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Monitoring the Quality of Invasive Cardiac Services: The Unintended Consequences of Public Reporting. March, 2010. Frederic S. Resnic, MD MSc, FACC Brigham and Women’s Hospital and Harvard Medical School. Brigham and Women’s Hospital. Case Summary.
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Monitoring the Quality of Invasive Cardiac Services: The Unintended Consequences of Public Reporting March, 2010 Frederic S. Resnic, MD MSc, FACC Brigham and Women’s Hospital and Harvard Medical School
Brigham and Women’s Hospital Case Summary • Mr. H. is an active 67 year old, with history of hypertension, coronary artery disease and dilated cardiomyopathy, who presented in acute pulmonary edema to an outside hospital. He had previously refused coronary angiography. • On presentation, patient was profoundly hypotensive and dyspneic and required mechanical ventilation and support with multiple vas0-pressor agents • Urgent catheterization revealed left main with severe three vessel CAD and a thrombotic (acute) lesion in right coronary artery. PCWP=38, pH=7.09 • Underwent successful emergent PCI of RCA with IABP support. Echo demonstrated EF=15% with global hypokinesis and inferior AK.
Brigham and Women’s Hospital Case Summary • Transferred to BWH CCU for urgent consideration of CABG. • Unable to wean IABP; continued pressor dependence, worsening O2 requirements, worsening renal function. • Deemed not surgical candidate by two staff cardiac surgeons due to excessively high perioperative risk. • Family sought “everything that can be done” • Referred for high risk PCI of unprotected left main coronary artery, LAD and LCx to potentially allow wean from IABP and pressor support.
Brigham and Women’s Hospital
Brigham and Women’s Hospital
Brigham and Women’s Hospital Hospital Course • Remained on pVAD support for 5 days with reduced vasopressor requirements. • Myocardial function stabilized enough for pVAD to be removed; however continued pressor dependent and CVVH required for volume balance. • Progressive multi-system organ failure with ARF, ARDS and progressive liver failure. No clear neurologic recovery despite weaning all sedation. • Ultimately, patient made comfort measures only and expired peacefully on hospital day 20.
Brigham and Women’s Hospital Issues Raised • When does therapy transition from compassionate high risk to futile care? • What are the hidden costs of public reporting? • While no acute complication of either PCI procedure, patient’s ultimate death is associated with pVAD supported PCI at receiving hospital (LAD/LCX) for purposes of MA DPH reporting. • Is risk adjusted mortality an adequate measure of cardiac quality for PCI? • Estimated mortality risk for this patient: ~ 40% per MA mortality prediction model.
Brigham and Women’s Hospital Overview • Defining “Quality” in Cardiac Surgery and Angioplasty • Benefits and risks of public release of individual quality monitoring results • Evidence for unintended consequences • Strategies for a more comprehensive approach to quality monitoring
Brigham and Women’s Hospital Interpreting Mass-DAC Reports Mass-DAC uses “Standardized Mortality Incidence Rates” (SMIR) to compare hospital risk adjusted in-hospital all-cause mortality as a measure of overall quality. Source: 2006 PCI in MA – www.massdac.org
Brigham and Women’s Hospital 2008 No Shock and No STEMI Risk Model Source: 2008 PCI in MA – www.massdac.org
Brigham and Women’s Hospital 2008: No Shock and No STEMI 2008 results indicate all centers performed within expectations. Source: 2008 PCI in MA – www.massdac.org
Brigham and Women’s Hospital 2008 Shock or STEMI Risk Model Source: 2008 PCI in MA – www.massdac.org
Brigham and Women’s Hospital 2008 Results: Shock or STEMI Again, no institutions identified as statistical outliers…. Source: 2008 PCI in MA – www.massdac.org
Brigham and Women’s Hospital Cardiac Quality: The Big Picture Clinical Outcomes Process Measures Access to Healthcare Appropriateness
Brigham and Women’s Hospital Cardiac Quality: The Big Picture Clinical Outcomes Process Measures Access to Healthcare Appropriateness
Brigham and Women’s Hospital Trade-Off’s in Public Reporting • Promotes Informed Consumer Choice • Hawthorne Effect • “Teeth” for Quality Monitoring • Accelerates Adoption of Best Practices • Transparency Benefits Risks
Brigham and Women’s Hospital Trade-Off’s in Public Reporting • Promotes Informed Consumer Choice • Hawthorne Effect • “Teeth” for Quality Monitoring • Accelerates Adoption of Best Practices • Transparency Benefits Risks
Brigham and Women’s Hospital Outcomes Trends in MA Unadjusted mortality has declined for both CABG and PCI treated patients in Massachusetts. Adapted from www.MassDac.org cardiac surgery and PCI reports 2002-2005
Brigham and Women’s Hospital Volume and Mortality Trends 2003-2007 Statewide results indicate a 7.5% per year reduction in elective (non Shock or STEMI) volume since 2003. Continued reduction in mortality of high risk group may indicate growing risk aversion by PCI operators. Source: 2007 PCI in MA – www.massdac.org
Brigham and Women’s Hospital Trade-Off’s in Public Reporting • Promotes Informed Consumer Choice • Hawthorne Effect • “Teeth” for Quality Monitoring • Accelerates Adoption of Best Practices • Transparency • Over-emphasis on MD • Emphasis on Low Risk Cases • Risk Avoidance of High Risk Cases • Up-coding and Gaming • Unmeasured Quality Parameters Ignored Benefits Risks
Brigham and Women’s Hospital NY State PCI Mortality Trends In-hospital mortality declined by 29% between 1998-2004, but was accompanied by a 43% reduction in the PCI treatment of cardiogenic shock. PCI for Cardiogenic Shock 1998-2004 NY PCI Mortality: 1998-2004 Adapted from: Annual Angioplasty Quality Reports 1997-2004 available from: www.health.state.ny.us/statistics/diseases/cardiovascular/
Brigham and Women’s Hospital Survival with Cardiogenic Shock Immediate revascularization confers sustained survival benefit is similar whether PCI or CABG is used. Hochman J et al. The SHOCK Trial 1999
Brigham and Women’s Hospital Risk Avoidance: Lessons from NY Michigan, with no public reporting, was compared to NY State for PCI risk factors and outcomes. MI Shock: 2.56% MI Shock: 2.56% MA Shock: 2.28% NY Shock: 0.38% Adapted from: Moscucci et al. JACC 45(11). June 2005.
Brigham and Women’s Hospital NY State in the SHOCK Trial • Investigators explored practice patterns of participating centers from NY State and all other U.S. enrolling centers in the SHOCK trial. • NY State was only state mandating public release of risk adjusted outcomes. • Provided a contemporaneous comparison with rigorous data collection and follow-up of high risk patient population in NY as compared with other regions. Apolito RA et al. Am Heart J February 2008
Brigham and Women’s Hospital NY State in the SHOCK Trial After institution of public reporting, centers in NY demonstrated lower rates of emergent revascularization as compared to non-NY centers. Time to CABG: NY = 101.2 hr Non-NY = 10.1hr Apolito RA et al. Am Heart J February 2008
Brigham and Women’s Hospital NY State in the SHOCK Trial Selective utilization leads to decreased mortality for PCI and CABG in Shock patients….However, overall mortality is increased in NY as compared to other states. Apolito RA et al. Am Heart J February 2008
Brigham and Women’s Hospital NY State in the SHOCK Trial Apolito RA et al. Am Heart J February 2008
Brigham and Women’s Hospital Comparing NY and MA Comparison of 2003 revascularization rates for cardiogenic shock demonstrate a 2-fold difference between the States. 71.3 cases 35.7 cases Cases of cardiogenic shock treated per 100,000 population Analysis based on data excerpted from public cardiac reports and U.S. census data
Brigham and Women’s Hospital Risk Adjustment Specificity We reviewed over 5,000 consecutive PCI procedures at BWH to assess the adequacy of data collection systems and risk adjustment algorithms for predicting mortality post-PCI. Possible PCI Related Definite PCI Related NOT Procedure Related Resnic FS and Welt FG Public Health Hazards of Risk Avoidance - JACC 2009
Brigham and Women’s Hospital Outcomes Trends in MA Unadjusted mortality has declined for both CABG and PCI treated patients in Massachusetts. Adapted from www.MassDac.org cardiac surgery and PCI reports 2002-2005
Brigham and Women’s Hospital Decline of rate of revascularization in Cardiogenic Shock in Massachusetts Between 2003 and 2005, the rates of revascularization in Massachusetts declined 37-43% 43% 37% Source: Mass-DAC Data Review. November 2007
Brigham and Women’s Hospital Cardiac Quality: The Big Picture Clinical Outcomes Process Measures Access to Healthcare Appropriateness
Brigham and Women’s Hospital Impact on Access to Care Disparities in access to CABG increased in NY, relative to other states, after the release of report cards Reduced Access Improved Access Source: Werner RM, Asch DA and Polsky D. Circulation March 2005
Brigham and Women’s Hospital Operator Volume and PCI Outcomes Exploration of Michigan data revealed a consistent trend toward improved risk adjusted outcomes with increasing operator volumes. Source: Moscucci et al. JACC August 2005
Brigham and Women’s Hospital Operator Volume and PCI Outcomes …. This trend was preserved within each expected risk quartile. Even in the lowest risk patients, low volume operators conferred twice the risk for death than high volume counterparts. Source: Moscucci et al. JACC August 2005
Brigham and Women’s Hospital Cardiac Quality: The Big Picture Clinical Outcomes Process Measures Access to Healthcare Appropriateness
Brigham and Women’s Hospital Appropriateness and Case Selection Creep ↑ Patient Benefit ↑ Survival ↓ Patient Benefit ↑ Survival Physician Preference Patient Benefit Acute Risk of Procedure ↑ Patient Benefit ↓ Survival ↓ Patient Benefit ↓ Survival Incremental Patient Health Benefit
Brigham and Women’s Hospital Appropriateness and Case Selection Creep Acute Risk of Procedure Incremental Patient Health Benefit
Brigham and Women’s Hospital Minimal CAD w/o Ischemia 75yo STEMI in Shock Focal CAD w/ Angina Focal CAD w/o Angina 65yo with Ant. STEMI Unstable Angina 55yo with NSTEMI 50yo STEMI in Shock 75yo ST Δ’s w/ Sepsis Appropriateness and Case Selection Creep Acute Risk of Procedure Incremental Patient Health Benefit
Brigham and Women’s Hospital Minimal CAD w/o Ischemia 75yo STEMI in Shock Focal CAD w/ Angina Focal CAD w/o Angina 65yo with Ant. STEMI Unstable Angina 55yo with NSTEMI 50yo STEMI in Shock 75yo ST Δ’s w/ Sepsis Appropriateness and Case Selection Creep Public Reporting can promote a Perverse Incentive Acute Risk of Procedure Incremental Patient Health Benefit
Brigham and Women’s Hospital Appropriateness and Case Selection Creep ↓ Patient Benefit ↑ Survival Acute Risk of Procedure ↑ Patient Benefit ↓ Survival Incremental Patient Health Benefit
Brigham and Women’s Hospital Improving Risk Adjustment • Based on physician input, beginning in 2006, Mass-DAC began prospectively collecting compassionate use classification information for all PCI cases. • Compassionate Use Prospectively Defined by any of: • Coma on presentation (Glasgow Coma score < 7) • Requirement for percutaneous assist support or percutaneous bypass (since amended to high anatomic risk with or without ventricular support) • CPR at start of procedure. • 100% adjudication for all compassionate use cases by trained interventional cardiologists. • Appeal process implemented to challenge adjudication decisions
Brigham and Women’s Hospital Decline of prevalence of Cardiogenic Shock in PCI and CABG in MA Between 2003 and 2005, the rates of revascularization in Massachusetts declined 37-43%..... Intro Comp Use Criteria Source: Mass-DAC Data Review. November 2008
Brigham and Women’s Hospital Outcomes of CU Admissions Source: Mass-DAC October 2009
Brigham and Women’s Hospital Improvement in Mortality Prediction Model (Shock/STEMI) Source: Mass-DAC October 2009
Brigham and Women’s Hospital Improvement in Mortality Prediction Model (Shock/STEMI) ROC Area: No CU: 0.87 w. CU: 0.90 P<0.01
Brigham and Women’s Hospital Why? Reclassification of Cases Source: Mass-DAC October 2009
Brigham and Women’s Hospital Reclassification of Cases with CU Source: Mass-DAC October 2009
Brigham and Women’s Hospital Decline of rate of revascularization in Cardiogenic Shock in Massachusetts Between 2003 and 2005, the rates of revascularization in Massachusetts declined 37-43%..... Intro Comp Use Criteria Source: Mass-DAC Data Review. November 2008