The issue of cardiac stenting has highlighted potential overuse of the devices that may lead to cardiac complications.
Cardiac stenting involves propping open a narrowed coronary artery with a small, metal mesh tube. During emergency surgery, for instance, when a patient is suffering a heart attack, a stent can save a life. Studies have long revealed, however, that stents are being implanted in patients who do not realize any significant benefit from stent implantation.
In one case highlighted by Bloomberg.com, a man implanted with 21 stents over eight months suffered a ripped blood vessel and involved the surgeon placing five tubes in one artery in one procedure, according to a Texas Medical Board staff complaint. The unnecessary stents weakened the man’s heart and led to clots, blockages “and ultimately his death,” the complaint alleged. According to Bloomberg.com, stents have been used on about 7 million Americans over the past decade.
Most experts agree that stents used to restore blood flow in heart attack patients are necessary and beneficial; however, these types of cases, and other acute cases, only account for about half of the procedures conducted yearly in the U.S. according to Bloomberg.com. About 700,000 stent procedures are conducted nationwide each year.
The other procedures, considered elective surgery, are conducted on patients in stable condition who are, many believe, being over-treated. When overused, stent use has been associated with death, injury, and fraud as well as mounting lawsuits, Bloomberg.com reported, citing what it described as “thousands of pages of court documents and regulatory filings, interviews with 37 cardiologists and 33 heart patients or their survivors, and more than a dozen medical studies.”
“Stenting belongs to one of the bleakest chapters in the history of Western medicine,” Nortin Hadler, a professor of medicine at the University of North Carolina at Chapel Hill, told Bloombeg.com. Cardiologists “are marching on” because “the interventional cardiology industry has a cash flow comparable to the GDP of many countries” and is not eager to lose that flow, he added.
According to a review by Bloomberg News of U.S. Food and Drug Administration records, at least 773 deaths were tied to cardiac stents in 2012, which was 71 percent higher than what was indicated in the FDA’s public files for 2008. There were also 4,135 non-fatal stent injuries reported to the FDA in 2012 that included perforated arteries, blood clots, and other incidents, and this figure was 33 percent higher than in 2008.
More than 1,500 patients have received letters from hospitals since 2010 advising them that their stents may not have been necessary. Also, according to Bloomberg.com, at least 11 hospitals have settled federal claims over allegations of unnecessary stenting and other issues in the catheterization labs where the procedures are conducted.
Although there are known benefits to opening newly blocked arteries during heart attack, studies continue to find little benefit for performing angioplasty with or without stents when not in an emergency situation