After reports of periprocedural stroke and death with the use of neurovascular stents for stent-assisted coiling (SAC), the US FDA issued a safety alert with recommendations for safe use of these devices in the treatment of unruptured brain aneurysms.
Reports received of periprocedural stroke and death may have been related to procedural risks or poor patient selection, the FDA determined.
“Neurovascular stents for SAC provide important options for the treatment of wide-neck brain aneurysms, and their technology continues to evolve. However, 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. Many patients with unruptured brain aneurysms can be managed conservatively with routine monitoring and follow-up depending on their individual risk factors for aneurysm rupture,” wrote the FDA’s William Maisel in the letter to healthcare providers.
In smaller brain aneurysms or in patients with reduced life expectancy, the risks of endovascular coiling may outweigh their benefits, the agency noted. Operators should also be aware that neurovascular stents are only approved for certain brain aneurysms, and that they should avoid use of these devices in patients who cannot take systemic anticoagulant or antiplatelet drugs.