Patients with type 2 diabetes mellitus and heart failure have adverse clinical outcomes, but the characteristics and prognosis of those with undiagnosed diabetes in this setting has not been ...established.
In total, 400 patients admitted consecutively with acute heart failure were grouped in three glycaemic categories: no diabetes, clinical diabetes (previously reported or with hypoglycaemic treatment) and undiagnosed diabetes. The latter was defined by the presence of at least two measurements of fasting plasma glycaemia ≥ 7 mmol/L before or after the acute episode.Group differences were tested by proportional hazards models in all-cause and cardiovascular mortality during a 7-year follow-up.
There were 188 (47%) patients without diabetes, 149 (37%) with clinical diabetes and 63 (16%) with undiagnosed diabetes. Patients with undiagnosed diabetes had a lower prevalence of hypertension, dyslipidaemia, peripheral vascular disease and previous myocardial infarction than those with clinical diabetes and similar to that of those without diabetes. The adjusted hazards ratios for 7-year total and cardiovascular mortality compared with the group of subjects without diabetes were 1.69 (95% CI: 1.17-2.46) and 2.45 (95% CI: 1.58-3.81) for those with undiagnosed diabetes, and 1.48 (95% CI: 1.10-1.99) and 2.01 (95% CI: 1.40-2.89) for those with clinical diabetes.
Undiagnosed diabetes is common in patients requiring hospitalization for acute heart failure. Patients with undiagnosed diabetes, despite having a lower cardiovascular risk profile than those with clinical diabetes, show a similar increased mortality.
Aim Right ventricular (RV) pump function is of essential clinical and prognostic importance in a variety of heart and lung diseases. While the evaluation of RV performance at rest has been ...implemented in the clinical setting, it is unknown whether this assessment during exercise may provide additional benefit. With this aim, we evaluated the exercise-induced pulmonary arterial systolic pressure (PASP) increase during exercise in patients with severe chronic obstructive pulmonary disease (COPD) as an expression of RV contractile reserve. Method Cardiopulmonary exercise testing (CPET) with synchronic echocardiography was performed in 81 patients. Patients were classified into two groups according to an exercise-induced PASP increase above 30 mmHg (High PSAP) or below 30 mmHg (Low PSAP) during maximal exercise. Patients were then followed for three years. Results Sixteen patients (20%) had low PSAP and 65 (80%) showed high PSAP. These were not significant clinical and functional differences. Low PSAP was associated with a significantly lower peak VO2 (mean (SD), 35 (2) % predicted) compared to high PSAP response (peak VO2 45 (3) % predicted), p=0.045. Factors associated with mortality were age and exercise-induced PASP. Seventeen patients died during the three years of follow-up (7 (39%) in the low PSAP group and only 10 (1%) in the high PSAP group, p=0.041). Conclusion Cardiopulmonary exercise testing with a synchronic echocardiography may be a useful tool for the assessment of RV contractile reserve in severe COPD patients. Exercise-induced PSAP emerges as a possible prognostic factor in these patients.
Aims
The LION‐HEART study was a multicentre, double‐blind, randomised, parallel‐group, placebo‐controlled trial evaluating the efficacy and safety of intravenous administration of intermittent doses ...of levosimendan in outpatients with advanced chronic heart failure.
Methods and results
Sixty‐nine patients from 12 centres were randomly assigned at a 2:1 ratio to levosimendan or placebo groups, receiving treatment by a 6‐hour intravenous infusion (0.2 μg/kg/min without bolus) every 2 weeks for 12 weeks. The primary endpoint was the effect on serum concentrations of N‐terminal pro‐B‐type natriuretic peptide (NT‐proBNP) throughout the treatment period in comparison with placebo. Secondary endpoints included evaluation of safety, clinical events and health‐related quality of life (HRQoL). The area under the curve (AUC, pg.day/mL) of the levels of NT‐proBNP over time for patients who received levosimendan was significantly lower than for the placebo group (344 × 103 95% Confidence Interval (CI) 283 × 103−404 × 103 vs. 535 × 103 443 × 103−626 × 103, p = 0.003). In comparison with the placebo group, the patients on levosimendan experienced a reduction in the rate of heart failure hospitalisation (hazard ratio 0.25; 95% CI 0.11–0.56; P = 0.001). Patients on levosimendan were less likely to experience a clinically significant decline in HRQoL over time (P = 0.022). Adverse event rates were similar in the two treatment groups.
Conclusions
In this small pilot study, intermittent administration of levosimendan to ambulatory patients with advanced systolic heart failure reduced plasma concentrations of NT‐proBNP, worsening of HRQoL and hospitalisation for heart failure. The efficacy and safety of this intervention should be confirmed in larger trials.
Aims
To evaluate the effect of iron deficiency (ID) and/or anaemia on health‐related quality of life (HRQoL) in patients with chronic heart failure (CHF).
Methods and results
We undertook a post‐hoc ...analysis of a cohort of CHF patients in a single‐centre study evaluating cognitive function. At recruitment, patients provided baseline information and completed the Minnesota Living with Heart Failure questionnaire (MLHFQ) for HRQoL (higher scores reflect worse HRQoL). At the same time, blood samples were taken for serological evaluation. ID was defined as serum ferritin levels <100 ng/mL or serum ferritin <800 ng/mL with transferrin saturation <20%. Anaemia was defined as haemoglobin ≤12 g/dL. A total of 552 CHF patients were eligible for inclusion, with an average age of 72 years and 40% in NYHA class III or IV. The MLHFQ overall summary scores were 41.0 ± 24.7 among those with ID, vs. 34.4 ± 26.4 for non‐ID patients (P = 0.003), indicating worse HRQoL. When adjusted for other factors associated with HRQoL, ID was significantly associated with worse MLHFQ overall summary (P = 0.008) and physical dimension scores (P = 0.002), whereas anaemia was not (both P > 0.05). Increased levels of soluble transferrin receptor were also associated with impaired HRQoL (P ≤ 0.001). Adjusting for haemoglobin and C‐reactive protein, ID was more pronounced in patients with anaemia compared with those without (P < 0.001).
Conclusion
In patients with CHF, ID but not anaemia was associated with reduced HRQoL, mostly due to physical factors.
Pulmonary vein isolation has evolved over the past years as an alternative for the treatment of symptomatic recurrences of atrial fibrillation refractory to antiarrhythmic drug treatment. Both ...radiofrequency energy and cryoballoon ablation have proven useful in this setting. We present the case of a 55-year-old male patient undergoing cryoballoon ablation complicated with pulmonary hemorrhage. The cause of this rare complication may be found in the damage of vascular venous structures near the ablation zone or, alternatively, in hemorrhagic damage of the pulmonary vein surrounding tissue (or less probably to direct injury of the lingular bronchus). The extremely low temperatures achieved in this case (which are often associated with deep balloon position inside the veins) are alarming and should alert the physician about the possibility of an excessively intrapulmonary vein deployment of the cryoablation balloon.
The BEAUTIFUL (morBidity-mortality EvAlUaTion of the If inhibitor ivabradine in patients with coronary artery disease and left ventricULar systolic dysfunction) study assessed the morbidity and ...mortality benefits of the HR-lowering agent ivabradine. The placebo arm of the BEAUTIFUL trial was a large cohort of patients with stable coronary artery disease (CAD) and left ventricular systolic dysfunction. A subanalysis in the placebo group tested the hypothesis that elevated resting HR at baseline was a marker for subsequent cardiovascular death and morbidity. The primary aim of the study was to test whether lowering the HR with ivabradine reduced cardiovascular death and morbidity in patients with CAD and left ventricular systolic dysfunction. In the overall analysis, reduction in HR with ivabradine did not improve cardiac outcomes compared with placebo. The most important finding of the study was that patients with high baseline HR had an increase in serious cardiovascular events including death (34%), hospital admission secondary to congestive heart failure (53%), acute myocardial infarction (46%), or revascularization procedure (38%). In addition, in the subset analysis focusing on patients with baseline HR > or =70 bpm and left ventricular ejection fraction <40% the agent resulted in a 36% decrease in hospital admissions secondary to fatal and nonfatal myocardial infarction and a 30% decrease in coronary revascularization. The first practical implication from the study includes that baseline HR should be recorded in addition to other risk factors such as BP and lipid profile, in the follow-up of patients with CAD. Attempts should be made to achieve HR <70 bpm by cardiac rehabilitation and routine use of appropriately dosed beta-blockers. Despite the neutral results obtained in the BEAUTIFUL study, ivabradine could be administered to the subgroup of patients in whom HR <70 bpm is not achieved despite proper dosing of beta-blockers and in those in whom beta-blockers are contraindicated. Furthermore, in clinical practice, ivabradine may be helpful for patients with stable CAD who have a high HR while receiving beta-blockers. Future studies are needed to confirm the hypothesis that single reduction of HR can improve cardiovascular prognosis.
Abstract Objectives To assess 1) the association of lipid oxidation biomarkers with 10-year coronary artery disease (CAD) events and subclinical atherosclerosis, and 2) the reclassification capacity ...of these biomarkers over Framingham-derived CAD risk functions, in a general population. Methods Within the framework of the REGICOR study, 4782 individuals aged between 25 and 74 years were recruited in a population-based cohort study. Follow-up of the 4042 who met the eligibility criteria was carried out. Plasma, circulating oxidized low-density lipoprotein (oxLDL) and oxLDL antibodies (OLAB) were measured in a random sample of 2793 participants. End-points included fatal and non-fatal acute myocardial infarction (AMI) and angina. Carotid intima-media thickness (IMT) in the highest quintile and ankle-brachial index <0.9 were considered indicators of subclinical atherosclerosis. Results Mean age was 50.0 (13.4) years, and 52.4% were women. There were 103 CAD events (34 myocardial infarction, 43 angina, 26 coronary deaths), and 306 subclinical atherosclerosis cases. Oxidized LDL was independently associated with higher incidence of CAD events (HR = 1.70; 95% Confidence Interval: 1.02–2.84), but not with subclinical atherosclerosis. The net classification index of the Framingham-derived CAD risk function was significantly improved when ox-LDL was included (NRI = 14.67% 4.90; 24.45, P = 0.003). No associations were found between OLAB and clinical or subclinical events. The reference values for oxLDL and OLAB are also provided (percentiles). Conclusions OxLDL was independently associated with 10-year CAD events but not subclinical atherosclerosis in a general population, and improved the reclassification capacity of Framingham-derived CAD risk functions.
Aims
Iron deficiency (ID), anaemia, and chronic kidney disease (CKD) are common co‐morbidities in chronic heart failure (CHF) and all independent predictors of unfavourable outcome. The combination ...of anaemia and CKD in CHF has been described as the cardiorenal–anaemia syndrome. However, the role of ID within this complex interplay of co‐existing pathologies is unclear.
Methods and results
We studied the clinical correlates of ID (defined as ferritin <100 µg/L or 100–299 µg/L in combination with a transferrin saturation <20%, anaemia) and renal dysfunction (defined as estimated glomerular filtration rate <60 mL/min/1.73 m2) and their prognostic implications in an international pooled cohort, comprising 1506 patients with CHF. Mean age was 64 ± 13 years, 74.2% were male, and 47.3% were in NYHA functional class III. The presence of ID, anaemia, CKD, or a combination of these co‐morbidities was observed in 69.3% of the patients. During a median (Q1–Q3) follow‐up of 1.92 years (1.18–3.26 years), 440 patients (29.2%) died. Eight‐year survival rates decreased significantly from 58.0% for no co‐morbidities to 44.6, 33.0, and 18.4%, for one, two, or three co‐morbidities, respectively (P < 0.001). Multivariate hazard models revealed ID to be the key determinant of prognosis, either individually (P = 0.04) or in combination with either anaemia (P = 0.006), CKD (P = 0.03), or both (P = 0.02).
Conclusions
Iron deficiency frequently overlaps with anaemia and/or CKD in CHF. The presence of ID amplifies mortality risk, either alone or in combination with anaemia, CKD, or both, making it a potential viable therapeutic target.
Background and purpose
Prospectively collected data comparing the safety and effectiveness of individual non-vitamin K antagonists (NOACs) are lacking. Our objective was to directly compare the ...effectiveness and safety of NOACs in patients with newly diagnosed atrial fibrillation (AF).
Methods
In GLORIA-AF, a large, prospective, global registry program, consecutive patients with newly diagnosed AF were followed for 3 years. The comparative analyses for (1) dabigatran vs rivaroxaban or apixaban and (2) rivaroxaban vs apixaban were performed on propensity score (PS)-matched patient sets. Proportional hazards regression was used to estimate hazard ratios (HRs) for outcomes of interest.
Results
The GLORIA-AF Phase III registry enrolled 21,300 patients between January 2014 and December 2016. Of these, 3839 were prescribed dabigatran, 4015 rivaroxaban and 4505 apixaban, with median ages of 71.0, 71.0, and 73.0 years, respectively. In the PS-matched set, the adjusted HRs and 95% confidence intervals (CIs) for dabigatran vs rivaroxaban were, for stroke: 1.27 (0.79–2.03), major bleeding 0.59 (0.40–0.88), myocardial infarction 0.68 (0.40–1.16), and all-cause death 0.86 (0.67–1.10). For the comparison of dabigatran vs apixaban, in the PS-matched set, the adjusted HRs were, for stroke 1.16 (0.76–1.78), myocardial infarction 0.84 (0.48–1.46), major bleeding 0.98 (0.63–1.52) and all-cause death 1.01 (0.79–1.29). For the comparison of rivaroxaban vs apixaban, in the PS-matched set, the adjusted HRs were, for stroke 0.78 (0.52–1.19), myocardial infarction 0.96 (0.63–1.45), major bleeding 1.54 (1.14–2.08), and all-cause death 0.97 (0.80–1.19).
Conclusions
Patients treated with dabigatran had a 41% lower risk of major bleeding compared with rivaroxaban, but similar risks of stroke, MI, and death. Relative to apixaban, patients treated with dabigatran had similar risks of stroke, major bleeding, MI, and death. Rivaroxaban relative to apixaban had increased risk for major bleeding, but similar risks for stroke, MI, and death.
Registration
URL:
https://www.clinicaltrials.gov
. Unique identifiers: NCT01468701, NCT01671007. Date of registration: September 2013.
Graphical abstract
Aims
The purpose of this study was to evaluate the effectiveness, feasibility, and safety of a 4‐week high‐intensity inspiratory muscle training (hi‐IMT) in patients with chronic heart failure (CHF).
...Methods and results
A double‐blind randomized clinical trial was carried out in 22 patients with CHF. Participants were assigned to the hi‐IMT or sham‐IMT group. The trainer device was a prototype of the Orygen‐Dual Valve®. The training workloads were adjusted weekly at the inspiratory pressure which allowed the performance of 10 consecutive maximal repetitions (10RM). Main outcomes were strength and endurance of the respiratory muscles assessed by maximal respiratory pressures (PImax and PEmax) and a 10RM manoeuvre, respectively. Twenty‐one patients presented impairment in respiratory muscle strength and endurance. Patients in the hi‐IMT group showed a significant improvement in both strength and endurance: inspiratory muscle strength in the intervention group increased 57.2% compared with 25.9% in the control group (P = 0.001). The percentage change in endurance was 72.7% for the hi‐IMT group compared with 18.2% in the sham‐IMT group (P < 0.001). No adverse effects occurred during the intervention.
Conclusion
A 4‐week hi‐IMT with the use of the Orygen‐Dual Valve® is shown to be an effective, feasible, and safe tool to improve weakness and fatigue of the inspiratory muscles. The key point of this study is to discuss immediate practical implications in terms of respiratory muscle dysfunction postulated as a potential prognostic factor and as an additional therapeutic target.
Trials registration
NCT01606553.
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