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1.
BMJ ; 368: l7078, 2020 Feb 05.
Artigo em Inglês | MEDLINE | ID: mdl-32024657

RESUMO

OBJECTIVES: To conduct a systematic review and meta-analysis of the effects of rosiglitazone treatment on cardiovascular risk and mortality using multiple data sources and varying analytical approaches with three aims in mind: to clarify uncertainties about the cardiovascular risk of rosiglitazone; to determine whether different analytical approaches are likely to alter the conclusions of adverse event meta-analyses; and to inform efforts to promote clinical trial transparency and data sharing. DESIGN: Systematic review and meta-analysis of randomized controlled trials. DATA SOURCES: GlaxoSmithKline's (GSK's) ClinicalStudyDataRequest.com for individual patient level data (IPD) and GSK's Study Register platforms, MEDLINE, PubMed, Embase, Web of Science, Cochrane Central Registry of Controlled Trials, Scopus, and ClinicalTrials.gov from inception to January 2019 for summary level data. ELIGIBILITY CRITERIA FOR SELECTING STUDIES: Randomized, controlled, phase II-IV clinical trials that compared rosiglitazone with any control for at least 24 weeks in adults. DATA EXTRACTION AND SYNTHESIS: For analyses of trials for which IPD were available, a composite outcome of acute myocardial infarction, heart failure, cardiovascular related death, and non-cardiovascular related death was examined. These four events were examined independently as secondary analyses. For analyses including trials for which IPD were not available, myocardial infarction and cardiovascular related death were examined, which were determined from summary level data. Multiple meta-analyses were conducted that accounted for trials with zero events in one or both arms with two different continuity corrections (0.5 constant and treatment arm) to calculate odds ratios and risk ratios with 95% confidence intervals. RESULTS: 33 eligible trials were identified from ClinicalStudyDataRequest.com for which IPD were available (21 156 patients). Additionally, 103 trials for which IPD were not available were included in the meta-analyses for myocardial infarction (23 683 patients), and 103 trials for which IPD were not available contributed to the meta-analyses for cardiovascular related death (22 772 patients). Among 29 trials for which IPD were available and that were included in previous meta-analyses using GSK's summary level data, more myocardial infarction events were identified by using IPD instead of summary level data for 26 trials, and fewer cardiovascular related deaths for five trials. When analyses were limited to trials for which IPD were available, and a constant continuity correction of 0.5 and a random effects model were used to account for trials with zero events in only one arm, patients treated with rosiglitazone had a 33% increased risk of a composite event compared with controls (odds ratio 1.33, 95% confidence interval 1.09 to 1.61; rosiglitazone population: 274 events among 11 837 patients; control population: 219 events among 9319 patients). The odds ratios for myocardial infarction, heart failure, cardiovascular related death, and non-cardiovascular related death were 1.17 (0.92 to 1.51), 1.54 (1.14 to 2.09), 1.15 (0.55 to 2.41), and 1.18 (0.60 to 2.30), respectively. For analyses including trials for which IPD were not available, odds ratios for myocardial infarction and cardiovascular related death were attenuated (1.09, 0.88 to 1.35, and 1.12, 0.72 to 1.74, respectively). Results were broadly consistent when analyses were repeated using trials with zero events across both arms and either of the two continuity corrections was used. CONCLUSIONS: The results suggest that rosiglitazone is associated with an increased cardiovascular risk, especially for heart failure events. Although increased risk of myocardial infarction was observed across analyses, the strength of the evidence varied and effect estimates were attenuated when summary level data were used in addition to IPD. Because more myocardial infarctions and fewer cardiovascular related deaths were reported in the IPD than in the summary level data, sharing IPD might be necessary when performing meta-analyses focused on safety. SYSTEMATIC REVIEW REGISTRATION: OSF Home https://osf.io/4yvp2/.

2.
JAMA ; 2020 Feb 10.
Artigo em Inglês | MEDLINE | ID: mdl-32040163

RESUMO

Importance: Acute myocardial infarction (AMI) complicated by cardiogenic shock is associated with substantial morbidity and mortality. Although intravascular microaxial left ventricular assist devices (LVADs) provide greater hemodynamic support as compared with intra-aortic balloon pumps (IABPs), little is known about clinical outcomes associated with intravascular microaxial LVAD use in clinical practice. Objective: To examine outcomes among patients undergoing percutaneous coronary intervention (PCI) for AMI complicated by cardiogenic shock treated with mechanical circulatory support (MCS) devices. Design, Setting, and Participants: A propensity-matched registry-based retrospective cohort study of patients with AMI complicated by cardiogenic shock undergoing PCI between October 1, 2015, and December 31, 2017, who were included in data from hospitals participating in the CathPCI and the Chest Pain-MI registries, both part of the American College of Cardiology's National Cardiovascular Data Registry. Patients receiving an intravascular microaxial LVAD were matched with those receiving IABP on demographics, clinical history, presentation, infarct location, coronary anatomy, and clinical laboratory data, with final follow-up through December 31, 2017. Exposures: Hemodynamic support, categorized as intravascular microaxial LVAD use only, IABP only, other (such as use of a percutaneous extracorporeal ventricular assist system, extracorporeal membrane oxygenation, or a combination of MCS device use), or medical therapy only. Main Outcomes and Measures: The primary outcomes were in-hospital mortality and in-hospital major bleeding. Results: Among 28 304 patients undergoing PCI for AMI complicated by cardiogenic shock, the mean (SD) age was 65.0 (12.6) years, 67.0% were men, 81.3% had an ST-elevation myocardial infarction, and 43.3% had cardiac arrest. Over the study period among patients with AMI, an intravascular microaxial LVAD was used in 6.2% of patients, and IABP was used in 29.9%. Among 1680 propensity-matched pairs, there was a significantly higher risk of in-hospital death associated with use of an intravascular microaxial LVAD (45.0%) vs with an IABP (34.1% [absolute risk difference, 10.9 percentage points {95% CI, 7.6-14.2}; P < .001) and also higher risk of in-hospital major bleeding (intravascular microaxial LVAD [31.3%] vs IABP [16.0%]; absolute risk difference, 15.4 percentage points [95% CI, 12.5-18.2]; P < .001). These associations were consistent regardless of whether patients received a device before or after initiation of PCI. Conclusions and Relevance: Among patients undergoing PCI for AMI complicated by cardiogenic shock from 2015 to 2017, use of an intravascular microaxial LVAD compared with IABP was associated with higher adjusted risk of in-hospital death and major bleeding complications, although study interpretation is limited by the observational design. Further research may be needed to understand optimal device choice for these patients.

3.
Circ Cardiovasc Qual Outcomes ; 13(2): e005948, 2020 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-32063049

RESUMO

BACKGROUND: The diagnosis of acute myocardial infarction (AMI) is missed more frequently in young women than men, which may be related to the cognitive psychology of the diagnostic process. Physicians start the diagnostic process by intuitively recognizing familiar symptom phenotypes, but little is known about how symptoms combine in individuals as unique symptom phenotypes. We examined how symptoms of AMI combine as unique symptom phenotypes in individual patients to compare the distribution of symptom phenotypes in women versus men. METHODS AND RESULTS: The VIRGO study (Variation in Recovery: Role of Gender on Outcomes of Young AMI Patients) was a multicenter, observational cohort study of 3501 young adults hospitalized with AMI. Data were collected on presenting symptoms with standardized interviews and from medical record abstraction. The number and distribution of unique symptom phenotypes were compared between women and men. Because of the 2:1 female-to-male enrollment ratio, women and men were compared with permutation testing and repeated subsampling. There were 426 interview-symptom phenotypes in women and 280 in men. The observed difference between women and men of 146 phenotypes was significant, even allowing for the greater enrollment of women (permutation P=0.004, median difference 110 under the null hypothesis of no association between sex and phenotype). The repeated subsample analysis also showed significantly more interview-symptom phenotypes in women than men (206.8±7.3 versus 188.6±6.0, P<0.001). Women were more broadly distributed among symptom phenotype subgroups than men (P<0.001). Similar findings were observed in the analysis of symptoms abstracted from the medical record. CONCLUSIONS: Women exhibited substantially more variation in unique symptom phenotypes than men, regardless of whether the symptoms were derived from structured interviews or abstracted from the medical record. These findings may provide an explanation for the higher missed diagnosis rate in young women with AMI and may have important implications for teaching and improving clinicians' ability to recognize the diagnosis of AMI in women.

4.
J Am Heart Assoc ; 9(4): e013606, 2020 Feb 18.
Artigo em Inglês | MEDLINE | ID: mdl-32063087

RESUMO

Background More than 600 000 coronary stents are implanted during percutaneous coronary interventions (PCIs) annually in the United States. Because no real-world surveillance system exists to monitor their long-term safety, claims data are often used for this purpose. The extent to which adverse events identified with claims data can be reasonably attributed to a specific medical device is uncertain. Methods and Results We used deterministic matching to link the NCDR (National Cardiovascular Data Registry) CathPCI Registry to Medicare fee-for-service claims for patients aged ≥65 years who underwent PCI with drug-eluting stents (DESs) between July 1, 2009 and December 31, 2013. We identified subsequent PCIs within 1 year of the index procedure in Medicare claims as potential safety events. We linked these subsequent PCIs back to the NCDR CathPCI Registry to ascertain how often the revascularization could be reasonably attributed to the same coronary artery as the index PCI (ie, target vessel revascularization). Of 415 306 DES placements in 368 194 patients, 33 174 repeat PCIs were identified in Medicare claims within 1 year. Of these, 28 632 (86.3%) could be linked back to the NCDR CathPCI Registry; 16 942 (51.1% of repeat PCIs) were target vessel revascularizations. Of these, 8544 (50.4%) were within a previously placed DES: 7652 for in-stent restenosis and 1341 for stent thrombosis. Of 16 176 patients with a claim for acute myocardial infarction in the follow-up period, 4446 (27.5%) were attributed to the same coronary artery in which the DES was implanted during the index PCI (ie, target vessel myocardial infarction). Of 24 288 patients whose death was identified in claims data, 278 (1.1%) were attributed to the same coronary artery in which the DES was implanted during the index PCI. Conclusions Most repeat PCIs following DES stent implantation identified in longitudinal claims data could be linked to real-world registry data, but only half could be reasonably attributed to the same coronary artery as the index procedure. Attribution among those with acute myocardial infarction or who died was even less frequent. Safety signals identified using claims data alone will require more in-depth examination to accurately assess stent safety.

5.
JAMA Intern Med ; 2020 Feb 17.
Artigo em Inglês | MEDLINE | ID: mdl-32065600

RESUMO

Importance: Chlorthalidone is currently recommended as the preferred thiazide diuretic to treat hypertension, but no trials have directly compared risks and benefits. Objective: To compare the effectiveness and safety of chlorthalidone and hydrochlorothiazide as first-line therapies for hypertension in real-world practice. Design, Setting, and Participants: This is a Large-Scale Evidence Generation and Evaluation in a Network of Databases (LEGEND) observational comparative cohort study with large-scale propensity score stratification and negative-control and synthetic positive-control calibration on databases spanning January 2001 through December 2018. Outpatient and inpatient care episodes of first-time users of antihypertensive monotherapy in the United States based on 2 administrative claims databases and 1 collection of electronic health records were analyzed. Analysis began June 2018. Exposures: Chlorthalidone and hydrochlorothiazide. Main Outcomes and Measures: The primary outcomes were acute myocardial infarction, hospitalization for heart failure, ischemic or hemorrhagic stroke, and a composite cardiovascular disease outcome including the first 3 outcomes and sudden cardiac death. Fifty-one safety outcomes were measured. Results: Of 730 225 individuals (mean [SD] age, 51.5 [13.3] years; 450 100 women [61.6%]), 36 918 were dispensed or prescribed chlorthalidone and had 149 composite outcome events, and 693 337 were dispensed or prescribed hydrochlorothiazide and had 3089 composite outcome events. No significant difference was found in the associated risk of myocardial infarction, hospitalized heart failure, or stroke, with a calibrated hazard ratio for the composite cardiovascular outcome of 1.00 for chlorthalidone compared with hydrochlorothiazide (95% CI, 0.85-1.17). Chlorthalidone was associated with a significantly higher risk of hypokalemia (hazard ratio [HR], 2.72; 95% CI, 2.38-3.12), hyponatremia (HR, 1.31; 95% CI, 1.16-1.47), acute renal failure (HR, 1.37; 95% CI, 1.15-1.63), chronic kidney disease (HR, 1.24; 95% CI, 1.09-1.42), and type 2 diabetes mellitus (HR, 1.21; 95% CI, 1.12-1.30). Chlorthalidone was associated with a significantly lower risk of diagnosed abnormal weight gain (HR, 0.73; 95% CI, 0.61-0.86). Conclusions and Relevance: This study found that chlorthalidone use was not associated with significant cardiovascular benefits when compared with hydrochlorothiazide, while its use was associated with greater risk of renal and electrolyte abnormalities. These findings do not support current recommendations to prefer chlorthalidone vs hydrochlorothiazide for hypertension treatment in first-time users was found. We used advanced methods, sensitivity analyses, and diagnostics, but given the possibility of residual confounding and the limited length of observation periods, further study is warranted.

6.
JAMA Netw Open ; 3(1): e1918619, 2020 Jan 03.
Artigo em Inglês | MEDLINE | ID: mdl-31913489

RESUMO

Importance: Given the emerging heart failure (HF) epidemic in China, monitoring and improving the quality of care for heart failure is a top priority. Objectives: To assess the quality of HF care provided to inpatients by examining the adherence to quality measures for HF care at the hospital level and to identify factors associated with the quality of care. Design, Setting, and Participants: In this multicenter, hospital-based, retrospective cross-sectional study in China, medical records of patients hospitalized for HF from January 1, 2015, to December 31, 2015, were analyzed from January 1, 2018, to May 20, 2019. In the first stage, simple random sampling stratified by economic-geographical regions in China was used to generate a list of participating hospitals. In the second stage, 15 538 hospitalizations from the 189 selected hospitals were systematically sampled, and 10 004 HF hospitalizations were included in the final sample. Main Outcomes and Measures: Adherence to the following 4 core performance measures at the hospital level: (1) left ventricular ejection fraction assessment during hospitalization; (2) evidence-based ß-blocker (bisoprolol, carvedilol, or metoprolol succinate) for eligible patients at discharge; (3) angiotensin-converting enzyme inhibitors or angiotensin receptor blockers for eligible patients at discharge; and (4) scheduled follow-up appointment at discharge. At the hospital level, a composite performance score (ranging from 0-1) was also calculated by averaging these measures. Results: In total, 10 004 hospital admissions for HF at 189 hospitals were included in this study. The median (interquartile range [IQR]) patient age at admission was 73 (65-80) years, and 5117 (51.1%) of the patients were men. Among all hospitals, the median rate of adherence to measure 1 was 66.7% (IQR, 45.5%-80.7%; range, 0%-100%). The rate for adherence to measure 2 was 14.8% (IQR, 0%-37.5%; range, 0%-81.8%), and the rate for measure 3 was 57.1% (IQR, 36.4%-75.0%; range, 0%-100%). For measure 4, the median rate of adherence was 11.5% (IQR, 3.3%-32.8%; range, 0%-96.7%). The median (IQR) composite performance score across all hospitals was 40.0% (26.9%-51.9%), with a range from 2.2% to 85.4%. The median odds ratios of adherence were 2.2 (95% CI, 2.0-2.4) for measure 1, 2.1 (95% CI, 1.8-2.4) for measure 2, 2.4 (95% CI, 2.0-2.9 for measure 3, and 4.8 (95% CI, 3.9-5.8) for measure 4 among hospitals. Conclusions and Relevance: The findings of this study suggest that quality of care for patients with HF in China may be substandard, and there is wide heterogeneity in the quality of care for HF among hospitals. The findings also suggest the need for a national strategy to improve and standardize the quality of HF care in China.

9.
BMJ ; 368: l6831, 2020 01 15.
Artigo em Inglês | MEDLINE | ID: mdl-31941686

RESUMO

OBJECTIVES: To determine whether patients discharged after hospital admissions for conditions covered by national readmission programs who received care in emergency departments or observation units but were not readmitted within 30 days had an increased risk of death and to evaluate temporal trends in post-discharge acute care utilization in inpatient units, emergency departments, and observation units for these patients. DESIGN: Retrospective cohort study. SETTING: Medicare claims data for 2008-16 in the United States. PARTICIPANTS: Patients aged 65 or older admitted to hospital with heart failure, acute myocardial infarction, or pneumonia-conditions included in the US Hospital Readmissions Reduction Program. MAIN OUTCOME MEASURES: Post-discharge 30 day mortality according to patients' 30 day acute care utilization; acute care utilization in inpatient and observation units and the emergency department during the 30 day and 31-90 day post-discharge period. RESULTS: 3 772 924 hospital admissions for heart failure, 1 570 113 for acute myocardial infarction, and 3 131 162 for pneumonia occurred. The overall post-discharge 30 day mortality was 8.7% for heart failure, 7.3% for acute myocardial infarction, and 8.4% for pneumonia. Risk adjusted mortality increased annually by 0.05% (95% confidence interval 0.02% to 0.08%) for heart failure, decreased by 0.06% (-0.09% to -0.04%) for acute myocardial infarction, and did not significantly change for pneumonia. Specifically, mortality increased for patients with heart failure who did not utilize any post-discharge acute care, increasing at a rate of 0.08% (0.05% to 0.12%) per year, exceeding the overall absolute annual increase in post-discharge mortality in heart failure, without an increase in mortality in observation units or the emergency department. Concurrent with a reduction in 30 day readmission rates, stays for observation and visits to the emergency department increased across all three conditions during and beyond the 30 day post-discharge period. Overall 30 day post-acute care utilization did not change significantly. CONCLUSIONS: The only condition with increasing mortality through the study period was heart failure; the increase preceded the policy and was not present among patients who received emergency department or observation unit care without admission to hospital. During this period, the overall acute care utilization in the 30 days after discharge significantly decreased for heart failure and pneumonia, but not for acute myocardial infarction.


Assuntos
Unidades de Observação Clínica/estatística & dados numéricos , Serviço Hospitalar de Emergência/estatística & dados numéricos , Insuficiência Cardíaca , Infarto do Miocárdio , Pneumonia , Cuidados Semi-Intensivos , Idoso , Idoso de 80 Anos ou mais , Feminino , Insuficiência Cardíaca/mortalidade , Insuficiência Cardíaca/terapia , Humanos , Revisão da Utilização de Seguros , Masculino , Sobremedicalização/prevenção & controle , Medicare/estatística & dados numéricos , Mortalidade , Infarto do Miocárdio/mortalidade , Infarto do Miocárdio/terapia , Alta do Paciente/estatística & dados numéricos , Readmissão do Paciente/estatística & dados numéricos , Pneumonia/mortalidade , Pneumonia/terapia , Estudos Retrospectivos , Cuidados Semi-Intensivos/métodos , Cuidados Semi-Intensivos/organização & administração , Cuidados Semi-Intensivos/tendências , Estados Unidos/epidemiologia
10.
Heart ; 2020 Jan 24.
Artigo em Inglês | MEDLINE | ID: mdl-31980439

RESUMO

OBJECTIVE: We aimed to estimate the current use of secondary prevention drugs and identify its associated individual characteristics among those with established cardiovascular diseases (CVDs) in the communities of China. METHODS: We studied 2 613 035 participants aged 35-75 years from 8577 communities in 31 provinces in the China Patient-Centered Evaluative Assessment of Cardiac Events Million Persons Project, a government-funded public health programme conducted from 2014 to 2018. Participants self-reported their history of ischaemic heart disease (IHD) or ischaemic stroke (IS) and medication use in an interview. Multivariable mixed models with a logit link function and community-specific random intercepts were fitted to assess the associations of individual characteristics with the reported use of secondary prevention therapies. RESULTS: Among 2 613 035 participants, 2.9% (74 830) reported a history of IHD and/or IS, among whom the reported use rate either antiplatelet drugs or statins was 34.2% (31.5% antiplatelet drugs, 11.0% statins and 8.3% both). Among the 1 530 408 population subgroups, which were defined by all possible permutations of 16 individual characteristics, reported use of secondary prevention drugs varied substantially (8.4%-60.6%). In the multivariable analysis, younger people, women, current smokers, current drinkers, people without hypertension or diabetes and those with established CVD for more than 2 years were less likely to report taking antiplatelet drugs or statins. CONCLUSIONS: The current use of secondary prevention drugs in China is suboptimal and varies substantially across population subgroups. Our study identifies target populations for scalable, tailored interventions to improve secondary prevention of CVD.

11.
JACC Heart Fail ; 8(1): 12-21, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-31606361

RESUMO

OBJECTIVES: This study sought to develop models for predicting mortality and heart failure (HF) hospitalization for outpatients with HF with preserved ejection fraction (HFpEF) in the TOPCAT (Treatment of Preserved Cardiac Function Heart Failure with an Aldosterone Antagonist) trial. BACKGROUND: Although risk assessment models are available for patients with HF with reduced ejection fraction, few have assessed the risks of death and hospitalization in patients with HFpEF. METHODS: The following 5 methods: logistic regression with a forward selection of variables; logistic regression with a lasso regularization for variable selection; random forest (RF); gradient descent boosting; and support vector machine, were used to train models for assessing risks of mortality and HF hospitalization through 3 years of follow-up and were validated using 5-fold cross-validation. Model discrimination and calibration were estimated using receiver-operating characteristic curves and Brier scores, respectively. The top prediction variables were assessed by using the best performing models, using the incremental improvement of each variable in 5-fold cross-validation. RESULTS: The RF was the best performing model with a mean C-statistic of 0.72 (95% confidence interval [CI]: 0.69 to 0.75) for predicting mortality (Brier score: 0.17), and 0.76 (95% CI: 0.71 to 0.81) for HF hospitalization (Brier score: 0.19). Blood urea nitrogen levels, body mass index, and Kansas City Cardiomyopathy Questionnaire (KCCQ) subscale scores were strongly associated with mortality, whereas hemoglobin level, blood urea nitrogen, time since previous HF hospitalization, and KCCQ scores were the most significant predictors of HF hospitalization. CONCLUSIONS: These models predict the risks of mortality and HF hospitalization in patients with HFpEF and emphasize the importance of health status data in determining prognosis. (Treatment of Preserved Cardiac Function Heart Failure with an Aldosterone Antagonist [TOPCAT]; NCT00094302).

12.
Am J Cardiol ; 125(3): 313-319, 2020 Feb 01.
Artigo em Inglês | MEDLINE | ID: mdl-31787249

RESUMO

The availability of social support is associated with health outcomes after acute myocardial infarction (AMI), yet previous studies have largely considered social support as a single entity, rather than examining its discrete domains. Furthermore, few studies have investigated the impact of social support in older AMI patients, in whom it may be especially important. We aimed to determine the associations between 5 discrete domains of social support - emotional support, informational support, tangible support, positive social interaction, and affectionate support - with 6-month readmission and mortality in older patients hospitalized for AMI, adjusting for known predictors of post-AMI outcomes. Three thousand six participants 75 years and older were recruited from a network of 94 hospitals across the United States. A 5-item version of the Medical Outcomes Study Social Support Survey was used to measure perceived social support, and readmission and mortality were ascertained 6 months after initial hospitalization. Independent associations were determined using multivariable regression. Among 3,006 participants, mean age was 82 years, 44% were female, and 11% non-white. Participants who were female, non-white, less educated, and lived alone tended to report lower social support. In multivariable analyses, low informational support was associated with readmission (odds ratio 1.22; 95% confidence interval 1.01 to 1.47), and low emotional support with mortality (odds ratio 1.43; 95% confidence interval 1.04 to 1.97). In conclusion, individual domains of social support had distinct, independent associations with post-AMI outcomes, lending a more nuanced and precise understanding of this important social determinant of health. Understanding these distinct associations can inform the development of interventions and policies to improve post-AMI outcomes.

13.
Ann Intern Med ; 2019 Dec 10.
Artigo em Inglês | MEDLINE | ID: mdl-31816630

RESUMO

Background: Older adults with acute myocardial infarction (AMI) have higher prevalence of functional impairments, including deficits in cognition, strength, and sensory domains, than their younger counterparts. Objective: To develop and evaluate the prognostic utility of a risk model for 6-month post-AMI mortality in older adults that incorporates information about functional impairments. Design: Prospective cohort study. (ClinicalTrials.gov: NCT01755052). Setting: 94 hospitals throughout the United States. Participants: 3006 persons aged 75 years or older who were hospitalized with AMI and discharged alive. Measurements: Functional impairments were assessed during hospitalization via direct measurement (cognition, mobility, muscle strength) or self-report (vision, hearing). Clinical variables associated with mortality in prior risk models were ascertained by chart review. Seventy-two candidate variables were selected for inclusion, and backward selection and Bayesian model averaging were used to derive (n = 2004 participants) and validate (n = 1002 participants) a model for 6-month mortality. Results: Participants' mean age was 81.5 years, 44.4% were women, and 10.5% were nonwhite. There were 266 deaths (8.8%) within 6 months. The final risk model included 15 variables, 4 of which were not included in prior risk models: hearing impairment, mobility impairment, weight loss, and lower patient-reported health status. The model was well calibrated (Hosmer-Lemeshow P > 0.05) and showed good discrimination (area under the curve for the validation cohort = 0.84). Adding functional impairments significantly improved model performance, as evidenced by category-free net reclassification improvement indices of 0.21 (P = 0.008) for hearing impairment and 0.26 (P < 0.001) for mobility impairment. Limitation: The model was not externally validated. Conclusion: A newly developed model for 6-month post-AMI mortality in older adults was well calibrated and had good discriminatory ability. This model may be useful in decision making at hospital discharge. Primary Funding Source: National Heart, Lung, and Blood Institute of the National Institutes of Health.

14.
BMJ Qual Saf ; 2019 Dec 12.
Artigo em Inglês | MEDLINE | ID: mdl-31831635

RESUMO

BACKGROUND: The degree to which elevated mortality associated with weekend or night-time hospital admissions reflects poorer quality of care ('off-hours effect') is a contentious issue. We examined if off-hours admissions for primary percutaneous coronary intervention (PPCI) were associated with higher adjusted mortality and estimated the extent to which potential differences in door-to-balloon (DTB) times-a key indicator of care quality for ST elevation myocardial infarction (STEMI) patients-could explain this association. METHODS: Nationwide registry-based prospective observational study using Myocardial Ischemia National Audit Project data in England. We examined how off-hours admissions and DTB times were associated with our primary outcome measure, 30-day mortality, using hierarchical logistic regression models that adjusted for STEMI patient risk factors. In-hospital mortality was assessed as a secondary outcome. RESULTS: From 76 648 records of patients undergoing PPCI between January 2007 and December 2012, we included 42 677 admissions in our analysis. Fifty-six per cent of admissions for PPCI occurred during off-hours. PPCI admissions during off-hours were associated with a higher likelihood of adjusted 30-day mortality (OR 1.13; 95% CI 1.01 to 1.25). The median DTB time was longer for off-hours admissions (45 min; IQR 30-68) than regular hours (38 min; IQR 27-58; p<0.001). After adjusting for DTB time, the difference in adjusted 30-day mortality between regular and off-hours admissions for PPCI was attenuated and no longer statistically significant (OR 1.08; CI 0.97 to 1.20). CONCLUSION: Higher adjusted mortality associated with off-hours admissions for PPCI could be partly explained by differences in DTB times. Further investigations to understand the off-hours effect should focus on conditions likely to be sensitive to the rapid availability of services, where timeliness of care is a significant determinant of outcomes.

15.
JAMA Netw Open ; 2(12): e1917885, 2019 Dec 02.
Artigo em Inglês | MEDLINE | ID: mdl-31851350

RESUMO

Importance: Prompt recognition of myocardial infarction symptoms is critical for timely access to lifesaving emergency cardiac care. However, patients with myocardial infarction continue to have a delayed presentation to the hospital. Objective: To understand the variation and disparities in awareness of myocardial infarction symptoms among adults in the United States. Design, Setting, and Participants: This cross-sectional study used data from the 2017 National Health Interview Survey among adult residents of the United States, assessing awareness of the 5 following common myocardial infarction symptoms among different sociodemographic subgroups: (1) chest pain or discomfort, (2) shortness of breath, (3) pain or discomfort in arms or shoulders, (4) feeling weak, lightheaded, or faint, and (5) jaw, neck, or back pain. The response to a perceived myocardial infarction (ie, calling emergency medical services vs other) was also assessed. Main Outcomes and Measures: Prevalence and characteristics of individuals who were unaware of myocardial infarction symptoms and/or chose not to call emergency medical services in response to these symptoms. Results: Among 25 271 individuals (13 820 women [51.6%; 95% CI, 50.8%-52.4%]; 17 910 non-Hispanic white individuals [69.9%; 95% CI, 68.2%-71.6%]; and 21 826 individuals [82.7%; 95% CI, 81.5%-83.8%] born in the United States), 23 383 (91.8%; 95% CI, 91.0%-92.6%) considered chest pain or discomfort a symptom of myocardial infarction; 22 158 (87.0%; 95% CI, 86.1%-87.8%) considered shortness of breath a symptom; 22 064 (85.7%; 95% CI, 84.8%-86.5%) considered pain or discomfort in arm a symptom; 19 760 (77.0%; 95% CI, 76.1%-77.9%) considered feeling weak, lightheaded, or faint a symptom; and 16 567 (62.6%; 95% CI, 61.6%-63.7%) considered jaw, neck, or back pain a symptom. Overall, 14 075 adults (53.0%; 95% CI, 51.9%-54.1%) were aware of all 5 symptoms, whereas 4698 (20.3%; 95% CI, 19.4%-21.3%) were not aware of the 3 most common symptoms and 1295 (5.8%; 95% CI, 5.2%-6.4%) were not aware of any symptoms. Not being aware of any symptoms was associated with male sex (odds ratio [OR], 1.23; 95% CI, 1.05-1.44; P = .01), Hispanic ethnicity (OR, 1.89; 95% CI, 1.47-2.43; P < .001), not having been born in the United States (OR, 1.85; 95% CI, 1.47-2.33; P < .001), and having a lower education level (OR, 1.31; 95% CI, 1.09-1.58; P = .004). Among 294 non-Hispanic black or Hispanic individuals who were not born in the United States, belonged to the low-income or lowest-income subgroup, were uninsured, and had a lower education level, 61 (17.9%; 95% CI, 13.3%-23.6%) were not aware of any symptoms. This group had 6-fold higher odds of not being aware of any symptoms (OR, 6.34; 95% CI, 3.92-10.26; P < .001) compared with individuals without these characteristics. Overall, 1130 individuals (4.5%; 95% CI, 4.0%-5.0%) chose a different response than calling emergency medical services in response to a myocardial infarction. Conclusions and Relevance: Many adults in the United States remain unaware of the symptoms of and appropriate response to a myocardial infarction. In this study, several sociodemographic subgroups were associated with a higher risk of not being aware. They may benefit the most from targeted public health initiatives.

17.
JAMA Netw Open ; 2(11): e1916021, 2019 Nov 01.
Artigo em Inglês | MEDLINE | ID: mdl-31755952

RESUMO

Importance: Determining the association of contrast volume during percutaneous coronary intervention (PCI) with the risk of acute kidney injury (AKI) is important for optimizing PCI safety. Objective: To quantify how the risk of AKI is associated with contrast volume, accounting for the possibility of nonlinearity and heterogeneity among different baseline risks. Design, Setting, and Participants: This prognostic study used data from the American College of Cardiology National Cardiovascular Data Registry CathPCI Registry for 1694 US hospitals. Derivation analysis included 2 076 694 individuals who underwent PCI from July 1, 2011, to June 30, 2015. Validation analysis included 961 863 individuals who underwent PCI from July 1, 2015, to March 31, 2017. Data analysis took place from July 2018 to May 2019. Exposure: Contrast volume during PCI. Main Outcomes and Measures: Acute kidney injury was defined using 3 thresholds for preprocedure to postprocedure creatinine level increase (ie, ≥0.3 mg/dL, ≥0.5 mg/dL, and ≥1.0 mg/dL). A model quantifying the association of contrast volume with AKI was developed, and the existence of nonlinearity and heterogeneity were examined by likelihood ratio tests. The model was derived in the training set (a random 50% of the derivation cohort), and performance was evaluated in the test set (the remaining 50% of the derivation cohort) and an independent validation set by area under the receiver operating characteristic curve (AUC) and calibration slope of observed vs predicted risks. Results: The 2 076 694 patients in the derivation set had a mean (SD) age of 65.1 (12.1) years, and 662 525 (31.9%) were women; 133 306 (6.4%) had creatinine level increases of at least 0.3 mg/dL, 66 626 (3.2%) had creatinine level increases of at least 0.5 mg/dL, and 28 378 (1.4%) had creatinine level increases of at least 1.0 mg/dL. In the validation set of 961 843 patients (mean [SD] age, 65.7 [12.1] years; 305 577 [31.8%] women), these rates were 62 913 (6.5%), 34 229 (3.6%), and 15 555 (1.6%), respectively. The association of contrast volume and AKI risk was nonlinear (χ226 = 1436.2; P < .001) and varied by preprocedural risk (χ220 = 105.6; P < .001). In the test set, the model yielded an AUC of 0.777 (95% CI, 0.775-0.779) for predicting risk of a creatinine level increase of at least 0.3 mg/dL, 0.839 (95% CI, 0.837-0.841) for predicting risk of a creatinine level increase of at least 0.5 mg/dL, and 0.870 (95% CI, 0.867-0.873) for predicting risk of a creatinine level increase of at least 1.0 mg/dL; it achieved a calibration slope of 0.998 (95% CI, 0.989-1.007), 0.999 (95% CI, 0.989-1.008), and 0.986 (95% CI, 0.973-0.998), respectively, for the AKI severity levels. The model had similar performance in the validation set (creatinine level increase of ≥0.3 mg/dL: AUC, 0.794; 95% CI, 0.792-0.795; calibration slope, 1.039; 95% CI, 1.030-1.047; creatinine level increase of ≥0.5 mg/dL: AUC, 0.845; 95% CI, 0.843-0.848; calibration slope, 1.063; 95% CI, 1.054-1.074; creatinine level increase of ≥1.0 mg/dL: AUC, 0.872; 95% CI, 0.869-0.875; calibration slope, 1.103; 95% CI, 1.089-1.117). Conclusions and Relevance: The association of contrast volume with AKI risk is complex, varies by baseline risk, and can be predicted by a model. Future research to evaluate the effect of the model on AKI is needed.

18.
Circulation ; 140(25): 2067-2075, 2019 Dec 17.
Artigo em Inglês | MEDLINE | ID: mdl-31760784

RESUMO

BACKGROUND: Medication nonadherence is associated with worse outcomes in patients with atherosclerotic cardiovascular disease (ASCVD), a group who requires long-term therapy for secondary prevention. It is important to understand to what extent drug costs, which are potentially actionable factors, contribute to medication nonadherence. METHODS: In a nationally representative survey of US adults in the National Health Interview Survey (2013-2017), we identified individuals ≥18 years with a reported history of ASCVD. Participants were considered to have experienced cost-related nonadherence (CRN) if in the preceding 12 months they reported skipping doses to save money, taking less medication to save money, or delaying filling a prescription to save money. We used survey analysis to obtain national estimates. RESULTS: Of the 14 279 surveyed individuals with ASCVD, a weighted 12.6% (or 2.2 million [95% CI, 2.1-2.4]) experienced CRN, including 8.6% or 1.5 million missing doses, 8.8% or 1.6 million taking lower than prescribed doses, and 10.5% or 1.9 million intentionally delaying a medication fill to save costs. Age <65 years, female sex, low family income, lack of health insurance, and high comorbidity burden were independently associated with CRN, with >1 in 5 reporting CRN in these subgroups. Survey respondents with CRN compared with those without CRN had 10.8-fold higher odds of requesting low-cost medications and 8.9-fold higher odds of using alternative, nonprescription, therapies. CONCLUSIONS: One in 8 patients with ASCVD reports nonadherence to medications because of cost. The removal of financial barriers to accessing medications, particularly among vulnerable patient groups, may help improve adherence to essential therapy to reduce ASCVD morbidity and mortality.

19.
Circulation ; 2019 Nov 11.
Artigo em Inglês | MEDLINE | ID: mdl-31707798

RESUMO

On July 9, 2018, Health Canada announced a voluntary recall of 6 generic valsartan products due to the detection of a known carcinogen nitrosodimethylamine (NDMA).1 In total, more than 22 countries, including the United States, initiated recalls. Despite an increase in drug recalls, few studies have evaluated their impact.2,3 The valsartan recall, of a frequently used oral medication for high prevalence chronic conditions, such as, hypertension, provides an opportunity to examine the consequences of a drug recall by patients and health care systems. We used a segmented regression analysis using multiple linked healthcare databases in Ontario, Canada, including the Ontario Drug Benefit (ODB) prescription claims database to identify our cohort of recalled valsartan users and to ascertain non-valsartan medication use, the Ontario Registered Persons database for vital status, Canadian Institute for Health Information for discharge diagnoses for hospital admissions, baseline comorbidities, and clinical outcomes, National Ambulatory Care Reporting System database for emergency department (ED) visits, and Statistics Canada census database for income datasets. These datasets were linked using unique encoded identifiers and analyzed at ICES. We included patients ≥65 years old who had been dispensed a supply of at least one recalled valsartan product that would cover the period up to and including the date of 7/9/2018, and were alive on this date.

20.
Artigo em Inglês | MEDLINE | ID: mdl-31734198

RESUMO

OBJECTIVES: This study sought to evaluate the association and burden of coronary artery calcium (CAC) with long-term, cause-specific mortality across the spectrum of baseline risk. BACKGROUND: Although CAC is a known predictor of short-term, all-cause mortality, data on long-term and cause-specific mortality are inadequate. METHODS: The CAC Consortium cohort is a multicenter cohort of 66,636 participants without coronary heart disease (CHD) who underwent CAC testing. The following risk factors (RFs) were considered: 1) current cigarette smoking; 2) dyslipidemia; 3) diabetes mellitus; 4) hypertension; and 5) family history of CHD. RESULTS: During the 12.5-years median follow-up, 3,158 (4.7%) deaths occurred; 32% were cardiovascular disease (CVD) deaths. Participants with CAC scores ≥400 had a significantly increased risk for CHD and CVD mortality (hazard ratio [HR]: 5.44; 95% confidence interval [CI]: 3.88 to 7.62; and HR: 4.15; 95% CI: 3.29 to 5.22, respectively) compared with CAC of 0. Participants with ≥3 RFs had a smaller increased risk for CHD and CVD mortality (HR: 2.09; 95% CI: 1.52 to 2.85; and HR: 1.84; 95% CI: 1.46 to 2.31, respectively) compared with those without RFs. Across RF strata, CAC added prognostic information. For example, participants without RFs but with CAC ≥400 had significantly higher all-cause, non-CVD, CVD, and CHD mortality rates compared with participants with ≥3 RFs and CAC of 0. CONCLUSIONS: Across the spectrum of RF burden, a higher CAC score was strongly associated with long-term, all-cause mortality and a greater proportion of deaths due to CVD and CHD. Absence of CAC identified people with a low risk over 12 years of follow-up, with most deaths being non-CVD in nature, regardless of RF burden.

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