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Objectives To correlate the severity of lung neovascularity (Sheehan vessels) with the cause and haemodynamic severity of pulmonary arterial hypertension (PAH), pulmonary artery (PA) size and heart disease type in patients with PH associated with congenital heart diseases (PAH-CHD) and idiopathic PH (IPAH). Methods We reviewed the HRCT and CT pulmonary angiography studies of 87 patients with PAH-CHD and 111 with IPAH; all had undergone right heart catheterisation. We evaluated the PA size and severity of neovascularity on CT. Results Neovascularity, which was found in 72% of PAHCHD (56% with Eisenmenger's syndrome) and in 22%of IPAH patients, is significantly related to the severity of PH and all patients with severe neovascularity had intermediate or high PH. All PAH-CHD patients had a dilated PA with a greater risk of developing severe dilatation (diameter >5 cm). The neovascularity correlated with the PA size only in IPAH. Conclusions Neovascularity even if not pathognomonic for PAH-CHD, is significantly more common in these patients, especially in Eisenmenger's syndrome. It is often the first CT sign to indicate the severity of PH in PAH-CHD and IPAH. A neovascularity ≥5 on CT indicates a intermediate or high PH. Key Points • Large retrospective studying specific lung disorders in patients with pulmonary arterial hypertension. • Neovascularity is often the first CT sign indicating the severity of pulmonary hypertension Alterations of lung parenchyma on CT in pulmonary hypertension are described • The first study to assess the severity of pulmonary hypertension by CT • If substantiated, CT might eventually replace some cardiac catheterisation for evaluating PH

Aims Many inoperable patients with severe aortic stenosis (AS) are not immediately eligible for transcatheter aortic valve implantation (TAVI). We evaluated the role of percutaneous balloon aortic valvuloplasty (BAV) in this setting. Methods and results Among 210 consecutive patients referred to our institution for BAV, we identified three groups: immediately eligible for TAVI (n=65, 31%), excluded from TAVI (n=67, 32%), BAV as a bridge to TAVI (n=78, 37%). This last group comprised patients with low left ventricular ejection fraction, frailty or enfeebled status, symptoms of uncertain origin, critical conditions, moderate-to-severe mitral valve regurgitation, need of major non-cardiac surgery. Outpatient clinic visit and echocardiography were performed around one month after BAV to decide the final therapeutic strategy. Mean age was 81±8 years and the vast majority of patients had comorbidities and high-risk features. The incidence of periprocedural adverse events was 6.4%: 5.1% death (four patients: one procedural complication, three, natural disease progression), 1.3% minor stroke. After BAV, 46% of these patients were deemed eligible for TAVI, and 28% for cardiac surgery. Patients who underwent TAVI after bridge BAV showed 94% 30-day survival. Conclusions BAV is a safe and effective tool to bridge selected patients to TAVI when indications are not obvious.

Aims: Treatment delay is a powerful predictor of survival in STEMI patients undergoing primary PCI. We investigated the effectiveness of pre-hospital triage with direct referral to PCI, alongside more conventional referral strategies. Methods and results: From January 2003 to December 2007, 1,619 STEMI patients were referred for primary PCI at our cathlab through two main triage groups: i.e., 1) following pre-hospital triage (n=524), 2) via more conventional triages (n=1,095) represented by the S. Orsola-Malpighi hospital emergency department triage (hub hospital) and local hospital triage. Pre-hospital diagnosis was associated with a 76 minute reduction in pain-to-balloon time (143 [107-216] vs. 219 [149-343], p=0.001) allowing mechanical revascularisation within 90 minutes from the first medical contact in the vast majority of the patients (>80%). Clinically, pre-hospital triage showed no significant reductions in terms of adjusted long-term mortality (HR 0.81, 95% CI 0.61-1.08; p=0.16) in the overall population. However, significant adjusted survival benefits were observed in high-risk groups (i.e., cardiogenic shock, TIMI risk score >30, diabetes mellitus). Conclusions: This study shows that pre-hospital diagnosis allows for significant reductions in primary PCI treatment delays and suggests the hypothesis that this referral strategy might provide long-term survival benefits especially in high-risk patients.

Survival and exercise performance are key targets of heart transplantation (HT). We designed this study to help in identifying (1) patients with chronic heart failure (CHF) at risk of poor exercise capacity after HT and (2) HT recipients presenting risk factors modifiable with exercise showing a potential impact on outcome. We enrolled 49 HT recipients (age 52 ± 12 years, 84% males) who underwent a cardiopulmonary exercise test before (9 ± 6 months) and after (20 ± 14 months) HT. In the CHF phase, lower peak oxygen consumption (VO(2) ) (odds ratio 0.69, P=0.017) independently predicted peak VO(2) improvement after HT. In the post-HT phase, body mass index (BMI) [adjusted hazard ratio (HR) 1.16, P=0.034] and VE (ventilation)/VCO(2) (carbon dioxide production) slope (adjusted HR 1.07, P=0.031) independently predicted mortality. In conclusion, CHF patients with only a moderate impairment of peak VO(2) are at a risk of failing to achieve a significant improvement of exercise performance after HT. In the post-HT phase, a BMI≥28 and/or a VE/VCO(2) slope ≥47 represent risk factors for death, which are potentially modifiable with exercise. Prospective randomized studies are needed to analyze the effects of training on functional capacity and outcome in the different subsets of HT recipients.

AIMS: Few studies have systematically evaluated the value of intra-procedural parameters in predicting response to cardiac resynchronization therapy (CRT). We investigated whether intracardiac (electrogram) measurements of electrical delays between the positioned right ventricular (RV) and left ventricular (LV) leads at implantation could predict the mid-term CRT response. METHODS AND RESULTS: Fifty-two patients underwent CRT implantation according to standard techniques and clinical indications. The RV-LV interlead electrical delay measured during spontaneous rhythm and the difference between the pacing-induced (Deltap) RV-LV interlead electrical delays measured during RV and LV pacing were defined intraoperatively using the electrical depolarizations registered at the ventricular leads on the device programmer. At 6 months, a reduction of LV end-systolic volume > or = 15% was used to define CRT responders. Responders (62%), when compared with non-responders, showed a higher proportion of ischaemic aetiology (P = 0.007) and a lower value of DeltapRV-LV interlead electrical delay (22.1 +/- 18.4 vs. 46.3 +/- 15.0 ms, P = 0.0001). At multivariate analysis, the DeltapRV-LV interlead electrical delay was the only independent predictor of response to CRT (P = 0.001). For such a parameter, the receiving operating characteristic curve analysis identified a cut-off value of 42 ms corresponding with the highest accuracy: sensitivity 90.6%; specificity 70%; positive and negative predictive value 83% and 82%, respectively. Conversely, no difference was ascertained between responders and non-responders when RV-LV interlead electrical delay was measured during spontaneous rhythm (76.1 +/- 28.5 vs. 89.6 +/- 21.2, P = 0.078). CONCLUSION: Intraprocedural measuring of paced RV-LV interlead electrical delay obtained during RV and LV pacing predicts mid-term CRT response.

To measure and compare the reliability and predictive validity of a four-level triage system (I-4L) and the new four-level model triage emergency method (TEM).This observational study was conducted in an urban hospital. Ten nurses were randomly selected to assign a triage level to 189 paper scenarios, using either the I-4L model (5 nurses) or the TEM model (5 nurses). We used weighted kappa statistics to measure the interrater and intrarater reliability of each triage tool and assessed the validity of each models based on the accuracy in predicting admission.Interrater reliability was kappa=0.73 [95% CI (confidence interval): 0.59-0.87] and kappa=0.79 (95% CI: 0.65-0.93) with I-4L and TEM, respectively. Intrarater reliability was kappa=0.82 (95% CI: 0.67-0.96) and kappa=0.78 (95% CI: 0.62-0.93), respectively. The accuracy of triage rating for admission prediction was similarly good with I-4L and TEM, namely, 79% (95% CI: 74-85) and 77% (95% CI: 74-85). The proportion of patients admitted per triage level was similar with the two models.The interrater and intrarater reliability for rating triage acuity and for accuracy in patient admission prediction was good with both models. Performance with the new model was similar to that of I-4L despite the nurses' short experience. The new TEM model has the advantage of predicting utilization of emergency department resources.

Aims To evaluate the predictive value of high sensitivity (hs) C-reactive protein levels on long-term survival in patients with ST-elevation myocardial infarction (STEMI) treated with primary PCI. Methods and results We conducted a retrospective analysis of 758 STEMI patients (from January 2003 to December 2005), with STEMI onset < 12 h and hs-C-reactive protein determination on admission. Patients were classified into four groups [I (hs-C-reactive protein < 0.48 mg/dL), II (hs-C-reactive protein ≥ 0.48 to < 1.2 mg/dL), III (hs-C-reactive protein ≥ 1.2 to < 3.1 mg/dL), IV (hs-C-reactive protein ≥ 3.1 mg/dL)] according to quartiles of hs-C-reactive protein serum level. The IV quartile hs-C-reactive protein group had a higher incidence of in-hospital mortality and cumulative adverse events. At a mean follow-up of 724 ± 376 days (range 0–1393), the IV quartile hs-C-reactive protein group showed lower estimated survival, lower estimated myocardial infarction-free survival and lower estimated event-free survival. At multivariable analysis hs-C-reactive protein appeared to be an independent predictor of long-term mortality (HR: 1.04, 95% CI: 1.01–1.07, P = 0.003), long-term mortality and re-infarction (HR: 1.03, 95% CI: 1.01–1.06, P = 0.008) and adverse events (HR: 1.03, 95% CI: 1.01–1.05, P = 0.03). Conclusion Evaluation of hs-C-reactive protein on admission in STEMI patients undergoing primary PCI allows reliable risk stratification of these patients.

Background In acute coronary syndromes (ACS), the influence of cerebro-vascular disease (CVD) and/or peripheral artery disease (PAD) on short-midterm outcome has been well established. Data on long-term outcome however, are limited. Our study aimed to explore the effect of CVD and PAD on long-term outcome in a cohort of unselected ACS patients, including ST-elevation (STE-ACS) and non-ST-elevation (NSTE-ACS). Methods and results The population consisted of 2046 consecutive patients with a confirmed final diagnosis of ACS; 896 (44%) had STE-ACS and 1150 (66%) NSTE-ACS. CVD alone was present in 98 patients (5%), 282 (14%) had PAD alone, and 30 (1.5%) had both. All cause mortality at 5 years was lowest in patients without CVD/PAD (33%), intermediate in patients with either CVD or PAD (62% and 63%, respectively) reaching 80% in those with both CVD and PAD. These findings were confirmed in the STE-ACS and NSTE-ACS subgroups. CVD and PAD remained independent predictors of mortality after multivariable analysis, the combined presence of both carrying the highest risk within each ACS type (HR 4.15, 95% CI 1.83–9.44 for STE-ACS; HR 2.14, 1.29–3.54 for NSTE-ACS). Patients with CVD and/or PAD were less likely to be treated invasively and received less evidence-based treatment at discharge. Conclusions Across the spectrum of ACS, extracardiac vascular disease harbors a negative long-term prognosis that worsens progressively with the number of affected arterial beds.

Background: Although atrial fibrillation (AF) is a known complication of amyloidotic cardiomyopathy (AC), a precise pathophysiological and prognostic characterization is not available. We therefore aimed to assess prevalence, incidence, risk factors and prognostic significance of AF in light-chain (AL), hereditary transthyretin-related (m-ATTR) and non-mutant transthyretin-related (wt-ATTR) AC. Methods: Retrospective study of 262 patients with AC (123 AL, 94 m-ATTR, 45 wt-ATTR) from a single center. Results: AF prevalence was 15% (AL 9%, m-ATTR 11%, wt-ATTR 40%). During a median follow-up of 1.2 years 11 patients developed AF (2.1% person-years). Age, heart failure (HF), left ventricular (LV) ejection fraction, renal involvement, left atrial size and right atrial pressure were independently associated with AF. AF was associated with incident HF but not with increased mortality. All AF patients were prescribed warfarin and none suffered thromboembolic events. Conclusions: In AC the prevalence of AF varies widely according to etiology with a mean value of 15% that reaches 40% in wt-ATTR amyloidosis. Age, HF, LV ejection fraction, left atrial size and right atrial pressure were the main independent risk factors, while wall thickness and etiology were not the main independent risk factors. AF does not seem to impact all-cause mortality but was strongly associated with prevalent and incident HF.

The aim of our study was to translate and to do a linguistic validation of the Composite Autonomic Symptom Score COMPASS 31. COMPASS 31 is a self-assessment instrument including 31 items assessing six domains of autonomic functions: orthostatic intolerance, vasomotor, secretomotor, gastrointestinal, bladder, and pupillomotor functions. This questionnaire has been created by the Autonomic group of the Mayo Clinic from two previous versions: the Autonomic Symptom Profile (ASP) composed of 169 items and the following COMPASS with 72 items selected from the ASP. We translated the questionnaire by means of a standardized forward and back-translation procedure. Thirty-six subjects, 25 patients with autonomic failure of different aethiologies and 11 healthy controls filled in the COMPASS 31 twice, 4 ± 1 weeks apart, once in Italian and once in English in a randomized order. The test-retest showed a significant correlation between the Italian and the English versions as total score. The evaluation of single domains by means of Pearson correlation when applicable or by means of Spearman test showed a significant correlation between the English and the Italian COMPASS 31 version for all clinical domains except the vasomotor one for the lack of scoring. The comparison between the patients with autonomic failure and healthy control groups showed significantly higher total scores in patients with respect to controls confirming the high sensitivity of COMPASS 31 in revealing autonomic symptoms.

The published data to support recommendations for prevention and management of well-appearing at-risk newborns (WAARNs) for early-onset sepsis (EOS) are limited.Retrospective cohort study comparing two different strategies for managing WAARNs (≥ 35 weeks' gestation) during a 6-year period (Period 1, from 2005 to 2007; Period 2, from 2009 to 2011). WAARNs were defined as healthy-appearing neonates evaluated because of risk factors for EOS. Laboratory evaluation plus simplified physical examination (Period 1) was compared with physical examination alone (PEA, Period 2). The use of antibiotics, the length of stay, the timeliness of diagnosis and the risk of falling ill immediately after hospital discharge in both periods were also compared.WAARNs receiving empirical antibiotics were 14/500 (Period 1) and 3/500 (Period 2, p = 0.01). Median length of stay was 4 (Period 1) and 3 days (Period 2, p = 0.04). Symptoms of EOS were earlier than laboratory evaluation results in 42/44 neonates. Severe disease was diagnosed within 6 h of life in all neonates. No WAARNs presented with EOS following hospital discharge.WAARNs managed through PEA received less unnecessary antibiotics and had a shorter length of stay. They had no increased risk of severe complications or increased risk of becoming ill following hospital discharge.

Studies from single institutions have analyzed BRAF in papillary microcarcinomas, sometimes with contradictory results. Most of them have provided limited integration of histological and clinical data. To obtain a comprehensive picture of BRAF V600E-mutated microcarcinomas and to evaluate the role of BRAF testing in risk stratification we performed a retrospective multicenter analysis integrating microscopical, pathological, and clinical information. Three hundred and sixty-five samples from 300 patients treated at six medical institutions covering different geographical regions of Italy were analyzed with central review of all cases. BRAF V600E statistical analysis was conducted on 298 microcarcinomas from 264 patients after exclusion of those that did not meet the required criteria. BRAF V600E was identified in 145/298 tumors (49%) including the following subtypes: 35/37 (95%, P

Background Cardiac allograft vasculopathy (CAV) remains the major cause of late graft-related death after heart transplantation (HT). Identification of patients at risk of cardiovascular events has relevant implications in appropriately guiding resources and intensity of follow-up. In this context, the prognostic relevance of serial coronary imaging long-term after HT is unexplored. Methods Recipients with intravascular ultrasound (IVUS) and coronary angiography performed 1 and 5 years after HT were monitored for subsequent 1 to 10 years to analyze the association of serial coronary imaging with cardiovascular death and major cardiovascular events (MACEs). Results Included were 131 patients. The MACE incidence was 31.8 per 1,000 patient-years, and cardiovascular mortality was 17.4 per 1,000 patient-years. Progression of coronary lesions detected by angiography and changes in IVUS-defined parameters, including an increase in maximal intimal thickness (MIT) ≥0.35 mm and vascular remodeling, predicted MACE occurrence. However, only MIT change ≥0.35 mm also predicted cardiovascular mortality. Among patients with normal or stable angiography, an MIT change ≥0.35 mm identified those with a significantly higher MACE rate (80 vs 13 events/1,000 patient-years). Worsening metabolic parameters appeared associated with the increasing severity of CAV development. Conclusions Combined imaging analysis of progression of angiographic lesions and IVUS-detected MIT between 1 and 5 years post-HT allows discriminating patients at high, intermediate, and low risk for adverse long-term cardiovascular outcomes. The metabolic syndrome milieu is confirmed as a key risk factor for long-term CAV progression and adverse prognosis.

We sought to evaluate the rates, time course, and causes of death in the long-term follow-up of unselected patients with acute coronary syndromes (ACS). We enrolled 2046 consecutive patients hospitalized from January 2004 to December 2005 with an audited final diagnosis of ACS. The primary study end point was 5-year all-cause mortality. In our series, 896 patients had ST-segment elevation (STE) and 1,150 non-ST-segment elevation (NSTE). Mean age of the study population was 71.6 years. Primary percutaneous coronary intervention was performed in 86% of STE-ACS, and 70% of NSTE-ACS was managed invasively. The 5-year all-cause mortality was 36.4% for STE-ACS and 42.0% for NSTE-ACS, with patients with STE-ACS showing a trend boarding statistical significance toward a lower risk of mortality (hazard ratio [HR] = 0.88, 95% confidence interval [CI] 0.76 to 1.02, p = 0.08). Landmark analysis demonstrated that patients with STE-ACS had a higher risk of 30-day mortality (STE-ACS vs NSTE-ACS HR = 1.53, 95% CI 1.16 to 2.06, p = 0.003) whereas the risk of NSTE-ACS increased markedly after 1 year (STE-ACS vs NSTE-ACS HR = 0.67, 95% CI 0.53 to 0.84, p = 0.001). The contribution of noncardiovascular (CV) causes to overall mortality increased from 3% at 30 days to 34% at 5 years, with cancer and infections being the most common causes of non-CV death both in STE-ACS and NSTE-ACS. In conclusion, long-term mortality after ACS is still too high both for STE-ACS and NSTE-ACS. Although patients with STE-ACS have a higher mortality during the first year, the mortality of patients with NSTE-ACS increases later, when non-CV co-morbidities gain greater importance.

Aims Treatment delay is a powerful predictor of survival in ST-elevation myocardial infarction (STEMI) patients undergoing primary percutaneous coronary intervention (PCI). We investigated effectiveness of pre-hospital diagnosis of STEMI with direct referral to PCI, alongside more conventional referral strategies. Methods and results From January 2003 to December 2004, 658 STEMI patients were referred for primary PCI at our intervention laboratory. Three predefined referral routes were compared: (1) for patients within 90 min drive of the PCI centre, pre-hospital diagnosis and direct transportation ( n =166), (2) diagnosis at the interventional hospital emergency department ( n =316), (3) diagnosis at local hospitals before transportation ( n =176). Pre-hospital diagnosis was associated with more than 45 min reduction in treatment delay ( P =0.001). No significant difference in in-hospital mortality was apparent in the overall study population. In the cardiogenic shock subgroup ( n =80), pre-hospital diagnosis was associated with a two-thirds reduction in in-hospital mortality ( P =0.019); mortality was only 6.2% in shock patients who underwent PCI in

BACKGROUND Data regarding the minimum duration of intrapartum antibiotic prophylaxis (IAP) required for preventing group B Streptococcus (GBS) early-onset sepsis are conflicting. Understanding factors that influence neonatal colonization (NC) might help us understand factors associated with failure of prophylaxis. METHODS This is a 14-month prospective cohort study conducted at a single tertiary care center with a screening-based strategy. Women were enrolled if they had ≥ 35 weeks' gestation and were GBS-positive at the vaginal site on admission. Their neonates were cultured from the throat and rectum at 24-48 h after birth. Colony growth was graded semiquantitatively (from 1+ to 4+). Uni- and multivariate logistic regression analyses were performed to evaluate risk factors for NC. RESULTS There were 502 neonates, 458 of whom were exposed to IAP. All cases of NC were associated with a lack of IAP exposure (P < 0.01), intrapartum fever ≥ 37.5°C (P < 0.01) and African ethnicity (P < 0.01). In the 458 IAP-exposed neonates, the rates of NC were low and did not vary significantly in the range of less than 1-12 h before delivery (score test for trend of odds, P = 0.13). The only independent factors associated with NC were intrapartum fever ≥ 37.5°C and heavy maternal colonization (P < 0.01 and P = 0.03, respectively). CONCLUSIONS Heavy maternal colonization, intrapartum fever, African ethnicity and lack of IAP exposure were associated with GBS transmission in neonates born to women who were tested positive on admission. Low rates of NC were found among IAP-exposed neonates irrespective of IAP duration.

End-stage hypertrophic cardiomyopathy (ES-HC) has an ominous prognosis. Whether genotype can influence ES-HC occurrence is unresolved. We assessed the spectrum and clinical correlates of HC-associated mutations in a large multicenter cohort with end-stage ES-HC. Sequencing analysis of 8 sarcomere genes (MYH7, MYBPC3, TNNI3, TNNT2, TPM1, MYL2, MYL3, and ACTC1) and 2 metabolic genes (PRKAG2 and LAMP2) was performed in 156 ES-HC patients with left ventricular (LV) ejection fraction (EF)

Objective To conduct a systematic review to check the level of validity and reliability of the Manchester Triage System and the quality of reporting of literature on this topic. Design This is a systematic review based on the PRISMA guideline on reporting systematic reviews. Data sources The systematic search of the international literature published from 1997 through 30 November 2012 in the PubMed, Embase, Cochrane Library, Cinahl, Web of Knowledge, and Scopus databases. Review methods This review included quantitative and qualitative research investigating the reliability and validity of the Manchester Triage System for the broad population of adults and children visiting the emergency department. After a systematic selection process, included studies were assessed on their quality by three researchers using the STARD guidelines. Results Twelve studies were included in the review. The studies investigated the inter- and intra-rater reliability using the “kappa” statistic; the validity was tested with many measures: validity in predicting mortality, hospital admission, under- and overtriage, used resources, and length of stay in the emergency department, as well as a reference standard rating. Conclusions In this review, the Manchester Triage System shows a wide inter-rater agreement range with a prevalence of good and very good agreement. Its safety was low because of the high rate of undertriage and the low sensitivity in predicting higher urgency levels. The high rate of overtriage could cause unnecessarily high use of resources in the emergency department. The quality of the reporting in studies of the reliability and validity of the Manchester Triage System is good.

Saber-sheath trachea is a specific radiographic parameter for chronic obstructive pulmonary disease (COPD), which consists of marked coronal narrowing associated with sagittal widening (tracheal index 2/3-0.67). The aim of this study was to investigate the correlation between saber-sheath trachea and clinical-radiological findings in a group of patients with COPD of varying severity.We evaluated the chest radiographs of 71 patients with COPD distributed as follows: GOLD class I, 8/71 (11.3 %); class II, 34/71 (47.9 %); class III, 16/71(22.5 %); class IV, 13/71 (18.3 %). In 52/71 (73.2 %) patients we also evaluated chest computed tomography (CT) scans. We analyzed the prevalence of saber-sheath trachea and its correlation with the Tiffenau index, GOLD stage and radiological signs of COPD. Moreover, we evaluated the sensitivity, specificity and accuracy of chest radiography as compared to CT taken as the gold standard, and the correlation between the radiographic and CT tracheal index.Saber-sheath trachea was found in 18/71 (25.4 %) patients, with a greater prevalence in patients with lower Tiffenau Index (p = 0.02), GOLD stages III-IV and visual severity score 3 (severe) on chest CT. Saber-sheath trachea was not found to be related to other radiological signs of COPD. The sensitivity, specificity and accuracy values of radiography were 72.2, 97.0 and 88.5 %, with perfect concordance between the radiographic and CT tracheal index (p 0.00001).Saber-sheath trachea is linked to the functional severity of airway obstruction, but not to other radiological signs of COPD. Thus, evaluation of the trachea at chest radiography is strongly recommended.

AIMS: To evaluate the relationship between ECG patterns and infarct related artery (IRA) in an all-comer population with ST-segment elevation myocardial infarction (STEMI) and validate current criteria for identifying IRA (right coronary artery (RCA) versus left circumflex artery (LCA)) in inferior STEMI and for diagnosing left main (LM) or left anterior descendent artery occlusion (LAD) in anterior STEMI.METHODS AND RESULTS: We retrospectively analysed ECGs at presentation and coronary angiogram in 885 consecutive patients undergoing primary percutaneous coronary intervention. Six ECG patterns were identified: anterior-STEMI (n=433; 49.0%), inferior-STEMI (i=365; 43.0%), lateral-STEMI (n=43; 5.0%), left bundle branch block (n=26; 3.0%), posterior-STEMI (n=7; 1.0%) and de Winter sign (n=7; 1.0%). The last two ECG patterns were univocally associated with LCA and proximal LAD occlusion respectively. In patients with inferior STEMI, predefined ECG algorithms showed high sensitivity(>90%) for RCA occlusion and high specificity(>90%) for LCA. The diagnostic performance was mainly determined by RCA dominance. In anterior STEMI the vectorial analysis of ST deviation in both frontal and horizontal planes could identify patients with LM/proximal LAD occlusion (adjusted-odds ratio for in-hospital mortality =2.45, 95% confidence interval: 1.31-4.56, p = 0.005) with low sensitivity (maximum 60%; using ST-depression in lead II, III, aVF + ΣSTE aVR + V1-ST depression V6≥0) and high specificity (maximum 95%; using ST-depression in inferior leads + ST-depression in V6).CONCLUSION: In STEMI undergoing primary percutaneous coronary intervention, six ECG patterns can be identified with a non-univocal relationship to the IRA. In inferior STEMI, vectorial analysis of ST deviation identifies IRA with a high appropriateness only when RCA is the dominant artery. In anterior STEMI, criteria derived from both frontal and horizontal planes identify LM/proximal LAD occlusion with high specificity but low sensitivity.

Several prospective studies have shown that high on-clopidogrel platelet reactivity (HPR) in patients undergoing percutaneous coronary intervention (PCI) is a risk factor for ischemic events. All studies were insufficiently powered to detect differences in stroke between patients with HPR and those without. Therefore, we performed a systematic review and meta-analysis of available publications aimed at determining whether patients undergoing PCI with HPR are also at increased risk of stroke. We searched for prospective studies enrolling patients undergoing PCI and treated with aspirin and clopidogrel that reported on clinical relevance of HPR to adenosine diphosphate. Study end point was the rate of stroke. We also investigated whether there was an interaction on the relative risk of stroke between HPR, clinical presentation, duration of follow-up, or laboratory methods. Fourteen studies including 11,959 patients were deemed eligible. On pooled analysis, the risk of stroke was higher in patients with HPR compared with patients with no HPR (1.2% vs 0.7%, relative risk on fixed effect 1.84, 95% confidence interval 1.21 to 2.80). There was no heterogeneity among the studies (I2 = 0%, p = 0.5). Clinical presentation (p = 0.39 for interaction), duration of follow-up (p = 0.87 for interaction), and laboratory method for detection of HPR (p = 0.99 for interaction) did not affect the relative increase in the risk of stroke in patients with HPR compared with patients with no HPR. In conclusion, in patients with coronary artery disease undergoing PCI, the presence of HPR to adenosine diphosphate is a risk factor for stroke. © 2014 Elsevier Inc. All rights reserved.

Background The effectiveness of coronary radiation therapy for the treatment of in-stent restenosis (ISR) has been established in several randomized clinical trials. The efficacy of this treatment in the general population is less well established. Methods and materials We report our experience in 118 consecutive patients with nonselected high-risk ISR who had undergone successful percutaneous coronary intervention and brachytherapy with 32 P β-irradiation and who were prospectively enrolled in a quantitative angiographic and clinical follow-up protocol at 7 months after the index procedure. The aim of this study was to investigate the independent predictor of angiographic restenosis after 32 P brachytherapy treatment. Results Of the patients, 28.8% were diabetics. The mean lesion and mean radiated lengths were, respectively, 30.1 ± 17.2 and 43.8 ± 16.9 mm. The ISR pattern was diffuse in 96% of the treated lesions; in particular, 22.1% presented an occlusive pattern and 37.1% a proliferative pattern. At follow-up angiographic, restenosis and major adverse cardiac events (MACE) rates were, respectively, 20.8% and 29.6%. The univariate predictors of angiographic restenosis were procedural geographic miss, pattern IV ISR, manual pullback maneuver of the radiation source, preprocedural lesion percentage stenosis and preprocedural lesion MLD. At logistic regression analysis, only geographic miss and pattern IV ISR were independent predictors of post intracoronary radiation therapy (IRT) angiographic restenosis. Conclusion These data indicate that 7-month angiographic restenosis after 32 P IRT in complex patients with ISR is not a frequent event and is predicted mainly by an occlusive lesion at baseline and by procedural geographical miss.

Objective: The aim of the study is to evaluate the application of neurally adjusted ventilatory assist (NAVA) in the respiratory weaning of patients affected by congenital diaphragmatic hernia (CDH). Methods: We analyzed the NAVA weaning in 12 neonates affected by CDH, relating the effectiveness of the electrical activation of the diaphragm (EAdi) signal to the type of CDH repair (with or without patch), the size of the patch, the stomach and His angle position, and the trend evaluation of some cardiorespiratory parameters with NAVA compared to pressure-support-ventilation (PSV). Results: 5 neonates submitted to primary repair showed a regular EAdi signal and were successfully weaned with NAVA. Of the seven patients submitted to patch repair, five operated with patch limited to the diaphragmatic postero-lateral area had an active EAdi signal that permitted weaning with NAVA. Only in two neonates with hemidiaphragm agenesis was NAVA not feasible due to the impossibility to capture the EAdi signal. Compared to PSV, NAVA allows a significant improvement of oxygenation-linked indexes and paCO2, while PIP is reduced. Conclusion: Neonatal CDH with a postero-lateral diaphragmatic defect allows the NAVA catheter to obtain a correct EAdi signal and develop a viable NAVA ventilation. The lower risk of lung injury in NAVA appears compatible with current ventilatory strategies considered useful in CDH

Objectives: To investigate the prognostic significance of baseline white blood cell count (WBCc) in non-ST-segment elevation acute coronary syndrome (NSTE-ACS) and its additive predictive value beyond the Global Registry of Acute Coronary Events (GRACE) score. Methods: We included 1,315 consecutive NSTE-ACS patients. Patients were divided in quartiles according to the WBCc (cells per 1 mm3) i.e. Q1 Results: The median age of the study population was 76 years. Overall, 335 patients (25.5%) died with 211 of these (16%) suffering from CVD. Patients in Q4 showed a higher cumulative probability of CVD compared to patients in Q1–Q3. On multivariable analysis, patients in Q4 were at higher risk of CVD [hazard ratio (HR) = 1.47, 95% confidence interval (CI) 1.09–1.98, p = 0.011]. WBCc as a continuous variable was also independently associated with the study end point (HR = 1.043; 95% CI 1.02–1.07; p = 0.001). However, the incorporation of WBCc into the GRACE score did not improve either prediction of risk (C-index = 0.796 for GRACE score with or without WBCc) or classification of risk [relative integrated discrimination improvement = 0.0154, 95% CI) –0.029 to 0.0618; continuous net reclassification improvement = –0.0676, 95% CI –0.2149–0.0738). Conclusions: WBCc was an independent predictor of 3-year CVD in patients with NSTE-ACS. However, it did not add prognostic information beyond the GRACE score.

Aim of the present review is to summarize the current knowledge about the potential relationship between miRNAs and hepatitis B virus (HBV)-hepatitis C virus (HCV) related liver diseases. A systematic computer-based search of published articles, according to the Preferred Reporting Items for Systematic reviews and Meta-Analysis Statement, was performed to identify relevant studies on usefulness of serum/plasma/urine miRNAs, as noninvasive biomarkers for early detection of HBV and HCV-induced hepatocellular carcinoma (HCC) development, as well as for its prognostic evaluation. The used Medical Subject Headings terms and keywords were: “HBV”, “HCV”, “hepatocellular carcinoma”, “microRNAs”, “miRNAs”, “diagnosis”, “prognosis”, “therapy”, “treatment”. Some serum/plasma miRNAs, including miR-21, miR-122, mi-125a/b, miR-199a/b, miR-221, miR-222, miR-223, miR-224 might serve as biomarkers for early diagnosis/prognosis of HCC, but, to date, not definitive results or well-defined panels of miRNAs have been obtained. More well-designed studies, focusing on populations of different geographical areas and involving larger series of patients, should be carried out to improve our knowledge on the potential role of miRNAs for HCC early detection and prognosis.

Aim Randomized controlled trials (RCTs) showed that biventricular (BiV) pacing reduces heart failure (HF) hospitalizations and mortality in patients with New York Heart Association (NYHA) class III–IV HF, left ventricular (LV) dysfunction, and wide QRS. We performed a systematic review and meta-analysis of the RCTs comparing LV-only vs. biventricular (BiV) pacing in candidates for cardiac resynchronization therapy (CRT). Methods and results The systematic review selected five RCTs (out of 1888 analysed reports) with a cumulative number of 372 patients randomized to BiV pacing and 258 to LV-only pacing. The meta-analysis shows that BiV pacing is not superior to LV-only pacing and that these two pacing modalities do not differ with regard to death or heart transplantation [LV-only vs. BiV pacing odds ratio (OR) 1.24, 95% confidence interval (CI) 0.57–2.70 with the fixed effect model, OR 1.25, 95% CI 0.48–3.24 with the random effect model]. Specific data on hospitalizations were available only in two RCTs with a cumulative number of 127 patients randomized to BiV and 123 to LV-only pacing. The meta-analysis shows that BiV pacing is not superior to LV-only pacing and that these two pacing modalities do not differ with regard to this outcome (LV-only vs. BiV pacing OR 0.86, 95% CI 0.49–1.50 with the fixed effect model, OR 0.86, 95% CI 0.49–1.50 with the random effect model). Conclusions Biventricular pacing is not superior to LV-only pacing, and these two pacing modalities appear to achieve similar efficacy in candidates for CRT for moderate to severe HF, in terms of all-cause mortality and hospitalizations during follow-up.

To compare the rate of neonatal respiratory morbidity in singletons versus twins delivered by pre-labour caesarean section.Uncomplicated pregnancies delivered by prelabor caesarean section at 34+0 to 37+6 weeks' gestation were retrospectively selected. For both singletons and twins caesarean delivery was undertaken electively only after amniocentesis and if the lecithin/sphingomyelin ratio was ≥2. Neonatal respiratory morbidity was compared in twins versus singletons.241 singletons and 100 twin neonates were included. Overall neonatal respiratory morbidity was comparable between the two groups (25/241 (11.7\%) versus 7/100 (7\%), p=.331). Between 34+0 and 36+6 weeks, however, the risk was higher among singleton than twins (15/46 (32.6\%) versus 6/72 (8.3\%), p

Background & Aims The hepatic vein pressure gradient (HVPG) is the standard used to determine the degree of portal hypertension (PH) and an important prognostic factor for patients with cirrhosis; HVPG values correlate with the presence of esophageal varices (EV). However, HVPG can only be accurately determined at specialized centers; noninvasive methods are needed to predict HVPG values and the presence of EV. We compared the diagnostic performance of spleen stiffness (SS) measurement by transient elastography with that of liver stiffness (LS) and of other recently proposed noninvasive tests. Methods We measured SS and LS in 100 consecutive patients with hepatitis C virus–induced cirrhosis. Patients were also assessed by FibroScan, HVPG, esophagogastroduodenoscopy, and liver biopsy. We also analyzed LS–spleen diameter to platelet ratio score and platelet count to spleen diameter. Results SS and LS were more accurate than other noninvasive parameters in identifying patients with EV and different degrees of PH. A linear model that included SS and LS accurately predicted HVPG values ( R 2 = 0.85). The results were internally validated using bootstrap analysis. Conclusions Measurement of SS can be used for noninvasive assessment and monitoring of PH and to detect EV in patients with hepatitis C virus–induced cirrhosis.

Background. Congenital diaphragmatic hernia (CDH) still has a high mortality despite advanced assistance techniques. The aim of this study is to verify the validity of fve respiratory and blood-gas-derived indices in defining presurgical stabilization: the oxygenation index (OI), the alveolar-arterial O2 gradient (A-aDO2), the arterial-alveolar O2 tension ratio (a/AO2), the arterial pH and the PaCO2. Methods. The study involved 73 neonates with CDH where the accuracy of stabilization was assessed through the survival percentage and the contemporary behaviour of mean arterial pressure (MAP), ductal shunting, urine output and lactate levels. The trend of the indices was compared in two groups (stable/ft for surgery vs unstable/unfit for surgery) at five times (PICU admission, 6, 12, 24 hours after admission, assessment of clinical stabilization). Results. Fifty-fve neonates were defined stabilized on the basis of the indices and underwent surgery with a 100% survival rate; 18 patients died before surgery, having never achieved clinical stabilization. MAP, ductal shunting, urine output and lactate levels were normal in the stabilized patients and altered in the non stabilized. Of the fve parameters considered, all three oxygenation-linked indices (OI, A-aDO2, a/AO2) are very powerful, whereas pH and PaCO2 appears valid but more tardive. Their progressive improvement (OI0.50, PaCO27.35) defined presurgical stabilization, thus allowing CDH surgical correction. Conclusion. The study confirms the validity of these indices as a guide to the treatment of neonates with CDH, showing a good reliability in identifying presurgical stabilization

BACKGROUND: While implications of myocardial fibrosis on left ventricular (LV) function at rest have been studied in hypertrophic cardiomyopathy (HCM), the pathophysiological consequences on dynamic LV outflow tract (LVOT) gradient have so far not been investigated in detail. OBJECTIVE: To evaluate the influence of myocardial fibrosis, detected by MRI as late-gadolinium enhancement (LGE), on LVOT gradient in HCM. DESIGN: Retrospective database analysis. SETTING: A single Italian cardiomyopathies referral centre. PATIENTS: Seventy-six HCM patients with normal ejection fraction at rest. INTERVENTIONS: Patients underwent cardiac MR and performed bicycle exercise echocardiogram within a month. RESULTS: LGE was present in 54 patients (71%), ranging from 0.2% to 32.4% of LV mass. There was a weak correlation between the amount of fibrosis and LVOT gradient variation during exercise in the overall population (r=-0.243, p=0.034) and a stronger correlation in patients with obstructive HCM at rest (r=-0.524, p=0.021). Patients with an LVOT gradient increase ≥50 mm Hg during exercise had a significantly lesser extent of fibrosis than those with an increase

Senile systemic amyloidosis (SSA) is a cardiomyopathy mainly affecting elderly men due to intramyocardial deposition of wild-type (nonmutant) transthyretin (TTR) ([1][1]). Since the heart is the only involved organ, SSA—which requires endomyocardial biopsy (EMB) for a definite diagnosis—is often

Background After a Kasai procedure, 70% of patients with biliary atresia develop chronic liver disease with portal hypertension and oesophageal varices. Aims To investigate the role of new non-invasive parameters in predicting the presence of varices in patients with biliary atresia after a Kasai procedure and to identify the cut-off values of these parameters in predicting the presence of varices. Methods 31 patients with biliary atresia who had undergone a Kasai portoenterostomy were studied. Clinical, biochemical and abdominal ultrasound examination, liver stiffness measurement (LSM), LSM-spleen diameter to platelet ratio score (LSPS) and upper digestive endoscopy were performed. Results 15 (47%) patients had oesophageal varices (Group A) and 16 had no varices (Group B). Median values of LSM (kPa) and LSPS were significantly higher in Group A than in Group B (LSM: 17.0 vs. 7.5, respectively; p = 0.0001; LSPS: 19.62 vs. 2.94, respectively; p = 0.0001). The optimal cut-offs for predicting oesophageal varices were: LSM > 10.6 kPa (sensitivity: 87%, specificity: 87.5%, PPV: 87%, NPV: 87.5%, and AUC: 0.92) and LSPS ≥9.2 (sensitivity: 91%, specificity: 92%, PPV: 91%, NPV: 92%, and AUC: 0.96). Conclusions Non-invasive methods can predict the presence of oesophageal varices in patients with biliary atresia; the sequential use of two non-invasive methods improves accuracy.

OBJECTIVES: To measure the reliability and predictive validity of a four-level triage system (I-4L). METHODS: This observational study was conducted in an urban hospital. Five nurses were randomly selected to assign a triage level to 246 paper scenarios, using the I-4L model. The I-4L model is a four-level triage system: urgency category (UC) 1 requires immediate response; UCs 2, 3 and 4 require assessment within 20, 60 and 120 min, respectively. Weighted kappa statistics were used to measure the inter-rater and intrarater reliability of the triage tool and the validity of the model was assessed based on the accuracy in predicting admission and in predicting a reference standard's triage code. RESULTS: The I-4L model's inter-rater reliability was kappa=0.73 (95% CI 0.67 to 0.79), and the intrarater reliability was kappa=0.82 (95% CI 0.67 to 0.96). Its accuracy of triage rating for admission and for prediction of a reference standard's triage code was good: 79% (95% CI 73% to 86%) and 93% (95% CI 89% to 96%), respectively. The percentages of patients admitted per triage level using the I-4L model was: 100% UC 1; 42% UC 2; 6% UC 3; and 2% UC 4. CONCLUSIONS: The I-4L triage model shows a good inter-rater and intrarater reliability for rating triage acuity and for accuracy in patient admission and prediction of a reference standard's triage code.

Background— Multidetector CT coronary angiography (MDCTCA) is capable of detecting coronary artery disease (CAD) with a high diagnostic accuracy. In particular, this technique is credited with having a negative predictive value close to 100%. However, data about the prognostic value of MDCTCA are currently lacking. We sought to determine the prognostic value of MDCTCA in patients with suspected but undocumented CAD and, in particular, the incremental prognostic value as compared with clinical risk and calcium scoring. Methods and Results— A total of 441 patients (age, 59.7±11.6 years) with suspected CAD underwent MDCTCA to evaluate the presence and severity of the disease. Patients were followed up as to the occurrence of hard cardiac events (cardiac death, nonfatal myocardial infarction, and unstable angina requiring hospitalization). Coronary lesions were detected in 297 (67.3%) patients. During a mean follow-up of 31.9±14.8 months, 44 hard cardiac events occurred in 40 patients. CT calcium scoring showed a statistically significant incremental prognostic value as compared to a baseline clinical risk model ( P =0.018), whereas MDCTCA provided an additional incremental prognostic value as compared with a baseline clinical risk model plus calcium scoring if considering both nonobstructive versus obstructive CAD ( P =0.016) or, better, plaque composition (calcified versus noncalcified and/or mixed plaques, P =0.0001). During follow-up, an excellent prognosis was noted in patients with normal coronary arteries, with an annualized incidence rate of 0.88% if compared with those with mild CAD (3.89%) and with patients with significant coronary disease (8.09%). The presence of noncalcified or mixed plaques, regardless of lesion severity, was found to be the strongest predictor of events ( P Conclusions— MDCTCA provides independent and incremental prognostic information as compared to baseline clinical risk factors and calcium scoring in patients with suspected CAD.

BACKGROUND & AIMS: Knowledge of pre-operative tumour grade is crucial in the management of hepatocellular carcinoma (HCC) because it can influence recurrence and survival after surgery. The accuracy of pre-operative needle core biopsy (NCB) in tumour grading has been assessed in only a few studies with conflicting results. Our aim was to determine the long-term safety and the overall accuracy of NCB in assessing tumour grading in subjects who had undergone liver resection for a single HCC. METHODS: Eighty-one cirrhotic patients with HCC who had undergone NCB before liver resection were selected. Only patients with a single HCC and with at least a five-year-follow-up were included. Tumour grading was scored according to a modified Edmondson-Steiner classification: well/moderately (low grade) vs poorly-differentiated (high grade). RESULTS: In the 81 patients with a solitary HCC (mean size 4.1 ± 2.3cm) tumour grade was correctly identified by NCB in 74 out of 81 (91.4%) HCCs. NCB overall sensitivity and specificity were 65% and 98.1%, respectively, with a PPV of 92% and an NPV of 91%. No major complications (in particular tumour seeding) were observed. The overall survival rates at 1, 3, and 5 years were 83%, 62%, and 44%, respectively; the recurrence rate after a 5-year-follow-up was 56.2% for low grade and 82.3% for high grade tumours (p

Background and Aims: The knowledge of natural history is essential for disease management. We evaluated the natural history (e.g. frequency and characteristics of symptoms and clinical outcome) of gallstones (GS) in a population-based cohort study. Methods: A total of 11 229 subjects (6610 men, 4619 women, age-range: 29–69 years, mean age: 48 years) were studied. At ultrasonography, GS were present in 856 subjects (338 men, 455 women) (7.1%). GS were followed by means of a questionnaire inquiring about the characteristics of specific biliary symptoms. Results: At enrolment, 580 (73.1%) patients were asymptomatic, 94 (11.8%) had mild symptoms and 119 (15.1%) had severe symptoms. GS patients were followed up for a mean period of 8.7 years; 63 subjects (7.3%) were lost to follow up. At the end of the follow up, of the asymptomatic subjects, 453 (78.1%) remained asymptomatic; 61 (10.5%) developed mild symptoms and 66 (11.4%) developed severe symptoms. In subjects with mild symptoms, the symptoms disappeared in 55 (58.5%), became severe in 23 (24.5%), remained stable in 16 (17%); in subjects with severe symptoms, the symptoms disappeared in 62 (52.1%), became mild in 20 (16.8%) and remained stable in 37 (31.1%). A total of 189 cholecystectomies were performed: 41.3% on asymptomatic patients, 17.4% on patients with mild symptoms and 41.3% on patients with severe symptoms. Conclusions: This study indicates that: (i) asymptomatic and symptomatic GS patients have a benign natural history; (ii) the majority of GS patients with severe or mild symptoms will no longer experience biliary pain; and (iii) a significant proportion of cholecystectomies are performed in asymptomatic patients. Expectant management still represents a valid therapeutic approach in the majority of patients.

Aims There is no cure for pulmonary arterial hypertension, but current approved treatment options include prostanoids, endothelin-receptor antagonists, and phosphodiesterase type-5 inhibitors. The effect on survival of these compounds has not been appropriately assessed in individual trials because of small sample size and short duration. We performed a meta-analysis of all randomized controlled trials with drugs published in this condition. Methods and results Trials were searched in the Medline database from January 1990 to October 2008. The primary analysis included only studies with a placebo comparator arm, the sensitivity analysis also included studies comparing two active treatment arms. The main outcome measure was all-cause mortality. Twenty-one trials were included in the primary analysis (3140 patients) and two additional studies (59 patients) were included in the sensitivity analysis. Average duration of the trials was 14.3 weeks. All-cause mortality rate in the control group was 3.8%. Active treatments were associated with a reduction in mortality of 43% (RR 0.57; 95% CI 0.35–0.92; P = 0.023); the sensitivity analysis confirmed a reduction in mortality of 38% (RR 0.62; 95% CI 0.39–1.00; P = 0.048). Conclusion The results of this meta-analysis suggest an improvement of survival in the patients treated with the targeted therapies approved for pulmonary arterial hypertension.

Little is known about the natural history and pathogenesis of small gallbladder polyps (10 mm, usually of the cholesterol type), particularly in Western populations. It is unclear if these polyps and gallstones represent different aspects of the same disease. The aim of this study was to characterize the natural history and pathogenesis of small gallbladder polyps.Fifty-six Caucasian patients with small gallbladder polyps, 30 matched gallstone patients, and 30 controls were enrolled in this 5-year prospective study. Patients underwent a symptomatic questionnaire, abdominal ultrasonography, and ultrasonographic evaluation of gallbladder motility at baseline and yearly intervals for 5 years. Cholesterol saturation index, cholesterol crystals in bile, and apolipoprotein E genotype were also determined.Most patients with polyps (mean size: 5.3 mm) were men (61%), asymptomatic, and had multiple polyps (57%). Polyps did not change in 91% of patients during follow-up. No subject experienced biliary pain or underwent cholecystectomy; four developed gallstones. Cholesterol saturation index was higher in patients with polyps or gallstones than in controls (P0.05). Cholesterol crystals were more frequent in patients with polyps than in controls (P0.0001) but less common than in gallstone patients (P0.0001). Polyps and gallstones were associated with nonapolipoprotein E4 phenotypes.The natural history of small gallbladder polyps was benign, as no patient developed specific symptoms and/or morphological changes in polyps. Consequently, a "wait and see" policy is advisable in these patients. Polyps have some pathogenetic mechanisms in common with gallstones, but few patients developed gallstones.

Aims To test the equivalence of high-dose bolus (HDB) tirofiban vs. abciximab during primary percutaneous coronary intervention (PPCI) in terms of ST-segment resolution (STR). Methods and results The FATA trial (Facilitated Angioplasty with Tirofiban or Abciximab) was a prospective, multicentre, open-label trial that enrolled 692 patients with ST-segment elevation myocardial infarction (STEMI) undergoing PPCI. Patients were randomized 1:1 to receive abciximab ( n = 341) or HDB tirofiban ( n = 351). Primary endpoint was the rate of complete (≥70%) STR 90 min after first balloon inflation. Thirty-day incidence of major bleedings, death, re-infarction and new revascularizations was also evaluated. Baseline characteristics of the two groups were well-balanced, with the exception of previous MI rates (tirofiban 6% vs. abciximab 2.6%, P = 0.03). The procedure was successful in 96.7% of the abciximab and in 96.6% of the tirofiban cohort ( P = 0.94). Complete STR was obtained in 67.05% of the tirofiban and 70.45% of the abciximab group (Δ −3.4%, 95% confidence interval −10.35 to +3.56), which falls beyond the predefined Δ ± 10% equivalence boundaries. Rates of secondary endpoints were similar between the two groups. Conclusion This study failed to show the equivalence of HBD of tirofiban and abciximab as adjunctive therapy to PPCI.

Abciximab therapy during primary percutaneous coronary intervention (PCI) has shown to ameliorate left ventricular (LV) function recovery in patients with ST elevated myocardial infarction. High-dose bolus tirofiban has similar effect on platelet inhibition. Whether this is associated with comparable efficacy on LV function recovery remains unclear. We sought to evaluate the impact on LV function of high-dose bolus tirofiban or abciximab in patients undergoing primary PCI with the predictors of favorable (or = 50%) LV ejection fraction (EF) and LV function recovery at 30 days. We studied 314 patients (abciximab n = 154; tirofiban n = 160) undergoing primary PCI in the randomized Facilitated Angioplasty with Tirofiban or Abciximab (FATA) Trial. LVEF was assessed within 48 hours and at 30 days after primary PCI. In patients with systolic dysfunction at baseline, LV function recovery was defined by either increase of LVEFor = 10% compared with baseline or LVEFor = 50%. Similar LVEF was observed in the 2 groups postprocedure (abciximab 49.7 +/- 10.1% vs tirofiban 49.3 +/- 10.1%, p = 0.9) and at 30 days (abciximab 53.1 +/- 9.8% vs tirofiban 52.5 +/- 10.2%, p = 0.6). Independent predictors of 30-day LVEFor = 50% were preprocedure Thrombolysis In Myocardial Infarction flow class0 (odds ratio = 2.4, 95% confidence interval 1.32 to 4.34), anterior location (odds ratio = 0.25, 95% confidence interval 0.15 to 0.42), and age (odds ratio = 0.97, 95% confidence interval 0.95 to 0.99). Preprocedure Thrombolysis In Myocardial Infarction flow grade0 was the only predictor of LV function recovery (odds ratio = 6.73, 95% confidence interval 2.69 to 16.88). In conclusion, this study showed no difference in LV function recovery in patients undergoing primary PCI treated either with abciximab or high-dose bolus tirofiban. Preprocedure Thrombolysis In Myocardial Infarction flow grade0 seems to be the most important predictor of favorable LVEF and LV function recovery at 30 days.

We investigated the impact of ambulance-based prehospital triage on treatment delay and all-cause mortality (in hospital and long term) in patients with ST-elevation myocardial infarction (STEMI) complicated by cardiogenic shock referred for primary percutaneous coronary intervention in a prospectively collected registry. During the study period (January 2003 to December 2005), a total of 121 patients was referred for primary percutaneous coronary intervention at our intervention laboratory through 2 main triage groups: (1) after prehospital, ambulance-telemedicine-based triage (42 patients) and (2) by more conventional routes (79 patients) represented by the institutional S. Orsola-Malpighi hospital emergency department triage (44 patients) and spoke hospital triage (35 patients). Total ischemic time was shorter in the prehospital triage (142 minutes, range 106 to 187, vs 212 minutes, range 150 to 366, p = 0.003). Patients with prehospital triage showed a lower rate (29% vs 54%, p = 0.01) of severely depressed (

OBJECTIVES: To see whether use of a sirolimus-eluting stent (SES) is superior to a third-generation thin-strut, cobalt-chromium stent (CCS) in terms of in-segment late loss at 9 months in patients with symptomatic coronary artery disease. BACKGROUND: Stent-strut thickness has been shown to be strictly related with risk of in-stent restenosis, but available demonstrations of the angiographic efficacy of SES have been based on comparisons with thick-strut bare metal control stents. METHODS: The primary outcome measure of this single-center, single-blind randomized comparative trial was 9-month in-segment late loss. Eligibility criteria were symptomatic coronary artery disease and target vessel diameter appropriate for implantation a 3-mm stent. Based on a power calculation, 104 patients were randomly assigned to receive a SES (Cypher™) or a CCS (Vision™). RESULTS: In-segment late loss was significantly lower in the SES group (0.18 ± 0.40 mm vs 0.58 ± 0.51 mm, P < 0.001). Regarding subsidiary outcome measures, in-segment restenosis (at 9 months) was recorded in 10% (5/50) patients treated with SES and 23% (11/48) receiving CCS (P = 0.14). No clinical difference between the two groups was apparent at 12 months. Freedom from target vessel failure at 12 months was 72% for SES patients and 68% for CCS patients (P = 0.65). CONCLUSIONS: In patients with de-novo coronary lesions at medium risk of restenosis the anti-proliferative effect of SES is greater than that of a thin-strut CCS. Nevertheless, the angiographic results of the CCS were rather good. It remains to be seen whether the angiographic superiority of SES can translate into clinical superiority. © 2007 Wiley-Liss, Inc.

Background High mortality rates were reported in ST-elevation myocardial infarction (STEMI) patients undergoing primary percutaneous coronary interventions (PPCI) "off-hours." The objective of this study was to evaluate this issue in a more recent population of patients with STEMI treated with PPCI in a high-volume tertiary center specifically dedicated to STEMI treatment. Methods and Results We analyzed in-hospital/1-year mortality among 985 consecutive patients with STEMI treated with PPCI between January 2003 and December 2005 in a high-volume (>1400 PCI/year) hub center in a STEMI provincial network organization during "normal-hours" (weekdays 08:00 am to 07:29 pm) and "off-hours" (weekdays 07:30 pm to 07:59 am and weekends). Most (61.2%) patients were treated during "off-hours". Clinical and angiographic characteristics of the "normal-hours" and "off-hours" groups were comparable (in both groups, glycoprotein IIb/IIIa were administered to ∼80% patients). The off-hours group tended toward higher median (25th-75th percentiles) total ischemic time (199 [135-312] minutes vs 179 [126-285] minutes; P = .052). Median electrocardiogram-to-balloon time was less than 90 minutes in both groups. Despite 20 minutes longer median total ischemic time, patients who underwent PPCI during "off-hours" showed similar post-PPCI Thrombolysis In Myocardial Infarction 3 flow grade and mean left ventricular ejection fraction. No difference could be observed between the 2 groups in terms of in-hospital and 1-year mortality rates. Conclusion This study provides evidence that the clinical effectiveness of "normal" and "off-hours" PPCI can be equivalent, at least when performed at a center specifically dedicated to STEMI treatment with frequent use of glycoprotein IIb/IIIa agents.

A knowledge of the predictive factors of the development and persistence of symptoms in gallstone patients (GS) plays a key role in clinical decision making. The aim of this study was to evaluate the presence of predictive factors for biliary pain development in GS, stressing the role of gallbladder motility.A total of 153 (104 women, 49 men) consecutive GS were enrolled. Gallbladder motility (%Emptying [%E], residual volume [RV]) was evaluated by ultrasonography and biliary symptoms were evaluated using a specific questionnaire in all GS at baseline and after 4 yr of follow-up.At enrolment, 61 GS reported recent (GSr) and 31 GS remote (GSo) (2 yr before) episodes of biliary pain, and 61 were asymptomatic (GSa). At baseline, GSr showed a greater %E and a smaller RV than both GSo and GSa (p0.001). After follow-up, biliary pain developed more frequently in GSr (33.3%) than in GSo (16%) and GSa (15%) (p= 0.04). The search for predictive factors of biliary pain development (by univariate and multivariate analyses) revealed a high %E, a small RV, and a history of biliary pain as risk factors.Efficient gallbladder motility is present in symptomatic GS and it represents a risk factor for biliary pain development while sluggish motility seems to play a protective role. Thus, gallbladder motility evaluation is a useful diagnostic tool in clinical decision making for GS; in symptomatic GS, a progressive reduction of gallbladder motility could suggest a "wait and see" management policy instead of an immediate surgical approach.

AIM: To simultaneously evaluate the presence of defects in gallbladder and gastric emptying, as well as in intestinal transit in gallstone patients (GS) and the effect of chronic ursodeoxycholic acid (UDCA) administration on these parameters and on serum bile acids and clinical outcome in GS and controls (CTR). METHODS: After a standard liquid test meal, gallbla-dder and gastric emptying (by ultrasound), oroileal transit time (OITT) (by an immunoenzymatic technique) and serum bile acids (by HPLC) were evaluated before and after 3 mo of UDCA (12 mg/kg bw/d) or placebo administration in 10 symptomatic GS and 10 matched healthy CTR. RESULTS: OITT was longer in GS than in CTR (P < 0.0001); UDCA significantly reduced OITT in GS (P < 0.0001), but not in CTR. GS had longer gastric half-emptying time (t1/2) than CTR (P < 0.0044) at baseline; after UDCA, t1/2 significantly decreased (P < 0.006) in GS but not in CTR. Placebo administration had no effect on gastric emptying and intestinal transit in both GS and CTR. CONCLUSION: The gallstone patient has simultaneous multiple impairments of gallbladder and gastric emptying, as well as of intestinal transit. UDCA administration restores these defects in GS, without any effect in CTR. These results confirm the pathogenetic role of gastrointestinal motility in gallstone disease and suggest an additional mechanism of action for UDCA in reducing bile cholesterol supersaturation.

The objective of this study was to determine the safety and efficacy of 32P β-brachytherapy in totally occlusive in-stent restenosis (ISR). Patients with occlusive ISR were generally excluded from the randomized clinical trials on intracoronary brachytherapy (utilizing either γ- or β-sources) that have shown reductions in restenosis rate and need for revascularization procedures. We analyzed short- and long-term effects of 32P β-brachytherapy (20 Gy) in 27 patients (28 lesions) with occlusive ISR and 84 (99 lesions) patients with nonocclusive high-risk ISR. The primary outcome measure was frequency of in-lesion angiographic binary restenosis at 7 months. Secondary endpoints were rates of major adverse cardiac events (MACE), target vessel revascularization (TVR), clinically driven TVR, and target lesion revascularization (TLR). 32P β-brachytherapy was feasible and safe and provided similar postprocedural angiographic results in the two clinically comparable groups. However, the 7-month binary restenosis rate was higher in the occlusive group, as were the MACE and late total occlusion rates. Multivariate logistic analysis of the overall population indicated occlusive pattern to be the only independent predictor of angiographic restenosis. In both groups, recurrent lesions most often showed a focal pattern with significant reduction of length. Although safe and effective in high-risk ISR, 32P brachytherapy at 20 Gy does not appear to be sufficient to avoid long-term restenosis in patients with occlusive lesions. Further studies should determine the most suitable source and dosage of brachytherapy for patients with occlusive ISR. Catheter Cardiovasc Interv 2004;63:433–438. © 2004 Wiley-Liss, Inc.

BACKGROUND Unstable angina is usually caused by acute thrombosis superimposed on a fissured plaque. Coronary artery stenting has been shown to improve short- and long-term results of coronary angioplasty in mainly stable patients with one-vessel disease, but it is uncertain whether its use in an unstable clinical setting can be safe and useful. This study sought to evaluate the results of coronary stenting in unstable angina and to determine patient, lesion and procedure-related predictors of 30-day and long-term ischemic events. METHODS We studied 266 consecutive patients (mean age 62 +/- 9 years) with unstable angina who underwent coronary artery stenting. The procedure was performed electively in 24%, in bailout situations in 11% and for a suboptimal result of conventional angioplasty in 65%. After stent implantation, patients were treated with anticoagulation (61) on combined antiplatelet therapy (200). Multivariate logistic regression analyses were performed to determine 30-day and long-term predictive factors of ischemic complications. RESULTS Procedural success was obtained in 261 patients (98.1%). During the first 30 days after stenting, one patient died from cardiogenic shock (0.3%) and six (22%) suffered a non-fatal Q-wave myocardial infarction. Patients with combined antiplatelet therapy had a significantly lower stent thrombosis rate (1.5% versus 11.4%, P = 0.002) than those treated with anticoagulant regimen. At long-term follow-up (17.7 +/- 9.4 months) cardiac mortality myocardial infarction and target-vessel revascularization rates were 0.4%, 1.5% and 9.3%, respectively. In multivessel and diabetic patients, a worse long-term event-free survival was observed. Logistic multivariate analysis revealed bailout stenting, anticoagulant therapy, implantation of stents longer than 15 mm as predictors of 30-day ischemic events. In addition, multivessel coronary artery disease and stent application with balloon size of less than 3 mm were predictive of long-term ischemic events. CONCLUSIONS This study demonstrates that, either electively or after failure of conventional angioplasty, coronary stenting represents an effective therapy for patients with unstable angina. In the same clinical setting, combined antiplatelet therapy is associated with a lower 30-day stent thrombosis rate than anticoagulant therapy. Bailout stenting, anticoagulant therapy, implantation of stents longer than 15 mm were shown to be predictors of 30-day ischemic events, whereas multivessel coronary artery disease and stent application with small balloon size were predictive of long-term ischemic events.