Mandatory public reporting of cardiac surgery outcomes: The 2003 to 2014 Massachusetts experience.

OBJECTIVES: Beginning in 2002, all 14 Massachusetts nonfederal cardiac surgery programs submitted Society of Thoracic Surgeons (STS) National Database data to the Massachusetts Data Analysis Center for mandatory state-based analysis and reporting, and to STS for nationally benchmarked analyses. We sought to determine whether longitudinal prevalences and trends in risk factors and observed and expected mortality differed between Massachusetts and the nation. METHODS: We analyzed 2003 to 2014 expected (STS predicted risk of operative [in-hospital + 30-day] mortality), observed, and risk-standardized isolated coronary artery bypass graft mortality using Massachusetts STS data (N = 39,400 cases) and national STS data (N = 1,815,234 cases). Analyses included percentage shares of total Massachusetts coronary artery bypass graft volume and expected mortality rates of 2 hospitals before and after outlier designation. RESULTS: Massachusetts patients had significantly higher odds of diabetes, peripheral vascular disease, low ejection fraction, and age ≥75 years relative to national data and lower odds of shock (odds ratio, 0.66; 99% confidence interval, 0.53-0.83), emergency (odds ratio, 0.57, 99% confidence interval, 0.52-0.61), reoperation, chronic lung disease, dialysis, obesity, and female sex. STS predicted risk of operative [in-hospital + 30-day] mortality for Massachusetts patients was higher than national rates during 2003 to 2007 (P < .001) and no different during 2008 to 2014 (P = .135). Adjusting for STS predicted risk of operative [in-hospital + 30-day] mortality, Massachusetts patients had significantly lower odds (odds ratio, 0.79; 99% confidence interval, 0.66-0.96) of 30-day mortality relative to national data. Outlier programs experienced inconsistent, transient influences on expected mortality and their percentage shares of Massachusetts coronary artery bypass graft cases. CONCLUSIONS: During 12 years of mandatory public reporting, Massachusetts risk-standardized coronary artery bypass graft mortality was consistently and significantly lower than national rates, expected rates were comparable or higher, and evidence for risk aversion was conflicting and inconclusive.

Drug-eluting stents versus bare metal stents prior to noncardiac surgery.

BACKGROUND: The safety of drug-eluting stents (DES) vs. bare metal stents (BMS) in the perioperative setting, a heightened state of inflammation and thrombosis is not well defined. METHODS: All adults undergoing noncardiac surgical (NCS) procedures within 1 year following percutaneous coronary intervention (PCI) in Massachusetts between April 1, 2004, and September 30, 2007, were identified from an administrative claims database. Patients were divided into those who received BMS vs. DES at index PCI. Primary net clinical outcome was death, myocardial infarction (MI) or bleeding within 30 days of NCS. Primary clinical outcome was 30-day death or MI. RESULTS: Among 8,415 (22% BMS) patients that satisfied our inclusion criteria, 1,838 BMS patients were matched with 3,565 DES patients with similar propensity scores. In the DES cohort, the 30-day primary net clinical outcome rate was lower with longer time from PCI to NCS (P = 0.02) with lowest rates if NCS was performed after 90 days from PCI (event rate 8.57, 7.53, 5.21, and 5.75% for 1-30, 31-90, 91-180, and 181-365 days from PCI to NCS). However, in the BMS cohort, the event rate was uniformly high regardless of the time from PCI to NCS (P = 0.60) (event rate 8.20, 6.56, 8.05, and 8.82% for 1-30, 31-90, 91-180, and 181-365 days from PCI to NCS). There was no significant difference between DES and the BMS group for 30-day primary net clinical outcome (6.64 vs. 7.89%; P = 0.10), but there was a 26% lower odds of primary clinical outcome (OR = 0.74, 95% CI 0.58-0.94) with DES when compared with BMS, driven mainly by differences in event rates when NCS was performed >90 days post PCI. CONCLUSION: DES implantation was not associated with higher adverse events after NCS. Moreover, the incidence of adverse events following NCS was lower when NCS was performed >90 days post-DES implantation suggesting that it may not be necessary to wait until 12 months post PCI with DES before NCS.

Long-term clinical outcomes following drug-eluting or bare-metal stent placement in patients with severely reduced GFR: Results of the Massachusetts Data Analysis Center (Mass-DAC) State Registry.

BACKGROUND: Patients with chronic kidney disease have been under-represented in randomized trials of drug-eluting stents relative to bare-metal stents and are at high risk of mortality. STUDY DESIGN: Cohort study with propensity score matching. SETTINGS & PARTICIPANTS: All adults with chronic kidney disease and severely decreased glomerular filtration rate (GFR; serum creatinine >2.0 mg/dL or dialysis dependence) undergoing percutaneous coronary intervention with stent placement between April 1, 2003, and September 30, 2005, at all acute-care nonfederal hospitals in Massachusetts. PREDICTOR: Patients were classified as drug-eluting stent-treated if all stents were drug eluting and bare-metal stent-treated if all stents were bare metal. Patients treated with both types of stents were excluded from the primary analysis. OUTCOMES & MEASUREMENTS: 2-year crude mortality risk differences (drug-eluting - bare-metal stents) were determined from vital statistics records, and risk-adjusted mortality, myocardial infraction (MI), and revascularization differences were estimated using propensity score matching of patients with severely reduced GFR based on clinical and procedural information collected at the index admission. RESULTS: 1,749 patients with severely reduced GFR (24% dialysis dependent) were treated with drug-eluting (n = 1,256) or bare-metal stents (n = 493) during the study. Overall 2-year mortality was 32.8% (unadjusted drug-eluting stent vs bare-metal stent; 30.1% vs 39.8%; P < 0.001). After propensity score matching 431 patients with a drug-eluting stent to 431 patients with a bare-metal stent, 2-year risk-adjusted mortality, MI, and target-vessel revascularization rates were 39.4% versus 37.4% (risk difference, 2.1%; 95% CI, -4.3 to 8.5; P = 0.5), 16.0% versus 19.0% (risk difference, -3.0%; 95% CI, -8.2 to 2.1; P = 0.3), and 13.0% versus 17.6% (risk difference, -4.6%; 95% CI, -9.5 to 0.3; P = 0.06). LIMITATIONS: Observational design, ascertainment of serum creatinine level >2.0 mg/dL and dialysis dependence from case report forms. CONCLUSIONS: In patients with severely decreased GFR, treatment with drug-eluting stents was associated with a modest decrease in target-vessel revascularization not reaching statistical significance and was not associated with a difference in risk-adjusted rates of mortality or MI at 2 years compared with bare-metal stents.

Comparison of clinical and administrative data sources for hospital coronary artery bypass graft surgery report cards.

BACKGROUND: Regardless of statistical methodology, public performance report cards must use the highest-quality validated data, preferably from a prospectively maintained clinical database. Using logistic regression and hierarchical models, we compared hospital cardiac surgery profiling results based on clinical data with those derived from contemporaneous administrative data. METHODS AND RESULTS: Fiscal year 2003 isolated coronary artery bypass grafting surgery results based on an audited and validated Massachusetts clinical registry were compared with those derived from a contemporaneous state administrative database, the latter using the inclusion/exclusion criteria and risk model of the Agency for Healthcare Research and Quality. There was a 27.4% disparity in isolated coronary artery bypass grafting surgery volume (4440 clinical, 5657 administrative), a 0.83% difference in observed in-hospital mortality (2.05% versus 2.88%), corresponding differences in risk-adjusted mortality calculated by various statistical methodologies, and 1 hospital classified as an outlier only with the administrative data-based approach. The discrepancies in volumes and risk-adjusted mortality were most notable for higher-volume programs that presumably perform a higher proportion of combined procedures that were misclassified as isolated coronary artery bypass grafting surgery in the administrative cohort. Subsequent analyses of a patient cohort common to both databases revealed the smoothing effect of hierarchical models, a 9% relative difference in mortality (2.21% versus 2.03%) resulting from nonstandardized mortality end points, and 1 hospital classified as an outlier using logistic regression but not using hierarchical regression. CONCLUSIONS: Cardiac surgery report cards using administrative data are problematic compared with those derived from audited and validated clinical data, primarily because of case misclassification and nonstandardized end points.