9/30/2016

A Bridge to Life MCS at UCSF Medical Center MCS: Yesterday, Today and Beyond Mechanical Circulatory Support Perfusion of Organs with Mechanical Devices

ExtraCorporeal Membrane Left Ventricular Assist Device Isolated Organ Oxygenation HeartWare LVAD Perfusion ECMO “ in a Box” Michele Kassemos, RN BSN Mechanical Circulatory Support UCSF Medical Center

What is a VAD? What is ECMO? It’s a pump! ExtraCorporeal Membrane Oxygenation A blood pump placed outside the body which circulates blood through an Ventricular Assist Device artificial membrane (or lung), and then back into the circulation, providing oxygenated blood to a patient in severe respiratory failure, cardiac failure, or both . A Mechanical Blood Pump that shunts blood from • Goal: Turning Blue Blood Red the back into the circulation • 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

The VAD “bypasses” the sick, weakened heart and provides circulation, or “flow,” to the body and vital organs

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Historical Context The early concepts of Mechanical Life Support

 1813 - Le Gallois - first descriptions of mechanical support in rabbits  1926 – Soviet physician Brukhonenko developed first primitive heart-lung machine

"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 History of MCS Pioneers of Heart & Lung Assist Pioneers of Heart & Lung Assist 1953 - Dr John Gibbon “Father of CPB” 1954-55 – Dr Lillihei First to successfully use CPB for “Cross Circulation” as biological oxygenator “…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.”

Dr Lillihei with pediatric survivor of cardiac surgery using cross circulation

JH Gibbon and wife Mali Cross circulation between parent and child using parent as heart/lung machine Miller BJ, Gibbon JH Jr ; Recent advances in the development of a mechanical heart and lung apparatus. Ann Surg 1951

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History of MCS History of MCS Pioneers of Heart & Lung Assist Pioneers of Heart & Lung Assist

1966 – Dr M. DeBakey First Successful VAD 1967 – Dr C. Barnard, South Africa • LVAD for failure to wean from CPB • First successful human heart transplant • Pneumatic, paracorporeal pump 1969 – Dr D. Cooley first Total Artificial Heart • Supported for 10 days, organ recovery, discharged • Lt Ventricular aneurysm repair, failure to wean from home CPB • Supported pt for 64 hrs until heart transplant performed • Concept of “Bridging to Transplant ” with MCS is established

Historical Context Historical Context st 1971 – Dr. Don Hill First adult ECMO survivor (Adult ARDS) 1 LVAD-to-Cardiac Transplants

1984 – 1st successful LVAD-to-transplant with Novacor LVAD Stanford (Oyer MD) 1984 –LVAD-to-transplant with pneumatic paracorporeal LVAD San Francisco (JD Hill) 1992 - LVAD-to-transplant with HeartMate IP LVAD Texas Heart Institute (Frazier)

Santa Barbara, CA 1971  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 Novacor HeartMate IP HeartMate Pearce- Donachey DDC Driver

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Historical Context Historical Context Today: Second Generation Pumps VADs Go Mobile in the 90s • 1991 – 1st successful of “untetherable” HeartMate VE LVAD Texas Heart (Frazier) New millennium brings “Continuous Flow” Rotary pumps (HM II, Jarvik, MicroDebakey) Centrifugal pumps (HeartWare, CentriMag, Rotoflow) • 1994 – HeartMate XVE LVAD FDA-approved for implantable pump for bridge-to-transplant 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? A New Era for Adult ECMO 2009 Essentially….nothing much 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

1972 2005

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

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CESAR Trial 2009 Flu Pandemic Conventional Ventilation or ECMO for Severe H1N1 Adult Respiratory Failure

• Conducted from 2001 – 2006 in UK • Influenza A virus causing ARDS in rare cases • Randomized controlled trial • Study from Australia & New Zealand (JAMA 2009) • Comparing conventional ventilation vs ECMO in patients w/ • observed an 80% ECMO survival rate of adults w/ H1N1 ARDS ARDS (n=68) • Randomized to either VV ECMO (90 pts) or continuing • ELSO: conventional care at referral hospitals (90 pts) • “Review of the H1N1 data shows 72% survival rate when ECMO is • ECMO group: 57 of 90 (63%) met endpoint instituted within 6 days of intubation; 31% when pt intubated for 7 days or longer” • Conventional ventilatory group: 41 of 87 (47%) met end point Why Game Changer? Why a Game Changer? • • 63 % survival rate – demonstrating efficacy in adults 70-80 % Survival if ECMO initiated sooner rather than later • Data to support increased survival in transporting to ECMO • Efficacy in ECMO as tx for Acute Respiratory Distress centers Syndrome in adults

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

UCSF Develops Mobile ECMO Team Dual lumen VV ECMO Cannula Only Center in Region During H1N1, and post CESAR Trial, ECMO referrals exploded  • Avalon Elite Patient’s too unstable for transport  VV ECMO cannula for respiratory failure “ECMO TO GO” team formed in 2009 under Charles Cannulation via Rt Internal Jugular Hoopes and Jasleen Kukreja  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

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History of Heart & Lung Asist UCSF at the forefront of bringing ECMO UCSF makes it’s mark from this….

2/26/2009 – Dr. Charles Hoopes @ UCSF is the first surgeon in US to place Avalon Cath for Ambulatory Lung Assist

st UCSF 1 ECMO center in the US using ambulatory ECMO as a bridge to lung transplant

To THIS!! Central VA ECMO “Ambulatory Bypass”

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

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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 Pipeline Technology What’s next? What’s next?

HeartWare mVAD – Continuous Flow Axial Pump HeartWare Pipeline  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

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Pipeline Technology Percutaneous Right-Sided Support Impella RP HeartMate III – Continuous Flow Centrifugal Pump Impella RP Right-sided percutaneous support  Superior Hematological Compatibility  Short-term support of RV  Minimized shear stress  Support RV post LVAD surgery  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

ECMO Circuits and Components Tandem Lung they’ve come a long way, Baby Ambulatory “Oxy-RVAD”

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

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Thank You for Your Time

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