Shared Decision-Making and Cardiovascular Health: A Scientific Statement From the American Heart Association.

Shared decision-making is increasingly embraced in health care and recommended in cardiovascular guidelines. Patient involvement in health care decisions, patient-clinician communication, and models of patient-centered care are critical to improve health outcomes and to promote equity, but formal models and evaluation in cardiovascular care are nascent. Shared decision-making promotes equity by involving clinicians and patients, sharing the best available evidence, and recognizing the needs, values, and experiences of individuals and their families when faced with the task of making decisions. Broad endorsement of shared decision-making as a critical component of high-quality, value-based care has raised our awareness, although uptake in clinical practice remains suboptimal for a range of patient, clinician, and system issues. Strategies effective in promoting shared decision-making include educating clinicians on communication techniques, engaging multidisciplinary medical teams, incorporating trained decision coaches, and using tools (ie, patient decision aids) at appropriate literacy and numeracy levels to support patients in their cardiovascular decisions. This scientific statement shines a light on the limited but growing body of evidence of the impact of shared decision-making on cardiovascular outcomes and the potential of shared decision-making as a driver of health equity so that everyone has just opportunities. Multilevel solutions must align to address challenges in policies and reimbursement, system-level leadership and infrastructure, clinician training, access to decision aids, and patient engagement to fully support patients and clinicians to engage in the shared decision-making process and to drive equity and improvement in cardiovascular outcomes.

Psychological Health and Ischemic Heart Disease in Women: A Review of Current Evidence and Clinical Considerations across the Healthspan.

PURPOSE OF REVIEW: Psychological health encompasses a constellation of negative and positive factors-i.e., psychosocial stress, depression, anxiety, trauma, loneliness and social isolation, anger and hostility, optimism, and a sense of purpose. This narrative review presents current evidence at the intersection of psychological health, risk of ischemic heart disease (IHD), and IHD-related outcomes, with an emphasis on associations in women. RECENT FINDINGS: For women, relations between psychological health and IHD reflect important sex and gender differences in biological and psychosocial factors. Although efforts devoted to understanding psychological health and IHD risk have varied by psychological factor-scientific evidence is strongest for psychosocial stress and depression, while anxiety, trauma, and positive psychological factors warrant more investigation-less optimal psychological health is consistently associated with an earlier and greater risk of IHD morbidity and mortality in women. Still, many past prospective studies of psychological factors and IHD risk had a limited representation of women, did not include analyses by sex, or failed to account for other influential, sex-specific factors. Thus, there are multiple pathways for further, rigorous investigation into psychological health-IHD associations, mechanisms, and empirically supported psychological interventions to mitigate IHD risk among women. Given the robust evidence linking psychological health with women's risk for IHD, implementing routine, brief, psychological screening is recommended. Significant life events, developmental milestones specific to women, and IHD diagnoses or events could cue further psychological assessment and referral, efforts which will mutually strengthen the evidence for integrated psychological and IHD care and delivery of such care to this vulnerable group.

Predictors of Health-Related Quality of Life Among Women Participating in an Appointment-Based Cardiac Rehabilitation Program.

BACKGROUND: An alternative patient-centered appointment-based cardiac rehabilitation (CR) program has led to significant improvements in health outcomes for patients with cardiovascular disease. However, less is known about the effects of this approach on health-related quality of life (HRQoL), particularly for women. OBJECTIVE: We examined the effects of a patient-centered appointment-based CR program on HRQoL by sex and examined predictors of HRQoL improvements specifically for women. METHODS: Data were used from an urban single-center CR program at Yale New Haven Health (2012-2017). We collected information on patient demographics, socioeconomic status, and clinical characteristics. The Outcome Short-Form General Health Survey (SF-36) was used to measure HRQoL. We evaluated sex differences in SF-36 scores using t tests and used a multivariate linear regression model to examine predictors of improvements in HRQoL (total SF-36 score) for women. RESULTS: A total of 1530 patients with cardiovascular disease (23.7% women, 4.8% Black; mean age, 64 ± 10.8 years) were enrolled in the CR program. Women were more likely to be older, Black, and separated, divorced, or widowed. Although women had lower total SF-36 scores on CR entry, there was no statistically significant difference in CR adherence or total SF-36 score improvements between sexes. Women who were employed and those with chronic obstructive pulmonary disease were more likely to have improvements in total SF-36 scores. CONCLUSION: Both men and women participating in an appointment-based CR program achieved significant improvements in HRQoL. This approach could be a viable alternative to conventional CR to optimize secondary outcomes for patients.

Three-Month Symptom Profiles Among Symptomatic Adults With Positive and Negative Severe Acute Respiratory Syndrome Coronavirus 2 Tests: A Prospective Cohort Study From the INSPIRE Group.

BACKGROUND: Long-term symptoms following severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection are a major concern, yet their prevalence is poorly understood. METHODS: We conducted a prospective cohort study comparing adults with SARS-CoV-2 infection (coronavirus disease-positive [COVID+]) with adults who tested negative (COVID-), enrolled within 28 days of a Food and Drug Administration (FDA)-approved SARS-CoV-2 test result for active symptoms. Sociodemographic characteristics, symptoms of SARS-CoV-2 infection (assessed with the Centers for Disease Control and Prevention [CDC] Person Under Investigation Symptom List), and symptoms of post-infectious syndromes (ie, fatigue, sleep quality, muscle/joint pains, unrefreshing sleep, and dizziness/fainting, assessed with CDC Short Symptom Screener for myalgic encephalomyelitis/chronic fatigue syndrome) were assessed at baseline and 3 months via electronic surveys sent via text or email. RESULTS: Among the first 1000 participants, 722 were COVID+ and 278 were COVID-. Mean age was 41.5 (SD 15.2); 66.3% were female, 13.4% were Black, and 15.3% were Hispanic. At baseline, SARS-CoV-2 symptoms were more common in the COVID+ group than the COVID- group. At 3 months, SARS-CoV-2 symptoms declined in both groups, although were more prevalent in the COVID+ group: upper respiratory symptoms/head/eyes/ears/nose/throat (HEENT; 37.3% vs 20.9%), constitutional (28.8% vs 19.4%), musculoskeletal (19.5% vs 14.7%), pulmonary (17.6% vs 12.2%), cardiovascular (10.0% vs 7.2%), and gastrointestinal (8.7% vs 8.3%); only 50.2% and 73.3% reported no symptoms at all. Symptoms of post-infectious syndromes were similarly prevalent among the COVID+ and COVID- groups at 3 months. CONCLUSIONS: Approximately half of COVID+ participants, as compared with one-quarter of COVID- participants, had at least 1 SARS-CoV-2 symptom at 3 months, highlighting the need for future work to distinguish long COVID. CLINICAL TRIALS REGISTRATION: NCT04610515.

Severe Fatigue and Persistent Symptoms at 3 Months Following Severe Acute Respiratory Syndrome Coronavirus 2 Infections During the Pre-Delta, Delta, and Omicron Time Periods: A Multicenter Prospective Cohort Study.

BACKGROUND: Most research on severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants focuses on initial symptomatology with limited longer-term data. We characterized prevalences of prolonged symptoms 3 months post-SARS-CoV-2 infection across 3 variant time-periods (pre-Delta, Delta, and Omicron). METHODS: This multicenter prospective cohort study of adults with acute illness tested for SARS-CoV-2 compared fatigue severity, fatigue symptoms, organ system-based symptoms, and ≥3 symptoms across variants among participants with a positive ("COVID-positive") or negative SARS-CoV-2 test ("COVID-negative") at 3 months after SARS-CoV-2 testing. Variant periods were defined by dates with ≥50% dominant strain. We performed multivariable logistic regression modeling to estimate independent effects of variants adjusting for sociodemographics, baseline health, and vaccine status. RESULTS: The study included 2402 COVID-positive and 821 COVID-negative participants. Among COVID-positives, 463 (19.3%) were pre-Delta, 1198 (49.9%) Delta, and 741 (30.8%) Omicron. The pre-Delta COVID-positive cohort exhibited more prolonged severe fatigue (16.7% vs 11.5% vs 12.3%; P = .017) and presence of ≥3 prolonged symptoms (28.4% vs 21.7% vs 16.0%; P < .001) compared with the Delta and Omicron cohorts. No differences were seen in the COVID-negatives across time-periods. In multivariable models adjusted for vaccination, severe fatigue and odds of having ≥3 symptoms were no longer significant across variants. CONCLUSIONS: Prolonged symptoms following SARS-CoV-2 infection were more common among participants infected during pre-Delta than with Delta and Omicron; however, these differences were no longer significant after adjusting for vaccination status, suggesting a beneficial effect of vaccination on risk of long-term symptoms. Clinical Trials Registration. NCT04610515.

Physician responses to apple watch-detected irregular rhythm alerts.

BACKGROUND: While the US Food and Drug Administration (FDA) has cleared smartwatch software for detecting atrial fibrillation (AF), there is lack of guidance on management by physicians. We sought to evaluate the approach to management of Apple Watch alerts for AF by physicians and assess whether respondent and case characteristics were associated with their approach. METHODS: We conducted a case-based survey of physicians practicing primary care, emergency medicine, and cardiology at 2 large academic centers (Yale and University of California San Francisco) between September and December 2021. Cases described asymptomatic patients receiving Apple Watch AF alerts; cases varied in sex, race, medical history, and notification frequency. We evaluated physician responses among prespecified diagnostic testing, referral, and treatment options. RESULTS: We emailed 636 physicians, of whom 95 (14.9%) completed the survey, including 39 primary care, 25 emergency medicine, and 31 cardiology physicians. Among a total of 192 cases (16 unique scenarios), physicians selected at least one diagnostic test in 191 (99.5%) cases and medications in 48 (25.0%). Physicians in primary care, emergency medicine, and cardiology reported varying preference for patient referral (14%, 30%, and 16%, respectively; P=.048), rhythm monitoring (84%, 46%, and 94%, respectively; P<.001), measurement of BNP (8%, 20%, and 2%; P=.003), and use of antiarrhythmics (16%, 4%, and 23%; P=.023). There were few physician differences in reported practices across patient demographics (sex and race), clinical complexity, and alert frequency of the clinical case. CONCLUSIONS: In hypothetical cases of patients presenting without clinical symptoms, physicians opted for further diagnostic testing and often to medical intervention based on Apple Watch irregular rhythm notifications. There was also considerable variation across physician specialties, suggesting a need for uniform clinical practice guidelines. Additional study is required before irregular rhythm notifications should be used in clinical settings.

Prevalence of Symptoms ≤12 Months After Acute Illness, by COVID-19 Testing Status Among Adults - United States, December 2020-March 2023.

To further the understanding of post-COVID conditions, and provide a more nuanced description of symptom progression, resolution, emergence, and reemergence after SARS-CoV-2 infection or COVID-like illness, analysts examined data from the Innovative Support for Patients with SARS-CoV-2 Infections Registry (INSPIRE), a prospective multicenter cohort study. This report includes analysis of data on self-reported symptoms collected from 1,296 adults with COVID-like illness who were tested for SARS-CoV-2 using a Food and Drug Administration-approved polymerase chain reaction or antigen test at the time of enrollment and reported symptoms at 3-month intervals for 12 months. Prevalence of any symptom decreased substantially between baseline and the 3-month follow-up, from 98.4% to 48.2% for persons who received a positive SARS-CoV-2 test results (COVID test-positive participants) and from 88.2% to 36.6% for persons who received negative SARS-CoV-2 test results (COVID test-negative participants). Persistent symptoms decreased through 12 months; no difference between the groups was observed at 12 months (prevalence among COVID test-positive and COVID test-negative participants = 18.3% and 16.1%, respectively; p>0.05). Both groups reported symptoms that emerged or reemerged at 6, 9, and 12 months. Thus, these symptoms are not unique to COVID-19 or to post-COVID conditions. Awareness that symptoms might persist for up to 12 months, and that many symptoms might emerge or reemerge in the year after COVID-like illness, can assist health care providers in understanding the clinical signs and symptoms associated with post-COVID-like conditions.

Association of vitamins, minerals, and lead with lipoprotein(a) in a cross-sectional cohort of US adults.

Lipoprotein(a)(Lp[a]) is a low-density lipoprotein-cholesterol (LDL-C)-like particle with potent pro-atherothrombotic properties. The association of Lp(a) with several circulating factors, including vitamins, remains unresolved. We performed an observational analysis using the National Health and Nutrition Examination Survey III cohort, a cohort used to monitor the nutrition status of US-citizens. We used multivariable linear regression to test associations of Lp(a) and LDL-C with levels of serum vitamins and minerals and whole-blood lead. Analyses controlled for factors known to associate with Lp(a) (age, sex, race/ethnicity, statin use, hemoglobin A1c, body mass index, hypertension, diabetes, glomerular filtration rate, alcohol intake, and saturated fat intake). LDL-C was corrected for Lp(a) mass. Multiple sensitivity tests were performed, including considering factors as categorical variables (deficient, normal, elevated). Among 7,662 subjects, Lp(a) correlated (ß-coefficient) positively (change per 1 conventional unit increase) with carotenoids (lycopene (0.17(0.06,0.28), p=0.005), lutein (0.19(0.07,0.30), p=0.002), ß-cryptoxanthin (0.21(0.05,0.37), p=0.01), ß-carotene (0.05(0.02,0.09), p=0.003), and α-carotene (0.15(0.01,0.30), p=0.04)) and lead (0.54(0.03,1.05), p=0.04) levels when tested as continuous variables. LDL-C had similar associations. Lp(a) did not associate with vitamins A, B12, C, or E retinyl esters, folate, RBC-folate, selenium, ferritin, transferrin saturation, or calcium. With factors as categorical variables, Lp(a) but not LDL-C negatively associated with elevated vitamin B12 (-5.41(-9.50, -1.53), p=0.01) and folate (-2.86(-5.09, -0.63), p=0.01). In conclusion, Lp(a) associated similarly to LDL-C when vitamins, minerals, and lead were tested as continuous variables, while only Lp(a) correlated with vitamin B12 and folate when tested as categorical variables. These observations are hypotheses generating and require further studies to determine causality.

National Trends and Disparities in Hospitalization for Acute Hypertension Among Medicare Beneficiaries (1999-2019).

BACKGROUND: In the past 2 decades, hypertension control in the US population has not improved and there are widening disparities. Little is known about progress in reducing hospitalizations for acute hypertension. METHODS: We conducted serial cross-sectional analysis of Medicare fee-for-service beneficiaries age 65 years or older between 1999 and 2019 using Medicare denominator and inpatient files. We evaluated trends in national hospitalization rates for acute hypertension overall and by demographic and geographical subgroups. We identified all beneficiaries admitted with a primary discharge diagnosis of acute hypertension on the basis of International Classification of Diseases codes. We then used a mixed effects model with a Poisson link function and state-specific random intercepts, adjusting for age, sex, race and ethnicity, and dual-eligible status, to evaluate trends in hospitalizations. RESULTS: The sample consisted of 397 238 individual Medicare fee-for-service beneficiaries. From 1999 through 2019, the annual hospitalization rates for acute hypertension increased significantly, from 51.5 to 125.9 per 100 000 beneficiary-years; the absolute increase was most pronounced among the following subgroups: adults ≥85 years (66.8-274.1), females (64.9-160.1), Black people (144.4-369.5), and Medicare/Medicaid insured (dual-eligible, 93.1-270.0). Across all subgroups, Black adults had the highest hospitalization rate in 2019, and there was a significant increase in the differences in hospitalizations between Black and White people from 1999 to 2019. Marked geographic variation was also present, with the highest hospitalization rates in the South. Among patients hospitalized for acute hypertension, the observed 30-day and 90-day all-cause mortality rates (95% CI) decreased from 2.6% (2.27-2.83) and 5.6% (5.18-5.99) to 1.7% (1.53-1.80) and 3.7% (3.45-3.84) and 30-day and 90-day all-cause readmission rates decreased from 15.7% (15.1-16.4) and 29.4% (28.6-30.2) to 11.8% (11.5-12.1) and 24.0% (23.5-24.6). CONCLUSIONS: Among Medicare fee-for-service beneficiaries age 65 years or older, hospitalization rates for acute hypertension increased substantially and significantly from 1999 to 2019. Black adults had the highest hospitalization rate in 2019 across age, sex, race and ethnicity, and dual-eligible strata. There was significant national variation, with the highest rates generally in the South.

Psychological Health, Well-Being, and the Mind-Heart-Body Connection: A Scientific Statement From the American Heart Association.

As clinicians delivering health care, we are very good at treating disease but often not as good at treating the person. The focus of our attention has been on the specific physical condition rather than the patient as a whole. Less attention has been given to psychological health and how that can contribute to physical health and disease. However, there is now an increasing appreciation of how psychological health can contribute not only in a negative way to cardiovascular disease (CVD) but also in a positive way to better cardiovascular health and reduced cardiovascular risk. This American Heart Association scientific statement was commissioned to evaluate, synthesize, and summarize for the health care community knowledge to date on the relationship between psychological health and cardiovascular health and disease and to suggest simple steps to screen for, and ultimately improve, the psychological health of patients with and at risk for CVD. Based on current study data, the following statements can be made: There are good data showing clear associations between psychological health and CVD and risk; there is increasing evidence that psychological health may be causally linked to biological processes and behaviors that contribute to and cause CVD; the preponderance of data suggest that interventions to improve psychological health can have a beneficial impact on cardiovascular health; simple screening measures can be used by health care providers for patients with or at risk for CVD to assess psychological health status; and consideration of psychological health is advisable in the evaluation and management of patients with or at risk for CVD.

A systematic review of the bidirectional relationship between depressive symptoms and cardiovascular health.

Depression is a mental health disorder associated with a 2-fold increase in cardiovascular disease risk. However, the association between depression and cardiovascular health (CVH), as reflected by the American Heart Association's (AHA) CVH metrics, is incompletely understood. We aimed to systematically review the current evidence to understand and clarify whether a bidirectional relationship exists between depressive symptoms and CVH. We conducted a systematic review by searching EMBASE, Google Scholar, PubMed and Web of Science from inception to May 2021. MeSH terms and keywords were used to identify studies with information on depressive symptoms and CVH. Among 132 articles screened, 11 studies were included with 101,825 participants. Eight studies were cross-sectional while 3 studies used a prospective cohort design. Five studies found an association between participants with unfavorable CVH and depressive symptoms. Six studies found an association between participants with depressive symptoms and unfavorable CVH. In summary, we found a bidirectional relationship may exist between depressive symptoms and CVH. Further research is required to quantify the risk and identify the biological mechanisms underlying the association between depressive symptoms and unfavorable CVH so adequate screening and interventions can be directed towards people with depressive symptoms or unfavorable CVH.

Practical and Ethical Considerations in Telehealth: Pitfalls and Opportunities.

Telehealth has been a long-awaited advancement with the potential to improve efficiency, convenience, and quality in healthcare. However, as telehealth becomes integrated into routine clinical care, it is imperative to consider the practical and ethical implications that could undermine or devalue care delivery. The medical profession must ensure that it is implemented judiciously and with robust quality standards, guided by fair and equitable policies that balance patient autonomy with rigorous standards of care and access. Such a system must recognize the opportunity for more patient input as stakeholders to tailor care to their needs and preferences, while also acknowledging the risk of suboptimal care if convenience is prioritized over quality. More studies of optimal care models are needed to integrate data in terms of both stakeholder input and outcomes.

Effect of institutional transcatheter aortic valve replacement volume on mortality: A systematic review and meta-analysis.

OBJECTIVE: We sought to conduct a systematic review and network meta-analysis to examine the association between institutional transcatheter aortic valve replacement (TAVR) volume and all-cause mortality. BACKGROUND: Since inception in 2011, there has been an exponential increase in the number of TAVR centers across the world. Multiple studies have questioned if a relationship exists between institutional TAVR volume and patient outcomes. METHODS: We performed a systematic literature search for relevant articles using a combination of free text terms in the title/abstract related to volume, TAVR, and patient outcomes. Two reviewers independently screened all titles/abstracts for eligibility based on pre-specified criteria. All-cause mortality data was pooled from eligible studies and centers were categorized as low-(30-50 cases), intermediate-, or high-volume (75-130 cases) based on their annual TAVR volumes. RESULTS: Our search yielded an initial list of 11,153 citations, 120 full text studies were reviewed and 7 studies met all inclusion and exclusion criteria, yielding a total of 1,93,498 TAVRs. Categorized according to center's annual volume; 25,062 TAVRs were performed in low-, 77,093 in intermediate- and 91,343 in high-volume centers. Network meta-analysis showed a relative reduction in mortality rates of 37%, 23% and 19%, for high volume versus low volume centers, high volume versus intermediate volume centers and intermediate versus low volume centers, respectively. CONCLUSIONS: Existing research clearly shows an inverse relationship between annual TAVR procedural volume and all-cause mortality. We need to focus on development of strong referral networks and consolidation rather than expansion of existing TAVR centers to improve patient outcomes, while ensuring adequate access-to-care.

Treatment decisions for patients with peripheral artery disease and symptoms of claudication: Development process and alpha testing of the SHOW-ME PAD decision aid.

Patients with peripheral artery disease (PAD) face a range of treatment options to improve survival and quality of life. An evidence-based shared decision-making tool (brochure, website, and recorded patient vignettes) for patients with new or worsening claudication symptoms was created using mixed methods and following the International Patient Decision Aids Standards (IPDAS) criteria. We reviewed literature and collected qualitative input from patients (n = 28) and clinicians (n = 34) to identify decisional needs, barriers, outcomes, knowledge, and preferences related to claudication treatment, along with input on implementation logistics from 59 patients and 27 clinicians. A prototype decision aid was developed and tested through a survey administered to 20 patients with PAD and 23 clinicians. Patients identified invasive treatment options (endovascular or surgical revascularization), non-invasive treatments (supervised exercise therapy, claudication medications), and combinations of these as key decisions. A total of 65% of clinicians thought the brochure would be useful for medical decision-making, an additional 30% with suggested improvements. For patients, those percentages were 75% and 25%, respectively. For the website, 76.5% of clinicians and 85.7% of patients thought it would be useful; an additional 17.6% of clinicians and 14.3% of patients thought it would be useful, with improvements. Suggestions were incorporated in the final version. The first prototype was well-received among patients and clinicians. The next step is to implement the tool in a PAD specialty care setting to evaluate its impact on patient knowledge, engagement, and decisional quality. ClinicalTrials.gov Identifier: NCT03190382.

Aspirin, Statins, and Primary Prevention: Opportunities for Shared Decision Making in the Face of Uncertainty.

PURPOSE OF REVIEW: The utility of aspirin and statins for primary prevention of atherosclerotic cardiovascular disease remains ambiguous in older adults. Current guidelines and recent data are vague and inconclusive. This review seeks to summarize the landscape of primary prevention of cardiovascular disease in older adults and explore the role of shared decision making. RECENT FINDINGS: Observational data suggest potential benefit of statin therapy in older adults. Aspirin is presently not recommended for primary prevention based on evidence from recent clinical trials. The implementation of shared decision making and decision aids in routine clinical practice remains challenging but may rise in coming years. Clinical trial data on the horizon may aid in solidifying guideline therapy for statin use. However, in the face of uncertainty, shared decision making between provider and patient should be utilized to determine whether pharmacotherapy may benefit older adults. Decision aids are an effective tool to guide this process.

Ideal cardiovascular health and resting heart rate in the Multi-Ethnic Study of Atherosclerosis.

Elevated resting heart rate (RHR) is associated with an increased cardiovascular disease (CVD) risk, but little is known about its association with cardiovascular health (CVH), assessed by the Life's Simple 7 (LS7) metrics. We explored whether ideal CVH was associated with RHR in a cohort free from clinical CVD. We conducted a cross-sectional analysis of baseline data (2000-2002) of 6457 Multi-Ethnic Study of Atherosclerosis participants in 2018. Each LS7 metric (smoking, physical activity, diet, body mass index, blood pressure, cholesterol and glucose) was scored 0-2. Total score ranged from 0 to 14. Scores of 0-8 indicate inadequate, 9-10 average, and 11-14 optimal CVH. RHR was categorized as <60, 60-69, 70-79 and ≥80 bpm. We used multinomial logistic regression to determine associations between CVH score and RHR, adjusting for age, sex, race/ethnicity, education, income, health insurance, and atrioventricular nodal blockers. Mean age of participants (standard deviation) was 62 (10) years; 53% were women; 47% had inadequate CVH, 33% average, and 20% optimal. Favorable CVH was associated with lower odds of having higher RHR. Compared to RHR <60 bpm, participants with optimal CVH had adjusted odds ratio (95% CI) of 0.55 (0.46-0.64) for RHR of 60-69 bpm, 0.34 (0.28-0.43) for 70-79 bpm, and 0.14 (0.09-0.22) for ≥80 bpm. A similar pattern was observed in the stratified analysis by sex, race/ethnicity and age. Favorable CVH was less likely to be associated with elevated RHR irrespective of sex, race/ethnicity and age. More research is needed to explore the usefulness of promoting ideal CVH to reduce elevated RHR, a known risk factor for CVD.

Financial barriers in accessing medical care for peripheral artery disease are associated with delay of presentation and adverse health status outcomes in the United States.

Patient-reported difficulties in affording health care and their association with health status outcomes in peripheral artery disease (PAD) have never been studied. We sought to determine whether financial barriers affected PAD symptoms at presentation, treatment patterns, and patient-reported health status in the year following presentation. A total of 797 United States (US) patients with PAD were identified from the Patient-centered Outcomes Related to TReatment Practices in Peripheral Arterial Disease: Investigating Trajectories (PORTRAIT) study, a prospective, multicenter registry of patients presenting to vascular specialty clinics with PAD. Financial barriers were defined as a composite of no insurance and underinsurance. Disease-specific health status was measured by Peripheral Artery Questionnaire (PAQ) and general health-related quality of life was measured by EuroQol 5 (EQ5D) dimensions at presentation and at 3, 6, and 12 months of follow-up. Among 797 US patients, 21% (n = 165) of patients reported financial barriers. Patients with financial barriers presented at an earlier age (64 ± 9.5 vs 70 ± 9.4 years), with longer duration of symptoms (59% vs 49%) (all p ⩽ 0.05), were more depressed and had higher levels of perceived stress and anxiety. After multivariable adjustment, health status was worse at presentation in patients with financial barriers (PAQ: -7.0 [-10.7, -3.4]; p < 0.001 and EQ5D: -9.2 [-12.74, -5.8]; p < 0.001) as well as through 12 months of follow-up (PAQ: -8.4 [-13.0, -3.8]; p < 0.001 and EQ5D: -9.7 [-13.2, -6.2]; p < 0.001). In conclusion, financial barriers are associated with later presentation as well as poorer health status at presentation and at 12 months. ClinicalTrials.gov Identifier: NCT01419080.

Association Between Industry Payments to Physicians and Device Selection in ICD Implantation.

Importance: Little is known about the association between industry payments and medical device selection. Objective: To examine the association between payments from device manufacturers to physicians and device selection for patients undergoing first-time implantation of a cardioverter-defibrillator (ICD) or cardiac resynchronization therapy-defibrillator (CRT-D). Design, Setting, and Participants: In this cross-sectional study, patients who received a first-time ICD or CRT-D device from any of the 4 major manufacturers (January 1, 2016-December 31, 2018) were identified. The data from the National Cardiovascular Data Registry ICD Registry was linked with the Open Payments Program's payment data. Patients were categorized into 4 groups (A, B, C, and D) corresponding to the manufacturer from which the physician who performed the implantation received the largest payment. For each patient group, the proportion of patients who received a device from the manufacturer that provided the largest payment to the physician who performed implantation was determined. Within each group, the absolute difference in proportional use of devices between the manufacturer that made the highest payment and the proportion of devices from the same manufacturer in the entire study cohort (expected prevalence) was calculated. Exposures: Manufacturers' payments to physicians who performed an ICD or CRT-D implantation. Main Outcomes and Measures: The primary outcome of the study was the manufacturer of the device used for the implantation. Results: Over a 3-year period, 145 900 patients (median age, 65 years; 29.6% women) received ICD or CRT-D devices from the 4 manufacturers implanted by 4435 physicians at 1763 facilities. Among these physicians, 4152 (94%) received payments from device manufacturers ranging from $2 to $323 559 with a median payment of $1211 (interquartile range, $390-$3702). Between 38.5% and 54.7% of patients received devices from the manufacturers that had provided physicians with the largest payments. Patients were substantially more likely to receive devices made by the manufacturer that provided the largest payment to the physician who performed implantation than they were from each other individual manufacturer. The absolute differences in proportional use from the expected prevalence were 22.4% (95% CI, 21.9%-22.9%) for manufacturer A; 14.5% (95% CI, 14.0%-15.0%) for manufacturer B; 18.8% (95% CI, 18.2%-19.4%) for manufacturer C; and 30.6% (95% CI, 30.0%-31.2%) for manufacturer D. Conclusions and Relevance: In this cross-sectional study, a large proportion of ICD or CRT-D implantations were performed by physicians who received payments from device manufacturers. Patients were more likely to receive ICD or CRT-D devices from the manufacturer that provided the highest total payment to the physician who performed an ICD or CRT-D implantation than each other manufacturer individually.

Heart Failure After Ischemic Stroke or Transient Ischemic Attack in Insulin-Resistant Patients Without Diabetes Mellitus Treated With Pioglitazone.

BACKGROUND: The IRIS trial (Insulin Resistance Intervention After Stroke) demonstrated that pioglitazone reduced the risk for both cardiovascular events and diabetes mellitus in insulin-resistant patients. However, concern remains that pioglitazone may increase the risk for heart failure (HF) in susceptible individuals. METHODS: In IRIS, patients with insulin resistance but without diabetes mellitus were randomized to pioglitazone or placebo (1:1) within 180 days of an ischemic stroke or transient ischemic attack and followed for ≤5 years. To identify patients at higher HF risk with pioglitazone, we performed a secondary analysis of IRIS participants without HF history at entry. HF episodes were adjudicated by an external review, and treatment effects were analyzed using time-to-event methods. A baseline HF risk score was constructed from a Cox model estimated using stepwise selection. Baseline patient features (individually and summarized in risk score) and postrandomization events were examined as possible modifiers of the effect of pioglitazone. Net cardiovascular benefit was estimated for the composite of stroke, myocardial infarction, and hospitalized HF. RESULTS: Among 3851 patients, the mean age was 63 years, and 65% were male. The 5-year HF risk did not differ by treatment (4.1% pioglitazone, 4.2% placebo). Risk for hospitalized HF was low and not significantly greater in pioglitazone compared with placebo groups (2.9% versus 2.3%, P=0.36). Older age, atrial fibrillation, hypertension, obesity, edema, high C-reactive protein, and smoking were risk factors for HF. However, the effect of pioglitazone did not differ across levels of baseline HF risk (hazard ratio [95% CI] for pioglitazone versus placebo for patients at low, moderate, and high risk: 1.03 [0.61-1.73], 1.10 [0.56-2.15], and 1.08 [0.58-2.01]; interaction P value=0.98). HF risk was increased in patients with versus those without incident myocardial infarction in both groups (pioglitazone: 31.4% versus 2.7%; placebo: 25.7% versus 2.4%; P<0.0001). Edema, dyspnea, and weight gain in the trial did not predict HF hospitalization but led to more study drug dose reduction with a lower mean dose of pioglitazone versus placebo (29±17 mg versus 33±15 mg, P<0.0001). Pioglitazone reduced the composite outcome of stroke, myocardial infarction, or hospitalized HF (hazard ratio, 0.78; P=0.007). CONCLUSIONS: In IRIS, with surveillance and dose adjustments, pioglitazone did not increase the risk of HF and conferred net cardiovascular benefit in patients with insulin resistance and cerebrovascular disease. The risk of HF with pioglitazone was not modified by baseline HF risk. The IRIS experience may be instructive for maximizing the net benefit of this therapy. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT00091949.