Publications by authors named "Dario Gregori"

346 Publications

P14/ARF-Positive Malignant Pleural Mesothelioma: A Phenotype With Distinct Immune Microenvironment.

Front Oncol 2021 22;11:653497. Epub 2021 Mar 22.

Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padova, Padova, Italy.

Introduction: The CDKN2A gene plays a central role in the pathogenesis of malignant pleural mesothelioma (MPM). The gene encodes for two tumor suppressor proteins, p16/INK4A and p14/ARF, frequently lost in MPM tumors. The exact role of p14/ARF in MPM and overall its correlation with the immune microenvironment is unknown. We aimed to determine whether there is a relationship between p14/ARF expression, tumor morphological features, and the inflammatory tumor microenvironment.

Methods: Diagnostic biopsies from 76 chemo-naive MPMs were evaluated. Pathological assessments of histotype, necrosis, inflammation, grading, and mitosis were performed. We evaluated p14/ARF, PD-L1 (tumor proportion score, TPS), and Ki-67 (percentage) by immunohistochemistry. Inflammatory cell components (CD3+, CD4+, CD8+ T lymphocytes; CD20+ B-lymphocytes; CD68+ and CD163+ macrophages) were quantified as percentages of positive cells, distinguishing between intratumoral and peritumoral areas. The expression of p14/ARF was associated with several clinical and pathological characteristics. A random forest-based machine-learning algorithm (Boruta) was implemented to identify which variables were associated with p14/ARF expression.

Results: p14/ARF was evaluated in 68 patients who had a sufficient number of tumor cells. Strong positivity was detected in 14 patients (21%) (11 epithelioid and 3 biphasic MPMs). At univariate analysis, p14/ARF-positive epithelioid mesotheliomas showed higher nuclear grade (G3) (p = 0.023) and higher PD-L1 expression (≥50%) (p = 0.042). The percentages of CD4 and CD163 in peritumoral areas were respectively higher and lower in p14/ARF positive tumors but did not reach statistical significance with our sample size (both p = 0.066). The Boruta algorithm confirmed the predictive value of PD-L1 percentage for p14/ARF expression in all histotypes.

Conclusions: p14/ARF-positive epithelioid mesotheliomas may mark a more aggressive pathological phenotype (higher nuclear grade and PD-L1 expression). Considering the results regarding the tumor immune microenvironment, p14/ARF-negative tumors seem to have an immune microenvironment less sensitive to immune checkpoint inhibitors, being associated with low PD-L1 and CD4 expression, and high CD163 percentage. The association between p14/ARF-positive MPMs and PD-L1 expression suggests a possible interaction of the two pathways. Confirmation of our preliminary results could be important for patient selection and recruitment in future clinical trials with anticancer immunotherapy.
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http://dx.doi.org/10.3389/fonc.2021.653497DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8019896PMC
March 2021

Bioengineered percutaneous heart valves for transcatheter aortic valve replacement: a comparative evaluation of decellularised bovine and porcine pericardia.

Mater Sci Eng C Mater Biol Appl 2021 Apr 5;123:111936. Epub 2021 Feb 5.

Cardiovascular Regenerative Medicine, Department of Cardiac Thoracic Vascular Sciences and Public Health, University of Padova, Padova, Italy; L.I.F.E.LA.B., CORIS, Veneto Region, Padua, Italy. Electronic address:

Glutaraldehyde-treated, surgical bioprosthetic heart valves undergo structural degeneration within 10-15 years of implantation. Analogous preliminary results were disclosed for percutaneous heart valves (PHVs) realized with similarly-treated tissues. To improve long-term performance, decellularised scaffolds can be proposed as alternative fabricating biomaterials. The aim of this study was to evaluate whether bovine and porcine decellularised pericardia could be utilised to manufacture bioengineered percutaneous heart valves (bioPHVs) with adequate hydrodynamic performance and leaflet resistance to crimping damage. BioPHVs were fabricated by mounting acellular pericardia onto commercial stents. Independently from the pericardial species used for valve fabrication, bioPHVs satisfied the minimum hydrodynamic performance criteria set by ISO 5840-3 standards and were able to withstand a large spectrum of cardiac output conditions, also during extreme backpressure, without severe regurgitation, especially in the case of the porcine group. No macroscopic or microscopic leaflet damage was detected following bioPHV crimping. Bovine and porcine decellularized pericardia are both suitable alternatives to glutaraldehyde-treated tissues. Between the two types of pericardial species tested, the porcine tissue scaffold might be preferable to fabricate advanced PHV replacements for long-term performance. CONDENSED ABSTRACT: Current percutaneous heart valve replacements are formulated with glutaraldehyde-treated animal tissues, prone to structural degeneration. In order to improve long-term performance, bovine and porcine decellularised pericardia were utilised to manufacture bioengineered replacements, which demonstrated adequate hydrodynamic behaviour and resistance to crimping without leaflet architectural alteration.
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http://dx.doi.org/10.1016/j.msec.2021.111936DOI Listing
April 2021

Exposure to Perfluoroalkyl Substances and Mortality for COVID-19: A Spatial Ecological Analysis in the Veneto Region (Italy).

Int J Environ Res Public Health 2021 03 8;18(5). Epub 2021 Mar 8.

Unit of Biostatistics, Epidemiology and Public Health, Department of Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padova, 35131 Padova, Italy.

Background: In the context of the COVID-19 pandemic, there is interest in assessing if per- and polyfluoroalkyl substances (PFAS) exposures are associated with any increased risk of COVID-19 or its severity, given the evidence of immunosuppression by some PFAS. The objective of this paper is to evaluate at the ecological level if a large area (Red Zone) of the Veneto Region, where residents were exposed for decades to drinking water contaminated by PFAS, showed higher mortality for COVID-19 than the rest of the region.

Methods: We fitted a Bayesian ecological regression model with spatially and not spatially structured random components on COVID-19 mortality at the municipality level (period between 21 February and 15 April 2020). The model included education score, background all-cause mortality (for the years 2015-2019), and an indicator for the Red Zone. The two random components are intended to adjust for potential hidden confounders.

Results: The COVID-19 crude mortality rate ratio for the Red Zone was 1.55 (90% Confidence Interval 1.25; 1.92). From the Bayesian ecological regression model adjusted for education level and baseline all-cause mortality, the rate ratio for the Red Zone was 1.60 (90% Credibility Interval 0.94; 2.51).

Conclusion: In conclusion, we observed a higher mortality risk for COVID-19 in a population heavily exposed to PFAS, which was possibly explained by PFAS immunosuppression, bioaccumulation in lung tissue, or pre-existing disease being related to PFAS.
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http://dx.doi.org/10.3390/ijerph18052734DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7967461PMC
March 2021

Prognostic role of MUC5B rs35705950 genotype in patients with idiopathic pulmonary fibrosis (IPF) on antifibrotic treatment.

Respir Res 2021 Apr 1;22(1):98. Epub 2021 Apr 1.

Respiratory Disease Unit, Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padova, Via Giustiniani 2, 35128, Padova, Italy.

Background: A common variant located in the promoter region of MUC5B (rs35705950) is the strongest risk factor for sporadic and familiar IPF, as well as a predictor of outcome. However, there are no data on the effect of MUC5B rs35705950 genotype on the prognosis of IPF patients on antifibrotic treatment. The aim of this study is to determine, in a phenotypically well-characterized population of patients with IPF treated with antifibrotics, the impact of MUC5B rs35705950 genotype on disease progression and survival.

Methods: 88 IPF patients on antifibrotic treatment were followed-up from 2014 until transplantation, death or end of follow-up (December 2019). Disease progression was defined as a forced vital capacity (FVC) loss ≥ 5% per year. All patients were genotyped for MUC5B rs35705950 by PCR amplification and Sanger sequencing.

Results: Out of 88 patients, 61 (69%) carried the mutant T allele (TT or TG) and 27 (31%) did not (GG). Carriage of the MUC5B rs35705950 T allele was not associated with a faster decline in FVC. Conversely, at the end of the follow-up, overall survival in carriers of the TT/TG genotype was longer compared to that of the GG genotype carriers. FVC (L) at baseline and time to respiratory failure at rest were independent predictors of worse prognosis.

Conclusions: In IPF patients on antifibrotic treatment, carriage of the MUC5B rs35705950 T allele is associated with longer survival, highlighting the usefulness of MUC5B genetic data in clinical decision making.
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http://dx.doi.org/10.1186/s12931-021-01694-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8017848PMC
April 2021

Cell Population Data (CPD) for Early Recognition of Sepsis and Septic Shock in Children: A Pilot Study.

Front Pediatr 2021 8;9:642377. Epub 2021 Mar 8.

Section of Clinical Biochemistry, University of Verona, Verona, Italy.

Innovative Cell Population Data (CPD) have been used as early biomarkers for diagnosing sepsis in adults. We assessed the usefulness of CPD in pediatric patients with sepsis/septic shock, in terms of early recognition and outcome prediction. We revised 54 patients (0-15 y) admitted to our Pediatric Intensive Care Unit (PICU) for sepsis/septic shock during a 4-year period. Twenty-eight patients were excluded, 26 septic patients were enrolled (G1). Forty children admitted for elective surgery served as controls (G2). Data on five selected CPD parameters, namely neutrophils fluorescence intensity (NE-SFL), monocytes cells complexity (MO-X), monocytes fluorescence intensity (MO-Y), monocytes complexity and width of dispersion of events measured (MO-WX), and monocytes cells size and width dispersion (MO-WZ), were obtained at time of PICU admission () by a hematological analyzer (Sysmex XN 9000®). As the primary outcome we evaluated the relevance of CPD for diagnosing sepsis/septic shock on PICU admission. Furthermore, we investigated if CPD at were correlated with C-reactive protein (CRP), patient survival, or complicated sepsis course. On PICU admission (), NE-SFL, MO-WX, and MO-Y were higher in sepsis/septic shock patients compared to controls. NE-SFL values were correlated with CRP values in G1 patients ( = 0.83). None of the five CPD parameters was correlated with survival or complicated sepsis course. We found higher values of NE-SFL, MO-WX, and MO-Y in children with sepsis/septic shock upon PICU admission. These parameters may be a promising adjunct for early sepsis diagnosis in pediatric populations. Larger, prospective studies are needed to confirm our preliminary observations.
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http://dx.doi.org/10.3389/fped.2021.642377DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7989813PMC
March 2021

Regional Differences in Mortality Rates During the COVID-19 Epidemic in Italy.

Disaster Med Public Health Prep 2020 Dec 22:1-7. Epub 2020 Dec 22.

Unit of Biostatistics, Epidemiology and Public Health, Department of Cardiac, Thoracic, Vascular Sciences, and Public Health, University of Padova, Italy.

Objective: The coronavirus disease 2019 (COVID-19) outbreak started in Italy on February 20, 2020, and has resulted in many deaths and intensive care unit (ICU) admissions. This study aimed to illustrate the epidemic COVID-19 growth pattern in Italy by considering the regional differences in disease diffusion during the first 3 mo of the epidemic.

Methods: Official COVID-19 data were obtained from the Italian Civil Protection Department of the Council of Ministers Presidency. The mortality and ICU admission rates per 100,000 inhabitants were calculated at the regional level and summarized by means of a Bayesian multilevel meta-analysis. Data were retrieved until April 21, 2020.

Results: The highest cumulative mortality rates per 100 000 inhabitants were observed in northern Italy, particularly in Lombardia (85.3; 95% credibility intervals [CI], 75.7-94.7). The difference in the mortality rates between northern and southern Italy increased over time, reaching a difference of 67.72 (95% CI, 66-67) cases on April 2, 2020.

Conclusions: Northern Italy showed higher and increasing mortality rates during the first 3 mo of the epidemic. The uncontrolled virus circulation preceding the infection spreading in southern Italy had a considerable impact on system burnout. This experience demonstrates that preparedness against the pandemic is of crucial importance to contain its disruptive effects.
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http://dx.doi.org/10.1017/dmp.2020.486DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7985634PMC
December 2020

Video-assisted thoracoscopic lobectomy after neoadjuvant chemotherapy for non-small cell lung cancer: a multicenter propensity-matched study.

Surg Endosc 2021 Mar 19. Epub 2021 Mar 19.

Thoracic Surgery Unit, Department of Cardiac, Thoracic and Vascular Sciences, University of Padova, Via Giustiniani 2, 35128, Padova, Italy.

Background: The role of video-assisted thoracoscopic surgery for the treatment of non-small-cell lung cancer after neoadjuvant chemotherapy remains controversial. The aim of this study is to demonstrate the reliability of video-assisted lobectomy compared to the open approach by evaluating perioperative and long-term outcomes.

Methods: In this retrospective, multicentric study from January 2010 to December 2018, we included all patients with non-small-cell lung cancer who underwent lobectomy through the video-assisted or open approach after neoadjuvant chemotherapy. The perioperative outcomes, including data concerning the feasibility of the surgical procedure, the occurrence of any medical and surgical complications and long-term oncological evidence, were collected and compared between the two groups. To minimize selection bias, propensity score matching was performed.

Results: A total of 286 patients were enrolled: 193 underwent thoracotomy lobectomy, and 93 underwent VATS lobectomy. The statistical analysis showed that surgical time (P < 0.001), drainage time (P < 0.001), days of hospitalization (P < 0.001) and VAS at discharge (P = 0.042) were lower in the VATS group. The overall survival and disease-free survival were equivalent for the two techniques on long-term follow-up.

Conclusions: VATS lobectomy represents a valid therapeutic option in patients affected by non-small-cell lung cancer after neoadjuvant chemotherapy. The VATS approach in our experience seems to be superior in terms of the perioperative outcomes, while maintaining oncological efficacy.
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http://dx.doi.org/10.1007/s00464-021-08431-zDOI Listing
March 2021

Handling Poor Accrual in Pediatric Trials: A Simulation Study Using a Bayesian Approach.

Int J Environ Res Public Health 2021 Feb 21;18(4). Epub 2021 Feb 21.

Unit of Biostatistics, Epidemiology and Public Health, Department of Cardiac Thoracic Vascular Sciences and Public Health, University of Padova, 35128 Padova, Italy.

In the conduction of trials, a common situation is related to potential difficulties in recruiting the planned sample size as provided by the study design. A Bayesian analysis of such trials might provide a framework to combine prior evidence with current evidence, and it is an accepted approach by regulatory agencies. However, especially for small trials, the Bayesian inference may be severely conditioned by the prior choices. The Renal Scarring Urinary Infection (RESCUE) trial, a pediatric trial that was a candidate for early termination due to underrecruitment, served as a motivating example to investigate the effects of the prior choices on small trial inference. The trial outcomes were simulated by assuming 50 scenarios combining different sample sizes and true absolute risk reduction (ARR). The simulated data were analyzed via the Bayesian approach using 0%, 50%, and 100% discounting factors on the beta power prior. An informative inference (0% discounting) on small samples could generate data-insensitive results. Instead, the 50% discounting factor ensured that the probability of confirming the trial outcome was higher than 80%, but only for an ARR higher than 0.17. A suitable option to maintain data relevant to the trial inference is to define a discounting factor based on the prior parameters. Nevertheless, a sensitivity analysis of the prior choices is highly recommended.
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http://dx.doi.org/10.3390/ijerph18042095DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7924849PMC
February 2021

Prior Elicitation for Use in Clinical Trial Design and Analysis: A Literature Review.

Int J Environ Res Public Health 2021 Feb 13;18(4). Epub 2021 Feb 13.

Unit of Biostatistics, Epidemiology and Public Health, Department of Cardiac Thoracic Vascular Sciences and Public Health, University of Padova, 35128 Padova, Italy.

Bayesian inference is increasingly popular in clinical trial design and analysis. The subjective knowledge derived from an expert elicitation procedure may be useful to define a prior probability distribution when no or limited data is available. This work aims to investigate the state-of-the-art Bayesian prior elicitation methods with a focus on clinical trial research. A literature search on the Current Index to Statistics (CIS), PubMed, and Web of Science (WOS) databases, considering "prior elicitation" as a search string, was run on 1 November 2020. Summary statistics and trend of publications over time were reported. Finally, a Latent Dirichlet Allocation (LDA) model was developed to recognise latent topics in the pertinent papers retrieved. A total of 460 documents pertinent to the Bayesian prior elicitation were identified. Of these, 213 (45.4%) were published in the "Probability and Statistics" area. A total of 42 articles pertain to clinical trial and the majority of them (81%) reports parametric techniques as elicitation method. The last decade has seen an increased interest in prior elicitation and the gap between theory and application getting narrower and narrower. Given the promising flexibility of non-parametric approaches to the experts' elicitation, more efforts are needed to ensure their diffusion also in applied settings.
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http://dx.doi.org/10.3390/ijerph18041833DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7917693PMC
February 2021

Anomalous left coronary artery from pulmonary artery repair: Outcomes from the European Congenital Heart Surgeons Association Database.

J Card Surg 2021 Mar 2. Epub 2021 Mar 2.

Pediatric and Congenital Cardiac Surgery Unit, Department of Cardiac, Thoracic and Vascular Sciences, University of Padua, Padua, Italy.

Introduction: We sought to determine the surgical outcomes of patients with anomalous origin of the left coronary artery from the pulmonary artery (ALCAPA) enrolled in the European Congenital Heart Surgeons Association (ECHSA) database.

Materials And Methods: From 1999 to 2019, 907 patients with ALCAPA underwent surgical repair and were included in the current study. The primary outcome was in-hospital mortality. Secondary outcomes included frequency and results of concomitant mitral valve surgery and postoperative mechanical circulatory support (MCS).

Results: The overall in-hospital mortality was 6% (54/907) and was significantly higher in neonates (p = .01), patients with lower body surface area (BSA) (p = .01), and those requiring postoperative MCS (p = .001). Associated mitral valve surgery was performed in 144 patients (15.9%) and was associated with longer cardiopulmonary bypass (CPB) and aortic cross-clamp times (AOX) (p ≤ .0001) but was not significantly related to an increase in in-hospital mortality. Postoperative MCS was required in 66 patients (7.3%). These patients were younger (p ≤ .001), had a lower BSA (p ≤ .001), and required a longer CPB (p ≤ .001) and AOX time (p ≤ .001).

Conclusions: ALCAPA repair can be achieved successfully, and with low surgical risk. Concomitant mitral valve procedures can be performed without increasing operative mortality. The use of MCS remains a valuable option, especially in younger patients.
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http://dx.doi.org/10.1111/jocs.15448DOI Listing
March 2021

Machine learning-based analysis of alveolar and vascular injury in SARS-CoV-2 acute respiratory failure.

J Pathol 2021 Feb 24. Epub 2021 Feb 24.

Department of Cardiac, Thoracic, Vascular Sciences, and Public Health, University of Padua Medical School, Padua, Italy.

Severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) pneumopathy is characterized by a complex clinical picture and heterogeneous pathological lesions, both involving alveolar and vascular components. The severity and distribution of morphological lesions associated with SARS-CoV-2 and how they relate to clinical, laboratory, and radiological data have not yet been studied systematically. The main goals of the present study were to objectively identify pathological phenotypes and factors that, in addition to SARS-CoV-2, may influence their occurrence. Lungs from 26 patients who died from SARS-CoV-2 acute respiratory failure were comprehensively analysed. Robust machine learning techniques were implemented to obtain a global pathological score to distinguish phenotypes with prevalent vascular or alveolar injury. The score was then analysed to assess its possible correlation with clinical, laboratory, radiological, and tissue viral data. Furthermore, an exploratory random forest algorithm was developed to identify the most discriminative clinical characteristics at hospital admission that might predict pathological phenotypes of SARS-CoV-2. Vascular injury phenotype was observed in most cases being consistently present as pure form or in combination with alveolar injury. Phenotypes with more severe alveolar injury showed significantly more frequent tracheal intubation; longer invasive mechanical ventilation, illness duration, intensive care unit or hospital ward stay; and lower tissue viral quantity (p < 0.001). Furthermore, in this phenotype, superimposed infections, tumours, and aspiration pneumonia were also more frequent (p < 0.001). Random forest algorithm identified some clinical features at admission (body mass index, white blood cells, D-dimer, lymphocyte and platelet counts, fever, respiratory rate, and PaCO ) to stratify patients into different clinical clusters and potential pathological phenotypes (a web-app for score assessment has also been developed; https://r-ubesp.dctv.unipd.it/shiny/AVI-Score/). In SARS-CoV-2 positive patients, alveolar injury is often associated with other factors in addition to viral infection. Identifying phenotypical patterns at admission may enable a better stratification of patients, ultimately favouring the most appropriate management. © 2021 The Pathological Society of Great Britain and Ireland. Published by John Wiley & Sons, Ltd.
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http://dx.doi.org/10.1002/path.5653DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8014445PMC
February 2021

Combining echocardiographic and anatomic variables to predict outcomes of mitral valve repair with the NeoChord procedure.

Ann Cardiothorac Surg 2021 Jan;10(1):122-130

Cardiac Surgery Unit, Department of Cardiac-Thoracic-Vascular Sciences and Public Health, University of Padua, Padua, Italy.

Background: Trans-apical, echo-guided NeoChord mitral valve (MV) repair is an innovative procedure to treat degenerative mitral regurgitation (MR) without concomitant annuloplasty. Recently, leaflet-to-annulus index (LAI) has been identified as a positive prognostic predictor of outcomes at 1-year follow up. The aim of this study is to develop a pre-operative predictor tool to assess probability of success with NeoChord procedure utilizing multi-factor echocardiographic and anatomic variables.

Methods: We included ninety-one consecutive patients with prolapse/flail of the posterior mitral leaflet, who subsequently underwent NeoChord MV repair between November 2013 and October 2016. All patients completed post-operative echocardiographic follow-up assessments for up to 2 years. A random forest regression algorithm identified and ranked the most relevant predictors of moderate-severe MR. A multi-variable Cox regression model was performed at follow-up intervals, to assess variables associated with residual MR that was classified as mild or less. Bootstrapping re-samples were used to validate an estimated survival model. Predictive accuracy was assessed using a discrimination index that corrected for over-optimism.

Results: We developed a nomogram which used the results of a multi-variable model to predict the probability of mild or less residual MR at follow-up periods (discharge, 1, 3, 6 months, 1 and 2 years). Identified predictors included LAI, systolic pulmonary artery pressure, indexed left ventricle end-systolic volume (iLVESV), prolapse/flail width (FW), systolic antero-posterior (AP) annulus diameter, systolic latero-lateral (LL) annulus diameter and presence of calcification.

Conclusions: A NeoChord MV repair prediction tool would be helpful in clinical decision-making and in the identification of patients who may benefit from a ringless mitral valve repair using the NeoChord procedure.
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http://dx.doi.org/10.21037/acs-2020-mv-96DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7867418PMC
January 2021

Resting Energy Expenditure in the Elderly: Systematic Review and Comparison of Equations in an Experimental Population.

Nutrients 2021 Jan 29;13(2). Epub 2021 Jan 29.

Unit of Biostatistics, Epidemiology and Public Health, Department of Cardiac, Thoracic, Vascular Sciences, and Public Health, University of Padova, Via Loredan 18, 35121 Padova, Italy.

Elderly patients are at risk of malnutrition and need an appropriate assessment of energy requirements. Predictive equations are widely used to estimate resting energy expenditure (REE). In the study, we conducted a systematic review of REE predictive equations in the elderly population and compared them in an experimental population. Studies involving subjects older than 65 years of age that evaluated the performance of a predictive equation vs. a gold standard were included. The retrieved equations were then tested on a sample of 88 elderly subjects enrolled in an Italian nursing home to evaluate the agreement among the estimated REEs. The agreement was assessed using the intraclass correlation coefficient (ICC). A web application, equationer, was developed to calculate all the estimated REEs according to the available variables. The review identified 68 studies (210 different equations). The agreement among the equations in our sample was higher for equations with fewer parameters, especially those that included body weight, ICC = 0.75 (95% CI = 0.69-0.81). There is great heterogeneity among REE estimates. Such differences should be considered and evaluated when estimates are applied to particularly fragile populations since the results have the potential to impact the patient's overall clinical outcome.
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http://dx.doi.org/10.3390/nu13020458DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7912404PMC
January 2021

Assessing school-based intervention strategies to foster the prevention of choking injuries in children: The results of the CHOP (CHOking Prevention) trial.

Health Soc Care Community 2021 Feb 5. Epub 2021 Feb 5.

Unit of Biostatistics, Epidemiology and Public Health, Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padova, Padova, Italy.

There are few public health programs aimed at reducing choking injuries, even though choking is one of the leading causes of death among unintentional injuries in young children. We present the results from the CHOP (CHOking Prevention) project community intervention trial, which aimed to compare three different school-based intervention strategies for food choking prevention. The trial enrolled 41 educational facilities, which were randomized to one of three different intervention strategies to inform about prevention of food choking, or to serve as the control group. In strategy A, education was delivered directly to families, whereas in strategy B, education was delivered first to teachers and by them to families, and in strategy C, education was delivered only to healthcare coordinators in each school and by them to teachers and families. All educational interventions were delivered in the schools by experts and certified trainers. The participants were asked about sociodemographic information and completed questionnaires (pre-, post- and follow-up of intervention). Information from the postintervention and follow-up questionnaires was synthesized into four indicators to evaluate the effectiveness of each intervention strategy. Of the 1,426 participants, 298 were involved in strategy A, 474 in strategy B, 491 in strategy C and 163 in the control group. At postintervention, the scores of the indicators in each strategy significantly outperformed those of the control group, with adjusted p < 0.05. At follow-up, the distribution of the indicator scores of each strategy was found to be not significantly different compared to those of the control group (p > 0.05). The results of this study suggest that a sustainable school-based public health intervention mediated by teachers is effective as direct training for families in improving knowledge about food choking injury prevention. Nevertheless, further improvements could be made to increase long-term information retention.
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http://dx.doi.org/10.1111/hsc.13298DOI Listing
February 2021

Lobectomy with artery reconstruction and pneumonectomy for NSCLC: a propensity score weighting study.

Ann Thorac Surg 2021 Jan 9. Epub 2021 Jan 9.

Thoracic surgery division, Department of Cardiac, Thoracic, Vascular Sciences and Public Health, Padova University Hospital, Padova Italy.

Background: The treatment of NSCLC is based, when suitable, on surgical resection. Pneumonectomy has been considered the standard surgical procedure for locally advanced lung cancers but it is associated with high mortality and morbidity rates. Reconstruction of the pulmonary artery, associated with parenchyma sparing techniques, is meant to be an alternative to pneumonectomy.

Methods: This retrospective single-centre study is based on a detailed and comprehensive analysis of the clinical and oncological data of patients treated between 2004 and 2016 through pneumonectomy or lobectomy with reconstruction of the pulmonary artery. A propensity score weighting approach, based on the pre-operative characteristics of two groups of 124 patients each was performed. The subsequent statistical analysis evaluated long and short-term clinical outcomes together with risk factors analysis.

Results: The comparison between pneumonectomy and pulmonary artery reconstructions showed a higher 30-days (p=0.02) and 90-days (p=0.03) mortality rate in the pneumonectomy group, together with a higher incidence of major complications (p=0.004). Long term results have shown comparable outcomes, both in terms of 5-years disease free survival (52.2% in pneumonectomy vs 46.0% in pulmonary artery reconstructions, p=0.57) and overall 5-years survival (41.9% vs 35.6% respectively, p=0.57). Risk factors analysis showed that cancer specific survival was related to lymph node status (p<0.01) and absence of adjuvant therapy (p=0.04). Lymph node status also influenced the risk of recurrence (p<0.01).

Conclusions: Lobectomy with reconstruction of the pulmonary artery is a valuable and oncologically safe alternative to pneumonectomy, with lower short-term mortality and morbidity, without affecting long-term oncological results.
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http://dx.doi.org/10.1016/j.athoracsur.2020.12.029DOI Listing
January 2021

A simple instrument to assess the risk of falling in postpartum women: the SLOPE scale (riSk of faLling in pOstPartum womEn).

J Obstet Gynaecol 2021 Jan 12:1-6. Epub 2021 Jan 12.

Unit of Biostatistics, Epidemiology and Public Health, Department of Cardiology, Thoracic and Vascular Sciences, University of Padova, Italy.

The purpose of this study was to introduce a novel instrument aimed at stratifying the risk of falling in postpartum patients. The research was a survey of a sample of 460 midwives working at different hospitals, mainly in Northern Italy, except for a hospital in Rome (Italy). The survey, consisting of 70 items, was conducted among midwives and asked them to express their opinion regarding the increased risk of falling in puerperal women on a Likert scale according to the characteristics listed in the questionnaire. Items were derived from the synthesis of scales available in the literature from settings other than the postpartum period, and interviews were conducted with midwives with great experience in this area. A shortened version was obtained using principal component analysis. A 30-item final scale was obtained, the SLOPE (riSk of faLling in pOst-Partum womEn), ranging from 0 to 100. The scale allows stratification of postpartum women at low (0-10), intermediate (10-20) and high risk (>20) of falling. The development of the SLOPE scale is the first step towards more rational evidence-based management of the risk of falling in postpartum women in current clinical practice. Impact statement Falls occurring in the postnatal period are not limited to women because infants are often involved in this adverse event, with several significant consequences. There is a lack of information on this issue due to the absence of both registries and scales for the prevention of falls. The main result of this study is the development of a novel scale to assess the falling risk in postpartum women. The development of this novel scale, even if based on midwives' experience and not on patients' data, is a first step towards a more rational evidence-based management of the risk of falling in postpartum women.
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http://dx.doi.org/10.1080/01443615.2020.1833847DOI Listing
January 2021

Comparing foreign body injuries patterns between Turkey and European Countries: are female Turkish children more vulnerable?

Int J Pediatr Otorhinolaryngol 2021 Mar 31;142:110605. Epub 2020 Dec 31.

Unit of Biostatistics, Epidemiology and Public Health, Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padova, Italy.

Objectives: The present study aimed at analyzing and comparing Foreign Body (FB) injuries patterns in children from Turkey and other European countries in order to assess any country and culturally specific aspects of FB risk.

Methods: Data from Susy Safe register were included in the analysis. For this study, ICD-935 (mouth, esophagus and stomach) and ICD-934 (trachea, bronchus, and lung) cases from European countries and from a single center in the Istanbul Bahcelievler State Hospital, Turkey, were extracted from the Susy database. A Multiple Correspondence Analysis (MCA) approach was employed to identify differences or similarities between the groups of FB injuries.

Results: The Turkey dataset has a larger proportion of females in comparison to the European data (p-value 0.002). According to the MCA analysis, the first two dimensions are explaining 48.11% of the variability (dimension 1, 37.44%; dimension 2, 10.67%). The three largest contributions to dimension 1 are via naturalis removal, not hospitalized, and ICD-935. The greatest contributions to dimension 2 are FB type, and consistency.

Conclusion: The most interesting study finding is the higher incidence of females suffering a FB injury in ICD-934-935 in the Turkey dataset compared to that seen in the European dataset and also higher than that for all ICD locations within the Susy Safe register. The higher incidence of females tends to go against the belief that boys suffer higher FB injuries and needs to be further investigated.
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http://dx.doi.org/10.1016/j.ijporl.2020.110605DOI Listing
March 2021

[Gender and age factors affecting the mortality during the COVID-19 epidemic in Italy].

Epidemiol Prev 2020 Sep-Dec;44(5-6 Suppl 2):252-259

Unit of Biostatistics, Epidemiology and Public Health, Department of Cardiac, Thoracic, Vascular Sciences, and Public Health, University of Padua, Padua (Italy).

Background: the COVID-19 epidemic severely affected Italy among European countries causing a considerable number of deaths across the country, especially in Northern Italy, leading also to serious problems to the Italian healthcare system, in particular the overcrowding of Intensive Care Units (ICU). In literature, the debate on the overall mortality during the COVID-19 epidemic, directly and indirectly, associated with the disease, is still open.

Objectives: to describe the time trend of the mortality in Italy during the COVID-19 pandemic accounting for age, gender, and geographical areas.

Design: analysis of mortality trend, by region, age, and gender.

Setting And Participants: the Italian mortality data, released by the Italian National Institute of Statistics (Istat), have been considered for the analyses. The data refer to the first four months of 2015-2019 and 2020, involving 7,270 municipalities, corresponding to 93% of the Italian population.

Main Outcome Measures: the mortality rates in the first four months of 2015-2019 and 2020, age-adjusted, have been calculated together with the percent variation. The data were analysed by gender, age class (<65; >=65 years), Region, and geographical areas (Northern versus Central-Southern Italy). The overall daily mortality series have been represented as rates over 100,000 resident population.

Results: in addition to the geographical location, the age component was a major determinant of the mortality pattern. The greater increase in the overall mortality was evidenced among elderly subjects in the Northern Italian Regions most affected by the epidemic. In these areas, also gender component played an important role in determining the mortality excess: higher mortality rates in the first four months of 2020 are observed for males in comparison to female populations.

Conclusions: this research reveals that the population components are an important issue in determining the COVID-19 mortality excess. For this reason, it is of primary importance to monitor mortality (overall and by COVID-19) by age and gender and to consider these components and the related factors (comorbidity, exposures affecting the lung) in the public prevention policies towards the protection of the most fragile population groups.
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http://dx.doi.org/10.19191/EP20.5-6.S2.125DOI Listing
January 2021

Ethics committees in the time of COVID-19.

Epidemiol Prev 2020 Sep-Dec;44(5-6 Suppl 2):113-118

Unit of Biostatistics, Epidemiology and Public Health, Department of Cardiac-Thoracic-Vascular Sciences and Public Health, University of Padua, Padua (Italy);

Background: ethics committees (ECs) protect the rights, safety, and well-being of research participants and ensure the scientific correctness of clinical research. COVID-19 pandemic and the lockdown from 9 March to 16 May 2020 have potentially influenced several activities, including ECs.

Objectives: to assess the impact of COVID-19 outbreak on Italian ECs and their performance during the lockdown.

Design: cross-sectional survey.

Setting And Participants: the survey was conducted in mid-June 2020 in Italy contacting all the 90 local ECs.

Main Outcome Measures: amount and kind of activities performed during the lockdown, characteristics of submitted studies and adoption of standard protocols of evaluation of research applications during the pandemic. Chi-square test was used to estimate the differences between territories with higher incidence (HI) and lower incidence (LI) of COVID-19.

Results: 258 questionnaires were collected from 46 ECs that participated in the study. Ten were excluded due to missing substantial data. Responses were divided into two groups according to location of EC: the HI (125 responses) and the LI (123 responses). Seventy-five percent of the HI describe an increase in the number of studies submitted, while 53% of the LI does not (p=0.001). Due to the pandemic and its effects on research, the 15% of participants belonging to HI territories reported that consideration and respect of research-related and general ethical principles could have decreased, as well the adoption of standard protocols of evaluation of research applications. EC secretariats located in HI Regions moved to smart working more than in LI ones (75% vs 59%; p=0.001). Where the EC workload increased significantly, it was reported that it was impossible to perform an accurate analysis of the submitted documentation, with the effect of providing a favorable opinion to studies of not excellent quality, though always ensuring the respect of ethical principles and patients' safety.

Conclusions: COVID-19 impact on ECs has been heavier in HI territories, but smart working has been effective in ensuring EC activities and the subsequent activation of clinical studies potentially useful to face the pandemic. Clear differences arise between ECs belonging to the Italian Regions that have recorded a HI of COVID-19 cases compared to those located in Regions with a LI of cases. In some EC members' perception, the high number of studies in the most affected Regions together with the emergency experienced during the lockdown may have exposed ECs to the risk of decreasing the adoption of ethical principles and standard protocols of evaluation of research applications.
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http://dx.doi.org/10.19191/EP20.5-6.S2.109DOI Listing
January 2021

Paediatric emergencies and related mortality in Nicaragua: results from a multi-site paediatric emergency registry.

Emerg Med J 2020 Dec 21. Epub 2020 Dec 21.

Departement of Anesthesia, Critical care, Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore di Milano Policlinico, Milan, Lombardy, Italy.

Background: We aim to describe the characteristics and outcomes of the severe spectrum of paediatric emergency visits using a multi-site registry developed as part of an international cooperation project.

Methods: This observational registry-based study presented descriptive statistics of clinical and outcome data on urgent-emergency paediatric visits from 7 Nicaraguan hospitals, including the national referral paediatric hospital, between January and December 2017. Extensive piloting to ensure data collection feasibility, sustainability and accuracy was carried out in 2016 with substantial input and feedback from local stakeholders.

Results: Overall, 3521 visits of patients <15 years of age, of whom two-thirds <5 years, met predefined inclusion criteria of urgent-emergency visits. Respiratory (1619/3498; 46%), gastrointestinal (407/3498; 12%) and neurological (368/3498; 11%) complaints were the most common symptoms. Malnutrition was reported in 18% (610/3448) of presentations. Mortality was 7% (233/3521); 52% (120/233) of deaths occurred in the <1-year subgroup; 32% (71/3521) of deaths occurred within the first 24 hours of presentation. The most common immediate causes of death were septic shock (99/233; 43%), respiratory failure (58/233; 25%) and raised intracranial pressure (24/233; 10%).

Conclusions: The mortality rate of urgent-emergency paediatric visits in Nicaragua is high, with younger children being most at risk and the majority of deaths being eventually caused by septic shock or respiratory failure. Our data provide useful information for the development of a Paediatric Emergency Care network to help direct training efforts, resources and logistic/organisational interventions to improve children's health in an emergency setting in Nicaragua.
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http://dx.doi.org/10.1136/emermed-2019-209324DOI Listing
December 2020

Profiling Patients by Intensity of Nursing Care: An Operative Approach Using Machine Learning.

J Pers Med 2020 Dec 14;10(4). Epub 2020 Dec 14.

Unit of Biostatistics, Epidemiology and Public Health, Department of Cardiac, Thoracic, Vascular Sciences, and Public Health, University of Padova, via Loredan, 18, 35121 Padova, Italy.

Physical function is a patient-oriented indicator and can be considered a proxy for the assignment of healthcare personnel. The study aims to create an algorithm that classifies patients into homogeneous groups according to physical function. A two-step machine-learning algorithm was applied to administrative data recorded between 2015 and 2018 at the University Hospital of Padova. A clustering-large-applications (CLARA) algorithm was used to partition patients into homogeneous groups. Then, machine learning technique (MLT) classifiers were used to categorize the doubtful records. Based on the results of the CLARA algorithm, records were divided into three groups according to the Barthel index: <45, >65, ≥45 and ≤65. The support vector machine was the MLT showing the best performance among doubtful records, reaching an accuracy of 66%. The two-step algorithm, since it splits patients into low and high resource consumption, could be a useful tool for organizing healthcare personnel allocation according to the patients' assistance needs.
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http://dx.doi.org/10.3390/jpm10040279DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7768500PMC
December 2020

Biological versus mechanical aortic valve replacement in non-elderly patients: a single-centre analysis of clinical outcomes and quality of life.

Interact Cardiovasc Thorac Surg 2020 Dec 12. Epub 2020 Dec 12.

Division of Cardiac Surgery, Department of Cardiac, Thoracic and Vascular Sciences, University of Padua, Padua, Italy.

Objectives: The aim of this study was to evaluate short- and long-term clinical outcomes, including the perceived health-related quality of life, in patients younger than 65 years having undergone aortic valve replacement either with biological or mechanical valve prostheses.

Methods: Between 2002 and 2013, 242 consecutive patients <65 years of age underwent isolated aortic valve replacement at our institution, either with biological (n = 134, 55.4%) or mechanical (n = 108, 44.6%) prostheses. Survival, health-related quality of life, short- and long-term clinical outcomes and echocardiographic data were analysed with a retrospective, single-centre study. Propensity matching was performed.

Results: No significant difference in survival was found between the 2 groups (mechanical versus biological: 100% vs 96.6% at 1 year, 98.2% vs 93.1% at 5 years and 92.3% vs 83.4% at 10 years after surgery, P = 0.091). For all the interviewed patients (n = 161, 66.5%), perceived quality of life at the latest follow-up was excellent. Need for reoperation was higher in the bioprosthetic group (8% vs 0%, P = 0.995), whereas the rate of major bleedings was higher in the mechanical valve group (3% vs 20%, P = 0.094). The mean and maximum transvalvular pressure gradients were 20.5 ± 9.7 and 37.4 ± 17.5 mmHg in the biological group and 14.8 ± 4.8 and 26.6 ± 9.2 mmHg in the mechanical group (P = 0.014).

Conclusions: No significant differences were found between biological and mechanical valves in terms of patients' survival, clinical outcomes and quality of life. Mean and maximum transvalvular pressure gradients were significantly higher in the biological group. The majority of patients would opt for the same prosthesis type, if asked to choose again.
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http://dx.doi.org/10.1093/icvts/ivaa306DOI Listing
December 2020

Reduction in all-cause mortality in COVID-19 patients on chronic oral anticoagulation: A population-based propensity score matched study.

Int J Cardiol 2021 04 11;329:266-269. Epub 2020 Dec 11.

Cardiology Clinic, Department of Cardiac, Thoracic, Vascular Sciences and Public Health, Padua University Hospital, Padua, Italy. Electronic address:

Background: Coronavirus disease 2019 (COVID-19) global pandemic has strikingly high mortality rate with hypercoagulability state being part of the imputed mechanisms. We aimed to compare the rates of in hospital mortality in propensity score matched cohorts of COVID-19 patients in chronic anticoagulation versus those that were not.

Methods: In this population-based study in the Veneto Region, we retrospectively reviewed all patients aged 65 years or older, with a laboratory-confirmed COVID-19 diagnosis. We compared, after propensity score matching, those who received chronic anticoagulation for atrial fibrillation with those who did not.

Results: Overall, 4697 COVID-19 patients fulfilled inclusion criteria, and the propensity score matching yielded 559 patients per arm. All-cause mortality rate ratio was significantly higher among non-anticoagulated patients (32.2% vs 26.5%, p = 0.036). On time to event analysis, all-cause mortality was found lower among anticoagulated patients, although the estimate was not statistically significant. (HR 0.81, 95%CI 0.65-1.01, p = 0.054).

Conclusion: Among elderly patients with COVID-19, those on chronic oral anticoagulant treatment for atrial fibrillation seem to be at lower risk of all-cause mortality compared to their propensity score matched non-anticoagulated counterpart. This finding needs to be confirmed in further studies.
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http://dx.doi.org/10.1016/j.ijcard.2020.12.024DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7833678PMC
April 2021

[Impact of COVID-19 pandemic on structural heart interventions in Italy].

G Ital Cardiol (Rome) 2020 Nov;21(11):45-47

Dipartimento di Scienze Biomediche Avanzate, Università degli Studi di Napoli "Federico II", Napoli.

Background: The coronavirus disease 2019 (COVID-19) pandemic has led to deferral of many non-urgent procedures in most healthcare systems worldwide. With this study we aimed to quantify the impact of COVID-19 on interventional treatment of structural heart disease (SHD) in Italy.

Methods: Numbers of transfemoral transcatheter aortic valve replacement (TAVR), percutaneous mitral valve repair (PMVR), left atrial appendage occlusion (LAAO), patent foramen ovale (PFO) closures performed over a 4-week period during the national lockdown in Italian centers performing over 60 structural heart interventions (SHI)/year were compared with the same 4-week period in 2019. Incidence rate reductions (IRR) were estimated by zero-inflated negative binomial regression.

Results: According to our nationwide analysis, SHIs were reduced by 79% as compared to the same period in 2019 (IRR 0.21, 95% confidence interval [CI] 0.15-0.29). This reduction was more substantial for PFO closure (IRR 0.03, 95% CI 0.01-0.07), LAAO (IRR 0.11, 95% CI 0.05-0.25) and PMVR (IRR 0.12, 95% CI 0.04-0.36) as compared to TAVR (IRR 0.31, 95% CI 0.22-0.47).

Conclusions: The COVID-19 pandemic caused a 79% drop in SHI volumes in Italy. PFO closure, LAAO and PMVR decreased more significantly as compared to TAVR. Further studies are needed to evaluate the impact of this reduction on outcomes of patients with SHD.
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http://dx.doi.org/10.1714/3487.34672DOI Listing
November 2020

Distance support and online intervention to blind and visually impaired children during the pandemic COVID-19.

Res Dev Disabil 2021 Jan 23;108:103816. Epub 2020 Nov 23.

Robert Hollman Foundation "Consultation and Support for the Development of Visually Impaired Children", Via Siena 1, Padova, Italy.

The COVID-19 pandemic imposed dramatic changes to everyone's daily routines, but especially to children with developmental disabilities. The Robert Hollman Foundation decided not to interrupt its service to all the visually impaired children and initiated a Distance Support Project. It was an online process covering all aspects of support for the children and involving audio-video calls, videos and tailored-made multisensory material created specifically for each child. A questionnaire, carried out after the 5-month project duration, was created to collect feedback from parents and professionals to understand the impact this project had on everyone involved. Overall both parents and professionals indicated high levels of satisfaction, but in a significant number of questions parents reported consistently higher levels of satisfaction (p-value <0.001). It was shown that parents felt reassured at this otherwise very difficult time because their children were able to continue their treatment, even if in a very different way. This fact encourages us to consider enriching our existing programmes of support and care, integrating this online approach when necessary. At the same time, it seems clear that the responses of the professionals indicate their belief that the benefits of the traditional ways of working remain of unquestionable importance for children with sight deprivation.
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http://dx.doi.org/10.1016/j.ridd.2020.103816DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7682482PMC
January 2021

Prognostic validation of partition values for quantitative parameters to grade functional tricuspid regurgitation severity by conventional echocardiography.

Eur Heart J Cardiovasc Imaging 2021 Jan;22(2):155-165

Department of Cardiovascular, Neural and Metabolic Sciences, Istituto Auxologico Italiano, IRCCS, S. Luca Hospital, Milan 20149, Italy.

Aims: Quantitative echocardiography parameters are seldom used to grade tricuspid regurgitation (TR) severity due to relative paucity of validation studies and lack of prognostic data. To assess the relationship between TR severity and the composite endpoint of death and hospitalization for congestive heart failure (CHF); and to identify the threshold values of vena contracta width (VCavg), effective regurgitant orifice area (EROA), regurgitant volume (RegVol), and regurgitant fraction (RegFr) to define low, intermediate, and high-risk TR based on patients' outcome data.

Methods And Results: A cohort of 296 patients with at least mild TR underwent 2D, 3D, and Doppler echocardiography. We built statistical models (adjusted for age, NYHA class, left ventricular ejection fraction, and pulmonary artery systolic pressure) for VCavg, EROA, RegVol, and RegFr to study their relationships with the hazard of outcome. The tertiles of the derived hazard values defined the threshold values of the quantitative parameters for TR severity grading. During 47-month follow-up, 32 deaths and 72 CHF occurred. Event-free rate was 14%, 48%, and 93% in patients with severe, moderate, and mild TR, respectively. Severe TR was graded as VCavg > 6 mm, EROA > 0.30 cm2, RegVol > 30 mL, and RegF > 45%.

Conclusion: This outcome study demonstrates the prognostic value of quantitative parameters of TR severity and provides prognostically meaningful threshold values to grade TR severity in low, intermediate, and high risk.
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http://dx.doi.org/10.1093/ehjci/jeaa282DOI Listing
January 2021

Downstream or upstream administration of P2Y12 receptor blockers in non-ST elevated acute coronary syndromes: study protocol for a randomized controlled trial.

Trials 2020 Nov 24;21(1):966. Epub 2020 Nov 24.

Division of Cardiology, Azienda Sanitaria Ospedaliera Ordine Mauriziano, Torino, Italy.

Background: The optimal timing to administer a P2Y12 inhibitor in patients presenting with a non-ST elevation acute coronary syndrome remains a topic of debate. Pretreatment with ticagrelor before coronary anatomy is known as a widely adopted strategy. However, there is poor evidence on how this compares with administration of a P2Y12 inhibitor after defining coronary anatomy (i.e., downstream administration). Moreover, there are limited head-to-head comparisons of the two P2Y12 inhibitors-ticagrelor and prasugrel-currently recommended by the guidelines.

Study Design: DUBIUS is a phase 4, multicenter, parallel-group, double randomized study conducted in NSTE-ACS patients designed to compare a pretreatment strategy (including only ticagrelor) versus a downstream strategy (including prasugrel or ticagrelor) and to compare downstream prasugrel with downstream ticagrelor. A total of 2520 patients will be randomly assigned to pretreatment with ticagrelor or to no pretreatment. The PCI group of the downstream arm will be further randomized to receive prasugrel or ticagrelor. The two primary hypotheses are that the downstream strategy is superior to the upstream strategy and that downstream ticagrelor is non-inferior to downstream prasugrel, both measured by the incidence of a composite efficacy and safety endpoint of death from vascular causes, non-fatal MI, or non-fatal stroke, and Bleeding Academic Research Consortium (BARC) type 3, 4, and 5 bleedings.

Conclusions: The DUBIUS study will provide important evidence related to the benefits and risks of pretreatment with ticagrelor compared with a strategy of no pretreatment. Moreover, the clinical impact of using downstream ticagrelor compared with downstream prasugrel will be assessed.

Trial Registration: ClinicalTrials.gov NCT02618837 . Registered on 1 December 2015.
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http://dx.doi.org/10.1186/s13063-020-04859-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7686679PMC
November 2020

Efficacy of immunosuppressive therapy in myocarditis: A 30-year systematic review and meta analysis.

Autoimmun Rev 2021 Jan 13;20(1):102710. Epub 2020 Nov 13.

Cardiology, Dept of Cardiac Thoracic Vascular Sciences and Public Health, University of Padova, Padova, Italy. Electronic address:

Aims: Myocarditis is an inflammation of the heart muscle, due to infectious, toxic or autoimmune causes. Literature reported controversial results in relation to the effect of immunosuppression (IS)/immunomodulation (IM). We aimed at assessing the effect of IS/IM by meta analysis.

Methods And Results: Using the P.R.I.S.M.A. approach, two researchers searched for relevant studies on PubMed, Embase, and the Central Registry of Controlled Trials of the Cochrane Library. Proposed MeSH terms were: "immunotherapy OR immune therapy OR immune modeling OR Immunosuppressive Agents" AND "combination OR combined with OR plus" AND "myocarditis OR cardiomyopathies OR inflammatory cardiomyopathy". The language was restricted to English. Reference lists of included articles and those relevant to the topic were hand searched for the identification of additional, potentially relevant articles. The cutoff date was from 1987 until 30th Nov 2019. Reported survival or mortality events or change of left ventricular ejection fraction (LVEF) after IS/IT were primary outcomes of the study; in addition, improvement of New York Heart Association class, follow-up biopsy (Bx) findings, viral genome clearance on Bx and recurrence of myocarditis were recorded if reported. Statistical analysis was conducted using Review Manager 5.3; 5452 studies were screened, of these 73 were assessed for eligibility, including 8 randomized control studies, 26 retrospective studies, 2 prospective studies and 1 case control study, 34 case reports and 2 case series. In prospective studies, the difference in mortality between the IS and control groups tended to be lower in the combined IS groups (12.5% vs. 18.2%) (95% CI of odds ratio 0.7(0.3, 1.64)) and the pooled difference of the increase of LVEF between the IS and control groups tended to be higher in the combined IS groups (95% CI 7.26 (-2.29, 16.81)). In retrospective studies, the difference of survival between the IS and control group was significantly in favor of IS (95%CI Hazard ratio 0.82(0.69, 0.96)).

Conclusions: A tailored IS may be considered in myocarditis, depending on the phase of the disease, and the type of underlying autoimmune or immune-mediated form.
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http://dx.doi.org/10.1016/j.autrev.2020.102710DOI Listing
January 2021

Spontaneous coronary artery dissection: Role of prognostic markers and relationship with genetic analysis.

Int J Cardiol 2021 Mar 22;326:19-29. Epub 2020 Oct 22.

Division of Cardiology, Department of Cardiothoracic Sciences, Azienda Sanitaria Universitaria Friuli Centrale - Ospedale Santa Maria della Misericordia, Piazzale Santa Maria della Misericordia 15, 33100 Udine, Italy; Institute of Applied and Basic Clinical Research (IRCAB Foundation), Piazzale Santa Maria della Misericordia 11, 33100 Udine, Italy.

Spontaneous coronary artery dissection (SCAD) is increasingly recognized as an important cause of myocardial infarction (MI). Currently there is little knowledge about prognostic factors for unfavorable outcome at long term follow-up; furthermore, there is also little knowledge about the genetics of these patients.

Aims: This observational and retrospective study describes long-term cardiovascular outcomes of a population affected by SCAD and assesses predictors of recurrent de novo SCAD and major adverse cardiovascular events (MACE). Furthermore, a correlation between genotype and adverse events at follow-up was sought.

Methods: Baseline characteristics, angiographic features, use of medication and long-term cardiovascular events were systematically ascertained between 2000 and 2019. Next generation sequencing was performed with a panel consisting of twenty genes of interest. Variants found were filtered based on their frequency and only frequencies <1% in the general population were considered as "positive".

Results: Seventy patients were enrolled and followed for a median time of 39.1 months. Median age was 52 years and the majority were women (86%). Use of hormone therapy (HT) (OR 3.64, p = 0.041) and presence of malignant ventricular arrhythmias (VAs) at onset (OR 7.03, p = 0.0073) were associated with a greater risk of recurrent de novo SCAD. Proximal type SCAD (OR 8.47, p < 0.0001) and presence of VAs at onset (OR 9.97, p = 0.047) were associated with a greater risk of MACE. A potential SCAD-associated mutation was detected in 27 patients (44%); 6 patients (22%) defined as genetically "positive" developed MACE vs. 2 patients (6%) defined as "negative" (p = 0.06 at univariate analysis). MACE at follow-up is reached earlier in genetically positive patients (7.9 vs. 42.5 months).

Conclusion: use of HT and VAs at SCAD onset are prognostic factors for recurrent de novo SCAD. Proximal SCAD site and VAs at SCAD onset were prognostic factors for MACE. Analysis by molecular genetics seems to be a promising tool for the possible additional role it could play in MACE prediction.
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http://dx.doi.org/10.1016/j.ijcard.2020.10.040DOI Listing
March 2021

Using Wearable Devices to Monitor Physical Activity in Patients Undergoing Aortic Valve Replacement: Protocol for a Prospective Observational Study.

JMIR Res Protoc 2020 Nov 12;9(11):e20072. Epub 2020 Nov 12.

Unit of Biostatistics, Epidemiology and Public Health, Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padova, Padova, Italy.

Background: In last few decades, several tools have been developed to measure physical function objectively; however, their use has not been well established in clinical practice.

Objective: This study aims to describe the preoperative physical function and to assess and compare 6-month postoperative changes in the physical function of patients undergoing treatment for aortic stenosis with either surgical aortic valve replacement (SAVR) or transcatheter aortic valve replacement (TAVR). The study also aims to evaluate the feasibility of wearable devices in assessing physical function in such patients.

Methods: This is a prospective observational study. The enrollment will be conducted 1 month before patients' SAVR/TAVR. Patients will be provided with the wearable device at baseline (activity tracker device, Garmin vívoactive 3). They will be trained in the use of the device, and they will be requested to wear it on the wrist of their preferred hand until 12 months after SAVR/TAVR. After baseline assessment, they will undergo 4 follow-up assessments at 1, 3, 6, and 12 months after SAVR/TAVR. At baseline and each follow-up, they will undergo a set of standard and validated tests to assess physical function, health-related quality of life, and sleep quality.

Results: The ethics committee of Vicenza in Veneto Region in Italy approved the study (Protocol No. 943; January 4, 2019). As of October 2020, the enrollment of participants is ongoing.

Conclusions: The use of the wearable devices for real-time monitoring of physical activity of patients undergoing aortic valve replacement is a promising opportunity for improving the clinical management and consequently, the health outcomes of such patients.

Trial Registration: Clinicaltrials.gov NCT03843320; https://tinyurl.com/yyareu5y.

International Registered Report Identifier (irrid): DERR1-10.2196/20072.
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http://dx.doi.org/10.2196/20072DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7691084PMC
November 2020