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What many don’t realize is, angioplasties are one of the most common medical procedures in the U.S., with over 1 million performed per year. Invented as an alternative to open-heart surgery in the 1970s, it’s a relatively safe procedure, but according to statistics, about 1 in 200 patients die after a non-emergency angioplasty.

When a doctor performs the procedure, a balloon-tipped catheter is inserted through an artery in the groin or arm to open up a vessel that has started narrowing, usually from coronary artery disease or atherosclerosis. While, 90 percent of the time, angioplasty successfully opens an artery clogged with cholesterol plaque, 40 percent of all patients experience recurring narrowing at the site, and thus, a stent may additionally be placed in the artery.

When used at the right time during a heart attack, angioplasty can be a lifesaver, opening the artery to prevent permanent damage to the heart muscle. Yet, complications requiring emergency care can result, and because of the high price tag – $16,000 per angioplasty – doctors may suggest it as a preventative procedure. Unfortunately, in this latter scenario, it’s estimated that as many as 40 percent of all angioplasties are medically unnecessary, exposing patients to complications that a hospital may not be prepared to handle.

Over Use

Three well-known cardiology groups – the American Heart Association, the American College of Cardiology, and the Society for Cardiovascular Angiography and Interventions – have recommendations for angioplasties that hospitals don’t always follow. Specifically, non-emergency angioplasty should only be performed with cardiac surgical support available on site, in case of complications, or the patient should be transferred to a hospital that can perform the angioplasty with adequate support. Yet, as multiple lawsuits have shown, angioplasties continue to be performed in hospitals without enough backup, and as a result, the patient experiences complications that could have otherwise been readily treated.

In response, the Journal of the American Heart Association released a study in 2011 concerning angioplasties’ over-recommendation. Researchers examined 500,000 percutaneous coronary intervention procedures and discovered that, in 15 percent of all cases, patients underwent inappropriate or questionable heart surgeries. As well, when patients had non-acute conditions, a greater number of recommended procedures were inappropriate or questionable.

What’s the alternative? Other studies have found that, when a patient isn’t showing signs of a heart attack, medication can be just as helpful in managing a non-acute condition.

What can happen when an angioplasty results in complications?

  • If medical professionals don’t respond soon enough during a heart attack, starting the angioplasty 60 to 90 minutes from the time the patients arrives, the patient’s heart may experience permanent damage.
  • The parts involved, particularly the balloon, have been known to injure the heart and puncture the arteries.
  • Over-inflating the balloon can have serious consequences, including permanent disability or death.
  • The procedure releases plaque into the arteries.
  • The patient may experience nephrogenic systemic fibrosis (NSF), if a gadolinium-based contrast agent is used during the procedure.

Off-Label Use

After at least one doctor started using angioplasty for transvascular autonomic modulation (TVAM), the FDA issued a warning in March 2017, stating that this off-label use isn’t safe.

What’s TVAM and how does it differ from a standard angioplasty? For this procedure, the doctor inserts a small catheter into the jugular vein after making a small incision, and uses the balloon to stretch the tissue. The result supposedly stimulates the surrounding nerves. Doctors have been recommending it for patients living with autonomic disorders, including Parkinson’s, multiple sclerosis, fibromyalgia, multiple system atrophy, and other nervous system disorders.

But, like standard angioplasty procedures, TVAM comes with serious risks. Balloons may rupture or migrate, which then may result in blood clots, cranial nerve damage, abdominal bleeding, ruptured blood vessels, a stroke, or death. Even if the patient doesn’t experience any of these side effects, a migrating balloon still needs to be surgically removed.

As of 2017, TVAM hasn’t been formally studied or approved by the FDA. However, Canadian researchers at British Columbia and Vancouver Coastal Health examined a pool of 104 patients living with MS who received TVAM. Data from this small group showed that patients who received TVAM and those who didn’t experienced similar outcomes.

At least one doctor continues to claim TVAM is a “miracle” treatment, even though, in 2012, the FDA first warned of the risks involved in a similar procedure. At the time, an experimental treatment for chronic cerebrospinal venous insufficiency (CCSVI) used angioplasty; yet, reports detailed its complications, including a stroke resulting in permanent paralysis and bleeding on the brain that turned fatal.

Lawsuits

As of 2017, claims involving angioplasties, both standard and off-label uses, have been on an individual basis, with plaintiffs filing suits against hospitals for delays or doctors for unnecessary procedures and complications. Although allegations vary, most fall under medical negligence or malpractice.