Volumetric Analysis: Effect on Diagnosis and Management of Indeterminate Solid Pulmonary Nodules in Routine Clinical Practice.

OBJECTIVE: To evaluate the effect of volumetric analysis on the diagnosis and management of indeterminate solid pulmonary nodules in routine clinical practice. METHODS: This was a retrospective study with 107 computed tomography (CT) cases of solid pulmonary nodules (range, 6-15 mm), 57 pathology-proven malignancies (lung cancer, n = 34; metastasis, n = 23), and 50 benign nodules. Nodules were evaluated on a total of 309 CT scans (average number of CTs/nodule, 2.9 [range, 2-7]). CT scans were from multiple institutions with variable technique. Nine radiologists (attendings, n = 3; fellows, n = 3; residents, n = 3) were asked their level of suspicion for malignancy (low/moderate or high) and management recommendation (no follow-up, CT follow-up, or care escalation) for baseline and follow-up studies first without and then with volumetric analysis data. Effect of volumetry on diagnosis and management was assessed by generalized linear and logistic regression models. RESULTS: Volumetric analysis improved sensitivity (P = 0.009) and allowed earlier recognition (P < 0.05) of malignant nodules. Attending radiologists showed higher sensitivity in recognition of malignant nodules (P = 0.03) and recommendation of care escalation (P < 0.001) compared with trainees. Volumetric analysis altered management of high suspicion nodules only in the fellow group (P = 0.008). κ Statistics for suspicion for malignancy and recommended management were fair to substantial (0.38-0.66) and fair to moderate (0.33-0.50). Volumetric analysis improved interobserver variability for identification of nodule malignancy from 0.52 to 0.66 (P = 0.004) only on the second follow-up study. CONCLUSIONS: Volumetric analysis of indeterminate solid pulmonary nodules in routine clinical practice can result in improved sensitivity and earlier identification of malignant nodules. The effect of volumetric analysis on management recommendations is variable and influenced by reader experience.

Obesity, organ failure, and transplantation: A review of the role of metabolic and bariatric surgery in transplant candidates and recipients.

Obesity is a risk factor for kidney, liver, heart, and pulmonary diseases, as well as failure. Solid organ transplantation remains the definitive treatment for the end-stage presentation of these diseases. Among many criteria for organ transplant, efficient management of obesity is required for patients to acquire transplant eligibility. End-stage organ failure and obesity are 2 complex pathologies that are often entwined. Metabolic and bariatric surgery before, during, or after organ transplant has been studied to determine the long-term effect of bariatric surgery on transplant outcomes. In this review, a multidisciplinary group of surgeons from the Society of American Gastrointestinal and Endoscopic Surgeons and the American Society for Transplant Surgery presents the current published literature on metabolic and bariatric surgery as a therapeutic option for patients with obesity awaiting solid organ transplantation. This manuscript details the most recent recommendations, pharmacologic considerations, and psychological considerations for this specific cohort of patients. Since level one evidence is not available on many of the topics covered by this review, expert opinion was implemented in several instances. Additional high-quality research in this area will allow for better recommendations and, therefore, treatment strategies for these complex patients.

Sustainability in surgical practice: a collaborative call toward environmental sustainability in operating rooms.

BACKGROUND: The healthcare system plays a pivotal role in environmental sustainability, and the operating room (OR) significantly contributes to its overall carbon footprint. In response to this critical challenge, leading medical societies, government bodies, regulatory agencies, and industry stakeholders are taking measures to address healthcare sustainability and its impact on climate change. Healthcare now represents almost 20% of the US national economy and 8.5% of US carbon emissions. Internationally, healthcare represents 5% of global carbon emissions. US Healthcare is an outlier in both per capita cost, and per capita greenhouse gas emission, with almost twice per capita emissions compared to every other country in the world. METHODS: The Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) and the European Association for Endoscopic Surgery (EAES) established the Sustainability in Surgical Practice joint task force in 2023. This collaborative effort aims to actively promote education, mitigation, and innovation, steering surgical practices toward a more sustainable future. RESULTS: Several key initiatives have included a survey of members' knowledge and awareness, a scoping review of terminology, metrics, and initiatives, and deep engagement of key stakeholders. DISCUSSION: This position paper serves as a Call to Action, proposing a series of actions to catalyze and accelerate the surgical sustainability leadership needed to respond effectively to climate change, and to lead the societal transformation towards health that our times demand.

Obesity, organ failure, and transplantation: a review of the role of metabolic and bariatric surgery in transplant candidates and recipients.

Obesity is a risk factor for kidney, liver, heart, and pulmonary diseases, as well as failure. Solid organ transplantation remains the definitive treatment for the end-stage presentation of these diseases. Among many criteria for organ transplant, efficient management of obesity is required for patients to acquire transplant eligibility. End-stage organ failure and obesity are 2 complex pathologies that are often entwined. Metabolic and bariatric surgery before, during, or after organ transplant has been studied to determine the long-term effect of bariatric surgery on transplant outcomes. In this review, a multidisciplinary group of surgeons from the Society of American Gastrointestinal and Endoscopic Surgeons and the American Society for Transplant Surgery presents the current published literature on metabolic and bariatric surgery as a therapeutic option for patients with obesity awaiting solid organ transplantation. This manuscript details the most recent recommendations, pharmacologic considerations, and psychological considerations for this specific cohort of patients. Since level one evidence is not available on many of the topics covered by this review, expert opinion was implemented in several instances. Additional high-quality research in this area will allow for better recommendations and, therefore, treatment strategies for these complex patients.

Erlotinib Plus Gemcitabine Compared With Gemcitabine Alone in Patients With Advanced Pancreatic Cancer: A Phase III Trial of the National Cancer Institute of Canada Clinical Trials Group.

PURPOSE: Patients with advanced pancreatic cancer have a poor prognosis and there have been no improvements in survival since the introduction of gemcitabine in 1996. Pancreatic tumors often overexpress human epidermal growth factor receptor type 1 (HER1/EGFR) and this is associated with a worse prognosis. We studied the effects of adding the HER1/EGFR-targeted agent erlotinib to gemcitabine in patients with unresectable, locally advanced, or metastatic pancreatic cancer. PATIENTS AND METHODS: Patients were randomly assigned 1:1 to receive standard gemcitabine plus erlotinib (100 or 150 mg/d orally) or gemcitabine plus placebo in a double-blind, international phase III trial. The primary end point was overall survival. RESULTS: A total of 569 patients were randomly assigned. Overall survival based on an intent-to-treat analysis was significantly prolonged on the erlotinib/gemcitabine arm with a hazard ratio (HR) of 0.82 (95% CI, 0.69 to 0.99; P = .038, adjusted for stratification factors; median 6.24 months v 5.91 months). One-year survival was also greater with erlotinib plus gemcitabine (23% v 17%; P = .023). Progression-free survival was significantly longer with erlotinib plus gemcitabine with an estimated HR of 0.77 (95% CI, 0.64 to 0.92; P = .004). Objective response rates were not significantly different between the arms, although more patients on erlotinib had disease stabilization. There was a higher incidence of some adverse events with erlotinib plus gemcitabine, but most were grade 1 or 2. CONCLUSION: To our knowledge, this randomized phase III trial is the first to demonstrate statistically significantly improved survival in advanced pancreatic cancer by adding any agent to gemcitabine. The recommended dose of erlotinib with gemcitabine for this indication is 100 mg/d.

FDA Public Workshop Summary-Addressing Challenges in Inhaled Antifungal Drug Development.

Allergic bronchopulmonary aspergillosis and invasive fungal diseases represent distinct infectious entities that cause significant morbidity and mortality. Currently, administered inhaled antifungal therapies are unapproved, have suboptimal efficacy, and are associated with considerable adverse reactions. The emergence of resistant pathogens is also a growing concern. Inhaled antifungal development programs are challenged by inadequate nonclinical infection models, highly heterogenous patient populations, low prevalence rates of fungal diseases, difficulties defining clinical trial enrollment criteria, and lack of robust clinical trial endpoints. On September 25, 2020, the US Food and Drug Administration (FDA) convened a workshop with experts in pulmonary medicine and infectious diseases from academia, industry, and other governmental agencies. Key discussion topics included regulatory incentives to facilitate development of inhaled antifungal drugs and combination inhalational devices, limitations of existing nonclinical models and clinical trial designs, patient perspectives, and industry insights.

Years of Life Lost to Firearm Suicide Among Young People in the US.

This cross-sectional study examines years of life lost among the top 3 causes of death and compares firearm suicide with other methods of suicide among individuals aged 10 to 24 years in the US.

Use of GLP-1 agonists in high risk patients prior to bariatric surgery: a cohort study.

INTRODUCTION: Body mass index (BMI) > 50 kg/m2 is associated with relatively increased morbidity and mortality with bariatric surgery (BS). There is reluctance to consider these patients operative candidates without preoperative weight loss. Glucagon-like peptide-1 (GLP-1) agonists have demonstrated effective weight loss in the post-BS setting. This study aims to determine the safety and efficacy of GLP-1 agonists in the pre-habilitation of patients with BMI > 50 kg/m2. METHODS: This is a retrospective review of bariatric surgery patients with BMI > 50 kg/m2 from a single bariatric center. Patients were compared by preoperative GLP-1 therapy status. All patients received medical, surgical, psychiatric, and nutritional evaluation and counseling. Preoperative BMI, change in weight from program intake until surgery, time to surgery, and perioperative complications were evaluated. RESULTS: 31 patients were included in the analysis. 18 (58%) received a GLP-1 agonist preoperatively. GLP-1 agonist use was associated with a 5.5 ± 3.2-point reduction in BMI compared to 2.9 ± 2.4 amongst controls (p = 0.026). There was no difference in the mean length of time in the bariatric program prior to surgery between groups (p = 0.332). There were no reported complications related to GLP-1 use in the preoperative setting and no difference in perioperative complications between groups (p = 0.245). DISCUSSION: GLP-1 agonist use in patients with a BMI > 50 kg/m2 results in significantly more weight loss prior to bariatric surgery, without increased time to surgery or complication rate. Further study is required to evaluate the long-term impact of preoperative GLP-1 agonist use prior to bariatric surgery. This therapy may improve perioperative and long-term outcomes in the very high-risk BMI population.

National usage of bariatric surgery for class I obesity: an analysis of the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program.

BACKGROUND: National and international consensus statements, as well as the National Institutes of Health (NIH), support the use of bariatric surgery for the treatment of class I obesity. Despite this, most payors within the United States limit reimbursement to the outdated 1991 NIH guidelines or a similar adaptation. OBJECTIVES: This study aimed to determine the safety of bariatric surgery in patients with lower BMI compared with standard patients, as well as determine U.S. utilization of bariatric surgery in class I obesity in 2015-2019. SETTING: A retrospective analysis was performed of the 2015-2019 Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP) database. METHODS: Laparoscopic sleeve gastrectomy and laparoscopic Roux-en-Y gastric bypass patients were divided into body mass index cohorts: class I obesity (<35 kg/m2) and severe obesity (≥35 kg/m2). Differences in preoperative patient selection and postoperative outcomes were established, and frequency trends were delineated. RESULTS: Analysis included 760,192 surgeries with 8129 (1%) for patients with class I obesity. The patients with class I obesity were older, more commonly female, and with lower American Society of Anesthesiologists (ASA) class, but with higher rates of type 2 diabetes, hyperlipidemia, and gastroesophageal reflux disease (P < .05). Variation was found for operative time, length of stay, 30-day readmission, and composite morbidity. Minimal annual variation was found for bariatric surgeries performed for patients with class I obesity. CONCLUSIONS: The short-term safety of bariatric surgery in patients with class I obesity was corroborated by this study. Despite consensus statements and robust support, rates of bariatric surgery in patients with class I obesity have failed to increase and remain limited to 1%. This demonstrates the impact of the outdated 1991 NIH guidelines regarding access to care for these potentially life-saving surgeries.

Putting Medical Boots on the Ground: Lessons from the War in Ukraine and Applications for Future Conflict with Near-Peer Adversaries.

In the past 20 years of the Global War on Terror, the US has seen substantial improvements in its system of medical delivery in combat. However, throughout that conflict, enemy forces did not have parity with the weaponry, capability, or personnel of the US and allied forces. War against countries like China and Russia, who are considered near-peer adversaries in terms of capabilities, will challenge battlefield medical care in many different ways. This article reviews the experience of a medical team, Global Surgical and Medical Support Group, that has been providing assistance, training, medical support, and surgical support to Ukraine since the Russian invasion began in February 2022. The team has extensive experience in medicine, surgery, austere environments, conflict zones, and building partner nation capacities. This article compares and contrasts the healthcare systems of this war against the systems used during the Global War on Terror. The lessons learned here could help the US anticipate challenges and successfully plan for the provision of medical care in a future conflict against an adversary with capabilities close to its own.

Why the military committee is important to SAGES?

BACKGROUND: SAGES established a military committee in 2009 and since that time. It may not be readily clear why a traditionally laparoscopic and endoscopic surgical society should have a military committee whose members' primary mission is combat surgery. Military surgeons have a second mission, though, which is to provide care for all its beneficiaries in all the surgical subspecialties. They also have a third mission, which is to train the next generation of military surgeons. The aim of this paper is to discuss the relationship with SAGES that enables the military to succeed in these missions and the benefits it provides to SAGES. METHODS: A historical review of the military committee and its activities since its inception in 2009. RESULTS: Through SAGES, military surgeons have a cost-effective means of developing professionally and receiving education in surgical areas outside of the battlefield arena, which the DOD does not provide. For 13 years, SAGES has also provided an academic venue for research in these specialties. With the addition of military members, SAGES can access more surgeons and surgical innovation like surgery in space and worldwide telemedicine. The military committee also gives SAGES an opportunity to directly contribute to the care of military service members, retirees, and VA beneficiaries, which benefits the United States as a whole. CONCLUSIONS: SAGES and the military have enjoyed a mutually beneficial relationship. The contributions of SAGES have undoubtedly saved and improved US service member and beneficiary lives. It has also improved the education and academic advancements of the military surgeons. SAGES also reaches more surgeons and has another platform for surgical innovation. The relationship should continue and be allowed to grow.

Effect of obesity on outcomes after breast reconstruction surgery, an analysis of national surgical quality improvement program.

BACKGROUND: Obesity is a risk factor for breast cancer and may affect the incidence, and outcomes of surgical treatment for breast cancer, including breast reconstruction. OBJECTIVE: This study aimed to evaluate outcomes of breast reconstruction in patients with obesity. METHODS: In a retrospective review of the NSQIP 2013-2018, adult patients who underwent breast reconstruction were included. Procedures were categorized to with or without an implant. Obesity was considered as body mass index(BMI)≥30 kg/m2. We made composite variables for 30-day any complication, wound complications, and major complications. Regression analysis was used to identify the independent effect of obesity on outcomes. RESULTS: A total of 46,042 patients were included(mean age 51.4 ± 11.1 years, 99.8% female). There were 3134(6.8%) patients with any complication, 2429(5.3%) with major, and 2772(6%) with wound complications, 2795 patients(6.1%) with unplanned re-operation, and 3 deaths. Obesity was an independent predictor of any complication, major complications, and wound complications(OR:1.83-1.87), and unplanned re-operation(OR:1.52). Wound complication was lower in the implant group(3.7% vs 10.9%) but obesity had a higher odds of wound complications in the implant group(2 vs 1.4). There was an increase in the odds of complications as BMI rises. CONCLUSION: Patients with a BMI>30 kg/m2 have a significantly higher risk of developing surgical complications following breast reconstruction with both implant and tissue reconstruction. Weight loss strategies should be considered in patients who need breast reconstruction surgeries and this may decrease the risk of postoperative wound complication and the need for reoperation.

SAGES 2022 guidelines regarding the use of laparoscopy in the era of COVID-19.

BACKGROUND: SARS-CoV-2 has changed global healthcare since the pandemic began in 2020. The safety of minimally invasive surgery (MIS) utilizing insufflation from the standpoint of safety to the operating room personnel is currently being explored. The aims of this guideline are to examine the existing evidence to provide guidance regarding MIS for the patient with, or suspecting of having, the SARS-CoV-2 as well as the healthcare team involved. METHODS: Systematic literature reviews were conducted for 2 key questions (KQ) regarding the safety of MIS in the setting of COVID-19 pandemic. Reporting followed the Preferred Reporting Items for Systematic Reviews and Meta-Analysis criteria. Evidence-based recommendations were formulated using a narrative synthesis of the literature by subject experts. Recommendations for future research were also proposed. RESULTS: In KQ1, a total of 1361 articles were reviewed, with 2 articles meeting inclusion. In KQ2, a total of 977 articles were reviewed, with 4 articles met inclusions criteria, of which 2 studies reported on the SARS-CoV2 virus specifically. Despite many publications in the field, very little well-controlled and unbiased data exist to inform the recommendations. Of that which is available, it shows that both laparoscopic and open operations in Covid-positive patients had similar rates of OR staff positivity rates; however, patients who underwent laparoscopic procedures had a lower perioperative mortality than open procedures. Also, SARS-CoV-2 particles have been detected in the surgical plume at laparoscopy. CONCLUSION: With demonstrated equivalence of operating room staff exposure, and noninferiority of laparoscopic access with respect to mortality, either laparoscopic or open approaches to abdominal operations may be used in patients with SARS-CoV-2. Measures should be employed for all laparoscopic or open cases to prevent exposure of operating room staff to the surgical plume, as virus can be present in this plume.

Expanding Approved Patient Populations for Rare Disease Treatment Using In Vitro Data.

In vitro cell-based data can be used to support the extension of pharmaceutical approval to patient subsets with unique genetic variants. A set of conditions should be satisfied to support the extension of approval. The disease mechanism should be well described, and the impact of variants on protein function should be reasonably understood. The incidence data should show that clinical trials for the variants in question are not practical. The overall safety and efficacy of the drug should be clear in adequate and well-controlled clinical trials. The clinical trial should include patients found to be responders and nonresponders so that both positive and negative predictive power of the in vitro assay may be measured. The mechanism of action of the drug should be clearly defined and should be consistent with the disease mechanism. The assay system should be qualified, including the following points: (i) each variant construct should be confirmed by bidirectional sequencing; (ii) the in vitro assay should directly measure the variant protein function in comparison with the reference protein; (iii) the assay should be formally validated to the extent possible, clearly demonstrating precision, reproducibility, and sensitivity used to support the efficacy claim; and (iv) the primary data should be available for inspection and analytical validation. The overall goal is a robust and validated cell-based system that can be shown to predict the outcome of targeted therapy.

Guidelines for the performance of minimally invasive splenectomy.

BACKGROUND: Minimally invasive splenectomy (MIS) is increasingly favored for the treatment of benign and malignant diseases of the spleen over open access approaches. While many studies cite the superiority of MIS in terms of decreased morbidity and length of stay over a traditional open approach, the comparative effectiveness of specific technical and peri-operative approaches to MIS is unclear. OBJECTIVE: To develop evidence-based guidelines that support clinicians, patients, and others in decisions on the peri-operative performance of MIS. METHODS: A guidelines committee panel of the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) including methodologists used the Grading of Recommendations Assessment, Development and Evaluation approach to grade the certainty of evidence and formulate recommendations. RESULTS: Informed by a systematic review of the evidence, the panel agreed on eight recommendations for the peri-operative performance of MIS for adults and children in elective situations addressing six key questions. CONCLUSIONS: Conditional recommendations were made in favor of lateral positioning for non-hematologic disease, intra-operative platelet administration for patients with idiopathic thrombocytopenic purpura instead of preoperative administration, and the use of mechanical devices to control the splenic hilum. Further, a conditional recommendation was made against routine intra-operative drain placement.

Laparoscopic splenectomy as a definitive management option for high-grade traumatic splenic injury when non operative management is not feasible or failed: a 5-year experience from a level one trauma center with minimally invasive surgery expertise.

Technique, indications and outcomes of laparoscopic splenectomy in stable trauma patients have not been well described yet. All hemodynamically non-compromised abdominal trauma patients who underwent splenectomy from 1/2013 to 12/2017 at our Level 1 trauma center were included. Demographic and clinical data were collected and analysed with per-protocol and an intention-to-treat comparison between open vs laparoscopic groups. 49 splenectomies were performed (16 laparoscopic, 33 open). Among the laparoscopic group, 81% were successfully completed laparoscopically. Laparoscopy was associated with a higher incidence of concomitant surgical procedures (p 0.016), longer operative times, but a significantly faster return of bowel function and oral diet without reoperations. No significant differences were demonstrated in morbidity, mortality, length of stay, or long-term complications, although laparoscopic had lower surgical site infection (0 vs 21%).The isolated splenic injury sub-analysis included 25 splenectomies,76% (19) open and 24% (6) laparoscopic and confirmed reduction in post-operative morbidity (40 vs 57%), blood transfusion (0 vs 48%), ICU admission (20 vs 57%) and overall LOS (7 vs 9 days) in the laparoscopic group. Laparoscopic splenectomy is a safe and effective technique for hemodynamically stable patients with splenic trauma and may represent an advantageous alternative to open splenectomy in terms of post-operative recovery and morbidity.

Canadian Society of Thoracic Radiology/Canadian Association of Radiologists Clinical Practice Guidance for Non-Vascular Thoracic MRI.

Historically thoracic MRI has been limited by the lower proton density of lung parenchyma, cardiac and respiratory motion artifacts and long acquisition times. Recent technological advancements in MR hardware systems and improvement in MR pulse sequences have helped overcome these limitations and expand clinical opportunities for non-vascular thoracic MRI. Non-vascular thoracic MRI has been established as a problem-solving imaging modality for characterization of thymic, mediastinal, pleural chest wall and superior sulcus tumors and for detection of endometriosis. It is increasingly recognized as a powerful imaging tool for detection and characterization of lung nodules and for assessment of lung cancer staging. The lack of ionizing radiation makes thoracic MRI an invaluable imaging modality for young patients, pregnancy and for frequent serial follow-up imaging. Lack of familiarity and exposure to non-vascular thoracic MRI and lack of consistency in existing MRI protocols have called for clinical practice guidance. The purpose of this guide, which was developed by the Canadian Society of Thoracic Radiology and endorsed by the Canadian Association of Radiologists, is to familiarize radiologists, other interested clinicians and MR technologists with common and less common clinical indications for non-vascular thoracic MRI, discuss the fundamental imaging findings and focus on basic and more advanced MRI sequences tailored to specific clinical questions.