This press release was first published by Baylor St. Luke's Medical Center on Dec. 12, 2016.
50cc Total Artificial Heart Implanted at Baylor St. Luke’s, Bringing New Hope to More Patients
Other device options were too large for the 55-year-old woman, who is the third person in the U.S. and the first in Texas to be discharged home with the 50cc Total Artificial Heart.
Dec. 20, 2016 – Doctors at CHI St. Luke’s Health–Baylor St. Luke’s Medical Center (Baylor St. Luke’s) announced that they have successfully implanted the new 50cc SynCardia temporary Total Artificial Heart into a patient suffering from end-stage, biventricular heart failure. The new device is a smaller version of the 70cc SynCardia temporary Total Artificial Heart, which received FDA approval in 2004. The patient is the third person in the country and the first in Texas to be discharged home with the 50cc Total Artificial Heart.
The procedure was performed by Jeffrey Morgan, MD, Surgical Director, Mechanical Circulatory Support and Cardiac Transplant, Texas Heart® Institute (THI) at Baylor St. Luke’s, and Chief, Division of Cardiothoracic Transplant and Circulatory Support, Baylor College of Medicine. For the last half-century, the Texas Heart® Institute at Baylor St. Luke’s has led the world in the push to develop a viable, durable total artificial heart.
“This device has the potential to revolutionize the field of artificial heart technology,” said Dr. Morgan. “Due to its smaller size, we can now treat patients who previously could not be treated with artificial heart technology and get them back to living a close to normal lifestyle.”
The 50cc Total Artificial Heart is designed to fit patients of smaller stature with life-threatening non-reversible biventricular (both sides) heart failure. These patients are typically women and adolescents who do not have the body surface area (1.85m² or less) to receive the 70cc Total Artificial Heart. With as many as 100,000 people in the U.S. in need of new hearts and a little more than 2,500 receiving a transplant last year, the Total Artificial Heart is designed to be used as a bridge to a donor heart transplant. The 70cc Total Artificial Heart is also undergoing an FDA-approved Investigational Device Exemption (IDE) clinical study in the U.S. for destination therapy, which provides long-term support to patients who are not candidates for transplant.
Similar to a heart transplant, the SynCardia Total Artificial Heart replaces both failing heart ventricles and the four heart valves. In most cases, the Total Artificial Heart restores blood flow, pumping up to 9.5 liters per minute, and eliminates complications associated with the patient's failing heart. This helps vital organs to recover faster and allows patients to be better transplant candidates when a donor heart does become available. As a result, patients usually see an improvement in their activity levels and overall quality of life.
“This device was instrumental in saving the patient’s life both by eliminating the symptoms and source of end stage heart failure and acting as bridge to transplant in someone dying from heart failure,” said the patient’s primary cardiologist Leo Simpson, MD, FACC, FHRS, FSCAI, Assistant Professor, Baylor College of Medicine and Director of Interventional Heart Failure, Baylor St. Luke’s.
The recently implanted patient is a 55-year-old woman who previously had a pacemaker. Other artificial heart devices were too large for her.
“This is an important step in the evolution of artificial heart devices,” said James T. Willerson, MD, President, THI. “We’re proud that THI continues to lead the way in such technology to help patients.”
Other notable accomplishments include the world’s first artificial heart implant in 1969 by Denton A. Cooley, MD, and when THI surgeons implanted the SynCardia Total Artificial Heart in four patients over a 12-day period. O.H. “Bud” Frazier, MD, performed those implants and also worked on research for the first pump used in the very first artificial heart implant.
“THI and Baylor St. Luke’s have a very rich history as clinical partners in cardiovascular care,” said Gay Nord, President, Baylor St. Luke’s Medical Center. “We’re excited to build upon this 60-plus year legacy as we continue to work together through innovative collaborations.”
CAUTION – In the United States, the 50cc SynCardia temporary Total Artificial Heart is an investigational device, limited by federal law to investigational use.
About SynCardia Systems, LLC
SynCardia Systems, LLC in Tucson, Ariz., is the privately-held manufacturer of the world's first and only FDA, Health Canada and CE approved Total Artificial Heart. For people suffering from end-stage heart failure affecting both sides of the heart (biventricular failure), the SynCardia temporary Total Artificial Heart is used as a bridge to transplant, helping them survive until a matching donor heart becomes available. SynCardia also manufactures the Freedom® portable driver, which powers the SynCardia Total Artificial Heart and allows clinically stable patients to be discharged from the hospital to enjoy life at home while they wait for a heart transplant.