iabp or impella support for complex coronary intervention
TRANSCRIPT
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