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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.

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.

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.

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.

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.

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.

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.

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

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.

Background: Although several contributions exist on the role of fractional exhaled NO (FeNO) in diagnosis and management of asthma, no studies have analysed the association between FeNO in patients with severe asthma and nasal polyposis. Aim: We investigated the potential association between FeNO and the presence of nasal polyps in patients affected by severe asthma. Methods: Study population included 93 severe asthmatic adult patients consecutively enrolled from four Italian specialist clinic centres from 2015 to 2018. In these patients lung function, asthma control, FeNO, blood eosinophils and CT scan of paranasal sinuses were evaluated. Results: Nasal polyposis was observed in 28 patients (30%). Among univariate predictors (lower BMI, higher FeNO, eosinophil and neutrophil count), recursive partitioning analysis identified as best predictors of nasal polyposis high values of eosinophil count (≥6.5% or >420 cells/mm3) and FeNO (≥39 ppb). The 40 patients with low eosinophil count and FeNO had a significant lower occurrence of nasal polyposis than those with higher values (8% vs 58%; p < 0.001). The stratification algorithm had a good performance in discriminate patients with and without nasal polyposis (area under the receiver operating characteristic curve of 0.768). Conclusions: Our results show that FeNO might improve to detect nasal polyposis in patients with severe asthma and a low level of blood eosinophils counts, identifying individuals with high susceptibility to this condition.

Aim of the study: In chronic heart failure (CHF) patients, renal congestion plays a key role in determining the progression of renal dysfunction and a worse prognosis. The aim of this study was to define the role of Doppler venous patterns reflecting renal congestion that predict heart failure progression. Methods: We enrolled outpatients affected by CHF, in stable clinical conditions and in conventional therapy. All patients underwent a clinical evaluation, routine chemistry, an echocardiogram and a renal echo-Doppler. Pulsed Doppler flow recording was performed at the level of interlobular renal right veins in the tele-expiratory phase. The venous flow patterns were divided into five groups according to the fluctuations of the flow. Type A and B were characterized by a continuous flow, whereas type C was characterized by a short interruption or reversal flow during the end-diastolic or protosystolic phase. Type D and E were characterized by a wide interruption and/or reversal flow. The occurrence of death and/or of heart transplantation and/or of hospitalization due to heart failure worsening was considered an event during follow-up. Results: During a median follow-up of 38 months, 126 patients experienced the considered end-point. Venous pattern C (HR 4.04, 95% CI: 2.14&ndash, 7.65, p &lt, 0.001), pattern D (HR 7.16, 95% CI: 3.69&ndash, 13.9, 0.001) and pattern E (HR 8.94, 95% CI: 4.65&ndash, 17.2, 0.001) were all associated with events using an univariate Cox regression analysis. Moreover, both the presence of pattern C (HR: 1.79, 95% CI: 1.09&ndash, 2.97, p: 0) and of pattern D or E (HR: 1.90, 95% CI: 1.16&ndash, 3.12, p: 0.011) remained significantly associated to events using a multivariate Cox regression analysis after correction for a reference model with an improvement of the overall net reclassification index (0.46, 95% CI 0.24&ndash, 0.68, 0.001). Conclusions: Our findings demonstrate the independent and incremental role of Doppler venous patterns reflecting renal congestion in predicting HF progression among CHF patients, thus suggesting its possible utility in daily clinical practice to better characterize patients with cardio-renal syndrome.

Background We described, in a large sample of patients with type 1 diabetes mellitus (T1DM) and GFR ≤ 60 mL/min/1.73 m2 (with or without albuminuria), the differences in the clinical features associated with the two different chronic kidney disease phenotypes and we investigated, in a subset of patients, the modulating role of albuminuria on kidney disease progression. Methods Clinical data of 1395 patients with T1DM were extracted from electronic medical records. Results Albuminuria was detected in 676 (48.5%) patients, with the remaining 719 (51.5%) patients having normoalbuminuric renal impairment. Those with albuminuria showed an evident worse cardiovascular risk profile as compared to patients with normoalbuminuria. A subgroup of 582 patients was followed up over a 4-year period. One hundred and twenty five patients (21.5%) showed a loss of eGFR > 30%. The proportion of patients reaching the renal outcome was significantly higher among those with baseline albuminuria as compared to patients with normoalbuminuria (P

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Background. Chronic kidney disease (CKD) entails a worse cardiovascular outcome. The aim of our work was to study the relationship between CKD and the achievement of recommended targets for glycated haemoglobin (HbA1c), low-density lipoprotein cholesterol (LDL-c) and blood pressure (BP) in a real-life sample of patients with type 2 diabetes mellitus (T2DM). Methods. We analysed a sample of 116 777 outpatients from the Network of the Italian Association of Clinical Diabetologists; all patients had T2DM and at least one measurement of HbA1c, LDL-c, BP, serum creatinine and albuminuria in the year 2010. The outcome was the achievement of HbA1c, LDL-c and BP values as recommended by International Guidelines. Results. In the entire sample, themean value ofHbA1c was 7.2± 1.2%, of LDL-c was 102 ± 33 mg/dL and of BP was 138/78 ± 19/ 9 mmHg. CKD and its components were associated with poor glycaemic and BP control, notwithstanding greater use of glucose and BP-lowering drugs, while no association was found with LDL-c values. Factors independently related to unsatisfactory glycaemic control included female gender, body mass index, duration of disease and high albuminuria. Men, older people and those taking statins were more likely to reach LDL-c target levels. Male gender, age and high albuminuria strongly affected the achievement of BP targets. Conclusions. CKD or its components, mainly high albuminuria, are associated with failure to reach therapeutic targets, especially for HbA1c and BP, despite a greater use of drugs in patients with T2DM.

We thank Dijkland et al for their interest in our article1 on prediction of functional outcome after stroke rehabilitation. Dr Dijkland raises some issues about the outcome measures and the predictive model for the secondary outcome. In general, models predictive of dichotomous clinical outcomes are most relevant in medical applications. Consistently, dichotomized outcome measures, including the Barthel index and the modified Rankin Scale, have been used to assess the effects of stroke treatment in clinical trials. For patients undergoing rehabilitation after a moderate-to-severe stroke, regaining minimal levels of disability or physical independence are clinically highly relevant outcomes. According to the article of Altman cited by Dijkland, we did not convert continuous explanatory variables to 2 (dichotomization) or multiple (categorization) groups, but …

Background/Aims: Apparent treatment resistant hypertension (aTRH) is highly prevalent in patients with type 2 diabetes (T2D) and chronic kidney disease (CKD). The impact of aTRH and achievement of recommended blood pressure (BP) values on the rate of glomerular filtration rate (eGFR) loss in CKD patients is poorly known. To assess the role of aTRH and time-updated BP control (BPC) on the progression of CKD in patients with T2D and hypertension (HT) in real life clinical practice. Methods: Clinical records from a total of 2,778 diabetic patients with HT and stage 3 CKD (i.e. baseline eGFR values between 30 and 60 ml/min) and regular visits during a four-year follow-up were analyzed. The association between BPC (i.e. 75% of visits with BP 30% reduction from baseline) or worsening of albuminuria status over time was assessed. Results: At baseline 33% of patients had aTRH. Over the 4-year follow-up, 20% had a >30% eGFR reduction. Patients with aTRH had an increased risk of eGFR loss >30% (OR 1.31; PConclusion: In patients with stage 3 CKD the presence of aTRH entails a faster loss of eGFR. More effective prevention of aTRH should be implemented as this condition is associated with a burden of risk not modifiable by tight BP reduction.

Objective To measure competition amongst providers and to examine whether a correlation exists with hospitals mortality for congestive heart failure (CHF), acute myocardial infarction (AMI), isolated-coronary artery bypass graft (CABG) or valve surgery. Design Cross-sectional study based on publically available data from the National Outcome Evaluation Program (Edition 2016) of the Italian Agency for Regional Health Services. Setting and participants Patients discharged during 2015 for CHF or AMI, and between 2014 and 2015 for cardiac surgery (respectively, from 662, 395 and 91 hospitals). Main outcome measures Risk-adjusted mortality rates at 30 days and measures of hospital competition for areas centred on hospital' location (fixed-radius 50-150 km, variable-radius to capture 10-30 hospitals and 6-10% of national volume). Competition was estimated as number of providers and Herfindahl-Hirschman Index (HHI). Results Indicators of competitions varied by condition and were sensitive to method used for the area definition. Hospital mortality after AMI and valve surgery increased with competition in areas identified by the variable-radius method (higher rates for a greater number of hospitals or lower HHIs). In area with fixed radius of 100-150 km, competition reduced mortality after CABG procedures (lower rates for a greater number of hospitals or smaller HHIs). Neither the number of hospitals nor HHI correlated with outcomes in CHF. Conclusions The measures of hospital competition changed according to definition of local market and results in mortality correlations varied among conditions. Understanding the relationship between hospital competition and outcomes is important to identify strategies to improve quality of care.

Background Antithrombin (AT) concentrations are reduced after cardiac surgery with cardiopulmonary bypass compared with the preoperative levels. Low postoperative AT is associated with worse short- and mid-term clinical outcomes. The aim of the study is to evaluate the effects of AT administration on activation of the coagulation and fibrinolytic systems, platelet function, and the inflammatory response in patients with low postoperative AT levels. Methods Sixty patients with postoperative AT levels of less than 65% were randomly assigned to receive purified AT (5000 IU in three administrations) or placebo in the postoperative intensive care unit. Thirty patients with postoperative AT levels greater than 65% were observed as controls. Interleukin 6 (a marker of inflammation), prothrombin fragment 1-2 (a marker of thrombin generation), plasmin–antiplasmin complex (a marker of fibrinolysis), and platelet factor 4 (a marker of platelet activation) were measured at six different times. Results Compared with the no AT group and control patients, patients receiving AT showed significantly higher AT values until 48 hours after the last administration. Analysis of variance for repeated measures showed a significant effect of study treatment in reducing prothrombin fragment 1-2 ( p = 0.009; interaction with time sample, p = 0.006) and plasmin–antiplasmin complex ( p p p = 0.877; interaction with time sample, p = 0.521) and platelet factor 4 ( p = 0.913; interaction with time sample, p = 0.543). No difference in chest tube drainage, reopening for bleeding, and blood transfusion was observed. Conclusions Antithrombin administration in patients with low AT activity after surgery with cardiopulmonary bypass reduces postoperative thrombin generation and fibrinolysis with no effects on platelet activation and inflammatory response.

OBJECTIVES: To evaluate performance of the European System for Cardiac Operation Risk Evaluation (EuroSCORE II), to assess the influence of model updating and to derive a hierarchical tree for modelling the relationship between EuroSCORE II risk factors and hospital mortality after cardiac surgery in a large prospective contemporary cohort of consecutive adult patients. METHODS: Data on consecutive patients, who underwent on-pump cardiac surgery or off-pump coronary artery bypass graft intervention, were retrieved from Puglia Adult Cardiac Surgery Registry. Discrimination, calibration, re-estimation of EuroSCORE II coefficients and hierarchical tree analysis of risk factors were assessed. RESULTS: Out 6293 procedures, 6191 (98.4%) had complete data for EuroSCORE II assessment with a hospital mortality rate of 4.85% and EuroSCORE II of 4.40 ± 7.04%. The area under the receiver operator characteristic curve (0.830) showed good discriminative ability of EuroSCORE II in distinguishing patients who died and those who survived. Calibration of EuroSCORE II was preserved with lower predicted than observed risk in the highest EuroSCORE II deciles. At logistic regression analysis, the complete revision of the model had most of reestimated regression coefficients not statistically different from those in the original EuroSCORE II model. When missing values were replaced with the mean EuroSCORE II value according to urgency and weight of intervention, the risk score confirmed discrimination and calibration obtained over the entire sample. A recursive tree-building algorithm of EuroSCORE II variables identified three large groups (55.1, 17.1 and 18.1% of procedures) with low-to-moderate risk (observed mortality of 1.5, 3.2 and 6.4%) and two groups (3.8 and 5.9% of procedures) at high risk (mortality of 14.6 and 32.2%). Patients with low-to-moderate risk had good agreement between observed events and predicted frequencies by EuroSCORE II, whereas those at greater risk showed an underestimation of expected mortality. CONCLUSIONS: This study demonstrates that EuroSCORE II is a good predictor of hospital mortality after cardiac surgery in an external validation cohort of contemporary patients from a multicentre prospective regional registry. The EuroSCORE II predicts hospital mortality with a slight underestimation in high-risk patients that should be further and better evaluated. The EuroSCORE II variables as a risk tree provides clinicians and surgeons a practical bedside tool for mortality risk stratification of patients at low, intermediate and high risk for hospital mortality after cardiac surgery.

Renal dysfunction may confound the clinical interpretation of N-terminal pro-B-type natriuretic peptide (NT-proBNP) concentration. This study investigated whether renal dysfunction influences the prognostic accuracy of NT-proBNP in acute decompensated heart failure (ADHF).We studied 908 ADHF patients. The primary outcome was 12-month mortality. Interaction between estimated glomerular filtration rate (eGFR) and NT-proBNP in predicting mortality was tested with the likelihood ratio test. The patients were classified into 3 eGFR strata: ≥60, 30-59, and30 ml·min(-1)·1.73 m(-2). Cox models were used to calculate the adjusted hazard ratios (HR) for NT-proBNP, modeled as a dichotomous or categorized variable, within each level of eGFR. NT-proBNP was categorized using optimal cut-offs defined in ROC analysis for each eGFR level. A total of 234 patients (25.8%) died. Testing for interaction was not significant (χ(2)=0.29; P=0.5928). The adjusted HR for NT-proBNP5,180 pg/ml was 2.09 (P0.001) in the highest, 1.7 (P0.001) in the intermediate, and 3.33 (P=0.010) in the lowest eGFR level. The adjusted HR for NT-proBNP above the optimal cut-offs defined on ROC analysis were 1.5 (P=0.239), 2.2 (P0.001), and 3.24 (P=0.002), respectively. The models incorporating NT-proBNP as a dichotomous or categorized variable had equivalent C-statistics.There was no evidence of interaction between eGFR and NT-proBNP in predicting mortality. The NT-proBNP cut-off of 5,180 ng/L provided independent prognostic information, irrespective of the level of residual renal function.

Background Apparent treatment resistant hypertension ( aTRH ) is highly prevalent in patients with type 2 diabetes mellitus (T2D) and entails worse cardiovascular prognosis. The impact of aTRH and long‐term achievement of recommended blood pressure ( BP ) values on renal outcome remains largely unknown. We assessed the role of aTRH and BP on the development of chronic kidney disease in patients with T2D and hypertension in real‐life clinical practice. Methods and Results Clinical records from a total of 29 923 patients with T2D and hypertension, with normal baseline estimated glomerular filtration rate and regular visits during a 4‐year follow‐up, were retrieved and analyzed. The association between time‐updated BP control (ie, 75% of visits with BP aTRH . Over the 4‐year follow‐up, 19% developed low estimated glomerular filtration rate and 12% an estimated glomerular filtration rate reduction ≥30% from baseline. Patients with aTRH showed an increased risk of developing both renal outcomes (adjusted odds ratio, 1.31 and 1.43; P aTRH . No association was found between BP control and renal outcomes in non‐ aTRH , whereas in aTRH , BP control was associated with a 30% ( P =0.036) greater risk of developing the renal end points. Conclusions ATRH entails a worse renal prognosis in T2D with hypertension. BP control is not associated with a more‐favorable renal outcome in aTRH . The relationship between time‐updated BP and renal function seems to be J‐shaped, with optimal systolic BP values between 120 and 140 mm Hg.

We evaluated 2,656 patients with type 1 diabetes mellitus and preserved renal function from the database of the Italian Association of Clinical Diabetologists network to identify clinical predictors for the development of chronic kidney disease. We measured estimated glomerular filtration rate (eGFR), urinary albumin excretion, HbA1c, lipids, blood pressure. Over a 5-year period 4.3% (n = 115) developed reduced eGFR (2), 18.0% (n = 477) albuminuria, and 21.0% (n = 559) either one of the renal endpoints (CKD). Odds ratios for eGFR below 90 mL/min/1.73 m2 (1.48, P

OBJECTIVES Minimally invasive valve surgery (MIVS) is associated with improved clinical outcome but longer cardiopulmonary bypass (CPB) time. The aim of the present study is to compare inflammatory and coagulation parameters in patients undergoing minimally invasive or standard valve surgery. METHODS A prospective non-randomized study was performed enrolling 79 patients undergoing mitral (20 right mini-thoracotomy and 18 standard sternotomy) and aortic valve (20 mini-sternotomy and 21 standard sternotomy) procedures. Blood samples were collected perioperatively to measure prothrombin fragment 1.2 (PF1.2, thrombin generation), plasmin antiplasmin complex (PAP, fibrinolysis), interleukin-6 (IL-6, inflammation). Plasma free haemoglobin (f-Hb) was assessed to evaluate haemolysis. RESULTS Patients in the minimally invasive group were younger and had less comorbidities CPB and cross-clamp times were comparable considering both aortic and mitral procedures, but longer in the mini-thoracotomy group. IL-6 and PAP were reduced in the minimally invasive group, particularly 2 h after CPB (respectively 102 ± 114 vs 34 ± 49 pg/ml, P