Integrated smoking cessation and mood management following acute coronary syndrome: Protocol for the post-acute cardiac event smoking (PACES) trial.

BACKGROUND: Approximately 400,000 people who smoke cigarettes survive Acute Coronary Syndrome (ACS; unstable angina, ST and non-ST elevation myocardial infarction) each year in the US. Continued smoking following ACS is an independent predictor of mortality. Depressed mood post-ACS is also predictive of mortality, and smokers with depressed mood are less likely to abstain from smoking following an ACS. A single, integrated treatment targeting depressed mood and smoking could be effective in reducing post-ACS mortality. METHOD/DESIGN: The overall aim of the current study is to conduct a fully powered efficacy trial enrolling 324 smokers with ACS and randomizing them to 12 weeks of an integrated smoking cessation and mood management treatment [Behavioral Activation Treatment for Cardiac Smokers (BAT-CS)] or control (smoking cessation and general health education). Both groups will be offered 8 weeks of the nicotine patch if medically cleared. Counseling in both arms will be provided by tobacco treatment specialists. Follow-up assessments will be conducted at end-of-treatment (12-weeks) and 6, 9, and 12 months after hospital discharge. We will track major adverse cardiac events and all-cause mortality for 36 months post-discharge. Primary outcomes are depressed mood and biochemically validated 7-day point prevalence abstinence from smoking over 12 months. DISCUSSION: Results of this study will inform smoking cessation treatments post-ACS and provide unique data on the impact of depressed mood on success of post-ACS health behavior change attempts. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03413423. Registered 29 January 2018. https://beta. CLINICALTRIALS: gov/study/NCT03413423 .

A Novel Thrombolytic Regimen for Mechanical Prosthetic Valve Thrombosis in a Patient With Antiphospholipid Syndrome.

Management of mechanical prosthetic valve thrombosis (PVT) includes medical and surgical options. Standard medical treatment involves thrombolytic therapy with repeated slow infusions of low-dose IV tissue plasminogen activator (t-PA). The evidence for managing mechanical PVT that does not respond to the standard t-PA dosing is limited in the setting of an exacerbating hypercoagulable condition. We present a case of a patient with a history of antiphospholipid syndrome who presented with a probable thromboembolic myocardial infarction secondary to a mechanical mitral valve thrombosis that did not improve with systemic anticoagulation and repeated standard t-PA dosing but rapidly resolved with ultraslow, high-dose t-PA.

The development and pilot testing of a behavioral activation-based treatment for depressed mood and multiple health behavior change in patients with recent acute coronary syndrome.

BACKGROUND: Patients with acute coronary syndrome (ACS) with depressed mood demonstrate poor cardiovascular behavioral risk profiles and elevated risk for recurrent ACS and mortality. Behavioral Activation (BA) offers an intervention framework for an integrated treatment targeting both depression and critical health behaviors post-ACS. Behavioral Activation for Health and Depression (BA-HD) was developed and pilot tested in a multiphase iterative process. METHODS: First, an initial treatment manual was conceptualized based on the team's prior work, as well as the extant literature. Second, qualitative interviews were conducted with target patients and target providers on the proposed BA-HD treatment rationale, content, and structure. Framework matrix analyses were used to summarize and aggregate responses. Third, an expert panel was convened to elicit additional manual refinements. Finally, patients with post-ACS depression and health behavior non-adherence were recruited to complete an open pilot trial to evaluate acceptability (Client Satisfaction Questionnaire [CSQ], exit interview) and treatment engagement (number of sessions attended; treatment completion was considered completion of 8 out of 10 possible sessions). RESULTS: The initial BA-HD treatment manual expanded an existing treatment manual for post-ACS BA-based mood management and smoking cessation to target four health behaviors relevant to post-ACS patients (e.g., smoking cessation, medication adherence, physical activity, and diet). After the initial conceptualization, ten post-ACS patients and eight cardiac rehabilitation professionals completed qualitative interviews. Patients endorsed bi-directional interactions between mood and health behaviors post-ACS. Both patients and providers expressed general support of the proposed treatment rationale and values-guided, collaborative goal-setting approach. Patients, providers, and experts provided feedback that shaped the iterative manual development. After the BA-HD manual was finalized, eight participants were enrolled in a single-arm pilot trial. The mean CSQ score was 30.57 ± 2.23, indicating high satisfaction. Seven out of eight (88%) completed treatment. Pre- to post treatment improvements in depressed mood and health behaviors were promising. CONCLUSIONS: BA-HD treatment is an acceptable approach to target both mood and health behaviors in post-ACS patients with depression. A future larger, controlled trial is needed to evaluate the efficacy of the BA-HD treatment. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04158219.

Feasibility of a Bike-Share Program in Adults With Serious Mental Illness Enrolled in an Outpatient Psychiatric Rehabilitation Program.

Background: Individuals with serious mental illness (SMI) die 10-25 years earlier than the general population, partially due to cardiovascular disease. Those with SMI have poor cardiovascular disease behavioral risk profiles, including low physical activity engagement. This study examined the feasibility of providing city bike-share access to individuals with SMI. Methods: Participants were outpatients with SMI in a psychiatric rehabilitation program and were provided with a complimentary bike-share program membership (Nice Ride). Demographic and clinical variables were extracted from medical records. Lab values, body mass index, 10-year cardiovascular disease risk score, and tobacco use were collected at intake. Nice Ride provided ride frequency and duration data. Results: Of 22 SMI patients enrolled, 72.7% completed ≥1 ride. Among users, median ride length was 9 minutes (interquartile range = 49.5) and 56.3% averaged ≥10 minutes of riding per week. Individuals living <0.5 miles from a station were more likely to be users. Riding ≥10 minutes per week was associated with lower body mass index and male gender. Conclusion: Further work is warranted to determine if bike-share programs offer a feasible, scalable, and cost-effective method for increasing physical activity in those with SMI. These findings are currently being used for program adaptation to increase uptake.

Metabolic syndrome cluster does not provide incremental prognostic information in patients with stable cardiovascular disease: A post hoc analysis of the AIM-HIGH trial.

BACKGROUND: Metabolic syndrome (MS) is a well-known risk factor for the development of cardiovascular (CV) disease; yet, controversy persists whether it adds incremental prognostic value in patients with established CV disease. OBJECTIVES: This study was performed to determine if MS is associated with worse CV outcomes in patients with established CV disease treated intensively with statins. METHODS: We performed a post hoc analysis of the Atherothrombosis Intervention in Metabolic Syndrome with Low HDL/High Triglycerides and Impact on Global Health Outcomes trial, in which patients with established CV disease and atherogenic dyslipidemia (n = 3414) were randomly assigned to receive extended release niacin or placebo during a mean 36-month follow-up, to assess whether the presence of MS or the number of MS components contributed to CV outcomes. RESULTS: The composite primary end point of CV events occurred in 15.1% of patients without MS vs 13.8%, 16.9%, and 16.8% of patients with MS in the subsets with 3, 4, and 5 MS components, respectively (corresponding adjusted hazard ratios 0.9, 1.1, and 1.1 relative to patients without MS), P = .55. Comparing subgroups with 3 vs 4 or 5 MS components, there was no significant difference in either the composite primary end point or secondary end points. Patients with diabetes mellitus had higher event rates, with or without the presence of MS. CONCLUSIONS: The presence of MS was not associated with worse CV outcomes in the AIM-HIGH population. The rate of CV events in statin-treated Atherothrombosis Intervention in Metabolic Syndrome with Low HDL/High Triglycerides and Impact on Global Health Outcomes patients with MS was not significantly influenced by the number of MS components.

High-density lipoprotein particles and markers of inflammation and thrombotic activity in patients with untreated HIV infection.

BACKGROUND: Untreated human immunodeficiency virus (HIV) infection is associated with changes in blood lipids, inflammation, thrombotic activity, and increased risk for cardiovascular disease. METHODS: We studied high-density lipoprotein particle (HDLp) concentrations and inflammatory (high-sensitivity C-reactive protein [hsCRP] and interleukin [IL] 6), endothelial activation (E-selectin and soluble intercellular adhesion molecule-1 [sICAM-1]), and thrombotic (fibrinogen and D-dimer) biomarkers in a group of 32 untreated HIV-infected and 29 uninfected persons. Differences in the levels of blood lipids and biomarkers by HIV status were examined before and after adjustment for age, sex, race/ethnicity, smoking status, body mass index, and the presence of hepatitis C. RESULTS: HIV-infected participants, compared with uninfected participants, had lower HDL cholesterol (HDLc) levels (-26%) and HDLp numbers (-21%), with reductions in large (-50%) and small (-20%) HDLp, specifically (P < or = .01 for all). A trend was present for higher total cholesterol (P = .15 and triglyceride levels (P = .11) among individuals with HIV infection. Levels of IL-6, sICAM-1, and D-dimer were 65%-70% higher in HIV-infected participants (P < or = .02 for all). Covariate adjustment did not diminish these associations. For HIV-infected participants, total and small HDLp (respectively) tended to correlate inversely with levels of IL-6 (P = .08 and P = .02), sICAM-1 (P < .01 for both) and D-dimer (P = .03 and p < .01). CONCLUSIONS: Persons with untreated HIV infection have lower HDLp (primarily large and small HDLp) and higher IL-6, sICAM-1, and D-dimer levels, and the relationship of these markers to HIV-mediated atherosclerotic risk requires further study.