The introduction of the neurovascular stent for stent-assisted coiling (SAC) was heralded as a medical breakthrough when it came out in the early 1990s. While it is still an appropriate treatment for some patients, extreme caution must be used when choosing this course of action to treat aneurysms, especially of the wide-necked variety.
The Food and Drug Administration (FDA) warns that some patients may be at increased risk of stroke or death during or after a neurovascular stent for SAC procedure.
What is Neurovascular Stent-Assisted Coiling?
A coil seals off the weak blood vessel and is held in place with a stent.
Neurovascular stents for stent-assisted coiling (SAC) offer a non-surgical, minimally invasive method to treat aneurysms in the brain. Popular SAC devices include the Neuroform EZ, made by Stryker Neurovascular, and Solitaire AB, made by Covidien.
An aneurysm is a weak spot in the blood vessel wall, which causes the vessel to bulge outward like a bubble. Though an aneurysm can occur in any blood vessel, this condition is especially dangerous in the brain because if the weakened vessel bursts, it can cause uncontrollable, and often fatal, brain bleeding.
Neurovascular stents are tubes made of metal mesh or plastic. These stents act as a kind of framework or scaffolding to hold open organs and blood vessels.
In procedures using neurovascular stents, doctors weave a microcatheter through the patient's groin to the aneurysm. Once there, a coil is released and inserted inside the weak and bulging blood vessel to seal it off and prevent more blood from entering the aneurysm. The stent holds the coil in place. This treatment is used for several types of aneurysms, including the intracranial, saccular, and wide-neck varieties.
Though stents with SAC are an important course of care for some patients, the risks may outweigh the benefits for others.
Are Neurovascular Stents With SAC Safe?
Neurovascular stents for SAC were introduced in the late 1990’s, so their long-term safety is still relatively unknown compared to other treatment methods like aneurysm clipping which has been performed for a longer period of time.
Studies that have been conducted on SAC safety report a risk of thromboembolic events (formation of blood clots inside blood vessels, often causing strokes) and hemorrhagic complications:
- "Stent-assisted coiling of intracranial aneurysms: clinical and angiographic results in 216 consecutive aneurysms": In a 2010 study examining more than 1,000 patients who underwent an SAC procedure between 2002 and 2009, immediate complete aneurysm occlusion (when the stent effectively closes the brain aneurysm to prevent blood from entering and causing the aneurysm to grow) occurred in less than half of the cases (46.3%). Permanent neurological complications happened in 7.4% of cases, and 4.6% of the procedures resulted in a patient fatality.
- “Stent-assisted coiling in acutely ruptured intracranial aneurysms: a qualitative, systematic review of the literature": A 2011 study of 212 patients who underwent a SAC procedure found that immediate complete aneurysm occlusion occurred in 63% of cases, serious intracranial hemorrhagic complications occurred in 8% of patients, and thromboembolic events occurred in 6% of patients. Nineteen percent of patients did not report a good clinical outcome. The authors warned that adverse effects appeared to be more common in stent-assisted coiling than other procedures to treat aneurysms, and overall the outcomes were worse.
- “Stent-supported aneurysm coiling: a literature survey of treatment and follow-up.”: A 2012 review of studies examining more than 1,500 patients in total found SAC procedures had an overall complication rate of 19%, mainly from thromboembolic events. The authors concluded that fatality rates are higher in SAC procedures compared with standard coiling procedures.
Who Shouldn't Receive a Neurovascular Stent for SAC?
Some patients are mistakenly or negligently selected to undergo an SAC procedure.
The FDA warns that neurovascular stents for SAC may not be a safe treatment method for every patient. Some patients are mistakenly or negligently selected to undergo an SAC procedure, and are at an increased risk of a stroke or death either during or directly after the operation as a result.
Patients who receive a neurovascular stent for SAC must undergo simultaneous anticoagulation and antiplatelet therapies in order for the device to work safely. Because of this, patients who are intolerant to these therapies are at a higher risk of thrombosis, stroke, and death if they receive a neurovascular stent for SAC.
Another risk is that the device may not work, and the brain aneurysm may still rupture. Factors known to increase the risk of an aneurysm rupturing include age (over 40 years old), a family history of aneurysms or subarachnoid hemorrhages (SAH), a previous SAH, gender (women are more likely to experience an SAH), ethnicity (African Americans are at an increased risk) , tobacco use, and hypertension.
Because of the risks associated with SAC procedures, the FDA warns that it may not be appropriate for patients with other serious comorbidities, or diseases, and/or those who have a reduced life expectancy.
What Concerns Does the FDA Have About SAC?
The FDA published an open letter to health care providers, in which they outlined several concerns regarding devices for SAC. The agency warned that “these procedures are not without risks, and careful patient selection and proper device use are critical to ensure that the benefits to the patient outweigh the risk of treatment.”
The FDA emphasizes that it is crucial to select a stent of the proper length and diameter according to the size of the aneurysm and affected vessel. The stent could prematurely shorten, leading to complications. Another consideration when using the device is that the microcatheter is compatible for use by the stent manufacturer.
It is also possible that micro-guidewires and microcatheters can become caught or entangled with the stent, causing the stent to move, injure the blood vessel, or rupture the aneurysm. Finally, the coils inserted into the vessel may bulge or fall out of the vessel or stent structure. It’s vital that all coil and device pieces are the right size and dimension for each individual patient.
Could You Qualify for a Neurovascular Stent Lawsuit?
Companies often put profit before quality or consumer care, and this mentality can be especially deadly in such a serious procedure. If you or a loved one suffered a stroke or death after undergoing a neurovasvular stent with SAC procedure, you may be eligible for a lawsuit.
ClassAction.com was created to help give patients a voice to fight giant corporations who would otherwise get away scot-free, regardless of the pain and suffering they have caused. Get in touch with us to see if you qualify to participate in the lawsuit.