Use of Re-entry Device to Recanalize Chronically Occluded and Thrombosed Inferior Vena Cava Filter in a Patient With Post-Thrombotic Syndrome

A 71-year-old man was referred to our endovascular clinic for revascularization of an occluded inferior vena cava (IVC) filter in the setting of post-thrombotic syndrome. The man had a past medical history of deep venous thrombosis (DVT) and bilateral pulmonary embolism (PE) that was diagnosed 11 years ago. At that time, a Celect inferior vena cava (IVC) filter (Cook Medical) was inserted, and the patient was prescribed continual anti-coagulation with apixaban.

Upon presentation in our clinic, the patient reported dyspnea on exertion and severe, progressive, bilateral lower extremity edema, despite compression stockings and conservative therapy that included anticoagulation for the past decade. His ambulation was limited to 25 feet due to significant discomfort in his lower extremities. A bilateral lower extremity lymphatic pump device was recently prescribed and resulted in mild relief. We conducted a physical examination that revealed more than three instances of bilateral lower extremity edema with varicosities, as well as the presence of abdominal varices. 

The patient was electively brought to the catheterization laboratory, where access was obtained in the right internal jugular vein (IJV) using ultrasound guidance and a micropuncture access kit with insertion of a 7 French (F) sheath. Bilateral right and left common femoral vein (CFV) access was obtained in a similar manner via insertion of 8F sheaths. 

Selective venography of the right external iliac vein (EIV) confirmed 100% occlusion of the common iliac vein (CIV), with extensive pelvic collaterals and no flow into the IVC. Selective venography of the left EIV revealed similar findings of 100% occlusion of the CIV. There were extensive pelvic collaterals without direct flow into the IVC across the occluded IVC filter. Selective venography of the IVC through the right IJV sheath confirmed 100% occlusion of the IVC just above the IVC filter, at the level of the patent bilateral renal veins (Figure 1). 

A 5F TriForce catheter (Cook Medical) with a tunneled CXI catheter (Cook Medical) was advanced over a .035-inch Glidewire Advantage (Terumo) and looped to cross the occlusion in the right EIV, CIV, and IVC filter into the reconstituted IVC. The same TriForce catheter with a tunneled CXI catheter was advanced with an .035 Glidewire Advantage wire to cross the occlusion in the left EIV, CIV, and IVC filter, but the TriForce catheter entered a subintimal plane in the reconstituted IVC architecture (Figure 2). 

Multiple attempts were made to re-enter the true lumen of the IVC using various techniques, including wire escalation with various CTO wires, and re-direction with angled support catheters. However, these attempts were unsuccessful. At this point, an Outback re-entry catheter (Cordis, a Cardinal Health company) was advanced over a V-14 ControlWire guidewire (Boston Scientific) into the subintimal plane of the IVC. The re-entry needle was introduced into the true lumen with a single thrust, and the Astato XS 20 guidewire (Asahi Intecc) was advanced to successfully re-enter the true lumen in the reconstituted IVC. A 4.0 ×  30 mm Emerge balloon (Boston Scientific) was used to pre-dilate the re-entry channel into the IVC with good expansion (Figure 3). 

A 6.0 × 80 mm EverCross balloon (Medtronic) was used to serially dilate the entire IVC occlusion across the filter and bilateral CIV and EIV with good expansion. Intravascular ultrasound (Visions PV) (Philips) was performed of the bilateral IVC, CIV, and EIV to determine stent sizing. 

Based on imaging findings, a self-expanding 16 ×  60 mm Wallstent (Boston Scientific) was deployed in the IVC into the left CIV, with a simultaneous, self-expanding 16 × 40 mm Wallstent in the IVC into the right CIV. An overlapping 14 × 40 mm Wallstent was deployed in the left CIV, and a concurrent, overlapping 14 × 60 mm Wallstent was deployed in the right CIV. Simultaneous balloon post dilatation of the IVC stents was performed with a 12 × 40 mm Mustang XXL balloon (Boston Scientific), as well as an EverCross 10 × 60 mm balloon from the left and right CFV access sites, respectively, with good expansion. The CIV stents were post dilated with 10 × 60 mm EverCross balloons bilaterally, with good expansion (Figure 4). 

Final, simultaneous venography of bilateral EIVs with runoff confirmed brisk flow. The brisk flow was seen through the entire bilateral iliac veins and IVC, through the IVC filter and into the reconstituted distal IVC above the filter. There was no evidence of extravasation (Figure 5). The duration of the procedure was 175 minutes, with contrast use of 200 cc and radiation exposure of 1.68 Gy.

The patient was started on dual antiplatelet therapy with aspirin and clopidogrel for 30 days. The patient also received anticoagulation with apixaban, along with compression stockings and leg elevation. The patient returned for 30-day follow-up with significant improvement in edema and anasarca, as well as disappearance of abdominal varices and improved ambulation.

Discussion 

Unretrieved IVC filters are the most common cause of IVC thrombosis and occlusion in the absence of congenital anomalies and are associated with significant morbidity and mortality.¹ The incidence of IVC thrombosis in the reported literature is 2.6% to 4%, but appears to be underestimated due to a lack of detection and reporting, as there is a rising number of unretrieved IVC filters in the United States.^2-5  Clinical indications for IVC filter placement include prevention of PE in patients with DVT who cannot receive anticoagulation due to a high risk of bleeding, patients who have failed anticoagulation, or patients with current anticoagulation that is inadequate.⁶ In a sense, IVC filter placement is contradictory, as the most common reason for insertion is contraindication to anticoagulation. Meanwhile, an inability to be anticoagulated with an indwelling IVC filter creates a thrombotic environment by way of the Virchow triad that can lead to IVC thrombosis and subsequent occlusion.⁷ 

The clinical manifestation of IVC thrombosis and occlusion includes post-thrombotic syndrome. Post-thrombotic syndrome includes moderate, severe, or persistent edema; trophic skin changes; varicose veins; stasis ulceration; and leg pain or numbness. Lumbar radicular pain, sciatica, and cauda equina syndrome may also develop from external compression of the spinal cord and nerves via dilated paraspinal collateral channels in the setting of chronic occlusion of the IVC.¹ The mortality rate of IVC thrombosis is twice that of DVT of the lower extremities. Thus, the risks of IVC implantation must be carefully weighed against its benefits prior to implantation.⁸ Treatment of IVC thrombotic syndrome becomes crucial to alleviating post-thrombotic syndrome symptoms, and improving patient morbidity and mortality. 

The efficacy and safety of IVC filters was evaluated in the PREPIC trial. IVC filter placement with routine anticoagulation in patients with proximal DVT showed a 4% absolute reduction in PE risk. However, this reduction was offset by twice the rate of recurrent DVT in 2 years in patients with IVC filters as compared to patients without filters.⁹ Further, the PREPIC 2 trial showed that routine placement of retrievable IVC filters in patients with PE and high risk of recurrence did not reduce the risk of recurrent PE when compared to anticoagulation alone.¹⁰  

Our patient presented with classic symptoms of IVC thrombosis with post-thrombotic syndrome and required the use of advanced chronic total occlusion (CTO) strategies, including re-entry techniques, to successfully recanalize the occluded IVC. 

To our knowledge, this is the first reported case of successful use of a percutaneous re-entry device for IVC revascularization in the setting of chronic IVC thrombotic syndrome with a chronically occluded filter. There have been other published case reports describing differing scenarios: recanalization of an acute to subacute IVC thrombosis in a 25-year-old woman on oral contraceptives with congenital infra-hepatic caval atresia after a prolonged air flight; right brachiocephalic vein occlusion in two dialysis patients; and recanalization of dialysis catheter-related subclavian vein occlusion in a case series of three patients.^11-13

The Outback re-entry catheter is a 6F-compatible device used for peripheral endovascular re-entry. It consists of a 22-gauge needle that is advanced through the side port for luminal re-entry. The catheter is advanced over a .014-inch guidewire, with orientation of the tip towards intraluminal re-entry using T- and L-shaped radiopaque markers visualized from 90-degree orthogonal views. Once the marker is positioned, the .014-inch guidewire is retained back into the catheter with intraluminal introduction of the 22-gauge nitinol needle. The .014-inch guidewire is then advanced into the true lumen through the needle, followed by withdrawal of the needle and catheter.¹⁴ Subsequent balloon angioplasty and stenting can then be performed over the retained guidewire. 

A single-center study of 91 patients with peripheral arterial CTOs evaluated the use of the Outback re-entry device for luminal recanalization. Of these cases, 52 were retrograde, and the re-entry catheter achieved a high success rate of 93%, with the major cause of failure being heavy calcification. In addition, the authors performed a systematic review of 11 studies, where 119 aorto-iliac and 464 infrainguinal CTOs were identified; use of the device had a pooled success rate of 90% and a complication rate of 4.3%.¹⁵ In another study of 249 femoropopliteal CTOs, the Outback re-entry device was used in 20.9% of cases, with a success rate of 64.5%. The most significant predictor for failure was moderate or severe calcification at the site of re-entry, followed by an acute aorto-iliac angle of <40 degrees.¹⁶ 

Although limited data exist in recanalization of chronic venous occlusions using a re-entry device, a high success rate can be theorized as long as there is proximity to the reconstituted vessel, as there is a lack of calcification in the venous system, along with a lack of acute aorto-iliac bifurcation angles. Additional studies are needed to further validate this hypothesis. 

Conclusion

We present a case of IVC thrombosis and chronic IVC filter occlusion with post-thrombotic syndrome that was successfully recanalized with advanced revascularization techniques, including the use of a percutaneous re-entry device. Complex revascularization of chronic occlusions in the IVC may require additional tools and advanced re-entry devices to ensure revascularization success.   

Disclosure: Dr George reports consulting for Boston Scientific, Cook Medical, and Medtronic. Dr Memon has no disclosures.

Manuscript submitted July 12, 2019; manuscript accepted August 9, 2019.

Address for correspondence: Jon C. George, MD, FACC, FSCAI, FAHA; Director, Cardiac Cath Lab; Einstein Medical Center; 5501 Old York Road, Philadelphia, PA 19130; Office Phone: (215) 456-7245; Office Fax: (215) 456-3533. Email: jcgeorgemd@gmail.com

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