Ceftolozane/Tazobactam for Treatment of Severe ESBL-Producing Enterobacterales Infections: A Multicenter Nationwide Clinical Experience (CEFTABUSE II Study)

Background. Few data are reported in the literature about the outcome of patients with severe extended-spectrum beta-lactamase-producing Enterobacterales (ESBL-E) infections treated with ceftolozane/tazobactam (C/T), in empiric or definitive therapy.Methods. A multicenter retrospective study was performed in Italy (June 2016-June 2019). Successful clinical outcome was defined as complete resolution of clinical signs/symptoms related to ESBL-E infection and lack of microbiological evidence of infection. The primary end point was to identify predictors of clinical failure of C/T therapy.Results. C/T treatment was documented in 153 patients: pneumonia was the most common diagnosis (n = 46, 30%), followed by 34 cases of complicated urinary tract infections (22.2%). Septic shock was observed in 42 (27.5%) patients. C/T was used as empiric therapy in 46 (30%) patients and as monotherapy in 127 (83%) patients. Favorable clinical outcome was observed in 128 (83.7%) patients; 25 patients were considered to have failed C/T therapy. Overall, 30-day mortality was reported for 15 (9.8%) patients. At multivariate analysis, Charlson comorbidity index >4 (odds ratio [OR], 2.3; 95% confidence interval [CI], 1.9-3.5; P = .02), septic shock (OR, 6.2; 95% CI, 3.8-7.9; P < .001), and continuous renal replacement therapy (OR, 3.1; 95% CI, 1.9-5.3; P = .001) were independently associated with clinical failure, whereas empiric therapy displaying in vitro activity (OR, 0.12; 95% CI, 0.01-0.34; P < .001) and adequate source control of infection (OR, 0.42; 95% CI, 0.14-0.55; P < .001) were associated with clinical success.Conclusions. Data show that C/T could be a valid option in empiric and/or targeted therapy in patients with severe infections caused by ESBL-producing Enterobacterales. Clinicians should be aware of the risk of clinical failure with standard-dose C/T therapy in septic patients receiving CRRT

The ACTonHEART study: rationale and design of a randomized controlled clinical trial comparing a brief intervention based on Acceptance and Commitment Therapy to usual secondary prevention care of coronary heart disease.

BACKGROUND: Modifiable risk factors, including life-style habits and psychological variables, have been increasingly demonstrated to have an important role in influencing morbidity and mortality in cardiovascular patients, and to account for approximately 90% of the population risk for cardiac events.Acceptance and Commitment Therapy (ACT) has shown effectiveness in promoting healthy behaviors, and improving psychological well-being in patients with chronic physical conditions. Moreover, a first application of an acceptance-based program in cardiac patients has revealed high treatment satisfaction and initial evidences of effectiveness in increasing heart-healthy behaviour. However, no clinical trial to date has evaluated the efficacy of an acceptance-based program for the modification of cardiovascular risk factors and the improvement of psychological well-being, compared to usual secondary prevention care. METHODS: Approximately 168 patients will be recruited from an outpatient cardiac rehabilitation unit and randomly assigned to receive usual care or usual care\u2009+\u2009a brief ACT-based intervention. The ACT group will be administered five group therapy sessions integrating educational topics on heart-healthy behaviours with acceptance and mindfulness skills. Participants will be assessed at baseline, six weeks later (post treatment for the ACT condition), at six and twelve months follow-up.A partially-nested design will be used to balance effects due to clustering of participants into small therapy groups. Primary outcome measures will include biological indicators of cardiovascular risk and self-reported psychological well-being. Treatment effects will be tested via multilevel modeling after which the mediational role of psychological flexibility will be evaluated. DISCUSSION: The ACTonHEART study is the first randomized clinical trial designed to evaluate the efficacy of a brief group-administered, ACT-based program to promote health behavior change and psychological well-being among cardiac patients. Results will address the effectiveness of a brief treatment created to simultaneously impact multiple cardiovascular risk factors. Conducted in the context of clinical practice, this trial will potentially offer empirical support to alternative interventions to improve quality of life and reduce mortality and morbidity rates among cardiac patients. TRIAL REGISTRATION: clinicaltrials.gov/ (NCT01909102)

The ACTonHEART study: rationale and design of a randomized controlled clinical trial comparing a brief intervention based on Acceptance and Commitment Therapy to usual secondary prevention care of coronary heart disease.

BACKGROUND: Modifiable risk factors, including life-style habits and psychological variables, have been increasingly demonstrated to have an important role in influencing morbidity and mortality in cardiovascular patients, and to account for approximately 90% of the population risk for cardiac events.Acceptance and Commitment Therapy (ACT) has shown effectiveness in promoting healthy behaviors, and improving psychological well-being in patients with chronic physical conditions. Moreover, a first application of an acceptance-based program in cardiac patients has revealed high treatment satisfaction and initial evidences of effectiveness in increasing heart-healthy behaviour. However, no clinical trial to date has evaluated the efficacy of an acceptance-based program for the modification of cardiovascular risk factors and the improvement of psychological well-being, compared to usual secondary prevention care. METHODS: Approximately 168 patients will be recruited from an outpatient cardiac rehabilitation unit and randomly assigned to receive usual care or usual care + a brief ACT-based intervention. The ACT group will be administered five group therapy sessions integrating educational topics on heart-healthy behaviours with acceptance and mindfulness skills. Participants will be assessed at baseline, six weeks later (post treatment for the ACT condition), at six and twelve months follow-up.A partially-nested design will be used to balance effects due to clustering of participants into small therapy groups. Primary outcome measures will include biological indicators of cardiovascular risk and self-reported psychological well-being. Treatment effects will be tested via multilevel modeling after which the mediational role of psychological flexibility will be evaluated. DISCUSSION: The ACTonHEART study is the first randomized clinical trial designed to evaluate the efficacy of a brief group-administered, ACT-based program to promote health behavior change and psychological well-being among cardiac patients. Results will address the effectiveness of a brief treatment created to simultaneously impact multiple cardiovascular risk factors. Conducted in the context of clinical practice, this trial will potentially offer empirical support to alternative interventions to improve quality of life and reduce mortality and morbidity rates among cardiac patients. TRIAL REGISTRATION: clinicaltrials.gov/ (NCT01909102)

Delirium in the acute phase after stroke: comparison between methods of detection

Delirium is an acute neuropsychiatric syndrome, very common in hospitalized people with medical and neurological conditions. The identification of delirium after stroke is not an easy task and validated psychometric instruments are needed to correctly identify it. We decided to verify if (1) formal training in DSM-V criteria is needed to correctly identify post-stroke delirium, (2) if the use of a brief psychometric instrument such as 4AT improves its identification, (3) the applicability of these scales in the stroke setting. In the first phase of this study we retrospectively studied 102 acute stroke patients in Stroke Units of San Martino Hospital (Genova, Italy) to evaluate delirium with clinical criteria, first by a neurologist without a formal training in DSM-V criteria and after training. Then, we enrolled 100 new acute stroke patients who underwent screening for delirium using 4AT scale and DSM-V criteria. In the first phase, DSM-V criteria training significantly increased the ability to capture delirium (5 vs. 15%). In the second phase, the 4AT was used for delirium screening revealing a 52% of cases of delirium, the same observed by the consensus diagnosis of two senior neurologists (that was 50%). In the second phase, the use of 4AT scale allowed to capture post-stroke delirium as well as the consensus diagnosis by two neurologists. The identification of post-stroke delirium is not an easy task and requires both formal training in DSM-V criteria as well as the application of brief scales, such as the 4AT

Development and initial validation of the Cardiovascular Disease Acceptance and Action Questionnaire (CVD-AAQ) in an Italian sample of cardiac patients

Psychological inflexibility refers to the attempt to decrease internal distress even when doing so is inconsistent with life values, and has been identified as a potential barrier to making and maintaining health behavior changes that are consistent with a heart-healthy lifestyle. Disease- and behavior-specific measures of psychological inflexibility have been developed and utilized in treatment research. However, no specific measure has been created for patients with heart disease. Thus, the CardioVascular Disease Acceptance and Action Questionnaire (CVD-AAQ) was developed. The present study is aimed to evaluate the psychometric properties of the CVD-AAQ and to explore its association with measures of psychological adjustment and cardiovascular risk factors in an Italian sample of 275 cardiac patients. Exploratory factor analysis showed a structural one-factor solution with satisfactory internal consistency and test-retest reliability. The relation with other measures was in the expected direction with stronger correlations for the theoretically consistent variables, supporting convergent and divergent validity. CVD-AAQ scores were associated with general psychological inflexibility, anxiety and depression and inversely correlated with psychological well-being. Moreover, the results showed that CVD-AAQ scores are associated with two relevant risk factors for cardiac patients, namely low adherence to medication and being overweight. In sum, results suggest that the CVD-AAQ is a reliable and valid measure of heart disease-specific psychological inflexibility with interesting clinical applications for secondary prevention care

Validation of the Trifecta Scoring Metric in Vacuum-Assisted Mini-Percutaneous Nephrolithotomy: A Single-Center Experience

Background: Scoring metrics to assess and compare outcomes of percutaneous nephrolithotomy (PCNL) are needed. We aim to evaluate prevalence and predictors of trifecta in a cohort of patients treated with vacuum-assisted mini-percutaneous nephrolithotomy (vmPCNL) for kidney stones. Methods: Data from 287 participants who underwent vmPCNL were analysed. Patients’ and stones’ characteristics as well as operative data were collected. Stone-free was defined as no residual stones. The modified Clavien classification was used to score postoperative complications. Trifecta was defined as stone-free status without complications after a single session and no auxiliary procedures. Descriptive statistics and logistic regression models tested the association between predictors and trifecta outcome. Results: After vmPCNL, 219 (76.3%) patients were stone-free, and 81 (28.2%) had postoperative complications (any Clavien). Of 287, 170 (59.2%) patients achieved trifecta criteria. Patients who achieved trifecta status had smaller stone volume (p p p p p p = 0.02) and multiple calyces being involved (OR 2.8 and OR 4.3 for two- and three-calyceal groups, respectively, all p < 0.01) were independent unfavourable risk factors for trifecta after accounting for age, BMI, gender, operative time, and number of access tracts. Conclusions: Trifecta status was achieved in 6 out of 10 patients after vmPCNL. Stone distribution in multiple calyceal groups and stone volume were independent unfavourable risk factors for trifecta

Renal function and peak exercise oxygen consumption in chronic heart failure with reduced left ventricular ejection fraction

Background: Chronic kidney disease is associated with sympathetic activation and muscle abnormalities, which may contribute to decreased exercise capacity. We investigated the correlation of renal function with peak exercise oxygen consumption (V˙O2) in heart failure (HF) patients. Methods and Results: We recruited 2,938 systolic HF patients who underwent clinical, laboratory, echocardiographic and cardiopulmonary exercise testing. The patients were stratified according to estimated glomerular filtration rate (eGFR). Mean follow-up was 3.7 years. The primary outcome was a composite of cardiovascular death and urgent heart transplantation at 3 years. On multivariable regression, eGFR was predictor of peakV˙O2 (P&lt;0.0001). Other predictors were age, sex, body mass index, HF etiology, NYHA class, atrial fibrillation, resting heart rate, Btype natriuretic peptide, hemoglobin, and treatment. After adjusting for significant covariates, the hazard ratio for primary outcome associated with peakVO2 &lt;12 ml ・ kg−1 ・ min−1 was 1.75 (95% confidence interval (CI): 1.06–2.91; P=0.0292) in patients with eGFR ≥60, 1.77 (0.87–3.61; P=0.1141) in those with eGFR of 45–59, and 2.72 (1.01– 7.37; P=0.0489) in those with eGFR &lt;45 ml ・ min−1 ・ 1.73 m−2. The area under the receiver-operating characteristic curve for peakV˙O2 &lt;12 ml ・ kg−1 ・ min−1 was 0.63 (95% CI: 0.54–0.71), 0.67 (0.56–0.78), and 0.57 (0.47–0.69), respectively. Testing for interaction was not significant. Conclusions: Renal dysfunction is correlated with peakV O2. A peakV O2 cutoff of 12 ml ・ kg–1 ・ min–1 offers limited prognostic information in HF patients with more severely impaired renal function