Just like a human heart, the SynCardia temporary Total Artificial Heart (TAH) is pulsatile and consists of two ventricles and four valves that pump blood throughout the body. The TAH is made of a special biocompatible plastic, which prevents the TAH from being rejected by the body.
Unlike other mechanical circulatory support (MCS) devices, such as left ventricular assist devices (LVADs) that assist the left side of the failing heart, the SynCardia TAH replaces both the left and right sides of the failing heart. In order to fit more patients, there are two sizes: the 70cc TAH and the 50cc TAH.
The 70cc TAH has been in clinical use for more than 35 years and implanted in more than 1,700 patients worldwide. The 70cc TAH underwent a 10-year pivotal clinical trial to demonstrate its safety and effectiveness. As a result of that clinical trial, during which 79% of patients who received the TAH were bridged to transplant, the 70cc TAH was approved for use as a bridge to transplant in the U.S. (2004), Canada (2005) and Europe (1999).
In an effort to make the 70cc TAH available to more patients, we’re currently conducting an FDA clinical trial of the 70cc TAH for use as destination therapy in patients who are not eligible for transplant.
Based on the 70cc TAH, we created the smaller 50cc TAH, designed to fit patients of smaller stature, including more women and adolescents. The 50cc TAH is approved for use in Europe (2014), Canada (2016), and the U.S. (2020).
As with all mechanical circulatory support (MCS) devices, there are risks of stroke, infection and bleeding with the TAH. However, your healthcare team has protocols in place to help reduce the occurrence of these complications.
Several patients have been supported by the TAH for more than 4.5 years.
The TAH is available at more than 140 SynCardia Certified Centers in 20 countries. Each center has undergone a comprehensive training program to become a SynCardia Certified Center. To find a center near you, click here.
The TAH has been covered by Medicare since 2008, and is covered by most large private payers and state Medicaid programs.
The TAH is approved for use in patients with end-stage heart failure affecting both sides of the heart (biventricular failure). A list of conditions (etiologies) patients have had prior to receiving the TAH is available here.
Although the 70cc TAH is currently approved as a bridge to transplant, we’re conducting an FDA clinical trial of the 70cc TAH as destination therapy for adults who do not qualify for a donor heart transplant. Learn more here.
The TAH has been used in patients as young as nine years old. However, both the 70cc and the 50cc TAHs are too large for use in babies, toddlers and small children.
During surgery, your surgeon will remove the bottom chambers of your heart (the left and right ventricles) as well as the four heart valves and replace them with the TAH, eliminating the symptoms and source of your heart failure so that you can begin your recovery. Many surgeons also take this opportunity to prepare for your eventual donor heart, which may reduce the amount of time your future transplant surgery will take.
Many patients describe an immediate improvement in their condition after waking up from the implant surgery, including having color return to their cheeks, being able to breathe easier and having increased vitality. Most patients are extubated (have their breathing tube removed) within 1 to 2 days and are out of bed sitting in a chair or walking around the floor shortly thereafter. Nutrition, exercise, a positive attitude and a strong support system are all important to a speedy recovery. Learn more about what to expect here.
Stable TAH patients who meet discharge criteria can return home while they wait for a matching donor heart using the Freedom® Portable Driver. This lightweight pump can be carried in the Freedom Backpack or Shoulder Bag and provides increased mobility and independence, allowing stable patients who meet discharge criteria to leave the hospital.
Although experiences vary based on the severity and length of illness, age, and other factors, many patients are able to return to active, “new-normal” lives at home with their loved ones. Discharged patients are able to resume their daily activities and hobbies, care for their children, exercise, enjoy shopping and go out to eat. In some cases, they even go back to work. Learn more about what to expect here.