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  1. 1. PCI in Facilities Without Cardiac Surgery On Site: An Expert Panel Review Other Considerations:Impacting Economies and Outcomes Monroe Township, New Jersey Tuesday, November 27, 2012 Ralph Brindis, MD MPH MACC Clinical Professor of Medicine University of California, San Francisco
  2. 2. Institute of Medicine Priorities for America • PCI without On-Site Surgery: We must overhaul the system to create care Wisely and Responsibly to ensure it is: Safe, Timely, Equitable, Efficient, Evidence-based and Patient-centered • Care should… • Be customized to patients’ needs and values • Have the patient be the source of control • Enable knowledge to be shared freelyInstitute of Medicine, Crossing the Quality Chasm: Adams, K & Corrigan,JM. Priority Areas for National Action:A New Health System for the Twenty-first Century Transforming Health Care Quality, IOM 2003
  3. 3. Emergent STEMI PCIPrimary Percutaneous CoronaryIntervention (PCI) is the mostcomplex, multi-disciplinary, andtime-sensitive therapeutic interventionin the world of medicine today. The Process is measured in Minutes The Outcomes are measured in Mortality Teamwork and smooth Transitions are essential ! Dr. Ivan Rokos,STEMI Systems, May 2007
  4. 4. 1. Time is Myocardium Mortality Reduction (%) 100 2. Infarct Size is Outcome 80 D 60 C 40 20 B A Extent of Myocardial Salvage 0 0 4 8 12 16 20 24 Time From Symptom Onset to Reperfusion Therapy, h Critical Time-dependent Period Time-independent Period Goal: Myocardial Salvage Goal: Open Infarct-Related ArteryGersh BJ, et al. JAMA. 2005;293:979.
  5. 5. Challenge is toSynchronize all theIndividualComponents …and seamlessly move STEMI patients safely & rapidly to the cath lab throughout the U.S. and the world!
  6. 6. Full Disclosure• This is my mother, Lenore• I love my mother!!!• I want the best care possible for my mother!!• My mother lived in East Brunswick, New Jersey
  7. 7. Percutaneous Coronary Intervention“At the Center of the Perfect Storm”Aging Population Increased CV Evidence Based Data Revascularization NCDR, CPORT, CPORT-E, NY State, California,Increased therapeutic Internationaloptions Patient – Centered Care Medical vs Revascularization Local AccessDirect to consumermarketing Local Care environment
  8. 8. The American Way Off-Site PCI Free Market Competition- Bane and Boon?State Health Dept. and Government Regulations?PCI Strategy: Top Down or Bottom Up????
  9. 9. The Cat is out of the Bag andThe Horse is out of the Barn!
  10. 10. Challenge IDEAL PATIENT CARE Need Volume Standards Vs. Vs.Economic Drivers Regionalization
  11. 11. The Ethical ChallengeMONEY PATIENT CARE
  12. 12. The American Way…… IOM’s Priority for America??• “…. has led to the uncomfortable situation in Texas in which many small (100 bed) community hospitals in close proximity to tertiary care centers have started stand-alone PCI programs with volumes < 100/year and many <50/year” David May, MD Chair- Elect, ACC Board of Governors
  13. 13. Michigan“ We have found that it is impossible for the state chapter to advocate a position on stand-alone PCI programs because every council memberhas conflicts of interest related to their employer, their personal beliefs, and their source of income” Claire Duvernoy, ACC Michigan Governor
  14. 14. Balancing Expectations: Economics and Clinical Outcomes “Force Field Analyses” Clinical OutcomesExpectations Economics
  15. 15. The Triumvirate Patients Practitioners/HospitalsPayers/Purchasers/Society
  16. 16. The TriumvirateThe Patient
  17. 17. Decision Making in PCI PATIENT INFLUENCES ON PCPs INFLUENCES ON SELF-REFERRAL CARDIOLOGISTS• Fear of missing Diagnosis• Asymptomatic screening • Fear of missing a diagnosis• Perception of patient anxiety PCP • Asymptomatic screening and expectations • Uncertainty of previous• Medico-legal liability test results• Uncertainty about best TESTING & • Perception of patient anxiety treatment leads to referral REFERRAL and expectations• Financial Gain • Belief in possible benefits CARDIOLOGIST of PCI in stable angina & asymptomatic patients • Medico-legal liability Adapted from: • Financial Gain Lin and Redberg, MORE TESTING Archives Int Med 2007 CATHETERIZATION
  18. 18. Patient Expectations About Elective PCI• 52 consecutive patients scheduled for first elective PCI completed semi-structured questionnaire prospectivelyDo you think the angioplasty will prevent a heart attack? Yes 75%Do you think the angioplasty will help you live longer? Yes 71% Holmboe et al. J Gen Intern Med 2000;15:632.
  19. 19. The TriumviratePhysicians/Hospitals
  20. 20. Physician’s “Force Field Analyses”• Practice Environment: • Patient expectation • Referring MD expectation • PCI physician’s expertise • Is this case appropriate for PCI ? • Malpractice fears? • Fee for Service environment • How does PCI contribute to my performance/outcomes measures ?
  21. 21. Physician’s “Force Field Analyses” for Off-Site PCI• Clinical Questions – Patient Selection: • Clinical Presentation? • Symptoms? • LV Function? • Other co-morbidities? • Optimal medical therapy? • Coronary Anatomy- defining/avoiding “High risk PCI” • LMCA, Other High risk subsets • “Heart Team” Concept : CV Surgery consultation Off-Site ???
  22. 22. Texas• No CON requirement- “Ever hospital (literally) wants a PCI program. If challenged that they are without SOS - claim they are starting a CABG program” • Motive: EMS will bypass non-STEMI hospitals with ANY sick patient independent of an ACS/STEMI diagnosis • No STEMI program = No ambulances = No $$$• 25 CABG programs in Dallas – 15-17 <100/year“..there are FOUR PCI programs in a 4 mile radius. Total FOUR Program volume is 220 cases. MD call is 1 in 2 and unacceptable. Incentives are aligned to $$ for each hospital with risk of worse care” Matt Phillips ACC TX Governor
  23. 23. Massachusetts• In 2006- Mass-COMM Elective PCI without SOS • Finished enrollment in 2011 with 11,000 patients • In centers already successfully performing Primary PCI • Hospital annual volume > 200/year, 75/yr MD • Study results soon to be released “… has an extensive consent form, but rarely patients were concerned about the issue. Unfortunately, I don’t think the patient consent forms adequately address the very real issues of conflict of interest inherent in a community (or tertiary care) program.” Dr. Fred Resnic, ACC MA Governor
  24. 24. California Elective PCI without SOS Pilot Study: 2011• Elective PCI Pilot without SOS vs. All California PCI Hospitals • Case mix : No significant differences • Elective PCI mortality, stroke, emergency CABG comparable outcomes • Off site PCI mortality not affected by PCI Off-Site hospital volume • PCI Off-Site volume varied between 100-400/year • 3 out of the 6 participating hospitals < 200/cases /year
  25. 25. PCI in the United StatesNCDR CathPCI Registry 2010-2011 Dehmer, et al JACC 2012
  26. 26. Percent of PCIs Performed at Low Volume Facilities Dehmer, et al JACC 2012
  27. 27. Physician/Hospital PCI Volume United States NCDR 2010National Median MD PCI volume: 87 casesMedian MD Primary PCI: 14 cases> 346 PCI Hospitals Surgery Off-SiteMedian PCI Hospital Volume Off-Site: 224 cases
  28. 28. The TriumviratePayers/Purchasers/Society
  29. 29. Payer/Purchasers/Regulator View?? Hospital PCI Off-Site Proliferation I gnorance of safety/efficacy M edico-legal fears A rrogance G ratuitous practice E conomic incentive E conomic incentive E conomic incentive
  30. 30. Payers/Purchasers/Society “Force Field Analysis”• Payment System Rewards Procedures • Quantity not necessarily Quality• Cost Control Mechanisms: • Reimbursement cuts, Pre-authorization, “outlaw” self-referral • Strategies to decrease low volume CABG/PCI centers • Horizon: Patient “Nudges” – to High Quality/Low Cost Sites?• Data - Clinical Outcomes ?• Data – PCI Off-Site vs On-Site Comparative Effectiveness?• Data – PCI Off-Site vs On-Site Cost Effectiveness?• ?Payers/Purchasers/Society Role : Top Down vs Bottom Up
  31. 31. Balancing Expectations: Economics and Clinical Outcomes “Force Field Analyses” Clinical OutcomesExpectations Economics Going Forward: Breaking Down the Force Field
  32. 32. Argument for PCI without SOS• Timely Access to Emergency PCI • Transfer-in First Door to Balloon in US < 120 minutes is only achieved in 33% of patients (ACTION-GWTG 2011) • “Walk-in/Drive-in” STEMIs are 50% of overall STEMI volume• Elective PCI increases PCI volume - ensures STEMI quality • The “Catch-22” of Primary PCI at Off-Site Facilities• Patient Convenience• MD Scheduling Convenience• Financial gains for the Off-Site PCI hospital ($20-50k/PCI)• Downwards volume trends in CABG Surgery
  33. 33. Disadvantages for PCI without SOS• 0.3% of patients require emergency CABG• More Off-Site hospitals reduce central receiving hospital PCI volumes with possible risk of reducing PCI safety/efficacy at larger hospitals• Might promote inappropriate PCI to satisfy volume criteria• Inefficiencies – Cost and Manpower expenditures• Central receiving hospitals lose important income• Central teaching hospitals lose teaching cases
  34. 34. Counter Argument to PCI without SOS Disadvantages• Predict only a small increase in new Off-site hospitals (predicted 10% in CA)• Major increase in # of Off-site hospitals would be due to conversion of On-site to Off-site status• In CA , potentially 25-50 reduction in # hospitals out of 120 performing CABG (low volume CABG supporting On-site PCI programs) and increase in CABG volume at central receiving hospitals
  35. 35. Why Perform Elective PCI at a Facility Without Surgery On Site?1. Minimize Rural Disparities2. Increase availability & ensure quality for Primary PCIOR MORE OFTEN THE “REAL” REASONS!!!3. Hospital financial incentives4. $$$$$5. Physician financial incentives6. $$$$$7. Euros8. Patient convenience9. Physician convenience
  36. 36. Triage and Transfer for PCI (in STEMI)• Each community and each facility in that community should have an agreed-upon plan for how STEMI patients are to be treated, including: – which hospitals should receive STEMI patients from EMS units capable of obtaining diagnostic ECGs – management at the initial receiving hospital, and – written criteria & agreements for expeditious transfer of patients from non-PCI-capable to PCI-capable facilities 2009 STEMI Focused Update. Appendix 5
  37. 37. North Carolina: RACE Centers and Regions 65 hospitals (10 PCI, 55 non PCI) Durham-Chapel Hill- Winston-Salem GreensboroAsheville Charlotte 10 PCI centers East Carolina 16 Transfer for PCI 28 Lytics Each non-PCI center was assessed for 11 Mixed reperfusion designation based on resources, transfer ability, and transfer time to PCI center
  38. 38. Great BritainNHS: “Top Down Approach”• National Infarct Angioplasty Project (NIAP)• 28 Integrated Networks performing Primary PCI• Defined Coverage areas• Defined MD Call• PPCI <10% to >70% !!!• Goal of 95%
  39. 39. Northern California Kaiser Permanente “Integrated Approach” Hub and Spoke Model – Tertiary Centers with On-Site Surgery, Spokes with Off- Site Surgery • 3 Hubs, 7 Spokes – Standardization of Lab equipment/design – MDs work at both Hub and Spoke – high MD volumes – Cath Lab staff rotate between Hub and Spoke – Excellent process, performance, and outcomes
  40. 40. Other Cardiovascular Procedures Wisely and Responsibly ???• TAVR • Responsible diffusion of Innovative Technology • CMS NCD: competency volume criteria in place • 190 active TAVR centers at present with potentially >1000 centers interested• Cardiac Transplant Programs • High volume center define as >15/year • Definite quality/volume relationship • Do we need 3 programs in Boston? • All 3 combined volume less than Cedars Sinai (45 vs 87)
  41. 41. Balancing Expectations: Economics and Clinical Outcomes “Force Field Analyses” Clinical OutcomesExpectations Economics Going Forward: CON or the American Way?
  42. 42. The American Way: The Politics is Local!!Free Market Competition- Bane and Boon?State Health Dept. and Government Regulations?PCI Strategy : Top Down or Bottom Up????
  43. 43. Donebedian’s Quality Triad • Systems • Process • Outcomes
  44. 44. Cath Lab Accreditation
  45. 45. Personnel and Facility Requirements for PCI Programs Without On-Site Surgical Backup
  46. 46. Patient and Lesion Selection for Elective PCI without SOS
  47. 47. Personalized Informed ConsentArnold, S. V. et al. Circ Cardiovasc Qual Outcomes 2008
  48. 48. Clinical Outcomes?
  49. 49. 2500 hospitals > 1000 cardiologists> 17 million clinical records PVI1998 2004 2005 2006 2007 2008 2010 2012
  50. 50. Executive Summary Performance Metrics
  51. 51. Doing the Right Thing Responsibly:Safe, Timely, Equitable, Efficient, Evidence-based & Patient-centered Clinical Concept Trials Guidelines, Credentialing, Accreditation Patient Centered QUALITY Outcomes & Cost Effectiveness Appropriate Linked Use Criteria CV Registries Performance
  52. 52. “I got a job to do here in New Jersey, thatsmuch bigger than politics, and I could care less about any of that stuff. I have a job to do.”