Autologous human serum for cell culture avoids the implantation of cardioverter-defibrillators in cellular cardiomyoplasty

Background: Current clinical experience with cellular cardiomyoplasty (using serum bovine-cultivated myoblasts) has demonstrated significant malignant ventricular arrhythmias and sudden deaths in patients. In some ongoing clinical trials the implantation of cardioverterdefibrillator is mandatory. We have hypothesized that contact of human cells with fetal bovine serum results after 3-week fixation of animal proteins on the cell surface, representing an antigenic substrate for immunological and inflammatory adverse events. Methods and Results: Autologous myoblasts were transplanted into infarcted LV in 20 patients (90% males, mean age 62±8 years). Cells were cultivated in a complete human medium during 3 weeks, using the patients' own serum obtained from a blood sample or from plasmapheresis. Injections were performed during CABG (2.1 grafts/pt). All patients had an uneventful recovery. At a mean follow-up of 14±5 months without mortality, no malignant cardiac arrhythmias are reported. LV ejection fraction improved from 28±3% to 52:k4.7% (p = 0.03), and regional wall motion score index (WMSI) from 3.1 to 1.4 (p = 0.04) in the cell-treated segments. Myocardial viability tests showed areas of regeneration. Patients moved from mean NYHA class 2.5 to class 1.2. Conclusions: A total autologous cell culture procedure was used in cellular cardiomyoplasty reducing the risk of arrhythmia. Human-autologous-serum cell expansion avoids the risk of prion, viral or zoonoses contamination. Since patients treated with noncultivated bone marrow cells are free of arrhythmia, the bovine-culture medium seems to be responsible for this complication. Cellular cardiomyoplasty may be efficient to avoid progression of ventricular remodeling and subsequent heart failure in ischemic heart disease

Treatment of heart failure with autologous skeletal myoblasts

The management of patients with heart failure is a daily challenge for cardiologists and cardiac surgeons. Pharmacotherapy, atrio-biventricular resynchronization, myocardial revascularization, valve repair techniques, latissimus dorsi cardiomyoplasty, acorn cardiac support device, heart transplantation and mechanical assist devices do not cover all the needs. The recent progress in cellular and molecular biology allows the development of new therapies for heart failure. Transplantation of Autologous Cells: One of the most innovative consists in the transplantation of autologous ex-vivo expanded cells into the myocardium for heart muscle regeneration. This approach is called “cellular cardiomyoplasty”

Cellular Cardiomyoplasty: Clinical Application

Myocardial regeneration can be induced with the implantation of a variety of myogenic and angiogenic cell types. More than 150 patients have been treated with cellular cardiomyoplasty worldwide, 18 patients have been treated by our group. Cellular cardiomyoplasty seems to reduce the size and fibrosis of infarct scars, limit postischemic remodelling, and restore regional myocardial contractility. Techniques for skeletal myoblasts culture and ex vivo expansion using autologous patient serum (obtained from plasmapheresis) have been developed by our group. In this article we propose (1) a total autologous cell culture technique and procedures for cell delivery and (2) a clinical trial with appropriate endpoints structured to determine the efficacy of cellular cardiomyoplasty

Italian consensus conference on guidelines for conservative treatment on lower limb muscle injuries in athlete.

Provide the state of the art concerning (1) biology and aetiology, (2) classification, (3) clinical assessment and (4) conservative treatment of lower limb muscle injuries (MI) in athletes. Seventy international experts with different medical backgrounds participated in the consensus conference. They discussed and approved a consensus composed of four sections which are presented in these documents. This paper represents a synthesis of the consensus conference, the following four sections are discussed: (i) The biology and aetiology of MIs. A definition of MI was formulated and some key points concerning physiology and pathogenesis of MIs were discussed. (ii) The MI classification. A classification of MIs was proposed. (iii) The MI clinical assessment, in which were discussed anamnesis, inspection and clinical examination and are provided the relative guidelines. (iv) The MI conservative treatment, in which are provided the guidelines for conservative treatment based on the severity of the lesion. Furthermore, instrumental therapy and pharmacological treatment were discussed. Knowledge of the aetiology and biology of MIs is an essential prerequisite in order to plan and conduct a rehabilitation plan. Another important aspect is the use of a rational MI classification on prognostic values. We propose a classification based on radiological investigations performed by ultrasonography and MRI strongly linked to prognostic factors. Furthermore, the consensus conference results will able to provide fundamental guidelines for diagnostic and rehabilitation practice, also considering instrumental therapy and pharmacological treatment of MI. Expert opinion, level IV

Italian consensus conference on guidelines for conservative treatment on lower limb muscle injuries in athlete

Provide the state of the art concerning (1) biology and aetiology, (2) classification, (3) clinical assessment and (4) conservative treatment of lower limb muscle injuries (MI) in athletes. Seventy international experts with different medical backgrounds participated in the consensus conference. They discussed and approved a consensus composed of four sections which are presented in these documents. This paper represents a synthesis of the consensus conference, the following four sections are discussed: (i) The biology and aetiology of MIs. A definition of MI was formulated and some key points concerning physiology and pathogenesis of MIs were discussed. (ii) The MI classification. A classification of MIs was proposed. (iii) The MI clinical assessment, in which were discussed anamnesis, inspection and clinical examination and are provided the relative guidelines. (iv) The MI conservative treatment, in which are provided the guidelines for conservative treatment based on the severity of the lesion. Furthermore, instrumental therapy and pharmacological treatment were discussed. Knowledge of the aetiology and biology of MIs is an essential prerequisite in order to plan and conduct a rehabilitation plan. Another important aspect is the use of a rational MI classification on prognostic values. We propose a classification based on radiological investigations performed by ultrasonography and MRI strongly linked to prognostic factors. Furthermore, the consensus conference results will able to provide fundamental guidelines for diagnostic and rehabilitation practice, also considering instrumental therapy and pharmacological treatment of MI. Expert opinion, level IV

Mental health states experienced by perinatal healthcare workers during covid-19 pandemic in italy

Background: The ongoing COVID-19 pandemic has had an impact on mental health status in a variety of populations. Methods: An online non-probability sample survey was used to assess psychological distress symptoms and burnout among perinatal healthcare professionals (PHPs) during the pandemic in Italy. The questionnaire included the Depression, Anxiety, and Stress Scale-21 (DASS-21) and the Maslach Burnout Inventory (MBI). Demographic and occupational factors associated with stress, anxiety, and depression symptoms were analyzed. Results: The sample size was 195. The estimated self-reported rates of moderate to severe anxiety symptoms, depression symptoms, and perceived stress levels were 18.7, 18.7, and 21.5%, respectively. Furthermore, 6.2% of respondents reported burnout. One factor associated with all three self-reported psychological distress issues was suffering from trauma unrelated to the pandemic (aOR: 7.34, 95% CI: 2.73–20.28 for depression; aOR: 6.13, 95% CI: 2.28–16.73 for anxiety; aOR: 3.20, 95% CI: 1.14–8.88 for stress). Compared to physicians, psychologists had lower odds of developing clinically significant depressive symptoms (aOR: 0.21, 95% CI: 0.04–0.94) and high stress levels (aOR: 0.19, 95% CI: 0.04–0.80). Conclusions: High rates of self-reported symptoms of depression and anxiety, as well as perceived stress, among PHPs were reported during the COVID-19 pandemic. Health authorities should implement and integrate timely and regular evidence-based assessment of psychological distress targeting PHPs in their work plans

Prevalence of comorbid anxiety and depressive symptomatology in the third trimester of pregnancy: Analysing its association with sociodemographic, obstetric, and mental health features

Background: Little is known about the prevalence of comorbid anxiety and depression (CAD) during pregnancy and its risk factors. The aims of this study are to determine the prevalence of CAD in the third trimester of pregnancy and analyse its association with socio-demographic, obstetric, and mental health features. Methods: In a sample of 934 Italian pregnant women, CAD was defined as having (1) a score of ≥ 10 on the EPDS - depression subscale and/or on the PHQ-9, and (2) a score of ≥ 40 on the State-Trait Anxiety Inventory State and/or a score of ≥ 6 on the EPDS - anxiety subscale. Logistic regression analyses were used to identify socio-demographic, obstetrics, and mental health risk factors of CAD. Results: The prevalence of CAD was 6.8%. Age between 30 and 35 years (OR=3.01, 95% CI: 1.22–7.45) compared to younger age, current sleep disorders (OR=7.88, 95% CI: 3.83–16.23), and preconception mood disorders (OR=2.76, 95% CI: 1.31–5.84) were associated with higher odds of CAD. Conversely, the presence of no or few economic problems (OR=0.21, 95% CI: 0.07–0.65; OR=0.26, 95% CI: 0.09–0.77) and the perception of enough or more than enough practical support from friends or relatives (OR=0.32, 95% CI: 0.13–0.80; OR=0.22, 95% CI: 0.09–0.53) were associated with lower odds of developing CAD. Limitations: The cross-sectional design; the use of self-report questionnaires. Conclusion: CAD is relatively common among third-trimester antepartum women. The provision of economic/practical support may reduce CAD prevalence and its direct and indirect costs

The limited screening accuracy of the Patient Health Questionnaire-2 in detecting depression among perinatal women in Italy

Background The PHQ-2 was recently recommended by the International Consortium for Health Outcomes Measurement as a form of initial perinatal screening, followed by the EPDS only for women with positive PHQ-2 score. However, the accuracy of the PHQ-2 in perinatal clinical practice has been barely researched, to date. In the present study, we aim to assess the accuracy of the PHQ-2 against the EPDS in a large sample of perinatal women. Methods A total of 1155 consecutive women attending eleven primary or secondary health care centres throughout Italy completed the EPDS and the PHQ-2 during pregnancy (27-40-weeks) or postpartum (1-13-weeks). Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), positive likelihood ratio, negative likelihood ratio, post-test probabilities and area under the curve (AUC) of the PHQ-2, using a cut-off of ≥ 3, were calculated. Main findings During pregnancy, PHQ-2 revealed low sensitivity (39.5%) and PPV (39.4%) but high specificity and NPV (97.5%). In postpartum, it revealed very low sensitivity (32.7%) and moderately high NPV (80.9%), but high specificity (99.3%) and PPV (94.4%). Given the low sensitivity despite the high specificity, the PHQ-2 demonstrated poor accuracy (AUC from 0.66 to 0.68). Conclusion Initial screening by means of PHQ-2 failed to identify an acceptable number of perinatal women at-risk of depression in Italian clinical practice. The PHQ-2 performance suggested that it has insufficient sensitivity and discriminatory power, and may be inadequate as a screening tool for maternal depression