iabp or impella support for complex coronary intervention

IABP or Impella Support for

Complex Coronary Intervention

Reginald Low MD Lum and Dere Professor of Cardiovascular Medicine

Chief, Division of Cardiovascular MedicineUniversity of California, Davis

Disclosures

•  Abbott Vascular – Consultant

•  Boston Scientific – Consultant

•  Direct Flow Medical – Consultant

Disclaimer

•  I, Reginald Low, did not willingly agree to debate this topic of IABP vs Impella in supported Percutaneous Coronary Intervention

•  Debating against Impella is like arguing against

Expectations

IABP

•  Intra Aortic Balloon Pump

•  Developed by Adrian Kantrowitz and team in 1960’s

•  Polyethylene balloon 30-50 cc’s

•  Deflates in Systole

•  Inflates in Diastole

•  Counter pulsation

•  Catheter size 7-8 French – Sheath size 8 French ID (9 French OD) or sheathless

•  Helium gas with low viscosity

•  Cost - $650

Impella

•  Impella 2.5 – FDA approved 2008•  Catheter based heart pump•  Self contained motor drives “Impeller” at up to 50,000 RPM•  Up to 2.5 liters per minute flow•  Catheter size 9 French •  Pump size 12 French•  Sheath size – 13 French ID (15 French OD – 5 mm)•  Cost - $20,000 ($25,000 for CP)

Mimic Heart’s Natural Function

Inflow (ventricle)

Outflow (aortic root)

aortic

valve

O2 Demand O2 Supply Cardiac Power

Output

EDV, EDP AOP Flow

Principles of Impella Design

IABP to Impella

Apples to Oranges

Apples to Oranges

Dr. Singh’d Flat Tire

Blood

•  Red cells are fragile•  Should it be churned at 50,000 RPM?•  Platelet and complement activation•  Blender speed 1000 – 25,000 RPM

Patient DW

•  55 yo female with diabetes, hyperlipidemia, CVA (3-15)•  Anterior MI -3-15•  CHF – LVEF 30-35%•  Cath – Severe 3 Vessel CAD•  3+ MR•  Referred for Cardiac Surgery

Coronary Angiogram

LAD Intervention

LAD

LCX

RCA

PROTECT II Trial Design

IMPELLA 2.5 + PCI

IABP + PCI

Primary Endpoint = 30-day Composite MAE* rate

1:1 R

Patients Requiring Prophylactic Hemodynamic Support During Non-Emergent High Risk PCI on

Unprotected LM/Last Patent Conduit and LVEF≤35% OR 3 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

Protect II

∙  452 Patients∙  226 IABP∙  226 Impella 2.5

∙  452/112 = 4 Patients per site

Protect II

Ł  7.5 French – IABPŁ  13 French ID (14+ French) - Impella

Protect II

Protect II

Impella arm – more rotational atherectomy, assoicated with higher rate of peri-procedural MI

Protect II

Protect II

Protect II

Protect II

Assessment

•  Left Ventricular Function•  Pulmonary artery pressure and wedge pressure•  Blood pressure•  Heart rate•  Risk Assessment - Coronary circulation

•  Left Main, Only remaining vessel, multivessel disease•  Complexity of intervention

•  Rotational atherectomy•  Pharmacologics

Strategy for Complex PCI

•  Guide•  Guide wire •  Pre-treatment

•  Balloon•  Angiosculpt•  Rotational atherectomy•  Laser

What’s Important?

•  IABP vs Impella?•  Highly Skilled Interventionalist•  Excellent Clinical Judgment•  Great Support Staff•  Complete toolbox•  Good hands manuevering the wires, catheters and devices

Thank You

University of California Davis Medical Center

IABP or Impella

Precision

Experts Discuss Protect II Trial

Experts Discuss Protect II Trial

Pa#entComorbidi#es

Heartfailure,diabetes,advancedage,peripheralvasculardisease,complex

lesions,historyofangina,priorsurgery

HemodynamicCompromise

Depressedejec#onfrac#on(LVEF<35%)

ComplexCoronaryArtery

Disease

Mul#-vesseldisease,LeKMaindisease

ProtectedPCI

Pa#ents

Protected PCI with Impella 2.5

Safe & Effective by FDA

for High Risk PCI in hemodynamically stable

patients

HCS-PP00908-016rD

Pa#entComorbidi#es

Heartfailure,diabetes,advancedage,peripheralvasculardisease,complex

lesions,historyofangina,priorsurgery

HemodynamicCompromise

Depressedejec#onfrac#on(LVEF<35%)

ComplexCoronaryArtery

Disease

Mul#-vesseldisease,LeKMaindisease

ProtectedPCI

Pa#ents

Protected PCI with Impella 2.5

Safe & Effective by FDA

for High Risk PCI in hemodynamically stable

patients

HCS-PP00908-016rD

Impella vs IABP

•  Trigger•  Arrhythmia•  LV Thrombus•  No better than IABP

Best Not to be All Thumbs!

Thank You

University of California Davis Medical Center