Team effort key to first post-FDA approval TAVI case in Chicago
At age 73, Geraldine Roman of Munster, Ind., launched what she calls her "third life" thanks to a new heart valve and a 17-member team of nurses, cardiac care technicians, cardiologists, heart surgeons and anesthesiologists.
Her journey illustrates how an innovative, non-surgical procedure -- in her case, a transcatheter aortic-valve implantation (TAVI), approved by the U.S. Food and Drug Administration in November -- can give someone a chance at a new life at any age.
This is not an experimental procedure. Although only recently approved in the U.S., more than 45,000 TAVI cases have been performed worldwide. Roman was the first patient in Chicago to undergo this procedure outside of a clinical-trial setting.
"This treatment offers an opportunity for several years of quality life to patients for whom no options previously existed," said TAVI team member Sandeep Nathan, MD, assistant professor of medicine.
"Life One" took Roman through school, early adulthood and her first marriage. She began her second life four decades ago when she remarried at 33, forming a new family with her daughter and her new husband’s four children.
Then late last fall, she believed the second chapter of her life was coming to a close when she broke her hip. At this point, Roman had accumulated what she called "a huge bundle of co-morbidities." She suffered from diabetes, asthma, and severe autoimmune disease including rheumatoid arthritis, as well as obesity and chronic back pain.
"I was already using a walker," she said. "The hip fracture put me in a wheelchair."
At a Munster rehabilitation facility, recovering from her hip injury, she began to feel short of breath whenever she tried to exercise. Roman said she was so disturbed by this new development that she decided to insert a do-not-resuscitate (DNR) order -- no CPR or other extraordinary life-saving measure to resuscitate breathing or a stopped heart -- into her already massive medical record.
Then on a cold winter day, she couldn’t catch her breath and soon felt pressure in her chest. One by one she recognized all the classic heart-attack symptoms. She called a nurse, who summoned a respiratory therapist who brought a physical therapist. Because of the DNR order, no one called 911. "This is the end," Roman said she remembered thinking. "Let it be."
Faced with mounting discomfort, however, she reconsidered and let them call an ambulance. Doctors at her local hospital added congestive heart failure to Roman’s long list of ailments. An angiogram revealed a 95 percent blockage to her left anterior descending coronary artery -- a vessel known as the "widow maker."
Plans to open the blockage with angioplasty and a stent were delayed when her doctors discovered calcium deposits coating her aortic valve. The mineral build-up restricted the motion of the valve’s leaflets, narrowing the outlet and preventing the heart from pumping blood through it.
Given her many medical problems, Roman was not eligible for valve surgery. Out of options, her doctors referred her to cardiologist Jafar Al-Sadir, MD, professor of medicine at the University of Chicago Medicine.
Al-Sadir recommended TAVI, a non-surgical approach to valve replacement. In this procedure, an artificial heart valve made of cow tissue and polyester supported by a stainless steel mesh frame is placed inside the damaged valve.
Roman was the "perfect first patient," according to interventional cardiologist Atman Shah, MD, assistant professor of medicine at the University of Chicago Medicine, a key member of Roman’s treatment team. "She understood all the issues, she had a great attitude, she needed to get this done quickly and she really had no other choice."
An engineering marvel manufactured by Edwards Lifesciences, the Sapien Transcatheter Heart Valve folds up into a fraction of its functional size. The collapsed valve is compressed for delivery and inserted into the tip of a thin catheter, about as wide as a pencil. This is inserted into an artery in the leg, threaded up through the aorta and down into the heart.
At the site of the stenosis, the inserted valve is released from the delivery catheter and expanded with a balloon. This pushes open the damaged valve and lodges the mechanical one within it, where it immediately starts to function. In Roman's case, the blood pumping through her body will allow her to walk again and should prevent her from needing supplementary oxygen.
In October 2010, the New England Journal of Medicine reported that patients with severe, symptomatic aortic stenosis who were not candidates for surgery were almost 40 percent more likely to be alive one year after having TAVI, with improved quality of life, than those treated with medicine only. A follow-up study found that TAVI was just as effective in patients considered eligible but high-risk for surgery as standard valve-replacement surgery.
Roman’s treatment is not the only TAVI "first" for the University of Chicago Medicine valve team. In December 2005, the team was able to get compassionate-use permission to treat an unusual case, a 16-year-old boy who needed a new valve but could not withstand surgery. The team replaced the pulmonary (vs. the aortic) valve, via catheter, the first such case in the United States. The patient went home the next day.
In Roman’s case, it will take a few days to get out of the hospital, but her treatment team has high hopes for a good recovery. "This was an inspiring team effort," Roberto Lang, MD, professor of medicine and director of the non-invasive cardiac imaging lab, said. "So many people came together to get this program up and running."
Roman is grateful for the collaboration. "I felt better the moment I woke up," she reported soon after getting her new valve. "My heart’s OK. Now, what can we do about this back pain?"