Just like a human heart, the SynCardia temporary Total Artificial Heart (TAH-t) is pulsatile and consists of two ventricles and four valves that pump blood throughout the body. The TAH-t is made of a special biocompatible plastic, which prevents the TAH-t 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-t replaces both the left and right sides of the failing heart. In order to fit more patients, there are two sizes: 70cc and 50cc.
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The 70cc TAH-t has been in clinical use for more than 35 years and implanted in more than 2000 patients worldwide. The 70cc TAH-t 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) and Canada (2005).
Based on the 70cc TAH-t, we created the smaller 50cc TAH, designed to fit patients of smaller stature, including more women and adolescents. The 50cc TAH-t is approved for use in 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-t. However, your healthcare team has protocols in place to help reduce the occurrence of these complications.
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The TAH-t has been covered by Medicare since 2008, and is covered by most large private payers and state Medicaid programs.
PATIENT SELECTION CRITERIA
The TAH-t 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-t is available here.
The TAH-t has been used in patients as young as nine years old. However, both the 70cc TAH-t and the 50cc TAH-t are too large for use in babies, toddlers and small children.