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462 Chapter 49/Thrombolytic Therapy for Acute Venous Thrombosis
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FIGURE 49.5 A. The EKOS LysUS® System (EKOS Corp, Bothell, WA) is an ultrasonic infusion system designed
for controlled and selective infusion of thrombolytics into the thrombosed veins. Ultrasound waves accelerate thrombolysis, reducing treatment time. The catheter was advanced proximally from an ultrasound-guided posterior tibial vein
puncture. B. Phlebogram showing popliteal vein thrombus. C. Post-ultrasound lysis, dissolution of thrombus in the distal
femoral vein, D. popliteal vein, and E. posterior tibial vein. F. Angioplasty and stenting were performed on the left iliac
vein, establishing normal venous drainage into the inferior vena cava.
ADJUNCTIVE TECHNIQUES TO
CATHETER-DIRECTED THROMBOLYSIS
Percutaneous mechanical thrombectomy techniques are
discussed in detail in Chapter 50. There appears to be a
higher incidence of embolic complications with mechanical
thrombectomy. In a prospective evaluation of pulse-spray
pharmacomechanical thrombolysis of clotted hemodialysis
27
grafts,
perfusion scan) occurred in 18% of patients treated with a
plasminogen activator pulse-spray solution versus 64% of
it was found that PE (documented by ventilation
patients treated with a heparinized saline pulse-spray solution (P = .04). Since clotted hemodialysis grafts are in direct
communication with the venous circulation, they can be
considered similar to proximal veins with acute DVT.
Observations would likely be magnifi ed when treating larger
venous thromboses.
In an experimental model, Greenberg and associates
28
evaluated mechanical, pharmacomechanical, and pharmacologic thrombolysis. Their fi ndings are consistent with anecdotal clinical observations as well as the results reported by
Kinney and associates.
27
Greenberg et al. demonstrated that
References 463
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pulse-spray mechanical thrombectomy was associated with
the largest number and greatest size of distal emboli. When
urokinase was added to the solution, the embolic particles
diminished in number and in size and increased the speed
of lysis with reperfusion. Catheter-directed thrombolysis
alone was associated with the slowest reperfusion but the
fewest distal emboli. In general, mechanical thrombectomy
alone most often is inadequate. Hemolytic complications of
rheolytic mechanical thrombectomy are common and occasionally can result in anemia and renal dysfunction.
A new device recently released for segmental and controlled pharmacomechanical thrombolysis is the reengineered Trellis catheter (Bacchus Vascular, Santa Clara, CA),
which is a hybrid catheter that isolates the thrombosed vein
segment between two occluding balloons (see Figure 49.4).
A lytic agent is infused into the thrombus between the
occluding balloons. The intervening catheter shaft assumes
a sign wave or spiral confi guration and, when activated,
spins at 15,000 rpm. After 10 to 15 minutes, the liquifi ed
thrombus and remaining fragments are aspirated. Phlebographic evaluation of the result is performed before moving
on to treat additional thrombosed vein segments (see Figure
49.4). The advantages of such a device are its ability to
incorporate mechanical and pharmacologic therapies, even
in patients with a contraindication to thrombolytic therapy
since the infusate is aspirated, and the rapidity with which
treatment can be achieved. The rationales behind the design
of this catheter are:
1. Rapidly resolve thrombus during a short course of
treatment.
2. Limit or avoid exposure to thrombolytic therapy by
aspirating liquifi ed thrombus and infused lytic agent.
3. Prevent PE by proximal balloon occlusion.
A clinical trial designed to evaluate the success and complication rate of this technique is under way.
An interesting new adjunct to catheter-directed thrombolysis is the addition of the emission of ultrasound waves
from the infusion catheter while delivering the plasminogen
activator (see Figure 49.5). Several reports have emerged
indicating that an infusion catheter with ultrasound transducers built into the infusion end of the catheter can be used
to accelerate thrombolysis.
29–32
In vitro studies have demon-
strated that ultrasound enhances the fi brinolytic activity
of tissue plasminogen activator (t-PA).
33–35
The potential
mechanism for augmented clot lysis has been extrapolated
from in vitro studies showing that ultrasound produces clot
fragmentation in the presence of t-PA, and consequently,
more t-PA binds to fi brin-binding sites due to the larger
available surface area.
36–38
The concept of a transducertipped catheter that delivers a fi brinolytic drug in combination with high frequency, low-intensity ultrasound has been
39
well described. In vivo models
and clinical trials40 are
now under way to assess the potential value of ultrasound
enhancement of thrombolysis for the management of acute
DVT.
The patient with phlegmasia cerulea dolens, summarized
in Figure 49.4, illustrates the advantage of using segmental,
pharmacomechanical thrombolysis and ultrasound-enhanced
catheter-directed thrombolysis to shorten treatment duration
and limit exposure to the thrombolytic agent, maximizing
the chance of a successful outcome.
Thrombolysis is effective and has become safer with the
direct intrathrombus infusion and adjunctive mechanical
techniques. As technology continues to improve, lytic infusion times will shorten, more patients will be offered a
treatment strategy that includes thrombus removal, and
many patients will be spared their otherwise certain postthrombotic morbidity.
References
1. O’Donnell TF Jr, Browse NL, Burnand KG, Thomas ML. The socio-
economic effects of an iliofemoral venous thrombosis, J Surg Res.
1977. 22: 483–488.
2. Akesson H, Brudin L, Dahlstrom JA, Eklof B, Ohlin P, Plate G.
Venous function assessed during a 5 year period after acute iliofemoral venous thrombosis treated with anticoagulation, Eur J Vasc
Surg. 1990. 4: 43–48.
3. Delis KT, Bountouroglou D, Mansfi eld AO. Venous claudication in
iliofemoral thrombosis: Long-term effects on venous hemodynamics,
clinical status, and quality of life, Ann Surg. 2004. 239: 118–126.
4. Shull KC, Nicolaides AN, Fernandes e Fernandes J, Miles C, Horner
J, Needham T et al. Signifi cance of popliteal refl ux in relation to ambulatory venous pressure and ulceration, Arch Surg. 1979. 114:
1304–1306.
5. Johnson BF, Manzo RA, Bergelin RO, Strandness DE Jr. Relationship
between changes in the deep venous system and the development of
the postthrombotic syndrome after an acute episode of lower limb deep
vein thrombosis: A one- to six-year follow-up, J Vasc Surg. 1995. 21:
307–312.
6. Cho JS, Martelli E, Mozes G, Miller VM, Gloviczki P. Effects of
thrombolysis and venous thrombectomy on valvular competence,
thrombogenicity, venous wall morphology, and function, J Vasc Surg.
1998. 28: 787–799.
7. Rhodes JM, Cho JS, Gloviczki P, Mozes G, Rolle R, Miller VM.
Thrombolysis for experimental deep venous thrombosis maintains
valvular competence and vasoreactivity, J Vasc Surg. 2000. 31:
1193–1205.
8. Killewich LA, Bedford GR, Beach KW, Strandness DE Jr. Spontane-
ous lysis of deep venous thrombi: Rate and outcome, J Vasc Surg.
1989. 9: 89–97.
9. Markel A, Manzo RA, Bergelin RO, Strandness DE Jr. Valvular refl ux
after deep vein thrombosis: Incidence and time of occurrence, J Vasc
Surg. 1992. 15: 377–382.
10. Meissner MH, Manzo RA, Bergelin RO, Markel A, Strandness DE Jr.
Deep venous insuffi ciency: The relationship between lysis and subsequent refl ux, J Vasc Surg. 1993. 18: 596–605.
11. Caps MT, Manzo RA, Bergelin RO, Meissner MH, Strandness DE Jr.
Venous valvular refl ux in veins not involved at the time of acute deep
vein thrombosis, J Vasc Surg. 1995. 22: 524–531.
12. Comerota AJ, Aldridge SE. Thrombolytic therapy for acute deep vein
thrombosis, Semin Vasc Surg. 1992. 5: 76–84.
13. Goldhaber SZ, Buring JE, Lipnick RJ, Hennekens CH. Pooled analyses
of randomized trials of streptokinase and heparin in phlebographically
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documented acute deep venous thrombosis, Am J Med. 1984. 76:
393–397.
14. Plate G, Einarsson E, Ohlin P, Jensen R, Qvarfordt P, Eklof B.
Thrombectomy with temporary arteriovenous fi stula: The treatment of
choice in acute iliofemoral venous thrombosis, J Vasc Surg. 1984. 1:
867–876.
15. Plate G, Akesson H, Einarsson E, Ohlin P, Eklof B. Long-term results
of venous thrombectomy combined with a temporary arterio-venous
fi stula, Eur J Vasc Surg. 1990. 4: 483–489.
16. Plate G, Eklof B, Norgren L, Ohlin P, Dahlstrom JA. Venous
thrombectomy for iliofemoral vein thrombosis—10-year results of a
prospective randomised study, Eur J Vasc Endovasc Surg. 1997. 14:
367–374.
17. Alkjaersig N, Fletcher AP, Sherry S. The mechanism of clot dissolution
by plasmin, J Clin Invest. 1959. 38: 1086–1095.
18. Bjarnason H, Kruse JR, Asinger DA, Nazarian GK, Dietz CA Jr.,
Caldwell MD et al. Iliofemoral deep venous thrombosis: Safety and
effi cacy outcome during 5 years of catheter-directed thrombolytic
therapy, J Vasc Interv Radiol. 1997. 8: 405–418.
19. Mewissen MW, Seabrook GR, Meissner MH, Cynamon J,
Labropoulos N, Haughton SH. Catheter-directed thrombolysis for
lower extremity deep venous thrombosis: Report of a national multicenter registry, Radiology. 1999. 211: 39–49.
20. Comerota AJ, Kagan SA. Catheter-directed thrombolysis for the treatment of acute iliofemoral deep venous thrombosis, Phlebology. 2001.
15: 149–155.
21. Verhaeghe R, Stockx L, Lacroix H, Vermylen J, Baert AL. Catheterdirected lysis of iliofemoral vein thrombosis with use of rt-PA, Eur
Radiol. 1997. 7: 996–1001.
22. Shortell CK, Queiroz R, Johansson M, Waldman D, Illig KA,
Ouriel K et al. Safety and effi cacy of limited-dose tissue plasminogen
activator in acute vascular occlusion, J Vasc Surg. 2001. 34: 854–
859.
23. Chang R, Cannon RO, III, Chen CC, Doppman JL, Shawker TH, Mayo
DJ et al. Daily catheter-directed single dosing of t-PA in treatment of
acute deep venous thrombosis of the lower extremity, J Vasc Interv
Radiol. 2001. 12: 247–252.
24. Castaneda F, Li R, Young K, Swischuk JL, Smouse B, Brady T.
Catheter-directed thrombolysis in deep venous thrombosis with use of
reteplase: Immediate results and complications from a pilot study, J
Vasc Interv Radiol. 2002. 13: 577–580.
25. Sillesen H, Just S, Jorgensen M, Baekgaard N. Catheter-directed
thrombolysis for treatment of ilio-femoral deep venous thrombosis is
durable, preserves venous valve function and may prevent chronic
venous insuffi ciency, Eur J Vasc Endovasc Surg. 2005. Epub.
26. Elsharawy M, Elzayat E. Early results of thrombolysis versus anticoagulation in iliofemoral venous thrombosis. A randomised clinical
trial, Eur J Vasc Endovasc Surg. 2002. 24: 209–214.
27. Kinney TB, Valji K, Rose SC, Yeung DD, Oglevie SB, Roberts AC
et al. Pulmonary embolism from pulse-spray pharmacomechanical
thrombolysis of clotted hemodialysis grafts: Urokinase versus heparinized saline, J Vasc Interv Radiol. 2000. 11: 1143–1152.
28. Greenberg RK, Ouriel K, Srivastava S, Shortell C, Ivancev K, Waldman
D et al. Mechanical versus chemical thrombolysis: An in vitro differentiation of thrombolytic mechanisms, J Vasc Interv Radiol. 2000. 11:
199–205.
29. Steffen W, Fishbein MC, Luo H, Lee DY, Nita H, Cumberland DC
et al. High intensity, low frequency catheter-delivered ultrasound
dissolution of occlusive coronary artery thrombi: An in vitro and in
vivo study, J Am Coll Cardiol. 1994. 24: 1571–1579.
30. Rosenschein U, Gaul G, Erbel R, Amann F, Velasguez D, Stoerger H
et al. Percutaneous transluminal therapy of occluded saphenous vein
grafts: Can the challenge be met with ultrasound thrombolysis? Circulation. 1999. 99: 26–29.
31. Tachibana K, Tachibana S. Ultrasound energy for enhancement of
fi brinolysis and drug delivery: Special emphasis on the use of a
transducer-tipped ultrasound system. In: Siegel RJ, ed. Ultrasound
Angioplasty. 1996. Boston: Kluwer. 121–133.
32. Tachibana K, Tachibana S. Prototype therapeutic ultrasound emitting
catheter for accelerating thrombolysis, J Ultrasound Med. 1997. 16:
529–535.
33. Trubestein G, Engel C, Etzel F, Sobbe A, Cremer H, Stumpff U.
Thrombolysis by ultrasound, Clin Sci Mol Med Suppl. 1976. 3:
697s–698s.
34. Ariani M, Fishbein MC, Chae JS, Sadeghi H, Michael AD, Dubin SB
et al. Dissolution of peripheral arterial thrombi by ultrasound, Circulation. 1991. 84: 1680–1688.
35. Rosenschein U, Bernstein JJ, DiSegni E, Kaplinsky E, Bernheim J,
Rozenzsajn LA. Experimental ultrasonic angioplasty: Disruption of
atherosclerotic plaques and thrombi in vitro and arterial recanalization
in vivo, J Am Coll Cardiol. 1990. 15: 711–712.
36. Lauer CG, Burge R, Tang DB, Bass BG, Gomez ER, Alving BM.
Effect of ultrasound on tissue-type plasminogen activator-induced
thrombolysis, Circulation. 1992. 86: 1257–1264.
37. Hong AS, Chae JS, Dubin SB, Lee S, Fishbein MC, Siegel RJ. Ultrasonic clot disruption: An in vitro study, Am Heart J. 1990. 120:
418–422.
38. Drobinski G, Brisset D, Philippe F, Kremer D, Laurian C, Montalescot
G et al. Effects of ultrasound energy on total peripheral artery occlusions: Initial angiographic and angioscopic results, J Interv Cardiol.
1993. 6: 157–163.
39. Atar S, Luo H, Nagai T, Siegel RJ. Ultrasonic thrombolysis: Catheterdelivered and transcutaneous applications, Eur J Ultrasound. 1999. 9:
39–54.
40. EKOS Corporation, Bothell, WA. Retrospective evaluation of thrombolysis with EKOS Lysus System.
CHAPTER
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50
Percutaneous Mechanical Thrombectomy in the
Treatment of Acute Deep Venous Thrombosis
COLLEEN M. JOHNSON, PRITHAM P. REDDY, and ROBERT B. MCLAFFERTY
INTRODUCTION
Deep venous thrombosis (DVT) is associated with signifi cant morbidity and mortality. Symptomatic DVT affects
250,000 to 300,000 people per year in the United States and
is responsible for approximately 300,000 hospital admissions per year.
utable to pulmonary embolism (PE) from DVT.3 The costs
for treatment of DVT are estimated between $1.2 and $2.4
billion per year.
Once the diagnosis of DVT is established, the goals of
therapy are: 1) prevention of PE, 2) prevention of thrombus
propagation, 3) preservation of valvular function, and 4)
prevention of post-thrombotic syndrome (PTS). Traditionally, treatment involves unfractionated heparin (UH) or low
molecular weight heparin (LMWH) as a bridge to oral anticoagulation. In addition to the prevention of PE and PTS,
therapeutic anticoagulation aids in the prevention of clot
propagation. Asbeutah et al. reported fi ve-year follow-up of
51 patients with 54 DVTs for PTS. Twenty-six limbs were
noted to have proximal involvement. When treated with
anticoagulation alone, 34% had thrombus resolution at one
month. Sixty-fi ve percent of limbs went on to develop refl ux
and 54% progressed to chronic venous insuffi ciency within
one year of diagnosis.
Surgical thrombectomy is an open procedure whereby
thrombus is manually extracted from a venotomy most commonly created in the femoral vein. Thrombus proximal to
the inguinal ligament is removed using a balloon catheter
and thrombus below is removed by compression of the limb
with an esmarch wrap (Spectrum Laboratories, Rancho
Dominguez, CA). Problems with this technique include
denuding endothelium, damage to the valves, and incomplete thrombus removal. Although still advocated by some
1–4
Nearly 50,000 deaths each year are attrib-
5
6
as the preferred method of treatment for DVT, the vast
majority of patients continue to be treated with
anticoagulation.
With the advent of thrombolytic drugs, some institutions
have treated DVTs with intravenous administration.
Although thrombolysis theoretically satisfi es all therapeutic
goals, complete thrombus resolution occurs in only about
50% of patients with nonobstructive thrombus and 10% of
those with obstructive thrombi.
cations such as retroperitoneal hematoma and intracranial
hemorrhage are markedly elevated in patients receiving systemic therapy when compared to patients treated with anticoagulation alone.
Regional or catheter-directed thrombolysis (CDT) has
been used with some success. Potential advantages include
administration of the pharmacologic agent directly into the
thrombus and less systemic side effects. AbuRahma et al.
reported complete resolution of symptoms in 83% of patients
undergoing CDT compared to 3% in the group receiving
anticoagulation alone.16 CDT also has proven advantageous
in the prevention of recurrent DVT in a large majority of
patients.17 Unfortunately, bleeding complications continue
to plague 4 to 6% of patients, and intracranial hemorrhage
still occurs in a small minority of patients.
requires one to three days of continuous therapy and represents a major disadvantage to prompt and safe treatment.
Comerota et al. reported a 21% incidence of severe PTS in
patients treated for DVT with heparin alone, compared to
5% in those treated with streptokinase.20 CDT in the management of DVT also has been proven superior to anticoagulation alone when evaluating health-related quality of
21
life.
Percutaneous mechanical thrombectomy (PMT) refers to
the technique whereby a catheter utilizing mechanical means
12–15
10,11
Serious bleeding compli-
18,19
CDT usually
7–9
The Vein Book
465
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Copyright © 2006, Elsevier Inc.
466 Chapter 50/Percutaneous Mechanical Thrombectomy in the Treatment of Acute Deep Venous Thrombosis
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can be used independently or coupled with pharmacologic
thrombolysis in the treatment of DVT. Preliminary data
show that treatment with PMT may provide quicker thrombus resolution than CDT alone.
21,22
With an increasing
emphasis on minimal invasiveness, recent years have witnessed an endovascular revolution that has ushered in many
different types of PMT catheters. Herein we provide a comprehensive review of the PMT catheters and descriptions of
more common treatment techniques.
TECHNIQUE
In order to successfully perform PMT, several general
premises must be considered. These include whether to
place a temporary vena cava fi lter, determining optimal site
for venous access, and how to traverse the thrombosis.
Although the technique unique to each PMT catheter is
highly variable, these general principles apply to most clinical scenarios in treating DVT. Following thrombus removal,
subsequent interventions such as balloon angioplasty and/or
stenting can be performed if necessary.
Temporary IVC Filter Placement
The risk of fatal PE during thrombolytic therapy of iliac
vein thrombus has been reported as high as 6%.24 All PMT
devices, including those that aspirate during treatment, generate small particles that can migrate to the pulmonary circulation. The placement of a retrievable IVC fi lter has
become a valuable adjunct to PMT. There are many types
of temporary IVC fi lters available with different time periods
for retrieval (see Table 50.1). Additionally, each fi lter varies
in the approach to deployment and retrieval. These important issues must be considered prior to PMT.
An in vitro model of early large volume DVT demon-
strated that in placing an IVC fi lter prior to PMT, 99% of
particles >500 μm were either macerated by the device or
captured by the fi lter.25 Trerotola et al. demonstrated a
signifi cant number of clinically signifi cant segmental and
subsegmental pulmonary emboli while evaluating the
Arrow-Trerotola Percutaneous Thrombectomy Device
(Arrow International, Reading, PA) in a canine model.26
Further investigations determined that use of a temporary
IVC fi lter reduced the number of pulmonary emboli as diagnosed by pulmonary angiography.
27
In the majority of patients, placement of a retrievable
IVC fi lter should be performed just prior to PMT. Generally,
access to the deployment site should be void of thrombus
and guidewire traversal should be observed with fl uoroscopy for any deviation or diffi culty that may indicate the
presence of thrombus. A venogram should be obtained prior
to deployment of the IVC fi lter to identify the renal veins
and to further ensure the proposed deployment location is
devoid of any thrombus. A low threshold to perform venography by selective catheterization should be considered if
nonselective venography fails to show important venous
tributaries.
28
Depending upon the results of PMT, the fi lter can be
removed immediately or remain in place one to three weeks
during the healing process. The IVC fi lter should remain in
place if contraindications to anticoagulation arise, development of recurrent DVT, or increases in DVT risk occur.
Venous Access
If possible, the same venous access for IVC fi lter placement should be used when selecting an access site to perform
PMT. The ipsilateral common femoral vein is the optimal
access site for thrombus confi ned to the iliocaval segments.
In this clinical scenario, the IVC fi lter should be placed via
the contralateral femoral vein. If the thrombosis is confi ned
to a single lower extremity, possible access sites include
either common femoral vein or the ipsilateral popliteal vein.
The internal jugular vein can also be used to access DVT in
the lower extremities.
TABLE 50.1 Retrievable IVC Filters
Insertion sites Retrieval sites
Filter Femoral Jugular Antecubital Femoral Jugular Antecubital
ALN (ALN Implants X X X X
Chirurgicaux, Ghisonaccia,
France)
Recovery (Bard Peripheral X X
Vascular, Tempe, AZ)
Günther Tulip (Cook X X X
Medical, Bloomington, IN)
OptEase (Cordis Endovascular, X X X X X
Warren, NJ)
SafeFlo (Rafael Medical, X X X X X X
Caesarea, Israel)
Devices 467
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Generally, access to LE DVT from the external iliac vein
to the superfi cial femoral vein is from the contralateral
common femoral vein. Selective catheterization comes over
the iliac vein bifurcation and the involved contralateral
venous segments are accessed in a retrograde direction. If
the thrombus burden is high or there is anticipated diffi culty
in performing a retrograde cannulation, antegrade access
through the ipsilateral popliteal vein is preferred.
The antegrade approach through the ipsilateral popliteal
vein to treat iliofemoral DVT remains the most common
alternative to the contralateral approach. With the patient in
the prone position, duplex ultrasound is required for needle
guidance. A micropuncture kit that uses a 22-gauge needle
and a 0.014″ wire aids in providing a nontraumatic safer
access. Advantages of antegrade access through the popliteal vein include ease of traversing valves and minimal need
for selective catheterization.
Other more remote sites such as the jugular and subclavian veins have been used to gain access to DVT. More
commonly these access sites may be required for direct
access to the confl uence of the common iliac veins. Occasionally, common iliac vein stenosis in combination with
thrombosis can be negotiated only via a retrograde approach
from the brachiocephalic veins. Treating iliofemoral DVT
may require dual access with the use of a snare to pull the
wire from one access site to another, thereby providing for
more stable access to treat with PMT. In the case of upper
extremity DVT treatment, venous access generally is
obtained at the ipsilateral basilic vein. This also requires
ultrasound guidance and use of a micropuncture kit.
Traversing the Thrombus
After defi ning the venous segment by venography as an
entry point to the thrombus, stable access with a sheath or
guiding catheter usually is required. A stiff hydrophilic
guidewire (Boston Scientifi c; Natick, MA) allows optimal
manipulation and guidance in gaining access into thrombus.
As the wire is advanced, a catheter is advanced over the wire
to maintain crossing and increase stability. Usually a straight
catheter such as a 4 Fr. glidecath (Boston Scientifi c, Natick,
MA) is used in combination with a stiff angled guidewire
(Boston Scientifi c, Natick, MA). Alternatively, an angled
catheter such as a Kumpe catheter (Cook; Bloomington, IN)
can be used with a straight guidewire (Boston Scientifi c;
Natick, MA). These combinations are particularly useful
when traversing thrombus in a retrograde direction. Valve
leafl ets can be negotiated with slow directed movements
under magnifi ed fl uoroscopy.
Another technique that can facilitate crossing thrombus
is forming the guidewire into a long “J” confi guration. This
maneuver takes advantage of the stiff portion of the guidewire while preventing trauma to the vein wall because the
fl oppy tip is in a “J” shape. When pushing antegrade through
older thrombus, this technique may prove useful. Emphasis
should be placed on not forcing wires, catheters, and PMT
systems into position. Careful continuous fl uoroscopic
imaging is mandatory when moving wires and catheters and
observing their tracking path is vital to avoiding injury. A
manifold hand injection system with the ability to withdraw
contrast and dilute with saline is helpful in facilitating quick,
periodic views to assure correct catheter position.
DEVICES
PMT catheters can be categorized a variety of ways. One
important distinction is whether the catheter has complete
or incomplete wall contact. Advantages of complete wall
contact include more thorough thrombus dissolution. Potential disadvantages include endothelial and valvular damage.
PMT catheters also can be categorized by their method of
thrombus dissolution. These mechanical methods include
rheolytic aspiration, rotational thrombectomy, and ultrasonic fragmentation. Rheolytic devices remove thrombus
based on the Venturi effect. This adaptation of the Bernoulli
effect states that fl uid moving at high speeds generates low
pressure zones. These low pressure zones create a partial
vacuum, termed the Venturi effect. In rheolytic thrombectomy devices, high speed saline jets are directed into the
thrombus creating low pressure zones near the catheter
where the fragments are aspirated through the device via the
vacuum effect. Theoretic advantages of rheolytic aspiration
include less valvular damage and decreased endothelial
damage.
The rotational devices are designed to spin at varying
speeds within the thrombus causing fragmentation. This
mechanism also can result in increased endothelial damage.
Ultrasonic fragmentation occurs through the delivery of
high-frequency, low-energy ultrasound. The ultrasound
waves cause the aggregated fi brin strands to dissociate
resulting in both increased permeability of the thrombus and
exposure of new plasminogen activator sites on the fi brin
strands. Thrombolytic drugs are forced into the thrombus by
the radial pressure generated by the ultrasound waves.
Finally, PMT catheters are designed to either aspirate
fragmented thrombus or create a near liquefaction of thrombus that migrates into the venous circulation. Ultimately, the
microemboli are propelled to the pulmonary circulation
where endogenous lysis takes place. The aspiration catheters
can increase blood loss associated with the procedure, and,
therefore, the operator must be vigilant in monitoring the
aspirated volume. Clinically signifi cant sequelae of pulmonary emboli from the nonaspiration catheters have not been
reported after treatment for DVT. Table 50.2 includes the
commercially available devices subsequently discussed in
this chapter.
468 Chapter 50/Percutaneous Mechanical Thrombectomy in the Treatment of Acute Deep Venous Thrombosis
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TABLE 50.2 PMT Devices
Method of
Device thrombus removal Wall contact Aspiration catheter FDA approved indication
AKónya Eliminator Mechanical Mechanical No Thrombosed AVF and dialysis grafts
Arrow-Trerotola Mechanical Complete Yes Thrombosed AVF and dialysis grafts
Angiojet
XMI Rheolytic Incomplete Yes Coronary or vein graft lesions >2 mm
XVG Rheolytic Incomplete Yes Thrombosed infrainguinal arteries >3 mm
Xpeedior 120 Rheolytic Incomplete Yes Thrombosed infrainguinal arteries >3 mm
AVX Rheolytic Incomplete Yes Thrombosed dialysis grafts
XMI-RX+ Rheolytic Incomplete Yes Thrombosed infrainguinal arteries >2 mm
DVX Rheolytic Incomplete Yes Thrombosed infrainguinal arteries >3 mm
Castaneda Over-the-Wire Brush Mechanical Complete No Thrombosed dialysis grafts
Helix Clot Buster Thrombectomy Mechanical Incomplete No Thrombosed AVF and dialysis grafts
Device (Amplatz Device)
Lysus Infusion System Ultrasonic Incomplete No Selective infusion of medication into
peripheral vessels
Oasis Thrombectomy System Rheolytic Incomplete Yes Thrombosed dialysis grafts
ProLumen Mechanical Complete Thrombosed dialysis grafts
Thrombex PMT Mechanical Incomplete Thrombosed dialysis grafts
Trellis Infusion System Mechanical Incomplete Yes
X-Sizer Catheter System Mechanical Yes Thrombosed dialysis grafts
AngioJet Thrombectomy System
Indications for use approved by the United States Food
and Drug Administration (FDA) of the AngioJet thrombectomy system (ATS) (Possis Medical, Minneapolis, MN)
include treatment of peripheral arterial occlusions, thrombosed hemodialysis grafts, and DVT. This dual lumen catheter (see Figure 50.1) operates on the Bernoulli-Venturi
principles. Saline or a thrombolytic drug are infused by a
drive unit to generate approximately 10,000 psi of pressure
within the catheter. The infusate is ejected from the catheter
in retrograde-directed, pulsatile jets. The jets generate low
pressure zones that allow for thrombus maceration and aspiration. An exhaust port near the tip of the catheter allows
for aspiration thereby avoiding the potential for localized
endothelial damage from a more eccentrically placed vortex.
Ninety-nine percent of the particulate matter generated by
the ATS is 0 to 12 μm in diameter.29 A separate pump drive
unit is necessary for the catheter to function with dual lumen
tubing that delivers the infusate and collects the effl uent. The
system functions in an isovolumetric manner with 60 cc/min
being infused and aspirated simultaneously.
Multiple catheters have been designed for use in vessels
of varying diameters and locations (see Table 50.3). Additionally, different types of tubing are available to allow for
saline infusion or power pulsation. Power pulsation is
designed to force standard pharmacologic thrombolytics
into the thrombus. In contrast, traditional CDT uses lacing,
whereby the drug seeps from the multiple side holes of an
infusion catheter.
Sharafuddin et al. evaluated endothelial damage incurred
after use of the ATS compared to the Fogarty balloon embo-
30
TABLE 50.3 AngioJet Thrombectomy System Catheters
Min. vessel Working Guidewire Sheath
Catheter diameter length compatibility compatibility
XMI-OTW ≥2 mm 135 cm 0.014″ 4 Fr.
XMI-RX+ ≥2 mm 135 cm 0.014″ 4 Fr.
XVG ≥3 mm 140 cm 0.014″ 5 Fr.
Xpeedior ≥3 mm 120 cm 0.035″ 6 Fr
DVX ≥3 mm 90 cm 0.035″ 6 Fr.
lectomy in a canine model. The ATS-treated vessels had
signifi cantly more endothelial coverage than vessels treated
with the Fogarty balloon.
31
Segments treated with the ATS
showed no difference in endothelial coverage or valvular
damage when histologically compared to untreated control
segments.
Thrombus extraction rates using the ATS range from 52
to 95%.22 This wide range of variability appear to be related
to the adjunctive use of pharmacologic thrombolysis.32 The
ATS has been used in the treatment of symptomatic lower
extremity DVT with success. Bush et al. reported the use of
the ATS in the treatment of 23 limbs in 20 patients. Technical success was achieved in 15 of the 23 treated limbs. The
remaining limbs demonstrated varying degrees of thrombus
removal. Seven of 12 patients being treated for iliofemoral
DVT had prophylactic IVC fi lters placed. Marked clinical
improvement within 24 hours of therapy was noted in 74%
of patients. Only three minor bleeding complications were
noted, and no one required a blood transfusion.
33
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A
FIGURE 50.1 A. Demonstrates the Bernoulli-Venturi effect as used by the Angiojet thrombectomy system. B. The
free-standing pump drive unit for the Angiojet thrombectomy system.
Kasirajan et al. reported similar results in 17 patients
treated with the ATS. Thrombus extraction rates were lower
with only 24% having >90% thrombus removal. Adjunctive
thrombolytic therapy was used in nine of 13 that demonstrated less than 90% thrombus extraction. Eighty-two
percent of patients had signifi cant clinical improvement and
no complications were reported.
34
The ATS also has been successfully used in the management of Paget-Schroetter’s syndrome, pulmonary embolism,
and mesenteric venous thrombosis.
35–37
Akonya Eliminator
The Eliminator catheter (IDev Technologies, Houston,
TX) is a nonmotor-driven thrombectomy device approved
by the FDA for thrombectomy of dialysis grafts. The device
utilizes a 6 Fr. adjustable basket that can accommodate
vessels from two to 10 mm in diameter. The catheter has
directional control that allows easy navigation of tortuous
vessels. The catheter has no drive unit, and through manipulation in an axial direction or manual rotation, the thrombus
can be stripped from the vein wall.
Arrow-Trerotola Percutaneous
Thrombectomy Device
The Arrow-Trerotola Percutaneous Thrombectomy
Device (ATPTD) fragments thrombus utilizing a selfexpanding 9-mm fragmentation cage. The device comes as
either an over-the-wire confi guration or the original design
B
whereby the cage is constrained by a sheath. The latter
device must be positioned across the thrombus before withdrawing the sheath and releasing the fragmentation cage. In
both devices, the cage rotates at 3000 rpm and is pulled
through the thrombus. The rotating cage strips and macerates thrombus from the vein wall creating a slurry that can
be aspirated through the sheath. Two passes of the device
usually provide optimal clot fragmentation.
38
Damage to the veins after thrombectomy with the ATPTD
was assessed in an experimental canine model. The device
was passed fi ve times in the antegrade direction through
thrombosed lateral saphenous veins. The venous segments
were assessed for endothelial loss, the presence of thrombus,
and valvular damage. Compared to valves designated as
controls in untreated thrombosed lateral saphenous veins,
valves in the experimental group treated with ATPTD had
signifi cantly less infl ammatory cell infi ltrates.
39
Technical success rates are reported between 92 and
100% when treating thrombosed dialysis grafts.
38,40,41
Procedure times are markedly shortened when compared to
pulse spray thrombolysis.38 Ninety-day patency rates range
from 39 to 70%.
38,41
Preliminary work has begun to evaluate the ATPTD for treating DVT. Animal studies indicate
promising local success rates, but segmental and subsegmental pulmonary emboli were demonstrated with concomitant increases in mean and systolic pulmonary arterial
pressure. Increasing pCO2 and acidosis were also observed.42
The thrombus fragments produced by the device range in
42
size from <1 mm to as high as 3 mm.
Truong et al. reported
successful PMT using the ATPTD in a patient that presented
with a subacute iliocaval thrombosis. A temporary Günther
470 Chapter 50/Percutaneous Mechanical Thrombectomy in the Treatment of Acute Deep Venous Thrombosis
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basket fi lter was placed prior to intervention. At three
months, magnetic resonance imaging (MRI) demonstrated
no recurrent thrombosis in the treated vessels.
43
HELIX Clot Buster
Previously marketed as the Amplatz Thrombectomy
Device, the HELIX Clot Buster (ev3, Plymouth, MN) was
the fi rst device approved by the FDA for percutaneous treatment of thrombosed dialysis grafts. Basic components
include an impeller mounted on a drive shaft that is powered
by a compressed air turbine. Rotation of the impeller at
150,000 rpm creates a vortex at the distal tip of the catheter
that draws in the thrombus and recirculates the particulate
matter. Particles from this PMT catheter are less than 1000
microns.44 Success rates of the HELIX for treatment of
thrombosed dialysis grafts range from 79 to 93%.
blunt tip design of the HELIX make it diffi cult to navigate
tortuous vessels.
Successful treatment of venous thrombosis has been
reported in multiple vascular segments using the HELIX.
Ufl acker reported treatment of nine acute and subacute
venous thromboses in the IVC and iliac veins (n = 3), SVC
and subclavian veins (n = 3), portal vein and transjugular
intrahepatic portosystemic shunt (TIPS) (n = 2), and an IVC
to pulmonary artery Fontan conduit (n = 1). Thromboses had
been present from two days to four weeks. Three patients
had failed prior CDT with urokinase. PMT was successful
in all CDT failures, but each required an adjunctive measure
to ensure long-term patency. One patient being treated for
an iliocaval thrombosis developed intraprocedural shortness
of breath attributed to pulmonary embolism despite placement of an IVC fi lter.47 Similarly, Smith et al. reported using
the HELIX in patients with DVT who had relative or absolute contraindications to pharmacologic thrombolysis. Treatment of DVT was performed in the superior mesenteric vein,
bilateral femoral veins, and the SVC and brachiocephallic
veins.48 Additionally, the HELIX has been used to treat
major and minor pulmonary emboli.
49
Hydrolyser
This multilumen catheter (Cordis, Warren, NJ) is designed
for over-the-wire use. It utilizes the Venturi effect to fragment thrombus (see Figure 50.2). Simultaneous infusion of
thrombolytic drugs or saline is possible through an injection
port. Aspiration takes place through a 6-mm elliptical
exhaust port that is located 4 mm proximal to the distal tip
of the catheter.
Disadvantages of the Hydrolyser (see Figure 50.3) can
include possible fl uid overload and hemolysis. Additionally,
the guidewire may obstruct the exhaust port and decrease
the amount of thrombus extracted. The eccentrically located
exhaust port creates an imbalanced vortex. This may result
45,46
The
FIGURE 50.2 The Venturi effect as used in the Hydrolyser Catheter
(Cordis Endovascular, Warren, NJ).
in tenting of the vessel toward the low pressure region and
increase the endothelial damage.
22
The Hydrolyser was compared to the ATS in an in vitro
model to determine the degree of embolization.50 The catheters were also compared with and without the guidewires
in place, as previous data has indicated decreased effectiveness when the guidewire remained. The Hydrolyser
demonstrated greater thrombus resolution and less distal
embolization when compared to the ATS. Thrombus destruction was improved for both catheters when the guidewire
remained in the catheter.
51
Successful cases of PMT using the Hydrolyser for the
treatment of acute DVT and pulmonary embolism have been
reported.
52–54
Henry et al. reported 83% technical success in
a variety of patients with arterial, bypass graft, and venous
thrombosis.53 Thrombus less than 10 days old provided the
optimal therapeutic window when using the Hydrolyser, and
segments treated took less than four minutes on average.53
Poon et al. reported on three women that had IVC thromboses treated with the Hydrolyser. None of these patients could
receive heparin or thrombolytics due to neurosurgical problems. All patients were successfully treated with the Hydrolyser and had complete resolution of their lower extremity
edema. Each patient had an IVC fi lter placed, and one patient
required a second treatment with the Hydrolyser.
54
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Lysus Infusion Catheter System
The Lysus Infusion Catheter System (EKOS Corporation, Bothell, WA) uses high-frequency, low-powered ultrasound to lyse thrombus. After traversal of the thrombus with
a guidewire, a multiholed drug delivery catheter is advanced
over the guidewire. The guidewire is removed and the ultrasound core is placed within the catheter. The ultrasound core
FIGURE 50.3 The Hydrolyser set-up.
contains many ultrasound transducers along its length, and
a separate control system regulates the ultrasound output and
temperature. The core is actively cooled by a saline infusion
that exits the distal tip of the catheter during treatment.
Thrombolytic drugs are infused via the multiholed delivery
catheter and the radial force generated by the ultrasound
propels the drug away from the catheter and deeper into the
more permeable thrombus.
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