A COVID-19 specific multiparametric and ECG-based score for the prediction of in-hospital mortality: ELCOVID score.

We aimed to develop and validate a COVID-19 specific scoring system, also including some ECG features, to predict all-cause in-hospital mortality at admission. Patients were retrieved from the ELCOVID study (ClinicalTrials.gov identifier: NCT04367129), a prospective, multicenter Italian study enrolling COVID-19 patients between May to September 2020. For the model validation, we randomly selected two-thirds of participants to create a derivation dataset and we used the remaining one-third of participants as the validation set. Over the study period, 1014 hospitalized COVID-19 patients (mean age 74 years, 61% males) met the inclusion criteria and were included in this analysis. During a median follow-up of 12 (IQR 7-22) days, 359 (35%) patients died. Age (HR 2.25 [95%CI 1.72-2.94], p < 0.001), delirium (HR 2.03 [2.14-3.61], p = 0.012), platelets (HR 0.91 [0.83-0.98], p = 0.018), D-dimer level (HR 1.18 [1.01-1.31], p = 0.002), signs of right ventricular strain (RVS) (HR 1.47 [1.02-2.13], p = 0.039) and ECG signs of previous myocardial necrosis (HR 2.28 [1.23-4.21], p = 0.009) were independently associated to in-hospital all-cause mortality. The derived risk-scoring system, namely EL COVID score, showed a moderate discriminatory capacity and good calibration. A cut-off score of ≥ 4 had a sensitivity of 78.4% and 65.2% specificity in predicting all-cause in-hospital mortality. ELCOVID score represents a valid, reliable, sensitive, and inexpensive scoring system that can be used for the prognostication of COVID-19 patients at admission and may allow the earlier identification of patients having a higher mortality risk who may be benefit from more aggressive treatments and closer monitoring.

[Screening for atrial fibrillation in the general population: experience from a cardiovascular risk campaign in the Emilia-Romagna Region]. / Screening della fibrillazione atriale nella popolazione generale: esperienza della campagna educazionale sul rischio cardiovascolare della Regione Emilia-Romagna.

BACKGROUND: Atrial fibrillation (AF) is a major cause of cerebral ischemia, and its early detection may impact on health. Both invasive and non-invasive devices can be used for the diagnosis of AF. The aim of our study was to estimate the prevalence of AF using a single-lead ECG device (MyDiagnostickTM) on an adult, asymptomatic population during a screening campaign. METHODS: A total of 2547 subjects underwent AF screening. RESULTS: The device detected an arrhythmia in 42 subjects (1.65%), and AF was confirmed on 12-lead ECG in 14 (0.55%) of them. The prevalence of confirmed AF increased in subjects over 65 years of age (1.21%) or with a CHA2DS2-VASc score ≥2 in males or ≥3 in females (1.33%). Furthermore, heart failure (odds ratio [OR] 8.62, 95% confidence interval [CI] 1.87-39.6, p=0.006) and diabetes (OR 4.55, 95% CI 1.25-16.5, p=0.021) significantly increased the risk of AF. CONCLUSIONS: During a screening campaign, the diagnosis of AF increases when subjects with a high thromboembolic risk are selected.

Electrocardiographic features of 431 consecutive, critically ill COVID-19 patients: an insight into the mechanisms of cardiac involvement.

AIMS: Our aim was to describe the electrocardiographic features of critical COVID-19 patients. METHODS AND RESULTS: We carried out a multicentric, cross-sectional, retrospective analysis of 431 consecutive COVID-19 patients hospitalized between 10 March and 14 April 2020 who died or were treated with invasive mechanical ventilation. This project is registered on ClinicalTrials.gov (identifier: NCT04367129). Standard ECG was recorded at hospital admission. ECG was abnormal in 93% of the patients. Atrial fibrillation/flutter was detected in 22% of the patients. ECG signs suggesting acute right ventricular pressure overload (RVPO) were detected in 30% of the patients. In particular, 43 (10%) patients had the S1Q3T3 pattern, 38 (9%) had incomplete right bundle branch block (RBBB), and 49 (11%) had complete RBBB. ECG signs of acute RVPO were not statistically different between patients with (n = 104) or without (n=327) invasive mechanical ventilation during ECG recording (36% vs. 28%, P = 0.10). Non-specific repolarization abnormalities and low QRS voltage in peripheral leads were present in 176 (41%) and 23 (5%), respectively. In four patients showing ST-segment elevation, acute myocardial infarction was confirmed with coronary angiography. No ST-T abnormalities suggestive of acute myocarditis were detected. In the subgroup of 110 patients where high-sensitivity troponin I was available, ECG features were not statistically different when stratified for above or below the 5 times upper reference limit value. CONCLUSIONS: The ECG is abnormal in almost all critically ill COVID-19 patients and shows a large spectrum of abnormalities, with signs of acute RVPO in 30% of the patients. Rapid and simple identification of these cases with ECG at hospital admission can facilitate classification of the patients and provide pathophysiological insights.

Vascular complications after balloon aortic valvuloplasty in recent years: Incidence and comparison of two hemostatic devices.

OBJECTIVES: To define the incidence of vascular complications (VC) after balloon aortic valvuloplasty (BAV) in recent years, and to compare the performance of two vascular closure devices (VCD). BACKGROUND: VC remain the most frequent drawback of BAV and are associated with adverse clinical outcomes. METHODS: All BAV procedures performed at 2 high-volume centers over a 6-year period (n = 930) were collected in prospective registries and investigated to assess the incidence of Valve Academic Research Consortium-2 (VARC-2) defined VC. Incidence of life-threatening, major and minor bleeding was also assessed. In-hospital major adverse cardiac and cerebrovascular events (MACCE) rate (composite of in-hospital death, myocardial infarction, TIA/stroke, and life-threatening bleeding) as well as 30-day survival was compared between a suture-mediated closure system and a collagen plug hemostatic device. RESULTS: A 9 Fr arterial sheath was used in most of the patients (84.1%). Vascular closure was obtained with the Angio-Seal in 643 patients (69.1%) and the ProGlide in 287 (30.9%). The overall incidence of major VC was 2.7%, and minor VC 6.6%, without significant differences between groups. The Angio-Seal group was associated with a higher rate of small hematomas (6.9% vs. 3.5%, P = 0.042), whilst blood transfusions were more frequent in the ProGlide group (6.6% vs. 3.5%, P = 0.034). Rates of in-hospital MACCE and 30-day survival were similar. Use of either VCD was not independently associated with major VC. CONCLUSIONS: VC rate after BAV is fairly low in experienced centers without major differences between the 2 most used VCD.

Long-term prognostic role of cerebrovascular disease and peripheral arterial disease across the spectrum of acute coronary syndromes.

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.

Sex-Related Outcomes in Elderly Patients Presenting With Non-ST-Segment Elevation Acute Coronary Syndrome: Insights From the Italian Elderly ACS Study.

OBJECTIVES: This study sought to investigate sex-related differences in treatment and outcomes in elderly patients with non-ST-segment elevation acute coronary syndromes (NSTEACS). BACKGROUND: Female sex and older age are usually associated with worse outcome in NSTEACS. The Italian Elderly ACS study enrolled NSTEACS patients aged 75 years of age and older in a randomized trial comparing an early aggressive with an initially conservative strategy and in a registry of patients with ≥1 exclusion criteria of the trial. METHODS: We compared sexes in the pooled populations of the trial and registry. RESULTS: A total of 645 patients (313 from the trial and 332 from the registry), including 301 women (47%), were enrolled. Women were slightly older than men (82.1 ± 5.0 years vs. 81.2 ± 4.5 years; p = 0.02), had lower hemoglobin levels (12.5 ± 1.6 g/dl vs. 13.3 ± 1.9 g/dl; p < 0.001), and underwent fewer coronary revascularizations during the index admission (37.2% vs. 45.0%; p = 0.04). In-hospital adverse event rates were similar in both sexes; severe bleeding was uncommon (0.3% vs. 0%). The 1-year primary endpoint (composite of death, nonfatal myocardial infarction, disabling stroke, cardiac rehospitalization, and severe bleeding) occurred less often in women (27.6% vs. 38.7%; p < 0.01). Women not undergoing revascularization showed a 3-fold higher mortality, both in-hospital (8.5% vs. 2.7%; p = 0.05) and at 1 year (21.6% vs. 8.1%; p = 0.002). CONCLUSIONS: Elderly women had a similar in-hospital outcome and better 1-year outcome compared with men. Coronary revascularization in women was associated with lower 1-year mortality, without an increase in severe bleeding. Elderly women with NSTEACS should always be considered for early revascularization.

Adherence to agents acting on the renin-angiotensin system in secondary prevention of non-fatal myocardial infarction: a self-controlled case-series study.

AIMS: In accordance with current guidelines, patients discharged after acute myocardial infarction (AMI) are usually prescribed agents acting on the renin-angiotensin system (ACE-I/ARB). However, adherence to prescribing medications is a recognized problem and most studies demonstrating the value of adherence were limited by their non-randomized design and by 'healthy-adherer' bias. Herein we sought to evaluate the relationship between adherence to ACE-I/ARB and risk of subsequent AMIs, by using the self-controlled case-series design which virtually eliminates interpersonal confounding, being based on intrapersonal comparisons. METHODS AND RESULTS: We linked data from three longitudinal registries containing information about hospitalizations, drug prescriptions, and vital status of all residents in an Italian region. From 30 089 patients hospitalized for AMI in the years 2009-11, we enrolled the 978 with non-fatal re-AMIs at Days 31-365 after discharge, receiving at least one ACE-I/ARB prescription collected at any of the regional pharmacies. Using information on prescriptions, each individual's observation time was then divided into periods exposed or unexposed to ACE-I/ARB. The relative re-AMI incidence rate ratios (IRRs) of ACE-I/ARB exposure were estimated by conditional Poisson regression. During drug-covered periods, the risk of AMI recurrence was ∼20% lower, i.e. the IRR (rate of recurrent AMI in exposed versus unexposed periods) was 0.79 (95% CI 0.66-0.96, P = 0.001). The benefit of ACE-I/ARB was confirmed also by sensitivity analyses considering only first recurrences, excluding cases with AMI within previous 3 years, or with long, not AMI, hospital re-admission. CONCLUSIONS: Poor adherence to ACE-I/ARB prescription medication was associated with a 20% increased risk of recurrent AMI. This was consistent with previous research, but the SCSS study design, even if not randomized, eased previous concerns about healthy-adherer bias.

Long-term outcomes and causes of death after acute coronary syndrome in patients in the Bologna, Italy, area.

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.

Association of bleeding, mortality and sex in acute coronary syndromes: the missing triangle.

AIMS: Percutaneous coronary intervention (PCI) and antithrombotic drugs are the standard therapy for patients with acute coronary syndromes (ACS), but their impact on bleeding and mortality in women has not been adequately investigated. METHODS: This was a prospective observational cohort study of ACS patients, who were referred to 6 of the 13 centres belonging to the REgistro regionale AngiopLastiche dell'Emilia-Romagna programme in Emilia-Romagna for coronary angiography and PCI between June 2010 and November 2011. The aim of the study was to verify whether the incidence of Global Registry of Acute Coronary Events-defined in-hospital bleeding after an ACS is significantly higher in women than in men, and to evaluate its impact on short and long-term mortality. RESULTS: The analysis involved a total of 1686 patients (511 women and 1175 men). The women were older and more frequently affected by hypertension, congestive heart failure and single-vessel disease; however, none of the clinical or procedural variables was significantly different between the sexes after statistical adjustment. There was a significantly higher rate of in-hospital bleeding among the women [8.6 vs. 5.8%; adjusted odds ratio 1.73, 95% confidence interval (CI) 1.19-2.52, P = 0.004], but the adjusted hazard ratio for short and long-term all-cause mortality was not significantly different. After optimal adjustment, bleeding, but not female sex, was identified as a predictor of short-term all-cause mortality (hazard ratio 2.68, 95% CI 1.21-5.93, P = 0.01), but this was not confirmed in the case of long-term mortality (hazard ratio 1.57, 95% CI 0.91-2.71, P = 0.10). CONCLUSION: After optimal adjustment for baseline differences, the findings of this contemporary Italian PCI registry study showed that women experience bleeding more frequently, but do not have worse mortality outcomes than men. Bleeding was confirmed as an independent predictor of short-term mortality.

Diagnostic performance of standard electrocardiogram for prediction of infarct related artery and site of coronary occlusion in unselected STEMI patients undergoing primary percutaneous coronary intervention.

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.

Recent temporal trends for first-time hospitalization for acute myocardial infarction. Treatment patterns and clinical outcome in a large cohort study.

BACKGROUND: The objective was to report recent trends in the incidence, adoption of evidence-based treatment, and clinical outcomes for first-time hospitalization for acute myocardial infarction. METHODS: This is a large retrospective population-based cohort study using medical administrative data (International Classification of Diseases, Ninth Revision, Clinical Modification, codes) performed in the Emilia-Romagna Region of Italy (approximately 4.5 million inhabitants). We identified 60,673 patients with a first hospitalization for acute myocardial infarction from 2002 through 2009. RESULTS: The standardized incidence rate per 100,000 person-years of acute myocardial infarction increased from 173 cases in 2002 to a peak of 197 cases in 2004 and then decreased each year thereafter to 167 cases in 2009. The proportion of patients who underwent coronary angiography and angioplasty in the acute phase increased over time, respectively, from 45.4% and 27.1% to 72.3% and 57.2% (P < .001). Medication use within 12 months of discharge increased for aspirin, ß-blockers, and statins. A reduction in crude and adjusted in-hospital all-cause (16.1% in 2002 vs 12.8% in 2009, P < .001) and cardiovascular mortality (13.6% in 2002 vs 9.5% in 2009, P < .001) was observed over time. At 1 year after hospital discharge, no significant variations occurred in adjusted risk for all-cause mortality or cardiovascular mortality. Notably, crude and adjusted risk for in-hospital and postdischarge bleeding showed a significant increment. CONCLUSIONS: The utilization of evidence-based treatments in patients with myocardial infarction increased between 2002 and 2009. These changes in practice over time favored a reduction in early case fatality at the cost of a significant increase in bleeding.

Relevance of gender in patients with acute myocardial infarction undergoing coronary interventions.

AIMS: To evaluate whether gender differences in terms of up to 4-year outcome still persist within patients with acute myocardial infarction (AMI) who uniformly underwent coronary revascularization, we performed a gender comparison in a large contemporary multicentre percutaneous intervention (PCI) registry. MATERIALS AND METHODS: We retrospectively analyzed data from 18,351 patients with AMI, who underwent percutaneous coronary interventions (5093 women and 13,258 men) in the Emilia Romagna region of Italy between July 2002 and December 2007. Median follow-up was 1174 days. RESULTS: After propensity score adjustment, differences in gender-related mortality were not temporarily homogeneous: 30-day adjusted mortality was higher in women than in men [hazard ratio (HR): 1.40, P < 0.0001], whereas thereafter female gender showed a significantly lower mortality risk (HR: 0.84, P = 0.01). Notably, younger women (<50 years old) both in the acute and postacute period had more than 3.6 higher risk of mortality when compared with men, whereas older women, particularly after the first 30-day post AMI, had similar (50-80 years old) or even better (≥ 80 years old) survival compared with men. Finally 1-month adjusted risk of heart failure and post PCI vascular complications requiring surgical treatment was higher in women while there was no detectable difference in terms of early and late AMI/unstable angina, stroke and angiographic stent thrombosis. CONCLUSION: In a contemporary large real-world AMI population treated with PCI, we found gender-related temporal and age-dependent adjusted differences in mortality. Our data suggest the hypothesis that biological gender-related differences could, in part, explain these findings.

Myopericarditis during a primary Epstein-Barr virus infection in an otherwise healthy young adult. An unusual and insidious complication. Case report and a 60-year literature review.

An otherwise healthy young man had infectious mononucleosis detected after an atypical clinical onset, including myocarditis and pericarditis. Our patient slowly but completely recovered from his cardiac complications after the course of his primary Epstein-Barr infection, as shown by periodical electrocardiographic and ultrasonographic studies, and a simple treatment with aspirin alone. Our case report is briefly reported, and discussed with regard to the existing literature, which has recorded such complications since the mid 1940s.

One-year clinical outcome in patients with acute coronary syndrome treated with concomitant use of clopidogrel and proton pump inhibitors: results from a regional cohort study.

OBJECTIVES: We sought to compare the 1-year risk of re-hospitalization for acute coronary syndrome (ACS) between patients taking clopidogrel with proton pump inhibitors (PPIs) vs. clopidogrel without PPIs. MATERIALS AND METHODS: We conducted a retrospective cohort study among 3896 patients with ACS, at low risk for gastrointestinal bleeding, discharged from all hospitals of the Emilia-Romagna region of Italy during the period January-August 2008. Patients' consumption of clopidogrel and PPIs at hospital discharge and follow-up was based on pharmacy refill data. Of these 3896 patients, 90% (n = 3519) were prescribed PPIs at hospital discharge and/or at some time during follow-up. RESULTS: At 1-year follow-up, hospitalization for ACS occurred in 15% of patients taking clopidogrel with PPIs vs. 3.4% of those taking clopidogrel without PPIs (P < 0.001). No difference in terms of all-cause mortality could be detected between the two groups. At multivariate regression analysis with PPI use as a time-varying covariate, periods of use of clopidogrel with PPIs were associated, at 1-year follow-up, with a significantly higher risk of hospitalization for ACS (hazard ratio 1.29, P = 0.025). Notably, this event occurred mostly in patients who underwent revascularization during the index hospitalization (n = 3045, hazard ratio 1.52, P = 0.004). No significant effect of PPI prescription could be observed in terms of 1-year all-cause mortality and revascularization. CONCLUSION: This study suggests the hypothesis that a concomitant use of clopidogrel and PPIs in patients with ACS, at low risk for gastrointestinal bleeding, having mostly undergone coronary revascularization, is associated with an approximately 30% higher risk of nonfatal hospitalization for ACS.

Impact of a territorial ST-segment elevation myocardial infarction network on prognosis of patients with out-of-hospital cardiac arrest.

INTRODUCTION: We sought to assess the effect of a territorial system of care for ST-elevation myocardial infarction (STEMI) on the outcome of out-of-hospital cardiac arrest (OOHCA). MATERIALS AND METHODS: We enrolled 720 patients who experienced a witnessed OOHCA of presumed cardiac origin during a four-year period in an area with a STEMI network and for whom resuscitation was attempted. RESULTS: Overall, 242 (33.6%) patients had return of spontaneous circulation (ROSC), 645 (90%) died before discharge. We observed a trend toward decreased overall mortality for OOHCA between the years 2004 and 2007, both in the entire population and in patients with ROSC (2004=94%; 2005=89%; 2006=85%; 2007=89%; P=0.064; 2004=81%; 2005=69%; 2006=65%; 2007=60%; P=0.076, respectively). On multivariable analysis, age, crew-witnessed arrest and presence of shockable rhythm were independent predictors of mortality. Patients who experienced OOHCA in the year 2006 (OR=0.47; 95% CI: 0.21-1.05; P=0.07) and 2007 (OR=0.51; 95% CI: 0.23-1.12; P=0.09) showed a strong trend toward decreased risk of mortality compared to year 2004. In patients with ROSC, the year 2007 was associated with a significant lower risk of mortality compared to year 2004 (OR=0.38; 95% CI: 0.15-0.96; P=0.04). CONCLUSIONS: Implementation of a territorial network of care for STEMI appears to be associated with reduced mortality OOHCA patients.

Safety and efficacy of early aggressive versus cholesterol-driven lipid-lowering strategies in heart transplantation: a pilot, randomized, intravascular ultrasound study.

BACKGROUND: Statins are recommended in heart transplantation regardless of lipid levels. However, it remains unknown whether dosing should be maximized or adjusted toward a pre-defined cholesterol threshold. METHODS: This pilot, randomized, open-label study compares an early maximal dose of fluvastatin (80 mg/day) with a strategy based on 20 mg/day subsequently titrated to target low-density lipoproteins (LDL) <100 mg/dl. Efficacy outcomes consisted of achieving an LDL level of <100 mg/dl at 12 months after transplant, and change in intracoronary ultrasound parameters. RESULTS: Fifty-two patients were randomized. Overall safety, and efficacy in achieving LDL targets (13 [50%] vs 14 [54%]; p = 0.8) were comparable between study arms, but 17 (65%) patients needed a dose increase in the titrated-dosing arm. Early LDL levels and average LDL burden were lower in the maximal-dosing arm (p < 0.05). Few patients developed an increase in maximal intimal thickness of >0.5 mm, with numerical prevalence in the titrated-dosing arm (3 [12.5%] vs 1 [5%]; p = 0.3). Intimal volume increased in the titrated-dosing (p < 0.01) but not in the maximal-dosing arm (p = 0.1), which accordingly showed a higher prevalence of negative remodeling (p = 0.02). CONCLUSIONS: Despite being as effective as the titrated-dosing approach in achieving LDL <100 mg/dl at 12 months after transplant, the maximal-dose approach was associated with a more rapid effect and with potential advantages in preventing pathologic changes in graft coronary arteries.

Pre-hospital ECG in patients undergoing primary percutaneous interventions within an integrated system of care: reperfusion times and long-term survival benefits.

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.