Genesis Among First in Nation to Use New Dissolving Heart Stent
Two days after federal regulators approved use of a revolutionary new dissolving coronary artery stent, Genesis became one of the first hospitals in the country to use it.
During a July 7 Cardiac Cath Lab procedure, 73-year-old Dennis Dean of Eldridge, Iowa, is believed to be the second person in the country to receive the Absorb stent following approval by the U.S. Food and Drug Administration (FDA). The Absorb stent is a new device designed to be absorbed into the bloodstream over time after it is implanted. It was approved for commercial use in the United States by the FDA on July 5.
The team that performed the procedure was led by Jon Robken, M.D., F.A.C.C., F.C.C.P., Cardiovascular Medicine, P.C. (CV Med), and Medical Director of the Genesis Structural Heart Program. It also included Kara Schanfish, Cardiovascular Specialist-RTR; Lynette Lennon, Cardiovascular Specialist-RTR/PACS Program Coordinator; and Sally Meister, RN. The patient, Dean, was discharged from the hospital the next day.
Because of its participation in Absorb clinical trials, Genesis is one of only a handful of interventional cardiology centers in the country to gain initial use of the Abbott Laboratories stent, the first-of-its-kind medical device. Stents are small, expandable mesh tubes used to open blocked arteries in people with Coronary Artery Disease. Coronary Artery Disease affects 15 million people in the United States and remains a leading cause of death worldwide, despite decades of therapeutic advances.
While stents are traditionally made of metal, Abbott's Absorb scaffold is made of polylactide, a naturally dissolving material similar to dissolving sutures. Absorb disappears completely in approximately three years, after it has done its job of keeping a clogged artery open and promoting healing of the treated artery segment. By contrast, metal stents are permanent implants that restrict vessel motion for the life of the person treated.
“The procedure went absolutely perfectly. The patient’s blockage was ideal for a bioresorbable scaffold,” said Dr. Robken. ”This is a very exciting advance in what we have to offer patients.
“We’ve learned through years of treating blockages in coronary arteries that it’s really important to have that vessel propped open and supported with a device for a good six months or so. During that time, a lot of the plaque, or blockage, gets reabsorbed and the artery grows new tissue. But beyond that six-month period, the stent is probably not necessary. The solution to that is to have a fully bioresorbable scaffold that starts to degenerate at six months, becomes softer, and after two-and-a-half to three years, is fully dissolved. The artery at that spot then can return to complete, normal function. It becomes smooth on the inside, is flexible again without residual plaque and can naturally dilate and narrow. That’s something we haven’t been able to offer patients in the past.”
The Absorb scaffold dissolves into water and carbon dioxide, basic natural substances already found in the body. No metal may also reduce the potential of future blockages that occur with permanent metallic stents, and allows easier access to other treatment options should they prove necessary in the patient's future.
“It’s exciting, it really is. I’m glad to get it done, I’m glad to have the doctor I’ve got and the nurses have just been terrific here,” said Dean. “Dr. Robken told me about it, how it was different from the rest, because I’ve got a few of the other ones (metal stents), that this one’s going to dissolve away. This is good, not just for me, but for anybody else who’s headed down this same road. This is a big thing.
“I love to ride motorcycle. I operate an excavator. I still work part time even though I’m retired. And I like to be able to do all those things. And the beauty of it is I should be able to after the procedure.”
Dr. Robken says Absorb isn’t appropriate for all blockages, but he envisions it being used initially in about 30 percent of the narrowings in new patients who haven’t had a previously documented blockage. He says that number could increase over time as refinements are made to the device and physicians gain experience with it.
“To have our hospital and our cardiologists chosen as one of the first sites to get the device in the United States really speaks to our program,” says Dr. Robken. “We have exceptionally good outcomes here, with low mortality, complication and readmission rates. Genesis and the cardiologists at CV Med are proud of the program, and this is one more reward for the work we’ve done in the past. We’re happy to have the scaffold and to be able to offer it to patients if they need it.”
In clinical studies conducted around the world, the Absorb bioresorbable stent demonstrated short- and mid-term outcomes comparable to the leading metallic stent—Abbott's Xience™ drug eluting stent.
Abbott's Absorb stent, sold commercially as the Absorb GT1 Bioresorbable Vascular Scaffold (BVS) system, is now available in more than 100 countries, including the United States, and has been used to treat more than 150,000 people with coronary artery disease worldwide.