Variation in the Diagnosis of Aspiration Pneumonia and Association with Hospital Pneumonia Outcomes.

RATIONALE: National efforts to compare hospital outcomes for patients with pneumonia may be biased by hospital differences in diagnosis and coding of aspiration pneumonia, a condition that has traditionally been excluded from pneumonia outcome measures. OBJECTIVES: To evaluate the rationale and impact of including patients with aspiration pneumonia in hospital mortality and readmission measures. METHODS: Using Medicare fee-for-service claims for patients 65 years and older from July 2012 to June 2015, we characterized the proportion of hospitals' patients with pneumonia diagnosed with aspiration pneumonia, calculated hospital-specific risk-standardized rates of 30-day mortality and readmission for patients with pneumonia, analyzed the association between aspiration pneumonia coding frequency and these rates, and recalculated these rates including patients with aspiration pneumonia. RESULTS: A total of 1,101,892 patients from 4,263 hospitals were included in the mortality measure analysis, including 192,814 with aspiration pneumonia. The median proportion of hospitals' patients with pneumonia diagnosed with aspiration pneumonia was 13.6% (10th-90th percentile, 4.2-26%). Hospitals with a higher proportion of patients with aspiration pneumonia had lower risk-standardized mortality rates in the traditional pneumonia measure (12.0% in the lowest coding and 11.0% in the highest coding quintiles) and were far more likely to be categorized as performing better than the national mortality rate; expanding the measure to include patients with aspiration pneumonia attenuated the association between aspiration pneumonia coding rate and hospital mortality. These findings were less pronounced for hospital readmission rates. CONCLUSIONS: Expanding the pneumonia cohorts to include patients with a principal diagnosis of aspiration pneumonia can overcome bias related to variation in hospital coding.

Comparison of Electrocardiographic Characteristics in Men Versus Women ≤ 55 Years With Acute Myocardial Infarction (a Variation in Recovery: Role of Gender on Outcomes of Young Acute Myocardial Infarction Patients Substudy).

Young women with acute myocardial infarction (AMI) have a worse prognosis than their male counterparts. We searched for differences in the electrocardiographic presentation of men and women in a large, contemporary registry of young adults with AMI that could help explain gender differences in outcomes. The qualifying electrocardiogram was blindly assessed by a central core lab in 3,354 patients (67% women) aged 18 to 55 years included in the Variation in Recovery: Role of Gender on Outcomes of Young AMI Patients study. Compared with men, women did not have a different frequency of sinus rhythm, and they had shorter PR and QRS intervals and longer QTc intervals. Intraventricular conduction disturbances were not different among genders. Notably, women were more likely than men to have abnormal Q waves in anterior leads and a lower frequency of Q waves in other territories. ST-segment elevation myocardial infarction (STEMI) diagnosis was less frequent in women than in men (44.6% vs 55.1%, p < 0.001). Among patients with STEMI, women had less magnitude and extent of ST-segment elevation than men. In patients with non-STEMI, the frequency, magnitude, and extent of ST-segment depression were not different among genders, but women had anterior ST-segment depression less frequently and anterior negative T waves more frequently compared with men. These differences remained statistically significant after adjusting for baseline characteristics. In conclusion, there are significant gender differences in the electrocardiographic presentation of AMI among young patients. Further studies are warranted to evaluate their impact on gender-related differences in the management and outcomes of AMI.

Editor's Choice-Sex differences in young patients with acute myocardial infarction: A VIRGO study analysis.

AIMS: Young women with acute myocardial infarction (AMI) have a higher risk of adverse outcomes than men. However, it is unclear how young women with AMI are different from young men across a spectrum of characteristics. We sought to compare young women and men at the time of AMI on six domains of demographic and clinical factors in order to determine whether they have distinct profiles. METHODS AND RESULTS: Using data from Variation in Recovery: Role of Gender on Outcomes of Young AMI Patients (VIRGO), a prospective cohort study of women and men aged ⩽55 years hospitalized for AMI ( n = 3501) in the United States and Spain, we evaluated sex differences in demographics, healthcare access, cardiovascular risk and psychosocial factors, symptoms and pre-hospital delay, clinical presentation, and hospital management for AMI. The study sample included 2349 (67%) women and 1152 (33%) men with a mean age of 47 years. Young women with AMI had higher rates of cardiovascular risk factors and comorbidities than men, including diabetes, congestive heart failure, chronic obstructive pulmonary disease, renal failure, and morbid obesity. They also exhibited higher levels of depression and stress, poorer physical and mental health status, and lower quality of life at baseline. Women had more delays in presentation and presented with higher clinical risk scores on average than men; however, men presented with higher levels of cardiac biomarkers and more classic electrocardiogram findings. Women were less likely to undergo revascularization procedures during hospitalization, and women with ST segment elevation myocardial infarction were less likely to receive timely primary reperfusion. CONCLUSIONS: Young women with AMI represent a distinct, higher-risk population that is different from young men.

Gender differences in physical activity following acute myocardial infarction in adults: A prospective, observational study.

Aims Despite the benefits of regular physical activity participation following acute myocardial infarction, little is known about gender differences in physical activity among patients after acute myocardial infarction. We described, by gender, physical activity trajectories pre- and post-acute myocardial infarction, and determined whether gender was independently associated with physical activity. Methods and results The Variation in Recovery: Role of Gender on Outcomes of Young AMI patients (VIRGO) study, conducted at 103 US, 24 Spanish, and three Australian hospitals, was designed, in part, to evaluate gender differences in lifestyle behaviors following acute myocardial infarction. We used baseline, one-month, and 12-month data collected from patients aged 18-55 years ( n = 3572). Patients were assigned to American Heart Association-defined levels of physical activity. A generalized estimating equation model was used to account for repeated measures within the same individual over time. Men were more active (≥150 min/wk moderate or ≥75 min/wk vigorous activity) than women at baseline (42% vs 34%), one month (45% vs 34%), and 12 months (48% vs 36%) (all p < 0.0001). Men engaged in a significantly longer duration of activity at each time point. When controlling for all other factors, women had 1.37 times the odds of being less active than men from pre-acute myocardial infarction to 12-months post-acute myocardial infarction (95% confidence interval: 1.21-1.55). Non-white race, non-active workplaces, smoking, diabetes, hypertension, and obesity were also associated independently with being less active over time (all p < 0.05). Conclusions Although activity increased modestly over time, women recovering from acute myocardial infarction were less likely to meet physical activity recommendations than were men. By identifying factors associated with low levels of activity during acute myocardial infarction recovery, targeted interventions can be introduced prior to hospital discharge.

Perceived Stress After Acute Myocardial Infarction: A Comparison Between Young and Middle-Aged Women Versus Men.

OBJECTIVE: The aim of the study was to examine how psychological stress changes over time in young and middle-aged patients after experiencing an acute myocardial infarction (AMI) and whether these changes differ between men and women. METHODS: We analyzed data obtained from 2358 women and 1151 men aged 18 to 55 years hospitalized for AMI. Psychological stress was measured using the 14-item Perceived Stress Scale (PSS-14) at initial hospitalization and at 1 month and 12 months after AMI. We used linear mixed-effects models to examine changes in PSS-14 scores over time and sex differences in these changes, while adjusting for patient characteristics and accounting for correlation among repeated observations within patients. RESULTS: Overall, patients' perceived stress decreased over time, especially during the first month after AMI. Women had higher levels of perceived stress than men throughout the 12-month period (difference in PSS-14 score = 3.63, 95% confidence interval = 3.08 to 4.18, p < .001), but they did not differ in how stress changed over time. Adjustment for patient characteristics did not alter the overall pattern of sex difference in changes of perceived stress over time other than attenuating the magnitude of sex difference in PSS-14 score (difference between women and men = 1.74, 95% confidence interval = 1.32 to 2.16, p < .001). The magnitude of sex differences in perceived stress was similar in patients with versus without post-AMI angina, even though patients with angina experienced less improvement in PSS-14 score than those without angina. CONCLUSIONS: In young and middle-aged patients with AMI, women reported higher levels of perceived stress than men throughout the first 12 months of recovery. However, women and men had a similar pattern in how perceived stress changed over time.

Sex Differences in Financial Barriers and the Relationship to Recovery After Acute Myocardial Infarction.

BACKGROUND: Financial barriers to health care are associated with worse outcomes following acute myocardial infarction (AMI). Yet, it is unknown whether the prevalence of financial barriers and their relationship with post-AMI outcomes vary by sex among young adults. METHODS AND RESULTS: We assessed sex differences in patient-reported financial barriers among adults aged <55 years with AMI using data from the Variation in Recovery: Role of Gender on Outcomes of Young AMI Patients study. We examined the prevalence of financial barriers and their association with health status 12 months post-AMI. Among 3437 patients, more women than men reported financial barriers to medications (22.3% vs 17.2%; P=0.001), but rates of financial barriers to services were similar (31.3% vs 28.9%; P=0.152). In multivariable linear regression models adjusting for baseline health, psychosocial status, and clinical characteristics, compared with no financial barriers, women and men with financial barriers to services and medications had worse mental functional status (Short Form-12 mental health score: mean difference [MD]=-3.28 and -3.35, respectively), greater depressive symptomatology (Patient Health Questionnaire-9: MD, 2.18 and 2.16), lower quality of life (Seattle Angina Questionnaire-Quality of Life: MD, -4.98 and -7.66), and higher perceived stress (Perceived Stress Score: MD, 3.76 and 3.90; all P<0.05). There was no interaction between sex and financial barriers. CONCLUSIONS: Financial barriers to care are common in young patients with AMI and associated with worse health outcomes 1 year post-AMI. Whereas women experienced more financial barriers than men, the association did not vary by sex. These findings emphasize the importance of addressing financial barriers to recovery post-AMI in young adults.

Sexual Activity and Function in the Year After an Acute Myocardial Infarction Among Younger Women and Men in the United States and Spain.

Importance: Most younger adults who experience an acute myocardial infarction (AMI) are sexually active before the AMI, but little is known about sexual activity or sexual function after the event. Objective: To describe patterns of sexual activity and function and identify indicators of the probability of loss of sexual activity in the year after AMI. Design, Setting, and Participants: Data from the prospective, multicenter, longitudinal Variation in Recovery: Role of Gender on Outcomes of Young AMI Patients study (conducted from August 21, 2008, to January 5, 2012) were assessed at baseline, 1 month, and 1 year. Participants were from US (n = 103) and Spanish (n = 24) hospitals and completed baseline and all follow-up interviews. Data analysis for the present study was conducted from October 15, 2014, to June 6, 2016. Characteristics associated with loss of sexual activity were assessed using multinomial logistic regression analyses. Main Outcomes and Measures: Loss of sexual activity after AMI. Results: Of the 2802 patients included in the analysis, 1889 were women (67.4%); median (25th-75th percentile) age was 49 (44-52) years (range, 18-55 years). At all time points, 637 (40.4%) of women and 437 (54.9%) of men were sexually active. Among people who were active at baseline, men were more likely than women to have resumed sexual activity by 1 month (448 [63.9%] vs 661 [54.5%]; P < .001) and by 1 year (662 [94.4%] vs 1107 [91.3%]; P = .01) after AMI. Among people who were sexually active before and after AMI, women were less likely than men to report no sexual function problems in the year after the event (466 [40.3%] vs 382 [54.8%]; P < .01). In addition, more women than men (211 [41.9%] vs 107 [30.5%]; P < .01) with no baseline sexual problems developed 1 or more incident problems in the year after the AMI. At 1 year, the most prevalent sexual problems were lack of interest (487 [39.6%]) and trouble lubricating (273 [22.3%]) among women and erectile difficulties (156 [21.7%]) and lack of interest (137 [18.8%]) among men. Those who had not communicated with a physician about sex in the first month after AMI were more likely to delay resuming sex (adjusted odds ratio [AOR], 1.51; 95% CI, 1.11-2.05; P = .008). Higher stress levels (AOR, 1.36; 95% CI, 1.01-1.83) and having diabetes (AOR, 1.90; 95% CI, 1.15-3.13) were significant indicators of the probability of loss of sexual activity in the year after the AMI. Conclusions and Relevance: Impaired sexual activity and incident sexual function problems were prevalent and more common among young women than men in the year after AMI. Attention to modifiable risk factors and physician counseling may improve outcomes.

Treatment for Multiple Acute Cardiopulmonary Conditions in Older Adults Hospitalized with Pneumonia, Chronic Obstructive Pulmonary Disease, or Heart Failure.

OBJECTIVES: To determine how often hospitalized older adults principally diagnosed with pneumonia, chronic obstructive pulmonary disease (COPD), or heart failure (HF) are concurrently treated for two or more of these acute cardiopulmonary conditions. DESIGN: Retrospective cohort study. SETTING: 368 U.S. hospitals in the Premier research database. PARTICIPANTS: Individuals aged 65 and older principally hospitalized with pneumonia, COPD, or HF in 2009 or 2010. MEASUREMENTS: Proportion of diagnosed episodes of pneumonia, COPD, or HF concurrently treated for two or more of these acute cardiopulmonary conditions during the first 2 hospital days. RESULTS: Of 91,709 diagnosed pneumonia hospitalizations, 32% received treatment for two or more acute cardiopulmonary conditions (18% for HF, 18% for COPD, 4% for both). Of 41,052 diagnosed COPD hospitalizations, 19% received treatment for two or more acute cardiopulmonary conditions (all of which involved additional HF treatment). Of 118,061 diagnosed HF hospitalizations, 38% received treatment for two or more acute cardiopulmonary conditions (34% for pneumonia, 9% for COPD, 5% for both). CONCLUSION: Hospitalized older adults diagnosed with pneumonia, COPD, or HF are frequently treated for two or more acute cardiopulmonary conditions, suggesting that clinical syndromes often fall between traditional diagnostic categories. Research is needed to evaluate the risks and benefits of real-world treatment for the many older adults whose presentations elicit diagnostic uncertainty or concern about coexisting acute conditions.

Return to Work After Acute Myocardial Infarction: Comparison Between Young Women and Men.

BACKGROUND: Return to work after acute myocardial infarction (AMI) is an important outcome and is particularly relevant to young patients. Women may be at a greater risk for not returning to work given evidence of their worse recovery after AMI than similarly aged men. However, sex differences in return to work after AMI has not been studied extensively in a young population (≤ 55 years). METHODS AND RESULTS: We analyzed data from 1680 patients with AMI aged 18 to 55 years (57% women) participating in the Variation in Recovery: Role of Gender on Outcomes of Young AMI Patients (VIRGO) study who were working full time (≥ 35 hours) before the event. Data were obtained by medical record abstraction and patient interviews. We conducted multivariable regression analyses to examine sex differences in return to work at 12 months after AMI, and the association of patient characteristics with return to work. When compared with young men, young women were less likely to return to work (89% versus 85%; 85% versus 89%, P=0.02); however, this sex difference was not significant after adjusting for patient sociodemographic characteristics, psychosocial factors, and health measures. Being married, engaging in a professional or clerical type of work, having more favorable physical health, and having no previous coronary disease or hypertension were significantly associated with a higher likelihood of return to work at 12 months. CONCLUSIONS: Among a young population, women are less likely to return to work after AMI than men. This disadvantage is explained by differences in demographic, occupational, and health characteristics.

Gender differences in pre-event health status of young patients with acute myocardial infarction: A VIRGO study analysis.

AIMS: We assessed gender differences in pre-event health status (symptoms, functioning, quality of life) in young patients with acute myocardial infarction and whether or not this association persists following sequential adjustment for important covariates. We also evaluated the interaction between gender and prior coronary artery disease, given that aggressive symptom control is a cornerstone of care in those with known coronary disease. METHODS AND RESULTS: A total of 3501 acute myocardial infarction patients (2349 women) aged 18-55 years were enrolled from 103 US/24 Spanish hospitals (2008-2012). Clinical/health status information was obtained by medical record abstraction and patient interviews. Pre-event health status was measured by generic (Short Form-12, EuroQoL) and disease-specific (Seattle Angina Questionnaire) measures. T-test/chi-square and multivariable linear/logistic regression analysis was utilized, sequentially adjusting for covariates. Women had more co-morbidities and significantly lower generic mean health scores than men (Short Form-12 physical health = 43 ± 12 vs. 46 ± 11 and mental health = 44 ± 13 vs. 48 ± 11); EuroQoL utility index = 0.7 ± 0.2 vs. 0.8 ± 0.2 and visual analog scale = 63 ± 22 vs. 67 ± 20, P < 0.0001 for all. Their disease-specific health status was also worse, with more angina (Seattle Angina Questionnaire angina frequency = 83 ± 22 vs. 87 ± 18), worse physical function (physical limitation = 78 ± 27 vs. 87 ± 21) and poorer quality of life (55 ± 25 vs. 60 ± 22, P<0.0001 for all). In multivariable analysis, the association between female gender and worse generic physical/mental health persisted, as well as worse disease-specific physical limitation and quality of life. The interaction between gender and prior coronary artery disease was not significant in any of the health status outcomes. CONCLUSION: Young women have worse pre-event health status as compared with men, regardless of their coronary artery disease history. While future studies of gender differences should adjust for baseline health status, an opportunity may exist to better address the pre-event health status of women at risk for acute myocardial infarction.

Hospital variation in admission to intensive care units for patients with acute myocardial infarction.

BACKGROUND: The treatment for patients with acute myocardial infarction (AMI) was transformed by the introduction of intensive care units (ICUs), yet we know little about how contemporary hospitals use this resource-intensive setting and whether higher use is associated with better outcomes. METHODS: We identified 114,136 adult hospitalizations for AMI from 307 hospitals in the 2009 to 2010 Premier database using codes from the International Classification of Diseases, Ninth Revision, Clinical Modification. Hospitals were stratified into quartiles by rates of ICU admission for AMI patients. Across quartiles, we examined in-hospital risk-standardized mortality rates and usage rates of critical care therapies for these patients. RESULTS: Rates of ICU admission for AMI patients varied markedly among hospitals (median 48%, Q1-Q4 20%-71%, range 0%-98%), and there was no association with in-hospital risk-standardized mortality rates (6% all quartiles, P = .7). However, hospitals admitting more AMI patients to the ICU were more likely to use critical care therapies overall (mechanical ventilation [from Q1 with lowest rate of ICU use to Q4 with highest rate 13%-16%], vasopressors/inotropes [17%-21%], intra-aortic balloon pumps [4%-7%], and pulmonary artery catheters [4%-5%]; P for trend < .05 in all comparisons). CONCLUSIONS: Rates of ICU admission for patients with AMI vary substantially across hospitals and were not associated with differences in mortality, but were associated with greater use of critical care therapies. These findings suggest uncertainty about the appropriate use of this resource-intensive setting and a need to optimize ICU triage for patients who will truly benefit.

Insurance and Prehospital Delay in Patients ≤55 Years With Acute Myocardial Infarction.

This prospective study assessed whether gender differences in health insurance help explain gender differences in delay in seeking care for patients in the US, with acute myocardial infarction (AMI). We also assessed gender differences in such prehospital delay for AMI in Spain, a country with universal insurance. We used data from 2,951 US and 496 Spanish patients aged 18 to 55 years with AMI. US patients were grouped by insurance status: adequately insured, underinsured, or uninsured. For each country, we assessed the association between gender and prehospital delay (symptom onset to hospital arrival). For the US cohort, we modeled the relation between insurance groups and delay of >12 hours. US women were less likely than men to be uninsured but more likely to be underinsured, and a larger proportion of women than men experienced delays of >12 hours (38% vs 29%). We found no association between insurance status and delays of >12 hours in men or women. Only 17.3% of Spanish patients had delays of >12 hours, and there were no significant gender differences. In conclusion, women were more likely than men to delay, although it was not explained by differences in insurance status. The lack of gender differences in prehospital delays in Spain suggests that these differences may vary by health care system and culture.

The Variation in Recovery: Role of Gender on Outcomes of Young AMI Patients (VIRGO) Classification System: A Taxonomy for Young Women With Acute Myocardial Infarction.

BACKGROUND: Current classification schemes for acute myocardial infarction (AMI) may not accommodate the breadth of clinical phenotypes in young women. METHODS AND RESULTS: We developed a novel taxonomy among young adults (≤55 years) with AMI enrolled in the Variation in Recovery: Role of Gender on Outcomes of Young AMI Patients (VIRGO) study. We first classified a subset of patients (n=600) according to the Third Universal Definition of MI using a structured abstraction tool. There was heterogeneity within type 2 AMI, and 54 patients (9%; including 51 of 412 women) were unclassified. Using an inductive approach, we iteratively grouped patients with shared clinical characteristics, with the aims of developing a more inclusive taxonomy that could distinguish unique clinical phenotypes. The final VIRGO taxonomy classified 2802 study participants as follows: class 1, plaque-mediated culprit lesion (82.5% of women; 94.9% of men); class 2, obstructive coronary artery disease with supply-demand mismatch (2a: 1.4% women; 0.9% men) and without supply-demand mismatch (2b: 2.4% women; 1.1% men); class 3, nonobstructive coronary artery disease with supply-demand mismatch (3a: 4.3% women; 0.8% men) and without supply-demand mismatch (3b: 7.0% women; 1.9% men); class 4, other identifiable mechanism (spontaneous dissection, vasospasm, embolism; 1.5% women, 0.2% men); and class 5, undetermined classification (0.8% women, 0.2% men). CONCLUSIONS: Approximately 1 in 8 young women with AMI is unclassified by the Universal Definition of MI. We propose a more inclusive taxonomy that could serve as a framework for understanding biological disease mechanisms, therapeutic efficacy, and prognosis in this population.

Hospital variability in use of anticoagulant strategies during acute myocardial infarction treated with an early invasive strategy.

BACKGROUND: During a myocardial infarction, no single best approach of systemic anticoagulation is recommended, likely due to a lack of comparative effectiveness studies and trade-offs between treatments. METHODS AND RESULTS: We investigated the patterns of use and site-level variability in anticoagulant strategies (unfractionated heparin [UFH] only, low-molecular-weight heparin [LMWH] only, UFH+LMWH, any bivalirudin) of 63 796 patients with a principal diagnosis of myocardial infarction treated with an early invasive strategy with percutaneous coronary intervention at 257 hospitals. About half (47%) of patients received UFH only, 6% UFH+LMWH, 7% LMWH only, and 40% bivalirudin. Compared with UFH, the median odds ratio was 2.90 for LMWH+UFH, 4.70 for LMWH only, and 3.09 for bivalirudin, indicating that 2 "identical" patients would have a 3- to 4-fold greater likelihood of being treated with anticoagulants other than UFH at one hospital compared with another. We then categorized hospitals as low- or high-users of LMWH and bivalirudin. Using hierarchical, multivariate regression models, we found that low bivalirudin-using hospitals had higher unadjusted bleeding rates, but the risk-adjusted and anticoagulant-adjusted bleeding rates did not differ across the hospital anticoagulation phenotypes. Risk-standardized mortality and risk-standardized length of stay also did not differ across hospital phenotypes. CONCLUSIONS: We found substantial site-level variability in the choice of anticoagulants for invasively managed acute myocardial infarction patients, even after accounting for patient factors. No single hospital-use pattern was found to be clinically superior. More studies are needed to determine which patients would derive the greatest benefit from various anticoagulants and to support consistent treatment of patients with the optimal anticoagulant strategy.

Gender differences in the trajectory of recovery in health status among young patients with acute myocardial infarction: results from the variation in recovery: role of gender on outcomes of young AMI patients (VIRGO) study.

BACKGROUND: Despite the excess risk of mortality in young women (≤55 years of age) after acute myocardial infarction (AMI), little is known about young women's health status (symptoms, functioning, quality of life) during the first year of recovery after an AMI. We examined gender differences in health status over time from baseline to 12 months after AMI. METHODS AND RESULTS: A total of 3501 AMI patients (67% women) 18 to 55 years of age were enrolled from 103 US and 24 Spanish hospitals. Data were obtained by medical record abstraction and patient interviews at baseline hospitalization and 1 and 12 months after AMI. Health status was measured by generic (Short Form-12) and disease-specific (Seattle Angina Questionnaire) measures. We compared health status scores at all 3 time points and used longitudinal linear mixed-effects analyses to examine the independent effect of gender, adjusting for time and selected covariates. Women had significantly lower health status scores than men at each assessment (all P values <0.0001). After adjustment for time and all covariates, women had Short Form-12 physical/mental summary scores that were -0.96 (95% confidence interval [CI], -1.59 to -0.32) and -2.36 points (95% CI, -2.99 to -1.73) lower than those of men, as well as worse Seattle Angina Questionnaire physical limitations (-2.44 points lower; 95% CI, -3.53 to -1.34), more angina (-1.03 points lower; 95% CI, -1.98 to -0.07), and poorer quality of life (-3.51 points lower; 95% CI, -4.80 to -2.22). CONCLUSION: Although both genders recover similarly after AMI, women have poorer scores than men on all health status measures, a difference that persisted throughout the entire year after discharge.

Depressive symptoms in younger women and men with acute myocardial infarction: insights from the VIRGO study.

BACKGROUND: Depression was recently recognized as a risk factor for adverse medical outcomes in patients with acute myocardial infarction (AMI). The degree to which depression is present among younger patients with an AMI, the patient profile associated with being a young AMI patient with depressive symptoms, and whether relevant sex differences exist are currently unknown. METHODS AND RESULTS: The Variation in Recovery: Role of Gender on Outcomes of Young AMI Patients (VIRGO) study enrolled 3572 patients with AMI (67.1% women; 2:1 ratio for women to men) between 2008 and 2012 (at 103 hospitals in the United States, 24 in Spain, and 3 in Australia). Information about lifetime history of depression and depressive symptoms experienced over the past 2 weeks (Patient Health Questionnaire; a cutoff score ≥10 was used for depression screening) was collected during index AMI admission. Information on demographics, socioeconomic status, cardiovascular risk, AMI severity, perceived stress (14-item Perceived Stress Scale), and health status (Seattle Angina Questionnaire, EuroQoL 5D) was obtained through interviews and chart abstraction. Nearly half (48%) of the women reported a lifetime history of depression versus 1 in 4 in men (24%; P<0.0001). At the time of admission for AMI, more women than men experienced depressive symptoms (39% versus 22%, P<0.0001; adjusted odds ratio 1.64; 95% CI 1.36 to 1.98). Patients with more depressive symptoms had higher levels of stress and worse quality of life (P<0.001). Depressive symptoms were more prevalent among patients with lower socioeconomic profiles (eg, lower education, uninsured) and with more cardiovascular risk factors (eg, diabetes, smoking). CONCLUSIONS: A high rate of lifetime history of depression and depressive symptoms at the time of an AMI was observed among younger women compared with men. Depressive symptoms affected those with more vulnerable socioeconomic and clinical profiles.

Sex differences in reperfusion in young patients with ST-segment-elevation myocardial infarction: results from the VIRGO study.

BACKGROUND: Sex disparities in reperfusion therapy for patients with acute ST-segment-elevation myocardial infarction have been documented. However, little is known about whether these patterns exist in the comparison of young women with men. METHODS AND RESULTS: We examined sex differences in rates, types of reperfusion therapy, and proportion of patients exceeding American Heart Association reperfusion time guidelines for ST-segment-elevation myocardial infarction in a prospective observational cohort study (2008-2012) of 1465 patients 18 to 55 years of age, as part of the US Variations in Recovery: Role of Gender on Outcomes of Young AMI Patients (VIRGO) study at 103 hospitals enrolling in a 2:1 ratio of women to men. Of the 1238 patients eligible for reperfusion, women were more likely to be untreated than men (9% versus 4%, P=0.002). There was no difference in reperfusion strategy for the 695 women and 458 men treated. Women were more likely to exceed in-hospital and transfer time guidelines for percutaneous coronary intervention than men (41% versus 29%; odds ratio, 1.65; 95% confidence interval, 1.27-2.16), more so when transferred (67% versus 44%; odds ratio, 2.63; 95% confidence interval, 1.17-4.07); and more likely to exceed door-to-needle times (67% versus 37%; odds ratio, 2.62; 95% confidence interval, 1.23-2.18). After adjustment for sociodemographic, clinical, and organizational factors, sex remained an important factor in exceeding reperfusion guidelines (odds ratio, 1.72; 95% confidence interval, 1.28-2.33). CONCLUSIONS: Young women with ST-segment-elevation myocardial infarction are less likely to receive reperfusion therapy and more likely to have reperfusion delays than similarly aged men. Sex disparities are more pronounced among patients transferred to percutaneous coronary intervention institutions or who received fibrinolytic therapy.

Intravenous fluids in acute decompensated heart failure.

OBJECTIVES: This study sought to determine the use of intravenous fluids in the early care of patients with acute decompensated heart failure (HF) who are treated with loop diuretics. BACKGROUND: Intravenous fluids are routinely provided to many hospitalized patients. METHODS: We conducted a retrospective cohort study of patients admitted with HF to 346 hospitals from 2009 to 2010. We assessed the use of intravenous fluids during the first 2 days of hospitalization. We determined the frequency of adverse in-hospital outcomes. We assessed variation in the use of intravenous fluids across hospitals and patient groups. RESULTS: Among 131,430 hospitalizations for HF, 13,806 (11%) were in patients treated with intravenous fluids during the first 2 days. The median volume of administered fluid was 1,000 ml (interquartile range: 1,000 to 2,000 ml), and the most commonly used fluids were normal saline (80%) and half-normal saline (12%). Demographic characteristics and comorbidities were similar in hospitalizations in which patients did and did not receive fluids. Patients who were treated with intravenous fluids had higher rates of subsequent critical care admission (5.7% vs. 3.8%; p < 0.0001), intubation (1.4% vs. 1.0%; p = 0.0012), renal replacement therapy (0.6% vs. 0.3%; p < 0.0001), and hospital death (3.3% vs. 1.8%; p < 0.0001) compared with those who received only diuretics. The proportion of hospitalizations that used fluid treatment varied widely across hospitals (range: 0% to 71%; median: 12.5%). CONCLUSIONS: Many patients who are hospitalized with HF and receive diuretics also receive intravenous fluids during their early inpatient care, and the proportion varies among hospitals. Such practice is associated with worse outcomes and warrants further investigation.

Effect of low perceived social support on health outcomes in young patients with acute myocardial infarction: results from the VIRGO (Variation in Recovery: Role of Gender on Outcomes of Young AMI Patients) study.

BACKGROUND: Social support is an important predictor of health outcomes after acute myocardial infarction (AMI), but social support varies by sex and age. Differences in social support could account for sex differences in outcomes of young patients with AMI. METHODS AND RESULTS: Data from the Variation in Recovery: Role of Gender on Outcomes of Young AMI Patients (VIRGO) study, an observational study of AMI patients aged ≤55 years in the United States and Spain, were used for this study. Patients were categorized as having low versus moderate/high perceived social support using the ENRICHD Social Support Inventory. Outcomes included health status (Short Form-12 physical and mental component scores), depressive symptoms (Patient Health Questionnaire), and angina-related quality of life (Seattle Angina Questionnaire) evaluated at baseline and 12 months. Among 3432 patients, 21.2% were classified as having low social support. Men and women had comparable levels of social support at baseline. On average, patients with low social support reported lower functional status and quality of life and more depressive symptoms at baseline and 12 months post-AMI. After multivariable adjustment, including baseline health status, low social support was associated with lower mental functioning, lower quality of life, and more depressive symptoms at 12 months (all P<0.001). The relationship between low social support and worse physical functioning was nonsignificant after adjustment (P=0.6). No interactions were observed between social support, sex, or country. CONCLUSION: Lower social support is associated with worse health status and more depressive symptoms 12 months after AMI in both young men and women. Sex did not modify the effect of social support.

Predictors of clinical trial data sharing: exploratory analysis of a cross-sectional survey.

BACKGROUND: A number of research funders, biomedical journals, pharmaceutical companies, and regulatory agencies have adopted policies advocating or mandating that clinical trialists share data with external investigators. We therefore sought to determine whether certain characteristics of trialists or their trials are associated with more unfavorable perceptions of data sharing. To date, no prior research has addressed this issue. METHODS: We conducted an exploratory analysis of responses to a cross-sectional, web-based survey. The survey sample consisted of trialists who were corresponding authors of clinical trials published in 2010 or 2011 in one of six general medical journals with the highest impact factors in 2011. The following key characteristics were examined: trialists' academic productivity and geographic location, trial funding source and size, and the journal in which it was published. Main outcome measures included: support for data sharing in principle, concerns with data sharing through repositories, and reasons for granting or denying requests. Chi-squared tests and Fisher's exact tests were used to assess statistical significance. RESULTS: Of 683 potential respondents, 317 completed the survey (response rate 46%). Both support for data sharing and reporting of specific concerns with sharing data through repositories exceeded 75%, but neither differed by trialist or trial characteristics. However, there were some significant differences in explicit reasons to share or withhold data. Respondents located in Western Europe more frequently indicated they have or would share data in order to receive academic benefits or recognition when compared with respondents located in the United States or Canada (58 versus 31%). In addition, respondents who were the most academically productive less frequently indicated they have or would withhold data in order to protect research subjects when compared with less academically productive respondents (24 versus 40%), as did respondents who received industry funding when compared with those who had not (24 versus 43%). CONCLUSIONS: Respondents indicated strong support for data sharing overall. There were few notable differences in how trialists viewed the benefits and risks of data sharing when categorized by trialists' academic productivity and geographic location, trial funding source and size, and the journal in which it was published.