The SynCardia temporary Total Artificial Heart (TAH) is a life-saving treatment option for patients diagnosed with end-stage biventricular heart failure — here’s what patients and their families should know.
Being diagnosed with end-stage heart failure can be a scary and overwhelming experience. However, it’s important to remember that you’re not alone or out of options. Not only are there expert healthcare professionals ready to help — there are also advanced, clinically proven treatment options available, including the SynCardia TAH.
What is the SynCardia Total Artificial Heart?
The SynCardia TAH is the world’s only commercially available total artificial heart. With more than 1,800 implants worldwide, the SynCardia TAH is approved for use as a bridge to transplant in patients with end-stage heart failure affecting both sides of the heart (biventricular failure). Bridge to transplant means that the SynCardia TAH is used to improve survival and quality of life in critically-ill patients waiting for a donor heart to become available.
Just like a heart transplant, the TAH replaces both lower chambers of the heart (the left and right ventricles) as well as the four heart valves to restore blood flow to the body and eliminate the symptoms and source of heart failure.
In addition, the TAH offers some advantages that a donor heart does not:
- The TAH is readily available when needed (no wait list)
- It is not restricted by blood type or antibody level (no matching required)
- It is biocompatible with the body (no anti-rejection medications needed)
Two Sizes to Fit Most Patients
The SynCardia TAH is manufactured in two sizes: 70cc and 50cc.
The 70cc TAH fits a majority of men and some women, and has been in clinical use for more than 35 years. It is the first and only TAH to receive regulatory approval in the U.S. (2004), Europe (1999) and Canada (2005) as a bridge to transplant. The 70cc TAH received FDA approval following a 10-year pivotal clinical trial to demonstrate its safety and effectiveness. During the trial, 79% of patients who received the TAH were bridged to a heart transplant.
In an effort to make the 70cc TAH available to more patients, SynCardia is currently conducting an FDA clinical trial of the 70cc TAH for use as destination therapy in patients who are not eligible for a heart transplant.
The 50cc TAH is a smaller version of the 70cc TAH, designed to fit patients of smaller stature, including more women and adolescents. It is approved for use as a bridge to transplant in Europe (2014) and Canada (2016) and is undergoing an FDA clinical trial in the U.S. for adult and pediatric use.
How Does the Total Artificial Heart Work?
Like a human heart, the SynCardia TAH is pulsatile and consists of two ventricles and four valves that pump blood throughout the body. The two ventricles are made of biocompatible plastic, which prevents the TAH from being rejected by the body. Each ventricle has a mechanical inflow valve and an outflow valve. These valves control the direction of blood flow in and out of the ventricle just like natural heart valves.
Inside each ventricle is a flexible, balloon-like membrane known as a diaphragm. The diaphragm divides the ventricle into two chambers: a blood chamber, which holds the blood when it enters the ventricle, and an air chamber.
Two tubes called cannulae connect to the air chambers of the ventricles. The cannulae exit the body through the abdominal wall and attach to two tubes called drivelines. These drivelines are connected to an external pump known as a driver.
The external driver provides pulsatile blood flow by producing pulses of air and vacuum that travel through the drivelines to inflate and deflate the TAH diaphragms, pushing blood in and out of the ventricles.
Who Can Benefit from the SynCardia TAH?
If you or a loved one is suffering from advanced or end-stage heart failure (NYHA Class III or IV) and your doctor has discussed an immediate or eventual need for a heart transplant, the SynCardia TAH may be an option for you and your doctor to consider.
There are a number of conditions that can contribute to the development of biventricular heart failure. To see a full list of conditions and learn more about whether you or your loved one may be a good candidate for the SynCardia TAH, click here.
Powering the SynCardia TAH
The C2 Driver is intended to pump and monitor the SynCardia TAH from implant through patient recovery in the hospital. In the operating room and during the initial stages of patient recovery, the C2 Driver is docked in the Hospital Cart, which features a large touch screen display, sturdy support handles and locking casters. It provides robust, reliable support for patients regaining their strength and mobility following the implant surgery.
After recovery from the surgery, stable TAH patients can be switched to the smaller, lighter Freedom Driver, which offers increased mobility and can be carried in the provided Backpack or Shoulder Bag. Patients on the Freedom Driver who meet discharge criteria can leave the hospital to enjoy active and independent lives at home with their loved ones while they wait for their transplants.
Some examples of activities SynCardia TAH patients have been able to enjoy with the Freedom Driver include:
- Going to the mall, athletic events, the zoo and county fairs with their families
- Cycling, basketball, hiking, golfing and other sports
- Trapshooting, fishing and hunting
- Taking interstate road trips
- Attending graduations and weddings
- Attending dances, concerts and other cultural events
For more information about the SynCardia TAH, download our Patient & Families guide or call our Heart Failure at 1-855-344-1166.