LOS ANGELES, Calif. (Ivanhoe Newswire) — Cardiologists’ excitement over an absorbable, dissolvable stent that hit the market last year is fading a bit. An FDA study shows that patients with it have higher rates of heart attack and thrombosis. A doctor in Los Angeles is standing by the new technology when it’s used by the right practitioners in the right patients.
Sixty-three-year-old Charles Tasso was at his dialysis center when his heart went into Afib.
Tasso explained, “I mean, I thought it was an elephant sitting on my chest. That’s the first time I had experienced any pain.”
Michael Chan, MD, an Interventional Cardiologist at St. Joseph Hospital in Orange, CA used the Absorb stent for Charles, who already has traditional metal stents. It’s made of polylactide, which is similar to what’s in dissolvable stitches. The stent dissolves in three years, so the artery is flexible again.
Dr. Chan stated, “It allows us to theoretically have less inflammation. Because of that, it also reduces the risk of clot formation that can form late on stents because of that metal exposure.” (Read Full Interview)
But an FDA review showed an 11 percent rate of cardiac problems like heart attack and a 1.9 percent rate of blood clots after two years with the Absorb stent. This compares with 7.9 percent and 0.8 percent with a metal stent. Abbott labs and Dr. Chan say the right implantation technique and the right patients minimize risk.
“I think that if it’s not used in the proper setting, then the risks are higher. We’ve seen that in smaller vessels that the heart attack risk as you mentioned, and risks of clotting are higher,” said Dr. Chan.
Nineteen percent of people in the study had arteries that are too small for the device under usage guidelines. Removing their results equalizes findings.
Dr. Chan continued, “As technology evolves, there are many in our field that feel like this will be the next generation.”
Dr. Chan will keep using the Absorb stent on patients who fit the stricter criteria, while the FDA does more study.
In May, Abbott laboratories restricted use of the Absorb stent to clinical use at select sites while it monitors implantation techniques and training. Some cardiac US facilities have stopped using the stent until more study is done. Dr. Chan has no financial interest in the stent or Abbott labs. As of September 14th, 2017, Abbott has stopped selling its first-generation Absorb Bioresorbable Vascular Scaffold.
Contributors to this news report include: Wendy Chioji, Field Producer; Rusty Reed, Videographer; Cyndy McGrath, Supervising Producer; Gabriella Battistiol, Assistant Producer; Roque Correa, Editor.
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TOPIC: ABSORBABLE STENT
REPORT: MB #4322
BACKGROUND: Clogged arteries occur when plaque accumulates in the arteries, preventing blood from being carried to the heart. It forms on the inner wall of the cavities and is a culmination of various substances that circulate in the blood such as calcium, fat, cholesterol, cellular waste, and fibrin. The body responds to the plaque buildup by multiplying the cells in the artery wall and secreting additional substances that can worsen the problem. As plaque deposits increase, a condition called atherosclerosis occurs which causes the arteries to narrow and harden. Clogged arteries in different parts of the body can lead to medical problems such as heart disease, carotid artery disease, and peripheral artery disease.There are several ways to test for clogged arteries: cholesterol screening, chest X-ray, CT scan, ultrasound, echocardiogram and cardiac stress test, angiogram, and MRI or PET scanning.
SYMPTOMS/TREATMENT: Symptoms of heart disease are chest pains and shortness of breath. Arterial plaque occurs as a result of easily correctable problems such as unhealthy diet, lack of exercise, being overweight, and smoking. However, there are instances where an individual might require surgery to prevent plaque accumulation. These procedures may include a stent replacement, bypass surgery, and balloon angioplasty. A stent replacement is when a small tube is placed in the artery to maintain the blood flow. Bypass surgery is when arteries from other parts of the body are moved to help oxygen-rich blood flow. Balloon angioplasty is when a device is used to push the plaque against the side walls of the arteries. Moreover, medications can help control some of the factors that lead to clogged arteries such as drugs specifically designed to lower cholesterol and high blood pressure.
NEW TECHNOLOGY: In 2016, an absorbable stent made from polymer scaffold was introduced, and it could be absorbed into the blood vessel wall. Cardiologists hoped that it would be as efficient as a metal scent, but safer. However, a new study revealed that patients who received the Absorb stent had significantly more cardiac complications than patients with the metal stent. Approximately 11 percent had heart attacks, a need for repeat procedures, or heart-related death. In comparison, only eight percent of the patients that received the conventional stent suffered the same problems. The latest technology in scaffold technology is the DESolve Scaffold System, a biodegradable stent that degrades in about one year, leaving behind a thin neointimal lining and a well-maintained lumen.
(Sources: Michael Chan, MD
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