Safety and efficacy of the VenaTech™ Retrievable inferior vena cava filter: a first-in-man single-center prospective study
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 object...
| Main Authors: | , , , , , |
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| Format: | Article |
| Language: | English |
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SpringerOpen
2022-10-01
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| Series: | CVIR Endovascular |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s42155-022-00325-y |
| _version_ | 1797996086633168896 |
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| author | Carole Déan Young Il Kim Olivier Sanchez Nicolas Martelli Marc Sapoval Oliver Pellerin |
| author_facet | Carole Déan Young Il Kim Olivier Sanchez Nicolas Martelli Marc Sapoval Oliver Pellerin |
| author_sort | Carole Déan |
| collection | DOAJ |
| description | 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 |
| first_indexed | 2024-04-11T10:11:54Z |
| format | Article |
| id | doaj.art-88011c2c73b84d09b10ffe0fcbe694c5 |
| institution | Directory Open Access Journal |
| issn | 2520-8934 |
| language | English |
| last_indexed | 2024-04-11T10:11:54Z |
| publishDate | 2022-10-01 |
| publisher | SpringerOpen |
| record_format | Article |
| series | CVIR Endovascular |
| spelling | doaj.art-88011c2c73b84d09b10ffe0fcbe694c52022-12-22T04:30:05ZengSpringerOpenCVIR Endovascular2520-89342022-10-01511810.1186/s42155-022-00325-ySafety and efficacy of the VenaTech™ Retrievable inferior vena cava filter: a first-in-man single-center prospective studyCarole Déan0Young Il Kim1Olivier Sanchez2Nicolas Martelli3Marc Sapoval4Oliver Pellerin5Université de Paris-Cité, PARCC, INSERM-970, Department of Interventional Radiology Assistance Publique - Hôpitaux de Paris - Hôpital Européen Georges-PompidouUniversité de Paris-Cité, PARCC, INSERM-970, Department of Interventional Radiology Assistance Publique - Hôpitaux de Paris - Hôpital Européen Georges-PompidouUniversité de Paris-Cité, IThEM INSERM UMR-S 1140, Department of Pneumology and Intensive Care Hôpital Européen Georges-Pompidou Assistance Publique - Hôpitaux de ParisUniversité Paris-Saclay GRADES, Department of Pharmacy, Assistance Publique - Hôpitaux de Paris - Hôpital Européen Georges-PompidouUniversité de Paris-Cité, PARCC, INSERM-970, Department of Interventional Radiology Assistance Publique - Hôpitaux de Paris - Hôpital Européen Georges-PompidouUniversité de Paris-Cité, PARCC, INSERM-970, Department of Interventional Radiology Assistance Publique - Hôpitaux de Paris - Hôpital Européen Georges-PompidouAbstract 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: NCT02674672https://doi.org/10.1186/s42155-022-00325-yInferior vena cava filtersPulmonary embolismDeep vein thrombosisInterventional imagingProspective studyFirst-in-man |
| spellingShingle | Carole Déan Young Il Kim Olivier Sanchez Nicolas Martelli Marc Sapoval Oliver Pellerin Safety and efficacy of the VenaTech™ Retrievable inferior vena cava filter: a first-in-man single-center prospective study CVIR Endovascular Inferior vena cava filters Pulmonary embolism Deep vein thrombosis Interventional imaging Prospective study First-in-man |
| title | Safety and efficacy of the VenaTech™ Retrievable inferior vena cava filter: a first-in-man single-center prospective study |
| title_full | Safety and efficacy of the VenaTech™ Retrievable inferior vena cava filter: a first-in-man single-center prospective study |
| title_fullStr | Safety and efficacy of the VenaTech™ Retrievable inferior vena cava filter: a first-in-man single-center prospective study |
| title_full_unstemmed | Safety and efficacy of the VenaTech™ Retrievable inferior vena cava filter: a first-in-man single-center prospective study |
| title_short | Safety and efficacy of the VenaTech™ Retrievable inferior vena cava filter: a first-in-man single-center prospective study |
| title_sort | safety and efficacy of the venatech™ retrievable inferior vena cava filter a first in man single center prospective study |
| topic | Inferior vena cava filters Pulmonary embolism Deep vein thrombosis Interventional imaging Prospective study First-in-man |
| url | https://doi.org/10.1186/s42155-022-00325-y |
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