Patients Supported for More Than 1 Year by the SynCardia Total Artificial Heart Experienced Acceptable Outcomes, Concludes International Study

Seventy-four percent of patients who were supported by the SynCardia temporary Total Artificial Heart for more than a year were either bridged to a donor heart or awaiting one, according to a study published in the ASAIO Journal for the American Society for Artificial Internal Organs.

In the introduction of the paper, “Results With SynCardia Total Artificial Heart Beyond 1 Year,” the authors write, “After a minimum of 1 year of support, 34 patients (72%) were successfully transplanted, 12 patients (24%) died while on device support, and 1 patient (2%) is still supported.”

The study by 18 cardiac surgeons from around the world was published December 10, 2014, eight days before the FDA approved an application by SynCardia Systems, Inc. to study the effective use of the SynCardia Total Artificial Heart for permanent use, also called destination therapy (DT). (Caution-The 70cc SynCardia Total Artificial Heart, when used for destination therapy, is an investigational device, limited by United States law to investigational use.)

Read the study “Results With SynCardia Total Artificial Heart Beyond 1 Year”

In the United States, the SynCardia Total Artificial Heart is currently approved as a bridge to a donor heart transplant for patients dying of end-stage biventricular heart failure. That is a condition in which the heart’s two ventricles can no longer pump enough blood for the patient to survive.

The authors studied medical records of 47 patients who received the SynCardia Total Artificial Heart between 1989 and 2011 and were supported for at least one year on the device. The mean age of patients was 50 (plus or minus 1.57 years) and the median support time was 554 days (365–1,373 days).

Thirty-three patients (70.2%) were categorized to an INTERMACS class. Twenty-three were in INTERMACS class I (crash and burn), seven were in class II (sliding on inotropes) and three were on class III (stable but inotrope-dependent).

Forty patients (85%) were discharged home. Of the seven patients who remained in-hospital, five were from the United States where, at the time of their TAH support, a portable driver was not available yet.

Of those who died, only two were from device failure. “In long-term support, the use of (the Total Artificial Heart) was safe,” according to the study. “…Device malfunctions are generally referred to as a rare complication with the (Total Artificial Heart).” Infections and hemorrhagic events were the leading causes of death among the patients in the study.

Among the findings:

• Every one of the 34 patients who had a donor heart transplant following long-term use of the SynCardia Heart successfully survived the surgery, according to the study.
• Following SynCardia Total Artificial Heart implant surgery, 30 patients needed renal replacement therapy; 22 (73%) recovered kidney function.
• Three of the 34 patients who had a donor heart transplant died, all from graft (donor heart) rejection. The median time of survival post-transplant was 145 days (50-328 days).
• There were 0.083 TE (thromboembolic) events per patient month. “…This data show that long-term (Total Artificial Heart) support does not increase the risk of TE events,” according to the report.
• Patients with a body surface area (BSA) of less than 1.8 m² had an increased incidence of death, hemorrhagic events and systemic infections. Standard fit criteria for use of the SynCardia Total Artificial Heart include a minimum BSA of 1.7 m² and an anteroposterior distance greater than 10 cm from the sternum to the 10th thoracic vertebra (T10).

The paper concludes with a list of study limitations and states, “However, the SynCardia (Total Artificial Heart) has emerged as a robust form of mechanical circulatory support for patients with biventricular failure. This study illustrates that support using the SynCardia (Total Artificial Heart) beyond 1 year has acceptable outcomes, but further improvements in the device, patient selection and long-term patient management need to be achieved to further reduce the major complications of infection, TE and hemorrhagic events.”

In the United States, SynCardia is working with the FDA to conduct a study on the effective use of a smaller, 50cc SynCardia Heart that will fit patients of smaller stature, including most women, smaller men and many adolescents. (Caution-In the United States, the 50cc SynCardia temporary Total Artificial Heart is an investigational device, limited by United States law to investigational use.)

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About the SynCardia temporary Total Artificial Heart

SynCardia Systems, Inc. in Tucson, Arizona is the privately-held owner and manufacturer of the world's first and only FDA, Health Canada and CE approved Total Artificial Heart for use as a bridge to transplant for people suffering from end-stage biventricular heart failure in which both ventricles can no longer pump enough blood for a person to survive.

More than 1,400 implants of the SynCardia Total Artificial Heart account for over 400 patient years of life on the device. Since January 2010 more than 550 SynCardia Hearts have been implanted.

The youngest patient to receive a SynCardia Heart was 9 years old; the oldest was 80 years old. The longest a patient has lived with a SynCardia Heart was nearly four years (1,374 days) before receiving a successful donor heart transplant Sept. 11, 2011.

SynCardia Systems also manufactures the Freedom® portable driver, which powers the SynCardia Heart while allowing clinically stable patients to be discharged from the hospital to live at home and in their communities. The wearable Freedom driver has been used by more than 200 patients, accounting for over 130 years of support.