CHLA Saving Lives With Berlin Artificial Heart
Last December, the FDA approved use of the life-saving Berlin Heart device for children nationwide. Children’s Hospital Los Angeles (CHLA) now has at least one or two patients on the device at any given time, according to hospital personnel.
A recent success story is 11-year-old Milan McMillan.
Milan was a normal appearing 11-year-old girl who had only had mild intermittent childhood “asthma.”
She had complained of abdominal pains and was prescribed an antacid medication a few months before a family barbecue in July when she was experiencing shortness of breath, chest and abdominal pain.
She awoke from sleep with shortness of breath, palpitations and her “heart racing.” Her parents took her to a local hospital, knowing she “didn’t look right.”
The emergency physician there detected a heart murmur, EKG abnormality and decreased heart function by echocardiography. Later that month she was transferred to Children’s Hospital’s Cardiothoracic Intensive Care Unit (CTICU).
Over the next days and weeks, Milan underwent testing and observation with medical interventions, including heart catheterization, with her parents by her side.
Because of the acute nature of her heart symptoms, her cardiologists suspected myocarditis and advised monitoring, inotropic support and treatment.
The medical team and family observed and hoped for improvement. But she couldn’t tolerate weaning off the intravenous support to oral heart failure medications and was subsequently referred to the heart transplant team for evaluation.
By August, she was wait listed as a heart transplant candidate.
“We could never imagine something like this in a million years,” said Milan’s mother, Karen McMillan. “She was an active member of the YMCA in water aerobics, karate and basketball.”
Milan was weak and becoming increasingly intolerant of even mild physical activities such as getting out of bed. She could not eat or drink very much as her heart failure caused poor blood flow to her other organs, such as her intestines, and she felt nausea and would vomit.
Doctors had to increase the doses of her intravenous heart supportive medications and they were reaching maximal doses.
The medical team began to discuss mechanical support with Milan and her parents and recommended a left ventricular assist device (LVAD), the Berlin Heart.
After four months in the hospital, the device was placed in September by Cardiothoracic Surgeon Dr. Cynthia Herrington and Milan was able to be weaned from other cardiac support medications as she recovered from the LVAD surgery and effects of her long-standing heart failure.
“The Berlin Heart really improved the quality of her life,” said Karen McMillan.
About the size of a softball, the device rests outside the body connected to the heart with tubes and attached to a pump and external drive. A long tube “lead” allowed Milan to move around her hospital room.
Having the device was “a little painful,” Milan said, but it kept me alive.”
Herrington also did the successful heart transplant in December and Milan was able to be home for the holidays. “She was on the heart transplant list for quite a while,” said Herrington.
At the time she was one of more than 250 children nationwide awaiting a heart transplant.
Facing the five-six hour hour procedure, Milan said: “I was scared; but I don’t remember it. Dr. Herrington told me I’d be okay.”
After six months in the hospital, Milan said, “It’s been fun and boring.”
Finally leaving the hospital, Milan was ecstatic bout being able to breathe fresh air and go outside. She was looking forward to gong to the movies and eating snacks.
She started sixth grade at Children’s enjoying history and math. She will continue to be home schooled.
“A bridge to transplant,” as Herrington describes it, the Berlin “is an amazingly good device,” she says. “Kids do well; and it keeps children alive to get a transplant.”
Children’s Hospital has been one of a handful of children’s hospitals nationwide utilizing the Berlin Heart for about four years under a study protocol.
A cardiac surgeon specializing in heart and lungs, Herrington has been training on the device as part of her specialty working with infants and children. “The work rewarding and challenging,” she says.
Chosen as part of an institutional study, Children’s has been implanting the device under “Compassionate Use.”
Since 1987, the FDA has had rules in place that have enabled patients, under specific circumstances, to access treatments that are still in development. These expanded access program rules were amended in 2009.