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Heart failure in the outpatient versus inpatient setting: findings from the BIOSTAT-CHF study.
Ferreira, JP, Metra, M, Mordi, I, Gregson, J, Ter Maaten, JM, Tromp, J, Anker, SD, Dickstein, K, Hillege, HL, Ng, LL, et al
European journal of heart failure. 2019;(1):112-120
Abstract
INTRODUCTION Patients with symptomatic heart failure (HF) require additive therapies and have a poor prognosis. However, patient characteristics and clinical outcome between HF patients treated in the outpatient setting vs. those who are hospitalized remain scarce. METHODS AND RESULTS The BIOlogy Study to TAilored Treatment in Chronic Heart Failure (BIOSTAT-CHF) included 2516 patients with symptoms and/or signs of HF: 1694 as inpatients and 822 as outpatients. Compared to ambulatory HF patients, inpatients had higher heart rate, urea, N-terminal pro-brain natriuretic peptide, lower blood pressure, lower estimated glomerular filtration rate, sodium, potassium, high-density lipoprotein cholesterol, had more often peripheral oedema, diabetes, anaemia, and were less often treated with beta-blockers and angiotensin-converting enzyme inhibitors (ACEi). Outpatients had a more frequent history of HF hospitalization and received more frequently beta-blockers and/or ACEi/angiotensin receptor blockers up-titrated to target doses (P < 0.001). Inpatients had higher rates of the primary outcome of death or HF hospitalization: incidence rate per 100 person-years of 33.4 [95% confidence interval (CI) 31.1-35.9] for inpatients vs. 18.5 (95% CI 16.4-21.0) for outpatients; adjusted hazard ratio 1.24 (95% CI 1.07-1.43). Subdividing patients into low, intermediate and high-risk categories, the primary outcome event rates were 14.3 (95% CI 12.3-16.7), 36.6 (95% CI 32.2-41.5), and 71.3 (95% CI 64.4-79.0) for inpatients vs. 8.4 (95% CI 6.6-10.6), 29.8 (95% CI 24.5-36.2), and 43.3 (95% CI 34.7-54.0) for outpatients, respectively. These findings were externally replicated. CONCLUSIONS Marked differences were observed between inpatients and outpatients with HF. Overall, inpatients were sicker and had higher event rates. However, a substantial proportion of outpatients had similar or higher event rates compared to inpatients. These findings suggest that HF outpatients also have poor prognosis and may be the focus of future trials.
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Recurrent diabetic ketoacidosis and a brief history of brittle diabetes research: contemporary and past evidence in diabetic ketoacidosis research including mortality, mental health and prevention.
Garrett, CJ, Choudhary, P, Amiel, SA, Fonagy, P, Ismail, K
Diabetic medicine : a journal of the British Diabetic Association. 2019;(11):1329-1335
Abstract
Pharmacological, technological and educational approaches have advanced the treatment of Type 1 diabetes in the last four decades and yet diabetic ketoacidosis (DKA) continues to be a leading cause of admission in Type 1 diabetes. This article begins by reviewing the contemporary epidemiological evidence in DKA. It highlights a rise in DKA episodes in the last two decades, with DKA continuing to be the leading cause of death in young people with Type 1 diabetes, and that DKA episodes are a marker for subsequent all-cause mortality. It also summarizes the limited evidence base for DKA prevention and associations with psychopathology. To emphasize the importance of this group with high-risk Type 1 diabetes and the degree to which they have been overlooked in the past two decades, the article summarizes the research literature of recurrent DKA during 1976-1991 when it was extensively investigated as part of the phenomenon of 'brittle diabetes'. This period saw numerous basic science studies investigating the pathophysiology of recurrent DKA. Subsequently, research centres published their experiences of brittle diabetes research participants manipulating their treatment under research conditions. Unfortunately, the driver for this behaviour and whether it was indicative of other people with ketoacidosis was not pursued. In summary, we suggest there has been a stasis in the approach to recurrent DKA prevention, which is likely linked to historical cases of mass sabotage of brittle diabetes research. Further investigation is required to clarify possible psychological characteristics that increase the risk of DKA and thereby targets for DKA prevention.
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Meta-analysis of risk factors for amputation in diabetic foot infections.
Sen, P, Demirdal, T, Emir, B
Diabetes/metabolism research and reviews. 2019;(7):e3165
Abstract
BACKGROUND Knowledge of risk factors is crucial to develop management and treatment protocols for the prevention of lower extremity amputation for patients with diabetic foot infections (DFIs). METHODS We searched the research literature for studies reporting risk factors for lower extremity amputation in patients with DFI. The main outcome variables included both minor and major amputations. This study was reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines, and the protocol was registered in PROSPERO (CRD42018118543). RESULTS A total of 2471 potential articles from the database search met the inclusion criteria. After reviewing the titles, abstracts, and full texts, remaining 25 articles were included in the final analysis. We identified 6132 patients with DFI in the 25 included articles. Of these, 1873 patients who underwent amputation were investigated. Male gender (odds ratio [OR]: 1.31), smoking (OR: 1.38), history of amputation (OR: 1.47), history of osteomyelitis (OR: 1.94), peripheral arterial disease (OR: 2.35), retinopathy (OR: 1.32), International Working Group on the Diabetic Foot (IWGDF) grades 3 and 4 (OR: 1.7 and 2.5), Wagner grades 4 and 5 (OR: 4.3 and 6.4), gangrene/necrosis (OR: 9.9), osteomyelitis (OR: 4.5), neuroischaemic DFI (OR: 3.06), severe infection (OR: 3.12), length of hospitalization (standardized mean difference [SMD]: 0.7), leukocytosis (OR: 1.76), mean erythrocyte sedimentation rate (ESR) (SMD: 0.5), mean C-reactive protein (CRP) (SMD: 0.8), tissue culture positivity (OR: 1.61), and isolation of Gram-negative bacteria from tissue culture (OR: 1.5) were found as predictors of amputation in DFI. CONCLUSIONS The present study highlighted some differences in diabetic foot ulcers and DFIs in terms of risk factors for lower extremity amputation. These data provide detailed information about risk factors for amputations among patients with DFI, thus contributing to the creation of new classification systems for assessment of high-risk patients.
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Meta-analyses of the effects of DPP-4 inhibitors, SGLT2 inhibitors and GLP1 receptor analogues on cardiovascular death, myocardial infarction, stroke and hospitalization for heart failure.
Sinha, B, Ghosal, S
Diabetes research and clinical practice. 2019;:8-16
Abstract
AIM: To assess the effects DPP-4i; SGLT2-i & GLP1-RA on CV death, MI, stroke and hHF. This is probably the first meta-analysis to assess the effects of these drugs on MI and stroke in totality, including non-fatal & fatal MI and stroke. METHODS Scientific databases were searched for RCTs with pre-specified inclusion criteria and each end-point from the selected 13 studies was reported as an effect size (M H odds ratio) with a 95% confidence interval P value. RESULTS The pooled analysis of all the 5 available CVOT with DPP-4i resulted in a neutral effect on MI, stroke, the combined end points of MI & Stroke, CV death and hHF. The pooled analysis of all the 5 available CVOTs with GLP1-RA resulted in a neutral effect on MI. However, there was a statistically significant 12% reduction in CV death (P = 0.01), 13% reduction in stroke (P = 0.02) and 11% reduction the combined end points of MI & Stroke (P = 0.001). The impact of GLP1-RA inhibitors on hHF was neutral. The pooled analysis of all the 3 available CVOTs with SGLT2-i resulted in a neutral effect on MI, stroke, the combined end points of MI & Stroke and CV death. There was however a statistically significant 28% reduction in hHF (P < 0.001). CONCLUSION DPP-4i & SGLT-2i are neutral as far as all aspects of CV outcomes are concerned except for hHF which is significantly reduced by the latter. GLP1-RA as a class reduce risk of ASCVD showing a significant reduction in MI and stroke.
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Angiotensin-Neprilysin Inhibition in Heart Failure with Preserved Ejection Fraction.
Solomon, SD, McMurray, JJV, Anand, IS, Ge, J, Lam, CSP, Maggioni, AP, Martinez, F, Packer, M, Pfeffer, MA, Pieske, B, et al
The New England journal of medicine. 2019;(17):1609-1620
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Abstract
BACKGROUND The angiotensin receptor-neprilysin inhibitor sacubitril-valsartan led to a reduced risk of hospitalization for heart failure or death from cardiovascular causes among patients with heart failure and reduced ejection fraction. The effect of angiotensin receptor-neprilysin inhibition in patients with heart failure with preserved ejection fraction is unclear. METHODS We randomly assigned 4822 patients with New York Heart Association (NYHA) class II to IV heart failure, ejection fraction of 45% or higher, elevated level of natriuretic peptides, and structural heart disease to receive sacubitril-valsartan (target dose, 97 mg of sacubitril with 103 mg of valsartan twice daily) or valsartan (target dose, 160 mg twice daily). The primary outcome was a composite of total hospitalizations for heart failure and death from cardiovascular causes. Primary outcome components, secondary outcomes (including NYHA class change, worsening renal function, and change in Kansas City Cardiomyopathy Questionnaire [KCCQ] clinical summary score [scale, 0 to 100, with higher scores indicating fewer symptoms and physical limitations]), and safety were also assessed. RESULTS There were 894 primary events in 526 patients in the sacubitril-valsartan group and 1009 primary events in 557 patients in the valsartan group (rate ratio, 0.87; 95% confidence interval [CI], 0.75 to 1.01; P = 0.06). The incidence of death from cardiovascular causes was 8.5% in the sacubitril-valsartan group and 8.9% in the valsartan group (hazard ratio, 0.95; 95% CI, 0.79 to 1.16); there were 690 and 797 total hospitalizations for heart failure, respectively (rate ratio, 0.85; 95% CI, 0.72 to 1.00). NYHA class improved in 15.0% of the patients in the sacubitril-valsartan group and in 12.6% of those in the valsartan group (odds ratio, 1.45; 95% CI, 1.13 to 1.86); renal function worsened in 1.4% and 2.7%, respectively (hazard ratio, 0.50; 95% CI, 0.33 to 0.77). The mean change in the KCCQ clinical summary score at 8 months was 1.0 point (95% CI, 0.0 to 2.1) higher in the sacubitril-valsartan group. Patients in the sacubitril-valsartan group had a higher incidence of hypotension and angioedema and a lower incidence of hyperkalemia. Among 12 prespecified subgroups, there was suggestion of heterogeneity with possible benefit with sacubitril-valsartan in patients with lower ejection fraction and in women. CONCLUSIONS Sacubitril-valsartan did not result in a significantly lower rate of total hospitalizations for heart failure and death from cardiovascular causes among patients with heart failure and an ejection fraction of 45% or higher. (Funded by Novartis; PARAGON-HF ClinicalTrials.gov number, NCT01920711.).
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Clinical Outcomes in Patients With Acute Decompensated Heart Failure Randomly Assigned to Sacubitril/Valsartan or Enalapril in the PIONEER-HF Trial.
Morrow, DA, Velazquez, EJ, DeVore, AD, Desai, AS, Duffy, CI, Ambrosy, AP, Gurmu, Y, McCague, K, Rocha, R, Braunwald, E
Circulation. 2019;(19):2285-2288
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Hospitalization Among Patients With Atrial Fibrillation and a Recent Acute Coronary Syndrome or Percutaneous Coronary Intervention Treated With Apixaban or Aspirin: Insights From the AUGUSTUS Trial.
Vora, AN, Alexander, JH, Wojdyla, DM, Aronson, R, Granger, CB, Darius, H, Windecker, S, Mehran, R, Averkov, O, Budaj, A, et al
Circulation. 2019;(23):1960-1963
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May nutritional status worsen during hospital stay? A sub-group analysis from a cross-sectional study.
Rinninella, E, Cintoni, M, De Lorenzo, A, Anselmi, G, Gagliardi, L, Addolorato, G, Miggiano, GAD, Gasbarrini, A, Mele, MC
Internal and emergency medicine. 2019;(1):51-57
Abstract
Hospital malnutrition is a detrimental prognostic factor regarding hospital mortality, complications, and length of stay. However, the role of hospitalization itself on nutritional status has not been fully elucidated. We report the results of a secondary analysis from the dataset of a recent cross-sectional study at Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy. Data from patients evaluated at admission and discharge were collected and compared. One hundred thirty-nine patients were evaluated. Mean length of stay was 13.6 (± 7.7) days. Patients at risk of malnutrition, according to NRS-2002, were 75 (53.9%), while 63 (45.3%) were malnourished according to ESPEN Criteria. Compared to admission, at discharge, patients reported a significant decrease in Mid-Upper Arm Circumference (MUAC)-from 26.5 cm (± 3.6) to 25.9 cm (± 3.7) (p = 0.016), a reduction in Phase angle (PhA)-from 4.25° (± 1.20) to 4.01° (± 1.15) (p = 0.005), fat-free mass (FFM)-from 47.5 kg (± 9.19) to 44.9 kg (± 9.4) (p = 0.03) and fat-free mass index (FFMI)-from 16.9 kg/m2 (± 2.3) to 15.8 kg/m2 (± 2.7) (p = 0.04). Laboratory data showed a reduction of albumin-from 29.2 (± 5.7) to 28.0 (± 5.9) (p = 0.01) and Onodera's PNI- from 29.1 (± 5.6) to 27.6 kg (± 5.6) (p = 0.039). At the multivariate linear regression analysis, the variables significantly associated with a worsening of PhA at discharge are the PhA value at admission and the diagnosis of malnutrition according to ESPEN Criteria. Hospitalization leads to significative changes in nutritional status. A clinical concern should be raised about the quality of hospital food and meal times and on the need for a clinical nutritionist on the ward.
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Rationale and design of the AFFIRM-AHF trial: a randomised, double-blind, placebo-controlled trial comparing the effect of intravenous ferric carboxymaltose on hospitalisations and mortality in iron-deficient patients admitted for acute heart failure.
Ponikowski, P, Kirwan, BA, Anker, SD, Dorobantu, M, Drozdz, J, Fabien, V, Filippatos, G, Haboubi, T, Keren, A, Khintibidze, I, et al
European journal of heart failure. 2019;(12):1651-1658
Abstract
AIMS: Iron deficiency (ID) is a common co-morbidity in heart failure (HF), associated with impaired functional capacity, poor quality of life and increased morbidity and mortality. Treatment with intravenous (i.v.) ferric carboxymaltose (FCM) has shown improvements in functional capacity, symptoms and quality of life in stable HF patients with reduced ejection fraction. The effect of i.v. iron supplementation on morbidity and mortality in patients hospitalised for acute HF (AHF) and who have ID has yet to be established. The objective of the present article is to present the rationale and design of the AFFIRM-AHF trial (ClinicalTrials.gov NCT02937454) which will investigate the effect of i.v. FCM (vs. placebo) on recurrent HF hospitalisations and cardiovascular (CV) mortality in iron-deficient patients hospitalised for AHF. METHODS AFFIRM-AHF is a multicentre, randomised (1:1), double-blind, placebo-controlled trial which recruited 1100 patients hospitalised for AHF and who had iron deficiency ID defined as serum ferritin <100 ng/mL or 100-299 ng/mL if transferrin saturation <20%. Eligible patients were randomised (1:1) to either i.v. FCM or placebo and received the first dose of study treatment just prior to discharge for the index hospitalisation. Patients will be followed for 52 weeks. The primary outcome is the composite of recurrent HF hospitalisations and CV mortality. The main secondary outcomes include the composite of recurrent CV hospitalisations and CV mortality, recurrent HF hospitalisations and safety-related outcomes. CONCLUSION The AFFIRM-AHF trial will evaluate, compared to placebo, the effect of i.v. FCM on morbidity and mortality in iron-deficient patients hospitalised for AHF.
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Effects of 6-months of oral ferrous and ferric supplement therapy in patients who were hospitalized for decompensated chronic heart failure.
Zdravkovic, SC, Nagorni, SP, Cojbasic, I, Mitic, V, Cvetkovic, P, Nagorni, I, Govedarovic, N, Davinic, I, Stanojevic, D
The Journal of international medical research. 2019;(7):3179-3189
Abstract
OBJECTIVE Anemia is common in patients with chronic heart failure (CHF). This study aimed to examine the frequency of iron deficiency anemia in patients with CHF. We investigated the effects of oral ferrous or ferric supplementation on prognosis of CHF and quality of life. METHODS A total of 201 patients with chronic decompensated heart failure were enrolled in a 6-month prospective study. Patients were randomly assigned to two groups. Patients in group I (n = 100) received ferrous fumarate and those in group II (n = 101) received ferric hydroxide polymaltose complex. Quality of life was measured by the 6-minute walking test (6MWT). RESULTS A total of 49% of the patients had iron-dependent anemia in group I and 53.3% were anemic in group II. In group I, the number of anemic patients was significantly lower at 6 months after admission compared with at initial admission (49% versus 45%). Significant improvements were observed in hemoglobin values, the 6MWT distance, and New York Heart Association class after 6 months in both groups. CONCLUSIONS Iron deficiency is a significant comorbidity in CHF, even without anemia. Iron should be replaced orally or intravenously because it significantly improves the quality of life of patients.