PRO-Angoff method for remote standard setting: establishing clinical thresholds for the upper digestive disease tool.

BACKGROUND: The Upper Digestive Disease (UDD) Tool™ is used to monitor symptom frequency, intensity, and interference across nine symptom domains and includes two Patient-Reported Outcome Measurement Information System (PROMIS) domains assessing physical and mental health. This study aimed to establish cut scores for updated symptom domains through standard setting exercises and evaluate the effectiveness and acceptability of virtual standard setting. METHODS: The extended Angoff method was employed to determine cut scores. Subject matter experts refined performance descriptions for symptom control categories and achieved consensus. Domains were categorized into good, moderate, and poor symptom control. Two cut scores were established, differentiating good vs. moderate and moderate vs. poor. Panelists estimated average scores for 100 borderline patients per item. Cut scores were computed based on the sum of the average ratings for individual questions, converted to 0-100 scale. RESULTS: Performance descriptions were refined. Panelists discussed that interpretation of the scores should take into account the timing of symptoms after surgery and patient populations, and the importance of items asking symptom frequency, severity, and interference with daily life. The good/moderate cut scores ranged from 21.3 to 35.0 (mean 28.6, SD 3.6) across domains, and moderate/poor ranged from 47.5 to 71.3 (mean 54.5, SD 7.0). CONCLUSIONS: Panelists were confident in the virtual standard setting process, expecting valid cut scores. Future studies can further validate the cut scores using patient perspectives and collect patient and physician preferences for displaying contextual items on patient- and physician-facing dashboard.

Esophagectomy Enhanced Recovery After Surgery Initiative Results in Improved Outcomes.

BACKGROUND: Esophagectomy for esophageal cancer is a procedure with high morbidity and mortality. This study developed a Multidisciplinary Esophagectomy Enhanced Recovery Initiative (MERIT) pathway and analyzed implementation outcomes in a single institution. METHODS: The MERIT pathway was developed as a practice optimization and quality improvement initiative. Patients were studied from November 1, 2021 to June 20, 2022 and were compared with historical control subjects. The Wilcoxon rank sum test and the Fisher exact test were used for statistical analysis. RESULTS: The study compared 238 historical patients (January 17, 2017 to December 30, 2020) with 58 consecutive MERIT patients. There were no significant differences between patient characteristics in the 2 groups. In the MERIT group, 49 (85%) of the patients were male, and their mean age was 65 years (range, 59-71 years). Most cases were performed for esophageal cancer after neoadjuvant therapy. Length of stay improved by 27% from 11 to 8 days (P = .27). There was a 12% (P = .05) atrial arrhythmia rate reduction, as well as a 9% (P = .01) decrease in postoperative ileus. Overall complications were reduced from 54% to 35% (-19%; P = .01). CONCLUSIONS: This study successfully developed and implemented an enhanced recovery after surgery pathway for esophagectomy. In the first year, study investigators were able to reduce overall complications, specifically atrial arrhythmias, and postoperative ileus.

Sublobar Resection, Stereotactic Body Radiation Therapy, and Percutaneous Ablation Provide Comparable Outcomes for Lung Metastasis-Directed Therapy.

BACKGROUND: Prolonged survival of patients with metastatic disease has furthered interest in metastasis-directed therapy (MDT). RESEARCH QUESTION: There is a paucity of data comparing lung MDT modalities. Do outcomes among sublobar resection (SLR), stereotactic body radiation therapy (SBRT), and percutaneous ablation (PA) for lung metastases vary in terms of local control and survival? STUDY DESIGN AND METHODS: Medical records of patients undergoing lung MDT at a single cancer center between January 2015 and December 2020 were reviewed. Overall survival, local progression, and toxicity outcomes were collected. Patient and lesion characteristics were used to generate multivariable models with propensity weighted analysis. RESULTS: Lung MDT courses (644 total: 243 SLR, 274 SBRT, 127 PA) delivered to 511 patients were included with a median follow-up of 22 months. There were 47 local progression events in 45 patients, and 159 patients died. Two-year overall survival and local progression were 80.3% and 63.3%, 83.8% and 9.6%, and 4.1% and 11.7% for SLR, SBRT, and PA, respectively. Lesion size per 1 cm was associated with worse overall survival (hazard ratio, 1.24; P = .003) and LP (hazard ratio, 1.50; P < .001). There was no difference in overall survival by modality. Relative to SLR, there was no difference in risk of local progression with PA; however, SBRT was associated with a decreased risk (hazard ratio, 0.26; P = .023). Rates of severe toxicity were low (2.1%-2.6%) and not different among groups. INTERPRETATION: This study performs a propensity weighted analysis of SLR, SBRT, and PA and shows no impact of lung MDT modality on overall survival. Given excellent local control across MDT options, a multidisciplinary approach is beneficial for patient triage and longitudinal management.

Use of the Intercostal Artery-based Latissimus Dorsi Muscle for Intrathoracic Reconstruction after Division of the Thoracodorsal Vessels and Latissimus Dorsi Muscle.

The latissimus dorsi muscle is the workhorse flap for intrathoracic reconstruction. Prior thoracotomy, which divides the latissimus dorsi muscle, limits the muscle's intrathoracic reach. We present our experience using the distal portion of the muscle for intrathoracic reconstruction based off an intercostal vessel. We also demonstrate the ability of this intercostal perforator to allow for chimeric flap elevation with a separate skin paddle, depending on the branching pattern of the intercostal vessels. This study provides a case series of three consecutive patients, treated between September 2021 and June 2022. The intrathoracic pathology addressed in these patients are bronchopleural fistula, aortoesophageal fistula, and bronchoesophageal fistula. All patients had the resolution of symptoms related to intrathoracic fistulae and did not experience recurrence. This novel pedicled muscle flap can be an additional option for patients with prior thoracotomy and avoids the morbidity which can be seen with the serratus or rectus abdominis muscle flaps.

Determinants of Long-term Survival Decades After Esophagectomy for Esophageal Cancer.

BACKGROUND: Long-term survival in esophagectomy patients with esophageal cancer is low due to tumor-related characteristics, with few reports of modifiable variables influencing outcome. We identified determinants of overall survival, time to recurrence, and disease-free survival in this patient cohort. METHODS: Adult patients who underwent esophagectomy for primary esophageal cancer from January 5, 2000, through December 30, 2010, at our institution were identified. Univariate Cox models and multivariable logistic regression analyses were used to identify associations between modifiable and unmodifiable patient and clinical variables and outcome of survival for the total cohort and a subgroup with locally advanced disease. RESULTS: We identified 870 patients with esophageal cancer who underwent esophagectomy. The median follow-up time was 15 years, and the 15-year overall survival rate was 25.2%, survival free of recurrence was 57.96%, and disease-free survival was 24.21%. Decreased overall survival was associated with the following unmodifiable variables: older age, male sex, active smoking status, history of coronary artery disease, advanced clinical stage, and tumor location. Decreased overall survival was associated with the following modifiable variables: use of neoadjuvant therapy, advanced pathologic stage, resection margin positivity, surgical reintervention, and blood transfusion requirement. The overall survival probability 6 years after esophagectomy was 0.920 (95% CI, 0.895-0.947), and time-to-recurrence probability was 0.988 (95% CI, 0.976-1.000), with a total of 17 recurrences and 201 deaths. CONCLUSIONS: Once patients survive 5 years, recurrence is rare. Long-term survival can be achieved in high-volume centers adhering to National Comprehensive Cancer Network guidelines using multidisciplinary care teams that is double what has been previously reported in the literature from national databases.

Developing & integrating a mobile application tool into a survivorship clinic for esophageal cancer patients.

Esophageal cancer (EC) patients are living longer due to enhanced screening and novel therapeutics, however, the post-esophagectomy long-term management remains challenging for patients, caregivers, and providers. Patients experience significant morbidity and have difficulty managing symptoms. Providers struggle to manage symptoms, affecting patients' quality of life and complicating care coordination between surgical teams and primary care providers. To address these patient unique needs and create a standardized method for evaluating patient reported long-term outcomes after esophagectomy for EC, our team developed the Upper Digestive Disease Assessment tool, which evolved to become a mobile application. This mobile application is designed to monitor symptom burden, direct assessment, and quantify data for patient outcome analysis after foregut (upper digestive) surgery, including esophagectomy. It is available to the public and enables virtual and remote access to survivorship care. Patients using the Upper Digestive Disease Application (UDD App) must consent to enroll, agree to terms of use, and acknowledge use of health-related information prior to gaining access to the UDD App. The results of patients scores can be utilized for triage and assessment. Care pathways can guide management of severe symptoms in a scalable and standardized method. Here we describe the history, process, and methodology for developing a patient-centric remote monitoring program to improve survivorship after EC. Programs like this that facilitate patient-centered survivorship should be an integral part of comprehensive cancer patient care.

Impact of FDG PET Standardized Uptake Value in Resected Clinical Stage IA Non-Small Cell Lung Cancer.

BACKGROUND: A significant proportion of patients with clinical stage IA non-small cell lung cancer (NSCLC) experience will recurrence and decreased survival after surgery. This study examined the impact of preoperative primary tumor positron emission tomography (PET) scan maximum standardized uptake value (SUVmax) on oncologic outcomes after surgery. METHODS: This was a retrospective review of 251 patients who underwent surgical treatment of clinical stage IA NSCLC at an academic medical center (2005-2014). Patients were classified according to PET SUVmax level (low vs high) for analysis of upstaging, tumor recurrence, and overall survival. RESULTS: Median SUVmax values were higher in squamous cell carcinoma than in adenocarcinoma (median 3.3 vs 7.2; P < .0001). There were 109 (43.4%) patients in the SUVmax low group and 142 (56.6%) in the SUVmax high group. Patients with SUVmax high had larger tumors. SUVmax high was associated with higher rates of nodal upstaging (16.2% vs 4.6% in SUVmax low; P = .004), particularly in N1 nodes. SUVmax high was independently associated with nodal upstaging (adjusted odds ratio, 3.95; 95% CI, 1.36-11.46; P = .011). SUVmax high was associated with time to recurrence (hazard ratio, 1.62; 95% CI, 1.03-2.54; P = .036), but this association was lost on multivariable analysis (hazard ratio, 1.52; 95% CI, 0.91-2.54; P = .106). SUVmax was not associated with overall survival. CONCLUSIONS: Preoperative PET SUVmax level is strongly associated with nodal upstaging, particularly in N1 nodes, in patients with clinical stage IA NSCLC who undergo resection. PET SUVmax should be regarded as a risk factor when considering candidacy for sublobar resections and in future trials involving patients with stage I NSCLC.

Food Deserts Increase Readmission After Esophagectomy for Cancer: A Multi-institutional Study.

BACKGROUND: Food deserts are low-income census tracts with poor access to supermarkets and are associated with worse outcomes in breast, colon, and a small number of esophageal cancer patients. This study investigated residency in food deserts on readmission rates in a multi-institutional cohort of esophageal cancer patients undergoing trimodality therapy. METHODS: A retrospective review of patients who underwent trimodality therapy at 6 high-volume institutions from January 2015 to July 2019 was performed. Food desert status was defined by the United States Department of Agriculture by patient ZIP Code. The primary outcome was 30-day readmission after esophagectomy. Multilevel, multivariable logistic regression was used to model readmission on food desert status adjusted for diabetes, insurance type, length of stay, and any complication, treating the institution as a random factor. RESULTS: Of the 453 records evaluated, 425 were included in the analysis. Seventy-three patients (17.4%) resided in a food desert. Univariate analysis demonstrated food desert patients had significantly increased 30-day readmission. No differences were seen in length of stay, complications, or 30-day mortality. In the adjusted logistic regression model, residing in a food desert remained a significant risk factor for readmission (odds ratio, 2.11; 95% CI, 1.07-4.15). There were no differences in 30-day, 90-day, or 1-year mortality based on food desert status, although readmission was associated with worse 90-day and 1-year mortality. CONCLUSIONS: Food desert residence was associated with 30-day readmission after esophagectomy in patients undergoing trimodality treatment for esophageal cancer in this multi-institutional population. Identification of patients residing in a food desert may allow surgeons to focus preventative interventions during treatment and postoperatively to improve outcomes.

Impact of adverse events on health-related quality of life after left ventricular assist device implantation: An STS INTERMACS analysis.

BACKGROUND: We sought to quantify the impact of pre- and postoperative variables on health-related quality of life (HRQOL) after left ventricular assist device (LVAD) implantation. METHODS: Primary durable LVAD implants between 2012 and 2019 in the Interagency Registry for Mechanically Assisted Circulatory Support were identified. Multivariable modeling using general linear models assessed the impact of baseline characteristics and postimplant adverse events (AEs) on HRQOL as assessed by the EQ-5D visual analog scale (VAS) and the Kansas City Cardiomyopathy Questionnaire-12 (KCCQ) at 6 months and 3 years. RESULTS: Of 22,230 patients, 9,888 had VAS and 10,552 had KCCQ reported at 6 months, and 2,170 patients had VAS and 2,355 had KCCQ reported at 3 years postimplant. VAS improved from a mean of 38.2 ± 28.3 to 70.7 ± 22.9 at 6 months and from 40.1 ± 27.8 to 70.3 ± 23.1 at 3 years. KCCQ improved from 28.2 ± 23.9 to 64.3 ± 23.2 at 6 months and from 29.8 ± 23.7 to 63.0 ± 23.7 at 3 years. Preimplant variables, including baseline VAS, had small effect sizes on HRQOL while postimplant AEs had large negative effect sizes. Recent stroke, respiratory failure, and renal dysfunction had the largest negative effect on HRQOL at 6 months, while recent renal dysfunction, respiratory failure, and infection had the largest negative effect at 3 years. CONCLUSIONS: AEs following LVAD implantation have large negative effects on HRQOL in early and late follow-up. Understanding the impact of AEs on HRQOL may assist shared decision-making regarding LVAD eligibility. Continued efforts to reduce post-LVAD AEs are warranted to improve HRQOL in addition to survival.

Pafolacianine for intraoperative molecular imaging of cancer in the lung: The ELUCIDATE trial.

OBJECTIVE: The study objective was to determine the clinical utility of pafolacianine, a folate receptor-targeted fluorescent agent, in revealing by intraoperative molecular imaging folate receptor α positive cancers in the lung and narrow surgical margins that may otherwise be undetected with conventional visualization. METHODS: In this Phase 3, 12-center trial, 112 patients with suspected or biopsy-confirmed cancer in the lung scheduled for sublobar pulmonary resection were administered intravenous pafolacianine within 24 hours before surgery. Participants were randomly assigned to surgery with or without intraoperative molecular imaging (10:1 ratio). The primary end point was the proportion of participants with a clinically significant event, reflecting a meaningful change in the surgical operation. RESULTS: No drug-related serious adverse events occurred. One or more clinically significant event occurred in 53% of evaluated participants compared with a prespecified limit of 10% (P < .0001). In 38 participants, at least 1 event was a margin 10 mm or less from the resected primary nodule (38%, 95% confidence interval, 28.5-48.3), 32 being confirmed by histopathology. In 19 subjects (19%, 95% confidence interval, 11.8-28.1), intraoperative molecular imaging located the primary nodule that the surgeon could not locate with white light and palpation. Intraoperative molecular imaging revealed 10 occult synchronous malignant lesions in 8 subjects (8%, 95% confidence interval, 3.5-15.2) undetected using white light. Most (73%) intraoperative molecular imaging-discovered synchronous malignant lesions were outside the planned resection field. A change in the overall scope of surgical procedure occurred for 29 of the subjects (22 increase, 7 decrease). CONCLUSIONS: Intraoperative molecular imaging with pafolacianine improves surgical outcomes by identifying occult tumors and close surgical margins.

Commentary: Gender differences in payments to cardiothoracic surgeons are unacceptable.

Every effort must be made by the leaders in our field, as well as by every individual cardiothoracic surgeon, to assure equal opportunity for all cardiothoracic surgeons, regardless of race, gender or any other sociodemographic source of bias. Every effort must be made by every surgeon, not just those in particular leadership roles. Opportunities for advancement must be equal in multiple domains, including clinical practice, patient referral, clinical leadership, academic leadership, institutional leadership and leadership in professional medical and surgical societies. Such actions to minimize bias and promote inclusivity will also ensure that cardiothoracic surgical care is provided by a workforce that represents the diversity of patients whom we serve. In the final analysis, it is an absolute fact that gender differences in payments to cardiothoracic surgeons are absolutely unacceptable and cannot be tolerated.

Impact of Federal Lung Cancer Screening Policy on the Incidence of Early-stage Lung Cancer.

BACKGROUND: In December 2013 the US Preventative Services Task Force (USPSTF) recommended annual lung cancer screening for high-risk patients. The Centers for Medicare & Medicaid Services (CMS) later announced coverage in 2015. The impact of these federal decisions at the population level is unknown. METHODS: Using the Surveillance, Epidemiology, and End Results database, we studied changes in lung cancer incidence by stage and linked to US census data to obtain age-adjusted estimates standardized to the US population. Based on age at diagnosis we stratified patients as age-eligible or age-ineligible for screening. We used difference-in-differences regression to determine the effect of screening on lung cancer incidence by stage. RESULTS: For all age groups the incidence of early-stage lung cancer both before and after the USPSTF guidelines remained relatively stable at 12.8 ± 0.52 and 13.5 ± 0.92 per 100,000 patients, respectively (P = .068). However the difference-in-differences analysis estimated an absolute increase in the age-adjusted incidence by 3.4 per 100,000 persons in the age-eligible group after the announcement of the guidelines (P = .007). The effect was even larger after the CMS decision (4.3/100,000 persons, P < .001). Similarly there was a 14.2 per 100,000 persons absolute reduction in the incidence of advanced-stage lung cancer (P < .001). CONCLUSIONS: The 2013 USPSTF lung cancer screening guidelines and CMS coverage decisions were associated with an increased incidence of early-stage lung cancer and decreased incidence of advance-staged lung cancer at the population level.

Preoperative Type and Screen Before General Thoracic Surgery: A Nomogram to Reduce Unnecessary Tests.

BACKGROUND: A preoperative type and screen (T&S) is traditionally routinely obtained before noncardiac thoracic surgery; however an intraoperative blood transfusion is rare. This practice is overly cautious and expensive. METHODS: We included adult patients undergoing major thoracic surgery at the Mayo Clinic from 2007 to 2016. Patients receiving a T&S blood test ≤72 hours of surgery was the main exposure. We randomly split the cohort into derivation and validation datasets. We used multiple logistic regression to create a parsimonious nomogram predicting the need for a T&S in relation to the likelihood of intraoperative blood transfusion. We validated the nomogram in terms of discrimination, calibration, and negative predictive value. RESULTS: Of 6280 patients 46.1% had a preoperative T&S, but only 7.1% received intraoperative transfusions. The derivation dataset had 4196 patients. Patients who had a T&S were more likely to have baseline hemoglobin level <10 g/dL (7.9% vs 3.6%, P < .001) and less likely to have minimally invasive operations (36.1% vs 43.5%, P < .001) but were otherwise similar in baseline age and comorbidities. A transfusion threshold of 5% was selected a priori. The nomogram included age, planned operation, approach, body mass index, and preoperative hemoglobin. The nomogram was validated with a c-statistic of 86% and a negative predictive value of 97.9%. Patients who needed a blood transfusion but who did not have a preoperative T&S did not have a higher rate of mortality (P = .121). CONCLUSIONS: An intraoperative blood transfusion during major thoracic surgery is a rare event. Patient who required transfusion but did not have a T&S did not have worse outcomes. A simple nomogram can aid in the selective use of T&S orders preoperatively.

Agreement Between Upper Digestive Disease App and Provider Evaluation of Esophagectomy Symptoms in a Mobile App Tool.

BACKGROUND: The objective of this study was to assess the criterion validity of score thresholds for the Upper Digestive Disease (UDD) App. METHODS: From December 15, 2017, to December 15, 2020, patients presenting after esophagectomy were offered the UDD App concurrent with a provider visit. This tool consists of 67 questions including 5 novel domains. Score thresholds were used to assign patients to a good, moderate, or poor category on the basis of domain scores. Providers were given performance descriptions for each domain and asked to assign patients to a category on the basis of their clinical evaluation. The weighted κ statistic was used to determine the magnitude of agreement between classifications based on the patients' UDD App scores and the providers' clinical evaluation. RESULTS: Fifty-nine patients in the study (76% male; median age, 63 years [interquartile range, 57-72 years]) reported outcomes using the UDD App. Providers reviewed between 1 and 10 patients at a median time of 296.5 days (interquartile range, 50-975 days) after esophagectomy. The magnitude of agreement between patients and providers was moderate for dysphagia (κ = 0.52; P < .001) and reflux (κ = 0.42; P < .001). Dumping-related hypoglycemia (κ = 0.03; P = .148), gastrointestinal complaints (κ = 0.02; P = .256), and pain (κ = 0.05; P < .184) showed minimal agreement, with providers underestimating the symptoms and problems reported by patients in these domains. CONCLUSIONS: Although there was agreement between UDD App assessment and provider evaluation of dysphagia and reflux after esophagectomy, there was discordance of scoring for dumping-related symptoms and pain. Future research is needed to determine whether thresholds for pain and dumping domains need to be revised or whether additional provider education on performance descriptions is needed.