What is a VAD? What is ECMO? Its a pump! ExtraCorporeal Membrane - - PowerPoint PPT Presentation

9/30/2016 1 A Bridge to Life

MCS: Yesterday, Today and Beyond

Michele Kassemos, RN BSN Mechanical Circulatory Support UCSF Medical Center

MCS at UCSF Medical Center

Mechanical Circulatory Support

Perfusion of Organs with Mechanical Devices

Left Ventricular Assist Device HeartWare LVAD ExtraCorporeal Membrane Oxygenation ECMO Isolated Organ Perfusion “Lung in a Box”

What is a VAD?

It’s a pump! Ventricular Assist Device

A Mechanical Blood Pump that shunts blood from the heart back into the circulation The VAD “bypasses” the sick, weakened heart and provides circulation, or “flow,” to the body and vital

• rgans

What is ECMO?

ExtraCorporeal Membrane Oxygenation

• Goal: Turning Blue Blood Red
• Indicated for severe respiratory and/or cardiac failure that is

refractory to maximal therapies

• Prolonged but temporary (usually <30 days)
• Allows for organ rest while avoiding further iatrogenic injury
• Sustains life while bridging to organ recovery or transplant

A blood pump placed outside the body which circulates blood through an artificial membrane (or lung), and then back into the circulation, providing

• xygenated blood to a patient in severe respiratory failure, cardiac failure, or

both.

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Historical Context

1813 - Le Gallois - first descriptions of mechanical support in rabbits 1926 – Soviet physician Brukhonenko developed first primitive heart-lung machine The early concepts of Mechanical Life Support

"The solution of the problem of the artificial circulation of the whole animal opens the door to the problem of operations on the heart, for example on the valve." Sergei S. Brukhonenko, 1928

Konstantinov, I MD, Alexi-Meskishvili, V MD, PhDb; Sergei S. Brukhonenko: the development of the first heart-lung machine for total body perfusion. Ann ThoracSurg 2000;69:962-966

History of MCS

Pioneers of Heart & Lung Assist

1953 - Dr John Gibbon “Father of CPB”

First to successfully use CPB for cardiac surgery

“…the idea occurred to me that if it were possible to remove continuously some of the blue blood from the patient’s swollen veins, put oxygen into the blood and allow carbon dioxide to escape from it, and then to inject continuously the new red blood back into the patient’s arteries, we might have been able to save her life.”

Miller BJ, Gibbon JH Jr ; Recent advances in the development of a mechanical heart and lung apparatus. Ann Surg 1951 JH Gibbon and wife Mali

1954-55 – Dr Lillihei

“Cross Circulation” as biological oxygenator

History of MCS

Pioneers of Heart & Lung Assist

Dr Lillihei with pediatric survivor of cardiac surgery using cross circulation Cross circulation between parent and child using parent as heart/lung machine

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History of MCS

Pioneers of Heart & Lung Assist

1966 – Dr M. DeBakey First Successful VAD

• LVAD for failure to wean from CPB
• Pneumatic, paracorporeal pump
• Supported for 10 days, organ recovery, discharged

home

History of MCS

Pioneers of Heart & Lung Assist

1967 – Dr C. Barnard, South Africa

• First successful human heart transplant

1969 – Dr D. Cooley first Total Artificial Heart

• Lt Ventricular aneurysm repair, failure to wean from

CPB

• Supported pt for 64 hrs until heart transplant performed
• Concept of “Bridging to Transplant ” with MCS is

established

Historical Context

1971 – Dr. Don Hill First adult ECMO survivor (Adult ARDS)

NIH-funded study stopped after 90% mortality rate in ECMO group From 1979-1995 Adult ECMO rarely used outside a number of small, dedicated centers

Santa Barbara, CA 1971

Historical Context

1st LVAD-to-Cardiac Transplants

1984 – 1st successful LVAD-to-transplant with Novacor LVAD

Stanford (Oyer MD)

1984 –LVAD-to-transplant with Thoratec pneumatic

paracorporeal LVAD San Francisco (JD Hill)

1992 - LVAD-to-transplant with HeartMate IP LVAD

Texas Heart Institute (Frazier)

Novacor HeartMate IP HeartMate Driver Pearce- Donachey DDC

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Historical Context

VADs Go Mobile in the 90s

• 1991 – 1st successful implant of “untetherable”

HeartMate VE LVAD Texas Heart (Frazier)

• 1994 – HeartMate XVE LVAD FDA-approved for

implantable pump for bridge-to-transplant

Historical Context

Today: Second Generation Pumps New millennium brings “Continuous Flow”

Rotary pumps (HM II, Jarvik, MicroDebakey) Centrifugal pumps (HeartWare, CentriMag, Rotoflow) April 2008 – HM II approved for bridge-to-transplant Jan 2010 – HM II approved for Destination Therapy Nov 2012 – HeartWare HVAD approved for bridge to transplant

Wait….What Happened to ECMO?

Essentially….nothing much

Up until early 2000s, ECMO still rarely used other than salvage cases, aka “Hail Mary Pass” 1972 2005

A New Era for Adult ECMO

2009

Major Game Changers for Adult ECMO

CESAR Trial – Oct 2009 H1N1 Influenza A epidemic – Fall of 2009 Avalon Dual Lumen VV Cannula FDA approved – Jan 2009

9/30/2016 5 CESAR Trial

Conventional Ventilation or ECMO for Severe Adult Respiratory Failure

• Conducted from 2001 – 2006 in UK
• Randomized controlled trial
• Comparing conventional ventilation vs ECMO in patients w/

ARDS

• Randomized to either VV ECMO (90 pts) or continuing

conventional care at referral hospitals (90 pts)

• ECMO group: 57 of 90 (63%) met endpoint
• Conventional ventilatory group: 41 of 87 (47%) met end point

Why a Game Changer?

• 63 % survival rate – demonstrating efficacy in adults
• Data to support increased survival in transporting to ECMO

centers

Peek et al (2009) Efficacy and economic assessment of conventional ventilatory support versus extracorporeal membrane oxygenation for severe adult respiratory failure (CESAR): a multicentre randomized controlled trial. Lancet

2009 Flu Pandemic H1N1

• Influenza A virus causing ARDS in rare cases
• Study from Australia & New Zealand (JAMA 2009)
• observed an 80% ECMO survival rate of adults w/ H1N1 ARDS

(n=68)

• ELSO:
• “Review of the H1N1 data shows 72% survival rate when ECMO is

instituted within 6 days of intubation; 31% when pt intubated for 7 days or longer”

Why Game Changer?

• 70-80 % Survival if ECMO initiated sooner rather than later
• Efficacy in ECMO as tx for Acute Respiratory Distress

Syndrome in adults

Dual lumen VV ECMO Cannula

• Avalon Elite

VV ECMO cannula for respiratory failure Cannulation via Rt Internal Jugular Leaving pt ambulatory Draining from two points (SVC & IVC) Flows directly back into Rt Atrium Very little recirculation rate(2%) Why a Game Changer? Improving candidacy for transplant Allows for ambulation Minimally invasive – no thoracotomy, no major artery cannulation

UCSF Develops Mobile ECMO Team

Only Center in Region

During H1N1, and post CESAR Trial, ECMO referrals exploded Patient’s too unstable for transport “ECMO TO GO” team formed in 2009 under Charles Hoopes and Jasleen Kukreja

9/30/2016 6 History of Heart & Lung Asist

UCSF makes it’s mark

2/26/2009 – Dr. Charles Hoopes @ UCSF is the first surgeon in US to place Avalon Cath for Ambulatory Lung Assist UCSF 1st ECMO center in the US using ambulatory ECMO as a bridge to lung transplant

UCSF at the forefront of bringing ECMO from this…. To THIS!!

“Ambulatory Oxy RVAD” PA to Lt Atrium w/ tunneled VAD cannulae. (ILD, RV Failure, hypoxia -> bridged to bilateral lung tx after 42 days of support). “Ambulatory Oxy RVAD” PA to LA central cannulation w/ VAD cannulae (PHTN, RV Failure, hypoxia, s/p PEA arrest to Bl lung Tx “Ambulatory Lung Assist” VV ECMO with DLC. End- Stage CF, Bridged to Bilateral Lung Transplant. 33 days on support.

Central VA ECMO

“Ambulatory Bypass”

“Walking Bypass” RA to AO central cannulation w/ VAD cannulae (PHTN, RV failure, s/p PEA arrest to Heart/Lung Tx)

9/30/2016 7 Happy Endings Central “Oxy RVAD”

“Oxy RVAD” PA to LA central cannulation w/ VAD cannulae (PHTN, RV failure, Hypoxia, s/p PEA arrest to Bil Lung Tx)

Pipeline Technology

What’s next?

HeartWare mVAD – Continuous Flow Axial Pump

70% smaller than HVAD

Reduced incision size Reduced complications (bleeding, RVF) Preservation of sternum

Full or partial support

Weaning Intervention in earlier stages of disease

Gimbaled Sewing Ring

Depth adjustment supporting smaller heart chambers

mVAD Advantage Trial in progress

Multi-center single arm trial 70 patients at 11 sites in Australis/Europe MVAD Video

Pipeline Technology

What’s next?

HeartWare Pipeline

9/30/2016 8 Pipeline Technology

HeartMate III– Continuous Flow

Centrifugal Pump

Superior Hematological Compatibility

Minimized shear stress Minimizes stasis Minimize interactions between blood and foreign surface

Full support

2 – 10 lpm flow Intervention in earlier stages of disease

Modular Driveline Momentum III Trial in progress

Multi-center trial Comercialized in Europe w/ over 200 implants Ongoing studies in 5 sites in US

Percutaneous Right-Sided Support

Impella RP

Impella RP Right-sided percutaneous support

Short-term support of RV Support RV post LVAD surgery

ECMO Circuits and Components they’ve come a long way, Baby Tandem Lung

Ambulatory “Oxy-RVAD”

Dual Lumen Cannula Inflow port: RA Outflow port: PA Minimally invasive approach

9/30/2016 9 Thank You for Your Time