This document discusses percutaneous coronary intervention (PCI) performed at facilities without on-site cardiac surgery. It reviews considerations around ensuring PCI is performed safely, timely, equitably, efficiently, and in a patient-centered manner. The document discusses balancing economics and clinical outcomes when determining appropriate access to PCI services. It reviews data on PCI volumes and outcomes in the United States, considerations for patient selection and informed consent for elective PCI without on-site surgery, and strategies for ensuring quality such as clinical trials, guidelines, credentialing, accreditation, and use of clinical registries to monitor outcomes and drive continuous quality improvement. The overarching goal discussed is providing responsible access to PCI services while prioritizing patient-centered care

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. 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 freely
Institute 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. Emergent STEMI PCI
Primary Percutaneous Coronary
Intervention (PCI) is the most
complex, multi-disciplinary, and
time-sensitive therapeutic intervention
in 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. 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 Artery
Gersh BJ, et al. JAMA. 2005;293:979.

5. Challenge is to
Synchronize all the
Individual
Components
…and seamlessly move
STEMI patients safely &
rapidly to the cath lab
throughout the U.S. and
the world!

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. 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 International
options
Patient – Centered Care
Medical vs Revascularization
Local Access
Direct to consumer
marketing
Local Care environment

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. The Cat is out of the Bag and
The Horse is out of the Barn!

10. Challenge
IDEAL PATIENT CARE
Need Volume Standards
Vs. Vs.
Economic Drivers Regionalization

11. The Ethical Challenge
MONEY PATIENT CARE

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. Michigan
“ We have found that it is impossible for the state
chapter to advocate a position on stand-alone
PCI programs because every council member
has conflicts of interest related to their employer,
their personal beliefs, and their source of
income”
Claire Duvernoy, ACC Michigan Governor

14. Balancing Expectations:
Economics and Clinical Outcomes
“Force Field Analyses”
Clinical Outcomes
Expectations Economics

15. The Triumvirate
Patients
Practitioners/Hospitals
Payers/Purchasers/Society

16. The Triumvirate
The Patient

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. Patient Expectations About
Elective PCI
• 52 consecutive patients scheduled for first elective PCI
completed semi-structured questionnaire prospectively
Do 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. The Triumvirate
Physicians/Hospitals

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. 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. 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. 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. 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. PCI in the United States
NCDR CathPCI Registry 2010-2011
Dehmer, et al JACC 2012

26. Percent of PCIs Performed at Low Volume Facilities
Dehmer, et al JACC 2012

27. Physician/Hospital PCI Volume
United States NCDR 2010
National Median MD PCI volume: 87 cases
Median MD Primary PCI: 14 cases
> 346 PCI Hospitals Surgery Off-Site
Median PCI Hospital Volume Off-Site: 224 cases

28. The Triumvirate
Payers/Purchasers/Society

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. 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. Balancing Expectations:
Economics and Clinical Outcomes
“Force Field Analyses”
Clinical Outcomes
Expectations Economics
Going Forward:
Breaking Down the Force Field

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. 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. 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. Why Perform Elective PCI at a Facility
Without Surgery On Site?
1. Minimize Rural Disparities
2. Increase availability & ensure quality for Primary PCI
OR MORE OFTEN THE “REAL” REASONS!!!
3. Hospital financial incentives
4. $$$$$
5. Physician financial incentives
6. $$$$$
7. Euros
8. Patient convenience
9. Physician convenience

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. North Carolina: RACE Centers and Regions
65 hospitals (10 PCI, 55 non PCI)
Durham-Chapel Hill-
Winston-Salem Greensboro
Asheville
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. Great Britain
NHS: “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. 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. 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. Balancing Expectations:
Economics and Clinical Outcomes
“Force Field Analyses”
Clinical Outcomes
Expectations Economics
Going Forward:
CON or the American Way?

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. Donebedian’s Quality Triad
• Systems
• Process
• Outcomes

44. Cath Lab Accreditation

45. Personnel and Facility
Requirements for
PCI Programs
Without On-Site
Surgical
Backup

46. Patient and Lesion Selection for Elective PCI without SOS

47. Personalized Informed Consent
Arnold, S. V. et al. Circ Cardiovasc Qual Outcomes 2008

48. Clinical Outcomes?

49. 2500 hospitals
> 1000 cardiologists
> 17 million clinical records
PVI
1998 2004 2005 2006 2007 2008 2010 2012

50. Executive Summary Performance Metrics

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. “I got a job to do here in New Jersey, that's
much bigger than politics, and I could care less
about any of that stuff. I have a job to do.”