Wellmont One of Limited National Centers of Excellence with Immediate Access to Groundbreaking Dissolving Heart Stent
Health system performs pioneering work with this technology as the leading enroller in two clinical trials
July 5, 2016 – Patients of the Wellmont CVA Heart Institute will be among the first in the nation and the only in this region eligible to receive a new type of device used to clear blockages in heart arteries – one that eventually dissolves and leaves no trace it was ever used.
The heart institute is one of a select few Centers of Excellence nationally to be immediately able to use a new bioabsorbable medicated stent, developed by Abbott Vascular, in patients to restore blood flow in an affected heart artery. This groundbreaking technology will be available to
heart institute patients with the Food and Drug Administration’s approval of the device on Tuesday, July 5.
“This is a game-changer in the cardiology profession and for our patients because it will enable them to receive the lifesaving care they need without an unnecessary, permanent metal stent in their heart arteries,” said Chris Metzger, M.D., an interventional cardiologist with the heart institute.
“It’s the first completely bioabsorbable stent and has the opportunity to revolutionize the treatment of coronary artery disease. This is a major development in the treatment of heart disease, and our experienced team is excited to incorporate this new device into our vast array of care options.”
Essentially, the new stent restores the artery to a natural state before it fully absorbs into the vessel. Should a patient experience blockage in the same artery in the future, physicians can easily insert stents into that artery as if the first case never happened. That is preferable for
interventional cardiologists, who would otherwise potentially need to maneuver the second stent through the first one.
A metal stent stays in the body. Dr. Metzger said metal stents also carry with them the risk for later development of scar tissue or blood clots. With the bioabsorable stent now available, physicians might be able to eliminate the need for qualifying patients to take two blood-thinning
medications long term and rely solely instead on an aspirin regimen.
The bioabsorable stent will be appropriate in most cases where a patient experiences a blockage, but that decision will still need to be reviewed individually, Dr. Metzger said. He noted the cost of a bioabsorbable medicated stent for patients and insurers is about the same as a standard permanent medicated
stent for selected higher-volume facilities.
Wellmont has immediate access to this technology because of its pioneering leadership with the device. For the pivotal clinical trial called ABSORB III, which proved this device’s effectiveness and safety, the heart institute and Holston Valley Medical Center were the leading enrollers of
patients in the nation, with all of the hospital’s interventional cardiologists participating. The heart institute and Holston Valley are again the leading enrollers in the ongoing ABSORB IV follow-up trial, which is designed to prove the benefits of this dissolving stent after five years.
During these two landmark trials, the heart institute and Holston Valley have enrolled 141 patients, which enabled many patients in the region to be the first ones in the United States to receive the bioabsorbable stent. In addition, interventional cardiologists with the heart institute who
are based at Holston Valley have implanted more absorbable stents than any other site in the nation to date. The ABSORB III study results led to an FDA panel unanimously approving release of this device for patient care.
Additionally, Dr. Metzger, who serves as medical director of the heart institute’s research program, was one of the leading authors when the ABSORB III study conclusions were recently published in the prestigious New England Journal of Medicine.
Insertion of this device initially will occur at Holston Valley, and Bristol Regional Medical Center is listed as a priority location to receive the technology in the near future. Because of the extensive experience of all Holston Valley interventional cardiologists, Mark Aziz, M.D.; Mark
Chang, M.D.; Herb Ladley, M.D.; Marc Mayhew, M.D.; Pabitra Saha, M.D.; and Dan Simpson, M.D., along with Dr. Metzger, have immediate approval to implant the bioabsorbable stent.
“It’s quite an honor to be part of the biggest breakthrough in coronary stents in several years,” said Jerry Blackwell, M.D., the heart institute’s president. “To be selected as one of a limited number of Centers of Excellence for the initial rollout demonstrates the tremendous respect the
national medical community has for the Wellmont CVA Heart Institute. But it also shows our commitment to deliver world-class care for our patients using the latest innovative approaches that change their lives exponentially.”
The heart institute has performed as the No. 1 or No. 2 enroller in the United States and globally in at least 29 top research trials, including being the current leading enroller in four major trials. The practice continually participates in more than 30 active studies.
“We are proud to be at the forefront of new technology and leading-edge clinical research, which present huge quality-of-life benefits for our patients,” Dr. Metzger said. “This latest outcome from the ABSORB III trial is the result of an outstanding collaborative effort of world-class research and
cardiac cath lab teams, along with the dedicated efforts of the entire Wellmont CVA Heart Institute team. We are grateful to have the full support of Wellmont’s leadership, and to be embraced by the patients and medical community in our region.”
Dr. Metzger said he has been asked to discuss at two upcoming major interventional cardiology meetings the proper implantation of the new stents. Those meetings are Transcatheter Cardiovascular Therapeutics and The Society for Cardiovascular Angiography and Interventions. It is
important for Dr. Metzger to share details with his colleagues across the nation because there are several nuances to proper deployment of these unique devices.
In addition to clinical research, the heart institute has made its mark with a broad range of programs and procedures that have resulted in the practice, Holston Valley and Bristol Regional being repeatedly ranked among the best in the country. In fact, Holston Valley was named No. 1 in the
nation for 2016 for medical excellence in interventional carotid care by CareChex®, a division of Comparion® Medical Analytics, four years after receiving the same honor for carotid artery stenting.
Knowing this history with research and the national rankings, Bart Hove, Wellmont Health System’s president and CEO, said he was not surprised to see the heart institute was in the middle of one of the most important developments in heart care.
“Every day, I’m impressed with the way our physicians and other medical professionals continue looking for ways to enhance the care we deliver our patients,” Hove said. “We are setting a standard for others to follow, and everyone at the Wellmont CVA Heart Institute is casting a large shadow.
Each person plays an important role in our delivery of high-quality care that is exposing our patients to care that rivals and, in some cases, surpasses what is available at some of the most prestigious medical facilities in the nation.”
For more information, please visit www.wellmont.org/absorb.