Publications by authors named "Aldo Salvi"

23 Publications

  • Page 1 of 1

Risk prediction of clinical adverse outcomes with machine learning in a cohort of critically ill patients with atrial fibrillation.

Sci Rep 2021 09 23;11(1):18925. Epub 2021 Sep 23.

Internal and Sub-Intensive Medicine Department, A.O.U. "Ospedali Riuniti" di Ancona, Via Conca 10, 60126, Ancona, Italy.

Critically ill patients affected by atrial fibrillation are at high risk of adverse events: however, the actual risk stratification models for haemorrhagic and thrombotic events are not validated in a critical care setting. With this paper we aimed to identify, adopting topological data analysis, the risk factors for therapeutic failure (in-hospital death or intensive care unit transfer), the in-hospital occurrence of stroke/TIA and major bleeding in a cohort of critically ill patients with pre-existing atrial fibrillation admitted to a stepdown unit; to engineer newer prediction models based on machine learning in the same cohort. We selected all medical patients admitted for critical illness and a history of pre-existing atrial fibrillation in the timeframe 01/01/2002-03/08/2007. All data regarding patients' medical history, comorbidities, drugs adopted, vital parameters and outcomes (therapeutic failure, stroke/TIA and major bleeding) were acquired from electronic medical records. Risk factors for each outcome were analyzed adopting topological data analysis. Machine learning was used to generate three different predictive models. We were able to identify specific risk factors and to engineer dedicated clinical prediction models for therapeutic failure (AUC: 0.974, 95%CI: 0.934-0.975), stroke/TIA (AUC: 0.931, 95%CI: 0.896-0.940; Brier score: 0.13) and major bleeding (AUC: 0.930:0.911-0.939; Brier score: 0.09) in critically-ill patients, which were able to predict accurately their respective clinical outcomes. Topological data analysis and machine learning techniques represent a concrete viewpoint for the physician to predict the risk at the patients' level, aiding the selection of the best therapeutic strategy in critically ill patients affected by pre-existing atrial fibrillation.
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September 2021

Clinical Method Applied to Focused Ultrasound: The Case of Wells' Score and Echocardiography in the Emergency Department: A Systematic Review and a Meta-Analysis.

Medicina (Kaunas) 2021 Jul 28;57(8). Epub 2021 Jul 28.

Internal and Subintensive Medicine Department, Azienda Ospedaliero-Universitaria "Ospedali Riuniti" di Ancona, 60100 Ancona, Italy.

bedside cardiac ultrasound is a widely adopted method in Emergency Departments (ED) for extending physical examination and refining clinical diagnosis. However, in the setting of hemodynamically-stable pulmonary embolism, the diagnostic role of echocardiography is still the subject of debate. In light of its high specificity and low sensitivity, some authors suggest that echocardiographic signs of right ventricle overload could be used to rule-in pulmonary embolism. In this study, we aimed to clarify the diagnostic role of echocardiographic signs of right ventricle overload in the setting of hemodynamically-stable pulmonary embolism in the ED. we performed a systematic review of literature in PubMed, Web of Science and Cochrane databases, considering the echocardiographic signs for the diagnosis of pulmonary embolism in the ED. Studies considering unstable or shocked patients were excluded. Papers enrolling hemodynamically stable subjects were selected. We performed a diagnostic test accuracy meta-analysis for each sign, and then performed a critical evaluation according to pretest probability, assessed with Wells' score for pulmonary embolism. 10 studies were finally included. We observed a good specificity and a low sensitivity of each echocardiographic sign of right ventricle overload. However, once stratified by the Wells' score, the post-test probability only increased among high-risk patients. signs of echocardiographic right ventricle overload should not be used to modify the clinical behavior in low- and intermediate- risk patients according to Wells' score classification. Among high-risk patients, however, echocardiographic signs could help a physician in detecting patients with the highest probability of pulmonary embolism, necessitating a confirmation by computed tomography with pulmonary angiography. However, a focused cardiac and thoracic ultrasound investigation is useful for the differential diagnosis of dyspnea and chest pain in the ED.
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July 2021

Early switch to oral anticoagulation in patients with acute intermediate-risk pulmonary embolism (PEITHO-2): a multinational, multicentre, single-arm, phase 4 trial.

Lancet Haematol 2021 Sep 4;8(9):e627-e636. Epub 2021 Aug 4.

Internal and Subintensive Medicine Department, Azienda Ospedaliero-Universitaria Ospedali Riuniti di Ancona, Ancona, Italy.

Background: Current guidelines recommend a risk-adjusted treatment strategy for the management of acute pulmonary embolism. This is a particular patient category for whom optimal treatment (anticoagulant treatment, reperfusion strategies, and duration of hospitalisation) is currently unknown. We investigated whether treatment of acute intermediate-risk pulmonary embolism with parenteral anticoagulation for a short period of 72 h, followed by a switch to a direct oral anticoagulant (dabigatran), is effective and safe.

Methods: We did a multinational, multicentre, single-arm, phase 4 trial at 42 hospitals in Austria, Belgium, France, Germany, Italy, Netherlands, Romania, Slovenia, and Spain. Adult patients (aged ≥18 years) with symptomatic intermediate-risk pulmonary embolism, with or without deep-vein thrombosis, were enrolled. Patients received parenteral low-molecular-weight or unfractionated heparin for 72 h after diagnosis of pulmonary embolism before switching to oral dabigatran 150 mg twice per day following a standard clinical assessment. The primary outcome was recurrent symptomatic venous thromboembolism or pulmonary embolism-related death within 6 months. The primary and safety outcomes were assessed in the intention-to-treat population. The study was terminated early, as advised by the data safety and monitoring board, following sample size adaptation after the predefined interim analysis on Dec 18, 2018. This trial is registered with the EU Clinical Trials Register (EudraCT 2015-001830-12) and (NCT02596555).

Findings: Between Jan 1, 2016, and July 31, 2019, 1418 patients with pulmonary embolism were screened, of whom 402 were enrolled and were included in the intention-to-treat analysis (median age was 69·5 years [IQR 60·0-78·0); 192 [48%] were women and 210 [52%] were men). Median follow-up was 217 days (IQR 210-224) and 370 (92%) patients adhered to the protocol. The primary outcome occurred in seven (2% [upper bound of right-sided 95% CI 3]; p<0·0001 for rejecting the null hypothesis) patients, with all events occurring in those with intermediate-high-risk pulmonary embolism (seven [3%; upper bound of right-sided 95% CI 5] of 283). At 6 months, 11 (3% [95% CI 1-5]) of 402 patients had at least one major bleeding event and 16 (4% [2-6]) had at least one clinically relevant non-major bleeding event; the only fatal haemorrhage occurred in one (<1%) patient before the switch to dabigatran.

Interpretation: A strategy of early switch from heparin to dabigatran following standard clinical assessment was effective and safe in patients with intermediate-risk pulmonary embolism. Our results can help to refine guideline recommendations for the initial treatment of acute intermediate-risk pulmonary embolism, optimising the use of resources and avoiding extended hospitalisation.

Funding: German Federal Ministry of Education and Research, University Medical Center Mainz, and Boehringer Ingelheim.
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September 2021

Patient-Reported Outcome Measurements (PROMs) After Discharge From the Emergency Department: A Cross-Sectional Study.

J Patient Exp 2021 18;8:23743735211007356. Epub 2021 Apr 18.

Management Department, Università Politecnica delle Marche, Ancona, Italy.

Background: The purpose of a patient-reported outcome (PRO) is to elicit the perspectives of patients and translate them into a reliable measurement questionnaire.

Objectives: The objective of this cross-sectional study was to detect a set of PROs and PRO measurements (PROMs) about patients with isolated trauma of the limbs receiving emergency department (ED) care.

Methods: A survey was performed in the ED using a questionnaire among the enrolled patients to identify which proposed outcomes were perceived as important by the patients according to their expectations.

Results: Ninety-six consecutive patients were conveniently enrolled. For each item of the questionnaire, the percentage of patients who agreed to perceive it important were calculated. Three items were perceived important by almost 85% of the patients: getting an x-ray (91%; 95% CI: 88%-98%), obtaining a written therapy (94%; 95% CI: 87%-97%), and feeling the physicians' and nurses' empathy (97%; 95% CI: 91%-99%). The ED system was able to satisfy 2 of the 3 agreed PROs in at least 85% of the cases: getting an x-ray (97%; 95% CI: 91%-99%) and obtaining a written therapy (97%; 95% CI: 91%-99%). Moreover, in 30/96 patients (31%; 95% CI: 22%-41%), all the PROs were satisfied, and in 75/96 patients (78%; 95% CI: 69%-85%), all agreed PROs were satisfied.

Conclusions: Our study shows an example of core of PROs proposed by the ED physicians and agreed by the patients. Moreover, we presented a set of PROMs which could be used to measure the quality of an ED.
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April 2021

Predictors of readmission requiring hospitalization after discharge from emergency departments in patients with COVID-19.

Am J Emerg Med 2021 Aug 22;46:146-149. Epub 2021 Apr 22.

Emergency Unit, Azienda Ospedaliero-Universitaria "Ospedali Riuniti", Ancona, Italy.

Introduction: Little is known on prevalence of early return hospital admission of subjects with COVID-19 previously evaluated and discharged from emergency departments (EDs). This study aims to describe readmission rate within 14 days of patients with COVID-19 discharged from ED and to identify predictors of return hospital admission.

Methods: We performed a retrospective cohort study of adult patients with COVID-19 discharged from two EDs. Return hospital admission was defined as an unscheduled return ED visit within 14 days after initial ED evaluation and discharge. We compared the group of patients who had a return hospital admission to those who did not. We also evaluated selected clinical characteristics (age, neutrophilia, SOFA, lactate dehydrogenase, C-reactive protein and D-dimer) associated with return hospital admission.

Results: Of 283 patients included in the study, 65 (22.9%) had a return ED visit within 14 days. 32 of those patients (11%) were then hospitalized, while the remaining 33 were again discharged. Patients requiring a return hospital admission was significantly older, had higher pro-calcitonin and D-dimer levels. Major predictors of return hospital admission were cognitive impairment (OR 17.3 [CI 4.7-63.2]), P/F < 300 mmHg (OR 8.6 [CI 1.6-44.3]), being resident in geriatric care facility (OR 7.6 [CI 2.1-26.4]) and neutrophilia (OR 5.8 [CI 1.6-22.0]).

Conclusion: Several factors are associated with 14-day return hospital admission in COVID-19 subjects. These should be considered when assessing discharge risk in ED clinical practice.
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August 2021

Diagnosis and Treatment of Deep Vein Thrombosis in the Emergency Department: Results of an Italian Nominal Group Technique Study.

Clin Appl Thromb Hemost 2020 Jan-Dec;26:1076029620959720

Internal and Vascular Medicine-Stroke Unit, 9309University of Perugia, Perugia, Italy.

Early diagnosis and treatment of deep vein thrombosis (DVT) is a main issue in the Emergency setting. With the aim of assisting clinicians in the diagnosis and the subsequent management of DVT in the Emergency Departments, a Nominal Group Technique (NGT) study was conducted. A panel of 5 Italian experts developed 21 consensus statements based on available evidence and their clinical experience. The agreed consensus statements may assist clinicians in applying the results of clinical studies and clinical experience to routine care settings, providing guidance on all aspects of the risk assessment, prophylaxis, early diagnosis and appropriate treatment of DVT in the EDs.
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July 2021

SOFA and qSOFA usefulness for in-hospital death prediction of elderly patients admitted for suspected infection in internal medicine.

Infection 2020 Dec 6;48(6):879-887. Epub 2020 Aug 6.

Internal Medicine Department, INRCA-IRCCS Hospital, Osimo (Ancona), Italy.

Purpose: To reduce intensive care unit overcrowding and optimize resources, elderly patients affected by suspected infection with declining clinical conditions could be managed in internal medicine departments with stepdown beds. However, commonly used prognostic scores, as Sequential Organ Failure Assessment (SOFA) or quick SOFA (qSOFA) have never been studied in this specific setting. The aim of this study was to evaluate the role and the accuracy of SOFA and qSOFA as prognostic scores in a population of elderly patients with suspected infection admitted to stepdown beds of two internal medicine departments.

Methods: Elderly patients admitted from the emergency department in the stepdown beds of two different internal medicine departments for suspected infection were assessed with SOFA and qSOFA scores at the admission. All patients were treated according to current guidelines. Age, sex, comorbidities, Charlson comorbidity index, SOFA and qSOFA were assessed. In-hospital death and length of hospital admission were also recorded.

Results: 390 subjects were enrolled. In-hospital death occurred in 144 (36.9%) patients; we observed that both SOFA (HR 1.189; 95% CI 1.128-1.253; p < 0.0001) and qSOFA (HR 1.803; 95% CI 1.503-2.164; p < 0.0001) scores were independently associated with an increased risk of in-hospital death. However, the accuracy of both SOFA (AUC: 0.686; 95% CI 0.637-0.732; p < 0.0001) and qSOFA (AUC: 0.680; 95% CI 0.641-0.735; p < 0.0001) in predicting in-hospital death was low in this population.

Conclusion: Elderly patients admitted to stepdown beds for suspected infection experience a high rate of in-hospital death; both SOFA and qSOFA scores can be useful to identify a group of patients who can benefit from admission to an intermediate care environment, however their accuracy is low.
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December 2020

Impact of atrial fibrillation in critically ill patients admitted to a stepdown unit.

Eur J Clin Invest 2020 Nov 29;50(11):e13317. Epub 2020 Jun 29.

Department of Biomedical Sciences and Public Health, Cardiology and Arrhythmology Clinic, Marche Polytechnic University, A.O.U. "Ospedali Riuniti", Ancona, Italy.

Background: Limited data are available on the clinical course of patients with history of atrial fibrillation (AF) when admitted in an intensive care environment. We aimed to describe the occurrence of major adverse events in AF patients admitted to a stepdown care unit (SDU) and to analyse clinical factors associated with outcomes, impact of dicumarolic oral anticoagulant (OAC) therapy impact and performance of clinical risk scores in this setting.

Materials And Methods: Single-centre, observational retrospective analysis on a population of subjects with AF history admitted to a SDU. Therapeutic failure (composite of transfer to ICU or death) was considered the main study outcome. Occurrence of stroke and major bleeding (MH) was considered as secondary outcomes. The performance of clinical risk scores was evaluated.

Results: A total of 1430 consecutive patients were enrolled. 194 (13.6%) reported the main outcome. Using multivariate logistic regression, age (odds ratio [OR]: 1.03, 95% confidence interval [CI]: 1.01-1.05), acute coronary syndrome (OR:3.10, 95% CI: 1.88-5.12), cardiogenic shock (OR:10.06, 95% CI: 5.37-18.84), septic shock (OR:5.19,95%CI:3.29-18.84), acute respiratory failure (OR:2.49, 95% CI: 1.67-3.64) and OAC use (OR: 1.61, 95% CI: 1.02-2.55) were independently associated with main outcome. OAC prescription was associated with stroke risk reduction and to both MH and main outcome risk increase. CHA DS -VASc (c-index: 0.545, P = .117 for stroke) and HAS-BLED (c-index:0.503, P = .900 for MH) did not significantly predict events occurrence.

Conclusions: In critically ill AF patients admitted to a SDU, adverse outcomes are highly prevalent. OAC use is associated to an increased risk of therapeutic failure, clinical scores seem unhelpful in predicting stroke and MH, suggesting a highly individualized approach in AF management in this setting.
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November 2020

The Prognostic Role of Procalcitonin in Critically Ill Patients Admitted in a Medical Stepdown Unit: A Retrospective Cohort Study.

Sci Rep 2020 03 11;10(1):4531. Epub 2020 Mar 11.

Internal and Emergency Medicine Department, Azienda Ospedaliero-Universitaria "Ospedali Riuniti", Ancona, Italy.

Procalcitonin (PCT) is a a marker of bacterial infection. Its prognostic role in the critically-ill patient, however, is still object of debate. Aim of this study was to evaluate the capacity of admission PCT (aPCT) in assessing the prognosis of the critically-ill patient regardless the presence of bacterial infection. A single-cohort, single-center retrospective study was performed evaluating critically-ill patients admitted to a stepdown care unit. Age, sex, Simplified Acute Physiology Score II (SAPS-II), shock, troponin-I, aPCT, serum creatinine, cultures and clinical endpoints (in-hospital mortality or Intensive Care Unit (ICU) transfer) were collected. Time free from adverse event (TF-AE) was defined as the time between hospitalization and occurrence of one of the clinical endpoints, and calculated with Kaplan-Meier curves. We engineered a new predictive model (POCS) adopting aPCT, age and shock.We enrolled 1063 subjects: 450 reached the composite outcome of death or ICU transfer. aPCT was significantly higher in this group, where it predicted TF-AE both in septic and non-septic patients. aPCT and POCS showed a good prognostic performance in the whole sample, both in septic and non-septic patients. aPCT showed a good prognostic accuracy, adding informations on the rapidity of clinical deterioration. POCS model reached a performance similar to SAPS-II.
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March 2020

Pulmonary embolism: a retrospective comparative study between patients with atypical vs typical clinical presentation

Recenti Prog Med 2019 Feb;110(2):93-97

Department of Internal Medicine, Ospedali Riuniti di Ancona, Italy.

Background: Natural history and outcomes of patients with pulmonary embolism (PE) without typical symptoms (atypical PE) remain unclear. The aim of the study is to compare the clinical characteristics and the prognosis between typical PE and atypical PE.

Methods: We retrospectively analyzed data from consecutive patients admitted to the Emergency Department (ED) because of a diagnosis of PE and classified them in two groups: typical PE and atypical PE. We defined PE to be typical in presence of almost one of the following symptoms or signs: dyspnea, chest pain, hemoptysis or signs of deep vein thrombosis.

Results: Of the 191 patients with PE, 154 (81%) had typical PE and 37 (19%) had atypical PE. Patients with atypical and typical PE seemed to had similar prognostic factor such as high risk sPESI (73% vs 65%, p=0.3), right ventricular dysfunction (30% vs 26%, p=0.6) and central PE at chest CT scan (38% vs 36%, p=0.8). The rate of 30 day mortality was 7% in the typical group and 8% in the atypical group (p=0.8). The length of stay in hospital was the same in the two groups (6 days; p=0.2).

Conclusions: We found that atypical and typical PE seem to be related diseases with a similar short term prognosis. Therefore, we could speculate that a missed diagnosis of PE in ED could expose the patients to a worsen prognosis. Further perspective studies are required for better investigate this diagnostic challenge.
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February 2019

Incomplete echocardiographic recovery at 6 months predicts long-term sequelae after intermediate-risk pulmonary embolism. A post-hoc analysis of the Pulmonary Embolism Thrombolysis (PEITHO) trial.

Clin Res Cardiol 2019 Jul 18;108(7):772-778. Epub 2018 Dec 18.

Université Paris Descartes, Sorbonne Paris Cité, Paris, France.

Introduction: Symptoms and functional limitation are frequently reported by survivors of acute pulmonary embolism (PE). However, current guidelines provide no specific recommendations on which patients should be followed after acute PE, when follow-up should be performed, and which tests it should include. Definition and classification of late PE sequelae are evolving, and their predictors remain to be determined.

Methods: In a post hoc analysis of the Pulmonary Embolism Thrombolysis (PEITHO) trial, we focused on 219 survivors of acute intermediate-risk PE with clinical and echocardiographic follow-up 6 months after randomisation as well as over the long term (median, 3 years after acute PE). The primary outcome was a composite of (1) confirmed chronic thromboembolic pulmonary hypertension (CTEPH) or (2) 'post-PE impairment' (PPEI), defined by echocardiographic findings indicating an intermediate or high probability of pulmonary hypertension along with New York Heart Association functional class II-IV.

Results: Confirmed CTEPH or PPEI occurred in 29 (13.2%) patients, (6 with CTEPH and 23 with PPEI). A history of chronic heart failure at baseline and incomplete or absent recovery of echocardiographic parameters at 6 months predicted CTEPH or PPEI at long-term follow-up.

Conclusions: CTEPH or PPEI occurs in almost one out of seven patients after acute intermediate-risk PE. Six-month echocardiographic follow-up may be useful for timely detection of late sequelae.
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July 2019

On being an internist in emergency medicine: a rare case of epigastric pain.

Intern Emerg Med 2018 08 4;13(5):713-715. Epub 2018 Apr 4.

Internal and Subintensive Medicine Department, Azienda Ospedaliero-Universitaria "Ospedali Riuniti"-Ancona, Via Conca n°10, Ancona, Italy.

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August 2018

Management of spontaneous soft-tissue hemorrhage secondary to anticoagulant therapy: A cohort study.

Am J Emerg Med 2018 12 23;36(12):2177-2181. Epub 2018 Mar 23.

Clinica Medica, Ospedali Riuniti di Ancona, Università Politecnica delle Marche, Italy.

Study Objective: The optimal management of patients receiving heparin, warfarin or direct anti-coagulant therapy who experience spontaneous, severe, life-threatening soft-tissue hemorrhage (SSTH) is unclear. The purpose of this study is to investigate efficacy and safety of the interventional protocol implemented in our department.

Methods: In this retrospective cohort study, we analyzed data from 80 consecutive patients with SSTH secondary to anticoagulation therapy diagnosed by the appropriate computed tomography scan. All patients received a structured clinical pathway, including aggressive resuscitation, reversal of coagulopathy when indicated, Interventional Radiology procedures by transcatheter embolization (TE), clinical observation and repeated laboratory controls.

Results: We enrolled 80 patients from 2013 to 2017. Angiography was performed in 60 patients (75%). It revealed the bleeding site in 46 cases, and a TE was performed in all. The rates of technical success of TE, primary clinical success and bleeding control were 98% (45/46), 91% (73/80) and 89% (71/80) respectively. In 5 patients (6%) the control of the bleeding was obtained with a second TE. Short-term and 30-day mortality was 5% (4 patients) and 11% (9 patients), respectively. No adverse events were observed.

Conclusion: A structured clinical pathway, including TE seems to be an effective and safe method to manage the patients with SSTH due to anticoagulant treatment.
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December 2018

Candidemia in the elderly: What does it change?

PLoS One 2017 11;12(5):e0176576. Epub 2017 May 11.

Laboratorio di Microbiologia, Azienda Ospedaliero Universitaria, Ospedali Riuniti Umberto I°-G.M. Lancisi-G. Salesi, Ancona, Italy.

Background: Candidemia is a life-threatening fungal infection and it can affect patients of all ages. Characterization of candidemia in the elderly is lacking.

Methods: We performed a retrospective study of adults (≥ 18 years) with candidemia diagnosed in our center in 2010-2015. Demographics, comorbidities, clinical and microbiologic characteristics, antifungal treatment and outcome were compared between older (≤65 years) and younger (>65 years) patients.

Results: Among 302 patients with candidemia identified during the study period, 188 (62%) belonged to the elderly group. Comorbidities were significantly more frequent in older patients and included chronic pulmonary diseases, cardiovascular diseases, diabetes mellitus, and chronic renal failure (p ranging from <0.0001 to 0.017). A significantly higher proportion of older patients had septic shock (p = 0.040) at the time of candidemia. Candida albicans accounted for 53% of isolates and there were no significant differences between patients' age and Candida species. Thirty-day mortality was significantly higher in older (45%) than in younger (28%) patients (p = 0.003). Factors associated with a significant higher proportion of death in the elderly included older age (i.e.: old-old), being hospitalized in ICU rather than in other wards, suffering from chronic pulmonary diseases, the presence of septic shock, multiple organ failure, dialysis and being infected with C. glabrata (p ranging from <0.0001 to 0.034). On multivariate analysis septic shock (HR 1.744 [CI95% 1.049-2.898], p = 0.032) and multiple organ failure (HR 2.242 [CI95% 1.070-4.698], p = 0.032) were independently associated with a higher risk of death. The probability of 30-days survival of older patients was significantly reduced when compared to that of younger patients (p = 0.005) who did not receive any treatment. In the elderly, there was a trend toward higher MICs for fluconazole/C. albicans, fluconazole/C. glabrata, amphotericin B/C. albicans, and caspofungin/C. glabrata.

Conclusions: In our study, we found that elderly patients with Candida bloodstream infections are characterized by a high mortality rate. In particular, the lack of any antifungal therapy as well as the occurrence of septic shock increased significantly the overall mortality. Additionally, we found that there was a trend of higher MIC for specific drug/Candida combination.
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September 2017

Impact of Thrombolytic Therapy on the Long-Term Outcome of Intermediate-Risk Pulmonary Embolism.

J Am Coll Cardiol 2017 Mar;69(12):1536-1544

Pulmonology and Intensive Care Service, Georges Pompidou European Hospital, Assistance Publique Hôpitaux de Paris, Paris, France; Paris Descartes University, Sorbonne Paris Cité, Paris, France; INSERM UMR S 970, Paris, France (INNOVTE, France).

Background: The long-term effect of thrombolytic treatment of pulmonary embolism (PE) is unknown.

Objectives: This study investigated the long-term prognosis of patients with intermediate-risk PE and the effect of thrombolytic treatment on the persistence of symptoms or the development of late complications.

Methods: The PEITHO (Pulmonary Embolism Thrombolysis) trial was a randomized (1:1) comparison of thrombolysis with tenecteplase versus placebo in normotensive patients with acute PE, right ventricular (RV) dysfunction on imaging, and a positive cardiac troponin test result. Both treatment arms received standard anticoagulation. Long-term follow-up was included in the third protocol amendment; 28 sites randomizing 709 of the 1,006 patients participated.

Results: Long-term (median 37.8 months) survival was assessed in 353 of 359 (98.3%) patients in the thrombolysis arm and in 343 of 350 (98.0%) in the placebo arm. Overall mortality rates were 20.3% and 18.0%, respectively (p = 0.43). Between day 30 and long-term follow-up, 65 deaths occurred in the thrombolysis arm and 53 occurred in the placebo arm. At follow-up examination of survivors, persistent dyspnea (mostly mild) or functional limitation was reported by 36.0% versus 30.1% of the patients (p = 0.23). Echocardiography (performed in 144 and 146 patients randomized to thrombolysis and placebo, respectively) did not reveal significant differences in residual pulmonary hypertension or RV dysfunction. Chronic thromboembolic pulmonary hypertension (CTEPH) was confirmed in 4 (2.1%) versus 6 (3.2%) cases (p = 0.79).

Conclusions: Approximately 33% of patients report some degree of persistent functional limitation after intermediate-risk PE, but CTEPH is infrequent. Thrombolytic treatment did not affect long-term mortality rates, and it did not appear to reduce residual dyspnea or RV dysfunction in these patients. (Pulmonary Embolism Thrombolysis study [PEITHO]; NCT00639743).
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March 2017

Neural hypernetwork approach for pulmonary embolism diagnosis.

BMC Res Notes 2015 Oct 29;8:617. Epub 2015 Oct 29.

Internal and Subintensive Medicine of Ospedali Riuniti, Ancona, Italy.

Background: Hypernetworks are based on topological simplicial complexes and generalize the concept of two-body relation to many-body relation. Furthermore, Hypernetworks provide a significant generalization of network theory, enabling the integration of relational structure, logic and analytic dynamics. A pulmonary embolism is a blockage of the main artery of the lung or one of its branches, frequently fatal.

Results: Our study uses data on 28 diagnostic features of 1427 people considered to be at risk of pulmonary embolism enrolled in the Department of Internal and Subintensive Medicine of an Italian National Hospital "Ospedali Riuniti di Ancona". Patients arrived in the department after a first screening executed by the emergency room. The resulting neural hypernetwork correctly recognized 94% of those developing pulmonary embolism. This is better than previous results obtained with other methods (statistical selection of features, partial least squares regression, topological data analysis in a metric space).

Conclusion: In this work we successfully derived a new integrative approach for the analysis of partial and incomplete datasets that is based on Q-analysis with machine learning. The new approach, called Neural Hypernetwork, has been applied to a case study of pulmonary embolism diagnosis. The novelty of this method is that it does not use clinical parameters extracted by imaging analysis.
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October 2015

Fibrinolysis for patients with intermediate-risk pulmonary embolism.

N Engl J Med 2014 Apr;370(15):1402-11

The authors' affiliations are listed in the Appendix.

Background: The role of fibrinolytic therapy in patients with intermediate-risk pulmonary embolism is controversial.

Methods: In a randomized, double-blind trial, we compared tenecteplase plus heparin with placebo plus heparin in normotensive patients with intermediate-risk pulmonary embolism. Eligible patients had right ventricular dysfunction on echocardiography or computed tomography, as well as myocardial injury as indicated by a positive test for cardiac troponin I or troponin T. The primary outcome was death or hemodynamic decompensation (or collapse) within 7 days after randomization. The main safety outcomes were major extracranial bleeding and ischemic or hemorrhagic stroke within 7 days after randomization.

Results: Of 1006 patients who underwent randomization, 1005 were included in the intention-to-treat analysis. Death or hemodynamic decompensation occurred in 13 of 506 patients (2.6%) in the tenecteplase group as compared with 28 of 499 (5.6%) in the placebo group (odds ratio, 0.44; 95% confidence interval, 0.23 to 0.87; P=0.02). Between randomization and day 7, a total of 6 patients (1.2%) in the tenecteplase group and 9 (1.8%) in the placebo group died (P=0.42). Extracranial bleeding occurred in 32 patients (6.3%) in the tenecteplase group and 6 patients (1.2%) in the placebo group (P<0.001). Stroke occurred in 12 patients (2.4%) in the tenecteplase group and was hemorrhagic in 10 patients; 1 patient (0.2%) in the placebo group had a stroke, which was hemorrhagic (P=0.003). By day 30, a total of 12 patients (2.4%) in the tenecteplase group and 16 patients (3.2%) in the placebo group had died (P=0.42).

Conclusions: In patients with intermediate-risk pulmonary embolism, fibrinolytic therapy prevented hemodynamic decompensation but increased the risk of major hemorrhage and stroke. (Funded by the Programme Hospitalier de Recherche Clinique in France and others; PEITHO EudraCT number, 2006-005328-18; number, NCT00639743.).
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April 2014

Multidetector CT scan for acute pulmonary embolism: embolic burden and clinical outcome.

Chest 2012 Dec;142(6):1417-1424

University of Perugia, and Department of Radiology, S Maria della Misericordia Hospital, Perugia, Italy.

Background: In patients with acute pulmonary embolism (PE), the correlation between the embolic burden assessed by multidetector CT (MDCT) scan and clinical outcomes remains unclear. Patients with symptomatic acute PE diagnosed based on MDCT angiography were included in a multicenter study aimed at assessing the prognostic role of the embolic burden evaluated with MDCT scan.

Methods: Embolic burden was assessed as (1) localization of the emboli as central (saddle or at least one main pulmonary artery), lobar, or distal (segmental or subsegmental arteries) and (2) the obstruction index by the scoring system of Qanadli. The primary outcome was 30-day all-cause death or clinical deterioration. Predictors of all-cause death or clinical deterioration were identified by Cox regression statistics.

Results: Overall, 579 patients were included in the study; 60 (10.4%) died or had clinical deterioration at 30 days. Central localization of emboli was not associated with all-cause death or clinical deterioration (hazard ratio [HR], 2.42; 95% CI, 0.77-7.59; P 5 .13). However, in 516 hemodynamically stable patients, central localization of emboli (HR, 8.3; 95% CI, 1.0-67; P 5 .047) was an independent predictor of all-cause death or clinical deterioration, whereas distal emboli were inversely associated with these outcome events (HR, 0.12; 95% CI, 0.015-0.97; P 5 .047). No correlation was found between obstruction index (evaluated in 448 patients) and all-cause death or clinical deterioration in the overall study population and in the hemodynamically stable patients.

Conclusions: In hemodynamically stable patients with acute PE, central emboli are associated with an increased risk for all-cause death or clinical deterioration. This risk is low in patients with segmental or subsegmental PE.
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December 2012

A management of blunt thoracic trauma in an emergency department observation unit: pre-post observational study.

J Trauma Acute Care Surg 2012 Jan;72(1):222-8

Department of Emergency Medicine, Medicina e Chirurgia d'Accettazione e d'Urgenza Ospedali Riuniti di Ancona, Ancona, Italy.

Background: The best management of patients with isolated blunt thoracic trauma at high risk of pulmonary complications (HRPC-BTT: ≥3 isolated rib fractures, sternal fracture, single or few pulmonary contusions or minimal pneumothorax) is still unclear. We compared efficacy and cost-effectiveness of a new clinical pathway involving an Emergency Department Observation Unit (EDOU) with routine care.


Design: Retrospective before-after study.

Setting: Level II Trauma Center within a Regional Teaching Hospital.

Participants: A consecutive series of patients with HRPC-BTT.

Interventions: a new clinical pathway involving EDOU was implemented.

Main Outcomes: Death rate, tube thoracostomy, and re-admission of discharged patients. Hospital admission rate, length of hospital occupancy, overall costs, and cost-effectiveness were also compared in pre- and post-EDOU period.

Results: Two hundred forty patients were eligible for the study: 110 patients in the pre-EDOU period and 130 in the post-EDOU period. Thirteen (12%) of the treated patients were re-admitted to the ED in the pre-EDOU period compared with only five (4%) when the EDOU was available (p = 0.03). The rate of tube thoracostomy performed in admitted patients significantly increased after EDOU implementation: 1 of 54 (1.9%) versus 4 of 32 (12.5%; p < 0.05). The rate of hospitalization decreased from 49% in the pre-EDOU period to 24% in the post-EDOU period (p < 0,005) and the length of stay in hospital in the pre-EDOU period was longer than in the EDOU period: mean 94.7 ± 79.6 versus 65.7 ± 60.6, respectively (p < 0.02). Cost analysis revealed no relevant change in cost-effectiveness per patient (median; interquartile range): €487; €103 to 1959 versus €616; €124 to 1455, respectively, in the pre- and post-EDOU period.

Conclusions: In managing patients affected by HRPC-BTT, a clinical pathway involving the EDOU seems to be more effective than routine care with little impact on cost.
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January 2012

Multidetector computed tomography for acute pulmonary embolism: diagnosis and risk stratification in a single test.

Eur Heart J 2011 Jul 18;32(13):1657-63. Epub 2011 Apr 18.

Stroke Unit, Department of Internal and Cardiovascular Medicine, University of Perugia, Perugia, Italy.

Aims: In patients with acute pulmonary embolism (PE), right ventricular dysfunction at echocardiography is associated with increased in-hospital mortality. The aims of this study in patients with acute PE were to identify a sensitive and simple criterion for right ventricular dysfunction at multidetector computed tomography (MDCT) using echocardiography as the reference standard and to evaluate the predictive value of the identified MDCT criterion for in-hospital death or clinical deterioration.

Methods And Results: Right ventricular dysfunction at MDCT was defined as the right-to-left ventricular dimensional ratio and was centrally assessed by a panel unaware of clinical and echocardiographic data. A right-to-left ventricular dimensional ratio ≥0.9 at MDCT had a 92% sensitivity for right ventricular dysfunction [95% confidence interval (CI) 88-96]. Overall, 457 patients were included in the outcome study: 303 had right ventricular dysfunction at MDCT. In-hospital death or clinical deterioration occurred in 44 patients with and in 8 patients without right ventricular dysfunction at MDCT (14.5 vs. 5.2%; P< 0.004). The negative predictive value of right ventricular dysfunction for death due to PE was 100% (95% CI 98-100). Right ventricular dysfunction at MDCT was an independent predictor for in-hospital death or clinical deterioration in the overall population [hazard ratio (HR) 3.5, 95% CI 1.6-7.7; P= 0.002] and in haemodynamically stable patients (HR 3.8, 95% CI 1.3-10.9; P= 0.007).

Conclusion: In patients with acute PE, MDCT might be used as a single procedure for diagnosis and risk stratification. Patients without right ventricular dysfunction at MDCT have a low risk of in-hospital adverse outcome.
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July 2011

Bolus tenecteplase for right ventricle dysfunction in hemodynamically stable patients with pulmonary embolism.

Thromb Res 2010 Mar 14;125(3):e82-6. Epub 2009 Oct 14.

Medicina Interna e Cardiovascolare-Stroke Unit, Università di Perugia, Perugia, Italy.

Introduction: The clinical benefit of thrombolytic treatment over heparin in patients with pulmonary embolism without hemodynamic compromise remains controversial. In these patients bolus tenecteplase has the potential to provide an effective and safe thrombolysis.

Methods: We evaluated the effect of tenecteplase on right ventricle dysfunction (RVD) assessed by echocardiography in hemodynamically stable patients with PE in a multicenter, randomized, double-blind, placebo-controlled study. RVD was defined as right/left ventricle end-diastolic dimension ratio >1 in the apical 4-chamber view. Patients were randomized to receive weight-adjusted single-bolus tenecteplase or placebo. All patients received unfractionated heparin. Reduction of RVD at 24 hours was the primary efficacy end-point and was evaluated by an independent committee unaware of treatment allocation.

Results: Overall, 58 patients were randomized. Echocardiograms were adequate for efficacy analysis in 51 patients, 23 randomized to tenecteplase and 28 to placebo. The reduction of right to left ventricle end-diastolic dimension ratio at 24 hours was 0.31+/-0.08 in patients randomized to tenecteplase as compared to 0.10+/-0.07 in patients randomized to placebo (p=0.04). One patient randomized to tenecteplase suffered a clinical event (recurrent pulmonary embolism) in comparison to three patients randomized to placebo (1 recurrent pulmonary embolism; 1 clinical deterioration and 1 non pulmonary embolism-related death). Two non fatal major bleedings occurred with tenecteplase (1 intracranial) and one with placebo.

Conclusion: In hemodynamically stable patients with PE, treatment with single bolus tenecteplase is feasible at the same dosages used for acute myocardial infarction and is associated with reduction of RVD at 24 hours. Whether this benefit is associated with an improved clinical outcome without excessive bleeding is currently explored in a large clinical trial.
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March 2010

Synchronised therapy and high-dose cyclophosphamide in proliferative lupus nephritis.

J Clin Apher 2002 ;17(2):72-7

Istituto di Clinica Medica, Ematologia ed Immunologia Clinica, Torrette di Ancona, Italy.

The aim of this open study was to compare the outcomes and side effects of plasmapheresis (PP) in patients with proliferative lupus nephritis treated with cyclophosphamide (Cyc) boluses. The study involved 28 consecutive patients. All of the patients met the ACR modified criteria for SLE and underwent a qualifying renal biopsy. In group I, patients were treated with synchronised therapy (PP, 50 ml/kg, followed by pulse Cyc, 750 mg/m(2), repeated monthly for 6 months), whereas in group II, they were given only intermittent Cyc boluses (at the same dosage). The data were collected in the patients' records according to a standardised protocol. Patients were followed-up for a mean of 4 years. The disease-free survival was analysed using Kaplan-Meier estimated survival curves ([S(t)]). At the end of the 6-month treatment period, a statistically significant number of patients in group I (75%) was in complete remission in comparison to group II (31%) (P < 0.02), whereas at long-term follow-up, these percentages were similar (41% vs. 50%, P = n.s.). The main functional and immunological parameters showed a normalisation in both groups. The risk of a poor renal outcome significantly correlated with high serum creatinine levels at the onset of nephritis (P < 0.05). We documented a higher rate of infectious complications in group I. This study reports that synchronised therapy is useful in inducing a faster remission in patients with proliferative lupus nephritis. However, it is not superior to conventional therapy at long term follow-up analysis. Positive results should be reinforced by a long-term maintenance therapy.
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July 2003