VenaTech Convertible Vena Cava Filter 6 Months after Conversion Follow-up.

Area of Science:

• Medical Devices
• Cardiovascular Interventions
• Interventional Radiology

Background:

• Inferior vena cava (IVC) filters are used to prevent pulmonary embolism (PE).
• The VenaTech convertible vena cava filter (VTCF) offers a retrievable option for PE prophylaxis.
• Assessing long-term safety and device-related adverse events is crucial for IVC filter technology.

Purpose of the Study:

• To evaluate device-related adverse events at 6 months following placement or conversion of the VenaTech convertible vena cava filter (VTCF).
• To compare the safety profile of converted VTCF versus non-converted VTCF at the 6-month follow-up interval.

Main Methods:

• Prospective, single-arm, multicenter study involving 149 patients with VTCF implantation.
• Conversion to a non-retrievable state was attempted in 64.4% of patients.
• Imaging evaluation at 6 months was performed for 76 converted and 28 non-converted filter subjects.

Main Results:

• In converted VTCF subjects (n=76), only 1.3% experienced IVC perforation (>3mm strut outside lumen); no PE, migration, fracture, or IVC thrombosis occurred.
• In non-converted VTCF subjects (n=28), 14.3% had complete or near-complete IVC thrombosis; no PE, penetration, fracture, or spontaneous conversion was observed.
• Converted VTCF demonstrated significantly lower rates of IVC thrombosis and migration compared to non-converted VTCF.

Conclusions:

• The VenaTech convertible vena cava filter (VTCF) exhibits a favorable safety profile with low adverse event rates at 6 months in its converted configuration.
• Non-converted VTCF configurations are associated with a higher risk of IVC thrombosis.
• These findings support the safety and efficacy of VTCF conversion for reducing IVC-related complications.