Comparison of Transcatheter Edge-to-Edge Mitral Valve Repair for Primary Mitral Regurgitation Outcomes to Hospital Volumes of Surgical Mitral Valve Repair.

BACKGROUND: Transcatheter edge-to-edge mitral valve (MV) repair (TEER) is an effective treatment for patients with primary mitral regurgitation at prohibitive risk for surgical MV repair (MVr). High-volume MVr centers and high-volume TEER centers have better outcomes than low-volume centers, respectively. However, whether MVr volume predicts TEER outcomes remains unknown. We hypothesized that high-volume MV surgical centers would have superior risk-adjusted outcomes for TEER than low-volume centers. METHODS: We combined data from the American College of Cardiology/Society of Thoracic Surgeons Transcatheter Valve Therapy registry and the Society of Thoracic Surgeons adult cardiac surgery database. MVr was defined as leaflet resection or artificial chords with or without annuloplasty and was evaluated as a continuous variable and as predefined categories (<25, 25-49, and ≥50 MV repairs/year). A generalized linear mixed model was used to evaluate risk-adjusted in-hospital/30-day mortality, 30-day heart failure readmission, and TEER success (mitral regurgitation ≤2+ and gradient <5 mm Hg). RESULTS: The study comprised 41 834 patients from 500 sites of which 332 (66.4%) were low, 102 (20.4%) intermediate, and 66 (13.2%) high-volume surgical centers (P<0.001). TEER success was 54.6% and was not statistically significantly different across MV surgical site volumes (P=0.4271). TEER mortality at 30 days was 3.5% with no significant difference across MVr volume on unadjusted (P=0.141) or adjusted (P=0.071) analysis of volume as a continuous variable. One-year mortality was 15.0% and was lower for higher MVr volume centers when adjusted for clinical and demographic variables (P=0.027). Heart failure readmission at 1 year was 9.4% and was statistically significantly lower in high-volume centers on both unadjusted (P=0.017) or adjusted (P=0.015) analysis. CONCLUSIONS: TEER can be safely performed in centers with low volumes of MV repair. However, 1-year mortality and heart failure readmission are superior at centers with higher MVr volume.

Impact of Diabetes on Pathologic Response to Multimodality Therapy for Esophageal Cancer.

BACKGROUND: The incidence of esophageal cancer has increased faster than that of most cancers. Evidence from other malignant neoplasms suggests that diabetic patients have a worse response to multimodality therapy. We hypothesized that diabetic patients with esophageal cancer will have a decreased response to neoadjuvant chemotherapy and radiation therapy compared with nondiabetic patients. METHODS: A retrospective study of The Society of Thoracic Surgeons General Thoracic Surgery Database identified all patients who had an esophagectomy after neoadjuvant therapy for esophageal cancer between 2012 and 2019. Patients were compared on the basis of the presence of diabetes. A pathologic complete response (pCR) was defined as ypT0 N0. The χ2 and Wilcoxon rank sum tests were used to compare patients' demographic and clinical characteristics between those with and those without diabetes. Multivariable logistic regression was used to evaluate the predictors of response to neoadjuvant therapy. RESULTS: Of the 9171 patients who met inclusion criteria, 2011 (22%) patients were diabetic and 7160 (78%) patients were nondiabetic. Patients with diabetes were older, more likely to be male, and more likely to have all comorbidities. Univariate analysis revealed that diabetic patients were less likely to have pCR (16% vs 18%; P = .026). Although multivariable analysis showed a trend toward diabetic patients' having lower odds of achieving pCR, diabetes was not independently associated with pCR (odds ratio, 0.89; 95% CI, 0.78-1.01; P = .075). CONCLUSIONS: Diabetic patients may be less likely than nondiabetic patients to achieve pCR after neoadjuvant treatment of esophageal cancer. This suggests the need for further exploration as diabetic patients with esophageal cancer can potentially benefit from different treatment paradigms compared with their nondiabetic counterparts.

Risk of Each of the Five Lung Lobectomies: A Society of Thoracic Surgeons Database Analysis.

BACKGROUND: The perioperative risk of pulmonary lobectomy as a solitary procedure has been extensively studied, yet the differences in outcomes between lobes, which have unique anatomy and a different amount of lung parenchyma, are entirely unknown. The purpose of this study was to define the risk of each of the 5 lobectomies. METHODS: The Society of Thoracic Surgeons Database was queried for patients undergoing lobectomy between 2008 and 2018. Patient and disease characteristics, operative variables, major morbidity, and 30-day mortality were examined. A multivariable logistic regression model (using the same variables in the current Society of Thoracic Surgeons lobectomy risk model) was developed to assess the contribution of lobectomy site to adverse outcomes. RESULTS: There were 65 006 patients analyzed. Adjusted perioperative mortality rate is lowest for right middle lobe (RML), 0.63%; intermediate for right upper lobe (RUL), left upper lobe (LUL), and left lower lobe (LLL), 1.08 to 1.24%; and highest for right lower lobe (RLL), 1.63%. The adjusted major morbidity rate is lowest for RML, 5.36%; intermediate for LLL and LUL, 7.82% to 8.33%; and highest for RUL and RLL, 8.94% to 9.32%. Adjusted intraoperative transfusion rate is lowest for RML, 1.37%; intermediate for RLL and LLL, 1.81% to 1.94%; and highest for RUL and LUL, 2.47% to 2.72%. CONCLUSIONS: There are clear differences in postoperative outcomes by lobectomy location. Mortality, major morbidity, and transfusion rate are lowest for RML but vary across other lobectomies. These differences should be appreciated in evaluating risk of operation, deciding on best therapy, counseling patients, and comparing outcomes.

Conversion to Thoracotomy During Thoracoscopic vs Robotic Lobectomy: Predictors and Outcomes.

BACKGROUND: Conversion to thoracotomy during minimally invasive lobectomy for lung cancer is occasionally necessary. Differences between video-assisted thoracoscopic surgery (VATS) and robotic-assisted thoracoscopic surgery (RATS) lobectomy conversion have not been described. METHODS: We queried The Society of Thoracic Surgeons General Thoracic Surgery Database from January 1, 2015 to December 31, 2018. Patients with prior thoracic operations and metastatic disease were excluded. Univariable comparisons with χ2 and Kruskal-Wallis tests and multivariable logistic regression modeling were performed. RESULTS: There were 27,695 minimally invasive lobectomies from 269 centers. Conversion to thoracotomy occurred in 11.0% of VATS and 6.0% of RATS (P < .001). Conversion was associated with increased mortality (P < .001), major complications (P < .001), and intraoperative (P < .001) and postoperative (P < .001) blood transfusions. Conversion from RATS occurred emergently (P < .001) and for vascular injury (P < .001) more frequently than from VATS, but there was no difference in overall major complications or mortality. Mortality after conversion was 3.1% for RATS and 2.2% for VATS (P = .24). Clinical cancer stage II or III (P < .001), preoperative chemotherapy (P = .003), forced expiratory volume in 1 second (P = .006), body mass index (P < .001), and left-sided resection (P = .0002) independently predicted VATS conversion. For RATS clinical stage III (P = .037), left-sided resection (P = .041), and forced expiratory volume in 1 second (P = .002) predicted conversion. Lower volume centers had increased rates of conversion (P < .001) in both groups. CONCLUSIONS: Conversion from minimally invasive to open lobectomy is associated with increased morbidity and mortality. Conversion occurs more frequently during VATS compared with RATS, albeit less often emergently, and with similar rates of overall mortality and major complications. Predictors, urgency, and reasons for conversion differ between RATS and VATS lobectomy and may assist in patient selection.

Impact of Chest Wall Resection on Mortality After Lung Resection for Non-Small Cell Lung Cancer.

BACKGROUND: Lung cancer invading the chest wall is treated with concomitant en bloc lung and chest wall resection (CWR). It is unclear how CWR affects postoperative outcomes of lung resection. We hypothesized that CWR would be associated with increased risk of adverse outcomes after lung cancer resection. METHODS: We performed a retrospective analysis of The Society of Thoracic Surgeons (STS) General Thoracic Surgery Database from 2016-2019. Patients with superior sulcus tumors were excluded. Patient demographic and operative outcomes were compared between those with and without CWR. Chest wall resection was added to existing STS lung risk models to determine the association with a composite adverse outcome, which included major morbidity and death. RESULTS: Among 41 310 lung resections, 306 (0.74%) occurred with concomitant CWR. Differences between those with and without CWR included demographic and comorbidities. Patients undergoing CWR were more likely to have the composite adverse outcome (64 of 306 [20.9%] vs 3128 of 41 004 [7.6%] for non-CWR resections, P < .001). Mortality was also increased among the CWR cohort (2.9% vs 1.1%, P = .003). CWR was associated with an increased risk of adverse composite outcome among all lung resection patients in a multivariable model (odds ratio 1.74, P = .0003) and the lobectomy subgroup (odds ratio 2.35, P < .0001). Among institutions with ≥10 lung resections, 49.1% performed lung resections with CWR. CONCLUSIONS: Concomitant CWR adds risk of adverse outcomes after lung cancer resection. As a subset of intuitions perform CWR, quality assessments should control for CWR. This variable will be incorporated into the STS lung cancer and lobectomy quality composite measures.

Palliative Care Always: Hepatology-Virtual Primary Palliative Care Training for Hepatologists.

Palliative care (PC) benefits patients with serious illness including end-stage liver disease (ESLD). As part of a cluster randomized trial, hepatologists were trained to deliver primary palliative care to patients with ESLD using an online course, Palliative Care Always: Hepatology (PCA:Hep). Here we present a multimethod formative evaluation (feasibility, knowledge acquisition, self-efficacy, and practice patterns) of PCA:Hep. Feasibility was measured by completion of coursework and achieving a course grade of >80%. Knowledge acquisition was measured through assessments before and throughout the course. Pre/post-course surveys were conducted to determine self-efficacy and practice patterns. The hepatologists (n = 39) enrolled in a 12-week online course and spent 1-3 hours on the course weekly. The course was determined to be feasible as 97% successfully completed the course and 100% passed. The course was acceptable to participants; 91.7 % reported a positive course experience and satisfaction with knowledge gained (91.6%). The pre/post knowledge assessment showed an improvement of 6.0% (pre 85.9% to post 91.9%, 95% CI [2.8, 9.2], P = 0.001). Self-efficacy increased significantly (P < 0.001) in psychological symptom management, hospice, and psychosocial support. A year after training, over 80% of the hepatologists reported integrating a variety of PC skills into routine patient care. Conclusion: PCA:Hep is feasible, acceptable, and improves learner knowledge and confidence in palliative care skills. This is a viable method to teach primary PC skills to specialists caring for patients with ESLD.

Adjustment Disorders in U.S. Active Duty Military Women: A Scoping Review for the Years 2000 to 2018.

BACKGROUND: Adjustment disorder (AD) is the most common mental health diagnosis in the U.S. military and is more than twice as likely to be diagnosed in active duty servicewomen as compared with male servicemembers. The literature on ADs, particularly in female servicemembers, has not been reviewed yet. We conducted a scoping review of the literature to explore the degree of research activity and summarize current literature gaps. METHODS: We created a PRISMA-ScR checklist and prospectively registered it in Open Science Framework. The literature search included articles (including studies and reports) published between 2000 and 2018 in either the grey literature or the following databases: Ovid Medline, CINAHL, Embase, PsycINFO, Web of Science, and Ovid Cochrane. We used DistillerSR to conduct title and abstracts screening, full-text screening, and data charting. The social ecological model for military women's health framework was used to organize the results. RESULTS: After screening 1,304 records, 29 were included for data charting. Most frequently, studies were descriptive (cross-sectional) (25%), with no randomized controlled studies. The studies primarily focused on ADs' risk factors in servicewomen (76%), followed by military readiness (38%). Only 14% addressed recommendations for treatments based on expert opinion, although they did not directly test interventions, and 7% focused on health outcomes. CONCLUSIONS: ADs affect the health of U.S. military women and military readiness, yet little is known about their successful treatment or health outcomes. Additional research in those areas is warranted.

Complications after Ravitch versus Nuss repair of pectus excavatum: A Society of Thoracic Surgeons (STS) General Thoracic Surgery Database analysis.

BACKGROUND: There are conflicting reports in the literature comparing outcomes after open Ravitch and minimally invasive Nuss procedures for pectus excavatum repair, and there is relatively little data available comparing the outcomes of these procedures performed by thoracic surgeons. METHODS: The 2010 to 2018 Society of Thoracic Surgeons General Thoracic Surgery Database was queried for patients age 12 or greater undergoing open or minimally invasive repair of pectus excavatum. Patients were stratified by operative approach. Multivariable logistic regression was performed with a composite outcome of 30-day complications. RESULTS: A total of 1,767 patients met inclusion criteria, including 1,017 and 750 patients who underwent minimally invasive pectus repair and open repair, respectively. Open repair patients were more likely to be American Society of Anesthesiologists (ASA) class III or greater (24% vs 14%; P < .001), have a history of prior cardiothoracic surgery (26% vs 14%; P < .001), and require longer operations (median 268 vs 185 minutes; P < .001). Open repair patients were more likely to require greater than 6 days of hospitalization (18% vs 7%; P < .001), undergo transfusion (7% vs 2%; P < .001), and be readmitted (8% vs 5%; P = .004). After adjustment, open repair was not associated with an increased risk of a composite of postoperative complications (odds ratio 0.99, 95% confidence interval 0.67-1.46). This finding persisted after propensity score matching (odds ratio 1.11, 95% confidence interval 0.74-1.67). CONCLUSION: Pectus excavatum repair procedure type was not associated with the risk of postoperative complications after adjustment. Further investigation is necessary to determine the impact of pectus excavatum repair type on recurrence and patient reported outcomes, including satisfaction, quality of life, and pain control.

Readmission After Lobectomy for Lung Cancer: Not All Complications Contribute Equally.

OBJECTIVE: The aim of this study was to identify independent predictors of hospital readmission for patients undergoing lobectomy for lung cancer. SUMMARY BACKGROUND DATA: Hospital readmission after lobectomy is associated with increased mortality. Greater than 80% of the variability associated with readmission after surgery is at the patient level. This underscores the importance of using a data source that includes detailed clinical information. METHODS: Using the Society of Thoracic Surgeons (STS) General Thoracic Surgery Database (GTSD), we conducted a retrospective cohort study of patients undergoing elective lobectomy for lung cancer. Three separate multivariable logistic regression models were generated: the first included preoperative variables, the second added intraoperative variables, and the third added postoperative variables. The c statistic was calculated for each model. RESULTS: There were 39,734 patients from 277 centers. The 30-day readmission rate was 8.2% (n = 3237). In the final model, postoperative complications had the greatest effect on readmission. Pulmonary embolus {odds ratio [OR] 12.34 [95% confidence interval (CI),7.94-19.18]} and empyema, [OR 11.66 (95% CI, 7.31-18.63)] were associated with the greatest odds of readmission, followed by pleural effusion [OR 7.52 (95% CI, 6.01-9.41)], pneumothorax [OR 5.08 (95% CI, 4.16-6.20)], central neurologic event [OR 3.67 (95% CI, 2.23-6.04)], pneumonia [OR 3.13 (95% CI, 2.43-4.05)], and myocardial infarction [OR 3.16 (95% CI, 1.71-5.82)]. The c statistic for the final model was 0.736. CONCLUSIONS: Complications are the main driver of readmission after lobectomy for lung cancer. The highest risk was related to postoperative events requiring a procedure or medical therapy necessitating inpatient care.

Variability in Smoking Status for Lobectomy Among Society of Thoracic Surgeons Database Participants.

BACKGROUND: Current smokers undergoing lobectomy are at greater risk of complications than are former smokers. The Society of Thoracic Surgeons (STS) composite score for rating program performance for lobectomy adjusts for smoking status, a modifiable risk factor. This study examined variability in the proportion of current smokers undergoing lobectomy among STS database participants. Additionally, the study determined whether each participant's rating changed if smoking was excluded from the risk adjustment model. METHODS: This is a retrospective analysis of the STS cohort used to develop the composite score for rating program performance for lobectomy. The study summarized the variability among STS database participants for performing lobectomy on current smokers and compared star ratings developed from models with and without smoking status. RESULTS: There were 24,912 patients with smoking status data: 23% current smokers, 62% former smokers, and 15% never smokers. There was significant variability among participants in the proportion of current smokers undergoing lobectomy (3% to 48.6%; P < .001). Major morbidity or mortality (composite) was greater in current smokers (12.1%) than in former smokers (8.6%) and never smokers (4.2%) (P < .001). Using the current risk adjustment model, participant star ratings were as follows: 1 star, n = 6 (3.2%); 2 stars, n = 170 (91.4%); and 3 stars, n = 10 (5.4%). When smoking status was excluded from the model, 1 participant shifted from a 2-star to a 3-star program. CONCLUSIONS: There is substantial variability among STS database participants with regard to the proportion of current smokers undergoing lobectomy. However, exclusion of smoking status from the model did not significantly affect participant star rating.

Initial and Longitudinal Cost of Surgical Resection for Lung Cancer.

BACKGROUND: The longitudinal cost of treating patients with non-small cell lung cancer (NSCLC) undergoing surgical resection has not been evaluated. We describe initial and 4-year resource use and cost for NSCLC patients aged 65 years of age or greater who were treated surgically between 2008 and 2013. METHODS: Using clinical data for NSCLC resections from The Society of Thoracic Surgeons General Thoracic Surgery Database linked to Medicare claims, resource use and cost of preoperative staging, surgery, and subsequent care through 4 years were examined ($2017). Cost of hospital-based care was estimated using cost-to-charge ratios; professional services and care in other settings were valued using reimbursements. Inverse probability weighting was used to account for administrative censoring. Outcomes were stratified by pathologic stage and by surgical approach for stage I lobectomy patients. RESULTS: Resection hospitalizations averaged 6 days and cost $31,900. In the first 90 days, costs increased with stage ($12,430 for stage I to $26,350 for stage IV). Costs then declined toward quarterly means more similar among stages. Cumulative costs ranged from $131,032 (stage I) to $205,368 (stage IV). In the stage I lobectomy cohort, patients selected for minimally invasive procedures had lower 4-year costs than did thoracotomy patients ($120,346 versus $136,250). CONCLUSIONS: The 4-year cost of surgical resection for NSCLC was substantial and increased with pathologic stage. Among stage I lobectomy patients, those selected for minimally invasive surgery had lower costs, particularly through 90 days. Potential avenues for improving the value of surgical resection include judicious use of postoperative intensive care and earlier detection and treatment of disease.

Factors Associated With Successful Postoperative Day One Discharge After Anatomic Lung Resection.

BACKGROUND: There are no criteria to estimate the risk of early discharge after anatomic lung resection. We hypothesized that demographic, clinical, and surgical variables could be used to predict successful postoperative day 1 (POD1) discharge after anatomic lung resection. METHODS: Patients with POD1 discharge after anatomic lung resection were identified in The Society of Thoracic Surgeons database from 2012 to 2018. Discharges were categorized as successful based on freedom from complications, readmission, or death. A multivariable model identified variables from univariate analysis and was further optimized using stepwise selection. This model was used to create a risk score of success. RESULTS: Among 62,785 patients who underwent anatomic lung resection, 2480 (3.9%) were discharged on POD1. Of the 2480 patients, 2129 (85.8%) had successful discharge and 351 (14.2%) had failed discharge due to postoperative complication (282; 11.3%), readmission (151; 6.1%), or death (9; 0.4%). In univariable analysis, successful POD1 discharge was associated with younger age, female sex, video-assisted thoracic surgery, higher forced expiratory volume in 1 second and diffusion capacity of lung for carbon monoxide, shorter operating room times, and lower rates of comorbidities. A risk model for successful discharge incorporated sex, age, body mass index, operative lobe, Zubrod score, American Society of Anesthesiologists class, coronary artery disease, chronic obstructive pulmonary disease, video-assisted thoracic surgery approach, and operating room time. Using this model, a risk score created, and derived estimated proportion of successful POD1 discharge varied from 75.6% to 92.9%. CONCLUSIONS: Demographic, clinical, and surgical variables are associated with successful POD1 discharge. This analysis suggests that a combination of demographic factors is associated with failed early discharge, and this understanding can be used in conjunction with clinical judgment to facilitate decisions regarding appropriateness of POD1 discharge.

Costs Associated With Lobectomy for Lung Cancer: An Analysis Merging STS and Medicare Data.

BACKGROUND: Costs related to care of patients who undergo lobectomy for lung cancer may vary depending on patient, disease, and treating facility characteristics. We aimed to identify underlying case mix factors that contribute to variability of 90-day costs of lobectomy for early-stage lung cancer. METHODS: The Society of Thoracic Surgeons General Thoracic Surgery Database was queried for lobectomy for clinical stage I lung cancer (2008-2013). Demographics, clinical outcomes, and 90-day episode-of-care costs across all care settings were analyzed for patients successfully linked to Medicare data. Hospital costs were estimated from charges using cost-to-charge ratios. Comprehensive regression models were created to identify impact of preoperative patient factors and hospital characteristics on costs, and to delineate additive costs due to perioperative outcomes and complications. RESULTS: The mean 90-day cost for lobectomy was $45,080 ± $38,239. Variables associated with significant additive costs were age greater than or equal to 75 years, American Society of Anesthesiologists classification III or IV, forced expiratory volume in 1 second less than 80% predicted, body mass index less than 18.5 or greater than 35, current or past smoker, cerebrovascular disease, chronic kidney disease, impaired functional status, open thoracotomy, prolonged operative time, government hospitals, metropolitan setting, and geographic location. Patients with 1 or more postoperative complication resulted in an overall mean added cost of $27,259. Added costs increased with the number of complications; isolated recurrent laryngeal nerve paresis ($3,911) and respiratory failure ($35,011) were associated with the least and most additive cost, respectively. CONCLUSIONS: Lobectomy is associated with substantial variability of episode-of-care costs. Variability is driven by patient demographic and clinical factors, hospital characteristics, and the occurrence and severity of complications.

Community Size and Lung Cancer Resection Outcomes: Studying The Society of Thoracic Surgeons Database.

BACKGROUND: Socioeconomic factors play key roles in surgical outcomes. Socioeconomic data within The Society of Thoracic Surgeons (STS) General Thoracic Surgery Database (GTSD) are limited. Therefore, we utilized community size as a surrogate to understand socioeconomic differences in lung cancer resection outcomes. METHODS: We retrospectively reviewed all lung cancer resections from January 2012 to January 2017 in the STS GTSD. This captured 68,722 patients from 286 centers nationwide. We then linked patient zip codes with 2013 Rural-Urban Continuum Codes to understand the association between community size and postoperative outcomes. Demographic and clinical variables were evaluated for relationships with 30-day mortality, major morbidity, and readmission. RESULTS: Zip codes were included in 47.2% of patients. Zip-coded patients were older, were more comorbid, had less advanced disease, and were more commonly treated with minimally invasive approaches than were those without zip code classification. For geocoded patients, multivariable analyses demonstrated that sex, insurance payor, and hospital region were associated with all 3 major endpoints. Community size, based on Rural-Urban Continuum Codes coding, was not associated with any primary endpoint. Invasive mediastinal staging was related to morbidity, greater pathological stage predicted mortality, and worsened clinical stage was associated with readmission. More invasive surgery and greater extent of lung resection were associated with all primary endpoints. CONCLUSIONS: Incomplete data capture can promote selection bias within the STS GTSD and skew outcomes reporting. Moreover, community size is an insufficient surrogate, compared with sex, insurance payor, hospital region, for understanding socioeconomic differences in lung cancer resection outcomes.

Volume Pledge is Not Associated with Better Short-Term Outcomes After Lung Cancer Resection.

PURPOSE: We examined the relationship between short-term outcomes and hospitals and surgeons who met minimum volume thresholds for lung cancer resection based on definitions provided by the Volume Pledge. A secondary aim was to evaluate the volume-outcome relationship to determine alternative thresholds in the event the Volume Pledge was not associated with outcomes. PATIENTS AND METHODS: We conducted a retrospective study (2015-2017) using the Society of Thoracic Surgeons General Thoracic Surgery Database. We used generalized estimating equations that accounted for confounding and clustering to compare outcomes across hospitals and surgeons who did and did not meet the Volume Pledge criteria: ≥ 40 patients per year for hospitals and ≥ 20 patients per year for surgeons. Our secondary aim was to model volume by using restricted cubic splines to determine the association between volume and short-term outcomes. RESULTS: Among 32,183 patients, 465 surgeons, and 209 hospitals, 16,630 patients (52%) received care from both a hospital and surgeon meeting the Volume Pledge criteria. After adjustment, there was no relationship with operative mortality, complications, major morbidity, a major morbidity-mortality composite end point, or failure to rescue. The Volume Pledge group had a 0.5 day (95% CI, 0.2 to 0.7 day) shorter length of stay. Our secondary aim revealed a nonlinear relationship between hospital volume and complications in which intermediate-volume hospitals had the highest risk of complications. Surgeon volume was associated with major morbidity, a major morbidity-mortality composite end point, and length of stay in an inverse linear fashion. Only 8% of surgeons had volumes associated with better outcomes. CONCLUSION: The Volume Pledge was not associated with better outcomes except for a marginally shorter length of stay. A re-examination of volume-outcome relationships for hospitals and surgeons yielded mixed results that did not reveal a practical alternative for volume-based quality improvement efforts.

Thrombolytic therapy in older acute ischemic stroke patients with gastrointestinal malignancy or recent bleeding.

BACKGROUND: There are limited data on the safety of intravenous recombinant tissue plasminogen activator (rtPA) for treating acute ischemic stroke in patients with gastrointestinal malignancy or recent gastrointestinal bleeding within 21 days of their index stroke. AIMS: To evaluate clinical outcomes in patients treated with rtPA for acute ischemic stroke who had gastrointestinal malignancy or recent gastrointestinal bleeding. METHODS: We identified patients who were treated with rtPA for acute ischemic stroke between 2/2009 and 12/2015 from the Get With The Guidelines-Stroke linked to Medicare claims data. Gastrointestinal malignancy and recent gastrointestinal bleeding were defined as any gastrointestinal malignancy hospitalisation within one year prior to acute ischemic stroke and gastrointestinal bleeding hospitalisation within 21 days prior to acute ischemic stroke, respectively. Outcomes of interest included in-hospital mortality and bleeding complications. RESULTS: Among 40,396 patients aged 65 years or older treated with rtPA for acute ischemic stroke from 1522 sites (mean age [SD] 81.0 [8.1] years; 41.9% women), 136 (0.3%) had gastrointestinal malignancy (n = 96) or recent gastrointestinal bleeding (n = 43). Patients with gastrointestinal malignancy or bleeding had more severe stroke than those without (median NIHSS [interquartile range]: 14.0 [8.0-19.0] vs. 11.0 [6.0-18.0]). The rates of in-hospital mortality and life-threatening systemic haemorrhage were not significantly different between those with and without gastrointestinal malignancy or bleeding (mortality: 10.3% vs. 9.0%, adjusted odds ratio [aOR] 1.01, 95%CI 0.58-1.75; bleeding: 2.3% vs. 1.2%, aOR 1.72, 95%CI 0.58-5.11). CONCLUSIONS: In this observational cohort, we did not find increased risk of in-hospital mortality and bleeding in rtPA-treated patients with gastrointestinal malignancy or recent gastrointestinal bleeding.

Equivalent Survival Between Lobectomy and Segmentectomy for Clinical Stage IA Lung Cancer.

BACKGROUND: The oncologic efficacy of segmentectomy is controversial. We compared long-term survival in clinical stage IA (T1N0) Medicare patients undergoing lobectomy and segmentectomy in The Society of Thoracic Surgeons database. METHODS: The Society of Thoracic Surgeons General Thoracic Surgery Database was linked to Medicare data in 14,286 lung cancer patients who underwent segmentectomy (n = 1654) or lobectomy (n = 12,632) for clinical stage IA disease from 2002 to 2015. Cox regression was used to create a long-term survival model. Patients were then propensity matched on demographic and clinical variables to derive matched pairs. RESULTS: In Cox modeling segmentectomy was associated with survival similar to lobectomy in the entire cohort (hazard ratio, 1.04; 95% confidence interval, 0.89-1.20; P = .64) and in the matched subcohort. A subanalysis restricted to the 2009 to 2015 population (n = 11,811), when T1a tumors were specified and positron emission tomography results and mediastinal staging procedures were accurately recorded in the database, also showed that segmentectomy and lobectomy continue to have similar survival (hazard ratio, 1.00; 95% confidence interval, 0.87-1.16). Subanalysis of the pathologic N0 patients demonstrated the same results. CONCLUSIONS: Lobectomy and segmentectomy for early-stage lung cancer are equally effective treatments with similar survival. Surgeons from The Society of Thoracic Surgeons database appear to be selecting patients appropriately for sublobar procedures.

The Society of Thoracic Surgeons Composite Score Rating for Pulmonary Resection for Lung Cancer.

BACKGROUND: The Society of Thoracic Surgeons (STS) General Thoracic Surgery Database (GTSD) has developed composite quality measures for lobectomy and esophagectomy. This study sought to develop a composite measure including all resections for lung cancer. METHODS: The STS lung cancer composite score is based on 2 outcomes: risk-adjusted mortality and morbidity. GTSD data were included from January 2015 to December 2017. "Star ratings" were created for centers with 30 or more cases by using 95% Bayesian credible intervals. The Bayesian model was performed with and without inclusion of the minimally invasive approach to assess the impact of approach on the composite measure. RESULTS: The study population included 38,461 patients from 256 centers. Overall operative mortality was 1.3% (495 of 38,461). The major complication rate was 7.9% (3045 of 38,461). The median number of nodes examined was 10 (interquartile range, 5 to 16); the median number of nodal stations sampled was 4 (interquartile range, 3 to 5). Positive resection margins were identified in 3.7% (1420 of 38,461). A total of 214 centers with 30 or more cases were assigned star ratings. There were 7 1-star, 194 2-star, and 13 3-star programs; 70.6% of resections were performed through a minimally invasive approach. Inclusion of minimally invasive approach, which was adjusted for in previous models, altered the star ratings for 3% (6 of 214) of the programs. CONCLUSIONS: Participants in the STS GTSD perform lung cancer resection with low morbidity and mortality. Lymph node data suggest that participants are meeting contemporary staging standards. There is wide variability among participants in application of minimally invasive approaches. The study found that risk adjustment for approach altered ratings in 3% of participants.

Operator Experience and Outcomes of Transcatheter Mitral Valve Repair in the United States.

BACKGROUND: Transcatheter mitral valve repair (TMVr) for the treatment of mitral regurgitation (MR) is a complex procedure that requires development of a unique skillset. OBJECTIVES: The purpose of this study was to examine the relationship between operator experience and procedural results of TMVr. METHODS: TMVr device procedures from the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy registry were analyzed with operator case number as a continuous and categorical (1 to 25, 26 to 50, and >50) variable. Outcomes of procedural success, procedural time, and in-hospital procedural complications were examined. The learning curve for the procedure was evaluated using generalized linear mixed models adjusting for baseline clinical variables. RESULTS: All TMVr device procedures (n = 14,923) performed by 562 operators at 290 sites between November 2013 and March 2018 were analyzed. Optimal procedural success (≤1+ residual MR without death or cardiac surgery) increased across categories of operator experience (63.9%, 68.4%, and 75.1%; p < 0.001), while procedural time and procedural complications decreased. Acceptable procedural success (≤2+ residual MR without death or cardiac surgery) also increased with operator experience, but the differences were smaller (91.4%, 92.4%, and 93.8%; p < 0.001). These associations remained significant in adjusted, continuous variable analyses. Visual inflection points in the learning curves for procedural time, procedural success, and procedural complications were evident after approximately 50 cases, with continued improvements observed out to 200 cases. CONCLUSIONS: For TMVr device procedures, operator experience was associated with improvements in procedural success, procedure time, and procedural complications. The effect of operator experience was greater when considering the goal of achieving 1+ residual MR.

Introducing Palliative Care within the Treatment of End-Stage Liver Disease: The Study Protocol of a Cluster Randomized Controlled Trial.

Introduction: Patients with end-stage liver disease (ESLD) suffer from myriad symptoms due to the systemic effects of the disease and unpredictable acute episodes, which contribute to progressive deterioration in quality of life (QOL). Despite clear evidence that palliative care (PC) improves QOL in other serious illnesses, PC is underutilized and delayed for ESLD patients. Through a comparative effectiveness trial of specialist led consultative PC (Model 1) versus trained hepatologist led PC (Model 2), we aim to build evidence on introducing PC into the routine outpatient care of ESLD patients. Objective: We hypothesize that trained hepatologist led PC model will have a better improvement in QOL compared to consultative PC model. Methods: This two-arm, multicenter cluster-randomized trial assesses the effectiveness of two PC models for patients with ESLD. Fourteen clinical centers will recruit 1260 patient-caregiver dyads. Each center is the unit of randomization. Hepatologists at sites randomized to the Model 2 have undergone web-based training in the principles of PC as pertained to ESLD. PC intervention is delivered over four visits (initial, one, two, and three months). Follow-up assessments occur at 6, 9, and 12 months. Eligible patients are those with new onset or ongoing complications of ESLD with a caregiver willing to participate. Outcomes: The primary outcome is change in patients' QOL from baseline to three months. Secondary outcomes include symptom burden, depression, distress, satisfaction with care, caregiver burden and QOL, goal concordant care, and health care utilization. Challenges and Contributions Engagement: A research advisory board has been developed with representatives from the participating centers, who have provided active feedback on the protocol, outcomes, study methods, and training program. Intervention Fidelity: Intervention fidelity will be maintained by adherence to a visit agenda and providers in both models completing a PC checklist after each study visit.