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Hemodynamic Support In High Risk PCI
Perwaiz M. Meraj MD FACC FSCAI
Director of Research, Associate Program DirectorAdvanced Hemodynamic Support, Complex Coronary, Structural Heart and Peripheral Vascular DiseaseNorthwell HealthHofstra Northwell School of Medicine
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Faculty Disclosure
Company Nature of Affiliation Unlabeled Product Usage
• Medtronic, Edwards
Lifesciences, Abiomed,
Boston Scientific,
Avinger, SJM
• Advisory Board, Consultant,
Research Grants• None
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A Growing Population Appropriate for PCI
PatientComorbidities
Heart failure, diabetes, advanced age, peripheral vascular disease, complex
lesions, unstable angina/NSTEMI, prior surgery
HemodynamicCompromise
Depressed ejection fraction (LVEF<35%)
ComplexCoronary Artery
Disease
Multi-vessel disease, Left Main diseaseProtected
PCIPatients
Protected PCINow FDA Indicated
Safe & Effective
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Percutaneous assist devices
Werdan K et al. Eur Heart J 2014;35:156-167
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Historical Perspectives
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Impella 2.5/CP Impella 5.0 Impella RP/AB
Impella Series of Devices
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15
Impella CP
Impella 2.5
Impella 2.5 Impella CP
Mean Flow Rate (L/min, max)
2.3 to 2.5 3.3. to 3.5 (at P9)
Catheter Size 9 Fr 9 Fr
Pump Size 12 Fr 14 Fr
Insertion Method Percutaneous via 13 Fr Introducer Sheath
Percutaneous via 14 Fr Introducer Sheath
Guidewire 0.018” Silicone Wire 0.018” PTFE Wire
Placement Measurement
Fluid-filled Pressure Lumen
Fluid-filled Pressure Lumen
Cannula Geometry Curved, Pigtail Curved, Pigtail
RPM 51,000 46,000
P-level P1-P9 (Boost Mode) P1-P9
Impella CPTM– Impella® 2.5 Comparison
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Impella® 2.5 Clinical Evidence Base (N=943*)Three
Prospective
Clinical Trials
Design TypeUsed in FDA
Submissions
Number of
PatientsPublished in
PROTECT I1 Safety
Feasibility
Elective / Urgent
20JACC Interv.
2009
PROTECT II2 RandomizedElective /
Urgent452 (225) Circulation 2012
Cardio ByPass3 Randomized Elective 199 (105) EJCTS 2002
Two Post Market Registries
EU Registry4,5 Multicenter
Open
Elective / Urgent
144 JACC 2009
Emergent 120 Circ HF 2013
US Registry6,7 Multicenter
Open
Elective / Urgent
175 CCI 2012
Emergent 154 JOIC 2013* Does not include control arm patients for randomized trials
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18
High Risk is a “Relative” PerceptionRisk Increases from SYNTAX, to BCIS to PROTECT II
SYNTAX1
(n=903)
BCIS2
(n=301)
PROTECT II3
(n=448)
Age (Mean±SD) 65±10 71±10 67±11
Diabetes (%) 26 35 52
Prior MI (%) 32 73 68
CHF (%) 4 - 87
Prior PCI 0 10 39
Prior CABG 0 15 33
LVEF ≤ 35% (%) ~2 100 100
Euroscore (Mean±SD) 4±3 - 18±18
Not Surgical Candidates (%) 0 - 64
In-hospital ~1.0 1.3 3.5
~3 month Mortality (%) 2.5 4.9 10.3
1 PCI arm in SYNTAX trial, Serruys et al. N Engl J Med. 2009; 2 Perera D et al, JAMA. 2010 Aug 25;304(8):867-74.3 O’Neill et al. Circulation 2012
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19
Surgical Co-Morbidities (STS, EuroScore)
AnatomicRisk
(SYNTAX)
Risk Stratification
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20
Surgical Co-Morbidities (STS, EuroScore)
AnatomicRisk
(SYNTAX)
Risk Stratification
SYNTAX
Trial
BCIS
TrialPROTECT
II
Trial
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Outline
• Clinical Investigations of “High Risk” Patients
• Hemodynamic Support in Elective/Urgent Setting
• Hemodynamic Support in Emergent Setting
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PROTECT II Trial Design
IMPELLA 2.5 +PCI
IABP + PCI
Primary Endpoint = 30-day Composite MAE* rate
1:1R
Patients Requiring Prophylactic Hemodynamic Support During Non-Emergent High Risk PCI on
Unprotected LM/Last Patent Conduit and LVEF≤35% OR3 Vessel Disease and LVEF≤30%
Follow-up of the Composite MAE* rate at 90 days
*Major Adverse Events (MAE) : Death, MI (>3xULN CK-MB or Troponin) , Stroke/TIA, Repeat Revasc, Cardiac or Vascular Operation or Vasc. Operation for limb ischemia, Acute Renal Dysfunction, Increase in Aortic insufficiency, Severe Hypotension, CPR/VT, Angio Failure
O’Neill et al, Circulation. 2012;126(14):1717-27
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23
Baseline Patient Characteristics
Patient Characteristics IABP(N=211)
Impella(N=216)
p-value
Age 67±11 68±11 0.583
Gender-Male 82.0% 80.6% 0.704
History of CHF 82.9% 91.2% 0.011
Current NYHA (Class III / IV) 54.9% 58.5% 0.485
Diabetes Mellitus 49.3% 53.2% 0.414
Renal insufficiency 30% 22.7% 0.086
Peripheral Vascular Disease 27.0% 25.4% 0.697
Implantable Cardiac Defib. 31% 35.6% 0.304
Prior CABG 28.9% 39.4% 0.023
LVEF 24.0±6.3 23.3±6.3 0.258
STS Mortality score 6±7 6±6 0.562
Not Surgical Candidate 64.5% 63.4% 0.825
SYNTAX score 29.5±13.7 30.3±13.2 0.595
O’Neill et al, Circulation. 2012;126(14):1717-27
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Hemodynamic Support Effectiveness
Cardiac Power Output
Maximal Decrease in CPO on device Support
from Baseline (in x0.01 Watts)
IABP Impella
N=138 N=141
- 4.2 ± 24
- 14.2 ± 27
p=0.001
O’Neill et al, Circulation. 2012;126(14):1717-27
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Procedural CharacteristicsProcedural Characteristics IABP
(N=211)
Impella(N=216)
p-
value
Use of Heparin 82.4% 93.5% <0.001
IIb/IIIa Inhibitors 26.5% 13.4% <0.001
Total Contrast Media (cc) 241±115 267±141 0.035
Rotational Atherectomy (RA) 9.0% 14.2% 0.083
Median # of RA Passes/lesion (IQ range) 1 (1-2) 3 (2-5) 0.001
Median # of RA passes/pt (IQ range) 2.0 (2.0-4.0) 5.0 (3.5-8.5) 0.003
Median RA time/lesion (IQ range sec) 40 (20-47) 60 (40-97) 0.004
RA of Left Main Artery 3.1% 8.0% 0.024
Total Support Time (hours) 8.23±21.0 1.86±2.7 <0.001
Discharge from Cath Lab on device 37.7% 5.6% <0.001
O’Neill et al, Circulation. 2012;126(14):1717-27
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PROTECT II: Per Protocol MAE (N=427)
IABP
IMPELLA
42.2%
51.0%
34.3%
40.0%
30 day MAE 90 day MAE
p=0.092
N=216N=211
p=0.023
N=215N=210
21 (12/9) Patients Excluded to Due Not Meeting Inclusion/Exclusion Criteria Prior to Analysis
4 LVEF > 35% 3 Active MI4 No Left Main or 3 V CAD10 Other Exclusions
Log rank test, p=0.048
IABP
IMPELLA
O’Neill et al, Circulation. 2012;126(14):1717-27
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90 day MAERelative Risk
[95% CI]Relative Risk
[95% CI]
Group
p-value
Interaction
p-value
0.79 [0.64, 0.97] 0.023
0.70 [0.55, 0.89] 0.003
1.19 [0.75, 1.91] 0.444
0.82 [0.53, 1.25] 0.351
0.78 [0.61, 0.99] 0.039
1.14 [0.75, 1.71] 0.540
0.71 [0.56, 0.91] 0.006
0.92 [0.62, 1.38] 0.697
0.74 [0.58, 0.95] 0.016
Pre-Specified Sub-group Analysis (PP)
With Atherectomy (n=52)
Without Atherectomy (n=373)
STS ≥ 10 (n=71)
STS < 10 (n=354)
1st Impella/IABP Pt per site (n=116)
After 1st Impella/IABP Pt (n=309)
ULM / Last conduit (n=101)
3VD (n=324)
Anatomy
PCI Procedure
STS Mortality Score
Roll in subject
Overall – Per Protocol (n=425)
Impella better IABP better0.0 0.5 1.0 1.5 2.0
0.087
0.845
0.092
0.348
PP= Per Protocol
O’Neill et al, Circulation. 2012;126(14):1717-27
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Complete or Incomplete Revascularization?ADVAN TAG E S V S . D I S ADVAN TAGES
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1.0%
2.9%
4.8%
6.7%
1.8%
3.7% 3.3%
2.0%
0%
2%
4%
6%
8%Medical Rx Revascularization
CSMC: Survival Benefit with Revascularization According to Ischemic Risk (F/U 1.9 yr)
% Total Ischemic Myocardium
1- 5% 5-10% 11-20% >20%
Car
dia
c D
eath
(%)
1331 56 718 109 545 243 252 267
P <0.0001
Hachamovitch R et al. Circulation 2003;107:2900-7
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0.0%
15.6%
22.3%
39.3%
0%
10%
20%
30%
40%
Dea
th o
r M
I Rat
e (%
)
COURAGE: Rates of Death or MI by Residual Ischemia on 6-18 MPS
p=0.002
0%(n=23)
p=0.023
p=0.063
1%-4.9%(n=141)
5%-9.9%(n=88)
>10%(n=62)
Shaw LA et al. Circulation 2008;117:1283-91
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0
10
20
30
40
50
60
70
80
NY PCI 2003 ARTS I 1997 ARTS III 2003 SYNTAX PCI
Incomplete Revasc Complete Revasc
Incomplete Revascularization is Common
Pat
ien
ts, %
Farooq et al, JACC 2013
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Why do we see IR?
• Small vessels with diffuse disease
• CTOs
• Hemodynamic instability
• No ischemia
• No viability
• Not the culprit lesion
• Revasc. may be assumed to be inappropriate
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Why Might CR be Beneficial?
Potential Advantages :
• Less early recurrent ischemia and subsequent procedures
• Better tolerance of events in other coronary distributions
• Preservation of LV function
• Reduced rate of MI ► Less SCD
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Farooq et al, JACC 2013
11.9
6 6.7
1.8
17.7
3.7
17.2
29.6
15.9
9.1 9.7
2.8
26.8
6.5
23.3
41.9
0
5
10
15
20
25
30
35
40
45
50
P=0.052
P=0.049 P=0.059
Pat
ien
ts (%
)
All-causeDeath
CardiacDeath
MI CVA All-causeRevascul-arization
StentThrom-
bosis
Death/CVA/MI
MACCE
Complete Revascularization
P=0.23
P<0.001
P=0.046
P=0.011
P<0.001
Incomplete Revascularization
CR vs. IR in SYNTAX
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Hannan EL et al. JACC Intv 2009;2:17-25
Significant baseline differences:• Age• Gender,• Diabetes,• race, • prior MI, • PAD, CHF,• # ds vessels,• LVEF,• type of stent
Adjusted 18-Month Survival
(n=3,499, 31.0%)
(n=7,795, 69.0%)
94.9
93.8
HR [(95%CI) = 1.23 (1.04–1.45)
P=0.01S
urv
ival
(%)
Months
90
95
100
0 6 12 18
Complete revascularizationIncomplete revascularization
IR in the DES Era:NY State Registry Database (n=11,294 MVD pts)
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IR Associated with Greater Risk of Long-term Mortality After Stenting in the Era of First-Gen DES
Conclusion: In patients with multivessel disease treated during the era of first-generation DES, incomplete revascularization increased 5-year mortality.
New York State database study of 21,767 patients with multi-vessel disease who underwent PCI, 10/2003 to 12/2005; median follow-up was 3.9 years.
Wu C, et al. Am J Cardiol. 2013
Long-term Mortality vs.
Complete RevascularizationHR (95% CI) P Value
Incomplete 1.16 (1.06-1.27) 0.001
One-Vessel Incomplete 1.13 (1.02-1.25) 0.1
Multivessel Incomplete 1.27 (1.03-1.57) 0.3
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0
2
4
6
8
10
12
0 1 2 3
Percentage of PCI Patients Undergoing CABG within 3y 4 IR Subgroups vs CR Group
Rec
eivi
ng
CA
BG
(%)
Years
6.4
8.910.3
4.9
4.6 4.55.7 5.7
7.68.0
6.7 6.54.95.9
6.9
1 vessel IR with no total occlusion2 vessels IR with no total occlusionIR with single total occlusionTotal occlusion and at least 1 other vessel IRComplete revascularization
Hannan EL, et al. Circulation. 2006;113:2406-2412.
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ARTS II: Repeat Revascularization
Sarno G, et al. Am J Cardiol. 2010
Cu
mu
lati
ve S
urv
ival
(%)
50
60
70
80
90
100
0
Any revascularization
75.4%PCI IR vs CABG CR: log rank P=0.00 (HR 3.58 [2.35-5.44])PCI IR vs CABG IR: log rank P=0.003 (HR 3.34 [1.52-7.33])PCI CR vs CABG CR: log rank P=0.00 (HR 2.44 [1.62-3.67])PCI CR vs CABG IR: log rank P=0.04 (HR 2.26 [1.04-4.95])PCI IR vs PCI CR: log rank P=0.03 (HR 1.48 [1.03-2.11])CABG IR vs CABG CR: log rank P=0.87 (HR 1.07 [0.47-2.41])
83.1%
92.2%
92.5%
365 730 1095 1460 1825
Time (Days)
CABG CR
CABG IR
PCI CR
PCI IR
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51.0%
43.3%37.7%38.2%
27.9%
22.6%
33.8%
23.3%
17.0%
0.0%
10.0%
20.0%
30.0%
40.0%
50.0%
60.0%
1 Vessel 2 Vessels 3 Vessels
MAE
MACCE 1
MACCE 2
Extent of Revascularization
(p = 0.06)
More Complete Revascularization
Improves 90 day Outcomes
(p = 0.013)
(p = 0.006)
PROTECT II Study
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Hemodynamic Compromise Based on Extent of Revascularization
-14.4% -15.6%
-22.0%
-3.4%-8.4% -8.6%
1 Vessel 2 Vessels 3 Vessels
IABP
p <0.001 p =0.001
p =0.004
Decrease in MAP During Procedure(in % from baseline)
PROTECT II Study
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Summary
• More extensive revascularization is associated with an improvement in 90 day outcome
• Moreover, the use of the Impella in patients undergoing more extensive revascularization resulted in fewer per-procedural hypotensive events and was associated with improved 90 day outcomes compared with IABP
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High Risk PCI
LV EF < 20%
Impella CP Impella 2.5
PCI
Hemodynamic Instability
Pre-Close Keep CP in placeConsider upgrading to CP if started with 2.5Add CP to RP if BiV Failure
Decreased RV Function
Impella RP
Yes No Yes
YesNo
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Case 1
• 87 year-old fully functional man with hypertension and hyperlipidemia.
• Recently, worsening dyspnea with exertion
• Life-limiting angina and dyspnea
• Labs: Cr 1.9 (CrCl = 25)
• TTE: EF 10%, severe segmental hypokinesis
• ECG: SR, 1st deg AVB, LAFB
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Heart Team Approach
• CT Surgical Evaluation
• 4v CABG risks and benefits
• High Risk PCI
• Without Support?
• With Support?• What support?
• Atherectomy?
• TVP?
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SYNTAX Score
• A prospective angiographic tool to grade the complexity of coronary artery disease
• Goal: Obtain evidence-based guidelines for selecting revascularization technique (surgery or PCI)
Number & location of
lesions
Tortuosity
Thrombus
Bifurcation
Total Occlusion
3 Vessel
Left Main
Dominance
SYNTAXscore
Calcification
Number & location of
lesions
Tortuosity
Thrombus
Bifurcation
Total Occlusion
3 Vessel
Left Main
Dominance
SYNTAXscore
Calcification
32
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ACC/AHA/SCAI PCI Guidelines: Heart Team Approach to Revascularization Decisions
A Heart Team approach to revascularization is recommended in patients with unprotected left main or complex CAD.
Calculation of the STS and SYNTAX scores is reasonable in patients with unprotected left main and complex CAD.
I IIa IIb III
I IIa IIb III
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Indications for CABG vs PCI in stable patients with lesions
suitable for both procedures and low predicted surgical
mortality
Subset of CAD by anatomy Favours CABG Favours PCI
1VD or 2VD – non proximal LAD IIb C I C
1VD or 2VD – proximal LAD I A IIa B
3VD simple lesions, full functional revascularization achievable with PCI,
SYNTAX score ≤ 22I A IIa B
3VD complex lesions, incomplete revascularizarion achievable with PCI,
SYNTAX score > 22I A III A
Left main (isolated or 1VD, ostium/shaft) I A IIa B
Left main (isolated or 1VD, bifurcation) I A IIb B
Left main + 2VD or 3VD, SYNTAX score ≤ 32 I A IIb B
Left main + 2VD or 3VD, SYNTAX score ≥ 33 I A III B
ESC guidelines 2010
STS Mortality = 27.8%STS Morbidity = 65.5%
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Post Procedure
• Discharged to home
• No functional capacity limitations
• EF from 10% to 40%
• QOL improvement
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Summary - Case in Point
• Successful case
• Patient went to rehab
• Community physician re-evaluated patient 4 weeks later and is feeling great
• Physician and Family are elated
• New referrals for new patients who otherwise would never be sent for revascularization
• Built on the success of that case in the cath lab – team with renewed purpose
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Case 2
• 80 year-old man
• Severe AS – AoV area of 0.4 cm2
• Mean TTE gradient = 45 mmHg
• Deemed too high risk for AVR
• Considering for TAVR
• Renal Dysfunction Cr = 2.5
• EF = 10%
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