Publications by authors named "Antonella Zambon"

114 Publications

When to suspect hidden hypercortisolism in type 2 diabetes: a meta-analysis.

Endocr Pract 2021 Jul 26. Epub 2021 Jul 26.

Department of Endocrine and Metabolic Diseases, IRCCS, Istituto Auxologico Italiano, Milan, Italy; Department of Medical Biotechnologies and Translational Medicine, University of Milan, Milan, Italy. Electronic address:

Objective: Among patients with type 2 diabetes (T2D), the prevalence of hidden hypercortisolism (HidHyCo, formally called subclinical hypercortisolism or mild autonomous cortisol secretion) was estimated to be 2.2-12.1%. The aim of this study was to investigate whether the available literature helps to identify the characteristics of T2D patients more frequently associated with HidHyCo.

Methods: A meta-analysis was performed using studies that assessed both the prevalence of HidHyCo in patients with T2D and the characteristics of these patients with and without HidHyCo. The DerSimonian and Laird (DSL) and the Hartung, Knapp, Sidik and Jonkman (HKSJ) methods were utilized.

Results: Among the 18 available studies, 6 studies provided the necessary data. The association between HidHyCo and advanced T2D (based on the patients' description given in each study in presence of micro/ microvascular complications, or insulin treatment plus hypertension, or hypertension treated with ≥2 drugs), hypertension, insulin treatment and dyslipidemia was reported in 5 (2184 patients), 6 (2283 patients), 3 (1440 patients), and 3 (987 patients) studies, respectively. HidHyCo was associated with advanced T2D as assessed with both DSL (odds ratio, OR, 3.47, 95% Confidence Interval, 95%CI, 2.12-5.67) and HKSJ method (OR 3.60, 95%CI 2.03-6.41) and with the prevalence of hypertension or of insulin treatment as assessed by the DSL approach (OR 1.92, 95%CI 1.05-3.50 and OR 2.29, 95%CI 1.07-4.91, respectively), but not as assessed with HKSJ method.

Conclusions: Patients with advanced T2D have a higher prevalence of HidHyCo. These data inform about the selection of T2D patients for HidHyCo screening.
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http://dx.doi.org/10.1016/j.eprac.2021.07.014DOI Listing
July 2021

Prognostic interplay of kidney function with sarcopenia, anemia, disability and cognitive impairment. The GLISTEN study.

Eur J Intern Med 2021 Jul 10. Epub 2021 Jul 10.

Department of Geriatrics, Neurosciences and Orthopaedics, Catholic University of the Sacred Heart, Rome, Italy.

Background: Interactions between chronic kidney disease (CKD) and several comorbidities may potentially affect prognosis of older hospitalized patients. This study aims at evaluating the prognostic interactions between estimated glomerular filtration rate (eGFR), anemia, sarcopenia, functional and cognitive dysfunction, and 3-year mortality among older patients discharged from acute care hospitals.

Methods: Our series consisted of 504 older adults enrolled in a multicenter observational study carried out in twelve Acute Geriatric and Internal Medicine wards throughout Italy. CKD was defined as an eGFR< 60 ml/min/1.73 m. Anemia, Short Portable Status Mental Questionnaire (SPMSQ), Basic Activities of Daily Living (BADL), sarcopenia, and Charlson index were considered in the analysis. 3-year survival was investigated by Cox regression and prognostic interactions among study variables were assessed by survival tree analysis. Accuracy of different survival models was investigated by C-index.

Results: eGFR < 30 mL/min/1.73 m, anemia, sarcopenia, SPMSQ ≥ 5, and impairment in 1 or more BADL were significantly associated with mortality. Survival tree analysis showed that patients with eGFR < 35.32 ml/min/1.73 m and SPMSQ ≥ 5 had the highest risk of mortality [hazard ratio (HR): 5.49, 95%CI: 3.04-9.94] followed by those with eGFR < 35.32 ml/min/1.73 m, hemoglobin < 11.95 g/dL and SPMSQ < 5 (HR:3.65; 95%CI: 2.21-6.02) and those with eGFR 35.32-47.99 ml/min/1.73 m and sarcopenia (HR:3.65; 95%CI: 1.99-6.69). Survival tree leaf node membership had good accuracy in predicting the study outcome (C-index: 0.73, 95%CI:0.70-0.76).

Conclusions: Interactions among study risk factors designed distinct risk profiles in older patients discharged from acute care hospitals, that may help identify patients needing targeted interventions and appropriate follow-up after discharge.
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http://dx.doi.org/10.1016/j.ejim.2021.06.031DOI Listing
July 2021

Body composition assessment using bioelectrical impedance analysis (BIA) in a wide cohort of patients affected with mild to severe obesity.

Clin Nutr 2021 Jun 28;40(6):3973-3981. Epub 2021 Apr 28.

IRCCS Istituto Auxologico Italiano, Obesity Unit, Laboratory of Nutrition and Obesity Research, Department of Endocrine and Metabolic Diseases, Milan, Italy. Electronic address:

Background & Aims: Obesity is characterized by fat mass excess (FM), extra cellular water increase (ECW) and, with ageing, decrease in fat free mass (FFM). The validity of body impedance analysis (BIA) in patients with mild to severe obesity is still debated. The purpose of this study is to describe the Resistance (Rz) and Reactance (Xc) values obtained by Body Impedance Analysis (BIA) in a wide cohort of Italian patients with mild to severe obesity. The secondary endpoint is to describe the resulting body composition values (as percentage and indexes) in this population.

Methods: The study enrolled adult in-patients with mild to severe obesity (classified with class I, II and III obesity) undergoing clinical care rehabilitation program for obesity complications and weight loss. BIA values were grouped by sex, BMI and age classes.

Results: A total of 8303 patients with obesity, aged 18 to 90 y, were studied. The Resistance (Rz) and Reactance (Xc) were reported by sex, age and BMI classes. In women and men both, the phase angle (PhA) decreases with increasing BMI (kg/m) and the resulting BIA vector was significantly shifted. The FM index (FMI) was higher (p < 0.0001) in women while FFM index (FFMI) was higher in men (p < 0.0001) and significantly associated with BMI. FFMI decreased with age in both sex (p < 0.0001). Skeletal mass (SM) presents a progressive reduction in relation to age and gender both.

Conclusions: The present BIA-based body composition analysis in a wide cohort of mild to severe obese patients revealed a significantly decreased Rz and Xc values with a consequent significant decrease of PhA in a BMI-dependent manner. The body compartments estimation with available equations was BMI, sex and age dependent. These observational results could be the basis for the development of new equations adapted for patients suffering from obesity.
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http://dx.doi.org/10.1016/j.clnu.2021.04.033DOI Listing
June 2021

Vitamin D and COVID-19 severity and related mortality: a prospective study in Italy.

BMC Infect Dis 2021 Jun 14;21(1):566. Epub 2021 Jun 14.

Department of Endocrine and Metabolic Diseases & Lab of Endocrine and Metabolic Research, IRCCS, Istituto Auxologico Italiano, Via Magnasco 2, 20149, Milan, Italy.

Background: Vitamin D deficiency has been suggested to favor a poorer outcome of Coronavirus disease-19 (COVID-19). We aimed to assess if 25-hydroxyvitamin-D (25OHD) levels are associated with interleukin 6 (IL-6) levels and with disease severity and mortality in COVID-19.

Methods: We prospectively studied 103 in-patients admitted to a Northern-Italian hospital (age 66.1 ± 14.1 years, 70 males) for severely-symptomatic COVID-19. Fifty-two subjects with SARS-CoV-2 infection but mild COVID-19 symptoms (mildly-symptomatic COVID-19 patients) and 206 subjects without SARS-CoV-2 infection were controls. We measured 25OHD and IL-6 levels at admission and focused on respiratory outcome during hospitalization.

Results: Severely-symptomatic COVID-19 patients had lower 25OHD levels (18.2 ± 11.4 ng/mL) than mildly-symptomatic COVID-19 patients and non-SARS-CoV-2-infected controls (30.3 ± 8.5 ng/mL and 25.4 ± 9.4 ng/mL, respectively, p < 0.0001 for both comparisons). 25OHD and IL-6 levels were respectively lower and higher in severely-symptomatic COVID-19 patients admitted to intensive care Unit [(ICU), 14.4 ± 8.6 ng/mL and 43.0 (19.0-56.0) pg/mL, respectively], than in those not requiring ICU admission [22.4 ± 1.4 ng/mL, p = 0.0001 and 16.0 (8.0-32.0) pg/mL, p = 0.0002, respectively]. Similar differences were found when comparing COVID-19 patients who died in hospital [13.2 ± 6.4 ng/mL and 45.0 (28.0-99.0) pg/mL] with survivors [19.3 ± 12.0 ng/mL, p = 0.035 and 21.0 (10.5-45.9) pg/mL, p = 0.018, respectively). 25OHD levels inversely correlated with: i) IL-6 levels (ρ - 0.284, p = 0.004); ii) the subsequent need of the ICU admission [relative risk, RR 0.99, 95% confidence interval (95%CI) 0.98-1.00, p = 0.011] regardless of age, gender, presence of at least 1 comorbidity among obesity, diabetes, arterial hypertension, creatinine, IL-6 and lactate dehydrogenase levels, neutrophil cells, lymphocytes and platelets count; iii) mortality (RR 0.97, 95%CI, 0.95-0.99, p = 0.011) regardless of age, gender, presence of diabetes, IL-6 and C-reactive protein and lactate dehydrogenase levels, neutrophil cells, lymphocytes and platelets count.

Conclusion: In our COVID-19 patients, low 25OHD levels were inversely correlated with high IL-6 levels and were independent predictors of COVID-19 severity and mortality.
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http://dx.doi.org/10.1186/s12879-021-06281-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8200788PMC
June 2021

Current Limitations of Invasive Exercise Hemodynamics for the Diagnosis of Heart Failure With Preserved Ejection Fraction.

Circ Heart Fail 2021 May 6;14(5):e007555. Epub 2021 May 6.

Department of Cardiology, Cliniques Universitaires de Bruxelles, Hôpital Académique Erasme, Belgium (C.D., A.B., J.-L.V.).

Background: Exercise hemodynamics can differentiate heart failure with preserved ejection fraction (HFpEF) from noncardiac dyspnea. However, respiratory pressure swings may impact hemodynamic measurements, potentially leading to misdiagnosis of HFpEF. Moreover, threshold values for abnormal hemodynamic response indicative of HFpEF are not universally accepted. Thus, we sought to evaluate the impact of respiratory pressure swings on hemodynamic data interpretation as well as the concordance among 3 proposed exercise hemodynamic criteria for HFpEF: (1) end-expiratory pulmonary artery wedge pressure (PAWP) ≥25 mm Hg; (2) PAWP/cardiac output slope >2 mm Hg/L per minute; and (3) respiratory-averaged (avg) mean pulmonary artery pressure >30 mm Hg, total pulmonary resistance >3 WU, PAWP ≥20 mm Hg.

Methods: Fifty-seven patients with unexplained dyspnea (70% women, 70±9 years) underwent exercise cardiac catheterization. The difference between end-expiratory and averaged hemodynamic values, as well as the concordance among the 3 hemodynamic definitions of HFpEF, were assessed.

Results: End-expiratory hemodynamics measurements were higher than values averaged across the respiratory cycle. During exercise, a larger proportion of patients exceeded the threshold of 25 mm Hg for PAWP rather than for PAWP (70% versus 53%, <0.01). The concordance of 3/3 HFpEF exercise hemodynamic criteria was recorded in 70% of patients. PAWP/cardiac output slope identified HFpEF more frequently than the other 2 criteria (81% versus 64% to 69%), incorporating over 97% of abnormal responses to the latter. Patients with 3/3 positive criteria had worse clinical, gas-exchange, and hemodynamic profiles.

Conclusions: Respiratory pressure swings impact on the exercise hemodynamic definitions of HFpEF that provide discordant results in 30% of patients. Equivocal diagnoses of HFpEF might be limited by adopting the most sensitive and inclusive criterion alone (ie, PAWP/cardiac output slope).
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http://dx.doi.org/10.1161/CIRCHEARTFAILURE.120.007555DOI Listing
May 2021

Frailty, post-operative delirium and functional status at discharge in patients with hip fracture.

Int J Geriatr Psychiatry 2021 Apr 27. Epub 2021 Apr 27.

School of Medicine and Surgery, Milano-Bicocca University, Monza, Italy.

Objective: To explore the effect of frailty, alone and in combination with post-operative delirium (POD), on the risk of poor function at discharge in patients with hip fracture (HF).

Methods: This is a prospective cohort study of patients with HF admitted to an Orthogeriatric Unit (OGU) between October 1, 2011 and March 15, 2019. POD was assessed using the 4AT and the Diagnostic and Statistical Manual of Mental Disorders (DSM) 5-edition criteria. A 22-items Frailty Index (FI) was created using the data collected on admission. The outcome measure was the Cumulated Ambulation Score (CAS) score at discharge. A log-binomial regression model was used to assess the effect of frailty and POD on CAS.

Results: A total of 988 patients (median age = 84.9 years, Interquartile range = 80.6-89.2) were included: 360 patients (36.4%) were frail and 411 (42%) developed POD. Poor functional status at discharge (CAS score ≤2) was more common in frail than non-frail patients (68.3% vs. 53.8%, p < 0.001) In a regression adjusted for confounders, frailty alone (Relative Risk, RR = 1.33, 95% Confidence Intervals, CI = 1.14-1.55) and POD alone (RR 1.38, 95% CI = 1.2-1.59) were associated with poor functional status at discharge; when combined, frailty and POD had an interaction, yielding a mild increase in the risk of poor outcome (RR 1.47, 95% CI = 1.28-1.69).

Conclusions: In older patients undergoing HF surgery, frailty, POD and their combination, are associated with poor functional status at discharge.
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http://dx.doi.org/10.1002/gps.5561DOI Listing
April 2021

Home blood pressure during COVID-19-related lockdown in patients with hypertension.

Eur J Prev Cardiol 2021 Feb 5. Epub 2021 Feb 5.

Department of Cardiovascular, Neural and Metabolic Sciences, IRCCS Istituto Auxologico Italiano, Ospedale San Luca, Via Magnasco, 2, 20149, Milan, Italy.

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http://dx.doi.org/10.1093/eurjpc/zwab010DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8135487PMC
February 2021

The 4-DSD: A New Tool to Assess Delirium Superimposed on Moderate to Severe Dementia.

J Am Med Dir Assoc 2021 07 3;22(7):1535-1542.e3. Epub 2021 Apr 3.

School of Medicine and Surgery, University of Milano-Bicocca, Milan, Italy.

Objectives: The purpose of this study was to create, standardize, and validate a new instrument, named 4-DSD, and determine its diagnostic accuracy in the diagnosis of delirium in subjects with moderate to severe dementia.

Design: Multicenter cross-sectional observational study.

Setting And Participants: Older patients consecutively admitted to acute and rehabilitation hospital wards.

Measures: The DSM-5 was used as the reference standard delirium assessment. The presence and severity of dementia was defined using the AD8 and the Global Deterioration Scale (GDS). The 4-DSD is a 4-item tool that ranges from 0 to 12. Item 1 measures alertness, item 2 altered function, item 3 attention, and item 4 acute change or fluctuation in mental status.

Results: A total of 134 patients were included in the study. Most of the patients were enrolled in acute hospital wards (60%), with 40% in rehabilitation settings. A minority of the patients were categorized with moderate dementia, with a GDS score of 5 (4%). Most of the patients were in the moderate-severe stage with a GDS score ≤6 (77%); 19% were classed as severe, with a GDS score of 7. A 4-DSD cutoff score ≥5 had a sensitivity of 80% and specificity of 80% with a positive predictive value (PPV) of 67% and a negative predictive value (NPV) of 89%. In the subgroup with moderate-severe dementia (n = 108), the sensitivity and the specificity were 79% and 82%, respectively, with a PPV and NPV of 62% and 92%. In the subgroup with severe dementia (n = 26) the sensitivity was 82% and the specificity 56% with a PPV of 78% and a NPV of 63%.

Conclusions And Implications: The availability of a specific tool to detect delirium in patients with moderate-severe dementia has important clinical and research implications, allowing all health care providers to improve their ability to identify it.
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http://dx.doi.org/10.1016/j.jamda.2021.02.029DOI Listing
July 2021

Association between renin-angiotensin-aldosterone system inhibitors and risk of dementia: A meta-analysis.

Pharmacol Res 2021 04 24;166:105515. Epub 2021 Feb 24.

Biostatistic Unit, IRCCS Istituto Auxologico Italiano, Milan, Italy; Department of Statistics and Quantitative Methods, University of Milano-Bicocca, Milan, Italy.

Objective: To evaluate the association of all RAAS inhibitors, ACE inhibitors (ACEIs) and angiotensin II receptor blockers (ARBs) on dementia onset (any dementia, Alzheimer's disease and vascular dementia) using a meta-analytic approach.

Methods: A systematic MEDLINE search was carried out to identify all observational studies published up to the 30th September 2020 evaluating the association between RAAS inhibitors and risk of dementia. Studies were included if original investigations considering incident dementia cases, with ACEIs and/or ARBs as exposure and other antihypertensives (AHs) use as reference, and if reporting association estimates and relative variability measures. Random effect pooled relative risks (pRR) and the corresponding 95% confidence intervals (95%CI) were calculated according to DerSimonian and Laird's (DL) or to Hartung Knapp Sidik Jonkman (HKSJ) method depending on the number of studies and between-studies heterogeneity. A linear mixed meta-regression model (MM) was applied to take into account correlation among association estimates from the same study.

Results: 15 studies were included in the meta-analysis. ARBs but not ACEIs' use led to a significant reduction of the risk of any dementia (pRR 0.78, 95%CI 0.70-0.87) and Alzheimer's disease (pRR 0.73, 95%CI 0.60-0.90). Moreover, when compared to ACEIs, ARBs reduced of 14% the risk of any dementia (pRR 0.86, 95%CI 0.79-0.94).

Conclusions: ARBs but not ACEIs led to a reduction in the risk of any dementia. The difference between ARBs and ACEIs in terms of preventive effectiveness could be due to distinct profiles of antagonism towards independent receptor pathways or to differential influences on amyloid metabolism.
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http://dx.doi.org/10.1016/j.phrs.2021.105515DOI Listing
April 2021

Low-blood pressure phenotype underpins the tendency to reflex syncope.

J Hypertens 2021 Jul;39(7):1319-1325

Department of Clinical Sciences, Lund University.

Background: We hypothesized that cardiovascular physiology differs in reflex syncope patients compared with the general population, predisposing such individuals to vasovagal reflex.

Methods: In this multicohort cross-sectional study, we compared aggregate data of resting SBP, DBP, pulse pressure (PP) and heart rate (HR), collected from six community-based cohort studies (64 968 observations) with those from six databases of reflex syncope patients (6516 observations), subdivided by age decades and sex.

Results: Overall, in male individuals with reflex syncope, SBP (-3.4 mmHg) and PP (-9.2 mmHg) were lower and DBP (+2.8 mmHg) and HR (+5.1 bpm) were higher than in the general population; the difference in SBP was higher at ages above 60 years. In female individuals, PP (-6.0 mmHg) was lower and DBP (+4.7 mmHg) and HR (+4.5 bpm) were higher than in the general population; differences in SBP were less pronounced, becoming evident only above 60 years. Compared with male individuals, SBP in female individuals exhibited slower increase until age 40 years, and then demonstrated steeper increase that continued throughout remaining life.

Conclusion: The patients prone to reflex syncope demonstrate a different resting cardiovascular haemodynamic profile as compared with a general population, characterized by lower SBP and PP, reflecting reduced venous return and lower stroke volume, and a higher HR and DBP, suggesting the activation of compensatory mechanisms. Our data contribute to a better understanding why some individuals with similar demographic characteristics develop reflex syncope and others do not.

Video Abstract: http://links.lww.com/HJH/B580.
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http://dx.doi.org/10.1097/HJH.0000000000002800DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8183486PMC
July 2021

Association of infrapopliteal medial arterial calcification with lower-limb amputations in high-risk patients: A systematic review and meta-analysis.

Vasc Med 2021 Apr 29;26(2):164-173. Epub 2020 Dec 29.

Department of Statistics and Quantitative Methods, University of Milano-Bicocca, Milan, Italy.

Medial arterial calcification (MAC) is a known risk factor for cardiovascular morbidity. The association between vascular calcifications and poor outcome in several vascular districts suggest that infrapopliteal MAC could be a risk factor for lower-limb amputation (LLA). This study's objective is to review the available literature focusing on the association between infrapopliteal MAC and LLA in high-risk patients. The PubMed and Embase databases were systematically searched. We selected original studies reporting the association between infrapopliteal MAC and LLAs in patients with diabetes and/or peripheral artery disease (PAD). Estimates were pooled using either a fixed-effects or a random-effects model meta-analysis. Heterogeneity was evaluated using the and statistics. Publication bias was investigated with a funnel plot and Egger test. The trim-and-fill method was designed to estimate the possibly missing studies. Influence analysis was conducted to search studies influencing the final result. Test of moderators was used to compare estimates in good versus non-good-quality studies. Fifteen articles satisfied the selection criteria ( = 6489; median follow-up: 36 months). MAC was significantly associated with LLAs (pooled adjusted risk ratio (RR): 2.27; 95% CI: 1.89-2.74; = 25.3%, -test: = 0.17). This association was kept in the subgroup of patients with diabetes (RR: 2.37; 95% CI: 1.76-3.20) and patients with PAD (RR: 2.48; 95% CI: 1.72-3.58). The association was maintained if considering as outcome only major amputations (RR: 2.11; 95% CI: 1.46-3.06). Our results show that infrapopliteal MAC is associated with LLAs, thus suggesting MAC as a possible new marker of the at-risk limb.
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http://dx.doi.org/10.1177/1358863X20979738DOI Listing
April 2021

Efficacy Profile and Safety of Very Low-Dose Rituximab in Patients with Graves' Orbitopathy.

Thyroid 2021 05 31;31(5):821-828. Epub 2021 Mar 31.

Department of Clinical Sciences and Community Health, Graves' Orbitopathy Center, Endocrinology, Milan, Italy.

Rituximab (RTX), a chimeric human-murine anti-CD20 monoclonal antibody, has been used for treatment of active moderate-severe Graves' orbitopathy (GO) since 2004 as second-line therapy in patients unresponsive to intravenous steroids. We conducted an open-label prospective study (EUDRACT 2012-001980-53) in which patients were treated with a single infusion of only 100 mg RTX to analyze the efficacy and safety of this low dose. Seventeen patients, of whom nine had disease that was unresponsive to intravenous methylprednisolone and eight with newly diagnosed GO, were enrolled. Disease activity was assessed with the clinical activity score (CAS) and severity with a composite ophthalmic score. Long-term surgical treatment and quality of life were also assessed, as well as treatment-related adverse events. Mean baseline CAS was 4.56 ± 0.96 and decreased to 1.25 ± 1.14 at 24 weeks ( = 0.001). Disease inactivation occurred within 24 weeks in >90% of patients and was unrelated to disease duration. Severity improved in about 60% of patients, with no relapses. All patients showed peripheral depletion of CD20 and CD19 cells at the end of RTX infusion (60 minutes). Two patients required surgical orbital decompression because of optic neuropathy (ON). Among adverse events observed, there was one patient who developed a cytokine release syndrome. A dose of 100 mg RTX is effective in patients with active moderate-severe GO. Low doses are better tolerated, expose patients to immune suppression for a shorter period of time, and are extremely cost effective, compared with higher doses. This dose, consistently with all other immunosuppressants, does not prevent the progression of GO to dysthyroid ON.
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http://dx.doi.org/10.1089/thy.2020.0269DOI Listing
May 2021

Office and Ambulatory Arterial Hypertension in Highlanders: HIGHCARE-ANDES Highlanders Study.

Hypertension 2020 12 11;76(6):1962-1970. Epub 2020 Nov 11.

From the Department of Cardiovascular, Neural and Metabolic Sciences (G.B., M.F.P., G.P.), University of Milano-Bicocca, Milan, Italy.

Millions of people worldwide live at high altitude, being chronically exposed to hypobaric hypoxia. Hypertension is a major cardiovascular risk factor but data on its prevalence and determinants in highlanders are limited, and systematic studies with ambulatory blood pressure monitoring are not available. Aim of this study was to assess the prevalence of clinic and ambulatory hypertension and the associated factors in a sample of Andean highlanders. Hypertension prevalence and phenotypes were assessed with office and ambulatory blood pressure measurement in a sample of adults living in Cerro de Pasco, Peru (altitude 4340 m). Basic clinical data, blood oxygen saturation, hematocrit, and Qinghai Chronic Mountain Sickness score were obtained. Participants were classified according to the presence of excessive erythrocytosis and chronic mountain sickness diagnosis. Data of 289 participants (143 women, 146 men, mean age 38.3 years) were analyzed. Office hypertension was present in 20 (7%) participants, while ambulatory hypertension was found in 58 (20%) participants. Masked hypertension was common (15%), and white coat hypertension was rare (2%). Among participants with ambulatory hypertension, the most prevalent phenotypes included isolated nocturnal hypertension, isolated diastolic hypertension, and systodiastolic hypertension. Ambulatory hypertension was associated with male gender, age, overweight/obesity, 24-hour heart rate, and excessive erythrocytosis. Prevalence of hypertension among Andean highlanders may be significantly underestimated when based on conventional blood pressure measurements, due to the high prevalence of masked hypertension. In highlanders, ambulatory hypertension may be independently associated with excessive erythrocytosis.
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http://dx.doi.org/10.1161/HYPERTENSIONAHA.120.16010DOI Listing
December 2020

Lactoferrin Concentration in Human Tears and Ocular Diseases: A Meta-Analysis.

Invest Ophthalmol Vis Sci 2020 10;61(12)

University of Milano Bicocca, Unit of Biostatistics, Epidemiology and Public Health, Department of Statistics and Quantitative Methods, Milan, Italy.

Purpose: To evaluate the potential of lactoferrin (Lf) as a diagnostic biomarker for ocular diseases using a meta-analytic approach.

Methods: All original studies reporting an estimate of the average Lf concentration in healthy subjects and those affected by ocular diseases were searched up to March 2020. The DerSimonian and Laird method was used to calculate the random effects pooled mean difference and the corresponding 95% confidence interval (CI) in Lf concentration between healthy subjects and those affected by dry eye (DE), Sjögren syndrome (SS), and diabetic retinopathy, separately. The presence of between-study heterogeneity was evaluated using the Cochran's Q test and the I2 index. Stratified analyses were performed to assess potential sources of heterogeneity and influence and cumulative analyses to evaluate the robustness of the results obtained. Publication bias was also evaluated using funnel plot and the Egger's test.

Results: The pooled mean differences in Lf concentrations between healthy subjects and those with DE, Sjögren syndrome, and diabetic retinopathy were respectively 0.62 (95% CI, 0.35-0.89) for DE, 3.78 (95% CI, -6.64 to 14.17), and 0.19 (95% CI, -4.00 to 4.39). Regarding DE, the stratified analysis showed that geographical area (P value Q test < 0.0001) and sample size (P < 0.0005) were sources of heterogeneity. Moreover, no study substantially influenced the results obtained and the pooled mean difference became statistically significant after a sample size of 220. Publication bias may affect the results of DE.

Conclusions: The results of the current meta-analysis suggest that Lf level in tears is a good candidate as dry eye syndrome diagnostic biomarker.
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http://dx.doi.org/10.1167/iovs.61.12.9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7552940PMC
October 2020

Can the adherence to quality of care indicators for early rheumatoid arthritis in clinical practice reduce risk of hospitalisation? Retrospective cohort study based on the Record Linkage of Rheumatic Disease study of the Italian Society for Rheumatology.

BMJ Open 2020 09 29;10(9):e038295. Epub 2020 Sep 29.

Statistics and Quantitative Methods, University of Milano-Bicocca, Milan, Lombardy, Italy.

Objective: To describe the adherence to quality of care indicators in early rheumatoid arthritis (RA) and to evaluate its impact on the risk of hospitalisation in a real-world setting.

Design: Retrospective cohort study.

Setting: Patients with early-onset RA identified from healthcare regional administrative databases by means of a validated algorithm between 2006 and 2012 in the Lombardy region (Italy).

Participants: The study cohort included 14 203 early-onset RA (71% female, mean age 60 years).

Outcome Measures: For each patient, a summary adherence score was calculated starting from the compliance to six quality indicators: (1-2) methotrexate or sulfasalazine or leflunomide with/without glucocorticoids, (3-4) other disease-modifying antirheumatic drugs (DMARDs) with/without glucocorticoids, (5) early interruption of glucocorticoids, (6) early clinical assessment.The relationship between low, intermediate and high categories of the summary score and the 12-month risk of hospitalisation for all causes and for RA was assessed.

Results: During a follow-up of 1 year, 2609 hospitalisations occurred, of which 704 were for RA (main or secondary diagnosis) and 252 primarily for RA. In a 7-year period (2006-2012), early DMARDs and timely clinical monitoring treatment increased (from 52% to 62% p trend <0.001 and from 25% to 30% p trend 0.009, respectively).Intermediate and high summary adherence score categories (compared with the low category) were related significantly with a lower risk of hospitalisation (adjusted HR 0.85 (95% CI 0.77 to 0.93), p<0.001 and HR 0.76 (95% CI 0.69 to 0.84), p<0.001, respectively). Among the indicators of the adherence score, early DMARD prescription showed the strongest positive impact, while long-term use of glucocorticoids was the worst negative one.

Conclusion: In early RA, adherence to quality standards of care is associated with a lower risk of hospitalisation. Future interventions to improve the adherence to quality standards of care in this setting should decrease the risk of hospitalisation with a significant impact on individual and population health.
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http://dx.doi.org/10.1136/bmjopen-2020-038295DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7526308PMC
September 2020

Identification of dietary patterns in a general population of North Italian adults and their association with arterial stiffness. The RoCAV study.

Nutr Metab Cardiovasc Dis 2021 01 11;31(1):44-51. Epub 2020 Aug 11.

EPIMED Research Center, Department of Medicine and Surgery, University of Insubria, Varese, Italy; Occupational, Preventive Medicine and Toxicology Unit, Varese University Hospital, Varese, Italy.

Background And Aims: The aims of this study were to identify dietary patterns in a general population of North Italian adults and to investigate the cross-sectional association between prevalent dietary patterns and arterial stiffness.

Methods And Results: Participants to the RoCAV study without chronic diseases at recruitment and with reliable dietary data were included. The food-frequency EPIC questionnaire was used to evaluate dietary habits. Dietary patterns were estimated using principal components analysis and Mediterranean diet adherence score (MedS). Carotid-femoral pulse wave velocity (cfPWV) was used as proxy of arterial stiffness. Basing on data from 2640 subjects (1608 men and 1032 women, mean ± SD 65.5 ± 6.7 years), four principal components (PC) were retained, explaining 24% of the overall variance. Considering 1284 subjects with cfPWV (mean ± SD 10.7 ± 2.5 m/s) data available, adherence to PC1 (Western-like dietary pattern) was associated with higher stiffness values (+0.29 m/s cfPWV for 1 SD increase of PC1, 95% CI:0.08,0.50; p = 0.007) in a multivariate model. Conversely, adherence to PC2 (Mediterranean-like) was not related to cfPWV values (-0.18, 95% CI: -0.36, 0.004; p = 0.06). Likewise, MedS and other PC patterns did not show any significant association with cfPWV. Mediation analysis showed that the association between Western-like dietary pattern and cfPWV is mediated by higher levels of leucocytes (9.2% of the effect, p = 0.047).

Conclusions: Our study in a Southern European population identified a Western-like dietary pattern associated with an increased cfPWV, a proxy of arterial stiffness. The association with cfPWV was in part mediated by inflammatory status.
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http://dx.doi.org/10.1016/j.numecd.2020.08.001DOI Listing
January 2021

Clinical benefits of sex steroids given as a priming prior to GH provocative test or as a growth-promoting therapy in peripubertal growth delays: Results of a retrospective study among ENDO-ERN centres.

Clin Endocrinol (Oxf) 2021 02 15;94(2):219-228. Epub 2020 Oct 15.

Department of Endocrine and Metabolic Diseases &, Lab of Endocrine and Metabolic Research, Istituto Auxologico Italiano IRCCS, Milan, Italy.

Objectives: Sex steroids, administered as a priming before GH stimulation tests (GHST) to differentiate between growth hormone deficiency (GHD) and constitutional delay of growth and puberty (CDGP) or as growth-promoting therapy using low-dose sex steroids (LDSS) in CDGP, are much debated. We aimed to compare auxological outcomes of CDGP or GHD children undergoing primed or unprimed GHST and to evaluate LDSS treatment in CDGP.

Design: Retrospective study among three paediatric University Hospitals in Italy and UK.

Methods: 184 children (72 females) aged 12.4 ± 2.08 years underwent primed (/P ) or unprimed (/P ) GHST and were followed up until final height (FH). CDGP patients were untreated (CDG P ) or received LDSS (CDGP ). The cohort included 34 CDG P /P , 12 CDGP /P , 51 GHD/P , 29 CDG P /P , 2 CDGP /P and 56 GHD/P . FH standard deviation score (SDS), Δ SDS FH-target height (TH) and degree of success (-1 ≤ Δ SDS FH-SDS TH ≤ +1) were outcomes of interest.

Results: GHD/P had better FH-SDS (-0.87 vs -1.49; P = .023) and ΔSDS FH-TH (-0.35 vs -0.77; P = .002) than CDGP /P . Overall, GHD/P showed the highest degree of success (90%, P = .006). Regardless of priming, both rhGH and LDSS improved degree of success compared to no treatment (89% and 86% vs 63%, P = .0009). GHD/P showed a trend towards a higher proportion of permanent GHD compared to GHD/P (30.43% vs 15.09%; P = .067).

Conclusion: In peripubertal children, priming before GHST improves diagnostic accuracy of GHST for idiopathic GHD. LDSS treatment improves auxological outcomes in CDGP.
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http://dx.doi.org/10.1111/cen.14337DOI Listing
February 2021

Determinants of the Lifestyle Changes during COVID-19 Pandemic in the Residents of Northern Italy.

Int J Environ Res Public Health 2020 08 28;17(17). Epub 2020 Aug 28.

Research laboratory of Preventive Medicine, IRCCS Istituto Auxologico Italiano, 20122 Milan, Italy.

Background: The confinement recommended during COVID-19 pandemic could affect behavior and health.

Methods: We conducted a self-reported survey in northern Italy to observe the lockdown effects on lifestyle changes and to assess their determinants. Prevalence Odds Ratio and Prevalence Risk Ratio were determined.

Results: 490 adults (84% female) completed the survey: 13% and 43% reported improved and unchanged sleep quality, respectively, while 43% had insomnia symptoms. Among the 272 active subjects in pre-lockdown, 14% continued habitual exercising, 18% increased it and 68% reduced it; 27% of sedentary subjects started physical exercise; 34% reported an improvement in diet quality; 42% increased food intake and 13% decreased it; and 38% of the smokers increased cigarette consumption. Age and the pre-lockdown habit of regular physical exercising were the mainly determinants of lifestyle changes whereas BMI, gender, and the presence of chronic diseases did not. Living with other people increased the likelihood of increasing the food intake ( = 0.002).

Conclusions: More than a third of people were able to positively reorganize their lives during the forced home confinement. It is worth to disseminate information to preserve a healthy lifestyle even when confined at home.
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http://dx.doi.org/10.3390/ijerph17176287DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7504331PMC
August 2020

Effect of high-altitude trekking on blood pressure and on asymmetric dimethylarginine and isoprostane production: Results from a Mount Ararat expedition.

J Clin Hypertens (Greenwich) 2020 08 6;22(8):1494-1503. Epub 2020 Aug 6.

Department of Cardiovascular Neural and Metabolic Sciences, IRCCS Istituto Auxologico Italiano, Milan, Italy.

The study aimed at exploring the mechanisms behind blood pressure and heart rate changes upon acute altitude exposure utilizing urinary excretion of biochemical factors involved in cardiovascular regulation. The study was conducted on 12 lowlander native male mountain climbers, living at sea level, exposed to altitudes ranging from 1800 to 5147 m above sea level over 4 days, during their ascent to Mount Ararat (Turkey). Blood pressure (measured by oscillometric method), heart rate, and blood oxygen saturation (SpO ) were recorded at rest (on awakening before food intake), in hypoxic conditions at 4200 m and at sea level before and after the altitude expedition. In the same study conditions (ie before-during-after the expedition), first-voided urinary samples were collected and assayed for 8-iso-prostaglandin F (8-iso-PGF ) and asymmetric dimethylarginine (ADMA) determination. Heart rate, and systolic and diastolic blood pressures were higher (P < .05) at high altitude than at the sea level. Furthermore, both urinary 8-iso-PGF and ADMA were significantly elevated (P < .01) at high altitude and returned to normal levels soon after returning to sea level. A 4-day exposure to high-altitude hypoxia induced a temporary increase in blood pressure and heart rate, confirming previous findings. Blood pressure increase at high altitude was associated with significantly enhanced production of biochemical mediators such as 8-iso-PGF2α, catecholamines, and ADMA, although we could not demonstrate a direct link between these parallel significant changes probably due to the forcefully limited sample size of our study, carried out in challenging environmental conditions at very high altitude.
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http://dx.doi.org/10.1111/jch.13961DOI Listing
August 2020

Postoperative and mid-term hemodynamic changes after replacement of the ascending aorta.

J Thorac Cardiovasc Surg 2020 May 27. Epub 2020 May 27.

Istituto Auxologico Italiano, IRCCS, Cardiology Unit, Milan, Italy; Department of Medicine and Surgery, University of Milano-Bicocca, Milan, Italy.

Objectives: To evaluate aortic distensibility and pulse waveform patterns associated with the ascending aortic aneurysm, and to analyze the postoperative and mid-term hemodynamic changes induced by prosthetic replacement of the ascending aorta.

Methods: Central blood pressure waves were recorded at the carotid artery level by means of a validated transcutaneous arterial tonometer in 30 patients undergoing prosthetic replacement of ascending aortic aneurysm and in 30 control patients. Measurements were obtained the day before surgery and 5 to 7 days and 16 to 20 months after surgery.

Results: The ascending aortic aneurysm was associated with a less steep slope of early systolic phase of the pressure curve (pulsus tardus) compared with a control group (0.54 ± 0.18 mm Hg/ms vs 0.69 ± 0.26 mm Hg/ms; P = .011). Replacing the ascending aorta with a noncompliant vascular prosthesis steepened the pulse pressure slope during the early systolic phase in the postoperative period (0.77 ± .29 mm Hg/ms), providing values comparable with those of the control group in the mid-term (0.67 ± .20 mm Hg/ms). No change in aortic stiffness was found either postoperatively or in the mid-term after ascending aorta surgical replacement (carotid-femoral pulse wave velocity: preoperative, 9.0 ± 2.6 m/s; postoperative, 9.0 ± 2.9 m/s; mid-term postoperative, 9.3 ± 2.8 m/s).

Conclusions: This study does not confirm the assumption that substitution of the viscoelastic ascending aorta with a rigid prosthesis can cause serious hemodynamic alterations downstream, because we did not observe a worsening of global aortic distensibility after insertion of a rigid prosthetic aorta. The ascending aortic aneurysm is associated with a pulsus tardus.
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http://dx.doi.org/10.1016/j.jtcvs.2020.05.031DOI Listing
May 2020

Diurnal Measurements of Macular Thickness and Vessel Density on OCT Angiography in Healthy Eyes and Those With Ocular Hypertension and Glaucoma.

J Glaucoma 2020 10;29(10):918-925

IRCCS Istituto Auxologico Italiano, Ophthalmology Unit.

Precis: Macular superficial capillary plexus (SCP) and thickness are reduced in eyes with glaucoma and ocular hypertension, but do not change significantly during the day. No relationships with age, intraocular pressure, systemic hypertension, or axial length were found.

Purpose: The purpose of this study was to evaluate diurnal differences in retinal thickness and vessel density (VD) of the macular SCP and deep capillary plexus (DCP) using optical coherence tomography angiography among 3 groups: eyes with glaucoma, eyes with ocular hypertension, and healthy eyes.

Methods: A consecutive series of individuals was recruited prospectively. Optical coherence tomography angiography was performed in the morning and in the evening.

Results: Forty eyes from 23 individuals with glaucoma (58.35±6 y), 52 eyes from 32 individuals with ocular hypertension (58.84±7 y), and 73 eyes from 44 controls (57.84±6 y) were enrolled. Morning and evening measurements of all SCP-VD and retinal thickness parameters were statistically significantly different (P<0.04) among the 3 groups of eyes. None of the DCP-VD parameters were significantly different. Daily changes in SCP-VD, DCP-VD, and retinal thickness among the groups of eyes were not statistically significant. Systemic hypertension, age, axial length, and diurnal changes in intraocular pressure were not significantly associated with diurnal fluctuations of SCP-VD, DCP-VD, or retinal thickness (P>0.19). A positive linear correlation in diurnal changes was found between SCP-VD and DCP-VD in the fovea and in the parafovea (r=0.5567 and 0.5892, respectively) and between SCP-VD and retinal thickness in the fovea and in the parafovea (r=-0.2288 and 0.2418, respectively).

Conclusions: Macular SCP-VD and thickness are reduced in eyes with glaucoma and ocular hypertension. Although diurnal changes in SCP-VD, DCP-VD and macular thickness were not significant among the groups, some linear correlations in increasing or decreasing values of the investigated parameters were found.
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http://dx.doi.org/10.1097/IJG.0000000000001580DOI Listing
October 2020

Understanding Factors Associated With Psychomotor Subtypes of Delirium in Older Inpatients With Dementia.

J Am Med Dir Assoc 2020 04;21(4):486-492.e7

Department of Clinical and Behavioral Neurology, Neuropsychiatry Laboratory, IRCCS Foundation S Lucia, Rome, Italy; Geriatric Unit, S. Gerardo Hospital, Monza, Italy.

Objectives: Few studies have analyzed factors associated with delirium subtypes. In this study, we investigate factors associated with subtypes of delirium only in patients with dementia to provide insights on the possible prevention and treatments.

Design: This is a cross-sectional study nested in the "Delirium Day" study, a nationwide Italian point-prevalence study.

Setting And Participants: Older patients admitted to 205 acute and 92 rehabilitation hospital wards.

Measures: Delirium was evaluated with the 4-AT and the motor subtypes with the Delirium Motor Subtype Scale. Dementia was defined by the presence of a documented diagnosis in the medical records and/or prescription of acetylcholinesterase inhibitors or memantine prior to admission.

Results: Of the 1057 patients with dementia, 35% had delirium, with 25.6% hyperactive, 33.1% hypoactive, 34.5% mixed, and 6.7% nonmotor subtype. There were higher odds of having venous catheters in the hypoactive (OR 1.82, 95% CI 1.18-2.81) and mixed type of delirium (OR 2.23, CI 1.43-3.46), whereas higher odds of urinary catheters in the hypoactive (OR 2.91, CI 1.92-4.39), hyperactive (OR 1.99, CI 1.23-3.21), and mixed types of delirium (OR 2.05, CI 1.36-3.07). We found higher odds of antipsychotics both in the hyperactive (OR 2.87, CI 1.81-4.54) and mixed subtype (OR 1.84, CI 1.24-2.75), whereas higher odds of antibiotics was present only in the mixed subtype (OR 1.91, CI 1.26-2.87).

Conclusions And Implications: In patients with dementia, the mixed delirium subtype is the most prevalent followed by the hypoactive, hyperactive, and nonmotor subtype. Motor subtypes of delirium may be triggered by clinical factors, including the use of venous and urinary catheters, and the use of antipsychotics. Future studies are necessary to provide further insights on the possible pathophysiology of delirium in patients with dementia and to address the optimization of the management of potential risk factors.
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http://dx.doi.org/10.1016/j.jamda.2020.02.013DOI Listing
April 2020

Obstructive sleep apnoea treatment and blood pressure: which phenotypes predict a response? A systematic review and meta-analysis.

Eur Respir J 2020 05 7;55(5). Epub 2020 May 7.

Section of General Medicine and Hypertension, Dept of Medicine, University of Verona, Verona, Italy

The treatment for obstructive sleep apnoea (OSA) with continuous positive airway pressure (CPAP) or mandibular advancement devices (MADs) is associated with blood pressure (BP) reduction; however, the overall effect is modest. The aim of this systematic review and meta-analysis of randomised controlled trials (RCTs) comparing the effect of such treatments on BP was to identify subgroups of patients who respond best to treatment.The article search was performed in three different databases with specific search terms and selection criteria. From 2289 articles, we included 68 RCTs that compared CPAP or MADs with either passive or active treatment. When all the studies were pooled together, CPAP and MADs were associated with a mean BP reduction of -2.09 (95% CI -2.78- -1.40) mmHg for systolic BP and -1.92 (95% CI -2.40- -1.43) mmHg for diastolic BP and -1.27 (95% CI -2.34- -0.20) mmHg for systolic BP and -1.11 (95% CI -1.82- -0.41) mmHg for diastolic BP, respectively. The subgroups of patients who showed a greater response were those aged <60 years (systolic BP -2.93 mmHg), with uncontrolled BP at baseline (systolic BP -4.14 mmHg) and with severe oxygen desaturations (minimum arterial oxygen saturation measured by pulse oximetry <77%) at baseline (24-h systolic BP -7.57 mmHg).Although this meta-analysis shows that the expected reduction of BP by CPAP/MADs is modest, it identifies specific characteristics that may predict a pronounced benefit from CPAP in terms of BP control. These findings should be interpreted with caution; however, they are particularly important in identifying potential phenotypes associated with BP reduction in patients treated for OSA.
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http://dx.doi.org/10.1183/13993003.01945-2019DOI Listing
May 2020

Prevalence, clinical correlates, and burden of undiagnosed aortic stenosis in older patients: a prospective study in a non-cardiologic acute hospital ward.

Aging Clin Exp Res 2020 Aug 22;32(8):1533-1540. Epub 2020 Jan 22.

Acute Geriatric Unit, San Gerardo Hospital, Monza, Italy.

Background: The epidemiology of aortic stenosis (AS) in older patients admitted to non-cardiologic acute hospital wards and the effect of AS on mid-term survival are incompletely reported. In a cohort of very old patients admitted to an acute geriatric unit (AGU), we aimed to assess: (1) the prevalence of newly and previously diagnosed AS; and (2) the association between AS severity and patients' 6-month mortality.

Methods: The patients consecutively admitted in two AGU rooms from February 2016 to February 2018 were assessed with echocardiography and AS severity was defined according to standard criteria. We assessed frailty using a 34-item Frailty Index (34-FI), which was operationalized using health variable information, and the Clinical Frailty Scale (CFS). Vital status at 6 months was extracted from Regional Register of Birth and Death.

Results: Two hundred and three patients (mean age 84.5 ± 6.0 SD, female gender 56.1%) were included. Of these, 57 (28.1%) had AS, mild in 9 (4.5%), moderate in 32 (16.1%) and severe in 16 (8.1%). A new diagnosis of AS was obtained in 42 (73.7%) patients, of whom 33 (78.6%) had moderate or severe AS. At 6 months, 61 (28.9%) patients died. In multiple regression models, after adjusting for covariates, frailty, as assessed with both FI and CFS, was independent predictor of 6-month mortality whereas AS was not.

Conclusions: Among older patients admitted to non-cardiologic acute hospital wards, AS was common and frequently underdiagnosed. The severity of AS was not associated with increased 6-month mortality, whereas frailty was the most important predictor.
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http://dx.doi.org/10.1007/s40520-020-01471-wDOI Listing
August 2020

Periodic limb movements during sleep and blood pressure changes in sleep apnoea: Data from the European Sleep Apnoea Database.

Respirology 2020 08 24;25(8):872-879. Epub 2019 Dec 24.

Sleep Disorders Center, Sahlgrenska University Hospital, Gothenburg University, Gothenburg, Sweden.

Background And Objective: OSA and PLMS are known to induce acute BP swings during sleep. Our current study aimed to address the independent effect of PLMS on BP in an unselected OSA patient cohort.

Methods: This cross-sectional analysis included 1487 patients (1110 males, no previous hypertension diagnosis or treatment, mean age: 52.5 years, mean BMI: 30.5 kg/m ) with significant OSA (defined as AHI ≥ 10) recruited from the European Sleep Apnoea Cohort. Patients underwent overnight PSG. Patients were stratified into two groups: patients with significant PLMS (PLMSI > 25 events/hour of sleep) and patients without significant PLMS (PLMSI < 25 events/hour of sleep). SBP, DBP and PP were the variables of interest. For each of these, a multivariate regression linear model was fitted to evaluate the relationship between PLMS and outcome adjusting for sociodemographic and clinical covariates (gender, age, BMI, AHI, ESS, diabetes, smoking and sleep efficiency).

Results: The univariate analysis of SBP showed an increment of BP equal to 4.70 mm Hg (P < 0.001) in patients with significant PLMS compared to patients without significant PLMS. This increment remained significant after implementing a multivariate regression model (2.64 mm Hg, P = 0.044). No significant increment of BP was observed for DBP and PP.

Conclusion: PLMS is associated with a rise in SBP regardless of AHI, independent of clinical and sociodemographic confounders. A PLMS phenotype may carry an increased risk for cardiovascular disease in OSA patients.
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http://dx.doi.org/10.1111/resp.13760DOI Listing
August 2020

Availability of Real-World Data in Italy: A Tool to Navigate Regional Healthcare Utilization Databases.

Int J Environ Res Public Health 2019 12 18;17(1). Epub 2019 Dec 18.

Centre of Epidemiology, Biostatistics and Information Technology, Università Politecnica delle Marche, 60126 Ancona (AN), Italy.

The purpose of the study was to map and describe the healthcare utilization databases (HUDs) available in Italy's 19 regions and two autonomous provinces and develop a tool to navigate through them. A census of the HUDs covering the population of a single region/province and recording local-level data was conducted between January 2014 and October 2016. The characteristics of each HUD regarding the start year, data type and completeness, data management system (DMS), data protection procedures, and data quality control adopted were collected through interviews with the database managers using a standard questionnaire or directly from the website of the regional body managing them. Overall, 352 HUDs met the study criteria. The DMSs, anonymization procedures of personal identification data, and frequency of data quality control were fairly homogeneous within regions, whereas the number of HUDs, data availability, type of identification code, and anonymization procedures were considerably heterogeneous across regions. The study provides an updated inventory of the available regional HUDs in Italy and highlights the need for greater homogeneity across regions to improve comparability of health data from secondary sources. It could represent a reference model for other countries to provide information on the available HUDs and their features, enhancing epidemiological studies across countries.
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http://dx.doi.org/10.3390/ijerph17010008DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6982131PMC
December 2019

Effects of acute exposure to moderate altitude on blood pressure and sleep breathing patterns.

Int J Cardiol 2020 02 30;301:173-179. Epub 2019 Oct 30.

Istituto Auxologico Italiano, IRCCS, Dept of Cardiovascular, Neural and Metabolic Sciences, San Luca Hospital, Milan, Italy; Dept of Medicine and Surgery, University of Milano-Bicocca, Milan, Italy. Electronic address:

Background: Acute exposure to high altitude (>2500 m) is known to induce a rise in blood pressure (BP) and the appearance of sleep related breathing alterations, in particular central sleep apneas and periodic breathing. Little information is available on whether this is the case in humans also for acute exposure to moderate altitude (between 1500 and 2500 m). Aim of this study was to evaluate the effects of acute exposure of healthy volunteers to moderate altitude on conventional and ambulatory BP as well as on the frequency and severity of breathing alterations during sleep.

Methods: Forty-four healthy lowlanders underwent 24-hour ambulatory BP monitoring and nocturnal cardio-respiratory sleep study at sea level and during acute (1-2 days after arrival) exposure to moderate altitude (2035 m, Sestriere, Italy). The key variables investigated included average systolic and diastolic BP and heart rate over daytime, night-time and 24 h, the frequency of obstructive and central apneas/hypopnoeas and the behaviour of oxygen saturation during sleep.

Results: Compared to sea level, during moderate altitude exposure mean systolic/diastolic BP increased significantly during daytime (respectively from 125.6 ± 10.9 to 130.6 ± 12.3, p = 0.0032 and from 78.8 ± 6.7 to 81.8 ± 7.7 mmHg, p = 0.0048) and during night-time (respectively from 102.4 ± 12.4 to 107.4 ± 12.7, p = 0.0028, and from 62.0 ± 8.2 to 65.8 ± 8.2 mmHg, p = 0.0014), with no change in nocturnal BP dipping. BP increase was more evident in participants aged over 40 years. Apnea-hypopnea index (AHI) increased from 1.60 (0.40-2.90) to 5.4 (2.90-10.60), p < 0.0001), mainly because of increasing frequency of hypopneas and central apneas, in particular in males aged over 40 years. No association was found between size of BP changes and AHI.

Conclusion: Our results indicate that in healthy subjects even exposure to moderate altitude may induce significant, although mild, changes in ambulatory BP and in respiratory patterns during sleep with gender and age-related differences. Further studies are needed to explore the clinical relevance of these findings.
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http://dx.doi.org/10.1016/j.ijcard.2019.09.034DOI Listing
February 2020

The relationship among frailty, delirium and attentional tests to detect delirium: a cohort study.

Eur J Intern Med 2019 Dec 21;70:33-38. Epub 2019 Nov 21.

Unit of Biostatistics, Epidemiology and Public Health, Department of Statistics and Quantitative Methods, University of Milano-Bicocca, Milan, Italy.

Background: Few studies explored if frailty predisposes to delirium in hospitalized older patients. The aims of this study were to evaluate if frailty: 1) is independently associated with delirium, and 2) affects the patient's performance in three tests of attention used to detect delirium.

Methods: Data are from a prospective cohort study of patients admitted to an Acute Geriatric Unit (AGU). Frailty was operationalized using the health deficit accumulation model (38-item Frailty Index). Delirium was screened using the 4AT, and the diagnosis confirmed with the DSM-5th criteria. During the first 7 days from the hospital admission, patients also underwent a double-blind assessment of attention using three ad hoc tests (i.e., Months of the year backwards, MOTYB; Days of the week backwards, DOWB; and Count backwards from 20 to 1, CB).

Results: Eighty-nine patients were included (mean age 83.1 years, standard deviation 6.0). Forty-two (47.19%) patients were frail, and 37 (41.7%) had delirium. The likelihood of delirium was significantly higher in frail compared to the non-frail patients; it was also inversely associated with the three attention tests. Using the MOTYB test, the ability to discriminate delirium was similar in patients with (Area Under the Receiving Operator Characteristic [AUROC] 0.88, 95% Confidence Interval [CI] 0.82-0.92) and without frailty (AUROC 0.93, 95%CI 0.90-0.95) whilst was markedly different between the same groups using either DOWB and CB.

Conclusions: Frailty is associated with delirium in hospitalized older patients and can influence the patient's performances at attentional tests that are commonly used to screen delirium.
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http://dx.doi.org/10.1016/j.ejim.2019.09.008DOI Listing
December 2019

Big data, observational research and P-value: a recipe for false-positive findings? A study of simulated and real prospective cohorts.

Int J Epidemiol 2020 06;49(3):876-884

Department of Statistics and Quantitative Methods, University of Milano-Bicocca, Milano, Italy.

Background: An increasing number of observational studies combine large sample sizes with low participation rates, which could lead to standard inference failing to control the false-discovery rate. We investigated if the 'empirical calibration of P-value' method (EPCV), reliant on negative controls, can preserve type I error in the context of survival analysis.

Methods: We used simulated cohort studies with 50% participation rate and two different selection bias mechanisms, and a real-life application on predictors of cancer mortality using data from four population-based cohorts in Northern Italy (n = 6976 men and women aged 25-74 years at baseline and 17 years of median follow-up).

Results: Type I error for the standard Cox model was above the 5% nominal level in 15 out of 16 simulated settings; for n = 10 000, the chances of a null association with hazard ratio = 1.05 having a P-value < 0.05 were 42.5%. Conversely, EPCV with 10 negative controls preserved the 5% nominal level in all the simulation settings, reducing bias in the point estimate by 80-90% when its main assumption was verified. In the real case, 15 out of 21 (71%) blood markers with no association with cancer mortality according to literature had a P-value < 0.05 in age- and gender-adjusted Cox models. After calibration, only 1 (4.8%) remained statistically significant.

Conclusions: In the analyses of large observational studies prone to selection bias, the use of empirical distribution to calibrate P-values can substantially reduce the number of trivial results needing further screening for relevance and external validity.
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http://dx.doi.org/10.1093/ije/dyz206DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7394945PMC
June 2020
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