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Balloon Angioplasty Linked to Fatal Neurological Events: Is It Really True?

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Percutaneous transluminal angioplasty (PTA), commonly known as balloon angioplasty, is a type of invasive procedure used for the treatment of peripheral arterial disease (PAD) or coronary artery disease (CAD). It is primarily used for the treatment of arteries that get narrowed because of the deposition of plaque on the inner walls.

Balloon angioplasty involves the insertion of a deflated balloon at the site of the narrowing with the help of a catheter. As soon as the balloon reaches the target site, it is inflated to open up the narrowed artery. This helps improve the flow of blood through the artery.

The catheter is mostly inserted through the femoral artery present in the groin region. A special dye is inserted through the catheter as well, which helps view the flow of blood through the artery and check for any narrowing. This insertion of dye through the artery in order to check for length and extent of narrowing is known as an angiogram.

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Balloon angioplasty is considered as a safe procedure widely across the world. In fact, in many countries, it has replaced surgical angioplasty as the first line of treatment for PAD.

But there are several risks associated with balloon angioplasty, especially with the off-label procedure. The balloon angioplasty complications were recently highlighted by the Food and Drug Administration in the United States.

What does FDA say?

According to the FDA, balloon angioplasty conducted for the treatment of autonomic dysfunction may lead to some serious complications. During such a off-label balloon angioplasty procedure called trans venous autonomic modulation (TVAM), the catheter is inserted into the venous system of the patient, and not the arterial system. This procedure is considered totally experimental.

The balloon is inflated in a similar manner to widen the walls of the veins. It has been long claimed that widening the veins’ walls using balloon angioplasty procedure can help relieve the symptoms of autonomic dysfunction associated with different types of neurological disorders.

However, the FDA has a different take altogether on the same matter. According to the federal body, the patient is exposed to a number of risks during this procedure and there is a definite likelihood of several serious complications occurring right after the procedure.

Patients undergoing off-label balloon angioplasty are at an increased risk of death, abdominal bleeding and other neurological complications such as cranial nerve damage and appearance of blood clot in the brain, leading to stroke.

Why does FDA believes so?

The FDA simply believes that the TVAM procedure for MS (multiple sclerosis), Parkinson’s disease and fibromyalgia among other neurological disorders is an unsafe procedure. The federal watchdog based its report on several factors, includes the following:

  • The balloon angioplasty device was approved by the FDA for its use only for the arterial system. It has never been approved as a safe and effective device for the treatment of any medical condition through the venous system.
  • Internal jugular venous stenosis treatment through balloon angioplasty is not considered safe in any category of patients.
  • TVAM procedure is not known to change the symptoms of autonomic dysfunction or improve the quality of life of the patients.

The FDA released its first safety communication back in May 2012. Since then, at least one case of balloon angioplasty complication has been recorded. The original placement in this case was done in the patient’s jugular vein, but the balloon ruptured and travelled all the way to the lung of the patient. This further required a surgery to remove the ruptured and migrated balloon from the lung.

What should you do?

Patients suffering from autonomic dysfunction because of one or the other neurological disorder and advised to undergo TVAM procedure are recommended to do the following:

  • Discuss the alternative options for autonomic dysfunction treatment and weigh the risks and benefits associated with each one of them.
  • Get complete knowledge about TVAM procedure cost, risks and complications.
  • Be aware of the fact that TVAM is not approved for venous intervention by the FDA and that it is an experimental procedure with no sure shot benefits.
  • Be aware of the fact that complications such as excessive bleeding, bruising, discomfort and pain may persist after TVAM procedure. In rare cases, stroke may also occur and prove fatal.

On the other hand, it is the responsibility of the healthcare provider to discuss all pros and cons associated with the treatment for autonomic dysfunction, especially TVAM, with the patient. In addition, they should inform the patients that TVAM is experimental and that no data is present to support it success in patients with autonomic dysfunction.

Best Candidates for Balloon Angioplasty

Patients who suffer from CAD are the best candidates for balloon angioplasty or stent placement procedure. CAD results because of atherosclerosis, which, in turn, results because of the deposition of plaques inside the artery that supply blood to the heart muscles.

The plaque buildup in the arteries cause it to narrow down, thus reducing the flow of blood to the heart. The slowing down of blood flow and further worsening of the condition may result in angina or chest pain. In serious cases, heart attack may end up taking the life of the patient suffering from CAD.

CAD is rarely treated with the help of medications as only its symptoms can be controlled. Blood thinning medications are given to some patients to make sure that the blood pressure is under control, as hypertension can end up worsening the condition of the patient.

Balloon angioplasty or stent placement is, thus, advised to patients with CAD inorder to lower their risk of heart attack and other fatal cardiovascular events.

Thus, balloon angioplasty is safe and effective for the treatment of arterial narrowing. But the same procedure used for the treatment of patients with autonomic dysfunction is still experimental and should not be considered safe for any category of patients as it may lead to serious neurological complications.

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