Search

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 = 126) through 1 year and 2.4% (n = 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 filter-related 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.

Purpose To prospectively assess the Sentry bioconvertible inferior vena cava (IVC) filter in patients requiring temporary protection against pulmonary embolism (PE). Materials and Methods At 23 sites, 129 patients with documented deep vein thrombosis (DVT) or PE, or at temporary risk of developing DVT or PE, unable to use anticoagulation were enrolled. The primary end point was clinical success, including successful filter deployment, freedom from new symptomatic PE through 60 days before filter bioconversion, and 6-month freedom from filter-related complications. Patients were monitored by means of radiography, computerized tomography (CT), and CT venography to assess filtering configuration through 60 days, filter bioconversion, and incidence of PE and filter-related complications through 12 months. Results Clinical success was achieved in 111 of 114 evaluable patients (97.4%, 95% confidence interval [CI] 92.5%–99.1%). The rate of freedom from new symptomatic PE through 60 days was 100% (n = 129, 95% CI 97.1%–100.0%), and there were no cases of PE through 12 months for either therapeutic or prophylactic indications. Two patients (1.6%) developed symptomatic caval thrombosis during the first month; neither experienced recurrence after successful interventions. There was no filter tilting, migration, embolization, fracture, or caval perforation by the filter, and no filter-related death through 12 months. Filter bioconversion was successful for 95.7% (110/115) at 6 months and for 96.4% (106/110) at 12 months. 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 12 months of imaging-intense follow-up.

Purpose A postmarketing surveillance registry was conducted to monitor the safety and effectiveness of the OptEase vena cava filter when used as a permanent filter. Materials and Methods This study was a nonrandomized, multicenter prospective trial with all patients receiving the OptEase vena cava filter for the prevention of pulmonary embolism (PE). A total of 11 clinical sites in the United States enrolled patients. A 1-month postimplantation follow-up examination was performed to determine potential filter migration and the presence of symptomatic thrombosis of the inferior vena cava (IVC) or lower extremities. At 6-month postimplantation follow-up, patients were again assessed for the safety and stability of the filter and any clinical evidence of symptomatic thrombosis. Results One hundred fifty patients were enrolled in this study. Fifty-five patients (36.6%) were unable to complete all of the necessary follow-up at 6 months. At 1 month, filter migration and filter-related symptomatic deep vein thrombosis was observed in one patient each (0.9% and 0.8%, respectively). At 6 months, no new cases of filter migration or filter-related symptomatic thrombosis were observed. Filter tilting (≥15° off the IVC axis) was observed in one patient at baseline (0.7%), four patients at 1-month follow-up (3.6%), and three patients (11.4%) at 6-month follow-up. Incidental findings on follow-up radiographs included filter fracture in two patients (1.8%) at 1 month and in one additional patient (4.3%) at 6 months. There were no clinical sequelae associated with the filter fracture. Conclusions The co-primary endpoints of filter migration and symptomatic thrombus formation at 1 month had an observed frequency of 0.9% and 0.8%, respectively. These co-primary endpoints were stable and unchanged at 6 months.