Multicenter Trial of the VenaTech Convertible Vena Cava Filter.

Area of Science:

• Vascular Surgery
• Interventional Cardiology
• Medical Device Technology

Background:

• Inferior Vena Cava (IVC) filters are used to prevent pulmonary embolism in high-risk patients.
• Filter conversion is a strategy to remove or modify IVC filters once the risk of pulmonary embolism has subsided.
• Assessing the safety and efficacy of convertible IVC filters is crucial for patient management.

Purpose of the Study:

• To evaluate the technical success rate of converting the VenaTech Convertible Vena Cava Filter.
• To determine the incidence of major device-related adverse events at 6 months post-conversion.
• To assess the safety and efficacy of the VenaTech Convertible filter in a real-world clinical setting.

Main Methods:

• A multicenter, prospective, single-arm study enrolled 149 patients requiring IVC filter implantation.
• The VenaTech Convertible filter was implanted in patients with venous thromboembolism, high-risk trauma, or for surgical prophylaxis.
• Filter conversion attempts were made when patients were no longer at risk for pulmonary embolism, with follow-up at 30 days, 3 months, and 6 months.

Main Results:

• All IVC filter implants were technically successful.
• The technical success rate for filter conversion was 92.7% (89/96).
• No major conversion-related adverse events were reported within 6 months; 89 converted and 32 unconverted patients completed follow-up without delayed complications.

Conclusions:

• The VenaTech Convertible filter demonstrates a high conversion rate and a low rate of 6-month device-related adverse events.
• The device appears safe and effective for caval filter conversion in the short term.
• Further long-term studies are warranted to fully establish the safety and efficacy profile of this convertible filter.