News | Congenital Heart | June 22, 2017

Italian Boy Becomes Youngest Patient Bridged to Transplant With SynCardia Total Artificial Heart

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

Italian Boy Becomes Youngest Patient Bridged to Transplant With SynCardia Total Artificial Heart

Andrei, 12, is the world’s youngest patient to be bridged to transplant with the SynCardia Total Artificial Heart. He is pictured after his heart transplant with his surgeon, Antonio Amodeo, M.D., at Bambino Gesù Children’s Hospital in Rome, Italy. Photo courtesy of Business Wire.

June 22, 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.

Diagnosed with dilated cardiomyopathy, Andrei began experiencing biventricular dysfunction in January 2017. 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 Total Artificial Heart 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 Antonio Amodeo, M.D., 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 Total Artificial Heart in 2016.

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

Similar to a heart transplant, the SynCardia Total Artificial Heart 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 Total Artificial Heart 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.

For more information: www.syncardia.com

Related Content

Left, the Melody pulmonary valve was the first transcatheter valve to be approved by the FDA in the United States a decade ago. Right, the Harmony transcatheter valve is in trials and is designed to treat patients with RVOT anomalies who develop severe PR typically when a pervious repair fails. Both valves are used to treat congenital heart defects. #SCAI #SCAI2020

Left, the Melody pulmonary valve was the first transcatheter valve to be approved by the FDA in the United States a decade ago. Right, the Harmony transcatheter valve is in trials and is designed to treat patients with RVOT anomalies who develop severe PR typically when a pervious repair fails. Both valves are used to treat congenital heart defects.

News | Congenital Heart | May 21, 2020
May 21, 2020 — Two late-breaking clinical trials on trans catheter valves to treat congenital heart disease were pres
SCAI Issues Position Statement on Adult Congenital Cardiac Interventional Training, Competencies and Organizational Recommendations. A congenital atrial septal defect closed using a transcatheter occluder, visualized on 3-D TEE ultrasound.

A congenital atrial septal defect closed using a transcatheter occluder, visualized on 3-D TEE ultrasound.

News | Congenital Heart | May 04, 2020
University of Arizona Leads Statewide Study of Congenital Heart Defects
News | Congenital Heart | October 24, 2019
Investigators at the University of Arizona Steele Children's Research Center are leading a statewide study as part of a...
Abbott Receives European CE Mark for Two Pediatric Heart Devices
News | Congenital Heart | September 20, 2019
Abbott announced approvals in Europe for two of its pediatric devices — the Masters HP 15mm rotatable mechanical heart...
High Blood Pressure, Cholesterol in Young Adults Associated With Later Heart Disease
News | Congenital Heart | July 16, 2019
Elevated blood pressure and cholesterol levels in young adulthood may lead to an increased risk of heart disease later...
Hypertension Found in Children Exposed to Flower Pesticides
News | Congenital Heart | June 03, 2019
Researchers at University of California San Diego School of Medicine found higher blood pressure and pesticide...
Edwards Recalls Miller and Fogarty Balloon Dilation Atrioseptostomy Catheters
News | Congenital Heart | April 29, 2019
Edwards Lifesciences is recalling the Miller Balloon Atrioseptostomy Catheter and Fogarty Dilation Atrioseptostomy...
New Pediatric Blood Pressure Guidelines Improve Premature Heart Disease Identification
News | Congenital Heart | April 22, 2019
New guidelines that classified more children as having elevated blood pressure  are better at predicting which kids are...
Better Options Needed for Children at Higher Risk of Premature Heart Disease
News | Congenital Heart | February 28, 2019
Obesity and severe obesity in childhood and adolescence have been added to the list of conditions that put children and...
Climate Change May Increase Congenital Heart Defects
News | Congenital Heart | January 30, 2019
Rising temperatures stemming from global climate change may increase the number of infants born with congenital heart...