It is a big year for Carla Collins. The mother of two will turn 40. She is preparing for her wedding in October. And she recently made medical history. In January, Collins became the first patient in the world to have a regenerative bio envelope implanted with her cardiac defibrillator. It’s a pouch created to protect the device and enhance healing.
Collins is an active runner, but her life unexpectedly came to a standstill two years ago after she fainted twice. One morning, she woke up with severe neck pain that lasted for a couple of days. She reluctantly went to the emergency room, where she underwent an electrocardiogram.
“The good news was I didn’t have a heart attack, but my results were abnormal,” Collins said.
Collins was diagnosed with long QT syndrome, a genetic heart condition causing rapid, chaotic heartbeats that can trigger fainting, seizures and even sudden death. She began seeing John Catanzaro, MD, a UF Health cardiac electrophysiologist, every six months.
“The news didn’t surprise me because my mother and uncle had it,” Collins said. “My mom’s heart suddenly stopped and my uncle had a few strokes, so I knew this was serious.”
Catanzaro suggested Collins have a cardiac defibrillator implanted under her skin near her heart. The device would monitor Collins’ heart rhythm and deliver a shock if she ever went into cardiac arrest, restarting her heart and saving her life.
“Carla had several relatives who had long QT syndrome and already had defibrillators,” Catanzaro said. “She qualified to have a defibrillator implanted, too, but she was not emotionally ready for one, which is not uncommon. We spent time during our visits discussing the risks and benefits of the implantable defibrillator and what life would be like after the implantation.”
At the time, Catanzaro was working with a medical supplier that provided protective pouches for standard transvenous defibrillators and pacemakers that make direct contact with the heart. He suggested they create a cover for their implantable defibrillator made from decellularized pig intestines. The decellularized nature prevents the body from having an inflammatory response to the device, keeping scar tissue and calcium from forming and potentially weakening a shock from the defibrillator.
“Current pouches are synthetic and contain antibiotics, but they do not create a natural healing environment around the defibrillator,” Catanzaro said.
The XXL SICD CanGaroo Bio Envelope became available around the time Collins decided to have her defibrillator implanted, and she agreed to include the envelope during her procedure.
“Someone has to be the first,” Collins said. “If we were all scared, there would be no progress. I also had a lot of confidence in Dr. Catanzaro, which was a big factor in my decision.”
Heart of the Home
The bio envelope and defibrillator were successfully implanted Jan. 8. After a six-week recovery, Collins returned to her life without restrictions. She thoroughly enjoys the time she spends with her 18- and 8-year-old sons. She has even gone back to running and completed a few 5Ks faster than she could before her procedure.
“I used to be scared to push myself and would stop doing housework if I felt slightly lightheaded,” Collins said. “Now I don’t have to worry. The reassurance I get from having the device is priceless.”
Catanzaro has since implanted the bio envelope in other patients and is following some of them to observe the long-term effects after implantation. The medical supplier is also looking into expanding its portfolio by finding other ways the envelope can be used.
“This is a perfect example of what happens when you apply an innovative concept to current technology,” Catanzaro said. “Applying regenerative medicine within the field of electrophysiology is an exciting and progressive move toward improving quality of life while continuing to save lives.”
Collins only has to see Catanzaro once a year. She is enrolled in remote monitoring and can transmit her heart rhythm if she has symptoms. The device is implanted under her left armpit, and Collins said most people don’t even know it is there.
“I am hoping that by the time my sons or grandchildren need one, it can be injected into their bodies,” Collins said. “My mother and uncle’s defibrillators were big and bulky. Mine is slightly bigger than a tangerine, but smaller than an orange. I know the technology will improve, and I am extremely proud that I am a part of that process.”