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. 2022 Oct 4;5(1):50.
doi: 10.1186/s42155-022-00325-y.

Safety and efficacy of the VenaTech™ Retrievable inferior vena cava filter: a first-in-man single-center prospective study

Carole Déan  1 , Young Il Kim  1 , Olivier Sanchez  2 , Nicolas Martelli  3 , Marc Sapoval  1 , Oliver Pellerin  4
Affiliations

Safety and efficacy of the VenaTech™ Retrievable inferior vena cava filter: a first-in-man single-center prospective study

Carole Déan et al. CVIR Endovasc. .

Abstract

Background: Venous thromboembolism (VTE) is a frequent condition worldwide, associated with significant morbidity and mortality. Though its primary treatment is anticoagulation, the placement of an inferior vena cava (IVC) filter is recommended in patients with some comorbidities. The objectives of this study were to evaluate the clinical safety and efficacy of the Venatech® retrievable IVC filter. This open-label prospective single-center study was conducted on 40 consecutive patients requiring temporary or permanent IVC filtration. Patient characteristics, technical success rates of filter placement and removal, and the occurrence of complications were assessed. Follow-up imaging was performed using CT-scan before retrieval or at 6 months in the permanent indication population.

Results: The filter was successfully implanted at the intended location in all the patients. Retrieval was attempted in 21 (52.5%) patients after a mean period of 50 days (range: 6-94 days), and the filter was successfully removed in 18 patients (85.7%). Reason for retrieval failure was filter with trapped thrombus (n = 2) and a > 15° tilt (n = 1). No complication was observed during the filter placement and retrieval. Follow-up imaging available in 30 patients (75%) demonstrated deep filter penetration (> 3 mm) in four patients (13.3%), severe filter tilt (> 15o) in five patients (16.7%), filter with trapped thrombus in three patients (10%), but no fracture or IVC thrombosis.

Conclusion: This prospective study showed encouraging preliminary results of the safety and efficacy of the Venatech® retrievable IVC filter. The filter was easily delivered in the intended position and successfully removed in a high percentage of patients.

Trial registration: ClinicalTrials.gov Identifier: NCT02674672.

Keywords: Deep vein thrombosis; First-in-man; Inferior vena cava filters; Interventional imaging; Prospective study; Pulmonary embolism.

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Conflict of interest statement

OP received a research grant from BBraun for the study and consulting fees.

Figures

Fig. 1
Fig. 1
Study flowchart
Fig. 2
Fig. 2
Anteroposterior angiography of the inferior vena cava before (a) and after filter implantation (b) for a 65 years old woman with current PE and DVT contra-indicated to anticoagulant therapy because of scheduled gynecological surgery (ovarian cancer). The angiography showed a fully patent inferior vena cava (a) and the filter was deployed bellow the lowest renal vein (b)
Fig. 3
Fig. 3
Anterioposterior view of snare manipulation to remove the filter. The patient was referred 90 days after implantation for filter removal. The cavogram showed a patent filter without tilt or filter struts vena cava penetration. A 20 mm snare was deployed over the filter hook. Since the filter was hooked, snare wire was pinned while the 13Fr catheter was advanced over the snare wire to collapse the filter. The filter was pulled into the 13fr catheter for extraction. The post extraction cavogram showed no abnormality.
Fig. 4
Fig. 4
VenaTech® Retrievable Filter
See this image and copyright information in PMC

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