Unnecessary and Defective Catheter?

Santa Clara, CAThe number of catheters reported to be defective over the last few years is mind-boggling. Over the past year alone several medical device manufacturers have recalled a combined four million catheters. Why so many? A study published yesterday may give one explanation.

In a study published in the Lancet (Nov 2, 2017) researchers suggest that a common procedure used to relieve chest pain in thousands of heart patients is unnecessary for many of them. The study focused on stents—tiny wire cages in tiny mesh tubes—to open blocked arteries and restore blood flow.

Stent and Catheter
To open a narrowed artery, a doctor may do a procedure called a percutaneous coronary intervention (PCI) or angioplasty. In it, a balloon-tipped catheter, or tube, is inserted into an artery and moved to the point of blockage. Then the balloon is inflated. The typical treatment for angina, or chest pain, is to thread a narrow catheter up from a blood vessel in the groin to the heart, squirt in a dye that allows a cardiologist to see blockages in arteries on X-rays, and then insert a stent in the blocked area, according to the New York Times(June 2015).

The Lancet study involved 200 patients with chest pain and coronary artery blockage. After they were treated with various medications for six weeks, they underwent angioplasty but only half of the patients were implanted with a stent. Six weeks later, both groups experienced less chest pain, and both groups also had improvement on treadmill tests, which left the researchers “stunned”.

If that doesn’t give pause to doubt the usefulness of stents and, in turn, catheters, the New York Times in 2015 reported there is no convincing evidence that stents reduce heart attack risk for people suffering from stable angina. And back in 2012 a nurse said that a doctor was performing heart procedures at a Florida Hospital’s catheter lab on patients who did not need them. The NYT reported about half, or 1,200 of the cardiac catheterizations performed at Lawnwood (the Florida hospital) were determined to have been done on patients without significant heart disease.

This recent Lancet study may be bad news for stent and catheter manufacturers, not to mention how many patients are questioning the procedure.

While the study doesn’t name brands, the most popular stent brands are Promus by Boston Scientific, Xience by Abbott Vascular, and Medtronic, according to Dicardiology.com. And these three companies are also the top catheter makers. Medtronic stock dropped nearly three percent yesterday when the study was made public, while Boston Scientific dropped 1.5 percent.

Medicare payments vary depending on what kind of stent is used and how many, but are anywhere from $10,000 to $17,000. Researchers say that over 500,000 heart patients worldwide opt for insertion of stents to relieve chest pain. Cha-ching.