Thomas wharton

Off Site PCI Expert Panel Review

Primary PCI –
Development and Outcomes
of a New Paradigm of Care

Thomas Wharton MD FACC FSCAI
Exeter Hospital, Exeter, NH

TPWharton

Limitations of Thrombolytic Agents

 Failure rate: 46% of patients receiving lytics are not
reperfused well enough to improve survival (GUSTO).
 Recurrent Events: In 20% to 40% of patients.
 Strokes: In 1.4% to 6.3%.
 Contraindications: Only 25% to 33% of patients with acute
M.I. may be eligible for thrombolytic therapy.
 Frequent Need for Subsequent Procedures: Cath, PTCA
 Are Given “Blindly”: Some patients will be treated
unnecessarily, because they have either spontaneously
reperfused or been mis-diagnosed.

A few of these patients will bleed into the head.

TPWharton

PAMI-1 STUDY
PAMI-1 STUDY

395 randomized lytic eligible pts with AMI :
 As compared with t-PA therapy for acute myocardial infarction,
immediate PTCA reduced the combined occurrence of nonfatal
reinfarction or death, was associated with a lower rate of intracranial
hemorrhage, and resulted in similar left ventricular systolic function.
NEJM 1993
NEJM 1993

90-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%

TPWharton

National Registry of Myocardial Infarction (NRMI)

 Only 35% of 241,000 AMI pts were treated with lytics.
 These lytic patients frequently needed other procedures:
 70.7% underwent cath later before discharge
 30.3% “ PTCA
 13.3% “ CABG

LYTICS (35%) NO LYTICS (65%)
Mortality 5.9% 13.0%
Major bleeding 2.8% 0.5%

TPWharton

Primary PCI is Superior to
Thrombolytic Therapy for Acute M.I.
Pooled data from 10 randomized trials (n=2,606):

Primary PTCA tPA p

value

Mortality 4.4 % 6.5 % 0.02

Death or Reinfarction 7.2 % 11.9 %
<0.001

Total Stroke 0.7 % 2.0 %
0.007
Weaver, JAMA 1997;278:2093
Hemorrhagic Stroke 0.1 % 1.1 % TPWharton

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

Brand new pooled data from 21 randomized trials (n=7,739):
Primary PCI Lytic Rx p value

Mortality 6.9 % 9.3 % 0.0002

Reinfarction 2.4 % 6.8% <0.0001
Total Stroke 1.0 % 2.0 % 0.0004

Hemorrhagic Stroke 0.05 % 1.1 % <0.0001

Combined 8.2 14.3 <0.0001

Keeley, Lancet 2003;361:13-20
TPWharton

Broader Applicability of Primary PCI

 Primary PTCA is arguably clinically superior to lytic therapy
in lytic-eligible patients.*
*Weaver, WD, JAMA 1997;278:2093

 But even if the therapies were equal, a majority of AMI patients are
not candidates for lytic therapy, due to
 bleeding contraindications,
 shock,
 late presentation,
 prior bypass surgery,
 non-diagnostic EKG’s
**Rogers WJ, AJM 1995;99:195

 This group is higher-risk than lytic-eligible patients.
These patients need an alternative to "morphine and bed rest."
TPWharton

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

High Bleeding Non-Diagnostic EKG,
50% Risk (n=337) 50% LBBB, Late Presentation
(n=737) 42.3%

% of Patients
Mortality (%)

24.7% 24.1%

16.4%

8.2%
2.2%

0% 0%
PTCA Conservative Mortality Combined Endpoint*
Therapy PTCA Lytic PTCA Lytic

*death, acute MI, stroke, CHF, angina

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

Primary PCI in Lytic Eligible Pts that are
High Risk (MITRA Registry)
High Risk Patients: Age >70, Anterior M.I., Heart Rate > 100

16 PCI Lytics 15.6%

12
9.8%

(%) 8
6.7%

4 3.6%
4.1%
3.2%
1.4% 0.5%
0
Death Reinfarction Death or Stroke
Re-MI
O’Neill, J Invasive Cardiol 1998:10 Suppl A:4A-10A
TPWharton

New Data From MITRA and MIR
German Registries
Pooled “real world” outcomes of nearly 10,000 AMI
patients in 2 German Registries, 1994-1998:

Primary PCI
Thrombolysis
Mortality 6.4%
11.3%
Primary angioplasty was associated with lower mortality in all
subgroups both high- andodds ratio 0.54,including pts >75 y.o. 0.67
low-risk, 95% confidence interval 0.43 to

As the mortality risk of the subgroup increased, the relative
benefit of primary PCI increased.
Zahn, JACC 2001;37:1827
TPWharton

Advantages of Primary PCI

 Can be used in virtually all infarct patients.
 Produces TIMI-3 flow over 90% of the time, not 54%.
 Does not cause intracranial bleeding.
 Reduces need for subsequent procedures (cath, PCI).
 Provides important angiographic information: patients
who need urgent surgery can be detected early.
 Opens vessels as fast or faster.
 Can improve prognosis in cardiogenic shock.
 Yields a five-fold reduction in mortality in high-risk STEMI
pts compared to thrombolytics.
TPWharton

Profiles of NRMI Registry Hospitals

Medical School Affiliation

27.6%

Cardiac Surgery

37.6%

Cardiac Catheterization Laboratory
Rogers WJ, Circulation 1994;90:2103
61.3% TPWharton

DANAMI – 2 Trial: Primary PCI vs. Lytics
at Hospitals With and Without PCI
PCI On Site or After Transfer Thrombolytic Therapy
14.2%
15% 13.7%
12.3%
Primary Endpoint (%)
(death, MI, CVA)

10% 8.5%
8.0%
6.7%

5%

0%
All Patients Presenting to Presenting to
Angioplasty Community
Centers Hospitals
(n = 1,572) (n = 442) (n = 1,129)
Andersen, ACC 2002 Presentation
TPWharton

Prague – 2 Trial
PRAGUE-2 Trial (Europe): Prospective randomization of 850 pts
to lytic therapy on-site vs. emergency transfer for primary PCI
•Thrombolytic Therapy (n = 421) Transfer for PCI (n = 429)
15.2%
30-Day Mortality (%)

Death / MI / CVA (%)
10.4%

10% 10% 8.4%

6.0%

0% 0%

Immediate transport of all STEMI patients for PCI is now part of the
national guidelines of the Czech Republic.
Widimsky, European Society of Cardiology, September, 2002
TPWharton

DANAMI-2 and PRAGUE-2

 The DANAMI-2 and PRAGUE-2 studies established
primary PCI as the treatment of choice for all patients
presenting with acute STEMI, regardless of where they
initially present.
 All such patients at hospitals without PCI should be
transferred immediately directly into the cath lab of a
PCI center, ideally with an “indoor-outdoor” time of <30
minutes.

TPWharton

Delay and Mortality of Primary PCI
After T ransfer:
PTCA On Site (n=9,311) PTCA After Transfer (n=1,307)
6.0h
6.0 10%

7.7%

3.7h
Time (hours)

Mortality (%)
4.0
5.0%
5%

2.0

0.0 0%

Time From Death
AMI Onset to PTCA (In-Hospital)
Transfer of acute MI patients to a surgical institution involves risk and
delay, and is associated with worse outcomes than PCI on site.
Tiefenbrunn, Circulation 1997:96:I-531
TPWharton

Guidelines Evolve as Medical Care Evolves

From the 1988 PCI Guidelines re Surgical Backup for PCI:
 “An experienced cardiovascular surgical team should
be available within the institution for all angioplasty
procedures,” and “there should be no exception
to this requirement.”
 “All arrangements requiring transportation of patients
to off-site surgical facilities fail to meet the necessary
standards of care exercised by prudent physicians
and cannot be condoned.”

TPWharton

Off Site PCI Expert Panel Review

without onsite
surgery
Primary PCI – ^
Development and Outcomes
n even newer
of a New Paradigm of Care !
a

Thomas Wharton MD FACC FSCAI
Exeter Hospital, Exeter, NH

TPWharton

Primary Angioplasty for the Treatment of
Acute Myocardial Infarction: Experience at Two
Community Hospitals Without Cardiac Surgery
Thomas 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

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

JACC April, 1999
JACC April, 1999

2001 ACC/AHA Guidelines for Off-Site PCI

The 2001 ACC/AHA guidelines designated primary PCI
at hospitals with off-site cardiac surgery as Class IIb:
“Usefulness/efficacy is less well established by
evidence/opinion,” provided that:
 > 36 procedures/yr are performed at such hospitals,
 by higher-volume operators (>75 procedures/yr),
 within 90 ± 30 min of admission,
 with a proven plan for rapid access to a
cardiac surgical center.

JACC 2001;37:2215 TPWharton

ACC/AHA 2001 PCI Guidelines
ACC/AHA 2001 PCI Guidelines

TPWharton

2001 ACC/AHA Guidelines for Off-Site PCI

 This Committee also designated non-emergent PCI as
Class III: stated that their Class III: “Not useful/effective,
and in some cases may be harmful.”

 This classification was based on “consensus opinion of
experts,” thus was not evidence-based
(Level of Evidence C).

TPWharton

CRITICAL PATHWAY: PRIMARY PCI AT HOSPITALS WITH OFF-SITE CARDIAC SURGICAL BACKUP
PRE-HOSPITAL:
Suspected AMI. Exeter Hospital
Diagnostic
EMS paramedic level of care,
aspirin, IV line, sublingual NTG, 12-lead
ST elevation ©2005 Wharton, Sinclair
ECG transmitted to ED, heparin.
ED physician calls interventional
No diagnostic ST Elevation
cardiologist and cath team.
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.

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.
EMERGENCY TRANSFER
to interventional / surgical hospital.
CATH LAB Activate Emergency Transfer Protocol
No
AVAILABLE? with "indoor-outdoor" ED time goal of 45 minutes.
Consider IABP (at capable hospitals)
if hemodynamically unstable.
Yes

Consent,
transport to cath lab.

CARDIAC CATH LAB: PRIMARY PCI
Arterial sheath; venous sheath if unstable or heart of IRA only.
block, IABP if in shock or hemodynamically unstable,
pacer as needed. Coronary angiography.
Yes
No

EMERGENCY CABG indicated
DETERMINE
with or without PCI: TIMI 3 FLOW
REVASCULARIZATION CABG
Activate Emergency Transfer IN IRA?
STRATEGY
Protocol.

Primary PCI
RISK
STRATIFICATION*
Medical AND MANAGEMENT
therapy
PRIMARY PCI *Clinical and angiographic Not
of IRA only. Monitor ACT, GP IIb/IIIa inhibitor. low risk: Age <70, 1-2 v low risk
Left ventriculogram. Consider right heart disease, EF >45%, no CHF
Low risk
catheterization, IABP, pacer if unstable. or arrhythmias, good PCI result.

Admit to interventional unit. Standard CCU care.
Fast-track cardiac rehabilitation; Target discharge on
MEDICAL THERAPY target discharge on hospital day hospital day 4-5,
ASA, GP IIb/IIIa inhibitor, beta blocker, ACE inhibitor 3 without pre-discharge ETT. consider ETT.
or ARB, statin, clopidogrel load and maintentance. Return to work at 2 weeks. Elective CABG if indicated.
Smoking cessation,risk factor identification and
modification, cardiac rehabilitation.
DISCHARGE; cardiac rehab phase II; ETT and lipid profile at 4 wks.

Circulation November 2005
Circulation November 2005
T Wharton, Exeter Hospital

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.”
JACC 2004
JACC 2004 TPWharton

 “The study by Wharton et al. is extremely relevant because currently
there is great debate regarding the appropriateness of performing
primary PCI at hospitals without on-site surgery. . .”
 “This study documents that superb outcomes can be achieved at
hospitals that do not offer on-site cardiac surgery. . .”

JACC 2004
JACC 2004 TPWharton

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

JACC 2004
JACC 2004 TPWharton

2005 Guidelines for PCI Off-Site

 Nevertheless the 2005 Guidelines Committee
maintained its Class IIb indication for Primary PCI at
hospitals without on-site cardiac surgery.
 The 2005 Guidelines Committee also maintained its
Class III indication for elective PCI at such hospitals,
and unfortunately introduced new and very inflammatory
language, arguably without valid justification, not citing
a large amount of new literature:

“Performing elective PCI in a setting without immediately
available onsite cardiac surgery potentially compromises
patient safety and is not recommended.”
TPWharton

TPW Presentation on Guidelines at ACC 2006

“In view of the rapidly accumulating evidence
of safety and efficacy, and no relevant evidence of harm
reported to date (the JAMA Medicare claims-coding
article notwithstanding),
strong consideration should be given now to upgrading
the Guidelines indication for non-emergent PCI from
Class III to Class IIb at centers with off-site backup that
can meet rigorous qualifications.”

TPWharton

TPW Presentation on Guidelines at ACC 2006

An audience member made the following observation at my
presentation at an ACC Guidelines session in 2006:

“Since the Guidelines Writing Committee’s conclusions
carry so much weight, and have such a powerful
influence on 3rd party payors, state regulators, and
litigation attorneys, the Writing Committee has a
profound responsibility to fairly consider, fairly
interpret, and rapidly update all of the available
information in this vital and growing field.”

TPWharton

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

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
Catheterization and Cardiovascular Interventions March, 2007

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, 2007 TPWharton

Catheterization and Cardiovascular Interventions March, 2007 TPWharton

Case 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.

TPWharton

Case Presentation

TPWharton

Case Presentation

• 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.

TPWharton

Arctic Sun Therapeutic Cooling Device

TPWharton

Updated 2005 AHA Guidelines for CPR

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
TPWharton

Case Presentation

• 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.

TPWharton

LUCAS External Compression CPR

TPWharton

Case Presentation
• 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.

TPWharton

Case Presentation

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

TPWharton

Case Presentation

• 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.

TPWharton

Case Presentation

• 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.”
TPWharton

Case Presentation

• 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.
TPWharton

Case Presentation

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

TPWharton

Case Presentation

• 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
stable elective patients in this lab, we wouldn’t
have had the experience to be able to perform
nearly so well in this case!”

TPWharton


TPWharton


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 !!
TPWharton

PCI-Staged vs. Same Setting of Care
Payor Cost Avoidance Scenario $7302
per case
cost
Sample based on 2010 Medicare
avoidance

$7+ Million
cost avoidance
with Statewide
Sample

•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
© Corazon, Inc. All rights reserved.

© Corazon, Inc. All rights reserved. 64

Thomas wharton

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Editor's Notes