Safety and usability of an endo staple line reinforcement device for pulmonary resections.

Background: Pulmonary resection can present technical challenges for surgeons due to the dissection and closure of tissues, which vary in thickness and elastic properties, occasionally leading to prolonged air leaks. Staple line reinforcements (SLRs) are widely utilized tools for fortifying the stability and integrity of closures in thoracic surgery, however, materials available and ease of use for both surgeon and scrub nurse have been suboptimal. A novel "click-and-go" device pre-loaded with bioabsorbable buttress material was recently developed, the Echelon Endopath SLR (ESLR, Ethicon, Inc., Cincinnati, OH, USA). This prospective study examines the safety and efficacy of this novel device in lung resections. Methods: Adult surgical candidates undergoing primary pulmonary resection (both open and thoracoscopic) where the ESLR would be used were enrolled. Exclusion included reoperation/revision in same anatomical location, hypersensitivity to polyglactin or related products, and body mass index (BMI) ≥46.0 kg/m2. The primary endpoint assessed the incidence of specific device-related adverse events (AEs): prolonged air leak and empyema. Additional endpoints included number of devices replaced during surgery due to slippage or bunching, and surgeon-reported usability responses. Data was summarized for AEs deemed device-related and usability questionnaire responses. Results: A total of 131 subjects were included in the primary endpoint analysis data set with 120 subjects completing the study (91.6%). The mean age at consent was 62.8±12.0 years and 55.7% were female. The most common primary indication for the procedure was malignancy 61.1%, and primary non-malignant lung disease (non-chronic obstructive pulmonary disease) 12.2%. Common procedures performed were wedge resection (58.0%) and lobectomy (34.4%). There were zero reported device-specific/-related AEs which counted toward the primary endpoint. Responses from a usability questionnaire found all surgeons (100.0%) reported the ease of setup was superior to previous devices utilized. Surgeons expressed greater confidence in the buttress material of the ESLR than that of previous SLR devices (strongly agree 88.9%; slightly agree 11.1%). Most also felt that there was less wastage with the click-and-go ESLR (strongly agree 77.8%, slightly agree 11.1%, neutral 11.1%). Conclusions: The ESLR device demonstrates safe and effective performance in this post-market study of specific thoracic procedures. Furthermore, surgeons found this was easier to use.

Esophagectomies for Malignancy Among General and Thoracic Surgeons: A Propensity Score Matched National Surgical Quality Improvement Program Analysis Stratified by Surgical Approach.

Previous studies of esophagectomy outcomes by surgical specialty do not address malignancy or surgical approach. We sought to evaluate these cases using a national database. The National Surgical Quality Improvement Program (NSQIP)-targeted esophagectomy data set was queried for esophagectomies for malignancy and grouped by surgeon specialty: thoracic surgery (TS) or general surgery (GS). 1:1 propensity score matching was performed. Associations of surgical specialty with outcomes of interest (30-day mortality, anastomotic leak, Clavien-Dindo grade ≥ 3, and positive margin rate) were assessed overall and in surgical approach subsets. 1463 patients met inclusion criteria (512 GS and 951 TS). Propensity score matching yielded matched groups of 512, with similar demographics, preoperative stage, and neoadjuvant therapy rates. All outcomes of interest were similar between TS and GS groups, both overall and when stratified by surgical approach. Esophagectomy for malignancy has a similar perioperative safety profile and positive margin rate among general and thoracic surgeons, regardless of surgical approach.

Long-term outcomes after robotic-assisted Ivor Lewis esophagectomy.

Robotic assistance has gained acceptance in thoracic procedures, including esophagectomy. There is a paucity of data regarding long-term outcomes for robotic esophagectomy. We previously reported our initial series of robot-assisted Ivor Lewis (RAIL) esophagectomy. We report long-term outcomes to assess the efficacy of the procedure. We performed a retrospective review of 112 consecutive patients who underwent a RAIL. Patient demographics, diagnosis, pathology, operative characteristics, post-operative complications, and long-term outcomes were documented. Descriptive statistical analysis was performed for all the variables. Primary endpoints were mortality and disease-free survival. Overall survival (OS) and disease-free survival (DFS) were calculated using the Kaplan-Meier method. Of the 112 patients, 106 had a diagnosis of cancer, with adenocarcinoma the dominant histology (87.5%). Of these 106 patients, 81 (76.4%) received neo-adjuvant chemoradiation. The 30-, 60-, and 90-day mortality was 1 (0.9%), 3 (2.7%), and 4 (3.6%), respectively. There were 9 anastomotic leaks (8%) and 18 (16.1%) patients had a stricture requiring dilation. All-patient OS at 1, 3, and 5 years was 81.4%, 60.5%, and 51.0%, respectively. For cancer patients, the 1-, 3-, and 5-year OS was 81.3%, 59.2%, and 49.4%, respectively, and the DFS was 75.3%, 42.3%, and 44.0%. We have shown that long-term outcomes after RAIL esophagectomy are similar to other non-robotic esophagectomies. Given the potential advantages of robotic assistance, our results are crucial to demonstrate that RAIL does not result in inferior outcomes.

Is Esophagectomy for Benign Conditions Benign?

BACKGROUND: Outcomes data on esophagectomy performed for benign conditions is scarce. Using the National Surgical Quality Improvement Program database, we sought to analyze outcomes of esophagectomy performed for benign conditions. METHODS: The National Surgical Quality Improvement Program database was queried for all esophagectomies performed from 2005 to 2015. Outcomes for benign conditions were analyzed and compared with outcomes for malignant conditions. RESULTS: Esophagectomy was performed in 7,477 patients during the study period. Of those, 6,762 underwent esophagectomy for malignant conditions and 715 for benign conditions. For patients with benign conditions, reconstruction was performed using gastric conduit in 631 and colon/intestine in 84. The anastomosis was intrathoracic in 420 and cervical in 295. Benign esophagectomies were more likely to be emergent (10.1% vs 0.4%, p < 0.001). In addition, these patients had a longer hospital length of stay (17.2 days vs 14.5 days, p < 0.001) and higher occurrence of Clavien-Dindo grade IV complications (25% vs 20%, p = 0.003). Mortality was similar at 4%. In patients with benign conditions, reconstruction with colon/intestine had higher occurrence of Clavien-Dindo Grade IV complications (37% vs 23%, p = 0.006), surgical wound infections (33% vs 16%, p < 0.001), and death (10% vs 4%, p = 0.017) compared with gastric reconstruction. Site of anastomosis did not affect outcomes. CONCLUSIONS: Benign esophagectomies are associated with significant morbidity. Although the site of the anastomosis does not alter outcomes, use of colon/intestine conduit should be pursued with caution.

Giant Cell Tumor of Bone Presenting as Left Posteromedial Chest Wall Tumor.

Giant cell tumor is a relatively uncommon bone tumor rarely originating from the chest wall. Given its proximity to vital structures in the thoracic cavity, treatment options may be challenging. We report the case of a patient with a giant cell tumor of the posterolateral chest wall with invasion of the thoracic spine treated with neoadjuvant denosumab, followed by surgical resection.

Robotic resection of a mediastinal parathyroid cyst.

Mediastinal parathyroid cysts (PC) are rare, benign lesions, reported in fewer than 150 cases worldwide. Although most are asymptomatic and discovered incidentally on imaging, symptoms of dyspnea, dysphagia, hoarseness, palpitations, hypercalcemia, and innominate or jugular venous thrombosis have been reported. Sternotomy or thoracotomy has traditionally been the approach used to resect mediastinal PCs. We describe the first reported case of a robot-assisted resection of a mediastinal PC.

The 5 Most Important Recent Publications Regarding Robotic Esophageal Surgery.

Robotic-assisted minimally invasive esophagectomy is gaining acceptance as a safe and effective alternative to open esophagectomy.

Prolonged Length of Stay after Esophageal Resection: Identifying Drivers of Increased Length of Stay Using the NSQIP Database.

BACKGROUND: Although influence of technical complications in association to hospital length of stay has been studied extensively in esophageal resection, nontechnical factors responsible for prolonged length of stay have not been reported. Using the NSQIP dataset, we hypothesized that we would be able to identify factors associated with prolonged length of stay after esophagectomy. STUDY DESIGN: National Surgical Quality Improvement Program data from 2005 to 2012 were reviewed for CPT codes for esophagectomy. Outlier status for length of stay was defined as >75th percentile. Logistic regression was used to predict outlier status and linear regression to discern factors contributing to longer lengths of stay. RESULTS: A total of 3,538 cases were reviewed. The 75th percentile for length of stay was 17 days. Preoperative predictors of hospital stay outliers include emergency surgery and frailty index (odds ratios = 3.7 and 3.6; p < 0.001). Deep organ space infection and progressive renal insufficiency had the highest likelihood of prolonged length of stay (odds ratios = 5.2 and 5.1; p < 0.001). Failure to wean off of ventilator in 48 hours, urinary tract infection, and pneumonia were associated with length of stay outlier (odds ratios = 3.7, 2.7, and 2.7; all p < 0.001). CONCLUSIONS: Urinary tract infection and pneumonia after esophagectomy are associated with longer hospital stays. Although meticulous surgical technique remains paramount, our study demonstrates that postoperative nontechnical complications factor into prolonged hospital stays. Focus on such factors can lead to reductions in hospital stays.

Clinical Utility of a Plasma Protein Classifier for Indeterminate Lung Nodules.

Evaluation of indeterminate pulmonary nodules is a complex challenge. Most are benign but frequently undergo invasive and costly procedures to rule out malignancy. A plasma protein classifier was developed that identifies likely benign nodules that can be triaged to CT surveillance to avoid unnecessary invasive procedures. The clinical utility of this classifier was assessed in a prospective-retrospective analysis of a study enrolling 475 patients with nodules 8-30 mm in diameter who had an invasive procedure to confirm diagnosis at 12 sites. Using this classifier, 32.0 % (CI 19.5-46.7) of surgeries and 31.8 % (CI 20.9-44.4) of invasive procedures (biopsy and/or surgery) on benign nodules could have been avoided. Patients with malignancy triaged to CT surveillance by the classifier would have been 24.0 % (CI 19.2-29.4). This rate is similar to that described in clinical practices (24.5 % CI 16.2-34.4). This study demonstrates the clinical utility of a non-invasive blood test for pulmonary nodules.

Characteristics of a novel treatment system for linear accelerator-based stereotactic radiosurgery.

The purpose of this study is to characterize the dosimetric properties and accuracy of a novel treatment platform (Edge radiosurgery system) for localizing and treating patients with frameless, image-guided stereotactic radiosurgery (SRS) and stereotactic body radiotherapy (SBRT). Initial measurements of various components of the system, such as a comprehensive assessment of the dosimetric properties of the flattening filter-free (FFF) beams for both high definition (HD120) MLC and conical cone-based treatment, positioning accuracy and beam attenuation of a six degree of freedom (6DoF) couch, treatment head leakage test, and integrated end-to-end accuracy tests, have been performed. The end-to-end test of the system was performed by CT imaging a phantom and registering hidden targets on the treatment couch to determine the localization accuracy of the optical surface monitoring system (OSMS), cone-beam CT (CBCT), and MV imaging systems, as well as the radiation isocenter targeting accuracy. The deviations between the percent depth-dose curves acquired on the new linac-based system (Edge), and the previously published machine with FFF beams (TrueBeam) beyond D(max) were within 1.0% for both energies. The maximum deviation of output factors between the Edge and TrueBeam was 1.6%. The optimized dosimetric leaf gap values, which were fitted using Eclipse dose calculations and measurements based on representative spine radiosurgery plans, were 0.700 mm and 1.000 mm, respectively. For the conical cones, 6X FFF has sharper penumbra ranging from 1.2-1.8 mm (80%-20%) and 1.9-3.8 mm (90%-10%) relative to 10X FFF, which has 1.2-2.2mm and 2.3-5.1mm, respectively. The relative attenuation measurements of the couch for PA, PA (rails-in), oblique, oblique (rails-out), oblique (rails-in) were: -2.0%, -2.5%, -15.6%, -2.5%, -5.0% for 6X FFF and -1.4%, -1.5%, -12.2%, -2.5%, -5.0% for 10X FFF, respectively, with a slight decrease in attenuation versus field size. The systematic deviation between the OSMS and CBCT was -0.4 ± 0.2 mm, 0.1± 0.3mm, and 0.0 ± 0.1 mm in the vertical, longitudinal, and lateral directions. The mean values and standard deviations of the average deviation and maximum deviation of the daily Winston-Lutz tests over three months are 0.20 ± 0.03 mm and 0.66 ± 0.18 mm, respectively. Initial testing of this novel system demonstrates the technology to be highly accurate and suitable for frameless, linac-based SRS and SBRT treatment.

Robot-Assisted Minimally Invasive Ivor Lewis Esophagectomy With Real-Time Perfusion Assessment.

BACKGROUND: Surgical resection is viewed as the most effective way to ensure both locoregional control and long-term survival in esophageal cancer. Although minimally invasive esophagectomy has been widely accepted as an alternative to open surgery, the role of robotic assistance has yet to be elucidated. We report our institutional experience with robotic-assisted Ivor Lewis esophagectomy using real-time perfusion assessment and demonstrate this as a safe and technically feasible alternative to traditional open Ivor Lewis esophagectomy. METHODS: A retrospective chart review of all patients undergoing robotic-assisted Ivor Lewis esophagectomy at a single institution from 2011 to 2014 was performed. Operative and postoperative outcomes were recorded. RESULTS: Fifty-four patients underwent robotic-assisted Ivor Lewis esophagectomy during the study period. Indication for surgery was cancer in 49 patients, 38 of whom underwent neoadjuvant chemoradiation therapy. The average operative time was 6 hours 2 minutes, and the average blood loss was 74 mL. There was 1 postoperative mortality (1.9%). Three (5.5%) patients experienced an anastomotic leak. The average number of lymph nodes harvested in cancer patients was 16.2 (range, 3 to 35). The average length of stay was 12.9 days. CONCLUSIONS: Our study demonstrates that robotic-assisted Ivor Lewis esophagectomy using real-time perfusion assessment is a safe and technically feasible alternative to traditional open Ivor Lewis esophagectomy. It allows for R0 resection with adequate lymph node harvesting and a short hospital stay.

Long-Term Survival After Local Resection of Cervical Esophageal Cancer.

Squamous cell carcinoma of the esophagus may be seen in patients with history of head and neck malignancies. Anatomic factors may limit management options. We present a case of second primary early cervical esophageal squamous cell cancer managed by local resection with reconstruction using a radial forearm flap.

LC-MS/MS quantitation of esophagus disease blood serum glycoproteins by enrichment with hydrazide chemistry and lectin affinity chromatography.

Changes in glycosylation have been shown to have a profound correlation with development/malignancy in many cancer types. Currently, two major enrichment techniques have been widely applied in glycoproteomics, namely, lectin affinity chromatography (LAC)-based and hydrazide chemistry (HC)-based enrichments. Here we report the LC-MS/MS quantitative analyses of human blood serum glycoproteins and glycopeptides associated with esophageal diseases by LAC- and HC-based enrichment. The separate and complementary qualitative and quantitative data analyses of protein glycosylation were performed using both enrichment techniques. Chemometric and statistical evaluations, PCA plots, or ANOVA test, respectively, were employed to determine and confirm candidate cancer-associated glycoprotein/glycopeptide biomarkers. Out of 139, 59 common glycoproteins (42% overlap) were observed in both enrichment techniques. This overlap is very similar to previously published studies. The quantitation and evaluation of significantly changed glycoproteins/glycopeptides are complementary between LAC and HC enrichments. LC-ESI-MS/MS analyses indicated that 7 glycoproteins enriched by LAC and 11 glycoproteins enriched by HC showed significantly different abundances between disease-free and disease cohorts. Multiple reaction monitoring quantitation resulted in 13 glycopeptides by LAC enrichment and 10 glycosylation sites by HC enrichment to be statistically different among disease cohorts.

Label-free glycopeptide quantification for biomarker discovery in human sera.

Glycan moieties of glycoproteins modulate many biological processes in mammals, such as immune response, inflammation, and cell signaling. Numerous studies show that many human diseases are correlated with quantitative alteration of protein glycosylation. In some cases, these changes can occur for certain types of glycans over specific sites in a glycoprotein rather than on the global abundance of the glycoprotein. Conventional analytical techniques that analyze the abundance of glycans cleaved from glycoproteins cannot reveal these subtle effects. Here we present a novel statistical method to quantify the site-specific glycosylation of glycoproteins in complex samples using label-free mass spectrometric techniques. Abundance variations between sites of a glycoprotein as well as different glycoforms, that is, glycopeptides with different glycans attached to the same site, can be detected using these techniques. We applied our method to an esophageal cancer study based on blood serum samples from cancer patients in an attempt to detect potential biomarkers of site-specific N-linked glycosylation. A few glycoproteins, including vitronectin, showed significantly different site-specific glycosylations within cancer/control samples, indicating that our method is ready to be used for the discovery of glycosylated biomarkers.

Gastroesophageal junction adenocarcinoma displays abnormalities in homologous recombination and nucleotide excision repair.

OBJECTIVE: Esophageal adenocarcinoma (EAC) continues to be a disease associated with high mortality. Among the factors leading to poor outcomes are innate resistance to currently available therapies, advanced stage at diagnosis, and complex biology. Platinum and ionizing radiation form the backbone of treatment for the majority of patients with EAC. Of the multiple processes involved in response to platinum chemotherapy or ionizing radiation, deoxyribonucleic acid (DNA) repair has been a major player in cancer sensitivity to these agents. DNA repair defects have been described in various malignancies. The purpose of this study was to determine whether alterations in DNA repair are present in EAC compared with normal gastroesophageal tissues. METHODS: We analyzed the expression of genes involved in homologous recombination (HR), nonhomologous end-joining, and nucleotide excision repair (NER) pathways in 12 EAC tumor samples with their matched normal counterparts. These pathways were chosen because they are the main pathways involved in the repair of platinum- or ionizing-radiation-induced damage. In addition, abnormalities in these pathways have not been well characterized in EAC. RESULTS: We identified increased expression of at least one HR gene in eight of the EAC tumor samples. Alterations in the expression of EME1, a structure-specific endonuclease involved in HR, were the most prevalent, with messenger (m)RNA overexpression in six of the EAC samples. In addition, all EAC samples revealed decreased expression of at least one of numerous NER genes including XPC, XPA, DDB2, XPF, and XPG. CONCLUSION: Our study identified DNA repair dysregulation in EAC involving two critical pathways, HR and NER, and is the first demonstration of EME1 upregulation in any cancer. These DNA repair abnormalities have the potential to affect a number of processes such as genomic instability and therapy response, and the consequences of these defects deserve further study in EAC.

Assessment of morbidity and mortality after esophagectomy using a modified frailty index.

BACKGROUND: Esophagectomy is associated with significant morbidity and mortality. This retrospective study examined use of a modified frailty index as a potential predictor of morbidity and mortality in esophagectomy patients. METHODS: National Surgical Quality Improvement Program Participant Use Files were reviewed for 2005 through 2010. Patients undergoing esophagectomy were selected based on CPT codes. A modified frailty index with 11 variables was used to determine correlation between frailty and postesophagectomy morbidity and mortality. Data were analyzed using χ(2) test and logistic regression. RESULTS: A total of 2,095 patients were included in the analysis. Higher frailty scores were associated with a statistically significant increase in morbidity and mortality. A frailty score of 0, 1, 2, 3, 4, and 5 had associated morbidity rates of 17.9% (142 of 795 patients), 25.1% (178 of 710 patients), 31.4% (126 of 401 patients), 34.4% (48 of 140 patients), 44.4% (16 of 36 patients), and 61.5% (8 of 13 patients), respectively. A frailty score of 0, 1, 2, 3, 4, and 5 had associated mortality rates of 1.8% (14 of 795 patients), 3.8% (27 of 710 patients), 4% (16 of 401 patients), 7.1% (10 of 140 patients), 8.3% (3 of 36 patients), and 23.1% (3 of 13 patients), respectively. When using multivariate logistic regression for mortality comparing age, functional status, prealbumin, emergency surgery, wound class, American Society of Anesthesiologists score, and sex, only age and frailty were statistically significant. The odds ratio was 31.84 for frailty (p = 0.015) and 1.05 (p = 0.001) for age. CONCLUSIONS: Using a large national database, a modified frailty index was shown to correlate with postesophagectomy morbidity and mortality. Such an index may be used to aid in improving risk assessment and patient selection for esophagectomy.