Mortality Rate in Breast Implant Surgery: Is an Additional Procedure Worthwhile to Mitigate BIA-ALCL Risk?

BACKGROUND: Because of poor knowledge of risks and benefits, prophylactic explantation of high BIA-ALCL risk breast implant (BI) is not indicated. Several surgical risks have been associated with BI surgery, with mortality being the most frightening. Primary aim of this study is to assess mortality rate in patients undergoing breast implant surgery for aesthetic or reconstructive indication. MATERIALS AND METHODS: In this retrospective observational cohort study, Breast Implant Surgery Mortality rate (BISM) was calculated as the perioperative mortality rate among 99,690 patients who underwent BI surgery for oncologic and non-oncologic indications. Mean age at first implant placement (A1P), implant lifespan (IL), and women's life expectancy (WLE) were obtained from a literature review and population database. RESULTS: BISM rate was 0, and mean A1P was 34 years for breast augmentation, and 50 years for breast reconstruction. Regardless of indication, overall mean A1P can be presumed to be 39 years, while mean BIL was estimated as 9 years and WLE as 85 years. CONCLUSION: This study first showed that the BISM risk is 0. This information, and the knowledge that BI patients will undergo one or more revisional procedures if not explantation during their lifetime, may help surgeons in the decision-making process of a pre-emptive substitution or explant in patients at high risk of BIA-ALCL. Our recommendation is that patients with existing macrotextured implants do have a relative indication for explantation and total capsulectomy. The final decision should be shared between patient and surgeon following an evaluation of benefits, surgical risks and comorbidities. LEVEL OF EVIDENCE IV: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

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.

[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.] / Relazione tra volumi di attività ed esiti dell'assistenza ospedaliera: evidenze epidemiologiche a supporto del processo di revisione del Decreto del Ministero della Salute n. 70 del 2 aprile 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.

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 < 0.001) and calibration (Hosmer-Lemeshow P = 0.847 vs P = 0.130) than the EuroSCORE II. The higher performances of the OBS AVR score were confirmed by the decision curve, net reclassification index (0.46, P = 0.011) and integrated discrimination improvement (0.02, P < 0.001) analyses. Five-year mortality increased significantly along increasing deciles of the OBS AVR score (P < 0.001). 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.