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IVC filter removal after extended implantation periods Arash Jaberi a, Mary Jiayi Tao b, Naomi Eisenberg c, Kongteng Tan a, Graham Roche-Nagle a,c,* a
Division of Interventional Radiology, University Health Network, Toronto General Hospital, Canada Department of Medical Imaging, University Health Network, Toronto General Hospital, Canada c Division of Vascular Surgery, University Health Network, Toronto General Hospital, Canada b
article info
abstract
Article history:
Objective: Life-threatening complications have been reported in patients with chronic
Received 21 May 2019
retrievable IVC filters. National health agencies have urged hospitals to assess all patients
Received in revised form
with retrievable IVC filters for filter removal. The aim of the current study was to identify
26 September 2019
those patients with unretrieved chronic IVC filters, document complications and removal
Accepted 11 October 2019
techniques.
Available online xxx
Methods: We identified a cohort with unretrieved IVC filters inserted between January 2001 and December 2013. These patients were invited back to clinic for review with CT imaging
Keywords:
to determine complications, if any, and offer removal. Data collected included de-
IVC filter
mographics, complications and retrieval characteristics.
Deep venous thrombosis
Results: 289 patients were discovered to still have a filter in situ. Of these, 193 patients were
Pulmonary embolism
verified as deceased. Eighty-nine patients were notified, with no current contact information available on the remaining seven. Thirty-six attended for review, 20 females, 16 males, with an average age of 63.5 years. Complications identified at CT were 2 occluded IVCs (5.8%), 4 fractured filters (11.7%) and filter penetration in all cases (37.5% grade 2, 56.25% grade 3). Sixteen patients agreed to proceed with filter removal, 10 declined the opportunity and 6 were unfit or had ongoing indication for the filter. Two are awaiting removal and two had IVC occlusion. Subsequent retrieval was successful in 93% of cases (14/15). The mean time to removal from implant was 3846.9 days (SD 980.3). Advanced techniques were utilized in 10 cases and there were no mortalities or morbidities. Conclusion: Retrievable inferior vena cava filters are not benign and practitioners need to be aware of regulatory guidelines. Unretrieved filters can be successfully retrieved using standard and advanced methods with low morbidity and mortality. © 2019 Published by Elsevier Ltd on behalf of Royal College of Surgeons of Edinburgh (Scottish charity number SC005317) and Royal College of Surgeons in Ireland.
Introduction Venous thromboembolism (VTE), deep venous thrombosis (DVT), and pulmonary emboli (PE) remain common diseases with significant clinical impact upon our patients. VTE occurs in approximately 100 persons per 100,000/year in the United States. This rate rises exponentially with age, from <5 cases per 100,000 inpatients <15 years old to ~500 (0.5%) per 100,000 persons at age 80 years.1 In the majority of cases, standard
medical therapy for VTE is oral anticoagulation therapy (OAT). In cases where either standard OAT is contraindicated or complications result from that therapy, practitioners may contemplate the insertion of inferior vena cava (IVC) filters. Inferior vena cava (IVC) filters are devices that partially interrupt the flow in the IVC in order to inhibit pulmonary embolism. Since its introduction in 1973 by Greenfield,2 there has been a rapid advance in technology that has included the launch of retrievable filters in 2003.3 The capacity for removal of these devices makes them favorable over permanent filters,
* Corresponding author. Division of Interventional Radiology, University Health Network, Toronto General Hospital, Canada. E-mail address:
[email protected] (G. Roche-Nagle). https://doi.org/10.1016/j.surge.2019.10.003 1479-666X/© 2019 Published by Elsevier Ltd on behalf of Royal College of Surgeons of Edinburgh (Scottish charity number SC005317) and Royal College of Surgeons in Ireland. Please cite this article as: Jaberi A et al., IVC filter removal after extended implantation periods, The Surgeon, https://doi.org/10.1016/ j.surge.2019.10.003
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principally in patients with short-term indications for their use. Since the establishment of retrievable filters, there has been a noticeable surge in filter insertion.4 In practice, research has demonstrated that such filters are frequently not removed. A recent systematic review of 37 studies showed that the mean retrieval rate was 34%,5 although it can be as low as 8.5%.6 Non retrieved filters pose a major health concern because of the potential for complications with longer indwelling times.5 In response to this, the U.S. Food and Drug Administration (FDA) issued an updated safety alert in 2014 recommending that physicians and clinicians implanting these devices accept responsibility for the ongoing care of these patients and follow up with each patient and to remove filters as soon as clinically appropriate.7 Health Canada followed with a similar recommendation encouraging each hospital to identify all patients who have a retrievable IVC filter placed and to develop a formal strategy to assess these patients for filter removal.8 At our institution we identified our removal rate as 41.6%.9 The aim of this study was to identify those patients with unretrieved, chronic IVC filters, assess them and document any complications and removal techniques employed.
Methods Using the dataset from a previous performed retrospective review of all IVC filter procedures performed between January 2001 and December 2013 at our institution, we identified a cohort with unretrieved IVC filters.9 Their mortality status was confirmed with the Ontario Ministry of Health using their health card number. All living patients were notified initially by mail and if no response was received within 6 weeks, they were notified by registered mail. Instructions were enclosed in the letter to contact the identified hospital contact or family doctor for a discussion about the status of the filter. A multidisciplinary specialist clinic was set up with same day CT venogram and consultation by vascular surgeon and interventional radiologist. All patients who responded were considered for filter removal with the risks and benefits of the procedure explained. Baseline demographics, indwelling time, complications and removal details were collected. Complications documented at CT included occlusion of IVC, fracture of filter and penetration grade. Filter strut penetration was evaluated by using the grading system of Oh et al.10: grade 0, no penetration; grade 1 penetration, tenting of the IVC; grade 2 penetration, extra luminal appearance on CT scan; and grade 3 penetration, involvement of the strut with an adjacent organ. The patients who consented for removal were booked as a day procedure and the techniques employed for removal documented. All procedures were performed with the patient receiving routine moderate sedation with fentanyl and midazolam. Advanced techniques included the hangman technique11 and the Endobronchial Forceps technique.12
were insertions and 31% (n ¼ 313) were retrievals. Of the 663 retrievable filters, successful removal rate was 41.6% (n ¼ 276); 22 patients had a failed retrieval attempt. Having excluded filters removed subsequent to the data collection period 289 patients were identified to still have a filter in situ. One hundred and ninety-three patients were confirmed as deceased, either internally and/or by Ministry of Health. Eighty-nine patients were notified and invited for consultation. No current contact information was available on the remaining seven and a further 2 letters were returned as moved with no forwarding address (Fig. 1). Thirty six attended for review (45%), 20 females, 16 males with an average age of 63.5 years. Complications documented at CT venogram were 2 occluded IVCs (5.8%) (Fig. 2A), 4 fractured filters (11.7%) (Fig. 2B) and filter penetration in all cases (Fig. 2C) (37.5% grade 2, 56.25% grade 3) (Table 1). Sixteen patients consented to proceed with filter removal, 10 declined and 6 were unfit or had ongoing indication for the filter. Two are currently awaiting removal and 2 had IVC occlusion. Retrieval was successful in 93% of cases (15/16). The failure was a 62 years old wheelchair bound female patient who was found to have a highly angulated and very embedded filter (grade 3) which could not be removed despite using the hangman technique and significant force. The mean time to removal of the filter from implant was 3846.9 days (SD 980.3 days). Advanced techniques were employed in 10 cases and there were no mortalities or morbidities sustained by the patients. The advanced techniques involved included the hangman technique in 9 cases and the forceps technique in one. The degree of filter tilt was assessed on imaging acquired before or during the attempted retrieval. The tilt angle in mediolateral and anteroposterior directions was calculated and the maximum documented. The results were <15 (n ¼ 6; 37.5%), >15 (n ¼ 10; 62.5%), and with an average tilt of 18 (range, 5e30 ). The mean fluoroscopy time was 23.2 min (range, 10e46.9 min). The filters removed were four Bard G2 filters (Bard Peripheral Vascular, Tempe AZ), seven Cook Gu¨nther Tulip filters and four Cook Celect filters (Cook Medical, Bloomington IN).
Results During the study period between January 2001 and December 2013, 1123 IVC filter procedures were performed; 69% (n ¼ 810)
Figure 1 e Consort flow chart.
Please cite this article as: Jaberi A et al., IVC filter removal after extended implantation periods, The Surgeon, https://doi.org/10.1016/ j.surge.2019.10.003
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Figure 2 e A. Occluded IVC, B. Fractured filter, C. Strut penetration.
Discussion In most cases, all patients with retrievable IVC filters should have the filter retrieved when the clinical indication for placement no longer exists, preferably within 30 days of placement. Indwelling filters that are no longer indicated should be retrieved without delay for several reasons. Notably, there are numerous reported long-term IVC filter complications, including IVC thrombosis, IVC penetration, chronic abdominal pain, and duodenal perforation.13 Moreover, with prolonged indwelling time there is an increased risk of failure of routine removal techniques, and the use of advanced techniques has been shown to augment the retrieval complication rate.14 Appreciation of the dangers of long-term IVC filters and recommendations from national bodies7,8 has led physicians to endeavor to retrieve IVC filters with prolonged indwelling times, principally in younger patients. In a systematic review of 1715 removed filters, Angel et al. described an average retrieval time of retrieval of 72 days, and successful retrieval up to 3006 days has been reported.13,15 The mean time to removal from implant in our study was 3846.9 days (SD 980.3). However, the success of retrieval attempts has been shown to diminish with prolonged indwelling times, which further underlines the necessity of regular follow-up for reassessment of risk and reflection of filter retrieval as early as possible.16,17 Fortunately, in our cohort we had only one failure from 16 attempts at removal of a chronic IVC filter. Even though the bulk of filters can be retrieved without issue, there are numerous factors that augment the possibility of retrieval failure, including embedded hooks, severe tilt, significant filter thrombus, caval occlusion, and filter strut penetration into the caval wall. All our patients received preretrieval CT scans. Dinglasan et al.16 describe a number of
statistically significant characteristics on pre-retrieval CT imaging that can help in identifying probable complicated retrievals. These include: (1) tilt angle in mediolateral and anteroposterior directions (>15 cutoff), (2) tip embedding (tightly opposed to IVC wall), (3) strut perforation, and (4) dwell time.16 The degree of filter strut perforation is based on a grading system: grade 0, all struts confined within the lumen; grade 1, strut external but immediately adjacent to the IVC wall; grade 2, struts completely outside IVC lumen; and grade 3, struts adjacent to or inserting into an adjacent organ or retroperitoneal structure.16 Our one retrieval failure was highly angulated and grade 3 embedded. Recognition of these elements can support procedure planning, patient consent, and referral to a tertiary center if required. Several studies have illustrated various advanced techniques for retrieval of these challenging IVC filters, including Desai et al., who recently performed a review of advanced techniques.1821 They also demonstrated that after a 7-month filter dwelling time, the likelihood of standard retrieval technique failure is high, with a calculated risk of 40.9%, and continues to increase with increasing dwell time. Consequently, after this time, advanced filter retrieval techniques are often crucial to maintain high overall rates of retrieval technical success.18 Kuo et al.22 demonstrated that complex retrieval methods could retrieve filters with 100% success in a series of 50 patients, where conventional methods had previously failed. Other published studies have documented higher procedure-related adverse event rates when performing advanced techniques. Al-Hakim et al.14 reported a complication rate of 5.3% when employing advanced retrieval techniques. In the present study, our complication rate was 0%. Other publications have found no relationship linking adverse event rates and filter dwell time or use of advanced techniques on multivariable analysis.23 Through clinical
Table 1 e Grading system for inferior vena cava filter interaction with IVC wall.10 Grade 0
Normal; filter strut confined entirely within IVC
0/16 (0)
Grade 1
Filter strut is immediately adjacent to external aspect of IVC wall, likely reflecting tenting of IVC wall Filter strut is entirely outside IVC lumen within retroperitoneum as evidenced by a “halo” of retroperitoneal fat around axially viewed strut Filter strut interacts with adjacent organ outside of IVC
1/16 (6.25)
Grade 2 Grade 3
5/16 (37.5) 9/16 (56.25)
Values are reported as n/N (%).
Please cite this article as: Jaberi A et al., IVC filter removal after extended implantation periods, The Surgeon, https://doi.org/10.1016/ j.surge.2019.10.003
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experience, it seems that advanced IVC retrieval procedures demonstrated a good safety profile. Admitting techniques differ based on the individual situations, we generally first attempt retrieval using a loop snare, sometimes employing several telescoping sheaths to both increase longitudinal rigidity and prevent buckling as the sheath is passed over the filter. If the hook cannot be engaged by the snare, a shaped guide catheter can be used to aide guidance of the snare toward the hook. If this fails, we will usually proceed directly to the Hangman technique, and resort to the loop snare technique or endobronchial forceps only for filters that fail these measures. There are limitations to this paper. The use of particular advanced techniques was based on physician preference. A further limitation is the single-center nature of our experience, thereby limiting broader clinical generalizability. Nonetheless, in both our analysis and previously published studies, retrieval of IVC filters with prolonged dwell time frequently requires advanced techniques and ideally should be undertaken in a center with a high level of familiarity in these procedures. In conclusion, awareness of the duration of implantation and the possibility for challenging retrieval are vital when contemplating IVC filter retrieval and consenting of patients. Pre retrieval CT can characterize factors that forecast the potential of failure of routine technique and should be contemplated for filters with a prolonged implantation time. A number of safe and effective advanced techniques have been illustrated for removal of filters that fail routine retrieval techniques. Acknowledging that advanced retrieval techniques can be related to higher complication rates, these techniques may be still be preferable to the consequences associated with leaving an IVC filter permanently in place.
Acknowledgments This paper was presented at the CANADIAN SOCIETY FOR VASCULAR SURGERY Annual Meeting e September 28e29, 2018, Montreal, Quebec, Canada.
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Please cite this article as: Jaberi A et al., IVC filter removal after extended implantation periods, The Surgeon, https://doi.org/10.1016/ j.surge.2019.10.003