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456 Cardiovascular Thrombus
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thrombus dissolution and extraction, balloon angioplasty, stenting, or, when indicated, emergent or urgent vascular surgery
are critical manag ement components. Altogether, timely and accurate diagnosis of flow-limiting thrombus obstructing
these major aortic branches and choosing the proper treatment are paramount requisites to avoid the loss of vital organs and
resultant catastrophic sequelae.
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[24] Hohenwalter EJ. Chronic mesenteric ischemia: diagnosis and treatment. Semin Intervent Radiol 2009;26:345e51.
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[26] Safioleas MC, Moulakakis KG, Papavassiliou VG, Kontzoglou K, Kostakis A. Acute mesenteric ischaemia, a highly lethal disease with a
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[27] Kozuch PL, Brandt LJ. Review article: diagnosis and management of mesenteric ischaemia with an emphasis on pharmacotherapy. Aliment
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[28] Mastoraki A, Mastoraki S, Tzivana E, et al. Mesenteric ischemia: pathogenesis and challenging diagnostic and therapeutic modalities. World J
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[29] Schofield N, Webb ST, Varcada M, Macfie A. Acute mesenteric ischemia. J Intensive Care Soc 2014;15:226e30.
Management Strategies for Thrombosis of Major Abdominal Aortic Branches Chapter | 31 457
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[30] Shah AS, Schwartz LB, Moawad J, Gewertz BL. Technique profile: mesenteric reconstructions for occlusive disease. Expert Rev Cardiovasc Ther
2015;13:1445e58.
[31] Zhao Y, Yin H, Yao C, et al. Management of acute mesenteric ischemia: a critical review and treatment algorithm. Vasc Endovascular Surg
2016;50:183e92.
[32] Tilsed JVT, Casamassima A, Kurihara H, et al. ESTES guidelines: acute mesenteric ischaemia. Eur J Trauma Emerg Surg 2016;42:253e70. https://
doi.org/10.1007/s00068-016-0634-0.
[33] Rosen RJ, Jain A. Interventions for mesenteric ischemia. In: Kipshidze N, Farred J, Rosen RJ, Dangas GS, Serruys PW, editors. Urgent inter-
ventional therapy. Chichester, West Sussex, England: Wiley-Blackwell; 2015. p. 442e57.
[34] Miura Y, Araki T, Terashima M. Mechanical recanalization for acute embolic occlusion at the origin of the superior mesenteric artery. Vasc
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[35] Yanar F, Agcaoglu O, Sarici IS, et al. Local thrombolytic therapy in acute mesenteric ischemia. World J Emerg Surg 2013;8:8.
[36] Resch TA, Acosta S, Sonesson B. Endovascular techniques in acute arterial mesenteric ischemia. Semin Vasc Surg 2010;23:29e35.
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[38] Walker TG. Mesenteric ischemia. Semin Intervent Radiol 2009;26:175e83.
[39] Stone JR, Wilkins LR. Acute mesenteric ischemia. Tech Vasc Interv Radiol 2015;18:24e30.
[40] Von Recklinghausen F. Haemorrhagische niereninfunktion. Virchof Arch Pathol Anat Physiol 1861;20:205e7.
[41] Fallahzadeh MK, Yatavelli RK, Kumar A, Singh N. Acute transplant renal artery thrombosis due to distal renal artery stenosis: a case report and
review of the literature. J Nephropathol 2014;3:105e8.
[42] Kumar B, Kumari S. Spontaneous renal artery thrombosis successfully intervened with drug eluting stent: a primary renal artery angioplasty. J Clin
Daign Res September 2017;11(9):OD14e5. https://doi.org/10.7860/JCDR/2017/28893.10660. Epub 2017 Sep. 1.
[43] Lopez VM, Glauser J. A case of renal artery thrombosis with renal infarction. J Emerg Trauma Shock 2010;3:302. https://doi.org/10.4103/0974-
2700.66569.
[44] Bourqault M, Grimbert P, Verret C, et al. Acute renal infarction: a case series. Clin J Am Soc Nephrol 2013;8:392e8.
[45] Koivuviita N, Tertti R, Heiro M, Manner I, Metsarinne K. Thromboembolism as a cause of renal artery occlusion and acute kidney injury: the
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2016;9:4e5.
Chapter 32
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Thrombotic Lesions in the Lower
Extremity Peripheral Arteries: Diagnosis
and Management
Nicolas W. Shammas
Midwest Cardiovascular Research Foundation, Davenport, IA, United States; University of Iowa Hospitals and Clinics, Iowa, IA, United States
INTRODUCTION: THROMBUS IN PERIPHERAL ARTERIAL DISEASE
Peripheral arterial disease (PAD) is characterized by a heightened inflammatory state [1,2]. The triad of inflammation,
atherosclerosis, and thrombosis is interlinked [3]. It is not uncommon to see thrombus in patients with PAD, particularly in
patients with total occlusions, whether de novo or restenotic [4]. The presence of thrombus, however, is best visualized by
intravascular ultrasound (IVUS), as angiography quite often underestimates its presence. In fact, fewer than half the
patients with thrombotic occlusions had visible thrombus on angiography compared with IVUS [4].
PAD patients tend to have a higher prevalence of diabetes and smoking, two risk factors that are associated with
thrombosis [5,6]. In addition to a heightened baseline inflammation, PAD patients display a sharp rise in inflammation with
endovascular intervention [7,8], which makes the postprocedure vascular system a milieu for acute thrombus formation and
predicts a higher rate for repeat revascularization [9e11].
Treatment of thrombotic lesions in lower extremity peripheral arteries is associ ated with distal embolization (Fig. 32.1),
prolonged procedure time, higher exposure to radiation and contrast dye, and adverse limb events [12e15]. Embolic filter
protection is often used by operators to reduce the risk of distal embolization [16,17] (Fig. 32.2). Data, however, remain
controversial as to how much embolic protection devices improve hard outcomes such as amputations or vascular-related
death. Also the cost effectiveness of these devices is unknown at this time.
THROMBOEMBOLIC OCCLUSIONS IN LOWER EXTREMITY PERIPHERAL ARTERIES
Acute thromboembolic occlusions (Fig. 32.3) may occur in peripheral arteries from remote vascular beds, most commonly
the heart, secondary to atrial fibrillation [18,19] or paradoxical embolization through an interatrial septal defect [20,21],or
from ulcerated plaques or aneurysms in the aorta [22], or from iatrogenic causes such as intravascular catheter manipulations. Other cardiac pathologies that lead to peripheral emboli include valvular heart disease, cardiomyopathy, cardiac
tumors, and endocarditis [23,24] . The occurrence of thromboemboli is sudden and the presentation is most frequently
acute. A sudden occlusion of a relatively normal lower extremity artery is likely to lead to acute limb ischemia (ALI)
needing emergent treatment.
Prevention of thromboemboli generally comprises oral anticoagulants in patients with atrial fibrillation [25] and a high
CHADS (congestive heart failure, hypertension, age >75 years, diabetes, history of stroke) or CHADS-VASc (vascular
disease, age 65e75 years, female sex category) score. A score of 2 or more is treated with an oral anticoagulant [26] such
as warfarin, an oral factor Xa inhibitor (rivaroxaban, apixaban, edoxaban), or an oral thrombin inhibitor (dabigatran).
Warfarin remains the mainstay of treatment for patients with prosthetic heart valves and atrial fibrillation secondary to
moderate or severe mitral stenosis.
Cardiovascular Thrombus. https://doi.org/10.1016/B978-0-12-812615-8.00032-6
Copyright © 2018 Elsevier Inc. All rights reserved.
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FIGURE 32.1 Large thrombus captured with an embolic protection device.
Prevention of distal embolization from paradoxical embolization is generally done with antiplatelet therapies (aspirin or
ADP receptor inhibitors). Data suggest that there is no advantage to the oral anticoagulant rivaroxaban over antiplatelet
therapy in these patients (NAVIGATE ESUS study) [27] and closure of the interatrial septal defect is likely to be more
effective than medical therapy alone (RESPECT trial) [28].
IN SITU THROMBOTIC OCCLUSIONS IN LOWER EXTREMITY ARTERIES
In situ thrombus in the lower extremity arteries is caused by either plaque rupture or the loss of laminar flow in a segment
of the artery with severe occlusion. Predisposing factors include smoking, diabetes, hypertension, hyperlipidemia, and
postrevascularization. The presence of collaterals is likely to lead to a subacute or chronic clinical presentation [29]. ALI is
typically sudden, the result of an acute arterial closure secondary to a distant embolus or in situ thrombus in a patient with
no prior significant obstructive disease and therefore no minimal collaterals.
TREATMENT OF THROMBUS IN LOWER EXTREMITY PERIPHERAL ARTERIES
There are several methods of thrombus removal from lower extremity peripheral arteries. These include catheter-directed
thrombolysis (CDT), which can be performed with or without ultrasound energy assistance (EkoSonic endovascular
FIGURE 32.2 Wirion (Gardia Medical) filter with large thrombus captured.
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FIGURE 32.3 Large thrombus in the profunda femoris.
system); aspiration thrombectomy (AT); mechanical thrombectomy (MT); and photoablation of thrombus. CDT continues
to be on the decline in favor of MT, which is highly effective in removing thrombus and shortens procedure time
considerably but is also more expensive. AT is commonly used as a first-line therapy when the thrombus is small and distal
into the vascular bed, but it is significantly less effective than MT.
Catheter-Directed Thrombolysis
CDT is targeted therapy of a lytic agent into a vessel with thrombotic occlusion. The concept behind CDT is to provide a
higher concentration of the lytic agent at the treatment location and therefore minimize the risk of bleeding associated with
systemic lysis. Several thrombolytic agents have been used for catheter-directed lysis. As of this writing, tissue plasminogen activator (tPA) and TNK-tPA (tenecteplase) are the two most commonly used agents.
In the Rochester study [30], thrombolysis had a better 1-year cumulative survival rate than surgery in patients presenting
with limb-threatening ischemia of less than 7 days duration. Lysis resulted in thrombus dissolution in 70% of patients and
had a rate of amputation similar to that of surgery. Also, length of hospital stay was similar between CDT and surgery. On
the other hand, the STILE trial [31] showed that surgery had a better composite clinical outcome (death, ongoing/recurrent
ischemia, major amputation, and major morbidity) than CDT at 30 days, driven by a reduction in recurrent ischemia. In this
intention-to-treat study, 28% of patients in the lytic arm did not receive lysis because catheter placement could not be
accomplished. Also, lysis reduced the magnitude of subsequent surgical procedure in 55.8% of patients, such as reducing an
above-the-knee amputation to a below-the-knee amputation. Also, in the subgroup of patients with ALI, CDT had a lower
amputation rate and length of hospital stay than surgery. In the TOPAS trial [32], patients randomized to lysis versus surgery
had a higher rate of bleeding but less need for open surgical procedures. Amputation and death were similar. tPA in general
requires less duration of infusion than urokinase. Compared with surgery, lysis is therefore effective, with similar mortality
and amputation, but carries higher bleeding. CDT appears to be more effective than surgery in the acute patient (<14 days of
symptoms), long lesions, graft occlusions, and embolic rather than thrombotic occlusions. A single bolus dose of tPA should
not exceed 10 mg. Infusion rate should be between 0.5 and 2 mg/h, not to exceed a total of 40 mg. A total of 500 U/h
unfractionated heparin is infused in the side arm of the sheath where the CDT catheter is placed. Typically, we do not
change the infusion rate during the tPA infusion, but following the infusion, the patient’s heparin is adjusted per a sliding
scale to achieve a goal of a maximum partial thromboplastin time of 1.5 times the normal.
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In patients with ALI, CDT as a sole therapy may not be fast enough to restore flow to a threatened limb, and cessation
of therapy may occur because of complications. CDT is therefore used in conjunction with aspiration or MT or with
surgical intervention for faster restoration of flow. Data on patients with ALI from the Danish Vascular Registry [33]
demonstrated that CDT was used alone in 55% of patients, in conjunction with endovascular therapy in 39%, and with
surgical intervention in 6%. At 30 days, patients treated with CDT alone had a patency of 68%, whereas those treated with
CDT and an endovascular procedure had a patency of 87% (P < .01). Complications of CDT in this registry included
cerebral hemorrhage in 0.8%, major bleeding in 16%, and gastrointestinal bleeding in 2%. The amputation and mortality
rates were 8% and 3% at 30 days and 16% and 22% on long-term follow-up. The only preprocedural variable that
correlated with mortality was the lack of visualized distal runoff. In contrast to the STILE trial [31], amputation was higher
in CDT patients with less than 2 weeks onset of symptoms. Porous balloons have been used to accelerate and shorten the
duration of lysis by directly injecting the lytic into the thrombus. In the ClearWay single-center prospective registry [34],
20 consecutive patients with subacute and chronic thrombotic occlusions were treated with an escalating dose of tPA using
the ClearWay balloon irrigation system (CW) (Atrium Medical Corp., Hudson, NH, USA). Five patients were used as
control (saline infusion thru CW). IVUS was used to quantitate plaqueethrombus volume and interpreted by the core
laboratory. There was no statistical difference in plaqueethrombus volume between baseline (pretreatment) and CW tPA
treatment (P ¼ .628, n ¼ 14). Following rheolytic thrombectomy (RT) post-CW lytic treatment, however, there was a
statistically significant reduction in plaqueethrombus volume versus CW lytic treatment alone (P ¼ .030) or pretreatment
baseline (P ¼ .029). Therefore, a short lysis time even with direct lytic infusion into a thrombus was not adequate to
remove the thrombus, and the addition of MT was necessary.
CDT in general without additional endovascular interventions is associated with higher reintervention, whether
endovascular or surgical; higher readmission rates; and higher costs [35]. In the author’s practice, MT is used as a first-line
therapy with or without adjunctive lysis depending on the outcome and restoration of good flow. In the case of a high
residual thrombus or overall suboptimal flow restoration, CDT is performed and the patient is brought back to the
endovascular suite for more definitive treatment.
Ultrasound-Accelerated Thrombolysis
Recently, the EKOS EndoWave infusion catheter system was approved for the “controlled and selective infusion of
physician-specified fluids, including thrombolytics, into the peripheral vasculature.” Ultrasound energy was shown to
accelerate lysis penetration deeper into a thrombus, allowing a faster lysis of a clot and shorter duration of lysis time. Early
observational data showed that the EKOS system allowed complete lysis of occlusions in 85%e95% of patients, with low
bleeding rates (<2%) [36,37]. In the Dutch Randomized Trial Comparing Standard Catheter-Dire cted Thrombolysis and
Ultrasound-Accelerated Thrombolysis for Arterial Thromboembolic Infrainguinal Disease (DUET) [38], 60 ALI patients
with recent (<50 days) infrainguinal native artery or bypass graft thrombotic occlusion were randomized to CDT versus
ultrasound-accelerated lysis. The primary outcome was thrombolysis time to achieve more than 95% thrombus lysis with
outflow through at least one infrapopliteal artery. Ultrasound-accelerated lysis achieved faster lysis than CDT alone (mean
17.7 h vs. 29.5 h, P ¼ .0009) with fewer units of urokinase (P ¼ .01). At 30 days, patenc y was 82% versus 71% in the
CDT and the ultrasound-accel erated lysis groups, respectively (P ¼ .35).
Aspiration Thrombectomy
AT is typically reserved for a small thrombus that is discrete. It is generally not effective for long occlusions or large
thrombus burden. Also, AT is limited by its inability to reach very small vessels. AT is nicely suited to a discrete embolus
lodging at the bifurcation of tibial vessels or within a stenotic segment of a vessel. The guiding catheter method is generally
effective if the catheter reaches the thrombus. The closer the diameter of the vessel size to the outer diameter of the guiding
catheter tip, the more likely a suction mechanism is quickly generated and the thrombus is aspirated. A 60-cc syringe is
used and a fast aspiration is created. Once the thrombus lodges itself in the catheter, aspiration stops. Keeping the negative
pressure on the syringe and pulling the guiding catheter out will frequently show the trapped thrombus.
Dedicated AT catheters have also been used, including the PriorityOne AC (Terumo Interventional Systems), the
Aspire (Control Medical Technology), Xpress-Way (Getinge), Export (Medtronic), ASAP aspiration catheter (Merit
Medical Systems), Pronto (Teleflex), and QuickCat (Spectranetics).
Schleder et al. [39] reported in 2015 on 47 patients treated with AT following infrainguinal angioplasty. AT alone had a
technical success rate of 64% (achieving residual narrowing less than 50%), but secondary technical success after balloon
angioplasty and stenting was 96% with excellent clinical outcome. Other investigators reported that thromboembolic
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material can be successfully aspirated with a 90% success rate [40]. We recommend AT as a first-line therapy given its low
cost, wide availability, and ease of use in the majority of focal or discrete thromboembolic material. However, long
thrombotic occlusions and large thrombi are likely to need MT or surgical embolectomy.
Mechanical Thrombectomy
Quite frequently thrombus may be large in size, more organized, and present in long total occlusions or in very small distal
vessels. Also, as it ages (within 2 weeks), it may have ingrowth of capillary vessels, smooth muscle cells, and connective
tissue and become adherent to the vessel wall. AT is likely to be ineffective under these conditions and MT with or without
lytic therapy becomes the preferred treatment of choice.
MT devices use various mechanisms of action (and quite often more than one mechanism). They can also be used as
stand-alone or pharmaco-assisted (with thrombolysis). Mechanisms of action of MT devices include maceration (or
disruption), suction, and in some instances recirculation. Several MT devices exist on the market.
Devices include (not a comprehensive list):
1. Rotational: Jetstream (Boston Scientific), Phoenix (Philips), Rotarex (Straub), Amplatz thrombectomy device/Helix
(Amplatzer thrombectomy device), Trellis device (Bacchus Vascular) (Fig. 32.4), Cleaner XT (Argon Medical
Devices), Solera (Bacchus Vascular), XTD “Extract Device” (Xtrak Medical), Thrombex PMT (Edwards), Aspirex
S (Straub), and ThromCat XT (Spectranetics)
2. Hydrodynamic (Venturi system): AngioJet (Boston Scientific), Hydrolyser (Cordis), and Oasis (Boston Scientific)
3. Suction devices: Indigo system (Penumbra)
Pharmacolysis has been used with the AngioJet (power-pulse spray) (Fig. 32.5), ultrasound-assisted lysis, and the
Trellis device. The addition of MT to lysis allows a faster thrombus treatment with reduced lytic dose and a procedure that
is likely to be accomplished in one visit to the catheterization laboratory.
AngioJet is likely to be the most frequently used MT device. In acute thrombotic lower extremity, the AngioJet was
shown to have high procedural success in patients with ALI and occlusive thrombus (Fig. 32.6). In one study of 22 vessels
(limbs) treated within 2 weeks of symptom onset, acute limb salva ge was achieved in 95% of patients and 6-month salvage
FIGURE 32.4 Trellis device extending from left external iliac to proximal left superficial femoral artery.
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(A) (B) (C) (D)
FIGURE 32.5 Power pulse turned on with AngioJet.
in 89% [41]. In a retrospective multicenter study of 99 consecutive patients the AngioJet was used to treat thrombotic
occlusions. In this study, 78.8% of patients presented within 2 weeks of symptom onset. Complete resolution of thrombus
occurred in 70.7% of patients and partial in 22.2%. Assisted thrombolysis was used in 37 (37.4%) patients. In-hospital and
30-day mortality were 4% and 7.1%, respectively. Amputation at 30 days was 4% [42].
FIGURE 32.6 Total thrombotic occlusion treated with the AngioJet device.
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TABLE 32.1 Advantages of Treatment of Thrombotic Lesions With Laser
True ablation of thrombus, soft and organized
Reduces platelet aggregation and enhances chemical lysis
No catheter exchanges needed
Single operator
Treatment likely to be completed in one setting
Less bleeding risk than catheter-directed thrombolysis
When the duration of the thrombus is older than 2 weeks, thrombectomy becomes more challenging using the AngioJet
system. In the prospective DETHROMBOSIS registry [4], 17 patients with a mean duration of symptom onset of
2.1 months were treated initially with RT, followed by power-pulse spray treatment with tPA (10 mg per 50 mL of normal
saline) for 20 min prior to repeating RT. Partial thrombus resolution occurred in 62.5% of patients and no resolution in
31.25%. Primary acute angiographic success was 100%. Distal embolization occurred in three patients (17.6% patients),
two requiring additional therapies.
When thrombus becomes more organized (more than 2 weeks old), our first line of treatment is rotational MT devices,
such as the Jetstream, or photoablation with the laser. In our experience, a more effective and predictable thrombus removal
is noted. We use embolic filter protection routinely, as distal embolization is not an infrequent occurr ence.
Photo-Thrombectomy Using the Laser
Photo-thrombectomy (Excimer laser, B-Laser) uses energy to ablate thrombus. Photo-energy can also be coupled with
aspiration as in the B-Laser from Eximo Medical (at this writing, investigational in the United States). Thrombus absorbs
midinfrared, visible, and UV wavelengths, making it an excellent target for laser ablation [43,44]. In addition, the laser has
several other advantages listed in Table 32.1. In a single-center prospective registry [45], 20 consecutive patients with
subacute and chronic symptoms were treated with the laser. Of the vessels treated, 95% were femoropopliteal, and embolic
filter protection was used in 75% of cases. Angiographically, the laser reduced lesion severity from 100% to 66.75% but
macrodebris were seen in 85.7% of all filters. Distal embolization with the laser was also confirmed in the prospective,
single-center, Distal Embolic Event Protection Using Excimer Laser Ablation in Peripheral Vascular Interventions (DEEP
EMBOLI) registry [14]. Excimer laser was applied in 20 patients and macrodebris were found in 22.2% of filters.
Therefore, the laser embolizes like other atherectomy and thrombectomy devices and the presence of thrombus is a
predictor of distal embolization. At this writing, the B-Laser (Eximo Medical) with built-in aspiration mechanism is being
tested in lower extremity femoropopliteal arterial disease (NCT02556255).
Operators prefer the laser over directional atherectomy in longer and more complex disease [46], probably because of
the relative ease of its use and the avoidance of multiple catheter removals and reinsertions. Also, with the advent of the
Turbo-Tandem and Turbo-Power catheters, more effective directional lasing is likely to be achieved. Finally, laser has been
applied to facilitate lysis in dialysis graft and venous application [47,48]. More data are needed on laser-facilitated lysis in
lower extremity arterial applications.
USE OF ANTICOAGULANTS AND ANTIPLATELETS WITH THROMBECTOMY
Unfractionated heparin remains the most widely used anticoagulant during lower extremity peripheral arterial interventions. Bivalirudin, a direct thrombin inhibitor, is a more predictable anticoagulant during endovascular procedures. In
contrast to heparin, it has the added advantage of inhibiting free and bound thrombin and thrombin-induced platelet
activation [49,50].
Maceration or disruption of thrombotic lesions is likely to further activate platelets and thrombin. Dual antiplatelet
therapy is indicated with aspirin and ADP receptor antagonists. The addition of vorapaxar (thrombin receptor inhibitor) has
also been shown to be beneficial in reducing ALI or peripheral revascularization in PAD patients but with no impact on
death, myocardial infarction, or stroke [51]. Vorapaxar has not been widely adopted because of higher bleeding risk and
expense. The adjunctive use of intravenous glycoprotein IIb/IIIa receptor antagonists may have a favorable effect on
reducing the incidence of slow flow and distal embolization [52,53], but definitive data are lacking.
466 Cardiovascular Thrombus
https://t.me/med1917
CONCLUSION
Thrombus is prevalent in lower extremity arterial interventions, particularly in total occlusions, whether de novo or
restenotic, and quite often is underestimated on angiography. Based on the symptom onset, a thrombus can be acute or
subacute (within 2 weeks) or chronic (more than 2 weeks). Thrombus responds better to MT with or without adjunctive
lysis when recent in onset, but is more difficult to treat when it becomes organized. In this case, the use of rotational
atherectomy devices such as the Jetstream device or photo-thrombectomy with the laser may provide better acute procedural results. CDT is effective in treating thrombus but often requires adjunctive MT to accelerate lysis and reduce the
lytic agent dosing. Also, the more organized the thrombus, the more likely the need for a longer lysis time, higher
thrombolysis dose, and subsequent bleeding complications. We believe that embolic protection is an important safeguard
against distal embolization when treating thrombotic lesions because of the high embolic potential in these patients.
Randomized studies are needed to evaluate different strategies in managing thrombot ic lesions.
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