1. Complex Coronary Cases
Supported by:
Abbott Vascular
Boston Scientific Corporation
Medtronic, Inc.
AstraZeneca
St Jude’s Medical
Abiomed
Vascular solution
Bracco Diagnostic

2. Disclosures
Samin K. Sharma, MBBS, FACC Speaker’s Bureau – Boston Scientific Corporation, Abbott Vascular Inc, AngioScore, The Medicines Company, Daiichi Sankyo, Inc. and Lilly USA, LLC Annapoorna S. Kini, MBBS, FACC Nothing to disclose Sameer Mehta, MBBS, FACC Consulting Fees – The Medicines Company American College of Cardiology Foundation staff involved with this case have nothing to disclose

3. Oct 15th 2013 Case #16: WA, 79 yr F Presentation:
Patient with long standing CAD history, prior MIs and severe LV dysfunction, presented on Sept 9th, 2013 with NSTEMI and CHF. Cardiac cath revealed 3 V calcific CAD (subtotal distal RCA, 80% mid LAD, 70% OM2) and LVEF 22%; SYNTAX score 23. Attempt to open RCA was unsuccessful. Patient underwent cardiac MRI revealing viability in all segments and CT surgery declined by the pt.
Prior History:
Hypertension, Hyperlipidemia, NIDDM, CVA-recovered, A.fib, s/p colon and lung ca resection
Medications: All once daily dosage
Carvedilol 6.25mg, ISMN 30mg, Losartan 50mg, ASA 81mg, Atorvastatin 80mg, Metformin 1000mg, Clopidogrel 75mg 3

4. Case# 16: cont… Cardiac Cath 9/10/2013: Right Dominance
3 V CAD with LVEF 22%
Left Main: No obstruction
LAD: 80% calcific mid LAD, 60% D1 bifurcation
LCx: 70% OM2
RCA: 80% mid and 99% distal severely calcified RCA lesion
Pt underwent attempt to open RCA was unsuccessful because of inability to cross RCA lesion due to calcification and tortuosity. IABP was inserted post procedure for chest pain and pt had no peri-procedure MI.
Plan Today:
- PCI of calcific RCA and LAD with Impella LV assist device 4

5. Appropriateness Criteria for Coronary Revascularization

6. Issues Involving The Case
LV support for High-risk PCI
Appropriateness of PCI (stent use)

7. Issues Involving The Case
LV support for High-risk PCI
Appropriateness of PCI (stent use)

8. Percutaneous LV Assist Devices
PTVA:
TandemHeart
IMPELLA:
Recovers 2.5
IABP

9. Hemodynamic Comparison of IABP with Impella
Pressure Loops of IABP vs. Impella
Effect on Cardiac Work
Balloon Pump
Reduces systolic
aortic pressure
Increases SV
Stroke Volume
increase offsets
pressure reduction
Impella
Unloads LV
Reduces diastolic
volume
Volume Reduction
Reduces PV loop area and cardiac work
Jones et al., J Invasive Cardiol 2012;10:544

10. O’Neill et al., Circulation 2012;126:1717

11. PROTECT II Study: Effectiveness of
Impella vs IABP Use During High-Risk PCI
IABP
Impella
p=0.087
p=0.312 %
30 Day MAE Day MAE
O’Neill et al., Circulation 2012;126:1717

12. O’Neill et al., Circulation 2012;126:1717

13. PROTECT II Study: 90-Day MAE Impact of Time and Experience
Years:
IABP
48.5% vs %
Impella 2.5
p=0.040
p=0.658
p=0.195
p=0.106 %
N=66
N=69
N=85
N=91
N=68
N=64
O’Neill et al., Circulation 2012;126:1717

14. IMPELLA-EUROSHOCK Registry: Mortality at 30 Days
and Secondary Efficacy Endpoints
Baseline
(N=120)
Primary endpoint
Mortality at 30 days (%)
64.2
Successfully weaned from support (%)
44.5
Long-term survival (after 317±526 days) (%)
28.3
Secondary endpoints
Successful implantation procedure (%)
99.2
Duration of Impella-2.5-support, hours
43.5±49.6
In-hospital MACCE (%) 15
Vascular complications (%)
28.6
Plasma lactate at admission, mmol/L
5.8±5.0
Plasma lactate after 24 hours, mmol/L
4.7±5.4
Plasma lactate after 48 hours, mmol/L
2.5±2.6
Lauten et al., Circ Heart Fail. 2013;6:23

15. PLVAD Assistance in Post Cardiac Arrest Shock: Comparison of IABP and IMPELLA Recover LP2.5 Outcome
IMPELLA (n=35)
IABP (n=43)
p Value
Alive with CPC 1 on day 28 (%) 23
29.5
0.61
Death from shock (%) 57 27
0.01
Death from recurrent arrhythmia (%)
5.7
6.6
0.99
Death from anoxic encephalopathy (%)
8.6
37.2
0.007
Need for ECLS (%) 11
4.44
0.40
Serious bleeding complication (%) 26 9
0.06
Vascular complication (%) 3 2
0.90
Manzo-Silberman et al., Resuscitation 2013;8:609

16. PLVAD Support for High-Risk PCI and CS: In-Hospital Clinical Events
Characteristics
High Risk PCI (n=57)
CS (n=17)
IABP (n=35)
PLVAD
(n=22)
p value
IABP (n=13)
PLVAD (n=4) p
value
Vascular complications (%) 9
0.07 -
Acute stent thrombosis (%)
0.95
Recurrent MI (%)
TVR (%)
MACE (%) 11
0.78 46 50
0.89
In-hospital death (%)
Shah et al., Cardiovasc Revasc Med 2012;13:101

17. PLVAD Support for High-Risk PCI and CS
Reported Event Rates in Patients Requiring Hemodynamic Support
for High-Risk PCI
Author n
Device
Endpoint
Rate (%)
Dixon et al. 20
IMP
Death, MI, TVR or CVA 30 days
Henriques et al. 19
Mortality in hospital 10
Al-Husami et al. 6 TH
Mortality 30 days 17
Froesch et al. 26
TH/IMP 14
Kovacic et al. 68
Death, MI, or TLR 30 days
Shah et al.
MACE in hospital 15
Shah et al., Cardiovasc Revasc Med 2012;13:101

18. LV Support during High-Risk PCI: LVEF + Lesion Complexity
Simple PCI
Complex PCI
No support
IABP
Simple PCI
Simple or Complex: Inoperable cases
Complex PCI: High Syntax
Score >32/STS>5 Extensive revasc.
IABP
Impella
Impella/PTVA
MSH: Of monthly 400 PCIs, approx 25 IABP (6.25%) and 4 Impella (1%) are used 18

19. Portable Heart-Lung Support System (LVAD/ECMO)
The CARDIOHELP System is the world’s smallest portable heart-lung support system. It is ideal for use in critical care, cardiac catheterization laboratories, the operating room and trauma rooms. Furthermore, it is the perfect solution for safe and effective patient transport. As a result, there are now new opportunities and treatment possibilities for extracorporeal circulation for cardiac and/or pulmonary support 19

20. Issues Involving The Case
LV support for High-risk PCI
Appropriateness of PCI (stent use)

22. ACCF/SCAI/STS/AATS/AHA/ASNC 2009 & 2012 Appropriateness Criteria for Coronary Revascularization
Patel et al. JACC 2009;53:
Patel et al. JACC Jan30, 2012.

23. Appropriateness Use Criteria for PCI
AUC Criteria from ACC-NCDR Results (n=500,00)
98.6
ALL
ACS PCI (71%)
Elective PCI (29%)
84.6 %
50.4
38.0
11.2
11.6
4.1
0.3
1.1
Appropriate
Uncertain
Inappropriate
Paul Chan. JAMA 2011;306:53.

24. Chan et al., JACC Sept 2013, Accepted Manuscript

25. Patient and Hospital Characteristics Associated with Inappropriate PCI
Results: Of 211,254 non-acute PCIs, 25,749 (12.2%) were classified as inappropriate. After multivariable adjustment, men (adjusted OR, 1.08 [95% CI: ]; p=<0.001) and whites (adjusted OR, 1.9 [ ]; p=<0.001) were more likely to undergo an inappropriate PCI, compared with women and non-whites. Compared with privately insured patients, those with Medicare (adjusted OR, 0.85 [ ], other public insurance (adjusted OR, 0.78 [ ]) and no insurance (adjusted OR, 0.56 [ ]) were less likely to undergo an inappropriate PCI (p=<0.001). Additionally, compared with urban hospitals, those admitted at rural hospitals were less likely to undergo inappropriate PCI, whereas those at suburban hospitals were more likely.
Chan et al., JACC Sept 2013, Accepted Manuscript

26. Patient and Hospital Predictors of Inappropriate PCI
HOSPITAL VARIABLES
95% Confidence Interval
p Value
Hospital location (reference: urban)
<0.001
Rural
0.92 ( )
Suburban
1.10 ( )
Teaching hospital
0.98 ( )
0.11
Public hospital
1.02 ( )
0.25
For-profit status (reference: university)
0.28
Government
0.87 ( )
Private
1.00 ( )
Onsite cardiothoracic surgery
1.03 ( )
0.20
Annual elective PCI volume, per 100 cases
0.99 ( )
Chan et al., JACC Sept 2013, Accepted Manuscript

27. MSH
3.7%
Hannan E et al. JACC 2012;59:1870. 27

28. Appropriateness of Revascularization by PCI: NY State vs
Appropriateness of Revascularization by PCI: NY State vs. MSH for Stable CAD in 2010 %
NYS
MSH N
Stable CAD %
Not Rated %
NYS
14743
37.4
27.5
MSH
2575
62.3
13.7 28 28

29. Appropriateness of PCI
AUC Metrics at MSH compared to ACC-NCDR
(n=1500 hospitals) for July-Dec 2012
Proportion of non-ACS PCI procedures at MSH classified Inappropriate %

30. Appropriateness of PCI
AUC Metrics at MSH compared to ACC-NCDR
(n=1500 hospitals) for Jan-June 2013
Proportion of non-ACS PCI procedures at MSH classified Inappropriate %

31. Pattern and Intensity of Optimal Medical Therapy (OMT) during PCI: Impact of COURAGE Trial: Data from ACC-NCDR CathPCI Registry
PRE- COURAGE (n=173,416)
Post- COURAGE (n=293,795)
66.0
63.5
64.3
61.8 %
43.5
44.7
40.0
41.1
OMT Pre-PCI
OMT Post-PCI
OMT Pre-PCI
OMT Post-PCI
All Cases (N=467,211)
COURAGE Trial type Cases (N=265,184)
W Borden et al. JAMA 2011;305:1882

32. Distribution of Appropriateness Score ACC Appropriateness Score
Inappropriate scores
Uncertain scores
Appropriate scores
(%)
18%
68%
ACC Appropriateness Score
Ko et al., J Am Coll Cardiol 2012;60:1876

33. Treatment According to Appropriate Categories
Ko et al., J Am Coll Cardiol 2012;60:1876

34. Death or ACS at 3 Years According
to AUC Criteria
Revascularization
No Revascularization
p=0.0087
p=0.12
p=0.97 %
n=991
n=326
n=311
Ko et al., J Am Coll Cardiol 2012;60:1876

35. Outcomes of PCI Patients According to Procedural Appropriateness
Inappropriate (N=54)
p=0.43
Uncertain (N=1604)
p=0.08
p=<0.001
p=0.01 %
p=0.25
p=0.32
In-hospital day MACE Mortality yr MACE Mortality TVR
Major Comp
Barbash et al., Cardiovasc Revasc Med 2013, Article in Press

36. Multivariable Analysis for Predictors of In-Hospital Mortality
Hazard Ratio
95% Confidence interval
P Value
Lower HR
Upper HR
“Appropriate” vs “Inappropriate”
0.31
0.09
1.02
0.05
“Uncertain” vs “Inappropriate”
0.41
0.12
1.39
0.15
Hypertension
0.85
0.34
2.12
0.73
Diabetes mellitus
2.04
1.12
3.70
0.02
Hypercholesterolemia
0.44
0.22
0.90
Smoker
0.35
1.55
0.42
Peripheral vascular disease
2.10
1.08
4.08
0.03
Previous CABG
1.36
0.51
3.65
0.54
History of CAD
0.76
1.69
Family history of CAD
0.28
0.13
0.62
0.001
LAD PCI
1.56
0.83
2.91
0.17
AHA/ACC type C lesion
1.64
0.92
2.93
DES
<0.001
Barbash et al., Cardiovasc Revasc Med 2013, Article in Press

37. JACC Cardiovasc Interv 2012;5:801

38. CMS doubles down on appropriateness with new prepayment review demonstration

40. Take Home Message: LV support for High-risk PCI and Appropriateness of PCI
LV support during high-risk PCI using Impella seems to have advantage (trend for lower MACE) over IABP but is associated with higher vascular complications (higher sheath size 13Fr for Impella vs. 7.5Fr for IABP. Role of both Impella or IABP in CS despite their ubiquitous use, is questionable and can’t be supported by published data.
Interventionalists have to take the prime responsibility of following the appropriate use criteria for PCI and use stents only in appropriate clinical and angiographic scenario.

41. Question # 1
Which of the following statement is true for Impella vs. IABP in the PROTECT II Trial of high-risk PCI:
Impella use reduced mortality
Impella use decrease MI
Impella use decreased CVA
Impella use decreased vascular complications
Impella use decreased TVR

42. Question # 2
As per ACC-NCDR data, what is the range of PCIs classified Inappropriate for the stable CAD at the present time :
<5%
5-10%
11-20%
20-30%
>30%

43. Question # 3
Following characteristics are associated with higher Inappropriate PCI use in stable CAD except :
A. White race
B. Female gender
C. Urban hospitals
D. Commercial insurance provider
E. Lower baseline hospital PCI volume

44. Question # 1
Which of the following statement is true for Impella vs. IABP in the PROTECT II Trial of high-risk PCI:
Impella use reduced mortality
Impella use decrease MI
Impella use decreased CVA
Impella use decreased vascular complications
Impella use decreased TVR
The correct answer is E as Impella use was associated with lower TVR at 90 days while other parameters did not differ significantly
O’Neill et al., Circulation 2012;126:1717

45. Question # 2
As per ACC-NCDR data, what is the range of PCIs classified Inappropriate for the stable CAD at the present time :
<5%
5-10%
11-20%
20-30%
>30%
The correct answer is C as 12-19% PCIs are classified as Inappropriate from ACC NCDR data
Paul Chan. JAMA 2011;306:53.
Chan et al., JACC Sept 2013, Accepted Manuscript

46. Question # 3
Following characteristics are associated with higher Inappropriate PCI use in stable CAD except :
A. White race
B. Female gender
C. Urban hospitals
D. Commercial insurance provider
E. Lower baseline hospital PCI volume
The correct answer is B as all other scenarios are associated with higher Inappropriate PCI use
Chan et al., JACC Sept 2013, Accepted Manuscript