In October 2015, high school track star and marathon runner Michael Spinelli was a healthy, busy Catholic University junior focused on his studies. On Halloween, the then-20-year-old awoke from a sound sleep with piercing pain in his chest, a tight jaw and pain down his arm. Minutes later an ambulance was transporting him to a nearby hospital. He was released hours later armed with pain medication and anti-inflammatories. His chest discomfort was attributed to bronchitis. Days later and in pain again, Michael returned to the hospital. A CT scan was performed, and an alarmed ED physician had him transported immediately to MedStar Washington Hospital Center.
There, Ezequiel Molina, MD, the cardiac surgeon on call, took one look at the CT images and realized Michael had a dangerous and deadly aortic dissection that had ruptured. “If he hadn’t arrived when he did, his condition would surely have been fatal,” says Dr. Molina. “With every hour past the onset of chest pain, the risk of death increases by 1 percent. In cases like Michael’s, 80 percent of patients die without emergency surgery.”
Michael had the more common and very dangerous Type A aortic dissection. Blood had surged through a tear in the ascending aorta and aortic root, causing the two layers of the vessel to separate—the result of pressure on a long-undiagnosed aortic aneurysm. “When we opened his chest and the pericardium, we could see blood from the leaking dissected aorta had started to accumulate around his heart.
A deadly full aortic rupture was imminent,” Dr. Molina adds. Michael’s body temperature was cooled to 28 degrees Celsius to protect the brain, heart and visceral organs, and the heart-lung machine was stopped. “We replaced the portion of aorta closest to the aortic arch with a permanent fabric graft,” Dr. Molina explains. “This was performed in just 14 minutes to reduce risk of stroke.”
The medical team restarted the heart-lung machine support, and Michael rewarmed, while his aortic root was replaced with a mechanical valve attached to a fabric graft, his coronary arteries were re-implanted and the two grafts connected together. “In essence, Michael has a new aorta that hopefully will last forever,” Dr. Molina says. Michael was out the hospital in just five days. “And while he will have to be monitored routinely and take a blood thinner daily, he should lead a full life,” Dr. Molina says.
MedStar Heart & Vascular Institute Offers Fully Dissolving Heart Stent
Following participation in ABSORB III and ABSORB IV clinical trials, MedStar Union Memorial Hospital in Baltimore and MedStar Washington Hospital Center were among the first to offer Absorb scaffolds as an alternative to metal stents after the devices were granted FDA approval on July 5. These bioresorbable devices, made from poly (L-lactic acid), or PLLA, were the first of their kind to receive FDA approval.
“The Absorb scaffold is a major advancement in treating coronary artery disease that has the potential to affect quality of life and address patients’ desire to leave no metallic stent behind,” says Ron Waksman, MD, director of Cardiovascular Research at MedStar Heart & Vascular Institute. Unlike metal stents, this bioresorbable scaffold will be completely hydrolyzed and absorbed within three years, so the vessel can restore its functionality and vasoreactivity properties and eliminate late complications from metallic stents.
The ABSORB III study confirms the efficacy and safety profile of this scaffold are similar to the best-in-class metallic drug-eluting stent. “Many patients don’t realize six-to-nine months after a stent has been placed in a blood vessel, it is no longer needed to prop open the vessel,” says John Wang, MD, chief of the Cardiac Catheterization Laboratory at Union Memorial and scientific director for Baltimore Cardiovascular Research. “The body has remodeled the vessel, and the stent is no longer needed. This is the first FDA-approved stent that gets absorbed by the body and disappears over two-to-three years. Now, even if we stent very distal in the blood vessel, it leaves open the possibility of performing bypass surgery as an option in the future.” Once the stent is absorbed, the blood vessel regains its normal biologic function and can once again constrict and relax.
As a first generation device, the new treatment is not an option for everyone. There is limited size matrix, and it is not appropriate for use in very small blood vessels. The new stents are also bulkier than metallic ones, making delivery somewhat more complicated. As with metal stents, a small number of patients will form clots. Patients receiving absorbable stents must adhere to a regimen of Plavix and aspirin for a minimum of one year, as opposed to the six months for those receiving the metal stents. With about one million stent procedures performed each year, Dr. Wang anticipates if we fast forward 10 years, the vast majority of stents used to treat coronary artery disease will be absorbable.