Acute Thrombolysis-Resistant Occlusive Left Femoral and Iliac Venous Thrombosis Treated with Mechanical Thrombectomy via the ClotTriever Device

Journal Pre-proof Acute thrombolysis-resistant occlusive left femoral and iliac venous thrombosis treated with mechanical thrombectomy via the ClotTriever device Amit Srivastava, MD, FACC, FABVM PII:

S0890-5096(19)30960-4

DOI:

https://doi.org/10.1016/j.avsg.2019.10.097

Reference:

AVSG 4763

To appear in:

Annals of Vascular Surgery

Received Date: 30 August 2019 Revised Date:

28 October 2019

Accepted Date: 29 October 2019

Please cite this article as: Srivastava A, Acute thrombolysis-resistant occlusive left femoral and iliac venous thrombosis treated with mechanical thrombectomy via the ClotTriever device, Annals of Vascular Surgery (2019), doi: https://doi.org/10.1016/j.avsg.2019.10.097. This is a PDF file of an article that has undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but it is not yet the definitive version of record. This version will undergo additional copyediting, typesetting and review before it is published in its final form, but we are providing this version to give early visibility of the article. 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. © 2019 Published by Elsevier Inc.

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Acute thrombolysis-resistant occlusive left femoral and iliac venous thrombosis treated with mechanical thrombectomy via the ClotTriever device Amit Srivastava, MD, FACC, FABVM1 1

Bay Area Heart Center, 5398 Park St N, St Petersburg, FL 33709, [email protected]

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Abstract

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Background: Deep vein thrombosis (DVT) is frequently treated by anticoagulation, which helps to

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prevent new thrombus formation, but to restore venous flow, additional efforts might be needed.

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Thrombolytic agents can help clear acute thrombus, but increased bleeding risk is a concern, frequent

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contraindications are another. One lesser discussed potential limitation is thrombus age, which can

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affect efficiency of treatment.

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Case: A 62-year-old female patient with extensive DVT affecting the IVC through the left femoral vein

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was initially treated with EKOS catheter directed thrombolysis (CDT) for 24 hours. Subsequent venogram

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revealed persistent occlusive femoral and iliac thrombus. We decided on mechanical thrombectomy via

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the ClotTriever catheter (Inari Medical, Irvine, California), a nitinol coring element with an attached

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collection bag that can remove wall adherend thrombus. We performed three passes with the device

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and removed large amounts of organized thrombus. Subsequent venography showed complete

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resolution of the occlusion. Finally, an underlying compression was treated via stenting.

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Conclusion: ClotTriever was effective in removing subacute and chronic thrombus, as demonstrated in

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this case with persistent extensive thrombus after 24h of CDT. The ClotTriever System adds a valuable

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option for vascular interventionalists to treat DVT.

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Keywords: Deep Vein Thrombosis, DVT, Mechanical thrombectomy, ClotTriever, persistent thrombosis

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Introduction:

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Patients with deep venous thrombosis (DVT) present on a spectrum, with symptoms ranging from non-

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detectable to severe leg swelling, pain, and redness [1]. Treatment of DVT has evolved over the last

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years. Nonetheless, guidelines remain conservative, favoring conventional treatment via anticoagulation

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for 3 months in most cases. While this is likely adequate to prevent new thrombus formation, additional

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efforts are often required to remove already present thrombus that causes symptoms. Utilizing

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thrombolytic agents, either systemically or via catheter directed therapies (CDT), can help in clearing

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thrombus. Recent data on the use of CDT in DVT has however been variable. The recently published

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ATTRACT trial received ample attention, with the conclusion that in acute proximal DVT, adding

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pharmaco-mechanical CDT (PCDT) to anticoagulation did not result in a lower post thrombotic syndrome

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(PTS) risk, one of the main serious DVT consequences, but conferred a higher risk of major bleeding [6].

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In addition, the mean degree of thrombus removal was limited to 76%, so a likely non-negligible number

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of patients showed less than optimal lysis results. Detailed and balanced discussions followed,

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highlighting for instance that there was a trend toward reduced moderate and/or severe PTS in the

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subgroup of patients with iliofemoral DVT [7]. However, the trade-off regarding bleeding risk is always a

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concern when using thrombolytic therapy, so are possible contraindications in a multitude of patients

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[8]. One lesser discussed limitation is thrombus age, with older, more organized thrombus presenting a

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challenge [9, 10]. Thus, while thrombolytic therapy has been shown to be advantageous in certain

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settings, alternative treatment options, especially for patients with contraindications, or those with

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thrombolytic-resistant thrombus are of high interest. One such option is the ClotTriever catheter (Inari

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Medical, Irvine, CA)[11, 12]. A mechanical thrombectomy device with a laser-cut nitinol coring element

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and an attached woven nitinol collection bag. Once inserted via a designated 13 French sheath, the

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catheter is advanced past the occluded segments, deployed, and slowly pulled back. This allows

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extraction of wall-adherent and, as this case report highlights, organized thrombus. The device can be

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removed from the patient, cleaned, and reinserted for repeat use to ensure maximum thrombus

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capture without the need for thrombolytic treatment.

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Case

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A 62-year-old female patient with an at least 2-week-old extensive DVT affecting the IVC through the left

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femoral vein (Figure 1) had initially been treated with ultrasound-accelerated thrombolysis via Ekosonic

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Endovascular System (EKOS) CDT (BTG International, London, UK) at 1mg an hour for 24 hours. On the

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next day, the patient was brought from the Intensive Care Unit (ICU) to the catherization lab in a fasting

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state, prepped and draped in the usual sterile fashion, receiving 8000 units of unfractionated heparin at

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the start of the procedure. Thrombolytic infusion was ceased, and the delivery catheter with the

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respective 7 French (F) sheath was removed. An 8 F sheath was then placed in the left popliteal vein to

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allow for a diagnostic venogram. This revealed persistent occlusive femoral and iliac venous thrombus

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(Figure 2). It was hence decided to proceed with mechanical thrombectomy via the ClotTriever (CT)

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catheter (Inari Medical, Irvine, California) to remove the thrombolytic-resistant occlusions in these

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segments. The CT device consists of a designated 13 French sheath with a funnel at the distal end, and a

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catheter, with a coring segment an attached collection bag. Once introduced into the system, the CT

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catheter is first advanced past the thrombus, then deployed and slowly pulled back, which can

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effectively remove wall adherend thrombus. The popliteal access site was first dilated with an 11 F

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sheath before the 13 F Inari CT sheath was introduced. Due to resident stenosis at the site of the funnel,

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we utilized an 8 x 80 mm Armada 0.035 inch balloon (Abbott Vascular, Santa Clara, CA) to predilate the

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site and aid in fully deploying the funnel. Next, we introduced the CT catheter and performed

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percutaneous mechanical thrombectomy of the IVC, left common and external iliac, as well as the

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common femoral and femoral veins. We performed three passes with the device and removed a large

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amount of thrombus, mostly chronic and organized, with some subacute and fresh appearing thrombus

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as well (Figure 3). Between each pass, the catheter was removed and manually cleaned. Venography

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after the final pass showed complete resolution of the occlusions (Figure 4). Finally, an underlying

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compression, which was identified via intravascular ultrasound (IVUS) (PV.035 Digital IVUS Catheter

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Philips IGTD, Amsterdam, Netherlands) was treated with a 18x60 WALLSTENT (Boston Scientific,

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Marlborough, MA) (Figure 5). The stent was deployed from the distal IVC through the origin of the left

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common iliac vein into the origin of the left external iliac vein and post-dilated using a 14mm balloon

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inflated to 6 atm. Final IVUS assessment confirmed excellent apposition and no evidence of residual

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stenosis. The patient tolerated the procedure well with no complications. Once the popliteal sheath was

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pulled, hemostasis was obtained via manual compression and the patient was transferred to the ICU for

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further observation and care. Continuous treatment was planned with oral anticoagulation, 10mg for 7

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days, then 5mg for the next 6 months. The patient was discharged the next day, feeling remarkably

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better with a near complete resolution of symptoms

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Discussion:

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The presented case highlights the ClotTriever mechanical thrombectomy device as an effective tool to

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remove acute, but also organized thrombus. The patient we treated showed persistent and extensive

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thrombus after 24 hours of catheter directed thrombolysis. We hence deemed it necessary to opt for a

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treatment option that would allow mechanical removal of the large occlusive thrombus. Data suggests

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that the effectiveness of thrombolysis can depend on thrombus age[9], but how frequent thrombolysis

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fails in DVT is often not readily reported. In a study of 92 patients with DVT symptoms averaging 11.1 ±

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9.6 days, treated with various combinations of CDT or pharmaco-mechanical thrombolysis, Avgerinos et

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al. reported an immediate treatment failure in 12% of patients [13]. Failed or incomplete lysis can have

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long-term implications. In the same study, primary patency loss at a mean of 16 ± 14 months was

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significantly associated with incomplete thrombolysis. In addition, PTS occurred in 50.6% of patients

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with thrombolytic failure versus in 16.3% of those without. Other studies often don’t directly report

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failure rates but thrombus resolution or changes in thrombus burden. Very early data from a small

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randomized study on thrombolytic intervention showed complete or ≥ 50 % lysis in only 28% of patients

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treated with tissue-type plasminogen activator (rt-PA), 29% patients with rt-PA plus heparin, and no

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patient treated with heparin alone [14]. A 2007 study showed higher lysis success rates, with only 6% of

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patients left with ≥50% residual thrombus [15]. A sub-analysis of the landmark CaVenT trial [16]

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reported that 50% of patients showed ≥90% resolution of initial thrombus burden with 9.8% left with

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≥50% and 2 patients with 0% resolution [17]. The study also found an inverse significant correlation

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between post-lysis thrombus scores and patency at 24 months and concluded that more efforts should

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be made to achieve and maintain an open vein. A 2014 meta-analysis studied the prognostic significance

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of residual venous obstruction (RVO) in detail and included 10 prospective studies and 2,527 DVT

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patients [18]. The study found that RVO was present in 1,380 patients (55.1%) after a median of 6

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months after a first unprovoked DVT. Multivariate analyses furthermore indicated that RVO was

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independently associated with VTE recurrence, which was strongest when RVO was detected early on. In

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addition RVO has been linked to the development of PTS. A recent meta-analysis of 12 studies and a

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total of 2,684 patients, found that, with an even higher odds ratio than venous reflux at the popliteal

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level, RVO was a significant predictor of PTS [19]. Based on this data, a strategy to remove as much of, or

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preferably the complete thrombus burden, while avoiding thrombolytic treatment risks seems desirable.

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This paradigm would also keep longer-term sequalae in mind.

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Conclusion

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The ClotTriever mechanical thrombectomy device was highly effective in removing acute but also

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organized thrombus in the presented case of a patient showing persistent and extensive thrombus after

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24h of CDT. The System adds a valuable front-line option to the therapeutic tool box for vascular

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interventional therapists to treat venous thrombus. Future studies are needed to define the device’s

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exact potential, not just regarding acute outcomes in a multitude of patients, but also in the context of

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longer-term clinical outcomes.

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Figure 1: Diagnostic imaging showing extensive DVT from IVC to the femoral vein. Panel (A): CTA showing IVC thrombus. Panel (B) showing the occluded femoral vein and (C) showing a lack of flow into the iliac vein and inferior vena cava

Figure 2: Diagnostic imaging after 24h of CDT with panel (A) showing persistent occlusion in the femoral vein and panel (B) showing a continuous lack of flow into the iliac vein and inferior vena cava

Figure 3: Images showing the ClotTriever catheter device removed from the patient in between passes and the manual clearing out of the thrombus for subsequent re-insertions.

Figure 4: Diagnostic imaging after 3 passes with the ClotTriever catheter, with panel (A) showing recanalization of the femoral vein and panel (B) showing a restored flow into the iliac vein and inferior vena cava. Panel (C) shows the removed, mostly organized thrombus.

Figure 5: Treating the underlying iliac vein compression, with panel (A) showing the compressed area on IVUS. Panel (B) showing the deployed WALLSTENT.

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