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Aims Takotsubo syndrome (TTS) is an acute and reversible left ventricular dysfunction and can be complicated by cardiogenic shock (CS). However, few data are available on optimal care in TTS complicated by CS. Aim of this study was to evaluate short- and long-term impact of intra-aortic balloon pumping (IABP) on mortality in this setting. Methods and results In a multi-centre, international registry on TTS, 2248 consecutive patients were enrolled from 38 centres from Germany, Italy, and Spain. Of the 2248 patients, 212 (9.4%) experienced CS. Patients with CS had a higher prevalence of diabetes (27% vs. 19%), male sex (25% vs. 10%), and right ventricular involvement (10% vs. 5%) (P < 0.01 in all cases). Forty-three patients with CS (20% of 212) received IABP within 8 h (interquartile range 4–18) after admission. No differences in terms of age, gender, cardiovascular risk factors, and admission left ventricular ejection fraction were found among patients with and without IABP. There were no significant differences in terms of 30-day mortality (16% vs. 17%, P = 0.98), length of hospitalization (18.9 vs. 16.7 days, P = 0.51), and need of invasive ventilation (35% vs. 41%, P = 0.60) among two groups: 30-day survival was not significantly different even after propensity score adjustment (log-rank P = 0.73). At 42-month follow-up, overall mortality in patients with CS and TTS was 35%, not significantly different between patients receiving IABP and not (37% vs. 35%, P = 0.72). Conclusions In a large multi-centre observational registry, the use of IABP was not associated with lower mortality rates at short- and long-term follow-up in patients with TTS and CS. [ABSTRACT FROM AUTHOR]

• Diabetic patients face higher Herpes Zoster hospitalization rates in Piedmont, Italy (2010–2019). • Key risk factors for hospitalization are age > 65, obesity, and poor glycaemic control. • Diabetes increases recurrent HZ hospitalizations and severe complications risk. This study explores the association between Herpes Zoster (HZ) hospitalizations and diabetes in Piedmont, Italy from 2010 to 2019. Focusing on the burden of HZ hospitalizations in diabetic and non-diabetic groups, it aims to identify risk factors in diabetics to enhance prevention strategies. In a two-phase study, we first compared age-standardized HZ hospitalization rates between diabetic and non-diabetic individuals from 2010 to 2019. We then examined hospitalization risk factors for HZ within a diabetic patient cohort managed by regional diabetes clinics. Of 3,423 HZ hospitalizations in 2010–2019, 17.9 % (613 cases) were diabetic patients, who exhibited higher hospitalization rates (15.9 to 6.0 per 100,000) compared to non-diabetese individuals. Among diabetics subjects risk factors for HZ hospitalization included age over 65, obesity (BMI > 30), and poor glycemic control (HbA1c > 8.0 %). These patients had a 40 % increased rehospitalization risk and a 25 % higher risk of severe complications, such as stroke and myocardial infarction, post-HZ. Diabetes markedly increases HZ hospitalization rates, rehospitalization, and complication risks. These findings underscore the need for preventive strategies, especially improved glycemic control among high-risk diabetic patients, to inform public health policies and clinical practices aimed at mitigating HZ's impact on this population. [ABSTRACT FROM AUTHOR]

Background: We aimed to study the impact of diabetes background on COVID-19 progression from swab testing to health outcomes in type 2 diabetes (T2DM).Methods: From the database of the diabetes units of Piedmont-Italy we extracted records of T2DM patients, which were linked with the swab-testing-database, and the database of hospital discharges. Five outcomes (PCR testing, PCR testing positivity, hospitalization, Intensive Care Unit (ICU), death) were evaluated using robust Poisson models.Results: Among 125,021 T2DM patients, 1,882 had a positive PCR test. Of these patients, 49.4% were hospitalized within 30 days, 11.8% were admitted to an ICU, and 27.1% died. Greater probability of death was associated with age, male sex, liver and renal impairment, Hba1c above 8%, and former smoking. Hospitalization and ICU admission were mainly affected by age, male sex, hypertension, and metabolic control. Notably, ICU admissions were reduced in very elderly people. No outcomes were associated with educational level.Conclusions: Hospitalization and ICU admission are heavily affected by age and local triage policy. A key finding was that men who were >75 years old and poorly compensated were highly vulnerable patients. Renal and/or hepatic impairment are additional factors. This information may be useful for addressing intervention priorities. [ABSTRACT FROM AUTHOR]

Aim: To compare the effectiveness of commonly used offloading devices for the treatment of neuropathic foot ulcers in patients with diabetes mellitus. This meta-analysis (MA) has been performed for giving an answer to clinical questions on this topic of the Italian guideline on diabetic foot syndrome., Methods: The present MA includes randomized controlled studies (duration > 12 weeks) comparing, in patients with diabetes mellitus and non-infected neuropathic foot ulcer: any offloading device vs either no offloading device or conventional footwear; removable versus non-removable offloading devices; surgical procedure vs other offloading approaches. The primary endpoint was ulcer healing., Results: A total of 184 studies were identified, and 18 were considered eligible for the analysis. We found that: any plantar off-loading, when compared to the absence of plantar offloading device, is associated with a higher ulcer healing (MH-OR: 3.13 [1.08, 9.11], p = 0.04, I 2  = 0%); total contact cast or nonremovable knee-high walker, compared to other offloading devices, had a higher ulcer healing rate (MH-OR: 2.64 [1.43, 4.89], p = 0.002, I 2  = 51%); surgical offloading for active ulcers in combination with post-surgery offloading achieves higher ulcer healing rate when compared to offloading devices alone (MH-OR: 6.77 [1.64, 27.93], p = 0.008, I 2  = 0%)., Conclusions: Any plantar offloading, compared to the absence of plantar offloading device, is associated with a higher ulcer healing rate. Total contact cast or nonremovable knee-high walker, compared to other offloading devices, is preferable. Surgical offloading for active ulcers, in combination with post-surgery offloading devices, achieves a higher ulcer healing rate when compared to other offloading devices alone. Further studies with a larger cohort of patients with diabetic neuropathic foot ulcers and extended follow-up periods are necessary., (© 2024. Springer-Verlag Italia S.r.l., part of Springer Nature.)

The treatment of patients with diabetic foot ulcers (DFUs) is extremely complex, requiring a comprehensive approach that involves a variety of different healthcare professionals. Several studies have shown that a multidisciplinary team (MDT) approach is useful to achieve good clinical outcomes, reducing major and minor amputation and increasing the chance of healing. Despite this, the multidisciplinary approach is not always a recognized treatment strategy. The aim of this meta-analysis was to assess the effects of an MDT approach on major adverse limb events, healing, time-to-heal, all-cause mortality, and other clinical outcomes in patients with active DFUs. The present meta-analysis was performed for the purpose of developing Italian guidelines for the treatment of diabetic foot with the support of the Italian Society of Diabetology (Società Italiana di Diabetologia, SID) and the Italian Association of Clinical Diabetologists (Associazione Medici Diabetologi, AMD). The study was performed using the Grading of Recommendations Assessment, Development, and Evaluation approach. All randomized clinical trials and observational studies, with a duration of at least 26 weeks, which compared the MDT approach with any other organizational strategy in the management of patients with DFUs were considered. Animal studies were excluded. A search of Medline and Embase databases was performed up until the May 1st, 2023. Patients managed by an MDT were reported to have better outcomes in terms of healing, minor and major amputation, and survival in comparison with those managed using other approaches. No data were found on quality of life, returning-to-walking, and emergency admission. Authors concluded that the MDT may be effective in improving outcomes in patients with DFUs., (© 2024. Springer-Verlag Italia S.r.l., part of Springer Nature.)

Aims: Diabetic foot syndrome (DFS) and its complications are a growing public health concern. The Italian Society of Diabetology (SID) and the Italian Association of Clinical Diabetologists (AMD), in collaboration with other scientific societies, will develop the first Italian guidelines for the treatment of DFS., Methods: The creation of SID/AMD Guidelines is based on an extended work made by 19 panelists and 12 members of the Evidence Review Team. Grading of Recommendations, Assessment, Development and Evaluations (GRADE) methodology has been used to decide aims, reference population, and target health professionals. Clinical questions have been created using PICO (Patient, Intervention, Comparison, Outcome) conceptual framework. The definition of questions has been performed using a two-step web-based Delphi methodology, a structured technique aimed at obtaining by repeated rounds of questionnaires a consensus opinion from a panel of experts in areas wherein evidence is scarce or conflicting, and opinion is important., Results: The mean age of panelists (26.3% women) was 53.7 ± 10.6 years. The panel proposed 34 questions. A consensus was immediately reached for all the proposed questions, 32 were approved and 2 were rejected., Conclusions: The areas covered by clinical questions included diagnosis of ischemia and infection, treatment of ischemic, neuropathic, and infected ulcers, prevention of foot ulceration, organization and education issues, and surgical management. The PICO presented in this paper are designed to provide indications for healthcare professionals in charge of diabetic foot treatment and prevention, primarily based on clinical needs of people with diabetic foot syndrome and considering the existing organization of health care., (© 2023. Springer-Verlag Italia S.r.l., part of Springer Nature.)

After percutaneous coronary interventions (PCIs), patients remain at high risk of developing recurrent cardiovascular events. Despite advances in interventional cardiology, the correct management of residual low-density lipoprotein cholesterol (LDL-C) risk continues to be crucial for improving long-term outcomes after PCI. However, several observational studies have demonstrated suboptimal LDL-C control, poor adherence to statin therapy, and underutilization of high-intensity statins, ezetimibe, and proprotein convertase subtilisin/kexin type 9 inhibitors in real-world clinical practice despite a strong endorsement from international guidelines. Recent studies have shown that early intensive lipid-lowering therapy stabilizes atheromatous plaque and increases fibrous cap thickness in patients with acute coronary syndrome. This finding emphasizes the importance of achieving therapeutic targets by establishing an effective treatment as early as possible. The aim of this expert opinion paper of the Interventional Cardiology Working Group of the Italian Society of Cardiology is to discuss the management of lipid-lowering therapy in patients undergoing PCIs according to Italian reimbursement policies and regulations, with a particular focus on the discharge phase., (Copyright © 2023 Italian Federation of Cardiology - I.F.C. All rights reserved.)

Since 1989, SIC Sport and a FMSI, in partnership with leading Italian Cardiological Scientific Associations (ANCE, ANMCO and SIC) have produced Cardiological Guidelines for Completive Sports Eligibility for athletes with heart disease (COCIS -- 1989, 1995, 2003, 2009 and 2017). The English version of the Italian Cardiological Guidelines for Competitive Sports Eligibility for athletes with heart disease was published in 2013 in this Journal. This publication is an update with respect to the document previously published in English in 2013. It includes the principal innovations that have emerged over recent years, and is divided into five main chapters: arrhythmias, ion channel disorders, congenital heart diseases, acquired valve diseases, cardiomyopathies, myocarditis and pericarditis and ischemic heart disease. Wherever no new data have been introduced with respect to the 2013 publication, please refer to the previous version. This document is intended to complement recent European and American guidelines but an important difference should be noted. The European and American guidelines indicate good practice for people engaging in physical activity at various levels, not only at the competitive level. In contrast, the COCIS guidelines refer specifically to competitive athletes in various sports including those with high cardiovascular stress. This explains why Italian guidelines are more restrictive than European and USA ones. COCIS guidelines address 'sports doctors' who, in Italy, must certify fitness to participate in competitive sports. In Italy, this certificate is essential for participating in any competition., (Copyright © 2021 Italian Federation of Cardiology - I.F.C. All rights reserved.)

Background and Aims: Excess morbidity and mortality from chronic liver disease in type 2 diabetes (T2DM) is recognized; however, the clinical features associated with liver fibrosis (LF) of any origin are poorly known. Metabolic status and/or coexisting complications over time may play a role., Methods and Results: We interrogated the database of the diabetes unit network of Piedmont (Italy) (71,285 T2DM patients) and calculated a fibrosis-4 score (FIB-4) from data recorded between 2006 and 2019. Comorbidities were obtained by linkage with hospital data. The study population was subdivided by aetiology of LF (alcoholic, viral, metabolic). Associations between upper level of FIB-4 and demographic and clinical variables were evaluated separately for each group using robust Poisson models and presented as prevalence ratios. Nearly one-quarter (24%) of T2DM patients had some form of LF: viral (0.44%) and alcoholic (0.53%) forms were far less frequent than metabolic ones (22.7%). Only 1 out of 5 of these patients had a history of known cirrhosis. Age, male sex, duration of diabetes, coronary disease, hyperuricemia, renal failure, and features of liver failure (e.g., lower body-mass index, lipid and HbA1c levels) were positively associated with metabolic LF. More intensive treatments with insulin and segretagogue emerged as a significant predictive indicators of LF of metabolic origin., Conclusion: A sizeable proportion of T2DM patients has some degree of LF, mainly of metabolic origin and often undiagnosed. There is a need to clarify whether the link between insulin therapy and advanced LF is causal or not., Competing Interests: Declaration of competing interest The authors have nothing to disclose., (Copyright © 2021 The Italian Diabetes Society, the Italian Society for the Study of Atherosclerosis, the Italian Society of Human Nutrition and the Department of Clinical Medicine and Surgery, Federico II University. Published by Elsevier B.V. All rights reserved.)

CoronaVIrus Disease-19 (COVID-19) had a huge impact on human health and economy. However, to this date, the effects of the pandemic on the training of young cardiologists are only partially known. To assess the consequences of the pandemic on the education of the cardiologists in training, we performed a 23-item national survey that has been delivered to 1443 Italian cardiologists in training, registered in the database of the Italian Society of Cardiology (SIC). Six hundred and thirty-three cardiologists in training participated in the survey. Ninety-five percent of the respondents affirmed that the training programme has been somewhat stopped or greatly jeopardized by the pandemic. For 61% of the fellows in training (FITs), the pandemic had a negative effect on their education. Moreover, 59% of the respondents believe that they would not be able to fill the gap gained during that period over the rest of their training. A negative impact on the psycho-physical well being has been reported by 86% of the FITs. The COVID-19 pandemic had an unparalleled impact on the education, formation and mental state of the cardiologists in training. Regulatory agencies, universities and politicians should make a great effort in the organization and reorganization of the teaching programs of the cardiologists of tomorrow., (Copyright © 2021 Italian Federation of Cardiology - I.F.C. All rights reserved.)

In over a year, the COVID-19 pandemic caused 2.69 million deaths and 122 million infections. Social isolation and distancing measures have been the only prevention available for months. Scientific research has done a great deal of work, developing in a few months safe and effective vaccines against COVID-19. In the European Union, nowadays, four vaccines have been authorized for use: Pfizer-BioNTech, Moderna, ChAdOx1 (AstraZeneca/Oxford), Janssen (Johnson & Johnson), and three others are currently under rolling review.Vaccine allocation policy is crucial to optimize the advantage of treatment preferring people with the highest risk of contagion. These days the priority in the vaccination program is of particular importance since it has become clear that the number of vaccines is not sufficient for the entire Italian population in the short term. Cardiovascular diseases are frequently associated with severe COVID-19 infections, leading to the worst prognosis. The elderly population suffering from cardiovascular diseases is, therefore, to be considered a particularly vulnerable population. However, age cannot be considered the only discriminating factor because in the young-adult population suffering from severe forms of heart disease, the prognosis, if affected by COVID-19, is particularly ominous and these patients should have priority access to the vaccination program. The aim of this position paper is to establish a consensus on a priority in the vaccination of COVID-19 among subjects suffering from different cardiovascular diseases.

Aim: The aim of this study was to detect predisposing CV risks factors and ECGs changes in COVID-19 patients., Methods: The study population included 60 noncritically ill patients with COVID-19 pneumonia admitted to our hospital between 16 March and 11 May 2020. Electrographic changes, evaluated from ECGs acquired at admission and at 7 days after starting COVID-19 therapy, were analysed. We also compared 45 patients without CV involvement with 15 patients with new onset of cardiac adverse events during hospitalization., Results: ECGs under treatment showed a lower heart rate (HR) (69.45 ± 8.06 vs 80.1 ± 25.1 beats/min, P = 0,001) and a longer QRS (102.46 ± 15.08 vs 96.75 ± 17.14, P = 0.000) and QT corrected (QTc) interval (452.15 ± 37.55 vs 419.9 ± 33.41, P = 0,000) duration than ECGs before therapy. Fifteen patients (25%) showed clinical CV involvement. Within this group, female sex, lower ejection fraction (EF), low serum haemoglobin, high Troponin I levels (TnI), low lymphocytes count, high serum IL-6 levels, or use of Tocilizumab (TCZ) were more represented., Conclusions: Patients admitted for SARS-CoV2 infection and treated with anti-COVID-19 drug therapy develop ECG changes such as reduction in HR and increase in QRS duration and QTc interval. One in four patients developed CV events. Gender, EF, heamoglobin values, TnI, lymphocytes count, IL-6 and use of TCZ can be considered as predisposing factors for CV involvement., (Copyright © 2021 Italian Federation of Cardiology - I.F.C. All rights reserved.)

Since its outbreak in China at the end of 2019, the new coronavirus disease (COVID-19) was characterized by both easy spreading and high mortality. The latter proved to be way more elevated in the North of Italy -with a peak of 18.4% in region Lombardia and even 31% in the city of Bergamo and surrounding county- than in the rest of the world. In an attempt to conceptualize the reasons for such a dramatic situation, four key elements have been identified: COVID-19 itself, old age, lung disease, and heart failure. Their harmful combination has been named "The deadly quartet". The underlying risk factors, among which a lot of them are distinctive features of the population in northern Italy, have been summarized as "unmodifiable", "partially modifiable", and "modifiable", for the sake of clarity. Up-to-date scientific evidence in this field has been described in the form of a narrative and easy-to-read review., (Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.net.)

Background After the coronavirus disease 2019 outbreak, social isolation measures were introduced to contain infection. Although there is currently a slowing down of the infection, a reduction of hospitalizations, especially for myocardial infarction, was observed. The aim of our study is to evaluate the impact of the infectious disease on ST-segment-elevation myocardial infarction (STEMI) care during the coronavirus disease 2019 pandemic, through the analysis of recent cases of patients who underwent percutaneous coronary intervention. Methods and Results Consecutive patients affected by STEMI from March 1 to 31, 2020, during social restrictions of Italian government, were collected and compared with patients with STEMI treated during March 2019. During March 2020, we observed a 63% reduction of patients with STEMI who were admitted to our catheterization laboratory, when compared with the same period of 2019 (13 versus 35 patients). Changes in all time components of STEMI care were notably observed, particularly for longer median time in symptom-to-first medical contact, spoke-to-hub, and the cumulative symptom-to-wire delay. Procedural data and in-hospital outcomes were similar between the 2 groups, whereas the length of hospitalization was longer in patients of 2020. In this group, we also observed higher levels of cardiac biomarkers and a worse left ventricular ejection fraction at baseline and discharge. Conclusions The coronavirus disease 2019 outbreak induced a reduction of hospital access for STEMI with an increase in treatment delay, longer hospitalization, higher levels of cardiac biomarkers, and worse left ventricular function.

Objective : Since the observation of several deaths from amyotrophic lateral sclerosis (ALS) among Italian professional soccer players, an association between ALS and soccer has been postulated. The objective of the study is to investigate the association between professional soccer and the risk of ALS in a large cohort of former professional soccer players with prolonged follow-up. Methods : All professional soccer players practicing in the period 1959-2000 were identified through the archives of an Italian soccer cards publisher. For each player, date and place of birth, playing role, and team history were recorded. Each player was followed since 15 years of age. Incident ALS cases were all soccer players first diagnosed during the period 1959-2018. The expected incidence rate was the number of ALS cases/100,000 person-years expected in the cohort. SIR was the ratio between observed and expected incidence rate. Results : 34 ALS cases were detected. The number of expected cases was 17.8. The SIR was 1.91 (95% CI 1.32-2.67) in the entire sample and 4.66 (95% CI 2.66-7.57) in subjects aged less than 45 years. The mean age at diagnosis was 45.0 years. Compared to the mean age of onset of ALS in the general population (65.2 years), the disease in former soccer players occurred 20.2 years earlier. Conclusions : Professional soccer players are at higher risk of developing ALS than the general population. Soccer players with ALS develop the disease at a younger than expected age.

Background: The impact of seasonal changes on the incidence of acute myocardial infarction has been incompletely appraised, especially in the modern era of primary percutaneous coronary intervention (PPCI). We aimed to appraise the overall and season-specific impact of climate changes on the daily rate of PCCI., Methods: Details on PPCI and climate changes were retrospectively collected in three high-volume Italian institutions with different geographical features. The association between rate of PPCI and temperature, atmospheric pressure (ATM), humidity and rainfall was appraised with Poisson models, with overall analyses and according to season of the year., Results: Details on 6880 days with a total of 4132 PPCI were collected. Overall adjusted analysis showed that higher minimum atmospheric pressure 3 days before PPCI were associated with lower risk (regression coefficient = 0.999 [95% confidence interval 0.998-1.000], p = 0.030). Focusing on season, in Winter PPCI rates were increased by lower same day mean temperature (0.973 [0.956-0.990], p = 0.002) and lower rainfall (0.980 [0.960-1.000], p = 0.049). Conversely, in Spring greater changes in atmospheric pressure 3 days before PPCI were associated with increased risk (1.023 [1.002-1.045], p = 0.032), with similar effects in Summer for minimum temperature on the same day (1.022 [1.001-1.044], p = 0.040)., Conclusions: Climate has a significant impact on the risk of PPCI in the current era, with a complex interplay according to season. Higher risk risk is expected with lower minimum atmospheric pressure in the preceding days, lower rainfall in Winter, greater changes in atmospheric pressure in Spring, and higher temperatures in Summer. These findings have important implications for prevention strategies., (Copyright © 2019 Elsevier B.V. All rights reserved.)

Importance: Takotsubo syndrome (TTS) is an acute, reversible heart failure syndrome featured by significant rates of in-hospital complications. There is a lack of data for risk stratification during hospitalization., Objective: To derive a simple clinical score for risk prediction of in-hospital complications among patients with TTS., Design, Setting, and Participants: In this prognostic study, 1007 consecutive patients were enrolled in the German and Italian Stress Cardiomyopathy (GEIST) registry from July 1, 2007, through December 31, 2017, and identified as the derivation cohort; 946 patients were enrolled in the Spanish Registry for Takotsubo Cardiomyopathy (RETAKO) as the external score validation. An admission risk score was developed using a stepwise multivariable regression analysis from 2 registries. Data analysis was performed from March 1, 2018, through July 31, 2018., Main Outcomes and Measures: In-hospital complications were defined as death, pulmonary edema, need for invasive ventilation, and cardiogenic shock. Four variables were identified as independent predictors of in-hospital complications and were used for the score: male sex, history of neurologic disorder, right ventricular involvement, and left ventricular ejection fraction (LVEF)., Results: Of the 1007 patients enrolled in the GEIST registry, 107 (10.6%) were male, with mean (SD) age of 69.8 (11.4) years. Overall rate of in-hospital complications was 23.3% (235 of 1007) (death, 4.0%; pulmonary edema, 5.8%; invasive ventilation, 6.4%; and cardiogenic shock, 9.1%). The GEIST prognosis score was derived by providing 20 points each for male sex and history of neurologic disorders and 30 points for right ventricular involvement and then subtracting the value in percent of LVEF (decimal values between 0.15 and 0.70). Score accuracy on area under the receiver operating characteristic curve analysis was 0.71, with a negative predictive power of 87% with scores less than 20. External validation in the RETAKO population (124 [13.1%] male; mean [SD] age, 69.5 [14.9] years) revealed an area under the curve of 0.73 (P = .46 vs GEIST derivation cohort). Stratification into 3 risk groups (<20, 20-40, and >40 points) classified 316 patients (40.9%) as having low risk; 342 (44.3%) as having intermediate risk, and 114 (14.8%) as having high risk of complications. The observed in-hospital complication rates were 12.7% for low-risk patients, 23.4% for intermediate-risk patients, and 58.8% for high-risk patients (P < .001 for trend). After 2.6 years of follow-up, patients with in-hospital complications had significantly higher rates of mortality than those without complications (40% vs 10%, P = .01)., Conclusions and Relevance: The GEIST prognostic score may be useful in early risk stratification for TTS. High-risk patients with TTS may require an intensive care unit stay, and low-risk patients with TTS could be discharged within a few days. In-hospital complications in patients with TTS may be associated with increased risk of long-term mortality.

Background and Aims: Hypoglycemia represents a relevant burden in people with diabetes. Consequences of hypoglycemia/fear of hypoglycemia on quality of life (QoL) and behaviors of patients with T1DM and T2DM were assessed., Methods and Results: HYPOS-1 was an observational retrospective study. Fear of hypoglycemia (Fear of Hypoglycemia Questionnaire, FHQ), general health status (visual analog scale of EuroQol questionnaire, EQ5D-VAS) psychological well-being (WHO-5 well being index, WHO-5), diabetes related distress (Problem Areas in Diabetes 5, PAID-5), and corrective/preventive behaviors following hypoglycemia were compared between people with and without previous experience of severe and symptomatic hypoglycemia and by tertiles of FHQ scores. A multivariate analysis was performed to identify factors associated with the likelihood of being in the third tertile of FHQ score. Overall, 2229 patients were involved. Severe hypoglycemia had statistically significant and clinically relevant (measured as effect sizes) negative impact on EQ5D-VAS, WHO-5, PAID-5, and FHQ both in T1DM and T2DM. In T2DM, symptomatic episodes had similar impact of severe hypoglycemia. Moving from the first to the third FHQ tertile, lower scores of EQ-5D VAS and WHO-5, and higher levels of PAID-5 were found. Patients in the third tertile performed more frequently corrective/preventive actions that negatively impact on metabolic control. Previous hypoglycemia, insulin treatment, female gender, age, and school education were the independent factors associated with increased likelihood to be in the third tertile., Conclusion: Not only severe but also symptomatic hypoglycemia negatively affect patient QoL, especially in T2DM. Addressing fear of hypoglycemia should be a goal of diabetes education., (Copyright © 2019 The Italian Society of Diabetology, the Italian Society for the Study of Atherosclerosis, the Italian Society of Human Nutrition, and the Department of Clinical Medicine and Surgery, Federico II University. Published by Elsevier B.V. All rights reserved.)

Background Current literature only reports variable information from single-center studies on the recurrence rate, the complications, and the outcome of patients with Takotsubo syndrome ( TTS) experiencing recurrent TTS . Therefore, a detailed description of clinical characteristics, predictors, and the prognostic impact of patients with TTS and recurrences in a multicenter registry is needed. Methods and Results We analyzed 749 patients with TTS from 9 European centers being part of the international, multicenter GEIST (German Italian Stress Cardiomyopathy) Registry. Patients were divided into the recurrence group and the nonrecurrence group. The recurrence rate at a median follow-up of 830 days (interquartile range, 118-1701 days) was 4%. Most recurrences were documented in the first 5 years after the index TTS episode. Up to 2 TTS recurrences were documented in 2 of 30 patients (6%). A variable ballooning pattern (n=6, 0.8%) with, in particular, involvement of the right ventricular occurred in 3 cases (0.4%) at the recurrence event. Except for the higher presence of arterial hypertension (86.7% versus 68.3%; P=0.03) in the recurrence group, no other baseline characteristics were different between groups. Observation of TTS complications during follow-up, including stroke, thromboembolic events, in-hospital death, and cardiogenic shock, revealed no significant differences between groups ( P>0.05), except the higher presence of pulmonary edema in the recurrence group versus the nonrecurrence group (13.3% versus 4.9%; P=0.04). Conclusions The incidence of TTS recurrence is estimated to be 4% in this multicenter TTS registry. A variable TTS pattern at recurrence is common in up to 20% of recurrence cases.

Background: Rheumatic heart disease (RHD) is a chronic condition responsible of congestive heart failure, stroke and arrhythmia. Almost eradicated in high-income countries (HIC), it persists in low- and middle-income countries. The purpose of the study was to assess the feasibility and meaningfulness of ultrasound-based RHD screening among the population of unaccompanied foreign minors in Italy and determine the burden of asymptomatic RHD among this discrete population., Methods: From February 2016 to January 2018, Médecins Sans Frontières conducted a weekly mobile screening by echocardiography in reception centers and family houses for unaccompanied foreign minors in Rome, followed by fix echocardiographic retesting for those resulting positive at screening. 'Definite' and 'borderline' cases were defined according to the World Hearth Federation criteria., Results: Six hundred fifty-three individuals (13-26 years old) were screened; 95.6% were below 18 years old (624/653). Six 'definite RHD' were identified at screening, yielding a detection rate of 9.2‰ (95% CI 4.1-20.3‰), while 285 (436.4‰) were defined as 'borderline' (95% CI 398.8-474.9‰). Out of 172 "non-negative borderline" cases available for being retested (113 "non-negative borderline" lost in follow-up), additional 11 were categorized as 'definite RHD', for a total of 17 'definite RHD', yielding a final prevalence of 26.0‰ (95% CI 16.2-41.5‰) (17/653), and 122 (122/653) were confirmed as 'borderline' (final prevalence of 186.8‰, 95% CI 158.7-218.7). In multivariate logistic regression analysis the presence of systolic murmur was a strong predictor for both 'borderline' (OR 4.3 [2.8-6.5]) and 'definite RHD' (OR 5.2 [1.7-15.2]), while no specific country/geographic area of origin was statistically associated with an increased risk of latent, asymptomatic RHD., Conclusions: Screening for RHD among the unaccompanied migrant minors in Italy proved to be feasible. The burden of 'definite RHD' was similar to that identified in resource-poor settings, while the prevalence of 'borderline' cases was higher than reported in other studies. In view of these findings, the health system of high-income countries, hosting migrants and asylum seekers, are urged to adopt screening for RHD in particular among the silent and marginalized population of refugee and migrant children.

: The introduction of percutaneous treatment of severe aortic stenosis with transcatheter aortic valve implantation (TAVI) remains one of the greatest achievements of interventional cardiology. In fact, TAVI emerged as a better option than either medical therapy or balloon aortic valvuloplasty for patients who cannot undergo surgical aortic valve replacement (SAVR) or are at high surgical risk. Recently, increased operator experience and improved device systems have led to a worldwide trend toward the extension of TAVI to low-risk or intermediate-risk patients. In this expert opinion paper, we first discuss the basic pathophysiology of aortic stenosis in different settings then the key results of recent clinical investigations on TAVI in intermediate-risk aortic stenosis patients are summarized. Particular emphasis is placed on the results of the nordic aortic valve intervention, placement of aortic transcatheter valves (PARTNER) 2 and Surgical Replacement and Transcatheter Aortic Valve Implantation Randomized trials. The PARTNER 2 was the first large randomized trial that evaluated the outcome of TAVI in patients at intermediate risk. The PARTNER 2 data demonstrated that TAVI is a feasible and reasonable alternative to surgery in intermediate-risk patients (Society of Thoracic Surgeons 4-8%), especially if they are elderly or frail. There was a significant interaction between TAVI approach and mortality, with transfemoral TAVI showing superiority over SAVR. Moreover, we examine the complementary results of the recently concluded Surgical Replacement and Transcatheter Aortic Valve Implantation trial. This prospective randomized trial demonstrated that TAVI is comparable with surgery (primary end point 12.6% in the TAVI group vs. 14.0% in the SAVR group) in severe aortic stenosis patients deemed to be at intermediate risk. We review the most relevant clinical evidence deriving from nonrandomized studies and meta-analyses. Altogether, clinical outcome available data suggest that TAVI with a newer generation device might be the preferred treatment option in this patient subgroup. Finally, the differences between the latest European and American Guidelines on TAVI were reported and discussed. The conclusion of this expert opinion article is that TAVI, if feasible, is the treatment of choice in patients with prohibitive or high surgical risk and may lead to similar or lower early and midterm mortality rates compared with SAVR in intermediate-risk patients with severe aortic stenosis.

Telemedicine applied to heart failure patients is a tool for recording, remote transmission, storage and interpretation of cardiocirculatory parameters and/or diagnostic images, useful, as emphasized by the latest guidelines, to allow for intensive home monitoring in patients with advanced heart failure or during the vulnerable post-acute phase to improve the prognosis and quality of life for patients.Recently, several meta-analyses have shown that the patterns of care supported by telemedicine are not only effective, but also economically advantageous. The benefit is unquestionable with a 30-35% reduction in mortality and a 15-20% reduction in hospitalizations. Patients implanted with cardiac devices can also benefit from an integrated remote clinical management as all modern devices can transmit technical and diagnostic data. However, telemedicine can bring benefits to the patient with heart failure only if it is part of a shared and integrated, multidisciplinary and multiprofessional "Chronic Care Model". Moreover, the future development of remote telemonitoring programs in our country goes through the primary use of products certified as medical device, field validation of organizational solutions proposed, a legislative and administrative adaptation to new care methods and the widespread growth of competence in clinical care to remotely manage the complexity of chronicity.With this consensus document the Italian Cardiology reaffirms its willingness to contribute to the government of the tumultuous and fragmented technological development, proposing a new phase of qualitative assessment, standardization of processes and testing the application of telemedicine to heart failure.

Background: Chronic obstructive pulmonary disease (COPD) is often associated with cardiovascular artery disease (CAD), representing a potential and independent risk factor for cardiovascular morbidity. Therefore, the aim of this study was to identify an algorithm for predicting the risk of CAD in COPD patients., Methods: We analyzed data of patients afferent to the Cardiology ward and the Respiratory Diseases outpatient clinic of Tor Vergata University (2010-2012, 1596 records). The study population was clustered as training population (COPD patients undergoing coronary arteriography), control population (non-COPD patients undergoing coronary arteriography), test population (COPD patients whose records reported information on the coronary status). The predicting model was built via causal relationship between variables, stepwise binary logistic regression and Hosmer-Lemeshow analysis. The algorithm was validated via split-sample validation method and receiver operating characteristics (ROC) curve analysis. The diagnostic accuracy was assessed., Results: In training population the variables gender (men/women OR: 1.7, 95%CI: 1.237-2.5, P < 0.05), dyslipidemia (OR: 1.8, 95%CI: 1.2-2.5, P < 0.01) and smoking habit (OR: 1.5, 95%CI: 1.2-1.9, P < 0.001) were significantly associated with CAD in COPD patients, whereas in control population also age and diabetes were correlated. The stepwise binary logistic regressions permitted to build a well fitting predictive model for training population but not for control population. The predictive algorithm shown a diagnostic accuracy of 81.5% (95%CI: 77.78-84.71) and an AUC of 0.81 (95%CI: 0.78-0.85) for the validation set., Conclusions: The proposed algorithm is effective for predicting the risk of CAD in COPD patients via a rapid, inexpensive and non-invasive approach., (Copyright © 2015 Elsevier Ltd. All rights reserved.)

Purpose: Small single-center comparative studies suggest improved outcomes in cardiac resynchronization therapy (CRT) patients implanted with a quadripolar left ventricular (LV) lead in comparison with non-quadripolar (bipolar) leads. This study represents the first large multicenter prospective registry comparing implant and 6-month postoperative lead performance following CRT-defibrillator (CRT-D) implantation with quadripolar vs. bipolar leads., Methods: During a 39-month period, 418 consecutive patients having CRT-D implantation attempts with either a quadripolar (n = 230) or bipolar LV lead (n = 188) were enrolled in the registry. The primary outcome of the study was LV lead failure defined as any abnormality, excluding infection, resulting in surgical lead revision or CRT termination. Additionally, operative and follow-up data were analyzed for significant difference between groups., Results: Baseline characteristics of both groups were similar. In 72.9 % of quadripolar leads versus 65.0 % of bipolar leads, the LV lead successfully engaged the predefined ideal target side branch (p = 0.47). Implant duration and fluoroscopy times were significantly shorter when a quadripolar lead was used (p = 0.007 and p = 0.001, respectively). The primary end point occurred in six patients (2.7 %) in the quadripolar group and in 14 patients (8.0 %) in the bipolar group (p = 0.02). Clinically significant phrenic nerve stimulation (PNS) occurred in 4.6 vs. 14.2 % of quadripolar vs. bipolar patients, respectively (p = 0.002); all PNS were resolved noninvasively through programming in the quadripolar group vs. 84 % in bipolar group (p = 0.75). The use of a bipolar lead was associated with a higher risk of surgical LV lead revision (6.3 vs. 2.3 %; p = 0.057) and a higher incidence of dislodgment (5.7 vs. 2.7 %; p = 0.16)., Conclusions: This multicenter study demonstrates that the use of a quadripolar LV lead results in significantly lower rates of lead-related problems and reduced procedural and fluoroscopic times for biventricular system implantation. This has important implications for LV pacing lead choice.

Aims: This study compares, from a prospective, observational, non-randomized registry, the post-implant hospitalization rates and associated healthcare resource utilization of cardiac resynchronization therapy-defibrillator (CRT-D) patients with quadripolar (QUAD) vs. bipolar (BIP) left ventricular (LV) leads., Methods and Results: Between January 2009 and December 2012, 193 consecutive patients receiving de novo CRT-D implants with either a QUAD (n = 116) or a BIP (n = 77) LV lead were enrolled at implant and followed until July 2013 at a single-centre, university hospital. Post-implant hospitalizations related to heart failure (HF) or LV lead surgical revision and associated payer costs were identified using ICD-9-CM diagnosis and procedure codes. Italian national reimbursement rates were determined. Propensity scores were estimated using a logistic regression model based upon 11 pre-implant baseline characteristics and were used to derive a 1 : 1 matched cohort of QUAD (n = 77) and BIP (n = 77) patients. Hospitalization rates for the two groups were compared using negative binomial regression and associated payer costs were compared using non-parametric bootstrapping (×10 000) and one-sided hypothesis test. Hospitalization rates of the QUAD group [0.15/ patient (pt)-year] were lower than those of the BIP group (0.32/ pt-year); the incidence rate ratio was 0.46, P = 0.04. The hospitalization costs for the QUAD group (434 ± 128 €/pt-year) were lower than those for the BIP group (1136 ± 362 €/pt-year). The average difference was 718 €/pt-year, P = 0.016., Conclusions: In this comparative effectiveness assessment of well-matched groups of CRT-D patients with quadripolar and bipolar LV leads, QUAD patients experienced a lower rate of hospitalizations for HF and LV lead surgical revision, and a lower cost burden. This has important implications for LV pacing lead choice., (© The Author 2014. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Chronic therapy with statins, antihypertensive and antiplatelet drugs is one of the most important interventions for primary and secondary prevention of cardiovascular disease. Adherence to drug treatment is key to successful therapeutic intervention, especially in chronic conditions. This holds particularly true in the setting of cardiovascular diseases, because poor adherence may have serious adverse effects in terms of morbidity and mortality. Many factors may contribute to poor adherence, which can be either patient-related or dependent on the healthcare system, the physician and the environment. The identification and appropriate correction of these factors may result in both clinical and economic benefits. In this setting it is also important to assess the implications of the increasing use of generic or equivalent drugs on adherence to pharmacological therapy.

Aims: Serious concerns have been recently raised about the reliability of the silicone-polyurethane copolymer (Optim™) lead insulation system. We sought to identify insulation defects and Optim-lead failures by systematic fluoroscopic and electrical assessment in a prospectively defined cohort of implantable cardioverter-defibrillator (ICD) patients., Methods and Results: Between July 2007 and December 2011, 234 patients were implanted with 413 optim-coated leads as part of an ICD system at a single centre. Fluoroscopic screening with high-resolution cine-fluoroscopy at 30 frames per second was offered to all patients. In addition, the electrical integrity of all implanted leads was assessed. Durata, Riata ST Optim, and low-voltage Optim leads were implanted in 199, 26, and 188 cases, respectively. During a total follow-up of 10 036 lead-months, there were 7 Optim-lead failures (defined as electrical malfunction resulting in lead replacement) and 31 deaths; no cases of electrical noises were encountered. The overall incidence of lead failure was 1.2 vs. 0.3 per 100 lead-years, for high- and low-voltage leads, respectively (P = 0.1). One hundred fifty-one patients agreed to undergo fluoroscopy screening; none of the 264 analysed Optim leads were found to have any fluoroscopically visible structural defects after an average of 31 months post-implant., Conclusion: This study represents the first systematic screening of Optim-coated leads in a large unselected cohort of ICD patients. Over a 5-year period few lead failures were observed and normal fluoroscopic appearance was present in all patients.

Objectives: We investigated the performance of a new intrathoracic multivector impedance monitoring system for the prediction of heart failure events in consecutive device-implanted patients., Methods: Eighty heart failure patients implanted with biventricular defibrillators with multivector impedance monitoring capability were prospectively enrolled. Clinical heart failure status and impedance data were assessed during follow-up and if patients presented with an alert or heart failure deterioration., Results: During follow-up (8.0 ± 4.4 months), 56 events of device alert for fluid index increase were identified in 29 patients, and a total of 39 heart failure events (defined by worsening of heart failure signs and symptoms) occurred in 23 patients. The sensitivity and positive predictive value (PPV) for heart failure deterioration was 61.5 and 42.9%, respectively. False-positive alerts occurred in 23 of 80 patients (28.8%), for an episode rate of 0.60 a year. Among all clinical heart failure events, decompensation caused hospitalization in 13 cases (33.3%), seven of them were preceded by an alert condition (53.8%) resulting in a sensitivity of 53.8% and a PPV of 17.9%., Conclusion: The present study confirms the feasibility and clinical usefulness of this novel multivector impedance monitoring system. It would be worthwhile to perform larger studies to assess its actual clinical value in heart failure patients.

We conducted a large population-based retrospective cross-sectional study for determining the extent of clinically recognized chronic obstructive pulmonary disease (COPD) and asthma, and the prevalence of associated cardiovascular diseases (CVDs), using information obtained from the Health Search Database (HSD) owned by the Italian College of General Practitioners (SIMG). Our study provides further evidence that patients with the diagnosis of COPD are at increased association with the diagnosis of most CVDs. It also documents that age clusters between 35 and 54 years are those at highest association of simultaneous presence of the diagnosis of CVD and that of COPD, with a progressive significant reduction in older age clusters. Moreover, it shows that the diagnosis of asthma is modestly associated with the diagnosis of different CV morbidities., (Copyright © 2011 Elsevier Ltd. All rights reserved.)

Introduction: In primary prevention implantable cardioverter defibrillator (ICD) patients, the incidence of appropriate ICD therapy is relatively low, prompting better risk stratification. Fragmented QRS (fQRS) on a 12-lead ECG has been associated with adverse outcomes. The aim of this study was to evaluate the prognostic value of fQRS in ICD recipients., Methods: Consecutive ICD patients implanted at our institution for primary prevention of sudden cardiac death (SCD) were retrospectively evaluated. Patients were divided in two groups based on the presence or the absence of fQRS on the ECG obtained before ICD implantation. The endpoint of the study was all-cause mortality or the occurrence of any appropriate ICD-delivered therapy, whether shock or antitachycardia pacing., Results: Among 394 ICD recipients (334 men, age 66.4  ±  11.0), fQRS was observed in 103 patients (26.1%). There were 189 patients (48.0%) with wide QRS at the time of implantation. Among these patients, fQRS was found in 29 individuals (28.2%). Patients in fQRS(+) group were more likely to have coronary artery disease and a lower QRS duration than those without fQRS. During a mean follow-up of 26.3  ±  17.5 months, mortality or ICD therapy were 19.4 and 22.4%, respectively, for fQRS(+) patients, and 15.2 and 22.8% for fQRS(-) patients (P = NS). By Kaplan-Meier analysis, event-free survival was similar in the two groups., Conclusion: In ICD recipients for primary prevention of SCD, fQRS is not helpful in selecting a subgroup of patients who benefit from prophylactic ICD implantation.

Introduction: Atrial fibrillation (AF) and diabetes mellitus type 2 (DM2) often coexist; however, a small number of patients with DM2 undergoing catheter ablation (CA) of AF have been included in previous studies. The aim of this study was to evaluate safety and efficacy of ablation therapy in DM2 patients with drug refractory AF., Methods and Results: From January 2005 to September 2006, 70 patients with a diagnosis of DM2 and paroxysmal (n = 29) or persistent (n = 41) AF were randomized to receive either pulmonary vein isolation or a new antiarrhythmic drug treatment (ADT) with a 1-year follow-up. The primary endpoint was the time to first AF recurrence. By Kaplan-Meier analysis, at the end of follow-up, 42.9% of patients in the ADT group and 80% of patients who received a single ablation procedure and were without medications were free of AF (P = 0.001). In the ablation group, a significant improvement in quality-of-life (QoL) scores as compared with ADT group was observed. Six patients in the ADT group (17.1%) developed significant adverse drug effects. Hospitalization rate during follow-up was higher in the ADT group (P = 0.01). The only complication attributable to ablation was one significant access-site hematoma., Conclusion: In patients with DM2, CA of AF provides significant clinical benefits over the ADT and appears to be a reasonable approach regarding feasibility, effectiveness, and low procedural risk.

Aims: Women have an increased risk for atrial fibrillation (AF)-related complications and there is evidence towards a reduced efficacy of the rhythm control strategy than men. A catheter-based strategy is therefore widely attractive, but the impact of gender on catheter ablation (CA) of AF remains undefined., Methods and Results: We included 221 consecutive patients (150 men) who underwent CA of drug-refractory AF. Gender differences in clinical presentation and outcomes were compared. Women were older (P = 0.002), had a longer history of AF (P = 0.04), and were more likely to have hypertension (P = 0.04). Moreover, a concomitant valvular heart disease tended to be more common in women (32.4 vs. 23.3%; P = 0.28) and left atrium dimensions were significantly larger (P = 0.003). However, acute success rate and complications rate were similar between genders. After 22.5 +/- 11.8 months of follow-up, the overall freedom from arrhythmia recurrences was similar (83.1 vs. 82.7% in men), and a similar improvement in SF-36 quality of life scores was achieved in both groups., Conclusion: Women are referred for AF ablation later with a more complex clinical pre-operative presentation. Despite this higher risk profile in women, no differences were detected in clinical outcomes. Our findings indicate that CA of AF appears to be safe and effective in women as in men.

Background: Electrocardiographic ambulatory ECG monitoring plays a central role in the diagnostic evaluation of patients with cardiac arrhythmias. We sought to evaluate the appropriateness of the prescription of ECG Holter recordings performed at our centre., Methods: We interviewed 2489 consecutive patients (49% male, aged 61 +/- 32 years) undergoing ECG Holter. We recorded the indication for the examination, the clinical characteristics of the patient and the speciality of the prescribing physician. The appropriateness of the test was evaluated., Results: We evaluated 2489 consecutive Holter recordings, of which 1298 (52%) were found to have been clearly appropriate (class I), 311 (13%) as probably or possibly appropriate (class II), and 880 (35%) as inappropriate (class III). The test was requested by a cardiologist in 776 cases (31%), of which 56.2% had a class I indication, 13.4% class II, and 30.4% class III. Tests requested by a non-cardiologist were clearly appropriate (class I) in 50% of cases, whereas 12% had a class II indication, and 38% were in class III. Supraventricular tachycardia was present in 33.4% of recordings with a class I indication, 9% of those in class II, and 57.6% of those in class III. Non-sustained ventricular tachycardia was present in 6% of those with class I indications, 2.6% of those in class II, and 7.4% of those in class III., Conclusion: Our data showed that the majority of Holter recordings prescribed in our region are appropriate. Tests prescribed by cardiologists constitute only 31% of the total volume, but are more often appropriately prescribed.