In vivo evaluation of the first dedicated combined flow-restoration and mechanical thrombectomy device in a swine model of acute vessel occlusion.

BACKGROUND AND PURPOSE

The use of self-expanding retrievable stents is an emerging and promising treatment strategy for acute stroke treatment. The concept combines the advantages of stent deployment with immediate flow-restoration and of mechanical thrombectomy with definitive thrombus removal. The present study was performed to gain more knowledge about the principle of combined flow restoration and thrombectomy in an established animal model using radiopaque thrombi evaluating efficiency, thrombus-device interaction and possible complications of the first dedicated flow-restoration and mechanical thrombectomy device.

MATERIALS AND METHODS

The Solitaire FR (4 × 20 mm) was evaluated in 15 vessel occlusions in an established animal model in swine. Flow-restoration effect at T0, T5, and T10; recanalization rate after retrieval; thromboembolic events; and complications were assessed. Radiopaque thrombi (10-mm length) were used for visualization of thrombus-device interaction during application and retrieval.

RESULTS

Immediate flow restoration was achieved in 80% of occlusions. Mean percentage of recanalization compared with the initial vessel diameter at T0 was 30.8%; at T5, 30.7%; and at T10, 25.4%. Re-occlusion occurred in 20.0% between T0 and T5 and in 13.3% between T5 and T10. Complete recanalization (TICI 3) after retrieval was achieved in 86.7%. In 2 cases (13.3%), partial recanalization was achieved, with the remaining thrombus in a side branch (TICI 2b). No thromboembolic event was observed. The assessment of thrombus-device interaction illustrated the compression of the thrombus against the vessel wall during deployment leading to partial flow restoration. During retrieval, the thrombus was retained by the stent struts even during the passage of vessel curvatures.

CONCLUSIONS

The Solitaire FR is a safe and effective combined flow-restoration and thrombectomy device in vivo. Partial flow restoration is achieved by thrombus compression immediately after deployment, but flow restoration decreases afterward until final retrieval results in maximal recanalization.