Stents are commonly used in the treatment of coronary artery disease to open clogged arteries and improve blood flow, but they can cause serious complications when not placed correctly. Dr. Elisabeth Mika is a cardiovascular surgeon at UPMC who has been using neurovascular stents to coily up stenoses without surgery for over 20 years.
When the neurovascular stent for stent-assisted coiling (SAC) was first introduced in the early 1990s, it was hailed as a medical breakthrough. While this is still a viable therapy for certain people, it should be used with great care when treating aneurysms, particularly those with a broad neck.
During or after a neurovascular stent for SAC treatment, certain patients may be at a greater risk of stroke or death, according to the Food and Drug Administration (FDA).
What is Neurovascular Stent-Assisted Coiling, and how does it work?
A stent holds the coil in place while it shuts off the weak blood artery.
Stent-assisted coiling (SAC) using neurovascular stents is a non-surgical, minimally invasive way of treating aneurysms in the brain. The Neuroform EZ from Stryker Neurovascular and the Solitaire AB from Covidien are two popular SAC devices.
An aneurysm is a weak area in the blood artery wall that causes it to swell outward like a bubble. Aneurysms may develop in any blood artery, but they are extremely hazardous in the brain because they can cause uncontrolled and frequently deadly brain hemorrhage if the weakened arterial breaks.
Stents for the arteries and veins are tubes composed of metal mesh or plastic. Stents serve as a framework or scaffolding to keep open organs and blood arteries open.
Doctors weave a microcatheter through the patient’s groin to the aneurysm in neurovascular stent treatments. A coil is then released and put into the weak and bulging blood artery to seal it off and prevent further blood from entering the aneurysm. The coil is held in place by the stent. This procedure is used to treat aneurysms of several forms, including intracranial, saccular, and wide-neck aneurysms.
For some individuals, stents with SAC constitute a critical course of treatment, while for others, the hazards may exceed the benefits.
Are SAC Neurovascular Stents Safe?
Because neurovascular stents for SAC were just launched in the late 1990s, their long-term safety is uncertain compared to other treatment options such as aneurysm cutting, which has been used for a longer time.
Studies on SAC safety have shown a risk of thromboembolic events (blood clots forming within blood arteries, commonly resulting in strokes) and hemorrhagic complications:
Who Shouldn’t Have a SAC Neurovascular Stent?
Some patients are chosen for SAC procedures through mistake or negligence.
Neurovascular stents for SAC may not be a safe therapeutic option for many patients, according to the FDA. As a consequence of being incorrectly or carelessly chosen for a SAC surgery, certain patients are at an elevated risk of stroke or death during or immediately after the treatment.
To ensure that a neurovascular stent for SAC works safely, patients must take anticoagulation and antiplatelet therapy at the same time. As a result, individuals who are intolerant to these medications are more likely to have thrombosis, stroke, or death if they get a neurovascular stent for SAC.
Another possibility is that the gadget fails and the brain aneurysm ruptures. Age (over 40 years old), a family history of aneurysms or subarachnoid hemorrhages (SAH), a previous SAH, gender (women are more likely to experience a SAH), ethnicity (African Americans are at an increased risk), tobacco use, and hypertension are all known to increase the risk of an aneurysm rupturing.
The FDA advises that SAC operations may not be recommended for patients with other major comorbidities or illnesses, as well as those with a shorter life expectancy, due to the hazards involved.
What are the FDA’s concerns about SAC?
The FDA sent an open letter to health-care practitioners in which they expressed their concerns about SAC devices. “These operations are not without dangers,” the FDA said, “and careful patient selection and correct device usage are necessary to ensure that the patient’s benefits balance the risk of therapy.”
The FDA underlines the need of choosing a stent that is the right length and diameter for the aneurysm and afflicted channel. The stent might become too short too soon, causing difficulties. Another factor to consider while utilizing the device is if the microcatheter is approved by the stent manufacturer.
Micro-guidewires and microcatheters may also get entangled or stuck in the stent, causing the stent to shift, harm the blood artery, or burst the aneurysm. Finally, the coils placed into the artery or stent construction may bulge or fall out. It’s critical that each patient’s coil and device parts have the correct size and dimension.
Do You Have a Case for a Neurovascular Stent?
Companies sometimes prioritize profit above quality or customer service, and this mindset may be extremely dangerous in such a delicate operation. You may be entitled for compensation if you or a loved one had a stroke or died as a result of a neurovasvular stent with SAC surgery.
ClassAction.com was established to offer patients a voice in the battle against large businesses that would otherwise go unpunished despite the pain and suffering they have inflicted. Please contact us to determine whether you are eligible to join the case.
Frequently Asked Questions
Is endovascular coiling safe?
What is a Neurovascular stent?
A: A neurovascular stent is a tube-shaped piece of medical device that widens an artery and provides additional support for the circulatory system.
Is aneurysm coiling safe?
A: The coiling of aneurysm is safe.