Online mindfulness program (COndiVIDere) for people with multiple sclerosis in the time of COVID-19: a pilot longitudinal study.

PURPOSE: This study aims to evaluate the feasibility and effectiveness of a mindfulness-based group intervention (The COndiVIDere program) delivered online to people with MS (PwMS) in the time of COVID-19. MATERIALS AND METHODS: This is a single-arm longitudinal study with a nested qualitative study. The COndiVIDere program is composed of five weekly sessions (1-h each) plus three booster monthly sessions. Data were collected immediately before the beginning of the program, after the five weekly sessions, and at 3- and 6-month follow-ups. RESULTS: Fifty PwMS participated in the program. Participants improved in anxiety, stress, loneliness and mindfulness ("non-judgmental inner experience" component). Improvements on most outcomes occurred at post-intervention and reached the statistically significant threshold at 3-month follow-up. Mindfulness improvements keep increasing at each time point. Qualitative data confirmed the COndiVIDere program feasibility and the positive psychological impacts on participants. Mindfulness, compassion and the group setting were considered the most important active elements. CONCLUSIONS: Study findings support COndiVIDere feasibility and effectiveness with PwMS and its broad applicability in this population.

COndiVIDere is a highly structured, brief, manualized, online mindfulness-based interventionIt is effective in improving participants' anxiety, stress, loneliness and mindfulnessIt can be effectively delivered online to people with MS with varied socio-demographic and clinical characteristics.

Coagulopathy is not predictive of bleeding in patients with acute decompensation of cirrhosis and acute-on-chronic liver failure.

BACKGROUND & AIMS: Understanding factors responsible for the increased bleeding tendency in acute-on-chronic liver failure (ACLF) would improve the management of these complications. We investigated coagulation alterations in ACLF and assessed whether they were predictive of bleeding. METHODS: Cirrhosis patients with ACLF (cases) and acute decompensation (AD, controls) were prospectively recruited and underwent an extensive haemostatic assessment including standard tests, pro and anticoagulant factors, thrombomodulin-modified thrombin generation (TG) and thromboelastometry (ROTEM® ). In study part 1 (case-control), we compared coagulation in ACLF vs AD. In study part 2 (prospective), all patients were followed for bleeding, and predictors of outcome were assessed. RESULTS: Ninety-one patients were included (51 with ACLF, 40 with AD). Infections and ascites/renal dysfunction were the most common precipitating and decompensating events. Platelet count was lower while INR and activated partial thrombin time were longer in ACLF cohort vs AD. Regarding clotting factors, fibrinogen and factor VIII were comparable between groups while protein C and antithrombin were significantly reduced in ACLF. Endogenous thrombin potential by TG was comparable between groups. Clotting formation time and clot stability by ROTEM® were significantly lower in ACLF, indicative of a more hypocoagulable state. No haemostasis alteration could discriminate between patients who had bleeding complications during hospitalization and those who did not. CONCLUSION: We found coagulation changes in ACLF to largely overlap with that of AD and evidence of preserved coagulation capacity in both groups. ROTEM alterations were indicative of a more pronounced hypocoagulable state in ACLF; however, no correlation was found between such alterations and bleeding.

Peculiar laboratory phenotype/ genotype relationship due to compound inherited protein C defects in a child with severe venous thromboembolism.

A 7-years-old child who developed unprovoked deep vein thrombosis (DVT) and pulmonary embolism (PE) was tested for inherited thrombophilia. Protein C (PC) antigen level (87 %) and PC coagulometric and amidolytic activities (12 % and 11 %, respectively) were consistent with a homozygous PC type IIA phenotype.The patient was carrier of two heterozygous missense mutations causing p.Arg32Cys substitution associated with a type I PC defect ("null allele", from the paternal side) and p.Gly433Ser substitution responsible for a type IIA PC defect (from the maternal side). Thus, the apparently normal PC antigen level in the proband was misleading in the interpretation of phenotype/genotype relationship of this compound PC defect. The child was also carrier of heterozygous prothrombin G20210A variant.Severe venous thromboembolism can occur in otherwise healthy children with complex inherited thrombophilia. Careful laboratory characterization of the phenotype/genotype relationship can be crucial to correctly classify PC defects and for their management with anticoagulants or replacement therapy.

On-treatment platelet reactivity in peripheral and coronary blood in patients undergoing primary PCI for ST-segment elevation myocardial infarction (STEMI).

Dual antiplatelet therapy is recommended in patients undergoing primary percutaneous coronary intervention (p-PCI) for ST-segment elevation myocardial infarction (STEMI). Pre-analytical variables may influence platelet function analysis results. Our aim was to evaluate the on-treatment platelet reactivity in peripheral artery vs coronary blood in patients with STEMI. We enrolled one hundred and nine patients who consecutively underwent p-PCI at Cardiology Unit of Padua University Hospital between June 2014 and June 2015. Before the procedure, all patients received intravenous aspirin 250 mg and either of the thienopyridines; clopidogrel 600 mg, prasugrel 60 mg or ticagrelor 180 mg. ASPI-test and ADP-test using multiple electrode aggregometry (MEA) were performed in samples collected from both a peripheral artery and the culprit coronary artery. 'Low responders' were patients with an ASPI-test or ADP-test value greater than or equal to a pre-established normal range. No significant differences were observed in ASPI-test values between peripheral (19 (median) [3-49 (10-90 percentiles)] U) vs coronary (12 [1-40] U, p = .06) blood and in ADP-test (40 [14-82] U vs 33 [7-79] U, p =.68) blood. In peripheral blood, fifteen (14%) patients were 'low aspirin' and forty-one (38%) 'low thienopyridines' responders. The prevalence of 'low clopidogrel' responders was higher (45%) than prasugrel (36%) and ticagrelor (33%). Similar results were observed in coronary blood. In patients undergoing p-PCI for STEMI, MEA platelet function observed in coronary arteries was consistent with peripheral artery blood's independently of the antiplatelet drug used. The clinical significance of peripheral and coronary on-aspirin/thienopyridines platelet reactivity needs further clarification.

Predictors of postoperative bleeding in children undergoing cardiopulmonary bypass: A preliminary Italian study.

BACKGROUND: Several characteristics such as demographics, pre-existing conditions, surgical procedure, perioperative coagulopathy may predispose children undergoing cardiopulmonary bypass (CPB) to bleeding complications. As yet, studies on risk factors for postoperative bleeding have brought mixed results. The purpose of our study was therefore to retrospectively evaluate the parameters able to predict postoperative bleeding in a group of consecutive children undergoing cardiac surgery involving CPB. METHODS: We collected demographic and perioperative laboratory data, as well as intraoperative transfusion requirements and blood loss during the first 24h after surgery in a group of consecutive children (aged ≥1month) scheduled for cardiac surgery with CPB at Padua University Hospital between June 2014 and April 2015. Cases were patients who experienced a 24-h postoperative blood loss ≥80th percentile. Univariate and multivariate logistic regression analyses were performed to determine the independent parameters associated with a high 24-h postoperative chest tube drainage volume. RESULTS: Eighty-three children (M:F 38:45; age range 1-168months) were enrolled. Age<7.7months (p 0.015), postoperative platelets <109×109/L (p 0.003) and postoperative D-dimer ≥2350µg/L (p 0.007) were the variables most significantly and independently associated with excessive 24-h postoperative blood loss. CONCLUSIONS: Although preliminary, our study identified younger age, lower postoperative platelet count and higher D-dimer plasma levels as possible risk factors for postoperative bleeding. As for coagulation parameters, our results suggested consumptive coagulopathy might cause a strong predisposition to postoperative bleeding in children. Large-scale prospective studies would provide insight into the early diagnosis and treatment of CPB-related coagulopathies.

Perioperative coagulation assessment of patients undergoing major elective orthopedic surgery.

Traditional coagulative parameters are of limited use in identifying perioperative coagulopathy occurring in patients undergoing major elective orthopedic surgery (MEOS). The aim of our study was to evaluate the coagulation changes in patients undergoing MEOS and to facilitate an early detection of perioperative coagulopathy in patients experiencing major intraoperative bleeding. We enrolled 40 consecutive patients (M/F 10/30, age range 34-90 years) who underwent MEOS at the Orthopedic Unit of the Padua University Hospital, Italy, between January 2014 and January 2015. Blood samples were obtained at the following time points: T0-pre: 30 min before surgery; T0-post: 30 min after the end of the procedure; T1: morning of the first postoperative day; T2: 7 ± 2 days after surgery. Patients who experienced an intraoperative blood loss ≥250 mL/h were considered as cases. Routine coagulative parameters, thromboelastometry and thrombin generation (TG) profiles were evaluated. At baseline, a significantly lower platelet count and FIBTEM MCF/AUC were observed in patents with excessive bleeding (p < 0.05 and 0.02/0.01, respectively). At T0-post and T1 intervals, cases showed hypocoagulation characterized by a significantly low platelet count (p = 0.001), prolonged CFT INTEM/EXTEM, reduction of alpha-angle and MaxV INTEM/EXTEM, MCF and AUC INTEM/EXTEM/FIBTEM (p < 0.05 in all comparisons). The only TG parameter standing out between study groups was time to peak at T0-pre. A low platelet count and fibrinogen activity were associated with significant intraoperative bleeding in patients undergoing MEOS. Thromboelastometry performed by ROTEM(®) identifies patients with coagulopathy.

Whole blood thromboelastometry profiles in women with preeclampsia.

BACKGROUND: Preeclampsia (PE) is a pregnancy complication characterized by high blood pressure and significant amounts of protein in the urine. Various coagulation abnormalities have been described in pregnant women with PE. The aim of the present case-control study was to evaluate whole blood thromboelastometry profiles, performed by ROTEM(®), in women with PE in order to better characterize the PE-related discoagulopathy. METHODS: Standard ROTEM(®) (Tem International GmbH, Munich, Germany) parameters evaluating clot initiation [clotting time (CT)], propagation [clot formation time (CFT); α-angle], stability [maximum clot firmness (MCF)] and lysis [maximum lysis (ML)] in INTEM, EXTEM, NATEM, and FIBTEM assays were performed in 30 consecutive pregnant women with PE at diagnosis. Sixty (1:2 ratio with cases) healthy pregnant women, matched for gestational age (± 2 weeks) with the cases, acted as controls. Platelet count, prothrombin time (PT), activated partial thromboplastin time (aPTT), fibrinogen, antithrombin and D-Dimer were also evaluated. RESULTS: Preeclamptic women showed a significantly more rapid propagation phase in EXTEM assay than controls (CFT 62 ± 15 vs. 75 ± 15 s and α-angle 78 ± 4 vs. 75 ± 4°, p<0.01 in both cases). Moreover, MCF was significantly higher and ML significantly lower in women with PE than in healthy pregnant women (p=0.001 for all comparisons). CONCLUSIONS: ROTEM(®) profiles in women with PE were characterized by an increased tissue factor driven clot propagation capability. In addition, higher clot stability due both to the increase in clot firmness and the decrease in blood fibrinolysis was observed. Larger studies are needed to identify the clinical relevance of ROTEM(®) alterations in women with PE.

Hypercoagulability detected by whole blood thromboelastometry (ROTEM®) and impedance aggregometry (MULTIPLATE®) in obese patients.

INTRODUCTION: Obesity has been associated with hypercoagulability and to increased risk of both arterial and venous thromboembolic events. Many different and complex changes in plasma coagulation factors have been described in patients with obesity. The aim of this case-control study is to evaluate hypercoagulability in a group of overweight and obese subjects by whole blood rotation thromboelastometry (ROTEM®) and impedance aggregometry (Multiplate®). METHODS: ROTEM® and Multiplate® analyses were performed in 80 subjects with a BMI ≥ 25 Kg/m(2), of whom 20 overweight [BMI = 25-29.9 Kg/m(2)], 20 with I degree obesity [BMI = 30-34.9 Kg/m(2)], 20 with II degree obesity [BMI = 35-39.9 Kg/m(2)] and 20 with III degree [BMI > 40 Kg/m(2)] and compared with 80 age and gender-matched normal weight healthy individuals. RESULTS: Thromboelastometry. In INTEM and EXTEM tests MCF and AUC were significantly increased in III degree obese compared with controls. MCF in FIBTEM was significantly higher in I, II and III degree obesity than controls (p = 0.027, 0.002 and < 0.001, respectively). Impedance aggregometry. A significant difference in platelet aggregation was found between III degree obese subjects and healthy controls in each of the tests considered. A significant correlation between FIBTEM-MCF and aggregometry parameters with BMI, waist circumference, leptin levels and high sensitive-C reactive proteins was also found. CONCLUSIONS: A relationship between hypercoagulability detected by whole blood thromboelastometry and aggregometry and increased fat mass is shown. Hypercoagulability also correlated with inflammatory markers. Point-of-care tests can be used to assess the degree of hypercoagulability and hyperaggregability in obese patients. Wider studies are needed to confirm our observations.

Short-term exposure to high levels of air pollution as a risk factor for acute isolated pulmonary embolism.

BACKGROUND: The association between air pollution exposure and occurrence of venous thromboembolism is a matter of debate. This retrospective case-control study investigated the associations between one month's exposure to elevated levels of different pollutants (i.e. PM10, CO, NOx, O3, SO2, Benzene, Benzoapyrene, Nickel, Lead Arsenic) and the development of acute isolated pulmonary embolism (PE). METHODS: The cases included 33 patients consecutively admitted to Padua Hospital with an objectively proven diagnosis of acute unprovoked (i.e. without predisposing conditions) isolated (i.e. without deep vein thrombosis) PE. The control group consisted of 72 consecutive patients with objectively proven acute provoked (i.e. associated to predisposing conditions) isolated PE. Average mean concentrations of pollutants in the month before PE diagnosis were computed by monitors located at 2 different sites throughout the city of Padua, and were obtained from the Regional Agency for Environmental Protection. RESULTS: Individuals who had PM10, NOx, Benzene, Benzoapyrene, Cadmium, and Lead exposure equal/above the 2nd tertile, measured in controls, showed a significant increase in the risk of unprovoked PE. In case of PM10 and Benzoapyrene this risk was not affected after adjustment for possible confounders. In fact, in the multivariate logistic regression analysis, the OR values were 5.24 (95% CI: 1.52-18.12) for PM10 and 3.95 (95% CI: 1.06-14.71) for Benzoapyrene exposure in the month before PE diagnosis. CONCLUSIONS: Our results, although preliminary, identify short-term (i.e. one month) exposure to elevate levels of air pollutants as a possible risk factor for the development of acute isolated PE. Larger studies are needed to confirm our results.

Whole blood rotation thromboelastometry (ROTEM®) profiles in subjects with non-neoplastic portal vein thrombosis.

The coagulation pattern and the determinants of portal vein thrombosis (PVT), both in patients with and without cirrhosis, are still largely unknown. The aim of this study was to evaluate whole blood thromboelastometry profile, performed by ROTEM®, of both cirrhotic and non-cirrhotic subjects with PVT. Two different groups were considered: i) 14 non-cirrhotic PVT patients, ii) 35 cirrhotic patients with PVT. Controls were sex- and age-matched healthy volunteers and cirrhotic subjects without PVT, respectively. ROTEM® assays (i.e. INTEM, EXTEM, NATEM, and FIBTEM) and traditional coagulative parameters (i.e. platelet count, PT/INR, aPTT, and fibrinogen) were performed on blood samples from each subject. There were no significant differences in ROTEM® profile, as for INTEM, EXTEM, and NATEM assays, and in traditional coagulative parameters, between PVT patients, both with and without cirrhosis, and control groups. Interestingly, Maximum Clot Firmness (MCF) in FIBTEM was significantly higher in non-cirrhotic PVT patients (19 mm) than in healthy volunteers (11 mm, p<0.05). The amplitude of MCF in FIBTEM revealed to be a useful tool to discriminate non-cirrhotic subjects with PVT from those without thrombotic events. Larger prospective studies are needed to evaluate the relevance of the association between the alterations of ROTEM® profiles and PVT in cirrhotic patients.