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collateral flow around occluded segments in the chest or arm; however, the chronically
obstructed vein segments may make further central venous access more complicated. In an
effort to prevent these long-term sequelae of DVT, the concept of DVT thrombolysis to
eradicate the clot has been developed. The theory is that heparin will stabilize the
thrombotic process, but vein damage maycontinue toevolve. With thrombolysis there is the
possibility to eradicate the clot and minimize damage to vein walls and vein valves.
Therefore, thrombolysis may be considered in all patients with significant DVT who do not
have contraindications (cerebral metastasis, recent surgery, etc.). Patients with acute DVT
less than 10 days old without a prior history of DVT are most likely to benefit from
thrombolysis (15).
TECHNIQUE
Many investigators have explored aggressive techniques to accelerate thrombolysis in the
belief that eradicating clots quickly will minimize vein damage and maximize vein wall
integrity and valve function, thereby minimizing long-term post-phlebitic syndrome.
Initial attempts at systemic thrombolysis proved relatively ineffective probably due to
shunting of blood past the area of obstruction resulting in poor penetration of thrombolytic
agents into the clot. It is possible that systemic (peripheral IV) administration of
thrombolytic agents shows some efficacy for pulmonary embolus dissolution due to the
flow pattern where systemic venous drainage has to flow through the pulmonary arterial
circulation. In contrast, in peripheral extremity flowing blood may not deliver drug to an
obstructed venous segment in the limb.
FLOW-DIRECTED THROMBOLYSIS
Specially designed tourniquets have been used to manipulate venous flow patterns in order
to drive flow of blood and drug into thrombosed venous segments. Pedal venography is
used to delineate flow patterns in the foot, calf and thigh. Tourniquets are then placed
with pressure pads specifically located to occlude superficial venous drainage and drive
flow into the deep system. This often includes a tourniquet at the malleolar level with
compression of the saphenous vein at the ankle. Thrombolytic agents are then infused into
the pedal catheter. The tourniquets are released for 15 minutes every hour during infusion
to prevent compressive complications. This is a slow technique and the treatment will
often last up to 48 hours. Periodic venography is performed at least daily to assess
response. Patients may often experience significant symptomatic improvement with in
four to twelve hours. The goal of treatment with this method is not complete eradication
of thrombus but, rather, improvement in symptoms and flow. This technique can be
particularly helpful for large clot burden in the calf in addition to more proximal thrombi.
CATHETER-DIRECTED THROMBOLYSIS
If a catheter is embedded directly into thrombus the potential exists to deliver
higher concentrations of thrombolytic agents to the clot than can be achieved with
a peripheral infusion.
The preferred method for catheter directed ileo-femoral DVT thrombolysis is to
access the popliteal vein with the patient in prone position. Ultrasound guidance should be
used to achieve single wall puncture and minimize the risk of popliteal artery injury.
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A micropuncture set with a 22-gauge needle can also be used to minimize potential for
bleeding complications. Once access to the popliteal vein is achieved venography can be
performed to further assess the extent of clot burden and flow. A steerable catheter and
guidewire can be used to traverse the thrombosed segments of femoral/iliac vein and
achieve access through the clot to the level of patent vein cephalad. Access from the
popliteal vein facilitates catheter passage to the IVC because the catheter traverses venous
valves in the direction of flow. Occasionally, additional catheter access is required from
jugular or contralateral approaches. These routes present the difficulty of traversing valve
leaflets, which may be closed. Finding the orifice of a closed valve in a thrombosed vein
segment can present a considerable challenge. Sometimes these retrograde access sites are
necessary, particularly if there is considerable popliteal/trifurcation thrombus and below
the knee thrombolysis is necessary. Alternatively, the pedal infusion method can be used
simultaneously with catheter directed technique to treat clots in the calf and thigh.
With this combination the infusion dose should be split between the two sites.
When access across the thrombosed segment is achieved, a system of variable length
multi-side hole infusion catheter and infusion guide wires can be used to deliver
thrombolytic drugs throughout the length of the clot. Often a 40–50 cm multi-side hole
infusion catheter such as the Cragg-McNamara valved infusion catheter (Microther-
apeutics, Inc, Irvine, CA) is sufficient to traverse the ileo-femoral length. A 12 cm infusion
length Katzen wire (Boston Scientific, Miami, FL) can be used coaxially to extend the
infusion length.
Various infusion regimens have been advocated with little data to support a specific
method. In general we lace the thrombus with 1–2 mg of tPA mixed in 10 cc of normal
saline. This is delivered over several minutes in a pulse-spray fashion to mechanically
disrupt the clot and drive the drug into the interstices of the thrombus to maximize drug-
clot contact. We then continue tPA infusion at 0.5–1 mg/hour infusion.
The patient is closely monitored in the ICU setting for signs of bleeding. CBC,
fibrinogen and coagulation parameters should be monitored every four to eight hours.
Follow-up imaging is performed in 12–24 hours or sooner if the patient’s clinical exam
changes significantly. Depending on the follow-up venography, catheter position can be
changed to optimize drug delivery to residual thrombus. Lytic infusion can be continued
for several days with interval imaging to assess progress. The infusion is continued as long
as the clot remains and progress is being demonstrated (Fig. 1). Lytic infusion should be
stopped if venography demonstrates, “lytic stagnation” where clot burden remains
unchanged despite continued infusion.
MECHANICAL THROMBECTOMY
Several methods have been utilized to accelerate the declotting process. Mechanical
devices can be used to decrease clot burden and to increase distribution of the thrombolytic
agent in the clot. Devices such as the Possis Angiojet Rheolytic Thrombectomy System
(Possis Medical, Inc, Minneapolis, MN), the Treretola Percutaneous Thrombolytic Device
(Arrow International, Inc, Reading PA), the Prolumen Rotational Thrombectomy System
(Datascope, Mahwah, NJ), or simple balloon maceration have been used as adjuncts to
thrombolytic therapy. It is possible to accelerate the declotting process and restore flow
to the ileo-femoral segment in one setting or one day rather than a two to four day infusion
using mechanical devices in conjunction with thrombolytic agents. Care should be taken
with these devices to avoid additional trauma to the vein wall and the valve complex.
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In particular, the wall-contact devices may cause additional valve trauma defeating the
potential benefit of thrombolysis.
We do not routinely place IVC filters prior to catheter direct thrombolysis because
the thrombus usually lyses from the outside in without significant embolization. With
aggressive use of mechanical declotting devices the risk of embolization may be greater
and use of IVC filtration may be more of a consideration. The retrievable filters, Gunther
Tulip (Cook, Inc, Bloomington, IN) and Recovery (Bard Inc, Tempe, AZ) are attractive
options for protection from pulmonary embolus.
PHARMACOLOGIC ADJUNCTS
Various drugs may also help accelerate the thrombolytic process. Antiplatelet agents
(abciximab, tirofiban, eftifibatide) may have a synergistic effect with thrombolytic agents
and accelerate the catheter directed thrombolytic process. In addition the newer
thrombolytic agents may accelerate the lytic process. These include Reteplase (r-PA,
Retavase, Centocor/Johnson and Johnson, Malvern, PA), which is a recombinant
Figure 1 Thrombolysis in acute iliofemoral thrombosis. (A) The left lower extremity had acute
swelling for five days that became progressively worse. After the ultrasound demonstrated
thrombosis, thrombolysis was performed. The catheter was inserted through the popliteal vein. (B)
The venogram shows acute thrombus in the iliofemoral veins. (C) After 36 hours most of
the thrombus was lysed and a stent was placed in the left common iliac vein for a residual stenosis.
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derivative of rt-PA with less fibrin affinity and increased half-life; Tenecteplase
(TNK-tPA, Genentech, INC), which is a triple mutated version of the parent molecule
rt-PA. It has enhanced fibrin specificity, a longer half-life, increased resistance to
plasminogen activator inhibitor-1 and an enhanced safety profile compared to rt-PA.
These are areas of investigation without conclusive data to form definite conclusions.
OUTCOME
Technical success rates have been reported ranging from 74–100% (16–18,31,34). The
type of thrombolytic does not appear to change acute or long-term outcome, and a lot of
thrombolytic agents have been used (19,20,30). While many short-term outcome studies
exist, few long-term studies have been performed. Of the long-term studies, most
comment on clinical outcome and few comment or study actual venous patency. Studies
with long-term venous patency data are listed in Tables 1 and 2.
With regards to clinical outcome, many studies have shown superior outcome with
thrombolysis. There is decreased long-term valvular incompetence, reflux, and CEAP
categorization in patients with having received thrombolysis (21). Additionally, long-term
follow-up of those patients treated with thrombolysis or anticoagulation reveals
significantly improved quality of life for the former (22).
Whether better results are achieved with thrombolysis delivered locally or
systemically is not clear. One prospective randomized study found high-dose systemic
thrombolysis to be superior to local thrombolysis or anticoagulation alone with regards to
acute outcome and CVD (20). Combination open/surgical thrombectomy and
thrombolysis has been described, but comparative studies are lacking (23). One such
study did demonstrate 100% patency and no CVD in 33 such patients at one-year (23).
Animal models comparing thrombectomy to thrombolysis have shown that thrombolysis
preserves more structural integrity and endothelial function, and this may explain why
patients undergoing thrombolysis fare better (24). Mewissen showed that those patients
with initial complete lysis had higher patency rates at one-year than those with incomplete
lysis (!50%), 75% versus 32%, respectively (36). The same large multicenter registry
Table 1 Upper Extremity DVT
Author Year Patients Mean follow-up
Primary
patency Comments
Schneider (31) 2004 21 1 year 92% TOS, multi-
modality
treatment
Sabeti (32) 2002 33 3.3 years 52% Systemic lysis
for axillo-
subclavian
DVT
Kreienberg (33) 2001 14 3.5 years 64% TOS, multi-
modality
treatment
Machleder (34) 1993 43 3.1 years 93% TOS, multi-
modality
treatment
Abbreviations: TOS, thoracic outlet obstruction; DVT, deep venous thrombosis.
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showed that proximal thrombi had more favorable outcomes, with the ileo-femoral veins
having a patency of 64% and the femoro-popliteal of 48% at one year.
Most studies with long-term venous patency outcome from upper extremity DVT
thrombolysis relate to thoracic outlet obstruction (TOS). The etiology of DVT in TOS and
the multimodality treatments employed in these studies makes drawing conclusions with
regards to thrombolysis and DVT difficult at best. Though thrombolysis may be superior in
axillo-subclavian thrombosis (25).
There is no level 1 data in the literature comparing thrombolysis to other treatment
arms (anticoagulation, surgical,endovascular, etc.). Thrombolysis does confer morbidity of
which major bleeding is the mostcommon with a reported incidence of 11–25% (15,26,34).
One series reported puncture site bleeding as accounting for 39% of major bleeding
complications (36). The incidence of PE has been variably reported at 1% and that of death
less than 0.5%(15,36). The relative risk conferred by thrombolysis for major bleed has been
reported as three-fold (27). Fibrinogen degradation products increasing to O200mg/L after
two hours of thrombolysis initiation have an associated odds ratio of 4.95 for parenchymal
bleed (28). The risk of bleeding is not felt to increase if fibrinogen levels remain O20% of
normal levels (29). The risk of bleeding or cerebrovascular accident has been shown to be
significant (30,35). Bearing these risks in mind, with appropriate patient and pathology
selection, treatment with thrombolysis should result in short- and long-term
favorable outcome.
KEY POINTS
† Thrombolysis is an acceptable treatment for extremity venous thrombosis.
† Long-term level-1 evidence is lacking as to whether thrombolysis is superior to
other modalities. However, several studies suggest short- and long-term clinical
benefits in favor of thrombolysis.
† Proximal acute thrombi fare better with thrombolysis. Complete initial
thrombolysis is favorably prognostic of long-term patency.
† Techniques, lytic agents, and protocols vary widely. None of these variables
have been shown to be superior.
† Complication rates and specifically bleeding are higher with thrombolysis when
compared to anticoagulation alone.
† Appropriate patient and pathology selection are paramount for success, patient
benefit, and for reducing adverse outcome.
Table 2 Lower Extremity DVT
Author Year Patients Mean follow-up
Primary
patency Comments
Elsharawy (35) 2002 18 6 months 72% Prospective
randomized
Mewissen (36) 1999 287 1 year 60% Multicenter
registry
Bjarnason (37) 1997 75 1 year 63% iliac Consecutive
review of
5 years
40% femoral
Abbreviation: DVT, deep venous thrombosis.
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deep venous system and the development of the postthrombotic syndrome after an acute
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3. Haenen JH, Wollersheim H, Janssen MC, et al. Evolution of deep venous thrombosis: a 2-year
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4. Ziegler S, Schillinger M, Maca TH, Minar E. Post-thrombotic syndrome after primary event of
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6. Neglen P, Thrasher TL, Raju S. Venous outflow obstruction: an underestimated contributor to
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8. Patel NH, Plorde JJ, Meissner M. Catheter-directed thrombolysis in the treatment of
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10. Hood DB, Weaver FA, Modrall JG, Yellin AE. Advances in the treatment of phlegmasia
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12. Robinson DL, Teitelbaum GP. Phlegmasia cerulea dolens: treatment by pulse-spray and
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13. Gutt CN, Oniu T, Wolkener F, Mehrabi A, Mistry S, Buchler MW. Prophylaxis and treatment
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14. Wells PS, Forster AJ. Thrombolysis in deep vein thrombosis: is there still an indication?
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15. Meissner MH. Thrombolytic therapy for acute deep vein thrombosis and the venous registry.
Rev Cardiovasc, Med 2002; 3S2:S53–S60.
16. Meissner MH. Axillary-subclavian venous thrombosis. Rev Cardiovasc Med 2002; 3:S33–S76.
17. Vedantham S, Vesely TM, Sicard GA, et al. Pharmacomechanical thrombolysis and early stent
placement for iliofemoral deep vein thrombosis. J Vasc Interv Radiol 2004; 15:565–574.
18. Semba CP, Dake MD. Iliofemoral deep venous thrombosis: aggressive therapy with catheter-
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20. Schweizer J, Kirch W, Koch R, et al. Short- and long-term results after thrombolytic treatment
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21. Laiho MK, Oinonen A, Sugano N, et al. Preservation of venous valve function after catheter-
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22. Comerota AJ, Throm RC, Mathias SD, Haughton S, Mewissen M. Catheter-directed
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23. Blattler W, Heller G, Largiader J, Savolainen H, Gloor B, Schmidli J. Combined regional
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26. Watson LI, Armon MP. Thrombolysis for acute deep vein thrombosis. Cochrane Database Syst
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Stroke 2004; 35:1323–1328.
29. Stewart D, Kong M, Novokhatny V, Jesmok G, Marder VJ. Distinct dose-dependent effects of
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30. Goldhaber SZ, Buring JE, Lipnick RJ, Hennekens CH. Pooled analyses of randomized trials
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40:599–603.
32. Sabeti S, Schillinger M, Mlekusch W, Haumer M, Ahmadi R, Minar E. Treatment of
subclavian-axillary vein thrombosis: long-term outcome of anticoagulation versus systemic
thrombolysis. Thromb Res 2002; 108:279–285.
33. Kreienberg PB, Chang BB, Darling RC, III, et al. Long-term results in patients treated with
thrombolysis, thoracic inlet decompression, and subclavian vein stenting for Paget-Schroetter
syndrome. J Vasc Surg 2001; 33:S100–S105.
34. Machleder HI. Evaluation of a new treatment strategy for Paget-Schroetter syndrome:
spontaneous thrombosis of the axillary-subclavian vein. J Vasc Surg 1993; 17:305–315.
35. Elsharawy M, Elzayat E. Early results of thrombolysis vs anticoagulation in iliofemoral venous
thrombosis. A randomised clinical trial. Eur J Vasc Endovasc Surg 2002; 24:209–214.
36. 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.
37. Bjarnason H, Kruse JR, Asinger DA, et al. Iliofemoral deep venous thrombosis: safety and
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16
Role of Surgery and Endovascular Therapies
in Lower Limb Deep Venous Thrombosis
Olivier Hartung, Yues S. Alimi, and Claude Juhan
Service de Chirurgie Vasculaire, Centre Hospitalier Universitaire Nord, Marseille, France
Deep venous thrombosis (DVT) is an acute condition of which the main serious
complications are phlegmasia cerulea, pulmonary embolism (PE), and in the long term
venous insuffiency. Heparin was the first efficient treatment of DVT, and Bauer was
the first to demonstrate the properties and the efficiency of heparin in 1950 (1). However,
as medical treatments are not completely able to avoid the main complications, inter-
ventional therapies have a place in the therapeutic arsenal, mainly in the case of
iliocaval DVT.
Surgical venous thrombectomy was first reported by La
¨
wen in 1938 (2), and during
the 1950s and 1960s, its use spread in France as well in the United States accompanied by
many encouraging reports (3,4) along with the introduction of the Fogarty catheter (5). But
enthusiasm was reduced after the study of Lansing in 1968 who reported high rates of
rethrombosis (6). Despite this, some teams continued to use surgical thrombectomy with
some refinements like the use of an arteriovenous fistula as proposed by Kunlin (7). At the
same time, by the early 1970s systemic thrombolysis had been introduced (8), and its use
poorly spread until the report of Semba (9) who emphasized the advantages of catheter
directed thrombolysis.
At present, when aggressive treatment of ileofemoral DVT is used, at least in
selected cases, different modalities are available. These techniques will be described,
results will be analyzed, and their specific advantages and complications will be discussed.
AIMS OF THE TREATMENT
The treatment of DVT should ideally avoid progression of the disease with proximal
extension, prevent PE and later postthrombotic syndrome by preserving the venous
outflow and functional valves. In order to accomplish this a treatment needs to make the
clot disappear without causing its fragmentation and embolization and without damaging
venous valves. The risk for developing such complications increases with the proximity of
the thrombus in the veins.
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The goal of heparin therapy is to avoid thrombus extension but it does not remove it
and lysis performed by the endogenous fibrinolytic response requires weeks to months.
Killewich reported a 14% rate of early extension (10). Moreover it does not protect against
PE (4% in case of iliofemoral thrombosis, 18% when the inferior vena cuva is involved)
(11) and the development of post thrombotic syndrome (74% of incompetent valves in the
femoropopliteal veins six months after iliofemoral DVT) (12). Despite these data heparin
remains the basis of treatment and is complementary to all the other modalities whatever
the form of heparin used (unfractionned or low molecular weight heparin) in the absence of
contra indications (13). Heparin treatment must be used in association with compressive
therapy using elastic stockings or non-elastic devices when applicable. This combination
does not completely avoid complications. For example, while treating iliofemoral DVT,
Akesson (14) showed that at five years, 50% of the iliac veins are still occluded with less
than 5% of preserved valvular function, and Johnson (15) that at three years, 88% of the
patients had a postthrombotic syndrome.
Clearly there is a need for techniques resulting in clot removal without embolization
while preserving valvular function. To date, two modalities have been developed to do this:
surgical thrombectomy and percutaneous techniques (thrombolysis and/or thrombectomy).
SURGICAL THROMBECTOMY
Since La
¨
wen’s initial report (2), many technical refinements have been added leading to
improvement in the results (e.g., use of heparin, Fogarty catheters, arterio-venous (AV),
fistula, positive end expiratory pressure (PEEP), stenting, etc.).
Technique of Surgical Thrombectomy
All patients should have preoperatively (16):
† a complete physical examination
† chest radiography
† an ECG
† a blood work up including thrombosis profile
† a thoraco-abdomino-pelvic angio-CT scan (contraindicated in pregnant patients)
which will have two main goals:
1. Delineate the thrombosis: determine the cephalad extension, search for
anatomic variation and for underlying chronic lesions (e.g., May-Thurner
syndrome, postthrombotic lesions, etc.) (Fig. 1) and also for PE; in our
practice there are currently no indications for preoperative phlebography
2. Exclude contraindication to the technique, mainly the presence of
malignant or inflammatory disease.
When such a procedure is considered for DVT, this work up should be rapidly
performed, preferably within a few hours. During this time, intravenous heparin should be
given. Before surgery, the patient should be cautiously moved and shaved in order to avoid
clot fragmentation and migration which could cause PE. Thus, calf compression, tight
flexion, and inguinal pressure should be avoided.
The procedure is performed under general anesthesia with the patient in dorsal
decubitus and prophylactic antibiotics are given. A cell saver device must be used.
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The operative field should include the whole abdomen, both inguinal regions and the
involved leg(s).
Iliofemoral Thrombectomy
Surgical approach to the common femoral vein (CFV) is performed through a vertical
incision located just medial to the femoral pulse. The great saphenous vein leads to the
sapheno–femoral junction. The CFV is exposed over a short length cephalad. Dissection
must be cautious and gently performed. It is preferable to dissect away the surrounding
structures without compressing, grasping or manipulating it. Surgical loops are passed
around the great saphenous vein and the CVF proximal and distal to it. A fourth tape is
used the same way to the second and the third to control the deep femoral veins without
dissecting them (Fig. 2A). Only the anterior aspect of the deep veins should be exposed
and this over the shortest length possible. A fifth tape is placed around the superficial
femoral artery.
Figure 1 CT scan of a patient presenting a left ilio-femoral deep venous thrombosis (DVT) with
May-Thurner syndrome.
Figure 2 Technique of iliofemoral thrombectomy: (A) Surgical approach, (B) thrombectomy with
a Fogarty catheter, (C) retrieval of the adherent clot using Vollmar rings, (D) thrombectomy of the
internal iliac vein with a suction device while the Fogarty catheter is inflated in the common iliac
vein.
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