CLINICAL INVESTIGATION · 2019. 11. 25. · CLINICAL INVESTIGATION Percutaneous Retrieval of...
Transcript of CLINICAL INVESTIGATION · 2019. 11. 25. · CLINICAL INVESTIGATION Percutaneous Retrieval of...
CLINICAL INVESTIGATION
Percutaneous Retrieval of Permanent Inferior Vena Cava Filters
Anobel Tamrazi1 • Vibhor Wadhwa1,2 • Brian Holly1 • Nikhil Bhagat3 •
Jonathan K. Marx1 • Michael Streiff4 • Mark L. Lessne1,5
Received: 20 June 2015 / Accepted: 13 September 2015
� Springer Science+Business Media New York and the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) 2015
Abstract
Purpose To evaluate the feasibility, risks, and techniques
of percutaneous removal of permanent TrapEase and
Simon Nitinol IVC filters.
Materials and Methods Between August 2011 and
August 2015, 12 patients (5 women, 7 men; age range,
26–75 years) underwent an attempt at percutaneous
removal of permanent TrapEase (10) and Simon Nitinol (2)
IVC filters due to a history of IVC filter complications or
need for lifelong anticoagulation due to the filter. Medical
records were reviewed for filter dwell time, presence of
iliocaval deep venous thrombosis, procedural technique,
and complications.
Results Filter dwell times ranged from 7 days to 15 years
(mean 5.1 years). Successful removal of permanent IVC
filters was possible in 11 of 12 patients (91.6 %). In 1
patient, a chronically thrombosed IVC filter could not be
removed despite laser sheath assistance, but was success-
fully recanalized with the PowerWire RF guidewire. In the
failed retrieval attempt, a stent was placed through the
chronically thrombosed IVC filter with restoration of in-
line flow. One major complication of large venous groin
hematoma was encountered.
Conclusions In carefully selected patients, percutaneous
removal of permanent IVC filters can be performed safely
despite prolonged filter dwell times. Extraction of chroni-
cally embedded permanent IVC filters may be facilitated
by jugular and femoral approaches, often with laser sheath
assistance. Chronic filter thrombosis and caval scarring
may increase the risk of retrieval failure.
Keywords Inferior vena cava � TrapEase � IVCfilter � Simon Nitinol
Introduction
Venous thromboembolism (VTE) represents a spectrum of
a disease, which includes deep vein thrombosis (DVT) and
pulmonary embolism (PE). It is the third most common
& Anobel Tamrazi
Vibhor Wadhwa
Brian Holly
Nikhil Bhagat
Jonathan K. Marx
Michael Streiff
Mark L. Lessne
1 Division of Vascular & Interventional Radiology, Johns
Hopkins University School of Medicine, 1800 Orleans Street,
Sheik Zayed Towers, Suite 7203, Baltimore, MD 21287,
USA
2 Department of Radiology, University of Arkansas for
Medical Sciences, Little Rock, AR, USA
3 Division of Vascular & Interventional Radiology, Kaiser
Permanente, McLean, VA, USA
4 Department of Hematology, Johns Hopkins University
School of Medicine, Baltimore, MD, USA
5 Vascular & Interventional Specialists of Charlotte Radiology,
Charlotte, NC, USA
123
Cardiovasc Intervent Radiol
DOI 10.1007/s00270-015-1214-0
cardiovascular illness after acute coronary syndrome and
stroke, with annual worldwide incidence rates ranging from
0.75 to 2.69 per 1000 individuals in the population [1].
Although anticoagulation is the therapy of choice for VTE,
it is not suitable in some patients with potential con-
traindications to anticoagulation, such as hemorrhagic
stroke, brain neoplasm, or craniospinal trauma. In such
patients, inferior vena cava (IVC) filters provide an alter-
native therapeutic strategy to prevent life-threatening PE.
The Prevention du Risque d’Embolie Pulmonaire par
Interruption Cave (PREPIC) study showed a significant
reduction in occurrence of PE in patients with proximal
DVT, as compared to patients without an IVC filter [2].
However, the study also showed an increased occurrence of
DVT with a 13 % IVC thrombosis rate at 8 years in a
population in whom approximately 50 % were receiving
anticoagulation. Other potential complications related to
long-term IVC filters include filter fracture, IVC perfora-
tion, and filter migration [3]. Due to the increased risk of
complications, the US Food and Drug Administration
issued an initial communication in 2010, recommending
that retrievable IVC filters be considered for removal once
protection from PE is no longer needed [4]. However,
patients who have permanent IVC filters, never designed
for removal, may still remain at risk for filter-related
complications. The TrapEase (Cordis, Bridgewater, NJ)
and Simon Nitinol (BARD Peripheral Vascular, Tempe,
AZ) filters are two such permanent devices, though their
removal techniques have been reported in few case reports
[5–10]. The purpose of this study was to evaluate the
feasibility, risks, and techniques of permanent TrapEase
and Simon Nitinol IVC filters in a series of 12 patients
using various endovascular techniques.
Materials and Methods
Institutional review board (IRB) exception was obtained
from our institution for this HIPAA compliant retrospective
study.
Patients
Between August 2011 and August 2015, 12 patients (5
women, 7 men; age range 26–69 years; average age
54.9 years) underwent an attempt at percutaneous removal
of permanent TrapEase (10 patients) or Simon Nitinol fil-
ters (2 patients) (Table 1). Inclusion criteria included a
history of IVC filter complication, such as filter-related
IVC thrombosis, or prescription of lifelong anticoagulation
due to the presence of the IVC filter. Patients with
asymptomatic IVC filters who required lifelong anticoag-
ulation regardless of IVC filter presence were not
considered for filter removal. Type of filter, dwell time,
indications for filter placement and retrieval, presence or
absence of caval clot on pre-procedural venogram, tech-
nique, route of access, and use of laser assistance were
recorded. The technique used in each case was categorized
whether removal was performed using standard vascular
sheaths from an internal jugular vein (IJV) approach, a
common femoral vein (CFV) approach, and if a laser
sheath was used. The data were recorded and analyzed
using Excel 2013 (Microsoft Inc., Seattle, WA).
Techniques of Filter Removal
Procedures were performed either under conscious sedation
or general anesthesia dependent on clinical scenario and
physician preference, by three fellowship trained vascular
& interventional radiologists at a high-volume, quaternary
care hospital. Initially, venography was performed using a
low-profile access sheath and a flush catheter in two pro-
jections to verify the position of the filter and assess for
IVC thrombus burden and contraindication to filter
removal. Thrombolysis of an acute or subacute iliocaval
thrombosis or recanalization of chronic iliocaval throm-
bosis was performed as needed; for acute iliocaval
thrombosis, patients were often scheduled for IVC filter
removal 2–4 weeks following initial thrombolysis.
For the filter removal procedure, 18–22 Fr Dry-Seal
sheaths (Cook Biotech Inc , West Lafayette, IN) were
routinely employed, allowing placement of a telescoping
12–18F sheath. All patients were heparinized (approxi-
mately 50 units/kg) during the retrieval procedures. An
in situ loop snare was formed around the filter apex using a
stiff glide wire (Terumo Corporation, Tokyo, Japan) that
was snared and externalized through the jugular or femoral
access; if both cranial and caudal controls of a TrapEase
filter were required, then the loop snare was formed from
both access sites (Fig. 1). Care was taken to form the loop
snare around the filter apex, avoiding passage lateral to the
apex and around the filter struts, which may distort the
filter and increase the difficulty of retrieval. For the Simon
Nitinol filters, the embedded tip was dissected using
endobronchial forceps (Bryan Corporation, Woburn, MA)
prior to loop snare (Fig. 2). In our experience, freeing the
filter tip allowed for a more stable loop snare formation
around the apex of the filter.
After successful wire loop of the filter apex, extraction
was attempted with blunt dissection using a 12–18F vas-
cular sheath often from simultaneous cranial and caudal
approaches. If the filter could not be sheathed due to
excessive resistance, a laser sheath (12–16F) (Spectranetics
Corporation, Colorado Springs, CO) was introduced
through either the jugular (Fig. 3) or femoral (Fig. 4) Dry-
Seal sheath, over the loop snare and a 6 or 7F sheath was
A. Tamrazi et al.: Percutaneous Retrieval of Permanent Inferior Vena Cava Filters
123
Table 1 List of patients who underwent percutaneous IVC Filter removal
Patient:
Age,
M/F
IVC
filter
dwell
time
Type of
filter
Indication for
filter
placement
Indication for filter
removal
Post-filter caval
thrombosis, thrombolysis
or recanalization
performed before filter
removal
Technique of filter removal Complication
26, M 7 days TrapEase DVT with CI
to AC
Repeat US showed
no evidence of
DVT; suspected
misdiagnosis at
outside hospital
No Blunt dissection from
jugular (12f) and femoral
(12f) approach
None
42, F 8 years TrapEase DVT and PE
with CI to
AC
To cessation of AC Yes: thrombolysis Laser-assisted extraction
from femoral approach
(14f) with simultaneous
blunt dissection from
jugular access (14f)
None
52, F 9 months TrapEase DVT and
submassive
PE with CI
to AC
To allow cessation
of AC
No Blunt dissection from
jugular (14f) and femoral
(14f) approach
None
65, F 8 years TrapEase DVT with CI
to AC
To allow cessation
of AC
No Laser-assisted extraction
from jugular approach
only
Post-retrieval
caval stenosis
responsive to
angioplasty
(Grade B
complication)
62, F 4 years TrapEase PE with CI to
AC
To allow cessation
of AC
No Laser-assisted extraction
from jugular approach
only
None
69, M 6 years TrapEase DVT and PE
with CI to
AC
Filter thrombosis
with post
thrombotic
syndrome
Yes: Recanalization with
RF wire
Failure: Attempted laser-
assisted extraction from
jugular approach only
Delayed, large
groin
hematoma
1 week post
procedure
(Grade D
complication)
57, M 4 years TrapEase DVT with CI
to AC
To allow cessation
of AC
Yes:
In 2013 due to filter and
IVC thrombosis.
Laser-assisted extraction
from jugular approach
only
None
63, M 15 years Simon
Nitinol
DVT and PE
with CI to
AC
Filter thrombosis
with post
thrombotic
syndrome
Yes 11/2014 due to filter
and IVC thrombosis.
Laser-assisted extraction
(14f) from jugular
approach only
None
44, F 4 years Simon
Nitinol
PE with CI to
AC
To allow cessation
of AC
No Laser-assisted extraction
(16f) and blunt dissection
(18f) from jugular
approach
None
60, M 3 months TrapEase PE with CI to
AC
To allow cessation
of AC
No Blunt dissection (16f) from
jugular and femoral
approach
None
75, M 8 years TrapEase DVT with CI
to AC
Chronic IVC
thrombosis with
post thrombotic
syndrome
Yes due to thrombosis of
inferior IVC and iliac
veins
Laser-assisted extraction
(16F) from jugular
approach only followed
by iliac vein stenting for
recanalization
None
44, M 4 years TrapEase Prophylactic
for trauma
To allow cessation
of AC
Yes: caval thrombosis
4 months post-filter
placement after holding
AC for 1.5 weeks. No
thrombolysis
performed
Laser-assisted extraction
(16F) from jugular
approach and blunt
dissection with bronchial
forceps and 16F sheath
from CFV
None
PE pulmonary embolism, AC anticoagulation, DVT deep vein thrombosis, CI contraindication
A. Tamrazi et al.: Percutaneous Retrieval of Permanent Inferior Vena Cava Filters
123
placed at the end of the laser sheath to provide a hemostatic
valve. The decision for cranial or caudal approach was
made based on the best apical loop snare position allowing
for filter collapse. The standard and laser sheaths were used
to collapse the filter as much as possible before activating
the laser. When laser activation was needed, gentle traction
was applied to the loop snare, while laser photoablation
was activated for 3–5 s bursts. Between laser bursts, the
larger external sheath was used for blunt dissection with
substantially greater traction.
A completion venogram was performed to evaluate for
procedural complications. Angioplasty and stenting was
performed subsequently as needed for flow limiting ste-
noses. Hemostasis was obtained at the access sites with a
single purse string suture. Early in the experience, patients
were admitted for overnight observation, but later the
procedure was performed on an outpatient basis. Post-re-
trieval complications were graded (A–D) according to their
severity. All patients were anticoagulated at least an
additional 2 weeks following filter retrieval.
Results
Filter dwell times ranged from 7 days to 15 years (mean
5.1 years). Successful removal of the permanent IVC filter
was possible in 11 of 12 patients (91.6 %) and restoration
of flow through the IVC was possible in 12 of 12 patients.
Fig. 1 A–C: A 52-year-old female with 9-month-old TrapEase filter.
A Loop snare is formed using a reverse curve catheter around superior
and inferior filter. B Filter is successfully removed using blunt
dissection with 12 and 14 Fr sheaths from superior and inferior
approaches. A 12F laser sheath was loaded into the system inferiorly,
but never activated since blunt dissection from above and below was
able to remove the filter successfully without need for photoablation.
C Completion cavagram shows no thrombus or vessel injury
A. Tamrazi et al.: Percutaneous Retrieval of Permanent Inferior Vena Cava Filters
123
Blunt dissection with a vascular sheath from both IJV and
CFV alone was sufficient in extracting three TrapEase fil-
ters, while laser photoablation was required in 8 of 11
successful retrievals in this study. In the cases requiring
laser assistance, IJV access was used in 8 cases and CFV
access was used in 1 case, which was supplemented by
sheath from the IJV. The choice of laser activation from a
jugular or femoral approach was determined based on
which end attained a better in situ loop snare control of the
biconical filter (Fig. 3 and 4). The Simon Nitinol filters
Fig. 2 A-D: A 63-year-old
male with 15-year-old Simon
Nitinol filter. A Endobronchial
forceps used to detach the tilted
tip of the filter from the IVC
wall allowing for proper loop
snare. B Loop snare is formed
using a reverse curve catheter
around the apex of the filter.
C Filter is successfully removed
using blunt dissection with 18F
ad laser photoablation with 16F
sheaths from superior approach.
D Photograph of a 15-year-old
Simon Nitinol filter removed
with laser assistance from
superior approach
A. Tamrazi et al.: Percutaneous Retrieval of Permanent Inferior Vena Cava Filters
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were accessed only from IJV and both cases required laser
photoablation (Fig. 2). A history of caval thrombosis was
found in 6/12 cases (50 %). Post-retrieval complications
were seen in two patients—one patient developed caval
stenosis which was responsive to angioplasty (grade B).
The other patient had a delayed, large groin hematoma
1 week post procedure which resolved on further follow-up
(grade D).
In the one failed retrieval case, the caudal aspect of the
TrapEase filter was scarred into a chronically obliterated
IVC (Fig. 5) that required PowerWire RF guidewire
(Baylis Medical, Montreal, QC, Canada) for recanalization
after failure of sharp recanalization with back end of Meier
wire (Boston Scientific, Natick, MA). The filter could not
be removed despite moderate tension on the laser sheath.
To treat the patient’s obstructive symptoms, stent recon-
struction of the IVC with exclusion of the TrapEase filter
was performed (Fig. 5) with restoration of in-line caval
flow.
Discussion
IVC filters have been shown to prevent PE in patients who
have contraindications to anticoagulation or those with
recurrent DVT/PE despite anticoagulation therapy [11].
The introduction of retrievable filters has led to dramatic
increase in the use of these devices [12]. Although, some
retrievable filters that have been indwelling for extended
periods may be as difficult to remove as permanent ones,
permanent filters are not designed for retrieval and poten-
tially place the patient at risk for filter-related complications,
including caval thrombosis, migration, filter fracture, and
IVC perforation [2]. The TrapEase filter is a type of per-
manent IVC filter, which has a biconical design with double
level filtration. Kalva et al. reported their experience with
TrapEase filters in a series of 751 patients, with the filter
showing high clinical efficacy [13]. However, the compli-
cations in their series included filter components fracture
(3 %), thrombus within the filter (25.2 %), thrombus
extending beyond the filter (1.5 %), and near total caval
occlusion (0.7 %). Thus, one in every four patients receiving
the filter may develop at least partial caval thrombosis during
the dwell time of this permanent filter. The Simon Nitinol
filter (SNF) is made of a nickel and titanium alloy, which
allows it to be mechanically stable. Poletti et al reported a
long-term follow-up of SNF and found that 5.3 % patients
developed DVT, 3.5 % patients had thrombosis of IVC, and
the rate of these complications was similar in patients with or
without anticoagulation therapy [14].
In addition, although the recent American College of
Chest Physicians guidelines [15] do not consider a
Fig. 3 A-B: A 65-year-old
female with 8-year-old
TrapEase filter complicated by
caval thrombosis. After
successful thrombolysis, the
patient returned for laser-
assisted permanent IVC filter
extraction. A The filter was can
be removed using laser
photoablation from a superior
approach only. B Completion
cavagram demonstrates non-
flow limiting stenosis at the
filter site
A. Tamrazi et al.: Percutaneous Retrieval of Permanent Inferior Vena Cava Filters
123
permanent IVC filter as an indication for extended anti-
coagulation, some hematologists may nonetheless advocate
for lifelong anticoagulation as long as the filter is in place
to minimize risk of caval thrombus, as is true in our center.
At our institution, nearly all patients in our series already
suffered a caval thrombosis or were committed to indefinite
anticoagulation due to their indwelling permanent IVC
filters. It has been suggested that the opposed biconical
design filters (TrapEase and OptEase) are more likely to be
associated with vena caval thrombosis, than the single-cone
design filters (Greenfield, Recovery, and Gunther-Tulip)
[16]. This may be due to the ‘‘margination effect’’ of the
filter wherein the captured thrombus marginates to the vena
caval wall, where the flow is the lowest and thus predis-
poses to thrombosis [17].
Removal of IVC filters once the patient has lost indi-
cation for caval filtration has been encouraged secondary
to these potential filter-related complications [18]. Chronic
filter implants lead to neointimal hyperplasia and dense
fibrosis, which tend to make the retrieval difficult [19].
Complex techniques to remove tilted, embedded, or frac-
tured retrievable IVC filters have been described [20].
Removal of permanent IVC filters has less often been
reported: Mousa et al. described a simple algorithm for
retrieval of two TrapEase filters up to 14 months after
implant [21] and Kuo et al have reported laser photoab-
lation for removal of SNF and biconical filters [22]. A
pre-procedural venogram is required in all patients to
exclude acute caval thrombus. If needed, pre-procedure
thrombolysis using tissue-type plasminogen activator
(tPA) or recanalization should be done. Laser photoabla-
tion was required in most of our successful cases (8/11);
however, attempting retrieval using standard blunt dis-
section first may be useful before using laser assistance
given the expense associated with the laser sheath. Tilted
or distorted filters are difficult to retrieve with standard
techniques, which require engaging the tip of the filter; for
removal of a Simon Nitinol filter, we used the endo-
bronchial forceps to free the tip from the caval wall
(Fig. 2), allowing for more stable loop snare of the filter
apex. In our failed TrapEase retrieval case, the inferior
portion of the TrapEase was densely embedded in chronic
caval occlusion (Fig. 5) and the filter was not removed
with moderate traction during laser sheath activation. The
patient’s obstructive symptoms were resolved by stent
reconstruction of his IVC, excluding the filter (Fig. 5).
Stenting through an IVC filter rather than removing it
remains a viable option with good outcomes [22] and
further studies regarding the outcomes and cost-effec-
tiveness of these two techniques is warranted.
Fig. 4 A-B: A 42-year-old female with 8-year-old TrapEase filter,
complicated by IVC thrombosis. A Following thrombolysis, the
patient returned for IVC filter removal using a combination of blunt
dissection from superior approach and laser photoablation from
below. B Close-up view of the superior and inferior approach sheaths
near the completion of filter extraction
A. Tamrazi et al.: Percutaneous Retrieval of Permanent Inferior Vena Cava Filters
123
Our study had several limitations. First, the sample size
of twelve patients is small, but it should be emphasized that
only selected patients were considered for removal and
many patients do not have a strong enough indication to
warrant complex retrieval attempt. Secondly, we have only
short-term outcomes for these patients as long-term follow-
up is outside the scope of this report. Third, this series
includes patients with TrapEase and Simon Nitinol IVC
filters, but not all the available permanent filters in the
market, and thus we cannot extrapolate our findings to
other permanent filter types.
In conclusion, percutaneous removal of permanent
TrapEase and Simon Nitinol IVC filters can be performed
safely on carefully selected patients despite prolonged filter
dwell times. Extraction of chronically embedded filters
may require jugular and femoral approaches, often with
laser sheath assistance. Proper loop snare of the filter apex
can facilitate sheathing, but chronic filter thrombosis and
caval scarring may increase the risk of retrieval failure.
Although many, or most patients with permanent IVC
filters do not warrant an attempt at removal, our experience
and techniques described above can permit retrieval of
permanent IVC filters that have resulted in caval throm-
bosis or that consign the patient to indefinite anticoagula-
tion and all its associated risks.
Funding Dr Michael Streiff has received research funding from
Daiichi-Sankyo, Janssen, and Portola and consulted for BiO2Medical,
Boehringer-Ingelheim, Daiichi-Sankyo, Eisai, and Janssen Health-
Care. Dr Mark L Lessne has received research funding from Merit
Medical, consulted for Apriomed, and is an investigator on Cook
Medical IVC filter trial.
Compliance with Ethical Standards
Conflict of Interest Anobel Tamrazi, Vibhor Wadhwa, Brian
Holly, Nikhil Bhagat, and Jonathan K Marx have no conflicts of
interest.
Ethical Approval All procedures performed in studies involving
human participants were in accordance with the ethical standards of
the institutional research committee and with the 1964 Helsinki
declaration and its later amendments or comparable ethical standards.
Fig. 5 A-D: A 69-year-old male with a 6-year-old TrapEase filter
with chronically obliterated IVC requiring RF wire recanalization
prior to attempted filter retrieval. A Chronic IVC filter with
completely obliterated IVC. B and C After successful RF wire
recanalization of inferior IVC, attempt was made to remove the filter
from cranial approach with laser photoablation without success. The
caudal aspect of the TrapEase filter was scarred into the chronically
obliterated IVC preventing safe retrieval of the filter. D Successful
recanalization of internal iliacs and IVC with kissing 12 mm
E-Luminexx stenting through the embedded TrapEase filter
A. Tamrazi et al.: Percutaneous Retrieval of Permanent Inferior Vena Cava Filters
123
Informed Consent Informed consent was obtained from all indi-
vidual participants included in the study.
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