- Email: [email protected]
Indications and Outcomes of Open Inferior Vena Cava Filter Removal
Accepted Manuscript Indications and outcomes of open inferior vena cava filter removal Kristofer M. Charlton-Ouw, MD, Shaikh Afaq, MD, Samuel S. Leake, BS, Harleen K. Sandhu, MD, MPH, Cristina N. Sola, RN, Naveed U. Saqib, MD, Ali Azizzadeh, MD, Hazim J. Safi, MD PII:
S0890-5096(17)30732-X
DOI:
10.1016/j.avsg.2017.05.038
Reference:
AVSG 3422
To appear in:
Annals of Vascular Surgery
Received Date: 21 March 2017 Revised Date:
15 May 2017
Accepted Date: 30 May 2017
Please cite this article as: Charlton-Ouw KM, Afaq S, Leake SS, Sandhu HK, Sola CN, Saqib NU, Azizzadeh A, Safi HJ, Indications and outcomes of open inferior vena cava filter removal, Annals of Vascular Surgery (2017), doi: 10.1016/j.avsg.2017.05.038. 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
1
3
Indications and outcomes of open inferior vena cava filter removal
RI PT
2
4
5
9 10
1
11
2
SC
Kristofer M Charlton-Ouw, MD1,2, Shaikh Afaq, MD1,2, Samuel S. Leake, BS1, Harleen K. Sandhu, MD, MPH1, Cristina N. Sola, RN1, Naveed U. Saqib, MD1,2, Ali Azizzadeh, MD1,2, Hazim J. Safi, MD1,2 Department of Cardiothoracic and Vascular Surgery, McGovern Medical School, University of Texas Health Science Center at Houston (UTHealth)
M AN U
6 7 8
Memorial Hermann Hospital System, Houston, Texas
12
TE D
13
Presented at the Vascular and Endovascular Surgery Society Annual Meeting 2017, Steamboat Springs, CO, USA.
16 17 18 19
The authors report no conflicts of interest with regard to this manuscript. Dr. Charlton-Ouw is a consultant with W.L. Gore and Associates. Dr. Azizzadeh is a consultant with W.L. Gore and Associates and Medtronic. No external funding sources were used in connection with this research.
21 22 23 24 25 26 27 28 29
AC C
20
EP
14 15
Corresponding Author: Kristofer M. Charlton-Ouw, MD Department of Cardiothoracic and Vascular Surgery University of Texas Health Science Center at Houston 6400 Fannin St, Ste 2850 Houston, TX 77030 Office 713-486-5100 [email protected]
ACCEPTED MANUSCRIPT 2
Abstract
31
Introduction: Despite recommendations for retrieval of inferior vena cava (IVC) filters, most are
32
not removed in a timely manner. Longer IVC filter dwell times are associated with caval wall
33
perforation and tilting that make percutaneous retrieval more difficult. Open IVC filter removal
34
is generally reserved for patients with symptoms referable to the filter, such as chronic back and
35
abdominal pain. We present our management algorithm and review of cases of open IVC filter
36
removal.
37
Methods: Patients referred for management of implanted IVC filters from May 2010 to May
38
2016 were included. Demographic and imaging were reviewed for cases requiring open surgical
39
removal.
40
Results: There were 221 percutaneous retrieval attempts in 218 patients. Successful retrieval
41
occurred in 196 (89%) attempts. There were 7 patients that had open surgical IVC filter removal
42
after failure of percutaneous retrieval. One patient had 2 filters and another had 3 filters. Except
43
for 1 case with complications during the percutaneous retrieval procedure, the remaining patients
44
all suffered from back or abdominal pain. All had significant filter strut penetration through the
45
caval wall into adjacent structures. Postoperatively, all patients had relief of pain. There were no
46
deaths and one patent had a minor ileus that spontaneously resolved.
47
Conclusions: Patients who fail percutaneous IVC filter retrieval can expect low morbidity and
48
prompt resolution of symptoms after open surgical removal via mini-laparotomy.
49
50
AC C
EP
TE D
M AN U
SC
RI PT
30
ACCEPTED MANUSCRIPT 3
51 52
Introduction Retrievable inferior vena cava (IVC) filters were developed to protect patients from fatal pulmonary embolism and to allow for device removal once this risk abated. However, multiple
54
studies have shown that device retrieval occurs in <50% of cases.1, 2 This is most often due to
55
lack of referral into a comprehensive follow-up program. The benefit of routine filter retrieval
56
has recently been called into question and may not be cost-effective.3 The counter argument is
57
that as many as a quarter of patients do have complications related to long-term indwelling
58
filters, including IVC thrombosis, filter dislocation, recurrent pulmonary embolism, penetration
59
of filter struts through pericaval structures, and chronic pain.4, 5 The U.S. Food and Drug
60
Administration reaffirmed its recommendation in 2014 that retrievable IVC filters should be
61
removed when reasonable.
SC
M AN U
62
RI PT
53
Most filters can be removed percutaneously using standard techniques but occasionally require creative maneuvers. Assuming the transient risk of pulmonary embolism has passed, the
64
optimal time of IVC filter retrieval is estimated to be 1-2 months after implantation.6 This is
65
outside the 12-day retrieval window of the Cordis OPTEASE filter and many filters tend to
66
become more difficult to remove over time. This is usually due to strut penetrations through the
67
caval wall leading to tilting and scar formation. Especially with deep filter strut penetration and
68
severe misalignment, percutaneous retrieval may not be possible without undue risk. We noted
69
several cases where the filter was nearly sideways in the IVC or entangled with a second filter.
70
Open IVC filter removal can be done through a retroperitoneal or transperitoneal mini-
71
laparotomy approach. We describe our indications for open filter removal, technique, and
72
outcomes in 7 cases.
AC C
EP
TE D
63
ACCEPTED MANUSCRIPT 4
73
75
Methods Patients referred for management of implanted IVC filters from May 2010 to May 2016
RI PT
74
were included. From 2011 to 2015, patients referred for IVC filter management were enrolled in
77
a prospective registry after signing informed consent. Thereafter, patients were periodically
78
contacted to assess for ongoing need for the IVC filter. Since 2015, contacting patients regarding
79
their IVC filter was deemed the practice standard and need for signed informed consent was
80
waived. Retrospective research access to the database was approved by the Committee for the
81
Protection of Human Subjects, the local ethics institutional review committee. Demographic and
82
imaging information was reviewed for cases requiring open surgical removal. Durable resolution
83
of symptoms was ascertained by accessing outpatient follow-up records.
M AN U
SC
76
85 86
Surgical technique
TE D
84
A standard technique is applied with the initial goal of obtaining access to the retroperitoneum and IVC and to allow inspection of the surrounding structures. In each case, a
88
midline laparotomy incision is made approximately 10 cm in length depending on the patient’s
89
anatomy. The small bowels are packed to the right side and the retroperitoneum is entered to the
90
left of the duodenum. The duodenum is elevated off of the IVC, retracted to the patient’s right
91
side, and inspected for any penetration. If needed, the struts or filter tines are carefully removed
92
with repair of the bowel wall.
93 94
AC C
EP
87
Control of the cava is with proximal and distal clamps after intravenous anticoagulation. However, inflammation and scarring around the cava can be significant making the dissection
ACCEPTED MANUSCRIPT 5
tedious. Direct pressure over the proximal and distal IVC with sponge sticks usually offers
96
adequate hemostasis. Once control is obtained, a longitudinal venotomy is made (Figure 1). An
97
endovenectomy is performed as needed to remove scar tissue surrounding the filters within the
98
lumen. It is important to keep in mind that the filter may embed itself in the renal vein or other
99
tributaries. Once the luminal surface is free of filter and scar, the venotomy is primarily repaired
100
with running 5-0 polypropylene suture (Figure 2). We find that a patch angioplasty is not usually
101
needed except in cases of chronic occlusion and scarring. After the repair, anticoagulation is
102
reversed and the laparotomy closed.
M AN U
103 104
105
SC
RI PT
95
Results
There were 221 percutaneous retrieval attempts in 218 patients during the study period. Only 2% of the filters were placed by our group; the remainder were referred to us for retrieval.
107
Successful percutaneous retrieval occurred in 196 (89%) attempts. There were 7 patients that had
108
open surgical IVC filter removal after failure of percutaneous retrieval. One additional patient
109
required median sternotomy and cardiopulmonary bypass after the filter migrated to the caval-
110
atrial junction during retrieval attempt at another hospital. Most were referred to us especially for
111
open removal after unsuccessful percutaneous retrieval by other groups. One patient had 2 filters
112
and another had 3 filters. Except for 2 cases with complications during the percutaneous retrieval
113
procedure that were transferred to us, the remaining patients all suffered from back or abdominal
114
pain. Symptomatic patients all had significant filter strut penetration through the caval wall into
115
adjacent structures.
AC C
EP
TE D
106
ACCEPTED MANUSCRIPT 6
116 117
Case 1 A 73-year-old man with a history of motor vehicle crash and deep vein thrombosis
118
(DVT) presented with scrotal and back pain. The patient was initially diagnosed and treated for
120
urinary tract infection. However, a computed tomography (CT) scan of the abdomen revealed
121
IVC thrombosis at the level of the renal arteries extending from two misaligned IVC filters
122
(Figure 3). A venogram demonstrated evidence of old organized thrombus in the iliac vein and
123
two IVC filters. An attempt to pass the wire through the IVC filter for thrombolysis failed. The
124
patient was started on rivaroxiban. The patient presented a few months later with persistent back
125
pain and worsening leg swelling despite anticoagulation. He underwent ultrasound-accelerated
126
thrombolysis with some reconstitution of the iliocaval veins. However, there was still significant
127
IVC thrombosis within the misaligned filters.
M AN U
SC
RI PT
119
After review of CT and venogram, we decided not to attempt another percutaneous
TE D
128
retrieval. A mini-laparotomy was performed and the two IVC filters were removed via a
130
longitudinal cavotomy. A caval endovenectomy was performed with primary repair of the vein
131
wall. Several filter barbs penetrating through the caval wall entered the duodenum requiring
132
suture repair of the small bowel. The patient was slow to recover bowel function but otherwise
133
recovered uneventfully. He reported resolution of back pain and improved, but not resolved, leg
134
swelling in office follow-up.
136 137
AC C
135
EP
129
Case 2 A 44-year-old woman presented to interventional radiology for elective removal of an
ACCEPTED MANUSCRIPT 7
ALN IVC filter. The filter was initially placed for recurrent history of pulmonary embolism
139
while on anticoagulation. Due to tilting of the filter with subsequent penetration into the renal
140
vein the percutaneous attempts were not successful. The interventional radiologist was unable to
141
extract the filter using the ALN cone via the right internal jugular vein. An attempt was also
142
made using a gooseneck snare. The snare became entrapped within the filter barbs and the snare
143
could not be retrieved (Figure 4) despite multiple attempts. The filter and snare were removed
144
via mini-midline laparotomy. The snare was entwined within the filter and was cut with a wire
145
cutter. The remainder of the snare was then removed out of the right internal jugular vein. After
146
removal of the filter, the inferior vena cava was primarily repaired.
M AN U
SC
RI PT
138
147 148
Case 3
A 50-year-old woman with a history of pulmonary embolism presented with severe
150
abdominal and back pain. Her IVC filter was misaligned on CT scan and she subsequently
151
underwent three attempts at percutaneous filter removal. Due to significant angulation, the filter
152
could not be removed. The patient was referred to us for open removal. Several of the struts were
153
found penetrating through the caval wall and entering the serosa of the duodenum as well as the
154
anterior spinal ligament. These were carefully removed at mini-laparotomy and a venotomy was
155
made in the IVC over the filter. The proximal hook of the filter was noted to have lodged into a
156
posterior lumbar vein explaining the difficulty with percutaneous retrieval. The filter was
157
dissected off the wall after several of the struts were cut with wire cutters. The venotomy was
158
primarily repaired. Postoperatively, the patient reported resolution of her back and abdominal
159
pain.
160
AC C
EP
TE D
149
ACCEPTED MANUSCRIPT 8
161
Case 4 A 25-year old man with a history of motor vehicle crash 6 years ago requiring a C3-C7
163
spinal fusion presented with right lower quadrant abdominal pain. After undergoing a CT scan,
164
the patient was found to have an IVC filter with severe angulation and barbs penetrating through
165
the caval wall. The patient reported that he never knew it was in place so he never sought
166
removal. An attempt at percutaneous removal was done at an outside hospital that was
167
unsuccessful.
SC
RI PT
162
He was referred to our center for open removal. We could find no other reason for his
M AN U
168
abdominal pain. After mini-laparotomy, the filter struts were found to be penetrating through the
170
caval wall in multiple directions including a barb through the duodenal wall and at least 1 strut
171
penetrating into the aorta. The inferior vena cava was opened longitudinally. Several of the barbs
172
were cut with Mayo scissors including the barb penetrating into the aorta. Care was taken to
173
ensure that the entire filter was removed without damaging the duodenum and the aorta. The
174
venotomy was primarily repaired. After recovery, the patient reported resolution of his
175
abdominal pain.
178
Case 5
AC C
177
EP
176
TE D
169
A 28-year-old woman presented to our facility with persistent abdominal pain. She had a
179
history of IVC filter placement a year before when she suffered a pelvic fracture. An attempt was
180
made at that time to remove the IVC filter percutaneously when she regained mobility but it was
181
noted that the filter was misaligned and imbedded into the caval wall. The filter could not be
182
removed and the patient later returned with complaints of abdominal pain. We could find no
183
other cause for her pain and she was scheduled for open filter removal. A midline mini-
ACCEPTED MANUSCRIPT 9
laparotomy incision was made. Several of the barbs were penetrating through the caval wall. One
185
of the barbs penetrated through the adventitia of the aorta and there was also a filter barb
186
penetrating into and through the gonadal vein. This was contributing to the severe angulation.
187
Several of the barbs were transected outside the IVC and a longitudinal venotomy was made to
188
extract the filter from the IVC as well as the gonadal vein. The venotomy was then primarily
189
repaired. She reported resolution of her abdominal pain in follow-up.
190
Case 6
SC
RI PT
184
A 50-year-old woman with chronic kidney disease was transferred from an outside
M AN U
191
hospital with abdominal pain. She had a history of right leg gunshot wound, below-knee
193
amputation, deep vein thrombosis, and IVC filter placement 25 years ago. She was diagnosed
194
with IVC thrombosis 10 years ago and had an additional IVC filter placed superior to the
195
thrombosis. On arrival, a CT scan showed an occluded IVC with several misaligned filters and
196
barbs penetrating through the caval wall into adjacent structures. No other cause for her severe
197
abdominal pain could be found. At laparotomy, 3 tangled filters were found in an occluded IVC.
198
One of the barbs was penetrating through the wall of the duodenum. The small bowel was
199
repaired with polyglactin suture. Postoperatively, she had prolonged ileus. She was discharged
200
home tolerating a regular diet on postoperative day 7.
201
Case 7
EP
AC C
202
TE D
192
A 36-year-old woman was admitted via the emergency room complaining of worsening,
203
severe abdominal and right groin pain. An extensive workup only revealed an angulated IVC
204
filter placed in the right common iliac vein. The filter was placed several years ago for deep vein
205
thrombosis and pulmonary embolism. Although she was given a diagnosis of hypercoagulable
ACCEPTED MANUSCRIPT 10
disorder, she was not placed on anticoagulation. An attempt was made at percutaneous retrieval
207
but this was unsuccessful due to extreme tilting. The filter was removed via transperitoneal mini-
208
laparotomy. Inspection of the abdomen did not show any other cause for her abdominal pain.
209
Several of the barbs were penetrating out of the vein wall into the L5 periosteum and
210
surrounding structures. The longitudinal venotomy in the right common iliac vein was repaired
211
primarily. She was started on oral anticoagulation postoperatively and was discharged home on
212
postoperative day 9.
SC
RI PT
206
214 215
M AN U
213
Discussion
Since 2011, we began a comprehensive IVC Filter Retrieval Program. Our goal was to percutaneously remove all filters within 3 months, regardless of insurance status, in patients
217
whose transient risk of venous thromboembolic events subsided.2 Many centers, including our
218
own, report retrieval rates of less than 50% and initial technical success of percutaneous retrieval
219
in 85-99% of cases.7-9 Failure to percutaneously retrieve the filter may be due to thrombus within
220
the filter or severe angulation; both can worsen over time.
EP
221
TE D
216
Angulation or tilting of the filter is associated with strut penetration through the caval wall. This appears to occur more frequently depending on IVC diameter, dwell time5 and filter
223
type. Strut penetration through the caval wall is commonplace and most patients are
224
asymptomatic.10 All patients referred for open filter removal had significant strut penetration into
225
adjacent structures, such as small bowel, spine and the aorta. Open surgical IVC filter removal is
226
generally reserved for symptomatic patients who failed percutaneous retrieval. By itself,
AC C
222
ACCEPTED MANUSCRIPT 11
227
asymptomatic strut penetration into pericaval structures is not a usual indication for open
228
removal. Our algorithm for filter retrieval is shown in Figure 5. Several centers published their experience of IVC filter removal via laparotomy and most
230
show low complication rates using slightly different surgical techniques.11-14 Although there may
231
be reporting bias, morbidity and mortality appear to be low in experienced centers. We find that
232
a 10-cm laparotomy is sufficient in most patients. The retroperitoneum can be entered directly
233
and the duodenum retracted to the right of the IVC without mobilization of the right colon.
234
Removal of the filter by cavotomy, endovenectomy and primary repair can be safely done
235
without the need for extensive caval reconstruction as observed in our case series.
236
Conclusion
SC
M AN U
237
RI PT
229
Regardless of symptoms, most patients are candidates for percutaneous IVC filter retrieval when the risk of pulmonary embolus subsides. We reserve open surgical removal of
239
misaligned IVC filters to patients suffering from symptoms, such as chronic pain. The symptoms
240
appear to be caused by filter strut penetration into adjacent structures. Other indications for open
241
IVC filter removal include complications during percutaneous filter retrieval, such as
242
dislodgement of the filter into the right atrium and retrieval device entanglement. Although open
243
surgery is the last resort for retrieval of IVC filters, it can be accomplished with minimal
244
morbidity and leads to resolution of symptoms.
EP
AC C
245
TE D
238
ACCEPTED MANUSCRIPT 12
Figure Legend Figure 1. Intraoperative image after opening the IVC. Note the filter strut within the iliolumbar tributary.
RI PT
Figure 2. Primary closure of the venotomy. Figure 3. Abdominal x-ray showing two misaligned IVC filters (arrows).
Figure 4. Fluoroscopy image taken during percutaneous retrieval attempt showing contrast extravasation, severe filter angulation, and goose-neck snare entrapment.
EP
TE D
M AN U
SC
Figure 5. Algorithm for retrieval evaluation of implanted IVC filters.
AC C
246 247 248 249 250 251 252 253 254 255 256 257 258 259 260
ACCEPTED MANUSCRIPT 13
261
303
References
EP
TE D
M AN U
SC
RI PT
1. Angel LF, Tapson V, Galgon RE, Restrepo MI and Kaufman J. Systematic review of the use of retrievable inferior vena cava filters. J Vasc Interv Radiol. 2011;22:1522-1530 e3. 2. Charlton-Ouw KM, Leake SS, Sola CN, Sandhu HK, Albarado R, Holcomb JB, Miller CC, 3rd, Safi HJ and Azizzadeh A. Technical and financial feasibility of an inferior vena cava filter retrieval program at a level one trauma center. Ann Vasc Surg. 2015;29:84-9. 3. Warner CJ, Richey EA, Tower DE, Condino AE, Tapp SJ, Tosteson AN and Walsh DB. Inferior vena cava filter retrieval provides no advantage in the average patient. J Vasc Surg Venous Lymphat Disord. 2015;3:142-6. 4. Stawicki SP, Sims CA, Sharma R, Weger NS, Truitt M, Cipolla J, Schrag SP, Lorenzo M, El Chaar M, Torigian DA, Kim PK and Sarani B. Vena cava filters: a synopsis of complications and related topics. J Vasc Access. 2008;9:102-10. 5. Lee JK, So YH, Choi YH, Park SS, Heo EY, Kim DK and Chung HS. Clinical course and predictive factors for complication of inferior vena cava filters. Thromb Res. 2014;133:53843. 6. Morales JP, Li X, Irony TZ, Ibrahim NG, Moynahan M and Cavanaugh KJ, Jr. Decision analysis of retrievable inferior vena cava filters in patients without pulmonary embolism. J Vasc Surg Venous Lymphat Disord. 2013;1:376-84. 7. Ray CE, Jr., Mitchell E, Zipser S, Kao EY, Brown CF and Moneta GL. Outcomes with retrievable inferior vena cava filters: a multicenter study. J Vasc Interv Radiol. 2006;17:1595604. 8. Tao MJ, Montbriand JM, Eisenberg N, Sniderman KW and Roche-Nagle G. Temporary inferior vena cava filter indications, retrieval rates, and follow-up management at a multicenter tertiary care institution. J Vasc Surg. 2016;64:430-437. 9. Etkin Y, Foley PJ, Wang GJ, Guzzo TJ, Roses RE, Fraker DL, Drebin JA and Jackson BM. Successful venous repair and reconstruction for oncologic resections. J Vasc Surg Venous Lymphat Disord. 2016;4:57-63. 10. Wood EA, Malgor RD, Gasparis AP and Labropoulos N. Reporting the impact of inferior vena cava perforation by filters. Phlebology. 2014;29:471-5. 11. Malgor RD and Labropoulos N. A systematic review of symptomatic duodenal perforation by inferior vena cava filters. J Vasc Surg. 2012;55:856-861 e3. 12. Connolly PH, Balachandran VP, Trost D and Bush HL, Jr. Open surgical inferior vena cava filter retrieval for caval perforation and a novel technique for minimal cavotomy filter extraction. J Vasc Surg. 2012;56:256-9; discussion 259. 13. Malek JY, Kwolek CJ, Conrad MF, Patel VI, Watkins MT, Lancaster RT and LaMuraglia GM. Presentation and treatment outcomes of patients with symptomatic inferior vena cava filters. Ann Vasc Surg. 2013;27:84-8. 14. Rana MA, Gloviczki P, Kalra M, Bjarnason H, Huang Y and Fleming MD. Open surgical removal of retained and dislodged inferior vena cava filters. J Vasc Surg Venous Lymphat Disord. 2015;3:201-6.
AC C
262 263 264 265 266 267 268 269 270 271 272 273 274 275 276 277 278 279 280 281 282 283 284 285 286 287 288 289 290 291 292 293 294 295 296 297 298 299 300 301 302
ACCEPTED MANUSCRIPT
Table. Patients requiring open surgical inferior vena cava removal. Indications for filter placement
Length of implant
Presenting symptoms
Percutaneous Operative attempts findings
74M
Trauma (prophylaxis)
2 filters placed, duration unknown
No attempts made after venogram and CT findings
Caval and duodenal penetration
44W
Failed 5 months anticoagulation (recurrent PE)
Recurrent caval thrombosis, leg swelling, back pain None
Multiple percutaneous attempts.
50W
Failed Unknown anticoagulation (History of DVT and PE)
Right groin and mid abdominal pain
At least 3 percutaneous attempts
25M
Trauma (prophylaxis)
Abdominal pain
Single attempt
28W
Trauma Pelvic Fracture (prophylaxis)
50W
Trauma – gunshot wound and DVT
Gooseneck snare entangled with filter. Penetration of caval wall, duodenum, and lumbar vein Caval, duodenal penetration; small aortocaval fistula Penetration of caval wall, aortic adventitia and gonadal vein Penetration of caval wall into duodenum. Filter in right common iliac vein with tilting and penetration through vein wall.
DVT/PE
3 filters, placed 10 and 25 years ago Unknown
SC
M AN U
TE D 1 year
EP
AC C
36W
6 years
Abdominal pain
Single attempt
Abdominal pain
Unknown
Abdominal and right groin pain
Single attempt
Postop length of stay (days) 7
RI PT
Age/ Gender
5
5
4
4
15
9
AC C
EP
TE D
M AN U
SC
RI PT
ACCEPTED MANUSCRIPT
AC C
EP
TE D
M AN U
SC
RI PT
ACCEPTED MANUSCRIPT
AC C
EP
TE D
M AN U
SC
RI PT
ACCEPTED MANUSCRIPT
AC C
EP
TE D
M AN U
SC
RI PT
ACCEPTED MANUSCRIPT
AC C
EP
TE D
M AN U
SC
RI PT
ACCEPTED MANUSCRIPT
S0890-5096(17)30732-X
DOI:
10.1016/j.avsg.2017.05.038
Reference:
AVSG 3422
To appear in:
Annals of Vascular Surgery
Received Date: 21 March 2017 Revised Date:
15 May 2017
Accepted Date: 30 May 2017
Please cite this article as: Charlton-Ouw KM, Afaq S, Leake SS, Sandhu HK, Sola CN, Saqib NU, Azizzadeh A, Safi HJ, Indications and outcomes of open inferior vena cava filter removal, Annals of Vascular Surgery (2017), doi: 10.1016/j.avsg.2017.05.038. 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
1
3
Indications and outcomes of open inferior vena cava filter removal
RI PT
2
4
5
9 10
1
11
2
SC
Kristofer M Charlton-Ouw, MD1,2, Shaikh Afaq, MD1,2, Samuel S. Leake, BS1, Harleen K. Sandhu, MD, MPH1, Cristina N. Sola, RN1, Naveed U. Saqib, MD1,2, Ali Azizzadeh, MD1,2, Hazim J. Safi, MD1,2 Department of Cardiothoracic and Vascular Surgery, McGovern Medical School, University of Texas Health Science Center at Houston (UTHealth)
M AN U
6 7 8
Memorial Hermann Hospital System, Houston, Texas
12
TE D
13
Presented at the Vascular and Endovascular Surgery Society Annual Meeting 2017, Steamboat Springs, CO, USA.
16 17 18 19
The authors report no conflicts of interest with regard to this manuscript. Dr. Charlton-Ouw is a consultant with W.L. Gore and Associates. Dr. Azizzadeh is a consultant with W.L. Gore and Associates and Medtronic. No external funding sources were used in connection with this research.
21 22 23 24 25 26 27 28 29
AC C
20
EP
14 15
Corresponding Author: Kristofer M. Charlton-Ouw, MD Department of Cardiothoracic and Vascular Surgery University of Texas Health Science Center at Houston 6400 Fannin St, Ste 2850 Houston, TX 77030 Office 713-486-5100 [email protected]
ACCEPTED MANUSCRIPT 2
Abstract
31
Introduction: Despite recommendations for retrieval of inferior vena cava (IVC) filters, most are
32
not removed in a timely manner. Longer IVC filter dwell times are associated with caval wall
33
perforation and tilting that make percutaneous retrieval more difficult. Open IVC filter removal
34
is generally reserved for patients with symptoms referable to the filter, such as chronic back and
35
abdominal pain. We present our management algorithm and review of cases of open IVC filter
36
removal.
37
Methods: Patients referred for management of implanted IVC filters from May 2010 to May
38
2016 were included. Demographic and imaging were reviewed for cases requiring open surgical
39
removal.
40
Results: There were 221 percutaneous retrieval attempts in 218 patients. Successful retrieval
41
occurred in 196 (89%) attempts. There were 7 patients that had open surgical IVC filter removal
42
after failure of percutaneous retrieval. One patient had 2 filters and another had 3 filters. Except
43
for 1 case with complications during the percutaneous retrieval procedure, the remaining patients
44
all suffered from back or abdominal pain. All had significant filter strut penetration through the
45
caval wall into adjacent structures. Postoperatively, all patients had relief of pain. There were no
46
deaths and one patent had a minor ileus that spontaneously resolved.
47
Conclusions: Patients who fail percutaneous IVC filter retrieval can expect low morbidity and
48
prompt resolution of symptoms after open surgical removal via mini-laparotomy.
49
50
AC C
EP
TE D
M AN U
SC
RI PT
30
ACCEPTED MANUSCRIPT 3
51 52
Introduction Retrievable inferior vena cava (IVC) filters were developed to protect patients from fatal pulmonary embolism and to allow for device removal once this risk abated. However, multiple
54
studies have shown that device retrieval occurs in <50% of cases.1, 2 This is most often due to
55
lack of referral into a comprehensive follow-up program. The benefit of routine filter retrieval
56
has recently been called into question and may not be cost-effective.3 The counter argument is
57
that as many as a quarter of patients do have complications related to long-term indwelling
58
filters, including IVC thrombosis, filter dislocation, recurrent pulmonary embolism, penetration
59
of filter struts through pericaval structures, and chronic pain.4, 5 The U.S. Food and Drug
60
Administration reaffirmed its recommendation in 2014 that retrievable IVC filters should be
61
removed when reasonable.
SC
M AN U
62
RI PT
53
Most filters can be removed percutaneously using standard techniques but occasionally require creative maneuvers. Assuming the transient risk of pulmonary embolism has passed, the
64
optimal time of IVC filter retrieval is estimated to be 1-2 months after implantation.6 This is
65
outside the 12-day retrieval window of the Cordis OPTEASE filter and many filters tend to
66
become more difficult to remove over time. This is usually due to strut penetrations through the
67
caval wall leading to tilting and scar formation. Especially with deep filter strut penetration and
68
severe misalignment, percutaneous retrieval may not be possible without undue risk. We noted
69
several cases where the filter was nearly sideways in the IVC or entangled with a second filter.
70
Open IVC filter removal can be done through a retroperitoneal or transperitoneal mini-
71
laparotomy approach. We describe our indications for open filter removal, technique, and
72
outcomes in 7 cases.
AC C
EP
TE D
63
ACCEPTED MANUSCRIPT 4
73
75
Methods Patients referred for management of implanted IVC filters from May 2010 to May 2016
RI PT
74
were included. From 2011 to 2015, patients referred for IVC filter management were enrolled in
77
a prospective registry after signing informed consent. Thereafter, patients were periodically
78
contacted to assess for ongoing need for the IVC filter. Since 2015, contacting patients regarding
79
their IVC filter was deemed the practice standard and need for signed informed consent was
80
waived. Retrospective research access to the database was approved by the Committee for the
81
Protection of Human Subjects, the local ethics institutional review committee. Demographic and
82
imaging information was reviewed for cases requiring open surgical removal. Durable resolution
83
of symptoms was ascertained by accessing outpatient follow-up records.
M AN U
SC
76
85 86
Surgical technique
TE D
84
A standard technique is applied with the initial goal of obtaining access to the retroperitoneum and IVC and to allow inspection of the surrounding structures. In each case, a
88
midline laparotomy incision is made approximately 10 cm in length depending on the patient’s
89
anatomy. The small bowels are packed to the right side and the retroperitoneum is entered to the
90
left of the duodenum. The duodenum is elevated off of the IVC, retracted to the patient’s right
91
side, and inspected for any penetration. If needed, the struts or filter tines are carefully removed
92
with repair of the bowel wall.
93 94
AC C
EP
87
Control of the cava is with proximal and distal clamps after intravenous anticoagulation. However, inflammation and scarring around the cava can be significant making the dissection
ACCEPTED MANUSCRIPT 5
tedious. Direct pressure over the proximal and distal IVC with sponge sticks usually offers
96
adequate hemostasis. Once control is obtained, a longitudinal venotomy is made (Figure 1). An
97
endovenectomy is performed as needed to remove scar tissue surrounding the filters within the
98
lumen. It is important to keep in mind that the filter may embed itself in the renal vein or other
99
tributaries. Once the luminal surface is free of filter and scar, the venotomy is primarily repaired
100
with running 5-0 polypropylene suture (Figure 2). We find that a patch angioplasty is not usually
101
needed except in cases of chronic occlusion and scarring. After the repair, anticoagulation is
102
reversed and the laparotomy closed.
M AN U
103 104
105
SC
RI PT
95
Results
There were 221 percutaneous retrieval attempts in 218 patients during the study period. Only 2% of the filters were placed by our group; the remainder were referred to us for retrieval.
107
Successful percutaneous retrieval occurred in 196 (89%) attempts. There were 7 patients that had
108
open surgical IVC filter removal after failure of percutaneous retrieval. One additional patient
109
required median sternotomy and cardiopulmonary bypass after the filter migrated to the caval-
110
atrial junction during retrieval attempt at another hospital. Most were referred to us especially for
111
open removal after unsuccessful percutaneous retrieval by other groups. One patient had 2 filters
112
and another had 3 filters. Except for 2 cases with complications during the percutaneous retrieval
113
procedure that were transferred to us, the remaining patients all suffered from back or abdominal
114
pain. Symptomatic patients all had significant filter strut penetration through the caval wall into
115
adjacent structures.
AC C
EP
TE D
106
ACCEPTED MANUSCRIPT 6
116 117
Case 1 A 73-year-old man with a history of motor vehicle crash and deep vein thrombosis
118
(DVT) presented with scrotal and back pain. The patient was initially diagnosed and treated for
120
urinary tract infection. However, a computed tomography (CT) scan of the abdomen revealed
121
IVC thrombosis at the level of the renal arteries extending from two misaligned IVC filters
122
(Figure 3). A venogram demonstrated evidence of old organized thrombus in the iliac vein and
123
two IVC filters. An attempt to pass the wire through the IVC filter for thrombolysis failed. The
124
patient was started on rivaroxiban. The patient presented a few months later with persistent back
125
pain and worsening leg swelling despite anticoagulation. He underwent ultrasound-accelerated
126
thrombolysis with some reconstitution of the iliocaval veins. However, there was still significant
127
IVC thrombosis within the misaligned filters.
M AN U
SC
RI PT
119
After review of CT and venogram, we decided not to attempt another percutaneous
TE D
128
retrieval. A mini-laparotomy was performed and the two IVC filters were removed via a
130
longitudinal cavotomy. A caval endovenectomy was performed with primary repair of the vein
131
wall. Several filter barbs penetrating through the caval wall entered the duodenum requiring
132
suture repair of the small bowel. The patient was slow to recover bowel function but otherwise
133
recovered uneventfully. He reported resolution of back pain and improved, but not resolved, leg
134
swelling in office follow-up.
136 137
AC C
135
EP
129
Case 2 A 44-year-old woman presented to interventional radiology for elective removal of an
ACCEPTED MANUSCRIPT 7
ALN IVC filter. The filter was initially placed for recurrent history of pulmonary embolism
139
while on anticoagulation. Due to tilting of the filter with subsequent penetration into the renal
140
vein the percutaneous attempts were not successful. The interventional radiologist was unable to
141
extract the filter using the ALN cone via the right internal jugular vein. An attempt was also
142
made using a gooseneck snare. The snare became entrapped within the filter barbs and the snare
143
could not be retrieved (Figure 4) despite multiple attempts. The filter and snare were removed
144
via mini-midline laparotomy. The snare was entwined within the filter and was cut with a wire
145
cutter. The remainder of the snare was then removed out of the right internal jugular vein. After
146
removal of the filter, the inferior vena cava was primarily repaired.
M AN U
SC
RI PT
138
147 148
Case 3
A 50-year-old woman with a history of pulmonary embolism presented with severe
150
abdominal and back pain. Her IVC filter was misaligned on CT scan and she subsequently
151
underwent three attempts at percutaneous filter removal. Due to significant angulation, the filter
152
could not be removed. The patient was referred to us for open removal. Several of the struts were
153
found penetrating through the caval wall and entering the serosa of the duodenum as well as the
154
anterior spinal ligament. These were carefully removed at mini-laparotomy and a venotomy was
155
made in the IVC over the filter. The proximal hook of the filter was noted to have lodged into a
156
posterior lumbar vein explaining the difficulty with percutaneous retrieval. The filter was
157
dissected off the wall after several of the struts were cut with wire cutters. The venotomy was
158
primarily repaired. Postoperatively, the patient reported resolution of her back and abdominal
159
pain.
160
AC C
EP
TE D
149
ACCEPTED MANUSCRIPT 8
161
Case 4 A 25-year old man with a history of motor vehicle crash 6 years ago requiring a C3-C7
163
spinal fusion presented with right lower quadrant abdominal pain. After undergoing a CT scan,
164
the patient was found to have an IVC filter with severe angulation and barbs penetrating through
165
the caval wall. The patient reported that he never knew it was in place so he never sought
166
removal. An attempt at percutaneous removal was done at an outside hospital that was
167
unsuccessful.
SC
RI PT
162
He was referred to our center for open removal. We could find no other reason for his
M AN U
168
abdominal pain. After mini-laparotomy, the filter struts were found to be penetrating through the
170
caval wall in multiple directions including a barb through the duodenal wall and at least 1 strut
171
penetrating into the aorta. The inferior vena cava was opened longitudinally. Several of the barbs
172
were cut with Mayo scissors including the barb penetrating into the aorta. Care was taken to
173
ensure that the entire filter was removed without damaging the duodenum and the aorta. The
174
venotomy was primarily repaired. After recovery, the patient reported resolution of his
175
abdominal pain.
178
Case 5
AC C
177
EP
176
TE D
169
A 28-year-old woman presented to our facility with persistent abdominal pain. She had a
179
history of IVC filter placement a year before when she suffered a pelvic fracture. An attempt was
180
made at that time to remove the IVC filter percutaneously when she regained mobility but it was
181
noted that the filter was misaligned and imbedded into the caval wall. The filter could not be
182
removed and the patient later returned with complaints of abdominal pain. We could find no
183
other cause for her pain and she was scheduled for open filter removal. A midline mini-
ACCEPTED MANUSCRIPT 9
laparotomy incision was made. Several of the barbs were penetrating through the caval wall. One
185
of the barbs penetrated through the adventitia of the aorta and there was also a filter barb
186
penetrating into and through the gonadal vein. This was contributing to the severe angulation.
187
Several of the barbs were transected outside the IVC and a longitudinal venotomy was made to
188
extract the filter from the IVC as well as the gonadal vein. The venotomy was then primarily
189
repaired. She reported resolution of her abdominal pain in follow-up.
190
Case 6
SC
RI PT
184
A 50-year-old woman with chronic kidney disease was transferred from an outside
M AN U
191
hospital with abdominal pain. She had a history of right leg gunshot wound, below-knee
193
amputation, deep vein thrombosis, and IVC filter placement 25 years ago. She was diagnosed
194
with IVC thrombosis 10 years ago and had an additional IVC filter placed superior to the
195
thrombosis. On arrival, a CT scan showed an occluded IVC with several misaligned filters and
196
barbs penetrating through the caval wall into adjacent structures. No other cause for her severe
197
abdominal pain could be found. At laparotomy, 3 tangled filters were found in an occluded IVC.
198
One of the barbs was penetrating through the wall of the duodenum. The small bowel was
199
repaired with polyglactin suture. Postoperatively, she had prolonged ileus. She was discharged
200
home tolerating a regular diet on postoperative day 7.
201
Case 7
EP
AC C
202
TE D
192
A 36-year-old woman was admitted via the emergency room complaining of worsening,
203
severe abdominal and right groin pain. An extensive workup only revealed an angulated IVC
204
filter placed in the right common iliac vein. The filter was placed several years ago for deep vein
205
thrombosis and pulmonary embolism. Although she was given a diagnosis of hypercoagulable
ACCEPTED MANUSCRIPT 10
disorder, she was not placed on anticoagulation. An attempt was made at percutaneous retrieval
207
but this was unsuccessful due to extreme tilting. The filter was removed via transperitoneal mini-
208
laparotomy. Inspection of the abdomen did not show any other cause for her abdominal pain.
209
Several of the barbs were penetrating out of the vein wall into the L5 periosteum and
210
surrounding structures. The longitudinal venotomy in the right common iliac vein was repaired
211
primarily. She was started on oral anticoagulation postoperatively and was discharged home on
212
postoperative day 9.
SC
RI PT
206
214 215
M AN U
213
Discussion
Since 2011, we began a comprehensive IVC Filter Retrieval Program. Our goal was to percutaneously remove all filters within 3 months, regardless of insurance status, in patients
217
whose transient risk of venous thromboembolic events subsided.2 Many centers, including our
218
own, report retrieval rates of less than 50% and initial technical success of percutaneous retrieval
219
in 85-99% of cases.7-9 Failure to percutaneously retrieve the filter may be due to thrombus within
220
the filter or severe angulation; both can worsen over time.
EP
221
TE D
216
Angulation or tilting of the filter is associated with strut penetration through the caval wall. This appears to occur more frequently depending on IVC diameter, dwell time5 and filter
223
type. Strut penetration through the caval wall is commonplace and most patients are
224
asymptomatic.10 All patients referred for open filter removal had significant strut penetration into
225
adjacent structures, such as small bowel, spine and the aorta. Open surgical IVC filter removal is
226
generally reserved for symptomatic patients who failed percutaneous retrieval. By itself,
AC C
222
ACCEPTED MANUSCRIPT 11
227
asymptomatic strut penetration into pericaval structures is not a usual indication for open
228
removal. Our algorithm for filter retrieval is shown in Figure 5. Several centers published their experience of IVC filter removal via laparotomy and most
230
show low complication rates using slightly different surgical techniques.11-14 Although there may
231
be reporting bias, morbidity and mortality appear to be low in experienced centers. We find that
232
a 10-cm laparotomy is sufficient in most patients. The retroperitoneum can be entered directly
233
and the duodenum retracted to the right of the IVC without mobilization of the right colon.
234
Removal of the filter by cavotomy, endovenectomy and primary repair can be safely done
235
without the need for extensive caval reconstruction as observed in our case series.
236
Conclusion
SC
M AN U
237
RI PT
229
Regardless of symptoms, most patients are candidates for percutaneous IVC filter retrieval when the risk of pulmonary embolus subsides. We reserve open surgical removal of
239
misaligned IVC filters to patients suffering from symptoms, such as chronic pain. The symptoms
240
appear to be caused by filter strut penetration into adjacent structures. Other indications for open
241
IVC filter removal include complications during percutaneous filter retrieval, such as
242
dislodgement of the filter into the right atrium and retrieval device entanglement. Although open
243
surgery is the last resort for retrieval of IVC filters, it can be accomplished with minimal
244
morbidity and leads to resolution of symptoms.
EP
AC C
245
TE D
238
ACCEPTED MANUSCRIPT 12
Figure Legend Figure 1. Intraoperative image after opening the IVC. Note the filter strut within the iliolumbar tributary.
RI PT
Figure 2. Primary closure of the venotomy. Figure 3. Abdominal x-ray showing two misaligned IVC filters (arrows).
Figure 4. Fluoroscopy image taken during percutaneous retrieval attempt showing contrast extravasation, severe filter angulation, and goose-neck snare entrapment.
EP
TE D
M AN U
SC
Figure 5. Algorithm for retrieval evaluation of implanted IVC filters.
AC C
246 247 248 249 250 251 252 253 254 255 256 257 258 259 260
ACCEPTED MANUSCRIPT 13
261
303
References
EP
TE D
M AN U
SC
RI PT
1. Angel LF, Tapson V, Galgon RE, Restrepo MI and Kaufman J. Systematic review of the use of retrievable inferior vena cava filters. J Vasc Interv Radiol. 2011;22:1522-1530 e3. 2. Charlton-Ouw KM, Leake SS, Sola CN, Sandhu HK, Albarado R, Holcomb JB, Miller CC, 3rd, Safi HJ and Azizzadeh A. Technical and financial feasibility of an inferior vena cava filter retrieval program at a level one trauma center. Ann Vasc Surg. 2015;29:84-9. 3. Warner CJ, Richey EA, Tower DE, Condino AE, Tapp SJ, Tosteson AN and Walsh DB. Inferior vena cava filter retrieval provides no advantage in the average patient. J Vasc Surg Venous Lymphat Disord. 2015;3:142-6. 4. Stawicki SP, Sims CA, Sharma R, Weger NS, Truitt M, Cipolla J, Schrag SP, Lorenzo M, El Chaar M, Torigian DA, Kim PK and Sarani B. Vena cava filters: a synopsis of complications and related topics. J Vasc Access. 2008;9:102-10. 5. Lee JK, So YH, Choi YH, Park SS, Heo EY, Kim DK and Chung HS. Clinical course and predictive factors for complication of inferior vena cava filters. Thromb Res. 2014;133:53843. 6. Morales JP, Li X, Irony TZ, Ibrahim NG, Moynahan M and Cavanaugh KJ, Jr. Decision analysis of retrievable inferior vena cava filters in patients without pulmonary embolism. J Vasc Surg Venous Lymphat Disord. 2013;1:376-84. 7. Ray CE, Jr., Mitchell E, Zipser S, Kao EY, Brown CF and Moneta GL. Outcomes with retrievable inferior vena cava filters: a multicenter study. J Vasc Interv Radiol. 2006;17:1595604. 8. Tao MJ, Montbriand JM, Eisenberg N, Sniderman KW and Roche-Nagle G. Temporary inferior vena cava filter indications, retrieval rates, and follow-up management at a multicenter tertiary care institution. J Vasc Surg. 2016;64:430-437. 9. Etkin Y, Foley PJ, Wang GJ, Guzzo TJ, Roses RE, Fraker DL, Drebin JA and Jackson BM. Successful venous repair and reconstruction for oncologic resections. J Vasc Surg Venous Lymphat Disord. 2016;4:57-63. 10. Wood EA, Malgor RD, Gasparis AP and Labropoulos N. Reporting the impact of inferior vena cava perforation by filters. Phlebology. 2014;29:471-5. 11. Malgor RD and Labropoulos N. A systematic review of symptomatic duodenal perforation by inferior vena cava filters. J Vasc Surg. 2012;55:856-861 e3. 12. Connolly PH, Balachandran VP, Trost D and Bush HL, Jr. Open surgical inferior vena cava filter retrieval for caval perforation and a novel technique for minimal cavotomy filter extraction. J Vasc Surg. 2012;56:256-9; discussion 259. 13. Malek JY, Kwolek CJ, Conrad MF, Patel VI, Watkins MT, Lancaster RT and LaMuraglia GM. Presentation and treatment outcomes of patients with symptomatic inferior vena cava filters. Ann Vasc Surg. 2013;27:84-8. 14. Rana MA, Gloviczki P, Kalra M, Bjarnason H, Huang Y and Fleming MD. Open surgical removal of retained and dislodged inferior vena cava filters. J Vasc Surg Venous Lymphat Disord. 2015;3:201-6.
AC C
262 263 264 265 266 267 268 269 270 271 272 273 274 275 276 277 278 279 280 281 282 283 284 285 286 287 288 289 290 291 292 293 294 295 296 297 298 299 300 301 302
ACCEPTED MANUSCRIPT
Table. Patients requiring open surgical inferior vena cava removal. Indications for filter placement
Length of implant
Presenting symptoms
Percutaneous Operative attempts findings
74M
Trauma (prophylaxis)
2 filters placed, duration unknown
No attempts made after venogram and CT findings
Caval and duodenal penetration
44W
Failed 5 months anticoagulation (recurrent PE)
Recurrent caval thrombosis, leg swelling, back pain None
Multiple percutaneous attempts.
50W
Failed Unknown anticoagulation (History of DVT and PE)
Right groin and mid abdominal pain
At least 3 percutaneous attempts
25M
Trauma (prophylaxis)
Abdominal pain
Single attempt
28W
Trauma Pelvic Fracture (prophylaxis)
50W
Trauma – gunshot wound and DVT
Gooseneck snare entangled with filter. Penetration of caval wall, duodenum, and lumbar vein Caval, duodenal penetration; small aortocaval fistula Penetration of caval wall, aortic adventitia and gonadal vein Penetration of caval wall into duodenum. Filter in right common iliac vein with tilting and penetration through vein wall.
DVT/PE
3 filters, placed 10 and 25 years ago Unknown
SC
M AN U
TE D 1 year
EP
AC C
36W
6 years
Abdominal pain
Single attempt
Abdominal pain
Unknown
Abdominal and right groin pain
Single attempt
Postop length of stay (days) 7
RI PT
Age/ Gender
5
5
4
4
15
9
AC C
EP
TE D
M AN U
SC
RI PT
ACCEPTED MANUSCRIPT
AC C
EP
TE D
M AN U
SC
RI PT
ACCEPTED MANUSCRIPT
AC C
EP
TE D
M AN U
SC
RI PT
ACCEPTED MANUSCRIPT
AC C
EP
TE D
M AN U
SC
RI PT
ACCEPTED MANUSCRIPT
AC C
EP
TE D
M AN U
SC
RI PT
ACCEPTED MANUSCRIPT