be similar in the two groups. CONCLUSIONS: Among patients with atrial fibrillation at risk for stroke, treatment with asundexian at a dose of 50 mg once daily was associated with a higher incidence of stroke or systemic embolism than treatment with apixaban in the period before the trial was stopped prematurely. There were fewer major bleeding events with asundexian than with apixaban during this time. (Funded by Bayer; OCEANIC-AF ClinicalTrials.gov number, NCT05643573; EudraCT number, 2022-000758-28.).

Renal Denervation for the Treatment of Hypertension: A Scientific Statement From the American Heart Association.

Hypertension is a leading risk factor for cardiovascular morbidity and mortality. Despite the widespread availability of both pharmacological and lifestyle therapeutic options, blood pressure control rates across the globe are worsening. In fact, only 23% of individuals with high blood pressure in the United States achieve treatment goals. In 2023, the US Food and Drug Administration approved renal denervation, a catheter-based procedure that ablates the renal sympathetic nerves, as an adjunctive treatment for patients in whom lifestyle modifications and antihypertensive medications do not adequately control blood pressure. This approval followed the publication of multiple randomized clinical studies using rigorous trial designs, all incorporating renal angiogram as the sham control. Most but not all of the new generation of trials reached their primary end point, demonstrating modest efficacy of renal denervation in lowering blood pressure across a spectrum of hypertension, from mild to truly resistant. Individual patient responses vary, and further research is needed to identify those who may benefit most. The initial safety profile appears favorable, and multiple ongoing studies are assessing longer-term efficacy and safety. Multidisciplinary teams that include hypertension specialists and adequately trained proceduralists are crucial to ensure that referrals are made appropriately with full consideration of the potential risks and benefits. Incorporating patient preferences and engaging in shared decision-making conversations will help patients make the best decisions given their individual circumstances. Although further research is clearly needed, renal denervation presents a novel treatment strategy for patients with uncontrolled blood pressure.

Safety and efficacy of aminophylline in the prevention of bradyarrhythmia during coronary atherectomy.

Coronary calcified lesions are commonly encountered and coronary atherectomy is commonly used for lesion modification during percutaneous coronary interventions (PCI). The release of adenosine during atherectomy can result in bradyarrhythmias and aminophylline is commonly used to prevent this reaction. We identified 138 patients to evaluate the safety and efficacy of intravenous (IV) aminophylline administration prior to coronary atherectomy. A total of 159 calcified lesions were treated, and the atherectomy device was orbital atherectomy, rotational atherectomy, and both in 52 %, 42 %, and 6 %; respectively. After administration of aminophylline, 4.3 % of patients required intraprocedural insertion of a transvenous pacer (TVP), and 18.1 % of patients required administration of IV atropine. Technical success was achieved in 98.6 % of patients, and no adverse reactions to aminophylline were reported. All patients survived to discharge. In conclusion, aminophylline administration prior to coronary atherectomy was safe and effective. No adverse effects of aminophylline were seen, and the rate of bailout TVP placement was low.

Transforming Hypertension Diagnosis and Management in The Era of Artificial Intelligence: A 2023 National Heart, Lung, and Blood Institute (NHLBI) Workshop Report.

Hypertension is among the most important risk factors for cardiovascular disease, chronic kidney disease, and dementia. The artificial intelligence (AI) field is advancing quickly, and there has been little discussion on how AI could be leveraged for improving the diagnosis and management of hypertension. AI technologies, including machine learning tools, could alter the way we diagnose and manage hypertension, with potential impacts for improving individual and population health. The development of successful AI tools in public health and health care systems requires diverse types of expertise with collaborative relationships between clinicians, engineers, and data scientists. Unbiased data sources, management, and analyses remain a foundational challenge. From a diagnostic standpoint, machine learning tools may improve the measurement of blood pressure and be useful in the prediction of incident hypertension. To advance the management of hypertension, machine learning tools may be useful to find personalized treatments for patients using analytics to predict response to antihypertension medications and the risk for hypertension-related complications. However, there are real-world implementation challenges to using AI tools in hypertension. Herein, we summarize key findings from a diverse group of stakeholders who participated in a workshop held by the National Heart, Lung, and Blood Institute in March 2023. Workshop participants presented information on communication gaps between clinical medicine, data science, and engineering in health care; novel approaches to estimating BP, hypertension risk, and BP control; and real-world implementation challenges and issues.

A focused update to the 2019 NLA scientific statement on use of lipoprotein(a) in clinical practice.

Since the 2019 National Lipid Association (NLA) Scientific Statement on Use of Lipoprotein(a) in Clinical Practice was issued, accumulating epidemiological data have clarified the relationship between lipoprotein(a) [Lp(a)] level and cardiovascular disease risk and risk reduction. Therefore, the NLA developed this focused update to guide clinicians in applying this emerging evidence in clinical practice. We now have sufficient evidence to support the recommendation to measure Lp(a) levels at least once in every adult for risk stratification. Individuals with Lp(a) levels <75 nmol/L (30 mg/dL) are considered low risk, individuals with Lp(a) levels ≥125 nmol/L (50 mg/dL) are considered high risk, and individuals with Lp(a) levels between 75 and 125 nmol/L (30-50 mg/dL) are at intermediate risk. Cascade screening of first-degree relatives of patients with elevated Lp(a) can identify additional individuals at risk who require intervention. Patients with elevated Lp(a) should receive early, more-intensive risk factor management, including lifestyle modification and lipid-lowering drug therapy in high-risk individuals, primarily to reduce low-density lipoprotein cholesterol (LDL-C) levels. The U.S. Food and Drug Administration approved an indication for lipoprotein apheresis (which reduces both Lp(a) and LDL-C) in high-risk patients with familial hypercholesterolemia and documented coronary or peripheral artery disease whose Lp(a) level remains ≥60 mg/dL [∼150 nmol/L)] and LDL-C ≥ 100 mg/dL on maximally tolerated lipid-lowering therapy. Although Lp(a) is an established independent causal risk factor for cardiovascular disease, and despite the high prevalence of Lp(a) elevation (∼1 of 5 individuals), measurement rates are low, warranting improved screening strategies for cardiovascular disease prevention.

Lipoprotein(a): An important piece of the ASCVD risk factor puzzle across diverse populations.

Elevated lipoprotein(a) (Lp[a]) is an independent, genetic risk factor for atherosclerotic cardiovascular disease (ASCVD) that impacts ~1.4 billion people globally. Generally, Lp(a) levels remain stable over time; thus, most individuals need only undergo Lp(a) testing through a non-fasting blood draw once in their lifetime, unless elevated Lp(a) is identified. Despite the convenience of the test for clinicians and patients, routine Lp(a) testing has not been widely adopted. This review provides a guide to the benefits of Lp(a) testing and solutions for overcoming common barriers in practice, including access to testing and lack of awareness. Lp(a) testing provides the opportunity to reclassify ASCVD risk and drive intensive cardiovascular risk factor management in individuals with elevated Lp(a), and to identify patients potentially less likely to respond to statins. Moreover, cascade screening can help to identify elevated Lp(a) in relatives of individuals with a personal or family history of premature ASCVD. Overall, given the profound impact of elevated Lp(a) on cardiovascular risk, Lp(a) testing should be an essential component of risk assessment by primary and specialty care providers.

Neighborhood-level social determinants of health and cardioprotective behaviors among church members in New Orleans, Louisiana.

BACKGROUND: Favorable neighborhood-level social determinants of health (SDoH) are associated with lower cardiovascular disease risk. Less is known about their influence on cardioprotective behaviors. We evaluated the associations between neighborhood-level SDoH and cardioprotective behaviors among church members in Louisiana. METHODS: Participants were surveyed between November 2021 to February 2022, and were asked about health behaviors, aspects of their neighborhood, and home address (to link to census tract and corresponding social deprivation index [SDI] data). Logistic regression models were used to assess the relation of neighborhood factors with the likelihood of engaging in cardioprotective behaviors: 1) a composite of healthy lifestyle behaviors [fruit and vegetable consumption, physical activity, and a tobacco/nicotine-free lifestyle], 2) medication adherence, and 3) receipt of routine medical care within the past year. RESULTS: Participants (n = 302, mean age: 63 years, 77% female, 99% Black) were recruited from 12 churches in New Orleans. After adjusting for demographic and clinical factors, perceived neighborhood walkability or conduciveness to exercise (odds ratio [OR]=1.25; 95% CI: 1.03, 1.53), availability of fruits and vegetables (OR=1.23; 95% CI: 1.07, 1.42), and social cohesion (OR=1.55; 95% CI: 1.22, 1.97) were positively associated with the composite of healthy lifestyle behaviors. After multivariable adjustment, SDI was in the direction of association with all three cardioprotective behavior outcomes, but associations were not statistically significant. CONCLUSIONS: In this predominantly Black, church-based population, neighborhood-level SDoH including the availability of fruits and vegetables, walkability or conduciveness to exercise, and social cohesion were associated with cardioprotective behaviors. Findings reiterate the need to address adverse neighborhood-level SDoH in the design and implementation of health interventions.

Impact of Antihypertensive Medication Changes After Renal Denervation Among Different Patient Groups: SPYRAL HTN-ON MED.

BACKGROUND: The SPYRAL HTN-ON MED (Global Clinical Study of Renal Denervation With the Symplicity Spyral Multi-electrode Renal Denervation System in Patients With Uncontrolled Hypertension in the Absence of Antihypertensive Medications)trial showed significant office and nighttime systolic blood pressure (BP) reductions in patients with hypertension following renal denervation (RDN) compared with sham-control patients, despite similar 24-hour BP reductions. We compared antihypertensive medication and BP changes among prespecified subpopulations. METHODS: The multicenter, randomized, sham-controlled, blinded SPYRAL HTN-ON MED trial (n=337) evaluated BP changes after RDN compared with a sham procedure in patients with hypertension prescribed 1 to 3 antihypertensive drugs. Most patients (n=187; 54%) were enrolled outside the United States, while 156 (46%) US patients were enrolled, including 60 (18%) Black Americans. RESULTS: Changes in detected antihypertensive drugs were similar between RDN and sham group patients in the outside US cohort, while drug increases were significantly more common in the US sham group compared with the RDN group. Patients from outside the United States showed significant reductions in office and 24-hour mean systolic BP at 6 months compared with the sham group, whereas BP changes were similar between RDN and sham in the US cohort. Within the US patient cohort, Black Americans in the sham control group had significant increases in medication burden from baseline through 6 months (P=0.003) but not in the RDN group (P=0.44). CONCLUSIONS: Patients enrolled outside the United States had minimal antihypertensive medication changes between treatment groups and had significant office and 24-hour BP reductions compared with the sham group. Increased antihypertensive drug burden in the US sham cohort, especially among Black Americans, may have diluted the treatment effect in the combined trial population. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02439775.

Life's essential eight as targets for cardiometabolic risk reduction among non-Hispanic black adults: A primary care approach.

Cardiovascular diseases remain the leading cause of death in the United States. Several studies have shown racial disparities in the cardiovascular outcomes. When compared to their Non-Hispanic White (NHW) counterparts, non-Hispanic Black (NHB) individuals have higher prevalence of cardiovascular risk factors and thus, increased mortality from atherosclerotic cardiovascular diseases. This is evidenced by lower scoring in the indices of the American Heart Association's Life Essential 8 among NHB individuals. NHB individuals score lower in blood pressure, blood lipids, nicotine exposure, sleep, physical activity level, glycemic control, weight, and diet when compared to NHW individuals. Measures to improve these indices at the primary care level may potentially hold the key in mitigating the health care disparities in cardiovascular health experienced by NHB individuals.

Humanistic and Economic Burden of Patients with Cardiorenal Metabolic Conditions: A Systematic Review.

INTRODUCTION: Diabetes is associated with significant economic burden. Moreover, cardiovascular disease (CVD), including heart failure, and chronic kidney disease (CKD) are common comorbidities, leading to premature mortality. We conducted a systematic review to assess the humanistic and economic burden of cardio-renal-metabolic (CRM) conditions in individuals ≥ 18 years with CVD, CKD, and type 2 diabetes mellitus. METHODS: We searched Embase® and Medline® databases from 2011 to January 10, 2022 for English publications reporting humanistic and economic burden outcomes from observational studies, real-world evidence, and economic model studies. Intervention and validation studies were excluded. Study quality was assessed using the Newcastle-Ottawa Scale. Abstracts/posters were identified from four conferences (2020-2022). RESULTS: Of 1804 studies identified, 22 (including four conference publications) were selected involving 351,296,930 participants (one modeled the US population); eight reported healthcare resource utilization (HCRU), seven only cost data, six HCRU and cost data, one reported quality-of-life data (11/18 and 7/18 had estimated low and medium risk of bias, respectively). Participants were predominantly ≥ 65 years and identified as having White ethnicity. Higher costs and HCRU were observed in patients with all three conditions compared to those with two or none. Urban/metropolitan and insured patients had higher healthcare expenditure and service utilization compared to uninsured and racial/ethnic minority populations. Comorbidities were associated with increased hospitalizations, higher costs, and more emergency department visits. In general, patients identified as having Black ethnicity had low odds of using healthcare services, possibly due to disparities in healthcare access and distrust in the system. Limitations included no adjustment for inflation and a predominance of retrospective studies. CONCLUSIONS: This review showed a greater economic burden for patients with CRM conditions, with a clear trend between increasing numbers of comorbidities and increasing healthcare costs/resource use. Comparisons between countries are complicated and the scarcity of evidence from minority racial and ethnic groups and lack of data from non-US geographies warrant further investigation.

Improving Hypertension Control in Vulnerable Populations Around the World.

PURPOSE OF REVIEW: This review aims to describe recent literature, guidelines, and approaches to reveal and reduce hypertension burden in disadvantaged populations. Hypertension is a major global health issue and the most potent risk factor for cardiovascular disease, morbidity, and mortality. It disproportionally affects vulnerable populations, including low-, middle-, and high-income countries. Specifically, the burden of hypertension is higher in US Black adults, and addressing social determinants of health is crucial for reducing disparities among vulnerable populations worldwide. RECENT FINDINGS: Multifactorial approaches, including lifestyle modifications and combination drug therapy, are essential in managing hypertension. Community-based interventions, team-based care, and telehealth strategies can also improve hypertension control. Additionally, renal nerve denervation is a potential treatment for resistant hypertension. Overall, to reduce the global hypertension burden among vulnerable populations, emphasis should be placed on equitable healthcare access and application of evidence-based medicine.

TEXT MY BP MEDS NOLA: A pilot study of text-messaging and social support to increase hypertension medication adherence.

Study objective: Non-Hispanic Black (NHB) adults have high hypertension (HTN) and cardiovascular disease (CVD) burden. Medication nonadherence limits control and self-measured blood pressure (SMBP) improves diagnosis and adherence. This predominantly NHB cohort pilot, via community-clinical linkages, with uncontrolled HTN and low adherence, utilized bidirectional electronic messaging (BEM) with team-care, to assess medication adherence, quality of life, and BP. Setting: Academic clinic and community sources. Design: Recruitment included: uncontrolled HTN (BP ≥130/80 mm Hg), low adherence (Krousel-Wood Medication Adherence Scale (K-Wood-MAS-4) ≥1 score), and smartphone access. Participants and interventions: Participants (N = 36) received validated Bluetooth-enabled BP devices, synced to smartphones, via a secured cloud-based application. Main outcome measures: Demographics, adherence scores, Centers for Disease Control and Prevention (CDC) health-related quality of life (HRQOL-14), BP, body mass index (BMI), 8 weeks daily BEM, SMBP and text responses were obtained. Results: Age was 58.7 ± 12.8 years; BMI 34.8 ± 7.9; 63.9 % female; 88.9 % self-identified NHB adults; 72.2 % with obesity; 74.3 % with diabetes. K-Wood-MAS-4 adherence composite score improved: 2.19 to 1.58 (median -0.5, p = 0.0001). Systolic BP decreased by 10.5 ± 20.0 mm Hg (median -11.0, p = 0.0027). QOL did not significantly change. Mean 7-day average SBP/DBP differences were -4.94 ± 16.82 (median -3.5, p = 0.0285) and -0.17 ± 7.42 (median 0, p = 0.7001), respectively. Social support with taking BP medication was: "yes" (n = 19); 143.8 mm Hg to 131.5 mm Hg (median -12.5, p = 0.0198) and "no" (n = 14); 142.32 mm Hg to 130.25 mm Hg (median -4.0, p = 0.0771). Conclusions: Community-clinical linkages and SMBP with BEM significantly improved medication adherence and SBP without modifying pharmacotherapy.