High Risk PCIHigh Risk PCIMMaking Possible the Impossibleaking Possible the Impossible

Ray Matthews MDProfessor of Clinical Medicine

Chief of CardiologyUniversity of Southern California

Disclosures

• Abiomed – Research SupportConsulting Agreement

• St Jude Medical – Research Support

Consulting Agreement

High Risk PCI

• 93 year old female with NSTEMI*

• Recurrent angina on medications

• Cath shows calcified distal left main bifurcation lesion

• Echo: EF 35% Anteroapical severe hypokinesis• Echo: EF 35% Anteroapical severe hypokinesis

• Surgical referral….”suggest stenting”

* Protect II pateint

Replicates Heart’s Natural Function

Inflow(ventricle)

Outflow(aortic root)

EDV, EDPEDV, EDP AOPAOP FlowFlow

Principles of Impella DesignPrinciples of Impella Design

O2 DemandO2 Demand O2 SupplyO2 SupplyCardiac Power

OutputCardiac Power

Output

EDV, EDPEDV, EDP AOPAOP FlowFlow

IMPELLA ®® ® HEART PUMP: HOW IT WORKS

Placement in Left Ventricle

Impeller and blood outflow

AnimationClick here

2.5 = 2.5 l/minCP = 4 l/min

6

HEMODYNAMICS OF IMPELLA®®

IN AMI CARDIOGENIC SHOCK

• 49 Yrs, Male

• Cold, Clammy skin

• Tachycardia

Pressure Tracings, Harvi1

MAPMAP51 mmHg51 mmHg

(61/44)(61/44)

Case Example* Impella CP OnImpella CP On

CirculatoryCirculatorySupportSupport(Increased MAP)(Increased MAP)

72 mmHg72 mmHg(75/71)(75/71)

• Tachycardia

• Cardiac Output: 3.3 L/min

• Wedge Pressure: 22 mmHg

• 75% Left main

• MAP 51mmHg, LVEDP 28 mmHg

(61/44)(61/44)

1. Physiologic computational modeling, Am J Physiol 1991* Not all patients will experience the same clinical outcomes or hemodynamic responses

LVEDPLVEDP28 mmHg28 mmHg

Ventricular UnloadingVentricular Unloading(Reduced LVEDP)(Reduced LVEDP)

20 mmHg20 mmHg

Time (60 seconds)

PROTECT II Trial Design

IMPELLA 2.5 +IABP +1:1

RR

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

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

IMPELLA 2.5 +PCI

IABP +PCI

Primary Endpoint = 30-day Composite MAE* rate

Follow-up of the Composite MAE* rate at 90 days*Major Adverse Events (MAE) :*Major Adverse Events (MAE) :Death, MI (>3xULN CKDeath, MI (>3xULN CK--MB or Troponin) , Stroke/TIA, Repeat Revasc, Cardiac or Vascular Operation or Vasc. Operation forMB or Troponin) , Stroke/TIA, Repeat Revasc, Cardiac or Vascular Operation or Vasc. Operation forlimb ischemia, Acute Renal Dysfunction, Increase in Aortic insufficiency, Severe Hypotension, CPR/VT, Angio Failurelimb ischemia, Acute Renal Dysfunction, Increase in Aortic insufficiency, Severe Hypotension, CPR/VT, Angio Failure

PROTECT II MACCE**PROTECT II MACCE**Per Protocol Population, N=426Per Protocol Population, N=426

Death, Stroke, MI,Death, Stroke, MI,RepeatRepeat revascrevasc.. IABPIABP

IMPELLAIMPELLA

8

Log rank test, p=0.04Log rank test, p=0.04

**Using x8ULN threshold for biomarkers or Q**Using x8ULN threshold for biomarkers or Q--wave forwave for PeriPeri--procedural MI (Stone et al Circulation 2001;104:642procedural MI (Stone et al Circulation 2001;104:642--647) and 2xULN647) and 2xULNthreshold for biomarkers for Spontaneous MI (Universal MI definition)threshold for biomarkers for Spontaneous MI (Universal MI definition)

9

PROTECTED PCI™

– INDICATION & SAFETY INFO.INDICATION FOR USE

The Impella 2.5™ System is a temporary (≤ 6 hours) ventricular support device indicated for use during high risk percutaneous coronary interventions (PCI) performed in elective or urgent, hemodynamically stable patients with severecoronary artery disease and depressed left ventricular ejection fraction, when a heart team, including a cardiac surgeon, hasdetermined high risk PCI is the appropriate therapeutic option. Use of the Impella 2.5 System in these patients may preventhemodynamic instability, which can result from repeat episodes of reversible myocardial ischemia that occur during plannedtemporary coronary occlusions and may reduce peri- and post-procedural adverse events.

CONTRAINDICATIONS

The Impella 2.5™ is contraindicated for use with patients experiencing any of the following conditions:

• Mural thrombus in the left ventricle

• Presence of a mechanical aortic valve or heart constrictive device

• Aortic valve stenosis/calcification (equivalent to an orifice area of 0.6 cm2 or less)

• Moderate to severe aortic insufficiency (echocardiographic assessment graded as ≥ +2)

• Severe peripheral arterial disease precluding placement of the Impella 2.5™ System

POTENTIAL ADVERSE EVENTS

Acute renal dysfunction, Aortic valve injury, Bleeding, Cardiogenic shock, Cerebral vascular accident/Stroke, Death,Hemolysis, Limb ischemia, Myocardial infarction, Renal failure, Thrombocytopenia and Vascular injury

In addition to the risks above, there are other WARNINGS and PRECAUTIONS associated with the Impella 2.5™. Visitwww.protectedpci.com/hcp/information/isi to learn more.

Anatomy vs. CABG RiskWhen to choose supported PCI ?

STS score

10

SYNTAX

score

PROTECT II patientsPROTECT II patients

High Risk PCI

• 73 year male

• NSTEMI – Refractory recurrent angina

• ESRD

• S/P AVR with prosthetic valve restenosis

• Severely Calcified coronaries

• EF 35%

• STS for AVR/CABG = 28% mortality

High Risk PCI

• PCI desirable but calcification makes very difficult

• PCI in combination with valve in valve TAVR as stagedprocedure best option

• Planning long rotablator total runs due to severe• Planning long rotablator total runs due to severecalcification in the setting of reduced LV function andaortic stenosis

AV gradients:63 mmHg max63 mmHg max33 mmHg meanVmax 4.0 m/sec

Future Technologies

• pVAD

• Smaller with higher flows

• Right sided support

*CAUTION – HeartMate PHP™ Percutaneous Heart Pump is an investigational device and is limited by Federal (or United States) law to investigational use.

29US-THO-05160487 | Approved for US Use Only

Catheter-based percutaneous heart pump delivered through 14F introducer; expandsto 24F when unsheathed

Designed to deliver > 4 lpm of flow at low RPMs

HEARTMATE PHP™ PERCUTANEOUS HEART PUMPA NOVEL ACUTE MCS THERAPY

Hig

h

Breaking the Link Between Size and Flow*

CoatedCannula

CannulaInlet

*CAUTION – HeartMate PHP™ Percutaneous Heart Pump is an investigational device and is limited by Federal (or United States) law to investigational use.Seyfarth, Sibbing, et al. J Am Coll Cardiology. 2008;52(19):1584-1588. Impella and Tandem Heart estimates based on manufacturer labeling. HeartMate PHP Percutaneous Heart Pump estimatesbased on preclinical bench testing.Impella is a trademark of Abiomed, Inc. Tandem Heart is a trademark of Cardiac Assist, Inc.

Larger

IABP Impella 2.5 PHP Impella CP TandemHeart

Impella 5.0

Flo

wR

ates

(LP

M)

Insertion Profile

Lo

w

Smaller

Cannula Inlet

Impeller

CannulaOutlet

30US-THO-05160487 | Approved for US Use Only

™™ ™ ™

™

Completed CE Mark study leading to approval in 2015

50 patients undergoing high-risk PCI (HRPCI)

Primary endpoints: avoidance of major adverse eventsat 30 days, device and procedural success

Pivotal US IDE underway

425 patients undergoing high-risk PCI

HEARTMATE PHP™ PERCUTANEOUS HEART PUMPCLINICAL STUDY ACTIVITY

425 patients undergoing high-risk PCI

Randomized 2:1 against Impella 2.5

*CAUTION – HeartMate PHP™ Percutaneous Heart Pump is an investigational device and is limited by Federal (or United States) law to investigational use.

31US-THO-05160487 | Approved for US Use Only

IMPELLA RP

RV InfarctionRV failure after durable VADPost cardiotomy RV failure

Temporary RV Support for…

32

Post cardiotomy RV failureMassive pulm embolusOthers

END