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Is LVIS Blue Stent Safe as an Adjunct to Coil Embolization of Intracranial Aneurysms?

Key findings

  • In 16 cases, the combination of the LVIS Blue stent and coil embolization was safe for treatment of intracranial aneurysms
  • The LVIS Blue was useful within both the proximal and distal anterior and posterior circulation
  • Ten of the 16 aneurysms were initially rated mRCC 3, but there was a high rate of transition to a satisfactory embolization result
  • The morbidity associated with these procedures was minimal

The LVIS Blue stent is approved by the Food and Drug Administration for treatment of unruptured, wide-neck, intracranial, saccular aneurysms in combination with coil embolization. However, the approval came under a humanitarian device exemption, and the stent’s effectiveness in this setting has not been demonstrated.

Noting that the porosity of the LVIS Blue is like that of available flow-diverting stents, a team of neurosurgeons reviewed patients who received the stent as a coil adjunct. They found that LVIS Blue is safe when combined with coil embolization for treatment of intracranial aneurysms within both the proximal and distal anterior and posterior circulation.

The study, published in the Journal of Interventional Neurosurgery, was conducted by a team of researchers at Mass General, including Matthew J. Koch, MD, Thabele M. Leslie-Mazwi, MDJames D. Rabinov, MD, and Aman B. Patel, MD.

The researchers reviewed a prospectively maintained database and identified 31 patients who had intracranial aneurysms treated with the LVIS Blue stent. Of those, 16 also had stent coil embolizations.

The aneurysms were treated throughout the intracranial circulation:

  • 5 proximal ophthalmic or communicating
  • 2 superior cerebellar artery
  • 2 internal cerebral artery terminus
  • 2 anterior communicating artery
  • 2 distal middle cerebral
  • 1 posterior inferior cerebellar artery
  • 2 basilar tip aneurysms

Six lesions were bifurcation-type (38%), with necks traversing more than one vessel of nearly equal caliber. The other 10 (62%) were sidewall-type.

Aneurysm closure was evaluated using the modified Raymond–Roy Classification (mRRC). Post-procedure, one case was graded as mRRC 1 (complete closure), five as mRRC 2 (persistent opacification of the aneurysm neck), and the remaining 10 as mRRC 3a or 3b (filling of the aneurysm dome).

There was a high rate of transition from mRCC 3 to a satisfactory embolization result: at six-month follow-up, all but two cases (88%) were mRRC 1 or 2. One of these cases was an internal cerebral artery terminus lesion with persistent retrograde aneurysm filling through the associated anterior cerebral artery. The other was a posterior communicating artery aneurysm.

All but one patient with bifurcation-type lesions had mRRC 1 or 2 at six-month follow-up. No significant difference in closure was noted between bifurcation-type and sidewall-type lesions. Parent vessel and covered daughter vessel patency was observed in all cases, with no evidence of decrement in flow in the covered vessel. The median coil packing density was low (16%), but density did not significantly affect the embolization result. These findings suggest that the LVIS Blue may have clinically relevant flow diversion properties.

The Mass General team concludes that because of the “overwhelmingly satisfactory” embolization results and minimal morbidity, the LVIS Blue merits further study as a coil adjunct and potentially also as a stand-alone flow-diverting stent.

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