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Dabigatran is a novel oral anti-coagulant (NOAC) that reduces risk of stroke in patients with non-valvular atrial fibrillation (NVAF). It does not require routine monitoring with laboratory testing which may have an adverse impact on adherence. We aimed to describe adherence to dabigatran in the first year after initiation and assess the association between non-adherence to dabigatran and clinical outcomes in a large integrated healthcare system. We studied a national cohort of 5,376 patients with NVAF, initiated on dabigatran between October-2010 and September-2012 at all Veterans Affairs hospitals. Adherence to dabigatran was calculated as proportion of days covered (PDC) and association between PDC and outcomes was assessed using standard regression techniques. Mean age of the study cohort was 71.3 ± 9.7 years; 98.3% were men and mean CHADS2 score was 2.4 ± 1.2 (mean CHA2DS2VASc score 3.2 ± 1.4). Median PDC was 94% (IQR 76%-100%; mean PDC 84% ± 22%) over a median follow-up of 244 days (IQR 140-351). A total of 1,494 (27.8%) patients had a PDC <80% and were classified as non-adherent. After multivariable adjustment, lower adherence was associated with increased risk for combined all-cause mortality and stroke (HR 1.13, 95% CI 1.07–1.19 per 10% decrease in PDC). Adherence to dabigatran was not associated with non-fatal bleeding or myocardial infarction. In the year after initiation, adherence to dabigatran for a majority of patients is very good. However, 28% of patients in our cohort had poor adherence. Furthermore, lower adherence to dabigatran was associated with increased adverse outcomes. Concerted efforts are needed to optimize adherence to NOACs.

ObjectiveTo determine the implications of applying guideline-recommended definitions of aortic stenosis to echocardiographic data captured in routine clinical care.MethodsRetrospective observational study of 213 174 patients who underwent transthoracic echocardiographic imaging within Allina Health between January 2013 and October 2017. The sensitivity, specificity, positive predictive value, negative predictive value and accuracy of echocardiographic measures for severe aortic stenosis were determined relative to the documented interpretation of severe aortic stenosis.ResultsAmong 77 067 patients with complete assessment of the aortic valve, 1219 (1.6%) patients were categorised as having severe aortic stenosis by the echocardiographic reader. Relative to the documented interpretation, aortic valve area (AVA) as a measure of severe aortic stenosis had the high sensitivity (94.1%) but a low positive predictive value (37.5%). Aortic valve peak velocity and mean gradient were specific (>99%), but less sensitive (<70%). A measure incorporating peak velocity, mean gradient and dimensionless index (either by velocity time integral or peak velocity ratio) achieved a balance of sensitivity (92%) and specificity (99%) with little detriment in accuracy relative to peak velocity and mean gradient alone (98.9% vs 99.3%). Using all available data, the proportion of patients whose echocardiogram could be assessed for aortic stenosis was 79.8% as compared with 52.7% by documented interpretation alone.ConclusionA measure that used dimensionless index in place of AVA addressed discrepancies between quantitative echocardiographic data and the documented interpretation of severe aortic stenosis. These findings highlight the importance of understanding the limitations of clinical data as it relates to quality improvement efforts and pragmatic research design.

In-hospital mortality rates from COVID-19 are high but appear to be decreasing for selected locations in the United States. It is not known whether this is because of changes in the characteristics of patients being admitted. To describe changing in-hospital mortality rates over time after accounting for individual patient characteristics. This was a retrospective cohort study of 20 736 adults with a diagnosis of COVID-19 who were included in the US American Heart Association COVID-19 Cardiovascular Disease Registry and admitted to 107 acute care hospitals in 31 states from March through November 2020. A multiple mixed-effects logistic regression was then used to estimate the odds of in-hospital death adjusted for patient age, sex, body mass index, and medical history as well as vital signs, use of supplemental oxygen, presence of pulmonary infiltrates at admission, and hospital site. In-hospital death adjusted for exposures for 4 periods in 2020. The registry included 20 736 patients hospitalized with COVID-19 from March through November 2020 (9524 women [45.9%]; mean [SD] age, 61.2 [17.9] years); 3271 patients (15.8%) died in the hospital. Mortality rates were 19.1% in March and April, 11.9% in May and June, 11.0% in July and August, and 10.8% in September through November. Compared with March and April, the adjusted odds ratios for in-hospital death were significantly lower in May and June (odds ratio, 0.66; 95% CI, 0.58-0.76; P < .001), July and August (odds ratio, 0.58; 95% CI, 0.49-0.69; P < .001), and September through November (odds ratio, 0.59; 95% CI, 0.47-0.73). In this cohort study, high rates of in-hospital COVID-19 mortality among registry patients in March and April 2020 decreased by more than one-third by June and remained near that rate through November. This difference in mortality rates between the months of March and April and later months persisted even after adjusting for age, sex, medical history, and COVID-19 disease severity and did not appear to be associated with changes in the characteristics of patients being admitted.

Importance The optimal approach to airway management during in-hospital cardiac arrest is unknown. Objective To describe hospital-level variation in endotracheal intubation during cardiopulmonary resuscitation (CPR) for in-hospital cardiac arrest and the association between hospital use of endotracheal intubation and arrest survival. Design, setting, participants Retrospective cohort study of adult patients suffering in-hospital cardiac arrest at Get With The Guidelines-Resuscitation participating hospitals between January, 2000, and December, 2016. Hospitals were categorized into quartiles based on the proportion of in-hospital cardiac arrest patients managed with endotracheal intubation during CPR. Risk-adjusted mixed models with random intercepts were created to assess the association between hospital quartile of in-hospital arrests managed with endotracheal intubation during CPR and survival to hospital discharge. Exposure Hospital rate of endotracheal intubation during CPR for in-hospital arrest Main outcomes and measures Survival to hospital discharge Results Among 155,252 patients suffering in-hospital cardiac arrest at 656 hospitals, 69.7% of patients received endotracheal intubation during CPR and overall survival to discharge was 24.8%. At the hospital level, the median rate of endotracheal intubation use was 71.2% (interquartile range, 63.6 to 78.1%; range, 26.6 to 100%). We found a strong inverse association between hospital rate of endotracheal intubation and survival to discharge (risk-adjusted odds ratio comparing highest intubation quartile vs. lowest intubation quartile, 0.81; 95% confidence interval (CI), 0.74 to 0.90; p value < .001). This association was modified by the presence of respiratory failure prior to arrest ( p for interaction < .001), and stratified analyses demonstrated lower patient survival at hospitals with higher rates of endotracheal intubation was limited to patients without respiratory failure prior to cardiac arrest. Conclusion In a national sample of patients suffering IHCA, the use of endotracheal intubation during CPR varied across hospitals. We found a strong inverse association between hospital use of endotracheal intubation during CPR and survival to discharge, but this association was confined to patients without respiratory failure prior to arrest. Identifying the optimal approach to airway management for in-hospital cardiac arrest may have a significant impact on patient survival.

Contrast-induced acute kidney injury (AKI) is a common and severe complication of percutaneous coronary intervention (PCI). Despite its substantial burden, contemporary data on the incremental costs of AKI are lacking. We designed this large, nationally representative study to examine: (1) the independent, incremental costs associated with AKI after PCI and (2) to identify the departmental components of cost contributing to the incremental costs associated with AKI. In this observational cross-sectional study from the Premier database, we analyzed 1,443,297 PCI patients at 518 US hospitals from 1/2006 to 12/2015. Incremental cost of AKI from a hospital perspective obtained by a microcosting approach, was estimated using mixed-effects, multivariable linear regression with hospitals as random effects. Costs were inflation-corrected to 2016 US$. AKI occurred in 82,683 (5.73%) of the PCI patients. Those with AKI had higher hospitalization cost than those without ($38,869, SD 42,583 vs $17,167 SD 13,994, p <0.001). After adjustment, the incremental cost associated with an AKI was $9,448 (95% confidence interval $9,338 to $9,558, p <0.001). AKI was also independently associated with an incremental length of stay of 3.6 days (p <0.001). Room and board costs were the largest driver of AKI costs ($4,841). Extrapolated to the United States, our findings imply an annual AKI cost burden of 411.3 million US$. In conclusion, in this national study of PCI patients, AKI was common and independently associated with ∼$10,000 incremental costs, implying a substantial burden of AKI costs in US hospitals. Successful efforts to prevent AKI in patients who underwent PCI could result in meaningful cost savings.

Objective Obesity is stigmatized and people with obesity report experiencing stigmatizing situations when seeking health care. The implications of these experiences are not well understood. This study tests an indirect effects model of negative care experiences as an intermediate variable between obesity and care avoidance/utilization and switching primary care doctors. Methods A survey was completed by 2380 primary care patients in the Learning Health Systems Network (LHSNet) Clinical Data Research Network with a BMI >25 kg/m2. Measures included scales assessing stigmatizing situations, perceived patient‐centered communication, perceived respect, having delayed needed care, and having looked for a new primary doctor in the past 12 months. Sequential and serial indirect effects of care experiences and respect in the association between BMI and care utilization outcomes was modeled. Results The hypothesized model was supported by findings. The associations between BMI and delaying needed care (OR = 1.06, p < 0.001) and attempting to switch primary doctors (OR = 1.02, p = 0.04) was mediated by both stigmatizing situations experienced in a health care context and lower patient‐centered communication. Lower perceived respect mediated the association between care experiences and utilization outcomes. Conclusions People with higher BMIs may avoid care or switch doctors as a result of stigmatizing experiences and poor communication with doctors. These outcomes may contribute to morbidity in people with obesity if they delay or avoid care for health concerns when symptoms first present.

Background The natural history of patients with moderate aortic stenosis (AS) is poorly understood. We aimed to determine the long-term outcomes of patients with moderate AS. Methods We examined patients with moderate AS defined by echocardiography in our healthcare system, and performed survival analyses for occurrence of death, heart failure (HF) hospitalization, and progression of AS, with accounting for symptoms, left ventricular dysfunction, and comorbidities. Results We examined 729 patients with moderate AS (median age, 76 years; 59.9 % men) with a median follow-up of 5.0 years (interquartile range: 2.0 to 8.1 years). The 5-year overall survival was 52.3 % (95 % confidence interval [CI]: 48.6 % to 56.0 %) and survival free of death or HF hospitalization was 43.2 % (95 % CI: 39.5 % to 46.9 %). Worse New York Heart Association (NYHA) functional class was associated with poor long-term survival, with mortality rates ranging from 7.9 % (95 % CI: 6.6–9.2 %) to 25.2 % (95 % CI: 20.2–30.3 %) per year. Among patients with minimal or no symptoms, no futility markers, and preserved left ventricular function, 5-year overall survival was 71.9 % (95 % CI: 66.4–77.4 %) and survival free of death or HF hospitalization was 61.4 % (95 % CI: 55.5–67.3 %). Risk factors associated with adverse events were age, NYHA class, low ejection fraction and high aortic valve velocity (all p  < 0.05). Conclusions Patients with moderate AS are at significant risk of death. Our findings highlight the need for more study into appropriate therapeutic interventions to improve the prognosis of these patients.

There is little data describing trends in the use of hydroxychloroquine for COVID-19 following publication of randomized trials that failed to demonstrate a benefit of this therapy. We identified 13,957 patients admitted for active COVID-19 at 85 U.S. hospitals participating in a national registry between March 1 and August 31, 2020. The overall proportion of patients receiving hydroxychloroquine peaked at 55.2% in March and April and decreased to 4.8% in May and June and 0.8% in July and August. At the hospital-level, median use was 59.4% in March and April (IQR 48.5–71.5%, range 0–100%) and decreased to 0.3% (IQR 0–5.4%, range 0–100%) by May and June and 0% (IQR 0–1.3%, range 0–36.4%) by July and August. The rate and hospital-level uniformity in deimplementation of this ineffective therapy for COVID-19 reflects a rapid response to evolving clinical information and further study may offer strategies to inform deimplementation of ineffective clinical care.

Establishing the validity of appropriate use criteria (AUC) for percutaneous coronary intervention (PCI) in the setting of stable ischemic heart disease can support their adoption for quality improvement. We conducted a post hoc analysis of 2,287 Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation trial patients with stable ischemic heart disease randomized to PCI with optimal medical therapy (OMT) or OMT alone. Within appropriateness categories, we compared rates of death, myocardial infarction, revascularization subsequent to initial therapy, and angina-specific health status as determined by the Seattle Angina Questionnaire in patients randomized to PCI + OMT to those randomized to OMT alone. A total of 1,987 patients (87.9%) were mapped to the 2012 publication of the AUC, with 1,334 (67.1%) classified as appropriate, 551 (27.7%) uncertain, and 102 (5.1%) as inappropriate. There were no significant differences between PCI and OMT alone in the rate of mortality and myocardial infarction by appropriateness classification. Rates of revascularization were significantly lower in patients initially receiving PCI + OMT who were classified as appropriate (hazard ratio 0.65; 95% confidence interval 0.53 to 0.80; p <0.001) or uncertain (hazard ratio 0.49; 95% confidence interval 0.32 to 0.76; p = 0.001). Furthermore, among patients classified as appropriate by the AUC, Seattle Angina Questionnaire scores at 1 month were better in the PCI-treated group compared with the medical therapy group (80 ± 23 vs 75 ± 24 for angina frequency, 73 ± 24 vs 68 ± 24 for physical limitations, and 68 ± 23 vs 60 ± 24 for quality of life; all p <0.01), with differences generally persisting through 12 months. In contrast, health status scores were similar throughout the first year of follow-up in PCI + OMT patients compared with OMT alone in patients classified as uncertain or inappropriate. In conclusion, these findings support the validity of the AUC in efforts to improve health care quality through optimal use of PCI.

Appropriate use criteria are a practical quality improvement tool that apply published trial evidence and the generalised recommendations of practice guidelines to specific clinical scenarios likely to be encountered in everyday practice.3 In these criteria, the clinical indication for a test or procedure is considered ‘appropriate’ when the expected clinical benefits, in terms of survival or health status (symptoms, functional status or quality of life), exceed the risks of the test or procedure and ‘inappropriate’ when the risks generally outweigh the benefits. The Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation (COURAGE)4 trial and the recent International Study of Comparative Health Effectiveness with Medical and Invasive Approaches (ISCHEMIA)5 trial demonstrated elective PCI for stable coronary artery disease is about health status improvement (ie, symptom burden, functional status and health-related quality of life), not a reduction in mortality or cardiovascular events. [...]patients with minimal preprocedural symptom burden who are less likely to have a large clinical improvement in symptoms following PCI (ie, ceiling effect) are lumped together with patients with a large preprocedural symptom burden and greater chance for clinical improvement. [...]we incorporate these data, the ability of appropriate use criteria to forecast patient outcomes from PCI remains cloudy.