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Poor functional status is highly prevalent among older patients hospitalized for HF and marks a downward inflection point in functional and prognostic trajectories. We assessed the prognostic value of 6-min walk test after transitional cardiac rehabilitation in older patients hospitalized for heart failure (HF).We studied 759 patients aged ≥60 years who had been transferred to six inpatient rehabilitation facilities (IRF) from acute care hospitals after a hospitalization for acute HF. The primary outcome was 3-year all-cause mortality. We used multivariable Cox analysis to determine the association between 6-min walk distance (6MWD) at discharge from the IRFs and the primary outcome, adjusting for established predictors of death. The optimal cutoff for 6MWD was considered as the one that maximized the chi-square statistic.Mean age was 75 ± 8 years. 6MWD significantly increased from admission to discharge (145 to 210 m; p 0.001). The optimal cutoff for 6MWD was 198 m. After full adjustment, the hazard ratio for each 50 m-increase in discharge 6MWD was 0.90 (0.87-0.94; p 0.001) and that for discharge 6MWD dichotomized at the optimal cutoff 0.48 (0.38-0.60; p 0.001). The incidence rate of death/100 person-years for the patients who walked198 m was 13.0 (10.0-15.5) compared with 30.8 (26.9-35.4) for those who walked198 m. A statistically significant interaction of discharge 6MWD with left ventricular ejection fraction (EF) on the risk of death was observed (p value for interaction 0.047).A rehabilitation intervention provided in the critical hospital-to-home transition period to older patients hospitalized for HF resulted in improved functional capacity. Increasing levels of functional capacity following rehabilitation were closely associated with decreasing risk of death; this association was significantly stronger for the subgroup with preserved EF.

Background Obstructive sleep apnoea syndrome (OSAS) is a highly prevalent disorder. The prognostic role of comorbidity in patients with OSAS and their role for risk stratification remain poorly defined. Methods We studied 1,592 patients with severe OSAS diagnosed by polysomnography. The primary outcome was all-cause mortality. The standardized mortality ratio (SMR) was estimated as the ratio of observed deaths to expected number of deaths in the general population. The expected numbers of deaths were derived using mortality rates from the general Apulian population. The association of comorbidities with all-cause mortality was assessed using multivariable Cox regression analysis. Finally, recursive-partitioning analysis was applied to identify the combinations of comorbidities that were most influential for mortality and to cluster the patients into risk groups according to individual comorbidities Results During 11,721 person-years of follow-up, 390 deaths (3.33 deaths/100 person-years) occurred. The median follow-up was 7 (4–10) years. The SMR was 1.47 (95% confidence intervals 1.33–1.63). Age, sex, obesity, cardiovascular diseases (CVD), moderate-to-severe chronic obstructive pulmonary disease (COPD), chronic kidney disease (CKD) and malignancy were independently associated with mortality risk. Recursive-partitioning analysis allowed distinguishing three clinical phenotypes differentially associated with mortality risk. The combination of CKD with CVDs or with moderate-to-severe COPD conferred the highest risk. Conclusions Severe OSAS is associated with increased risk for all-cause death. Age and comorbidity are crucial predictors of mortality in patients with severe OSAS. Clustering patients according to comorbidities allows identifying clinically meaningful phenotypes.

OBJECTIVES Sutureless aortic valve prostheses have been introduced to facilitate the implant process, speed up the operating time and improve haemodynamic performance. The goal of this study was to assess the potential advantages of using sutureless prostheses during minimally invasive aortic valve replacement in a large multicentre population. METHODS From 2011 to 2019, a total of 3402 patients in 11 hospitals underwent isolated aortic valve replacement with minimal access approaches using a bioprosthesis. A total of 475 patients received sutureless valves; 2927 received standard valves. The primary outcome was the incidence of 30-day deaths. Secondary outcomes were the occurrence of major complications following procedures performed with sutureless or standard bioprostheses. Propensity matched comparisons was performed based on a multivariable logistic regression model. RESULTS The annual number of sutureless valve implants increased over the years. The matching procedure paired 430 sutureless with 860 standard aortic valve replacements. A total of 0.7% and 2.1% patients with sutureless and standard prostheses, respectively, died within 30 days (P = 0.076). Cross-clamp times [48 (40–62) vs 63 min (48–74); P = 0.001] and need for blood transfusions (27.4% vs 33.5%; P = 0.022) were lower in patients with sutureless valves. No difference in permanent pacemaker insertions was observed in the overall population (3.3% vs 4.4% in the standard and sutureless groups; P = 0.221) and in the matched groups (3.6% vs 4.7% in the standard and sutureless groups; P = 0.364). CONCLUSIONS The use of sutureless prostheses is advantageous and facilitates the adoption of a minimally invasive approach, reducing cardiac arrest time and the number of blood transfusions. No increased risk of permanent pacemaker insertion was observed.

Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia, occurring in 1–2% of the general population. Catheter ablation has become an important treatment modality for patients with symptomatic drug-refractory AF. We report data regarding the AF ablation approaches and modalities in the Italian “real world.” The survey was set-up to collect data on ablation procedure across Italy. All centers performing AF ablation were invited, regardless of the number of annual procedures, to complete a questionnaire regarding their ablation approaches. All centers reported data regarding procedures performed during the year 2017. A total of 3260 procedures were reported from 49 participating hospitals. Most of Italian regions were included in the study. The majority of the centers performed “Always” pulmonary vein isolation (PVI) in paroxysmal and persistent AF catheter ablation, while adjunctive lesions in persistent AF ablation were planned in most of them but not all, and 16% never performed lesions other than PVI. During ablation procedure, vitamin k inhibitors were uninterrupted in 55% of centers, while direct oral anticoagulant in 44% of centers was used uninterruptedly. No relationship was observed between patient data and the number of procedures performed at each center. This survey suggests that the adherence of Italian centers to the most recent European Society of Cardiology guidelines for AF ablation is reasonably high.

Electrolyte serum disorders are associated with poor outcome in chronic heart failure. The aim of this study sought to identify the main driver of incident hypochloremia in chronic HF (CHF) outpatients and to determine the prognostic value of baseline and incident hypochloremia.Consecutive CHF outpatients were enrolled and clinical, laboratoristic and echocardiographic evaluations were performed at baseline and repeated yearly in a subgroup of patients. Baseline and incident hypochloremia were evaluated. During an up to 5-year follow-up, all-cause mortality was the primary end-point for outcome.Among 506 patients enrolled, 120 patients died during follow-up. At baseline, hypochloremia was present in 10% of patients and it was associated with mortality at univariate (HR: 3.25; 95%CI: 2.04-5.18; p0.001) and at multivariate analysis (HR 2.14; 95%CI: 1.23-3.63; p: 0.005) after correction for well-established CHF prognostic markers. Among patients with repeated evaluations and without baseline hypochloremia, in 13% of these, incident hypochloremia occurred during follow-up and furosemide equivalent daily dose was its first determinant (HR for 1 mg/die: 1.008; 95%CI: 1.004-1.013; p0.001) at forward stepwise logistic regression analysis. Finally, incident hypochloremia was associated with mortality at univariate (HR: 4.69; 95%CI: 2.69-8.19; p0.001) as well as at multivariate analysis (HR: 2.97; 95%CI: 1.48-5.94; p: 0.002).In CHF outpatients baseline and incident hypochloremia are independently associated with all-cause mortality, thus highlighting the prognostic role of serum chloride levels which are generally unconsidered. Future studies should evaluate if the strict monitoring and correction of hypochloremia could exert a beneficial effect on prognosis.

Objective We investigated the performance of four prognostic tools in predicting 180-day mortality for patients admitted for acute decompensated heart failure (ADHF) by calculating sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) over a range of risk thresholds, in addition to discrimination and calibration. Study Design and Setting We studied 1,458 patients. The risk assessment was performed using the Acute Decompensated Heart Failure National Registry (ADHERE) model and the Get With The Guidelines (GWTG), ADHF/NT-proBNP, and Acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart Failure (ASCEND) risk scores. Results C-statistics ranged from 0.727 for the ADHERE model to 0.767 for the ADHF/NT-proBNP score. The ADHF/NT-proBNP risk score, the ADHERE model, and the ASCEND risk score, but not the GWTG risk score, were also well calibrated. Sensitivity and PPV were modest at the >30% risk threshold and ranged from 55% for the ADHF/NT-proBNP risk score to 38.8% for the ADHERE model and from 46.7% for the ADHF/NT-proBNP risk score to 42.1% for the ASCEND risk score, respectively. There was a modest agreement between the risk scores in classifying the patients across risk strata or in classifying those who died as being at >30% risk of death. Conclusion Although risk assessment tools work well for stratifying patients, their use in estimating the risk of mortality for individuals has limited clinical utility.

Mitral valve surgery (MVS) is evolving. Compared to standard sternotomy (S-MVS), minimally invasive method (Mini-MVS) has been increasingly adopted in the last years with encouraging results for both repairs and replacements. We evaluated trends of surgical approaches and operative outcomes in a multicenter study involving 10 cardiac surgical centers in Italy.Patients who received isolated mitral valve surgery, including only a concomitant tricuspid valve repair, from January 2011 up to December 2017. Minimally invasive approach (right anterior mini-thoracotomy) and standard sternotomy was performed in 2602 and 1947 patients, respectively. Stratifying by surgery, 1493 patients per group were paired using a propensity matching procedure.The minimally invasive approach has been progressively more frequent over the years (from 27.5% in 2011 to 71.7% in 2017). Compared to S-MVS, Mini-MVS patients were younger with less preoperative comorbidities and less frequently operated for valve replacement or in association with tricuspid repair. The 30-day mortality was lower in the Mini-MVS (overall 1.2% vs 2.7%; p 0.001) as well as the incidence of most postoperative complications. Subjects paired by propensity score had similar 30-day mortality (1.9% vs 1.8%, p = 0.786) but lower blood transfusion and permanent pace-maker insertion. Cardiopulmonary bypass and cross-clamp time, initially longer in the Mini-MVS patients, became shorter in recent years for the minimally invasive approach.In a large multi-institutional recent cohort, minimally invasive mitral valve surgery has drastically increased being the preferred technique and appears to be safe with procedural duration shorter than the beginning.

OBJECTIVES The need for concomitant tricuspid surgery in patients who need mitral valve surgery casts doubt on its feasibility via a minimally invasive approach. Our goal was to evaluate the short-term outcomes of patients undergoing concomitant mitral and tricuspid valve surgery either with a standard full sternotomy (full-MTS) or a minimally invasive approach (mini-MTS). METHODS The outcomes of patients who had combined mitral and tricuspid valve surgery in 11 centres were retrospectively evaluated. The primary outcome was the incidence of 30-day mortality. A propensity score matched cohort was selected to create 2 comparable groups stratified by surgery (valve replacement or repair). RESULTS During the study period, 1048 consecutive patients had combined mitral and tricuspid valve surgery (730 full-MTS, 318 mini-MTS). The matching procedure paired 192 full-MTS to 192 mini-MTS procedures. After matching, mini-MTS was associated with longer cardiopulmonary bypass [123 min, standard deviation (SD) 46, vs 102 min, SD 36, P = 0.001] and cross-clamping times (89 min, SD 34, vs 78 min, SD 29, P = 0.003). Although the hospital length of stay was shorter (8 days, interquartile range 7-12 vs 9 days, interquartile range 7–14, P = 0.034) with mini-MTS before matching, this difference disappeared after matching. No differences in other major complications or in 30-day mortality were observed: 48 deaths (4.6%), 36 of which (4.9%) occurred in patients who had a full-MTS and 12 (3.8%), in patients who had a mini-MTS (4.7% in both approaches paired by propensity). CONCLUSIONS The mini-MTS approach proved to be safe and effective in patients requiring concomitant mitral and tricuspid surgery. We could not demonstrate any difference in short-term outcomes between the 2 surgical approaches, indicating that there is not a preferred surgical approach.

Aim: To test inter-fraction reproducibility, intrafraction stability, technician aspects, and patient/physician’s comfort of a dedicated immobilization solution for Brain Linac-based radiation therapy (RT). Methods: A pitch-enabled head positioner with an open-face mask were used and, to evaluate inter- and intrafraction variations, 1–3 Cone-Beam Computed Tomography (CBCT) were performed. Surface Guided Radiation Therapy (SGRT) was used to evaluate intrafraction variations at 3 time points: initial (i), final (f), and monitoring (m) (before, end, and during RT). Data regarding technician mask aspect were collected. Results: Between October 2019 and April 2020, 69 patients with brain disease were treated: 45 received stereotactic RT and 24 conventional RT; 556 treatment sessions and 863 CBCT’s were performed. Inter-fraction CBCT mean values were longitudinally 0.9 mm, laterally 0.8 mm, vertically 1.1 mm, roll 0.58°, pitch 0.59°, yaw 0.67°. Intrafraction CBCT mean values were longitudinally 0.3 mm, laterally 0.3 mm, vertically 0.4 mm, roll 0.22°, pitch 0.33°, yaw 0.24°. SGRT intrafraction mean values were: i_, m_, f_ longitudinally 0.09 mm, 0.45 mm, 0.31 mm; i_, m_, f_ laterally 0.07 mm, 0.36 mm, 0.20 mm; i_, m_, f_ vertically 0.06 mm, 0.31 mm, 0.22 mm; i_, m_, f_ roll 0.025°, 0.208°, 0.118°; i_, m_, f_ pitch 0.036°, 0.307°, 0.194°; i_, m_, f_ yaw 0.039°, 0.274°, 0.189°. Conclusions: This immobilization solution is reproducible and stable. Combining CBCT and SGRT data confirm that 1 mm CTV-PTV margin for Linac-based SRT was adequate. Using open-face mask and SGRT, for conventional RT, radiological imaging could be omitted.

The prognostic value of change in six-minute walking distance (6MWD) after treatment to predict mortality in heart failure (HF) remains a controversial issue. We assessed the prognostic value of rehabilitation-induced improvement in 6MWD in predicting mortality in patients with HF.We studied 2257 patients admitted to six inpatient rehabilitation facilities after a hospitalization for HF (N. 912) or because of worsening functional capacity and/or deteriorating clinical status (N. 1345). A six-minute walking test was performed at admission and discharge. The primary outcome was 3-year all-cause mortality after discharge from cardiac rehabilitation. We used multivariable Cox proportional hazard modeling to assess the association of increase in 6MWD with 3-year mortality, adjusting for established predictors of mortality.6MWD significantly increased by 61 m (p .001) from admission to discharge and 969 patients (42.9%) achieved an increase in 6MWD50 m. After full adjustment, an increase in 6MWD50 m was associated with a 22% decreased risk for 3-year mortality (HR 0.78 [95% CI 0.68-0.91]; p = .002). When modeled as a continuous variable, improvement in 6MWD remained independently associated with decreased risk for 3-year mortality (HR per each 50 m increase: 0.92 [95% CI 0.88-0.96]).Rehabilitation-induced improvement in 6MWD was associated with a significantly reduced risk for 3-year mortality. Our data also suggest that an improvement in 6MWD of more than 50 m could represent a clinically meaningful endpoint of cardiac rehabilitation for patients with heart failure.

Background: the role that sex plays in impacting cardiac rehabilitation (CR) outcomes remains an important gap in knowledge. Methods: we assessed sex differences in clinical and functional outcomes in 2345 older patients with heart failure (HF) admitted to inpatient CR. Three outcomes were considered: (1) the composite outcome of death during the index admission to CR or transfer to acute care; (2) three-year mortality; (3) change in six-minute walking distance (6MWD) from admission to discharge. Sex differences in outcomes were assessed using multivariable Cox or logistic regression models. Results: the hazard ratios of the composite outcome and of three-year mortality for females vs. males were 0.71 (95%CI:0.50–1.00; p = 0.049) and 0.68 (95%CI:0.59–0.79; p < 0.001), respectively. The standardized mean difference in 6MWD increase from admission to discharge between males and females was 0.10. The odds ratio of achieving an increase in 6MWD at discharge to values higher than the optimal sex-specific thresholds for predicting mortality for females vs. males was 2.21 (95%CI:1.53–3.20; p < 0.001). Conclusion: our findings suggest that older females with HF undergoing CR have better prognosis and garner similar improvement in 6MWD compared with their male counterparts. Nonetheless, females were more likely to achieve levels of functional capacity predictive of improved survival.

AIMS Atrial fibrillation (AF) has been highlighted as a growing epidemic. Evidence is lacking on the role of different risk factors within both genders especially in AF patients referred for catheter ablation (CA). The objective was the evaluation of differences between men and women in the associations with aging, obesity and hypertension as the most highly contributing factors to AF onset and progression. METHODS Cases selected among patients scheduled for CA as a rhythm-control strategy and controls from a recent Italian national survey on the population's health conditions were analysed to quantify the strength of association and to assess the existence of gender differences. To reduce the effect of possible confounding factors, both cases and controls were selected without preexisting comorbidities other than hypertension. RESULTS At multivariate logistic regression analysis, cases (534 patients, 166 women) were significantly associated with the male sex, higher age, presence of obesity and hypertension in comparison to controls (17,983 subjects, 9,409 women). At analyses gender-stratified, age and obesity had a significant greater association in women than men. On the contrary, hypertension was relatively more frequent in men than women. CONCLUSION Although mechanisms linking risk factors and AF are complex, this study suggests the existence of differences mediated by gender in AF drug-refractory patients who underwent CA. A tailored public health programme to reduce the growing burden of AF needs to be designed to prevent and counter the increasing epidemic of the most common cardiac arrhythmia as well as its progression in more resistant forms.

Objective To investigate the association of CR participation with all-cause mortality after a hospitalization for HF and to describe the characteristics and functional and clinical outcomes of heart failure (HF) patients undergoing inpatient cardiac rehabilitation (CR). Design Multicenter cohort study. The association between CR participation and all-cause mortality from discharge from the acute care setting was assessed using Cox regression analysis adjusting for established prognostic factors. Setting Six inpatients rehabilitation facilities (IRF). Participants 3,219 HF patients admitted to inpatient CR between January 2013 and December 2016. Of these patients, 1,455 had been transferred directly from acute care hospitals after a hospitalization for HF (CR-Group 1) and 1,764 had been admitted from the community due to worsening functional disability or worsening clinical conditions (CR-Group 2). Six hundred thirty-three patients not referred to CR after a hospitalization for HF served as control group (non-CR Group). Intervention Cardiac rehabilitation. Main outcome measure long-term mortality. Secondary outcomes were: 1. Change in functional capacity, as assessed by change in 6-minute walking distance (6MWD) from admission to discharge; 2. Clinical outcomes of the index inpatient rehabilitation admission, including in-hospital mortality and unplanned (re)admission to the acute care. Results Compared with the non-CR Group, the adjusted hazard ratios of mortality at 1, 3, and 5 years for CR-Group 1 patients were 0.82 (0.68-0.97), 0.81 (0.71-0.93), and 0.80 (0.70-0.91). 6MWD increased from 230 to 292 m (p 50 m improvement. Overall, 2.5% of the patients died in hospital and 4.7% of the patients experienced unplanned (re)admissions to acute care, with significant differences between Group 1 and Group 2. Conclusions Our data show that inpatient CR is effective in improving functional capacity and suggest that inpatient CR provided in the earliest period following a hospitalization for HF is associated with long-term improved survival.

Background The COVID-19 pandemic has posed several challenges to the provision of newborn nutrition and care interventions including maternal support, breastfeeding and family participatory care. Italy was the first country to be exposed to SARS-CoV-2 in Europe. One of the measures adopted by the Italian government during COVID-19 pandemic was the total lockdown of the cities with complete confinement at home. We aimed to examine the impact of the lockdown caused by COVID-19 pandemic on exclusive breastfeeding in non-infected mothers. Methods We prospectively enrolled 204 mother-baby dyads during lockdown (9 March to 8 May 2020) that we compared to previously studied 306 mother-baby dyads admitted during the year 2018. To reduce the possible effect of confounding factors on exclusive breastfeeding, a 1:1 matching was performed by using an automatized procedure of stratification that paired 173 mother-baby dyads. Feeding modality was collected at discharge, 30 and 90 days of newborn’s life. Exclusive breastfeeding was considered when the infant received only breast milk and no other liquids or solids were given with the exception of vitamins, minerals or medicines. Results At discharge 69.4% of infants were exclusively breastfed during lockdown versus 97.7% of control group, 54.3% at 30 days vs 76.3 and 31.8% vs 70.5% at 90 days (p p Conclusions Lockdown and home confinement led to a decrease of exclusively breastfeeding in the studied population. Considering the timing to shift from exclusive to non-exclusive breastfeeding, differences between study groups were concentrated during hospital stay and from 30- to 90 days of a newborn’s life, confirming that the hospital stay period is crucial in continuing exclusive breastfeeding at least for the first 30 days, but no longer relevant at 90 days of life.

Stroke is among the leading causes of death and disability worldwide. Approximately 20–25% of stroke survivors present severe disability, which is associated with increased mortality risk. Prognostication is inherent in the process of clinical decision-making. Machine learning (ML) methods have gained increasing popularity in the setting of biomedical research. The aim of this study was twofold: assessing the performance of ML tree-based algorithms for predicting three-year mortality model in 1207 stroke patients with severe disability who completed rehabilitation and comparing the performance of ML algorithms to that of a standard logistic regression. The logistic regression model achieved an area under the Receiver Operating Characteristics curve (AUC) of 0.745 and was well calibrated. At the optimal risk threshold, the model had an accuracy of 75.7%, a positive predictive value (PPV) of 33.9%, and a negative predictive value (NPV) of 91.0%. The ML algorithm outperformed the logistic regression model through the implementation of synthetic minority oversampling technique and the Random Forests, achieving an AUC of 0.928 and an accuracy of 86.3%. The PPV was 84.6% and the NPV 87.5%. This study introduced a step forward in the creation of standardisable tools for predicting health outcomes in individuals affected by stroke.

In a previous study, we found that miR-150-5p was specifically downregulated in patients with advanced heart failure (HF). Here, we investigated the long-term prognostic potential of miR-150-5p.We studied optimally-treated HF outpatients with reduced ejection fraction. The primary outcome comprised the composite of death, urgent heart transplantation (HT) and ventricular assist device (VAD) implantation within 30 months. We used recursive partitioning analysis to identify the optimal log miR-150-5p cut-off. The association of log miR-150-5p with the primary outcome was examined using Cox regression analysis. We used the Meta-Analysis Global Group in Chronic Heart Failure (MAGGIC) risk score for adjustment in multivariable analysis. Finally, we compared the global fit of three models (MAGGIC score + miR-150-5p, MAGGIC score + NT-proBNP, and NT-proBNP + miR-150-5p) using Akaike Information Criterion.Recursive partitioning analysis identified the value of -2.22 as the optimal cut-off for log miR-150-5p. Thirty-month survival free of urgent HT/VAD implantation was 31% among the patients with log miR-150-5p-2.22 and 86% among those with log miR-150-5p-2.22. Crude hazard ratio (HR) of the primary outcome for log miR-150-5p expression level-2.22 was 6.70 (95% CI: 2.31-19.38; P0.001). After adjusting for the MAGGIC score in multivariable analysis, the HR was 4.40 (95% CI: 1.52-12.77; P=0.006). Adding log miR-150-5p to the MAGGIC score led to an increase of 0.047 in C-index. The model combining miR-150-5p and MAGGIC score had a 73% likelihood of representing the best-fit model of those evaluated.Our data generate the hypothesis that miR-150-5p may represent a novel risk marker in HF with reduced ejection fraction.

BACKGROUND: Oxygen therapy represents the elective therapy to improve the quality of life for patients with chronic respiratory diseases like COPD and interstitial lung disease. Lightweight portable oxygen concentrators (POCs) are a valid alternative to traditional systems such as portable compressed oxygen cylinders. However, patient preference and the possible psychological implications related to the use of both devices have been poorly assessed. We sought to evaluate patient preference between the ambulatory oxygen systems (ie, a POC or a small cylinder) for patients with COPD and interstitial lung disease experiencing exertional desaturation in a rehabilitation setting. Furthermore, the use of one device in comparison with the other was related to specific mechanical characteristics and related to perceived quality of life, anxiety, and depressive symptoms. METHODS: 30 subjects with COPD and interstitial lung disease, who demonstrated exertional desaturation on room air during 6-min walk test (6MWT), were recruited. Each subject performed 2 6MWTs, in random order: one breathing oxygen via a POC and one with a portable compressed oxygen cylinder. Both devices were set up to ensure oxyhemoglobin saturation between 92% and 95% during the 6MWTs. All subjects completed a questionnaire assessing anxiety, depression, and quality of life. Each device was randomly assigned to each subject for 1 week, and then replaced with the other in the following week. At the end of the trial period, all subjects completed a questionnaire evaluating several aspects of the oxygen therapy devices. RESULTS: There were no significant differences in oxygen saturation or the mean distances achieved during the 6MWTs between the 2 portable oxygen devices. The subjects expressed greater preference for the POC (73.3%), basing their choice mainly on ease of transport and lower weight. Subjects’ age also correlated with preferences: younger subjects were more negatively focused on the weight of the portable compressed oxygen cylinder, whereas older subjects considered the POC easier to manage. No significant differences in preferences were present between COPD and interstitial lung disease. CONCLUSIONS: The POC and the portable compressed oxygen cylinder performed in a comparable manner during 6MWT for subjects with COPD and interstitial lung disease and exertional desaturation. Subjects preferred the POC because it was associated with better mobility.

Background: Parkinson's disease (PD) starts asymmetrically and it maintains a certain degree of asymmetry throughout its course. Once functional disability proceeds, people with PD can change their dominant hand due to the increased disease severity. This is particularly true for hand dominance, while no studies have been performed so far exploring the behavioral changes of lower limb utilization in PD according to the lateralized symptom dominance. In the current study, we aim to track the foot preference of participants with PD to respond to the Pull Test.Methods: Forty-one subjects suffering from PD, with a H&Y scale ≤ 2, were recruited. A motor evaluation was performed, including the motor part of the MDS-UPDRS, its axial and lateralized scores (for more and less affected side), two Timed Tests, namely Time to Walk a standard distance (TW, in seconds) and Time Up and Go Test (TUG, in seconds), and the Pull Test. The preferred foot (right or left) involved in the step backward was recorded. Thirty-seven healthy controls underwent a motor assessment which included the Pull Test and the Timed Tests. Both participants with PD and controls were right-handed. To evaluate the relationship between the response to Pull-Test and PD-symptoms, subjects with PD were further divided into two groups: (1) Right more affected side (Right-MAS), and (2) Left more affected side (Left-MAS).Results: Both groups of subjects with PD (Right-MAS and Left-MAS) during the Pull Test shifted significantly their leg use preference toward the opposite side than the more affected side: Right-MAS used preferentially their left leg (71%) and vice versa (p < 0.001). The limb preference shift was especially true for Left-MAS group that almost invariably used their right, dominant leg to respond to the Pull Test (95%). Similar results were obtained comparing people with PD and Controls.Conclusions: This study shows that the limb used to respond to the Pull Test generally predicts the contralateral side of worse PD involvement. As the disease takes place, it prevails over hemispheric dominance: right-handed subjects with left side PD-onset and worse lateralization tend to be hyper-right-dominant, while right-handed subjects with right side PD-onset and worse impairment tend to behave as left-handers. Lateralization of symptoms in PD is still a mysterious phenomenon; more studies are needed to better understand this association and to optimize tailored rehabilitation programs for people with PD.

Non-verbal figural fluency is related to executive functions and specifically to the ability to create as many unique designs as possible, while minimizing their repetitions. An Italian version of figural fluency is the Modified Five-Point Test (MFPT), which is highly employed in the clinical practice of neuropsychologists. To date, reference data of Italian population are limited to a sample aged between 16 and 60 years old. Thus, the current study aims to provide normative data of the MFPT in the context of a population-based setting, conducted in Southern Italy. We collected N = 340 Italian healthy subjects, aged over 65 years old (range: 65–91), pooled across subgroups for age, sex, and education. Multiple regression analyses were performed to estimate the effect of age, education, and sex on the participant’s performance. Equivalent scores and cut-off scores were also defined for the number of unique designs (UDs) and the number of strategies (CSs). Multiple regression analyses revealed that UDs increase with decreasing age and increasing educational level. CSs are influenced by higher educational levels but neither by age nor sex. A significant inverse correlation between the UDs and percentage of errors occurred, suggesting that a higher number of UDs are associated with a fewer number of errors and higher CSs employed. The MFPT provides a measure of cognitive functioning in terms of the ability to initiate and realize designs, affording useful hints for clinical settings. The MFPT may represent a handy and useful tool with a specific focus in the differentiation of healthy versus pathological aging.

Aims Uninterrupted anticoagulation is recommended during the ablation of atrial fibrillation. This meta-analysis compared the safety and efficacy of uninterrupted direct oral anticoagulants (DOACs) to uninterrupted vitamin K antagonists (VKAs) during atrial fibrillation ablation. Methods The meta-analysis included eligible randomized controlled trials from 2009 to 2019. Odds ratios (ORs) and 95% confidence intervals were pooled using a random effects model and a sensitivity analysis was performed by sequentially removing one study or DOAC at a time. Results Six studies were included; 1288 received DOAC and 1081 VKA. Pooled ORs indicated a lower nonsignificant incidence in DOACs vs. VKA of composite outcome of major bleeding, stroke, or transient ischemic attack, and mortality (0.69; 0.28-1.71; 31 vs. 45 events), major bleeding alone (0.66; 0.30-1.47; 27 vs. 41 events), and cardiac tamponade (0.56; 0.21-1.45; eight vs. 13 events) with a slightly higher occurrence of minor bleeding (1.17; 0.89-1.56; 139 vs. 106 events) and silent cerebral thromboembolic events (1.12; 0.75-1.66; 72 vs. 58 among 442 and 376 patients performing MRI study). Sensitivity analyses confirmed overall results: pooled ORs ranged from 0.56 to 1.00 for the composite outcome and from 0.54 to 0.92 for major bleedings. Conclusion Uninterrupted DOAC is a safe and effective alternative to uninterrupted VKA during atrial fibrillation ablation.

Objective: We sought to determine sex differences in outcomes in patients with severe stroke who had been admitted to inpatient rehabilitation. Methods: We studied 1,316 patients aged 18 to 99 (mean 72) classified as case-mix groups 0108, 0109, and 0110 of the Medicare case-mix classification system. These groups encompass the most severe strokes. Three outcomes were analyzed: (1) 3-year mortality from admission to rehabilitation; (2) combined outcome of transfer to acute care or death within 90 days from admission to rehabilitation; (3) functional outcome, including proportional recovery in motor functioning and good functional outcome as defined by achievement of a Functional Independence Measure (FIM)-motor score ≥65 points at discharge. Multivariable regression analyses were used to assess sex-difference in each outcome between women and men. The covariates examined included age, marital status, comorbidities, time from stroke onset to rehabilitation admission

Background and Purpose— Prediction of outcome after stroke rehabilitation may help clinicians in decision-making and planning rehabilitation care. We developed and validated a predictive tool to estimate the probability of achieving improvement in physical functioning (model 1) and a level of independence requiring no more than supervision (model 2) after stroke rehabilitation. Methods— The models were derived from 717 patients admitted for stroke rehabilitation. We used multivariable logistic regression analysis to build each model. Then, each model was prospectively validated in 875 patients. Results— Model 1 included age, time from stroke occurrence to rehabilitation admission, admission motor and cognitive Functional Independence Measure scores, and neglect. Model 2 included age, male gender, time since stroke onset, and admission motor and cognitive Functional Independence Measure score. Both models demonstrated excellent discrimination. In the derivation cohort, the area under the curve was 0.883 (95% confidence intervals, 0.858–0.910) for model 1 and 0.913 (95% confidence intervals, 0.884–0.942) for model 2. The Hosmer–Lemeshow χ 2 was 4.12 ( P =0.249) and 1.20 ( P =0.754), respectively. In the validation cohort, the area under the curve was 0.866 (95% confidence intervals, 0.840–0.892) for model 1 and 0.850 (95% confidence intervals, 0.815–0.885) for model 2. The Hosmer–Lemeshow χ 2 was 8.86 ( P =0.115) and 34.50 ( P =0.001), respectively. Both improvement in physical functioning (hazard ratios, 0.43; 0.25–0.71; P =0.001) and a level of independence requiring no more than supervision (hazard ratios, 0.32; 0.14–0.68; P =0.004) were independently associated with improved 4-year survival. A calculator is freely available for download at https://goo.gl/fEAp81 . Conclusions— This study provides researchers and clinicians with an easy-to-use, accurate, and validated predictive tool for potential application in rehabilitation research and stroke management.

Cardiopulmonary bypass (CPB) surgery, despite heparin administration, elicits activation of coagulation system resulting in coagulopathy. Anti-inflammatory effects of steroid treatment have been demonstrated, but its effects on coagulation system are unknown. The primary objective of this study is to assess the effects of methylprednisolone on coagulation function by evaluating thrombin generation, fibrinolysis, and platelet activation in high-risk patients undergoing cardiac surgery with CPB. The Steroids In caRdiac Surgery study is a double-blind, randomized, controlled trial performed on 7507 patients worldwide who were randomized to receive either intravenous methylprednisolone, 250 mg at anesthetic induction and 250 mg at initiation of CPB (n = 3755), or placebo (n = 3752). A substudy was conducted in 2 sites to collect blood samples perioperatively to measure prothrombin fragment 1.2 (PF1+2, thrombin generation), plasmin-antiplasmin complex (PAP, fibrinolysis), platelet factor 4 (PF4 platelet activation), and fibrinogen. Eighty-one patients were enrolled in the substudy (37 placebo vs 44 in treatment group). No difference in clinical outcome was detected, including postoperative bleeding and need for blood products transfusion. All patients showed changes of all plasma biomarkers with greater values than baseline in both groups. This reaction was attenuated significantly in the treatment group for PF1.2 (P = 0.040) and PAP (P = 0.042) values at the first intraoperative measurement. No difference between groups was detected for PF4. Methylprednisolone treatment attenuates activation of coagulation system in high-risk patients undergoing CPB surgery. Reduction of thrombin generation and fibrinolysis activation may lead to reduced blood loss after surgery.

Objectives: Cardiac surgery induces a systemic inflammatory reaction that has been associated with postoperative mortality and morbidity. Many studies have characterized this reaction through laboratory biomarkers while clinical studies generally are lacking. This study aimed to assess the incidence of postoperative systemic inflammation after cardiac surgery, and the association of postoperative systemic inflammation with preoperative patients' characteristics and postoperative outcomes.Design: Retrospective analysis of prospectively collected data. Analysis of the overall population and of propensity-matched subgroups.Setting: Cardiac surgery intensive care unit.Patients: Adult patients who underwent cardiac surgery with cardiopulmonary bypass (CPB) between June 2016 and June 2017.Interventions: Mixed cardiac surgery operations on CPB.Measurements and Main Results: During the study period, 502 patients underwent cardiac surgery with CPB. One hundred forty-two patients (28.3%) fulfilled SIRS criteria at 24 hours. After performing a multivariate analysis to adjust for the procedure type and preoperative systemic inflammatory reaction syndrome (SIRS) parameters, the occurrence of SIRS was associated inversely with age and extracardiac arteriopathy, and it was associated positively with preoperative white blood cell count. Vasopressors were used more frequently in SIRS patients who further experienced longer mechanical ventilation time and length of stay in the intensive care unit (ICU). The incidence of a composite outcome including death, transient ischemic attack/stroke, renal replacement therapy, bleeding, postoperative intra-aortic balloon pump insertion, and a length of stay in ICU >96 hours was more frequent in SIRS-positive patients. There was no difference between overall and matched subgroups for in hospital mortality.Conclusion: In this retrospective study, the clinical signs of SIRS were detected in a substantial percentage of patients who underwent cardiac surgery. The postoperative SIRS criteria were associated with a more complicated postoperative course and higher postoperative morbidity. (C) 2019 Elsevier Inc. All rights reserved.

Background: Thyroid disorders may have a negative impact on the prognosis of patients affected by chronic heart failure (CHF). Objective: The aim of the current study was to evaluate the prognostic role of all thyroid disorders over a long term follow-up in a single centre large sample of CHF outpatients. Methods: In all patients, the function of the thyroid was evaluated at the enrolment and during the follow- up. On the basis of free triiodothyronine (T3), free thyroxine (fT4) and thyroid-stimulating hormone (TSH) serum levels, patients were classified into one of the following four categories: euthyroid subjects, patients affected by hypothyroidism, low T3 (LT3) syndrome and hyperthyroidism. During the follow-up, death for all causes was assessed as primary end-point, whereas time to the first hospitalization for heart failure worsening was the secondary end-point analyzed. Results: Among 762 patients, 190 patients were affected by hypothyroidism (Hypo). LT3 syndrome was diagnosed in 15 patients and 59 patients were affected by hyperthyroidism (Hyper). During a long term follow-up (5.1±3.7 years), 303 patients died. Patients with Hypo showed an increased risk of death as well as of hospitalization due to heart failure worsening at univariate regression analysis. At multivariate regression analysis, Hypo remained associated with hospitalization after correction for age >75 years, ischemic aetiology, diabetes, therapy with ACE-inhibitors or ARBs, therapy with betablockers and with aldosterone antagonists, NYHA class 3, systolic arterial pressure 1000 pg/ml. At multivariate analysis, the independent association with death was significant only for the subgroup of patients with TSH >10 mIU/L. LT3 was independently associated with both heart failure hospitalization and death, whereas Hyper was not associated with any of the two considered end-points. Conclusion: Hypo is associated with a worse prognosis over a long-term follow-up. The association with heart failure hospitalization is not dependent on the baseline TSH levels, whereas the association with death is significant only when TSH >10 mIU/L. Finally, Hyper does not have any association with a worse prognosis.

Objectives Treatment of aortic valve stenosis is evolving, indications for transcatheter approach (TAVI) have increased but also surgical valve replacement has changed with the use of minimally invasive approaches. Comparisons between TAVI and surgery have rarely been done with minimally invasive techniques (mini-SAVR) in the surgical arm. Aim of the present study is to compare mini-SAVR and TAVI in a multicenter recent cohort. Methods Evaluated were 2904 patients undergone mini-SAVR (2407) or TAVI (497) in 10 different centers in the period 2011–2016. The Heart Team approved treatment for complex cases. The primary outcome is the incidence of 30-day mortality following mini-SAVR and TAVI. Secondary outcomes are the occurrence of major complications following both procedures. Propensity matched comparisons was performed based on multivariable logistic regression model. Results In the overall population TAVI patients had increased surgical risk (median EuroSCORE II 3.3% vs. 1.7%, p ≤ 0.001) and 30-day mortality was higher (1.5% and 2.8% in mini-SAVR and TAVI respectively, p = 0.048). Propensity score identified 386 patients per group with similar baseline profile (median EuroSCORE II ~3.0%). There was no difference in 30-day mortality (3.4% in mini-SAVR and 2.3% in TAVI; p = 0.396) and stroke, surgical patients had more blood transfusion, kidney dysfunction and required longer ICU and hospital length of stay while TAVI patients had more permanent pace maker insertion. Conclusions Mini-SAVR and TAVI are both safe and effective to treat aortic stenosis in elderly patients with comorbidities. A joint evaluation by the heart-team is essential to direct patients to the proper approach., Highlights • A comparison between TAVI and minimally invasive techniques has rarely been done • In a propensity-matched comparison from 10 different hospitals, TAVI and mini-SAVR provided optimal short-term outcome. • 30-day mortality was 3.4% in mini-SAVR and 2.3% in TAVI (p = 0.396) • Mini-SAVR and TAVI are both safe and effective to treat aortic stenosis in elderly patients with comorbidities.