clinical case update - Journal of Invasive Cardiology

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Supplement C to the Journal of Invasive Cardiology, October 2013
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C linical C ase U pdate
PharmacoMechanical Thrombolysis using the Rapid Lysis
Technique: A Safe and Effective Alternative for the Removal of DVT
Mark J. Garcia, MD, FSIR
Case Report
of the clot, and the degree of post-thrombotic syndrome
that they may be suffering from. You want to ensure
that they have been treated conservatively, at least initially. The patient should be on therapeautic anticoagulation and wearing elastic compression. We know by
published studies, that the greater the extent and more
central the thrombus burden is, the less likely the body
will resolve the clot on its own, and the greater the likelihood of the patient developing post-thrombotic syndrome. We will intervene more rapidly on a patient with
a more extensive clot burden, but in general, the patient
should still be therapeutically anticoagulated to see how
he or she does. In the population of patients where you
can wait and see how conservative management works,
we will do serial ultrasounds to find out if the body is
starting to resolve the clot burden itself. If they are not,
then we will intervene. It is reasonable to attempt conservative therapy with compression stockings and anticoagulation for 2-4 weeks with a follow-up ultrasound
and if there is no improvement, then treat the clot.
A 55-year-old obese female patient presented with remote history of deep vein thrombosis (DVT) and inferior vena cava (IVC) filter placement with recent transient
ischemic attacks. She underwent incisional hernia repair
and postoperatively developed a large abdominal wall
hematoma. Following surgical evacuation, she developed
severe bilateral leg swelling with phlegmasia. Venous
Doppler study demonstrated extensive and occlusive
DVT from the IVC through the bilateral lower extremities. Initially, the left leg and IVC venography confirmed
extensive thrombosis (Figure 1), which was followed by
rapid lysis pharmacomechanical thrombolysis. 25 mg
tPA was placed in 500 mL NSS, and after a total of 561
mL solution and a total procedure time of 48 minutes,
we achieved complete lysis with restoration of flow in the
left leg (Figure 2).
Four days later, the patient returned for treatment of
the contralateral, right leg. She had significant reduction
in size and pain of left leg. Figure 3 demonstrates occlusive DVT of the entire right leg.
Repeat rapid lysis technique was utilized with 25
mg tPA in 500 mL NSS and a total of 500 mL used.
Post-treatment venography (Figure 4) shows a widely
patent right leg deep venous system with restoration
of brisk flow. Patient was discharged on anticoagulation with follow-up, demonstrating patency of the deep
veins and no sequelae of post-thrombotic syndrome.
One of the tools you utilize for DVT treatment is the
AngioJet thrombectomy system for thrombus removal
and specifically what you call the rapid lysis approach.
Can you describe that procedure?
In one of the first cases where I performed this technique, we had a patient who was 7.5 months pregnant,
and recently suffered from a motor vehicle accident
with multiple pelvic fractures and injuries. She underwent an emergent C-section with placement of an IVC
filter. Soon after, she developed thrombosis extending
down both legs, and developed phlegmasia. Because of
her injuries and surgery, she wasn’t a candidate for catheter directed lytic therapy. I can’t honestly tell you what
led us to do this, but to my knowledge, this was the
first case of “pharmacomechanical thrombolysis.” We
combined the tPA into the AngioJet saline solution and
we used the AngioJet catheter inside an 8 French hockey
stick guide catheter, which allowed the AngioJet catheter to gain apposition along the wall of the vein. The
standard rheolytic treatment technique was to put the
AngioJet catheter over a wire, which kept it within the
Conclusion
The case shown exemplifies the benefits achieved
with a more aggressive approach to the management of
acute peripheral thrombus. The rapid lysis technique,
by gaining circumferential wall-to-wall apposition, aids
in speeding clot resolution and efficacy of clot removal
and hopefully decreasing the time to restoration of flow
and preventing irreversible vessel damage.
Can you describe your approach for treating deep vein
thrombosis?
My approach to the treatment of DVT is to evaluate
the patient and determine the extent of the clot, the age
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Figure 1. Occlusive deep vein thrombosis from the popliteal access to the IVC
filter.
Figure 2. Post-rapid lysis venography
shows patency of the entire deep venous system.
center of the lumen. This allowed for effective removal
of the clot within the center of the lumen, but would
leave a lot of thrombus circumferentially around the
wall. Nonetheless, we placed the AngioJet through the
angled guide catheter and we started to spiral the angled guide catheter with the AngioJet tip just outside the
guide catheter, while retracting them together through
the thrombus, centrally to the peripheral clot. We found
that by getting 360° wall apposition while retracting the
system, we were seeing a significantly improved resolu-
tion of the clot, which prompted us to use this technique
as our standard. We have our patients therapeutically
anticoagulated before they get on the table. We typically
gain access at the popliteal vein under ultrasound guidance. We perform an initial venogram and cross the clot
all the way to the central aspect before we put in the 8
French sheath. Coaxially, we place the 8 French hockey
stick guide catheter, through which we put the AngioJet
catheter with the TPA in the solution rather than heparin. We perform the spiraling technique from the central
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For any patient deemed a reasonable candidate to have DVT
removal, we utilize the rapid lysis
technique. We showed in our own
registry that when we use this
technique, 50%-60% of the time,
we completely remove the clot in
a single session and have no need
to do any further cathether infusion of tPA. For the remainder
of the patients, we may have to
drip tPA, but it has significantly
reduced the amount of time until
you get complete clot lysis. There
are several benefits for this technique: 1) you can potentially resolve the thrombus in a single sesFigure 3. Extensive, occlusive deep vein thrombosis is shown in entire right
sion; 2) there is no need for ICU
lower extremity.
beds; 3) there is decreased risk for
bleeding from catheter directed
thrombolysis because of the decreased need for catheter lysis; 4) there is a reduction in the amount of
time to completion as well as the resources that are
needed for lytic patients; and 5) we believe it is an
overall cost-effective method to treat DVT patients.
How much lytic do you typically use during this
approach?
Depending on the volume of clot that needs to
be removed (for example, a single leg or pelvic vein
that needs to be treated), we will use 10 mg of tPA
in a 500 mg bag of saline. If it is a more extensive
clot burden, I will put 25 mg of tPA in a 1000-mg
bag because that is how our tPA doses are divided
up in our institution.
Figure 4. Post-treatment venography shows a widely patent
right leg deep venous system with restoration of brisk flow.
The rapid lysis approach is similar to the AngioJet power pulse feature in that they both combine mechanical thrombectomy and pharmacological thrombolysis in a single treatment session.
Can you please describe the benefits around each
and provide an overview?
Although both methods utilize tPA in the saline solution, the techniques are actually quite different. The
power pulse technique shuts off the outflow from the
AngioJet machine as you slowly advance the catheter
over a wire through the clot while quickly spot-pulsing the drive unit. The system is emitting the saline/tPA
solution into the clot as you move forward with the
outflow blocked off. With our technique, the outflow
is open, we start at the central aspect of the clot, and
we spiral the guiding catheter and AngioJet catheter together while the system is “on” and being retracted. A
major difference with the power pulse technique is that
to the peripheral aspect of the clot. The key is to rotate
the guide catheter rather than the AngioJet catheter,
while slowly retracting both through the clot burden.
The premise that the open flowing vein is much better than one with clot dates back years through the venous registries. Our goal was to remove as much of the
clot as possible and hopefully avoid catheter-directed
thrombolysis if possible. If standard thrombolysis was
used, the time for thrombolysis was certainly decreased
by debulking the thrombus burden. That technique has
been our standard of care for treating DVT over the last
15-16 years.
When do you utilize the rapid lysis approach for your
DVT patients?
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you are pulsing a pressurized volume of solution into
a closed system filled with clot. There is a small risk
that the clot could break off more easily and potentially
cause a pulmonary embolism. However, with the rapid lysis technique, the outflow is open and functioning
with the vacuum phenomenon occurring so that the embolization risk is minimized. In the last 15-16 years and
over 1000 patients, we have not had a single problem
with pulmonary embolism. This is one of the reasons
why I like the rapid lysis technique better.
In summary, although they are very similar in that
they are both pharmacomechanical techniques with
the tPA in the bag, they differ with the outflow being
closed or open. Additionally, power pulse technique
is over the wire and therefore dependent on the wire
position whereas we are spiraling along the wall to
achieve better wall apposition and a larger area of vessel treatment for clot removal.
level of anticoagulation, we saw no further rethrombosis.
This justified our reason for wanting people therapeutically anticoagulated. After they are anticoagulated, we
gain access under ultrasound guidance at the appropriate
level and we perform our technique.
Thirdly, the tPA goes directly in the saline solution
bag without heparin; just tPA and saline.
The biggest key is using the hockey stick guide catheter, allowing for wall-to-wall apposition and a more
rapid and effective method of thrombus removal than if
you just go over the wire the standard way. Also, when
the procedure is completed, whether it is a single session or adjuvant catheter direct lytic therapy is needed, patients get pneumatic compression boots placed
immediately after rapid lysis, and continue until they
are discharged. They are discharged on the appropriate
therapeutic anticoagulation for the appropriate period
based on the underlying cause and whether or not it was
provoked. Typically we will keep them therapeutically
anticoagulated on Lovenox before we transition them
over to rivaroxaban or warfarin. Lastly, they are given
elastic compression stockings.
So, to summarize, the 2 tips that are most important
are: therapeutic anticoagulation and wall-to-wall apposition with the rapid lysis technique.
Do you have any suggested tips and tricks on the rapid
lysis approach?
Yes, there are several tips and tricks we’ve learned
over the years. First, make sure that the patients are well
hydrated prior to the procedure because of the AngioJet
phenomenon with hemoglobinuria. We make sure that
every patient is extremely well hydrated before and after
the case until the urine clears and the creatinine is normal. Secondly, patients need to be therapeutically anticoagulated before treating them. When we have patients referred to us, whether they come in through the ER, from
a direct admission, or are an in-patient, they are usually
given a therapeutic, weight-based dose of enoxaparin.
We will get them on the table with Lovenox® being given. The reason we want patients therapeutically anticoagulated prior to treatment is because we found out very
early on, that early rethrombosis occurred when the PTT
levels were below 60. We are inciting a hypercoagulable
state just by removing the clot itself, even if we are not
injuring the vessel. Our hematologist suggested a target
PTT between 70 and 90, and when we obtained that
How did this technique change your practice?
One of the most notable differences the technique has
had on our practice is that it changed the paradigm of
what was considered absolute contraindications to lytic
therapy. We are a level I trauma center with a large cancer center so we see a lot of trauma and cancer patients
with DVT. This technique has changed the paradigm
for those patients who were considered absolute contraindications to lytic therapy due to catastrophic bleeding risks. This technique has worked well in that population without bleeding complications, thus enabling
us to improve their quality of life by downgrading the
absolute contraindications to relative contraindications
and allowing for a larger population to be treated.
AngioJet® Thrombectomy Systems
General Indications/Contraindications
AngioJet System peripheral indications include: breaking up and removing thrombus from infra-inguinal peripheral arteries, upper and lower extremity peripheral arteries, upper
extremity peripheral veins, ileofemoral, infra-iliac and lower extremity veins, A-V access conduits, and for use with the AngioJet Power Pulse Kit for the control and selective infusion
of physician specified fluids, including thrombolytic agents, into the peripheral vascular system. AngioJet System coronary indications include: removing thrombus in the treatment
of patients with symptomatic coronary artery or saphenous vein graft lesions prior to balloon angioplasty or stent placement. Do not use in patients: who are contraindicated for
intracoronary or endovascular procedures, who cannot tolerate contrast media, and in whom the lesion cannot be accessed with the wire guide.
General Warnings and Precautions
The System has not been evaluated for treatment of pulmonary embolism in the US and some other countries or for use in the carotid or cerebral vasculature. Some AngioJet
devices have not been evaluated for use in coronary vasculature. Operation of the catheter may cause embolization of some thrombus and/or thrombotic particulate debris. Cardiac
arrhythmias may occur and cardiac rhythm should be monitored during catheter use and appropriate management employed, if needed. Systemic heparinization is advisable to
avoid pericatheterization thrombus and acute rethrombosis. Operation of the System causes transient hemolysis. Large thrombus burdens may result in significant hemoglobinemia
which should be monitored. Consider hydration, as appropriate. Before coronary AngioJet treatment, verify the presence of thrombus because routine use of AngioJet in every STEMI
patient, without proper selection for thrombus, has been associated with increased mortality risk. Do not use the system in the coronary vasculature without placing a temporary
pacing catheter to support the patient through hemodynamically significant arrhythmias which may occur.
Potential Adverse Events
Potential adverse events (in alphabetical order) which may be associated with use of the system are similar to those associated with other interventional procedures and include
but are not limited to the following: abrupt closure of treated vessel, acute myocardial infarction, acute renal failure, arrhythmias (including VF and VT), bleeding from access site,
death, dissection, embolization (proximal or distal), emergent CABG, hematoma, hemolysis, hemorrhage requiring transfusion, hypotension/hypertension, infection at access site,
myocardial ischemia, pain, pancreatitis, perforation, pseudoaneurysm, reactions to contrast medium, stroke/CVA, thrombosis/occlusion, total occlusion of treated vessel, vascular
aneurysm, vascular spasm, vessel wall or valve damage.
Indications, operating specifications and availability may vary by country. Check with local product representation and country-specific Information For Use for your country.
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