Association of abnormal p-wave parameters with brain MRI morphology: The atherosclerosis risk in communities neurocognitive study (ARIC-NCS).

BACKGROUND: Recent evidence indicates that abnormal P-wave parameters (PWPs)-ECG markers of atrial myopathy-are associated with incident dementia, independent of atrial fibrillation (AF) and clinical ischemic stroke. However, the mechanisms remain unclear and may include subclinical vascular brain injury. Hence, we evaluated the association of abnormal PWPs with brain MRI correlates of vascular brain injury in the Atherosclerosis Risk in Communities Neurocognitive Study (ARIC-NCS). METHODS: ARIC-NCS participants who underwent 3T brain MRI scans in 2011-2013 were included. PWPs were measured from standard 12-lead ECGs. Brain MRI outcomes included cortical infarcts, lacunar infarcts, cerebral microhemorrhages, brain volumes, and white matter disease (WMD) volume. We used weighted multivariable logistic and linear regression to evaluate the associations of abnormal PWPs with brain MRI outcomes. RESULTS: Among 1715 participants (mean age, 76.1 years; 61% women; 29% Black), 797 (46%) had ≥1 abnormal PWP. After multivariable adjustment, including adjusting for prevalent AF, abnormal P-wave terminal force in lead V1 (aPTFV1) and prolonged P-wave duration (PPWD) were associated with increased odds of both cortical (OR 1.41; 95% CI, 1.14 to 1.74 and OR 1.30; 95% CI, 1.04 to 1.63, respectively) and lacunar infarcts (OR 1.36; 95% CI, 1.15 to 1.63 and OR 1.37; 95% CI, 1.15 to 1.65, respectively). Advanced interatrial block (aIAB) was associated with higher odds of subcortical microhemorrhage (OR 2.04; 95% CI, 1.36 to 3.06). Other than a significant association between aPTFV1 with lower parietal lobe volume, there were no other significant associations with brain or WMD volume. CONCLUSION: In this exploratory analysis of a US community-based cohort, ECG surrogates of atrial myopathy are associated with a higher prevalence of brain infarcts and microhemorrhage, suggesting subclinical vascular brain injury as a possible mechanism underlying the association of atrial myopathy with dementia.

Association of a Community Population and Clinic Education Intervention Program With Guideline-Based Aspirin Use for Primary Prevention of Cardiovascular Disease: A Nonrandomized Controlled Trial.

Importance: Low-dose aspirin is used for primary prevention of cardiovascular disease in approximately one-third of the US adult population. Overuse and underuse are common and not concordant with guidelines. Objective: To test a community and clinic education intervention to improve guideline-based aspirin use for the primary prevention of cardiovascular disease. Design, Setting, and Participants: The Ask About Aspirin project was a nonrandomized controlled trial conducted from, July 1, 2015, to March 31, 2020, using professional education, traditional media, and digital media to improve guideline-based aspirin use. The adult population (aged 45-79 years for men and 55-79 years for women) and primary care clinics in Minnesota were the education targets. The 4 adjacent states were controls. Interventions: The statewide campaign distributed billboards, newspaper articles and other print material, and radio announcements. An Ask About Aspirin website was heavily promoted. Primary care clinics identified appropriate aspirin candidates, and clinicians received continuing education about aspirin. Main Outcomes and Measures: Guideline-based aspirin use by the target population. Results: Cross-sectional random telephone surveys of 8342 men aged 45 to 79 years and women aged 55 to 79 years were conducted at baseline, 2 years, and 4 years after the intervention. Participation was similar between men and women (baseline: 973 [49%] vs 1001 [51%]; year 4: 912 [50%] vs 930 [50%]). Age during the study also was similar (baseline: 64.7 [IQR, 64.4-65.1] years; year 4: 66.2 [IQR, 65.8-66.5] years). A validated questionnaire evaluated aspirin use. The Ask About Aspirin website had more than 1 million visits; 124 primary care clinics with more than 1000 participating clinicians were part of the education program. Small, nonsignificant increases in discussions with clinicians regarding aspirin resulted (baseline: 341 of 1001 [34%]; year 4: 339 of 930 [36%]; P = .27). Overall aspirin use decreased after the release of new US Preventive Services Task Force guidelines in 2016 and 3 aspirin randomized clinical trials in 2018 suggested reduced aspirin use (baseline: 816 of 1974 [41%]; year 4: 629 of 1842 [34%]; P < .001). Decreases were also noted from year 2 to year 4 in appropriate use (year 2: 597 of 1208 [49%]; year 4: 478 of 1191 [40%]; P < .001) and overuse (year 2: 170 of 602 [28%]; year 4: 151 of 651 [23%]; P = .04). There were no significant differences between Minnesota and the control states. Conclusions and Relevance: In this nonrandomized controlled trial, a multiyear statewide campaign was not associated with increased appropriate aspirin use for cardiovascular disease prevention. Contextual factors during the project, including guideline changes and media controversy following the new trials, undermined study goals. These findings suggest that although education programs using social media for cardiovascular disease prevention can result in millions of hits, the use of this strategy to encourage behavior change is problematic, even with supportive clinical sites. Trial Registration: ClinicalTrials.gov Identifier: NCT02607917.

News coverage about aspirin as a countervailing force against low-dose aspirin campaign promotion.

Organized health promotion efforts sometimes compete with news media, social media, and other sources when providing recommendations for healthy behavior. In recent years, patients have faced a complicated information environment regarding aspirin use as a prevention tool for heart health. We explored the possibility that campaign promotion of low-dose aspirin use might have been undermined by news coverage in the USA detailing controversies regarding aspirin use. Using time series data on low-dose aspirin sales in Minnesota, USA, we assessed whether news coverage of aspirin or audience engagement with the Ask About Aspirin campaign website predicted subsequent changes in low-dose aspirin sales, over and above any secular trend. News coverage predicted actual low-dose aspirin purchases whereas exposure to a state-level campaign did not. While a campaign effort to encourage people at risk to discuss low-dose aspirin use with their health care providers did not generate substantive changes in low-dose aspirin tablet sales in the areas of Minnesota monitored for this study, past news coverage about aspirin use, including news about negative side effects, may have suppressed low-dose aspirin sales during this same period. The extent of news coverage about aspirin and heart health had a negative effect on tablet sales recorded in greater Minnesota approximately a month later in an ARIMA time series model, coefficient = -.014, t = -2.33, p = .02. Presented evidence of news coverage effect suggests health campaign assessment should consider trends in the public information environment as potential countervailing forces.

A community-based group randomized trial to increase aspirin use for primary prevention of cardiovascular disease: Study protocol and baseline results for the "Ask About Aspirin" initiative.

BACKGROUND: USPSTF evidence-based recommendations for the use of low-dose aspirin for primary prevention of cardiovascular disease were published in 2009. We describe a statewide campaign using innovative methods to educate the public and health communities about appropriate aspirin use. METHODS/DESIGN: The "Ask About Aspirin" initiative is designed to lower the number of first heart attacks and strokes in the State of Minnesota by promoting the appropriate use of low dose aspirin. A health system intervention combined with an aspirin awareness media campaign will be evaluated in a pragmatic group randomized controlled trial including 267 primary care clinics within 84 health systems over a four year period. Matched pairs of geographic territories will be randomized to intervention (12 territories) or control (12 territories). The primary outcome of appropriate aspirin use will be measured at the individual level, by community-based telephone surveys of 100 participants in each of the 24 geographically determined clusters. DISCUSSION: We briefly describe the rationale for the interventions being studied, as well as the major design choices. Rigorous research designs such as the one described here are necessary to determine whether evidence-based recommendations can be effectively disseminated in multiple health systems. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02607917.

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.

Low-dose aspirin for primary prevention of cardiovascular disease: Trends in use patterns among African American adults in Minnesota, 2015-2019.

Cardiovascular disease (CVD) disproportionately affects African Americans. Aspirin has long been recommended to reduce cardiovascular events. However, national guideline changes in 2016 limited the aspirin recommended population and several clinical trials questioning the utility of primary prevention aspirin were published in 2018. In light of the recent guidelines and study findings, we investigated primary prevention aspirin use among urban African American adults. Using three cross-sectional surveys, we collected data from self-identified African Americans with no CVD in 2015, 2017 and 2019, querying information on CVD risk factors, health behaviors and beliefs, and aspirin use. Poisson regression modeling was used to estimate age- and risk-factor adjusted aspirin prevalence, trends and associations. A total of 1491 African Americans adults, ages 45-79, were included in this analysis; 61% were women. There was no change in age- and risk factor-adjusted aspirin use over the 3 surveys for women (37%, 34% and 35% respectively) or men (27%, 25%, 30% respectively). However, fewer participants believed aspirin was helpful in 2019 compared to 2015-75% versus 84% (p < 0.001). Aspirin discussions with a health care practitioner were highly associated with aspirin use (adjusted RR 2.97, 95% CI 2.49-3.54) and aspirin use was 2.56 times higher (adjusted RR 95% CI 2.17-3.03) in respondents who agreed that people close to them thought they should take aspirin compared with those who disagreed or did not know. Despite major changes in national guidelines, overall primary prevention aspirin use did not significantly change in these African American samples from 2015 to 2019.

Life's Simple 7 cardiovascular health score and premature atrial contractions: The atherosclerosis risk in communities (ARIC) study.

BACKGROUND: Premature atrial contractions (PACs) are associated with increased risk of atrial fibrillation (AF) and ischemic stroke. Although lifestyle and risk factor modification reduces AF incidence, their relationship to PACs frequency is unclear. We assessed the association of Life's Simple 7 (LS7) and individual LS7 factors in midlife with PACs frequency in late life in the Atherosclerosis Risk in Communities (ARIC) Study. METHODS: We followed 1924 participants from ARIC clinic Visit 3 (1993--95) to Visit 6 (2016-17) when a 2-week continuous heart rhythm monitor (Zio®XT Patch) was applied. LS7 factors were assessed at Visit 3 and a composite score was calculated. PACs frequency was categorized as minimal (<0.1%), occasional (≥0.1%-5%) and frequent (>5%). Logistic regression was used to evaluate the association of LS7 score and individual factors with PACs frequency. RESULTS: Each 1-point LS7 score increase was associated with lower odds of frequent PACs vs. no PACs (OR [95% CI]: 0.87 [0.78, 0.98]) and frequent PACs vs. occasional PACs (OR [95% CI]: 0.88 [0.79, 0.98]). Of the individual LS7 factors, compared with ideal physical activity, poor physical activity was associated with 81% higher odds of frequent PACs vs. no PACs. Compared with ideal BMI, poor BMI was associated with 41% higher odds of occasional PACs vs. no PACs. CONCLUSION: Lifestyle risk factors, particularly physical activity and BMI, are associated with higher odds of PACs frequency. More research is needed to determine whether modifying these risk factors in midlife would prevent frequent PACs, and thereby prevent AF and stroke in older age.

Aspirin Use and Misuse for the Primary Prevention of Cardiovascular Diseases.

INTRODUCTION: Daily aspirin use for primary cardiovascular disease prevention is common among adults. Numerous clinical trials observe reduced cardiovascular disease with regular low-dose aspirin. The U.S. Preventive Services Task Force in 2016 published guidelines for aspirin use, but controversy exists about the side effects, and overuse or underuse may be common despite the guidelines. Using the Task Force recommendations, this paper describes the prevalence of appropriate aspirin use and physician advice in a population sample. METHODS: A random sample of men and women (aged 50-69 years) living in the Upper Midwest in 2017-2018 were surveyed, collecting demographic data, health history, and aspirin use. Appropriate primary prevention with aspirin was defined as having ≥10% cardiovascular disease risk (hypertension, hyperlipidemia, diabetes, smoking) with daily or every other day aspirin use. Those with prevalent cardiovascular disease were labeled as secondary prevention. RESULTS: A total of 1,352 adults were surveyed (697 women, 655 men). The criteria for secondary prevention were fulfilled in 188 participants, and these were eliminated from the analysis. In the remaining group, aspirin was indicated in 32.9% (383 of 1,164). Among those, 46.0% (176 of 383) were appropriate users, and 54.0% (207 of 383) were nonusers despite indications. Overuse, where aspirin is not indicated, was common at 26.9% (210 of 781). Discussion with a physician, although reported in 29% of subjects, was associated with some improvement in the appropriate use but also with overuse and underuse. CONCLUSIONS: Aspirin use for primary cardiovascular disease prevention is common. However, many adults are medicating without indication (overuse) or are not using aspirin despite guidelines (underuse).

Organizational Costs and Benefits of a Health System Quality Improvement Intervention to Increase Aspirin Use for Primary Prevention of Heart Attack and Stroke.

Performance improvement on clinical quality outcomes typically requires significant effort by personnel in health care organizations. Understanding the cost of quality improvement is important given diffusion of value-based contracting. This study investigates the organizational costs and benefits associated with planning and implementing the Ask about Aspirin intervention to increase use of low-dose aspirin in clinically recommended patient populations. Data from 4 health systems in Minnesota were used to estimate personnel effort and labor resource costs as well as corresponding benefits, measured as the change in aspirin use among eligible candidates during the study period. Overall personnel effort across the 4 systems was approximately 3900 hours with corresponding resource costs estimated to be $214,385. Aspirin use increased 4.7% overall, corresponding to roughly 1530 new users in the aspirin candidate population. Significant variation was observed by system in total hours reported, distribution of effort by activity type, and in benefits realized from the intervention.

Aspirin Use and Awareness for Cardiovascular Disease Prevention Among Hispanics: Prevalence and Associations with Health Behavior Beliefs.

Cardiovascular disease (CVD) persists as the leading cause of death and disability in many Americans including Hispanics. Primary prevention for CVD may be achieved through regular aspirin use in high risk individuals. This study examined regular aspirin use and specific attitudes and social norms toward CVD and aspirin use within an urban Hispanic population in Minnesota. A sample of primary prevention Hispanics aged 45-79 years were surveyed about CVD history and risk factors, aspirin use, demographic characteristics, and health beliefs and social norms in relation to CVD and aspirin. Relative risk estimation using Poisson regression with robust error variance was used to examine associations with aspirin use. In this sample of 152 Hispanics (55% women), the mean age was 53 years, 70% had a regular healthcare provider, and 22% used aspirin. Aspirin discussions with a regular healthcare provider were strongly associated with aspirin use (adjusted risk ratio 3.02, 95% CI 1.20-7.60). There was a positive association between health beliefs and social norms that affirm preventive behaviors and aspirin use (adjusted linear risk ratio 1.23, 95% CI 1.04-1.45) while uncertainty about the role of aspirin for individual use and in the community was negatively associated with aspirin use (adjusted linear risk ratio 0.85, 95% CI 0.70-1.03). This growing population may benefit from health education about CVD risk and the role of aspirin in prevention.

Association of Abnormal P-Wave Indices With Dementia and Cognitive Decline Over 25 Years: ARIC-NCS (The Atherosclerosis Risk in Communities Neurocognitive Study).

Background Abnormal P-wave indices (PWIs)-reflecting underlying left atrial abnormality-are associated with increased risk of stroke independent of atrial fibrillation. We assessed whether abnormal PWIs are associated with incident dementia and greater cognitive decline, independent of atrial fibrillation and ischemic stroke. Methods and Results We included 13 714 participants (mean age, 57±6 years; 56% women; 23% black) who were followed for dementia through the end of 2015. (Abnormal P-wave terminal force in lead V1, ≥4000 µV×ms), abnormal P-wave axis (>75° or <0°), prolonged P-wave duration (>120 ms), and advanced interatrial block were determined from ECGs at visits 2 to 4. Dementia was adjudicated by an expert panel using data from cognitive tests and hospitalization International Classification of Diseases codes. Cognitive function was measured longitudinally using 3 neuropsychological tests. Cox proportional hazards models were used to assess the association between time-dependent abnormal PWIs with incident dementia. Linear regression models were used to evaluate PWIs with cognitive function over time. At the conclusion of the study, 19%, 16%, 28%, and 1.9% of participants had abnormal P-wave terminal force in lead V1, abnormal P-wave axis, prolonged P-wave duration, and advanced interatrial block, respectively. During mean follow-up of 18 years, there were 1390 (10%) dementia cases. All abnormal PWIs except advanced interatrial block were associated with an increased risk of dementia even after adjustment for incident atrial fibrillation and stroke: multivariable hazard ratio of abnormal P wave terminal force in lead V1=1.60, 95% CI, 1.41 to 2.83; abnormal P-wave axis, hazard ratio =1.36, 95% CI, 1.17 to 2.57; prolonged P-wave duration, hazard ratio=1.60, 95% CI, 1.42 to 1.80. Only abnormal P-wave terminal force in lead V1 was associated with greater decline in global cognition. Conclusions Abnormal PWIs are independently associated with an increased risk of dementia. This novel finding should be replicated in other cohorts and the underlying mechanisms should be evaluated.

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.

Aspirin Use for Cardiovascular Disease Prevention in an African American Population: Prevalence and Associations with Health Behavior Beliefs.

Cardiovascular disease (CVD) is a leading cause of morbidity and mortality in the United States, disproportionately affecting African Americans. Aspirin is an effective, low cost option to reduce cardiovascular events. This study sought to describe the use of aspirin for CVD prevention in African Americans and evaluate associations with demographics, cardiovascular risk factors and health behaviors and beliefs. A total of 684 African Americans adults ages 45-79 years completed surveys and were included in this analysis. Proportions of aspirin use were stratified by primary and secondary prevention and by number of CVD risk factors in the primary prevention population. Logistic regression was used to evaluate associations with aspirin use. Secondary prevention aspirin use was 62%. Primary prevention aspirin use was 32% overall and increased to 54% in those with > 2 CVD risk factors. A history of diabetes [adjusted odds ratio (aOR) 3.42, 95% CI 2.18-5.35] and hypertension (aOR 2.25, 95% CI 1.39-3.65) were strongly associated with primary prevention aspirin use, but a conversation with a health care provider was even stronger (aOR 6.41, 95% CI 4.07-10.08). Participants who answered positively to statements about people similar to them taking aspirin or that close contacts think they should take aspirin, were much more likely to take aspirin (aOR 4.80; 95% CI 2.58-8.93 and aOR 7.45; 95% CI 4.70-11.79 respectively). These findings support a hypothesis that aspirin use may increase by encouraging conversations with health care providers and creating a supportive social environment for aspirin use. Further studies need to be done to test this hypothesis.

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.

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.

Supervised exercise, stent revascularization, or medical therapy for claudication due to aortoiliac peripheral artery disease: the CLEVER study.

BACKGROUND: Treatment for claudication that is due to aortoiliac peripheral artery disease (PAD) often relies on stent revascularization (ST). However, supervised exercise (SE) is known to provide comparable short-term (6-month) improvements in functional status and quality of life. Longer-term outcomes are not known. OBJECTIVES: The goal of this study was to report the longer-term (18-month) efficacy of SE compared with ST and optimal medical care (OMC). METHODS: Of 111 patients with aortoiliac PAD randomly assigned to receive OMC, OMC plus SE, or OMC plus ST, 79 completed the 18-month clinical and treadmill follow-up assessment. SE consisted of 6 months of SE and an additional year of telephone-based exercise counseling. Primary clinical outcomes included objective treadmill-based walking performance and subjective quality of life. RESULTS: Peak walking time improved from baseline to 18 months for both SE (5.0 ± 5.4 min) and ST (3.2 ± 4.7 min) significantly more than for OMC (0.2 ± 2.1 min; p < 0.001 and p = 0.04, respectively). The difference between SE and ST was not significant (p = 0.16). Improvement in claudication onset time was greater for SE compared with OMC, but not for ST compared with OMC. Many disease-specific quality-of-life scales demonstrated durable improvements that were greater for ST compared with SE or OMC. CONCLUSIONS: Both SE and ST had better 18-month outcomes than OMC. SE and ST provided comparable durable improvement in functional status and in quality of life up to 18 months. The durability of claudication exercise interventions merits its consideration as a primary PAD claudication treatment.

Development of administrative data algorithms to identify patients with critical limb ischemia.

Administrative data have been used to identify patients with various diseases, yet no prior study has determined the utility of International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM)-based codes to identify CLI patients. CLI cases (n=126), adjudicated by a vascular specialist, were carefully defined and enrolled in a hospital registry. Controls were frequency matched to cases on age, sex and admission date in a 2:1 ratio. ICD-9-CM codes for all patients were extracted. Algorithms were developed using frequency distributions of these codes, risk factors and procedures prevalent in CLI. The sensitivity for each algorithm was calculated and applied within the hospital system to identify CLI patients not included in the registry. Sensitivity ranged from 0.29 to 0.92. An algorithm based on diagnosis and procedure codes exhibited the best overall performance (sensitivity of 0.92). Each algorithm had differing CLI identification characteristics based on patient location. Administrative data can be used to identify CLI patients within a health system. The algorithms, developed from these data, can serve as a tool to facilitate clinical care, research, quality improvement, and population surveillance.

The impact of prolonged lower limb ischemia on amputation, mortality, and functional status: the FRIENDS registry.

BACKGROUND: Peripheral artery disease (PAD) is a major cause of cardiovascular ischemic events and amputation. Knowledge gaps exist in defining and measuring key factors that predict these events. The objective of this study was to assess whether duration of limb ischemia would serve as a major predictor of limb and patient survival. METHODS: The FReedom from Ischemic Events: New Dimensions for Survival (FRIENDS) registry enrolled consecutive patients with limb-threatening peripheral artery disease at a single tertiary care hospital. Demographic information, key clinical care time segments, functional status and use of revascularization, and pharmacotherapy data were collected at baseline, and vascular ischemic events, cardiovascular mortality, and all-cause mortality were recorded at 30 days and 1 year. RESULTS: A total of 200 patients with median (interquartile range) age of 76 years (65-84 years) were enrolled in the registry. Median duration of limb ischemia was 0.75 days for acute limb ischemia (ALI) and 61 days for chronic critical limb ischemia (CLI). Duration of limb ischemia of <12, 12 to 24, and >24 hours in patients with ALI was associated with much higher rates of first amputation (P = .0002) and worse amputation-free survival (P = .037). No such associations were observed in patients with CLI. CONCLUSIONS: For individuals with ischemic symptoms <14 days, prolonged limb ischemia is associated with higher 30-day and 1-year amputation, systemic ischemic event rates, and worse amputation-free survival. No such associations are evident for individuals with chronic CLI. These data imply that prompt diagnosis and revascularization might improve outcomes for patients with ALI.

A 16-month community-based intervention to increase aspirin use for primary prevention of cardiovascular disease.

INTRODUCTION: Cardiovascular diseases are the leading causes of disability and death in the United States. Primary prevention of these events may be achieved through aspirin use. The ability of a community-based intervention to increase aspirin use has not been evaluated. The objective of this study was to evaluate an educational intervention implemented to increase aspirin use for primary prevention of cardiovascular disease in a small city in Minnesota. METHODS: A community-based intervention was implemented during 16 months in a medium-sized community in Minnesota. Messages for aspirin use were disseminated to individuals, health care professionals, and the general population. Independent cross-sectional samples of residents (men aged 45-79, women aged 55-79) were surveyed by telephone to identify candidates for primary prevention aspirin use, examine their characteristics, and determine regular aspirin use at baseline and after the campaign at 4 months and 16 months. RESULTS: In primary prevention candidates, regular aspirin use rates increased from 36% at baseline to 54% at 4 months (odds ratio = 2.05; 95% confidence interval, 1.09-3.88); the increase was sustained at 52% at 16 months (odds ratio = 1.89; 95% confidence interval, 1.02-3.49). The difference in aspirin use rates at 4 months and 16 months was not significant (P = .77). CONCLUSION: Aspirin use rates for primary prevention remain low. A combined public health and primary care approach can increase and sustain primary prevention aspirin use in a community setting.