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2. medicine
3. surgery

4/17/2015
DEEP VEIN THROMBOSIS
PULMONARY EMBOLISM
INDICATIONS FOR
ENDOVASCULAR/SURGICAL
TREATMENT
Pulmonary embolism
• Overview
• Classification: hemodyn instability; anatomical;
symptomatic
• Treatment: anticoagulation
• Thrombolytics, systemic, catheter-directed
thrombolysis, pharmacomechanical thrombectomy
• Surgery: pulmonary thrombectomy, RVAD, Impella-P
• Role of IVC filters, indications, long-term concerns,
removal
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4/17/2015
Thrombolytic tx in acute PE and DVT
• Lytic agents activate plasminogen to form
plasmin, resulting in the accelerated lysis of
thrombi – used in MI, CVA, PE, DVT, acute arterial
occlusion
• Contraindications: intracranial neoplasm, recent
(<2 months) intracranial or spinal surgery or
trauma, h/o ICB, active bleeding.
• Relative contraindications: severe uncontrolled
HTN >200/110; nonhemorrhagic CVA w/I 3 mon.;
surgery w/I last 10 days, pregnancy (1-2% death,
8% fetal loss). Menstruation not CI.
Systemic tPA for PE
• Mult trials; hemodyn stable pts w/ RV dysfx;
most show lower mortality 2.2 vs 3.9% but
higher bleeding 9.2 vs 3.4%; less benefit in
older pts
• Most devastating complic w/systemic tPA is
ICH – 3% pts = higher than rate ICH in AMI
• Mult trials; all show acute improvement RV fx,
most show late improvement; lower PA press
and PVR in late f/u ie. benefits persistent
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4/17/2015
Endovasc tx PE
• ULTIMA Trial – ULTrasound accelerated thrombolysis of pulMonAry
embolism – 50 pts w/ PE and enlarged RVs (RV/LV ratio > 1)
randomized standard anticoag vs Actilyse delivers via EKO EkoSonic
encovasc device. Enrollment completed. Hopes to prove that tx will
signif reduce RV size at 24hrs w/o incr bleeding or other adverse
events
• SEATTLE Trial – Submassive and massive pulmonary Embolism tx w/
ultrasound AcceleraTed Thrombolysis Therapy – 120 pts. Enrollment
complete. 24mg activase via EKOS
• Treatment here at NMHI, Albuquerque: EKOS, t-PA, one to two
catheters directed into PEs,12-24hrs; another 24hrs sometimes
• good results both by angio and symptoms, O2 requirements, less
SOB, hemodynamics, shorter hospital stays, etc.
EKOS
• Two components: the Intelligent Drug Delivery Catheter (IDDC) and
the MicroSonic Device (MSD)
• MSD contains small transducers which use Rapid Pulse Modulation
(RPM) intermittent bursts of high frequency low power ultrasonic
waveforms which penetrate the thrombus. This penetration causes
the fibrin strands to thin which in turn exposes the plasminogen
receptor sites
• With the plasminogen receptor sites exposes, the tPA is able to
have a greater effect on the clot, dissolving it in shorter times than
conventional CDT. The tPA is delivered thru the IDDC which is
computer modulated to sense what is happening inside the clot,
deliver the optimal amt of ultrasonic energy and monitors amt of
heat by-product via thermal sensors. The tPA is administered via
multiple side holes; the cooling saline solution is delivered thru the
middle lumen exiting the end hole.
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4/17/2015
Surgical pulmonary thrombectomy
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Variable mortality
M/S, CPB, opening PA, removing clots
RV failure
RVAD, Impella-P
Deep vein thrombosis
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Overview
Treatment
Long-term sequale
Catheter-directed thrombolysis
Pharmacomechanical thrombectomy
PTA/stents
Surgical treatment
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4/17/2015
Deep vein thrombosis
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Superficial vein thrombosis
Below knee (distal) DVT
Ilio-femoral (proximal) DVT
Upper extremity DVT
Treatment rec DVT
• 1st episode isolated distal DVT -> anticoag for 3 months
• 1st episode isolated proximal DVT -> anticoag for min of
3 months to indefinite
• Pts w/ persistent but reversible risk factors (continued
estrogen use, prolonged immobility trauma) ->
continue anticoag for finite period until risk factor
resolved
• Pts w/unprovoked recurrent DVT, esp prox DVT ->
indefinite anticoag (unless bleeding risk high)
• DVT w/ HIT -> nonheparin anticoag; argatroban,
bivalirudin, coumadin
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4/17/2015
Phlegmasia cerulea dolens (PCD)
• Massive iliofemoral DVT, lower extremity swelling
from obstructed venous drainage, severe pain,
cyanosis and/or blanching (alba) w/o cyanosis,
edema, compromised arterial perfusion,
blebs/bullae, compartment syndrome, venous
gangrene, shock
• 5-6th decades, women, malignancy 20-40% pts;
10% idiopathic; left > right, 3-4X
• Emergency thrombolysis and/or thrombectomy
Systemic tPA for lower extr DVT
• More rapid and complete lysis of clot 95%pts
• reduced rate of PST post thrombotic
syndrome 43 vs 64%
• No decrease mortality or recurrent
thromboembolism
• Higher rate of bleeding 9 vs 4%
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4/17/2015
Catheter directed thrombolysis
• Observational trials, small; extensive iliofemoral DVT
• No effect on mortality or DVT recurrence, incr bleeding
risks compared to anticoag alone
• Lower rates of PTS and improved venous patency at 2
yrs vs anticoag alone -34 vs 70%
• Small randomized trial iliofem DVT comparing systemic
vs CDT -> better venous valvular competence
preservation w/ CDT 44 vs 13% w/ less reflux in both
deep and superficial veins
• Radomized trial 209pts, iliofem DVT: less PTS at 2 yrs in
pts received CDT vs anticoag alone 41 vs 56% ; venous
patency higher 66 vs 47%
Endovascular treatment of DVT
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Catheter-directed thrombolysis
Pharmacomechanical thrombectomy
Angiojet
Trellis
EKOS
PTA/stents
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4/17/2015
Current recommendations for massive
iliofemoral or proximal femoral DVT
• If high risk of limb gangrene; if massive swelling,
severely symptomatic
• If < 14 days
• If no contraindications to tPA and if accept bleeding
risks
• Catheter-directed thrombolysis or
pharmacomechanical thrombectomy; followed by
PTA/stents if indicated
• Followed by anticoagulation
• To achieve rapid clot lysis, rapid symptomatic relief,
restore limb perfusion if CPD/venous gangrene, and to
reduce the incidence of post-thrombotic syndrome
ATTRACT TRIAL
• Closed in December; final report pending
• NIH funded, Phase III, multicenter, randomized, openlabel, assessor-blinded, parallel two-arm, controlled
clinical trial
• 692 pts w/ symptomatic prox DVT, iliofemoral DVT
randomized to receive pharmacomechanical catheterdirected thrombolysis (PCDT); enrolled over 2 yrs; then
followed for 2 yrs
• Primary goal to answer 5 questions: does PCDT prevent
the Post Thrombotic Syndrome (PTS)? Improve quality
of life? Safe? Cost-effective? mechanism (residual clot
and/or valvular reflux)?
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4/17/2015
ATTRACT TRIAL
• PCDT w/ intrathrombus delivery of rt-PA (maximum
allowable dose 35mg) into the DVT over a perior of up
to 24 hrs. hree methods of initial rt-PA delivery used:
• 1. Trellis-8 Peripheral Infusion System – max first
session rt-pa dose 25mg
• 2. AngioJet Rheolytic Thrombectomy System – max first
seesion tPA dose 25 mg
• 3. Catheter-directed tPA infusion for up to 24 hrs at
0.01mg/kg/hr (max 1mg/hr) via multisidehole infusion
catheter
• Before and afterwards pts get standard antiooagulation
ATTRACT TRIAL
• Rational for trial
• Major burden of PTS on DVT pt and US healthcare
system
• The association btwn rapid clot lysis and prevention of
PTS
• The proven ability of rt-PA to dissolve clot in prox DVT
• Recent advanced in CDT methods which may lower
bleeding risks
• The major clinical controversy on whether CDT should
be routinely used for first-line DVT tx
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4/17/2015
ATTRACT TRIAL
• Seeks to resolve the major controversy among physicians
re: best way to treat pts w/ prox DVT
• w/ standard anticoagulation, 25-50% DVT pts will develop
PTS – daily pain, fatigue, swelling LE, venous stasis dis w/
loss mobility, ability to work, leg ulcers, infection,
amputation/death – common, morbid, expensive condition
• Previous studies of systemic thrombolysis, surgical
thrombectomy, and catheter-directed thrombolysis shown
that early removal clots may decr PTS, but poorly designed,
imperfect studies. Newer modalities, catheter based
devices are more effective w/ lower dose/risk of tPA.
• Will determine if PCDT should be routinely used to prevent
PTS in pts w/ symptomatic DVT above the pop vein
ATTRACT TRIAL
• ATTRACT – if positive, will validate the Open
Vein Hypothesis, catalyze change in current
initial tx DVT; encourage early referral of DVT
pts for PCDT, which would improve its efficacy;
extend PCDT to other DVT subgroups; incr
investment in novel clot removal technologies
that don’t cause bleeding, etc
• If negative, will eliminate routine use of costly,
invasive tx.
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4/17/2015
IVC FILTERS
• Cook Celect – retrievable; non-retrievable - Greenfield,
bird’s nest
• Acute proximal DVT w/ absolute contraindication to
anticoag tx (recent surgery, ICH, active GI bleeding)
• Recurrent PE despite adeq anticoag
• Pts in whom another PE would be poorly tolerated or
fatal (poor cardiopulm reserve, massive prior PE,
hemodyn unstable)
• Remove the filter once contraindication to anticoag
resolves, then complete conventional course anticoag
Complications of IVCFs
• Up to 40% insertion site thrombosis, CFV, rare
in prophylactic vs therapeutic
• Up to 40% incid progression of DVT prox
acutely
• Late DVT – at 2 yrs 21% vs 12%; at 8 yrs 36% vs
28%; but overall mortality and incid
postthrombotic syndrome = same
• IVC thrombosis 3-30%; increased BLE edema,
venous stasis dis
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4/17/2015
IVC Filters
• FDA rec “implanting physicians and clinicians
responsible for the ongoing care of patients w/
retrievable IVCFs consider removing the filter as
soon as protection is no longer needed”
• Filter retrieval achieved in > 90% attempts < 1 yr;
difficulty increases w/ time
• Overall retrieval rate 8-34%; high if placed
prophylactically (except for cancer), lower for
therapeutic indic
Chronic thromboembolic pulmonary
hypertension
• 1-5% survivors of PE
• First 2 yrs
• Progressive DOE, RV failure, syncope or nearsyncope
• 38% no documented h/o PE
• ECHO, PFTs, V/Q scan, RT heart cath, pulmonary
angio, CT-PA, MRA
• Treatment – pulm HTN tx; surgical PTE, heart-lung
transplant
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