Who is the high risk patient?

High risk of periproceduralHigh risk of periproceduraldeath or other major complications(hemodynamic compromise, MI,stroke, dialysis)

Contributors of Risk

stroke, dialysis)

Governed by

Lesion/Procedure

PatientPresentation

1. Patient presentation (shock,STEMI, cardiac arrest)

2. Patient substrate (elderly, low

Presentation

Patient Substrate

2. Patient substrate (elderly, lowEF, renal failure, frailty)

3. Lesion risk (unprotected leftmain, high risk bifurcation,main, high risk bifurcation,calcification, CTO)

The Emerging High Risk Patient

High Lesion Risk with PoorHigh Lesion Risk with PoorPatient Substrate in the Non-STEMI or Elective Setting

- Less acute presentations

- Low EF, heart failure

Contributors of Risk

Lesion/Proce

- Low EF, heart failure

- Declined for surgery

- Elderly, diabetic, kidney dzLesion/Procedure

PatientPresentation

Patient

- Elderly, diabetic, kidney dz

- Calcified vessels, CTOs, lastremaining vessel, degeneratedvein graft Patient

Substratevein graft

- High readmission rates.

Grading Risk for LM or MV disease

• SYNTAX score• SYNTAX score

• STS

• SYNTAX II

4

SYNTAX 5 Year outcomes

Equipoise in the low SYNTAXScore group

5Mohr et al. Lancet 2013.

Score group

Left Main subgroup

Differences less in the LMGroup

6

Surgical Turndowns

SYNTAX RegistryMGH/BWH SurgicalTurndown RegistrySYNTAX Registry Turndown Registry

7Waldo, et al. Circulation 2014.

6 fold increase in IH mortality comparedto eligible pts, after “adjustment”

Complete vs. Incomplete Revasc

• Association between• Association betweencomplete revasc andoutcomes as beenstudies in > 35studies in > 35studies, > 80,000patients.

• Complete revasc• Complete revascassociated withlower mortality andMI.

30% reduction in mortality.MI.

30% reduction in mortality.22% reduction in MI.

Observed for both CABG and PCI.

8

Observed for both CABG and PCI.

Garcia et al. JACC 2013.

CTO PCI

70 % of total PCI Procedural success MACE• CTO PCI is

infrequent55.5

57.159.2 59.8

61.9

50

60

70 % of total PCI Procedural success MACEinfrequent

• Associated with 2xMACE rate as non-

30

40

%

MACE rate as non-CTO PCI

• Success ~60%

3.2 3.5 3.8 4.2 4.81.9 1.6 1.7 1.4 1.3

10

20

• Success ~60%

• Operator volumeassociated with 1.9 1.6 1.7 1.4 1.3

02009 2010 2011 2012 2013

associated withhigher success rate,decreased MACE.

Brilakis et al, JACC Cardiovasc Intv 2015.

234 of 1,387 sites (17%) never performed CTO PCI

IABP for Low EF, High Risk PCI

BCIS-1BCIS-1

301 pts with EF < 30,High myocardium atHigh myocardium atrisk

No shock or acute MIwithin 48 hrs

HR 0.66 (0.44-0.98, p=0.039)

IABP vs. no IABP

10

HR 0.66 (0.44-0.98, p=0.039)

PROTECT II Trial Design

Patients Requiring Prophylactic Hemodynamic SupportPatients Requiring Prophylactic Hemodynamic SupportDuring Non-Emergent High Risk PCI on

Unprotected LM/Last Patent Conduit and LVEF≤35% OR3 Vessel Disease and LVEF≤30%

1:1

RR

3 Vessel Disease and LVEF≤30%

IMPELLA 2.5 +PCI

IABP +PCI

1:1

Primary Endpoint = 30-day Composite MAE* ratePrimary Endpoint = 30-day Composite MAE* rate

Follow-up of the Composite MAE* rate at 90 days*Major Adverse Events (MAE)*Major Adverse Events (MAE) ::DeathDeath,, MI (>3xULN CKMI (>3xULN CK--MB orMB or TroponinTroponin) ,) , Stroke/TIA, RepeatStroke/TIA, Repeat RevascRevasc, Cardiac or Vascular Operation or, Cardiac or Vascular Operation or VascVasc. Operation for. Operation forlimb ischemia,limb ischemia, Acute Renal Dysfunction, Increase in Aortic insufficiency, Severe Hypotension, CPR/VT,Acute Renal Dysfunction, Increase in Aortic insufficiency, Severe Hypotension, CPR/VT, AngioAngio FailureFailure

High Risk is a “Relative” PerceptionHigh Risk is a “Relative” PerceptionRisk Increases from SYNTAX, to BCIS to PROTECT IIRisk Increases from SYNTAX, to BCIS to PROTECT II

SYNTAX

PCI arm

(n=903)

BCIS

(n=301)

PROTECT II

(n=448)

(n=903)

Age (Mean±SD) 65±10 71±10 67±11

Male (%) 76 79 82

DM (%) 26 35 52DM (%) 26 35 52

Prior Stroke - 8 15

Prior MI (%) 32 73 68

CHF (%) 4 - 87CHF (%) 4 - 87

Prior PCI 0 10 39

Prior CABG 0 15 33

LVEF ≤ 30% (%) 1.3 100 92LVEF ≤ 30% (%) 1.3 100 92

Euroscore (Mean±SD) 4±3 - 18±18

In-hospital Mortality (%) ~1.0 1.3 3.5

~3 month Mortality (%) 2.5 4.9 10.3

12

~3 month Mortality (%) 2.5 4.9 10.3

Hemodynamic Compromise Based onHemodynamic Compromise Based onExtent of RevascularizationExtent of RevascularizationExtent of RevascularizationExtent of Revascularization

Decrease in MAP During Procedure

1 Vessel 2 Vessels 3 VesselsIABP Impella

Decrease in MAP During Procedure(in % from baseline)

-3.4%

1 Vessel 2 Vessels 3 VesselsIABP Impella

-14.4%

-3.4%

-8.4% -8.6%

-14.4%-15.6%

-22.0%p <0.001 p =0.001 p =0.004-22.0%

PROTECT II StudyPROTECT II Study

Impella for Low EF, High Risk PCI

• PROTECT 2• PROTECT 2

• 452 pts with 3VD or LM,depressed EFdepressed EFrandomized to IABP vs.Impella 2.5.

• Primary endpoint in-hospital or 30-day death,MI, stroke, TIA, repeatMI, stroke, TIA, repeatrevasc, CV operation,AKI, proceduralhypotension, VT, CPR,hypotension, VT, CPR,AI, PCI failure

14

30-day: IABP 40.1 vs. Impella 35.1,P = 0.277

IABP Impella

p = 0.73735.0%

28.5%32.5%

30%

40%p = 0.737

p = 0.015

28.5%

15.9%20%

30%

15.9%

10%

0%

1 Vessel 2 or 3 Vessels1 Vessel 2 or 3 Vessels

Extent of RevascularizationPROTECT II StudyPROTECT II Study

16

LVEF Improvement Post PCILVEF Improvement Post PCI

33 % ± 11

p<0.001p<0.001

33 % ± 11

22%22%

27 % ± 9

BaselineBaseline 90 days90 days

LVEF (%)LVEF (%)LVEF (%)LVEF (%)

N=304 patients with LVEF measurements available at baseline and 90 daysN=304 patients with LVEF measurements available at baseline and 90 days

17

NYHA Improvement Post PCINYHA Improvement Post PCI

p<0.001p<0.001

17%8%

p<0.001p<0.001

Class IVClass IV58%58%

18%

17%8%Class IVClass IV

58%58%reductionreduction

in Class III,IVin Class III,IV

30%45%Class IIIClass III

in Class III,IVin Class III,IV

44%31%Class IIClass II

7%BaselineBaseline 90 days90 days

NYHA Class DistributionNYHA Class Distribution

Class IClass I

NYHA Class DistributionNYHA Class Distribution

N=223 patients with NHYA assessment available at baseline and 90 daysN=223 patients with NHYA assessment available at baseline and 90 days

Gray Area of PPCI

3-vessel CAD with EF < 30%*

ULM EF < 35%*

LRA with EF < 35%*

ULM that is L dominant

ULM with occluded RCA

Retrograde via LRARetrograde via LRA

MV Atherectomy

ULM Atherectomy

EF < 35%EF < 35%

PCWP > 20

MVO2 < 55

Severe MR

> 2 Criteria

Recommend PPCISevere MR

Severe Pulmonary HTN

High risk for Hemodynamic Collapse

Henriques et al, Am Heart J. 2014;0:1-9.e5

20

Study DeviceStudy Device Learning Curve EffectLearning Curve Effect20

IABPIABP

Per Protocol Population 90day OutcomePer Protocol Population 90day Outcome(N=423)(N=423)IABPIABP

IMPELLAIMPELLA

(N=423)(N=423)

MAE= Major Adverse Event RateMAE= Major Adverse Event Rate

N=82N=82N=82N=82 N=63N=63N=63N=63 N=68N=68N=65N=65

MAE= Major Adverse Event RateMAE= Major Adverse Event Rate

Cohen et al, Catheter Cardiovasc Interv. 2014:83:1057–1064

High Risk Revasc Guidelines -

22

ACC/AHA/SCAI PCI Guidelines 2011

AUC on Multivessel CAD

23

PCI Appropriate Use Criteria, 2012

O ld… very old…O ld… very old…

Frail… very frailFrail… very frail Frail… very frailFrail… very frail

L otsofcoL otsofco--m orbidities…m orbidities…

•• P riorCA BG (poorL V function)P riorCA BG (poorL V function)•• P riorCA BG (poorL V function)P riorCA BG (poorL V function)

•• CKDCKD

•• S evereCO P DS evereCO P D

•• P VDP VD

•• ChronicA FChronicA F

•• Cancerinrem issionCancerinrem ission•• Cancerinrem issionCancerinrem ission

…..but still enjoying life.!

Conclusion

• Supported PCI Improves Outcomes In High Risk Patients

• Coronary Artery Disease is Changing

• Learn Hemodynamics• Learn Hemodynamics

• Right Heart Cath

• Large unmet need for revascularization in high risk• Large unmet need for revascularization in high riskpatients

• Tools – Know how to use them BEFORE you need them

• Develop Protocol For Your Hospital

Skill Sets

• Hemodynamics

• Interventional volume

• Atherectomy – Laser, Rotablator, Orbital Atherectomy• Atherectomy – Laser, Rotablator, Orbital Atherectomy

• Imaging

• Treatment Plan• Treatment Plan

• Right heart cath

• Large Bore Devices• Large Bore Devices

• Peripheral Skills

26

Techniques and Tools

• Guide Extension –Inchworm or BAT

• Wires – Know a Few Well

• Impella – Insertion and Management• Impella – Insertion and Management

• Trapping Balloon – Trapliner – Trapper

• CTO strategies• CTO strategies

• Retrograde CART

• Crossboss and Stingray• Crossboss and Stingray

• Twinpass

• Covered Stents• Covered Stents

• Closure Devices

Study DeviceStudy Device Learning Curve EffectLearning Curve Effect

IABPIABP

Study DeviceStudy Device Learning Curve EffectLearning Curve EffectPer Protocol Population 90day OutcomePer Protocol Population 90day Outcome

(N=423)(N=423)IABPIABP

IMPELLAIMPELLA

(N=423)(N=423)

MAE= Major Adverse Event RateMAE= Major Adverse Event Rate

N=82N=82N=82N=82 N=63N=63N=63N=63 N=68N=68N=65N=65

MAE= Major Adverse Event RateMAE= Major Adverse Event Rate

2828

IABP for STEMI/Shock

Thiele, et al. NEJM. 2012.

Impella for MI and Shock

• No randomized data

• USPella registry

– 154 pts– 154 pts

– Insertion pre-PCIvs. post-PCI in AMIwith shockwith shock

– More completerevascularizationrevascularizationwith pre-PCIinsertion

O’Neill et al. J Interv Cardiol 2014.

31

…With Further Investigations* andInnovationsInnovations

Percutaneous Biventricular Support

Impella RP(RV support)

Impella CP(LV support)

Impella Right Side Support TrialClinicalTrials.gov Identifier:NCT01777607

J Interv Cardiol. 2011

34

Martinez et al CCI 2012

35

Martinez C et al ACC 2011

Catheter Cardiovasc Interv. 2012 Dec1;80(7):1201-9

37

IABP TandemHeart ImpellaHemopumpECMO CPS

90’s80’s70’s 00’s

®

InflowInflow(ventricle)(ventricle)

OutflowOutflow(aortic root)(aortic root)

®

(ventricle)(ventricle)(aortic root)(aortic root)

AOPAOPFlowFlow EDV, EDPEDV, EDP

MicrovascularMicrovascularResistanceResistance

MechanicalMechanicalWorkWork

WallWallTensionTension

CoronaryCoronaryFlowFlow

ResistanceResistance

Cardiac PowerCardiac PowerCardiac PowerCardiac PowerOutputOutput

Hemodynamic ProtectionHemodynamic Protection

OO22 DemandDemand

Unloading to RecoveryUnloading to Recovery

OO22 SupplySupply

40

41

42

43

44

High-Risk PCIHigh-Risk PCI

Harjai and O’neill. J Interv Cardiol. 2010

IschemicCardiomyopathyCardiomyopathy

• STICH Trial –• STICH Trial –CABG trial withmany limitations,but still our bestbut still our bestevidence.

• Inducible• Induciblemyocardialischemia andviability did not alterviability did not alterthe benefit/risk ofCABG vs. medicaltherapytherapy

47

Bonow et al. NEJM, 2011; Panza JACC, et al 2013.Velasquez NEJM 2011.

Wide variation in success

Institutions with > 30 CTOsOperators with > 10 CTOs

48

This represents an enormous opportunity to improve care

Hemodynamic Support

2011 ACC/AHA/SCAI 2014 ESC Guidelines:2011 ACC/AHA/SCAIGuidelines:

Class II b: elective

2014 ESC Guidelines:

Class II b: Short-termmech support in ACSClass II b: elective

insertion of anappropriate

mech support in ACSpatients with cardiogenicshock may beappropriate

hemodynamic supportdevice as an adjunct to

shock may beconsidered.

device as an adjunct toPCI may be reasonablein carefully selectedhigh-risk patients.high-risk patients.

49

51

Martinez C et al.Submitted

52

Hemodynamic Support EffectivenessHemodynamic Support Effectiveness

Cardiac Power OutputCardiac Power Output

Maximal Decrease in CPO on device SupportMaximal Decrease in CPO on device Supportfrom Baseline (in x0.01 Watts)from Baseline (in x0.01 Watts)

IABPIABP ImpellaImpella

N=138N=138 N=141N=141

-- 4.24.2 ±± 2424

p=0.001p=0.001

-- 14.214.2 ±± 2727

p=0.001p=0.001

CPO= Cardiac Power Output = Cardiac Output x Mean Arterial Pressure x 0.0022 (CPO= Cardiac Power Output = Cardiac Output x Mean Arterial Pressure x 0.0022 (FinckeFincke R,R, HochmanHochman J et alJ et al JACC 2004; 44:340-348)

CPO data available only for 279 patients (N=138 IABP and N=141CPO data available only for 279 patients (N=138 IABP and N=141 ImpellaImpella))

Long-Term Follow-up of Elective CTO PCI:Evidence for Mortality Benefit?Evidence for Mortality Benefit?

• 14,439 CTO PCIs between 2005-2009 in England and Wales.

• Successful CTO PCI and Complete revasc associated with• Successful CTO PCI and Complete revasc associated withimproved survival

Causation vs. Confounding?

George et al, JACC. 2014.

IMPELLA RPIMPELLA RP

Outflow in PA• Flow: 4.0 l/mn

• Access: Femoral vein

• Diameter pump: 21F

• Length cannula: + 140.0mm

• Diameter cannula: 7.0mm

Inflow in IVC

• Diameter cannula: 7.0mm

• Placement: monorail guide wire

• Sensor: afterload sensitiveInflow in IVC

• Sensor: afterload sensitive

• Flow monitoring: pressure sensor