[Standards and outcome measures in cardiovascular rehabilitation. Position paper GICR/IACPR]. / Requisiti e indicatori in cardiologia riabilitativa: documento di consenso del GICR/IACPR.

Despite major improvements in diagnostics and interventional therapies, cardiovascular diseases remain a major health care and socio-economic problem in Italy. Costs and resources required are increasing in close correlation to both the improved quality of care and to the population ageing. There is an overwhelming evidence of the efficacy of cardiac rehabilitation (CR) in terms of reduction in morbidity and mortality after acute cardiac events. CR services are by definition multi-factorial and comprehensive. Furthermore, systematic analysis and monitoring of the process of delivery and outcomes is of paramount importance. The aim of this position paper promoted by the Italian Association for Cardiovascular Prevention and Rehabilitation (GICR-IACPR) is to provide specific recommendations to assist CR staff in the design, evaluation and development of their care delivery organization. The position paper should also assist health care providers, insurers, policy makers and consumers in the recognition of the quality of care requirements, standards and outcome measure, quality and performance indicators, and professional competence involved in such organization and programs. The position paper i) include comprehensive CR definition and indications, ii) describes priority criteria based on the clinical risk for admission to both inpatient or outpatient CR, and iii) defines components and technological, structural and organizing requirements for inpatient or outpatient CR services, with specific indicators and standards, performance measures and required professional skills. A specific chapter is dedicated to the requirements for highly specialized CR services for patients with more advanced cardiovascular diseases.

[Takotsubo syndrome in a young woman during puerperium: case report]. / Sindrome di Takotsubo nel puerperio: caso clinico.

INTRODUCTION: Takotsubo syndrome is a reversibile cardiomyopathy that often occurs during an emotional stress and is more frequent in post-menopausal women. CASE PRESENTATION: We describe a clinic case of a 42 years old woman, admitted to our emergency unit because of a thoracic pain. The ECG showed ST-T elevation in V1-V4, the echocardiography revealed akinesia of apical segment of left ventricle. Coronary arteries were free from significant stenosis and ventriculography showed akinesia of apical segment of left ventricle. In the following days, ECG evolved toward a normalization of ST-T segment with appearance of negative T wave in V2-V6, and also the echocardiography showed a normalized LV wall motion. The patient was discharged and ECG and echocardiography were normal at two months follow up. CONCLUSION: In this case report, a young woman during puerperium presented with a Takotsubo syndrome. We speculate that the high Prolactin level and her emotional state contributed to the clinical manifestation of the syndrome.

High pulse pressure and low mean arterial pressure: two predictors of death after a myocardial infarction.

OBJECTIVES: Although the negative prognostic implication of a clinical history of arterial hypertension in myocardial infarction (MI) survivors is well known, the predictive role of the blood pressure (BP) regimen after MI is not well defined. The aim of this study was to investigate the prognostic significance of different BP indices in post-MI. METHODS AND RESULTS: We evaluated the relationship between baseline systolic, diastolic, pulse and mean arterial pressure (MAP), measured by sphygmomanometry at discharge from hospital or within 3 months of an MI, and total and cardiovascular mortality in 11 116 patients enrolled in the GISSI-Prevenzione trial. Over 3.5 years of follow-up, 999 patients died, 657 of them from cardiovascular causes. Low mean and high pulse pressure were significantly associated with total and cardiovascular mortality after controlling for potential confounders in the multivariate analysis. As compared with patients with less extreme BP values, patients with MAP of 80 mmHg or less (n = 1241; 11.2%) had a 48% higher risk of cardiovascular death [95% confidenceinterval (CI) 1.16-1.87; P = 0.001] and those with pulse pressure greater than 60 mmHg (n = 958; 8.6%) had a 35% higher risk (95% CI 1.09-1.69; P = 0.007); only four subjects (0.04%) had both a high pulse pressure and a low MAP (relative risk of cardiovascular death 3.48; 95% CI 0.48-25.88; P = 0.218). CONCLUSIONS: Our results show for the first time an additional prognostic importance of two easily measurable components of BP, definitely high pulse pressure (> 60 mmHg) and low MAP (< or = 80 mmHg), in a large sample of non-selected patients surviving MI who entered a modern programme of cardiovascular prevention.

Early protection against sudden death by n-3 polyunsaturated fatty acids after myocardial infarction: time-course analysis of the results of the Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto Miocardico (GISSI)-Prevenzione.

BACKGROUND: Our purpose was to assess the time course of the benefit of n-3 polyunsaturated fatty acids (PUFAs) on mortality documented by the GISSI-Prevenzione trial in patients surviving a recent (<3 months) myocardial infarction. METHODS AND RESULTS: In this study, 11 323 patients were randomly assigned to supplements of n-3 PUFAs, vitamin E (300 mg/d), both, or no treatment (control) on top of optimal pharmacological treatment and lifestyle advice. Intention-to-treat analysis adjusted for interaction between treatments was carried out. Early efficacy of n-3 PUFA treatment for total, cardiovascular, cardiac, coronary, and sudden death; nonfatal myocardial infarction; total coronary heart disease; and cerebrovascular events was assessed by right-censoring follow-up data 12 times from the first month after randomization up to 12 months. Survival curves for n-3 PUFA treatment diverged early after randomization, and total mortality was significantly lowered after 3 months of treatment (relative risk [RR] 0.59; 95% CI 0.36 to 0.97; P=0.037). The reduction in risk of sudden death was specifically relevant and statistically significant already at 4 months (RR 0.47; 95% CI 0.219 to 0.995; P=0.048). A similarly significant, although delayed, pattern after 6 to 8 months of treatment was observed for cardiovascular, cardiac, and coronary deaths. CONCLUSIONS: The early effect of low-dose (1 g/d) n-3 PUFAs on total mortality and sudden death supports the hypothesis of an antiarrhythmic effect of this drug. Such a result is consistent with the wealth of evidence coming from laboratory experiments on isolated myocytes, animal models, and epidemiological and clinical studies.

[Epidemiology of acute coronary syndrome in Campania]. / Epidemiologia delle sindromi coronariche acute in Campania.

Recent observational studies have pointed out many problems regarding the pre-hospital and in-hospital management of patients with acute coronary syndrome (ACS). The present study analyses the epidemiology of ACS in Campania Region. It has enrolled the 92.3% of coronary care units (CCU) of the Campania. The results indicate that 77% of patients admitted in CCU have ACS and the time of admission in CCU is still too long. Moreover the vast majority of patients arrive at the hospital without emergency ambulance and 48% of patients admitted in CCU for ACS with elevated ST segment do not receive any reperfusion therapy; compared with the 35.1% of patients included in the BLITZ study. The challenge of the SSN in the next future is to improve the "decision making" in the management of patients with ACS. This goal could be reached by an optimal organization of the hospital and out-of-hospital emergency services creating an integrated network of cardiological assistance.

[The ISYDE project. A survey on Cardiac Rehabilitation in Italy]. / Il progetto ISYDE (Italian Survey on Cardiac Rehabilitation). Lo stato della Cardiologia Riabilitativa in Italia.

In 2001-2002 the Italian Working Group on Cardiac Rehabilitation (CR) developed the ISYDE project, a survey on CR in Italy. In 2001, the CR units were 144 (57% in the North of the country), 58% in general hospitals, 23% in private hospitals, 8% in rehabilitative hospital, and only 2% in university clinics. Patients admitted to CR were 60,819 (vs 37.049 in 1996, +64%); 86% of CR units treated > 100 pts/year (vs 66% in 1996; +32%). Patients were admitted to CR units after cardiosurgery in 55% of cases, after myocardial infarction in 22%, and for chronic heart failure in 9.6%, without significant differences respect to 1996. A special survey investigated the work-up performed in patients with recent myocardial infarction. The admission ranges from 11th to 20th day, the mean duration of the CR programs ranges from 21 to 34 days. Most of italian CR units have a definite program for risk stratification and secondary prevention. In particular, the programs of exercise training, educational interventions concerning diet, lifestyle, and smoking cessation, and psychological intervention are well designed, developed, and evaluated before discharge in most cases. In conclusion, although in recent years the number of CR units are increasing, and the quality of care may be well-established by serial evaluations scheduled before discharge and during the long-term follow-up, a further development is mandatory to face the needs of cardiac patients in the post-acute and chronic phase of a cardiac disease.

[Recommendations for cardiovascular rehabilitation in diabetes mellitus]. / Raccomandazioni per la riabilitazione cardiovascolare nel paziente con diabete mellito.

Cardiac rehabilitation is accepted as an important component in the management of heart disease. Diabetes Mellitus is a chronic disease frequently associated to ischemic heart disease and both disease require continuing medical care, aggressive treatment of other risk factors, educational programs for self management of disease to prevent acute complication. The scientific community should offer standard of care for management of diabetic patients with coronary artery disease, and should design new strategies to promote prevention in this high risk patients. The need to define characteristics and peculiar problems of diabetics patients with ischemic heart disease encouraged the Board of the Italian Group of Cardiac Rehabilitation and Prevention (GICR) to set up a working group composed of cardiologists and diabetologists chosen on the basis of their proven specific experience. The document is subdivided in six parts. In the first section is described the cardiovascular risks in patients with diabetes and the importance of post-prandial hyperglycemia and glycemic variability. We analyse also the difference in prevalence of ischemic heart disease in Italian diabetic patients compared with other countries. In the second section we described clinical presentation of ischemic heart disease in diabetic patients such as acute myocardial infarction and unstable angina, and the revascularization procedures (balloon angioplasty and coronary bypass surgery). We analysed the differences between the procedures and the evidence-based results. In patients with myocardial infarction we analysed the evidence-based therapy and specific advantages of aspirin, beta-blockers and ace-inhibitor in diabetic patients. In this section we also posed particular attention to the clinical course of patients who underwent bypass grafting and to the impact of diabetes on short and long-term results and on main intervention-related complications including deep infections, mediastinitis, neurological problems, renal failure. In the third section we evaluated the factors responsible of atherosclerosis progression and their treatment, and we underlined that cardiac rehabilitation is less effective for patients with diabetes mellitus. Suggestions proposed in this paper about risk factors are in line with the recommendations of standards guidelines of American Diabetics Association. In patients with concomitant diabetes and ischemic heart disease we suggest blood pressure <130/80, LDL-cholesterol <100 mg/dl, triglycerides <150 mg/dl and daily physical activity. In the fourth section we analysed therapeutic regimens and management of diabetes. We posed particular attention on insulin therapy in acute phase of myocardial infarction and in recent coronary bypass grafting, and chronic use of oral antidiabetic drugs or insulin. In the fifth section we provided some recommendations on the organization of educational programs and physical activity in these patients. In the last section we provided some information on diagnosis of coronary artery disease in diabetes, aim of screening and in which patients is need to perform diagnostic tests. We described the available diagnostic tests with the differences in each method.

[Spontaneous dissection of 2 coronary branches in a young man. Report of a clinical case]. / Dissezione spontanea di due rami coronarici in un giovane maschio. Descrizione di un caso clinico.

Spontaneous coronary dissection is responsible for acute coronary syndromes particularly in females during and in the peri-partum period. It rarely occurs in patients without atherosclerotic coronary plaques. We report a particular clinical course of a 39-year-old patient with spontaneous dissection of two coronary arteries. His clinical course suggested only medical treatment, with aspirin, beta-blockers and ACE-inhibitors. At 3 months of follow-up the patient is free of symptoms.

Global secondary prevention strategies to limit event recurrence after myocardial infarction: results of the GOSPEL study, a multicenter, randomized controlled trial from the Italian Cardiac Rehabilitation Network.

BACKGROUND: Secondary prevention is not adequately implemented after myocardial infarction (MI). We assessed the effect on quality of care and prognosis of a long-term, relatively intensive rehabilitation strategy after MI. METHODS: We conducted a multicenter, randomized controlled trial in patients following standard post-MI cardiac rehabilitation, comparing a long-term, reinforced, multifactorial educational and behavioral intervention with usual care. A total of 3241 patients with recent MI were randomized to a 3-year multifactorial continued educational and behavioral program (intervention group; n = 1620) or usual care (control group; n = 1621). The combination of cardiovascular (CV) mortality, nonfatal MI, nonfatal stroke, and hospitalization for angina pectoris, heart failure, or urgent revascularization procedure was the primary end point. Other end points were major CV events, major cardiac and cerebrovascular events, lifestyle habits, and drug prescriptions. RESULTS: End point events occurred in 556 patients (17.2%). Compared with usual care, the intensive intervention did not decrease the primary end point significantly (16.1% vs 18.2%; hazard ratio [HR], 0.88; 95% confidence interval [CI], 0.74-1.04). However, the intensive intervention decreased several secondary end points: CV mortality plus nonfatal MI and stroke (3.2% vs 4.8%; HR, 0.67; 95% CI, 0.47-0.95), cardiac death plus nonfatal myocardial infarction (2.5% vs 4.0%; HR, 0.64; 95% CI, 0.43-0.94), and nonfatal MI (1.4% vs 2.7%; HR, 0.52; 95% CI, 0.31-0.86). A marked improvement in lifestyle habits (ie, exercise, diet, psychosocial stress, less deterioration of body weight control) and in prescription of drugs for secondary prevention was seen in the intervention group. CONCLUSION: The GOSPEL Study is the first trial to our knowledge to demonstrate that a multifactorial, continued reinforced intervention up to 3 years after rehabilitation following MI is effective in decreasing the risk of several important CV outcomes, particularly nonfatal MI, although the overall effect is small. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT00421876.

GlObal Secondary Prevention strategiEs to Limit event recurrence after myocardial infarction: the GOSPEL study. A trial from the Italian Cardiac Rehabilitation Network: rationale and design.

BACKGROUND: Cardiac rehabilitation programmes are a proven treatment for individuals with recent myocardial infarction, resulting in reduced morbidity and mortality compared to usual care. Unfortunately, following completion of a cardiac rehabilitation programme, risk factors and lifestyle behaviours may deteriorate. The GlObal Secondary Prevention strategiEs to Limit event recurrence after myocardial infarction (GOSPEL) study investigates the benefits of a programme of continued educational and behavioural interventions to achieve optimal long-term secondary prevention goals. DESIGN: This will be a multicentre, randomized, controlled study carried out in 78 Italian cardiac rehabilitation centres. METHODS: After completion of an initial cardiac rehabilitation programme, patients with recent (<3 months) myocardial infarction were randomized to either a long-lasting (over 3 years) multifactorial continued educational and behavioural programme (intensive approach) or usual care (control) group. Intensive approach patients participated in extensive cardiac rehabilitation sessions, monthly from months 1 to 6, then every 6 months for 3 years. Each session consisted of aerobic exercise, comprehensive lifestyle and risk factor counselling, and clinical assessment. Usual care patients returned to their family physicians' care, and attended the reference centre only for the 6-month and then annual scheduled assessment. The efficacy of the two different strategies will be evaluated in terms of morbidity and mortality as primary endpoint. RESULTS: From January 2001 through December 2002, 3241 patients were enrolled. Results will be available in mid 2006. CONCLUSIONS: The GOSPEL trial, the rationale and design of which we present here, was designed to test a new strategy of secondary prevention delivery and to raise standards of long-term secondary prevention in Italy. With a cohort of over 3200 patients, GOSPEL is the largest randomized, multifactorial lifestyle and risk factor intervention trial after myocardial infarction conducted so far.