The Society of Thoracic Surgeons voluntary public reporting initiative: the first 4 years.

OBJECTIVES: To evaluate participant characteristics and outcomes during the first 4 years of the Society of Thoracic Surgeons (STS) public reporting program. BACKGROUND: This is the first detailed analysis of a national, voluntary, cardiac surgery public reporting program using STS clinical registry data and National Quality Forum-endorsed performance measures. METHODS: The distributions of risk-adjusted mortality rates, multidimensional composite performance scores, star ratings, and volumes for public reporting versus nonreporting sites were studied during 9 consecutive semiannual reporting periods (2010-2014). RESULTS: Among 8929 unique observations (∼1000 STS participant centers, 9 reporting periods), 916 sites (10.3%) were classified low performing, 6801 (76.2%) were average, and 1212 (13.6%) were high performing. STS public reporting participation varied from 22.2% to 46.3% over the 9 reporting periods. Risk-adjusted, patient-level mortality rates for isolated coronary artery bypass grafting were consistently lower in public reporting versus nonreporting sites (P value range: <0.001-0.0077). Reporting centers had higher composite performance scores and star ratings (23.2% high performing and 4.5% low performing vs 7.6% high performing and 13.8% low performing for nonreporting sites). STS public reporting sites had higher mean annualized coronary artery bypass grafting volumes than nonreporting sites (169 vs 145, P < 0.0001); high-performing programs had higher mean coronary artery bypass grafting volumes (n = 241) than average (n = 139) or low-performing (n = 153) sites. Risk factor prevalence (except reoperation) and expected mortality rates were generally stable during the study period. CONCLUSIONS: STS programs that voluntarily participate in public reporting have significantly higher volumes and performance. No evidence of risk aversion was found.

Measurement of small molecule binding kinetics on a protein microarray by plasmonic-based electrochemical impedance imaging.

We report on a quantitative study of small molecule binding kinetics on protein microarrays with plasmonic-based electrochemical impedance microscopy (P-EIM). P-EIM measures electrical impedance optically with high spatial resolution by converting a surface charge change to a surface plasmon resonance (SPR) image intensity change, and the signal is not scaled to the mass of the analyte. Using P-EIM, we measured binding kinetics and affinity between small molecule drugs (imatinib and SB202190) and their target proteins (kinases Abl1 and p38-α). The measured affinity values are consistent with reported values measured by an indirect competitive binding assay. We also found that SB202190 has weak bindings to ABL1 with KD > 10 µM, which is not reported in the literature. Furthermore, we found that P-EIM is less prone to nonspecific binding, a long-standing issue in SPR. Our results show that P-EIM is a novel method for high-throughput measurement of small molecule binding kinetics and affinity, which is critical to the understanding of small molecules in biological systems and discovery of small molecule drugs.

Summary of bi-shRNA/GM-CSF augmented autologous tumor cell immunotherapy (FANG™) in advanced cancer of the liver.

Therapies for advanced hepatocellular carcinoma (HCC) are limited. We carried out a phase I trial of a novel autologous whole-cell tumor cell immunotherapy (FANG™), which incorporates a dual granulocyte macrophage colony-stimulating factor (GM-CSF) expressive/bifunctional small hairpin RNA interference (bi-shRNAi) vector. The bi-shRNAi DNA targets furin, which is a proconvertase of transforming growth factors beta (TGFß) 1 and 2. Safety, mechanism, immunoeffectiveness, and suggested benefit were previously shown [Senzer et al.: Mol Ther 2012;20:679-689; Senzer et al.: J Vaccines Vaccin 2013;4:209]. We now provide further follow-up of a subset of 8 HCC patients. FANG manufacturing was successful in 7 of 8 attempts (one failure due to insufficient cell yield). Median GM-CSF expression was 144 pg/10(6) cells, TGFß1 knockdown was 100%, and TGFß2 knockdown was 93% of the vector-transported cells. Five patients were vaccinated (1 or 2.5×10(7) cells/intradermal injection, 6-11 vaccinations). No FANG toxicity was observed. Three of these patients demonstrated evidence of an immune response to the autologous tumor cell sample. Long-term follow-up demonstrated survival of 319, 729, 784, 931+, and 1,043+ days of the FANG-treated patients. In conclusion, evidence supports further assessment of the FANG immunotherapy in HCC.

Phase I trial of "bi-shRNAi(furin)/GMCSF DNA/autologous tumor cell" vaccine (FANG) in advanced cancer.

We performed a phase I trial of FANG vaccine, an autologous tumor-based product incorporating a plasmid encoding granulocyte-macrophage colony-stimulating factor (GMCSF) and a novel bifunctional short hairpin RNAi (bi-shRNAi) targeting furin convertase, thereby downregulating endogenous immunosuppressive transforming growth factors (TGF) ß1 and ß2. Patients with advanced cancer received up to 12 monthly intradermal injections of FANG vaccine (1 × 10(7) or 2.5 × 10(7) cells/ml injection). GMCSF, TGFß1, TGFß2, and furin proteins were quantified by enzyme-linked immunosorbent assay (ELISA). Safety and response were monitored. Vaccine manufacturing was successful in 42 of 46 patients of whom 27 received ≥1 vaccine. There were no treatment-related serious adverse events. Most common grade 1, 2 adverse events included local induration (n = 14) and local erythema (n = 11) at injection site. Post-transfection mean product expression GMCSF increased from 7.3 to 1,108 pg/10(6) cells/ml. Mean TGFß1 and ß2 effective target knockdown was 93.5 and 92.5% from baseline, respectively. Positive enzyme-linked immunospot (ELISPOT) response at month 4 was demonstrated in 9 of 18 patients serially assessed and correlated with survival duration from time of treatment (P = 0.025). Neither dose-adverse event nor dose-response relationship was noted. In conclusion, FANG vaccine was safe and elicited an immune response correlating with prolonged survival. Phase II assessment is justified.

Serological survey to estimate SARS-CoV-2 infection and antibody seroprevalence at a large public university: A cross-sectional study.

OBJECTIVE: This study investigated the seroprevalence of SARS-CoV-2 antibodies among adults over 18 years. DESIGN: Prospective cohort study. SETTINGS: A large public university. PARTICIPANTS: This study took volunteers over 5 days and recruited 1064 adult participants. PRIMARY OUTCOME MEASURES: Seroprevalence of SARS-CoV-2-specific antibodies due to previous exposure to SARS-CoV-2 and/or vaccination. RESULTS: The seroprevalence of the antireceptor binding domain (RBD) antibody was 90% by a lateral flow assay and 88% by a semiquantitative chemiluminescent immunoassay. The seroprevalence for antinucleocapsid was 20%. In addition, individuals with previous natural COVID-19 infection plus vaccination had higher anti-RBD antibody levels compared with those who had vaccination only or infection only. Individuals who had a breakthrough infection had the highest anti-RBD antibody levels. CONCLUSION: Accurate estimates of the cumulative incidence of SARS-CoV-2 infection can inform the development of university risk mitigation protocols such as encouraging booster shots, extending mask mandates or reverting to online classes. It could help us to have clear guidance to act at the first sign of the next surge as well, especially since there is a surge of COVID-19 subvariant infections.

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.

Surgical approaches to the thymus in patients with myasthenia gravis.

Myasthenia gravis is an autoimmune disorder of neuromuscular transmission affecting 2 out of every 100,000 people. Neurologists and surgeons still debate what role surgery should play in its management. Many patients who might benefit from thymectomy are denied the opportunity because of misconceptions, ignorance, or trepidation. By offering effective methods of less invasive thymectomy to these patients, a significant number of patients and treating neurologists previously unwilling to consider surgery may realize the benefits of this established, proven treatment alternative. The surgical approaches reviewed include: transcervical, videothoracoscopic, robotic-assisted, transsternal, and combined transcervical-transsternal maximal thymectomy.

The Society of Thoracic Surgeons General Thoracic Surgery Database 2019 Update on Outcomes and Quality.

The Society of Thoracic Surgeons General Thoracic Surgery Database (STS GTSD) remains the most robust thoracic surgical database in the world, providing participating institutions semiannual risk-adjusted performance reports and facilitating multiple quality improvement initiatives each year. In 2018, the STS GTSD Data Collection Form was substantially revised to acquire the most important variables with the least data manager burden. In addition, a composite quality measure for all pulmonary resections for cancer was developed, and the impact that minimally invasive approaches have on the model was assessed. The 2018 database audit found that the accuracy of the database remains high, ranging from 92.5% to 98.4%. In 2019, the STS GTSD Task Force plans to focus on increasing generalizability of the database, initiating esophagectomy outcome public reporting, and creating customizable real-time dashboards. This review summarizes all national aggregate outcome, quality measurement, and improvement initiatives from the STS GTSD over the past 12 months.

Defining Proficiency for The Society of Thoracic Surgeons Participants Performing Thoracoscopic Lobectomy.

BACKGROUND: Parameters defining attainment and maintenance of proficiency in thoracoscopic video-assisted thoracic surgery (VATS) lobectomy remain unknown. To address this knowledge gap, this study investigated the institutional performance curve for VATS lobectomy by using risk-adjusted cumulative sum (Cusum) analysis. METHODS: Using The Society of Thoracic Surgeons General Thoracic Surgery Database, the study investigators identified centers that had performed a total of 30 or more VATS lobectomies. Major morbidity, mortality, and blood transfusion were deemed primary outcomes, with expected incidence derived from risk-adjusted regression models. Acceptable and unacceptable failure rates for outcomes were set a priori according to clinical relevance and informed by regression model output. RESULTS: Between 2001 and 2016, 24,196 patients underwent VATS lobectomy at 159 centers with a median volume of 103 (range, 30 to 760). Overall rates of operative mortality, major morbidity, and transfusion were 1% (244 of 24,189), 17.1% (4,145 of 24,196), and 4% (975 of 24,196), respectively. Of the highest-volume centers (≥100 cases), 84% (65 of 77) and 82 % (63 of 77) (p = 0.48) were proficient by major morbidity standards by their 50th and 100th cases, respectively. Similarly, 92% (71 of 77) and 90% (69 of 77) (p = 0.41) of centers showed proficiency by transfusion standards by their 50th and 100th cases, respectively. Three performance patterns were observed: (1) initial and sustained proficiency, (2) crossing unacceptability thresholds with subsequent improved performance; and (3) crossing unacceptability thresholds without subsequent improved performance. CONCLUSIONS: VATS lobectomy outcomes have improved with lower mortality and transfusion rates. The majority of high-volume centers demonstrated proficiency after 50 cases; however, maintenance of proficiency is not ensured. Cusum provides a simple yet powerful tool that can trigger internal audits and performance improvement initiatives.

Ibrutinib inhibition of ERBB4 reduces cell growth in a WNT5A-dependent manner.

Alterations in ERBB family members have been associated with many tumor malignancies. EGFR and ERBB2 have been extensively explored in clinical oncology and several drugs currently target them therapeutically. However, the significance of ERBB4 as a potential therapeutic target remains mostly unexplored, even though ERBB4 is overexpressed or mutated in many solid tumors. Using a unique functional protein microarray platform, we found that ibrutinib inhibits ERBB4 activity in the same nM range as its canonical target, BTK. Cell-based assays revealed that ibrutinib treatment inhibited cell growth and decreased phosphorylation of ERBB4 and downstream targets MEK and ERK in cancer cell lines with high levels of endogenous ERBB4. In vivo, ibrutinib-responsive mouse xenograft tumors showed decreased tumor volumes with ibrutinib treatment. Interestingly, global gene expression comparisons between responsive and non-responsive cells identified a signature featuring the WNT pathway that predicts growth responsiveness to ibrutinib. Non-responsive ERBB4-expressing cell lines featured elevated activity of the WNT pathway, through the overexpression of WNT5A. Moreover, inhibition of WNT5A expression led to an ibrutinib response in non-responsive cell lines. Our data show that inhibiting ERBB4 reduces cell growth in cells that have low WNT5A expression and reveal a link between the ERBB4 and WNT pathways.

Database Audit in Thoracic Surgery.

Administrative data are less accurate and relevant than specialty-specific, procedure-specific, risk-adjusted data collected in voluntary registries such as the Society of Thoracic Surgeons-General Thoracic Surgery Database (GTSD). Voluntary clinical databases must be proven accurate and complete before they are accepted as credible information sources. With substantial growth of the GTSD, an annual audit was initiated in 2010 to assess the completeness, accuracy, and quality of the data collected. The audit process is essential in validating data quality and adding credibility and value to volunteer clinical registries. It serves as an important tool for improvement of patient care.

Establishing a Dedicated General Thoracic Surgery Subspecialty Program Improves Lung Cancer Outcomes.

BACKGROUND: Various factors may influence outcomes after lobectomy for lung cancer. Postgraduate subspecialty training in general thoracic surgery with a focus on minimally invasive surgery (MIS) and thoracic oncology was completed by an established cardiothoracic surgeon on the hospital staff in July 2007, and principles emphasized in that training were incorporated into practice through formation of a subspecialty program. We hypothesized that establishing a dedicated general thoracic surgeon-lead subspecialty program, with focus on MIS and thoracic oncology, would improve short-term and long-term outcomes. METHODS: Patients entered into the hospital cancer registry have survival status updated annually through correspondence with patients, physicians, and searches of the Social Security Death Index and obituaries. The registry was queried for all patients undergoing lobectomy for lung cancer, 2002 to 2013, and divided into two groups for comparison, before and after, based on operation date relative to January 2008. Patients (n = 279) who had lobectomy for lung cancer were identified in the registry. Data included surgical approach (percent of video-assisted thoracoscopy [VATS]), pathologic stage, number of lymph nodes and stations sampled, hospital length of stay (LOS), and survival. χ2 statistics were used for proportions, t tests for continuous variables, and a nonparametric test for LOS. A Cox proportional hazard model was created, and survival curves were constructed using time between operation and death or last follow-up. RESULTS: Patients having lobectomy in the after group had substantially more VATS procedures (53.9% versus 9.5%), decreased LOS (median 3.5 versus 7.0 days), greater mean total lymph nodes (9.0 versus 6.3), and nodal stations (4.2 versus 2.8) sampled per patient. Thirty-day, 90-day, and 1-year survival were similar in both groups. Overall survival was better in the after group (hazard ratio [HR] 0.41, 95% confidence interval: 0.25 to 0.68), and this survival benefit remained statistically significant when comparing groups stratified by lung cancer stage (stage I: HR 0.46, stage II: HR 0.32, combined stage III to IV: HR 0.19). CONCLUSIONS: Establishing a dedicated general thoracic surgeon-lead subspecialty program, with focus on MIS and thoracic oncology, can substantially improve short-term outcomes with increased VATS utilization, decreased LOS, and increased lymph node sampling. Long-term survival was also significantly improved.

The Society of Thoracic Surgeons Composite Score for Rating Program Performance for Lobectomy for Lung Cancer.

BACKGROUND: The Society of Thoracic Surgeons (STS) has developed multidimensional composite quality measures for common cardiac surgery procedures. This first composite measure for general thoracic surgery evaluates STS participant performance for lobectomy in lung cancer patients. METHODS: The STS lobectomy composite score is composed of two outcomes: risk-adjusted mortality; and any-or-none, risk-adjusted major complications. General Thoracic Surgery Database data were included from 2011 to 2014 to provide adequate sample size, and 95% Bayesian credible intervals were used to determine "star ratings." The STS participants were also compared with national benchmarks (including non-STS participants) using the National Inpatient Sample. Comparisons of discharge mortality, postoperative length of stay, and percent of stage I lung cancers resected using minimally invasive approaches are not included in star ratings but will be reported to participants in STS feedback reports. RESULTS: The study population included 20,657 lobectomy patients from 231 participating centers. Operative mortality was 1.5%, major complication rate was 9.6%, and median postoperative length of stay was 4 days. Risk-adjusted mortality and major complication rates varied threefold from highest performing (three-star) to lowest performing (one-star) programs. Approximately 5% of participants were one-star, 7% were three-star, and 88% were two-star programs. CONCLUSIONS: The STS has developed the first general thoracic surgery quality composite measure to compare programs performing lobectomy for lung cancer. This measure will be used for quality assessment and provider feedback, and will be made available for voluntary public reporting.

The Society of Thoracic Surgeons Lung Cancer Resection Risk Model: Higher Quality Data and Superior Outcomes.

BACKGROUND: The Society of Thoracic Surgeons (STS) creates risk-adjustment models for common cardiothoracic operations for quality improvement purposes. Our aim was to update the lung cancer resection risk model utilizing the STS General Thoracic Surgery Database (GTSD) with a larger and more contemporary cohort. METHODS: We queried the STS GTSD for all surgical resections of lung cancers from January 1, 2012, through December 31, 2014. Logistic regression was used to create three risk models for adverse events: operative mortality, major morbidity, and composite mortality and major morbidity. RESULTS: In all, 27,844 lung cancer resections were performed at 231 centers; 62% (n = 17,153) were performed by thoracoscopy. The mortality rate was 1.4% (n = 401), major morbidity rate was 9.1% (n = 2,545), and the composite rate was 9.5% (n = 2,654). Predictors of mortality included age, being male, forced expiratory volume in 1 second, body mass index, cerebrovascular disease, steroids, coronary artery disease, peripheral vascular disease, renal dysfunction, Zubrod score, American Society of Anesthesiologists rating, thoracotomy approach, induction therapy, reoperation, tumor stage, and greater extent of resection (all p < 0.05). For major morbidity and the composite measure, cigarette smoking becomes a risk factor whereas stage, renal dysfunction, congestive heart failure, and cerebrovascular disease lose significance. CONCLUSIONS: Operative mortality and complication rates are low for lung cancer resection among surgeons participating in the GTSD. Risk factors from the prior lung cancer resection model are refined, and new risk factors such as prior thoracic surgery are identified. The GTSD risk models continue to evolve as more centers report and data are audited for quality assurance.

Predictors of Major Morbidity or Mortality After Resection for Esophageal Cancer: A Society of Thoracic Surgeons General Thoracic Surgery Database Risk Adjustment Model.

BACKGROUND: The purpose of this analysis was to revise the model for perioperative risk for esophagectomy for cancer utilizing The Society of Thoracic Surgeons General Thoracic Surgery Database to provide enhanced risk stratification and quality improvement measures for contributing centers. METHODS: The Society of Thoracic Surgeons General Thoracic Surgery Database was queried for all patients treated for esophageal cancer with esophagectomy between July 1, 2011, and June 30, 2014. Multivariable risk models for major morbidity, perioperative mortality, and combined morbidity and mortality were created with the inclusion of surgical approach as a risk factor. RESULTS: In all, 4,321 esophagectomies were performed by 164 participating centers. The most common procedures included Ivor Lewis (32.5%), transhiatal (21.7%), minimally invasive esophagectomy, Ivor Lewis type (21.4%), and McKeown (10.0%). Sixty-nine percent of patients received induction therapy. Perioperative mortality (inpatient and 30-day) was 135 of 4,321 (3.4%). Major morbidity occurred in 1,429 patients (33.1%). Major morbidities include unexpected return to operating (15.6%), anastomotic leak (12.9%), reintubation (12.2%), initial ventilation beyond 48 hours (3.5%), pneumonia (12.2%), renal failure (2.0%), and recurrent laryngeal nerve paresis (2.0%). Statistically significant predictors of combined major morbidity or mortality included age more than 65 years, body mass index 35 kg/m(2) or greater, preoperative congestive heart failure, Zubrod score greater than 1, McKeown esophagectomy, current or former smoker, and squamous cell histology. CONCLUSION: Thoracic surgeons participating in The Society of Thoracic Surgeons General Thoracic Surgery Database perform esophagectomy with low morbidity and mortality. McKeown esophagectomy is an independent predictor of combined postoperative morbidity or mortality. Revised predictors for perioperative outcome were identified to facilitate quality improvement processes and hospital comparisons.

Failure to Rescue Rates After Coronary Artery Bypass Grafting: An Analysis From The Society of Thoracic Surgeons Adult Cardiac Surgery Database.

BACKGROUND: Failure to rescue (FTR) is increasingly recognized as an important quality indicator in surgery. The Society of Thoracic Surgeons National Database was used to develop FTR metrics and a predictive FTR model for coronary artery bypass grafting (CABG). METHODS: The study included 604,154 patients undergoing isolated CABG at 1,105 centers from January 2010 to January 2014. FTR was defined as death after four complications: stroke, renal failure, reoperation, and prolonged ventilation. FTR was determined for each complication and a composite of the four complications. A statistical model to predict FTR was developed. RESULTS: FTR rates were 22.3% for renal failure, 16.4% for stroke, 12.4% for reoperation, 12.1% for prolonged ventilation, and 10.5% for the composite. Mortality increased with multiple complications and with specific combinations of complications. The multivariate risk model for prediction of FTR demonstrated a C index of 0.792 and was well calibrated, with a 1.0% average difference between observed/expected (O/E) FTR rates. With centers grouped into mortality terciles, complication rates increased modestly (11.4% to 15.7%), but FTR rates more than doubled (6.8% to 13.9%) from the lowest to highest terciles. Centers in the lowest complication rate tercile had an FTR O/E of 1.14, whereas centers in the highest complication rate tercile had an FTR O/E of 0.91. CONCLUSIONS: CABG mortality rates vary directly with FTR, but complication rates have little relation to death. FTR rates derived from The Society of Thoracic Surgeons data can serve as national benchmarks. Predicted FTR rates may facilitate patient counseling, and FTR O/E ratios have promise as valuable quality metrics.

Penetration, Completeness, and Representativeness of The Society of Thoracic Surgeons Adult Cardiac Surgery Database.

BACKGROUND: The Society of Thoracic Surgeons (STS) Adult Cardiac Surgery Database (ACSD) has been successfully linked to the Centers for Medicare and Medicaid (CMS) Medicare database, thereby facilitating comparative effectiveness research and providing information about long-term follow-up and cost. The present study uses this link to determine contemporary completeness, penetration, and representativeness of the STS ACSD. METHODS: Using variables common to both STS and CMS databases, STS operations were linked to CMS data for all CMS coronary artery bypass graft (CABG) surgery hospitalizations discharged between 2000 and 2012, inclusive. For each CMS CABG hospitalization, it was determined whether a matching STS record existed. RESULTS: Center-level penetration (number of CMS sites with at least one matched STS participant divided by the total number of CMS CABG sites) increased from 45% in 2000 to 90% in 2012. In 2012, 973 of 1,081 CMS CABG sites (90%) were linked to an STS site. Patient-level penetration (number of CMS CABG hospitalizations done at STS sites divided by the total number of CMS CABG hospitalizations) increased from 51% in 2000 to 94% in 2012. In 2012, 71,634 of 76,072 CMS CABG hospitalizations (94%) occurred at an STS site. Completeness of case inclusion at STS sites (number of CMS CABG cases at STS sites linked to STS records divided by the total number of CMS CABG cases at STS sites) increased from 88% in 2000 to 98% in 2012. In 2012, 69,213 of 70,932 CMS CABG hospitalizations at STS sites (98%) were linked to an STS record. CONCLUSIONS: Linkage of STS and CMS databases demonstrates high and increasing penetration and completeness of the STS database. Linking STS and CMS data facilitates studying long-term outcomes and costs of cardiothoracic surgery.

Patient selection and current practice strategy for off-pump coronary artery bypass surgery.

OBJECTIVE: Previous studies comparing off-pump coronary artery bypass surgery (OPCABG) to conventional techniques utilizing cardiopulmonary bypass (CABG-CPB) have failed to provide patient selection guidelines. We sought to determine guidelines, attempting to rectify the limitations of previous studies. METHODS AND RESULTS: A retrospective analysis of prospectively collected data from the Society of Thoracic Surgeons National Database, from January 1999 through December 2000, identified 204 602 multivessel coronary artery bypass (CABG) patients. Unadjusted and risk-adjusted odds ratios (OR) were calculated to compare OPCABG and CABG-CPB morbidity and mortality. A propensity model was developed to identify factors associated with selection for OPCABG. All off-pump patients were pair-matched with on-pump patients based on their propensity to receive an off-pump procedure. Off-pump patients, 8.8% of the total, had significantly different patient characteristics than the on-pump group. Characteristics associated with OPCABG selection included fewer diseased vessels, absence of left main disease, fewer bypass grafts, no previous CABG, older age, chronic lung disease, and renal failure. Unadjusted and risk-adjusted odds ratios indicate a significant off-pump survival benefit and decreased morbidity including stroke and renal failure in the overall group. Propensity matching also showed a significant OPCABG survival benefit [OR (95% CI) 0.83 (0.72, 0.96)]. Subgroup analysis of propensity-matched groups identified off-pump survival benefits in patients with previous CABG (OR=0.53), diabetics (OR=0.66), LVEF between 30% to 50% (OR=0.75), females (OR=0.79), and age 66 to 75 years (OR=0.80). CONCLUSIONS: OPCABG imparts some survival benefit to most patient subgroups. Higher risk patients including those undergoing reoperative CABG, diabetics, and the elderly may gain the most benefit.

Does reporting of coronary artery bypass grafting from administrative databases accurately reflect actual clinical outcomes?

OBJECTIVES: Quality assessment of coronary artery bypass grafting has traditionally been performed with data from clinical databases. Administrative databases that rely primarily on information collected for billing purposes increasingly have been used as tools for public reporting of outcomes quality. The correlation of administrative data with clinical data for clinical quality assessment has not been confirmed. METHODS: With data from a clinical database, we analyzed the outcomes of all patients who underwent coronary artery bypass grafting surgery in 1 hospital between 1999 and 2001. This information was collected before, during, and after the surgery and hospitalization by designated clinical individuals involved with the patient's care and then entered into an audited clinical database (The Society of Thoracic Surgeons National Cardiac Database). These data were then compared with administrative data collected on the same cohort of patients for the number of procedures performed and mortality rate as reported by the federal government (Medical Provider Analysis and Review), state government (Texas Health Care Information Council), hospital system (HCA, Inc, Casemix Database), and an internet Web site (healthgrades.com). Data were analyzed on the basis of the population reported, definitions used, risk assessment algorithms, and case volumes. RESULTS: By using the audited The Society of Thoracic Surgeons database as the standard and aggregating the reporting of case volumes by the inclusion criteria of various sources of administrative data, we found variances in the reported procedure volumes and mortality. Case volumes were overreported by as much as 21% in all patients and underreported by up to 16% or more in Medicare patients. Mortality in administrative data exceeded that reported in clinical data by 21%. Reasons for variances included time period reported (calendar vs fiscal year), population reported (all patients, Medicare patients, Medicare patients aged >/= 65 years), date used for the patient record captured (date of surgery, discharge), and the definition of mortality. Different proprietary risk-adjusting algorithms used magnified variances with risk-adjusted mortality exceeding the Society of Thoracic Surgeons data by as much as 61%. CONCLUSIONS: Substantial variability of reported outcomes is seen in administrative data sets compared with an audited clinical database in the end points of the number of procedures performed and mortality. This variability makes it challenging for the nonclinician unfamiliar with outcomes analysis to make an informed decision.

The Society of Thoracic Surgeons Composite Measure of Individual Surgeon Performance for Adult Cardiac Surgery: A Report of The Society of Thoracic Surgeons Quality Measurement Task Force.

BACKGROUND: Previous composite performance measures of The Society of Thoracic Surgeons (STS) were estimated at the STS participant level, typically a hospital or group practice. The STS Quality Measurement Task Force has now developed a multiprocedural, multidimensional composite measure suitable for estimating the performance of individual surgeons. METHODS: The development sample from the STS National Database included 621,489 isolated coronary artery bypass grafting procedures, isolated aortic valve replacement, aortic valve replacement plus coronary artery bypass grafting, mitral, or mitral plus coronary artery bypass grafting procedures performed by 2,286 surgeons between July 1, 2011, and June 30, 2014. Each surgeon's composite score combined their aggregate risk-adjusted mortality and major morbidity rates (each weighted inversely by their standard deviations) and reflected the proportion of case types they performed. Model parameters were estimated in a Bayesian framework. Composite star ratings were examined using 90%, 95%, or 98% Bayesian credible intervals. Measure reliability was estimated using various 3-year case thresholds. RESULTS: The final composite measure was defined as 0.81 × (1 minus risk-standardized mortality rate) + 0.19 × (1 minus risk-standardized complication rate). Risk-adjusted mortality (median, 2.3%; interquartile range, 1.7% to 3.0%), morbidity (median, 13.7%; interquartile range, 10.8% to 17.1%), and composite scores (median, 95.4%; interquartile range, 94.4% to 96.3%) varied substantially across surgeons. Using 98% Bayesian credible intervals, there were 207 1-star (lower performance) surgeons (9.1%), 1,701 2-star (as-expected performance) surgeons (74.4%), and 378 3-star (higher performance) surgeons (16.5%). With an eligibility threshold of 100 cases over 3 years, measure reliability was 0.81. CONCLUSIONS: The STS has developed a multiprocedural composite measure suitable for evaluating performance at the individual surgeon level.