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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

Faculty Disclosure

Company Nature of Affiliation Unlabeled Product Usage

• Medtronic, Edwards

Lifesciences, Abiomed,

Boston Scientific,

Avinger, SJM

• Advisory Board, Consultant,

Research Grants• None

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

Percutaneous assist devices

Werdan K et al. Eur Heart J 2014;35:156-167

Historical Perspectives

Impella 2.5/CP Impella 5.0 Impella RP/AB

Impella Series of Devices

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

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

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

19

Surgical Co-Morbidities (STS, EuroScore)

AnatomicRisk

(SYNTAX)

Risk Stratification

20

Surgical Co-Morbidities (STS, EuroScore)

AnatomicRisk

(SYNTAX)

Risk Stratification

SYNTAX

Trial

BCIS

TrialPROTECT

II

Trial

Outline

• Clinical Investigations of “High Risk” Patients

• Hemodynamic Support in Elective/Urgent Setting

• Hemodynamic Support in Emergent Setting

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

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


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


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


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


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


Complete or Incomplete Revascularization?ADVAN TAG E S V S . D I S ADVAN TAGES

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

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

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

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

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

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

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)

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

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.

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

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

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

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

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

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

Heart Team Approach

• CT Surgical Evaluation

• 4v CABG risks and benefits

• High Risk PCI

• Without Support?

• With Support?• What support?

• Atherectomy?

• TVP?

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

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

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%

Post Procedure

• Discharged to home

• No functional capacity limitations

• EF from 10% to 40%

• QOL improvement

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

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%

Thanks

Perwaiz Meraj MD FACC FSCAINorthwell [email protected]

support in pci - sdinterventions.com · hemodynamic support in high risk pci ... state database...

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