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166
How long should
the patient’s treated
extremity remain
immobile post-
procedure?
The patient should remain at bedrest with
the accessed limb immobile for 4–6hours,
after which the patient may ambulate as
tolerated. Early ambulation is desirable to
encourage optimal flow dynamics within
the vasculature.
When should
therapeutic
anticoagulation
be restarted post-
procedure?
Therapeutic anticoagulation should be
resumed within 2hours after sheath
removal and access site hemostasis.
Unfractionated heparin and low
molecular weight heparin are often
used to bridge patients to an oral
anticoagulation agent until therapeutic
levels are reached. The oral anticoagulant
is started the same day as sheath removal.
For DVT cases, oral anticoagulant should
be continued for 3months to 6months,
depending on presence or absence of
PTS.If stents are placed, antiplatelet
therapy should be added.
What is the
follow-up regimen
after treating lower
extremity DVT?
Follow-up after treatment of lower
extremity DVT consists of imaging
surveillance often with venous duplex
ultrasound and monitoring for clinical
signs and symptoms of recurrent DVT or
development of PTS.The time frame for
follow-up is extremely variable depending
upon severity of initial disease and
institutional practice often ranging from a
few weeks to months post-procedure. For
any patient who develops acute symptoms
of DVT recurrence, a CT venogram may
be considered.
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Complications
What is the
most common
complication of
CDT?
Bleeding is the most common complication
of CDT.Large volume hemorrhage is
rare, which is generally considered to be
that which requires transfusion (about
3–5%) and causes intracranial bleeding or
bleeding that leads to fatality.
What measures
can be taken in the
event of bleeding at
the venous access
site?
Upsizing the sheath and/or compression
can be used to control percutaneous
bleeding at the access site. If this
is unsuccessful, the thrombolytic
administration is generally discontinued.
What are the most
lethal complications
associated with
CDT?
Intracranial bleeding has been found to be
associated with the highest mortality rate
in this procedure.
What is the risk of
intracranial bleeding
with CDT?
The absolute risk of intracranial
bleeding following CDT is unclear, but
generally has been found to be rare in
the literature. A pooled analysis of 19
studies discussed in the 2014 quality
improvement guidelines for the treatment
of lower extremity DVT in JVIR found
reported rates to be between 0 and 1%
for intracranial bleeding following CDT,
in comparison with 3–6% with systemic
tPA, and about 0.25–1.5% with standard
oral anticoagulation. This data justifies
the contraindication for IV tPA use in the
treatment of most DVTs.
(continued)
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What is the RIETE
score?
It is a score to predict the risk for major
bleeding within 3months of anticoagulant
therapy in patients with acute deep vein
thrombosis. On multivariate analysis, age
> 75years, recent bleeding, cancer,
creatinine levels > 1.2mg/dl, anemia, and
pulmonary embolism at baseline were
independently associated with an increased
risk for major bleeding. The score is
composed of assigning 2 points to recent
bleeding, 1.5 to abnormal creatinine levels
or anemia, and 1 point to the remaining
variables.
0– low risk
1–4– intermediate risk
> 4 high risk
What are common
laboratory
guidelines that
suggest a poor
candidate for CDT?
Hemoglobin < 9mg/dl, INR > 1.6 before
starting warfarin therapy, or platelets
< 100,000/mL.It should be noted that
these laboratory values are loosely defined
and differ based on individual clinical
scenarios.
Landmark Research
Attract trial
Vedantham S, Goldhaber SZ, Julian JA, et al.
Pharmacomechanical catheter-directed thrombolysis for
deep-vein thrombosis. N.Engl. J.Med. 377, 2240–2252 (2017).
• Multicenter analysis with 692 patients comparing rates of
post-thrombotic syndrome in patients with acute proximal
DVT receiving anticoagulation therapy alone versus anti-
coagulation plus pharmacomechanical thrombolysis
• Between 6 and 24months of follow-up, there was no sig-
nificant difference in the percentage of patients who devel-
oped post-thrombotic syndrome (PTS) between the
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anticoagulation alone and anticoagulation plus pharma-
comechanical thrombolysis groups
• The severity scores of PTS were significantly lower in the
pharmacomechanical thrombolysis group
• Pharmacomechanical thrombolysis also reduces early
deep vein thrombosis symptoms such as leg pain and calf
circumference
• Pharmacomechanical thrombolysis led to less major bleed-
ing (fatal or intracranial hemorrhage) than found in past
studies
CaVenT study
Enden T, Haig Y, Klow NE, et al. Long term outcome after
additional catheter-directed thrombolysis versus standard
treatment for acute iliofemoral deep vein thrombosis (the
CaVenT study): a randomised controlled trial. Lancet
2012;379:31–8.
Haig Y, Enden T, Grøtta O, et al. Post-thrombotic syn-
drome after catheter-directed thrombolysis for deep vein
thrombosis (CaVenT): 5-year follow-up results of an open-
label, randomised controlled trial. Lancet Haematol
2016;3:e64-e71.
• Multicenter analysis with 209 patients comparing long
term outcome in patients with acute DVT
• This study found a decreased risk of PTS over periods 2
and 5years in patients receiving catheter-directed throm-
bolysis as opposed to anticoagulation alone
• The difference in the CaVenT results and Attract trial have
been thought to be due to the difference in sample size,
geographic and demographic scope of the patients assessed
in each study, and the greater use of mechanical therapies
in the Attract trial as opposed to longer thrombolytic infu-
sions used in the CaVenT.
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ULTIMA RCT
Kucher N, Boekstegers P, Müller OJ, etal. Randomized, con-
trolled trial of ultrasound-assisted catheter-directed throm-
bolysis for acute intermediate-risk pulmonary embolism.
Circulation. 2014 Jan 28;129(4):479-86. doi: https://doi.
org/10.1161/CIRCULATIONAHA.113.005544. Epub 2013
Nov 13.
• 59 patients with acute main or lower lobe pulmonary
embolism and echocardiographic right ventricular to left
ventricular dimension (RV/LV) ratio ≥1.0 were random-
ized to receive unfractionated heparin and ultrasound-
assisted catheter directed thrombolysis (CDT) or
unfractionated heparin alone
• This study found significant reversal of right ventricular
dilatation at 24 hours in the CDT group, whereas no
improvement in right ventricular enlargement was found
in the heparin alone group.
• No major bleeding was found in either group
Society of Interventional Radiology Position Statement on
Catheter-Directed Therapy for Acute Pulmonary Embolism
Kuo, William T. et al. Society of Interventional Radiology
Position Statement on Catheter-Directed Therapy for Acute
Pulmonary Embolism. Journal of Vascular and Interventional
Radiology, Volume 29, Issue 3, 293–297.
• “The Society of Interventional Radiology (SIR) considers
the use of catheter directed therapy (CDT) or thromboly-
sis to be an acceptable treatment option for carefully
selected patients with massive (ie, high-risk) pulmonary
embolism (PE) involving the proximal pulmonary arterial
vasculature, in accordance with multidisciplinary guide-
lines. SIR defines acute proximal PE as new main or lobar
emboli identified on radiographic imaging within 14days
of PE symptoms.”
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SEATTLE II
Piazza G, Hohlfelder B, Jaff MR, etal. A Prospective, Single-
Arm, Multicenter Trial of Ultrasound-Facilitated, Catheter-
Directed, Low-Dose Fibrinolysis for Acute Massive and
Submassive Pulmonary Embolism: The SEATTLE II Study.
JACC Cardiovasc Interv. 2015 Aug 24;8(10):1382–92. doi:
https://doi.org/10.1016/j.jcin.2015.04.020.
• 150 patients with acute massive (n = 31) or submassive
(n=119) PE and right ventricular to left ventricular diam-
eter (RV/LV) ratio ≥0.9 on chest computed tomography
received catheter directed thrombolytics to assess safety
and efficacy of CDT in treating PE in a single arm, pro-
spective, multi-center trial
• The study found that catheter-directed, low-dose fibrinoly-
sis reduced RV dilation, decreased pulmonary hyperten-
sion, decreased anatomic thrombus burden, and yielded a
lower rate of intracranial hemorrhage in patients with
acute massive and submassive PE.
PERFECT
Kuo WT, Banerjee A, Kim PS, et al. Pulmonary Embolism
Response to Fragmentation, Embolectomy, and Catheter
Thrombolysis (PERFECT): Initial Results From a Prospective
Multicenter Registry. Chest. 2015 Sep;148(3):667–673. doi:
https://doi.org/10.1378/chest.15- 0119.
• Prospective multicenter study of 101 patients treated with
CDT for acute PE to evaluate for safety and efficacy of
CDT.
• Clinical efficacy was defined as achieving stabilization of
hemodynamics, improvement in pulmonary hypertension,
or improved right-sided heart strain.
• Efficacy was achieved in 24 of 28 patients with massive PE
(85.7%; 95% CI, 67.3%–96.0%) and 71 of 73 patients with
submassive PE (97.3%; 95% CI, 90.5%–99.7%)
• CDT improves clinical outcomes in patients with acute PE
while minimizing the risk of major bleeding
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FLARE study
Tu T, Toma C, Tapson VF, Adams C, et al. A Prospective,
Single-Arm, Multicenter Trial of Catheter-Directed
Mechanical Thrombectomy for Intermediate-Risk Acute
Pulmonary Embolism. JACC Cardiovasc Interv. Volume 12,
Issue 9, May 2019. doi: https://doi.org/10.1016/j.
jcin.2018.12.022.
• Prospective multicenter study of 106 patients treated with
percutaneous mechanical thrombectomy (FlowTriever
System) for treatment of acute intermediate-risk PE to
evaluate safety and effectiveness
• Primary effectiveness endpoint was defined as reduction
in RV/LV ratio. Primary safety endpoint included any
major bleeding or device related complication within
48hours of treatment.
• There was an average 25% reduction in RV/LV ratio with
minimal major bleeding or device-related complications (4
patients, 3.8%).
• Mechanical thrombectomy is safe and effective in treat-
ment of PE, as previously found in prior studies.
Common Questions
How long is
anticoagulation
therapy
recommended after
initial VTE?
Oral anticoagulation is recommended
for a minimum of 3months after initial
VTE.Optimal duration of anticoagulation
past 3months remains unknown and
depends on the underlying cause of VTE, if
identifiable.
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What is the best
way to prevent
symptomatic
PE after DVT
treatment?
It is important to maintain adequate
anticoagulation before, during, and after
any endovascular DVT treatment. It is
also important to avoid the use of only
mechanical thrombolysis in patients who
are eligible to receive pharmacologic
thrombolysis as well. Routine
placement of IVC filters before or after
pharmacomechanical therapy procedures is
not recommended.
What is the utility
of ultrasound
surveillance during
clinical follow-up?
To monitor for recurrent DVT, valvular
insufficiency, or other venous damage
When should IVC
filter removal be
considered?
Patient has no indication for permanent
filter.
Risk of PE is acceptably low (achievement
of sustained appropriate primary treatment
or change in clinical status).
Patient is not anticipated to return to a
high-risk hypercoagulable state for PE.
Life expectancy is greater than 6months.
Filter can be safely retrieved.
Patient agrees to removal.
What resources
can be offered
to patients post-
procedurally to
reduce lower
extremity swelling?
Patients may be offered the option to
wear graduated compression stockings
(20–30mmHg or 30–40mmHg) daily.
Although stockings are generally effective
at decreasing lower extremity swelling, they
have not been shown to prevent PTS.
When should a
patient follow
up in clinic post-
procedure?
The patient should be evaluated in clinic
within 1month of procedure. Proper
maintenance of oral anticoagulation is
essential to avoid re-thrombosis.
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Further Reading
Albers GW, Bates VE, Clark WM, Bell R, Verro P, Hamilton
SA. Intravenous tissue-type plasminogen activator for treat-
ment of acute stroke: the Standard Treatment with Alteplase to
Reverse Stroke (STARS) study. JAMA. 2000;283(9):1145–50.
Aujesky D, Obrosky DS, Stone RA, Auble TE, Perrier A, Cornuz
J, Roy PM, Fine MJ.Derivation and validation of a prognostic
model for pulmonary embolism. Am J Respir Crit Care Med.
2005;172(8):1041–6. Epub 2005 Jul 14
Baldwin Z, etal. Catheter-directed thrombolysis for deep venous
thrombosis. Vasc Endovasc Surg. 2004;28(1):1–9.
Caplin DM, Nikolic B, Kalva SP, Ganguli S, Saad WE, Zuckerman
DA, etal. Quality improvement guidelines for the performance
of inferior vena cava filter placement for the prevention of pul-
monary embolism. J Vasc Interv Radiol. 2011;22(11):1499–506.
Fleck D, Albadawi H, Shamoun F, Knuttinen G, Naidu S, Oklu
R. Catheter-directed thrombolysis of deep vein thrombosis:
literature review and practice considerations. Cardiovasc Diagn
Ther. 2017;7(Suppl 3):S228–37.
Kaufman JA, Kinney TB, Streiff MB, Sing RF, Proctor MC, Becker
D, et al. Guidelines for the use of retrievable and convertible
vena cava filters: report from the society of interventional
radiology multidisciplinary consensus conference. J Vasc Interv
Radiol. 2006;17(3):449–59.
Kuo WT, Sista AK, Faintuch S, Dariushnia SR, Baerlocher MO,
Lookstein RA, etal. Society of interventional radiology position
statement on catheter-directed therapy for acute pulmonary
embolism. J Vasc Interv Radiol. 2018;29(3):293–7.
Miller DJ, Simpson JR, Silver B.Safety of thrombolysis in acute isch-
emic stroke: a review of complications, risk factors, and newer
technologies. Neurohospitalist. 2011l;1(3):138–47.
Oklu R, Wicky S. Catheter-directed thrombolysis of deep venous
thrombosis. Semin Thromb Hemost. 2013;39(4):446–51.
O’sullivan GJ, Semba CP, Bittner CA, Kee ST, Razavi MK, Sze DY,
etal. Endovascular management of iliac vein compression (may-
thurner) syndrome. J Vasc Interv Radiol. 2000;11(7):823–36.
Pisters R, Lane DA, Nieuwlaat R, de Vos CB, Crijns HJ, Lip GY.A
novel user-friendly score (HAS-BLED) to assess 1-year risk of
major bleeding in patients with atrial fibrillation: the Euro Heart
Survey. Chest. 2010;138(5):1093–100.
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Protack C, Bakken A, Patel N, Saad W, Waldman D, Davies
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lower extremity deep venous thrombosis without prophylactic
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Ruíz-Giménez N, Suárez C, González R, Nieto JA, Todolí JA,
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arm, multicenter trial of catheter-directed mechanical throm-
bectomy for intermediate-risk acute pulmonary embolism.
JACC Cardiovasc Interv. 2019;12(9)
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jcin.2018.12.022
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Vedantham S, Millward SF, Cardella JF, Hofmann LV, Razavi MK,
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with use of adjunctive catheter-directed intrathrombus throm-
bolysis. J Vasc Interv Radiol. 2009;20(7 Suppl):S332–5.
Vedantham S, Sista AK, Klein SJ, Nayak L, Razavi MK, Kalva
SP, etal. Quality improvement guidelines for the treatment of
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thrombus removal. J Vasc Interv Radiol. 2014;25(9):1317–25.
Watson L, Broderick C, Armon MP. Thrombolysis for acute deep
vein thrombosis. Cochrane Database Syst Rev. 2014:CD002783.
Windecker S, Stortecky S, Meier B.Paradoxical embolism. J Am Coll
Cardiol. 2014;64(4):403–15.
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