At the beginning of June 2020, there were nearly 7 million reported cases of coronavirus disease 2019 (COVID-19) worldwide and over 400,000 deaths in people with COVID-19. The objective of this study ...was to determine associations between comorbidities listed in the Charlson comorbidity index and mortality among patients in the United States with COVID-19.
A retrospective cohort study of adults with COVID-19 from 24 healthcare organizations in the US was conducted. The study included adults aged 18-90 years with COVID-19 coded in their electronic medical records between January 20, 2020, and May 26, 2020. Results were also stratified by age groups (<50 years, 50-69 years, or 70-90 years). A total of 31,461 patients were included. Median age was 50 years (interquartile range IQR, 35-63) and 54.5% (n = 17,155) were female. The most common comorbidities listed in the Charlson comorbidity index were chronic pulmonary disease (17.5%, n = 5,513) and diabetes mellitus (15.0%, n = 4,710). Multivariate logistic regression analyses showed older age (odds ratio OR per year 1.06; 95% confidence interval CI 1.06-1.07; p < 0.001), male sex (OR 1.75; 95% CI 1.55-1.98; p < 0.001), being black or African American compared to white (OR 1.50; 95% CI 1.31-1.71; p < 0.001), myocardial infarction (OR 1.97; 95% CI 1.64-2.35; p < 0.001), congestive heart failure (OR 1.42; 95% CI 1.21-1.67; p < 0.001), dementia (OR 1.29; 95% CI 1.07-1.56; p = 0.008), chronic pulmonary disease (OR 1.24; 95% CI 1.08-1.43; p = 0.003), mild liver disease (OR 1.26; 95% CI 1.00-1.59; p = 0.046), moderate/severe liver disease (OR 2.62; 95% CI 1.53-4.47; p < 0.001), renal disease (OR 2.13; 95% CI 1.84-2.46; p < 0.001), and metastatic solid tumor (OR 1.70; 95% CI 1.19-2.43; p = 0.004) were associated with higher odds of mortality with COVID-19. Older age, male sex, and being black or African American (compared to being white) remained significantly associated with higher odds of death in age-stratified analyses. There were differences in which comorbidities were significantly associated with mortality between age groups. Limitations include that the data were collected from the healthcare organization electronic medical record databases and some comorbidities may be underreported and ethnicity was unknown for 24% of participants. Deaths during an inpatient or outpatient visit at the participating healthcare organizations were recorded; however, deaths occurring outside of the hospital setting are not well captured.
Identifying patient characteristics and conditions associated with mortality with COVID-19 is important for hypothesis generating for clinical trials and to develop targeted intervention strategies.
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DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
Depression and anxiety are highly prevalent in patients with cardiovascular disease (CVD) and influence their mental well-being and CVD prognosis. The primary objective was to assess the ...effectiveness of cognitive behavioral therapy (CBT) for depression and anxiety in patients with CVD. Secondary objectives were to assess the impact of CBT on cardiovascular mortality, cardiovascular events, patient satisfaction, and quality of life.
MEDLINE, PsycINFO, CINAHL, CENTRAL, and alternative sources were searched for randomized controlled trials and observational studies with a control. Studies were required to assess CBT in coronary heart disease, acute coronary syndrome, atrial fibrillation, or postmyocardial infarction patients, with anxiety and/or depression. Studies were independently screened by two reviewers and critically appraised using the Cochrane Risk of Bias tool. The random-effects model was used to pool standardized mean differences (SMD).
Twelve randomized controlled trials were included. At follow-up, depression (SMD = -0.35, 95% confidence interval CI = -0.52 to -0.17, p < .001, I = 59%) and anxiety (SMD = -0.34, 95% CI = -0.65 to -0.03, p = .03, I = 71%) scores were significantly lower in CBT patients compared with controls. Change in mental health quality of life (SF-12) was also significantly greater for CBT patients, compared with controls (mean difference = 3.62, 95% CI = 0.22 to 7.02, p = .04, I = 0%). No differences in patient satisfaction or cardiovascular events were evident between CBT and control groups. Among the study reports included in this meta-analysis, data specific to cardiovascular mortality were not reported.
Cognitive behavioral therapy seems to be an effective treatment for reducing depression and anxiety in patients with CVD and should be considered in standard clinical care.
Mobile Health technology for the management of patients with atrial fibrillation is unknown.
The simple mobile AF (mAF) App was designed to incorporate clinical decision-support tools (CHA2DS2-VASc ...Congestive heart failure, Hypertension, Age ≥75 years, Diabetes Mellitus, Prior Stroke or TIA, Vascular disease, Age 65–74 years, Sex category, HAS-BLED Hypertension, Abnormal renal/liver function, Stroke, Bleeding history or predisposition, Labile INR, Elderly, Drugs/alcohol concomitantly, SAMe-TT2R2 Sex, Age <60 years, Medical history, Treatment, Tobacco use, Race scores), educational materials, and patient involvement strategies with self-care protocols and structured follow-up. Patients with atrial fibrillation were randomized into 2 groups (mAF App vs usual care) in a cluster randomized design pilot study. Patients' knowledge, quality of life, drug adherence, and anticoagulation satisfaction were evaluated at baseline, 1 month, and 3 months. Usability, feasibility, and acceptability of the mAF App were assessed at 1 month.
A total of 113 patients were randomized to mAF App intervention (mean age, 67.4 years; 57.5% were male; mean follow-up, 69 days), and 96 patients were randomized to usual care (mean age, 70.9 years; 55.2% were male; mean follow-up, 95 days). More than 90% of patients reported that the mAF App was easy, user-friendly, helpful, and associated with significant improvements in knowledge compared with the usual care arm (P values for trend <.05). Drug adherence and anticoagulant satisfaction were significantly better with the mAF App versus usual care (all P < .05). Quality of life scores were significantly increased in the mAF App arm versus usual care, with anxiety and depression reduced (all P < .05).
The pilot mAFA Trial is the first prospective randomized trial of Mobile Health technology in patients with atrial fibrillation, demonstrating that the mAF App, integrating clinical decision support, education, and patient-involvement strategies, significantly improved knowledge, drug adherence, quality of life, and anticoagulation satisfaction.
Stroke prevention in atrial fibrillation (AF), most commonly with warfarin, requires maintenance of a narrow therapeutic target (INR 2.0 to 3.0) and is often poorly controlled in practice. Poor ...patient-understanding surrounding AF and its treatment may contribute to the patient's willingness to adhere to recommendations.
A theory-driven intervention, developed using patient interviews and focus groups, consisting of a one-off group session (1-6 patients) utilising an "expert-patient" focussed DVD, educational booklet, self-monitoring diary and worksheet, was compared in a randomised controlled trial (ISRCTN93952605) against usual care, with patient postal follow-ups at 1, 2, 6, and 12-months. Ninety-seven warfarin-naïve AF patients were randomised to intervention (n=46, mean age (SD) 72.0 (8.2), 67.4% men), or usual care (n=51, mean age (SD) 73.7 (8.1), 62.7% men), stratified by age, sex, and recruitment centre. Primary endpoint was time within therapeutic range (TTR); secondary endpoints included knowledge, quality of life, anxiety/depression, beliefs about medication, and illness perceptions.
Intervention patients had significantly higher TTR than usual care at 6-months (76.2% vs. 71.3%; p=0.035); at 12-months these differences were not significant (76.0% vs. 70.0%; p=0.44). Knowledge increased significantly across time (F (3, 47) = 6.4; p<0.01), but there were no differences between groups (F (1, 47) = 3.3; p = 0.07). At 6-months, knowledge scores predicted TTR (r=0.245; p=0.04). Patients' scores on subscales representing their perception of the general harm and overuse of medication, as well as the perceived necessity of their AF specific medications predicted TTR at 6- and 12-months.
A theory-driven educational intervention significantly improves TTR in AF patients initiating warfarin during the first 6-months. Adverse clinical outcomes may potentially be reduced by improving patients' understanding of the necessity of warfarin and reducing their perception of treatment harm. Improving education provision for AF patients is essential to ensure efficacious and safe treatment. The trial is registered with Current Controlled Trials, ISRCTN93952605, and details are available at www.controlled-trials.com/ISRCTN93952605.
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DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
Objective To clarify the impact of digoxin on death and clinical outcomes across all observational and randomised controlled trials, accounting for study designs and methods.Data sources and study ...selection Comprehensive literature search of Medline, Embase, the Cochrane Library, reference lists, and ongoing studies according to a prospectively registered design (PROSPERO: CRD42014010783), including all studies published from 1960 to July 2014 that examined treatment with digoxin compared with control (placebo or no treatment).Data extraction and synthesis Unadjusted and adjusted data pooled according to study design, analysis method, and risk of bias.Main outcome measures Primary outcome (all cause mortality) and secondary outcomes (including admission to hospital) were meta-analysed with random effects modelling.Results 52 studies were systematically reviewed, comprising 621 845 patients. Digoxin users were 2.4 years older than control (weighted difference 95% confidence interval 1.3 to 3.6), with lower ejection fraction (33% v 42%), more diabetes, and greater use of diuretics and anti-arrhythmic drugs. Meta-analysis included 75 study analyses, with a combined total of 4 006 210 patient years of follow-up. Compared with control, the pooled risk ratio for death with digoxin was 1.76 in unadjusted analyses (1.57 to 1.97), 1.61 in adjusted analyses (1.31 to 1.97), 1.18 in propensity matched studies (1.09 to 1.26), and 0.99 in randomised controlled trials (0.93 to 1.05). Meta-regression confirmed that baseline differences between treatment groups had a significant impact on mortality associated with digoxin, including markers of heart failure severity such as use of diuretics (P=0.004). Studies with better methods and lower risk of bias were more likely to report a neutral association of digoxin with mortality (P<0.001). Across all study types, digoxin led to a small but significant reduction in all cause hospital admission (risk ratio 0.92, 0.89 to 0.95; P<0.001; n=29 525).Conclusions Digoxin is associated with a neutral effect on mortality in randomised trials and a lower rate of admissions to hospital across all study types. Regardless of statistical analysis, prescription biases limit the value of observational data.
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BFBNIB, CMK, NMLJ, NUK, PNG, SAZU, UL, UM, UPUK
The risk of stroke is heterogeneous across different groups of patients with atrial fibrillation (AF), being dependent on the presence of various stroke risk factors. We provide recommendations for ...antithrombotic treatment based on net clinical benefit for patients with AF at varying levels of stroke risk and in a number of common clinical scenarios.
Systematic literature reviews were conducted to identify relevant articles published from the last formal search perfomed for the Antithrombotic and Thrombolytic Therapy: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (9th Edition). The overall quality of the evidence was assessed using the GRADE (Grading of Recommendations, Assessment, Development, and Evaluation) approach. Graded recommendations and ungraded consensus-based statements were drafted, voted on, and revised until consensus was reached.
For patients with AF without valvular heart disease, including those with paroxysmal AF, who are at low risk of stroke (eg, CHA
DS
-VASc congestive heart failure, hypertension, age ≥ 75 (doubled), diabetes, stroke (doubled)-vascular disease, age 65-74 and sex category (female) score of 0 in males or 1 in females), we suggest no antithrombotic therapy. The next step is to consider stroke prevention (ie, oral anticoagulation therapy) for patients with 1 or more non-sex CHA
DS
-VASc stroke risk factors. For patients with a single non-sex CHA
DS
-VASc stroke risk factor, we suggest oral anticoagulation rather than no therapy, aspirin, or combination therapy with aspirin and clopidogrel; and for those at high risk of stroke (eg, CHA
DS
-VASc ≥ 2 in males or ≥ 3 in females), we recommend oral anticoagulation rather than no therapy, aspirin, or combination therapy with aspirin and clopidogrel. Where we recommend or suggest in favor of oral anticoagulation, we suggest using a non-vitamin K antagonist oral anticoagulant drug rather than adjusted-dose vitamin K antagonist therapy. With the latter, it is important to aim for good quality anticoagulation control with a time in therapeutic range > 70%. Attention to modifiable bleeding risk factors (eg, uncontrolled BP, labile international normalized ratios, concomitant use of aspirin or nonsteroidal antiinflammatory drugs in an anticoagulated patient, alcohol excess) should be made at each patient contact, and HAS-BLED (hypertension, abnormal renal/liver function 1 point each, stroke, bleeding history or predisposition, labile international normalized ratio, elderly (0.65), drugs/alcohol concomitantly 1 point each) score used to assess the risk of bleeding where high risk patients (≥ 3) should be reviewed and followed up more frequently.
Oral anticoagulation is the optimal choice of antithrombotic therapy for patients with AF with ≥1 non-sex CHA
DS
-VASc stroke risk factor(s).
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
Integrated care for the clinical management of atrial fibrillation patients is advocated as a holistic way to improve outcomes; the simple Atrial fibrillation Better Care (ABC) pathway has been ...proposed. The ABC pathway streamlines care as follows: ‘A’ Avoid stroke; ‘B’ Better symptom management; ‘C’ Cardiovascular and Comorbidity optimization.
We performed a post hoc analysis of the Atrial Fibrillation Follow-Up Investigation of Rhythm Management (AFFIRM) trial. An ‘integrated care’ approach was defined according to the ABC pathway. Patients fulfilling all criteria were categorized as the ‘ABC’ group; those not fulfilling all criteria were the ‘non-ABC’ group. Trial-adjudicated all-cause death, composite outcome of stroke/major bleeding/cardiovascular death, and first hospitalization were the main study outcomes.
Among the 4060 patients in the original cohort, 3169 (78%) had available data to compare integrated care (ABC; n = 222; 7%) vs non-ABC (n = 2947; 93%) management. Over a median follow-up of 3.7 (interquartile range, 2.8-4.6) years, atrial fibrillation patients managed with integrated care (ABC group) had lower rates for all study outcomes (all P < .001) compared with the non-ABC group. A Cox multivariable regression analysis showed that atrial fibrillation patients managed in the ABC group had a significantly lower risk of all-cause death (hazard ratio HR, 0.35; 95% confidence interval CI, 0.17-0.75), composite outcome (HR, 0.35; 95% CI, 0.18-0.68), and first hospitalization (HR, 0.65; 95% CI, 0.53-0.80).
The simple ABC pathway allows the streamlining of integrated care for atrial fibrillation patients in a holistic manner and is associated with a lower risk of adverse outcomes (including mortality, stroke/major bleeding/cardiovascular death, and hospitalization).
IMPORTANCE: Atrial fibrillation (AF) is associated with an increase in mortality and morbidity, with a substantial increase in stroke and systemic thromboembolism. Strokes related to AF are ...associated with higher mortality, greater disability, longer hospital stays, and lower chance of being discharged home than strokes unrelated to AF. OBJECTIVE: To provide an overview of current concepts and recent developments in stroke prevention in AF, with suggestions for practical management. EVIDENCE REVIEW: A comprehensive structured literature search was performed using MEDLINE for studies published through March 11, 2015, that reported on AF and stroke, bleeding risk factors, and stroke prevention. FINDINGS: The risk of stroke in AF is reduced by anticoagulant therapy. Thromboprophylaxis can be obtained with vitamin K antagonists (VKA, eg, warfarin) or a non-VKA oral anticoagulant (NOAC). Major guidelines emphasize the important role of oral anticoagulation (OAC) for effective stroke prevention in AF. Initially, clinicians should identify low-risk AF patients who do not require antithrombotic therapy (ie, CHA2DS2-VASc score, 0 for men; 1 for women). Subsequently, patients with at least 1 stroke risk factor (except when the only risk is being a woman) should be offered OAC. A patient’s individual risk of bleeding from antithrombotic therapy should be assessed, and modifiable risk factors for bleeding should be addressed (blood pressure control, discontinuing unnecessary medications such as aspirin or nonsteroidal anti-inflammatory drugs). The international normalized ratio should be tightly controlled for patients receiving VKAs. CONCLUSIONS AND RELEVANCE: Stroke prevention is central to the management of AF, irrespective of a rate or rhythm control strategy. Following the initial focus on identifying low-risk patients, all others with 1 or more stroke risk factors should be offered OAC.
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