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Italian Boy Becomes Youngest Patient Bridged to Transplant with the SynCardia temporary Total Artificial Heart

June 21, 2017

Syncardia Systems, LLC., a Picard Medical Company

The smaller 50cc temporary Total Artificial Heart helped rejuvenate the critically-ill 12-year-old’s vital organs until a matching donor heart became available two weeks later.

Story At-A-Glance

  • A 12-year-old with dilated cardiomyopathy was hospitalized due to end-stage heart failure.
  • Doctors at Bambino Gesù Children’s Hospital implanted the SynCardia 50cc temporary Total Artificial Heart (TAH) to save his life and help him get stronger for transplant.
  • Two weeks later, the boy received a matching donor heart, becoming the youngest patient bridged to transplant with the SynCardia TAH.

 

June 21, 2017 – A 12-year-old boy at Bambino Gesù Children’s Hospital in Rome, Italy, has become the world’s youngest patient to be bridged to a heart transplant with the SynCardia temporary Total Artificial Heart (TAH).

Diagnosed with dilated cardiomyopathy, Andrei began experiencing biventricular dysfunction in January. Two months later, he was admitted to the hospital with end-stage heart failure. The 12-year-old needed a heart transplant, but a matching donor heart wasn’t available.

To save Andrei’s life, on April 21, doctors removed his failing heart and implanted the 50cc TAH to restore blood flow to his body and help him get stronger for transplant. Two weeks later, Andrei received the matching donor heart he’d been waiting for.

“I use the Total Artificial Heart because it is more versatile than BIVAD support with the Berlin Heart, the only alternative, and the Total Artificial Heart permits patients to be discharged from the hospital,” said Dr. Antonio Amodeo, Surgical Director of the Heart Failure Program at Bambino Gesù Children’s Hospital. “The 50cc Total Artificial Heart was the best option based on the age and size of this patient.”

At the time of implant, Andrei was 17 days younger than the previous record-holder, a 12-year-old girl in the United Kingdom who was successfully bridged to transplant with the 50cc TAH in 2016.

The 50cc TAH is a smaller version of SynCardia’s 70cc TAH, the first and only heart replacement device to attain commercial approval in the U.S., Canada and Europe. Designed to fit patients of smaller stature, including more women and adolescents, the 50cc TAH has the CE mark for use in Europe and is undergoing an FDA-approved Investigational Device Exemption (IDE) clinical study in the U.S.

Similar to a heart transplant, the SynCardia TAH replaces the failing heart and restores blood flow to the body, allowing the patient to begin their recovery from heart failure. Unlike a donor heart, the TAH cannot be rejected and is readily available at SynCardia Certified Centers, providing a new heart without the wait to patients with end-stage biventricular heart failure.

About SynCardia Systems, LLC

Headquartered in Tucson, Ariz., SynCardia manufactures the world’s only commercially approved total artificial heart. In clinical use for more than 35 years and with more than 1,800 implants, the SynCardia temporary Total Artificial Heart (TAH) is the most widely used and extensively studied TAH in the world.

By partnering with, training and supporting healthcare teams at more than 140 transplant hospitals and heart failure programs in more than 20 countries, SynCardia helps create better outcomes for critically ill adults and adolescents whose best chance at survival is total heart replacement. When a donor heart isn’t an available option, SynCardia provides a new heart without the wait for patients with end-stage heart failure affecting both sides of the heart (biventricular failure).