Publications by authors named "Maria-Letizia Bacchi-Reggiani"

131 Publications

Prediction of functional loss in emergency surgery is possible with a simple frailty screening tool.

World J Emerg Surg 2021 Mar 18;16(1):12. Epub 2021 Mar 18.

Department of General Surgery, Policlinico S. Orsola-Malpighi, 40138, Bologna, Italy.

Background: Senior adults fear postoperative loss of independence the most, and this might represent an additional burden for families and society. The number of geriatric patients admitted to the emergency room requiring an urgent surgical treatment is rising, and the presence of frailty is the main risk factor for postoperative morbidity and functional decline. Frailty assessment in the busy emergency setting is challenging. The aim of this study is to verify the effectiveness of a very simple five-item frailty screening tool, the Flemish version of the Triage Risk Screening Tool (fTRST), in predicting functional loss after emergency surgery among senior adults who were found to be independent before surgery.

Methods: All consecutive individuals aged 70 years and older who were independent (activity of daily living (ADL) score ≥5) and were admitted to the emergency surgery unit with an urgent need for abdominal surgery between December 2015 and May 2016 were prospectively included in the study. On admission, individuals were screened using the fTRST and additional metrics such as the age-adjusted Charlson Comorbidity Index (CACI) and the ASA score. Thirty- and 90-day complications and postoperative decline in the ADL score where recorded. Regression analysis was performed to identify preoperative predictors of functional loss.

Results: Seventy-eight patients entered the study. Thirty-day mortality rate was 12.8% (10/78), and the 90-day overall mortality was 15.4% (12/78). One in every four patients (17/68) experienced a significant functional loss at 30-day follow-up. At 90-day follow-up, only 3/17 patients recovered, 2 patients died, and 12 remained permanently dependent. On the regression analysis, a statistically significant correlation with functional loss was found for fTRST, CACI, and age≥85 years old both at 30 and 90 days after surgery. fTRST≥2 showed the highest effectiveness in predicting functional loss at 90 days with AUC 72 and OR 6.93 (95% CI 1.71-28.05). The institutionalization rate with the need to discharge patients to a healthcare facility was 7.6% (5/66); all of them had a fTRST≥2.

Conclusion: fTRST is an easy and effective tool to predict the risk of a postoperative functional decline and nursing home admission in the emergency setting.
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http://dx.doi.org/10.1186/s13017-021-00356-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7977323PMC
March 2021

Size and location of spontaneous portosystemic shunts predict the risk of decompensation in cirrhotic patients.

Dig Liver Dis 2021 Jan 4. Epub 2021 Jan 4.

Department of Medical and Surgical Sciences (DIMEC), University of Bologna, Via Massarenti 9, Bologna 40138, Italy.

Background: The prognostic role of spontaneous portosystemic shunts (SPSS) has been poorly investigated.

Aims: To evaluate the impact of the presence of SPSS, as well as their characteristics, on the risk of decompensation.

Methods: This is a retrospective cohort study of 235 advanced chronic liver disease (ACLD) patients with available imaging examination, transient elastography, and upper endoscopy. ACLD was defined as liver stiffness measurement (LSM) >10 kPa. Competitive risk analyses were performed to identify the factors associated with the main outcome.

Results: SPSS were reported in 141 (60%) of the patients. Non-viral etiology was independently associated with SPSS presence [Odds-Ratio (OR): 2.743;95%-Interval-of-Confidence (IC):1.129-6.664]. During a follow-up of 37 (20-63) months, SPSS were found predictors of any decompensation type [Subhazard Ratio (SHR):2.264; 95%-IC:1.259-4.071], independently from a history of decompensation or high-risk-varices presence. The risk of complications was higher in patients with large (SHR: 3.775; 95%-IC: 2.016-7.070) and multiple (SHR:3.832; 95%-IC: 2.004-7.330) shunts, and in those with gastrorenal shunts (SHR:2.636; 95%-IC:1.521-4.569).

Conclusions: The presence, size, and number of SPSS predict not only the risk of hepatic encephalopathy but that of any type of decompensation across all stages of cirrhosis. Future studies should explore the possibility of treating shunts to prevent decompensation.
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http://dx.doi.org/10.1016/j.dld.2020.12.114DOI Listing
January 2021

Comparison of prognostic models in advanced hepatocellular carcinoma patients undergoing Sorafenib: A multicenter study.

Dig Liver Dis 2020 Dec 19. Epub 2020 Dec 19.

Azienda Ospedaliero-Universitaria di Bologna, via Albertoni 15, Bologna, Italia; Department of Medical and Surgical Sciences, Division of Semeiotics, University of Bologna, Bologna, Italy.

Background: Sorafenib is the gold standard therapy for the advanced hepatocellular carcinoma (HCC). No scoring/staging is universally accepted to predict the survival of these patients.

Aims: To evaluate the accuracy of the available prognostic models for HCC to predict the survival of advanced HCC patients treated with Sorafenib included in the Italian Liver Cancer (ITA.LI.CA.) multicenter cohort.

Methods: The performance of several prognostic scores was assessed through a Cox regression-model evaluating the C-index and the Akaike Information Criterion (AIC).

Results: Data of 1129 patients were analyzed. The mean age of patients was 61.6 years, and 80.8% were male. During a median follow-up period of 13 months, 789 patients died. The median period of Sorafenib administration was 4 months. All the prognostic scores were able to predict the overall survival (p<0.001) at univariate analysis, except the Albumin-Bilirubin score. The Italian Liver Cancer score (CLIP) yielded the highest accuracy (C-index 0.604, AIC 9898), followed by the ITA.LI.CA. prognostic score (C-index 0.599, AIC 9915).

Conclusions: The CLIP score had the highest accuracy in predicting the overall survival of HCC patients treated with Sorafenib, although its performance remained poor. Further studies are needed to refine the current ability to predict the outcome of HCC patients undergoing Sorafenib.
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http://dx.doi.org/10.1016/j.dld.2020.12.001DOI Listing
December 2020

Factors influencing liberation from mechanical ventilation in coronavirus disease 2019: multicenter observational study in fifteen Italian ICUs.

J Intensive Care 2020 Oct 15;8(1):80. Epub 2020 Oct 15.

Alma Mater Studiorum, Dipartimento di Scienze Mediche e Chirurgiche, Anesthesia and Intensive Care Medicine, Policlinico di Sant'Orsola, Università di Bologna, Bologna, Italy.

Background: A large proportion of patients with coronavirus disease 2019 (COVID-19) develop severe respiratory failure requiring admission to the intensive care unit (ICU) and about 80% of them need mechanical ventilation (MV). These patients show great complexity due to multiple organ involvement and a dynamic evolution over time; moreover, few information is available about the risk factors that may contribute to increase the time course of mechanical ventilation. The primary objective of this study is to investigate the risk factors associated with the inability to liberate COVID-19 patients from mechanical ventilation. Due to the complex evolution of the disease, we analyzed both pulmonary variables and occurrence of non-pulmonary complications during mechanical ventilation. The secondary objective of this study was the evaluation of risk factors for ICU mortality.

Methods: This multicenter prospective observational study enrolled 391 patients from fifteen COVID-19 dedicated Italian ICUs which underwent invasive mechanical ventilation for COVID-19 pneumonia. Clinical and laboratory data, ventilator parameters, occurrence of organ dysfunction, and outcome were recorded. The primary outcome measure was 28 days ventilator-free days and the liberation from MV at 28 days was studied by performing a competing risks regression model on data, according to the method of Fine and Gray; the event death was considered as a competing risk.

Results: Liberation from mechanical ventilation was achieved in 53.2% of the patients (208/391). Competing risks analysis, considering death as a competing event, demonstrated a decreased sub-hazard ratio for liberation from mechanical ventilation (MV) with increasing age and SOFA score at ICU admission, low values of PaO/FiO ratio during the first 5 days of MV, respiratory system compliance (C) lower than 40 mL/cmHO during the first 5 days of MV, need for renal replacement therapy (RRT), late-onset ventilator-associated pneumonia (VAP), and cardiovascular complications. ICU mortality during the observation period was 36.1% (141/391). Similar results were obtained by the multivariate logistic regression analysis using mortality as a dependent variable.

Conclusions: Age, SOFA score at ICU admission, C, PaO/FiO, renal and cardiovascular complications, and late-onset VAP were all independent risk factors for prolonged mechanical ventilation in patients with COVID-19.

Trial Registration: NCT04411459.
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http://dx.doi.org/10.1186/s40560-020-00499-4DOI Listing
October 2020

Prediction of neonatal coarctation of the aorta at fetal echocardiography: a scoring system.

J Matern Fetal Neonatal Med 2020 Nov 17:1-10. Epub 2020 Nov 17.

Department of Obstetrics and Gynecology, Fetal Medicine Unit, S. Orsola University Hospital, Bologna, Italy.

Introduction: Coarctation of the aorta (CoA) is common and can lead to neonatal emergency. Despite its burden, antenatal detection of this condition remains inaccurate.

Objective: To evaluate the diagnostic performance of fetal echocardiography and to design a scoring system for risk stratification of CoA in suspected cases.

Design: A retrospective cohort study.

Setting: S. Orsola Hospital, Bologna, Italy.

Population: About 140 fetuses referred for suspected CoA to our tertiary center in a 9-year period.

Methods: The following parameters were systematically obtained at fetal echocardiography: ventricular disproportion, great vessels asymmetry, transverse aortic arch hypoplasia, flow turbulence, and -scores of the ascending aorta and of the aortic isthmus. Associated anomalies were recorded, if present. When CoA was not confirmed at birth, neonates were followed up for 12 months to identify also a tardive onset of this condition.

Main Outcome Measures: The primary outcome was the presence of COA after birth.

Results: 108 fetuses were eligible for the purpose of the study. CoA was confirmed postnatally in 55 neonates (50.9%). Arch hypoplasia yielded the highest correlation with CoA. The affected neonates presented also significantly lower scores of the ascending aorta and of the aortic isthmus. Earlier gestational age at referral was positively correlated with neonatal CoA. An odds ratio-based multiparametric model was designed to build a scoring system (AUC 0.89).

Conclusion: In our cohort, no single ultrasound parameter was sufficiently accurate to predict postnatal CoA. The scoring system permitted a better identification of the affected fetuses.
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http://dx.doi.org/10.1080/14767058.2020.1849109DOI Listing
November 2020

Factors influencing liberation from mechanical ventilation in coronavirus disease 2019: multicenter observational study in fifteen Italian ICUs.

J Intensive Care 2020 15;8:80. Epub 2020 Oct 15.

Alma Mater Studiorum, Dipartimento di Scienze Mediche e Chirurgiche, Anesthesia and Intensive Care Medicine, Policlinico di Sant'Orsola, Università di Bologna, Bologna, Italy.

Background: A large proportion of patients with coronavirus disease 2019 (COVID-19) develop severe respiratory failure requiring admission to the intensive care unit (ICU) and about 80% of them need mechanical ventilation (MV). These patients show great complexity due to multiple organ involvement and a dynamic evolution over time; moreover, few information is available about the risk factors that may contribute to increase the time course of mechanical ventilation.The primary objective of this study is to investigate the risk factors associated with the inability to liberate COVID-19 patients from mechanical ventilation. Due to the complex evolution of the disease, we analyzed both pulmonary variables and occurrence of non-pulmonary complications during mechanical ventilation. The secondary objective of this study was the evaluation of risk factors for ICU mortality.

Methods: This multicenter prospective observational study enrolled 391 patients from fifteen COVID-19 dedicated Italian ICUs which underwent invasive mechanical ventilation for COVID-19 pneumonia. Clinical and laboratory data, ventilator parameters, occurrence of organ dysfunction, and outcome were recorded. The primary outcome measure was 28 days ventilator-free days and the liberation from MV at 28 days was studied by performing a competing risks regression model on data, according to the method of Fine and Gray; the event death was considered as a competing risk.

Results: Liberation from mechanical ventilation was achieved in 53.2% of the patients (208/391). Competing risks analysis, considering death as a competing event, demonstrated a decreased sub-hazard ratio for liberation from mechanical ventilation (MV) with increasing age and SOFA score at ICU admission, low values of PaO/FiO ratio during the first 5 days of MV, respiratory system compliance (C) lower than 40 mL/cmHO during the first 5 days of MV, need for renal replacement therapy (RRT), late-onset ventilator-associated pneumonia (VAP), and cardiovascular complications.ICU mortality during the observation period was 36.1% (141/391). Similar results were obtained by the multivariate logistic regression analysis using mortality as a dependent variable.

Conclusions: Age, SOFA score at ICU admission, C, PaO/FiO, renal and cardiovascular complications, and late-onset VAP were all independent risk factors for prolonged mechanical ventilation in patients with COVID-19.

Trial Registration: NCT04411459.
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http://dx.doi.org/10.1186/s40560-020-00499-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7558552PMC
October 2020

Spleen Stiffness Measurements Predict the Risk of Hepatic Decompensation After Direct-Acting Antivirals in HCV Cirrhotic Patients.

Ultraschall Med 2020 Jul 16. Epub 2020 Jul 16.

DIMEC, University of Bologna, Italy.

Purpose:  Little evidence is available regarding the risk of hepatic decompensation (HD) after direct-acting antivirals (DAAs) in patients with advanced chronic liver disease. Our aim was to assess the risk of decompensation and the prognostic role of noninvasive tests, such as liver (LSM) and spleen (SSM) stiffness measurements, in the prediction of decompensation after sustained virologic response (SVR) by DAAs.

Materials And Methods:  A cohort study involving 146 cirrhotic patients treated with DAAs in our tertiary center with LSM and SSM available both before and six months after treatment (SVR24). A historical cohort of 92 consecutive cirrhotic patients with active HCV was used as a control group. A propensity score inverse probability weighting method was used to account for differences between the groups. Time-dependent models for the prediction of decompensation were applied to account for changes in noninvasive tests after therapy.

Results:  The decompensation incidence in the DAA cohort was 7.07 (4.56-10.96) per 100 person-years (PYs), which was significantly lower than in the active HCV cohort. The DAA therapy was an independent protective factor for HD development (SHR: 0.071, 95 %-CI: 0.015-0.332). SSM ≥ 54 kPa was independently associated with decompensation despite SVR achievement (SHR: 4.169, 95 %-CI: 1.050-16.559), alongside with a history of decompensation (SHR: 7.956, 95 %-CI: 2.556-24.762). SSM reduction < 10 % also predicted the risk of decompensation after SVR24.

Conclusion:  The risk of decompensation was markedly reduced after DAA therapy, but it was not eliminated. Paired SSM values stratified the risk of decompensation after SVR better than other noninvasive tests.
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http://dx.doi.org/10.1055/a-1205-0367DOI Listing
July 2020

Impact of Elective, Uncomplicated Target Lesion Revascularization on Cardiac Mortality After Elective Percutaneous Coronary Intervention of Unprotected Left Main Coronary Artery Disease.

Am J Cardiol 2020 08 13;128:94-100. Epub 2020 May 13.

Cardiology Unit, Cardio-Thoraco-Vascular Department, University Hospital of Bologna, Bologna, Italy.

This study sought to investigate the impact of elective, uncomplicated target lesion revascularization (TLR) on long-term cardiac mortality after percutaneous coronary intervention (PCI) of unprotected left main coronary artery (ULMCA) disease. Consecutive patients undergoing PCI for ULMCA disease between January 2003 and December 2015 in 1 interventional center in Northern Italy were included. Patients presenting with cardiogenic shock, ST-segment elevation myocardial infarction (MI), as well as those undergoing urgent or complicated TLR were excluded. The primary endpoint of the study was cardiac mortality. Among the 418 patients fulfilling the study criteria, 79 (18.46%) underwent elective, uncomplicated TLR. After a median follow-up of 5.5 years, there were 23 cardiac deaths among patients undergoing elective, uncomplicated TLR versus 50 in patients not undergoing TLR. After adjusting for possible confounders, TLR was an independent predictor of cardiac mortality (Hazard ratio [HZ] = 1.92, 95% confidence interval [CI]: 1.05 to 3.49; p = 0.03). Patients undergoing TLR had also significantly higher rates of the composite of cardiac death, MI and stroke compared with the no TLR group (adjusted HR = 1.76, 95% CI 1.14 to 2.72). In conclusion, elective, uncomplicated TLR after PCI of ULMCA disease is associated with increased risk of long-term cardiac mortality. Reducing the risk of TLR after PCI of ULMCA disease may potentially improve the survival of these patients.
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http://dx.doi.org/10.1016/j.amjcard.2020.04.053DOI Listing
August 2020

Long-term outcome of prosthesis-patient mismatch after transcatheter aortic valve replacement.

Int J Cardiol 2020 Nov 5;318:27-31. Epub 2020 Jul 5.

Interventional Cardiology Unit, Cardio-Thoracic-Vascular Department, University Hospital of Bologna, Policlinico S. Orsola-Malpighi, Bologna, Italy. Electronic address:

Background: Incidence and long-term clinical consequences of prosthesis-patient mismatch (PPM) after transcatheter aortic valve replacement (TAVR) are still unclear.

Methods: We enrolled 710 consecutive patients who underwent TAVR. PPM was defined as absent if the index orifice area (iEOA) was >0.85 cm2/m2, moderate if the iEOA was between 0.65 and 0.85 cm2/m2 or severe if the iEOA was <0.65 cm2/m2.

Results: Among the 566 patients fulfilling the study criteria, the distribution of PPM was as follows: 50.5% none (n = 286), 43% moderate PPM (n = 243) and 6.5% severe PPM (n = 37). At 5-year follow-up, patients with severe PPM had a significantly higher incidence of the combined endpoint of cardiovascular death, acute myocardial infarction and stroke (p = .025) compared with the other patients. After adjusting the results for possible confounders, severe PPM remained an independent predictor of long-term adverse outcome (HR: 2.46; 95% Confidence Interval: 1.10-5.53). The independent predictors of severe PPM were valve-in-valve procedure and body mass index. Balloon-expandable valves were not associated with higher rates of severe PPM in comparison with self-expandable valves (8% vs. 5%, respectively, p = .245).

Conclusions: In our study severe PPM emerged as a risk factor for long-term major adverse cardiac and cerebrovascular events.
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http://dx.doi.org/10.1016/j.ijcard.2020.06.033DOI Listing
November 2020

Dry Eye Disease and Tear Cytokine Levels-A Meta-Analysis.

Int J Mol Sci 2020 Apr 28;21(9). Epub 2020 Apr 28.

Ophthalmology Unit, DIMES, Alma Mater Studiorum University of Bologna and S.Orsola-Malpighi Teaching Hospital, 40138 Bologna, Italy.

Background-It is recognized that inflammation is an underlying cause of dry eye disease (DED), with cytokine release involved. We systematically reviewed literature with meta-analyses to quantitatively summarize the levels of tear cytokines in DED. Methods-The PubMed, Embase, Web of Science, Ovid, Cochrane, and Scopus databases were reviewed until September 2019, and original articles investigating tear cytokines in DED patients were included. Differences of cytokines levels of DED patients and controls were summarized by standardized mean differences (SMD) using a random effects model. Study quality was assessed by applying Newcastle-Ottawa-Scale and the GRADE quality score. Methods of analytical procedures were included as covariate. Results-Thirteen articles investigating 342 DED patients and 205 healthy controls were included in the meta-analysis. The overall methodological quality of these studies was moderate. Systematic review of the selected articles revealed that DED patients had higher tear levels of interleukin (IL)-1β, IL-6, chemokine IL-8, IL-10, interferon-γ, IFN-γ, and tumor necrosis factor-α, TNF-α as compared to controls. Evidence was less strong for IL-2 and IL-17A. Conclusions-Data show that levels of tear cytokines in DED and control display a great variability, and further studies of higher quality enrolling a higher number of subjects are needed, to define a cut-off value.
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http://dx.doi.org/10.3390/ijms21093111DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7246678PMC
April 2020

Coronary Protection to Prevent Coronary Obstruction During TAVR: A Multicenter International Registry.

JACC Cardiovasc Interv 2020 03 12;13(6):739-747. Epub 2020 Feb 12.

Cedars-Sinai Medical Center, Los Angeles, California.

Objectives: The aim of this study was to investigate the safety and efficacy of coronary protection by preventive coronary wiring and stenting across the coronary ostia in patients at high risk for coronary obstruction after transcatheter aortic valve replacement (TAVR).

Background: Coronary obstruction following TAVR is a life-threatening complication with high procedural and short-term mortality.

Methods: Data were collected retrospectively from a multicenter international registry between April 2011 and February 2019.

Results: Among 236 patients undergoing coronary protection with preventive coronary wiring, 143 had eventually stents implanted across the coronary ostia after valve deployment. At 3-year follow-up, rates of cardiac death were 7.8% in patients receiving stents and 15.7% in those not receiving stents (adjusted hazard ratio: 0.42; 95% confidence interval: 0.14 to 1.28; p = 0.13). There were 2 definite stent thromboses (0.9%) in patients receiving stents, both occurring after TAVR in "valve-in-valve" procedures. In patients not receiving stents, there were 4 delayed coronary occlusions (DCOs) (4.3%), occurring from 5 min to 6 h after wire removal. Three cases occurred in valve-in-valve procedures and 1 in a native aortic valve procedure. Distance between the virtual transcatheter valve and the protected coronary ostia <4 mm was present in 75.0% of patients with DCO compared with 30.4% of patients without DCO (p = 0.19).

Conclusions: In patients undergoing TAVR at high risk for coronary obstruction, preventive stent implantation across the coronary ostia is associated with good mid-term survival rates and low rates of stent thrombosis. Patients undergoing coronary protection with wire only have a considerable risk for DCO.
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http://dx.doi.org/10.1016/j.jcin.2019.11.024DOI Listing
March 2020

Impact of coronary bypass or stenting on mortality and myocardial infarction in stable coronary artery disease.

Int J Cardiol 2020 06 23;309:63-69. Epub 2020 Jan 23.

Dipartimento di Medicina Specialistica, Diagnostica e Sperimentale, Alma Mater Studiorum Università di Bologna, Italy.

Background: To assess whether coronary bypass (CABG) or stenting reduce the risk of mortality and myocardial infarction (MI) compared with optimal medical therapy (OMT) in stable coronary artery disease (CAD).

Methods: We performed a systematic review and network meta-analysis of contemporary randomized controlled trials comparing OMT, CABG and different stent types in stable CAD. All-comer trials were included if the rate of patients with acute myocardial infarction (AMI) was≤20%. Endpoints were all-cause mortality and MI.

Results: Ninety-seven trials including 75,754 patients were analyzed at a weighted mean follow up of 42.5 months. Compared to OMT, CABG was associated with a lower risk of death (OR = 0.84; 95%CI:0.71-0.97). After exclusion of trials in left main and/or multivessel disease(LM/MVD) this benefit was not statistically significant (OR = 0.89; 95%CI:0.74-1.06). CABG was associated with a lower risk of MI (OR = 0.67;95%CI: 0.49-0.91) showing, however, a certain degree of inconsistency (p=0.10). None of the stent types included was associated with a lower risk of death. However, durable-polymer-CoCr-everolimus-eluting stent, by mixed evidence, after exclusion of either LM/MVD (OR = 0.73;95%CI: 0.54-0.98) or all-comer/post-MI trials (OR = 0.62;95%CI:0.39-0.98) was associated with a lower risk of MI than OMT. Similar findings, by indirect evidence, were confirmed for bio-absorbable-polymer-CoCr-sirolimus eluting stent (LMV/MVD trials excluded OR = 0.46; 95%CI = 0.29-0.74, all-comer/post-MI trials excluded: OR = 0.41;95%CI:0.22-0.79).

Conclusions: In stable CAD, CABG reduces the risk of mortality and MI compared to OMT, especially in patients with higher extent of CAD. Our study suggests that some of second and latest-generation drug-eluting stents may reduce the risk of MI. Future research should confirm these latter findings.
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http://dx.doi.org/10.1016/j.ijcard.2020.01.054DOI Listing
June 2020

Does the Site of Origin of the Microcarcinoma with Respect to the Thyroid Surface Matter? A Multicenter Pathologic and Clinical Study for Risk Stratification.

Cancers (Basel) 2020 01 19;12(1). Epub 2020 Jan 19.

Department of Translational and Precision Medicine, "Sapienza" University of Rome, Rome 00185, Italy.

It is unclear whether the site of origin of papillary thyroid microcarcinoma (mPTC) with respect to the thyroid surface has an influence on clinicopathologic parameters. The objectives of the study were to: (i) Accurately measure the mPTC distance from the thyroid surface; (ii) analyze whether this distance correlates with relevant clinicopathologic parameters; and (iii) investigate the impact of the site of origin of the mPTC on risk stratification. Clinicopathologic features and mutational status were analyzed and correlated with the site of origin of the mPTC in a multicenter cohort of 298 mPTCs from six Italian medical institutions. Tumors arise at a median distance of 3.5 mm below the surface of the thyroid gland. Statistical analysis identified four distinct clusters. Group A, mPTC: size ≥ 5 mm and distance of the edge of the tumor from the thyroid capsule = 0 mm; group B, mPTC: size ≥ 5 mm and distance of the edge of the tumor from the thyroid capsule > 0 mm; group C, mPTC: size < 5 mm and distance of the edge of the tumor from the thyroid capsule = 0 mm; and group D, mPTC: size < 5 mm and distance of the edge of the tumor from the thyroid capsule > 0 mm. Univariate analysis demonstrates significant differences between the groups: Group A shows the most aggressive features, and group D the most indolent ones. By multivariate analysis, group A tumors are characterized by tall cell histotype, V600E mutation, tumor fibrosis, aggressive growth with invasive features, vascular invasion, lymph node metastases, and intermediate ATA risk. The mPTC clinicopathologic features vary according to the tumor size and distance from the thyroid surface. A four-group model may be useful for risk stratification and to refine the selection of nodules to be targeted for fine needle aspiration.
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http://dx.doi.org/10.3390/cancers12010246DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7016743PMC
January 2020

Predictors of survival in malignant aortic tumors.

J Vasc Surg 2020 05 17;71(5):1771-1780. Epub 2019 Dec 17.

Vascular Surgery, Department of Experimental, Diagnostic and Specialty Medicine, University of Bologna, Policlinico Sant'Orsola-Malpighi, Bologna, Italy.

Objective: Malignant aortic tumors (MATs) are exceedingly rare, and a comprehensive review of clinical and therapeutic aspects is lacking in the literature. The aim of this study was to analyze all known cases of MATs and to identify predictors of patients' survival.

Methods: All patients diagnosed with an aortic tumor treated in a single center along with all case reports and reviews available in the literature through a specific PubMed search using keywords such as "malignant" and "aorta" or "aortic," "tumor," or "sarcoma" or "angiosarcoma" were analyzed. The tumor's primary location, clinical presentation, histologic subtype, and treatment choice were examined. Survival at 1 year, 3 years, and 5 years and the possible preoperative and operative outcome predictors were evaluated using Kaplan-Meier analysis with a log-rank test and by Cox regression for multivariate analysis.

Results: In addition to the 5 cases treated in our center, 218 other cases of MAT were reported in the literature from 1873 to 2017. The mean age of the patients was 60.1 ± 11.9 years, and the male to female ratio was 1.59:1. The median overall survival from diagnosis was 8 (7-9) months; 1-, 3-, and 5-year survival rates were 26%, 7.6%, and 3.5%, respectively. Chronic hypertension (P = .03), fever (P = .03), back pain (P = .01), asthenia (P = .04), and signs of peripheral embolization (P = .007) were significant predictors of a poor result. Histologic subtypes had a different impact on survival, with no statistical significance. Compared with other treatment strategies, combined surgical-medical therapy had the best impact on the median survival rate (surgical-medical, 12 [8-24] months; medical, 8 [5-10] months; surgical 7 [2-16] months; no treatment, 2 [0.5-15] months; P = .001). Analyzing exclusively medical approaches, chemotherapy and radiotherapy had the best impact on median survival rate compared with untreated patients (chemotherapy-radiotherapy, 18 [10-26] months; radiotherapy, 16 [8-20] months; chemotherapy, 10 [7-24] months; no medical treatment, 6 [2-16] months; P = .005); these data were not sustained by multivariate analysis.

Conclusions: Aortic tumors are a malignant pathologic condition with a short survival rate after initial diagnosis. Survival is further diminished in the presence of clinical factors such as hypertension, fever, back pain, asthenia, and signs of peripheral embolization. Combined surgical and medical treatment, particularly with chemotherapy and radiotherapy, has shown the highest survival rate.
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http://dx.doi.org/10.1016/j.jvs.2019.09.030DOI Listing
May 2020

Interleukin 28 Polymorphisms and Hepatocellular Carcinoma Development after Direct Acting Antiviral Therapy for Chronic Hepatitis C.

J Gastrointestin Liver Dis 2019 Dec 9;28(4):449-456. Epub 2019 Dec 9.

Department of Medical and Surgical Sciences (DIMEC), University of Bologna, Gastroenterology and Hepatology Unit, S. Orsola- Malpighi University Hospital, Bologna, Italy; Centre for Applied Biomedical Research (CRBA), University of Bologna, S. Orsola- Malpighi University Hospital, Bologna, Italy.

Background And Aims: Cirrhotic patients with hepatitis C virus (HCV) infection remain at risk of developing hepatocellular carcinoma (HCC) even after the sustained virologic response (SVR). We aimed to evaluate whether the IL28 (rs12979860) single nucleotide polymorphism (SNP) may constitute a predisposing genetic factor and to identify the SVR patients at risk of HCC.

Methods: Two hundred patients undergoing DAAs treatment for chronic hepatitis C with advanced fibrosis (F3- F4) were consecutively enrolled. Besides normal routine laboratory testing for HCV, patients' sera were evaluated also for retinol, retinol-binding protein 4 and the following SNPs: PNPLA3 (rs738409), TM6SF2 (rs58542926), MBOAT7 (rs641738), IL28B (rs12979860), TIMP-1 (rs4898), TIMP-2 (rs8179090), NF-kB promoter (rs28362491). Statistical analyses were conducted using Stata/SE 14.2 statistical software (Stata Corp, College Station, TX).

Results: Almost all patients (197/200) obtained SVR24. Seventeen patients had a previous history of treated HCC before DAAs. Six patients developed HCC recurrence and five patients developed de novo HCC after a mean period of 18 months since EOT. All these patients had SVR. A significant association between IL28B - TT genotype and HCC development after DAAs therapy was observed (OR 4.728, CI 95% 1.222 - 18.297, p=0.024).

Conclusion: IL28B rs12979860 polymorphism was significantly associated with HCC development after DAAs. Assessment of this SNP may better identify patients at risk of developing HCC after treatment. Further prospective studies are required to confirm these hypotheses.
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http://dx.doi.org/10.15403/jgld-309DOI Listing
December 2019

In vitro thrombogenicity of drug-eluting and bare metal stents.

Thromb Res 2020 01 14;185:43-48. Epub 2019 Nov 14.

Columbia University Medical Center/New York-Presbyterian Hospital and the Cardiovascular Research Foundation, New York, NY, United States.

Aims: We sought to investigate the thrombogenicity of different DES and BMS in an in vitro system of stent perfusion.

Material And Methods: The experimental model consisted of a peristaltic pump connected to 4 parallel silicone tubes in which different stents were deployed. Blood was drawn from healthy volunteers and the amount of stent surfaced-induced thrombus deposition was determined using I-fibrinogen.

Results: Compared to Resolute, Biomatrix and Vision, Xience was associated with the lowest amount of stent surface-induced thrombus formation, with a significant difference compared to Vision (I-fibrinogen median value deposition [IQ range]: 50 ng [25-98] versus 560 ng [320-1520], respectively, p < 0.05), but not to other DES. In the second set of experiments Fluoropolymer-coated BMS not eluting drug was associated with a significant 3-fold reduction in I-fibrinogen deposition (245 ng [80-300]) compared to Vision (625 ng [320-760], p < 0.05), but a 7-fold increase compared to Xience (35 ng [20-60], p < 0.05). Finally Xience was associated with a significantly greater absorption of albumin compared to BMS.

Conclusions: In an in vitro system of stent perfusion, Xience was associated with the lowest amount of stent surface-induced thrombus formation compared with Resolute, Biomatrix and Vision, with a noted synergistic effect between the fluoropolymer and the drug.
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http://dx.doi.org/10.1016/j.thromres.2019.11.016DOI Listing
January 2020

Epidemiology and complications of late-onset sepsis: an Italian area-based study.

PLoS One 2019 22;14(11):e0225407. Epub 2019 Nov 22.

Dipartimento di Medicina Specialistica, Diagnostica e Sperimentale, Azienda Ospedaliero-Universitaria S. Orsola-Malpighi-Università di Bologna, Bologna, Italy.

Background: Most studies regarding late-onset sepsis (LOS) address selected populations (i.e., neonates with low birth weight or extremely preterm neonates). Studying all age groups is more suitable to assess the burden of single pathogens and their clinical relevance.

Methods: This is a retrospective regional study involving paediatric departments and NICUs in Emilia-Romagna (Italy). Regional laboratory databases were searched from 2009 to 2012. Records of infants (aged 4 to 90 days) with a positive blood or cerebrospinal fluid (CSF) culture were retrospectively reviewed and analysed according to acquisition mode (whether hospital- or community-acquired).

Results: During the study period, there were 146,682 live births (LBs), with 296 patients experiencing 331 episodes of LOS (incidence rate: 2.3/1000 LBs). Brain lesions upon discharge from the hospital were found in 12.3% (40/296) of cases, with death occurring in 7.1% (23/296; 0.14/1000 LBs). With respect to full-term neonates, extremely preterm or extremely low birth weight neonates had very high risk of LOS and related mortality (> 100- and > 800-fold higher respectively). Hospital-acquired LOS (n = 209) was significantly associated with very low birth weight, extremely preterm birth, pneumonia, mechanical ventilation, and death (p< 0.01). At multivariate logistic regression analysis, catecholamine support (OR = 3.2), central venous line before LOS (OR = 14.9), and meningitis (OR = 44.7) were associated with brain lesions or death in hospital-acquired LOS (area under the ROC curve 0.81, H-L p = 0.41). Commonly identified pathogens included coagulase-negative staphylococci (CoNS n = 71, 21.4%), Escherichia coli (n = 50, 15.1%), Staphylococcus aureus (n = 41, 12.4%) and Enterobacteriaceae (n = 41, 12.4%). Group B streptococcus was the predominant cause of meningitis (16 of 38 cases, 42%). Most pathogens were sensitive to first line antibiotics.

Conclusions: This study provides the first Italian data regarding late-onset sepsis (LOS) in all gestational age groups. Compared to full-term neonates, very high rates of LOS and mortality occurred in neonates with a lower birth weight and gestational age. Group B streptococcus was the leading cause of meningitis. Excluding CoNS, the predominant pathogens were Escherichia coli and Staphylococcus aureus. Neonates with hospital-acquired LOS had a worse outcome. Antibiotic associations, recommended for empirical treatment of hospital- or community-acquired LOS, were adequate.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0225407PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6874360PMC
March 2020

Differences in cardiac phenotype and natural history of laminopathies with and without neuromuscular onset.

Orphanet J Rare Dis 2019 11 19;14(1):263. Epub 2019 Nov 19.

Cardiology Unit, Cardio-Thoracic-Vascular Department, Sant'Orsola-Malpighi Hospital, University of Bologna, Via G. Massarenti 9, 40138, Bologna, Italy.

Objective: To investigate differences in cardiac manifestations of patients affected by laminopathy, according to the presence or absence of neuromuscular involvement at presentation.

Methods: We prospectively analyzed 40 consecutive patients with a diagnosis of laminopathy followed at a single centre between 1998 and 2017. Additionally, reports of clinical evaluations and tests prior to referral at our centre were retrospectively evaluated.

Results: Clinical onset was cardiac in 26 cases and neuromuscular in 14. Patients with neuromuscular presentation experienced first symptoms earlier in life (11 vs 39 years; p <  0.0001) and developed atrial fibrillation/flutter (AF) and required pacemaker implantation at a younger age (28 vs 41 years [p = 0.013] and 30 vs 44 years [p = 0.086] respectively), despite a similar overall prevalence of AF (57% vs 65%; p = 0.735) and atrio-ventricular (A-V) block (50% vs 65%; p = 0.500). Those with a neuromuscular presentation developed a cardiomyopathy less frequently (43% vs 73%; p = 0.089) and had a lower rate of sustained ventricular tachyarrhythmias (7% vs 23%; p = 0.387). In patients with neuromuscular onset rhythm disturbances occurred usually before evidence of cardiomyopathy. Despite these differences, the need for heart transplantation and median age at intervention were similar in the two groups (29% vs 23% [p = 0.717] and 43 vs 46 years [p = 0.593] respectively).

Conclusions: In patients with laminopathy, the type of disease onset was a marker for a different natural history. Specifically, patients with neuromuscular presentation had an earlier cardiac involvement, characterized by a linear and progressive evolution from rhythm disorders (AF and/or A-V block) to cardiomyopathy.
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http://dx.doi.org/10.1186/s13023-019-1245-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6862731PMC
November 2019

The complex interplay among atherosclerosis, inflammation, and degeneration in ascending thoracic aortic aneurysms.

J Thorac Cardiovasc Surg 2020 Dec 1;160(6):1434-1443.e6. Epub 2019 Oct 1.

Cardiology, Department of Experimental Diagnostic and Specialty Medicine, Alma Mater Studiorum, University of Bologna, Bologna, Italy. Electronic address:

Objective: To assess the histopathological findings of a large series of ascending thoracic aortic aneurysm (TAA) surgical specimens applying the updated classification on noninflammatory degenerative and inflammatory aortic diseases proposed by the Association for European Cardiovascular Pathology and the Society for Cardiovascular Pathology clinicopathological correlations.

Methods: A total of 255 patients surgically treated for ascending TAA were enrolled. Surgical ascending aorta specimens were examined.

Results: The histopathological substrate of ascending TAAs was mainly degenerative (67.5%), but with a remarkable prevalence of atherosclerotic lesions (18.8%) and aortitis (13.7%). Degenerative patients more frequently had bicuspid aortic valve (37.2%; P = .002). Patients in the atherosclerotic group were older (median age, 69 years; P < .001), more often with a history of hypertension (87.5%; P = .059), hypercholesterolemia (75%; P = .019), diabetes (16.6%; P = .054), current smoking (22.9%; P = .066), and a history of coronary artery disease (18.7%; P = .063). Patients with aortitis represented the older group (median age, 75 years, P < .001), were mostly females (68.6%; P < .001), and had a larger ascending aorta diameter (median, 56 mm; P < .001). Both patients with atherosclerosis and aortitis presented a higher incidence of concomitant abdominal aortic aneurysm (20.8% and 22.8%, respectively; P < .001).

Conclusions: Although degenerative histopathology is the most frequent substrate in ascending TAA, atherosclerosis and inflammation significantly contribute to the development of chronic aortic thoracic disease.
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http://dx.doi.org/10.1016/j.jtcvs.2019.08.108DOI Listing
December 2020

Real-life comparison of pirfenidone and nintedanib in patients with idiopathic pulmonary fibrosis: A 24-month assessment.

Respir Med 2019 11 18;159:105803. Epub 2019 Oct 18.

Alma Mater University, Department of Clinical, Integrated and Experimental Medicine (DIMES), Respiratory and Critical Care Unit, S. Orsola-Malpighi Hospital Bologna, Bologna, Italy. Electronic address:

Background: Real-life data on the use of pirfenidone and nintedanib to treat patients with idiopathic pulmonary fibrosis (IPF) are still scarce.

Methods: We compared the efficacy of either pirfenidone (n = 78) or nintedanib (n = 28) delivered over a 24-month period in patients with IPF, followed at two regional clinic centers in Italy, with a group of patients who refused the treatment (n = 36), and who were considered to be controls. All patients completed regular visits at 1- to 3-month intervals, where primary [forced vital capacity (FVC) and diffusing capacity of the lungs for carbon monoxide (DLCO)] and secondary outcomes (side effects, treatment compliance, and mortality) were recorded.

Results: Over time, the decline in FVC and DLCO was significantly higher (p = 0.0053 and p = 0.037, respectively) in controls when compared with the combined treated group, with no significant difference between the two treated groups. Compared to patients with less advanced disease (GAP (Gender, Age, Physiology) stage I), those in GAP stages II and III showed a significantly higher decline in both FVC and DLCO irrespective of the drug taken. Side effects were similarly reported in patients receiving pirfenidone and nintedanib (5% and 7%, respectively), whereas mortality did not differ among the three groups.

Conclusion: This real-life study demonstrated that both pirfenidone and nintedanib were equally effective in reducing the decline of FVC and DLCO versus non-treated patients after 24 months of treatment; however, patients with more advanced disease were likely to show a more rapid decline in respiratory function.
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http://dx.doi.org/10.1016/j.rmed.2019.105803DOI Listing
November 2019

Multicenter observational study on the reliability of the HEART score.

Clin Exp Emerg Med 2019 Sep 30;6(3):212-217. Epub 2019 Sep 30.

Emergency Department, University Hospital of Parma, Parma, Italy.

Objective: To rapidly and safely identify the risk of developing acute coronary syndrome in patients with chest pain who present to the emergency department, the clinical use of the History, Electrocardiogram, Age, Risk Factors, and Troponin (HEART) scoring has recently been proposed. This study aimed to assess the inter-rater reliability of the HEART score calculated by a large number of Italian emergency physicians.

Methods: The study was conducted in three academic emergency departments using clinical scenarios obtained from medical records of patients with chest pain. Twenty physicians, who took the HEART score course, independently assigned a score to different clinical scenarios, which were randomly administered to the participants, and data were collected and recorded in a spreadsheet by an independent investigator who was blinded to the study's aim.

Results: After applying the exclusion criteria, 53 scenarios were finally included in the analysis. The general inter-rater reliability was good (kappa statistics [κ], 0.63; 95% confidence interval, 0.57 to 0.70), and a good inter-rater agreement for the high- and low-risk classes (HEART score, 7 to 10 and 0 to 3, respectively; κ, 0.60 to 0.73) was observed, whereas a moderate agreement was found for the intermediate-risk class (HEART score, 4 to 6; κ, 0.51). Among the different items of the HEART score, history and electrocardiogram had the worse agreement (κ, 0.37 and 0.42, respectively).

Conclusion: The HEART score had good inter-rater reliability, particularly among the high- and low-risk classes. The modest agreement for history suggests that major improvements are needed for objectively assessing this component.
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http://dx.doi.org/10.15441/ceem.18.045DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6774007PMC
September 2019

Surgical Risk Scores Applied to Transcatheter Aortic Valve Implantation: Friends or Foes? Short-Term and Long-Term Outcomes From a Single-Center Registry.

J Invasive Cardiol 2019 Oct;31(10):E282-E288

Interventional Cardiology Unit, Cardio-Thoracic-Vascular Department, Policlinico S.Orsola-Malpighi (Pavilion 23), Via Massarenti 9, 40138 Bologna, Italy.

Background: Transcatheter aortic valve implantation (TAVI) is a valid alternative to surgical aortic valve replacement for the treatment of symptomatic aortic stenosis. The EuroScore (ES) II, logistic EuroScore (log ES), and the Society of Thoracic Surgeons (STS) score are the most applied scores for surgical risk stratification. However, their predictive value for patients undergoing TAVI is still unclear.

Aim: To evaluate the performance of STS, log ES and ES II as predictors of short-term and long-term mortality in patients undergoing TAVI.

Methods: Between February 2008 and October 2017, a total of 384 patients underwent transfemoral TAVI at our institution and constituted the study population. Patients were divided into three groups based on the class of risk (low, intermediate, and high) calculated by each score. In-hospital complications, 30-day outcomes, and 5-year outcomes were assessed.

Results: In-hospital mortality rate was 2.6% (n = 10). All scores over-estimated the risk of 30-day mortality, especially for the highest risk classes. At the end of follow-up (5 years), STS risk stratification was able to stratify all-cause and cardiovascular (CV) mortality (P<.01 and P=.02, respectively). Patients with intermediate ES II risk showed a lower survival rate (P=.04) while CV deaths did not differ between classes of risk. All-cause mortality and CV mortality curves did not diverge according to the patients' risk profiles derived from log ES.

Conclusion: Conventional surgical risk scores are not appropriate to predict 30-day mortality in patients undergoing transfemoral TAVI. STS assessment was the only risk score able to stratify long-term all-cause and CV mortality.
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October 2019

Factors affecting the number of lymph nodes retrieved after colo-rectal cancer surgery: A prospective single-centre study.

Surgeon 2020 Feb 16;18(1):31-36. Epub 2019 Jul 16.

Addenbrookes Hospital - University of Cambridge, UK. Electronic address:

Background: The number of harvested lymph nodes (LNs) in colorectal cancer surgery relates to oncologic radicality and accuracy of staging. In addition, it affects the choice of adjuvant therapy, as well as prognosis. The American Joint Committee on Cancer defines at least 12 LNs harvested as adequate in colorectal cancer resections. Despite the importance of the topic, even in high-volume colorectal centres the rate of adequacy never reaches 100%. The aim of this study was to identify factors that affect the number of harvested LNs in oncologic colorectal surgery.

Materials And Methods: We prospectively collected all consecutive patients who underwent colorectal cancer resection from January 1st 2013 to December 31st 2017 at Emergency Surgery Unit St Orsola University Hospital of Bologna.

Results: Six hundred and forty-three consecutive patients (382 elective, 261 emergency) met the study inclusion criteria. Emergency surgery and laparoscopic approach did not have a significant influence on the number of harvested LNs. The adequacy of lymphadenectomy was negatively affected by age >80 (OR 3.47, p < 0.001), ASA score ≥3 (OR 3.48, p < 0.001), Hartmann's or rectal resection (OR 3.6, p < 0.001) and R1-R2 resection margins (OR 3.9, p = 0.006), while it was positively affected by T-status ≥3 (OR 0.33 p < 0.001).

Conclusion: Both the surgical technique and procedure regimen did not affect the number of lymphnodes retrieved. Age >80 and ASA score ≥3 and Hartmann's procedure or rectal resection showed to be risk factors related to inadequate lymphadenectomy in colorectal cancer surgery.
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http://dx.doi.org/10.1016/j.surge.2019.05.002DOI Listing
February 2020

Risk factors for group B streptococcus early-onset disease: an Italian, area-based, case-control study.

J Matern Fetal Neonatal Med 2020 Jul 17;33(14):2480-2486. Epub 2019 Jul 17.

Unità Operativa di Terapia Intensiva Neonatale, Dipartimento Integrato Materno-Infantile, Azienda Ospedaliero-Universitaria Policlinico, Modena, Italy.

Intrapartum antibiotic prophylaxis (IAP) prevents group B streptococcus (GBS) early-onset disease (EOD). No European study evaluates the relative impact of risk factors (RFs) for EOD after a screening-based strategy and widespread IAP use We aimed to evaluate the risks of EOD in an Italian region where a screening-based strategy for preventing EOD was implemented. Cases of EOD born at or above 35 weeks' gestation were reviewed and matched with controls. There were 109 cases of EOD among 532,154 live births. Most cases had negative GBS prenatal screening (56/91, 61.5%) and were unexposed to IAP (86/109, 78.9%). At multivariate analysis, GBS bacteriuria ( = 6.99), positive prenatal screening ( = 13.7) and maternal intrapartum fever ( = 188.3) were associated with an increased risk of EOD, whereas intrapartum beta-lactam antibiotics were associated with a decreased risk of EOD (≥4 h:  = 0.008; <4 h:  = 0.04). Neonates born to nonfebrile, GBS positive pregnant women, receiving beta-lactam antibiotics had very low probability of EOD, particularly if IAP was adequate. GBS positive prenatal screening, GBS bacteriuria and intrapartum fever are associated with EOD. Intrapartum beta-lactam antibiotics reduce the probability of EOD in neonates born to nonfebrile mothers.
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http://dx.doi.org/10.1080/14767058.2019.1628943DOI Listing
July 2020

Predictors of time to sputum smear conversion in patients with pulmonary tuberculosis under treatment.

New Microbiol 2019 Jul 3;42(3):171-175. Epub 2019 Jun 3.

Department of Experimental, Diagnostic and Specialty Medicine - Unit of Microbiology, S. Orsola-Malpighi University Hospital, Bologna, Italy.

Sputum acid-fast bacilli smear conversion is a fundamental index of treatment response and reduced infectivity in patients with pulmonary tuberculosis (P-TB). To date, there are no models to predict the time to sputum conversion based on patient characteristics. This study aims to ascertain the time to sputum conversion in patients with smear-positive P-TB under treatment, and the variables associated with time to smear conversion. We retrospectively evaluated the time to sputum smear conversion of 89 patients with smear-positive P-TB undergoing treatment at the S. Orsola-Malpighi University Hospital, Bologna (Italy), a referral centre for the diagnosis of TB. Multivariate Cox regression analysis was performed to document variables independently associated with time to conversion. Median time to sputum smear conversion was 24 days (IQR 12-54); the sputum smear converted within the first 2 months of treatment in 78.7% patients. Multivariate Cox regression analysis showed that older age, high baseline mycobacterial load detected by Xpert MTB/RIF, and severity of lung involvement are predictors of persistent smear positivity. The identification of risk factors delaying smear conversion allowed us to develop predictive models that may greatly facilitate the management of smear-positive patients in terms of the duration of respiratory isolation and treatment.
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July 2019

Open distal anastomosis in the frozen elephant trunk technique: initial experiences and preliminary results of arch zone 2 versus arch zone 3†.

Eur J Cardiothorac Surg 2019 Sep;56(3):564-571

Cardiac Surgery Unit, Cardio-Thoracic-Vascular Department, S. Orsola Hospital, Alma Mater Studiorum - University of Bologna, Bologna, Italy.

Objectives: We compared the results of 2 groups of patients who underwent aortic arch replacement with the frozen elephant trunk technique. In the first group, the distal anastomosis was performed in arch zone 2; in the second control group, the distal anastomosis was performed in arch zone 3.

Methods: Between January 2007 and April 2018, the frozen elephant trunk technique was used in 282 patients. The median age was 62 years (range 18-83 years), and 233 patients were men (82.6%). Two different frozen elephant trunk prostheses were used: the Jotec E-vita open prosthesis in 167 patients (59.2%) and the Vascutek Thoraflex hybrid prosthesis in 115 patients (40.8%). Patients were divided into 2 groups according to the distal anastomosis site: zone 2 group (69 patients) and zone 3 group (213 patients). The main indications were chronic aortic dissection (n = 164, 58.2%), degenerative aneurysm (n = 72, 25.5%) and acute aortic dissections (n = 45, 16%).

Results: The overall in-hospital mortality rate was 17%: 20% for the zone 2 group and 16% for the zone 3 group, without significant differences, also in terms of cardiopulmonary bypass and myocardial ischaemia times. However, the visceral ischaemia time was significantly shorter for the zone 2 group, whereas the antegrade selective cerebral perfusion time was significantly longer for the same group. Recurrent laryngeal nerve injury rate was lower in the zone 2 group. The overall postoperative paraplegia rate was 3.5%, whereas the occurrence of permanent neurological dysfunction and dialysis was 9% and 19%, respectively, with no significant differences between the groups.

Conclusions: 'Proximalization' of the distal anastomosis can be used for arch reconstruction, especially in complex cases such as reoperations or acute aortic dissections. Furthermore, with the aid of branched hybrid grafts, a reduction of the visceral ischaemia time is achieved.
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http://dx.doi.org/10.1093/ejcts/ezz103DOI Listing
September 2019

Coronary artery disease and reasonably incomplete coronary revascularization in high-risk patients undergoing transcatheter aortic valve implantation.

Catheter Cardiovasc Interv 2020 01 27;95(1):19-27. Epub 2019 Mar 27.

Cardiology Unit, Cardio-Thoracic-Vascular Department, University Hospital of Bologna, Bologna, Italy.

Objectives: To evaluate the long-term impact of coronary artery disease (CAD) and heart team-guided incomplete coronary revascularization in patients undergoing transcatheter aortic valve implantation (TAVI).

Background: Revascularization strategy of CAD diagnosed with routine coronary angiography before TAVI is uncertain.

Methods: Five hundred and forty consecutive TAVI patients were classified as having CAD or normal coronary arteries (no-CAD). Within the CAD group, patients were further classified as those with complete (CR) versus incomplete revascularization (IR). Revascularization strategy was guided by the Heart Team following an algorithm largely based on current guidelines. Main outcome of interest was the incidence of 5-year cardiovascular (CV) death.

Results: Prevalence of CAD was 53.9%. CAD patients showed significantly lower left ventricular ejection fraction (LVEF: 55.8 ± 13.4% CAD vs. 61.4% ± 12.1 no-CAD, p < .0001), lower gradients, and larger ventricular volumes in comparison with the no-CAD group. Within the CAD group, 138 patients (47.4%) received CR and 153 (52.6%) IR. In-hospital mortality was 3.9%, without significant difference between groups (4.0% no-CAD vs. 3.8% CAD, p = .88; 2.9% CR vs. 4.6% IR, p = .45). Median follow-up was 57.8 months. Five-year survival free from CV death was 79.6% in the CAD versus 77.9% in the no-CAD group (p = .98), and 84.3% in the CR versus 74.3% in the IR groups (p = .25). These results were confirmed excluding patients with previous revascularization. At multivariable analyses, presentation with acute coronary syndrome (ACS) was significantly associated with 5-year CV death.

Conclusions: CAD is frequent in patients undergoing TAVI but portends an adverse prognosis only when presenting with ACS. Heart-team directed complete or reasonably incomplete revascularization was associated with comparable outcomes.
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http://dx.doi.org/10.1002/ccd.28211DOI Listing
January 2020

Group B Streptococcus early-onset disease and observation of well-appearing newborns.

PLoS One 2019 20;14(3):e0212784. Epub 2019 Mar 20.

Terapia Intensiva Neonatale, Dipartimento Integrato Materno-Infantile, Azienda Ospedaliero-Universitaria Policlinico, Modena, Italy.

Background: International guidelines lack a substantial consensus regarding management of asymptomatic full-term and late preterm neonates at risk for early-onset disease (EOS). Large cohorts of newborns are suitable to increase the understanding of the safety and efficacy of a given strategy.

Methods: This is a prospective, area-based, cohort study involving regional birth facilities of Emilia-Romagna (Italy). We compared cases of EOS (at or above 35 weeks' gestation) registered in 2003-2009 (baseline period: 266,646 LBs) and in 2010-2016, after introduction of a new strategy (serial physical examinations, SPEs) for managing asymptomatic neonates at risk for EOS (intervention period: 265,508 LBs).

Results: There were 108 cases of EOS (baseline period, n = 60; intervention period, n = 48). Twenty-two (20.4%) remained asymptomatic through the first 72 hours of life, whereas 86 (79.6%) developed symptoms, in most cases (52/86, 60.5%) at birth or within 6 hours. The median age at presentation was significantly earlier in the intrapartum antibiotic prophylaxis (IAP)-exposed than in the IAP-unexposed neonates (0 hours, IQR 0.0000-0.0000 vs 6 hours, IQR 0.0000-15.0000, p<0.001). High number of neonates (n = 531) asymptomatic at birth, exposed to intrapartum fever, should be treated empirically for each newborn who subsequently develops sepsis. IAP exposed neonates increased (12% vs 33%, p = 0.01), age at presentation decreased (median 6 vs 1 hours, p = 0.01), whereas meningitis, mechanical ventilation and mortality did not change in baseline vs intervention period. After implementing the SPEs, no cases had adverse outcomes due to the strategy, and no cases developed severe disease after 6 hours of life.

Conclusions: Infants with EOS exposed to IAP developed symptoms at birth in almost all cases, and those who appeared well at birth had a very low chance of having EOS. The risk of EOS in neonates (asymptomatic at birth) exposed to intrapartum fever was low. Although definite conclusions on causation are lacking, our data support SPEs of asymptomatic newborns at risk for EOS. SPEs seems a safe and effective alternative to laboratory screening and empirical antibiotic therapy.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0212784PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6426194PMC
November 2019

Risk-Benefit Profile of Longer-Than-1-Year Dual-Antiplatelet Therapy Duration After Drug-Eluting Stent Implantation in Relation to Clinical Presentation.

Circ Cardiovasc Interv 2019 03;12(3):e007541

Cardiovascular Research Foundation, New York, NY (P.G., T.P.V., G.W.S.).

Background: We sought to determine whether the risks and benefits of prolonging dual-antiplatelet therapy (DAPT) beyond 1 year after drug-eluting stent implantation depend on clinical presentation in a meta-analysis of randomized controlled trials.

Methods And Results: Randomized controlled trials comparing ≤1- versus >1-year DAPT after drug-eluting stent placement were searched through MEDLINE, EMBASE, Cochrane databases, and proceedings of international meetings. The primary efficacy end point was myocardial infarction, whereas the primary safety end point was major bleeding. Net clinical benefit was defined as the composite of myocardial infarction or major bleeding. Outcomes were analyzed according to patient presentation with stable ischemic heart disease versus acute coronary syndromes. The meta-analysis included 6 trials with a total of 21 457 patients, including 14 132 with stable ischemic heart disease and 7325 with acute coronary syndrome. After a median follow-up of 19.5 months, ≤1-year DAPT was associated with higher rates of myocardial infarction compared with >1-year DAPT (hazard ratio [HR], 1.63; 95% CI, 1.37-1.95), with no interaction apparent between treatment effect and clinical presentation. Shorter DAPT was associated with reduced rates of major bleeding compared with longer DAPT (HR, 0.64; 95% CI, 0.42-0.99) with no significant interaction between treatment effect and clinical presentation. However, a net clinical benefit of >1-year DAPT was present in patients with acute coronary syndrome (HR of shorter versus longer DAPT, 1.59; 95% CI, 1.24-2.02) but not in those with stable ischemic heart disease (HR, 1.15; 95% CI, 0.89-1.51; P=0.04). Shorter DAPT was also associated with lower rates of noncardiac mortality compared with longer DAPT (HR, 0.71; 95% CI, 0.52-0.96), with no significant interaction between treatment effect and clinical presentation ( P=0.12).

Conclusions: Compared with ≤1-year DAPT, >1-year DAPT reduces the risk of myocardial infarction but increases the risk of major bleeding and noncardiac mortality. A net clinical benefit of extended DAPT was apparent for patients with acute coronary syndrome but not for those with stable ischemic heart disease.
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http://dx.doi.org/10.1161/CIRCINTERVENTIONS.118.007541DOI Listing
March 2019