Cardiomyopathy:

• Restrictive
• Infiltrative
• Hypertrophic
• Dilated

Congenital paediatric and adult conditions:

• Ventricular septal defect
• Transposition of the great arteries
• Failed Fontan circulation

Transplant rejection.

Persistent ventricular tachycardia.

A UNIQUE DESIGN

SynCardia Total Artificial Heart is made of two biocompatible plastic ventricles with four valves. Each ventricle has a diaphragm that separates the internal chamber (where blood flows) from the external chamber (where the pneumatic mechanism acts). The ventricles are connected to an external power supplied called “controller” by two small air tubes called “hoses”, providing a pulsatile flow. The hoses leave the abdominal wall of the patient just under the rib cage.

The unique design of the total artificial heart allows the patient’s body to adjust automatically blood flow according to the activity level. During exercise, the increased muscular and body movements take more blood flow to the heart. There is no need to change heart rate as the body adjusts automatically the amount of blood pumped by the total artificial heart.

Two sizes designed to adapt to most patients:

• 70cc: Designed for patients with a body surface >1.70 m2

• 50cc: Designed for patients with a body surface between 1.2 and 1.85 m2

Proven reliability: During 30 years of use, the valves have never failed in SynCardia total artificial heart. The diaphragm, which is responsible for pumping blood in and outside the ventricles, has shown a failure index lower than 1% in over 1,000 implants. Currently the longest time that a patient has been assisted by the total artificial heart is 1,374 days (almost four years) before a successful heart transplant.

ADVANTAGES OF THE DEVICE

As with a heart transplant, SynCardia total artificial heart is the only device that:

Eliminates the symptoms and the cause of end-stage heart failure:

• Replaces both damaged heart ventricles.

• Replaces the tricuspid, pulmonary, mitral and aortic valve.

Removes the complications of the native heart:

• No ventricular failure/dysfunction or need for inotropics.

• No valvular disorders.

• No arrhythmia or need for pacemakers or defibrillator.

It provides an immediate, safe flow of up to 9.5 l/min through each ventricle:

• Restores immediately a normal cardiac index (CI).

• Helps restore normal central venous pressures (CVP).

• Helps solve pulmonary hypertension (PAP).

• Restores normal haemodynamics and organic perfusion.

Unlike a donor heart, SynCardia total artificial heart:

• Is available immediately at centres certified by SynCardia.

• Does not require expensive immunosuppressive agents, that can cause subsequent complications.

• Provides consistent quality and reliable performance.

Bridge to transplant

Implantation of SynCardia total artificial heart:

Due to its unique design, the total artificial heart does not require sensors, motors or electronic devices of any type inside the body.
All electronic devices are located safely outside the body in the external controller, which feeds the total artificial heart with air and vacuum pulses.
It is never needed to operate again for repairing or replacing electronic devices. SynCardia hospital controller impels the total artificial heart from implantation until the condition of the patient is stable.

Once stability is achieved, patients who meet the necessary requirements are then connected to the portable Freedom® controller, which allows the patient to move more easily at the hospital. Patients who meet the criteria for discharge can leave the hospital to wait for a compatible donor heart at home and in their communities.