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Biomedical subjects

Luigi Tavazzi

Publications and source records attributed to Luigi Tavazzi.

At least 55 records · Page 3Linked to original sources
PubMed2005

Therapeutic approach in patients with stable angina.

Which therapeutic strategy among medical, interventional and surgical options should be preferred in patients with chronic stable ischemic heart disease is an important public health problem. The available scientific evidence does not help much to facilitate the choice among the three available strategies of medical treatment, percutaneous coronary intervention and coronary artery bypass grafting. In this area practice-based medicine overwhelms evidence-based medicine. However, existing findings are discussed. The present experience in diabetic patients is highlighted; in such patients surgery is generally recommended but the results obtained by percutaneous coronary intervention with the currently available tools are improving markedly. Pharmacological therapy is also improving, particularly in the prevention of the progression of atherothrombosis and consequently of cardiovascular events. Actually two categories of drugs should be recognized: those prescribed to prevent death and myocardial infarction and those with antianginal and anti-ischemic effects aimed at alleviating symptoms and reducing ischemia. The first group of drugs includes antiplatelet-antithrombotic agents, lipid-lowering agents and angiotensin-converting enzyme inhibitors; the second group includes beta-blockers, calcium antagonists and nitrates. A good integration of the two classes of drugs, combined with an appropriate use of coronary revascularization procedures, should yield the maximum possible benefit in the individual patient.

Adrenergic beta-Antagonists↗
PubMed2005

Right ventricular dysfunction in advanced heart failure.

For many years cardiologists were not interested in studying right ventricular function and the role of the right ventricle in heart failure and in other disease states has therefore been largely underestimated. More recently a consensus has grown on the critical role of right ventricular function in patients with advanced congestive heart failure. The estimation of right ventricular function is nowadays warranted in the standard evaluation of patients with heart failure either due to ischemic heart disease or to primary dilated cardiomyopathy, since it is helpful in the clinical assessment and in the prognostic stratification of such patients. Most information may be obtained non-invasively using sound but simple and reproducible echocardiographic indicators of right ventricular function.

Disease Progression↗
PubMed2005

[Determinants of late-onset heart failure in myocardial infarction survivors: GISSI Prevenzione trial results].

INTRODUCTION AND OBJECTIVES: Improvement in the early phase of myocardial infarction (MI) is associated with a higher rate of late complications, including late-onset heart failure (LHF). The factors predicting LHF are not well understood. Our aims were to identify the factors predicting LHF and to determine the survival rate in these patients. PATIENTS AND METHOD: The GISSI-Prevenzione trial involved 11,323 low-risk patients (NYHA class < or = II) who had had a recent MI (< 3 months). It was a multicenter, open-label, clinical trial of the efficacy of treatment with polyunsaturated fatty acids, vitamin E, both, or neither. Patients with heart failure at baseline and those whose ejection fraction was unknown (n = 2908) were excluded from the present analysis. Late-onset heart failure was defined prospectively as hospital admission due to heart failure. A Cox regression model adjusted for major covariates was used for risk analysis. RESULTS: The study included 8415 patients. During 3.5 years of follow-up, 192 (2.3%) developed LHF. The risk of LHF could be predicted from readily available parameters: age (per year; RR=1.07; 95% CI, 1.05-1.09), ejection fraction (per 1% increment; RR=0.96; 95% CI, 0.94-0.97), heart rate (> or = 74 beats/min; RR=1.62; 95% CI, 1.21-2.16), white blood cell count (> or = 8900 per ml; RR=1.42; 95% CI, 1.05-1.94), diabetes (RR=1.62; 95% CI, 1.17-2.24), hypertension (RR=1.76; 95% CI, 1.33-2.34), peripheral artery disease (RR=2.11; 95% CI, 1.32-3.37), and reinfarction (RR=2.09; 95% CI, 1.28-3.39). LHF was associated with poor survival: (RR=2.34; 95% CI, 1.63-3.36). CONCLUSIONS: The risk of LHF in post-MI patients can be predicted from readily available parameters. LHF was associated with a poor prognosis.

Aged↗
PubMed2005

[Economic impact of cardiac resynchronization therapy in patients with heart failure. Available evidence and evaluation of the CRT-Eucomed model for analysis of cost-effectiveness].

Several clinical trials show that cardiac resynchronization therapy (CRT) in patients with moderate-severe heart failure increases survival, improves quality of life and reduces hospital admissions. The high cost of this new technology, incurred by health organizations at the moment of the implant, requires to assess whether its use is economically rational for the Italian Health Service. The paper summarizes evidences of the impact of CRT on the use of hospital resources and on quality of life, and presents a model to calculate incremental costs per quality adjusted life years (QALYs) gained in patients with moderate-severe heart failure treated with optimal medical therapy. The model is based on efficacy data drawn from clinical trials and on other information concerning the Italian context collected and validated by a team of experts from Assobiomedica and the Italian Federation of Cardiology. The model estimates that the incremental cost per QALY gained attributable to CRT is Euro 63,225 if all effects (years of life gained, increased quality of life and reduction of hospital costs) are censored at the end of the first year after the implant and Euro 21,720 if all effects are censored at the end of the third year. Cost-effectiveness of CRT is thus strongly dependent upon the duration of its effects: longer benefits of the therapy compensate initial costs and thus make the technology more cost-effective. In order to get better estimates of the economic profile of CRT it is required to collect more precise data from routine practice on survival, quality of life and hospital resources. The model presented can be easily adapted to take into account new evidence and to calculate cost per QALY gained in regional and local contexts.

Cardiac Pacing, Artificial↗
PubMed2005

[Rationale, characteristics and study design of PREAMI (Perindopril and Remodelling in the Elderly with Acute Myocardial Infraction)].

Angiotensin-converting enzyme (ACE) inhibitors reduce mortality and morbidity in patients with heart failure and/or left ventricular systolic dysfunction and in patients with acute myocardial infarction (AMI), especially those with heart failure and/or evidence of left ventricular systolic dysfunction. ACE-inhibitors prevent cardiac events in patients at high cardiovascular risk and/or with documented coronary artery disease. There is a lack of data on the role of ACE-inhibitors in the elderly population with AMI and preserved left ventricular function. Nevertheless, the issue is of primary importance, considering the median age of patients with AMI and heart failure, the high risk of death, heart failure and left ventricular remodeling in the elderly, and the progressive aging of the general population. The multicenter and international (109 centers from five European countries), double-blind, randomized, parallel PREAMI (Perindopril and Remodelling in the Elderly with Acute Myocardial Infarction) trial evaluated the effects of the ACE-inhibitor perindopril in the elderly (aged > or =65 years) with AMI and preserved or mildly depressed left ventricular systolic function (ejection fraction > 40%). The combined primary endpoint was death, hospitalization for heart failure, and left ventricular remodeling (considered as an increase in left ventricular end-diastolic volume > or = 8%). Secondary endpoints included: each single primary endpoint, cardiovascular death, hospitalization for reinfarction or angina, and revascularization. The study involved 1252 patients, with an average age of 73 years, and AMI, treated with recommended usual therapy (antithrombotic drugs, beta-blockers, ACE-inhibitors). After 11 +/- 4 days from AMI, patients were randomized to receive either perindopril (4 mg/day for the first month and 8 mg/day for the remaining 11 months) or placebo, in addition to the recommended conventional therapy. Clinical assessment was performed at fixed times and included two-dimensional echocardiography (to evaluate left ventricular remodeling), Holter electrocardiographic monitoring (to assess heart rate variability and arrhythmias), and blood sampling (for safety evaluation). This review provides details on the background, rationale and study design of PREAMI.

Age Factors↗
PubMed2004

Increased circulating hematopoietic and endothelial progenitor cells in the early phase of acute myocardial infarction.

Endothelial progenitor cell (EPC) mobilization has been reported following tissue damage, whereas no data are available regarding the mobilization of hematopoietic progenitor cells (HPCs). We performed the phenotypic and functional analysis of circulating CD34+ progenitor cells in patients with acute myocardial infarction (AMI), assessed from admission up to 60 days, in patients with stable angina pectoris (SA), and in healthy controls (CTRLs). In patients with AMI at admission (T0), the number of circulating CD34+ cells was higher (P < .001) than in CTRLs and became comparable with CTRLs within 60 days. Both the number of CD34+ cells coexpressing CD33, CD38, or CD117 and the number of HPCs was higher (P < .02 for all) in patients with AMI at T0 than in CTRLs, as was the number of hematopoietic colonies (P < .03). Patients with AMI (T0) had a significantly increased number of CD34+ vascular endothelial growth factor receptor 2-positive (VEGFR-2+) cells (P < .002) with respect to CTRLs, including CD34(+) CD133(+)VEGFR-2+ and CD34+ CD117(+)VEGFR-2+ EPCs. The number of endothelial colonies was higher in patients with AMI (T0) than in CTRLs (P < .05). No significant difference was documented between patients with SA and CTRLs. Spontaneous mobilization of both HPCs and EPCs occurs within a few hours from the onset of AMI and is detectable until 2 months.

Adult↗
PubMed2004

Doppler-derived mitral deceleration time as a strong prognostic marker of left ventricular remodeling and survival after acute myocardial infarction: results of the GISSI-3 echo substudy.

OBJECTIVES: The goal of this study was to assess the impact of left ventricular (LV) diastolic filling on remodeling and survival after acute myocardial infarction (AMI). BACKGROUND: Little is known regarding the link between LV filling, its changes over time, and six-month remodeling and late survival in uncomplicated AMI. METHODS: Doppler mitral profile, end-diastolic volume index (EDVi) and end-systolic volume index (ESVi), ejection fraction (EF), and wall motion abnormalities (%WMA) were evaluated in 571 patients from the GISSI-3 Echo substudy at baseline, pre-discharge, and six months after AMI. Patients with baseline early mitral deceleration time (DT) 130 ms were assigned to the restrictive group (n = 147), and those with DT >130 ms to the nonrestrictive group (n = 424). RESULTS: Restrictive group patients had greater baseline ESVi and %WMA and lower EF than nonrestrictive group, and six-month greater LV dilation (EDVi, ESVi: p < 0.001 for EDVi and ESVi), smaller decrease in %WMA decrease (p < 0.01), and larger EF impairment (p < 0.008). Among the restrictive group, patients (n = 56) with pre-discharge persistent restrictive filling (n = 56) showed six-month greater LV enlargement (p < 0.001) and EF impairment (p < 0.009) than those (n = 91) with reversible restrictive filling. Baseline %WMA and EDVi, together with pre-discharge persistent restrictive filling, predicted severe (>20%) LV dilation. Four-year survival was 93% in nonrestrictive patients versus 88% in the restrictive group (p < 0.06), and 93% in pre-discharge reversible restrictive versus 79% in persistent restrictive (p < 0.0003). The single best predictor of mortality, by Cox analysis, was pre-discharge persistent restrictive filling (chi-square 14.88). CONCLUSIONS: Left ventricular dilation may occur even after uncomplicated AMI and may be paralleled by an improvement in LV filling. However, a baseline restrictive filling that persists at pre-discharge identifies more compromised patients at higher risk for six-month remodeling and four-year mortality.

Aged↗
PubMed2004

Left atrium remodeling after acute myocardial infarction (results of the GISSI-3 Echo Substudy).

To evaluate the existence, timing, and determinants of post-infarction left atrial remodeling, we studied a subgroup of 514 patients from the Third Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto Miocardico Echo Substudy who underwent 4 serial 2-dimensional echocardiograms up to 6 months after acute myocardial infarction. This study is the first to demonstrate, in a large series of patients, the existence of early and late left atrial remodeling after low-risk acute myocardial infarction and the relation of left atrial remodeling to left ventricular remodeling.

Aged↗
PubMed2004

Targeted anticytokine therapy in patients with chronic heart failure: results of the Randomized Etanercept Worldwide Evaluation (RENEWAL).

BACKGROUND: Studies in experimental models and preliminary clinical experience suggested a possible therapeutic role for the soluble tumor necrosis factor antagonist etanercept in heart failure. METHODS AND RESULTS: Patients with New York Heart Association class II to IV chronic heart failure and a left ventricular ejection fraction < or =0.30 were enrolled in 2 clinical trials that differed only in the doses of etanercept used. In RECOVER, patients received placebo (n=373) or subcutaneous etanercept in doses of 25 mg every week (n=375) or 25 mg twice per week (n=375). In RENAISSANCE, patients received placebo (n=309), etanercept 25 mg twice per week (n=308), or etanercept 25 mg 3 times per week (n=308). The primary end point of each individual trial was clinical status at 24 weeks. Analysis of the effect of the 2 higher doses of etanercept on the combined outcome of death or hospitalization due to chronic heart failure from the 2 studies was also planned (RENEWAL). On the basis of prespecified stopping rules, both trials were terminated prematurely owing to lack of benefit. Etanercept had no effect on clinical status in RENAISSANCE (P=0.17) or RECOVER (P=0.34) and had no effect on the death or chronic heart failure hospitalization end point in RENEWAL (etanercept to placebo relative risk=1.1, 95% CI 0.91 to 1.33, P=0.33). CONCLUSIONS: The results of RENEWAL rule out a clinically relevant benefit of etanercept on the rate of death or hospitalization due to chronic heart failure.

Adolescent↗
PubMed2004

Participation versus education: the GISSI story and beyond.

Approximately 20 years ago, the Italian cardiology community realized the scientific importance and the potential impact on clinical practice of the new concept of evidence-based medicine and launched (without funds) a national megatrial, the Gruppo Italiano por lo Studio della Streptochinasi nell'Infarto Miocardico (GISSI) study. In the following 20 years, 4 GISSI trials have been carried out, and a fifth is underway. The conceptual process that followed this experience shaped the role of the medico-scientific society that sponsored these trials as an active player in research, with the public health as the common target. This process of getting together was founded on the basic principle that active participation can be much more effective and rewarding than education (a passive process). Accordingly, further studies were undertaken dealing with clinical epidemiology, observational outcome research introduced complementarily to develop lines of clinical investigation along 2 mainstreams: ischemic heart disease and heart failure. The original decision to directly sponsor countrywide research projects in critical and relevant areas of care had broader implications not only for the role of scientific societies, but more generally for the nurture of independent research, which is today widely recognized to be at risk. The articulation among experimental, observational, and evaluative protocols in which all caring physicians are allowed to be producers and authors and not simply users of knowledge can favor a cultural continuity that minimizes the risk of parallelisms and gaps between research and care.

Biomedical Research↗
PubMed2004

A phase II, double-blind, randomized, placebo-controlled, dose comparative study of the efficacy, tolerability, and safety of MCC-135 in subjects with chronic heart failure, NYHA class II/III (MCC-135-GO1 study): rationale and design.

BACKGROUND: Chronic heart failure (CHF) can be caused either by a predominant abnormality in systolic function (systolic heart failure) or a predominant abnormality in diastolic function (diastolic heart failure). Randomized clinical trials have identified a number of pharmaceutical agents that can reduce morbidity and mortality in patients with systolic heart failure. Despite significant therapeutic advances, systolic heart failure continues to result in high rates of morbidity and mortality. In contrast to systolic heart failure, no randomized clinical trials have been performed in patients with diastolic heart failure. Common to the mechanisms causing both systolic and diastolic heart failure are abnormalities in calcium homeostasis. Mitsubishi Pharma Corporation has developed a compound (MCC-135, INN; caldaret) whose mechanism of action is proposed to be modulation of calcium homeostasis at the sarcoplasmic reticulum and cellular membrane. The purpose of this study was to test the safety, tolerability, and efficacy of MCC-135 in patients with mild to moderate heart failure. METHODS: This was a phase II, multicenter, randomized, double-blind study of parallel group design comparing 3 oral dose regimens of MCC-135 (5 mg, 25 mg, 50 mg, twice daily) with a placebo control. The treatment period was 24 weeks. A total of 511 patients were recruited from 69 centers in the United States and Europe. One hundred and twenty-five patients were recruited in each of the 4 treatment groups. Patients in each treatment group were divided into 2 cohorts: those with an ejection fraction < or = 40%, and those with an ejection fraction >40% as determined by core laboratory analysis of echocardiographic studies. CONCLUSION: Patient recruitment was completed in September 2002. Patient follow-up was completed by February 2003; the results will be available for release in 2004.

Adolescent↗
PubMed2004

Interventricular and intraventricular dyssynchrony are common in heart failure patients, regardless of QRS duration.

AIMS: The study aimed at evaluating the prevalence of interventricular and intraventricular contractile dyssynchrony in heart failure patients with either normal or prolonged QRS duration. METHODS AND RESULTS: Echocardiography and tissue Doppler imaging (TDI) were performed in 158 consecutive patients with advanced left ventricular dysfunction (LVEF<35%); 61 patients had a normal QRS duration (Group 1), 21 patients had left bundle branch block with a QRS duration between 120 and 150 ms (Group 2) and 76 patients had a QRS duration #10878;150 ms (Group 3). Interventricular dyssynchrony (defined by the presence of an interventricular mechanical delay greater than 40 ms) was found in 12.5%, 52.4% and 72% of patients in Group 1, 2 and 3, respectively (p < 0.001). Intraventricular dyssynchrony (defined by the presence of one or more differences greater than 50 ms among regional pre-ejection periods) was observed in 29.5%, 57.1% and 71% of patients in Group 1, 2 and 3, respectively (p < 0.001). No relationship was found between interventricular and intraventricular dyssynchrony. CONCLUSIONS: A substantial proportion of heart failure patients with a slightly prolonged QRS or even with normal conduction may exhibit ventricular dyssynchrony. Both standard echocardiography and TDI are necessary to describe the entire spectrum of mechanical abnormalities due to dyssynchrony.

Echocardiography, Doppler, Color↗