the recent VAD innovations from the Ventricular Assist Device (VAD) program at
the Heart Institute at Cincinnati Children’s Hospital, include:
In July of 2012, a Berlin EXCOR was placed in a 12 month old boy with restrictive cardiomyopathy. This device implantation was unusual because of its cannula placement, in the right atrium. The child was transplanted without complication and is back at home in Kentucky.
In September 2012, Dr. Morales and team implanted the first VAD in a Duchenne muscular dystrophy (DMD) patient in the United States. This patient had a HeartMate II implanted and was discharged to home.
In November of 2012, our program implanted a SynCardia Total Artificial (TAH) Heart into a 19-year-old woman with transplant rejection, making her the first female at a children’s hospital to undergo this procedure. She was also transferred to the Freedom Driver for discharge home. She was successfully transplanted.
In February of 2013, the first female DMD patient (very rare for disease to affect a female) had a HeartWare device placed. She was discharged and followed in the VAD/Destination clinic and is now home in Oregon. She’s now how the device for 3 years.
In March 2015, a previously healthy16-year-old boy was transported on extracorporeal membrane oxygenation (ECMO) to the Heart Institute from UK Healthcare. The patient was quickly diagnosed with dilated cardiomyopathy with both severe right and left heart dysfunction. He was successfully implanted with the TAH 3 days later. Three months later he received a heart transplant and he is doing well.
In July 2015, a 10 year old obese boy with dilated cardiomyopathy was implanted with a Heartware device. The VAD gave him more energy and stamina so that he was able to do cardiac rehab. He was able to lose over 20 pounds prior to his heart transplant in October 2015.
In August 2015, a 25 year old was bridged to transplant with a TAH. He had his first transplant at Cincinnati Children’s in 2002. Five years ago he placed back on the list for a second transplant; and he had the device implanted when he required more support while waiting. He received his second transplant in September 2015.
National Reputation and Training
Our VAD/MCS program is an international training site for the Berlin Excor device. Onsite training is offered to healthcare professionals including surgical training and in situ simulations. Recently in October 2015, our program hosted a training session for surgeons, physicians, nurses, and perfusionists from across the country. Our center is also a training site for the Syncardia TAH.
Cincinnati Children’s is part of many investigational trials for new and existing devices. We are also enrolling consented patient data in a national registry.
Dr. Morales is the national principal investigator of the FDA-approved Clinical Trial to determine if a 50cc SynCardia TAH is viable for pediatric patients. Dr. Lorts is the medical monitor for the pediatric arm and Dr. Jefferies is the medical monitor for the adult arm. The new 50cc device is smaller than the current 70cc device and would be able to support children as young as 10 years of age. The patient would also be able to go home while they wait for transplant.
The Heart Institute will also be the FIT assessment investigator for the study, which uses advanced 3D imaging and virtual surgery to determine if the Total Artificial Heart can fit in these children’s chest cavities.