A Southern Arizona woman has become the first Total Artificial Heart patient in Tucson to leave the hospital while awaiting a heart transplant, thanks to a portable machine that powers her heart.
Marcela Padilla, 21, walked out of University Medical Center Jan. 20 with a backpack slung over her shoulder. Inside was the Freedom portable driver, powering the SynCardia temporary Total Artificial Heart implanted in her chest.
Padilla is the fifth person and the first woman in the nation to use the Freedom, which is undergoing a U.S. Food and Drug Administration-approved clinical study in the U.S. The driver is approved for commercial use in Europe.
Dr. M. Cristina Smith, director of Heart Transplant and Ventricular-Assist Device Services and assistant professor of surgery at the University of Arizona department of surgery, said the Freedom gives hope to those awaiting transplant.
"Up until now if you had biventricular failure – the failure of both sides of your heart – and your only option was the Total Artificial Heart, you knew you were stuck in the hospital until we could find you a matching donor heart,'' said Smith, who implanted Padilla's Total Artificial Heart last September.
During the wait for a donor heart, patients have been tethered to "Big Blue," a 418-pound machine that powers the Total Artificial Heart. Patients can wait months for a transplant, with an average wait of 144 days in 2009.
Smith hopes the Freedom driver will aid in saving more lives.
"What we're really hoping is down the road this can be an option for people who are walking that fine line between being a transplant candidate and not being a transplant candidate because their organs are starting to fail,'' she said. "There are people who get to us a little too late. People can be on this a couple of months to improve organ function.
"We might be able to bring those people back from the brink and make them transplant candidates where they were not,'' she added.
It is unknown how long Padilla will wait for a donor heart. But after extensive training in the use of the 13.5-pound Freedom for Padilla and her family, she was allowed to wait for her new heart at home.
"It was so exciting to go home and be with the baby,'' Padilla said.
Padilla gave birth to a baby boy, Santiago, on April 25, 2010. She and her husband, Jesus Valenzuela, were thrilled at becoming parents. But four days later, Padilla struggled to breathe. "I was short of breath. I couldn't sleep at night. I couldn't take care of Santiago. I was too weak and I was really swollen.''
Doctors hoped medication would help her weakened heart. But Padilla was dying.
Smith is unsure what caused the idiopathic cardiomyopathy. Pregnancy could have strained a heart that was already genetically weak. Padilla's twin sister needed a heart transplant at age 11. In September, there were no options but to remove the dying portion of her heart and implant the Total Artificial Heart.
"We held off as long as we could but it was clear she was going to have worsening organ failure to a point where we would never be able to transplant her,'' Smith said.
In December, Padilla got the "gift of Freedom." She was switched over to the portable driver, and on Jan. 20, she got the OK to return to a home in Tucson where she is staying until a heart is found.
"I feel really good now and I can do more,'' she said. "I can take care of my son.''
Smith said Padilla, like the other approximately 25 patients throughout the world who have used Freedom, is doing well. The first patient in the U.S. to go home with Freedom was discharged from the Mayo Clinic Arizona last May.
"It's a win on multiple levels,'' she said. "It gives the patient the opportunity to be home surrounded by loved ones. The hospital and the health system also win. You don't have someone stuck in a hospital bed. The cost savings to the health care system is going to be pretty significant.
"We're so excited to be able to have this opportunity and that we were able to give it to such a wonderful young mom and her wonderful family,'' Smith said. "It's just heartwarming.''
Richard G. Smith is technical director of the UMC Artificial Heart Program and co-founder and chief technical officer at SynCardia, the Tucson company that manufactures the Total Artificial Heart. It is the only FDA, Health Canada and CE approved Total Artificial Heart in the world. Since 1985, more than 900 Total Artificial Hearts have been implanted in the world, with 115 at UMC.
During the 10-year pivotal clinical study, 79 percent of patients receiving the Total Artificial Heart survived to transplant, the highest bridge-to-transplant rate for any approved heart device.
Smith has been involved in the transplant program at UA since the 1980s, and as a biomedical engineer, has spent the last 25 years working toward developing a compact driver that would allow patients to go home.
"Dozens of engineers from around the country came together to create this,'' he said of Freedom. Users plug the device into a standard outlet at home, and batteries also can be charged with a car charger.
He said it is part of a surgeon's tool box used to save people dying from heart failure. Also in use is the Left Ventricular Assist Device, which helps the left ventricle of a patient's heart pump more blood. For example, the LVAD is used by former Vice President Dick Cheney.
Dr. Robert Poston, new chief of cardiothoracic surgery at the UA, said, "Soon, robotic-assisted surgery will be used at UMC to implant these heart-assist devices minimally invasively."
"The Division of Cardiothoracic Surgery continues to be a leader in providing the most advanced, cutting-edge technology to patients in Southern Arizona," said Dr. Rainer Gruessner, chairman of the UA department of surgery.
For people like Padilla, with failure of both ventricles, the Total Artificial Heart is a lifesaver.
Work is taking place on the design of the next-generation driver, which is expected to weigh less and run more quietly. Patients such as Padilla are helping guide the design. With thousands of people waiting for heart transplants in the U.S., the Freedom can aid in bridging more people to transplant.
"This is going to be in thousands of people across the world in the next five years,'' Smith said of the Total Artificial Heart and Freedom combo. "Its use will expand very quickly.''