Thomas wharton

TPWhartonTPWharton

Primary PCI –

Development and Outcomes

of a New Paradigm of Care

Thomas Wharton MD FACC FSCAI

Exeter Hospital, Exeter, NH

Primary PCI –





Off Site PCI Expert Panel ReviewOff Site PCI Expert Panel Review

TPWhartonTPWharton

Failure rate: 46% of patients receiving lytics are not Failure rate: 46% of patients receiving lytics are not reperfused well enough to improve survival (GUSTO).reperfused well enough to improve survival (GUSTO).

Recurrent Events: In 20% to 40% of patients.Recurrent Events: In 20% to 40% of patients.

Strokes: In 1.4% to 6.3%.Strokes: In 1.4% to 6.3%.

Contraindications: Only 25% to 33% of patients with acute Contraindications: Only 25% to 33% of patients with acute M.I. may be eligible for thrombolytic therapy.M.I. may be eligible for thrombolytic therapy.

Frequent Need for Subsequent Procedures: Cath, PTCAFrequent Need for Subsequent Procedures: Cath, PTCA

Are Given “Blindly”: Some patients will be treated Are Given “Blindly”: Some patients will be treated unnecessarily, because they have either spontaneously unnecessarily, because they have either spontaneously reperfused or been mis-diagnosed.reperfused or been mis-diagnosed.

A few of these patients will bleed into the head. A few of these patients will bleed into the head.

Failure rate: 46% of patients receiving lytics are not Failure rate: 46% of patients receiving lytics are not reperfused well enough to improve survival (GUSTO).reperfused well enough to improve survival (GUSTO).

Recurrent Events: In 20% to 40% of patients.Recurrent Events: In 20% to 40% of patients.

Strokes: In 1.4% to 6.3%.Strokes: In 1.4% to 6.3%.

Contraindications: Only 25% to 33% of patients with acute Contraindications: Only 25% to 33% of patients with acute M.I. may be eligible for thrombolytic therapy.M.I. may be eligible for thrombolytic therapy.

Frequent Need for Subsequent Procedures: Cath, PTCAFrequent Need for Subsequent Procedures: Cath, PTCA

Are Given “Blindly”: Some patients will be treated Are Given “Blindly”: Some patients will be treated unnecessarily, because they have either spontaneously unnecessarily, because they have either spontaneously reperfused or been mis-diagnosed.reperfused or been mis-diagnosed.

A few of these patients will bleed into the head. A few of these patients will bleed into the head.

Limitations of Thrombolytic AgentsLimitations of Thrombolytic AgentsLimitations of Thrombolytic AgentsLimitations of Thrombolytic Agents

NEJM 1993NEJM 1993

395 randomized lytic eligible pts with AMI : 395 randomized lytic eligible pts with AMI :

As compared with t-PA therapy for acute myocardial infarction, As compared with t-PA therapy for acute myocardial infarction, immediate PTCA reduced the combined occurrence of immediate PTCA reduced the combined occurrence of nonfatal nonfatal reinfarction or deathreinfarction or death, was associated with a lower rate of , was associated with a lower rate of intracranialintracranial hemorrhagehemorrhage, and resulted in similar left ventricular systolic function., and resulted in similar left ventricular systolic function.

PAMI-1 STUDYPAMI-1 STUDY

TPWhartonTPWharton

90-Minute Coronary Patency: PAMI vs GUSTO90-Minute Coronary Patency: PAMI vs GUSTO90-Minute Coronary Patency: PAMI vs GUSTO90-Minute Coronary Patency: PAMI vs GUSTO

FLOW GRADE PTCA (PAMI) tPA (GUSTO)

TIMI 0-1 (no flow) 6% 19%

TIMI 2 (slow flow) -- 27%

TIMI 3 (brisk flow) 94% 54%

FLOW GRADE PTCA (PAMI) tPA (GUSTO)

TIMI 0-1 (no flow) 6% 19%

TIMI 2 (slow flow) -- 27%

TIMI 3 (brisk flow) 94% 54%

TPWhartonTPWharton

Only 35% of 241,000 AMI pts were treated with Only 35% of 241,000 AMI pts were treated with lytics.lytics.

These lytic patients frequently needed other procedures:These lytic patients frequently needed other procedures:

70.7% underwent cath later before discharge70.7% underwent cath later before discharge

30.3% 30.3% “ “ PTCA PTCA

13.3% 13.3% ““ CABG CABG

LYTICS (35%)LYTICS (35%) NO LYTICS NO LYTICS (65%)(65%)

MortalityMortality 5.9% 5.9% 13.0%13.0%

Major bleedingMajor bleeding 2.8% 2.8% 0.5% 0.5%

Only 35% of 241,000 AMI pts were treated with Only 35% of 241,000 AMI pts were treated with lytics.lytics.

These lytic patients frequently needed other procedures:These lytic patients frequently needed other procedures:

70.7% underwent cath later before discharge70.7% underwent cath later before discharge

30.3% 30.3% “ “ PTCA PTCA

13.3% 13.3% ““ CABG CABG

LYTICS (35%)LYTICS (35%) NO LYTICS NO LYTICS (65%)(65%)

MortalityMortality 5.9% 5.9% 13.0%13.0%

Major bleedingMajor bleeding 2.8% 2.8% 0.5% 0.5%

National Registry of Myocardial Infarction (NRMI)National Registry of Myocardial Infarction (NRMI)National Registry of Myocardial Infarction (NRMI)National Registry of Myocardial Infarction (NRMI)

TPWhartonTPWharton

Pooled data from 10 randomized trials (n=2,606):Pooled data from 10 randomized trials (n=2,606):Pooled data from 10 randomized trials (n=2,606):Pooled data from 10 randomized trials (n=2,606):

Primary PCI is Superior to Primary PCI is Superior to Thrombolytic Therapy for Acute M.I.Thrombolytic Therapy for Acute M.I.


Primary PTCAPrimary PTCA tPAtPA p p

valuevalue

MortalityMortality 4.4 % 4.4 %6.5 %6.5 % 0.020.02

Death or ReinfarctionDeath or Reinfarction 7.2 % 7.2 % 11.9 %11.9 %

<0.001<0.001

Total StrokeTotal Stroke 0.7 % 0.7 % 2.0 % 2.0 %

0.0070.007

Hemorrhagic StrokeHemorrhagic Stroke 0.1 % 0.1 % 1.1 %1.1 %

<0.001<0.001

Weaver, JAMA 1997;278:2093Weaver, JAMA 1997;278:2093

TPWhartonTPWharton



Brand new pooled data from 21 randomized trials (n=7,739):Brand new pooled data from 21 randomized trials (n=7,739):

Primary PCIPrimary PCI Lytic RxLytic Rx p valuep value

MortalityMortality 6.9 % 6.9 %9.3 %9.3 % 0.00020.0002

ReinfarctionReinfarction 2.4 % 2.4 % 6.8%6.8% <<0.00010.0001

Total StrokeTotal Stroke 1.0 % 1.0 % 2.0 % 2.0 % 0.00040.0004

Hemorrhagic StrokeHemorrhagic Stroke 0.05 % 0.05 % 1.1 %1.1 % <0.0001<0.0001

CombinedCombined 8.28.2 14.314.3 <0.0001<0.0001

Keeley, Lancet 2003;361:13-20Keeley, Lancet 2003;361:13-20

TPWhartonTPWharton

Broader Applicability of Primary PCIBroader Applicability of Primary PCIBroader Applicability of Primary PCIBroader Applicability of Primary PCI

Primary PTCA is arguably clinically superior to lytic therapyPrimary PTCA is arguably clinically superior to lytic therapy

in lytic-eligible patients.* in lytic-eligible patients.*

*Weaver, WD, JAMA 1997;278:2093*Weaver, WD, JAMA 1997;278:2093

But even if the therapies were equal, a majority of AMI patients are But even if the therapies were equal, a majority of AMI patients are

not candidates for lytic therapy, due tonot candidates for lytic therapy, due to

bleeding contraindications,bleeding contraindications,

shock,shock,

late presentation, late presentation,

prior bypass surgery, prior bypass surgery,

non-diagnostic EKG’snon-diagnostic EKG’s

**Rogers WJ, AJM 1995;99:195**Rogers WJ, AJM 1995;99:195

This group is higher-risk than lytic-eligible patients. This group is higher-risk than lytic-eligible patients.

These patients need an alternative to These patients need an alternative to "morphine and bed rest.""morphine and bed rest."

TPWhartonTPWharton

Primary PCI vs. Other Treatments in Patients Primary PCI vs. Other Treatments in Patients Ineligible for Lytic Therapy (MITRA Registry)Ineligible for Lytic Therapy (MITRA Registry)Primary PCI vs. Other Treatments in Patients Primary PCI vs. Other Treatments in Patients Ineligible for Lytic Therapy (MITRA Registry)Ineligible for Lytic Therapy (MITRA Registry)

Zahn, Catheter Cardiovasc Interv 1999;46:127 Zahn, Z Kardiol 1999;88:418Zahn, Catheter Cardiovasc Interv 1999;46:127 Zahn, Z Kardiol 1999;88:418

PTCA Conservative Mortality Combined Endpoint*Therapy PTCA Lytic PTCA Lytic

*death, acute MI, stroke, CHF, angina

8.2%

24.1%

16.4%

42.3%

0%

50%

PTCA Conservative or Fibrinolytic Therapy

Non-Diagnostic EKG, LBBB, Late Presentation

(n=737)

2.2%

24.7%

0%

50%

High Bleeding Risk (n=337)

% o

f Pat

ient

s

Mor

talit

y (%

)

TPWhartonTPWharton

Primary PCI in Lytic Eligible Pts that are Primary PCI in Lytic Eligible Pts that are High Risk (MITRA Registry)High Risk (MITRA Registry)

Primary PCI in Lytic Eligible Pts that are Primary PCI in Lytic Eligible Pts that are High Risk (MITRA Registry)High Risk (MITRA Registry)

(%)

O’Neill, J Invasive Cardiol 1998:10 Suppl A:4A-10AO’Neill, J Invasive Cardiol 1998:10 Suppl A:4A-10A

High Risk Patients: Age >70, Anterior M.I., Heart Rate > 100High Risk Patients: Age >70, Anterior M.I., Heart Rate > 100

Death Reinfarction Death or Stroke

9.8%

6.7%

15.6%

3.6%3.2%

1.4%

4.1%

0.5%0

4

8

12

16 PCI Lytics

Death Reinfarction Death or StrokeRe-MI

TPWhartonTPWharton

New Data From MITRA and MIRNew Data From MITRA and MIRGerman RegistriesGerman Registries

New Data From MITRA and MIRNew Data From MITRA and MIRGerman RegistriesGerman Registries

Zahn, JACC 2001;37:1827Zahn, JACC 2001;37:1827

Primary angioplasty was associated with lower mortality in all Primary angioplasty was associated with lower mortality in all

subgroups both high- and low-risk, subgroups both high- and low-risk, including pts >75 y.o.including pts >75 y.o.

As the mortality risk of the subgroup increased, the relative As the mortality risk of the subgroup increased, the relative

benefit of primary PCI increased.benefit of primary PCI increased.

Primary angioplasty was associated with lower mortality in all Primary angioplasty was associated with lower mortality in all

subgroups both high- and low-risk, subgroups both high- and low-risk, including pts >75 y.o.including pts >75 y.o.

As the mortality risk of the subgroup increased, the relative As the mortality risk of the subgroup increased, the relative

benefit of primary PCI increased.benefit of primary PCI increased.

Pooled “real world” outcomes of nearly 10,000 AMI Pooled “real world” outcomes of nearly 10,000 AMI

patients in 2 German Registries, 1994-1998:patients in 2 German Registries, 1994-1998:

Pooled “real world” outcomes of nearly 10,000 AMI Pooled “real world” outcomes of nearly 10,000 AMI

patients in 2 German Registries, 1994-1998:patients in 2 German Registries, 1994-1998:

Primary PCIPrimary PCIThrombolysisThrombolysis

MortalityMortality 6.4%6.4%

11.3%11.3%odds ratio 0.54, 95% confidence interval 0.43 to 0.67odds ratio 0.54, 95% confidence interval 0.43 to 0.67

Primary PCIPrimary PCIThrombolysisThrombolysis

MortalityMortality 6.4%6.4%

11.3%11.3%odds ratio 0.54, 95% confidence interval 0.43 to 0.67odds ratio 0.54, 95% confidence interval 0.43 to 0.67

TPWhartonTPWharton

Can be used in virtually all infarct patients.Can be used in virtually all infarct patients.

Produces TIMI-3 flow over 90% of the time, not 54%.Produces TIMI-3 flow over 90% of the time, not 54%.

Does not cause intracranial bleeding.Does not cause intracranial bleeding.

Reduces need for subsequent procedures (cath, PCI).Reduces need for subsequent procedures (cath, PCI).

Provides important angiographic information: patients Provides important angiographic information: patients

who need urgent surgery can be detected early.who need urgent surgery can be detected early.

Opens vessels as fast or faster.Opens vessels as fast or faster.

Can improve prognosis in cardiogenic shock.Can improve prognosis in cardiogenic shock.

Yields a five-fold reduction in mortality in high-risk STEMI Yields a five-fold reduction in mortality in high-risk STEMI

pts compared to thrombolytics.pts compared to thrombolytics.

Can be used in virtually all infarct patients.Can be used in virtually all infarct patients.

Produces TIMI-3 flow over 90% of the time, not 54%.Produces TIMI-3 flow over 90% of the time, not 54%.

Does not cause intracranial bleeding.Does not cause intracranial bleeding.

Reduces need for subsequent procedures (cath, PCI).Reduces need for subsequent procedures (cath, PCI).

Provides important angiographic information: patients Provides important angiographic information: patients

who need urgent surgery can be detected early.who need urgent surgery can be detected early.

Opens vessels as fast or faster.Opens vessels as fast or faster.

Can improve prognosis in cardiogenic shock.Can improve prognosis in cardiogenic shock.

Yields a five-fold reduction in mortality in high-risk STEMI Yields a five-fold reduction in mortality in high-risk STEMI

pts compared to thrombolytics.pts compared to thrombolytics.

Advantages of Primary PCIAdvantages of Primary PCIAdvantages of Primary PCIAdvantages of Primary PCI

TPWhartonTPWharton

Profiles of NRMI Registry HospitalsProfiles of NRMI Registry HospitalsProfiles of NRMI Registry HospitalsProfiles of NRMI Registry Hospitals

Rogers WJ, Circulation 1994;90:2103 Rogers WJ, Circulation 1994;90:2103

Medical School AffiliationMedical School Affiliation

27.6%27.6%

Cardiac SurgeryCardiac Surgery

37.6%37.6%

Cardiac Catheterization LaboratoryCardiac Catheterization Laboratory

61.3%61.3%

TPWhartonTPWharton

DANAMI – 2 Trial: Primary PCI vs. LyticsDANAMI – 2 Trial: Primary PCI vs. Lyticsat Hospitals With and Without PCIat Hospitals With and Without PCI

DANAMI – 2 Trial: Primary PCI vs. LyticsDANAMI – 2 Trial: Primary PCI vs. Lyticsat Hospitals With and Without PCIat Hospitals With and Without PCI

Andersen, ACC 2002 PresentationAndersen, ACC 2002 Presentation

8.0%

13.7%

6.7%

12.3%

8.5%

14.2%

0%

5%

10%

15%

Prim

ary

Endp

oint

(%

)(d

eath

, MI,

CVA

)Pr

imar

y En

dpoi

nt (

%)

(dea

th, M

I, C

VA)

All PatientsAll Patients Presenting toPresenting to Presenting toPresenting toAngioplastyAngioplasty CommunityCommunity

CentersCenters HospitalsHospitals(n = 1,572)(n = 1,572) (n = 442)(n = 442) (n = 1,129)(n = 1,129)

All PatientsAll Patients Presenting toPresenting to Presenting toPresenting toAngioplastyAngioplasty CommunityCommunity

CentersCenters HospitalsHospitals(n = 1,572)(n = 1,572) (n = 442)(n = 442) (n = 1,129)(n = 1,129)

PCI On Site or After Transfer Thrombolytic Therapy

TPWhartonTPWharton

Immediate transport of all STEMI patients for PCI is now part of the Immediate transport of all STEMI patients for PCI is now part of the national guidelines of the Czech Republic.national guidelines of the Czech Republic.

Prague – 2 TrialPrague – 2 TrialPrague – 2 TrialPrague – 2 Trial

10.4%

6.0%

0%

10%

15.2%

8.4%

0%

10%

PRAGUEPRAGUE-2-2 Trial (Europe): Prospective randomization of Trial (Europe): Prospective randomization of 850 pts 850 pts to to lytic therapylytic therapy on-site on-site vs. vs. emergency transferemergency transfer for primary PCI for primary PCI

Widimsky, European Society of Cardiology, September, 2002Widimsky, European Society of Cardiology, September, 2002

•Thrombolytic Therapy (n = 421) Transfer for PCI (n = 429)30

-Day

Mor

talit

y (%

)

Dea

th /

MI /

CVA

(%)

TPWhartonTPWharton

The DANAMI-2 and PRAGUE-2 studies established The DANAMI-2 and PRAGUE-2 studies established

primary PCI as the treatment of choice for primary PCI as the treatment of choice for allall patients patients

presenting with acute STEMI, regardless of where they presenting with acute STEMI, regardless of where they

initially present.initially present.

All such patients at hospitals without PCI should be All such patients at hospitals without PCI should be

transferred immediately directly into the cath lab of a transferred immediately directly into the cath lab of a

PCI center, ideally with an “indoor-outdoor” time of <30 PCI center, ideally with an “indoor-outdoor” time of <30

minutes.minutes.

The DANAMI-2 and PRAGUE-2 studies established The DANAMI-2 and PRAGUE-2 studies established

primary PCI as the treatment of choice for primary PCI as the treatment of choice for allall patients patients

presenting with acute STEMI, regardless of where they presenting with acute STEMI, regardless of where they

initially present.initially present.

All such patients at hospitals without PCI should be All such patients at hospitals without PCI should be

transferred immediately directly into the cath lab of a transferred immediately directly into the cath lab of a

PCI center, ideally with an “indoor-outdoor” time of <30 PCI center, ideally with an “indoor-outdoor” time of <30

minutes.minutes.

DANAMI-2 and PRAGUE-2DANAMI-2 and PRAGUE-2DANAMI-2 and PRAGUE-2DANAMI-2 and PRAGUE-2

TPWhartonTPWharton

Delay and Mortality of Primary PCI Delay and Mortality of Primary PCI After T ransfer: After T ransfer:

Delay and Mortality of Primary PCI Delay and Mortality of Primary PCI After T ransfer: After T ransfer:

Tiefenbrunn, Circulation 1997:96:I-531Tiefenbrunn, Circulation 1997:96:I-531

Transfer of acute MI patients to a surgical institution involves risk and Transfer of acute MI patients to a surgical institution involves risk and delay, and is associated with worse outcomes than PCI on site.delay, and is associated with worse outcomes than PCI on site.

5.0%

7.7%

0%

5%

10%

Time From DeathAMI Onset to PTCA (In-Hospital)

PTCA On Site (n=9,311) PTCA After Transfer (n=1,307)

3.7h

6.0h

0.0

2.0

4.0

6.0

Mor

talit

y (%

)

Tim

e (h

ours

)

TPWhartonTPWharton

From the 1988 PCI Guidelines re Surgical Backup for PCI:From the 1988 PCI Guidelines re Surgical Backup for PCI:

““An experienced cardiovascular surgical team should An experienced cardiovascular surgical team should

be available within the institution for be available within the institution for allall angioplasty angioplasty

procedures,” and procedures,” and ““there should be no exception there should be no exception

to this requirement.to this requirement.””

““All arrangements requiring transportation of patients All arrangements requiring transportation of patients

to off-site surgical facilities to off-site surgical facilities fail to meet the necessary fail to meet the necessary

standards of care exercised by prudent physicians standards of care exercised by prudent physicians

and cannot be condoned.and cannot be condoned.””

From the 1988 PCI Guidelines re Surgical Backup for PCI:From the 1988 PCI Guidelines re Surgical Backup for PCI:

““An experienced cardiovascular surgical team should An experienced cardiovascular surgical team should

be available within the institution for be available within the institution for allall angioplasty angioplasty

procedures,” and procedures,” and ““there should be no exception there should be no exception

to this requirement.to this requirement.””

““All arrangements requiring transportation of patients All arrangements requiring transportation of patients

to off-site surgical facilities to off-site surgical facilities fail to meet the necessary fail to meet the necessary

standards of care exercised by prudent physicians standards of care exercised by prudent physicians

and cannot be condoned.and cannot be condoned.””

Guidelines Evolve as Medical Care EvolvesGuidelines Evolve as Medical Care EvolvesGuidelines Evolve as Medical Care EvolvesGuidelines Evolve as Medical Care Evolves

TPWhartonTPWharton

Primary PCI –





Primary PCI –





Off Site PCI Expert Panel ReviewOff Site PCI Expert Panel Review

without onsite surgery^

without onsite surgery^

an even newer !

JACC April, 1999JACC April, 1999

506 consecutive pts: 506 consecutive pts:

““Primary angioplasty in patients with AMI can be performed safely Primary angioplasty in patients with AMI can be performed safely and effectively in community hospitals without on-site cardiac and effectively in community hospitals without on-site cardiac surgery when rigorous program criteria are established.”surgery when rigorous program criteria are established.”

Primary Angioplasty for the Treatment of Acute Myocardial Infarction: Experience at Two Community Hospitals Without Cardiac SurgeryThomas P. Wharton, Jr., MD, FACC, Nancy Sinclair McNamara, RN, BSN, Frank A. Fedele, MD, FACC, Mark I. Jacobs, MD, FACC, Alan R.

Gladstone, MD, Erik Funk, MD, FACC

Exeter and Portsmouth, New Hampshire

TPWhartonTPWharton

The 2001 ACC/AHA guidelines designated The 2001 ACC/AHA guidelines designated primary PCIprimary PCI

at hospitals with off-site cardiac surgery as at hospitals with off-site cardiac surgery as Class IIb:Class IIb:

“Usefulness/efficacy is less well established by “Usefulness/efficacy is less well established by

evidence/opinion,” provided that:evidence/opinion,” provided that:

> 36 procedures/yr are performed at such hospitals,> 36 procedures/yr are performed at such hospitals,

by higher-volume operators (>75 procedures/yr),by higher-volume operators (>75 procedures/yr),

within 90 within 90 30 min of admission, 30 min of admission,

with a proven plan for rapid access to a with a proven plan for rapid access to a

cardiac surgical center.cardiac surgical center.

The 2001 ACC/AHA guidelines designated The 2001 ACC/AHA guidelines designated primary PCIprimary PCI

at hospitals with off-site cardiac surgery as at hospitals with off-site cardiac surgery as Class IIb:Class IIb:

“Usefulness/efficacy is less well established by “Usefulness/efficacy is less well established by

evidence/opinion,” provided that:evidence/opinion,” provided that:

> 36 procedures/yr are performed at such hospitals,> 36 procedures/yr are performed at such hospitals,

by higher-volume operators (>75 procedures/yr),by higher-volume operators (>75 procedures/yr),

within 90 within 90 30 min of admission, 30 min of admission,

with a proven plan for rapid access to a with a proven plan for rapid access to a

cardiac surgical center.cardiac surgical center.

JACC 2001;37:2215JACC 2001;37:2215JACC 2001;37:2215JACC 2001;37:2215

2001 ACC/AHA Guidelines for Off-Site PCI2001 ACC/AHA Guidelines for Off-Site PCI2001 ACC/AHA Guidelines for Off-Site PCI2001 ACC/AHA Guidelines for Off-Site PCI

TPWhartonTPWharton

ACC/AHA 2001 PCI GuidelinesACC/AHA 2001 PCI Guidelines

TPWhartonTPWharton

2001 ACC/AHA Guidelines for Off-Site PCI2001 ACC/AHA Guidelines for Off-Site PCI2001 ACC/AHA Guidelines for Off-Site PCI2001 ACC/AHA Guidelines for Off-Site PCI

This Committee also designated This Committee also designated non-emergent PCInon-emergent PCI as as

Class III: stated that their Class III: “Not useful/effective, Class III: stated that their Class III: “Not useful/effective,

and in some cases may be harmful.” and in some cases may be harmful.”

This classification was based on “consensus opinion of This classification was based on “consensus opinion of

experts,” thus was not evidence-based experts,” thus was not evidence-based

(Level of Evidence C).(Level of Evidence C).

This Committee also designated This Committee also designated non-emergent PCInon-emergent PCI as as

Class III: stated that their Class III: “Not useful/effective, Class III: stated that their Class III: “Not useful/effective,

and in some cases may be harmful.” and in some cases may be harmful.”

This classification was based on “consensus opinion of This classification was based on “consensus opinion of

experts,” thus was not evidence-based experts,” thus was not evidence-based

(Level of Evidence C).(Level of Evidence C).

PRE-HOSPITAL: Suspected AMI.

EMS paramedic level of care, aspirin, IV line, sublingual NTG, 12-lead

ECG transmitted to ED, heparin.

EMERGENCY DEPARTMENT: AMI diagnosed. >30 minutes of uncontrolled

ischemic pain with positive serum markers and/or ECG with >1mm of ST deviation or LBBB.

Call interventional cardiologist and cath team.

ED physician calls interventional cardiologist and cath team.

EMERGENCY DEPARTMENT TREATMENT: ASA (if not given by EMS), heparin or enoxaparin,

IV beta blocker, nitropaste, morphine, second IV line. Consider platelet GP IIb/IIIa inhibitor, clopidogrel.

Treat pain, CHF, shock, arrhythmias.

Consent, transport to cath lab.

PRIMARY PCI of IRA only. Monitor ACT, GP IIb/IIIa inhibitor.

Left ventriculogram. Consider right heart catheterization, IABP, pacer if unstable.

No diagnostic ST Elevation

CATH LAB AVAILABLE?

Yes

No

DETERMINE REVASCULARIZATION

STRATEGY

MEDICAL THERAPY ASA, GP IIb/IIIa inhibitor, beta blocker, ACE inhibitor

or ARB, statin, clopidogrel load and maintentance. Smoking cessation,risk factor identification and

modification, cardiac rehabilitation.

EMERGENCY CABG indicated with or without PCI:

Activate Emergency Transfer Protocol.

TIMI 3 FLOW IN IRA?

PRIMARY PCI of IRA only.

No

RISK STRATIFICATION*

AND MANAGEMENT

Admit to interventional unit. Fast-track cardiac rehabilitation; target discharge on hospital day 3 without pre-discharge ETT.

Return to work at 2 weeks.

Standard CCU care. Target discharge on

hospital day 4-5, consider ETT.

Elective CABG if indicated.

Low risk

Not low risk

CRITICAL PATHWAY: PRIMARY PCI AT HOSPITALS WITH OFF-SITE CARDIAC SURGICAL BACKUP

Diagnostic ST elevation

EMERGENCY TRANSFER to interventional / surgical hospital.

Activate Emergency Transfer Protocol with "indoor-outdoor" ED time goal of 45 minutes.

Consider IABP (at capable hospitals) if hemodynamically unstable.

CARDIAC CATH LAB: Arterial sheath; venous sheath if unstable or heart

block, IABP if in shock or hemodynamically unstable, pacer as needed. Coronary angiography.

CABG

Primary PCI

Medical therapy

Yes

DISCHARGE; cardiac rehab phase II; ETT and lipid profile at 4 wks.

*Clinical and angiographic low risk: Age <70, 1-2 v disease, EF >45%, no CHF or arrhythmias, good PCI result.

Exeter Hospital

©2005 Wharton, Sinclair

Circulation November 2005Circulation November 2005T Wharton, Exeter Hospital

TPWhartonTPWhartonJACC 2004JACC 2004

Primary PCI in 500 high-risk pts at 19 off-site hospitals was compared to pts transferred after presentation to non-PCI hospitals:

“On-site PA and transfer groups had similar 30-day outcomes, and more rapid reperfusion for on-site PA.”


““The study by Wharton et al. is extremely relevant because currently The study by Wharton et al. is extremely relevant because currently there is great debate regarding the appropriateness of performing there is great debate regarding the appropriateness of performing primary PCI at hospitals without on-site surgery. . .”primary PCI at hospitals without on-site surgery. . .”

““This study documents that superb outcomes can be achieved at This study documents that superb outcomes can be achieved at hospitals that do not offer on-site cardiac surgery. . .” hospitals that do not offer on-site cardiac surgery. . .”

““The study by Wharton et al. is extremely relevant because currently The study by Wharton et al. is extremely relevant because currently there is great debate regarding the appropriateness of performing there is great debate regarding the appropriateness of performing primary PCI at hospitals without on-site surgery. . .”primary PCI at hospitals without on-site surgery. . .”

““This study documents that superb outcomes can be achieved at This study documents that superb outcomes can be achieved at hospitals that do not offer on-site cardiac surgery. . .” hospitals that do not offer on-site cardiac surgery. . .”


““I believe the data presented by Wharton et al. provide sufficient I believe the data presented by Wharton et al. provide sufficient evidence to revise these guidelines to provide a class IIa indication evidence to revise these guidelines to provide a class IIa indication (weight of evidence/opinion is in favor of usefulness/efficacy) for (weight of evidence/opinion is in favor of usefulness/efficacy) for primary PCI at hospitals with catheterization laboratories but without primary PCI at hospitals with catheterization laboratories but without on-site surgery.”on-site surgery.”

““I believe the data presented by Wharton et al. provide sufficient I believe the data presented by Wharton et al. provide sufficient evidence to revise these guidelines to provide a class IIa indication evidence to revise these guidelines to provide a class IIa indication (weight of evidence/opinion is in favor of usefulness/efficacy) for (weight of evidence/opinion is in favor of usefulness/efficacy) for primary PCI at hospitals with catheterization laboratories but without primary PCI at hospitals with catheterization laboratories but without on-site surgery.”on-site surgery.”

TPWhartonTPWharton

2005 Guidelines for PCI Off-Site2005 Guidelines for PCI Off-Site2005 Guidelines for PCI Off-Site2005 Guidelines for PCI Off-Site

Nevertheless the 2005 Guidelines Committee Nevertheless the 2005 Guidelines Committee

maintained its Class IIb indication for Primary PCI at maintained its Class IIb indication for Primary PCI at

hospitals without on-site cardiac surgery.hospitals without on-site cardiac surgery.

The 2005 Guidelines Committee also maintained its The 2005 Guidelines Committee also maintained its

Class III indication for elective PCI at such hospitals, Class III indication for elective PCI at such hospitals,

and unfortunately introduced new and very inflammatory and unfortunately introduced new and very inflammatory

language, language, arguablyarguably without valid justification, without valid justification, not citing not citing

a large amount of new literature:a large amount of new literature:

““Performing elective PCI in a setting without immediately Performing elective PCI in a setting without immediately

available onsite cardiac surgery available onsite cardiac surgery potentially compromises potentially compromises

patient safety and is not recommendedpatient safety and is not recommended.” .”

Nevertheless the 2005 Guidelines Committee Nevertheless the 2005 Guidelines Committee

maintained its Class IIb indication for Primary PCI at maintained its Class IIb indication for Primary PCI at

hospitals without on-site cardiac surgery.hospitals without on-site cardiac surgery.

The 2005 Guidelines Committee also maintained its The 2005 Guidelines Committee also maintained its

Class III indication for elective PCI at such hospitals, Class III indication for elective PCI at such hospitals,

and unfortunately introduced new and very inflammatory and unfortunately introduced new and very inflammatory

language, language, arguablyarguably without valid justification, without valid justification, not citing not citing

a large amount of new literature:a large amount of new literature:

““Performing elective PCI in a setting without immediately Performing elective PCI in a setting without immediately

available onsite cardiac surgery available onsite cardiac surgery potentially compromises potentially compromises

patient safety and is not recommendedpatient safety and is not recommended.” .”

TPWhartonTPWharton

““In view of the rapidly accumulating evidence In view of the rapidly accumulating evidence

of safety and efficacy, and no relevant evidence of harm of safety and efficacy, and no relevant evidence of harm

reported to date (the JAMA Medicare claims-coding reported to date (the JAMA Medicare claims-coding

article notwithstanding), article notwithstanding),

strong consideration should be given now to upgrading strong consideration should be given now to upgrading

the Guidelines indication for non-emergent PCI from the Guidelines indication for non-emergent PCI from

Class III to Class IIb at centers with off-site backup that Class III to Class IIb at centers with off-site backup that

can meet rigorous qualifications.”can meet rigorous qualifications.”

““In view of the rapidly accumulating evidence In view of the rapidly accumulating evidence

of safety and efficacy, and no relevant evidence of harm of safety and efficacy, and no relevant evidence of harm

reported to date (the JAMA Medicare claims-coding reported to date (the JAMA Medicare claims-coding

article notwithstanding), article notwithstanding),

strong consideration should be given now to upgrading strong consideration should be given now to upgrading

the Guidelines indication for non-emergent PCI from the Guidelines indication for non-emergent PCI from

Class III to Class IIb at centers with off-site backup that Class III to Class IIb at centers with off-site backup that

can meet rigorous qualifications.”can meet rigorous qualifications.”

TPW Presentation on Guidelines at ACC 2006TPW Presentation on Guidelines at ACC 2006TPW Presentation on Guidelines at ACC 2006TPW Presentation on Guidelines at ACC 2006

TPWhartonTPWharton

An audience member made the following observation at my An audience member made the following observation at my

presentation at an ACC Guidelines session in 2006:presentation at an ACC Guidelines session in 2006:

““Since the Guidelines Writing Committee’s conclusions Since the Guidelines Writing Committee’s conclusions

carry so much weight, and have such a powerful carry so much weight, and have such a powerful

influence on influence on 33rdrd party payors party payors, , state regulatorsstate regulators, and , and

litigation attorneyslitigation attorneys, the Writing Committee has a , the Writing Committee has a

profound responsibility to fairly profound responsibility to fairly considerconsider, fairly , fairly

interpretinterpret, and rapidly , and rapidly update update all of the available all of the available

information in this vital and growing field.”information in this vital and growing field.”

TPW Presentation on Guidelines at ACC 2006TPW Presentation on Guidelines at ACC 2006TPW Presentation on Guidelines at ACC 2006TPW Presentation on Guidelines at ACC 2006

Critical Pathways in Cardiology June 2005Critical Pathways in Cardiology June 2005

Catheterization and Cardiovascular Interventions March, 2007Catheterization and Cardiovascular Interventions March, 2007

1 Gathered facts and trends on prevalence of PCI without on-site surgery

2 Reviewed existing guidelines worldwide on PCI without onsite surgery

3 Reviewed literature related to PCI without on-site surgery much more comprehensively than did the 2005 ACC/AHA Guidelines

4 Defined the best practice methods for PCI without on-site surgery

5 Made recommendations on the role of PCI without on-site surgery

1 Gathered facts and trends on prevalence of PCI without on-site surgery

2 Reviewed existing guidelines worldwide on PCI without onsite surgery

3 Reviewed literature related to PCI without on-site surgery much more comprehensively than did the 2005 ACC/AHA Guidelines

4 Defined the best practice methods for PCI without on-site surgery

5 Made recommendations on the role of PCI without on-site surgery

TPWhartonTPWharton

Patient Selection Criteria – PRIMARY PCI Patient Selection Criteria for Angioplasty and Emergency Aortocoronary Bypass at Hospitals Without On-Site Cardiac Surgery Avoid intervention in hemodynamically stable patients with: Significant (> 60%) stenosis of an unprotected Left Main (LM)

coronary artery upstream from an acute occlusion in the left coronary system that might be disrupted by the angioplasty catheter

Extremely long or angulated infarct-related lesions with TIMI grade 3 flow

Infarct-related lesions with TIMI Grade 3 flow in stable patients with three vessel disease

Infarct-related lesions of small or secondary vessels Lesions in other than the infarct artery Transfer for emergent aortocoronary bypass surgery patients with: High-grade residual left main or multivessel coronary disease and

clinical or hemodynamic instability o After angioplasty or occluded vessels o Preferably with intraaortic balloon pump support

Table 16: American College of Cardiology/ American Heart Association Percutaneous Coronary Intervention Guidelines. Adapted with permission from Wharton TP Jr, McNamara NS, Fedele FA, Jacobs MI, Gladstone AR, Funk EJ. Primary angioplasty for the treatment of acute myocardial infarction: experience at two community hospitals without cardiac surgery. Journal of American College of Cardiology 1999; 33: 1257-65.

Patient Selection Criteria – PRIMARY PCI Patient Selection Criteria for Angioplasty and Emergency Aortocoronary Bypass at Hospitals Without On-Site Cardiac Surgery Avoid intervention in hemodynamically stable patients with: Significant (> 60%) stenosis of an unprotected Left Main (LM)

coronary artery upstream from an acute occlusion in the left coronary system that might be disrupted by the angioplasty catheter

Extremely long or angulated infarct-related lesions with TIMI grade 3 flow

Infarct-related lesions with TIMI Grade 3 flow in stable patients with three vessel disease

Infarct-related lesions of small or secondary vessels Lesions in other than the infarct artery Transfer for emergent aortocoronary bypass surgery patients with: High-grade residual left main or multivessel coronary disease and

clinical or hemodynamic instability o After angioplasty or occluded vessels o Preferably with intraaortic balloon pump support

Table 16: American College of Cardiology/ American Heart Association Percutaneous Coronary Intervention Guidelines. Adapted with permission from Wharton TP Jr, McNamara NS, Fedele FA, Jacobs MI, Gladstone AR, Funk EJ. Primary angioplasty for the treatment of acute myocardial infarction: experience at two community hospitals without cardiac surgery. Journal of American College of Cardiology 1999; 33: 1257-65. Catheterization and Cardiovascular Interventions March, 2007Catheterization and Cardiovascular Interventions March, 2007

TPWhartonTPWhartonCatheterization and Cardiovascular Interventions March, 2007Catheterization and Cardiovascular Interventions March, 2007

TPWhartonTPWharton

TPWhartonTPWharton

Case PresentationCase Presentation

• Two weeks before Hurricane Sandy this 59 y.o. lady lost her adult son tragically.

• Two days after the son’s death, she collapsed at home.

• Her husband, not knowing CPR, called 911 and ran to the neighbor’s house.

• The neighbor ran over and started CPR.

• EMS administered 3 shocks for ventricular fibrillation (VF), epinephrine boluses, performed intubation, and transmitted EKG to ED.

• Two weeks before Hurricane Sandy this 59 y.o. lady lost her adult son tragically.

• Two days after the son’s death, she collapsed at home.

• Her husband, not knowing CPR, called 911 and ran to the neighbor’s house.

• The neighbor ran over and started CPR.

• EMS administered 3 shocks for ventricular fibrillation (VF), epinephrine boluses, performed intubation, and transmitted EKG to ED.

TPWhartonTPWharton


TPWhartonTPWharton

• After 30 minutes in the field, a pulse was felt.

• On arrival in the ED she was unresponsive, fixed pupils, with thready carotids and no peripheral pulse.

• A countershock was required for recurrent VF.

• The Arctic Sun therapeutic cooling system was applied in the E.D.

• After 30 minutes in the field, a pulse was felt.

• On arrival in the ED she was unresponsive, fixed pupils, with thready carotids and no peripheral pulse.

• A countershock was required for recurrent VF.

• The Arctic Sun therapeutic cooling system was applied in the E.D.


TPWhartonTPWharton

Arctic Sun Therapeutic Cooling DeviceArctic Sun Therapeutic Cooling Device

TPWhartonTPWharton

Class II: Conditions for which there is conflicting evidence and/or a divergence of opinion about the usefulness/efficacy of a procedure or treatment.

IIa. Weight of evidence/opinion is in favor of usefulness/efficacy.IIb. Usefulness/efficacy is less well established by evidence/opinion.

Circulation 2005; 112:IV-206 – IV-211

Updated 2005 AHA Guidelines for CPRUpdated 2005 AHA Guidelines for CPR

TPWhartonTPWharton

• She was then taken to the Cath Lab, shocky and very acidotic, on 2 pressors and the cooling device.

• On arrival at the cath lab she developed pulseless electrical activity (PEA).

• The Lucas cardiac compression device was applied, with a radiolucent back plate to allow fluoroscopy. This produced an excellent pulse.

• She was then taken to the Cath Lab, shocky and very acidotic, on 2 pressors and the cooling device.

• On arrival at the cath lab she developed pulseless electrical activity (PEA).

• The Lucas cardiac compression device was applied, with a radiolucent back plate to allow fluoroscopy. This produced an excellent pulse.


TPWhartonTPWharton

LUCAS External Compression CPRLUCAS External Compression CPR

TPWhartonTPWharton

• After bifemoral access we were able to use cranially-angluated fluoroscopy to position an intraaortic balloon while on the Lucas CPR device.

• On the balloon pump and pressors, we were able to discontinue the Lucas CPR device.

• Severe metabolic acidosis responded only poorly to aggressive treatment.

• She remained unresponsive, pressor dependent.

• After bifemoral access we were able to use cranially-angluated fluoroscopy to position an intraaortic balloon while on the Lucas CPR device.

• On the balloon pump and pressors, we were able to discontinue the Lucas CPR device.

• Severe metabolic acidosis responded only poorly to aggressive treatment.

• She remained unresponsive, pressor dependent.


TPWhartonTPWharton


(Coronary angiography was shown which demonstrated a totally occluded proximal LAD artery with no antegrade flow and no collateralizaion, successfully recanalized with PCI/stenting.)

(Coronary angiography was shown which demonstrated a totally occluded proximal LAD artery with no antegrade flow and no collateralizaion, successfully recanalized with PCI/stenting.)

TPWhartonTPWharton

• On reperfusion she developed incessant VF, requiring 7 countershocks, amiodarone boluses, empiric Mg++ and K+ IV.

• She remained pressor and balloon pump dependent, acidotic, unresponsive, cardiac output 1.6 L/m, wedge pressure 30mmHg, no urine.

• After 18 h and the addition of dobutamine, her hemodyamics began to improve.

• After 24 hours she was re-warmed.

• On reperfusion she developed incessant VF, requiring 7 countershocks, amiodarone boluses, empiric Mg++ and K+ IV.

• She remained pressor and balloon pump dependent, acidotic, unresponsive, cardiac output 1.6 L/m, wedge pressure 30mmHg, no urine.

• After 18 h and the addition of dobutamine, her hemodyamics began to improve.

• After 24 hours she was re-warmed.


TPWhartonTPWharton


TPWhartonTPWharton

• Pressors were weaned, IABP removed on day 3, extubated day 6.

• Her echo EF had improved to 50-55% with minimal anterior wall hypokinesis.

• By extubation on day 7 she was completely alert, very talkative.

• One of the first things she said moments after extubation was that she had visited her deceased son; that he was “with God;” but God told her “get back home, I don’t want you yet.”

• Pressors were weaned, IABP removed on day 3, extubated day 6.

• Her echo EF had improved to 50-55% with minimal anterior wall hypokinesis.

• By extubation on day 7 she was completely alert, very talkative.

• One of the first things she said moments after extubation was that she had visited her deceased son; that he was “with God;” but God told her “get back home, I don’t want you yet.”


TPWhartonTPWharton


TPWhartonTPWharton

• This extraordinary outcome demonstrates what a flawless “chain of survival” can accomplish, from EMS in the field, thru ED, thru respiratory and ICU nursing care.

• In particular, this outcome would not have been possible without expert 24/7 PCI available nearby, at the point of first patient contact.

• She is now home, enjoying Thanksgiving with her family, completely mentally intact and with excellent cardiac function.

• This extraordinary outcome demonstrates what a flawless “chain of survival” can accomplish, from EMS in the field, thru ED, thru respiratory and ICU nursing care.

• In particular, this outcome would not have been possible without expert 24/7 PCI available nearby, at the point of first patient contact.

• She is now home, enjoying Thanksgiving with her family, completely mentally intact and with excellent cardiac function.


TPWhartonTPWharton

• The door-to-defibrillation-to-cooling-to-Lucas CPR-to-balloon pump time

(D-2-D-2-C-2-L-2-IABP time) (D-2-D-2-C-2-L-2-IABP time) was 86 minutes.

• The LAD coronary was opened in 18m more.

• Her brain was very poorly perfused for about 2 hours.

• Locally available immediate primary PCI meant the difference between life and death in this woman.

• The door-to-defibrillation-to-cooling-to-Lucas CPR-to-balloon pump time

(D-2-D-2-C-2-L-2-IABP time) (D-2-D-2-C-2-L-2-IABP time) was 86 minutes.

• The LAD coronary was opened in 18m more.

• Her brain was very poorly perfused for about 2 hours.

• Locally available immediate primary PCI meant the difference between life and death in this woman.


TPWhartonTPWharton

• One of the cath lab staff observed after the procedure—and this was his own idea—

““Ya know, Dr. Wharton, if we didn’t do so many Ya know, Dr. Wharton, if we didn’t do so many stable elective patients in this lab, we wouldn’t stable elective patients in this lab, we wouldn’t have had the experience to be able to perform have had the experience to be able to perform nearly so well in this case!”nearly so well in this case!”

• One of the cath lab staff observed after the procedure—and this was his own idea—

““Ya know, Dr. Wharton, if we didn’t do so many Ya know, Dr. Wharton, if we didn’t do so many stable elective patients in this lab, we wouldn’t stable elective patients in this lab, we wouldn’t have had the experience to be able to perform have had the experience to be able to perform nearly so well in this case!”nearly so well in this case!”


TPWhartonTPWharton


TPWhartonTPWharton

4.8. PCI in Hospitals Without On-Site Surgical

Backup: Recommendations

CLASS IIa

1. Primary PCI is reasonable in hospitals without onsite cardiac surgery, provided that appropriate planning for program development has been accomplished.

CLASS IIb

1. Elective PCI might be considered in hospitals without on-site cardiac surgery, provided that appropriate planning for program development has been accomplished and rigorous clinical and angiographic criteria are used for proper patient selection.


Better Late than Never !!Better Late than Never !!Better Late than Never !!Better Late than Never !!

© Corazon, Inc. All rights reserved. 64

PCI-Staged vs. Same Setting of CarePayor Cost Avoidance Scenario Sample based on 2010 Medicare

•Hospital component for PCI based on CMS split of case volume across DRGs 246-251•Physician Pro-fee for dx cath based on CMS left heart cath & PCI blended payment rate based on 1.4 stents/case•Transport based on State ground rates + 10 miles & a blend of Advanced Life Support levels

$7302 per case

cost avoidance

© Corazon, Inc. All rights reserved.

$7+ Million cost avoidance with Statewide

Sample

Thomas wharton

Documents

Transcript of Thomas wharton