[Appropriateness in Cardiology: a statement of the ANMCO Veneto Region]. / L'appropriatezza prescrittiva in Cardiologia: documento dell'ANMCO Regione Veneto.

Inappropriate tests are responsible for longer waiting lists, higher economical costs for the National Health System and major clinical risks due to radiation exposure from prescription abuse of diagnostic testing. Clinical inappropriateness frequently derives from poor knowledge of guidelines, "defensive medicine" approach and/or repeat requests of patients and family members. About one third of non-invasive imaging tests are considered inappropriate.In order to define the most appropriate instruments for the follow-up of the most common cardiovascular diseases with the highest risk of inappropriateness, all the cardiologists of the Veneto Region (Italy), along with the local chapters of the main national cardiology societies and general practitioners have been involved by the Regional Section of the Italian Association of Hospital Cardiologists (ANMCO) in several scientific meetings on the following topics: hypertension, chronic ischemic heart disease, valvular heart disease, heart failure, and atrial fibrillation. This has led to the present document where: (i) the most appropriate clinical and diagnostic strategies are taken into account, and (ii) the most robust scientific evidence is provided for the regulatory commission of the Veneto Region Health Service to identify inappropriateness, prescription unsuitability, and economical sustainability.

Treatment with inotropes and related prognosis in acute heart failure: contemporary data from the Italian Network on Heart Failure (IN-HF) Outcome registry.

BACKGROUND: In the recent Italian Network on Heart Failure (IN-HF) Outcome registry, including 1,855 patients with acute heart failure (AHF), we reviewed the use of inotropes and their prognostic implication on in-hospital and 12-month mortality. METHODS: IN-HF Outcome is a prospective, multicenter, observational, study involving 61 Italian cardiology centers. AHF patients have been enrolled over a 2-year period and followed-up for 1 year. Inotropes were used in 360 patients (19.4%). RESULTS: Patients who received inotropes had a more severe clinical and hemodynamic profile than those who did not and exhibited a significantly higher rate of in-hospital (21.4% vs 2.7%, p < 0.01) and 1-year (50.6% vs 17.7%, p < 0.01) mortality. At entry, systolic blood pressure (SBP) was ≤ 110 mm Hg in 58%, 111 to 130 mm Hg in 24.5%, and > 130 mm Hg in 17.5%. Multivariable analyses showed use of inotropes was the strongest predictor of all-cause death. These data were confirmed by propensity score analyses. According to SBP at entry, the 2 groups with SBP > 110 mm Hg who took inotropes, despite a more favorable clinical profile, exhibited a similar worse prognosis, particularly at 1 year: 56.3% (≤ 110 mm Hg), 43.7% (111-130 mm Hg), and 40.3% (>130 mm Hg) vs 17.7%. CONCLUSIONS: Inotropes were used in nearly 20% of the patient admitted for AHF, and this treatment was associated with a short-term to medium-term poor prognosis. An inappropriate use of inotropes in patients with normal to high SBP, and presumably preserved cardiac output, may have significantly contributed to affect the all-group outcome.

Relation between serum sodium levels and prognosis in outpatients with chronic heart failure: neutral effect of treatment with beta-blockers and angiotensin-converting enzyme inhibitors: data from the Italian Network on Congestive Heart Failure (IN-CHF database).

INTRODUCTION: The predictive role of hyponatremia has been tested in acute and chronic heart failure. Sodium level is inversely related with renin-angiotensin-aldersterone system (RAAS) and sympathetic nervous activity but important issues remain unresolved. Our aim was to define the level of hyponatremia able to predict 1-year outcomes and investigate the relation between sodium levels and mortality and the effect of beta-blockers and angiotensin-converting enzyme (ACE) inhibitors on this relation. METHODS: We analyzed 4670 patients enrolled in the IN-CHF Italian Registry. We controlled the predictivity of hyponatremia, testing it either as a continuous variable and dividing the study sample into three severity groups: group 1 (≥136  mEq/l; n = 4207), group 2 (131-135  mEq/l; n = 389) and group 3 (≤130  mEq/l; n = 74). The linearity of the relationship between sodium levels and mortality was also tested. RESULTS: Mild-to-moderate and severe hyponatremia (groups 2 and 3) independently predicted the 1-year mortality. The relation between sodium concentration and death was not linear and a decrease of 1  mEq/l of sodium increased death rate only for values of sodium 142.9  mEq/l or less. This relationship was not modified by beta-blocker and ACE inhibitor therapies. CONCLUSION: Our data confirm the negative prognostic value of hyponatremia, even of moderate degree, independently of the use of recommended treatments for heart failure.

The predictive value of stable precursor fragments of vasoactive peptides in patients with chronic heart failure: data from the GISSI-heart failure (GISSI-HF) trial.

AIMS: Though various neurohormonal systems are concurrently activated during heart failure (HF), their biological effectors are not always easy to measure due to their short life in vivo, instability in biological samples, or very low concentrations. We measured the plasma concentrations of four stable precursor fragments of neurohormonal systems in patients with chronic HF and evaluated their relationship with outcome. METHODS AND RESULTS: This study was performed in 1237 patients with chronic and stable HF enrolled in the GISSI-heart failure trial (GISSI-HF). The following four precursor fragments, mid-regional pro-atrial natriuretic peptide (MR-proANP), mid-regional pro-adrenomedullin (MR-proADM), C-terminal pro-endothelin-1 (CT-proET-1) and C-terminal pro-vasopressin (CT-proAVP or copeptin), were measured at randomization and after 3 months. Baseline concentrations were independent predictors of clinical outcome (median follow-up 3.9 years). The addition of MR-proANP improved net reclassification for mortality when added to multivariable models based on clinical risk factors alone [net reclassification improvement (NRI) = 0.12, P = 0.0007] or together with NT-proBNP (NRI = 0.06, P = 0.01). Changes in MR-proANP concentrations were related to mortality [HR (95% CI) 1.38 (0.99-1.93), P = 0.0614 and 1.58 (1.13-2.21), P = 0.0078 in the middle and highest vs. lowest tertiles], while changes in the other markers were not. CONCLUSION: In patients with chronic and stable HF enrolled in a multicentre, randomized, clinical trial, measurement of stable precursor fragments of vasoactive peptides provided prognostic information independent of natriuretic peptides which are currently the best biomarkers for risk stratification.

Prevalence and prognostic value of elevated urinary albumin excretion in patients with chronic heart failure: data from the GISSI-Heart Failure trial.

BACKGROUND: Increased urinary excretion of albumin is an early sign of kidney damage and a risk factor for progressive cardiovascular and renal diseases and heart failure. There is, however, only limited information on the prevalence and prognostic role of urinary albumin excretion in patients with established chronic heart failure. METHODS AND RESULTS: A total of 2131 patients enrolled in 76 sites participating in the GISSI-Heart Failure trial provided a first morning spot sample of urine at any of the clinical visits scheduled in the trial to calculate the urinary albumin-to-creatinine ratio. The relation between log-transformed urinary albumin-to-creatinine ratio and all-cause mortality (428 deaths, time from urine collection to event or censoring) was evaluated with Cox multivariable models adjusted for all significant risk factors at the time of urine collection, in the study population, and in patients without diabetes or hypertension. Almost 75% of the patients had normal urinary albumin excretion, but 19.9% had microalbuminuria (30 to 299 mg/g creatinine) and 5.4% had overt albuminuria (>or=300 mg/g). There was a progressive, significant increase in the adjusted rate of mortality in the study population (hazard ratio, 1.12; 95% CI, 1.05 to 1.18 per 1-U increase of log(urinary albumin-to-creatinine ratio), P=0.0002) and in the subgroup of patients without diabetes or hypertension. Randomized treatments (n-3 polyunsaturated fatty acids or rosuvastatin) had no major impact on albumin excretion. CONCLUSIONS: Independently of diabetes, hypertension, or renal function, elevated albumin excretion is a powerful prognostic marker in patients with chronic heart failure.

Levels of circulating pro-angiogenic cells predict cardiovascular outcomes in patients with chronic heart failure.

BACKGROUND: Circulating pro-angiogenic cells (PACs) contribute to vascular and myocardial regeneration. A low level of PACs is associated with worse outcome in patients with coronary heart disease. However, little is known about PACs in heart failure (HF). METHODS AND RESULTS: Blood was sampled at baseline in 111 patients with HF, 67 from 5 Italian Centers and 44 from Frankfurt, Germany. In cultured mononuclear cells from peripheral blood, PACs were counted as double-stained by tetramethylindocarbocyanine-labeled acetylated LDL and fluorescein-5-isothiocyanate-labeled lectin. Mean age of the patients was 62 years, 12 were females, 66 had ischemic etiology, 26 were in New York Heart Association Class >II. Cutoffs for PACs were assessed by receiver operating characteristic curves, to identify the optimal cutoffs for PAC level in predicting outcomes. Mean level of PACs was 35+/-29 (mean+/-SD) cells/mm(2), 2- to 3-fold lower than in age-matched healthy volunteers, but unrelated to severity of HF, age, or sex. Over 2.5 years, 12 cardiovascular deaths and 47 first hospitalizations for cardiovascular reasons were recorded. After adjustment for demographic and clinical variables, elevated creatinine and natriuretic peptides, and PACs

Effect of n-3 polyunsaturated fatty acids and rosuvastatin in patients with heart failure: results of the GISSI-HF trial.

Epidemiological, experimental studies and post hoc analyses of randomized trials suggested that n-3 polyunsaturated fatty acids (PUFA) and statins could be beneficial in chronic heart failure. Two double-blind, placebo-controlled, randomized clinical trials investigated the efficacy and safety of n-3 PUFA 1 g daily (R1) and rosuvastatin 10 mg daily (R2) in patients with heart failure. In total, 6975 and 4574 patients were randomized in R1 and R2, respectively; the main reason for excluding patients from R2 being the open-label administration of statin treatment. Primary end points were death, and death or admission to hospital for cardiovascular reasons. n-3 PUFA, but not rosuvastatin, significantly decreased the two coprimary end points: 56 and 44 patients needed to be treated with n-3 PUFA for a median duration of 3.9 years to avoid one death or one cumulative event. Both drugs were safe and were tolerated. A simple and safe treatment with n-3 PUFA provides a beneficial advantage in patients with heart failure in a context of usual care.

B-type natriuretic Peptide-guided treatment for predicting outcome in patients hospitalized in sub-intensive care unit with acute heart failure.

BACKGROUND: Studies with natriuretic peptides have suggested that physicians do not treat heart acute failure (AHF) aggressively enough, and predischarge B-type natriuretic peptide (BNP) levels may be a useful reminder that more treatment is required. The purpose of this study was to demonstrate that variations in BNP levels during hormone-guided treatment and measured body hydration status enable the timing of the patient's discharge to be optimized. METHODS AND RESULTS: We retrospectively evaluated 186 patients admitted for AHF. All subjects underwent serial bioelectrical impedance analysis and BNP measurement. Therapy was titrated according to BNP value to reach a BNP value of <250 pg/mL, whenever is possible. A BNP value on discharge of <250 pg/mL (obtained in 54% of the patients) predicted a 16% event rate within 6 months, whereas a value >250 pg/mL was associated with a far higher percentage (78%) of adverse events. Among the former, no significant differences in event rate were seen in relation to the time necessary to obtain a reduction in BNP values below 250 pg/mL (14 versus 18%, chi-square = 0.3, NS). Cox regression showed that a BNP cutoff value of 250 pg/mL is the most accurate predictors of events. CONCLUSIONS: Our study demonstrates the usefulness of BNP in intrahospital stratification of AHF, in the decision-making process, and as a tool for "tailored therapy." Integrating this approach into the routine assessment of HF patients would allow clinicians to more accurately identify high-risk patients, who may derive increased benefit from intensive in-hospital management strategies.

Fall in readmission rate for heart failure after implementation of B-type natriuretic peptide testing for discharge decision: a retrospective study.

BACKGROUND: B-type natriuretic peptide is the most powerful predictor of long term prognosis in patients hospitalised with heart failure. On an outsetting basis, a decrease in B-type natriuretic peptide levels is associated to a decrease in event rate for outpatients managed using the neuro-hormone levels as the target in heart failure therapy. We have retrospectively checked whether the addition of pre-discharge B-type natriuretic peptide levels to a clinical-instrumental decisional score for discharge decision in patients admitted for heart failure reduced readmission rate for heart failure and related cost. METHODS: We studied two series of consecutive patients admitted to the Heart Failure Unit due to acute heart failure as a main diagnosis. One-hundred and forty-nine patients discharged on the basis of the sole clinical acumen were compared to one hundred and sixty-six subjects discharged adding B-type natriuretic peptide levels to the decisional score. RESULTS: During a six-month follow-up period, there were 52 readmissions (35%) among the clinical group (n=149) compared with 38 (23%) readmissions in the B-type natriuretic peptide group (n=166) (chi(2)=5.5; P=0.02). Survival did not differ between groups (87%). Changes in B-type natriuretic peptide values were correlated to clinical events: a B-type natriuretic peptide value on discharge of < or =250 pg/ml or a reduction of > or =30% in B-type natriuretic peptide values predicted a 23% event rate (death, plus readmission for heart failure), whereas a far higher percentage (71%) were observed in the remaining patients (chi(2)=32.7; P=0.001). Likewise, the overall costs of care were lower (-7%) in the B-type natriuretic peptide group: 2.781+/-923 vs 2.978+/-1.057 euros per patient respectively. CONCLUSIONS: our study suggest that the addition of pre-discharge B-type natriuretic peptide levels to a clinical-instrumental decisional score for discharge decision in patients admitted for heart failure may contribute to reduce the number of readmissions and related cost.

[BNP-guided therapy optimizes the timing of discharge and the medium term risk stratification in patients admitted for congestive heart failure]. / La terapia guidata dal BNP consente l'ottimizzazione del timing di dimissione e la stratificazione del rischio a medio termine nel paziente ricoverato per scompenso cardiaco.

BACKGROUND: Congestive heart failure (HF) is one of the most important cause of hospitalizations and is associated with high cost. Despite a consistent body of data demonstrating the benefits of drug therapy in HF, persistently high rates of readmission, especially within six months of discharge, continue to be documented. Neurohormonal activation characterizes the disease; plasma brain natriuretic peptide (BNP), is correlated with the severity of left ventricular dysfunction and relates to outcome. OBJECTIVE: The aim of the study was to evaluate if plasma levels of BNP would provide an index to guide drug treatment and to predict medium-term prognosis in HF patients (pts) after hospital discharge. METHODS AND RESULTS: We evaluated 200 consecutive pts (age 77 +/- 10 (35-96) years, 49% male versus 51% female) hospitalized for HF (DRG 127). Standard echocardiography was performed and left ventricular systolic/diastolic function was assessed; plasma BNP levels were measured with a rapid point-of-care assay (Triage BNP Test, Biosite Inc, San Diego, CA) on days 1 and after initial treatment. Using a cut-off of 240 pg/ml and/or changes in plasma BNP (days 2-3 after admission), 2 groups were identified: the low BNP group-responders (n = 68, BNP < 240 pg/ml and/or > or = 30% reduction) and the high BNP group-non responders (n = 132, BNP > or = 240 pg/ml and/or < 30% reduction). The high BNP group showed a different pattern of clinical variables according to the severity of the disease New York Heart Association (NYHA) functional class, left ventricular ejection fraction, ischemic etiology and age. A sustained elevation of plasma BNP (> 240 pg/mL) indicated the presence of a clinical unstable condition requiring further intervention whereas pts with low BNP values were discharged after 24 hours. During a mean follow-up period of 3 months, there were 62 cardiac events, including 15 cardiac deaths, 22 readmissions for worsening heart failure and 25 clinical decompensation requiring diuretic treatment. The incidence of clinical events was significantly greater in pts with higher levels of BNP (admission and discharge) than in those with lower levels (42% vs. 10%) and plasma values > 500 pg/ml identified a subgroup at high risk of death. CONCLUSIONS: The influence of BNP in the clinical course and prognosis of patients hospitalized for HF has not been studied. After initial treatment pts need to be risk stratified by means of the BNP test, to guide further management and to identify subjects with poor prognosis. An aggressive therapeutic and follow-up strategy may be justified for pts with high BNP levels and/or no changes after hospital admission for worsening HF. The changes in plasma BNP level at discharge were significantly related to cardiac events.

[Heart failure in Eastern Veneto: prevalence, hospitalization rate, adherence to guidelines and social costs]. / Lo scompenso cardiaco nel veneto orientale: prevalenza, ospedalizzazione, aderenza alle linee guida e costi sociali.

Heart failure is a prominent problem of public health, requiring innovating methods of health services organization. Nevertheless, data are still not available on prevalence, hospitalization rate, adherence to Guidelines and social costs in the general Italian population. The necessity to identifying patients with heart failure derives from the efficacy of new therapeutic interventions in reducing morbidity and mortality. In this study we aimed to identify, in a subset of the Eastern Veneto population, patients with heart failure through a pharmacologic-epidemiologic survey. The study was divided in 5 phases: (1) identification of patients on furosemide in the year 2000 in the ASL 10 of Eastern Veneto general population, through an analysis of a specific pharmaceutic service database; (2) definition of the actual prevalence of heart failure in a casual sample of these patients, through data base belonging to general practitioners, cardiologists, or others. Diagnosis was based on the following criteria: (a) previous diagnosis of heart failure; (b) previous hospitalization for heart failure; (c) clinical evidence, with echocardiographic control in unclear cases; (3) survey of hospitalizations; (4) evaluation of adhesion to guidelines, through both databases and questionnaires; (5) analysis of the social costs of the disease, with a retrospective "bottom up" approach. From a total population of 198,000 subjects, we identified 4502 patients on furosemide. In a casual sample of 10,661 subjects we defined a prevalence of heart failure in Eastern Veneto of 1.1%, that increased to 7.1% in octagenarians. The prescription of life saving drugs was satisfactory, while rather poor was the indication to echocardiography and to cardiologic consultation. Hospitalization rate for DRG 127 was low: 2.1/1000 inhabitants/year in the general population and 12.5 /1000 inhabitants/year in patients >70 years of age. Yearly mortality was 10.3%. Social costs were elevated (15.394 Euros/patient/year), due to a relevant sanitary component (hospital 53%, drugs 28%) and particularly a to an indirect cost component. In conclusion, the assumption of furosemide lends itself as a good marker for identifying patients with heart failure. Patient identification is simple, cheap and cost-efficient, and can be easily reproduced in other regional areas.

B-type natriuretic peptide predicts postdischarge prognosis in elderly patients admitted due to cardiogenic pulmonary edema.

To examine the prognostic role of predischarge B-type natriuretic peptide (BNP) levels in elderly patients admitted to the hospital due to cardiogenic pulmonary edema, 203 patients consecutively admitted to the Heart Failure Unit of the Cardiology Department were retrospectively evaluated. The primary clinical end point selected was a combination of: 1) deaths; plus 2) readmissions to the hospital for heart failure in the 6 months after discharge. Thirty-one deaths (15.3%) and 44 readmissions for heart failure (21.7%) were recorded. Cox multivariate regression analysis confirmed that BNP cutoff values (identified on receiver-operated curve analysis) are the most accurate predictor of events. Hazard ratios (HRs) increased from the lowest, for BNP < or = 200 pg/mL (HR=1), through BNP 201-499 pg/mL (HR=2.3200; p=0.0174), to the highest, for BNP > or = 500 pg/mL (HR=3.6233; p=0.0009). This study demonstrates that BNP is useful in predischarge risk stratification of elderly patients with cardiogenic pulmonary edema.

B-type natriuretic peptide can predict the medium-term risk in patients with acute heart failure and preserved systolic function.

BACKGROUND: Half of patients with heart failure (HF) have preserved left ventricular ejection fraction (LVEF). Neurohormonal activation characterizes the disease and measurement of plasma B-type natriuretic peptide (BNP) indicates the severity of left ventricular dysfunction. The purpose of this study was to test the hypothesis that measurement of BNP levels in ambulatory patients with HF and preserved LVEF can predict the occurrence of cardiovascular events in the next 6 months. METHODS AND RESULTS: We enrolled 233 consecutive patients admitted to the Outpatient Heart Failure Clinic (OHFC), on stabilization after an episode of acute HF, with a LVEF > 50%. Standard echocardiography was performed and left ventricular systolic/diastolic function was assessed. Plasma BNP levels were measured on admission to OHFC. Patients were followed for 6 months; the main endpoint combined cardiovascular death or readmission for HF. Among the 233 patients discharged, 48 endpoints occurred (death: n = 15; readmission: n = 33). Receiver operated curve analysis shows that BNP levels are strong predictors of subsequent events (area under the curve = 0.84; CI = 0.78-0.88). Multivariate Cox regression showed that the cutoff values identified by receiver operated curve analysis (200-500 pg/mL) of the neurohormone are the most accurate predictors of events: HR = 2.2 (P < .04) and HR = 5.8 (P < .001), respectively, for 201-499 pg/mL and > or = 500 pg/mL ranges. CONCLUSION: BNP level is a strong predictor for cardiovascular mortality and early readmission in patients with diastolic HF. The results suggest that BNP levels might be used successfully to guide the intensity of follow-up after a decompensation, because increased BNP levels were associated with a progressively bad prognosis.

The NT-proBNP assay identifies very elderly nursing home residents suffering from pre-clinical heart failure.

BACKGROUND: Little is known about the prevalence of heart failure among very old people, although hospitalisation rates for chronic heart failure are very high. Recently, brain natriuretic peptides have emerged as important diagnostic and prognostic serum markers for congestive heart failure. AIMS: The main purpose of our study was to determine whether there is a cut-off for NT-proBNP for detecting the echocardiographic features of left ventricular systolic and/or diastolic dysfunction and clinical heart failure among old people living in nursing homes. Secondarily, we investigated the medium-term prognostic power of the neurohormone levels. METHODS: We screened 101 old people (80% females, aged 84+/-9 years) from two nursing homes. We prospectively evaluated whether we could effectively stratify patients using a combination of (1) restrictive clinical criteria, (2) NT-proBNP measurements (Elecsys System, Roche Diagnostics) and (3) echocardiography for all patients. RESULTS: Forty-two percent of the subjects had left ventricular dysfunction: 11% systolic, 23% diastolic and 8% both systolic and diastolic. The mean NT-proBNP concentration was 2806+/-7028 pg/ml in the 42 patients with left ventricular systolic and/or diastolic dysfunction, compared with 365+/-456 pg/ml in the 59 patients with normal left ventricular function (p<0.01, Z=-4.8 Mann-Whitney U test). The neurohormone proved to be a good predictor of events within 6 months [area under the receiver-operated curve (ROC)=0.79]. CONCLUSIONS: Blood NT-proBNP concentrations can play an important role in stratifying old people into left ventricular dysfunction risk groups. The neurohormone is an independent marker for death or admission for heart failure in the medium term.

Anemia in patients with heart failure: prevalence and prognostic role in a controlled trial and in clinical practice.

BACKGROUND: Aims of the present study were (1) to confirm the prognostic role of anemia in patients with heart failure (HF) and (2) to analyze this aspect in relatively unselected patients with HF monitored prospectively in a community setting (IN-CHF), and in patients selected for enrollment into the Valsartan Heart Failure Trial (Val-HeFT). METHODS AND RESULTS: In both Val-HeFT and IN-CHF Registry, anemia was defined as a hemoglobin (Hb) level < or = 11 g/dL in women and < or = 12 g/dL in men. Of the 2411 patients of the IN-CHF Registry, 15.5% had anemia, whereas in the 5010 patients of the Val-HeFT trial, the prevalence was 9.9%. In the IN-CHF registry, 1-year all-cause mortality was significantly higher in anemic patients (25.9%) than in patients without anemia (13.2%) (P < .0001). The association of anemia with mortality was confirmed by the multivariable analysis (hazard ratio [HR] 1.54, 95% confidence interval [CI] 1.20-1.97). The risk of death decreased by 9.7% for each gram of Hb. The Val-HeFT trial showed an all-cause mortality rate for anemic patients of 29.6% over a mean follow-up period of 22.4 months versus 18.5% (P < .0001) in patients without anemia. After adjustment, anemia retained its negative independent prognostic role (HR 1.26, 95% CI 1.04-1.52). When Hb was considered as a continuous variable, the risk of death decreased by 7.8% for each gram of Hb. CONCLUSIONS: Anemia was confirmed to be an independent negative prognostic factor in patients with HF. This finding is consistent in 2 different clinical contexts, a controlled trial and a registry in clinical practice, in which patient characteristics and outcome are largely different.

[A comprehensive management system for heart failure improves clinical outcomes and reduces medical resource utilization]. / Una proposta di protocollo per la gestione ambulatoriale dei pazienti dimessi con diagnosi di scompenso cardiaco: il progetto collaborativo Venetia-HF.

BACKGROUND: Hospital admissions for heart failure are common and readmission rates are high. Many admissions and readmissions may be avoidable, so that alternative strategies are needed to improve long-term management. METHODS: We conducted a randomized trial of the effect of a guideline-based intervention on rates of readmission within 90 days of hospital discharge and costs of care for patients who were hospitalized due to decompensated heart failure. The intervention consisted of comprehensive education of the patient and family, a prescribed diet and intensive application of guidelines' recommendations on pharmacological therapy. The intervention started before discharge and continued thereafter with follow-up visits for up to 3 months. Two hundred and nine guideline-managed patients were compared to 209 concurrent normally-discharged patients. RESULTS: Patients in the study group were more prescribed beta-blockers, ACE-inhibitors, angiotensin receptor blockers, and spironolactone. Sixteen patients (8%) in the intervention group and 31 (15%) among controls were readmitted for DRG 127, within 3 months of discharge (Fisher's exact test, p < 0.01), while the 6-month mortality rate was similar between groups (9 and 11.5% respectively). Quality of life significantly improved from 5.6 +/- 1.0 to 6.1 +/- 1.9 (Mann-Whitney U-test, p < 0.05). The overall costs of care were lower for guideline-managed patients (110 vs 150 Euro per patient per month), due to the lower readmission rates. CONCLUSIONS: Our study showed that a guideline-based management program for patients with heart failure at discharge improves quality of life and reduces readmission for DRG 127 and total bed days, allowing relevant cost savings.

[Proposed protocol for the ambulatory management of patients discharged with heart failure diagnosis: collaborative project Venice-HF]. / Una proposta di protocollo per la gestione ambulatoriale dei pazienti dimessi con diagnosi di scompenso cardiaco: il progetto collaborativo Venetia-HF.

BACKGROUND: Hospital admissions for heart failure are common and readmission rates are high. Many admissions and readmissions may be avoidable, so that alternative strategies are needed to improve long-term management. METHODS: We conducted a randomized trial of the effect of a guideline-based intervention on rates of readmission within 90 days of hospital discharge and costs of care for patients who were hospitalized due to decompensated heart failure. The intervention consisted of comprehensive education of the patient and family, a prescribed diet and intensive application of guidelines' recommendations on pharmacological therapy. The intervention started before discharge and continued thereafter with follow-up visits for up to 3 months. Two hundred and nine guideline-managed patients were compared to 209 concurrent normally-discharged patients. RESULTS: Patients in the study group were more prescribed beta-blockers, ACE-inhibitors, angiotensin receptor blockers, and spironolactone. Sixteen patients (8%) in the intervention group and 31 (15%) among controls were readmitted for DRG 127, within 3 months of discharge (Fisher's exact test, p < 0.01), while the 6-month mortality rate was similar between groups (9 and 11.5% respectively). Quality of life significantly improved from 5.6 +/- 1.0 to 6.1 +/- 1.9 (Mann-Whitney U-test, p < 0.05). The overall costs of care were lower for guideline-managed patients (110 vs 150 Euro per patient per month), due to the lower readmission rates. CONCLUSIONS: Our study showed that a guideline-based management program for patients with heart failure at discharge improves quality of life and reduces readmission for DRG 127 and total bed days, allowing relevant cost savings.

Antihypertensive effects of lacidipine during effort in mild to moderate hypertension.

The aim of this study was to evaluate the effects of chronic treatment with lacidipine on blood pressure, heart rate and double product during and immediately after physical effort in mild to moderate hypertensive patients. This was a single-center, randomized, double-blind, crossover, placebo-controlled clinical trial. Eighteen hypertensive patients (56% males, median age 53 years) were randomized to lacidipine 4 mg o.i.d. followed by placebo or to placebo followed by lacidipine 4 mg o.i.d. Lacidipine compared with placebo exerted a significant antihypertensive effect, lowering SBP and DBP both at baseline and either during or after exercise test. The average incremental changes of SBP and DBP between pre-exercise stage and maximal effort did not show any significant differences between treatments. HR during treatment with lacidipine was higher than during treatment with placebo both at rest and after exercise, but at maximal effort, HR was not different from placebo. The average values of DP at maximal effort, and during recovery, did not show any significant differences. Lacidipine 4 mg was effective in lowering blood pressure and in maintaining its antihypertensive effect throughout and after physical exercise, without enhancing double product value, which is an indirect index of myocardial oxygen consumption.