application of appropriate use criteria in clinical...
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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
kof P
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Com
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Lik
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ood
of G
ood
Long-te
rm
Outc
om
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CA
BG
Morta
lity
Ris
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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.