Total Artificial Heart

TotalWhat
Artificial Heart
Metrics should be Met for
Standard Care

What Metrics Should Francisco A. Arabía, MD

be Met for Standard Use? MBA
Cedars-Sinai Heart Institute
For Future Technology?

Francisco A Arabía, MD MBA

Director for Surgical Device Management Advance Heart Disease
Cedars-Sinai Heart Institute
Disclosure
Disclosure
SynCardia Systems, Carmat TAH, BiVACOR TAH, Medtronics

• Consultant:
• SynCardia Systems, BiVACOR TAH, Carmat TAH, Dragon TAH, Medtronic
Patients who can benefit from TAH
• Severe Biventricular failure

• Structural Damage
Indications for TAH (current state)
• Failed Heart Transplant ( acute or chronic)
• Unresponsive malignant arrhythmias
• Restrictive Cardiomyopathies
• Severe structural damage (post Infarction VSD)
• Cardiac Malignancies
• Congenital abnormalities
• RV Failure post LVAD
• Ventricular Thrombosis
• Chagas Disease
Life Expectancy
Why an Artificial Heart ?
• Pros
• No RV Failure,
• No AICD
• No Heart Failure Medications
• Greater availability

• Cons
• Need for anticoagulation
• No recovery
Ideal Characteristics
• Recipient size independent
• Quite, NO DRIVELINE
• No anticoagulation
• Components longevity (10 -20 years or longer)
• Long term Power Supply
• Easy surgical placement and exchange (or transplant)
• Diagnostic Telemetry
• IMPLANT AND FORGET
 Table Comparison of TAHs

Characteristic SynCardia TAH CARMAT TAH BiVACOR TAH

Energy Source Pneumatic Electromechanical Electromagnetic
Durability ? 5+ years 5 – 10 years 10 – 20 years
Portability Driver 5 – 12 # ? In development
TETs No No Yes
Anticoagulation Yes ? ?
Pulsatility Yes Yes Yes
Latest TAH Data
Figure 4. Survival curve (K-M) for total artificial heart patients stratified by total center volume. TAH,
total artificial heart

Intermacs - TAH Project 5

 SYNCARDIA

Pneumatic driven flexible membrane

SIZE (Weight) 400ml (160g) (70cc)
POWER --
FLOW / RATE 9 LPM
LIFETIME 5+ Years

Physiological Interaction

• Pulsatile (fixed rate, % systole left/right)

• Balancing via passive partial filling

• No (significant) autonomous adjustment

for cardiac demand >1700 patients MAX@5+years

www.syncardia.com
 CARMAT
Electrohydraulically driven flexible bio-membrane
SIZE (Weight) 750 ml (850g)
POWER (6LPM) 30 W
FLOW / RATE 2-9 LPM (35-150 BPM)
LIFETIME 5+ years

Physiological Interaction
• Pulsatile with alternating left/right ejection

• Balancing via 2 individual pumps and

compliance chamber for actuating fluid

• Autonomous adjustment based on sensor

measurements 5 Patients MAX@9month

www.carmatsa.com
 REINHEART

Voice call Electrically driven flexible membrane

SIZE (Weight) 89x90mm (923g)
POWER <20W
FLOW / RATE Max: 7.5 LPM (160 BPM)
LIFETIME durability 7+ years

Physiological Interaction

• Pulsatile with alternating left/right ejection

• Balancing via passive filling and systole-

diastole timing + compliance chamber

• No adjustment for cardiac demand Bovine In-vivo Trial 2+ days

Pelletier(2015), Laumen(2013), Fritschi(2013), Finocchiaro(2012)

 HELICAL FLOW TAH (UPTAH4)

Twin helical flow rotors back to back

SIZE (Weight) 77 x φ80mm (565g)
POWER --
FLOW MAX 13LPM
BEARING HYDRODYNAMIC

Physiological Interaction
• Pump speeds are modulated to produce pulsatile
outflow

• Two physically separate helical flow pumps with

pressure sensors at the inlet

• Two physiological controllers (1/R & ΔP)

2 x goats @ 68-100days

Sheng-Yuan(2013), Abe (2015)

 OREGONHEART

Single impeller with novel shuttling mechanism

SIZE (Weight) --
POWER (6LPM) --
FLOW --
BEARING HYDRODYNAMIC

Physiological Interaction

• Pulsatile outflow pump with no contact

• Left-right balance is adjusted by varying the

left and right dwell times

• TAH pumps alternately into systemic and

pulmonary circulation

www.oreganheart.com
 CLEVELANDHEART

Single rotor - passive axial movement

SIZE (Weight) 98.4 x φ62mm (486g)
POWER / SPEED (6LPM) 10W / 2600RPM
FLOW MAX 9LPM
BEARING HYDRODYNAMIC

Physiological Interaction

• Pulsatile outflow via speed modulation

• Passive left-right flow balancing with passively

floating rotor – NO SENSORS

• Physiological controller and suction prevention

mechanism
2 x Cow @ 90days

Fumoto (2010), Fukamachi (2010), Karimov (2015)

DRAGON HYBRID

Physiological Interaction

Continuous Flow, maybe

pulsatile

In-vitro testing maybe this year.

 BiVACOR

Single rotor – passive/active axial movement

SIZE (Weight) 60 x φ71mm (512g)
POWER / SPEED (6LPM) 7W / 2000RPM
FLOW MAX 15+LPM
BEARING MAGNETIC

Physiological Interaction

• Pulsatile outflow via speed modulation

• Passive left-right flow balancing with rotor

axial movement

• Physiological controller to match cardiac

demand
1 x Cow @30 days, 1 x Cow @90 days
This information is confidential and remains the property of BiVACOR Inc.

www.bivacor.com
In the NEAR FUTURE
• Multiple options

• The intent is long-term Destination Therapy

• Food and Drug Administration