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British Journal of Radiology (2006) 79, 584-591
© 2006 British Institute of Radiology
doi: 10.1259/bjr/54853087
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Full paper

Prophylactic implantation of inferior vena cava filter during interventional radiological treatment for deep venous thrombosis of the lower extremity

T Yamagami, MD, PhD T Kato, MD T Hirota, MD R Yoshimatsu, MD T Matsumoto, MD and T Nishimura, MD, PhD

Department of Radiology, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, 465 Kajii-chyo, Kawaramachi-Hirokoji, Kamigyo, Kyoto, 602-8566, Japan


   Abstract
Top
 Abstract
Introduction
 Subjects and methods
 Results
 Discussion
 References
 
The purpose of this study was to evaluate the filtering effect of the Gunther tulip retrievable vena cava filter (GTF) during treatment of deep venous thrombosis (DVT) in the lower extremity using various interventional radiological procedures. Subjects of the study were all 17 consecutive patients (8 women, 9 men; age range 18–87 years; mean age 55.9 years) with symptomatic lower limb DVT referred for interventional radiological treatment between February 2001 and September 2004. In all of these patients, the GTF was implanted during interventional radiological treatment. Trapped thrombus in the filter was evaluated with venocavography performed repeatedly during the treatment for DVT. Implantation of a total of 29 GTFs was successfully performed in the 17 patients. In 10 (58.8%), more than 2 filters were subsequently implanted to prolong implantation time. Also in 10 patients, the DVT resolved after therapy and retrieval of the final GTF was successful with one exception. Worsening of or new formation of pulmonary embolism was avoided in all patients. In 8 (47.1%) of the 17 patients, a trapped thrombus in the GTF was observed during treatment for DVT. In six patients the trapped thrombus was large, filling more than half the height of the filter. In conclusion, we found that the GTF is effective in filtering the relieved thrombus from DVT in the lower extremity and in protecting against movement of the thrombus to the pulmonary artery during therapies with interventional radiological procedures.


   Introduction
Top
 Abstract
 Introduction
Subjects and methods
 Results
 Discussion
 References
 
The initial symptoms of deep venous thrombosis (DVT) in the lower extremities may be quite severe [1, 2] and, additionally, there is substantial risk of pulmonary embolism [1, 3]. Moreover, in DVTs that remain, delayed complications are possible, including the spectrum of debilitating symptoms referred to as post-thrombotic syndrome [4]. Therefore, treatment of DVT is necessary. Traditionally, therapy for DVT has consisted of systemic intravenous administration of heparin [5]. Other options have been systemic intravenous administration of fibrinolytic agents such as urokinase or streptokinase [5–7]. Recombinant tissue plasminogen activator is gaining attention as an effective fibrinolytic agent [8, 9]. Systemic thrombolysis is more effective than heparinization, but less effective than catheter-directed thrombolysis, which is an interventional radiological treatment that has recently become widely accepted as useful in treating DVT [4, 9–11]. Most recently, other interventional radiological procedures such as manual aspiration of thrombus [12], mechanical thrombectomy [4, 13, 14], percutaneous transluminal angioplasty [13, 15] and self-expandable metallic stent placement [4, 13, 15, 16] have sometimes been combined with catheter-directed thrombolysis to improve the quality of treatment for DVT.

Theoretically, a thrombus released from the DVT during catheter-directed thrombolysis could move to the pulmonary artery, which may cause pulmonary embolism. Thus, some physicians implant inferior vena cava filters prophylactically to prevent such an occurrence [17–20]. However, the prophylactic use of an inferior vena cava filter is considered by some to be unnecessary [1, 10, 11], with the result that this procedure is currently very controversial. Nevertheless, in our daily clinical work, we have experienced many situations where, if a filter had not been implanted during catheter-directed thrombolysis, severe pulmonary embolism might have occurred. Many interventional radiological procedures for DVT other than catheter-directed thrombolysis have been developed [12–16], but there is little information on the prophylactic use of filters in these procedures [21].

When such prophylactic use of filters is required, ideally, a permanent inferior vena cava filter would not be placed, considering the long life expectancy of such patients [22, 23]. Hence, temporary vena cava filters have been widely used [17, 24]. However, paralleling the increase in the use of temporary vena cava filters have been reports describing complications related to their insertion, mainly associated with their structure, where part of the device projects from the insertion site [24–26]. Because of such problems, it would be advantageous to use a retrievable vena cava filter, that is, a permanent filter that can be retrieved when necessary. The Gunther tulip retrievable vena cava filter (GTF) (Cook, Bjaeverskov, Denmark) is among the commercially available retrievable vena cava filters.

The present study evaluated whether an inferior vena cava filter could have a role in filtering a thrombus released from the lower limb during treatment of lower extremity DVT using various interventional radiological procedures. Also examined were the feasibility and safety of a GTF used for that purpose.


   Subjects and methods
Top
 Abstract
 Introduction
 Subjects and methods
Results
 Discussion
 References
 
Patients
The cohort of this study was 17 consecutive patients (8 women, 9 men; age range 18–87 years; mean age 55.9 years) who were treated for symptomatic DVT of the lower extremity, utilizing various interventional radiological procedures between February 2001 and September 2004, at our institution. In all of these patients, traditional intravenously administered systemic anticoagulation and/or thrombolysis had been performed first as a treatment for DVT. However, despite such treatment, DVT developed. A GTF was implanted to prevent the complication of pulmonary embolism during the entire period of interventional radiological treatment of DVT (Figure 1Go). Interval from initial symptoms to start of therapy for DVT was within 1 week in 11 patients, between 1 week and 4 weeks in 5 patients and after 6 weeks in 1 patient.


Figure 1
Figure 1
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  		Figure 1. A 19-year-old man (patient no. 6). (a) Venography shows venous thrombus distributing from the left common iliac vein to the left femoral vein (arrows). Note that Gunther tulip retrievable vena cava filter (GTF) was implanted at the inferior vena cava with an approach from the right jugular vein. (b) Venography obtained immediately after catheter-directed thrombolysis still shows that much of the thrombus remained. Note that multiple side holes of the catheter for catheter-directed thrombolysis were positioned in the segment of the thrombus (arrows). (c) Venocavography obtained from the right femoral vein shows that thrombus filling greater than the height of filter was captured in the filter (arrows). This image was obtained just after manual aspiration, mechanical thrombectomy and percutaneous transluminal angioplasty were performed. These interventional radiological procedures were performed after catheter-directed thrombolysis, as shown in Figure 1a,bGo, and prolonged thrombolysis performed subsequently in the ward through the catheter with its tip positioned at the thrombosed segment. (d) Roentgenogram shows a temporary filter (arrow) (Neuhaus Protect, Toray) that was inserted at the cephalad level of GTF before GTF with thrombus was retrieved to be exchanged with a new GTF. (e) Venography through the right femoral vein, obtained after GTF was exchanged for a new one (arrow), shows no thrombus remaining in the inferior vena cava. The new GTF was implanted to continue treatment for the DVT, further avoiding the complication of pulmonary embolism. 7 days after this, metallic stent placement was performed, then venous thrombus resolved and rapid blood flow in the previously obstructed segment due to thrombus in the left common and external iliac and femoral vein was obtained.

 
In all cases, the existence of lower extremity DVT was diagnosed by ultrasound. When extension of the thrombus from the lower extremity to the inferior vena cava was suspected, enhanced abdominal CT was performed. Intravenous ascending venography with contrast injection into the vein of the foot was also performed as an interventional radiological diagnostic procedure.

Before starting therapies for DVT, enhanced chest CT was performed in all 17 patients to evaluate the existence of pulmonary embolism. Pulmonary embolism was found in two patients, who received intravenously administered anticoagulation and thrombolytic therapies for pulmonary embolism, in addition to therapies for DVT. Enhanced chest CT was also obtained after therapies for DVT in all 17 patients.

Procedures
All interventional radiological procedures performed as therapy for DVT and GTF placement and retrieval were performed by one of three experienced interventional radiologists in our institution after written informed consent was obtained from each patient. The consent included use of records, images, data, etc. for research purposes. Our institution does not require institutional review board approval for this type of report. Principles of the Declaration of Helsinki were followed.

The following are interventional radiological therapies for DVT that were performed in our institution and that were reviewed retrospectively in all 17 patients who received such therapy.

In the angiography suite, catheter-directed thrombolysis was performed after a 0.035-inch guide-wire was advanced via a 5-French catheter over the thrombosed segment and this catheter was exchanged with a commercially available multiside-hole catheter (Cragg-McNamara Valved Infusion Catheter; Micro Therapeutics, Irvine, CA). Venous access was through the femoral, jugular, or popliteal vein. After positioning the tip of the multiside-hole catheter in the thrombosed segment, a mixture of 120 000–240 000 IU urokinase and 1000–2000 IU heparin diluted by 20–40 ml of physiological saline was manually administered over a period of approximately 10 min. In the majority of patients (n = 16), because the thrombus remained, 120 000–240 000 IU urokinase per day was further administered persistently via the catheter which remained positioned in the thrombosed segment over a prolonged period, even after the patient returned to the ward from the angiography suite. Heparin was administered systemically during the lytic procedure and after lysis to keep the partial thromboplastin time at 75–100 s.

When DVT was shown to be completely or almost completely resolved on venography via the catheter inserted for catheter-directed thrombolysis, lysis was stopped. But if much of the thrombus remained as shown on this venography, manual aspiration of the venous thrombus and/or mechanical thrombectomy were often combined concurrently with or after catheter-directed thrombolysis. For manual aspiration, after a 10-French or 11-French with 11 cm long sheath introducer was inserted from the femoral vein at the site of the thrombosis, an 8-French with 25 cm long sheath was advanced through the wider sheath into the segment occupied by the thrombus. The 8-French sheath was fitted with a syringe by which the clot was manually aspirated. After the aspiration, the 8-French sheath was withdrawn from the 10-French or 11-French sheath. If clots of thrombus were observed, the 8-French sheath was reinserted and the thrombus was aspirated. These steps were repeated until the venous thrombus was no longer observed by aspiration. Alternatively, in the more recent cases, after a 6-French sheath introducer was inserted from the femoral vein at the site of DVT, the venous thrombus was aspirated utilizing a 6-French catheter (Thrombuster; Kaneka, Tokyo, Japan). This catheter is commercially available and was developed exclusively for aspiration of a venous thrombus. Mechanical thrombectomy was performed using a commercially available thrombectomy device (Hydrolyser; Cordis or Oasis; Boston Scientific) with access from the femoral vein.

When an underlying stenosis or obstruction due to a non-fresh thrombus remained, percutaneous transluminal angioplasty for the segment that was narrowed due to thrombus was occasionally performed. If necessary, a self-expandable metallic stent was placed to obtain sufficient relief of the lesion, particularly at the level of the iliac vein. With the femoral or jugular venous approach, percutaneous transluminal angioplasty was performed with a commercially available angioplasty balloon catheter after advancing a 0.035-inch guidewire over the narrowed lesion. The angioplasty balloon catheter was positioned in the narrow segment, after which percutaneous transluminal angioplasty was performed for the entire narrow segment. Either the Ultra-thin diamond balloon catheter (Boston Scientific, Watertown, MA) or the Power flex plus balloon catheter (Cordis, Miami, FL) was used. For self-expandable metallic stent placement, an Easywall stent (Boston Scientific) or spiral Gianturco Z stent (Cook) was implanted with the femoral venous approach. Placement over the area of joint movement (i.e. hip joint) was avoided.

During the entire period of therapy by the above-described interventional radiological procedures, the GTF remained in place. When the period of implantation greatly exceeded 10–14 days, the period cited in many reports within which a filter could be withdrawn safely [27–30], the first implanted GTF was retrieved and another inserted near at a different site from the former GTF.

When the venous thrombus in the lower extremities resolved after therapy, as shown on intravenous venography of the lower extremity, the GTF was retrieved and reinsertion was not required. However, when it remained in spite of various therapies, the last GTF inserted during therapy was left in the vena cava without retrieval to play a role thereafter as a permanent inferior vena cava filter.

After a venacavogram was performed to plan the position of filter placement, the GTF was introduced through the right internal jugular vein and was positioned at the cephalad side of the top of the venous thrombus. In cases when insertion from the right internal jugular vein was difficult, the right subclavian vein was used to introduce the GTF. In principle, the GTF was positioned at the infrarenal inferior vena cava. The GTF was placed through the sheath introducer according to the manufacturer's instructions. Retrieval was performed using the GTF retrieval set supplied by the manufacturer (Cook). Details of techniques to place and retrieve the GTF are described elsewhere [29, 31].

Venocavography was performed repeatedly via the inserted catheter positioned in the thrombosed segment to perform catheter-directed thrombolysis continuously over a prolonged period in the ward. After retrieving the catheter for thrombolysis, venocavography was obtained through an 18-gauge intravenous catheter (Surflo; Terumo, Tokyo, Japan) or a 4-French catheter, which was inserted from the femoral vein in which the thrombus did not exist. In cases when a GTF was exchanged or retrieved, just prior to retrieval, venocavography was performed through the sheath. Trapped thrombus in the filter was evaluated from all these venocavograms obtained by various approaches. Also, immediately after retrieving the GTF, venography was performed to confirm that no thrombus remained where the retrieved GTF had been implanted.

Investigated parameters
We retrospectively investigated the following: selected interventional radiological treatments for DVT, state of DVT after such therapies, number of GTFs implanted and retrieved, rate of success in preventing through GTF placement the worsening or development of pulmonary embolism and degree of trapped thrombus in the filter.


   Results
Top
 Abstract
 Introduction
 Subjects and methods
 Results
Discussion
 References
 
As shown in Tables 1Go and 2Go, implantation in the planned position of a total of 29 GTFs was successful in 17 patients with DVT in the lower extremity for which various therapies utilizing interventional radiological procedures were performed. Details of each GTF implanted are shown in Table 3Go. In four patients, the GTF was placed at the suprarenal inferior vena cava for the following reasons. In two of those four patients, a venous thrombus existed in the inferior vena cava just below the level of entry of the renal vein, leaving insufficient space for implantation in the infrarenal inferior vena cava. The third patient had a double inferior vena cava with the thrombus in both. In the fourth patient, placement of an additional GTF at the cephalad level of the normally placed GTF was necessary.


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  		Table 1. Characteristics of patients with deep venous thrombosis of the lower extremity

 

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  		Table 2. Usage of Gunther retrievable vena cava filter

 

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  		Table 3. Characteristics of each Gunther retrievable vena cava filter

 
Retrieval of the GTF was successful in all 22 attempts, with one exception (Table 3Go). The implantation period per filter before retrieval was 10.4±5.0 days (mean±SD; range 0–18 days; median 13 days). The period of treatment with GTFs in place was 19.1±8.2 days (mean±SD; range 5–37 days; median 20 days). In 10 (58.8%) of the 17 patients, more than 2 filters were subsequently implanted to prolong implantation time. No complications were encountered relating to filter insertion and retrieval. In both patients having a pulmonary embolism at the beginning of interventional radiological treatments for DVT as shown in Table 1Go, the pulmonary embolism had resolved at the end of therapy for DVT. Pulmonary embolism did not occur in any of the 15 patients without pre-existing pulmonary embolism.

On venocavography performed repeatedly during the entire period of therapies for DVT with interventional radiological techniques, in 8 (47.1%) of the 17 patients, a trapped clot of thrombus was observed. Trapped thrombus filled < 1/4 the height of the filter in 1, from ≥1/4 to < 1/2 in 1, and ≥1/2 but within the height of the filter in 4. In 2, the trapped thrombus occupied greater than the height of the filter. Among those eight patients, in only one patient was catheter-directed thrombolysis the only interventional radiological procedure performed. In the remaining seven patients, other interventional radiological procedures were added. In other words, a trapped thrombus in the filter was confirmed in one (25.0%) of four patients who received only catheter-directed thrombolysis. However, a trapped thrombus was observed in seven (53.8%) of 13 patients in whom other interventional radiological treatments were combined with catheter-directed thrombolysis. The difference was not significant (p = 0.34, Fisher's exact probability test).

All filters containing a trapped thrombus as revealed on venocavogram were retrieved without any complications, including pulmonary embolism. Attempts were made to decrease all trapped thrombi in the filter by catheter-directed thrombolysis, whereby the catheter tip that had been in the DVT lesion was repositioned to the filter. In two cases, both of which had a trapped thrombus that occupied greater than the height of the filter, manual aspiration of the thrombus in the filter was additionally performed using the sheath introducer inserted from the femoral vein into the inside of the filter. As a result, two GTFs were retrieved after the thrombus resolved following attempts to decrease the size of the captured thrombus by means such as catheter-directed thrombolysis. Regarding the remaining six cases, the size of the thrombus in the filter either did not change or had increased, so the filter was replaced with a new one. In exchanging the filter, a temporary filter (Antheor; Boston Scientific, Watertown, MA, n = 4, or Neuhaus Protect, Toray Medical, Tokyo, Japan, n = 1) or another GTF (n = 1) was temporarily placed at the cephalad level of the GTF, trapping the thrombus exclusively during the GTF retrieval procedure. Thus, the thrombus dropped from the first GTF was captured during GTF retrieval. In the case of another GTF used temporarily, displacement of that freshly placed GTF avoided by taking meticulous care in using the retrieval kit during the procedure to remove the originally implanted GTF. Venocavography after retrieval revealed no thrombus remaining where the first GTF had been placed in any of the eight patients. Figure 1Go shows one such case.


   Discussion
Top
 Abstract
 Introduction
 Subjects and methods
 Results
 Discussion
References
 
There has been much controversy regarding the prophylactic use of inferior vena cava filters to prevent the occurrence of pulmonary embolism during catheter-directed thrombolysis of lower extremity DVT [1, 9–11, 17–21]. Some researchers have advocated that such filter placement is necessary during catheter-directed thrombolysis only in patients who have large, mobile, free-floating thrombi within the inferior vena [1]. On the other hand, there has been little discussion on the necessity of filter placement during therapies for DVT with interventional radiological procedures other than catheter-directed thrombolysis [21].

Pulmonary embolism occurred in only two (0.9%) of 214 patients who received catheter-directed thrombolysis for DVT in the lower extremity without inferior vena cava filter placement, according to Bjarnason et al [1], and in only 6 (1.3%) of 473 patients, according to Mewissen et al [11]. However, one of the six cases was a fatality. Some investigators [1, 9–11] insist that prophylactic use of an inferior vena cava filter during catheter-directed thrombolysis is unnecessary because of such a low rate of pulmonary embolism.

In a summary of their experience with implantation of temporary vena cava filters in 132 patients with DVT who were receiving thrombolytic therapy, Thery et al [32] observed a clot lysed by thrombolytic therapy in the filter in 41 (31%) of the 132 patients. None of the 132 patients experienced pulmonary embolism. This suggests that the filter might prevent pulmonary embolism during thrombolytic treatment in at least 41 of these patients, if not in all 132 patients.

Some researchers [17–21, 30, 33, 34] propose that the prophylactic use of an inferior vena cava filter is necessary in view of the high rate of trapped thrombus in these filters during therapies for DVT, as revealed by Thery et al [32], and attach great importance to the potential mortality in such cases, although rare [11]. Based on these opinions, we perform therapy for DVT under the prophylactic protection against pulmonary embolism by using the GTF.

Ease and safety of insertion of GTF is well known [21, 27–31, 33, 35, 36], with some of these reports citing its use as a non-permanent filter [21, 27, 29, 30, 33–36]. Millward et al [33] reported that attempts at retrieval were successful in 98% of 53 GTFs. According to some previous reports [27–30], the maximal period of implantation before successful retrieval was recommended as no longer than 10–14 days. Although we had roughly followed this recommended period to implant the GTF in the patients presented here, successful retrieval of a GTF after implantation longer than 14 days has been reported, as described in some recently published studies. Millward et al [33] noted that the maximal period of implantation before successful retrieval was 25 days, and very recently Terhaar et al [37] reported a period of 126 days. Also, we would like to mention that other retrievable filters are now available that can be left in place for much longer [38]. Few complications related to GTF placement have been reported [33, 39]. Millward et al [33] documented filter occlusion in two (5%) of 90 patients with an implanted GTF; no serious complications were documented. However, another case report [39] described right atrial migration.

Our study also showed good results in insertion and retrieval of GTFs. Insertion of all 29 GTFs and retrieval of 95.5% (21) of 22 GTFs were successfully accomplished. The maximal period of implantation before successful retrieval was 18 days. No complications were encountered in filter placement and retrieval. In seven patients in whom the lower extremity DVT remained in spite of various treatments and in who the possibility of pulmonary embolism remained, the GTF was used as a permanent filter by simply leaving it in the inferior vena cava. On the other hand, the GTF was retrieved in 9 of the 10 patients as it was no longer needed after successful resolution of the deep venous thrombus.

In the present study, in which a retrievable inferior vena cava filter was placed in all 17 patients with DVT who underwent various interventional radiological treatments such as catheter-directed thrombolysis, no worsening or development of pulmonary embolism in any of the 17 patients was seen. However, in eight (47.1%) patients a trapped thrombus in the filter was confirmed during interventional radiological treatments. This was despite adequate anticoagulation therapy. In these eight patients, especially in the six in whom the thrombus captured by the GTF filled greater than half the height of the filter, it is possible that if the filters had not been implanted, the thrombus might have moved to the pulmonary artery causing pulmonary embolism. Furthermore, we would like to note that the rate of occurrence of trapped thrombus in the filter was higher in cases that were treated not only with catheter-directed thrombolysis, but additionally with other interventional radiological procedures than in those solely treated by catheter-directed thrombolysis (53.8% versus 25.0%). The difference, however, was not statistically significant.

In addition, our results showed that the DVT did not extend to the inferior vena cava in six (75.0%) of our eight cases with a captured thrombus in the filter. This might suggest that limiting the indication for a filter to large, mobile, free-floating thrombi within the inferior vena cava is insufficient to avoid a pulmonary embolism in such situations.

We want to reiterate that, from the standpoint of preventing pulmonary embolism during therapies for DVT in the lower extremity with various interventional radiological procedures, the inferior vena cava filter played an important role in filtering a thrombus released from the lower limb. However, the use of permanent or temporary filters had some drawbacks, as previous studies have suggested [22–26]. Hence, when interventional radiological procedures are performed as therapy for DVT, prophylactic placement of a retrievable filter, such as GTF, should be employed, especially when another interventional radiological procedure is added to the catheter-directed thrombolysis, which is the procedure most commonly performed.

Received for publication August 30, 2005. Revision received November 13, 2005. Accepted for publication January 10, 2006.


   References
Top
 Abstract
 Introduction
 Subjects and methods
 Results
 Discussion
 References
 

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