Indications and Outcomes of Open Inferior Vena Cava Filter Removal

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...

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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.

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Indications and outcomes of open inferior vena cava filter removal

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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)

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Memorial Hermann Hospital System, Houston, Texas

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Presented at the Vascular and Endovascular Surgery Society Annual Meeting 2017, Steamboat Springs, CO, USA.

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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.

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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]

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Abstract

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Introduction: Despite recommendations for retrieval of inferior vena cava (IVC) filters, most are

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not removed in a timely manner. Longer IVC filter dwell times are associated with caval wall

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perforation and tilting that make percutaneous retrieval more difficult. Open IVC filter removal

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is generally reserved for patients with symptoms referable to the filter, such as chronic back and

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abdominal pain. We present our management algorithm and review of cases of open IVC filter

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removal.

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Methods: Patients referred for management of implanted IVC filters from May 2010 to May

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2016 were included. Demographic and imaging were reviewed for cases requiring open surgical

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removal.

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Results: There were 221 percutaneous retrieval attempts in 218 patients. Successful retrieval

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occurred in 196 (89%) attempts. There were 7 patients that had open surgical IVC filter removal

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after failure of percutaneous retrieval. One patient had 2 filters and another had 3 filters. Except

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for 1 case with complications during the percutaneous retrieval procedure, the remaining patients

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all suffered from back or abdominal pain. All had significant filter strut penetration through the

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caval wall into adjacent structures. Postoperatively, all patients had relief of pain. There were no

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deaths and one patent had a minor ileus that spontaneously resolved.

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Conclusions: Patients who fail percutaneous IVC filter retrieval can expect low morbidity and

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prompt resolution of symptoms after open surgical removal via mini-laparotomy.

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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

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studies have shown that device retrieval occurs in <50% of cases.1, 2 This is most often due to

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lack of referral into a comprehensive follow-up program. The benefit of routine filter retrieval

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has recently been called into question and may not be cost-effective.3 The counter argument is

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that as many as a quarter of patients do have complications related to long-term indwelling

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filters, including IVC thrombosis, filter dislocation, recurrent pulmonary embolism, penetration

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of filter struts through pericaval structures, and chronic pain.4, 5 The U.S. Food and Drug

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Administration reaffirmed its recommendation in 2014 that retrievable IVC filters should be

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removed when reasonable.

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Most filters can be removed percutaneously using standard techniques but occasionally require creative maneuvers. Assuming the transient risk of pulmonary embolism has passed, the

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optimal time of IVC filter retrieval is estimated to be 1-2 months after implantation.6 This is

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outside the 12-day retrieval window of the Cordis OPTEASE filter and many filters tend to

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become more difficult to remove over time. This is usually due to strut penetrations through the

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caval wall leading to tilting and scar formation. Especially with deep filter strut penetration and

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severe misalignment, percutaneous retrieval may not be possible without undue risk. We noted

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several cases where the filter was nearly sideways in the IVC or entangled with a second filter.

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Open IVC filter removal can be done through a retroperitoneal or transperitoneal mini-

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laparotomy approach. We describe our indications for open filter removal, technique, and

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outcomes in 7 cases.

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Methods Patients referred for management of implanted IVC filters from May 2010 to May 2016

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were included. From 2011 to 2015, patients referred for IVC filter management were enrolled in

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a prospective registry after signing informed consent. Thereafter, patients were periodically

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contacted to assess for ongoing need for the IVC filter. Since 2015, contacting patients regarding

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their IVC filter was deemed the practice standard and need for signed informed consent was

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waived. Retrospective research access to the database was approved by the Committee for the

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Protection of Human Subjects, the local ethics institutional review committee. Demographic and

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imaging information was reviewed for cases requiring open surgical removal. Durable resolution

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of symptoms was ascertained by accessing outpatient follow-up records.

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Surgical technique

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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

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midline laparotomy incision is made approximately 10 cm in length depending on the patient’s

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anatomy. The small bowels are packed to the right side and the retroperitoneum is entered to the

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left of the duodenum. The duodenum is elevated off of the IVC, retracted to the patient’s right

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side, and inspected for any penetration. If needed, the struts or filter tines are carefully removed

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with repair of the bowel wall.

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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

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tedious. Direct pressure over the proximal and distal IVC with sponge sticks usually offers

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adequate hemostasis. Once control is obtained, a longitudinal venotomy is made (Figure 1). An

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endovenectomy is performed as needed to remove scar tissue surrounding the filters within the

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lumen. It is important to keep in mind that the filter may embed itself in the renal vein or other

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tributaries. Once the luminal surface is free of filter and scar, the venotomy is primarily repaired

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with running 5-0 polypropylene suture (Figure 2). We find that a patch angioplasty is not usually

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needed except in cases of chronic occlusion and scarring. After the repair, anticoagulation is

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reversed and the laparotomy closed.

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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.

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Successful percutaneous retrieval occurred in 196 (89%) attempts. There were 7 patients that had

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open surgical IVC filter removal after failure of percutaneous retrieval. One additional patient

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required median sternotomy and cardiopulmonary bypass after the filter migrated to the caval-

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atrial junction during retrieval attempt at another hospital. Most were referred to us especially for

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open removal after unsuccessful percutaneous retrieval by other groups. One patient had 2 filters

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and another had 3 filters. Except for 2 cases with complications during the percutaneous retrieval

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procedure that were transferred to us, the remaining patients all suffered from back or abdominal

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pain. Symptomatic patients all had significant filter strut penetration through the caval wall into

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adjacent structures.

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Case 1 A 73-year-old man with a history of motor vehicle crash and deep vein thrombosis

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(DVT) presented with scrotal and back pain. The patient was initially diagnosed and treated for

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urinary tract infection. However, a computed tomography (CT) scan of the abdomen revealed

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IVC thrombosis at the level of the renal arteries extending from two misaligned IVC filters

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(Figure 3). A venogram demonstrated evidence of old organized thrombus in the iliac vein and

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two IVC filters. An attempt to pass the wire through the IVC filter for thrombolysis failed. The

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patient was started on rivaroxiban. The patient presented a few months later with persistent back

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pain and worsening leg swelling despite anticoagulation. He underwent ultrasound-accelerated

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thrombolysis with some reconstitution of the iliocaval veins. However, there was still significant

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IVC thrombosis within the misaligned filters.

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After review of CT and venogram, we decided not to attempt another percutaneous

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retrieval. A mini-laparotomy was performed and the two IVC filters were removed via a

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longitudinal cavotomy. A caval endovenectomy was performed with primary repair of the vein

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wall. Several filter barbs penetrating through the caval wall entered the duodenum requiring

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suture repair of the small bowel. The patient was slow to recover bowel function but otherwise

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recovered uneventfully. He reported resolution of back pain and improved, but not resolved, leg

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swelling in office follow-up.

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Case 2 A 44-year-old woman presented to interventional radiology for elective removal of an

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ALN IVC filter. The filter was initially placed for recurrent history of pulmonary embolism

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while on anticoagulation. Due to tilting of the filter with subsequent penetration into the renal

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vein the percutaneous attempts were not successful. The interventional radiologist was unable to

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extract the filter using the ALN cone via the right internal jugular vein. An attempt was also

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made using a gooseneck snare. The snare became entrapped within the filter barbs and the snare

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could not be retrieved (Figure 4) despite multiple attempts. The filter and snare were removed

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via mini-midline laparotomy. The snare was entwined within the filter and was cut with a wire

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cutter. The remainder of the snare was then removed out of the right internal jugular vein. After

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removal of the filter, the inferior vena cava was primarily repaired.

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Case 3

A 50-year-old woman with a history of pulmonary embolism presented with severe

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abdominal and back pain. Her IVC filter was misaligned on CT scan and she subsequently

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underwent three attempts at percutaneous filter removal. Due to significant angulation, the filter

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could not be removed. The patient was referred to us for open removal. Several of the struts were

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found penetrating through the caval wall and entering the serosa of the duodenum as well as the

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anterior spinal ligament. These were carefully removed at mini-laparotomy and a venotomy was

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made in the IVC over the filter. The proximal hook of the filter was noted to have lodged into a

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posterior lumbar vein explaining the difficulty with percutaneous retrieval. The filter was

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dissected off the wall after several of the struts were cut with wire cutters. The venotomy was

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primarily repaired. Postoperatively, the patient reported resolution of her back and abdominal

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pain.

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Case 4 A 25-year old man with a history of motor vehicle crash 6 years ago requiring a C3-C7

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spinal fusion presented with right lower quadrant abdominal pain. After undergoing a CT scan,

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the patient was found to have an IVC filter with severe angulation and barbs penetrating through

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the caval wall. The patient reported that he never knew it was in place so he never sought

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removal. An attempt at percutaneous removal was done at an outside hospital that was

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unsuccessful.

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He was referred to our center for open removal. We could find no other reason for his

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abdominal pain. After mini-laparotomy, the filter struts were found to be penetrating through the

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caval wall in multiple directions including a barb through the duodenal wall and at least 1 strut

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penetrating into the aorta. The inferior vena cava was opened longitudinally. Several of the barbs

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were cut with Mayo scissors including the barb penetrating into the aorta. Care was taken to

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ensure that the entire filter was removed without damaging the duodenum and the aorta. The

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venotomy was primarily repaired. After recovery, the patient reported resolution of his

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abdominal pain.

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Case 5

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A 28-year-old woman presented to our facility with persistent abdominal pain. She had a

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history of IVC filter placement a year before when she suffered a pelvic fracture. An attempt was

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made at that time to remove the IVC filter percutaneously when she regained mobility but it was

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noted that the filter was misaligned and imbedded into the caval wall. The filter could not be

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removed and the patient later returned with complaints of abdominal pain. We could find no

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other cause for her pain and she was scheduled for open filter removal. A midline mini-

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laparotomy incision was made. Several of the barbs were penetrating through the caval wall. One

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of the barbs penetrated through the adventitia of the aorta and there was also a filter barb

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penetrating into and through the gonadal vein. This was contributing to the severe angulation.

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Several of the barbs were transected outside the IVC and a longitudinal venotomy was made to

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extract the filter from the IVC as well as the gonadal vein. The venotomy was then primarily

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repaired. She reported resolution of her abdominal pain in follow-up.

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Case 6

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A 50-year-old woman with chronic kidney disease was transferred from an outside

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hospital with abdominal pain. She had a history of right leg gunshot wound, below-knee

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amputation, deep vein thrombosis, and IVC filter placement 25 years ago. She was diagnosed

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with IVC thrombosis 10 years ago and had an additional IVC filter placed superior to the

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thrombosis. On arrival, a CT scan showed an occluded IVC with several misaligned filters and

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barbs penetrating through the caval wall into adjacent structures. No other cause for her severe

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abdominal pain could be found. At laparotomy, 3 tangled filters were found in an occluded IVC.

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One of the barbs was penetrating through the wall of the duodenum. The small bowel was

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repaired with polyglactin suture. Postoperatively, she had prolonged ileus. She was discharged

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home tolerating a regular diet on postoperative day 7.

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A 36-year-old woman was admitted via the emergency room complaining of worsening,

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severe abdominal and right groin pain. An extensive workup only revealed an angulated IVC

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filter placed in the right common iliac vein. The filter was placed several years ago for deep vein

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thrombosis and pulmonary embolism. Although she was given a diagnosis of hypercoagulable

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disorder, she was not placed on anticoagulation. An attempt was made at percutaneous retrieval

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but this was unsuccessful due to extreme tilting. The filter was removed via transperitoneal mini-

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laparotomy. Inspection of the abdomen did not show any other cause for her abdominal pain.

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Several of the barbs were penetrating out of the vein wall into the L5 periosteum and

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surrounding structures. The longitudinal venotomy in the right common iliac vein was repaired

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primarily. She was started on oral anticoagulation postoperatively and was discharged home on

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postoperative day 9.

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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

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whose transient risk of venous thromboembolic events subsided.2 Many centers, including our

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own, report retrieval rates of less than 50% and initial technical success of percutaneous retrieval

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in 85-99% of cases.7-9 Failure to percutaneously retrieve the filter may be due to thrombus within

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the filter or severe angulation; both can worsen over time.

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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

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type. Strut penetration through the caval wall is commonplace and most patients are

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asymptomatic.10 All patients referred for open filter removal had significant strut penetration into

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adjacent structures, such as small bowel, spine and the aorta. Open surgical IVC filter removal is

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generally reserved for symptomatic patients who failed percutaneous retrieval. By itself,

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asymptomatic strut penetration into pericaval structures is not a usual indication for open

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removal. Our algorithm for filter retrieval is shown in Figure 5. Several centers published their experience of IVC filter removal via laparotomy and most

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show low complication rates using slightly different surgical techniques.11-14 Although there may

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be reporting bias, morbidity and mortality appear to be low in experienced centers. We find that

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a 10-cm laparotomy is sufficient in most patients. The retroperitoneum can be entered directly

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and the duodenum retracted to the right of the IVC without mobilization of the right colon.

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Removal of the filter by cavotomy, endovenectomy and primary repair can be safely done

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without the need for extensive caval reconstruction as observed in our case series.

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Conclusion

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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

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misaligned IVC filters to patients suffering from symptoms, such as chronic pain. The symptoms

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appear to be caused by filter strut penetration into adjacent structures. Other indications for open

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IVC filter removal include complications during percutaneous filter retrieval, such as

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dislodgement of the filter into the right atrium and retrieval device entanglement. Although open

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surgery is the last resort for retrieval of IVC filters, it can be accomplished with minimal

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morbidity and leads to resolution of symptoms.

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Figure Legend Figure 1. Intraoperative image after opening the IVC. Note the filter strut within the iliolumbar tributary.

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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.

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Figure 5. Algorithm for retrieval evaluation of implanted IVC filters.

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References

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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.

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Table. Patients requiring open surgical inferior vena cava removal. Indications for filter placement

Length of implant

Presenting symptoms

Percutaneous Operative attempts findings

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Trauma (prophylaxis)

2 filters placed, duration unknown

No attempts made after venogram and CT findings

Caval and duodenal penetration

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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

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6 years

Abdominal pain

Single attempt

Abdominal pain

Unknown

Abdominal and right groin pain

Single attempt

Postop length of stay (days) 7

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Age/ Gender

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4

4

15

9

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