Detecting the vulnerable carotid plaque: the Carotid Artery Multimodality imaging Prognostic study design.

BACKGROUND: Carotid artery disease is highly prevalent and a main cause of ischemic stroke and vascular dementia. There is a paucity of information on predictors of serious vascular events. Besides percentage diameter stenosis, international guidelines also recommend the evaluation of qualitative characteristics of carotid artery disease as a guide to treatment, but with no agreement on which qualitative features to assess. This inadequate knowledge leads to a poor ability to identify patients at risk, dispersion of medical resources, and unproven use of expensive and resource-consuming techniques, such as magnetic resonance imaging, positron emission tomography, and computed tomography. OBJECTIVES: The Carotid Artery Multimodality imaging Prognostic (CAMP) study will: prospectively determine the best predictors of silent and overt ischemic stroke and vascular dementia in patients with asymptomatic subcritical carotid artery disease by identifying the noninvasive diagnostic features of the 'vulnerable carotid plaque'; assess whether 'smart' use of low-cost diagnostic methods such as ultrasound-based evaluations may yield at least the same level of prospective information as more expensive techniques. STUDY DESIGN: We will compare the prognostic/predictive value of all proposed techniques with regard to silent or clinically manifest ischemic stroke and vascular dementia. The study will include ≥300 patients with asymptomatic, unilateral, intermediate degree (40-60% diameter) common or internal carotid artery stenosis detected at carotid ultrasound, with a 2-year follow-up. The study design has been registered on Clinicaltrial.gov on December 17, 2020 (ID number NCT04679727).

Effect of High-Titer Convalescent Plasma on Progression to Severe Respiratory Failure or Death in Hospitalized Patients With COVID-19 Pneumonia: A Randomized Clinical Trial.

Importance: Convalescent plasma (CP) has been generally unsuccessful in preventing worsening of respiratory failure or death in hospitalized patients with COVID-19 pneumonia. Objective: To evaluate the efficacy of CP plus standard therapy (ST) vs ST alone in preventing worsening respiratory failure or death in patients with COVID-19 pneumonia. Design, Setting, and Participants: This prospective, open-label, randomized clinical trial enrolled (1:1 ratio) hospitalized patients with COVID-19 pneumonia to receive CP plus ST or ST alone between July 15 and December 8, 2020, at 27 clinical sites in Italy. Hospitalized adults with COVID-19 pneumonia and a partial pressure of oxygen-to-fraction of inspired oxygen (Pao2/Fio2) ratio between 350 and 200 mm Hg were eligible. Interventions: Patients in the experimental group received intravenous high-titer CP (≥1:160, by microneutralization test) plus ST. The volume of infused CP was 200 mL given from 1 to a maximum of 3 infusions. Patients in the control group received ST, represented by remdesivir, glucocorticoids, and low-molecular weight heparin, according to the Agenzia Italiana del Farmaco recommendations. Main Outcomes and Measures: The primary outcome was a composite of worsening respiratory failure (Pao2/Fio2 ratio <150 mm Hg) or death within 30 days from randomization. Results: Of the 487 randomized patients (241 to CP plus ST; 246 to ST alone), 312 (64.1%) were men; the median (IQR) age was 64 (54.0-74.0) years. The modified intention-to-treat population included 473 patients. The primary end point occurred in 59 of 231 patients (25.5%) treated with CP and ST and in 67 of 239 patients (28.0%) who received ST (odds ratio, 0.88; 95% CI, 0.59-1.33; P = .54). Adverse events occurred more frequently in the CP group (12 of 241 [5.0%]) compared with the control group (4 of 246 [1.6%]; P = .04). Conclusions and Relevance: In patients with moderate to severe COVID-19 pneumonia, high-titer anti-SARS-CoV-2 CP did not reduce the progression to severe respiratory failure or death within 30 days. Trial Registration: ClinicalTrials.gov Identifier: NCT04716556.

The involvement of pharmacies in the screening of undiagnosed atrial fibrillation.

Early identification of atrial fibrillation (AF) is now a priority in cardiovascular prevention because AF is common although often asymptomatic, and is associated with poor outcomes that are highly preventable with appropriate medical treatment. In Italy, AF prevalence among subjects aged ≥65 years ranges from 5 to 6% in observational studies based on the diagnosis recorded by general practitioners to 10-11% in studies where ECG screening is routinely offered. It is thus evident that a large number of subjects are not detected by conventional approach, and new strategies are required to increase early detection of AF. In particular, the changing position of pharmacies in the health system should be considered. Because of its small geographical size, insular nature and captive population, the Isle of Elba represents an ideal setting to test new strategies for stroke reduction. The Elba-FA project was thus designed to determine the feasibility and impact of the combined involvement of pharmacies and general practices to screen undiagnosed AF, with the ultimate aim of reducing the burden of stroke and arterial thromboembolism. The findings obtained with this approach might have broad implications for cardiovascular prevention at the general population level in Italy.

Simplified PESI score and sex difference in prognosis of acute pulmonary embolism: a brief report from a real life study.

Prognostic stratification of acute pulmonary embolism (PE) remains a challenge in clinical practice. Simplified PESI (sPESI) score is a practical validated score aimed to stratify 30-day mortality risk in acute PE. Whether prognostic value of sPESI score differs according to sex has not been previously investigated. Therefore the aim of our study was to provide information about it. Data records of 452 patients, 180 males (39.8 %) and 272 females (60.2 %) discharged for acute PE from Internal Medicine wards of Tuscany (Italy) were analysed. sPESI was retrospectively calculated. Variables enclosed in sPESI score, all cause in-hospital mortality and overall bleedings were compared between sexes. Moreover, predictive ability of sPESI score as prognosticator of all cause in-hospital mortality was tested and compared between sexes. sPESI score 0 (low risk) was found in 17.7 % of males and 13.6 % of females (p = 0.2323). We didn't find significant difference in sPESI scoring distribution. Age ≥80 years (51.4 vs. 33.8 %, p = 0.0003) and heart rate ≥110 bpm (23.5 vs. 14.4 %, p = 0.0219) were found significantly more prevalent in females, whereas active cancer (23.8 vs. 39.4 %, p = 0.0004) and cardio-respiratory diseases (19.8 vs. 27.7 %, p = 0.0416) were in males. All cause in-hospital mortality was 0 % in both genders for sPESI score 0, whereas it was 5.4 % in females and 13.6 % in males with sPESI score 1-2 (p = 0.0208) and 22 % in females and 19.3 % in males with sPESI score ≥3 (p = 0.7776). Overall bleedings were significantly more frequent in females compared with males (4.77 vs. 0.55 %, p = 0.0189). In females overall bleedings ranged from 2.7 % in sPESI score 0 to 6 % in sPESI score ≥3. Predictive ability of sPESI score as prognosticator of all cause in-hospital mortality was higher in females compared to males (AUC 0.72 vs. 0.67, respectively). In real life different co-morbidity burdens in females compared to males. Females seems to be at lower risk of all cause in-hospital mortality for sPESI score ≤2 but at higher risk of bleeding, irrespective from sPESI scoring. Predictive ability of sPESI score seems better in females.

Systemic mastocytosis with skeletal involvement: a case report and review of the literature.

Systemic Mastocytosis (SM) comprises a heterogeneous group of disorders of mast cell proliferation. Infiltration, including skin and bone, of multiple mast cells may occur as cutaneous and systemic variants. A rare form of osteoporosis has been also described as expression of the skeletal involvement. Here, we describe a case of a 57-years-old woman with SM and, according to the clinical diagnosis, evaluate the possible mechanism underlying osteoporosis. Moreover, a review of the literature, particularly regarding the use of bisphosphonates in this rare disease is also presented.

Physical injuries caused by a transient loss of consciousness: main clinical characteristics of patients and diagnostic contribution of carotid sinus massage.

AIMS: To evaluate the prevalence and the characteristics of secondary trauma among patients referred to the emergency department (ED) for a transient loss of consciousness (TLOC). METHODS AND RESULTS: Over a 24 months period, all the patients referred to our ED for a TLOC were evaluated according to the ESC Guidelines on Syncope and enrolled in the study. Among 1253 consecutive patients with TLOC (1114 with a true syncope and 139 with a non-syncopal condition) 365 (29.1%) reported a trauma, in 59 cases (4.7%) severe. The frequency and the characteristics of trauma did not differ among the two main categories of TLOC. Out of 54 patients with syncope and a severe trauma, 20 (37%) had a definite diagnosis after a guidelines-based initial evaluation, and further 17 (31.5%) during the hospital course. Among these latter, carotid sinus syndrome was by far the most common diagnosis. CONCLUSION: Among patients referred to the ED for a TLOC secondary trauma is a common complication, whose characteristics are of little utility to discover the specific cause of the symptom. For older patients with syncope complicated by a severe trauma carotid sinus massage should be the first diagnostic manoeuvre to be undertaken after a non-diagnostic initial evaluation.

Hospital admission of patients referred to the Emergency Department for syncope: a single-hospital prospective study based on the application of the European Society of Cardiology Guidelines on syncope.

AIMS: To evaluate the applicability and the clinical impact of the European Society of Cardiology (ESC) Guidelines' recommendations for hospital admission of patients with syncope in a District Hospital Emergency Department (ED). METHODS AND RESULTS: From September 2002 to August 2004, 1124 patients with syncope [out of 1308 with transient loss of consciousness (TLC)] were evaluated according to the ESC Guidelines. Overall, 566 patients with syncope (50.1%) were admitted and 558 (49.9%) were discharged. Out of the 1124 patients with syncope, 440 (39.1%) presented at least one ESC Guidelines' criterion for hospitalization. Out of the 440, 393 (89.3%) were admitted, whereas 511 out of the 684 (74.7%) without indication for admission were discharged. A significant difference was found between the adherence rates for admission and for discharge (P<0.001). The appropriateness of the ED medical decision was 69.4% for hospital admission and 91.6% for discharge (P<0.001). CONCLUSION: Although an acceptable ED adherence to the guidelines' indications was attained, better implementation strategies are still advisable. The ESC Guidelines' indications are applicable to the majority of patients entering the ED for a TLC. In addition, when the guidelines' indications are observed, a high percentage of patients with syncope have still to be hospitalized.

In-hospital management and outcome in women with acute myocardial infarction (data from the AMI-Florence Registry).

Primary percutaneous coronary intervention proved to be superior to thrombolysis in reducing ST-segment elevation acute myocardial infarction (STEAMI) mortality. However, whether such benefit is similar in women and men remains unclear. The aim of the present analysis was to assess the independent effect of female gender on management and on early and 1-year mortality in Florence, Italy, where primary percutaneous coronary intervention is the preferred reperfusion strategy for STEAMI. The study included a cohort of 920 unselected patients with STEAMI (men = 627, women = 293) prospectively enrolled in the AMI-Florence, population-based registry over 12 months. Women were older (76 vs 68 years, p <0.001) and more frequently had Killip class >I heart failure than men. The median delay to hospital admission was marginally longer in women (160 vs 130 minutes, p = 0.09). Coronary reperfusion treatment was performed less often in women (49% vs 58%, p <0.013); primary percutaneous coronary intervention was performed more often in both genders (90% vs 91%) and with similar median door-to-balloon time (50 vs 45 minutes, p = 0.44). Both in-hospital (16% vs 8%, p <0.001) and 1-year mortality (25% vs 18%, p = 0.016) were higher in women. However, after adjusting for age and other baseline characteristics, reperfusion treatment (odds ratio 1.27, 95% confidence interval [CI] 0.78 to 2.08) and 1-year mortality (hazard ratio [HR] 0.91, 95% CI 0.67 to 1.24) were independent of female gender. Compared with conservative therapy, reperfusion treatment was associated with a similar reduction in 1-year mortality in women (HR 0.59, 95% CI 0.34 to 1.02) and men (HR 0.58, 95% CI 0.37 to 0.92). Our data suggest that older age and several age-related factors may largely account for the higher mortality of women after STEAMI. Even in the general population,improvement in prognosis associated with reperfusion treatment is independent of gender.

Age-related changes in treatment strategies for acute myocardial infarction: a population-based study.

OBJECTIVES: To compare across four age groups (<65, 65-74, 75-84, > or =85) the determinants of coronary reperfusion therapy (CRT) use in ST-segment elevation acute myocardial infarction (STE-AMI). DESIGN: Population-based, observational study. SETTING: Performed in the health district of Florence, Italy, where percutaneous coronary intervention (PCI) is the preferred CRT. PARTICIPANTS: Nine hundred thirty patients with STE-AMI prospectively enrolled in the Florence AMI registry. MEASUREMENTS: Use of CRT, clinical factors associated with CRT use. RESULTS: CRT use was reduced from 71% at younger than 65 to 31% at aged 85 and older (P<.001). After adjusting for chronic comorbidity, Killip class, admission hospital category, hospitalization delay, and AMI location, CRT use was 29% (P=.17) lower at age 75 to 84 and 63% (P<.001) lower at age 85 and older than at younger than 65. Within each age group, the probability of receiving CRT was three to five times greater in patients directly admitted to the hospital with PCI facilities. Acute cardiac failure and chronic comorbidity were associated with lower CRT use only in patients aged 65 and older. Patients aged less than 85 years who received reperfusive therapy had a significantly lower risk of death (-44%, P=.045) at 1 year, whereas it was less evident and nonsignificant (-27%, P=.27) in patients aged 85 and older. CONCLUSION: Results confirm that, although they might substantially benefit from CRT during STE-AMI, older patients are excluded from CRT even when eligible. This further indicates that clinicians are not yet completely prepared to manage most efficiently frail elderly with AMI, a task requiring a specific interdisciplinary training program in geriatric cardiology.