Promoting Aspirin Use for Cardiovascular Disease Prevention Among an Adult Internet-Using Population: A Pilot Study.

Cardiovascular disease prevention strategies include aspirin use as a preventive measure. The internet can be used to raise public awareness, promote healthy lifestyles, and improve disease management. This pilot study describes the feasibility of an educational website to recruit and follow adult internet users to examine whether they talked to their physician about aspirin and initiated aspirin use. As part of a statewide intervention promoting an aspirin regimen to prevent heart attacks and strokes in Minnesota, visitors to the website were encouraged to complete an aspirin candidacy tool. Between October, 2015 and February, 2016, men 45-79 and women 55-79 who identified as aspirin candidates were invited to participate in a 6-month study involving four, 5 min online surveys to examine physician discussions about aspirin, aspirin use, and mobile technology use. During the 5-month recruitment period, 234 adults enrolled in the study. Of the 174 who completed the baseline survey and at least one follow-up survey, 74 (43.5%) did not use aspirin at baseline. During follow-up, 12 (16.2%) talked to their doctor about aspirin and 31 (41.8%) initiated aspirin use. Internet, social media, and mobile technology use were high among this population. An educational website may have provided a cue to action for aspirin discussions with physicians and aspirin initiation. More research is needed to evaluate the utility of on-line tools to increase appropriate aspirin use among internet-using populations.

Use of a Geographic Information System to create treatment groups for group-randomized community trials: The Minnesota Heart Health Program.

BACKGROUND: Group-randomized trials of communities often rely on the convenience of pre-existing administrative divisions, such as school district boundaries or census entities, to divide the study area into intervention and control sites. However, these boundaries may include substantial heterogeneity between regions, introducing unmeasured confounding variables. This challenge can be addressed by the creation of exchangeable intervention and control territories that are equally weighted by pertinent socio-demographic characteristics. The present study used territory design software as a novel approach to partitioning study areas for The Minnesota Heart Health Program's "Ask about Aspirin" Initiative. METHODS: Twenty-four territories were created to be similar in terms of age, sex, and educational attainment, as factors known to modify aspirin use. To promote ease of intervention administration, the shape and spread of the territories were controlled. Means of the variables used in balancing the territories were assessed as well as other factors that were not used in the balancing process. RESULTS: The analysis demonstrated that demographic characteristics did not differ significantly between the intervention and control territories created by the territory design software. CONCLUSIONS: The creation of exchangeable territories diminishes geographically based impact on outcomes following community interventions in group-randomized trials. The method used to identify comparable geographical units may be applied to a wide range of population-based health intervention trials. TRIAL REGISTRATION: National Institutes of Health (Clinical Trials.gov), Identifier: NCT02607917 . Registered on 16 November 2015.

Use of online promotion to encourage patient awareness of aspirin use to prevent heart attack and stroke.

BACKGROUND: Literature on health promotion evaluation and public understanding of health suggests the importance of investigating behaviour over time in conjunction with information environment trends as a way of understanding programme impact. We analysed population response to online promotion of an educational tool built by the Ask About Aspirin campaign in the USA to inform people about aspirin as a preventive aid. METHODS: We collected 156 weeks of time series data on audience behaviour, namely use of a self-assessment tool. We then used the Autoregressive Integrated Moving Average (ARIMA) modelling to predict that outcome as a function of paid search engine advertising, paid social media promotion and general search interest in aspirin. RESULTS: Through ARIMA modelling of tool engagement data adjusted for outcome series autocorrelation, we found a significant effect of online promotional effort on audience behaviour. Total paid search advertising positively predicted weekly total of individuals who started using the self-assessment tool, coefficient=0.023, t=3.28, p=0.001. This effect did not appear to be an artefact of broader secular trends, as Google search data on the topic of aspirin use did not add explanatory power in the final model nor did controlling for general search interest eliminate the significant coefficient for paid search promotion. CONCLUSION: Results hold implications both for educational tool development and for understanding health promotion campaign effects. We witnessed substantial but ephemeral effects on tool use as a function of paid search efforts, suggesting prioritisation of efforts to affect search engine results as a dissemination tactic.

Traditional and nontraditional glycemic markers and risk of peripheral artery disease: The Atherosclerosis Risk in Communities (ARIC) study.

BACKGROUND AND AIMS: Traditional glycemic markers, fasting glucose and hemoglobin A1c (HbA1c), predict incident peripheral artery disease (PAD). However, it is unknown whether nontraditional glycemic markers, fructosamine, glycated albumin, and 1,5-anhydroglucitol, are associated with PAD and whether these glycemic markers demonstrate particularly strong associations with severe PAD, critical limb ischemia (CLI). METHODS: We quantified the associations of these five glycemic markers with incident PAD (hospitalizations with PAD diagnosis or leg revascularization) in 11,634 ARIC participants using Cox regression models. Participants were categorized according to diabetes diagnosis and clinical cut-points of glycemic markers (nontraditional glycemic markers were categorized according to percentiles corresponding to the HbA1c cut-points). RESULTS: Over a median follow-up of 20.7 years, there were 392 cases of PAD (133 were CLI with tissue loss). HbA1c was more strongly associated with incident PAD than fasting glucose, with adjusted hazard ratios (HR) 6.00 (95% CI, 3.73-9.66) for diagnosed diabetes with HbA1c ≥ 7% and 3.53 (2.39-5.22) for no diagnosed diabetes with HbA1c ≥ 6.5% compared to no diagnosed diabetes with HbA1c <5.7%. Three nontraditional glycemic markers demonstrated risk gradients intermediate between HbA1c and fasting glucose and their risk gradients were substantially attenuated after adjusting for HbA1c. All glycemic markers consistently demonstrated stronger associations with CLI than PAD without CLI (p for difference <0.02 for all glycemic markers). CONCLUSIONS: Nontraditional glycemic markers were associated with incident PAD independent of fasting glucose but not necessarily HbA1c. Our results also support the importance of glucose metabolism in the progression to CLI.

High-sensitivity cardiac troponin and natriuretic peptide with risk of lower-extremity peripheral artery disease: the Atherosclerosis Risk in Communities (ARIC) Study.

Aims: Cardiac troponin T (cTnT) is suggested as a predictor of amputation in patients with peripheral artery disease (PAD). However, cTnT-PAD association has not been systematically studied in a large study. This study evaluated the association of high-sensitivity cTnT (hs-cTnT) with PAD incidence and also explored whether natriuretic peptide (NT-proBNP), another representative cardiac marker, predicts PAD risk. Methods and results: Among 12 288 middle-aged adults, the associations of hs-cTnT and NT-proBNP with incident PAD (hospitalizations with PAD diagnosis or leg revascularization [cases with rest pain or tissue loss considered as critical limb ischaemia (CLI)]) were quantified with multivariable Cox regression models. The risk discrimination was assessed by c-statistic. During a follow-up over 22 years, 454 participants developed PAD (164 CLI cases). In demographically adjusted models, the highest category of hs-cTnT (≥14 vs. <3 ng/L) and NT-proBNP (≥258.3 vs. <51.5 pg/mL) showed ∼8- and 10-20-fold higher risk of PAD and CLI, respectively. Even after adjusting for potential confounders and each other, hazard ratios were greater for CLI than for PAD (7.74 95% confidence interval [95% CI 4.43-13.55] vs. 2.84 [2.02-4.00] for the highest vs. reference hs-cTnT category and 4.63 [2.61-8.23] vs. 3.16 [2.23-4.49] for the highest vs. reference NT-proBNP category). The addition of these cardiac markers improved c-statistics for CLI. Conclusion: High-sensitivity cTnT and NT-proBNP were independently associated with incident PAD, particularly its severe form, CLI. Although future studies are warranted to investigate pathophysiological mechanisms behind these associations, our study suggests the usefulness of cardiac markers to identify individuals at high risk of CLI.

PORTRAIT (Patient-Centered Outcomes Related to Treatment Practices in Peripheral Arterial Disease: Investigating Trajectories): Overview of Design and Rationale of an International Prospective Peripheral Arterial Disease Study.

BACKGROUND: Health status outcomes, including symptoms, functional status, and quality of life, are critically important outcomes from patients' perspectives. The PORTRAIT study (Patient-Centered Outcomes Related to Treatment Practices in Peripheral Arterial Disease: Investigating Trajectories) was designed to prospectively define health status outcomes and examine associations between patients' characteristics and care to these outcomes among those presenting with new-onset or worsened claudication. METHODS AND RESULTS: PORTRAIT screened 3637 patients with an abnormal ankle-brachial index and new, or worsened, claudication symptoms from 16 peripheral arterial disease (PAD) specialty clinics in the United States, the Netherlands, and Australia between June 2, 2011, and December 3, 2015. Of the 1608 eligible patients, 1275 (79%) were enrolled. Before treatment, patients were interviewed to obtain their demographics, PAD symptoms and health status, psychosocial characteristics, preferences for shared decision-making, socioeconomic, and cardiovascular risk factors. Patients' medical history, comorbidities, and PAD diagnostic information were abstracted from patients' medical records. Serial information about patients' health status, psychosocial, and lifestyle factors was collected at 3, 6, and 12 months by a core laboratory. Follow-up rates ranged from 84.2% to 91%. Clinical follow-up for PAD-related hospitalizations and major cardiovascular events is ongoing. CONCLUSIONS: PORTRAIT systematically collected serial PAD-specific health status data as a foundation for risk stratification, comparative effectiveness studies, and clinicians' adherence to quality-based performance measures. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01419080.

Contemporary Primary Prevention Aspirin Use by Cardiovascular Disease Risk: Impact of US Preventive Services Task Force Recommendations, 2007-2015: A Serial, Cross-sectional Study.

BACKGROUND: No previous study has evaluated the impact of past US Preventive Services Task Force statements on primary prevention (PP) aspirin use in a primary care setting. The aim of this study was to evaluate temporal changes in PP aspirin use in a primary care population, stratifying patients by their 10-year global cardiovascular disease risk, in response to the 2009 statement. METHODS AND RESULTS: This study estimated biannual aspirin use prevalence using electronic health record data from primary care clinics within the Fairview Health System (Minnesota) from 2007 to 2015. A total of 94 270 patient encounters had complete data to estimate a 10-year cardiovascular disease risk score using the 2013 American College of Cardiology/American Heart Association global risk estimator. Patients were stratified into low- (<10%), intermediate- (10-20%), and high- (≥20%) risk groups. Over the 9-year period, PP aspirin use averaged 43%. When stratified by low, intermediate and high risk, average PP aspirin use was 41%, 63%, and 73%, respectively. Average PP aspirin use decreased after the publication of the 2009 US Preventive Services Task Force recommendation statement: from 45% to 40% in the low-risk group; from 66% to 62% in the intermediate-risk group; and from 76% to 73% in the high-risk group, before and after the guideline. CONCLUSIONS: Publication of the 2009 US Preventive Services Task Force recommendation was not associated with an increase in aspirin use. High risk PP patients utilized aspirin at high rates. Patients at intermediate risk were less intensively treated, and patients at low risk used aspirin at relatively high rates. These data may inform future aspirin guideline dissemination.

Serum 25-hydroxyvitamin D is associated with incident peripheral artery disease among white and black adults in the ARIC study cohort.

BACKGROUND AND AIMS: Low 25-hydroxyvitamin D [25(OH)D] concentrations have been associated with peripheral artery disease (PAD). Prevalence of low 25(OH)D and PAD differ between whites and blacks. However, these associations have not been studied prospectively or in a population based cohort. We tested the hypothesis that low 25(OH)D is associated with greater risk of incident PAD in white and black adults. METHODS: 25(OH)D was measured in serum collected at ARIC visit 2 (1990-1992). We followed 11,789 ARIC participants free of PAD at visit 2 through 2011 for incident PAD events. 25(OH)D (ng/mL) was categorized as deficient (<20), insufficient (20 to <30) or sufficient (≥30). PAD was defined by an ankle brachial index (ABI) of <0.9 at ARIC visits 3 or 4 or a hospital diagnosis with an ICD-9 code indicating PAD during follow-up. Analysis used multivariable-adjusted Cox proportional hazards regressions. RESULTS: Over a mean follow-up of 17.1 years, 1250 incident PAD events were identified. 22% of whites and 61% of blacks were 25(OH)D deficient. After adjustment for demographic characteristics, the hazard ratio (95% CI) of PAD in participants with deficient versus sufficient 25(OH)D was 1.49 (1.26, 1.76). Inclusion of BMI, physical activity, and smoking status attenuated the association [1.25 (1.06, 1.48)]. The association between 25(OH)D and PAD was qualitatively stronger in blacks (p for interaction = 0.20). CONCLUSIONS: Deficient 25(OH)D was associated with increased risk of PAD in black and white participants. Whether treatment of low vitamin D through supplementation or modest sunlight exposure prevents PAD is unknown.

Lower Extremity Peripheral Artery Disease and Quality of Life Among Older Individuals in the Community.

BACKGROUND: Evidence regarding the association of lower extremity peripheral arterial disease with quality of life (QOL) is mainly from selected clinical populations or relatively small clinical cohorts. Thus, we investigated this association in community-derived populations. METHODS AND RESULTS: Using data of 5115 participants aged 66 to 90 years from visit 5 (2011-2013) of the Atherosclerosis Risk in Communities Study, we quantified the associations of ankle-brachial index (ABI) with several QOL parameters, including 12-item Short-Form Health Survey (SF-12), after accounting for potential confounders using linear and logistic regression models. Peripheral arterial disease defined by an ABI <0.90 (n=402), was independently associated with a low SF-12 Physical Component Summary score (-3.26 [95% CI -5.60 to -0.92]), compared to the ABI reference 1.10 to 1.19 (n=1900) but not with the Mental Component Summary score (-0.07 [-2.21 to 2.06]). A low ABI was significantly associated with poorer status of all SF-12 physical domains (physical functioning, role-physical, bodily pain, and general health) but only vitality out of 4 mental domains. Similarly, low ABI values were more consistently associated with other physically related QOL parameters (leisure-time exercise/activity/walking) than mentally related parameters (significant depressive symptoms and hopeless feeling). Lower physical QOL was observed even in individuals with borderline low ABI (0.90 to 0.99; n=426). CONCLUSIONS: Low ABI (even borderline) was independently associated with poor QOL, especially for physical components, in community-dwelling older adults. QOL is a critical element for older adults, and thus, further studies are warranted to assess whether peripheral arterial disease-specific management can improve QOL in older populations.

Ankle-brachial index and physical function in older individuals: The Atherosclerosis Risk in Communities (ARIC) study.

BACKGROUND AND AIMS: Most prior studies investigating the association of lower extremity peripheral artery disease (PAD) with physical function were small or analyzed selected populations (e.g., patients at vascular clinics or persons with reduced function), leaving particular uncertainty regarding the association in the general community. METHODS: Among 5262 ARIC participants (age 71-90 years during 2011-2013), we assessed the cross-sectional association of ankle-brachial index (ABI) with the Short Physical Performance Battery (SPPB) score (0-12), its individual components (chair stands, standing balance, and gait speed) (0-4 points each), and grip strength after accounting for potential confounders, including a history of coronary disease, stroke, or heart failure. RESULTS: There were 411 participants (7.8%) with low ABI ≤0.90 and 469 (8.9%) participants with borderline low ABI 0.91-1.00. Both ABI ≤0.90 and 0.91-1.00 were independently associated with poor physical function (SPPB score ≤6) compared to ABI 1.11-1.20 (adjusted odds ratio 2.10 [95% CI 1.55-2.84] and 1.86 [1.38-2.51], respectively). The patterns were largely consistent across subgroups by clinical conditions (e.g., leg pain or other cardiovascular diseases), in every SPPB component, and for grip strength. ABI >1.3 (472 participants [9.0%]), indicative of non-compressible pedal arteries, was related to lower physical function as well but did not necessarily reach significance. CONCLUSIONS: In community-dwelling older adults, low and borderline low ABI suggestive of PAD were independently associated with poorer systemic physical function compared to those with normal ABI. Clinical attention to PAD as a potential contributor to poor physical function is warranted in community-dwelling older adults.

Baseline assessment and comparison of arterial anatomy, hyperemic flow, and skeletal muscle perfusion in peripheral artery disease: The Cardiovascular Cell Therapy Research Network "Patients with Intermittent Claudication Injected with ALDH Bright Cells" (CCTRN PACE) study.

BACKGROUND: Peripheral artery disease (PAD) is important to public health as a major contributor to cardiovascular morbidity and mortality. Recent developments in magnetic resonance imaging (MRI) techniques permit improved assessment of PAD anatomy and physiology, and may serve as surrogate end points after proangiogenic therapies. METHODS: The PACE study is a randomized, double-blind, placebo-controlled clinical trial designed to assess the physiologic impact and potential clinical efficacy of autologous bone marrow-derived ALDHbr stem cells. The primary MRI end points of the study are as follows: (1) total collateral count, (2) calf muscle plasma volume (a measure of capillary perfusion) by dynamic contrast-enhanced MRI, and (3) peak hyperemic popliteal flow by phase-contrast MRI (PC-MRI). RESULTS: The interreader and intrareader and test-retest results demonstrated good-to-excellent reproducibility (interclass correlation coefficient range 0.61-0.98) for all magnetic resonance measures. The PAD participants (n=82) had lower capillary perfusion measured by calf muscle plasma volume (3.8% vs 5.6%) and peak hyperemic popliteal flow (4.1 vs 13.5mL/s) as compared with the healthy participants (n=16), with a significant level of collateralization. CONCLUSIONS: Reproducibility of the MRI primary end points in PACE was very good to excellent. The PAD participants exhibited decreased calf muscle capillary perfusion as well as arterial flow reserve when compared with healthy participants. The MRI tools used in PACE may advance PAD science by enabling accurate measurement of PAD microvascular anatomy and perfusion before and after stem cell or other PAD therapies.

Relationship of Albuminuria and Renal Artery Stent Outcomes: Results From the CORAL Randomized Clinical Trial (Cardiovascular Outcomes With Renal Artery Lesions).

Randomized clinical trials have not shown an additional clinical benefit of renal artery stent placement over optimal medical therapy alone. However, studies of renal artery stent placement have not examined the relationship of albuminuria and treatment group outcomes. The CORAL study (Cardiovascular Outcomes in Renal Atherosclerotic Lesions) is a prospective clinical trial of 947 participants with atherosclerotic renal artery stenosis randomized to optimal medical therapy with or without renal artery stent which showed no treatment differences (3(5.8% and 35.1% event rate at mean 43-month follow-up). In a post hoc analysis, the study population was stratified by the median baseline urine albumin/creatinine ratio (n=826) and analyzed for the 5-year incidence of the primary end point (myocardial infarction, hospitalization for congestive heart failure, stroke, renal replacement therapy, progressive renal insufficiency, or cardiovascular disease- or kidney disease-related death), for each component of the primary end point, and overall survival. When baseline urine albumin/creatinine ratio was ≤ median (22.5 mg/g, n=413), renal artery stenting was associated with significantly better event-free survival from the primary composite end point (73% versus 59% at 5 years; P=0.02), cardiovascular disease-related death (93% versus 85%; P≤ 0.01), progressive renal insufficiency (91% versus 77%; P=0.03), and overall survival (89% versus 76%; P≤0.01), but not when baseline urine albumin/creatinine ratio was greater than median (n=413). These data suggest that low albuminuria may indicate a potentially large subgroup of those with renal artery stenosis that could experience improved event-free and overall-survival after renal artery stent placement plus optimal medical therapy compared with optimal medical therapy alone. Further research is needed to confirm these preliminary observations. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT00081731.

Nutritional status and body composition in patients with peripheral arterial disease: A cross-sectional examination of disease severity and quality of life.

Nutritional and body weight recommendations for cardiovascular diseases are well established, yet there are no equivalent guidelines for peripheral arterial disease (PAD). This cross-sectional study measured the prevalence of cardiovascular-related nutritional and body composition risk factors in sixty PAD patients and their association with PAD severity. A diet that exceeds daily recommended intake of fat and that falls short of recommended intakes of fiber, folate, and vitamin D was associated with increased leg pain and walking difficulty. Increased body fat and waist circumference were associated with diminished walking ability and poorer psychosocial quality of life. Future prospective investigations are merited to inform both PAD clinical care and disease management guidelines.

The effect of gender on outcomes of aortoiliac artery interventions for claudication.

OBJECTIVE: To explore the relationship between gender, native artery diameters, and outcomes of stent revascularization (ST) in the "Claudication: Exercise versus Endoluminal Revascularization" trial. METHODS: A comparative analysis was performed of the impact of gender, age, weight, height, body mass index, and body surface area on revascularization outcomes at baseline and 6months in 55 arterial segments of aorta, common iliac artery, and external iliac artery (EIA). RESULTS: Women demonstrated smaller diameter of the EIA. However, the clinical outcomes of revascularization were not negatively affected by the gender-based differences. CONCLUSION: Gender-based differences are unlikely to significantly impact outcome of ST.

Population Trends in Aspirin Use for Cardiovascular Disease Prevention 1980-2009: The Minnesota Heart Survey.

BACKGROUND: Daily low-dose aspirin is recommended for primary prevention of myocardial infarction and stroke in higher-risk patients. Population trends in aspirin use for cardiovascular disease (CVD) prevention in an urban population (Minneapolis/St. Paul, 2010 population 2.85 million) from 1980 to 2009 were evaluated. METHODS AND RESULTS: Surveys of randomly selected adults aged 25 to 74 years were collected at 5-year intervals. Self-reports of regular aspirin use for CVD prevention and history of CVD were obtained. Six cross-sectional surveys included 12 281 men and 14 258 women. Age-adjusted aspirin use for primary prevention increased during this period from 1% to 21% among men and 1% to 12% among women. Aspirin use was highest in those aged 65 to 74 years. For secondary prevention, age-adjusted aspirin use increased from 19% to 74% among men and 11% to 64% among women. While data are based on self-report, a substudy using a biochemical indicator of aspirin use (serum thromboxane B2) supports the validity of self-report. CONCLUSIONS: Aspirin for CVD prevention is commonly used by a large and growing portion of the general population. It is not known if this is based on professional advice or self-prescribed use. It is also likely that many who would benefit do not use aspirin and others use aspirin inappropriately.

Cost-Effectiveness of a Statewide Campaign to Promote Aspirin Use for Primary Prevention of Cardiovascular Disease.

BACKGROUND: The U.S. Preventive Services Task Force in 2009 recommended increased aspirin use for primary prevention of cardiovascular disease (CVD) in men ages 45 to 79 years and women ages 55 to 79 years for whom benefit outweighs risk. This study estimated the clinical efficacy and cost-effectiveness of a statewide public and health professional awareness campaign to increase regular aspirin use among the target population in Minnesota to reduce first CVD events. METHODS AND RESULTS: A state-transition Markov model was developed, adopting a payer perspective and lifetime time horizon. The main outcomes of interest were quality-adjusted life years, costs, and the number of CVD events averted among those without a prior CVD history. The model was based on real-world data about campaign effectiveness from representative state-specific aspirin use and event rates, and estimates from the scholarly literature. Implementation of a campaign was predicted to avert 9874 primary myocardial infarctions in men and 1223 primary ischemic strokes in women in the target population. Increased aspirin use was associated with as many as 7222 more major gastrointestinal bleeding episodes. The cost-effectiveness analysis indicated cost-saving results for both the male and female target populations. CONCLUSIONS: Using current U.S. Preventive Services Task Force recommendations, a state public and health professional awareness campaign would likely provide clinical benefit and be economically attractive. With clinician adjudication of individual benefit and risk, mechanisms can be made available that would facilitate achievement of aspirin's beneficial impact on lowering risk of primary CVD events, with minimization of adverse outcomes.

The Contribution of Tobacco Use to High Health Care Utilization and Medical Costs in Peripheral Artery Disease: A State-Based Cohort Analysis.

BACKGROUND: Tobacco use is an important preventable cause of peripheral artery disease (PAD) and a major determinant of adverse clinical outcomes. OBJECTIVES: This study hypothesized that tobacco use by PAD patients would be associated with higher health care utilization and associated costs. METHODS: We conducted a retrospective, cross-sectional study using 2011 claims data from the largest Minnesota health plan. The total cohort included individuals with 12 months of continuous enrollment and ≥ 1 PAD-related claim. Tobacco cessation pharmacotherapy billing codes were queried in a subgroup with pharmacy benefits. Outcomes were total costs, annual proportion of members hospitalized, and primary discharge diagnoses. RESULTS: A PAD cohort of 22,203 was identified, comprising 1,995 (9.0%) tobacco users. A subgroup of 9,027 with pharmacy benefits included 1,158 (12.8%) tobacco users. The total cohort experienced 22,220 admissions. The pharmacy benefits subgroup experienced 8,152 admissions. Within 1 year, nearly one-half the PAD tobacco users were hospitalized, 35% higher than nonusers in the total cohort (p < 0.001) and 30% higher in the subgroup (p < 0.001). In both cohorts, users were more frequently admitted for peripheral or visceral atherosclerosis (p < 0.001), acute myocardial infarction (p < 0.001), and coronary heart disease (p < 0.05). Observed costs in the total cohort were $64,041 for tobacco users versus $45,918 for nonusers. Costs for tobacco users also were consistently higher for professional and facility-based care, persisting after adjustment for age, sex, comorbidities, and insurance type. CONCLUSIONS: Tobacco use in PAD is associated with substantial increases in PAD-related hospitalizations, coronary heart disease and PAD procedures, and significantly greater costs. The results suggest that immediate provision of tobacco cessation programs may be especially cost effective.

The Cutaneous, Net Clinical, and Health Economic Benefits of Advanced Pneumatic Compression Devices in Patients With Lymphedema.

IMPORTANCE: The prevalence and clinical burden of lymphedema is known to be increasing. Nevertheless, evidence-based comparative effectiveness data regarding lymphedema therapeutic interventions have been poor. OBJECTIVE: To examine the impact of an advanced pneumatic compression device (APCD) on cutaneous and other clinical outcomes and health economic costs in a representative privately insured population of lymphedema patients. DESIGN, SETTING, AND PARTICIPANTS: Retrospective analysis of a deidentified private insurance database from 2007 through 2013, and multivariate regression analysis comparing outcomes for the 12 months before and after APCD purchase, adjusting for baseline patient characteristics. Patients with lymphedema who received an APCD who were commercially insured and Medicare managed care enrollees from a large, national US managed care health insurer. The study population was evaluated as cancer-related and non-cancer-related lymphedema cohorts. INTERVENTION: Receipt of an APCD. MAIN OUTCOMES AND MEASURES: Rates of cellulitis, use of lymphedema-related manual therapy, outpatient hospital visits, and inpatient hospitalizations. Lymphedema-related direct costs were measured for home health care, hospital outpatient care, office visits, emergency department use, and inpatient care. RESULTS: The study sample included 718 patients (374 in the cancer cohort and 344 in the noncancer cohort). In both cohorts, use of an APCD was associated with similar reductions in adjusted rates of cellulitis episodes (from 21.1% to 4.5% in the cancer cohort and 28.8% to 7.3% in the noncancer cohort; P < .001 for both), lymphedema-related manual therapy (from 35.6% to 24.9%in the cancer cohort and 32.3% to 21.2% in the noncancer cohort; P < .001 for both), and outpatient visits (from 58.6% to 41.4% in the cancer cohort and 52.6% to 31.4% in the noncancer cohort; P < .001 for both). Among the cancer cohort, total lymphedema-related costs per patient, excluding medical equipment costs, were reduced by 37% (from $2597 to $1642, P = .002). The corresponding decline in costs for the noncancer cohort was 36% (from $2937 to $1883, P = .007). CONCLUSIONS AND RELEVANCE: The study found an association between significant reductions in episodes of cellulitis (cancer vs noncancer cohorts) and outpatient care and costs of APCD acquisition within a 1-year time frame in patients with both cancer-related and non-cancer-related lymphedema.