A novel, comprehensive tool for predicting 30-day mortality after surgical aortic valve replacement

OBJECTIVES: We sought to develop and validate a novel risk assessment tool for the prediction of 30-day mortality after surgical aortic valve replacement incorporating a patient's frailty. METHODS: Overall, 4718 patients from the multicentre study OBSERVANT was divided into derivation (n=3539) and validation (n=1179) cohorts. A stepwise logistic regression procedure and a criterion based on Akaike information criteria index were used to select variables associated with 30-day mortality. The performance of the regression model was compared with that of European System for Cardiac Operative Risk Evaluation (EuroSCORE) II. RESULTS: At 30 days, 90 (2.54%) and 35 (2.97%) patients died in the development and validation data sets, respectively. Age, chronic obstructive pulmonary disease, concomitant coronary revascularization, frailty stratified according to the Geriatric Status Scale, urgent procedure and estimated glomerular filtration rate were independent predictors of 30-day mortality. The estimated OBS AVR score showed higher discrimination (area under curve 0.76 vs 0.70, P CONCLUSIONS: The OBS AVR risk score showed high discrimination and calibration abilities in predicting 30-day mortality after surgical aortic valve replacement. The addition of a simplified frailty assessment into the model seems to contribute to an improved predictive ability over the EuroSCORE II. The OBS AVR risk score showed a significant association with long-term mortality.Peer reviewe

Comparison of 3 randomized clinical trials of frontline therapies for malignant pleural mesothelioma

Importance: Some recently proposed frontline therapies for malignant pleural mesothelioma (MPM) are very costly, yet their impact on quality of life and overall survival of these patients remains arguable. Given the high social toll of this aggressive occupational cancer, it is paramount to establish the real clinical benefit of these treatments. Objective: To directly compare and analyze the statistical robustness of the 3 randomized clinical trials (RCTs) of frontline therapies recommended for MPM since 2003. Design, Setting, and Participants: This comparative effectiveness study assessed the following phase 3 RCTs: the Mesothelioma Cisplatin Pemetrexed Study (MPS) of cisplatin plus pemetrexed vs cisplatin; the Mesothelioma Avastin Cisplatin Pemetrexed Study (MAPS) of cisplatin plus pemetrexed plus bevacizumab vs cisplatin plus pemetrexed; and the CheckMate743 (CM743) study of nivolumab plus ipilimumab vs cisplatin plus pemetrexed. Data collection dates for the RCTs ranged from April 1999 to April 2018. Data for this study were analyzed from February to October 2021. Main Outcomes and Measures: Patient selection criteria, superiority of the intervention groups, survival-inferred fragility index, and censoring patterns in each RCT. Results: A total of 1501 patients were included in the analysis (1170 men [77.9%]; range of median age for treatment groups, 60 [IQR, 19-84] to 69 [IQR, 65-75] years). A virtual comparison of overall survival in MAPS vs the CM743 study showed no statistically significant difference (hazard ratio [HR], 0.97 [95% CI, 0.79-1.20]; P = .79), and the survival-inferred fragility index in the intention-to-treat (ITT) populations was as low as 0.22% of the total sample size in MPS, −0.45% of the total sample size in MAPS, and 0.99% of the total sample size in the CM743 trial. Moreover, reverse restricted mean survival time (RMST) analysis of overall survival using RMST-difference (RMST-D) demonstrated differential censoring in the ITT population of the CM743 trial favoring the control group (0.56 [95% CI, 0.18-0.94]; P = .004) and in the nonepithelioid group (reverse RMST-D, 0.90 [95% CI, 0.001-1.79]; P = .048). Conclusions and Relevance: This comparative effectiveness study found no survival benefit in the CM743 trial over MAPS, despite the inclusion of patients with worse prognosis in the latter trial. Moreover, the statistical conclusions of all the examined trials were shown to be extremely fragile, and the findings of differential censoring in the CM743 trial and in the ITT nonepithelial subset raised additional areas of concern. These findings suggest that selection criteria, fragility, and censoring patterns may affect the original conclusions drawn for the respective trials, casting a shadow on the real benefit. This model of analysis lays a rigorous groundwork extendable to trials of all cancer treatments before their registration

Postero-medial approach procedure in the supine position for one-step anterior and posterior ankle arthroscopy.

Standard arthroscopy of the ankle does not allow to approach at the same time the anterior and posterior compartments. Keeping the patient supine and with the application of judicious traction, anterior ankle arthroscopy allows to examine the various intra-articular structures, but treat is limited only to anterior pathology. Also, it is not possible to explore posterior compartment and posterior hindfoot through an anterior approach. Normally, for those patients in whom both the anterior and posterior compartments were to be operated upon, surgery is stopped, and the patient has to be re-positioned. We describe a 2 postero-medial hindfoot portals procedure, which allows to reach both the posterior aspect of the ankle joint and the extra-articular compartment of the hindfoot keeping the patient supine throughout the procedure. After arthroscopy of the anterior compartment using standard anterior portals, 2 postero-medial endoscopic approaches make it possible to visualize and treat pathologies of the posterior ankle and of the hindfoot, without prolonging the operation through the need to reposition the patient in the prone position

Arthroscopic anterior talofibular ligament reconstructin in chronic ankle instability: Two years results

Purpose: In chronic lateral ankle instability, primary ligament repair is not always possible because of poor quality of the local tissues. A free autologous or allograft tendon graft or synthetic grafts are suitable alternative. We describe middle term results of arthroscopic reconstruction of the anterior talofibular ligament (ATFL) using a free autologous ipsilateral gracilis graft in patients with chronic ankle instability. Methods: Eleven patients with chronic lateral ankle instability with imaging evidence of isolated ATFL tear underwent arthroscopic reconstruction of the ATFL using a free ipsilateral gracilis graft. Functional and subjective assessment were performed after an average of 24 months following the index procedure. Results: At 24 months, all patients showed objective improvements. One patient reported transient dysaesthesiae on the dorsolateral aspect of the foot and heel. Conclusions: Arthroscopic isolated reconstruction of the ATFL with a free ipsilateral gracilis grafts is safe, allowing restoration of joint stability and low surgical morbidity. Study design: Case serie

Infections in hospital departments. What is hospital responsibility?

Infections in hospitals still have a high incidence and many of them could be avoided through better welfare standards. To try to overcome them, a strategy based on prevention is needed, but cleaning, disinfection and sterilization procedures are also a key tool. It is important to provide for all healthcare professionals a constant update and the creation of protocols that take into account the technical, scientific and economic aspects, but also specific operational needs, so that the proposed solutions can be applied in daily routines. The authors outline the mandatory duties to the doctors and hospital and underline the need to document in the clinical record the treatments performed. In case of infections occurred in hospital environment, the patient must demonstrate the guilty nature of the hospital's conduct, the existence of a harm and the causal connection. The hospital must demonstrate that asepsis measures were adopted according to the actual scientific knowledge and they must cover not only the treatment but also the diagnosis, all the activities prior to surgery and the postoperative phase. The sentences examined show that hospitals can avoid being accused of negligence and imprudence only if they can prove that they have implemented all prophylaxis measures contained in the guidelines and protocols. They must demonstrate that the infection was caused by an unforeseeable event. While some initiatives to improve the quality of hospital care have already allowed a decrease in the incidence and cost of these infections, much remains to be done.Infections in hospitals still have a high incidence and many of them could be avoided through better welfare standards. To try to overcome them, a strategy based on prevention is needed, but cleaning, disinfection and sterilization procedures are also a key tool. It is important to provide for all healthcare professionals a constant update and the creation of protocols that take into account the technical, scientific and economic aspects, but also specific operational needs, so that the proposed solutions can be applied in daily routines. The authors outline the mandatory duties to the doctors and hospital and underline the need to document in the clinical record the treatments performed. In case of infections occurred in hospital environment, the patient must demonstrate the guilty nature of the hospital's conduct, the existence of a harm and the causal connection. The hospital must demonstrate that asepsis measures were adopted according to the actual scientific knowledge and they must cover not only the treatment but also the diagnosis, all the activities prior to surgery and the postoperative phase. The sentences examined show that hospitals can avoid being accused of negligence and imprudence only if they can prove that they have implemented all prophylaxis measures contained in the guidelines and protocols. They must demonstrate that the infection was caused by an unforeseeable event. While some initiatives to improve the quality of hospital care have already allowed a decrease in the incidence and cost of these infections, much remains to be done

Relationship between hospital volumes and health outcomes: epidemiological evidence supporting the revision process of the Ministry of Health Decree no. 70 of 2 April 2015

Since its enactment on 2 April 2015, the Decree of the Ministry of Health no.70 has provided a key framework for the reorganization of services to enhance the quality and safety of care. This decree presents the volume thresholds for a series of nosological areas and diagnostic-therapeutic procedures, aiming to improve healthcare outcomes. These thresholds are expected to be periodically updated based on the most recent scientific developments. AIM: In this perspective, this work intends to establish whether statistical correlations exist between volumes of activity and outcomes of hospital care. The scope is limited to several clinical conditions and therapeutic procedures for which specific indicators are provided by the National Healthcare Outcomes Programme (Programma Nazionale Esiti - PNE). METHODS: For each condition or procedure, the analysis shows the volume-outcome relationship by hospital centre by means of the Levenberg-Marquardt algorithm (software: XLSTAT). The existence of breakpoints is assessed through the use of segmented models (software: "segmented" R-Package). RESULTS: The results show a statistical correlation for the following: acute myocardial infarction (breakpoint: 91 hospitalizations per year; 95% CI: 81-101; p<0.0001); repair of an unruptured abdominal aortic aneurysm (breakpoint: 69 procedures per year; 95% CI: 52-86; p=0.146); lung cancer (breakpoint: 96 procedures per year; 95% CI: 60-132; p<0.01); knee arthroplasty (breakpoint: 91 procedures per year; 95% CI: 51-131; p=0.484). Conversely, the statistical analysis did not allow to accurately highlight a breakpoint for the isolated aorto-coronary bypass, percutaneous transluminal coronary angioplasty and hip arthroplasty. CONCLUSIONS: These results represent a useful knowledge contribution to support the revision process of the above-mentioned Decree. As regards the procedures that may not be currently assessed through this statistical analysis method, literature data is referred to that confirm that the current regulatory thresholds are in the safe range