PCI in Facilities Without PCI in Facilities Without Cardiac Surgery On Site:Cardiac Surgery On Site:An Expert Panel ReviewAn Expert Panel Review

Other Considerations:Other Considerations: Impacting Economies and Outcomes Impacting Economies and Outcomes

Monroe Township, New JerseyMonroe Township, New JerseyTuesday, November 27, 2012Tuesday, November 27, 2012

Ralph Brindis, MD MPH MACCRalph Brindis, MD MPH MACCClinical Professor of MedicineClinical Professor of Medicine

University of California, San Francisco University of California, San Francisco

Institute of Medicine Priorities for AmericaInstitute of Medicine Priorities for America

• We must overhaul the system to create We must overhaul the system to create care to ensure it is:care to ensure it is:

Safe, Timely, Equitable, Efficient, Safe, Timely, Equitable, Efficient, Evidence-based and Patient-centeredEvidence-based and Patient-centered

• Care should…Care should…• Be customized to patients’ needs and valuesBe customized to patients’ needs and values

• Have the patient be the source of controlHave the patient be the source of control

• Enable knowledge to be shared freelyEnable knowledge to be shared freely

Adams, K & Corrigan,JM. Priority Areas for National Action:

Transforming Health Care Quality, IOM 2003 Institute of Medicine, Crossing the Quality Chasm:

A New Health System for the Twenty-first Century

PCI without On-Site Surgery:PCI without On-Site Surgery: Wisely and Responsibly Wisely and Responsibly

Primary Percutaneous Coronary Primary Percutaneous Coronary

Intervention (PCI) is the most Intervention (PCI) is the most

complex, multi-disciplinary, and complex, multi-disciplinary, and

time-sensitive therapeutic intervention time-sensitive therapeutic intervention

in the world of medicine today.in the world of medicine today.

Dr. Ivan Rokos,STEMI Systems, May 2007Dr. Ivan Rokos,STEMI Systems, May 2007

Emergent STEMI PCIEmergent STEMI PCI

The The ProcessProcess is measured inis measured in MinutesMinutesTheThe OutcomesOutcomes are measured inare measured in MortalityMortalityTeamworkTeamwork and smooth and smooth TransitionsTransitions are essential !are essential !

BB

CC

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Myocardial SalvageMyocardial Salvage

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00 44 88 1212 1616 2020 2424Time From Symptom Onset to Reperfusion Therapy, hTime From Symptom Onset to Reperfusion Therapy, h

Critical Time-dependent PeriodCritical Time-dependent PeriodGoal: Myocardial SalvageGoal: Myocardial Salvage

Time-independent PeriodTime-independent PeriodGoal: Open Infarct-Related ArteryGoal: Open Infarct-Related Artery

Gersh BJ, et al. Gersh BJ, et al. JAMA.JAMA. 2005;293:979. 2005;293:979.

1. Time is Myocardium1. Time is Myocardium2. Infarct Size is Outcome2. Infarct Size is Outcome

Challenge is to Challenge is to Synchronize all the Synchronize all the Individual Individual ComponentsComponents

……and seamlessly move and seamlessly move STEMI patients safely & STEMI patients safely & rapidly to the cath lab rapidly to the cath lab throughout the U.S. and throughout the U.S. and the world!the world!

Full DisclosureFull Disclosure

• This is my mother, LenoreThis is my mother, Lenore• I love my mother!!!I love my mother!!!• I want the best care possible I want the best care possible

for my mother!!for my mother!!• My mother lived in East My mother lived in East

Brunswick, New JerseyBrunswick, New Jersey

Percutaneous Coronary Intervention

“At the Center of the Perfect Storm”

Percutaneous Coronary Intervention

“At the Center of the Perfect Storm”

Aging PopulationAging Population Increased CV Increased CV

RevascularizationRevascularization

Increased therapeutic Increased therapeutic optionsoptions Medical vs RevascularizationMedical vs Revascularization

Direct to consumer Direct to consumer marketingmarketing Local Care environmentLocal Care environment

Evidence Based DataEvidence Based Data NCDR, CPORT, CPORT-E, NCDR, CPORT, CPORT-E,

NY State, California, NY State, California, InternationalInternational

Patient – Centered CarePatient – Centered Care Local Access Local Access

The American WayOff-Site PCI

The American WayOff-Site PCI

Free Market Competition- Bane and Boon?Free Market Competition- Bane and Boon?

State Health Dept. and Government Regulations?State Health Dept. and Government Regulations?

PCI Strategy: Top Down or Bottom Up????PCI Strategy: Top Down or Bottom Up????

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

ChallengeChallengeChallengeChallenge

Need

Vs.

Economic Drivers

Volume Standards

Vs.

Regionalization

IDEAL PATIENT CARE

The Ethical ChallengeThe Ethical ChallengeThe Ethical ChallengeThe Ethical Challenge

MONEY PATIENT CARE

The American Way…… IOM’s Priority for America??

The American Way…… IOM’s Priority for America??

• “…“…. has led to the uncomfortable situation in Texas . has led to the uncomfortable situation in Texas in which many small (100 bed) community in which many small (100 bed) community hospitals in close proximity to tertiary care centers hospitals in close proximity to tertiary care centers have started stand-alone PCI programs with have started stand-alone PCI programs with volumes < 100/year and many <50/year”volumes < 100/year and many <50/year”

David May, MD Chair- Elect, ACC Board of GovernorsDavid May, MD Chair- Elect, ACC Board of Governors

MichiganMichigan

“ “ We have found that it is impossible for the state We have found that it is impossible for the state chapter to advocate a position on stand-alone chapter to advocate a position on stand-alone PCI programs because every council member PCI programs because every council member

has conflicts of interest related to their employer, has conflicts of interest related to their employer, their personal beliefs, and their source of income”their personal beliefs, and their source of income”

Claire Duvernoy, ACC Michigan GovernorClaire Duvernoy, ACC Michigan Governor

Balancing Expectations: Economics and Clinical Outcomes

“Force Field Analyses”

Balancing Expectations: Economics and Clinical Outcomes

“Force Field Analyses”

ExpectationsExpectations EconomicsEconomics

Clinical OutcomesClinical Outcomes

The TriumvirateThe Triumvirate

PatientsPatients

Practitioners/HospitalsPractitioners/Hospitals

Payers/Purchasers/SocietyPayers/Purchasers/Society

The TriumvirateThe Triumvirate

The PatientThe Patient

INFLUENCES ON PCPsINFLUENCES ON PCPs

• Fear of missing Diagnosis Fear of missing Diagnosis • Asymptomatic screeningAsymptomatic screening• Perception of patient anxiety Perception of patient anxiety and expectationsand expectations• Medico-legal liabilityMedico-legal liability• Uncertainty about best Uncertainty about best treatment leads to referraltreatment leads to referral• Financial GainFinancial Gain

INFLUENCES ON INFLUENCES ON CARDIOLOGISTSCARDIOLOGISTS

• Fear of missing a diagnosisFear of missing a diagnosis• Asymptomatic screeningAsymptomatic screening• Uncertainty of previous Uncertainty of previous test resultstest results• Perception of patient anxiety Perception of patient anxiety and expectationsand expectations• Belief in possible benefits Belief in possible benefits of PCI in stable angina &of PCI in stable angina & asymptomatic patientsasymptomatic patients• Medico-legal liabilityMedico-legal liability• Financial GainFinancial Gain

SELF-REFERRALSELF-REFERRAL

TESTING &TESTING & REFERRALREFERRAL

Decision Making in PCI

CATHETERIZATIONCATHETERIZATION

CARDIOLOGISTCARDIOLOGIST

PCPPCP

PATIENTPATIENT

MORE TESTING MORE TESTING Adapted from:Adapted from:Lin and Redberg, Lin and Redberg, Archives Int Med 2007Archives Int Med 2007

Patient Expectations About Elective PCI

Patient Expectations About Elective PCI

• 52 consecutive patients scheduled for first 52 consecutive patients scheduled for first elective PCI elective PCI completed semi-structured questionnaire prospectivelycompleted semi-structured questionnaire prospectively

Holmboe et al. J Gen Intern Med 2000;15:632.

Do you think the angioplasty will prevent a heart attack?Do you think the angioplasty will prevent a heart attack?

YesYes 75%75%

Do you think the angioplasty will help you live longer?Do you think the angioplasty will help you live longer?

YesYes 71%71%

The TriumvirateThe Triumvirate

Physicians/HospitalsPhysicians/Hospitals

Physician’s “Force Field Analyses”Physician’s “Force Field Analyses”

• Practice Environment:Practice Environment:• Patient expectationPatient expectation• Referring MD expectationReferring MD expectation• PCI physician’s expertisePCI physician’s expertise• Is this case appropriate for PCI ?Is this case appropriate for PCI ?• Malpractice fears?Malpractice fears?• Fee for Service environmentFee for Service environment• How does PCI contribute to my performance/outcomes How does PCI contribute to my performance/outcomes

measures ?measures ?

Physician’s “Force Field Analyses”for Off-Site PCI

Physician’s “Force Field Analyses”for Off-Site PCI

• Clinical Questions – Patient Selection:Clinical Questions – Patient Selection:• Clinical Presentation?Clinical Presentation?• Symptoms?Symptoms?• LV Function?LV Function?• Other co-morbidities?Other co-morbidities?• Optimal medical therapy?Optimal medical therapy?• Coronary Anatomy- defining/avoiding “High risk PCI” Coronary Anatomy- defining/avoiding “High risk PCI”

• LMCA, Other High risk subsetsLMCA, Other High risk subsets

• ““Heart Team” Concept Heart Team” Concept : CV Surgery consultation Off-Site ??? : CV Surgery consultation Off-Site ???

TexasTexas• No CON requirement- No CON requirement- “Ever hospital (literally) wants a PCI program. If “Ever hospital (literally) wants a PCI program. If

challenged that they are without SOS - claim they are starting a CABG program”challenged that they are without SOS - claim they are starting a CABG program”• Motive: EMS will bypass non-STEMI hospitals with ANY sick patient Motive: EMS will bypass non-STEMI hospitals with ANY sick patient

independent of an ACS/STEMI diagnosisindependent of an ACS/STEMI diagnosis• No STEMI program = No ambulances = No $$$No STEMI program = No ambulances = No $$$

• 25 CABG programs in Dallas – 15-17 <100/year25 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. ..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 $$ for each hospital with risk of MD call is 1 in 2 and unacceptable. Incentives are aligned to $$ for each hospital with risk of worse care” worse care”

Matt Phillips ACC TX GovernorMatt Phillips ACC TX Governor

MassachusettsMassachusetts• In 2006- Mass-COMM Elective PCI without SOSIn 2006- Mass-COMM Elective PCI without SOS

• Finished enrollment in 2011 with 11,000 patientsFinished enrollment in 2011 with 11,000 patients• In centers already successfully performing Primary PCIIn centers already successfully performing Primary PCI• Hospital annual volume > 200/year, 75/yr MDHospital annual volume > 200/year, 75/yr MD• Study results soon to be releasedStudy results soon to be released

“… “… has an extensive consent form, but rarely patients were concerned has an extensive consent form, but rarely patients were concerned about the issue. Unfortunately, about the issue. Unfortunately, I don’t think the patient consent I don’t think the patient consent forms adequately address the very real issues of conflict of forms adequately address the very real issues of conflict of interest inherent in a community (or tertiary care) programinterest inherent in a community (or tertiary care) program.” Dr. .” Dr. Fred Resnic, ACC MA Governor Fred Resnic, ACC MA Governor

California Elective PCI without SOS Pilot Study: 2011

California Elective PCI without SOS Pilot Study: 2011

• Elective PCI Pilot without SOS vs. Elective PCI Pilot without SOS vs. All California PCI Hospitals All California PCI Hospitals

• Case mix : No significant differences Case mix : No significant differences • Elective PCI mortality, stroke, emergency CABG Elective PCI mortality, stroke, emergency CABG

comparable outcomescomparable outcomes• Off site PCI mortality not affected by PCI Off-Site Off site PCI mortality not affected by PCI Off-Site

hospital volumehospital volume• PCI Off-Site volume varied between 100-400/yearPCI Off-Site volume varied between 100-400/year• 3 out of the 6 participating hospitals < 200/cases /year3 out of the 6 participating hospitals < 200/cases /year

PCI in the United StatesNCDR CathPCI Registry 2010-2011

PCI in the United StatesNCDR CathPCI Registry 2010-2011

Dehmer, et al JACC 2012

Percent of PCIs Performed at Low Volume FacilitiesPercent of PCIs Performed at Low Volume Facilities

Dehmer, et al JACC 2012

Physician/Hospital PCI Volume United States NCDR 2010

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

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

The TriumvirateThe Triumvirate

Payers/Purchasers/SocietyPayers/Purchasers/Society

Payer/Purchasers/Regulator View??Hospital PCI Off-Site Proliferation

Ignorance of safety/efficacy

Medico-legal fears

Arrogance

Gratuitous practice

Economic incentive

Economic incentive

Economic incentive

Payers/Purchasers/Society “Force Field Analysis”

Payers/Purchasers/Society “Force Field Analysis”

• Payment System Rewards ProceduresPayment System Rewards Procedures• Quantity not necessarily QualityQuantity not necessarily Quality

• Cost Control Mechanisms:Cost Control Mechanisms:• Reimbursement cuts, Pre-authorization, “outlaw” self-referralReimbursement cuts, Pre-authorization, “outlaw” self-referral• Strategies to decrease low volume CABG/PCI centersStrategies to decrease low volume CABG/PCI centers• Horizon: Patient “Nudges” – to High Quality/Low Cost Sites?Horizon: Patient “Nudges” – to High Quality/Low Cost Sites?

• Data - Clinical Outcomes ?Data - Clinical Outcomes ?• Data – PCI Off-Site vs On-Site Comparative Effectiveness?Data – PCI Off-Site vs On-Site Comparative Effectiveness?• Data – PCI Off-Site vs On-Site Cost Effectiveness?Data – PCI Off-Site vs On-Site Cost Effectiveness?• ?Payers/Purchasers/Society Role : Top Down vs Bottom Up ?Payers/Purchasers/Society Role : Top Down vs Bottom Up

Balancing Expectations: Economics and Clinical Outcomes

“Force Field Analyses”

Balancing Expectations: Economics and Clinical Outcomes

“Force Field Analyses”

ExpectationsExpectations EconomicsEconomics

Clinical OutcomesClinical Outcomes

Going Forward:

Breaking Down the Force Field

Argument for PCI without SOSArgument for PCI without SOS• Timely Access to Emergency PCI Timely Access to Emergency PCI

• Transfer-in First Door to Balloon in US < 120 minutes is only achieved in Transfer-in First Door to Balloon in US < 120 minutes is only achieved in 33% of patients 33% of patients (ACTION-GWTG 2011)(ACTION-GWTG 2011)

• ““Walk-in/Drive-in” STEMIs are 50% of overall STEMI volumeWalk-in/Drive-in” STEMIs are 50% of overall STEMI volume

• Elective PCI increases PCI volume - ensures STEMI qualityElective PCI increases PCI volume - ensures STEMI quality• The “Catch-22” of Primary PCI at Off-Site FacilitiesThe “Catch-22” of Primary PCI at Off-Site Facilities

• Patient ConveniencePatient Convenience• MD Scheduling Convenience MD Scheduling Convenience • Financial gains for the Off-Site PCI hospital ($20-50k/PCI)Financial gains for the Off-Site PCI hospital ($20-50k/PCI)• Downwards volume trends in CABG SurgeryDownwards volume trends in CABG Surgery

Disadvantages for PCI without SOSDisadvantages for PCI without SOS

• 0.3% of patients require emergency CABG0.3% of patients require emergency CABG• More Off-Site hospitals reduce central receiving hospital More Off-Site hospitals reduce central receiving hospital

PCI volumes with possible risk of reducing PCI PCI volumes with possible risk of reducing PCI safety/efficacy at larger hospitalssafety/efficacy at larger hospitals

• Might promote inappropriate PCI to satisfy volume criteriaMight promote inappropriate PCI to satisfy volume criteria• Inefficiencies – Cost and Manpower expendituresInefficiencies – Cost and Manpower expenditures• Central receiving hospitals lose important incomeCentral receiving hospitals lose important income• Central teaching hospitals lose teaching casesCentral teaching hospitals lose teaching cases

Counter Argument to PCI without SOS Disadvantages

Counter Argument to PCI without SOS Disadvantages

• Predict only a small increase in Predict only a small increase in newnew Off-site Off-site hospitals (predicted 10% in CA)hospitals (predicted 10% in CA)

• Major increase in # of Off-site hospitals would be Major increase in # of Off-site hospitals would be due to conversion of On-site to Off-site statusdue to conversion of On-site to Off-site status

• In CA , potentially 25-50 reduction in # hospitals In CA , potentially 25-50 reduction in # hospitals out of 120 performing CABG (low volume CABG out of 120 performing CABG (low volume CABG supporting On-site PCI programs) and supporting On-site PCI programs) and increaseincrease in in CABG volume at central receiving hospitalsCABG volume at central receiving hospitals

Why Perform Elective PCI at a Facility Without Surgery On Site?

Why Perform Elective PCI at a Facility Without Surgery On Site?

1.1. Minimize Rural Disparities Minimize Rural Disparities 2.2. Increase availability & ensure quality for Primary PCIIncrease availability & ensure quality for Primary PCI

3.3. Hospital financial incentivesHospital financial incentives4.4. $$$$$$$$$$5.5. Physician financial incentivesPhysician financial incentives6.6. $$$$$$$$$$7.7. EurosEuros8.8. Patient conveniencePatient convenience9.9. Physician conveniencePhysician convenience

OR MORE OFTEN THE “REAL” REASONS!!!OR MORE OFTEN THE “REAL” REASONS!!!

Triage and Transfer for PCI (in STEMI)Triage and Transfer for PCI (in STEMI)Triage and Transfer for PCI (in STEMI)Triage and Transfer for PCI (in STEMI)

2009 STEMI Focused Update. Appendix 52009 STEMI Focused Update. Appendix 5

• Each community and each facility in that community Each community and each facility in that community should have an agreed-upon plan for how STEMI should have an agreed-upon plan for how STEMI patients are to be treated, including: patients are to be treated, including:

– which hospitals should receive STEMI patients from EMS which hospitals should receive STEMI patients from EMS units capable of obtaining diagnostic ECGs units capable of obtaining diagnostic ECGs

– management at the initial receiving hospital, andmanagement at the initial receiving hospital, and– written criteria & agreements for expeditious transfer of written criteria & agreements for expeditious transfer of

patients from non-PCI-capable to PCI-capable facilitiespatients from non-PCI-capable to PCI-capable facilities

10 PCI centers16 Transfer for PCI28 Lytics11 Mixed

North Carolina: RACE Centers and RegionsNorth Carolina: RACE Centers and Regions65 hospitals65 hospitals (10 PCI, 55 non PCI) (10 PCI, 55 non PCI)

Asheville

Winston-SalemDurham-Chapel Hill-

Greensboro

Charlotte

East Carolina

Each non-PCI center was assessed forreperfusion designation based on resources, transfer ability, and transfer time to PCI center

Great BritainGreat BritainNHS: NHS: “Top Down“Top Down Approach” Approach”

Great BritainGreat BritainNHS: NHS: “Top Down“Top Down Approach” Approach”

• National Infarct Angioplasty Project (NIAP)National Infarct Angioplasty Project (NIAP)

• 28 Integrated Networks performing Primary PCI28 Integrated Networks performing Primary PCI

• Defined Coverage areasDefined Coverage areas

• Defined MD CallDefined MD Call

• PPCI <10% to >70% !!!PPCI <10% to >70% !!!

• Goal of 95%Goal of 95%

Northern California Kaiser Permanente“Integrated Approach”

Northern California Kaiser Permanente“Integrated Approach”

Hub and Spoke ModelHub and Spoke Model

– Tertiary Centers with On-Site Surgery, Spokes with Off-Site Tertiary Centers with On-Site Surgery, Spokes with Off-Site SurgerySurgery• 3 Hubs, 7 Spokes3 Hubs, 7 Spokes

– Standardization of Lab equipment/designStandardization of Lab equipment/design– MDs work at both Hub and Spoke – high MD volumesMDs work at both Hub and Spoke – high MD volumes– Cath Lab staff rotate between Hub and SpokeCath Lab staff rotate between Hub and Spoke– Excellent process, performance, and outcomesExcellent process, performance, and outcomes

Other Cardiovascular ProceduresWisely and Responsibly ???

Other Cardiovascular ProceduresWisely and Responsibly ???

• TAVRTAVR• Responsible diffusion of Innovative TechnologyResponsible diffusion of Innovative Technology• CMS NCD: competency volume criteria in placeCMS NCD: competency volume criteria in place• 190 active TAVR centers at present with potentially >1000 centers 190 active TAVR centers at present with potentially >1000 centers

interested interested

• Cardiac Transplant ProgramsCardiac Transplant Programs• High volume center define as >15/yearHigh volume center define as >15/year

• DefiniteDefinite quality/volume relationship quality/volume relationship

• Do we need 3 programs in Boston?Do we need 3 programs in Boston?• All 3 combined volume less than Cedars Sinai (45 vs 87)All 3 combined volume less than Cedars Sinai (45 vs 87)

Balancing Expectations: : Economics and Clinical Outcomes

“Force Field Analyses”

Balancing Expectations: : Economics and Clinical Outcomes

“Force Field Analyses”

ExpectationsExpectations EconomicsEconomics

Clinical OutcomesClinical Outcomes

Going Forward: CON or the American Way?

The American Way:The Politics is Local!!The American Way:

The Politics is Local!!

Free Market Competition- Bane and Boon?Free Market Competition- Bane and Boon?

State Health Dept. and Government Regulations?State Health Dept. and Government Regulations?

PCI Strategy : Top Down or Bottom Up????PCI Strategy : Top Down or Bottom Up????

Donebedian’s Quality Triad Donebedian’s Quality Triad Donebedian’s Quality Triad Donebedian’s Quality Triad

• SystemsSystems• ProcessProcess

• OutcomesOutcomes

Cath Lab AccreditationCath Lab Accreditation

Personnel and FacilityPersonnel and FacilityRequirements forRequirements for

PCI ProgramsPCI ProgramsWithout On-Site Without On-Site

SurgicalSurgicalBackupBackup

Patient and Lesion Selection for Elective PCI without SOSPatient and Lesion Selection for Elective PCI without SOS

Arnold, S. V. et al. Arnold, S. V. et al. Circ Cardiovasc Qual Outcomes Circ Cardiovasc Qual Outcomes 20082008

Personalized Informed Consent

Clinical Outcomes?Clinical Outcomes?Clinical Outcomes?Clinical Outcomes?

1998 2004 2005 2006 2007 2008 2010 2012

PVI

2500 hospitals> 1000 cardiologists

> 17 million clinical records

Executive Summary Performance MetricsExecutive Summary Performance Metrics

Doing the Right Thing Responsibly:Doing the Right Thing Responsibly: Safe, Timely, Equitable, Efficient, Evidence-based & Patient-centeredSafe, Timely, Equitable, Efficient, Evidence-based & Patient-centered

ConceptConcept

OutcomesOutcomes

Clinical Trials

Clinical Trials

Guidelines, Credentialing,Accreditation

Guidelines, Credentialing,Accreditation

AppropriateUse CriteriaAppropriateUse Criteria

PerformancePerformancePerformancePerformance

Patient CenteredQUALITY

& CostEffectiveness

Patient CenteredQUALITY

& CostEffectiveness

LinkedCV

Registries

LinkedCV

Registries

“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.”

“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.”