Feasibility of the Protrieve Sheath for Embolic Protection During Venous Thrombectomy in Twenty-two Patients.

Background: The Protrieve Sheath (Inari Medical; Irvine, CA) is a thromboembolic protection device for venous thrombectomy. An extended feasibility study was conducted for device use in deep vein thrombectomy and inferior vena cava (IVC) filter removal.

Methods: Twenty-two patients, including 12 (55.5%) females and 10 (45.5%) males (mean age 55.8 ± 13.9 years, range 28-81 years), underwent deep venous thrombectomy using the Protrieve Sheath for embolic protection between November 2022 and July 2024 (21 months). The Food and Drug Administration-approved modified sheath contains an extendable nitinol mesh for large vessel thrombectomy outside the heart including the extremities, ileocaval, IVC, and superior vena cava. The following demographic information was recorded: presenting symptoms, procedural indications, obstructed venous segments, Protrieve Sheath access and deployment sites, thrombectomy devices utilized (ClotTriever, Inthrill, Lightning Flash 16, RevCore), need for stent reconstruction, technical success, clinical success, procedural complications related to device access and deployment, clinically significant embolic events, procedure-related injury, hematoma, mortality, death, and removed thrombi histological analyses. Technical success was defined as successfully deploying the Protrieve Sheath funnel proximal to the thrombectomy site. Clinical success was defined as improvement in presenting venous occlusive symptoms without procedure-related venous thromboembolism. All patients were followed with bilateral lower extremity duplex ultrasounds and computed tomography venogram abdomen and pelvis at 1 month, 3 months, 6 months, and 12 months. Patients were seen in clinic at 1 month, 3 months, 6 months, and 12 months.

Results: The most common presenting symptom was extremity swelling (n = 19; 86.4%). Nine (40.9%) patients had malignant, and 13 (59.1%) had benign etiologies of venous obstruction. Of the 9 patients with malignancy, 5 were determined to be tumor thrombus on histological analysis (n = 5, 55.5%). Obstructed venous segments included the IVC and lower extremity (n = 13; 59.1%), isolated lower extremity (n = 4; 18.2%), isolated IVC (n = 3; 13.6%), thoracic central veins and superior vena cava (n = 1; 4.5%), and isolated thoracic central vein (n = 1; 4.5%). The Protrieve Sheath access sites included the right internal jugular vein (n = 20; 90.9%) for IVC and lower extremity obstructions and the right common femoral vein (n = 2; 9.1%) for thoracic central vein and superior vena cava obstructions. The Protrieve Sheath funnel deployment locations included intrahepatic IVC in 18 patients (n = 13; 81.8%), suprarenal IVC in 2 (n = 2; 9.1%), and superior cavoatrial junction in 2 (n = 2; 9.1%). Ten (45.5%) patients required stent reconstruction following thrombectomy. Technical success was achieved in all patients. Clinical success was achieved in 21 (95.5%) patients. No immediate device-related adverse events including mesh maldeployment of the Protrieve Sheath, hemorrhage, or clinically significant embolic events occurred.

Conclusion: Use of the Protrieve Sheath during large-bore venous mechanical thrombectomy resulted in favorable technical and clinical outcomes without device-related adverse events or clinically significant thromboembolic events. These results suggest further implementation and investigation of the devices use in complex large vessel thromboembolic disease. Comparative studies to standard technique can better quantify the potential benefits of this device.