Application of Appropriate Use

Criteria in Clinical Care of CAD

Application of Appropriate Use

Criteria in Clinical Care of CAD

Peter K. Smith, MD

Professor and Chief

Thoracic Surgery

Duke University

4/29/2012

Influence of Severity and Location of Stenosis on Cardiac DeathOver a 7-Year Mean Follow-up in 29,082 Patients Catheterized for CAD at Duke Between

1986–2000 and Treated Without Revascularization

Influence of Severity and Location of Stenosis on Cardiac DeathOver a 7-Year Mean Follow-up in 29,082 Patients Catheterized for CAD at Duke Between

1986–2000 and Treated Without Revascularization

Relative Chance of Cardiac Death

Relative Chance of Cardiac Death

Number of PatientsNumber of Patients

0

23

34

37

42

0

23

34

37

42

None ≥≥≥≥ 50%

One 50–74%

Two or Three 50–74%

One ≥≥≥≥ 75%

Two ≥≥≥≥ 75%; None ≥≥≥≥ 95%

None ≥≥≥≥ 50%

One 50–74%

Two or Three 50–74%

One ≥≥≥≥ 75%

Two ≥≥≥≥ 75%; None ≥≥≥≥ 95%

GroupGroup Severity and Location of StenosisSeverity and Location of Stenosis

A

B

C

D

E

A

B

C

D

E

0 20 40 60 80 100 0 4000 8000

42

48

50

42

48

50

59

71

76

81

94

98

100

59

71

76

81

94

98

100

Two ≥≥≥≥ 75%; None ≥≥≥≥ 95%

One ≥≥≥≥ 95% Prox. LAD or 50–74% LM

Two ≥≥≥≥ 75%; At least one ≥≥≥≥ 95%

Two ≥≥≥≥ 75% with ≥≥≥≥ 95% LAD or 25–49% LM or three ≥≥≥≥ 75% and < 95%

Two ≥≥≥≥ 75% with either Prox. LAD or LM 50–74%

Three ≥≥≥≥ 75% and two or three ≥≥≥≥ 95%

Three ≥≥≥≥ 75% and either ≥≥≥≥ 75% Prox. LAD or 25–49% LM

Three ≥≥≥≥ 75% and either ≥≥≥≥ 95% Prox. LAD or 50–74% LM

≥≥≥≥ 75% LM

≥≥≥≥ 95% LM

Two ≥≥≥≥ 75%; None ≥≥≥≥ 95%

One ≥≥≥≥ 95% Prox. LAD or 50–74% LM

Two ≥≥≥≥ 75%; At least one ≥≥≥≥ 95%

Two ≥≥≥≥ 75% with ≥≥≥≥ 95% LAD or 25–49% LM or three ≥≥≥≥ 75% and < 95%

Two ≥≥≥≥ 75% with either Prox. LAD or LM 50–74%

Three ≥≥≥≥ 75% and two or three ≥≥≥≥ 95%

Three ≥≥≥≥ 75% and either ≥≥≥≥ 75% Prox. LAD or 25–49% LM

Three ≥≥≥≥ 75% and either ≥≥≥≥ 95% Prox. LAD or 50–74% LM

≥≥≥≥ 75% LM

≥≥≥≥ 95% LM

E

F

G

H

I

J

K

L

M

N

E

F

G

H

I

J

K

L

M

N

Revascularization vs Medical Therapy 1986-2000

0.6

0.7

0.8

0.9

1

Survival Probability

Revascularization Medical Therapy

Low Severity CAD

0.1

0.2

0.3

0.4

0.5

0.6

0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17

Years

Survival Probability

Revascularization vs Medical Therapy 1986-2000

0.6

0.7

0.8

0.9

1

Survival Probability

Revascularization Medical Therapy

Low Severity CAD

Intermediate Severity CAD

P<0.05

0.1

0.2

0.3

0.4

0.5

0.6

0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17

Years

Survival Probability

Revascularization vs Medical Therapy 1986-2000

0.6

0.7

0.8

0.9

1

Survival Probability

Revascularization Medical Therapy

Low Severity CAD

Intermediate Severity CAD

P<0.05

0.1

0.2

0.3

0.4

0.5

0.6

0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17

Years

Survival Probability

High Severity CAD

P<0.05

J Am Coll Cardiol Intv

2009;2:614-21

"CABG remains the standard of care for patients with complex disease

Outcome CABG surgery, n=819 (%) PCI, n=879 (%) p

MACCE 23.6 33.5 <0.001

Death/stroke/MI 14.6 18 0.07

All-cause mortality 8.8 11.7 0.048

Cardiac death 4.3 7.6 0.004

Stroke 3.7 2.3 0.06

MI 3.8 8.3 <0.001

Repeat

revascularization11.9 23 <0.001

SYNTAX 4-year cumulative results

"CABG remains the standard of care for patients with complex disease

and an intermediate or high SYNTAX score. However, PCI may be an

acceptable alternative revascularization method to CABG when treating

patients with less complex diseases (SYNTAX score <22), including left

main." To put it another way, 75% of patients with left main or three-

vessel disease are still best treated with CABG, but for the remaining

25%, "PCI is an alternative to surgery, at least out to four years," Serruys

commented.

CABG PCI P value

Death 6.0% 2.6% 0.21

CVA 4.1% 0.9% 0.12

Cumulative Event Rate (%)

P=0.33

Left Main

TAXUS (N=118)

CABG (N=104)

MACCE to 3 Years by SYNTAX Score Tercile Low Scores (0-22)

Cumulative Event Rate (%)

40

30

>

>

MI 2.0% 4.3% 0.36

Death, CVA or MI

11.0% 6.9% 0.26

Revasc. 13.4% 15.4% 0.69Months Since Allocation

Cumulative Event Rate (%)

P=0.33

18.0%

23.0%

Months Since Allocation

Cumulative Event Rate (%)

0 12 24

0

20

30

10

36

Site-reported Data; ITT populationCumulative KM Event Rate ± 1.5 SE; log-rank P value

>

<

<

CABG PCI P value

Death 12.4% 4.9% 0.06

CVA 2.3% 1.0% 0.46P=0.90

Left Main

TAXUS (N=103)

CABG (N=92)

MACCE to 3 Years by SYNTAX Score Tercile Intermediate Scores (23-32)

Cumulative Event Rate (%)

40

30

>

>

MI 3.3% 5.0% 0.63

Death, CVA or MI

15.6% 10.8% 0.29

Revasc. 14.0% 15.9% 0.75

P=0.90

23.4%23.4%

Months Since Allocation

Cumulative Event Rate (%)

0 12 24

0

20

30

10

36

Site-reported Data; ITT populationCumulative KM Event Rate ± 1.5 SE; log-rank P value

>

<

<

P=0.003

Left Main

TAXUS (N=135)

CABG (N=149)

MACCE to 3 Years by SYNTAX Score Tercile High Scores (>32)

37.3%

Left Main

Cumulative Event Rate (%)

40

30

CABG PCI P value

Death 7.6% 13.4% 0.10

CVA 4.9% 1.6% 0.13>

<

21.2%

Months Since Allocation

Cumulative Event Rate (%)

0 12 24

0

20

30

10

36

MI 6.1% 10.9% 0.18

Death, CVA or MI

15.7% 20.1% 0.34

Revasc. 9.2% 27.7% <0.001

Site-reported Data; ITT populationCumulative KM Event Rate ± 1.5 SE; log-rank P value

<

<

<

SYNTAX Randomized Patients

68%

CABG

BetterSyntax Score CABG PCI Total % of Total

0-22 171 181 352 32%

23-32 208 207 415 38%

>=33 166 155 321 30%

Total 1088

3 Vessel Disease

41%

Total 1088

Syntax Score CABG PCI Total % of Total

Randomized 0-22 103 118 221 32%

Randomized 23-32 92 103 195 28%

Randomized >=33 150 135 285 41%

Total 701

Left Main CAD

SYNTAX All Patients

Syntax Score CABG PCI Total % of Total

0-22 171 181 352 19%

23-32 208 207 415 22%

>=33 166 155 321 17%

Registry (Mean 38) 646 133 779 42%

3 Vessel Disease

81%

CABG

Better

Syntax Score CABG PCI Total % of Total

Randomized 0-22 103 118 221 19%

Randomized 23-32 92 103 195 16%

Randomized >=33 150 135 285 24%

Registry (Mean 38) 431 55 486 41%

Total 1187

Left Main CAD

Registry (Mean 38) 646 133 779 42%

Total 1867

65%

The Usual Talking Points

• Increased stroke with CABG

• Revascularization drives the difference, and is

not a major complicationnot a major complication

• Neurocognitive Dysfunction with CABG

• The patient made me do it

A Heart Team approach to revascularization is

recommended in patients with unprotected left main or

complex CAD.

Heart Team Approach to

Revascularization Decisions

I IIa IIb III

Calculation of the STS and SYNTAX scores is reasonable

in patients with unprotected left main and complex CAD.

I IIa IIb III

CABG to improve survival is recommended for patients with significant (≥50% diameter stenosis) left main coronary artery stenosis.

PCI to improve survival is reasonable as an alternative to CABG in

Revascularization to Improve Survival: Left

Main CAD Revascularization

I IIa IIb III

I IIa IIb IIIPCI to improve survival is reasonable as an alternative to CABG in selected stable patients with significant (≥50% diameter stenosis) unprotected left main CAD with: 1) anatomic conditions associated with a low risk of PCI procedural complications and a high likelihood of a good long-term outcome (e.g., a low SYNTAX score [≤22], ostial or trunk left main CAD); and 2) clinical characteristics that predict a significantly increased risk of adverse surgical outcomes (e.g., STS-predicted risk of operative mortality ≥5%).

I IIa IIb III

PCI to improve survival may be reasonable as an alternative to CABG in selected stable patients with significant (≥50% diameter stenosis) unprotected left main CAD with: 1) anatomic conditions associated with a low to intermediate risk of PCI procedural complications and an intermediate to high likelihood of good long-term outcome (e.g., low-intermediate SYNTAX score of <33, bifurcation left main CAD); and

Revascularization to Improve Survival: Left

Main CAD Revascularization (cont.)

I IIa IIb III

intermediate SYNTAX score of <33, bifurcation left main CAD); and2) clinical characteristics that predict an increased risk of adverse surgical outcomes (e.g., moderate-severe chronic obstructive pulmonary disease, disability from previous stroke, or previous cardiac surgery; STS-predicted risk of operative mortality >2%).

PCI to improve survival should not be performed in

stable patients with significant (≥50% diameter stenosis)

unprotected left main CAD who have unfavorable anatomy

for PCI and who are good candidates for CABG.

Revascularization to Improve Survival: Left

Main CAD Revascularization (cont.)

I IIa IIb III

for PCI and who are good candidates for CABG.Harm

CABG with a left internal mammary artery graft to improve survival is reasonable in patients with a significant (≥70% diameter) stenosis in the proximal LAD artery and evidence of extensive ischemia.

Revascularization to Improve Survival: Non-

Left Main CAD Revascularization (cont.)

I IIa IIb III

It is reasonable to choose CABG over PCI to improve survival in patients with complex 3-vessel CAD (e.g., SYNTAX score >22) with or without involvement of the proximal LAD artery who are good candidates for CABG.

I IIa IIb III

CABG is probably recommended in preference to PCI to improve survival in patients with multivessel CAD and diabetes mellitus, particularly if a LIMA graft can be anastomosed to the LAD artery.

Revascularization to Improve Survival: Non-

Left Main CAD Revascularization (cont.)

I IIa IIb III

2012 Update Appropriateness Criteria

• All the usual talking points, plus

– Unmeasured Confounders such as diffuse vs focal

CAD, frailty, medical compliance and patient

preference

– Industry conflict not explicitly declared

Crossroads

• Appropriate Use Criteria to be utilized to deny

payment when criteria are not designated as

“appropriate” unless:“appropriate” unless:

– Specific documentation of exception for “uncertain”

– Second opinion from surgeon for “inappropriate”

• Dramatic shift in leadership in Cardiology away

from Industry support.

ACCF-STS Database Collaboration

on the Comparative Effectiveness of

Revascularization Strategies

(ASCERT)

• 86,244 CABG and 103,549 PCI with two- or three-

vessel disease, age >= 65

• STS and NCDR clinical data matched

• CMS outcome and resource data

• Longitudinal 3-Year follow-up for mortality

Unnecessary stenting case in Tennessee grabs

government attention

June 10, 2011 | Reed Miller

Jackson, TN - The US Department of Justice is looking into charges of fraudulent billing leveled by a Tennessee cardiologist against another cardiologist and two hospitals.

Dr Wood Deming (Regional Cardiology Consultants, Jackson, TN) is accusing Dr Elie Hage

Korban (Heart and Vascular Center of West Tennessee, Jackson) of "blatant overutilization of

cardiac medical services, including, but not limited to, cardiac sonography, scintigraphic stress

imaging, angiography, angioplasty, and stenting" in order to defraud government insurance

programs, according to documents filed with the US District Court for Western Tennessee.

Deming also alleges that the executives of Jackson-Madison County General Hospital and the

Regional Hospital of Jackson and radiologist Dr Joel Perchik (Advanced Radiology, Jackson,

TN) condoned or assisted in Korban's fraud in addition to engaging in a bilateral kickback and

self-referral scheme [1].

Slide Set EditorsL. David Hillis, MD, FACC, Chair and Peter K. Smith, MD, FACC, Vice-Chair

CABG Guideline Writing Committee MembersL. David Hillis, MD, FACC, Chair

Peter K. Smith, MD, FACC, Vice-Chair

Special Thanks To

Richard A. Lange, MD, FACCJeffrey L. Anderson, MD, FACC

Developed in Collaboration with the American Association for Thoracic Surgery, Society of Cardiovascular Anesthesiologists, and Society for Thoracic Surgeons

Richard A. Lange, MD, FACC

Martin J. London, MD

Michael J. Mack, MD, FACC

Manesh R. Patel, MD, FACC

John D. Puskas, MD, FACC

Joseph F. Sabik, MD, FACC

Ola Selnes, PhD

David M. Shahian, MD, FACC, FAHA

Jeffrey C. Trost, MD, FACC

Michael D. Winniford, MD, FACC

Jeffrey L. Anderson, MD, FACC

John A. Bittl, MD, FACC

Charles R. Bridges, MD, ScD, FACC, FAHA

John G. Byrne, MD, FACC

Joaquin E. Cigarroa, MD, FACC

Verdi J. DiSesa, MD, FACC

Loren F. Hiratzka, MD, FACC

Adolph M. Hutter, Jr., MD, MACC, FAHA

Michael E. Jessen, MD, FACC

Ellen C. Keeley, MD, MS

Stephen J. Lahey, MD

UPLM PCI to Improve Survival (SIHD)

Ris

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Lik

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COR LOE

IIaFor SIHD when low risk of PCI complications and

high likelihood of good long-term outcome (e.g.,

SYNTAX score of ≤22, ostial or trunk left main CAD),

B

Low Hi HiSYNTAX score of ≤22, ostial or trunk left main CAD),

and a signficantly increased CABG risk (e.g., STS-

predicted risk of operative mortality ≥5%)

IIbFor SIHD when low to intermediate risk of PCI

complications and intermediate to high likelihood of good

long-term outcome (e.g., SYNTAX score of <33,

bifurcation left main CAD) and increased CABG risk

(e.g., moderate-severe COPD, disability from prior

stroke, prior cardiac surgery, STS-predicted operative

mortality >2%)

B

III: HarmFor SIHD in patients (versus performing

CABG) with unfavorable anatomy for PCI and who are

good candidates for CABG

BHi Low Low

Comprehensive Update

• 1264 References

• New Sections

– Cardiac Anesthesiology/TEE

– Hybrid Coronary Revascularization– Hybrid Coronary Revascularization

– Anti-Platelet Therapy

– Cardiac Rehabilitation

• Revascularization harmonized with PCI

Guidelines

Anesthetic Considerations

Efforts are recommended to improve interdisciplinary

communication and patient safety in the perioperative

environment (e.g., formalized checklist-guided

multidisciplinary communication).

I IIa IIb III

A fellowship-trained cardiac anesthesiologist (or experienced

board-certified practitioner) credentialed in the use of

perioperative TEE is recommended to provide or supervise

anesthetic care of patients who are considered to be at high

risk.

I IIa IIb III

Intraoperative TEE

Intraoperative TEE should be performed for evaluation of acute,

persistent, and life-threatening hemodynamic disturbances that have

not responded to treatment.

I IIa IIb III

I IIa IIb III

Intraoperative TEE should be performed in patients undergoing

concomitant valvular surgery.

Intraoperative TEE is reasonable for monitoring of hemodynamic

status, ventricular function, regional wall motion, and valvular

function in patients undergoing CABG.

I IIa IIb III

Bypass Graft Conduit

When anatomically and clinically suitable, use of a second IMA to graft

the left circumflex or right coronary artery (when critically stenosed and

perfusing LV myocardium) is reasonable to improve the likelihood of

survival and to decrease reintervention.

I IIa IIb III

Complete arterial revascularization may be reasonable in patients less

than or equal to 60 years of age with few or no comorbidities.

I IIa IIb III

In patients referred for elective CABG, clopidogrel and

ticagrelor should be discontinued for at least 5 days before

surgery and prasugrel for at least 7 days to limit blood

transfusions.

Preoperative Antiplatelet Therapy

I IIa IIb III

transfusions.

In patients referred for elective CABG, prasugrel should be

discontinued for at least 7 days to limit blood transfusions.I IIa IIb III

Preoperative Antiplatelet Therapy

(cont.)In patients referred for urgent CABG, clopidogrel and ticagrelor

should be discontinued for at least 24 hours to reduce major

bleeding complications.

In patients referred for CABG, short-acting intravenous

glycoprotein IIb/IIIa inhibitors (eptifibatide or tirofiban) should I IIa IIb III

I IIa IIb III

glycoprotein IIb/IIIa inhibitors (eptifibatide or tirofiban) should

be discontinued for at least 2 to 4 hours before surgery and

abciximab for at least 12 hours beforehand to limit blood loss

and transfusions.

Preoperative Antiplatelet Therapy

(cont.)

In patients referred for urgent CABG, it may be reasonable to

perform surgery less than 5 days after clopidogrel or ticagrelor

has been discontinued and less than 7 days after prasugrel has

I IIa IIb III

has been discontinued and less than 7 days after prasugrel has

been discontinued.