- Email: [email protected]
Efficacy and Retrievability of Aegisy Vena Cava Filter: A Single Center Experience in 213 Patients
Accepted Manuscript Efficacy and Retrievability of Aegisy Vena Cava Filter: A Single Center Experience in 213 Patients Haiyan Li, M.D., Zhongzhi Jia, M.D., Xin Chen, M.D., Feng Tian, M.D., Xin Wang, M.D. PII:
S0890-5096(16)30413-7
DOI:
10.1016/j.avsg.2016.02.025
Reference:
AVSG 2840
To appear in:
Annals of Vascular Surgery
Received Date: 18 November 2015 Revised Date:
4 February 2016
Accepted Date: 13 February 2016
Please cite this article as: Li H, Jia Z, Chen X, Tian F, Wang X, Efficacy and Retrievability of Aegisy Vena Cava Filter: A Single Center Experience in 213 Patients, Annals of Vascular Surgery (2016), doi: 10.1016/j.avsg.2016.02.025. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
ACCEPTED MANUSCRIPT
Efficacy and Retrievability of Aegisy Vena Cava Filter: A Single Center Experience in 213
2
Patients
3
Haiyan Li1 M.D., Zhongzhi Jia2 M.D., Xin Chen1 M.D., Feng Tian2 M.D., Xin Wang1 M.D.
RI PT
1
4
1: Department of Cardiology, No. 2 People’s Hospital of Changzhou, Nanjing Medical
6
University, Xing Long Road 29#, Chang Zhou, Jiangsu Province, China, 213003
7
2: Department of Interventional Radiology, No. 2 People’s Hospital of Changzhou, Nanjing
8
Medical University, Xing Long Road 29#, Chang Zhou, Jiangsu Province, China, 213003
9 Corresponding author: Xin Wang
11
E-mail: [email protected]
12
Tele: 86-13616106021
13
Fax：86-0519-88115560
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Abstract
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Objective: To retrospectively evaluate the safety, efficacy and retrievability of the Aegisy vena
25
cava filter (Lifetech Scientific Co. Ltd., Shenzhen, China).
26
Methods: Data from all patients who underwent Aegisy vena cava filter placement for
27
pulmonary embolism (PE) prophylaxis during catheter-directed thrombolysis (CDT) or
28
aspiration thrombectomy for the proximal deep venous thrombosis (DVT) were included and
29
analyzed.
30
Results: From Oct 2006 to Sep 2015, a total of 213 patients were included in this study. All the
31
filters were successfully placed without any difficulty. Filter removal was attempted in 112
32
(52.6%) patients after a median duration of 12 days (range, 9-15) placement, and were successful
33
in 107 (95.5%) patients. Venography was performed pre- and post- filter removal, severe tilt was
34
seen in 5 (4.5%, 5/112) patients, and neither filter migration nor deformity was seen in any of the
35
patients. No procedure-related complication was observed in any of the patients. A total of 47
36
(22.1%) patients underwent thorax or pulmonary CT for cancer or other reasons before the filters
37
were retrieval, and no segmental PE was seen. Also, no symptomatic PE breakthrough was seen
38
in any of the patients after the filter placement.
39
Conclusion: Aegisy vena cava filter is a safe and effective device for PE prophylaxis during
40
CDT or aspiration thrombectomy for the proximal DVT. Although only half patients presented
41
for removal, the retrievability of Aegisy vena cava filter is high.
42
Keywords: pulmonary embolism; deep venous thrombosis; inferior vena cava; filter; aegisy
43
Introduction
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Retrievable inferior vena cava (IVC) filters have been developed to provide temporary and
45
permanent protection from pulmonary embolism (PE). Indications for IVC filter implantation
46
include contraindication to or complication of anticoagulation therapy in the presence of venous
47
thromboembolic disease, or recurrent PE despite anticoagulation. Prophylactic filter placement
48
may be considered for protection of patients with deep venous thrombosis (DVT) with floating
49
thrombus.1
SC
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When a patient’s clinical indication for PE protection no longer exists , the retrievable IVC filter can be removed to reduce the risk of potential long-term complications that may result from
52
a permanent IVC filter. As the use of these devices has become more widespread, various
53
problems have arisen, such as limb penetration,2 filter fracture and distant migration of fracture
54
fragments.3, 4 There are several available IVC retrievable filters, such as Denali IVC filter (Bard
55
Peripheral Vascular, Tempe, Arizona), Celect and Gunther Tulip (Cook, Bloomington, Indiana),
56
OptEase (Cordis, Miami Lakes, Florida), Option (Angiotech, Vancouver, BC, Canada), ALN
57
(ALN Implants Chirurgicaux, Ghisonaccia, France), and Crux IVC filter (Crux Biomedical,
58
California, USA), and all of them were proved to be safety and efficacy.3, 5-7
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Aegisy (Lifetech Scientific, Shenzhen, China) vena cava filter was approved by China Food and Drug Administration (CFDA) as a optional IVC filter, it can be used as a temporary or
61
permanent protection from PE, and was used widely in China. However, isolated reports of
62
safety, efficacy and retrievability of the Aegisy vena cava filter have been presented in the
63
literature. In this study, we sought to retrospectively evaluate the safety, efficacy and
64
retrievability of the Aegisy vena cava filter.
65
Materials and Methods
66
Study Design
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This retrospective study was approved by our institutional review board, and informed consents
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to treatment were obtained from all the study patients. Cases were identified through the
69
departmental procedural logs. Patient demographics, clinical information, and procedural data
70
were gathered from patients’ medical records.
71
Designs of the Aegisy Filter
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Aegisy vena cava filter is a laser cut from nitinol alloy, which is composed of 55.4% nickel and
73
44.6% titanium. It has a symmetrical double basket design in which proximal and distal baskets
74
are connected by six straight struts. It has anchoring barbs only on the inferior end of each of the
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six straight struts. A centrally located hook at the caudal basket is intended for filter snaring.
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(Figure 1, 2). There are three subtypes of this filter, including 18 mm, 25 mm, and 32 mm in
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diameter, and the types of 25 mm and 32 mm are most used. It can be introduced by way of
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either the femoral or the jugular route. The Aegisy filter should be removal within 14 days
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according to the manufacturer’s recommendations.
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Placement and Retrieval Techniques
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Aegisy filters were placed via the common femoral or right internal jugular vein by a 6 Fr-
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catheter. Filters were retrieved through the common femoral vein. IVC cavagram was obtained
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to ensure the position of the filter and the absence of any thrombus. If the filter was to be
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removed, a 10 Fr 60-cm retrieval sheath (Lifetech Scientific Co. Ltd., Shenzhen, China) was
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placed 3 to 4 cm below the filter hook. The hook was grasped by an Amplatz Goose Neck Snare
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(ev3; Plymouth, MN, USA). The filter was collected in the sheath and removed. The procedure
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was completed after control venography was performed using the same sheath.
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Definitions
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Migration refers to the change in the filter position from the original placement (≧1 cm).4 Tilt
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was defined as the angulation between the long axes of the filter and the vena cava. Tilt was
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deemed to be severe if greater than 15°, and the filter hook attached to the IVC wall.4 Because
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the standard cavagram was obtained only in anteroposterior projection, tilt refers to the lateral
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axial deviation. A PE breakthrough was defined as new PE occurring after IVC filter placement.4
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Indication change was defined a temporary indication has been changed for lifelong protection
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against PE clinically after inserting an optional filter.
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Measurements
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In accordance with the aforementioned definitions, analysis of these complications was
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performed by two researchers independently through review of the appropriate images. These
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images were harvested from the imaging archive and saved as digital files. The cavagrams of
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post-placement and preretrieval images were selected, compared and analysised.
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Study End Points
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Presence of PE breakthrough evidenced by clinical features and/or imaging studies was the
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primary outcome measure of the present study. The following end points were also evaluated: (1)
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difficulty in the placemen or retrieval of the filter, and (2) filter migration or tilt.
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Follow-up
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In patients with clinical findings suggestive of PE breakthrough, computed tomography (CT)
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angiography was performed. Patients with suspected DVT were evaluated with Doppler US and
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venography. When patients underwent thorax CT examination for other reasons, the images were
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also examined for the presence of PE. Similarly, when the patients underwent abdominal CT or
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spinal CT/magnetic resonance imaging for other reasons, the images were also examined for
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filter status, migration, tilt and thrombosis.
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Results
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From Oct 2006 to Sep 2015, a total of 276 patients in whom Aegisy vena cava filter was placed
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in a single institution, and 63 patients were excluded, including lost of follow-up (n=31),
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contraindication for anticoagulation (n=21), and development of PE/DVT despite adequate
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anticoagulation (n=11) (Figure 3). A total of 213 patients (127 women, 86 men, mean age, 52.6
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± 8.1 years, rage, 24-78 years) who underwent Aegisy vena cava filter placement for PE
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prophylaxis during CDT or aspiration thrombectomy for the proximal DVT were included in the
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final analyzed, and all the Aegisy filters were placed for PE prophylaxis during CDT or
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aspiration thrombectomy for the proximal DVT. All the Aegisy vena cava filters were
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successfully placed without any difficulty. Radiographic images of the vena cava obtained just
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after placement of the filter did not show the presence of severe tilt, deformity or cava injury in
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any of the patients.
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Of the 213 patients who with filter placement, a total of 150 (70.4%, 150/213) patients were
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scheduled to undergo filter removal, and 63 (29.6%, 63/213) patients have been placed the
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Aegisy filters for permanent use due to ongoing malignancy, old age and poor condition. Of the
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150 patients, filter removal was attempted only in 112 (74.7%, 112/150) patients after a mean
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duration of 12 days (range 9 to 15), and filter removal was abandoned in 38 (25.3%, 38/150)
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patients for patients’ poor condition (n=14), ongoing malignancy (n=10), indication change and
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ongoing need for PE protection (n=8), IVC filter thrombus (n=3) and patient refusal (n=3); also,
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the 38 patients were remaining thrombus of the deep vein at the 14 days of filter placement, and
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left in place as a permanent IVC filter. Of the 112 patiens, removal attempts were successful in
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107 (95.5%, 107/112) patients, and 5 (4.5%, 5/112) patients failed for inability to engage the
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filter hook for the filter hook attached to the IVC wall due to filter tilting. Venography was
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performed pre- and post- filter removal, severe tilt was seen in 5 (4.5%, 5/112) patients, and no
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filter migration and vena cava damage were seen in any of the patients. Of note, the 5 cases who
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with severe tilt at filter retrieval were all presented of tilt (<15°) after placement of the filter. No
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procedure-related complication was observed in any of the patients.
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A total of 47 (22.1%) patients underwent thorax or pulmonary CT for cancer or other
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reasons before the filters were retrieval, and no segmental PE was seen. Also, no symptomatic
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PE breakthrough was seen in any of the patients after the filter placement.
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Discussion
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The results of this study demonstrated that Aegisy vena cava filter is a safe and effective device
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for PE prophylaxis during CDT or aspiration thrombectomy for the proximal DVT. Although
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only 52.6% patients presented for removal, the retrievability of the Aegisy vena cava filter is
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high (95.5%).
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There are several available IVC retrievable filters. Most filters have a conical shape and are
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being retrieved from a jugular approach. The Aegisy vena cava filter, similar to the Optease filter,
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is one kind of the filters with a diamond-like shape that is retrieved from an inferior approach
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(femoral). The results of this study were similar to the previous reports about Optease filter:
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effective for PE prophylaxis, low rate of filter migration, tilt, fracture, and deformity.8, 9 Also has
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high rate of filter retrievability.8, 9 We believe that the results of this study have directe
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relationship with the structure of Aegisy vena cava filter.
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Due to its structure, there are six vertical struts, which adhere to the caval wall after
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deployment and can thus become covered with intima over time. This seems to be the indwelling
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time limiting factor of the Aegisy IVC filter. This problem does not exist with conical filters with
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only the tips of the legs attaching to the caval wall. Therefore, the most important limitation of
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Aegisy as a retrievable filter is its requirement for an early retrieval (within 14 days according to
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the manufacturer’s recommendations), whereas conical filters can be retrieved after much longer
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time as published: 158.1 days (range, 2-518 days) for Celect filter,3 127.6 days (range, 3-361
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days) for G2 filter. According this study, filter removal was abandoned in 25.3% (38/150)
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patients for patients’ poor condition, ongoing malignancy, indication change and ongoing need
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for PE protection, IVC filter thrombus, and patient refusal; also the 38 patients were remaining
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thrombus at the 14 days of filter placement. In this condition, the filters were left in place as a
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permanent IVC filter. Recently, Scher D, et al.10 reported 5 Optease filters were successfully
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retrieved after an average 977 days (range, 123-2,584 d) placement. However, all patients
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exhibited IVC stenosis after filter retrieval, and an IVC pseudoaneurysm was present following
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retrieval in one case. There was no data about the retrievability of Aegisy IVC filter after a long
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time placement.
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Migration rates vary greatly among types and models of filters and filter manufacturers,11-13
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and even among different observers for the same filter model.11, 14 Although many reports
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proved that the filter migration have close relationship with the ratio of filter and IVC diameter.15
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The mechanism of filter migration is not clear. There are three subtypes of Aegisy vena cava
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filter, and the 25 mm and 32 mm in diameters of Aegisy vena cava filter were most used in this
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study, and no filter migration was observed.
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Filter tilt is a well-recognized phenomenon that is most commonly associated with conical
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filters.3, 4 Although the filter struts anchored at the caval wall form a relatively stable base, the tip
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floats freely without support. Over time, movement in the IVC or radial force in the filter allows
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the filter to reposition itself to its most stable position.3 In this study, 5 filters failed for inability
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to engage the filter hook for the filter hook attached to the IVC wall due to filter tilting. The tilt
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rate was lower than reported conical filters,3 which maybe related with the diamond-like shape of
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Aegisy vena cava filter. The tilting problem was not preventable with this device and led to the
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device not being retrieved by using conventional snares or retrieval cone catheter techniques. It
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was reported that the success rate of IVC filter retrieval can be as high as 97%-100% by
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advanced retrieval technique, such like curved catheter technique, loop-and-snare technique,
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balloon assisted technique, forceps technique, excimer laser technology.16-19 However, the
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advanced retrieval techniques were not used after discussion with the 5 patients. We believe the
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5 filters can be removed in using the advanced retrieval techniques mentioned above.
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Study Limitations
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The limitation of this study was its retrospective nature, which may limit the generalizability of
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the observed results. Also, the fact that the true rates of PE in the patients is unknown as only
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symptomatic patients underwent evaluation for PE. Furthermore, just like zhou’s reported4 tilt
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was defined as only that which occurred as lateral deviation; tilt in the anteroposterior plane
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cannot be determined by reviewing standard cavagrams.
195
Conclusions
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Aegisy vena cava filter is a safe and effective device for PE prophylaxis. Although only half
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patients presented for removal, the retrievability of the Aegisy vena cava filter is high.
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Acknowledgement
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None.
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Funding
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None.
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Conflicts of interest
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The authors indicated no potential conflicts of interest.
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References
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7. 8. 9.
10. 11.
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Grassi CJ, Swan TL, Cardella JF, et al. Quality improvement guidelines for percutaneous permanent inferior vena cava filter placement for the prevention of pulmonary embolism. J Vasc Interv Radiol 2003;14:S271-S275. Jia Z, Wu A, Tam M, et al. Caval Penetration by Inferior Vena Cava Filters: A Systematic Literature Review of Clinical Significance and Management. Circulation 2015;132. Zhou D, Spain J, Moon E, et al. Retrospective review of 120 celect inferior vena cava filter retrievals: experience at a single institution. J Vasc Interv Radiol 2012;23:1557-63. Zhu X, Tam MD, Bartholomew J, et al. Retrievability and device-related complications of the G2 filter: a retrospective study of 139 filter retrievals. J Vasc Interv Radiol 2011;22:806-12. Rimon U, Bensaid P, Golan G, et al. Optease vena cava filter optimal indwelling time and retrievability. Cardiovasc Intervent Radiol 2011;34:532-5. Mahrer A, Zippel D, Garniek A, et al. Retrievable vena cava filters in major trauma patients: prevalence of thrombus within the filter. Cardiovasc Intervent Radiol 2008;31:785-9. Turba UC, Arslan B, Meuse M, et al. Günter Tulip Filter Retrieval Experience: Predictors of Successful Retrieval. CardioVascular and Interventional Radiology 2009;33:732-738. Onat L, Ganiyusufoglu AK, Mutlu A, et al. OptEase and TrapEase vena cava filters: a single-center experience in 258 patients. Cardiovasc Intervent Radiol 2009;32:992-7. Oliva VL, Szatmari F, Giroux MF, et al. The Jonas study: evaluation of the retrievability of the Cordis OptEase inferior vena cava filter. J Vasc Interv Radiol 2005;16:1439-45; quiz 1445. Scher D, Venbrux A, Okapal K, et al. Retrieval of TRAPEASE and OPTEASE Inferior Vena Cava Filters with Extended Dwell Times. J Vasc Interv Radiol 2015;26:1519-1525. Tam MD, Spain J, Lieber M, et al. Fracture and distant migration of the Bard Recovery filter: a retrospective review of 363 implantations for potentially life-threatening complications. J Vasc Interv Radiol 2012;23:199-205 e1. Wang W, Zhou D, Obuchowski N, et al. Fracture and Migration of Celect IVC Filters: A Retrospective Review of 741 Consecutive Implantations. J Vasc Interv Radiol 2013;24:1719-1722. Hull JE, Han J, Giessel GM. Retrieval of the recovery filter after arm perforation, fracture, and migration to the right ventricle. J Vasc Interv Radiol 2008;19:1107-11. Nicholson W, Nicholson WJ, Tolerico P, et al. Prevalence of fracture and fragment embolization of Bard retrievable vena cava filters and clinical implications including cardiac perforation and tamponade. Arch Intern Med 2010;170:1827-31. Shmuter Z, Frederic FI, Gill JR. Fatal migration of vena caval filters. Forensic Sci Med Pathol 2008;4:116-121.
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19.
Van Ha TG, Vinokur O, Lorenz J, et al. Techniques used for difficult retrievals of the Gunther Tulip inferior vena cava filter: experience in 32 patients. J Vasc Interv Radiol 2009;20:92-9. Doody O, Noë G, Given MF, et al. Assessment of Snared-Loop Technique When Standard Retrieval of Inferior Vena Cava Filters Fails. CardioVascular and Interventional Radiology 2008;32:145-149. Kuo WT, Cupp JS, Louie JD, et al. Complex Retrieval of Embedded IVC Filters: Alternative Techniques and Histologic Tissue Analysis. CardioVascular and Interventional Radiology 2011;35:588-597. Kuo WT, Odegaard JI, Louie JD, et al. Photothermal ablation with the excimer laser sheath technique for embedded inferior vena cava filter removal: initial results from a prospective study. J Vasc Interv Radiol 2011;22:813-23.
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260
Aegisy vena cava filter (Lifetech Scientific) with caudal retrieval hook and caudal fixation barbs.
261
Figure 2
262
Aegisy vena cava filter has a symmetrical double basket design in which proximal and distal
263
baskets are connected by six straight struts.
264
Figure 3
265
Patient management flow chart.
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S0890-5096(16)30413-7
DOI:
10.1016/j.avsg.2016.02.025
Reference:
AVSG 2840
To appear in:
Annals of Vascular Surgery
Received Date: 18 November 2015 Revised Date:
4 February 2016
Accepted Date: 13 February 2016
Please cite this article as: Li H, Jia Z, Chen X, Tian F, Wang X, Efficacy and Retrievability of Aegisy Vena Cava Filter: A Single Center Experience in 213 Patients, Annals of Vascular Surgery (2016), doi: 10.1016/j.avsg.2016.02.025. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
ACCEPTED MANUSCRIPT
Efficacy and Retrievability of Aegisy Vena Cava Filter: A Single Center Experience in 213
2
Patients
3
Haiyan Li1 M.D., Zhongzhi Jia2 M.D., Xin Chen1 M.D., Feng Tian2 M.D., Xin Wang1 M.D.
RI PT
1
4
1: Department of Cardiology, No. 2 People’s Hospital of Changzhou, Nanjing Medical
6
University, Xing Long Road 29#, Chang Zhou, Jiangsu Province, China, 213003
7
2: Department of Interventional Radiology, No. 2 People’s Hospital of Changzhou, Nanjing
8
Medical University, Xing Long Road 29#, Chang Zhou, Jiangsu Province, China, 213003
9 Corresponding author: Xin Wang
11
E-mail: [email protected]
12
Tele: 86-13616106021
13
Fax：86-0519-88115560
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Abstract
24
Objective: To retrospectively evaluate the safety, efficacy and retrievability of the Aegisy vena
25
cava filter (Lifetech Scientific Co. Ltd., Shenzhen, China).
26
Methods: Data from all patients who underwent Aegisy vena cava filter placement for
27
pulmonary embolism (PE) prophylaxis during catheter-directed thrombolysis (CDT) or
28
aspiration thrombectomy for the proximal deep venous thrombosis (DVT) were included and
29
analyzed.
30
Results: From Oct 2006 to Sep 2015, a total of 213 patients were included in this study. All the
31
filters were successfully placed without any difficulty. Filter removal was attempted in 112
32
(52.6%) patients after a median duration of 12 days (range, 9-15) placement, and were successful
33
in 107 (95.5%) patients. Venography was performed pre- and post- filter removal, severe tilt was
34
seen in 5 (4.5%, 5/112) patients, and neither filter migration nor deformity was seen in any of the
35
patients. No procedure-related complication was observed in any of the patients. A total of 47
36
(22.1%) patients underwent thorax or pulmonary CT for cancer or other reasons before the filters
37
were retrieval, and no segmental PE was seen. Also, no symptomatic PE breakthrough was seen
38
in any of the patients after the filter placement.
39
Conclusion: Aegisy vena cava filter is a safe and effective device for PE prophylaxis during
40
CDT or aspiration thrombectomy for the proximal DVT. Although only half patients presented
41
for removal, the retrievability of Aegisy vena cava filter is high.
42
Keywords: pulmonary embolism; deep venous thrombosis; inferior vena cava; filter; aegisy
43
Introduction
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Retrievable inferior vena cava (IVC) filters have been developed to provide temporary and
45
permanent protection from pulmonary embolism (PE). Indications for IVC filter implantation
46
include contraindication to or complication of anticoagulation therapy in the presence of venous
47
thromboembolic disease, or recurrent PE despite anticoagulation. Prophylactic filter placement
48
may be considered for protection of patients with deep venous thrombosis (DVT) with floating
49
thrombus.1
SC
50
RI PT
44
When a patient’s clinical indication for PE protection no longer exists , the retrievable IVC filter can be removed to reduce the risk of potential long-term complications that may result from
52
a permanent IVC filter. As the use of these devices has become more widespread, various
53
problems have arisen, such as limb penetration,2 filter fracture and distant migration of fracture
54
fragments.3, 4 There are several available IVC retrievable filters, such as Denali IVC filter (Bard
55
Peripheral Vascular, Tempe, Arizona), Celect and Gunther Tulip (Cook, Bloomington, Indiana),
56
OptEase (Cordis, Miami Lakes, Florida), Option (Angiotech, Vancouver, BC, Canada), ALN
57
(ALN Implants Chirurgicaux, Ghisonaccia, France), and Crux IVC filter (Crux Biomedical,
58
California, USA), and all of them were proved to be safety and efficacy.3, 5-7
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M AN U
51
Aegisy (Lifetech Scientific, Shenzhen, China) vena cava filter was approved by China Food and Drug Administration (CFDA) as a optional IVC filter, it can be used as a temporary or
61
permanent protection from PE, and was used widely in China. However, isolated reports of
62
safety, efficacy and retrievability of the Aegisy vena cava filter have been presented in the
63
literature. In this study, we sought to retrospectively evaluate the safety, efficacy and
64
retrievability of the Aegisy vena cava filter.
65
Materials and Methods
66
Study Design
AC C
60
3
ACCEPTED MANUSCRIPT
This retrospective study was approved by our institutional review board, and informed consents
68
to treatment were obtained from all the study patients. Cases were identified through the
69
departmental procedural logs. Patient demographics, clinical information, and procedural data
70
were gathered from patients’ medical records.
71
Designs of the Aegisy Filter
72
Aegisy vena cava filter is a laser cut from nitinol alloy, which is composed of 55.4% nickel and
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44.6% titanium. It has a symmetrical double basket design in which proximal and distal baskets
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are connected by six straight struts. It has anchoring barbs only on the inferior end of each of the
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six straight struts. A centrally located hook at the caudal basket is intended for filter snaring.
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(Figure 1, 2). There are three subtypes of this filter, including 18 mm, 25 mm, and 32 mm in
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diameter, and the types of 25 mm and 32 mm are most used. It can be introduced by way of
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either the femoral or the jugular route. The Aegisy filter should be removal within 14 days
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according to the manufacturer’s recommendations.
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Placement and Retrieval Techniques
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Aegisy filters were placed via the common femoral or right internal jugular vein by a 6 Fr-
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catheter. Filters were retrieved through the common femoral vein. IVC cavagram was obtained
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to ensure the position of the filter and the absence of any thrombus. If the filter was to be
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removed, a 10 Fr 60-cm retrieval sheath (Lifetech Scientific Co. Ltd., Shenzhen, China) was
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placed 3 to 4 cm below the filter hook. The hook was grasped by an Amplatz Goose Neck Snare
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(ev3; Plymouth, MN, USA). The filter was collected in the sheath and removed. The procedure
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was completed after control venography was performed using the same sheath.
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Definitions
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Migration refers to the change in the filter position from the original placement (≧1 cm).4 Tilt
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was defined as the angulation between the long axes of the filter and the vena cava. Tilt was
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deemed to be severe if greater than 15°, and the filter hook attached to the IVC wall.4 Because
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the standard cavagram was obtained only in anteroposterior projection, tilt refers to the lateral
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axial deviation. A PE breakthrough was defined as new PE occurring after IVC filter placement.4
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Indication change was defined a temporary indication has been changed for lifelong protection
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against PE clinically after inserting an optional filter.
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Measurements
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In accordance with the aforementioned definitions, analysis of these complications was
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performed by two researchers independently through review of the appropriate images. These
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images were harvested from the imaging archive and saved as digital files. The cavagrams of
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post-placement and preretrieval images were selected, compared and analysised.
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Study End Points
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Presence of PE breakthrough evidenced by clinical features and/or imaging studies was the
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primary outcome measure of the present study. The following end points were also evaluated: (1)
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difficulty in the placemen or retrieval of the filter, and (2) filter migration or tilt.
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Follow-up
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In patients with clinical findings suggestive of PE breakthrough, computed tomography (CT)
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angiography was performed. Patients with suspected DVT were evaluated with Doppler US and
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venography. When patients underwent thorax CT examination for other reasons, the images were
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also examined for the presence of PE. Similarly, when the patients underwent abdominal CT or
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spinal CT/magnetic resonance imaging for other reasons, the images were also examined for
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filter status, migration, tilt and thrombosis.
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Results
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From Oct 2006 to Sep 2015, a total of 276 patients in whom Aegisy vena cava filter was placed
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in a single institution, and 63 patients were excluded, including lost of follow-up (n=31),
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contraindication for anticoagulation (n=21), and development of PE/DVT despite adequate
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anticoagulation (n=11) (Figure 3). A total of 213 patients (127 women, 86 men, mean age, 52.6
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± 8.1 years, rage, 24-78 years) who underwent Aegisy vena cava filter placement for PE
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prophylaxis during CDT or aspiration thrombectomy for the proximal DVT were included in the
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final analyzed, and all the Aegisy filters were placed for PE prophylaxis during CDT or
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aspiration thrombectomy for the proximal DVT. All the Aegisy vena cava filters were
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successfully placed without any difficulty. Radiographic images of the vena cava obtained just
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after placement of the filter did not show the presence of severe tilt, deformity or cava injury in
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any of the patients.
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Of the 213 patients who with filter placement, a total of 150 (70.4%, 150/213) patients were
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scheduled to undergo filter removal, and 63 (29.6%, 63/213) patients have been placed the
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Aegisy filters for permanent use due to ongoing malignancy, old age and poor condition. Of the
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150 patients, filter removal was attempted only in 112 (74.7%, 112/150) patients after a mean
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duration of 12 days (range 9 to 15), and filter removal was abandoned in 38 (25.3%, 38/150)
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patients for patients’ poor condition (n=14), ongoing malignancy (n=10), indication change and
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ongoing need for PE protection (n=8), IVC filter thrombus (n=3) and patient refusal (n=3); also,
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the 38 patients were remaining thrombus of the deep vein at the 14 days of filter placement, and
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left in place as a permanent IVC filter. Of the 112 patiens, removal attempts were successful in
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107 (95.5%, 107/112) patients, and 5 (4.5%, 5/112) patients failed for inability to engage the
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filter hook for the filter hook attached to the IVC wall due to filter tilting. Venography was
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performed pre- and post- filter removal, severe tilt was seen in 5 (4.5%, 5/112) patients, and no
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filter migration and vena cava damage were seen in any of the patients. Of note, the 5 cases who
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with severe tilt at filter retrieval were all presented of tilt (<15°) after placement of the filter. No
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procedure-related complication was observed in any of the patients.
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A total of 47 (22.1%) patients underwent thorax or pulmonary CT for cancer or other
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reasons before the filters were retrieval, and no segmental PE was seen. Also, no symptomatic
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PE breakthrough was seen in any of the patients after the filter placement.
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Discussion
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The results of this study demonstrated that Aegisy vena cava filter is a safe and effective device
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for PE prophylaxis during CDT or aspiration thrombectomy for the proximal DVT. Although
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only 52.6% patients presented for removal, the retrievability of the Aegisy vena cava filter is
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high (95.5%).
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being retrieved from a jugular approach. The Aegisy vena cava filter, similar to the Optease filter,
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is one kind of the filters with a diamond-like shape that is retrieved from an inferior approach
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(femoral). The results of this study were similar to the previous reports about Optease filter:
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effective for PE prophylaxis, low rate of filter migration, tilt, fracture, and deformity.8, 9 Also has
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high rate of filter retrievability.8, 9 We believe that the results of this study have directe
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relationship with the structure of Aegisy vena cava filter.
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Due to its structure, there are six vertical struts, which adhere to the caval wall after
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deployment and can thus become covered with intima over time. This seems to be the indwelling
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time limiting factor of the Aegisy IVC filter. This problem does not exist with conical filters with
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only the tips of the legs attaching to the caval wall. Therefore, the most important limitation of
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Aegisy as a retrievable filter is its requirement for an early retrieval (within 14 days according to
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the manufacturer’s recommendations), whereas conical filters can be retrieved after much longer
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time as published: 158.1 days (range, 2-518 days) for Celect filter,3 127.6 days (range, 3-361
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days) for G2 filter. According this study, filter removal was abandoned in 25.3% (38/150)
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patients for patients’ poor condition, ongoing malignancy, indication change and ongoing need
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for PE protection, IVC filter thrombus, and patient refusal; also the 38 patients were remaining
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thrombus at the 14 days of filter placement. In this condition, the filters were left in place as a
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permanent IVC filter. Recently, Scher D, et al.10 reported 5 Optease filters were successfully
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retrieved after an average 977 days (range, 123-2,584 d) placement. However, all patients
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exhibited IVC stenosis after filter retrieval, and an IVC pseudoaneurysm was present following
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retrieval in one case. There was no data about the retrievability of Aegisy IVC filter after a long
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time placement.
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Migration rates vary greatly among types and models of filters and filter manufacturers,11-13
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and even among different observers for the same filter model.11, 14 Although many reports
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proved that the filter migration have close relationship with the ratio of filter and IVC diameter.15
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The mechanism of filter migration is not clear. There are three subtypes of Aegisy vena cava
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filter, and the 25 mm and 32 mm in diameters of Aegisy vena cava filter were most used in this
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study, and no filter migration was observed.
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Filter tilt is a well-recognized phenomenon that is most commonly associated with conical
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filters.3, 4 Although the filter struts anchored at the caval wall form a relatively stable base, the tip
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floats freely without support. Over time, movement in the IVC or radial force in the filter allows
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the filter to reposition itself to its most stable position.3 In this study, 5 filters failed for inability
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to engage the filter hook for the filter hook attached to the IVC wall due to filter tilting. The tilt
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rate was lower than reported conical filters,3 which maybe related with the diamond-like shape of
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Aegisy vena cava filter. The tilting problem was not preventable with this device and led to the
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device not being retrieved by using conventional snares or retrieval cone catheter techniques. It
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was reported that the success rate of IVC filter retrieval can be as high as 97%-100% by
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advanced retrieval technique, such like curved catheter technique, loop-and-snare technique,
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balloon assisted technique, forceps technique, excimer laser technology.16-19 However, the
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advanced retrieval techniques were not used after discussion with the 5 patients. We believe the
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5 filters can be removed in using the advanced retrieval techniques mentioned above.
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Study Limitations
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The limitation of this study was its retrospective nature, which may limit the generalizability of
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the observed results. Also, the fact that the true rates of PE in the patients is unknown as only
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symptomatic patients underwent evaluation for PE. Furthermore, just like zhou’s reported4 tilt
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was defined as only that which occurred as lateral deviation; tilt in the anteroposterior plane
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cannot be determined by reviewing standard cavagrams.
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Conclusions
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Aegisy vena cava filter is a safe and effective device for PE prophylaxis. Although only half
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patients presented for removal, the retrievability of the Aegisy vena cava filter is high.
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Acknowledgement
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None.
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Funding
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None.
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Conflicts of interest
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The authors indicated no potential conflicts of interest.
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References
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Grassi CJ, Swan TL, Cardella JF, et al. Quality improvement guidelines for percutaneous permanent inferior vena cava filter placement for the prevention of pulmonary embolism. J Vasc Interv Radiol 2003;14:S271-S275. Jia Z, Wu A, Tam M, et al. Caval Penetration by Inferior Vena Cava Filters: A Systematic Literature Review of Clinical Significance and Management. Circulation 2015;132. Zhou D, Spain J, Moon E, et al. Retrospective review of 120 celect inferior vena cava filter retrievals: experience at a single institution. J Vasc Interv Radiol 2012;23:1557-63. Zhu X, Tam MD, Bartholomew J, et al. Retrievability and device-related complications of the G2 filter: a retrospective study of 139 filter retrievals. J Vasc Interv Radiol 2011;22:806-12. Rimon U, Bensaid P, Golan G, et al. Optease vena cava filter optimal indwelling time and retrievability. Cardiovasc Intervent Radiol 2011;34:532-5. Mahrer A, Zippel D, Garniek A, et al. Retrievable vena cava filters in major trauma patients: prevalence of thrombus within the filter. Cardiovasc Intervent Radiol 2008;31:785-9. Turba UC, Arslan B, Meuse M, et al. Günter Tulip Filter Retrieval Experience: Predictors of Successful Retrieval. CardioVascular and Interventional Radiology 2009;33:732-738. Onat L, Ganiyusufoglu AK, Mutlu A, et al. OptEase and TrapEase vena cava filters: a single-center experience in 258 patients. Cardiovasc Intervent Radiol 2009;32:992-7. Oliva VL, Szatmari F, Giroux MF, et al. The Jonas study: evaluation of the retrievability of the Cordis OptEase inferior vena cava filter. J Vasc Interv Radiol 2005;16:1439-45; quiz 1445. Scher D, Venbrux A, Okapal K, et al. Retrieval of TRAPEASE and OPTEASE Inferior Vena Cava Filters with Extended Dwell Times. J Vasc Interv Radiol 2015;26:1519-1525. Tam MD, Spain J, Lieber M, et al. Fracture and distant migration of the Bard Recovery filter: a retrospective review of 363 implantations for potentially life-threatening complications. J Vasc Interv Radiol 2012;23:199-205 e1. Wang W, Zhou D, Obuchowski N, et al. Fracture and Migration of Celect IVC Filters: A Retrospective Review of 741 Consecutive Implantations. J Vasc Interv Radiol 2013;24:1719-1722. Hull JE, Han J, Giessel GM. Retrieval of the recovery filter after arm perforation, fracture, and migration to the right ventricle. J Vasc Interv Radiol 2008;19:1107-11. Nicholson W, Nicholson WJ, Tolerico P, et al. Prevalence of fracture and fragment embolization of Bard retrievable vena cava filters and clinical implications including cardiac perforation and tamponade. Arch Intern Med 2010;170:1827-31. Shmuter Z, Frederic FI, Gill JR. Fatal migration of vena caval filters. Forensic Sci Med Pathol 2008;4:116-121.
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Van Ha TG, Vinokur O, Lorenz J, et al. Techniques used for difficult retrievals of the Gunther Tulip inferior vena cava filter: experience in 32 patients. J Vasc Interv Radiol 2009;20:92-9. Doody O, Noë G, Given MF, et al. Assessment of Snared-Loop Technique When Standard Retrieval of Inferior Vena Cava Filters Fails. CardioVascular and Interventional Radiology 2008;32:145-149. Kuo WT, Cupp JS, Louie JD, et al. Complex Retrieval of Embedded IVC Filters: Alternative Techniques and Histologic Tissue Analysis. CardioVascular and Interventional Radiology 2011;35:588-597. Kuo WT, Odegaard JI, Louie JD, et al. Photothermal ablation with the excimer laser sheath technique for embedded inferior vena cava filter removal: initial results from a prospective study. J Vasc Interv Radiol 2011;22:813-23.
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Aegisy vena cava filter (Lifetech Scientific) with caudal retrieval hook and caudal fixation barbs.
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Figure 2
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Aegisy vena cava filter has a symmetrical double basket design in which proximal and distal
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baskets are connected by six straight struts.
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Figure 3
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Patient management flow chart.
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