Anaemia and Congestion in Heart Failure: Correlations and Prognostic Role.

The aim of this study was to evaluate the relationship between anaemia and biomarkers of central/peripheral congestion in heart failure (HF) and the impact on mortality. We retrospectively evaluated 434 acute/chronic HF (AHF/CHF) patients. Anaemia was defined as haemoglobin levels <12 g/dL (women) or <13 g/dL (men). The brain natriuretic peptide (BNP) and hydration index (HI) were measured. The endpoint of the study was all-cause mortality. Anaemia occurred in 59% of patients with AHF and in 35% with CHF (p < 0.001) and showed a significant correlation with the NYHA functional class and renal function. BNP and HI were significantly higher in patients with anaemia than in those without anaemia. Independent predictors of anaemia included BNP, estimated creatinine clearance (eCrCL), and HI. The all-cause mortality rate was 21%, which was significantly higher in patients with anaemia than in those without anaemia (30% vs. 14%, p < 0.001; hazard ratio: 2.6). At multivariate Cox regression analysis, BNP, eCrCL, and HI were independent predictors for mortality (Hazard ratios: 1.0002, 0.97, and 1.05, respectively), while anaemia was not. Anaemia correlates with HF status, functional class, renal function, BNP, and HI. Anaemia was not an independent predictor for mortality, acting as a disease severity marker in congestive patients rather than as a predictor of death.

Creatinine Clearance Measurement with Bioelectrical Impedance Analysis in Heart Failure Patients: Comparison with Estimated-Creatinine Clearance Formulas.

BACKGROUND: Kidney disease is common in patients with heart failure (HF). The Donadio equation combines plasma creatinine and bioimpedance vector analysis (BIVA) to estimate creatinine clearance. This study aimed to compare the Donadio formula to the Cockcroft-Gault (CG), Modification of Diet in Renal Disease Study (MDRD-4), and Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equations in patients with HF. METHODS: We analysed data from 900 patients (mean age: 76 ± 10 years) with HF. All of them underwent clinical, laboratory, BIVA, and echocardiographic evaluations. RESULTS: Donadio equation overestimated eGFR as compared to CG and CKD-EPI formulas (+6.8 and +12 mL/min/1.73 m2, respectively) while computing similar results to MDRD-4 (overestimation: +0.1 mL/min/1.73 m2). According to the different formulas, the prevalence of renal insufficiency (eGFR< 30 ml/min/1.73 m2) in relation to the different formulas was as follows: 24% with Donadio, 21% with CG, 13% with MDRD-4, and 23% with CKD-EPI formulas. All the equations demonstrated a high precision rate (r>0.8 for all). There was a "good" agreement between the Donadio and CG/MDRD-4 formulas and "fair" with the CDK-EPI formula. The Donadio equation showed a high accuracy in predicting severe renal dysfunction (eGFR< 30 mL/min/1.73 m2) in patients with HF (AUC > 0.9), showing comparable performances to CG. CONCLUSION: The Donadio formula provided an estimation of GFR comparable to MDRD-4 in HF patients, independently from acute or chronic HF conditions. The use of BIVA in HF patients may be adopted both for HF management and for evaluating kidney function.

Plasma Levels of Intact Parathyroid Hormone and Congestion Burden in Heart Failure: Clinical Correlations and Prognostic Role.

Circulating parathyroid hormone (PTH) concentrations increase in heart failure (HF) and are related to disease severity. The relationship between PTH and congestion is still a matter of debate. The objective of this analysis was to evaluate the role of PTH as a marker of congestion and prognosis in HF. We enrolled 228 patients with HF. Intact PTH concentrations and HYDRA score (constituted by: B-type natriuretic peptide, blood urea nitrogen−creatinine ratio, estimated plasma volume status, and hydration status) were evaluated. The study endpoint was all-cause mortality. PTH levels were higher in acute compared with chronic HF and in patients with clinical signs of congestion (i.e., peripheral oedema and orthopnea). PTH concentrations significantly correlated with NYHA class and HYDRA score. At multivariate analysis of HYDRA score, estimated glomerular filtration rate (eGFR), and corrected serum calcium were independently determinants of PTH variability. Fifty patients (22%) died after a median follow-up of 408 days (interquartile range: 283−573). Using univariate Cox regression analysis, PTH concentrations were associated with mortality (hazard ratio [HR]: 1.003, optimal cut-off: >249 pg/mL­area under-the-curve = 0.64). Using multivariate Cox regression analysis, PTH was no longer associated with death, whereas HYDRA score, left ventricular ejection fraction, and eGFR acted as independent predictors for mortality (HR: 1.96, 0.97, and 0.98, respectively). Our study demonstrated that intact PTH was related to clinical and subclinical markers of congestion. However, intact PTH did not act as an independent determinant of all-cause death in HF patients.

Long-term mortality of patients ablated for atrial fibrillation: a retrospective, population-based epidemiological study in Apulia, Italy.

OBJECTIVES: Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia associated with substantial morbidity and mortality. Data on long-term risk and mortality after catheter ablation for AF are lacking. The aim of this study was to evaluate all-cause mortality and the long-term risk of death in patients who underwent catheter ablation for AF compared with the general population. DESIGN: Retrospective, population-based epidemiological study. SETTING: We analysed data from patients residing in Apulia region who underwent AF ablation between January 2009 and June 2019. PARTICIPANTS: 1260 patients (914 male, mean age 60±11 years). OUTCOMES: Vital status and dates of death to 31 December 2019 were obtained by using regional Health Information System. The expected number of deaths was derived using mortality rates from the general regional population by considering age-specific and gender-specific death probability provided for each calendar year by the Italian National Institute of Statistics. Standardised mortality ratios (SMRs) were calculated by dividing the observed number of deaths among patients by the expected number of deaths estimated from the general population. RESULTS: During follow-up (6449 person-years), 95 deaths were observed (1.47 deaths per 100 person-years). Although overall long-term mortality after AF ablation was not different to that of the general population (SMR 1.05 (95% CI 0.86 to 1.28; p=0.658)), the number of observed events was significantly increased in patients with heart failure (HF) at baseline or who developed HF during follow-up (SMR 2.40 (1.69 to 3.41; p<0.001) and 1.75 (1.17 to 2.64; p=0.007), respectively) and reduced in those without (SMR 0.63 (0.47 to 0.86; p=0.003)). CONCLUSION: Long-term mortality of patients undergoing AF ablation is similar to that of the general population. Patients with HF had an increased risk while those without seem to have a better risk profile.

Respiratory failure and bioelectrical phase angle are independent predictors for long-term survival in acute heart failure.

Background. The assessment of long-term mortality in acute decompensated heart failure (ADHF) is challenging. Respiratory failure and congestion play a fundamental role in risk stratification of ADHF patients. The aim of this study was to investigate the impact of arterial blood gases (ABG) and congestion on long-term mortality in patients with ADHF. Methods and results. We enrolled 252 patients with ADHF. Brain natriuretic peptide (BNP), blood urea nitrogen (BUN), phase angle as assessed by means of bioimpedance vector analysis, and ABG analysis were collected at admission. The endpoint was all-cause mortality. At a median follow-up of 447 d (interquartile range [IQR]: 248-667), 72 patients died 1-840 d (median 106, IQR: 29-233) after discharge. Respiratory failure types I and II were observed in 78 (19%) and 53 (20%) patients, respectively. The ROC analyses revealed that the cut-off points for predicting death were: BNP > 441 pg/mL, BUN > 1.67 mmol/L, partial pressure in oxygen (PaO2) ≤69.7 mmHg, and phase angle ≤4.9°. Taken together, these four variables proved to be good predictors for long-term mortality in ADHF (area under the curve [AUC] 0.78, 95% CI 0.72-0.78), thus explaining 60% of all deaths. A multiparametric score based on these variables was determined: each single-unit increase promoted a 2.2-fold augmentation of the risk for death (hazard ratio [HR] 2.2, 95% CI 1.8-2.8, p< .0001). Conclusions. A multiparametric approach based on measurements of BNP, BUN, PaO2, and phase angle is a reliable approach for long-term prediction of mortality risk in patients with ADHF.

Sex Differences in the Evaluation of Congestion Markers in Patients with Acute Heart Failure.

The impact of sex on the assessment of congestion in acute heart failure (AHF) is still a matter of debate. The objective of this analysis was to evaluate sex differences in the evaluation of congestion at admission in patients hospitalized for AHF. We consecutively enrolled 494 AHF patients (252 female). Clinical congestion assessment, B-type natriuretic peptide levels analysis, blood urea nitrogen to creatinine ratio (BUN/Cr), plasma volume status estimate (by means of Duarte or Kaplam-Hakim PVS), and hydration status evaluation through bioimpedance analysis were performed. There was no difference in medications between men and women. Women were older (79 ± 9 yrs vs. 77 ± 10 yrs, p = 0.005), and had higher left ventricular ejection fraction (45 ± 11% vs. 38 ± 11%, p < 0.001), and lower creatinine clearance (42 ± 25 mL/min vs. 47 ± 26 mL/min, p = 0.04). The prevalence of peripheral oedema, orthopnoea, and jugular venous distention were not significantly different between women and men. BUN/Cr (27 ± 9 vs. 23 ± 13, p = 0.04) and plasma volume were higher in women than men (Duarte PVS: 6.0 ± 1.5 dL/g vs. 5.1 ± 1.5 dL/g, p < 0.001; Kaplam−Hakim PVS: 7.9 ± 13% vs. −7.3 ± 12%, p < 0.001). At multivariate logistic regression analysis, female sex was independently associated with BUN/Cr and PVS. Female sex was independently associated with subclinical biomarkers of congestion such as BUN/Cr and PVS in patients with AHF. A sex-guided approach to the correct evaluation of patients with AHF might become the cornerstone for the correct management of these patients.

Pro-inflammatory cytokines as emerging molecular determinants in cardiolaminopathies.

Mutations in Lamin A/C gene (lmna) cause a wide spectrum of cardiolaminopathies strictly associated with significant deterioration of the electrical and contractile function of the heart. Despite the continuous flow of biomedical evidence, linking cardiac inflammation to heart remodelling in patients harbouring lmna mutations is puzzling. Therefore, we profiled 30 serum cytokines/chemokines in patients belonging to four different families carrying pathogenic lmna mutations segregating with cardiac phenotypes at different stages of severity (n = 19) and in healthy subjects (n = 11). Regardless lmna mutation subtype, high levels of circulating granulocyte colony-stimulating factor (G-CSF) and interleukin 6 (IL-6) were found in all affected patients' sera. In addition, elevated levels of Interleukins (IL) IL-1Ra, IL-1ß IL-4, IL-5 and IL-8 and the granulocyte-macrophage colony-stimulating factor (GM-CSF) were measured in a large subset of patients associated with more aggressive clinical manifestations. Finally, the expression of the pro-inflammatory 70 kDa heat shock protein (Hsp70) was significantly increased in serum exosomes of patients harbouring the lmna mutation associated with the more severe phenotype. Overall, the identification of patient subsets with overactive or dysregulated myocardial inflammatory responses could represent an innovative diagnostic, prognostic and therapeutic tool against Lamin A/C cardiomyopathies.

The Prognostic Impact of Estimated Creatinine Clearance by Bioelectrical Impedance Analysis in Heart Failure: Comparison of Different eGFR Formulas.

The estimation of glomerular filtration rate (eGFR) provides prognostic information in patients with heart failure (HF). Bioelectrical impedance analysis may calculate eGFR (Donadio formula). The aim of this study was to evaluate the impact of the Donadio formula in predicting all-cause mortality in patients with HF as compared to Cockroft-Gault, MDRD-4 (Modification of Diet in renal Disease Study), and Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formulas. Four-hundred thirty-six subjects with HF (52% men; mean age 75 ± 11 years; 42% acute HF) were enrolled. Ninety-two patients (21%) died during the follow-up (median 463 days, IQR 287-669). The area under the receiver operator characteristic curve for eGFR, as estimated by Cockroft-Gault formula (AUC = 0.75), was significantly higher than those derived from Donadio (AUC = 0.72), MDRD-4 (AUC = 0.68), and CKD-EPI (AUC = 0.71) formulas. At multivariate analysis, all eGFR formulas were independent predictors of death; 1 mL/min/1.73 m2 increase in eGFR-as measured by Cockroft-Gault, Donadio, MDRD-4, and CKD-EPI formulas-provided a 2.6%, 1.5%, 1.2%, and 1.6% increase, respectively, in mortality rate. Conclusions. eGFR, as calculated with the Donadio formula, was an independent predictor of mortality in patients with HF as well as the measurements derived from MDRD4 and CKD-EPI formulas, but less accurate than Cockroft-Gault.

Comparison of absorbable and permanent sutures for laparoscopic sacrocervicopexy: A randomized controlled trial.

INTRODUCTION: Pelvic organ prolapse is a common cause of morbidity and decreased quality of life among women and is treatable by laparoscopic sacrocolpopexy. Recent data suggest that absorbable sutures are a feasible and appealing option for mesh attachment given a potential decreased risk of complications related to mesh erosion. The aim of the present study was to demonstrate the non-inferiority of absorbable sutures to permanent sutures for laparoscopic sacrocervicopexy. MATERIAL AND METHODS: We performed a randomized, single-blinded, non-inferiority trial comparing late-absorbable sutures (group A) to non-absorbable sutures (group B) for anterior and posterior vaginal mesh fixation during laparoscopic sacrocervicopexy at a single center in Italy. The primary outcome was prolapse correction at 12 months after surgery, defined as the absence of a pelvic organ prolapse leading edge reaching or extending below the level of the hymen and the absence of bulge symptoms. Secondary outcomes included intraoperative parameters, postoperative characteristics, and long-term morbidity. Statistical analyses were performed using STATA version 16. RESULTS: A total of 150 patients with pelvic organ prolapse were prospectively randomized 1:1 into two groups (A or B). Baseline characteristics and intraoperative parameters including blood loss, operation time, and intraoperative complications were comparable between groups. The success rate was 100% in both groups and no differences in prolapse correction were observed. The rates of de novo urinary incontinence and persistent urinary incontinence were also similar between groups. The rate of mesh erosion at 12 months was 0% in group A and 4% in group B (P = .24). CONCLUSIONS: Late absorbable sutures are non-inferior to non-absorbable sutures for laparoscopic sacrocervicopexy in terms of procedural success. Moreover we did not see any differences in terms of operative parameters, or intraoperative and postoperative characteristics, although the study was not powered to these outcomes.

Congestion and nutrition as determinants of bioelectrical phase angle in heart failure.

BACKGROUND: The whole-body bioelectrical phase-angle (PhA) is emerging as a new tool in stratifying prognosis in patients with both acute (AHF) and chronic heart failure (CHF). OBJECTIVE: To evaluate the determinants of PhA in HF patients. METHODS: We analyzed data from 900 patients with AHF or CHF (mean age: 76±10 years, 54% AHF). Clinical, serum biochemical, echocardiographic and bioelectrical measurements were collected from all of patients. PhA was quantified in degrees. Congestion was assessed by a multiparametric approach, including the presence of peripheral edema, brain natriuretic peptides (BNP) plasma levels, blood urea nitrogen to creatinine ratio (BUN/Cr), and relative plasma volume status (PVS) calculated by Kaplan-Hakim's formula. Geriatric Nutritional Risk Index (GNRI) was adopted as indicator for nutritional status. RESULTS: At univariate analysis, PhA was significantly lower in females, in patients with peripheral edema, and AHF. PhA significantly correlates age, BNP, PVS, BUN/Cr, and GNRI. At multivariate analysis, congestion biomarkers emerged as the major determinant of PhA as they explained the 34% of data variability, while age, GNRI, and gender only explained 6%, 0.5%, and 0.5%, respectively (adjusted R2 = 0.41). In particular, PVS (regression of coefficient B=-0.17) explained the 20% of PhA variability, while peripheral congestion (B=-0.27) and BNP (B=-0.15) contributed to 10% and 2%, respectively. CONCLUSIONS: The main determinant of bioelectrical PhA in patients with HF is congestion and PVS in particular, while nutritional status has marginal impact.

Multiparametric approach to congestion for predicting long-term survival in heart failure.

BACKGROUND: Congestion is a marker of adverse prognosis in patients with heart failure (HF). In addition to brain natriuretic peptide (BNP), estimated plasma volume status (ePVS), bioimpedance vector analysis (BIVA), and blood urea nitrogen/creatinine ratio (BUN/Cr) are emerging as new markers for congestion. The aim of this study was to evaluate the prognostic value of BNP, ePVS, BIVA, and BUN/Cr in HF. METHODS: We analyzed the data from 436 patients with acute or chronic heart failure (AHF, n=184, and CHF, n=252, respectively). BNP, ePVS, hydration index (HI%), and BUN/Cr were collected from all patients at admission. The endpoint was all-cause mortality. RESULTS: Ninety-two patients died after a median follow-up of 463 days (IQR: 287-669). The cumulative mortality of all of the patients was 21% (31% and 13% in AHF and CHF, respectively, p<0.0001). The optimal cut-offs for death occurrence were BNP: >441pg/mL, ePVS: >5.3dL/gr, HI: >73.8%, BUN/Cr: >25. Multivariate Cox regression analysis maintained an independent predictive value for mortality (HR 2. 1, HR 2.2, HR 2.1, and HR 1.7; C-index 0.756). AHF status was no longer associated with death. Together, these variables explained 40% of the risk of death (R2 adjusted=0.40). Patients with all four parameters below or above their optimal cut-off had mortality rates of 4% and 59%, respectively. CONCLUSIONS: BNP, ePVS, BIVA, and BUN/Cr at admission provide independent and complementary prognostic information in patients with HF and, when combined, explain the 40% risk of death in these patients independent from the acute or chronic HF condition.

Full sternotomy and minimal access approaches for surgical aortic valve replacement: a multicentre propensity-matched study.

OBJECTIVES: Surgical aortic valve replacement (AVR) can be performed via a full sternotomy or a minimal access approach (mini-AVR). Despite long-term experience with the procedure, mini-AVR is not routinely adopted. Our goal was to compare contemporary outcomes of mini-AVR and conventional AVR in a large multi-institutional national cohort. METHODS: A total of 5801 patients from 10 different centres who had a mini-AVR (2851) or AVR (2950) from 2011 to 2017 were evaluated retrospectively. Standard aortic prostheses were used in all cases. The use of the minimally invasive approach has increased over the years. The primary outcome is the incidence of 30-day deaths following mini-AVR and AVR. Secondary outcomes are the occurrence of major complications following both procedures. Propensity-matched comparisons were performed based on the multivariable logistic regression model. RESULTS: In the overall population patients who had AVR had an increased surgical risk based on the EuroSCORE, and the 30-day mortality rate was higher (1.5% and 2.3% in mini-AVR and AVR, respectively; P = 0.048). Propensity scores identified 2257 patients per group with similar baseline profiles. In the matched groups, patients who had mini-AVR, despite longer cardiopulmonary bypass (81 ± 32 vs 76 ± 28 min; P = 0.004) and cross-clamp (64 ± 24 vs 59 ± 21 min; P ≤ 0.001) times, had lower 30-day mortality rates (1.2% vs 2.0%; P = 0.036), reduced low cardiac output (0.8% vs 1.4%; P = 0.046) and reduced postoperative length of stay (9 ± 8 vs 10 ± 7 days; P = 0.004). Blood transfusions (36.4% vs 30.8%; P ≤ 0.001) and atrial fibrillation (26.0% vs 21.5%, P ≤ 0.001) were higher in patients who had the mini-AVR. CONCLUSIONS: In a large multi-institutional recent cohort, minimal access approach aortic valve replacement is associated with reduced 30-day mortality rates and shorter postoperative lengths of stay compared to standard sternotomy. A prospective randomized trial is needed to overcome the possible biases of a retrospective study.

Cardiopulmonary support in patients undergoing catheter ablation of poorly tolerated ventricular arrhythmias and electrical storm.

INTRODUCTION: Catheter ablation is an important treatment option for sustained ventricular arrhythmias (VA) that are refractory to pharmacological treatment; however, patients with fast VA or electrical storm (ES) are at risk for cardiogenic shock. We report our experience using cardiopulmonary support with extracorporeal membrane oxygenation (ECMO) during catheter ablation of VA. METHODS: Nineteen patients (mean age, 62 ± 10 years; 84% male) were referred to our center for CA of ES between January 2017 and April 2018. ES was defined as the occurrence of ≥3 ventricular tachycardia or ventricular fibrillation episodes requiring electrical cardioversion or defibrillation in a 24-hour period. ECMO support was implemented for all patients. RESULTS: CA of ES was completed in all patients. Activation mapping was performed for all VTs and substrate modification was performed by targeting sites identified by late/fragmented abnormal potentials. VTs were not inducible after ablation in 16 of 19 patients (84%). With regard to procedural complications, two patients underwent percutaneous angioplasty with stenting for a femoral artery dissection and one patient was treated for a dislodged ECMO arterial cannula and subsequent hemorrhagic shock. After a median follow-up of 10 months, three patients died from refractory heart failure and one patient died as a result of ES. Overall, the procedural success rate was 68% and the Kaplan-Meier mortality rate was 21%. CONCLUSIONS: ECMO support may be used for ablation procedures in patients with ES.

Serum biochemical determinants of peripheral congestion assessed by bioimpedance vector analysis in acute heart failure.

BACKGROUND: The pathophysiology of peripheral congestion is poorly investigated in patients with acute heart failure (AHF). OBJECTIVES: to evaluate the relative contribution of serum colloid osmotic pressure (COP), relative plasma volume status (PVS), biomarkers of renal function, electrolytes, haemoglobin, and brain natriuretic peptide (BNP) in peripheral fluid overload using bioimpedance vector analysis (BIVA). METHODS: We retrospectively analysed data from 485 patients with AHF. Hydration status was evaluated by semiquantitative and quantitative approach using BIVA (R/Xc graph) and Hydration Index (HI), respectively. COP was calculated from albumin and total protein concentration, while relative PVS was calculated from validated equations. RESULTS: Congestion assessed by BIVA was observed in 304 (63%) patients and classified as mild (30%), moderate (42%), and severe (28%). On univariate analysis, HI was inversely correlated with COP (P < 0.01), glomerular filtration rate (P < 0.01), and haemoglobin (P < 0.01), while positive correlations were found for relative PVS (P < 0.05), BNP (P < 0.01), and blood urea nitrogen (BUN; P < 0.01). On stepwise multivariate analysis, COP explained 12% of the total variability, while BUN, PVS, haemoglobin, and BNP added a further 6%, 4%, 2%, and 1%, respectively, to the final explanatory model. CONCLUSIONS: COP was the major determinant of the presence and entity of peripheral congestion assessed by BIVA. BUN, PVS, haemoglobin, and BNP revealed reduced influence on congestion as compared with COP. Routine laboratory testing could be useful in peripheral fluid accumulation. Future studies should evaluate the relationship between COP and pharmacological target therapies for the fluid management of AHF patients.

Five-Year Predictors of Insulin Initiation in People with Type 2 Diabetes under Real-Life Conditions.

We performed a real-life analysis of clinical and laboratory parameters, in orally treated T2DM patients aiming at identifying predictors of insulin treatment initiation. Overall, 366955 patients (55.8% males, age 65 ± 11 years, diabetes duration 7 ± 8 years) were followed up between 2004 and 2011. Each patient was analyzed step-by-step until either eventually starting insulin treatment or getting to the end of the follow-up period. Patients switching to insulin showed a worse global risk profile, longer disease duration (10 ± 9 years vs. 6 ± 7 years, respectively; p < 0.001), higher HbA1c (8.0 ± 1.6% vs. 7.2 ± 1.5%, respectively; p < 0.001), higher triglycerides, a greater prevalence of arterial hypertension, antihypertensive, lipid-lowering and aspirin treatment, a higher rate of nonproliferative/proliferative retinopathy, and a nearly 4 times lower prevalence of the "diet alone." They also showed a higher prevalence of subjects with eGFR < 60 ml/min/1.73 m2 (24.0% vs. 16.2%, respectively; p < 0.001). Multivariate analysis identified diabetes duration, HbA1c, triglyceride and low HDL-C values, presence of retinopathy or renal dysfunction, and sulphonylurea utilization (the risk being approximately 3 times greater in the latter case) as independent predictors of insulin treatment initiation. LDL-C, lipid-lowering treatment, and overweight/obese seem to be protective. Results of tree analysis showed that patients on sulphonylurea, with high HbA1c, eGFR below 50 ml/min/1.73 m2, and at least 5-year disease duration, are at very high risk to start insulin treatment. We have to stick to this real-life picture, of course, until enough data are collected on patients treated with innovative medications which are expected to improve beta cell survival and further delay treatment-related insulin requirement.

Antihyperglycemic treatment in patients with type 2 diabetes in Italy: the impact of age and kidney function.

We describe AHA utilization pattern according to age and renal function in type 2 diabetes mellitus (T2DM), in real-life conditions. The analysis was performed using the data set of electronic medical records collected between 1 January and 31 December, 2011 in 207 Italian diabetes centers. The study population consisted of 157,595 individuals with T2DM. The AHA treatment regimens was evaluated. Kidney function was assessed by eGFR, estimated using the CKD-EPI formula. Other determinations: HbA1c, blood pressure (BP), low- density lipoprotein (LDL-c), total and high density lipoprotein cholesterol (TC and HDL-c), triglycerides (TG) and serum uric acid (SUA). Quality of care was assessed through Q score. The proportion of subjects taking metformin declined progressively across age quartiles along with eGFR values, but remained high in oldest subjects (i.e. 54.5 %). On the other hand, the proportion of patients on secretagogues or insulin increased with aging (i.e. 54.7% and 37% in the fourth age quartile, respectively). The percentage of patients with low eGFR (i.e. <30 ml/min/1.73m2) taking either metformin or sulphonilureas/repaglinide was particularly high (i.e. 15.3% and 34.3% respectively). In a large real-life cohort of T2DM, metformin or sulphonylureas/repaglinide, although not recommended, are frequently prescribed to elderly subjects with severe kidney disease.

A Multiparametric Approach Based on NT-proBNP, ST2, and Galectin3 for Stratifying One Year Prognosis of Chronic Heart Failure Outpatients.

Galectin-3 and ST2 are emerging biomarkers involved in myocardial fibrosis. We evaluate the relevance of a multiparametric biomarker approach based on increased serum levels of NT-proBNP, galectin-3, and ST2 in stratifying the prognosis of chronic heart failure (CHF) outpatients. In 315 CHF outpatients in stable clinical condition clinical and echocardiographic evaluations were performed. Routine chemistry and serum levels of NT-proBNP, galectin-3, and ST2 were also assessed. During a 12 month follow-up, cardiovascular death, and/or heart failure (HF) occurred in 64 patients. The presence of NT-proBNP, galectin-3, and ST2 were higher than the recommended cutoffs and were all associated with events at univariate Cox regression analysis, as well as in a multivariate analysis including the three biomarkers. When a score based on the number of biomarkers above the recommended cut-offs was used (in a range of 0-3), it was associated with events both with respect to the univariate (HR 2.96, 95% CI 2.21-3.95, p < 0.001, C-index 0.78) and the multivariate (HR 1.52, 95% CI 1.06-2.17, p: 0.023, C-index 0.87) analyses, after correction for the variables of a reference model. Our results suggest that an easy prognostic approach based on the combination of three biomarkers, although with partially-overlapping pathophysiological mechanisms, is able to identify patients with the highest risk of heart failure progression.

Occurrence over time and regression of nonalcoholic fatty liver disease in type 2 diabetes.

BACKGROUND: This analysis was aimed to assess the incidence, regression, and correlated factors of nonalcoholic fatty liver disease (NAFLD) in type 2 diabetes, which are poorly known. METHODS: Nonalcoholic fatty liver disease (defined as fatty liver index [FLI] score ≥ 60) in patients with type 2 diabetes, and related factors was investigated in a nationwide database containing information from the Italian network of diabetes clinics. A 10% variation of FLI was the cut-off considered in the analyses of a cohort of 5030 patients, which was separately conducted for those who developed, maintained, or recovered from FLI-assessed NAFLD (FLI-NAFLD) over a 3-year period. RESULTS: At baseline, FLI-NAFLD was diagnosed in 61.3% of patients. Within the 3-year study period, FLI-NAFLD occurred in 313 patients and remitted in 410. The FLI score remained unchanged in 4307. Body-mass index (odds ratio, 1.45 95%; confidence interval, 1.35-1.55), abdominal obesity (2.11; 1.64-2.72), low HDL cholesterol levels (1.38; 1.02-1.87), and triglycerides (1.20; 1.12-1.28) all emerged as notable negative prognostic factors for the development or maintenance of FLI-NAFLD. The regression rate of FLI-NAFLD was higher among patients who managed to partially control these factors. Male sex and established organ damage, especially kidney function (1.64; 1.12-2.42), were independent risk predictors. Unlike other diabetes complications, FLI-NAFLD was more frequent among younger patients or those with a shorter duration of diabetes. CONCLUSIONS: FLI-assessed NAFLD is a dynamic condition, with about 5% of diabetic patients entering or leaving the status every year. Younger male patients with insulin resistance or organ damage have a higher risk of presenting with FLI-NAFLD at baseline, developing FLI-NAFLD within 3 years, and a lower probability of regression.

Predictors of Long-Term Mortality in Older Patients Hospitalized for Acutely Decompensated Heart Failure: Clinical Relevance of Natriuretic Peptides.

BACKGROUND: Acute heart failure is a common cause of hospitalization among older patients. Optimized risk stratification might improve the outcome for this subgroup of patients. Natriuretic peptides have been used in the diagnosis of heart failure and in evaluating the prognosis of patients hospitalized for heart failure. However, their utility in the elderly is still controversial. OBJECTIVE: To evaluate long-term survival and prognostic factors for elderly patients hospitalized for acutely decompensated heart failure and evaluate the prognostic utility of NT-proBNP. DESIGN: Retrospective, multicenter cohort study. SETTING: Two Italian hospitals. PARTICIPANTS: Two hundred seventy-nine patients, aged >75 years; hospitalized for decompensation of chronic, established heart failure. METHODS: Baseline clinical data were recorded at admission. The primary outcome was long-term mortality. RESULTS: In-hospital, 12-month and 5-year mortality were, respectively, 10%, 36%, and 77%. NT-proBNP, eGFR, hemoglobin, diabetes, systolic blood pressure, and moderate to severe tricuspid regurgitation were independently associated with long-term prognosis and were entered into a multivariate model, with a C-index of 0.765 for the determination of high-risk patients. The C-index for NT-proBNP to predict mortality at 2 and 12 months was 0.740 and 0.756, respectively. The optimal cutoff point for predicting mortality at 2 and 12 months was 8,444 pg/mL (hazard ratio 5.33) and 8,275 pg/mL (hazard ratio 6.03), respectively. CONCLUSION: Elderly patients hospitalized for acutely decompensated heart failure had a poor long-term outcome, especially in the subgroup with reduced ejection fraction (EF). In addition to EF and comorbidities, NT-pro-BNP remained independently prognostic among elderly patients hospitalized with heart failure.

Sexual Dysfunction in Type 2 Diabetes at Diagnosis: Progression over Time and Drug and Non-Drug Correlated Factors.

AIMS: To present the longitudinal data of the SUBITO-DE study, a prospective survey involving male patients with new or recently diagnosed type 2 diabetes mellitus (T2DM) (<24 months). MATERIALS AND METHODS: Sexual function was assessed in male patients with T2DM at baseline (phase 1) and after a mean follow-up of 18 months (phase 2). Standard metabolic parameters and sexual and depressive symptoms were evaluated. RESULTS: Six of the 499 enrolled patients died of different causes during phase 1. Of the 493 surviving men invited to participate in phase 2, 450 (mean age 59.0±9.0 years) (90.2%) accepted and 43 (8.2%) were lost to follow-up. As compared to baseline, the proportion of the men who reported improvement in erectile dysfunction (ED) at follow-up was nearly double that of the men who reported worsening of ED (22.6% vs. 12.8%). The increase in frequency of sexual activity the men reported at follow-up assessment indicates that many never treated before baseline were taking an ED drug during the study period (106 subjects). Phosphodiesterase type 5 inhibitors (PDE5i) were the ED drugs most commonly taken at both baseline and follow-up. An overall improvement over baseline values was observed in metabolic targets for T2DM and depressive symptoms. Conversely, no change in lifestyle behaviors was recorded during the study. CONCLUSIONS: Sexual dysfunction is a major concern in men with T2DM. The SUBITO-DE study demonstrates that, when combined with adequate counseling and tailored PDE5i therapy, an integrated approach to achieving metabolic targets in men with T2DM can improve sexual function as well as depressive symptoms.