Final Two-Year Outcomes for the Sentry Bioconvertible Inferior Vena Cava Filter in Patients Requiring Temporary Protection from Pulmonary Embolism

Abstract

Purpose: To report final 2-year outcomes with the Sentry bioconvertible inferior vena cava (IVC) filter in patients requiring temporary protection against pulmonary embolism (PE). Materials and Methods:In a prospective multicenter trial, the Sentry filter was implanted in 129 patients with documented deep vein thrombosis (DVT) and/or PE (67.5%) or who were at temporary risk of developing DVT/PE (32.6%). Patients were monitored and bioconversion status ascertained by radiography, computed tomography (CT), and CT venography through 2 years. Results:The composite primary 6-month endpoint of clinical success was achieved in 97.4% (111/114) of patients. The rate of new symptomatic PE was 0% (n ¼ 126) through 1 year and 2.4% (n ¼ 85) through the second year of follow-up, with 2 new nonfatal cases at 581 and 624 days that were adjudicated as not related to the procedure or device. Two patients (1.6%) developed symptomatic caval thrombosis during the first month and underwent successful interventions without recurrence. No other filter-related symptomatic complications occurred through 2 years. There was no filter tilting, migration, embolization, fracture, or caval perforation and no filterrelated deaths through 2 years. Filter bioconversion was successful for 95.7% (110/115) of patients at 6 months, 96.4% (106/110) of patients at 12 months, and 96.5% (82/85) of patients at 24 months. Through 24 months of follow-up, there was no evidence of late-stage IVC obstruction or thrombosis after filter bioconversion or of thrombogenicity associated with retracted filter arms. Conclusions:The Sentry IVC filter provided safe and effective protection against PE, with a high rate of intended bioconversion and a low rate of device-related complications, through 2 years of follow-up.

Endovascular management of symptomatic deep vein thrombosis with combined approach

“…13 Through 24 months of follow-up, there was no evidence of late-stage IVC obstruction or thrombosis after filter bioconversion or of thrombogenicity associated with retracted filter arms. 14…”

“…13 In recent times, interest has grown about bioconvertible filters such as the Boston Sentry. 13,14 In the first work, 13 with a 1-year follow-up, 129 patients were enrolled, with a technical success of 97.4%. At 1 year, there were no cases of new symptomatic pulmonary embolisms, two patients presented symptomatic caval thrombosis in the first month.…”

Gone in 60 days: our first experience with a bioconvertible IVC filter

“…The filter was evaluated in a multicentre prospective trial of 129 patients with either documented DVT/PE or at temporary risk of DVT/PE [ 10 ]. The rate of new symptomatic PE was 0% ( n = 126) through one year and 2.4% ( n = 85) through the second year.…”

“…The Sentry filter has been evaluated in a multicentre prospective trial of 129 patients with either documented DVT/PE or at temporary risk of DVT/PE. It has shown a high rate of successful bioconversion, strong protection against pulmonary emboli and a low rate of device-related complications through 2 years of follow-up [ 10 ].…”

Back to the Basics: Inferior Vena Cava Filters

“…Once the biodegradable component is completely dissolved, the IVCF transforms into an open configuration and spontaneously converts into a caval stent without the need for a separate procedure. 23…”