Protrieve Sheath embolic protection during venous thrombectomy: early experience in seventeen patients.

Abstract

Purpose: The Protrieve Sheath (Inari Medical; Irvine, CA) is designed for embolic protection during venous thrombectomy. This report describes experience with its use.

Materials and methods: Between November 2022 and December 2023 (13 months), seventeen patients, including nine (52.9%) females and eight (47.1%) males (mean age 58.8 ± 13.3 years, range 37-81 years), underwent deep venous thrombectomy following the Protrieve Sheath placement for embolic protection. Gender, age, presenting symptoms, procedural indications, obstructed venous segments, the Protrieve Sheath access and deployment sites, thrombectomy devices utilized, need for stent reconstruction, technical success, clinical success, adverse events (the Protrieve Sheath maldeployment or clinically significant embolic events), removed thrombi analyses, and mortality were recorded. Technical success was defined as successful deployment of the Protrieve Sheath funnel central to the thrombectomy site. Clinical success was defined as improvement in presenting venous occlusive symptoms without procedure-related venous thromboembolism.

Results: The most common presenting symptom was extremity swelling (n = 15; 88.2%). Nine (52.9%) patients had malignant and eight (47.1%) had benign etiologies of venous obstruction. Obstructed venous segments included the inferior vena cava (IVC) and lower extremity (n = 9; 52.9%), isolated lower extremity (n = 4; 23.5%), isolated IVC (n = 2; 11.8%), thoracic central veins and superior vena cava (n = 1; 5.9%), and isolated thoracic central vein (n = 1; 5.9%). The Protrieve Sheath access sites included the right internal jugular vein (n = 15; 88.2%) for IVC and lower extremity obstructions and the right common femoral vein (n = 2; 11.8%) for thoracic central vein and superior vena cava obstructions. The Protrieve sheath funnel deployment locations included intrahepatic IVC in 13 patients (n = 13; 76.5%), suprarenal IVC in two (n = 2; 11.8%), and inferior cavoatrial junction in two (n = 2; 11.8%). Thrombectomy devices used included the ClotTriever System (Inari Medical) (n = 15; 88.2%), the InThrill Thrombectomy System (Inari Medical) (n = 4; 23.5%), the FlowTriever System (Inari Medical) (n = 2; 11.8%), the Lightning Flash 16 Aspiration System (Penumbra; Salt Lake City, UT) (n = 2; 11.8%), the Cleaner Rotational Thrombectomy System (Argon; Plano, TX) (n = 1; 5.9%), and the RevCore Thrombectomy System (Inari Medical) (n = 1; 5.9%). Ten (58.8%) patients required stent reconstruction following thrombectomy. Technical success was achieved in all patients. Clinical success was achieved in 16 (94.1%) patients. No immediate adverse events, including the Protrieve Sheath maldeployment 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.