Most often, when companies issue press releases they are about regulatory approvals, product launches, clinical results or quarterly financials. It’s quite refreshing therefore to find SynCardia, supplier of the Total Artificial Heart, telling us what other people are saying about it, most specifically how and when to use it.
First the device’s credentials: SynCardia tells us that more than 400 of its Total Artificial Heart implants have been performed since January 2011, the device providing almost 130,000 patient days of support in nearly 1,300 implants performed to date. The youngest patient to receive a SynCardia Heart was 9 years old; the oldest was 76 years old.
So what is the U.S. Heart Transplant fraternity saying about it? Well, according to SynCardia, thought leaders in the field recently detailed the best practices for a growing list of uses for the system, demonstrating how the world’s first and only FDA, Health Canada and CE approved Total Artificial Heart can give very sick patients with end-stage biventricular heart failure second chances at life. They shared cases that illustrate the use of the SynCardia Total Artificial Heart as a bridge to donor heart transplant for patients whose complex medical conditions require the SynCardia Heart for survival.
Highlights include two cases of patients with cardiac sarcoma, in each case, the cancerous, failing heart having been removed and a SynCardia Heart implanted. One of the physicians involved said; “I think the use of the SynCardia Total Artificial Heart can be a viable alternative, especially to young patients who have isolated cardiac tumor and may become transplant candidates. It’s a viable option for patients who have no other options.”
Transplant Rejection & Recovery of Kidney Function
Another specialist, Dr. Angela Lorts, Cincinnati Children’s Hospital Medical Center detailed the case of a 19-year-old woman who suffered both failure of one remaining kidney and rejection of a donor heart. She was implanted with the SynCardia Total Artificial Heart in Nov. 2012. For almost two months after the implant surgery, she continued to produce no urine, so she was scheduled for surgery on Jan. 2, 2013 to receive a permanent catheter. However, on Jan. 1, she began making urine. She was transplanted with a second donor heart last December.
Ventricular Septal Defect (VSD)
Dr. Igor Gregoric, Memorial Hermann – Texas Medical Center detailed his case of a 63-year-old male who had a heart attack resulting in a large VSD followed by cardiogenic shock. The patient was placed on a cardiac assist device, but when doctors could not close the growing defect, they replaced the device and his failing heart with a SynCardia Heart.
Ventricular Assist Device (VAD) Failure
Dr. Francisco Arabia, Cedars-Sinai Medical Center and Dr. Vigneshwar Kasirajan, Virginia Commonwealth University Medical Center discussed the use of the SynCardia Heart because of infection and thrombosis that sometimes occur after a VAD implant. They noted that in some VAD failure patients dealing with arrhythmias, or rapid heartbeat, SynCardia Heart implants could be a better choice because of the difficulty in controlling the condition.
SynCardia plans to launch clinical trials this summer using the smaller 50cc SynCardia Total Artificial Heart designed for people of smaller stature. Once approved by the FDA, it and the 70cc size will allow all adults and many adolescents to be eligible for a SynCardia Heart implant. And when it comes to pediatric patients, doctors at Cincinnati Children’s say they have used the “software for fit” studies to determine which pediatric patients might be able to receive a 70cc SynCardia Heart implant. “It’s really helpful for the congenital kids because you can reconstruct and see where everything is going to fit,” said Dr Angela Lorts. The software is planned to be used following the FDA-approved 50cc SynCardia Total Artificial Heart study.
Source: SynCardia Systems, Inc., PR Newswire