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First-generation drug eluting stents (DES) reduced the incidence of restenosis and need for repeated target lesion revascularization but, in autoptic studies, frequently resulted in incomplete endothelial coverage, which is an important predictor of late adverse events and increased mortality after stent implantation. More recently, not only uncovered, but also malapposed or protruding struts have been considered vulnerable structures, as they are deemed to perturb blood flow, whereas only struts well embedded into the vessel wall are considered stable. We compared the number of uncovered and of other vulnerable (protruding or malapposed) struts among three different second-generation drug-eluting stents (DES) (Cre8, Biomatrix, Xience), using optical coherence tomography (OCT) 6 months after implantation. Moreover, we analyzed the relationship between the percentage of vulnerable struts and the clinical characteristics of patients. 60 patients with stable angina or non-ST-Elevation acute coronary syndrome and indication to percutaneous angioplasty were randomly assigned to receive one of the three DES. After 6 months, OCT images were obtained. After 6 months, OCT images were obtained (1289 cross sections; 10,728 struts). None of the three DES showed non-coated struts or areas of stent thrombosis. Significant differences in the average number of protruding struts (Cre8: 33.9 ± 12.6; Biomatrix: 26.2 ± 18.1; Xience: 13.2 ± 8.5; p < 0.001) and in the proportion of malapposed struts (Cre8: 0.7%; Biomatrix: 0.9%; Xience: 0.0%; p = 0.040) and of incomplete stent apposition area (Cre8: 10.4%; Biomatrix: 4.7%; Xience: 0.7%; p < 0.001) were observed. No significant difference was found in neointimal hyperplasia area with a not significant tendency toward greater minimal and maximal struts thickness for Biomatrix. In comparison with Cre8 and Biomatrix, Xience showed a significantly lower proportion of vulnerable struts in all clinical sub-groups considered. In the group of 60 patients a significant relation was found between age and number of vulnerable struts (p = 0.014). The three second-generation DES were similarly effective in permitting neo-intimal formation and complete struts coating 6 months after implantation, but Cre8 and Biomatrix showed a greater proportion of protruding and malapposed struts.Trail Registry: Clinical Trials.gov Identifier: NCT02850497.

Objectives: Observational studies on early surgery in infective endocarditis have conflicting results. This study aims to compare the treatment strategies for early surgery (within 2 weeks of diagnosis) and late surgery/medical therapy in terms of survival among patients with the left-sided infective endocarditis., Methods: This study included patients with the left-sided infective endocarditis registered between 2006 and 2010 in the Italian Registry of Infective Endocarditis (RIEI). A Cox proportional hazards model was used to estimate the effect of these treatment strategies on overall survival and included sociodemographic and clinical characteristics associated with treatment, risk factors for mortality and early surgery as a time-dependent covariate to avoid indication and immortal time biases., Results: Among the 502 patients included, 184 (36.7%) underwent early surgery. Of the remaining 318 patients, 138 underwent late surgery. The early surgery group had fewer patients with comorbidities and with enterococcus as the causative microorganism, but this group had more complicated cardiac conditions. No difference in mortality risk was estimated between the treatment groups including early surgery as time-dependent variables (adjusted hazard ratio  = 0.95, 95% confidence interval 0.55-1.63), while a distorted and overestimated beneficial effect of surgery was estimated considering surgery as a non-time-dependent variable (adjusted hazard ratio 0.41, 95% confidence interval 0.25-0.70)., Conclusions: Our study did not confirm a better overall survival in patients undergoing early surgery. However, even with the use of statistical techniques to control biases, we could not draw definitive conclusions that early surgery is not beneficial. Our results need to be assessed by randomized trials before any changes in clinical practice can be recommended.

Introduction: The epidemiology of infective endocarditis (IE) is changing due to a number of factors, including aging and health related comorbidities and medical procedures. The aim of this study is to describe the main clinical, epidemiologic and etiologic changes of IE from a large database in Italy., Methods: We prospectively collected episodes of IE in 17 Italian centers from July 2007 to December 2010., Results: We enrolled 677 patients with definite IE, of which 24% health-care associated. Patients were male (73%) with a median age of 62 years (IQR: 49-74) and 61% had several comorbidities. One hundred and twenty-eight (19%) patients had prosthetic left side IE, 391 (58%) native left side IE, 94 (14%) device-related IE and 54 (8%) right side IE. A predisposing cardiopathy was present in 50%, while odontoiatric and non odontoiatric procedures were reported in 5% and 21% of patients respectively. Symptoms were usually atypical and precocious. The prevalent etiology was represented by Staphylococcus aureus (27%) followed by coagulase-negative staphylococci (CNS, 21%), Streptococcus viridans (15%) and enterococci (14%). CNS and enterococci were relatively more frequent in patients with intravascular devices and prosthesis and S. viridans in left native valve. Diagnosis was made by transthoracic and transesophageal echocardiography in 62% and 94% of cases, respectively. The in-hospital mortality was 14% and 1-year mortality was 21%., Conclusion: The epidemiology is changing in Italy, where IE more often affects older patients with comorbidities and intravascular devices, with an acute onset and including a high frequency of enterococci. There were few preceding odontoiatric procedures., (Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.)

Background: Antibiotic prophylaxis of patients believed to be at a risk of developing infective endocarditis has been recently revisited with limited indications compared with the previous body of knowledge in use by the medical community. As a consequence, most of the healthcare specialists in cardiology and infectious diseases have doubts related to the enormous change that has been proposed. In this study, we report the results of an Italian consensus of experts in cardiology and infectious diseases, with the aim to offer a national document that illustrates the reasons for such a change through the review of the basis of infective endocarditis prophylaxis, the historical background, and the reasons for the change, providing practical conclusions and illustrating grey areas., Methods: The main guidelines published on the topic of antibiotic prophylaxis for infective endocarditis were discussed as well as the risk of anaphylaxis. Overall, the group agreed that the evidence for prophylaxis is weak and limited to few case-control studies, expert opinion, clinical experience, and descriptive studies., Results: The 'downgrading' of the indications for prophylaxis is mainly due to a cultural change and a more critical attitude towards available published data. Although the group acknowledge the critical view of the previously published guidelines, it seems to be more practical to consider the issue of prophylaxis without the evidence required by guidelines but rather as a consensus document based on the available data., Conclusion: Contemporary guidelines on infective endocarditis prophylaxis challenge previous recommendations based on a low level of evidence. The main recommendation of the study group is to underline that prophylaxis may often be based on adequate education without the administration of antibiotics, which only remains suggested, following the usual practice, in patients with heart diseases, when the risk of a complicated prognosis following infective endocarditis may be anticipated.

Background: More than 380,000 angiographic procedures are performed every year in Italian hospitals, with an increase rate of 8% per year. Although contrast media (CM) are considered relatively safe, adverse drug reactions (ADRs) remain an important issue., Objectives: The objective of this study was to quantify the incidence of immediate and delayed nonrenal ADRs to iodinated CM in an Italian cohort and to evaluate whether their different physicochemical properties are able to affect the incidence of immediate or delayed ADRs., Methods: A prospective intensive monitoring study was conducted on a cohort of patients undergoing radiodiagnostic procedures with iodinated CM enrolled in two hospitals in Tuscany, Italy. To evaluate both immediate (within 1 h after CM administration) and delayed (>1 h to 1 week after CM administration) ADRs to CM, two questionnaires were administered. Adverse events (AEs) were analyzed to check the causality assessment between CM and ADR. If more than one symptom occurred in the same patient, they were treated as a single event., Results: One thousand five hundred and fourteen subjects who were exposed to iodinated CM completed the questionnaires. Mean age [standard deviation (SD)] was 65.4 (13.3) years, and 57.9% were male patients. A total of 178 [11.8%; 95% confidence interval (CI) 10.1-13.4] ADRs were reported. Thirty-four (2.2%; 1.5-3.1) and 144 (9.5%; 8.0-11.1) developed immediate and delayed ADRs, respectively. Both types of ADRs were experienced by six subjects (0.4%; 0.1-0.8). One hundred and seventy-six cases (98.8%; 96.0-99.8) were classified as possible and two (1.1%; 0.1-3.9) as probable ADRs. Monomeric low-osmolal (iopromide, iomeprol, iobitridol) and dimeric iso-osmolal (iodixanol) groups mainly reported delayed allergy-like ADRs of mild severity. Only one immediate reaction was severe. Multivariate analysis confirmed a higher risk of immediate reactions occurring for monomeric CM (OR 4.3; 95% CI 1.2-15.7), whereas the risk of delayed ADRs was significantly higher for the dimeric group (OR 1.8; 1.1-2.5)., Conclusions: Monomeric CM were more frequently involved in immediate ADRs, whereas dimeric CM were involved in delayed reactions. Although severe life-threatening ADRs to CM were confirmed to be rare, due to the large use of these drugs, they still retain clinical and epidemiological significance.

In the last 30 years, major improvements have been made in understanding the pathogenesis, diagnosis and treatment of infective endocarditis. Nevertheless, mortality still remains high, close to 30-40% at 1 year, and its reduction remains the main challenge. Moreover, important epidemiological changes have been recorded. Social changes in Western countries have led to an increase in the mean length of life, and thus in degenerative valvular diseases, whereas rheumatic heart disease has almost disappeared. Increasing medicalization has led to a rise in complications and diseases related to longer hospital stay, surgical therapies and other invasive interventions. At the same time, there is an increase in immunosuppressive therapies, diseases such as cancer, diabetes mellitus and renal insufficiency that may enhance the disease. Further knowledge is needed for specific subgroups to improve both treatment and prognosis. Nevertheless, randomized trials are lacking to guide the management of the disease, and the role and indications of antibiotic prophylaxis are still the subject of debate. International multicenter studies are providing new important findings based on the experience of tertiary centers; these results may reflect referral biases. The proposal of an Italian national registry on infective endocarditis (RIEI) will overcome these limitations and provide a wide picture of the national presentation of the disease. The aim of the registry is to improve the management of infective endocarditis, through a better understanding of demographic, clinical, therapeutic and prognostic features of the disease in the real world. The background, rationale, aims and expected results of the registry are reviewed.

Rationale: Colchicine seems to be well tolerated and effective in the treatment and prevention of pericarditis. A preliminary clinical trial has shown that colchicine may be considered not only for the treatment of postpericardiotomy syndrome (PPS), but also for its primary prevention., Study Design: The COPPS study is a multicentre, double-blind, randomised trial. On the third postoperative day, 360 patients, 180 in each treatment arm, will be randomised to receive placebo or colchicine (1.0 mg twice daily for the first day followed by a maintenance dose of 0.5 mg twice daily for 1 month in patients > or =70 kg, and halved doses for patients <70 kg or intolerant to the highest dose). The primary efficacy endpoint is the incidence of PPS at 12 months. Secondary endpoints are disease-related hospitalisation, cardiac tamponade, constrictive pericarditis, and relapses at 18 months. Additional analysis will include the time to PPS., Implications: The COPPS trial will evaluate the use of colchicine for the primary prevention of PPS. This study will also provide important information on the frequency, clinical presentation, and prognosis of this syndrome in clinical practice.

Background: Colchicine is safe and effective in the treatment and prevention of recurrent pericarditis after failure of conventional treatment. The recent guidelines of the European Society of Cardiology suggest that colchicine might be useful even in the treatment of the first episode. However, the use of the drug is not based on any strong evidence obtained from clinical trials, and no randomized placebo-controlled trial is available to guide the management of acute pericarditis., Study Design: The Investigation on Colchicine for Acute Pericarditis (ICAP) trial will enroll 240 patients in a prospective, randomized, double-blind, multicenter investigation of colchicine compared to placebo in patients with acute pericarditis. The primary efficacy end point is the recurrence rate at 18 months. The secondary end points are symptom persistence at 72 h, remission rate at 1 week, number of recurrences, time to first recurrence, disease-related hospitalization, cardiac tamponade, and constrictive pericarditis., Implications: The ICAP trial will be the first randomized placebo-controlled trial in this area. This trial will provide important evidence regarding the possible benefit of the early use of colchicine in the treatment of acute pericarditis and the primary prevention of recurrences, the most troublesome and commonest complication of pericarditis.

Background: Intravenous drug users (IDUs) are at increased risk of infective endocarditis (IE)., Patients and Methods: Episodes of IE in IDUs were retrospectively analyzed in this multicenter study. Cases were collected between 1986 and 1999. Only definite diagnosis according to the Duke criteria were analyzed., Results: Two hundred and sixty-three cases, including 100 cases in HIV-positive patients, were observed in IDUs. Any right-sided involvement was detected in 167 out of 263 cases (63.5%) and any left-sided involvement in 115 out of 263 cases (43.7%). The tricuspid valve (TV) alone was affected in 135 cases (51.3%), the mitral valve alone in 32 patients (12.1%), the aortic valve alone in 41 cases (15.6%) and the pulmonic valve alone in 3 cases. Staphylococcus aureus was isolated in 156 cases (59.3%) and Streptococcus spp. in 33 cases (12.5%). No major differences were observed between HIV-negative and HIV-positive patients. Any TV valve involvement was significantly associated with female rather than male gender (p = 0.02). There was a significant association between S. aureus etiology and TV involvement (p < 0.0001). The mortality rate was 16%. On multivariate analysis, only left-side IE (p = 0.0006; OR 5.2; 95% CI 2.0-13.5) and age greater than 35 years (p = 0.0068; OR 3.6; 95% CI 1.4-9.0) were independently associated with mortality., Conclusions: Infective endocarditis in IDUs is significantly associated with right-side localization (63.5% for any rightsided heart involvement vs 43.7% for any left-sided heart involvement; OR 2.24; 95% CI 1.55-3.23; p < 0.001). S. aureus is the microorganism most frequently isolated and is significantly associated with TV involvement. Any left-side involvement and age greater than 35 years are independently associated with mortality. HIV infection does not appear to have a significant effect on mortality.

Background: Intravenous drug users (IVDUs) are at increased risk of infective endocarditis. Moreover, HIV infection is common in IVDUs, with a reported prevalence of 40-90%. The clinical features of IVDUs with infective endocarditis and HIV infection may be peculiar. Few data have been reported on the diagnostic accuracy of Duke criteria in IVDUs with or without HIV infection, and a comparison of these two populations is lacking., Methods: The present study aimed to compare prospectively the clinical features of patients with infective endocarditis with or without HIV infection and to evaluate the diagnostic accuracy of Duke criteria in these patients. The study population consisted of 201 consecutive adult IVDUs with a suspected infective endocarditis (102 patients with HIV infection and 99 patients without HIV infection)., Results: Infective endocarditis was the final diagnosis in 40 of 102 patients (38.2%) with HIV infection and in 55 of 99 HIV-negative patients (55.6%). Despite similar baseline features, longer vegetations were recorded in infective endocarditis without HIV infection (23.7 +/- 7.1 mm versus 13.6 +/- 6.8 mm; P = 0.001). Patients with infective endocarditis and HIV infection had a higher total mortality at 2 months (respectively 12.5% versus 1.8%; P = 0.09); almost all the deaths were recorded in patients with AIDS or a CD4 cell count below 200 per microl, and no deaths were recorded in patients with HIV infection and a CD4 cell count > 500 per microl., Conclusions: Despite no identical clinical features, Duke criteria had a similar sensitivity, specificity and diagnostic accuracy in IVDUs with and without HIV infection.

Background: The clinical and epidemiological profiles of infective endocarditis (IE) are continuously evolving. We report the results of a 2-year multicenter prospective survey that investigated new trends in the epidemiology, microbiological and clinical features and the prognosis of IE., Methods: From January 2000 through December 2001, a prospective multicenter survey on IE was conducted in the region of Piedmont, Italy (4.2 million inhabitants)., Results: A total of 267 patients with suspected IE were enrolled, of whom 147 received a definite diagnosis of IE, as confirmed by pathology or follow-up data. The annual estimated incidence of IE was 36 cases per 1 million inhabitants in urban Turin and 30 cases per 1 million inhabitants in the province of Turin. A predisposing heart disease was detected in 70.8% of cases, with prosthetic valve involvement in 27 (18%). The incidence of injection drug use was 10%. Twenty-two cases (15%) were related to invasive procedures. Causative microorganisms included: streptococci 37.4% (oral streptococci 17.7%, group D streptococci 9.5%, pyogenic streptococci 3.4%, enterococci 6.8%), staphylococci 34%, other pathogens 28.5%. Blood cultures were negative in 25% of cases. The mean time between symptom onset and hospital admission was 39.7 days; this interval was shorter and associated with a poorer prognosis in cases of IE due to Staphylococcus aureus infection (p < 0.001). The delay in carrying out echocardiographic and blood culture evaluation often led to a late diagnosis as defined by the Duke criteria (8.2 +/- 7.4 days after admission). Valve surgery was performed in 31% of patients. The in-hospital mortality was 14% and that at 3 months 18%., Conclusions: In Piedmont, the incidence of IE is similar to the rates reported in other recent series. Still, the diagnosis and management of IE remain a challenge. The variegated clinical manifestations of IE and its changing epidemiology require constant surveillance.

Objectives: We sought to investigate the safety and efficacy of a protocol for acute pericarditis triage and outpatient management of low-risk cases., Background: Acute pericarditis has generally a brief and benign course after empiric treatment by non-steroidal anti-inflammatory drugs, and routine hospitalization of most patients may be unnecessary., Methods: From January 1996 to December 2001, all consecutive cases of acute pericarditis were evaluated on a day-hospital basis. Patients without clinical poor prognostic predictors (fever >38 degrees C, subacute onset, immunodepression, trauma, oral anticoagulant therapy, myopericarditis, severe pericardial effusion, cardiac tamponade) were considered low-risk cases and assigned to outpatient treatment with high-dose oral aspirin. Patients with poor prognostic predictors or aspirin failure were hospitalized for etiology search and treatment. A clinical and echocardiographic follow-up was performed at 48 to 72 h, 7 to 10 days, 1 month, 6 months, and 1 year., Results: Two hundred fifty-four out of 300 (84.7%) patients were selected as low-risk cases. Outpatient treatment was efficacious in 221 out of 254 (87%) cases. Thirty-three out of 254 patients were hospitalized because of aspirin failure. Patients treated on an out-of-hospital basis had no serious complications after a mean follow-up of 38 months (no cases of cardiac tamponade). A higher frequency of recurrences and constriction was recorded in aspirin-resistant cases than in aspirin responders (60.6% vs. 10.4% for recurrences and 9.1% vs. 0.5% for constriction, respectively; all p < 0.01)., Conclusions: A protocol for acute pericarditis triage and outpatient therapy of low-risk cases is safe and efficacious and may reduce management costs.

Background: Over the last years, the use of oral anticoagulant treatment (OAT) has increased dramatically, principally for the prevention of embolic stroke in patients with atrial fibrillation. This study was aimed at evaluating the efficacy and safety of the management of OAT in a real-practice situation., Methods: Nine hundred and three consecutive unselected patients, 250 of whom with atrial fibrillation, referred for the control of OAT to the Anticoagulation Clinic of the University of Florence were studied. The total follow-up period was 1679 patient-years., Results: The rate of major bleeding events was 0.8 per 100 patient-years in atrial fibrillation patients. In patients with a target INR > or = 3 a significantly higher rate of bleeding (p = 0.02) with respect to patients with a target INR < 3 was observed., Conclusions: A low incidence of complications may be obtained even in elderly atrial fibrillation patients on OAT followed in an Anticoagulation Clinic specifically devoted to this management.

Calcium channel blockers and ACE-inhibitors are among the most common drugs prescribed for the initial treatment of hypertension. While their ability to control surrogate outcomes, such as blood pressure and left ventricular hypertrophy, is proven, there is limited evidence of their prevention of major cardiovascular events, including mortality. The aim of our work was to assess the use of these drugs in Italy in comparison with beta-blockers and diuretics. We examined the consumption of the four main antihypertensive classes of drugs (beta-blockers, diuretics, calcium channel blockers and ACE- inhibitors). In-hospitalization data from the GIFA (Gruppo Italiano di Farmacoepidemiologia nell'Anziano) database were used. During the period from 1988 to 1995, the most frequently prescribed antihypertensive drugs were calcium channel blockers (47%) followed by diuretics (37%), ACE-inhibitors (33%) and beta-blockers (5.5%). Changes over time in the use of these drugs were analysed: ACE-inhibitors had the greatest increase in use over time. Calcium channel blockers, ACE-inhibitors and beta-blockers were usually prescribed to the youngest patients (aged <65 years), while diuretics to the oldest. Calcium channel blockers were prescribed to 60% of patients with myocardial infarction and to 55% of those with congestive heart failure. In conclusion, our study demonstrates that the Italian physicians very often prescribe drugs like calcium channel blockers and ACE-inhibitors. Among these pharmacological agents, enalapril (twice per day) and slow release calcium channel blockers are the most frequently prescribed drugs., (Copyright 2000 Academic Press.)

To assess whether serum creatinine and age are associated with headache induced by nitrates, 2742 hospitalized patients taking nitrates were studied during their hospital stay. Those patients with admission serum creatinine levels from 97 to 133 mumol/L and > 133 mumol/L were compared with patients with creatinine levels < 97 mumol/L. Gender, body mass index, comorbidity, cognitive status, new intake of nitrates, number of daily administrations, and daily dosage, as well as intake of angiotensin converting enzyme inhibitors, calcium antagonists, diuretics and nonsteroidal anti-inflammatory drugs were examined as possible confounders. Fifty-six patients had headaches that had a causal link with intake of nitrates. Compared with the lowest creatinine group, after adjustment for potential confounding variables, the odds ratios and 95% confidence interval (95% CI) for headache caused by nitrates associated with increasing serum creatinine levels were 0.6 (95% CI, 0.3 to 1.1) and 0.2 (95% CI, 0.0 to 1.2), respectively (p for trend = 0.013). Increasing age was inversely associated with headache (odds ratio for 10-year increase, 0.6 [95% CI, 0.5 to 0.7]). Serum creatinine and age were independently and inversely associated with headache caused by nitrates.