Anatomic Lung Resection Outcomes After Implementation of a Universal Thoracic ERAS Protocol Across a Diverse Health Care System.

OBJECTIVE: We sought to evaluate how implementing a thoracic enhanced recovery after surgery (ERAS) protocol impacted surgical outcomes after elective anatomic lung resection. BACKGROUND: The effect of implementing the ERAS Society/European Society of Thoracic Surgery thoracic ERAS protocol on postoperative outcomes throughout an entire health care system has not yet been reported. METHODS: This was a prospective cohort study within one health care system (January 2019-March, 2023). A thoracic ERAS protocol was implemented on May 1, 2021 for elective anatomic lung resections, and postoperative outcomes were tracked using the electronic health record and Vizient data. The primary outcome was overall morbidity; secondary outcomes included individual complications, length of stay, opioid use, chest tube duration, and total cost. Patients were grouped into pre-ERAS and post-ERAS cohorts. Bivariable comparisons were performed using independent t -test, χ 2 , or Fisher exact tests, and multivariable logistic regression was performed to control for confounders. RESULTS: There were 1007 patients in the cohort; 450 (44.7%) were in the post-ERAS group. Mean age was 66.2 years; most patients were female (65.1%), white (83.8%), had a body mass index between 18.5 and 29.9 (69.7%), and were ASA class 3 (80.6%). Patients in the postimplementation group had lower risk-adjusted rates of any morbidity, respiratory complication, pneumonia, surgical site infection, arrhythmias, infections, opioid usage, ICU use, and shorter postoperative length of stay (all P <0.05). CONCLUSIONS: Postoperative outcomes were improved after the implementation of an evidence-based thoracic ERAS protocol throughout the health care system. This study validates the ERAS Society/European Society of Thoracic Surgery guidelines and demonstrates that simultaneous multihospital implementation can be feasible and effective.

The Effect of Laparoscopic Gastric Ischemic Preconditioning Prior to Esophagectomy on Anastomotic Stricture Rate and Comparison with Esophagectomy-Alone Controls.

BACKGROUND: Benign anastomotic stricture is a recognized complication following esophagectomy. Laparoscopic gastric ischemic preconditioning (LGIP) prior to esophagectomy has been associated with decreased anastomotic leak rates; however, its effect on stricture and the need for subsequent endoscopic intervention is not well studied. METHODS: This was a case-control study at an academic medical center using consecutive patients undergoing oncologic esophagectomies (July 2012-July 2022). Our institution initiated an LGIP protocol on 1 January 2021. The primary outcome was the occurrence of stricture within 1 year of esophagectomy, while secondary outcomes were stricture severity and frequency of interventions within the 6 months following stricture. Bivariable comparisons were performed using Chi-square, Fisher's exact, or Mann-Whitney U tests. Multivariable regression controlling for confounders was performed to generate risk-adjust odds ratios and to identify the independent effect of LGIP. RESULTS: Of 253 esophagectomies, 42 (16.6%) underwent LGIP prior to esophagectomy. There were 45 (17.7%) anastomotic strictures requiring endoscopic intervention, including three patients who underwent LGIP and 42 who did not. Median time to stricture was 144 days. Those who underwent LGIP were significantly less likely to develop anastomotic stricture (7.1% vs. 19.9%; p = 0.048). After controlling for confounders, this difference was no longer significant (odds ratio 0.46, 95% confidence interval 0.14-1.82; p = 0.29). Of those who developed stricture, there was a trend toward less severe strictures and decreased need for endoscopic dilation in the LGIP group (all p < 0.20). CONCLUSION: LGIP may reduce the rate and severity of symptomatic anastomotic stricture following esophagectomy. A multi-institutional trial evaluating the effect of LGIP on stricture and other anastomotic complications is warranted.

Prospective Evaluation of a Universally Applied Laparoscopic Gastric Ischemic Preconditioning Protocol Prior to Esophagectomy with Comparison with Historical Controls.

BACKGROUND: Anastomotic leak after esophagectomy is associated with significant morbidity and mortality. Our institution began performing laparoscopic gastric ischemic preconditioning (LGIP) with ligation of the left gastric and short gastric vessels prior to esophagectomy in all patients presenting with resectable esophageal cancer. We hypothesized that LGIP may decrease the incidence and severity of anastomotic leak. METHODS: Patients were prospectively evaluated following the universal application of LGIP prior to esophagectomy protocol in January 2021 until August 2022. Outcomes were compared with patients who underwent esophagectomy without LGIP from a prospectively maintained database from 2010 to 2020. RESULTS: We compared 42 patients who underwent LGIP followed by esophagectomy with 222 who underwent esophagectomy without LGIP. Age, sex, comorbidities, and clinical stage were similar between groups. Outpatient LGIP was generally well tolerated, with one patient experiencing prolonged gastroparesis. Median time from LGIP to esophagectomy was 31 days. Mean operative time and blood loss were not significantly different between groups. Patients who underwent LGIP were significantly less likely to develop an anastomotic leak following esophagectomy (7.1% vs. 20.7%, p = 0.038). This finding persisted on multivariate analysis [odds ratio (OR) 0.17, 95% confidence interval (CI) 0.03-0.42, p = 0.029]. The occurrence of any post-esophagectomy complication was similar between groups (40.5% vs. 46.0%, p = 0.514), but patients who underwent LGIP had shorter length of stay [10 (9-11) vs. 12 (9-15), p = 0.020]. CONCLUSIONS: LGIP prior to esophagectomy is associated with a decreased risk of anastomotic leak and length of hospital stay. Further, multi-institutional studies are warranted to confirm these findings.

Retrospective Evaluation of Splenic Artery Embolization Outcomes in the Management of Blunt Splenic Trauma: A Single Centre Experience at a Large Level 1 Trauma Centre.

PURPOSE: Retrospective review of splenic artery embolization (SAE) outcomes performed for blunt abdominal trauma. MATERIALS AND METHODS: 11-year retrospective review at a large level-1 Canadian trauma centre. All patients who underwent SAE after blunt trauma were included. Technical success was defined as angiographic occlusion of the target vessel and clinical success was defined as successful non-operative management and splenic salvage on follow-up. RESULTS: 138 patients were included of which 68.1% were male. The median age was 47 years (interquartile range (IQR) = 32.5 years). The most common mechanisms of injury were motor vehicle accidents (37.0%), mechanical falls (25.4%), and pedestrians hit by motor vehicles (10.9%). 70.3% of patients had American Association for the Surgery of Trauma (AAST) grade 4 injuries. Patients were treated with proximal SAE (n = 97), distal SAE (n = 23) or combined SAE (n = 18), and 68% were embolized with an Amplatzer plug. No significant differences were observed across all measures of hospitalization (Length of hospital stay: x2(2) = .358, P = .836; intensive care unit (ICU) stay: x2(2) = .390, P = .823; ICU stay post-procedure: x2(2) = 1.048, P = .592). Technical success and splenic salvage were achieved in 100% and 97.8% of patients, respectively. 7 patients (5%) had post-embolization complications and 7 patients (5%) died during hospital admission, but death was secondary to other injuries sustained in the trauma rather than complications related to splenic injury or its management. CONCLUSION: We report that SAE as an adjunct to non-operative management of blunt splenic trauma can be performed safely and effectively with a high rate of clinical success.

Is IQWiG's 15% Threshold Universally Applicable in Assessing the Clinical Relevance of Patient-Reported Outcomes Changes? An ISPOR Special Interest Group Report.

This article discusses a recent methodological change to assess the additional benefit of drug intervention by the German Federal Joint Committee (Gemeinsamer Bundesausschuss), a key stakeholder in EUnetHTA21 (European Network for Health Technology Assessment joint consortium for future EU HTA regulation), methodological workstream. The German Federal Joint Committee (Gemeinsamer Bundesausschuss) set a universal individual response threshold at ≥ 15% of the scale range of the measurement instrument, for all patient-reported outcomes, to achieve an additional benefit rating for a given pharmaceutical intervention. This approach is originally based on a corresponding recommendation from the Institute for Quality and Efficiency in Health Care. The merits of this approach are reviewed from various perspectives, including the evidence basis, statistical and psychometric considerations, and regulatory perspectives by the ISPOR Clinical Outcomes Assessment Special Interest Group's multistakeholder group of authors (academia, contract research organizations, and industry). Particular focus is placed on the patient perspective within the Institute for Quality and Efficiency in Health Care approach. The article development incorporated feedback from ISPOR members during well-attended ISPOR US and European conference presentations and 2 formal rounds of written review. The authors concluded that the ≥ 15% response threshold is incongruent with previously defined and scientifically established thresholds and is not well-suited for universal implementation. Further scientific evidence and discussion among all stakeholders are needed, especially should this universal rule be considered in the context of future joint clinical assessments of health technologies in the European Union scheduled from 2025 onward.

Factors Affecting Cuff Extrusion of Tunneled Hemodialysis Catheters.

PURPOSE: To identify patient and procedural factors associated with extrusion of the Dacron cuff from the subcutaneous tunnel of tunneled hemodialysis catheters (THDCs). MATERIALS AND METHODS: Single center 5-year retrospective analysis of 625 catheters in 293 adult patients. Patient data included age, gender, body mass index (BMI), and common comorbidities. Procedural details included type of procedure (new insertion vs. exchange), operator seniority, side of insertion, catheter model and presence of catheter wings skin-sutures. Complications were reported as cumulative risk over time and Cox proportional hazards model was used to evaluate risk factors for cuff extrusion (CE). RESULTS: Median patient follow-up was 503 days (188,913 catheter-days) and median catheter survival 163 days. CE occurred in 23.8% of catheters, at a rate of 0.79 per 1,000 catheter-days and a median time of 64 days. It was more common than infection (14.6%) and inadequate flow (15.5%). The 1-month and 12-month risk of CE was 5.9% and 21.3% respectively. A first episode of CE was a strong predictor of future CE episodes. The only patient factor that affected the risk of CE was BMI (Hazard Ratio 2.36 for obese patients). Procedural factors that affected the risk of CE, adjusted for BMI, were catheter model, type of procedure (lower risk for new insertions) and catheter wings skin-sutures; the latter reduced the 30-day CE risk by 76% without increasing catheter-related infections. CONCLUSION: Cuff extrusion is common in long-term THDCs. The risk increases with obesity, history of previous cuff extrusion, certain catheter models and absence of wing-sutures.

Enhanced Recovery After Surgery Protocol Minimizes Intensive Care Unit Utilization and Improves Outcomes Following Pulmonary Resection.

BACKGROUND: Enhanced recovery after surgery (ERAS) protocols have been associated with improved postoperative outcomes but require further validation in thoracic surgery. This study evaluated outcomes of patients undergoing pulmonary resection before and after implementation of an ERAS protocol. METHODS: Electronic medical records were queried for all patients undergoing pulmonary resection between April 2017 and April 2019. Patients were grouped into pre- and post-ERAS cohorts based on dates of operation. The ERAS protocol prioritized early mobilization, limited invasive monitoring, euvolemia, and non-narcotic analgesia. Primary outcome measures included intensive care unit (ICU) utilization, postoperative pain metrics, and perioperative morbidity. Regression analyses were performed to identify predictors of morbidity. Subgroup analyses were performed by pulmonary risk profile and surgical approach. RESULTS: A total of 64 pre- and 67 post-ERAS patients were included in the study. ERAS implementation was associated with reduced postoperative ICU admission (pre: 65.6% vs. post: 19.4%, p < 0.0001), shorter ICU median length of stay (LOS) (pre: 1 vs. post: 0, p < 0.0001), and decreased opioid usage measured by median morphine milligram equivalents (pre: 40.5 vs. post: 20.0, p < 0.0001). Post-ERAS patients also reported lower visual analog scale (VAS) pain scores on postoperative days (POD) 1 and 2 (pre: 6.3/5.6 vs. post: 5.3/4.2, p = 0.04/0.01) as well as average VAS pain score over POD0-2 (pre: 6.2 vs. post: 5.2, p = 0.005). CONCLUSIONS: Implementation of an ERAS protocol for pulmonary resection, which dictated reduced ICU admissions, did not increase major postoperative morbidity. Additionally, ERAS-enrolled patients reported improved postoperative pain control despite decreased opioid utilization.

Sequence of biologic therapies and surgery affects survival in non-small cell lung cancer.

BACKGROUND AND OBJECTIVES: Biologic therapy is changing the landscape of lung cancer treatment. The objectives of this study were to compare overall survival (OS) between patients with non-small cell lung cancer (NSCLC) undergoing neoadjuvant and adjuvant biologic therapy in combination with surgery and to evaluate the impact of chemotherapy on survival after combination biologic therapy and surgery. METHODS: The National Cancer Database was queried for cases of NSCLC from 2004 to 2016. Patient treatment was categorized into neoadjuvant and adjuvant biologic therapy in combination with surgery. Kaplan-Meier curves were generated to compare OS between treatment groups and between those who did and did not also undergo chemotherapy. Cox regression was used to identify factors predictive of OS. RESULTS: Six hundred seventy-three patients underwent both biologic therapy and surgery. The unadjusted overall 5-year OS was longer for patients undergoing neoadjuvant biologic therapy than for those undergoing adjuvant biologic therapy (P = .006), with OS being 56.2% and 33.0%, respectively. When comparing OS between those who did and did not undergo additional chemotherapy, no difference was observed. CONCLUSIONS: Neoadjuvant biologic therapy was associated with longer OS than adjuvant biologic therapy. Chemotherapy did not have an effect on OS when combined with biologic therapy and surgery.

Radiofrequency Ablation for the Palliative Treatment of Bone Metastases: Outcomes from the Multicenter OsteoCool Tumor Ablation Post-Market Study (OPuS One Study) in 100 Patients.

PURPOSE: To evaluate the effectiveness of radiofrequency (RF) ablation as measured by change in worst pain score from baseline to 3 mo after RF ablation for the palliative treatment of painful bone metastases. MATERIALS AND METHODS: One hundred patients (mean age, 64.6 y) underwent RF ablation for metastatic bone disease and were followed up to 6 mo. Subjects' pain and quality of life were measured before RF ablation and postoperatively by using the Brief Pain Index and European Quality of Life questionnaires. Opioid agent use and device-, procedure-, and/or therapy-related adverse events (AEs) were collected. RESULTS: Eighty-seven patients were treated for tumors involving the thoracolumbar spine and 13 for tumors located in the pelvis and/or sacrum. All ablations were technically successful, and 97% were followed by cementoplasty. Mean worst pain score decreased from 8.2 ± 1.7 at baseline to 3.5 ± 3.2 at 6 mo (n = 22; P < 0.0001 for all visits). Subjects experienced significant improvement for all visits in average pain (P < .0001), pain interference (P < .0001), and quality of life (P < .003). Four AEs were reported, of which 2 resulted in hospitalization for pneumonia and respiratory failure. All 30 deaths reported during the study were attributed to the underlying malignancy and not related to the study procedure. CONCLUSIONS: Results from this study show rapid (within 3 d) and statistically significant pain improvement with sustained long-term relief through 6 mo in patients treated with RF ablation for metastatic bone disease.

Health Preference Research in Europe: A Review of Its Use in Marketing Authorization, Reimbursement, and Pricing Decisions-Report of the ISPOR Stated Preference Research Special Interest Group.

OBJECTIVE: This study examines European decision makers' consideration and use of quantitative preference data. METHODS: The study reviewed quantitative preference data usage in 31 European countries to support marketing authorization, reimbursement, or pricing decisions. Use was defined as: agency guidance on preference data use, sponsor submission of preference data, or decision-maker collection of preference data. The data could be collected from any stakeholder using any method that generated quantitative estimates of preferences. Data were collected through: (1) documentary evidence identified through a literature and regulatory websites review, and via key opinion leader outreach; and (2) a survey of staff working for agencies that support or make healthcare technology decisions. RESULTS: Preference data utilization was identified in 22 countries and at a European level. The most prevalent use (19 countries) was citizen preferences, collected using time-trade off or standard gamble methods to inform health state utility estimation. Preference data was also used to: (1) value other impact on patients, (2) incorporate non-health factors into reimbursement decisions, and (3) estimate opportunity cost. Pilot projects were identified (6 countries and at a European level), with a focus on multi-criteria decision analysis methods and choice-based methods to elicit patient preferences. CONCLUSION: While quantitative preference data support reimbursement and pricing decisions in most European countries, there was no utilization evidence in European-level marketing authorization decisions. While there are commonalities, a diversity of usage was identified between jurisdictions. Pilots suggest the potential for greater use of preference data, and for alignment between decision makers.

Food Refusal Secondary to Psychosis: A Case Series and Literature Review.

The aim of this article is to emphasize that starvation is an important potential consequence of psychosis and to provide recommendations for management of this condition. A review of the literature on food refusal and starvation in patients with psychotic illnesses was performed. Our search strategy returned 54 articles with one article meeting inclusion criteria. Additional independent research returned an additional four cases of patients with psychosis engaging in self-starvation. The cases of several patients from our institution who engaged in self-starvation behaviors as a result of psychosis are also presented. The management and outcomes of each of these 10 patients are discussed. Starvation secondary to psychosis is an important but underappreciated consequence of psychosis that can lead to serious adverse outcomes in these patients. Few cases have been reported in the literature. More study is warranted to develop evidence-based management guidelines.

Medical Nutrition Terminology and Regulations in the United States and Europe-A Scoping Review: Report of the ISPOR Nutrition Economics Special Interest Group.

BACKGROUND: The term medical nutrition (MN) refers to nutritional products used under medical supervision to manage disease- or condition-related dietary needs. Standardized MN definitions, aligned with regulatory definitions, are needed to facilitate outcomes research and economic evaluation of interventions with MN. OBJECTIVES: Ascertain how MN terms are defined, relevant regulations are applied, and to what extent MN is valued. METHODS: ISPOR's Nutrition Economics Special Interest Group conducted a scoping review of scientific literature on European and US MN terminology and regulations, published between January 2000 and August 2015, and pertinent professional and regulatory Web sites. Data were extracted, reviewed, and reconciled using two-person teams in a two-step process. The literature search was updated before manuscript completion. RESULTS: Of the initial 1687 literature abstracts and 222 Web sites identified, 459 records were included in the analysis, of which 308 used MN terms and 100 provided definitions. More than 13 primary disease groups as per International Classification of Disease, Revision 10 categories were included. The most frequently mentioned and defined terms were enteral nutrition and malnutrition. Less than 5% of the records referenced any MN regulation. The health economic impact of MN was rarely and insufficiently (n = 19 [4.1%]) assessed, although an increase in economic analyses was observed. CONCLUSIONS: MN terminology is not consistently defined, relevant European and US regulations are rarely cited, and economic evaluations are infrequently conducted. We recommend adopting consensus MN terms and definitions, for example, the European Society for Clinical Nutrition and Metabolism consensus guideline 2017, as a foundation for developing reliable and standardized medical nutrition economic methodologies.

Portal Vein Embolization: Correlation of Future Liver Remnant Hypertrophy to Type of Embolic Agent Used.

PURPOSE: The purpose of this study was to compare the effectiveness of portal vein embolization (PVE) with different embolic agents used at our centre. Specifically, the effectiveness of N-butyl cyanoacrylate (NBCA) glue is compared with that of polyvinyl alcohol (PVA) particles. METHODS: We performed a retrospective chart review of all patients (N = 77) who underwent PVE at our institution over a 5-year period. Pre- and postprocedural computed tomography or magnetic resonance imaging, when available, were used to measure the volume of total liver volume and future liver remnant (FLR). The absolute values obtained were used to calculate percentage of FLR. The growth in FLR was determined 4-6 weeks after PVE. Technical details of the procedure including the type and amount of embolic agent used were obtained from the chart reviews, electronic patient records, and radiology reports. Statistical analysis was performed using Kruskal-Wallis test, Wilcoxon rank sum test, and the Spearman correlation coefficient with post hoc analysis. Results are expressed as mean ± SD (P < .05 considered statistically significant). RESULTS: NBCA (n = 29) produced a mean change in FLR of 14.8% compared with 9.3% for PVA particles (n = 24; P = .007). Mean change in FLR was 10.1% in the group where a combination of NBCA and PVA particles was used (n = 24). The effect of glue volume and glue-to-lipiodol ratio on the outcome was not found to be statistically significant (P = .5 and .7, respectively). CONCLUSIONS: We conclude that NBCA glue is a better embolic agent than PVA particles in inducing liver hypertrophy.

ISPOR Code of Ethics 2017 (4th Edition).

As the leading health economics and outcomes research (HEOR) professional society, ISPOR has a responsibility to establish a uniform, harmonized international code for ethical conduct. ISPOR has updated its 2008 Code of Ethics to reflect the current research environment. This code addresses what is acceptable and unacceptable in research, from inception to the dissemination of its results. There are nine chapters: 1 - Introduction; 2 - Ethical Principles respect, beneficence and justice with reference to a non-exhaustive compilation of international, regional, and country-specific guidelines and standards; 3 - Scope HEOR definitions and how HEOR and the Code relate to other research fields; 4 - Research Design Considerations primary and secondary data related issues, e.g., participant recruitment, population and research setting, sample size/site selection, incentive/honorarium, administration databases, registration of retrospective observational studies and modeling studies; 5 - Data Considerations privacy and data protection, combining, verification and transparency of research data, scientific misconduct, etc.; 6 - Sponsorship and Relationships with Others (roles of researchers, sponsors, key opinion leaders and advisory board members, research participants and institutional review boards (IRBs) / independent ethics committees (IECs) approval and responsibilities); 7 - Patient Centricity and Patient Engagement new addition, with explanation and guidance; 8 - Publication and Dissemination; and 9 - Conclusion and Limitations.

Percutaneous Recanalization of Iliac Artery Occlusions by Radiofrequency Perforation: Initial Experience.

The success rate of endovascular therapy for iliac occlusions is often limited by failure to traverse the lesion. A single institution's experience with the use of radiofrequency-assisted recanalization of occlusions in 10 iliac arteries is described. The median length of occlusion was 43 mm (range, 14-64 mm; mean, 42 mm). Revascularization was achieved in all cases. One case was complicated by vessel perforation with no adverse sequelae after stent insertion. All patients reported symptom resolution, and no target lesion reintervention or surgery was required. The median follow-up was 42 months (range, 11-63 mo; mean, 35 mo).

A Fully Electronically Steerable Therapeutic Ultrasound Phased Array With MR-Guidance.

Recently, MRI-guided focused ultrasound (FUS) has shown great promise in treating various conditions non-invasively. OBJECTIVE: The focus of this article is to introduce an MRI-guided FUS device, which can provide full electronic steering range without mechanical movement and with low near-field heating. A pilot study was conducted in order to investigate the feasibility, and safety of the device in a large animal model and a pilot clinical trial. METHODS: A flat, fully steerable FUS phased array with 4096 elements was designed and manufactured to be compatible with an MR scanner. Pre-clinical experiments were carried out for testing the accuracy of the focus at different steering angles as well as evaluating the ablation efficiency using MR thermometry. Eleven patients with uterine fibroids were treated in the pilot clinical trial. RESULTS: Pre-clinical results showed successful ablation at various steering angles with reasonable targeting accuracy and no off-target heating. During the pilot clinical study, effective fibroid ablation was achieved with significant symptom reduction observed over time. In general, the treatment results showed the system to be effective in ablating deep tissue volumes. The device was successful at efficiently ablating large volumes with minimal near-field heating and eliminating the need for mechanical translation. CONCLUSIONS: Being capable of providing high acoustic power, full electronic steering range in 3D for large volume ablations, this device can provide a safe and efficient treatment option as an outpatient procedure for uterine fibroids and other pelvic and abdominal tumors.

The Society of Thoracic Surgeons General Thoracic Surgery Database: 2023 Update on Outcomes and Research.

The Society of Thoracic Surgeons General Thoracic Surgery Database (GTSD) continues its trajectory of growth and enhancement, solidifying its stature as a premier global thoracic surgical database. The past year witnessed a notable expansion with the inclusion of 10 additional participating sites, now totaling 287, augmenting the database's repository to more than 800,000 procedures. A significant stride was made in refining the data audit process, thereby elevating the accuracy and completeness metrics, a testament to the relentless pursuit of data integrity. The GTSD further broadened its research apparatus, with 15 scholarly publications, a 50% uptick from the preceding year. These publications underscore the database's instrumental role in advancing thoracic surgical knowledge. In a concerted effort to alleviate data entry exigencies, the GTSD Task Force also instituted streamlined data submission protocols, a move lauded by participant sites. This report delineates the recent advancements, volume trajectories, and outcome metrics and encapsulates the prolific research output emanating from the GTSD, reflecting a year of substantial progress and academic fecundity.