Two-Year Outcomes from the Cook Inferior Vena Cava Filter (CIVC) Study.

PURPOSE

To report 2-year outcomes from a prospective, multicenter, nonrandomized, single-arm study designed to further assess the safety and effectiveness of the Celect and Günther Tulip Vena Cava Filters.

MATERIALS AND METHODS

The Cook Inferior Vena Cava Filter (CIVC) study enrolled patients requiring temporary or permanent inferior vena cava (IVC) filter placement for the prevention of pulmonary embolism (PE). The primary effectiveness endpoint was the rate of technical placement success and 12-month freedom from new symptomatic PE while a filter was indwelling. The primary safety endpoint was the rate of 12-month freedom from major adverse events. The primary endpoints were assessed for the Celect stratum, and secondary endpoints and secondary measures were assessed for the Celect stratum and Günther Tulip stratum. Follow-up was through 2 years or 1 month following retrieval.

RESULTS

Between 2014 and 2017, 473 patients (57.3% male; mean age, 61.1 years [SD ± 16.1]) were enrolled at 28 institutions: 324 in the Celect stratum and 149 in the Günther Tulip stratum. Filters were primarily placed for current deep vein thrombosis (48.4%) and/or current PE (20.7%). The primary effectiveness endpoint rate was 97.8%. The protocol analysis yielded a primary safety rate of 81.5% (P = .369); however, the post hoc analysis resulted in a primary safety rate of 86.7% (P = .001). The rate of successful filter retrieval was 94.9%. Only 2 patients had symptomatic filter leg interactions with the IVC. One death was adjudicated as device-/procedure-related.

CONCLUSIONS

CIVC study results support the safety and effectiveness of the Celect and Günther Tulip filters for the prevention of PE.