Retrievable IVC square stent filter: Experimental study

In vitro and in vivo evaluation of a new retrievable, home-made, inferior vena cava (IVC) Square stent filter (SSF) with two trapping levels. In vitro, the SSF was compared in a flow model with the stainless steel Greenfield filter (SGF) for emboli-trapping efficiency by serially passing 300 emboli...

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Bibliographic Details
Published in:Cardiovascular and interventional radiology 1999-05, Vol.22 (3), p.239-245
Main Authors: PAVCNIK, D, UCHIDA, B. T, KELLER, F. S, CORLESS, C. L, RÖSCH, J
Format: Article
Language:English
Subjects:
Animals
Biological and medical sciences
Biomedical materials
Efficiency
EMBOLI
Embolism
Equipment Design
EVALUATION
Filters
FLOW MODELS
Implants
IN VITRO
In vitro methods and tests
IN VIVO
In vivo methods and tests
Medical sciences
Pneumology
Pulmonary Embolism - prevention & control
Pulmonary hypertension. Acute cor pulmonale. Pulmonary embolism. Pulmonary vascular diseases
RADIOLOGY AND NUCLEAR MEDICINE
Stability analysis
Stainless Steel
STAINLESS STEELS
Stents
Stock exchanges
Surgical implants
SWINE
Trapping
VASCULAR DISEASES
Vena Cava Filters
Vena Cava, Inferior - pathology
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Summary:In vitro and in vivo evaluation of a new retrievable, home-made, inferior vena cava (IVC) Square stent filter (SSF) with two trapping levels. In vitro, the SSF was compared in a flow model with the stainless steel Greenfield filter (SGF) for emboli-trapping efficiency by serially passing 300 emboli of 3 and 6 mm in diameter and 15-30 mm in length in each type of filter. Nine swine were used for the in vivo testing of the SSF for deployment and retrievability, emboli-trapping efficiency, stability, and self-centering ability and two were used (total of 11 swine) for testing repositioning and retrievability of the SSF at 2 weeks and for gross and histologic IVC changes at 2 months. In vitro, the SSF and SGF had similar efficiency in trapping large emboli but the SSF had significantly better efficiency than the SGF for trapping all sizes of emboli (91.7% vs 81%), medium size emboli (93% vs 80%), and small emboli (86% vs 69%). Efficiency decreased in both filters from the first to the fifth embolus in each series but was still significantly better for the SSF. With the SSF, 89% of emboli were caught at the primary and 11% at the secondary filtration level. In the nine animals used for acute studies, the SSF was easily placed in all 27 attempts, assumed a central position 26 times, and was easily retrieved in 21 of 22 attempts. One tilted filter needed additional manipulation for retrieval. During emboli injection in five swine, the SSF had 97.2% emboli-trapping efficiency and demonstrated good stability. In the two animals used for longer-term evaluation, the filters were easily retrieved 2 weeks after implantation. Histologic evaluation at 2 months showed neointimal proliferation around the SSF wires in contact with the IVC wall, which was otherwise normal. The SSF is a promising filter. It is easy to place and retrieve, is stable after placement, and has high efficiency for trapping emboli. Promising results justify further experimental and eventual clinical studies with a commercially manufactured SSF.
ISSN:0174-1551
1432-086X
DOI:10.1007/s002709900374