Total Artificial Heart

What Metrics Should be Met for Standard Use? For Future Technology?

Francisco A Arabía, MD MBADirector for Surgical Device Management Advance Heart Disease

Cedars-Sinai Heart Institute

Total Artificial HeartWhat Metrics should be Met for

Standard Care

Francisco A. Arabía, MD MBA

Cedars-Sinai Heart Institute

Disclosure

• Consultant:• SynCardia Systems, BiVACOR TAH, Carmat TAH, Dragon TAH, Medtronic

Disclosure

SynCardia Systems, Carmat TAH, BiVACOR TAH, Medtronics

Patients who can benefit from TAH

• Severe Biventricular fai lure

• 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

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

• Balancing via passive partial filling

• No (significant) autonomous adjustment for cardiac demand

SIZE (Weight) 400ml (160g) (70cc)

POWER --

FLOW / RATE 9 LPM

LIFETIME 5+ Years

Pneumatic driven flexible membrane

Physiological Interaction

www.syncardia.com

>1700 patients MAX@5+years

CARMAT

• Pulsatile with alternating left/right ejection

• Balancing via 2 individual pumps and compliance chamber for actuating fluid

• Autonomous adjustment based on sensor measurements

SIZE (Weight) 750 ml (850g)

POWER (6LPM) 30 W

FLOW / RATE 2-9 LPM (35-150 BPM)

LIFETIME 5+ years

Electrohydraulically driven flexible bio-membrane

Physiological Interaction

www.carmatsa.com

5 Patients MAX@9month

REINHEART

• Pulsatile with alternating left/right ejection

• Balancing via passive filling and systole-diastole timing + compliance chamber

• No adjustment for cardiac demand

SIZE (Weight) 89x90mm (923g)

POWER <20W

FLOW / RATE Max: 7.5 LPM (160 BPM)

LIFETIME durability 7+ years

Voice call Electrically driven flexible membrane

Physiological Interaction

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

Bovine In-vivo Trial 2+ days

HELICAL FLOW TAH (UPTAH4)

• 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)

SIZE (Weight) 77 x φ80mm (565g)

POWER --

FLOW MAX 13LPM

BEARING HYDRODYNAMIC

2 x goats @ 68-100days

Twin helical flow rotors back to back

Physiological Interaction

Sheng-Yuan(2013), Abe (2015)

OREGONHEART

• 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

SIZE (Weight) --

POWER (6LPM) --

FLOW --

BEARING HYDRODYNAMIC

Single impeller with novel shuttling mechanism

Physiological Interaction

www.oreganheart.com

CLEVELANDHEART

• Pulsatile outflow via speed modulation

• Passive left-right flow balancing with passively floating rotor – NO SENSORS

• Physiological controller and suction prevention mechanism

SIZE (Weight) 98.4 x φ62mm (486g)

POWER / SPEED (6LPM) 10W / 2600RPM

FLOW MAX 9LPM

BEARING HYDRODYNAMIC

Single rotor - passive axial movement

Physiological Interaction

2 x Cow @ 90days

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

DRAGON HYBRID

Continuous Flow, maybe pulsatile

In-vitro testing maybe this year.

Physiological Interaction

BiVACOR

• Pulsatile outflow via speed modulation

• Passive left-right flow balancing with rotor axial movement

• Physiological controller to match cardiac demand

SIZE (Weight) 60 x φ71mm (512g)

POWER / SPEED (6LPM) 7W / 2000RPM

FLOW MAX 15+LPM

BEARING MAGNETIC

Single rotor – passive/active axial movement

Physiological Interaction

1 x Cow @30 days, 1 x Cow @90 days

www.bivacor.com

This information is confidential and remains the property of BiVACOR Inc.

In the NEAR FUTURE

• Multiple options

• The intent is long-term Destination Therapy

• Food and Drug Administration