Risk of Cardiovascular Toxicity According to Tumor Laterality Among Older Patients With Early Stage Non-small Cell Lung Cancer Treated With Radiation Therapy.

BACKGROUND: The long-term risk of cardiovascular outcomes from either stereotactic body radiation therapy (SBRT) or three-dimensional conformal radiation therapy (3DCRT) plus intensity-modulated radiation therapy (IMRT) to treat early stage non-small cell lung cancer (NSCLC) is largely unknown. As continued adoption of SBRT accelerates, it is important to delineate unforeseen cardiovascular risks associated with treatment. RESEARCH QUESTION: Does the long-term risk of cardiovascular outcomes for patients with early stage NSCLC treated with either SBRT or 3DCRT plus IMRT differ by tumor laterality? STUDY DESIGN AND METHODS: Data from the Surveillance, Epidemiology, and End Results registry linked to Medicare was analyzed to identify a sample of 3,256 patients (1,506 treated with SBRT and 1,750 treated with 3DCRT plus IMRT) with node-negative stage I or IIA NSCLC. Cardiovascular events were identified using diagnosis codes, and outcomes were compared between left- and right-sided tumors. We assumed that tumor laterality was random and that the radiation field for left-sided tumors likely would result in greater dose to cardiac tissues. Cox regression models were fit to quantify the association of laterality on outcomes. RESULTS: Patients were followed up for a median of 2 years. Those treated with SBRT showed no difference in hazard of any cardiovascular outcomes by tumor laterality, including the cardiovascular composite (hazard ratio [HR] comparing left- vs right-sided tumors, 0.98; 95% CI, 0.84-1.15). In contrast, patients treated with 3DCRT plus IMRT showed a greater risk of congestive heart failure (HR, 1.23; 95% CI, 1.01-1.48) and percutaneous coronary artery intervention (HR, 2.24; 95% CI, 1.12-4.47). INTERPRETATION: Patients with left- vs right-sided early stage NSCLC showed similar rates of cardiovascular events when treated with SBRT. However, these patients also showed higher rates of select cardiac events when they were treated with 3DCRT plus IMRT. This study provides evidence that SBRT may provide a safer option over 3DCRT plus IMRT for patients with left-sided early stage NSCLC and underscores the need for long-term follow-up for patients treated with radiation therapy.

Optimal treatment strategies for stage I non-small cell lung cancer in veterans with pulmonary and cardiac comorbidities.

BACKGROUND: Veterans are at increased risk of lung cancer and many have comorbidities such as chronic obstructive pulmonary disease (COPD) and coronary artery disease (CAD). We used simulation modeling to assess projected outcomes associated with different management strategies of Veterans with stage I non-small cell lung cancer (NSCLC) with COPD and/or CAD. PATIENTS AND METHODS: Using data from a cohort of 14,029 Veterans (years 2000-2015) with NSCLC we extended a well-validated mathematical model of lung cancer to represent the management and outcomes of Veterans with stage I NSCLC with COPD, with or without comorbid CAD. We simulated multiple randomized trials to compare treatment with lobectomy, limited resection, or stereotactic body radiation therapy (SBRT). Model output estimated expected quality adjusted life years (QALY) of Veterans with stage I NSCLC according to age, tumor size, histologic subtype, COPD severity and CAD diagnosis. RESULTS: For Veterans <70 years old lobectomy was associated with greater projected quality-adjusted life expectancy regardless of comorbidity status. For most combinations of tumors and comorbidity profiles there was no dominant treatment for Veterans ≥80 years of age, but less invasive treatments were often superior to lobectomy. Dominant treatment choices differed by CAD status for older patients in a third of scenarios, but not for patients <70 years old. CONCLUSIONS: The harm/benefit ratio of treatments for stage I NSCLC among Veterans may vary according to COPD severity and the presence of CAD. This information can be used to direct future research study design for Veterans with stage I lung cancer and COPD and/or CAD.

Novel composite trachea grafts using 3-dimensional printing.

Objective: Porcine-derived small intestine submucosa (SIS) extracellular matrix (ECM) surgical patches claim to have greater regenerative properties compared with dermal extracellular matrices. We hypothesized that using SIS-ECM in a bioengineered composite tracheal graft would allow better incorporation into the native tissue. Methods: Two types of size-matched polycaprolactone support scaffolds were designed: rigid and flexible. The SIS-ECM was wrapped around the polycaprolactone supports lining the inside and outside of the graft. The grafts were implanted in 4 Yorkshire pigs, replacing an ∼2 cm segment of native trachea. Airway patency was evaluated with computed tomography scans and explanted grafts were examined grossly and histologically. Results: All animals survived through the immediate postoperative period. Generally, extraluminal examination showed a smooth transition between native and graft without significant volumetric loss. Animals that received the flexible design survived ∼10 days longer than those that received the rigid design; however, severe perianastomotic intraluminal granulation tissue was observed. The rigid design had less significant intraluminal granulation tissue development at the distal anastomosis, but partial dehiscence had occurred at the proximal anastomosis interrupting graft incorporation. Conclusions: The generally good extraluminal graft incorporation in our composite tracheal graft highlights some increased regenerative capabilities of SIS-ECM. However, the presence of intraluminal granulation tissue indicates that its use as an off-the-shelf, unaltered substrate in an airway graft is still not ideal. Further research must be conducted to determine whether a modification of the substrate is possible to enhance luminal airway incorporation and to exert control over the mechanisms responsible for granulation tissue development.

Successes and Failures in Tracheal Bioengineering: Lessons Learned.

BACKGROUND: Controversy in tracheal reconstruction using grafts and bioengineered constructs highlights the importance of animal studies before human application. Small animal models help to refine designs but do not adequately model sizes relevant to human anatomy. We have conducted extensive large animal studies and summarize our findings in 26 consecutive transplants. METHODS: We pooled 26 large animal studies together to investigate common elements related to successes and failures. In general the engineered tracheal graft consisted of a decellularized extracellular matrix surgical patch supported by a 3-dimensional-printed plastic polymer scaffold. Circumferential graft coverage ranged from 50% to 100%, spanning the length of 4 to 6 tracheal rings. Some grafts included embedded stem cells. Control grafts were fabricated without the support scaffold. At death grafts were harvested and examined grossly and through histology. RESULTS: The support scaffold prevented graft malacia and collapse. Luminal epithelialization was most extensive in grafts with smaller circumferential coverage. Smaller circumferential coverage was also associated with longest animal survival. Chondrogenesis was only observed in grafts with embedded stem cells. Survival time was shortest in 100% circumferential grafts. Granulation tissue was an issue for all graft designs. CONCLUSIONS: Large animal models capture challenges and complexities relevant to human anatomy. Development of granulation tissue remains a challenge, especially in circumferential grafts. Significant additional research is needed to investigate granulation tissue formation and to provide actionable insight into its management.

Adjuvant Radiation Therapy for Thoracic Soft Tissue Sarcomas: A Population-Based Analysis.

BACKGROUND: The role of adjuvant radiation therapy (RT) in the management of thoracic soft tissue sarcomas (STSs) remains unclear. We aimed to study the characteristics of patients with thoracic STS who received RT after surgical resection and investigate the impact of RT on survival outcomes. METHODS: We queried National Cancer Database to identify patients with surgically resected thoracic STS from 2004 to 2012. Factors associated with receiving adjuvant RT were identified. Analyses were performed to identify prognostic factors and compare overall survival (OS) in both unmatched and propensity score-matched cohorts. RESULTS: Overall, 1215 patients were identified, of whom 557 (45.8%) received adjuvant RT. Tumor grade (odds ratio [OR], 2.87; 95% confidence interval [CI], 2.18-3.77), tumor size (OR, 1.82; 95% CI, 1.36-2.42), and tumor margins (OR, 1.97; 95% CI, 1.43-2.72) were found to be significant predictors of receiving RT. Mean OS of patients receiving RT in the unmatched cohort was 91 months vs 88 months for patients who did not (P = .556). When adjusted for all variables, adjuvant RT was found to be associated with improved survival (hazard ratio, 0.79; 95% CI, 0.61-0.96). Survival analysis of the matched cohort also demonstrated improved survival with adjuvant RT (120 months vs 100 months; P = .02). Subgroup analysis in both the unmatched and matched cohorts showed patients with high-grade tumors more likely to benefit from adjuvant RT. CONCLUSIONS: This population-based analysis is the largest dataset of primary thoracic STSs to date and suggests significant survival benefit associated with adjuvant RT. The improvement in OS was more notable in patients with high-grade tumors. Randomized prospective studies are warranted to further understand the benefit of RT in this group.

Association of tumor location with economic outcomes and air leak complications in thoracic lobectomies: results from a national hospital billing dataset.

Purpose: To assess whether tumor location during thoracic lobectomies affects economic outcomes or air leak complications. Patients and methods: Retrospective, observational study using Premier Healthcare Database. The study included patients aged ≥18 years who underwent elective inpatient thoracic lobectomy for lung cancer between 2012 and 2014 (first qualifying=index admission). Three mutually exclusive tumor location groups were formed: upper lobe, middle lobe, and lower lobe. Primary outcomes were index admission's length of stay (LOS), total hospital costs, and operating room time; in-hospital air leak complications (composite of air leak/pneumothorax) served as an exploratory outcome. Multivariable models were used to examine the association between tumor location and the study outcomes, accounting for covariates and hospital-level clustering. Results: 8,750 thoracic lobectomies were identified: upper lobe (n=5,284), middle lobe (n=512), and lower lobe (n=2,954). Compared with the upper lobe, the middle and lower lobe groups had statistically significant (p<0.05): shorter adjusted LOS (7.0 days upper vs 5.8 days middle, 6.6 days lower), lower adjusted mean total hospital costs ($26,177 upper vs $23,109 middle, $24,557 lower), and lower adjusted odds of air leak complications (odds ratio middle vs upper=0.81, 95% CI=0.74-0.89; odds ratio lower vs upper=0.60, 95% CI=0.46-0.78). Findings were similar but varied in statistical significance when stratified by open and video-assisted thoracoscopic surgery approach. Conclusion: Among patients undergoing elective thoracic lobectomy for lung cancer in real-world clinical practice, upper lobe tumors were significantly associated with increased in-hospital resource use and air leak complications as compared with lower or middle lobe tumors.

Mutational landscape of head and neck squamous cell carcinomas in a South Asian population.

Head and neck squamous cell carcinoma (HNSCC) is the sixth most common cancer type globally and contributes significantly to burden of disease in South Asia. In Pakistan, HNSCC is among the most commonly diagnosed cancer in males and females. The increasing regional burden of HNSCC along with a unique set of risk factors merited a deeper investigation of the disease at the genomic level. Whole exome sequencing of HNSCC samples and matched normal genomic DNA analysis (n=7) was performed. Significant somatic single nucleotide variants (SNVs) were identified and pathway analysis performed to determine frequently affected signaling pathways. We identified significant, novel recurrent mutations in ASNS (asparagine synthetase) that may affect substrate binding, and variants in driver genes including TP53, PIK3CA, FGFR2, ARID2, MLL3, MYC and ALK. Using the IntOGen platform, we identified MAP kinase, cell cycle, actin cytoskeleton regulation, PI3K-Akt signaling and other pathways in cancer as affected in the samples. This data is the first of its kind from the Pakistani population. The results of this study can guide a better mechanistic understanding of HNSCC in the population, ultimately contributing new, rational therapeutic targets for the treatment of the disease.

Robotic Thoracic Surgery Training for Residency Programs: A Position Paper for an Educational Curriculum.

OBJECTIVE: Robotic-assisted surgery is increasingly being used in thoracic surgery. Currently, the Integrated Thoracic Surgery Residency Program lacks a standardized curriculum or requirement for training residents in robotic-assisted thoracic surgery. In most circumstances, because of the lack of formal residency training in robotic surgery, hospitals are requiring additional training, mentorship, and formal proctoring of cases before granting credentials to perform robotic-assisted surgery. Therefore, there is necessity for residents in Integrated Thoracic Surgery Residency Program to have early exposure and formal training on the robotic platform. We propose a curriculum that can be incorporated into such programs that would satisfy both training needs and hospital credential requirements. METHODS: We surveyed all 26 Integrated Thoracic Surgery Residency Program Directors in the United States. We also performed a PubMed literature search using the key word "robotic surgery training curriculum." We reviewed various robotic surgery training curricula and evaluation tools used by urology, obstetrics gynecology, and general surgery training programs. We then designed a proposed curriculum geared toward thoracic Integrated Thoracic Surgery Residency Program adopted from our credentialing experience, literature review, and survey consensus. RESULTS: Of the 26 programs surveyed, we received 17 responses. Most Integrated Thoracic Surgery Residency Program directors believe that it is important to introduce robotic surgery training during residency. Our proposed curriculum is integrated during postgraduate years 2 to 6. In the preclinical stage postgraduate years 2 to 3, residents are required to complete introductory online modules, virtual reality simulator training, and in-house workshops. During clinical stage (postgraduate years 4-6), the resident will serve as a supervised bedside assistant and progress to a console surgeon. Each case will have defined steps that the resident must demonstrate competency. Evaluation will be based on standardized guidelines. CONCLUSIONS: Expansion and utilization of robotic assistance in thoracic surgery have increased. Our proposed curriculum aims to enable Integrated Thoracic Surgery Residency Program residents to achieve competency in robotic-assisted thoracic surgery and to facilitate the acquirement of hospital privileges when they enter practice.

Radiation therapy improves survival for unresectable postpneumonectomy lung tumors.

BACKGROUND: Additional resection for cancer in the single lung is often considered a prohibitive risk. The role of radiation therapy (RT) in this patient population is less clear with very limited available data. In this study, we sought to examine patients with postpneumonectomy lung cancer not amenable to surgery, identify factors associated with receiving RT, and determine the impact of RT on survival outcomes. METHODS: The Surveillance, Epidemiology, and End Results (SEER) database (1988-2013) was queried for patients with inoperable contralateral lung cancer after pneumonectomy. Univariate and multivariate analyses were performed to identify factors associated with the receipt of RT. Survival outcomes were examined using the Kaplan-Meier method. RESULTS: In total, 191 patients with inoperable postpneumonectomy lung cancer were included. RT was delivered to 122 (63.9%) patients; 69 (36.1%) patients did not receive RT. On multivariate analysis, disease stage was identified as the only predictor associated with receipt of RT (P < 0.001). The median overall survival (OS) and disease-specific survival (DSS) for patients receiving RT were higher than those for patients who did not receive RT (25 versus 8 mo and 29 versus 10 mo, respectively; P < 0.001). Similarly, patients who received RT had a higher 3-y OS (34% versus 14%, P < 0.001) than those who did not receive RT. On subset analysis, survival benefit with RT was observed in patients with all tumor size groups, and there was a trend toward superior survival in patients with stage I/II disease, who received RT compared with those who did not. On multivariate Cox regression analysis, RT use was independently associated with decreased hazards of death after adjusting for other factors (HR, 0.539; P < 0.001). CONCLUSIONS: Based on our analysis of the Surveillance, Epidemiology, and End Results (SEER) database, RT is associated with improved outcomes in inoperable patients with a contralateral lung cancer after pneumonectomy compared with observation alone.

Racial Disparity in Utilization of High-Volume Hospitals for Surgical Treatment of Esophageal Cancer.

BACKGROUND: Utilization of high-volume hospitals (HVH) for esophagectomy has been associated with improved perioperative outcomes and reduced mortality. We aimed to test the hypothesis that black-white racial disparities exist in HVH utilization and identify predictors of in-hospital surgical outcomes of esophageal cancer while adjusting for HVH utilization patterns. METHODS: We queried the New York Statewide Planning and Research Cooperative System database (1995 to 2012) for esophageal cancer patients who underwent surgical resection exclusively. Only records for patients with self-reported white or black race and a valid New York State ZIP code were included (n = 2,895). Analysis was performed to identify factors associated with HVH hospital (≥20 esophagectomies/year) utilization and determine predictors of complications and in-hospital mortality. RESULTS: Black patients (361 [12.5%]) were significantly different (p < 0.001) than their white counterparts in the proportion of women, Medicaid, income distribution, and privately insured individuals. Although 55% patients overall utilized an HVH, blacks were significantly less likely to utilize an HVH than whites (odds ratio [OR], 0.18; 95% confidence interval [CI], 0.14 to 0.24), even though 74.5% resided within 8.9 miles of one. Operations performed at HVHs were associated with lower in-hospital mortality (OR, 0.48; 95% CI, 0.35 to 0.65); however, mortality remained higher for blacks (OR, 2.04; 95% CI, 1.65 to 3.30; propensity matched OR, 2.45; 95% CI, 1.5 to 4.03). CONCLUSIONS: Black patients were less likely to undergo esophagectomy at an HVH and experienced higher mortality. Efforts should be made to understand factors influencing patients' decision process and improve referral practices to ensure optimal care is provided across all segments of the population, irrespective of race, insurance, or income status.

Pulmonary Resection for Second Lung Cancer After Pneumonectomy: A Population-Based Study.

BACKGROUND: Pulmonary resection for a second lung cancer after pneumonectomy is generally considered to be at prohibitive risk. Using a population-based database, we examined treatment patterns and survival in patients who underwent pulmonary resection after pneumonectomy for lung cancer. METHODS: We queried the Surveillance, Epidemiology, and End Results (SEER) database (1988-2012) to identify patients who underwent pneumonectomy and subsequently experienced contralateral non-small cell lung cancer (NSCLC). Multivariate logistic regression was performed to identify the factors associated with the receipt of surgical resection. Survival was estimated with the Kaplan-Meier method. RESULTS: Of 13,370 patients who underwent pneumonectomy, 402 (3.0%) experienced subsequent contralateral NSCLC, and 170 (42%) met the selection criteria. Surgical resection was performed in 63 (37.1%) cases (sublobar n = 56, lobectomy, n = 7). Patients with stage I/II disease and tumor size 2 cm or smaller were more likely to undergo surgical procedures. The 1-month and 3-month mortality after resection was 11.1% (sublobar resection 10.7%, lobectomy 14.3%) and 12.7% (sublobar 12.5%, lobectomy 14.3%), respectively. The overall 1-year and 3-year survival after surgical resection was 79% and 54%, respectively. The patients who underwent sublobar resection had higher median overall survival than did those who underwent lobectomy (42 vs 18 months). Similarly, median survival after resection for metachronous tumors was higher than after resection for metastatic cancers (40 vs 28 months). CONCLUSIONS: On the basis of our analysis of the SEER database, sublobar resection can be performed in selected patients with small tumors (≤2 cm) and early-stage disease (stage I/II). Although perioperative mortality is significant, the favorable 1-year and 3-year survival may justify the role of an additional procedure on the single lung.

Three-Dimensional-Printed Bioengineered Tracheal Grafts: Preclinical Results and Potential for Human Use.

BACKGROUND: We aimed to develop a process using three-dimensional (3D) printing to create bioengineered tracheal grafts (BETGs) for reconstruction of anterior tracheal defects in a large-animal model (porcine) that would have translational relevance for potential human use. METHODS: Preoperative computed tomographic scans were used to create virtual 3D models of the animal airways. Anatomically scaled tracheal grafts were subsequently developed using 3D-printed polycaprolactone and extracellular matrix. A 4-cm anterior tracheal defect (about 50% of the length of the subject trachea) was surgically created in 4-week-old female Yorkshire pigs and reconstructed using the customized grafts. Gross and microscopic analyses of the grafts were performed. RESULTS: The BETGs were implanted in 7 animals. There was adequate graft-native trachea size match at the operation. The trachea was successfully reconstructed in all cases. Gross examination at autopsy showed a structurally intact, well-incorporated graft. Histologic evaluation showed respiratory mucosal coverage and vascularity of the graft. Five of 7 animals outlived the 3-month study period. The animals had approximately 100% growth during the study period. CONCLUSIONS: We report of a 3D-printed BETG to repair long-segment anterior tracheal defects in a large-animal model. Although the study duration is short, this work presents an efficient strategy for tracheal graft bioengineering with potential translational relevance for human use.

Circumferential Three-Dimensional-Printed Tracheal Grafts: Research Model Feasibility and Early Results.

BACKGROUND: Methods for tracheal graft research have presented persistent challenges to investigators, and three-dimensional (3D)-printed biosynthetic grafts offer one potential development platform. We aimed to develop an efficient research platform for customizable circumferential 3D-printed tracheal grafts and evaluate feasibility and early structural integrity with a large-animal model. METHODS: Virtual 3D models of porcine subject tracheas were generated using preoperative computed tomography scans. Two designs were used to test graft customizability and the limits of the construction process. Designs I and II used 270-degree and 360-degree external polycaprolactone scaffolds, respectively, both encompassing a circumferential extracellular matrix collagen layer. The polycaprolactone scaffolds were made in a fused-deposition modeling 3D printer and customized to the recipient's anatomy. Design I was implanted in 3 pigs and design II in 2 pigs, replacing 4-ring tracheal segments. Data collected included details of graft construction, clinical outcomes, bronchoscopy, and gross and histologic examination. RESULTS: The 3D-printed biosynthetic grafts were produced with high fidelity to the native organ. The fabrication process took 36 hours. Grafts were implanted without immediate complication. Bronchoscopy immediately postoperatively and at 1 week demonstrated patent grafts and appropriate healing. All animals lived beyond a predetermined 1-week survival period. Bronchoscopy at 2 weeks showed significant paraanastomotic granulation tissue, which, along with partial paraanastomotic epithelialization, was confirmed on pathology. Overall survival was 17 to 34 days. CONCLUSIONS: We propose a rapid, reproducible, resource efficient method to develop various anatomically precise grafts. Further graft refinement and strategies for granulation tissue management are needed to improve outcomes.

Primary Non-Hodgkin's Lymphoma of the Gallbladder: A Population-based Analysis.

BACKGROUND/AIM: Primary Non-Hodgkin's lymphoma of the gallbladder (PNHL-GB) is extremely rare and data on clinical characteristics, optimal management and outcomes of these patients are limited to anecdotal reporting. We, therefore, sought to examine these patients using a population-based database. MATERIALS AND METHODS: Surveillance, epidemiology, and end results (SEER) database was queried between 1973 and 2013. RESULTS: One hundred and six cases with PNHL-GB were identified (mean age=70.5 ±15 years, whites 92%, male: female 1.03:1). The majority of patients had loco-regional disease (61%) and DLBCL histology (33%). Ninenty cases (85%) had undergone surgical resection, 6 (5.6%) received radiotherapy. Median overall survival (OS) of the entire cohort was 41 months with a 5-year survival rate of 40%. Patients receiving adjuvant RT had superior OS compared to surgery alone (140 ±27 vs. 86 ±16 months, respectively) and patients with DLBCL demonstrated lower survival compared to other histologies (13 vs. 53 months, respectively, p=0.034). CONCLUSION: Our study presents the largest dataset of PNHL-GB describing clinical features and outcomes of these patients in addition to summarizing the literature.

Reconstruction of Anterior Tracheal Defects Using a Bioengineered Graft in a Porcine Model.

BACKGROUND: Reconstruction of long-segment tracheal defects can be challenging and a suitable tracheal substitute remains lacking. We sought to create a bioengineered tracheal graft to repair such lesions using acellullar bovine dermis extracellular matrix (ECM) and male human mesenchymal stem cells (hMSCs) and implant it in a porcine model. METHODS: hMSCs were seeded on the ECM and incubated for 1 week with chondrogenic factors. An anterior 4 cm × 3 cm defect was surgically created in the trachea of 4-week-old female Yorkshire pigs. The defect was reconstructed using the bioengineered graft (n = 7) or control (n = 3, ECM only). The study duration was 3 months. RESULTS: Survival ranged from 7 days (n = 3) to 3 months (n = 7). Early death was due to graft malacia (n = 1, control), graft infection (n = 1, bioengineered), and pneumonia (n = 1, bioengineered). There was substantial animal growth at 3 months (>200% weight). Surveillance bronchoscopy showed patent airway, mild stenosis, and integration of the graft with the native trachea. On histology, luminal epithelialization and neovascularization with scant submucosa were observed in both the bioengineered graft and control groups. Chondrogenesis was seen only in the bioengineered graft. The neocartilage was less mature and organized compared to native cartilage. SRY immunostain was positive in the neocartilage but not control or native trachea. CONCLUSIONS: We demonstrate the feasibility of the bioengineered graft for reconstruction of long anterior tracheal defects with favorable short-term outcomes. Furthermore, we show its ability to facilitate chondrogenesis, neovascularization, and epithelialization. Importantly, it supported rapid animal growth offering potential solutions for both pediatric and adult applications.

Pneumopericardium Leading to Cardiac Tamponade in a Patient with Lung Cancer.

Pneumopericardium resulting in cardiac tamponade in patients with lung cancer is not documented. We report a case of squamous cell carcinoma of the lung complicated by pneumopericardium and subsequent cardiac tamponade. The patient underwent an urgent pericardial window with rapid improvement in symptoms. We discuss the possible pathogenesis and treatment options for this rare condition.

Robotically Assisted Thoracic Surgery: Proposed Guidelines for Privileging and Credentialing.

OBJECTIVE: Increased use of robotically assisted thoracic surgery (RATS) necessitates effective credentialing guidelines to ensure safe outcomes. We provide a stepwise algorithm for granting privileges and credentials in RATS. This algorithm reflects graduated responsibility and complexity of the surgical procedures performed. Furthermore, it takes into account volume, outcomes, surgeon's competency, and appropriateness of robot usage. METHODS: We performed a literature review for available strategies to grant privileges and credentials for implementing robotic surgery. The following terms were queried: robot, robotic, surgery, and credentialing. We provide this algorithm on the basis of review of the literature, our institutional experience, and the experience of other medical centers around the United States. RESULTS: Currently, two pathways for robotic training exist: residency and nonresidency-trained. In the United Sates, Joint Commission: Accreditation, Health Care, Certification requires hospitals to credential and privilege physicians on their medical staff. In the proposed algorithm, a credentialing designee oversees and reviews all requests. Residency-trained surgeons must fulfill 20 cases with program directors' attestation to obtain full privileges. Nonresidency-trained surgeons are required to fulfill simulation, didactics including online modules, wet laboratories (cadaver or animal), and observation of at least two cases before provisional privileges can be granted. A minimum number of cases (10 per year) are required to maintain privileges. All procedures are monitored via departmental QA/QI committee review. Investigational uses of the robot require institutional review board approval, and complex operations may require additional proctoring and QA/QI review. CONCLUSIONS: Safety concerns with the introduction of novel and complex technologies such as RATS must be paramount. Our algorithm takes into consideration appropriate use and serves as a basic guideline for institutions that wish to implement a RATS program.

Treatment of Benign Tracheal Stenosis Using Endoluminal Spray Cryotherapy.

Importance: Tracheal stenosis is a debilitating disorder with heterogeneity in terms of disease characteristics and management. Repeated recurrences substantially alter patients' quality of life. There is limited evidence for the use of spray cryotherapy (SCT) in the management of benign airway disease. Objective: To report our early results for the use of SCT in patients with benign tracheal stenosis. Design, Setting, and Participants: Data were extracted from the medical records of a consecutive series of patients with benign airway stenosis secondary to granulomatosis with polyangiitis (GPA) (n = 13), prior tracheotomy or tracheal intubation (n = 8), and idiopathic strictures (n = 5) treated from September 1, 2013, to September 30, 2015, at a tertiary care hospital. Main Outcomes and Measures: Airway narrowing was quantified on a standard quartile grading scale. Response to treatment was assessed by improvement in airway caliber and the time interval for reintervention. Exposures: Delivery of 4 5-second SCT cycles and 2 balloon dilatations. Results: Twenty-six patients (median [range] age, 53 [16-83] years; 20 [77%] female) underwent 48 SCT sessions. Spray cryotherapy was successfully used without any substantial intraoperative or postoperative complications in all patients. In a median (range) follow-up of 11 (1-26) months, all patients had improvement in symptoms. Before the institution of SCT, 23 patients (88%) had grade III or IV stenosis. At the last evaluation after induction of SCT, 4 (15%) had grade III or IV stenosis, with a mean (SD) change of 1.39 (0.51) (P < .001). Patients with GPA required significantly fewer SCT procedures (mean [SD], 1.38 [0.96] vs 2.31 [1.18]; P = .03) during the study period. Conclusions and Relevance: Spray cryotherapy was a safe adjunct modality to accomplish airway patency in patients with benign tracheal stenosis. Although efficacy evidence is limited for SCT, it may be useful for patients who have experienced treatment failure with conventional modalities. Further analysis of this cohort will determine the physiologic durability of the reported short-term changes. Additional trials are warranted for further evaluation of this modality.