Coronary Stent Overuse Leading to More Deaths: Report

The overuse of coronary stents is costing lives, according to a new investigative report that indicates many heart stent operations are unnecessary.  

Stent implant operations that are not needed contribute to patient deaths and a number of other serious health problems, according to a recent report by Bloomberg News that looked at thousands of pages of court records and several studies conducted in recent years.

In 2012 alone, the FDA reports that at least 773 people died in cases linked to cardiac stents, representing a 71% increase since 2008. The agency’s adverse event reporting system also logged 4,135 non-fatal stent injuries in the same year, a 33% increase over 2008. These numbers are even more troubling when considering that it is widely acknowledged that adverse events reported to the FDA only represent about 1% to 10% of all problems associated with medical devices or prescription medications.

Investigators say that when stents are used as they are intended, in acute cases, such as restoring blood flow after a heart attack, they are beneficial. However, there are more than 700,000 coronary heart stent operations every year, and those cases account for only half of that number. The rest are elective surgeries, and one researcher estimates that two-thirds of those, or more than 200,000 operations every year, are unnecessary.

Stent Profits May Lead to Abuses

Concerns have emerged in recent years over the increase in use of coronary stents, with many reports suggesting that doctors and medical providers may be putting their own financial interests before the interests of patients when recommending heart stent placement.

According to a 2011 study published in the Journal of the American Heart Association (JAMA), it was estimated that 15% of all stent operations were likely unnecessary.

The coronary stent business rakes in big bucks. Over the last 10 years, the 7 million coronary stent operations in the U.S. have cost about $110 billion.

Some say that the lucrative money linked to coronary stents have also led to illegal activity. A number of hospitals and doctors have been investigated and in some cases fired or even jailed for implanting unnecessary stents in unsuspecting patients who were lied to and told their lives were at risk.

In late 2009 and early 2010, Maryland’s St. Joseph Medical Center sent letters to more than 600 former patients of Dr. Mark Midei, informing them that a review of their medical records demonstrated that they may have received a stent that was unnecessary.

Midei was stripped of his license to practice medicine in Maryland, fired from the hospital and has faced hundreds of lawsuits over unnecessary stents.

Stent procedures, which are designed to prop open arteries that are significantly blocked, can cost $10,000 or more. Typically, most experts agree that a patient should have at least a 70% artery blockage for a stent implant to be necessary, and many patients have reported being told that they had blockages over that amount, but a subsequent review of records from the procedure found blockages that were well under 50%, which is generally considered “insignificant.”

The investigation into Midei’s activities revealed that Abbott Laboratories, the makers of the coronary stents he was using, lavished him with gifts, including holding a pig roast at his house. When the controversy over his procedures broke, the company spirited him away to Japan in the hopes that he could keep on promoting their coronary heart stents while the investigation continued.

Another Maryland doctor, John R. McLean, was ultimately sentenced to eight years in prison for unnecessary coronary stent procedures in a case where the judge said greed clearly played a factor. Another Louisiana doctor got 10 years in 2009 in a similar case. During his trial his attorneys argued that his crimes were actually the industry standard.