Publications by authors named "Alberto Zangrillo"

368 Publications

Influence of reduced muscle mass and quality on ventilator weaning and complications during intensive care unit stay in COVID-19 patients.

Clin Nutr 2021 Aug 16. Epub 2021 Aug 16.

Unit of General Medicine and Advanced Care, IRCCS San Raffaele Scientific Institute, Italy.

Background & Aims: Sarcopenia, a loss of muscle mass, quality and function, which is particularly evident in respiratory muscles, has been associated with many clinical adverse outcomes. In this study, we aimed at evaluating the role of reduced muscle mass and quality in predicting ventilation weaning, complications, length of intensive care unit (ICU) and of hospital stay and mortality in patients admitted to ICU for SARS-CoV-2-related pneumonia.

Methods: This was an observational study based on a review of medical records of all adult patients admitted to the ICU of a tertiary hospital in Milan and intubated for SARS-CoV-2-related pneumonia during the first wave of the COVID-19 pandemic. Muscle mass and quality measurement were retrieved from routine thoracic CT scans, when sections passing through the first, second or third lumbar vertebra were available.

Results: A total of 81 patients were enrolled. Muscle mass was associated with successful extubation (OR 1.02, 95% C.I. 1.00-1.03, p = 0.017), shorter ICU stay (OR 0.97, 95% C.I. 0.95-0.99, p = 0.03) and decreased hospital mortality (HR 0.98, 95% C.I. 0.96-0.99, p = 0.02). Muscle density was associated with successful extubation (OR 1.07, 95% C.I. 1.01-1.14; p = 0.02) and had an inverse association with the number of complications in ICU (Β -0.07, 95% C.I. -0.13 - -0.002, p = 0.03), length of hospitalization (Β -1.36, 95% C.I. -2.21 - -0.51, p = 0.002) and in-hospital mortality (HR 0.88, 95% C.I. 0.78-0.99, p = 0.046).

Conclusions: Leveraging routine CT imaging to measure muscle mass and quality might constitute a simple, inexpensive and powerful tool to predict survival and disease course in patients with COVID-19. Preserving muscle mass during hospitalisation might have an adjuvant role in facilitating remission from COVID-19.
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http://dx.doi.org/10.1016/j.clnu.2021.08.004DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8364854PMC
August 2021

Testosterone in males with COVID-19: A 7-month cohort study.

Andrology 2021 Aug 18. Epub 2021 Aug 18.

Division of Experimental Oncology/Unit of Urology, URI, IRCCS Ospedale San Raffaele, Milan, Italy.

Background: Circulating testosterone levels have been found to be reduced in men with severe acute respiratory syndrome coronavirus 2 infection, COVID-19, with lower levels being associated with more severe clinical outcomes.

Objectives: We aimed to assess total testosterone levels and the prevalence of total testosterone still suggesting for hypogonadism at 7-month follow-up in a cohort of 121 men who recovered from laboratory-confirmed COVID-19.

Materials And Methods: Demographic, clinical, and hormonal values were collected for all patients. Hypogonadism was defined as total testosterone ≤9.2 nmol/L. The Charlson Comorbidity Index was used to score health-significant comorbidities. Descriptive statistics and multivariable linear and logistic regression models tested the association between clinical and laboratory variables and total testosterone levels at follow-up assessment.

Results: Circulating total testosterone levels increased at 7-month follow-up compared to hospital admittance (p < 0.0001), while luteinizing hormone and 17β-estradiol levels significantly decreased (all p ≤ 0.02). Overall, total testosterone levels increased in 106 (87.6%) patients, but further decreased in 12 (9.9%) patients at follow-up, where a total testosterone level suggestive for hypogonadism was still observed in 66 (55%) patients. Baseline Charlson Comorbidity Index score (OR 0.36; p = 0.03 [0.14, 0.89]) was independently associated with total testosterone levels at 7-month follow-up, after adjusting for age, BMI, and IL-6 at hospital admittance.

Conclusions: Although total testosterone levels increased over time after COVID-19, more than 50% of men who recovered from the disease still had circulating testosterone levels suggestive for a condition of hypogonadism at 7-month follow-up. In as many as 10% of cases, testosterone levels even further decreased. Of clinical relevance, the higher the burden of comorbid conditions at presentation, the lower the probability of testosterone levels recovery over time.
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http://dx.doi.org/10.1111/andr.13097DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8444879PMC
August 2021

Associations Between Expiratory Flow Limitation and Postoperative Pulmonary Complications in Patients Undergoing Cardiac Surgery.

J Cardiothorac Vasc Anesth 2021 Jul 24. Epub 2021 Jul 24.

Anesthesiology, Critical Care and Pain Medicine Division, Department of Medicine and Surgery, University of Parma, Parma, Italy.

Objectives: To determine whether driving pressure and expiratory flow limitation are associated with the development of postoperative pulmonary complications (PPCs) in cardiac surgery patients.

Design: Prospective cohort study.

Setting: University Hospital San Raffaele, Milan, Italy.

Participants: Patients undergoing elective cardiac surgery.

Measurements And Main Results: The primary endpoint was the occurrence of a predefined composite of PPCs. The authors determined the association among PPCs and intraoperative ventilation parameters, mechanical power and energy load, and occurrence of expiratory flow limitation (EFL) assessed with the positive end-expiratory pressure test. Two hundred patients were enrolled, of whom 78 (39%) developed one or more PPCs. Patients with PPCs, compared with those without PPCs, had similar driving pressure (mean difference [MD] -0.1 [95% confidence interval (CI), -1.0 to 0.7] cmHO, p = 0.561), mechanical power (MD 0.5 [95% CI, -0.3 to 1.1] J/m, p = 0.364), and total energy load (MD 95 [95% CI, -78 to 263] J, p = 0.293), but they had a higher incidence of EFL (51% v 38%, p = 0.005). Only EFL was associated independently with the development of PPCs (odds ratio 2.46 [95% CI, 1.28-4.80], p = 0.007).

Conclusions: PPCs occurred frequently in this patient population undergoing cardiac surgery. PPCs were associated independently with the presence of EFL but not with driving pressure, total energy load, or mechanical power.
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http://dx.doi.org/10.1053/j.jvca.2021.07.035DOI Listing
July 2021

A radiological predictor for pneumomediastinum/pneumothorax in COVID-19 ARDS patients.

J Crit Care 2021 Aug 11;66:14-19. Epub 2021 Aug 11.

Department of Radiology, IRCCS San Raffaele Scientific Institute, Milan, Italy; School of Medicine, Vita-Salute San Raffaele University, Milan, Italy.

Purpose: To determine whether Macklin effect (a linear collection of air contiguous to the bronchovascular sheath) on baseline CT imaging is an accurate predictor for subsequent pneumomediastinum (PMD)/pneumothorax (PNX) development in invasively ventilated patients with COVID-19-related acute respiratory distress syndrome (ARDS).

Materials And Methods: This is an observational, case-control study. From a prospectively acquired database, all consecutive invasively ventilated COVID-19 ARDS patients who underwent at least one baseline chest CT scan during the study time period (February 25th, 2020-December 31st, 2020) were identified; those who had tracheal lesion or already had PMD/PNX at the time of the first available chest imaging were excluded.

Results: 37/173 (21.4%) patients enrolled had PMD/PNX; specifically, 20 (11.5%) had PMD, 10 (5.8%) PNX, 7 (4%) both. 33/37 patients with subsequent PMD/PNX had Macklin effect on baseline CT (89.2%, true positives) 8.5 days [range, 1-18] before the first actual radiological evidence of PMD/PNX. Conversely, 6/136 patients without PMD/PNX (4.4%, false positives) demonstrated Macklin effect (p < 0.001). Macklin effect yielded a sensitivity of 89.2% (95% confidence interval [CI]: 74.6-96.9), a specificity of 95.6% (95% CI: 90.6-98.4), a positive predictive value (PV) of 84.5% (95% CI: 71.3-92.3), a negative PV of 97.1% (95% CI: 74.6-96.9) and an accuracy of 94.2% (95% CI: 89.6-97.2) in predicting PMD/PNX (AUC:0.924).

Conclusions: Macklin effect accurately predicts, 8.5 days in advance, PMD/PNX development in COVID-19 ARDS patients.
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http://dx.doi.org/10.1016/j.jcrc.2021.07.022DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8357628PMC
August 2021

Impact of COVID-19 Pandemic on Out-of-Hospital Cardiac Arrest System-of-Care: A Systematic Review and Meta-Analysis.

Prehosp Emerg Care 2021 Sep 14:1-12. Epub 2021 Sep 14.

Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy (TS, FDA, MR, MS, GL, AZ); School of Medicine, Vita-Salute San Raffaele University, Milan, Italy (GL, AZ); Emergency Medical Services (SUEM 118), Venice, Italy (FS).

COVID-19 pandemic overwhelmed healthcare systems and diverted resources allocated for other conditions. This systematic review and meta-analysis aimed to analyse how the pandemic impacted the system-of-care of out-of-hospital cardiac arrest. We searched PubMed and Embase up to May 31, 2021, for studies comparing out-of-hospital cardiac arrests that occurred during the COVID-19 pandemic versus a non-pandemic period. Survival at hospital discharge or at 30 days was the primary outcome. We included 24 studies for a total of 75,952 patients. Out-of-hospital cardiac arrests during COVID-19 pandemic had lower survival (19 studies; 603/11,666 [5.2%] vs. 1320/17,174 [7.7%]; OR = 0.54; 95% CI, 0.44-0.65;  = 0.001) and return of spontaneous circulation (4370/24353 [18%] vs. 7401/34510 [21%]; OR = 0.64; 95% CI, 0.55-0.75;  < 0.001) compared with non-pandemic periods. Ambulance response times (10.1 vs 9.0 minutes, MD = 1.01; 95% CI, 0.59-1.42;  < 0.001) and non-shockable rhythms (18,242/21,665 [84%] vs. 19,971/24,817 [81%]; OR = 1.27; 95% CI, 1.10-1.46; P < 0.001) increased. Use of supraglottic airways devices increased (2853/7645 [37%] vs. 2043/17521 [12%]; OR = 1.97; 95% CI, 1.42-2.74;  < 0.001). The COVID-19 pandemic affected the system-of-care of out-of-hospital cardiac arrest, and patients had worse short-term outcomes compared to pre-pandemic periods. Advanced airway management strategy shifted from endotracheal intubation to supraglottic airway devices.

Review Registration: PROSPERO CRD42021250339.
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http://dx.doi.org/10.1080/10903127.2021.1967535DOI Listing
September 2021

Pneumothorax and barotrauma in invasively ventilated patients with COVID-19.

Respir Med 2021 Jul 30;187:106552. Epub 2021 Jul 30.

Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy; School of Medicine, Vita-Salute San Raffaele University, Milan, Italy.

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http://dx.doi.org/10.1016/j.rmed.2021.106552DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8323514PMC
July 2021

Percutaneous tracheostomy in COVID-19 patients: a new apneic approach.

Braz J Anesthesiol 2021 Jul 27. Epub 2021 Jul 27.

IRCCS San Raffaele Scientific Institute, Department of Anesthesia and Intensive Care, Milan, Italy.

Background: Percutaneous dilation tracheostomy is an aerosol-generating procedure carrying a documented infectious risk during respiratory virus pandemics. For this reason, during the COVID-19 outbreak, surgical tracheostomy was preferred to the percutaneous one, despite the technique related complications increased risk.

Methods: We describe a new sequence for percutaneous dilation tracheostomy procedure that could be considered safe both for patients and healthcare personnel. A fiberscope was connected to a video unit to allow bronchoscopy. Guidewire positioning was performed as usual. While the established standard procedure continues with the creation of the stoma without any change in mechanical ventilation, we retracted the bronchoscope until immediately after the access valve in the mount tube, allowing normal ventilation. After 3 minutes of ventilation with 100% oxygen, mechanical ventilation was stopped without disconnecting the circuit. During apnea, the stoma was created by dilating the trachea and the tracheostomy cannula was inserted. Ventilation was then resumed. We evaluated the safeness of the procedure by recording any severe desaturation and by performing serological tests to all personnel.

Results: Thirty-six patients (38%) of 96 underwent tracheostomy; 22 (23%) percutaneous dilation tracheostomies with the new approach were performed without any desaturation. All personnel (150 operators) were evaluated for serological testing: 9 (6%) had positive serology but none of them had participated in tracheostomy procedures.

Conclusion: This newly described percutaneous dilation tracheostomy technique was not related to severe desaturation events and we did not observe any positive serological test in health workers who performed the tracheostomies.
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http://dx.doi.org/10.1016/j.bjane.2021.07.013DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8313898PMC
July 2021

Direct oral anticoagulants in patients with nonvalvular atrial fibrillation and extreme body weight.

Eur J Clin Invest 2021 Jul 26:e13658. Epub 2021 Jul 26.

Cardiology Unit, IRCCS San Raffaele Hospital, Milan, Italy.

Background: Limited clinical data exist describing the use of direct oral anticoagulants (DOACs) in patient with extreme body weight. Thus, the International Society of Thrombosis and Haemostasis (ISTH) recommends avoiding DOACs in patients with weight >120 Kg, and on the contrary, no restrictions exist for underweight patients.

Objective: To evaluate the effects of extreme body weight on DOAC activity and to compare the clinical outcomes of patients with an extreme body weight versus patients with a normal weight (61-119 Kg) treated with DOACs.

Methods: Single tertiary care Italian centre multidisciplinary registry including nonvalvular atrial fibrillation (NVAF) patients treated with DOACs. Based on weight, three subcohorts were defined: (i) underweight patients (≤60 Kg); (ii) patients with a normal weight (61-119 Kg, as control group); and (iii) overweight patients (≥120 Kg). Primary efficacy endpoint was 2-year rate of thromboembolic events. Primary safety endpoint was 2-year rate of major bleeding. Event-free survival curves among groups were compared using Cox-Mantel test.

Results: 812 NVAF patients were included, 108 patients weighed ≤60 Kg (13%, underweight), 688 weighed between 61 and 119 Kg (85%, normal weight), and 16 weighed ≥120 Kg (2%, overweight). In particular, among underweight patients, dabigatran was prescribed in 26% patients, apixaban in 27%, rivaroxaban in 28% and edoxaban in 22% ones. Instead, among overweight patients, 44% were treated with dabigatran, 25% with apixaban, 25% with rivaroxaban and 4% with edoxaban. Underweight patients were older, more frequently women, with lower creatinine clearance and a history of previous strokes, resulting in higher CHA2DS2-VASc score than in both remaining groups. Up to 2 years, no statistically significant difference was observed between the three groups of weight for thromboembolic events (P = .765) and for overall bleeding (P = .125), but a trend towards decreased overall bleeding rates was noticed as weight increased (24.1% vs 16.7% vs 12.5%, respectively).

Conclusion: In this tertiary care centre registry, 15% of patients treated with DOACs presented an extreme weight. Compared to patients with a normal weight, no significant rates of thromboembolic events were observed for underweight or overweight patients. A trend towards decreased overall bleeding frequency as weight increased was highlighted up to 2 years. The present results should be considered as preliminary and hypothesis generating.
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http://dx.doi.org/10.1111/eci.13658DOI Listing
July 2021

QTc interval prolongation, inflammation, and mortality in patients with COVID-19.

J Interv Card Electrophysiol 2021 Jul 22. Epub 2021 Jul 22.

Arrhythmia Unit and Electrophysiology Laboratories, IRCCS San Raffaele Scientific Institute, Milan, Italy.

Purpose: Systemic inflammation has been associated with corrected QT (QTc) interval prolongation. The role of inflammation on QTc prolongation in COVID-19 patients was investigated.

Methods: Patients with a laboratory-confirmed SARS-CoV-2 infection admitted to IRCCS San Raffaele Scientific Institute (Milan, Italy) between March 14, 2020, and March 30, 2020 were included. QTc-I was defined as the QTc interval by Bazett formula in the first ECG performed during the hospitalization, before any new drug treatment; QTc-II was the QTc in the ECG performed after the initiation of hydroxychloroquine drug treatment.

Results: QTc-I was long in 45 patients (45%) and normal in 55 patients (55%). Patients with long QTc-I were older and more frequently males. C-Reactive protein (CRP) and white blood cell (WBC) count at hospitalization were higher in patients with long QTc-I and long QTc-II. QTc-I was significantly correlated with CRP levels at hospitalization. After a median follow-up of 83 days, 14 patients (14%) died. There were no deaths attributed to ventricular arrhythmias. Patients with long QTc-I and long QTc-II had a shorter survival, compared with normal QTc-I and QTc-II patients, respectively. In Cox multivariate analysis, independent predictors of mortality were age (HR = 1.1, CI 95% 1.04-1.18, p = 0.002) and CRP at ECG II (HR 1.1, CI 95% 1.0-1.1, p = 0.02).

Conclusions: QTc at hospitalization is a simple risk marker of mortality risk in COVID-19 patients and reflects the myocardial inflammatory status.
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http://dx.doi.org/10.1007/s10840-021-01033-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8295006PMC
July 2021

Safety and efficacy of Direct Oral Anticoagulants (DOACs) in very elderly patients (≥ 85 years old) with non-valvular atrial fibrillation. The Experience of an Italian tertiary care center.

Minerva Med 2021 Jun 28. Epub 2021 Jun 28.

Cardiology Unit, IRCCS San Raffaele Hospital, Milan, Italy.

Background: Limited real-world data are available regarding the comparison about safety and efficacy of DOACs prescription in very elderly patients (≥85 years) with non-valvular atrial fibrillation (NVAF). Concern about the risk of bleeding with anticoagulation in very older patients still represents an important challenge for clinicians.

Objective: To evaluate the different prevalence of major bleeding and thromboembolic events between very elderly NVAF patients (≥85 years) compared to those non very elderly (<85 years).

Methods: Single center multidisciplinary registry including NVAF patients treated with DOACs. Primary safety endpoint was 2-year rate of major bleeding. Primary efficacy endpoint was 2-year rate of thromboembolic events. Event-free survival curves among groups were compared using Cox-Mantel test.

Results: 908 NVAF consecutive patients were included, of these, 805 patients were <85 years (89%) and 103 patients were very elderly patients with ≥85 years (11%). Compared to patients <85 years, those very elderly have higher CHA2DS2-VASc score (p=0.001), higher rate of hypertension (p=0.001), diabetes mellitus (p=0.030), previous bleeding events (p<0.001), previous stroke/TIA/SE (p=<0.001), heart failure (p=<0.001), and lower creatinine clearance (p<0.001). In terms of safety endpoints (overall ISTH-major bleeding) no significative difference between two groups (p=0.952) were observed up to 2-year follow-up. Systemic thromboembolic event (primary efficacy endpoint) was significantly higher in patients with ≥85 years (p=0.027). The incidence of all-cause death was significantly higher in very elderly patients (p<0.001).

Conclusions: This single center registry, showed that the use of DOACs in very elderly NVAF was safe and is a therapeutic option to be pursued for stroke prevention especially for those who are at high risk of ischemic events.
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http://dx.doi.org/10.23736/S0026-4806.21.07432-2DOI Listing
June 2021

A novel evidence-based algorithm to predict thromboembolism in patients with COVID-19: preliminary data from a single-centre cohort.

Minerva Med 2021 Jun 11. Epub 2021 Jun 11.

Unit of General Medicine and Advanced Care, IRCCS Ospedale San Raffaele, Milan, Italy.

Background: Severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2)-related disease (COVID-19) is an infectious disease characterised by systemic inflammation, which might enhance baseline thrombotic risk, especially in hospitalised patients. Little is, however, known about predictors of thrombotic complications in patients with COVID-19.

Methods: We prospectively followed up 180 hospitalised COVID-19 patients. Demographics, clinical and laboratory features at presentation and past medical history were tested as predictors of the first thrombotic complication through multivariate Cox regression analysis and a categorical score generated based on the results.

Results: Sixty-four thromboses were recorded in 54 patients, of whom seven with thrombosis on admission and 47 with thrombosis during hospitalisation. Patients with thrombosis were mainly Caucasian and diabetic, had marked baseline signs of inflammation and organ damage, lower PaO2/FiO2 ratio, higher D-dimer levels and history of major haemorrhages. The latter three variables were independently associated to thrombotic complications and concurred to a 0-5 score, which accounted for 80% of the total sample variability. Patients with three or more points of the newly generated score were at higher risk for thrombotic complications (HR=4.9, p<0.001). Patients with thrombotic complications were more likely to be admitted to intensive care and/or to die (HR=1.9, p=0.036). Five of 180 patients were diagnosed with disseminated intravascular coagulation and three of them died. Eleven minor and no major bleeding events were observed.

Conclusions: Patients with COVID-19 are at increased risk for thrombosis and might be stratified on admission based lower Pao2/FiO2 ratio, higher D-dimer levels and history of major haemorrhages.
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http://dx.doi.org/10.23736/S0026-4806.21.07331-6DOI Listing
June 2021

Venoarterial Extracorporeal Membrane Oxygenator Support in Lung Cancer Resection.

Ann Thorac Surg 2021 Jun 7. Epub 2021 Jun 7.

Department of Thoracic Surgery, IRCCS San Raffaele Scientific Institute, Milan, Italy; Faculty of Medicine and Surgery, Vita-Salute San Raffaele University, Milan, Italy. Electronic address:

Cardiovascular comorbidities often prevent patients with otherwise resectable early-stage lung cancer from undergoing surgery due to prohibitive peri-operative risk. Here we describe the first intraoperative use of venoarterial (VA) ECMO in a stage cIIA lung cancer patient with arterial infiltration and severe post-ischemic dilated cardiomyopathy (EF 23%) undergoing left upper lobectomy with pulmonary artery angioplasty. Providing intra-operative cardiovascular and respiratory function support, VA-ECMO represents a suitable option for patients with heart failure, ensuring adequate hemodynamic profile and reducing the risk of complications. These otherwise inoperable patients can thus be offered a potentially curative surgical resection of the malignancy. Surgery is the standard treatment for patients with early-stage lung cancer . However, several patients with advanced heart failure may be excluded from surgery due to prohibitive perioperative risk. Providing circulatory and respiratory support, extracorporeal membrane oxygenator (ECMO) may represent a suitable option for such patients . While there is a published experience on intraoperative use of veno-venous (VV) ECMO, primarily in thoracic surgery , an extremely limited number of reports considered the use of venoarterial (VA)-ECMO in patients undergoing non-cardiac surgery . VA-ECMO is currently indicated in patients with cardiovascular failure and concomitant cardiac pump dysfunction, as in post-operative ARDS associated with septic shock ; outside the intensive care unit, the use of pre-emptive VA-ECMO has traditionally been limited to patients undergoing elective ventricular tachycardia ablation and structural heart procedures. Here we report the first case of intraoperative use of VA-ECMO in a patient with resectable lung cancer and ischemic heart disease with prohibitive left ventricular function, and describe the benefits of this new indication.
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http://dx.doi.org/10.1016/j.athoracsur.2021.05.040DOI Listing
June 2021

Immunosuppressive strategies in invasively ventilated ARDS COVID-19 patients.

Minerva Anestesiol 2021 08 8;87(8):891-902. Epub 2021 Jun 8.

Unit of Immunology, Rheumatology, Allergy and Rare Diseases (UnIRAR), IRCCS San Raffaele Hospital, Vita-Salute San Raffaele University, Milan, Italy.

Background: COVID-19 is associated with elevated levels of inflammatory cytokines. We present the characteristics and outcomes of patients treated in the Intensive Care Unit (ICU) with immunosuppressive drugs, either tocilizumab or anakinra compared with controls.

Methods: A single-center observational prospective study on ICU invasively ventilated COVID-19 patients. The primary outcome was the clinical improvement at day 28. A Bayesian framework was employed, and all analyses were adjusted for confounders.

Results: Sixty-one consecutive invasively ventilated patients were included, nine (14.7%) received tocilizumab and 15 (24.6%) received anakinra. Over the first seven days, tocilizumab was associated with a greater decrease in C-reactive protein (P<0.001). After adjusting for confounders, the probability of clinical improvement at day 28 compared to control was 7∙6% (OR=0.36 [95% CrI: 0.09-1.46]) for tocilizumab and 40.9% (OR=0.89 [95% CrI: 0.32-2.43]) for anakinra. At day 28, the probability of being in a better clinical category was 2.5% (OR=2.98 [95% CrI: 1.00-8.88]) for tocilizumab, and 49.5% (OR=1.00 [95% CrI: 0.42-2.42]) for anakinra.

Conclusions: In invasively ventilated COVID-19 patients, treatment with anakinra was associated with a higher probability of clinical improvement compared to tocilizumab; however, treatment with either drug did not result in clinically meaningful improvements compared with controls.
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http://dx.doi.org/10.23736/S0375-9393.21.15339-8DOI Listing
August 2021

The ABCDE bundle implementation in an intensive care unit: Facilitators and barriers perceived by nurses and doctors.

Int J Nurs Pract 2021 Jun 8:e12984. Epub 2021 Jun 8.

IRCCS San Raffaele Scientific Institute, Vita-Salute San Raffaele University, Milan, Italy.

Aim: To describe the facilitators and barriers perceived by healthcare teams after the implementation of the Awakening, Breathing, Coordination, Delirium monitoring/management and Early mobility bundle in an intensive care unit in Italy. This multicomponent intervention strategy has been associated with lower probabilities of delirium, improved functional outcomes and shorter duration of mechanical ventilation.

Methods: A survey study conducted between June 2015 and May 2016 explored variables related to intensive care unit team members: perceptions of delirium; knowledge of the Awakening, Breathing, Coordination, Delirium monitoring/management and Early mobility bundle; teamwork perception and resource availability.

Results: Most of the participants affirmed having reasonable knowledge of delirium, outcomes of delirious episodes, Awakening, Breathing, Coordination, Delirium monitoring/management and Early mobility bundle components and their effectiveness. Low coordination between healthcare professionals was identified as a barrier. Overall, the time elapsing from the beginning of implementation of the bundle determined an increase in levels of awareness and confidence in the application of the bundle protocol and the Confusion Assessment Method Intensive Care Unit scale.

Conclusion: Issues with the Awakening, Breathing, Coordination, Delirium monitoring/management and Early mobility bundle relating to coordination, management and interdisciplinary ward rounds are critical and should be remedied and monitored. This study could provide the basis for improving bundle implementation strategies and surveying levels of progression in other intensive care units.
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http://dx.doi.org/10.1111/ijn.12984DOI Listing
June 2021

After Action Reviews of COVID-19 response: Case study of a large tertiary care hospital in Italy.

Int J Health Plann Manage 2021 Sep 6;36(5):1758-1771. Epub 2021 Jun 6.

Department of Public Health, Experimental and Forensic Medicine, University of Pavia, Pavia, Italy.

Background: After-Action Reviews (AARs) are management tools used to evaluate the response to public health emergencies at the national and subnational level. Aim of this study is to apply available AAR models to assess and critically appraise COVID-19 response of San Raffaele Scientific Institute, a large university hospital in Milan, Italy.

Methods: We designed an AAR based on the key-informant interview format, following the methodology proposed by the 2019 World Health Organization Guidance for AAR. After systematic assessment of the hospital reorganization, we conducted 36 semi-structured interviews to professionals with executive, clinical, technical and administrative roles. We designed an ad-hoc questionnaire exploring four areas: (i) staff management; (ii) logistics and supplies; (iii) COVID-19 diagnosis and clinical management; (iv) communication.

Results: Overall, the hospital response was evaluated as effective and sufficiently prompt. Participants stressed the relevance of: (i) strong governance and coordination; (ii) readiness and availability of healthcare personnel; (iii) definition of a model of care based on a multidisciplinary approach. Challenges were reported for communication management and staff training.

Conclusions: This study is one of the first applications of the AAR to the COVID-19 response in hospital settings, which can be successfully adapted or scaled up to other settings in order to implement preparedness strategies for future public health emergencies.
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http://dx.doi.org/10.1002/hpm.3258DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8239549PMC
September 2021

Trend and Pattern of 100 Acute Respiratory Distress Syndrome Patients Referred for Venovenous Extracorporeal Membrane Oxygenation Treatment in a National Referral Center in North Italy During the Last Decade.

J Cardiothorac Vasc Anesth 2021 May 3. Epub 2021 May 3.

Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy.

Objective: Current evidence supports centralization of patients with refractory acute respiratory distress syndrome (ARDS) to institutions with a high level of expertise and with extracorporeal membrane oxygenation (ECMO) capabilities. The aim of this study was to analyze and report the data of transferred refractory ARDS patients managed with venovenous (VV) ECMO at a national referral center over the last 11 years.

Design: Observational study.

Setting: Referral center in Italy.

Participants: The study comprised 100 patients treated from May 2009-November 2020.

Interventions: None.

Measurements And Main Results: The mean age was 54 ± 14 years, and 65% of patients were male. Patients were treated throughout the year, with seasonal peaks in the winter months. The majority of patients were referred from hospitals within the Lombardia region (81%), mainly from the city of Milan and surrounding area (36% of the total). The most common etiology of refractory ARDS was H1N1 influenza A (42 patients [42%]), followed by bacterial pneumonia (35 patients [35%]), and severe acute respiratory syndrome due to Sars-CoV-2 infection (five patients [5%]). All patients were severely hypoxic at the time of VV ECMO treatment. No transport-related complication was recorded. The most common configuration used in the authors' clinical practice was a bicaval dual-lumen configuration (61 patients [61%]), followed by a femoro-jugular configuration (38 patients [38%]). The intensive care unit survival rate was 55%.

Conclusions: Referral to a specialized center for VV ECMO treatment should be considered expeditiously in case of refractory ARDS, which often is lethal. Transport of patients with an unstable condition, although challenging, is feasible, and centralization of patient care is associated with good outcomes.
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http://dx.doi.org/10.1053/j.jvca.2021.04.037DOI Listing
May 2021

Epicardial adipose tissue characteristics, obesity and clinical outcomes in COVID-19: A post-hoc analysis of a prospective cohort study.

Nutr Metab Cardiovasc Dis 2021 06 3;31(7):2156-2164. Epub 2021 May 3.

Division of Immunology, Transplantation and Infectious Diseases, IRCCS San Raffaele Scientific Institute, Milan, Italy; School of Medicine, Vita-Salute San Raffaele University, Milan, Italy.

Background And Aims: Obesity-related cardiometabolic risk factors associate with COVID-19 severity and outcomes. Epicardial adipose tissue (EAT) is associated with cardiometabolic disturbances, is a source of proinflammatory cytokines and a marker of visceral adiposity. We investigated the relation between EAT characteristics and outcomes in COVID-19 patients.

Methods And Results: This post-hoc analysis of a large prospective investigation included all adult patients (≥18 years) admitted to San Raffaele University Hospital in Milan, Italy, from February 25th to April 19th, 2020 with confirmed SARS-CoV-2 infection who underwent a chest computed tomography (CT) scan for COVID-19 pneumonia and had anthropometric data available for analyses. EAT volume and attenuation (EAT-At, a marker of EAT inflammation) were measured on CT scan. Primary outcome was critical illness, defined as admission to intensive care unit (ICU), invasive ventilation or death. Cox regression and regression tree analyses were used to assess the relationship between clinical variables, EAT characteristics and critical illness. One-hundred and ninety-two patients were included (median [25th-75th percentile] age 60 years [53-70], 76% men). Co-morbidities included overweight/obesity (70%), arterial hypertension (40%), and diabetes (16%). At multivariable Cox regression analysis, EAT-At (HR 1.12 [1.04-1.21]) independently predicted critical illness, while increasing PaO/FiO was protective (HR 0.996 [95% CI 0.993; 1.00]). CRP, plasma glucose on admission, EAT-At and PaO/FiO identified five risk groups that significantly differed with respect to time to death or admission to ICU (log-rank p < 0.0001).

Conclusion: Increased EAT attenuation, a marker of EAT inflammation, but not obesity or EAT volume, predicts critical COVID-19.

Trial Registration: NCT04318366.
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http://dx.doi.org/10.1016/j.numecd.2021.04.020DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8091800PMC
June 2021

Diaries in intensive care units: An Italian qualitative study.

Nurs Crit Care 2021 May 30. Epub 2021 May 30.

Center for Nursing Research and Innovation, Vita-Salute San Raffaele University, Milan, Italy.

Background: The literature emphasizes the importance of the intensive care unit (ICU) diary to fill the gaps and recover the delusional memories of patients admitted to ICU in order to build the history of their illness. The ICU diary is a measure originally intended to support the severely ill patient, but it would also seem to be useful for family members and carers. According to our analysis of the literature, this study is the first description of the contents of ICU diaries in the Italian context.

Aim: The aim of the study was to describe the contents of ICU patients' diaries filled in by their caregivers, in order to explore the experience and significance attributed to the diaries.

Design: A qualitative longitudinal narrative investigation was conducted at an ICU during the period from April 2016 to April 2017 with a sample composed of 32 families.

Methods: The participants were caregivers selected through purposive sampling. An ICU nurse explained the study to caregivers and offered the opportunity to participate.

Results: The sample included 32 diaries. Through the analysis we identified seven themes: future plans and memories; the people who care for the patient and the context; the love surrounding the patient; the clinical progression of the patient and the passage of time; what happens outside the patient's life; references to the usefulness/non-usefulness of the diary; communication/reflection on the likely death of the patient.

Conclusions: Some themes emerged that have never explored in the literature, and it would be necessary to understand whether the themes that emerged depend on cultural issues.

Relevance To Clinical Practice: The diaries could be adapted to the Italian context and this could make the diary a common practice in Italy as well.
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http://dx.doi.org/10.1111/nicc.12668DOI Listing
May 2021

Respiratory Impairment Predicts Response to IL-1 and IL-6 Blockade in COVID-19 Patients With Severe Pneumonia and Hyper-Inflammation.

Front Immunol 2021;12:675678. Epub 2021 Apr 29.

Università Vita-Salute San Raffaele, IRCCS San Raffaele Scientific Institute, Milan, Italy.

Background: Restraining maladaptive inflammation is considered a rationale strategy to treat severe (COVID-19) but available studies with selective inhibitors of pro-inflammatory cytokines have not provided unequivocal evidence of survival advantage. Late administration is commonly regarded as a major cause of treatment failure but the optimal timing for anti-cytokine therapy initiation in COVID-19 patients has never been clearly established.

Objectives: To identify a window of therapeutic opportunity for maximizing the efficacy of interleukin (IL)-1 and IL-6 blockade in COVID-19.

Methods: Survival at the longest available follow-up was assessed in severe hyper-inflamed COVID-19 patients treated with anakinra, tocilizumab, sarilumab, or standard of care, stratified according to respiratory impairment at the time of treatment initiation.

Results: 107 patients treated with biologics and 103 contemporary patients treated with standard of care were studied. After a median of 106 days of follow-up (range 3-186), treatment with biologics was associated with a significantly higher survival rate compared to standard therapy when initiated in patients with a PaO/FiO ≥ 100 mmHg (p < 0.001). Anakinra reduced mortality also in patients with PaO/FiO < 100 mmHg (p = 0.04).

Conclusions: IL-1 and IL-6 blocking therapies are more likely to provide survival advantage in hyper-inflamed COVID-19 patients when initiated before the establishment of severe respiratory failure.
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http://dx.doi.org/10.3389/fimmu.2021.675678DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8117339PMC
May 2021

Intravascular Ultrasound Imaging and Endovascular Treatment of Left Ventricle Assist Device (HM3) Outflow Graft Obstruction.

JACC Cardiovasc Interv 2021 Jul 12;14(13):1497-1499. Epub 2021 May 12.

Department of Anesthesia and Intensive Care, IRCCS San Raffaele Hospital, Vita-Salute San Raffaele University, Milan, Italy.

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http://dx.doi.org/10.1016/j.jcin.2021.03.025DOI Listing
July 2021

Quantitative assessment of lung involvement on chest CT at admission: Impact on hypoxia and outcome in COVID-19 patients.

Clin Imaging 2021 Sep 29;77:194-201. Epub 2021 Apr 29.

Experimental Imaging Center, Radiology Unit, IRCCS San Raffaele Hospital, Milan, Italy; School of Medicine, Vita-Salute San Raffaele University, Milan, Italy.

Background: The aim of this study was to quantify COVID-19 pneumonia features using CT performed at time of admission to emergency department in order to predict patients' hypoxia during the hospitalization and outcome.

Methods: Consecutive chest CT performed in the emergency department between March 1st and April 7th 2020 for COVID-19 pneumonia were analyzed. The three features of pneumonia (GGO, semi-consolidation and consolidation) and the percentage of well-aerated lung were quantified using a HU threshold based software. ROC curves identified the optimal cut-off values of CT parameters to predict hypoxia worsening and hospital discharge. Multiple Cox proportional hazards regression was used to analyze the capability of CT quantitative features, demographic and clinical variables to predict the time to hospital discharge.

Results: Seventy-seven patients (median age 56-years-old, 51 men) with COVID-19 pneumonia at CT were enrolled. The quantitative features of COVID-19 pneumonia were not associated to age, sex and time-from-symptoms onset, whereas higher number of comorbidities was correlated to lower well-aerated parenchyma ratio (rho = -0.234, p = 0.04) and increased semi-consolidation ratio (rho = -0.303, p = 0.008). Well-aerated lung (≤57%), semi-consolidation (≥17%) and consolidation (≥9%) predicted worst hypoxemia during hospitalization, with moderate areas under curves (AUC 0.76, 0.75, 0.77, respectively). Multiple Cox regression identified younger age (p < 0.01), female sex (p < 0.001), longer time-from-symptoms onset (p = 0.049), semi-consolidation ≤17% (p < 0.01) and consolidation ≤13% (p = 0.03) as independent predictors of shorter time to hospital discharge.

Conclusion: Quantification of pneumonia features on admitting chest CT predicted hypoxia worsening during hospitalization and time to hospital discharge in COVID-19 patients.
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http://dx.doi.org/10.1016/j.clinimag.2021.04.033DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8081746PMC
September 2021

The 5 Reasons Why People Die of Coronavirus Disease 2019.

J Cardiothorac Vasc Anesth 2021 Apr 1. Epub 2021 Apr 1.

Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute; Faculty of Medicine, Vita-Salute San Raffaele University, Milan, Italy.

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http://dx.doi.org/10.1053/j.jvca.2021.03.045DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8012269PMC
April 2021

Less is more: We are administering too much protamine in cardiac surgery.

Ann Card Anaesth 2021 Apr-Jun;24(2):178-182

Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute; School of Medicine, Vita-Salute San Raffaele University, Milan, Italy.

Context: Protamine is routinely administered to neutralize the anticlotting effects of heparin, traditionally at a dose of 1 mg for every 100 IU of heparin-a 1:1 ratio protamine sparing effects-but this is based more on experience and practice than literature evidence. The use of Hemostasis Management System (HMS) allows an individualized heparin and protamine titration. This usually results in a decreased protamine dose, thus limiting its side effects, including paradox anticoagulation.

Aims: This study aims to assess how the use of HMS allows to reduction of protamine administration while restoring the basal activated clotting time (ACT) at the end of cardiac surgery.

Settings And Design: A retrospective observational study in a tertiary care university hospital.

Subjects And Methods: We analyzed data from 42 consecutive patients undergoing cardiopulmonary bypass (CPB) for cardiac surgery. For all patients HMS tests were performed before and after CPB, to determine how much heparin was needed to reach target ACT, and how much protamine was needed to reverse it.

Results: At the end of cardiopulmonary bypass, 2.2 ± 0.5 mg/kg of protamine was sufficient to reverse heparin effects. The protamine-to-heparin ratio was 0.56:1 over heparin total dose (a 44% reduction) and 0.84:1 over heparin initial dose (a 16% reduction).

Conclusion: A lower dose of protamine was sufficient to revert heparin effects after cardiopulmonary bypass. While larger studies are needed to confirm these findings and detect differences in clinically relevant outcomes, the administration of a lower protamine dose is endorsed by current guidelines and may help to avoid the detrimental effects of protamine overdose, including paradox bleeding.
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http://dx.doi.org/10.4103/aca.ACA_26_19DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8253032PMC
April 2021

[Transcatheter aortic valve implantation for aortic regurgitation in patients with left ventricular assist device].

G Ital Cardiol (Rome) 2021 03;22(3 Suppl 1):39S-42S

Emodinamica e Cardiologia Interventistica, IRCCS Ospedale San Raffaele, Milano.

Aortic valve regurgitation is a not negligible complication of prolonged support with continuous-flow left ventricular assist device (LVAD) and is associated with recurrence of heart failure and reduced survival. Transcatheter aortic valve implantation has been described as a feasible option in this setting, usually with self-expanding prosthesis. Giving the absence of valvular calcification, a proper prosthesis oversizing should be guaranteed in order to achieve sufficient sealing and avoid prosthesis migration or paravalvular leak. Current self-expanding prosthesis may be too small to fit aortic annulus anatomies without calcification and with the need of significant oversize. We report the first case of 32 mm balloon expandable Myval prosthesis implantation in a patient with LVAD-related aortic regurgitation. Large balloon-expandable prosthesis can be considered when a significant oversize is needed.
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http://dx.doi.org/10.1714/3578.35633DOI Listing
March 2021

Pneumothorax/pneumomediastinum in non-intubated COVID-19 patients: Differences between first and second Italian pandemic wave.

Eur J Intern Med 2021 06 19;88:144-146. Epub 2021 Mar 19.

Department of Radiology, IRCCS San Raffaele Scientific Institute, Milan, Italy; School of Medicine, Vita-Salute San Raffaele University, Milan, Italy.

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http://dx.doi.org/10.1016/j.ejim.2021.03.018DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7972796PMC
June 2021

Trigger and Target for Fibrinogen Supplementation Using Thromboelastometry (ROTEM) in Patients Undergoing Open Thoraco-Abdominal Aortic Aneurysm Repair.

Eur J Vasc Endovasc Surg 2021 05 24;61(5):799-808. Epub 2021 Mar 24.

Department of Anaesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy; University Vita-Salute San Raffaele, Milan, Italy.

Objective: To determine the relationship between the value of fibrinogen assessed by the FIBTEM clot amplitude at 10 minutes (A10 FIBTEM) measured on admission to the intensive care unit (ICU) and the amount of drainage output at 24 hours, to investigate whether the A10 FIBTEM predicts severe bleeding (SB), and to define A10 FIBTEM thresholds to prevent (trigger) and treat (target) severe bleeding by fibrinogen supplementation.

Methods: In a single centre, retrospective observational study, 166 patients underwent elective open thoraco-abdominal aortic aneurysm (TAAA) repair between March 2016 and January 2019. Exclusion criteria were emergency, congenital, or acquired coagulopathy, or administration of PY inhibitor antiplatelet agents in the five days before surgery. All patients were managed intra-operatively and post-operatively according to a rotational thromboelastometry driven transfusion protocol. The principal endpoint was a composite outcome, which included bleeding, large volume transfusion, and re-operation.

Results: FIBTEM clot amplitude after 10 minutes measured on ICU admission and post-operative bleeding at 24 hours showed an inverse linear relationship (R = .03; p = .026). Performance of A10 FIBTEM in predicting SB evaluated by Receiving Operating Curve analysis showed an area under the curve of 0.63 (95% CI 0.56 - 0.70; p = .026) with a best cutoff of 9 mm. An A10 FIBTEM of 3 mm was the cutoff associated with a positive predictive value of 50%, while an A10 FIBTEM of 9 mm showed a negative predictive value of 92%. On multivariable analysis, an A10 FIBTEM ≤ 3 mm remained independently associated with SB.

Conclusion: The present investigation shows for the first time in a population undergoing open TAAA repair that an A10 FIBTEM ≤ 3mm on ICU admission is associated with post-operative severe bleeding. Trigger and target values for fibrinogen supplementation, based on A10 FIBTEM, have been provided. The transferability and reliability of these cutoff values require further study.
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http://dx.doi.org/10.1016/j.ejvs.2021.02.046DOI Listing
May 2021

Continuous infusion versus intermittent administration of meropenem in critically ill patients (MERCY): A multicenter randomized double-blind trial. Rationale and design.

Contemp Clin Trials 2021 05 6;104:106346. Epub 2021 Mar 6.

University Hospital O.O.R.R. Foggia, Foggia, Italy.

Objective: Meropenem is a β-lactam, carbapenem antibacterial agent with antimicrobial activity against gram-negative, gram-positive and anaerobic micro-organisms and is important in the empirical treatment of serious infections in Intensive Care Unit (ICU) patients. Multi-drug resistant gram-negative organisms, coupled with scarcity of new antibiotic classes, forced healthcare community to optimize the therapeutic potential of available antibiotics. Our aim is to investigate the effect of continuous infusion of meropenem against bolus administration, as indicated by a composite outcome of reducing death and emergence of extensive or pan drug-resistant pathogens in a population of ICU patients.

Design: Double blind, double dummy, multicenter randomized controlled trial (1:1 allocation ratio).

Setting: Tertiary and University hospitals.

Interventions: 600 ICU patients with sepsis or septic shock, needing by clinical judgment antibiotic therapy with meropenem, will be randomized to receive a continuous infusion of meropenem 3 g/24 h or an equal dose divided into three daily boluses (i.e. 1g q8h).

Measurements: The primary endpoint will be a composite outcome of reducing death and emergence of extensive or pan drug-resistant pathogens. Secondary endpoints will be death from any cause at day 90, antibiotic-free days at day 28, ICU-free days at day 28, cumulative SOFA-free (Sequential Organ Failure Assessment) score from randomization to day 28 and the two, separate, components of the primary endpoint. We expect a primary outcome reduction from 52 to 40% in the continuous infusion group.

Conclusions: The trial will provide evidence for choosing intermittent or continuous infusion of meropenem for critically ill patients with multi-drug resistant gram-negative infections.
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http://dx.doi.org/10.1016/j.cct.2021.106346DOI Listing
May 2021

Predictors of Pneumothorax/Pneumomediastinum in Mechanically Ventilated COVID-19 Patients.

J Cardiothorac Vasc Anesth 2021 Feb 6. Epub 2021 Feb 6.

Department of Radiology, IRCCS San Raffaele Scientific Institute, Milan, Italy; School of Medicine, Vita-Salute San Raffaele University, Milan, Italy.

Objective: To determine the incidence, predictors, and outcome of pneumothorax (PNX)/pneumomediastinum (PMD) in coronavirus disease 2019 (COVID-19) acute respiratory distress syndrome (ARDS).

Design: Observational study.

Setting: Tertiary-care university hospital.

Participants: One hundred sixteen consecutive critically ill, invasively ventilated patients with COVID-19 ARDS.

Interventions: The authors collected demographic, mechanical ventilation, imaging, laboratory, and outcome data. Primary outcome was the incidence of PNX/PMD. Multiple logistic regression analyses were performed to identify predictors of PNX/PMD.

Measurements And Main Results: PNX/PMD occurred in a total of 28 patients (24.1%), with 22 patients developing PNX (19.0%) and 13 developing PMD (11.2%). Mean time to development of PNX/PMD was 14 ± 11 days from intubation. The authors found no significant difference in mechanical ventilation parameters between patients who developed PNX/PMD and those who did not. Mechanical ventilation parameters were within recommended limits for protective ventilation in both groups. Ninety-five percent of patients with PNX/PMD had the Macklin effect (linear collections of air contiguous to the bronchovascular sheaths) on a baseline computed tomography scan, and tended to have a higher lung involvement at intensive care unit (ICU) admission (Radiographic Assessment of Lung Edema score 32.2 ± 13.4 v 18.7 ± 9.8 in patients without PNX/PMD, p = 0.08). Time from symptom onset to intubation and time from total bilirubin on day two after ICU admission were the only independent predictors of PNX/PMD. Mortality was 60.7% in patients who developed PNX/PMD versus 38.6% in those who did not (p = 0.04).

Conclusion: PNX/PMD occurs frequently in COVID-19 patients with ARDS requiring mechanical ventilation, and is associated with increased mortality. Development of PNX/PMD seems to occur despite use of protective mechanical ventilation and has a radiologic predictor sign.
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http://dx.doi.org/10.1053/j.jvca.2021.02.008DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8054543PMC
February 2021

Two-months quality of life of COVID-19 invasively ventilated survivors; an Italian single-center study.

Acta Anaesthesiol Scand 2021 08 15;65(7):912-920. Epub 2021 Mar 15.

Vita-Salute University San Raffaele, Milano, Italia, Anesthesia and Intensive Care, Milan, Italy.

Background: COVID-19 disease can lead to severe functional impairments after discharge. We assessed the quality of life of invasively ventilated COVID-19 ARDS survivors.

Methods: We carried out a prospective follow-up study of the patients admitted to the Intensive Care Units (ICUs) of a teaching hospital. Patients affected by COVID-19 ARDS who required invasive ventilation and were successfully discharged home were assessed through the telephone administration of validated tests. We explored survival, functional outcomes, return to work, quality of life, cognitive and psychological sequelae. The main variables of interest were the following: demographics, severity scores, laboratory values, comorbidities, schooling, working status, treatments received during ICU stay, complications, and psychological, cognitive, functional outcomes.

Results: Out of 116 consecutive invasively ventilated patients, overall survival was 65/116 (56%) with no death occurring after hospital discharge. Forty-two patients were already discharged home with a median follow-up time of 61 (51-71) days after ICU discharge and 39 of them accepted to be interviewed. Only one patient (1/39) experienced cognitive decline. The vast majority of patients reported no difficulty in walking (32/35:82%), self-care (33/39:85%), and usual activities (30/39:78%). All patients were either malnourished (15/39:38%) or at risk for malnutrition (24/39:62%). Exertional dyspnea was present in 20/39 (51%) patients. 19/39 (49%) reported alterations in senses of smell and/or taste either before or after hospitalization.

Conclusions: Invasively ventilated COVID-19 ARDS survivors have an overall good recovery at a 2-months follow-up which is better than what was previously reported in non-COVID-19 ARDS patients.
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http://dx.doi.org/10.1111/aas.13812DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8014684PMC
August 2021

Interleukin-1 and interleukin-6 inhibition compared with standard management in patients with COVID-19 and hyperinflammation: a cohort study.

Lancet Rheumatol 2021 Apr 3;3(4):e253-e261. Epub 2021 Feb 3.

Unit of Immunology, Rheumatology, Allergy and Rare Diseases, IRCCS San Raffaele Scientific Institute, Milan, Italy.

Background: Patients with severe COVID-19 develop a life-threatening hyperinflammatory response to the virus. Interleukin (IL)-1 or IL-6 inhibitors have been used to treat this patient population, but the comparative effectiveness of these different strategies remains undetermined. We aimed to compare IL-1 and IL-6 inhibition in patients admitted to hospital with COVID-19, respiratory insufficiency, and hyperinflammation.

Methods: This cohort study included patients admitted to San Raffaele Hospital (Milan, Italy) with COVID-19, respiratory insufficiency, defined as a ratio of the partial pressure of oxygen to the fraction of inspired oxygen of 300 mm Hg or less, and hyperinflammation, defined as serum C-reactive protein concentration of 100 mg/L or more or ferritin concentration of 900 ng/mL or more. The primary endpoint was survival, and the secondary endpoint was a composite of death or mechanical ventilation (adverse clinical outcome). Multivariable Cox regression analysis was used to compare clinical outcomes of patients receiving IL-1 inhibition (anakinra) or IL-6 inhibition (tocilizumab or sarilumab) with those of patients who did not receive interleukin inhibitors, after accounting for baseline differences. All patients received standard care. Interaction tests were used to assess the probability of survival according to C-reactive protein or lactate dehydrogenase concentrations.

Findings: Of 392 patients included between Feb 25 and May 20, 2020, 275 did not receive interleukin inhibitors, 62 received the IL-1 inhibitor anakinra, and 55 received an IL-6 inhibitor (29 received tocilizumab and 26 received sarilumab). In the multivariable analysis, compared with patients who did not receive interleukin inhibitors, patients treated with IL-1 inhibition had a significantly reduced mortality risk (hazard ratio [HR] 0·450, 95% CI 0·204-0·990, p=0·047), but those treated with IL-6 inhibition did not (0·900, 0·412-1·966; p=0·79). In the multivariable analysis, there was no difference in adverse clinical outcome risk in patients treated with IL-1 inhibition (HR 0·866, 95% CI 0·482-1·553; p=0·63) or IL-6 inhibition (0·882, 0·452-1·722; p=0·71) relative to patients who did not receive interleukin inhibitors. For increasing C-reactive protein concentrations, patients treated with IL-6 inhibition had a significantly reduced risk of mortality (HR 0·990, 95% CI 0·981-0·999; p=0·031) and adverse clinical outcome (0·987, 0·979-0·995; p=0·0021) compared with patients who did not receive interleukin inhibitors. For decreasing concentrations of serum lactate dehydrogenase, patients treated with an IL-1 inhibitor and patients treated with IL-6 inhibitors had a reduced risk of mortality; increasing concentrations of lactate dehydrogenase in patients receiving either interleukin inhibitor were associated with an increased risk of mortality (HR 1·009, 95% CI 1·003-1·014, p=0·0011 for IL-1 inhibitors and 1·006, 1·001-1·011, p=0·028 for IL-6 inhibitors) and adverse clinical outcome (1·006, 1·002-1·010, p=0·0031 for IL-1 inhibitors and 1·005, 1·001-1·010, p=0·016 for IL-6 inhibitors) compared with patients who did not receive interleukin inhibitors.

Interpretation: IL-1 inhibition, but not IL-6 inhibition, was associated with a significant reduction of mortality in patients admitted to hospital with COVID-19, respiratory insufficiency, and hyperinflammation. IL-6 inhibition was effective in a subgroup of patients with markedly high C-reactive protein concentrations, whereas both IL-1 and IL-6 inhibition were effective in patients with low lactate dehydrogenase concentrations.

Funding: None.
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http://dx.doi.org/10.1016/S2665-9913(21)00012-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7906668PMC
April 2021
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