Clinical experience with Günther temporary inferior vena cava filters

Clinical experience with Günther temporary inferior vena cava filters

Journal of Clinical Imaging 30 (2006) 108 – 113 Clinical experience with Gqnther temporary inferior vena cava filters Ioannis S. Kaskarelis, Maria Ko...

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Journal of Clinical Imaging 30 (2006) 108 – 113

Clinical experience with Gqnther temporary inferior vena cava filters Ioannis S. Kaskarelis, Maria Koukoulaki4, Chrysanthi E. Chlapoutaki, Dimitris E. Skarpalezos, Asimina D. Baltouka, Theodoros K. Vagdatlis, Vasiliki A. Androutsopoulou, Ion Bellenis bEvangelismos Q General Hospital of Athens, 45-47 Ipsilantou Street, 106 76 Athens, Greece Received 10 August 2005; received in revised form 7 September 2005; accepted 7 September 2005

Abstract This retrospective study was performed to evaluate the safety and effectiveness of Gqnther temporary inferior vena cava (IVC) filters. Fifteen Gqnther temporary filters were placed in 13 patients because of deep vein thrombosis (DVT) with pulmonary embolism (PE) despite DVT prophylaxis (9/13) or temporary contraindications for anticoagulants as well as recent or pending surgery (4/13). No clinical manifestation of PE was observed during the filtration or during the removal. Gqnther temporary IVC filters are easy and safe to use, and are effective in clot trapping, protecting patients at high risk for PE in whom anticoagulation treatment failed or is contraindicated. D 2006 Elsevier Inc. All rights reserved. Keywords: Pulmonary embolism; Vena cava filter; Gqnther temporary filter; Interventional procedure

1. Introduction Venous thromboembolism is a potential cause of serious illness that may be fatal. The exact incidence of deep vein thrombosis (DVT) and pulmonary embolism (PE) is not known. However, it is estimated that over 40% of patients with diagnosed DVT suffer from clinically asymptomatic PE [1,2]. Although anticoagulation therapy is mandatory once DVT or PE is diagnosed, in cases that anticoagulation is contraindicated or complicated by adverse events, interruption of inferior vena cava (IVC) by a filter device was proposed as an alternative in the late 1960s [3]. The continuing improvement of these devices has increased their use and expanded their indications. Their efficacy for prophylactic purposes of PE was evaluated in a randomized trial which demonstrated that filter insertion reduced the occurrence of PE compared to treatment with heparin initially, but there was no beneficial long-term effect [4]. Therefore, only patients

4 Corresponding author. Tel.: +30 2107201032; fax: +30 2107233421. E-mail address: [email protected] (M. Koukoulaki). 0899-7071/06/$ – see front matter D 2006 Elsevier Inc. All rights reserved. doi:10.1016/j.clinimag.2005.09.024

with contraindications or complications of anticoagulation should be considered for placement of IVC filter [5,6]. Considering the long-term complications of permanent filtration, temporary and retrievable filters were developed, especially for patients who required transient protection from thromboembolic events [7]. This retrospective study was performed to evaluate the safety and effectiveness of Gqnther temporary IVC filter.

2. Patients and methods 2.1. Study design Patients who had received a Gqnther temporary IVC filter were identified from the radiology department database between June 1999 and December 2002. All patients who were included in this study had proven DVT, diagnosed clinically and confirmed by color duplex sonography. Clinically suspected PE was confirmed by ventilation/ perfusion scans and spiral CT scanograms (eight-slice CT scanner with 3-mm thickness of slices, 120 ml of contrast medium used). Selective pulmonary angiography was

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In cases with heparin-induced thrombocytopenia (HIT) that could not receive heparin, patency of the introducer sheath was attempted by infusing normal saline through the sidefitting arm.

Fig. 1. Gqnther temporary filter. Implantation and verification of filter position (indicated by arrow) by fluoroscopy with the use of contrast infusion through the left femoral vein.

performed in patients when noninvasive diagnostic tests were not diagnostic, because of low probability of lung scintigraphy and high clinical suspicion. 2.2. Device assessment 2.2.1. Details of Gu¨nther temporary IVC filters Gqnther temporary IVC filters (William Cook Europe, Bjaeverskov, Denmark), which are retrievable up to 10 days after insertion, were used in all patients. Gqnther temporary IVC filters are designed for percutaneous placement via the femoral vein for temporary interruption of IVC. The device consists of a stainless steel basket filter (expanded diameter 30 mm and length 4.5 cm) connected to a 0.097-cm stainless steel wire shaft, inner catheter, and 5-F introducer sheath with flushing port for introduction. 2.2.2. Procedure A team of experienced interventional radiologists performed the placement of temporary filters. All filter insertions took place at the angiography room of the vascular interventional unit of the department of radiology. The filters were inserted through the common femoral vein (right or left). A vena cavogram was performed prior to filter insertion in order firstly to measure the diameter of the IVC, as the placement of Gqnther filter is contraindicated for inferior vena cava larger than 30 mm, and, secondly, to investigate the presence of floating thrombi. 2.2.3. Technique of insertion The Seldinger technique was used for the catheterization of the vein, and the device was advanced so that the filter was positioned just below the orifice of the lowest renal vein. After the filter placement, which was confirmed by fluoroscopy, the introducer sheath was withdrawn until the tilt was placed in close proximity to the expanded filter. In order to maintain the patency of the introducer sheath, 1500 IU of heparin in 5 ml of normal saline was infused through the side-fitting arm every 8 h.

2.2.4. Filter follow-up and removal The position of the filter was confirmed during the procedure and reevaluated 4 days later with fluoroscopy (Figs. 1 and 2) and X-rays. All patients were reviewed daily, and if clinical indication arose Doppler sonography of the insertion vein and a contrast venogram through the sidefitting arm were performed. Filters were removed within 10 days of insertion according to the manufacturer’s instructions to prevent filter ingrowth and formation of neointima. 2.2.5. Filter retrieval procedure In all patients, a contrast venogram was performed prior to filter removal in order to rule out the presence of thrombi captured in the filter. If there was no thrombus formation, the device was retrieved through the insertion sheath. In cases of limited thrombus formation, thrombolysis was attempted with the use of alteplase (rt-PA, activase, Genentech, San Francisco, CA) in dilution of 0.02 mg/ml with administration rate of 50 ml/h (titrating dose between 0.25 and 1.0 mg/h). In cases that thrombolysis was unsuccessful, the device was retrieved through the Gu¨nther Temporary Vena Cava Retrieval Set (William Cook Europe), given that the thrombi diameter did not exceed the inner diameter of the sheath (22 F).

3. Results 3.1. Patient assessment 3.1.1. Recruitment Between June 1999 and December 2002, 13 patients (seven males and six females), with median age 49.5 years

Fig. 2. Gqnther temporary filter in place (indicated by arrow). Implantation through the right femoral vein. Oblique view.

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Table 1 Summary of patient data

1

Age

Sex

Associated conditions

Indications

Access (vein)

Duration (days)

Cavogram findings

Permanent filter

20

M

Multitrauma, PE/DVT

Anticoagulation contraindicated Anticoagulation contraindicated Anticoagulation contraindicated

Right femoral Right femoral Right femoral

9 7 7

No thrombi No thrombi No thrombi

No Yes

Anticoagulation contraindicated

Right femoral

9

No thrombi

No

Anticoagulation contraindicated

Right femoral

7

No thrombi

No

Failure of anticoagulation

Right femoral

6

No thrombi

No

Anticoagulation contraindicated

Right femoral

2

b

No

Anticoagulation contraindicated Failure of anticoagulation Anticoagulation contraindicated Anticoagulation contraindicated HIT Anticoagulation contraindicated

Right femoral Left femoral Left femoral Right femoral Right femoral Right femoral

7 8 8 9 8 3

Thrombi in filter Thrombi in filter No thrombi No thrombi No thrombi Thrombi in filter

Yes Yes

Failure of anticoagulation

Right femoral

2

Thrombi in filter

Yes

No compliance in anticoagulation

Left femoral

10

No thrombi

Yes

2

74

F

3

72

F

4

43

M

5

58

F

6

42

F

7 8 9

41 70 39

M M M

10 11

44 47

F M

12

20

F

73

M

13 a b

IVC thrombi, PE, cardiac surgery PE, DVT, malignancy (brain metastasis) PE, DVT, malignancy (brain metastasis) Recurrent PE, floating thrombus Molar pregnancy, DVT, PE, multiorgan failure Brain AVM bleeding, PE PE, DVT DVT, recent surgery DVT, history of PE DVT, immobility, recent CVA DVT, IV drug user, osteomyelitis PE, DVT

a

a

No Yes Yes

Received second temporary filter. Deceased.

(range 20 –74 years old) (Table 1), were identified who received 15 Gqnther temporary IVC filters. Patients considered as candidates for temporary filtration required prophylaxis for PE for an estimated period of less than 10 days. 3.2. Indications for temporary IVC filter Indications for filter placement were DVT or PE in patients either with contraindication for anticoagulation treatment or with complications of anticoagulation. Complications of anticoagulation were considered the incidence of recurrent venous thromboembolism while on anticoagulation treatment (in three cases) and heparin induced thrombocytopenia (in one case). One patient was not compliant to anticoagulation treatment and therefore was suitable for temporary filtration. 3.3. Diagnosis of DVT and PE Deep vein thrombosis was diagnosed clinically in 10 patients, and diagnosis was confirmed by color Doppler sonography. Clinically suspected PE was confirmed by ventilation/perfusion scans and spiral computed tomography (CT) scanograms (eight patients). Pulmonary angiography was performed in one patient in whom noninvasive diagnostic tests were not diagnostic but had high clinical suspicion. Pulmonary embolism was diagnosed in nine cases.

3.4. Contraindication for anticoagulation As far as the contraindications for anticoagulation treatment are concerned, three patients had recent or pending surgical operation, two patients had malignant disease with brain metastasis, one patient had multitrauma, one had cerebral bleeding, and another patient had molar pregnancy and multiorgan failure. 3.5. Device insertion All filters were inserted without any immediate complications with success rate of 100%. The filters were inserted through the right common femoral vein in 12 cases and through the left common femoral vein in three cases. The femoral vein was preferred to the jugular vein in case the filter was thrombosed and thrombolysis failed, in which case another filter could be placed above the first one to avoid thrombi migration. No patient developed symptomatic PE while the filter was in place or during removal. One patient died because of multiorgan failure after the intervention independently of filter placement. 3.6. Device removal Patients who remained at high risk for PE after the first 10 days or those whose filters contained thrombi were considered for insertion of a new temporary or permanent filter. The median dwell time of filter in place was 6.8 days

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Fig. 3. Placement of an LGM permanent filter (indicated by arrow upperleft) using the internal jugular approach, above an existing Gqnther temporary filter (indicated by arrow lower-right) containing thrombi.

(range 2 –10 days). Prior to removal of the Gqnther filter, a vena cavogram was performed. Four out of 15 filters contained thrombi; thrombolysis was attempted with the use of alteplase. Complete thombolysis was achieved in three cases (cases 7, 12, 13), and the filter was retrieved through the insertion sheath. In one case, the device was retrieved using the Gqnther Temporary Vena Cava Retrieval Set because of the remaining thrombi in the filter. Because the need for protection from PE extended beyond the period of 10 days, two patients (2/13, 15.4%) (cases 1 and 9) were considered for a second temporary filter when the initial filter was removed because of prolonged waiting time for surgery. In seven patients, a permanent filter replaced the temporary filter. It was decided that these patients would benefit from long-term prophylaxis for PE. The permanent filter was placed using the right jugular vein approach prior to removal of the temporary filter (Fig. 3). 3.7. Complications There were no clinical, angiographic, or color Doppler signs of thrombosis in the insertion vein. No thrombi were detected on the connecting wire or introducer sheath. No wound haematoma at the insertion site was found during filtration or after removal of the filter. No infection was caused due to the insertion of the filter or the remaining wire and sheath. Neither air embolism nor filter migration was noted in our patients.

4. Discussion From 1997 until 2002, 44 vena cava filter insertions were performed in our department, the recent years with an increasing rate that almost doubles every year. The types of filters were 16 temporary IVC filters (Gqnther temporary/Cook) and 28 permanent filters, namely, Gqnther Tulip retrievable/Cook (n=7, three of which were retrieved and four remained) or LGM/B-Brown

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(n=9) or Bird’s Nest/Cook (n=12). The type of filter to be inserted (permanent or temporary) was chosen according to each patient’s individual need. Although indications for insertion of permanent filter are well defined [8,9], indications for temporary filters are still a controversial issue. Patients who require limited period prophylaxis, especially young patients with long life expectancy, multiple-trauma patients, and critically ill surgical patients, should be considered as suitable candidates for temporary filtration [8]. Different types of permanent filters like the Greenfield [10] or the Vena-Tech LGM [11] have been used during the last 30 years, and a variety of complications have been reported either during procedure assessment or after filter placement [5,6]. Among intraoperative complications including bleeding (6–15%) [12] or thrombosis of the assessed site (35%) [13], sheath kinking, tilting of the device, malposition or incomplete opening, recurrent PE, IVC penetration, and caval thrombosis are considered the most serious and common delayed complications. Ferris et al. [14] reported 4% recurrent PE post-filter placement (11 patients, eight whom of died), 19% IVC thrombosis, 9% caval wall perforation. More recent report by Athanasoulis et al. [15] shows 5.6% PE after filter insertion, fatal in 3.8% of cases, 3.2% post-filter caval thrombosis, and very low prevalence of IVC penetration (0.1%). Migration or fracture of filter is a less common complication. Moreover, it should be noted that an in vitro comparison of two types of permanent filters (titanium Greenfield and LG-Medical) with two types of temporary filters (Filcard International and Gqnther) demonstrated the superiority of temporary filters in clot trapping even in the smallest clots tested [6]. Long-term complications of permanent caval filtration should not be underestimated, and the option of temporary filters should be considered in patients with long life expectancy and limited requirement of protection from PE such as young injured patients or patients who have to undergo surgical operations. In the beginning, there was an attempt to construct permanent filters that would be retrievable like the Amplatz filter [16]. Afterwards, temporary devices were developed and there have been several reports with the use of various temporary filters (Gqnther temporary [17], Antheor [18], Prolyser [13], Bird’s Nest temporary [19], Tempofilter [20]). Temporary filters are attached to a catheter or guide wire that protrudes out of the insertion site and should be removed after a certain period of time. Preliminary results with the use of Gqnther filter suggested that temporary filters are safe and effective in selected patients [17,21,22]. Millward et al. [17] reported successful placement of 17 Gqnther filters with no incidence of PE with the filter in place. Similar results were reported by Linsenmaier et al. [21] and Vos et al. [22], which show that Gqnther temporary filter is safe and protects against recurrent PE. The temporary filters should be removed approximately 10 –14 days after placement before the

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development of neointima. However, patient’s need for prolonged protection from PE may require the replacement of the temporary filter with another temporary or a permanent filter or a temporary retrievable filter [23]. In our series, a second Gqnther filter was placed in two patients because they were young multitrauma patients and their surgical assessment was delayed, and a permanent filter was placed in seven patients due to prolonged need for PE protection. Inferior vena cava thrombosis with the filter in place is a well-known complication of the permanent filters, but it is reported to have a similar prevalence as in the case of temporary filters [17,24]. The entrapment of thrombus in the filter is another adverse event that can be correlated to IVC thrombosis. Therefore, it should be taken into consideration when the filter is retrieved. In four cases, thrombus was found in the filter, so we attempted thrombolysis of the formulated thrombus, which was successful in three cases, and temporary filter was retrieved safely. However, it was decided that these patients would benefit from a permanent filter given their complicated history. The insertion of filter through the common femoral vein should be preferred instead of the internal jugular or brachial vein whenever possible. Captured thrombi in the filter inserted through the jugular vein may cause iatrogenic PE while retrieving the filter, a life-threatening complication. Among the filters currently available in Europe (Gqnther temporary/ Cook, Tempofilter/B-Braun, Lysofilter/B-Braun), the Gqnther temporary is the only one that can be placed either from a femoral or from a jugular approach and can be retrieved safely through the femoral vein in case of limited thrombi formation. Moreover, a permanent filter could be placed additionally using the internal jugular approach above the temporary filter, if prolonged filtration is required. The filter design and its insertion approach put patients to an increased risk of complications. Skin infections or haematoma at the insertion point, sepsis, and air embolism can occur [25,26]. As a result, IVC filter is not appropriate for immunosuppressed patients. Our patients did not experience any of the above adverse events. The filters were successfully inserted and retrieved before the 10th day after filter placement. Placement of temporary IVC filters is generally safe, having relatively low incidence of complications. As they are effective for protection from PE for a short period of time, their use should be considered for patients with longer life expectancy who do not need long-term protection from venous thromboembolism, such as young multitrauma patients or patients with pending surgical procedures. Therefore, it is worth attempting the placement of a temporary device instead of a permanent filter. The development of novel temporary retrievable filters with more flexible period of removal required up to 6 months would permit interventional radiologists to avoid the replacement of a temporary filter with another temporary

or with a permanent filter [27]. However, because of the high cost of retrievable filters compared to other available filters and the little existing experience, more clinical trials are needed to prove and confirm their efficacy [28]. The Gqnther temporary IVC filter is safe and effective and should be preferably opted for young patients with long life expectancy and patients with multiple trauma.

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