To test the effectiveness of mid-regional pro-adrenomedullin (MR-proADM) in comparison to C-reactive protein (CRP), procalcitonin (PCT), D-dimer, lactate dehydrogenase (LDH) in predicting mortality ...in COVID-19-ICU-patients.
All consecutive COVID-19 adult patients admitted between March and June 2020 to the ICU of a referral, university hospital in Northern-Italy were enrolled. MR-proADM and routine laboratory test were measured within 48 hours from ICU admission, on day 3, 7 and 14. Survival curves difference with MR-proADM cut-off set to 1.8 nmol/L were tested using log-rank test. Predictive ability was compared using area under the curve and 95% confidence interval of different receiver-operating characteristics curves.
57 patients were enrolled. ICU and overall mortality were 54.4%. At admission, lymphocytopenia was present in 86% of patients; increased D-dimer and CRP levels were found in 84.2% and 87.7% of patients respectively, while PCT values > 0.5 μg/L were observed in 47.4% of patients. MR-proADM, CRP and LDH were significantly different between surviving and non-surviving patients and over time, while PCT, D-dimer and NT-pro-BNP did not show any difference between the groups and over time; lymphocytes were different between surviving and non-surviving patients only. MR-proADM was higher in dying patients (2.65±2.33vs1.18±0.47, p<0.001) and a higher mortality characterized patients with MR-proADM >1.8 nmol/L (p = 0.016). The logistic regression model adjusted for age, gender, cardiovascular disease, diabetes mellitus and PCT values confirmed an odds ratio = 10.3 95%CI:1.9-53.6 (p = 0.006) for MR-proADM >1.8 nmol/L and = 22.2 95%CI:1.6-316.9 (p = 0.022) for cardiovascular disease. Overall, MR-proADM had the best predictive ability (AUC = 0.85 95%CI:0.78-0.90).
In COVID-19 ICU-patients, MR-proADM seems to have constantly higher values in non-survivor patients and predict mortality more precisely than other biomarkers. Repeated MR-proADM measurement may support a rapid and effective decision-making. Further studies are needed to better explain the mechanisms responsible of the increase in MR-proADM in COVID-19 patients.
Objective: Increased risk for adverse pregnancy outcomes with advancing maternal age has been described but the strength of association remains debated, particularly in presence of confounding ...factors such as parity, twin pregnancy and pregnancy from assisted reproductive technologies. The aim of this study was to evaluate pregnancy outcomes in a large cohort of women aged over 40 years. The hypothesis was that advanced maternal age may be an independent risk factor for adverse pregnancy outcome.
Study design: We reviewed the clinical records of 56,211 women who delivered at Sant'Anna University Hospital, Turin, Italy, in the period between 2009 and 2015. Of these, 3798 women aged over 40 years were divided into two age groups (40 − 44 years and ≥45 years). Women of any parity, with singleton or twin pregnancies, or with assisted reproductive technology pregnancies were included. Women aged less than 40 years were considered as controls. Primary outcome measures were maternal and perinatal complications. Comparisons were performed using Chi-square test and Fisher's exact test. Univariate analysis and logistic regression analysis were performed to test the possible independent role of maternal age as a risk factor for adverse pregnancy outcome.
Results: Maternal age was an independent risk factor for gestational diabetes (age 40-44 years: odds ratios (OR) 2.10, 95% CI 1.80-2.45; age ≥45 years: OR 2.83, 95% CI 1.79-4.46) and early-onset preeclampsia (age 40-44 years: OR 2.10, 95% CI 1.63-2.70; age ≥45 years: OR 3.16, 95% CI 1.68-5.94). The risk for placenta praevia was higher in the women aged 40-44 years (OR 1.87, 95% CI 1.36-2.57). Neonatal outcomes were similar among groups, except for the rate of birth weight less than 2500 g, which was higher in women aged 40-44 years (OR 1.27, 95% CI 1.12-1.42). However, older women showed an overall higher incidence of preterm birth.
Conclusions: Maternal age over 40 years is an independent risk factor for adverse pregnancy outcomes, particularly for the mother. Pregnancies in women over 40 years should be considered at risk and carefully monitored with individualized care protocols.
Interest in right minithoracotomy mitral valve surgery (MVS) is rapidly growing and, to date, different perfusion strategies and aortic clamping techniques are available. However each approach ...carries specific advantages and drawbacks. This retrospective study analyses our experience in right minithoracotomy MVS with different arterial perfusion and aortic clamping strategies, highlighting the results of a patient tailored approach.
Between March 2009 and March 2014, 460 patients with a full preoperative work-up that included also aortoiliac-femoral axis' screening underwent right minithoracotomy MVS. One hundred and eight were redo cases (23.5%), 63 had aortoiliac atheromatous disease or significant tortuosity (13.7%), and 38 had chronic obstructive pulmonary disease (8.3%). Based on anatomy and comorbidities, each patient was allocated to the most appropriate of 3 approaches: femoral arterial cannulation with endoaortic balloon (P+EB) (247, 53.7%) or with transthoracic clamp (P+XC) (150, 32.6%), and direct aortic cannulation with endoaortic balloon occlusion (C+EB) (63, 13.7%).
No cases of aortic dissection were reported. Early outcome were similar between the 3 groups; no differences were reported in terms of stroke rate (1.7% in the P+EB, 2% in the P+XC, and no cases in the C+EB group; p = NS) and 30-day mortality (2.1% in the P+EB, 2.7% in the P+XC, and 1.6% in the C+EB group; p = NS). Logistic regression showed no influences of arterial perfusion and aortic clamping techniques on 30-day mortality and stroke.
Right minithoracotomy MVS can routinely be performed with favorable outcomes in all comers when perfusion strategies and clamping techniques are carefully selected after proper evaluation of the patient's preoperative characteristics.
The impact of gender on outcome in critically ill patients is unclear. We investigated the influence of gender on the epidemiology of severe sepsis and associated morbidity and mortality in a large ...cohort of ICU patients in the region of Piedmont in Italy.
This was a post-hoc analysis of data from a prospective, multicenter, observational study in which all patients admitted to one of 24 participating medical and/or surgical ICUs between 3 April 2006 and 29 September 2006 were included.
Of the 3,902 patients included in the study, 63.5% were male. Female patients were significantly older than male patients (66±16 years vs. 63±16 years, P<0.001). Female patients were less likely to have severe sepsis and septic shock on admission to the ICU and to develop these syndromes during the ICU stay. ICU mortality was similar in men and women in the whole cohort (20.1% vs. 19.8%, P=0.834), but in patients with severe sepsis was significantly greater in women than in men (63.5% vs. 46.4%, P=0.007). In multivariate logistic regression analysis with ICU outcome as the dependent variable, female gender was independently associated with a higher risk of ICU death in patients with severe sepsis (odds ratio=2.33, 95% confidence interval=1.23 to 4.39, P=0.009) but not in the whole cohort (odds ratio=1.07, 95% confidence interval=0.87 to 1.34).
In this large regional Italian cohort of ICU patients, there were more male than female admissions. The prevalence of severe sepsis was lower in women than in men, but female gender was independently associated with a higher risk of death in the ICU for patients with severe sepsis.
Abstract
Background
Hypercapnic exacerbations are severe complications of chronic obstructive pulmonary disease (COPD), characterized by negative impact on prognosis, quality of life and healthcare ...costs. The present standard of care for acute exacerbations of COPD is non-invasive ventilation; when it fails, the use of invasive mechanical ventilation is inevitable, but is associated with extremely poor prognosis. Extracorporeal circuits designed to remove CO
2
(ECCO
2
R) may enhance the efficacy of NIV to remove CO
2
and avoid the worsening of respiratory acidosis, which inevitably leads to failure of non-invasive ventilation. Although the use of ECCO
2
R for acute exacerbations of COPD is steadily increasing, solid evidence on its efficacy and safety is scarce, thus the need for a randomized controlled trial.
Methods
multicenter randomized controlled unblinded clinical trial including 284 (142 per arm) patients with acute hypercapnic respiratory failure caused by exacerbation of COPD, requiring respiratory support with NIV. The primary outcome is event free survival at 28 days, a composite outcome defined by survival in absence of prolonged mechanical ventilation, severe hypoxemia, septic shock and second episode of COPD exacerbation. Secondary outcomes are incidence of endotracheal intubation and tracheostomy, intensive care and hospital length-of-stay and 90-day mortality.
Discussion
Acute exacerbations of COPD represent a significant burden in terms of prognosis, quality of life and healthcare costs. Lack definite evidence despite increasing use of ECCO
2
R justifies a randomized trial to evaluate whether patients with acute hypercapnic acidosis not responsive to NIV should undergo invasive mechanical ventilation (with all serious related risks) or be treated with ECCO
2
R to avoid invasive ventilation but be exposed to possible adverse events of ECCO
2
R. Owing to its pragmatic nature, sample size and composite primary outcome, this trial aims at providing valuable answers to relevant questions for clinical treatment of acute exacerbations of COPD.
Trial registration
ClinicalTrials.gov
,
NCT04582799
. Registered 12 October 2020, .
Objective
Custodiol® and St. Thomas cardioplegia are widely employed in mini-thoracotomy mitral valve (MV) operations. One-dose of the former provides 3 h of myocardial protection. Conversely, St. ...Thomas solution is usually reinfused every 30 min and safety of single delivery is unknown. We aimed to compare single-shot St. Thomas versus Custodiol® cardioplegia.
Methods
Primary endpoint of the prospective observational study was cardiac troponin T level at different post-operative time-points. Propensity-weighted treatment served to adjust for confounding factors.
Results
Thirty-nine patients receiving St. Thomas were compared with 25 patients receiving Custodiol® cardioplegia; cross-clamping always exceeded 45 min. No differences were found in postoperative markers of myocardial injury. Ventricular fibrillation at the resumption of electric activity was more frequent following Custodiol® cardioplegia (
P
= .01).
Conclusion
Effective myocardial protection exceeding 1 h of ischemic arrest can be achieved with a single-dose St. Thomas cardioplegia in selected patients undergoing right mini-thoracotomy MV surgery.
Abstract Objective Transcatheter aortic valve implantation (TAVI) and sutureless aortic valve replacement (SU-AVR) are suitable alternatives to conventional surgery. The aim of this study is to ...compare early outcomes of patients undergoing TAVI and SU-AVR. Methods Data were analyzed on patients who underwent TAVI and patients who underwent SU-AVR. Two matched cohorts (TAVI vs SU-AVR) were created using propensity scores; all analyses were repeated for transapical TAVI and transfemoral TAVI, separately. Outcomes were defined according to Valve Academic Research Consortium–2 criteria. Results A total of 2177 patients were included in the analysis: 1885 (86.6%) treated with TAVI; 292 (13.4%) treated with SU-AVR. Mortality in unmatched TAVI and SU-AVR patients was 7.1% and 2.1%, respectively, at 30 days, and 12.9% and 4.6%, respectively, at 1 year. No differences were found in 30-day mortality in the 214 matched patient pairs (3.7% vs 2.3%; P = .4), but patients treated with TAVI showed a lower incidence of device success (85.9% vs 98.6%; P < .001) and pacemaker implantation (2.8% vs 9.4%; P = .005), and a higher incidence of any paravalvular leakage (PVL). Conclusions SU-AVR is associated with better device success and a lower incidence of PVL, compared with TAVI. Nevertheless, patients treated with SU-AVR were more likely to receive a permanent pacemaker. SU-AVR and TAVI provide good results in patients who have severe symptomatic aortic valve stenosis. Given the multiple therapeutic options available, patients may receive the treatment that is most appropriate for their clinical and anatomical characteristics.
Background and Objectives: Some biomarkers of ovarian responsiveness to gonadotropins and the total number of retrieved oocytes are known to affect the success rate after controlled ovarian ...stimulation (COS) and in vitro fertilization (IVF). The aim of this study was to study another putative marker, the Ovarian Sensitivity Index (OSI: (number of retrieved oocytes/total gonadotropin dose) × 1000), assessing whether (a) it correlates with ovarian responsiveness biomarkers, (b) it is an independent predictor of clinical pregnancy, (c) it predicts clinical pregnancy comparably to the number of retrieved oocytes, and (d) it is consistent in the repeated COS cycles of the same woman. Design: retrospective analysis. Setting: public IVF Unit in University Hospital. Cases and Measurements: 1612 patients submitted to 3353 IVF cycles were included, their OSI was calculated and it was correlated with the ovarian responsiveness biomarkers (age, BMI, anti-Mullerian hormone, antral follicle count). The OSI and the total number of oocytes were compared for their value in predicting clinical pregnancy. The inter-cycle consistency of the OSI was estimated in 209 patients who underwent two consecutive cycles in which the ovarian stimulation regimen was changed from the Gonadotropin-releasing Hormone (GnRH)-agonist long protocol to the GnRH-antagonist protocol or vice-versa. Results: The OSI turned out to be significantly related to age and BMI (inversely), the anti-Mullerian hormone (AMH) and the antral follicle count (AFC) (directly), to be an independent predictor of clinical pregnancy, and to correlate with clinical pregnancy better than the total number of oocytes (p < 0.0001 vs. <0.002). In patients who underwent two consecutive COS cycles changing stimulation regimen, the OSI showed 82% consistency. Conclusion(s): The OSI significantly correlates to the currently used biomarkers of ovarian responsiveness; it is an independent predictor of clinical pregnancy; it is more predictive of clinical pregnancy than the total number of oocytes, and is highly consistent in repeated IVF cycles even when the COS protocol changes. These characteristics make the OSI quite suitable to be incorporated into more complex prediction models of IVF outcome.
Pre- and post-treatment staging of anal cancer are often inaccurate. The role of positron emission tomograpy-computed tomography (PET-CT) in anal cancer is yet to be defined. The aim of the study was ...to compare PET-CT with CT scan, sentinel node biopsy results of inguinal lymph nodes, and anal biopsy results in staging and in follow-up of anal cancer.
Fifty-three consecutive patients diagnosed with anal cancer underwent PET-CT. Results were compared with computed tomography (CT), performed in 40 patients, and with sentinel node biopsy (SNB) (41 patients) at pretreatment workup. Early follow-up consisted of a digital rectal examination, an anoscopy, a PET-CT scan, and anal biopsies performed at 1 and 3 months after the end of treatment. Data sets were then compared.
At pretreatment assessment, anal cancer was identified by PET-CT in 47 patients (88.7%) and by CT in 30 patients (75%). The detection rates rose to 97.9% with PET-CT and to 82.9% with CT (P=.042) when the 5 patients who had undergone surgery prior to this assessment and whose margins were positive at histological examination were censored. Perirectal and/or pelvic nodes were considered metastatic by PET-CT in 14 of 53 patients (26.4%) and by CT in 7 of 40 patients (17.5%). SNB was superior to both PET-CT and CT in detecting inguinal lymph nodes. PET-CT upstaged 37.5% of patients and downstaged 25% of patients. Radiation fields were changed in 12.6% of patients. PET-CT at 3 months was more accurate than PET-CT at 1 month in evaluating outcomes after chemoradiation therapy treatment: sensitivity was 100% vs 66.6%, and specificity was 97.4% vs 92.5%, respectively. Median follow-up was 20.3 months.
In this series, PET-CT detected the primary tumor more often than CT. Staging of perirectal/pelvic or inguinal lymph nodes was better with PET-CT. SNB was more accurate in staging inguinal lymph nodes.
In this study we aimed at retrospectively assessing in a homogeneous group of IVF patients whether the addition of Early Embryo Viability Assessment (Eeva™) to standard morphology increases the ...accuracy of embryo selection in case of double embryo transfer (DET) on day 3 or single embryo transfer (SET) on day 5. Eeva™ is an algorhythm aimed at indicating on day 3, according to morphokinetic parameters observed in the first three days of embryo growth, which embryos are more likely to develop into viable blastocysts and implant. A total number of 328 patients were included in the study; IVF or ICSI were performed and 428 embryos were transferred, either with DET on day 5, or (when at least four top scored embryos were available on day 3) with SET of day 5. Four groups were considered: (a) patients receiving day 3 DET with embryos selected by standard morphology (DET-3 M, n = 106, receiving 212 embryos), (b) patients receiving day 3 DET with embryos selected by morphology plus Eeva™ (DET-3 ME group, n = 48, receiving 96 embryos), (c) patients receiving day 5 SET with a blastocyst selected by standard morphology (SET-5 M group, n = 126, receiving 126 embryos), and (d) patients receiving day 5 SET with a blastocyst selected by morphology plus Eeva™ (SET-5 ME group, n = 48, receiving 48 embryos). Overall, a clinical pregnancy rate of 49.1%, implantation rate of 40%, and ongoing pregnancy rate of 43.6% were observed. The implantation rate was significantly higher in DET-3 ME group than in DET-3 M group (44.8% vs. 30.2%, p < 0.02), whereas it was comparable in groups DET-3 ME, SET-5 M and SET-5 ME. Differently, the ultrasound-verified clinical pregnancy rate and the ongoing pregnancy rate at 12 weeks did not significantly differ in all four groups. Overall, our findings suggest that Eeva™ algorhythm can improve embryo selection accuracy of standard morphology when ET on day 3 is scheduled, leading to a higher implantation rate, but its impact on ongoing pregnancy and live birth needs to be further clarified.