A 42-year-old female presented with chest pain, shortness of breath, and hypotension due to massive bilateral pulmonary emboli. Initial treatment with thrombolytic infusion and pigtail rotation catheter failed to improve her condition. Angiojet mechanical thrombectomy was then performed across the clots, which improved her hypotension and oxygenation. Catheter-directed thrombectomy is an alternative treatment to systemic thrombolysis for massive pulmonary embolism when thrombolysis is contraindicated or has failed. It allows for direct delivery of thrombolytics or mechanical disruption of clots and can rapidly improve hemodynamics. However, the optimal technique and regimen remains uncertain given limited data currently.
13. pathophysiology of PE
Jaff MR et al. Management of massive and submassive pulmonary embolism, iliofemoral deep vein thrombosis, and chronic
thromboembolic pulmonary hypertension: a scientific statement from the American Heart Association. Circulation 2011; 123:1788-1830.
14. definitions
Massive PE: Acute PE with sustained hypotension
(SBP <90 mmHg) for at least 15 minutes without
other cause
Or drop in SBP >40 mmHg
Or pulselessness/cardiac arrest
Or HR <40 with signs or symptoms of shock
Massive PE inpatient mortality is 15-50%
Jaff MR et al. Management of massive and submassive pulmonary embolism, iliofemoral deep vein thrombosis, and chronic
thromboembolic pulmonary hypertension: a scientific statement from the American Heart Association. Circulation 2011; 123:1788-1830.
15. definitions
Submassive PE: Acute PE without systemic
hypotension but with either RV dysfunction or
myocardial necrosis
RV dysfunction could include:
RV dilation on echo or CT (RV diameter/LV diameter >0.9)
Elevation of BNP (>90 pg/mL)
EKG changes (new RBBB, anteroseptal ST changes,
anteroseptal TWI)
Myocardial necrosis is defined as troponin I >0.4 ng/mL
Inpatient mortality of submassive PE is 5-12%
Jaff MR et al. Management of massive and submassive pulmonary embolism, iliofemoral deep vein thrombosis, and chronic
thromboembolic pulmonary hypertension: a scientific statement from the American Heart Association. Circulation 2011; 123:1788-1830.
16. definitions
Low-risk PE: Everybody else
Short-term mortality about 1%
Jaff MR et al. Management of massive and submassive pulmonary embolism, iliofemoral deep vein thrombosis, and chronic
thromboembolic pulmonary hypertension: a scientific statement from the American Heart Association. Circulation 2011; 123:1788-1830.
17. anticoagulation versus thrombolysis
Heparin allows passive reduction of thrombus size
No substantial improvement in first 24 hours
65-70% reduction in perfusion defect by 7 days
Thrombolysis actively promotes hydrolysis of fibrin
Convert native circulating plasminogen into plasmin
Plasmin cleaves fibrin, lysing the thrombus
30-35% reduction in perfusion defect in first 24 hours
65-70% reduction in perfusion defect by 7 days
Jaff MR et al. Management of massive and submassive pulmonary embolism, iliofemoral deep vein thrombosis, and chronic
thromboembolic pulmonary hypertension: a scientific statement from the American Heart Association. Circulation 2011; 123:1788-1830.
18. treatment of PE
Systemic anticoagulation
IV thrombolytics
Standard FDA-approved therapy for PE with hemodynamic
instability
100 mg tPA IV over 2 hours
Catheter directed therapy – uncertain indications
Thrombolytic infusion
Mechanical thrombolysis
Mechanical thrombectomy
Surgical embolectomy
19. ACCP 2012 recommendations
In patients with acute PE associated with
hypotension (eg, systolic BP <90 mmHg) who do not
have a high bleeding risk, we suggest systemically
administered thrombolytic therapy over no such
therapy (Grade 2C)
Guyatt GH, et al. Executive summary: antithrombotic therapy and prevention of thrombosis, 9th ed: American College of Chest Physicians
evidence-based practice guidelines. Chest 2012;141: 2 suppl 7S-47S.
20. Jaff MR et al. Management of massive and submassive pulmonary embolism, iliofemoral deep vein thrombosis, and chronic
thromboembolic pulmonary hypertension: a scientific statement from the American Heart Association. Circulation 2011; 123:1788-1830.
21. contraindications to systemic lysis
Absolute Relative
Any prior intracranial Age >75
hemorrhage Current anticoagulation
Brain AVM or tumor Pregnancy
CVA in last 3 months Noncompressible vascular
Active bleeding or puncture
bleeding diathesis Traumatic/prolonged CPR
Recent surgery Internal bleeding in last
encroaching on spinal month
canal or brain Uncontrolled HTN (SBP
>180 or DBP >110)
Recent significant head
Remote stroke
trauma
Major surgery in last 3
weeks
22. contraindications to systemic lysis
Half of all patients with acute PE have contraindications
to systemic lysis
Piazza G, Goldhaber SZ. Management of submassive pulmonary embolism. Circulation 2010; 122:1124-1129.
23. systemic lysis in massive PE
The good The bad
Recurrent PE or death is Overall major bleeding rate
reduced from 19.0% to 9.4% of ~20%
compared to heparin alone
Intracranial hemorrhage rate
~3%
30% reduction in PA
pressures
Effects not immediate (2
hour infusion + time for drug
15% increase in cardiac to work)
index
Many patients are
Noninvasive contraindicated
Marshall PS, Mathews KS, Siegel MD. Diagnosis and management of life-threatening pulmonary embolism. J Intensive Care Med
2011;26:275-294.
26. catheter-directed therapy (CDT)
Alternative or additive
treatment for massive PE
Wide variety of devices
and techniques, with the
goal of rapidly reducing clot
burden
Thrombus fragmentation
Thrombus aspiration
Intra-thrombus lytic
administration
32. history of CDT for PE
Verstraete et al 1988: 34 randomized patients, no
benefit seen for PA lysis over IV systemic lysis (50
mg tPA)
Administered lytics into the main trunk of the PA
Did not place lytic directly into thrombus
No mechanical fragmentation or aspiration of the
thrombus
Tapson et al 1994: Animal model showed that
intra-thrombus administration of lytic was faster
and more effective
Improves exposure of drug to thrombus surface
Fava et al 1997: 17 patients, intraclot
fragmentation + lysis produced clinical
improvement in 88%
Dozens more studies over the next decade, all
observational, using a wide variety of devices, lytic
agents, regimens
33.
34. ACCP 2008 recommendations
“For most patients with PE, we recommend against
use of interventional catheterization techniques
except in selected highly compromised PE patients
who are unable to receive thrombolytic therapy
because of bleeding risk, or whose critical status
does not allow sufficient time for thrombolytic therapy
to be effective.”
Kearon C et al. Antithrombotic therapy for venous thrombembolic disease:American College Chest Physicians evidence-based clinical
practice guidelines (8th edition). Chest 2008;133:454S-545S.
35. CDT: meta-analysis
Meta-analysis of CDT for massive PE
6 prospective, 29 retrospective uncontrolled studies (level 2)
Total 594 patients
Variety of techniques, most commonly pigtail rotation (70%) combined
with intraclot lysis [on-table (67%) and/or via infusion catheter (60%)]
Clinical success in 86.5%
Stabilized hemodynamics, resolved hypoxia, and survival to discharge
Compare to 77% survival rate in ICOPER
Major hemorrhage in 2.4%, only one case of cerebral hemorrhage
(0.2%)
Compare to 22% major hemorrhage rate and 3% cerebral hemorrhage
rate in ICOPER
Catheter-directed therapy may be considered a first-line treatment
option in lieu of IV tPA
Kuo WT, et al. Catheter-directed therapy for the treatment of massive pulmonary embolism: systematic review and meta-analysis of modern
techniques. J Vasc Interv Radiol 2009;20:1431-1440.
36. CDT: analysis of the meta-analysis
Pooled clinical success rate of 86.5%
96% received CDT as 1st adjunct to heparin (no prior systemic lysis)
33% initiated with mechanical treatment alone – no on-table lytic drug
Minor complication rate 8%
Groin hematoma
Bradycardia, renal insufficiency, hemoglobinuria, hemoptysis, heart block (all
Angiojet)
Embolus dislocation
PA dissection
Major complication rate 2.4%
Large groin hematoma (pRBC)
Non-cerebral hemorrhage (pRBC)
Severe hemoptysis
Renal failure
Central vascular perforation causing tamponade
5 deaths (all Angiojet) – bradycardia, apnea, widespread distal embo, ICH
Kuo WT, et al. Catheter-directed therapy for the treatment of massive pulmonary embolism: systematic review and meta-analysis of modern
techniques. J Vasc Interv Radiol 2009;20:1431-1440.
37. IV tPA vs. CDT for massive PE
IV tPA (ICOPER registry) CDT (Stanford meta-analysis)
2454 patients, global 594 patients, global
304 treated with IV lysis All treated with mechanical
thrombectomy +/- catheter-directed
lysis
1/3 were hemodynamically
unstable
All hemodynamically unstable
23% PE mortality
13.5% PE mortality
22% major complications
2.4% major complications
3% cerebral hemorrhage
<0.2% cerebral hemorrhage
Kuo WT, et al. Catheter-directed therapy for the treatment of massive pulmonary embolism: systematic review and meta-analysis of modern
techniques. J Vasc Interv Radiol 2009;20:1431-1440.
38. CDT for massive PE: the good and bad
The good The bad
1. Less invasive than surgery 1. No universal protocol
2. Off-label use
2. Can quickly debulk central PE,
without needing 2 hour infusion
3. Limited availability/expertise
3. Useful when IV tPA fails or is 4. May delay treatment if angio
contraindicated suite not ready
5. Fear of complications (Angiojet)
4. Appears safer than systemic
lysis (~20 mg tPA vs. 100 mg
tPA)
Guyatt GH, et al. Executive summary: antithrombotic therapy and prevention of thrombosis, 9th ed: American College of Chest Physicians
evidence-based practice guidelines. Chest 2012;141: 2 suppl 7S-47S.
Jaff MR et al. Management of massive and submassive pulmonary embolism, iliofemoral deep vein thrombosis, and chronic
thromboembolic pulmonary hypertension: a scientific statement from the American Heart Association. Circulation 2011; 123:1788-1830.
39. CDT for massive PE: consensus statements
AHA 2011 ACCP 2012
1. Reasonable for patients with 1. Suggested for massive PE with
massive PE and contraindication to thrombolysis
contraindications to lysis (class (grade 2C)
IIa)
2. Suggested for massive PE with
failed thrombolysis (grade 2C)
2. Reasonable for patients with
massive PE who remain
unstable after systemic lysis 3. Suggested for massive PE with
(class IIa) shock likely to cause death
within hours (grade 2C)
Guyatt GH, et al. Executive summary: antithrombotic therapy and prevention of thrombosis, 9th ed: American College of Chest Physicians
evidence-based practice guidelines. Chest 2012;141: 2 suppl 7S-47S.
Jaff MR et al. Management of massive and submassive pulmonary embolism, iliofemoral deep vein thrombosis, and chronic
thromboembolic pulmonary hypertension: a scientific statement from the American Heart Association. Circulation 2011; 123:1788-1830.
40. CDT for massive PE: controversies
Should CDT replace IV tPA as first-line therapy at
institutions with expertise?
Delay in treatment?
Should CDT be an adjunctive treatment to IV tPA?
Perform in all patients, stopping the IV infusion once the angio
suite is ready?
Perform only in patients where IV tPA did not work?
What regimen should be used?
Which mechanical thrombectomy device is best?
Should on-table lysis be performed?
Should prolonged intra-thrombus lytic infusion be performed?
What contraindications are truly contraindications for
CDT?
41. PERFECT registry
Pulmonary Embolism Response to Fragmentation,
Embolectomy, & Catheter Thrombolysis
Prospective observational trial
Primary outcome measures
Resolution of hypoxia (post-procedure and 3 months)
Survival from acute PE (post-procedure and 3 months)
Stabilization of hemodynamics (post-procedure and 3
months)
Estimated completion in 2014
44. submassive pulmonary embolism
“No consensus on the exact definition of “submassive”
or “intermediate-risk” PE exists to date.”
Normotensive patient with predictors of poor outcome
Evidence that several factors predict poor outcome in
normotensive patients with PE
PEITHO Investigators, American Heart Journal, Volume 163, Issue 1, Jan 2012, Pg 33-38
45. prognosticating in submassive PE
Imaging
Echocardiogram
Presence of RV dysfunction doubles all-cause mortality at 3 months
Useful to differentiate low-risk from submassive PE
CTA
Signs of RV strain correlate well with echo
Cardiac biomarkers
Troponin I
Released from RV in response to pressure overload and RV ischemia/infarction
Meta-analysis: elevated troponin increases mortality risk of PE 6-fold
Troponin I <0.07 ng/mL has 98% negative predictive value for in-hospital mortality
BNP
Neurohormone sythesized and released by the ventricles in response to strain
May take several hours after onset of RV strain to see increased BNP
BNP <50-85 has 99% negative predictive value for death in normotensive patients
Because of high NPV, a low troponin or BNP level may mean echo not needed
D-dimer
93% sensitive for segmental PE or larger, 50% sensitive for subsegmental PE
D-dimer <1500 mcg/mL has 99% NPV for 3-month all-cause mortality
Marshall PS, Mathews KS, Siegel MD. Diagnosis and management of life-threatening pulmonary embolism. J Intensive Care Med
2011;26:275-294.
46. right heart dysfunction
RV:LV ratio > 0.9 has been shown to be a predictor of
in-hospital mortality
1.9% if RV/LV < 0.9
6.6% if RV/LV > 0.9
Fremont B, Pacouret G, Jacobi D. CHEST 2008;133:358-362
48. clinical outcomes of submassive PE
3-12 % inpatient mortality
1-5% develop Chronic Thromboembolic Disease with
PAH
49. ACCP 2012 guidelines for submassive PE
5.6.1.2. In most patients with acute PE not associated with
hypotension, we recommend against systemically administered
thrombolytic therapy (Grade 1C).
5.6.1.3. In selected patients with acute PE not associated with
hypotension and with a low risk of bleeding whose initial clinical
presentation or clinical course after starting anticoagulant therapy
suggests a high risk of developing hypotension, we suggest
administration of thrombolytic therapy (Grade 2C).
5.6.2.2. In patients with acute PE, when a thrombolytic agent is
used, we suggest administration through a peripheral vein over a
pulmonary artery catheter (Grade 2C).
50. AHA 2011 guidelines for submassive PE
1. Fibrinolysis may be considered for patients with submassive acute PE
judged to have clinical evidence of adverse prognosis (new hemodynamic
i stability, worsening respiratory insufficiency, severe RV dysfunction, or
major myocardial necrosis) and low risk of bleeding complications (Class
IIb; Level of Evidence C).
2. Fibrinolysis is not recommended for patients with low-risk PE (Class III;
Level of Evidence B) or submassive acute PE with minor RV dysfunction,
minor myocardial necrosis, and no clinical worsening (Class III; Level of
Evidence B).
3. Either catheter embolectomy or surgical embolectomy may be
considered for patients with submassive acute PE judged to have clinical
evidence of adverse prognosis (new hemodynamic instability, worsening
respiratory failure, severe RV dysfunction, or major myocardial necrosis)
(Class IIb; Level of Evidence C).
4. Catheter embolectomy and surgical thrombectomy are not
recommended for patients with low-risk PE or submassive acute PE with
minor RV dysfunction, minor myocardial necrosis, and no clinical
worsening (Class III; Level of Evidence C).
51. Piazza G, Goldhaber SZ. Management of submassive pulmonary embolism. Circulation 2010; 122:1124–1129
52. role of IR in submassive PE
Role of catheter directed treatment of submassive PE was slotted
for “Hot Topic” debate at SIR 2012
Rationale for CDT in submassive PE
Rapid debulking of thrombus
Prevention of adverse outcomes
Early
Worsening right ventricular afterload/cardiac ischemia, respiratory
compromise
Late
Chronic thromboembolic disease and pulmonary hypertension
Limit dose of thrombolytic
Reduction in hemorrhage rate
53. Role for catheter treatment of submassive
PE requires an answer to these questions
How important is rapid clearance of thrombus?
Role of thrombolysis
How does the effectiveness of catheter directed
thrombolysis compare to systemically delivered lytic
agents?
54. Role for catheter treatment of submassive
PE requires an answer to these questions
How important is rapid clearance of thrombus?
Role of thrombolysis
How does the effectiveness of catheter directed
thrombolysis compare to systemically delivered lytic
agents?
55. role of thrombolysis in submassive PE
Registries have failed to show a survival benefit in
patients with submassive PE
Jaff 2011
56. role of thrombolysis in submassive PE
Meta-analysis of 9 randomized control trials of
thrombolytics and heparin in treatment of acute PE
461 patients included in analysis
Mortality
4.6% lytic
7.7% heparin
Bleeding
12.9% lytic (2.1% fatal)
8.6% heparin
Recurrence of PE slightly decreased in lytic group
Agnelli. Arch Internal Medicine 2002
57. role of thrombolysis in submassive PE
Management Strategies and Prognosis of Pulmonary
Embolism Trial 3
256 patients randomized to
100 mg tPA administered IV over 2 hours followed by infusion
of unfractionated heparin
Placebo + heparin
tPA group had lower rate of in-hospital death or escalation
of care
Largely attributed to escalation of care
Konstantinides S, Geibel A, Heusel G, Heinrich F, Kasper W. Heparin plus alteplase compared with heparin
alone in patients with submassive pulmonary embolism. N Engl J Med 2002; 347:1143–1150.
59. role of thrombolysis in submassive PE
Kline et al evaluated echocardiograms in patients with
submassive PE at the time of diagnosis and at 6 months
Two groups
Heparin
tPA + heparin
Pts treated with tPA had a greater median decrease in
pulmonary systolic pressure
22 mmHg vs 2 mmHg
6 months – PA pressure elevated in 27% of pts treated
with only heparin
50% of patients had symptoms of PAH
Kline JA, Steuerwald MT, Marchick MR, Hernandez-Nino J, Rose GA. Prospective evaluation of right ventricular
function and functional status 6 months after acute submassive pulmonary embolism: frequency of persistent or
subsequent elevation in estimated pulmonary artery pres- sure. Chest 2009; 136:1202–1210.
64. Role for catheter treatment of submassive
PE requires an answer to these questions
How important is rapid clearance of thrombus?
Role of thrombolysis
How does the effectiveness of catheter directed
thrombolysis compare to systemically delivered lytic
agents?
65. comparative effectiveness of IV tPA vs. CDT
for submassive PE
We don’t know
Literature regarding catheter based approach is limited
to case series and meta-analyses
70. evidence needed
Clinical benefits of escalation of therapy for acute PE
beyond anticoagulation?
Reduction of mortality
Prevention of chronic thromboembolic disease
Improved outcomes with catheter directed thrombolyis
vs systemic thrombolysis?
More effective?
Reduced hemorrhage?
72. ongoing clinical trials
PEITHO STUDY
Pulmonary Embolism Thrombolysis trial
Prospective, multicenter, randomized, double-blind
IV Tenecteplase + UFH vs UFH
Randomized within 2 hours of dx of PE with RV dysfunction
and myocardial injury
Primary outcome
Death or hemodynamic collapse within 7 days
Safety outcomes
Related to hemorrhage
Long term follow-up
Death
Echo evaluation for PAH and RV dysfunction
75. ULTIMA trial
ULTrasound Accelerated ThrombolysIs of PulMonAry
Embolism
Comparison of ultrasound-accelerated thrombolysis
through the EKOS catheter system vs systemic
anticoagulation with heparin
Two arm, prospective, randomized
Experimental arm: low-dose (<20 mg) r-tPA + full dose
IV heparin
Control arm: IV heparin alone
76. ULTIMA trial
Primary endpoint
Reduction of RV/LV ratio: RV/LV ratio will be
measured by echocardiography at baseline and at 24
hours
Inclusion criteria
Patients with acute PE symptoms < 14 days.
CT evidence of PE in at least one main or proximal lower lobe
pulmonary artery
RV/LV end diastolic diameter ratio is ≥ 1.0
77. SEATTLE II
Submassive and massive pulmonary Embolism
treatment with AcceleraTed ThromboLysis thErapy
Question: Will t-PA delivered via the EKOS catheter +
IV heparin decrease the ratio of RV to LV diameter
within 48 hours in patients with massive or submassive
PE?
Single arm, prospective study
All pts get catheter directed t-PA + IV UFH
PE diagnosed on CT
Submassive inclusion
RV:LV ratio > 0.9 on CT angiography
78. SEATTLE II
Primary outcomes
RV:LV Diameter Ratio measured at 48 hours
Major bleeding at 72 hours
Inclusion criteria
CT evidence of proximal PE Age ≥ 18 years AND
PE symptom duration ≤14 days AND
Massive PE or
Submassive PE
(RV:LV ≥ 0.9 on contrast-enhanced chest CT)
79. summary
The role of early thrombolysis in treatment of massive
and submassive PE is not well defined and currently
under active investigation
IRs have the tools and skills to perform catheter
directed treatment of acute PE
Infusion of lytic agents
Mechanical thrombolysis and thrombectomy
Theoretical rationale for catheter directed treatment of
PE
Rapid clot debulking
Reduction of lytic agent (decreased hemorrhage)
80.
81. Stanford PE protocol
Massive PE
Anesthesia involved when possible
8F sheath into common femoral vein, select main PA
Measure pulmonary pressures (if time)
Bury pigtail into clot
Administer bolus of tPA (start with 10 mg per lung)
Pigtail fragmentation
Conclude the procedure when hemodynamic improvement with resolution
of shock is achieved, regardless of angiographic results.
Submassive PE
Treated with CDT if there is RV strain or severe hypoxia
No bolus dose, no fragmentation
Place infusion catheter across clot and perform low-dose infusion
PERFECT registry
82. Proposed CDT recommendations by JVIR
SBP <90 mmHg or drop >40 mmHg
Cardiogenic shock with hypoxia
Circulatory collapse requiring CPR
RV strain +/- pulm HTN
Precapillary pulm HTN
Widened A-a O2 gradient (>50 mmHg)
Clinically severe PE with CI to anticoagulation or lytic
therapy
Uflacker R. Interventional therapy for pulmonary embolism. J Vasc Interv Radiol 2001;12:147-164
83. systemic thrombolysis
Potential benefits Potential harm
More rapid symptom Hemorrhage
resolution ~20% major hemorrhage
Stabilization of ~3% cerebral
respiratory and heart hemorrhage
function
Reduction of RV
damage
Reduced risk of chronic
PE with pulmonary HTN
Increased probability of
survival
84. systemic thrombolysis
In hemodynamically unstable patients, systemic lysis
reduces recurrent PE and death (OR 0.45)
No proven advantage of one lytic over another
2-hour infusion provides faster results and less risk
compared to longer infusions
Unfractionated heparin should be stopped when decision
to deliver lytics is made; then resumed after infusion
without a bolus [?]
Greatest benefit when delivered within 48 hours of
symptom onset
Marshall PS, Mathews KS, Siegel MD. Diagnosis and management of life-threatening pulmonary embolism. J Intensive Care Med
2011;26:275-294.
85. Intraclot lytic injection is essential
Proximal vortex
Schmitz-Rode T, Kilbinger M, Gunther RW. Simulated flow pattern in massive pulmonary embolism: significance for selective
intrapulmonary thrombolysis. Cardiovasc Intervent Radiol 1998;21:199-204.
86. catheter-directed lysis
111 patients with massive PE had CDT
200k-500k units of urokinase in situ
Mechanical fragmentation in 85% (pigtail rotation +/- balloon angioplasty)
Catheter placed most obstructed segment and infused 100k units/hr for mean 22 hours
Heparin to achieve PTT 2-2.3x normal
Technical success in 100%
On table fragmentation + initial bolus did not reduce mean PAP
Mean PA pressure reduced from 40 to 25 mmHg at conclusion of lysis
Mean PA pressure was 20 mmHg at 30-90 day follow-up (only 6% had mean PA pressure >25
mmHg)
4 major complications (4%), 1 death
1 cerebral hemorrhage (death)
1 gluteus hematoma
1 GI hemorrhage
1 jugular DVT
De Gregorio et al. Endovascular treatment of a haemodynamically unstable massive pulmonary embolism using fibrinolysis and
fragmentation. Experience in 111 patients in a single centre. Why don’t we follow ACCP recommendations?
87. ACCP 2012 recommendations
“In patients with acute PE associated with
hypotension and who have (i) contraindications to
thrombolysis, (ii) failed thrombolysis, or (iii) shock
that is likely to cause death before systemic
thrombolysis can take effect (eg, within hours), if
appropriate expertise and resources are available,
we suggest catheter-assisted thrombus removal over
no such intervention (Grade 2C)”
Guyatt GH, et al. Executive summary: antithrombotic therapy and prevention of thrombosis, 9th ed: American College of Chest Physicians
evidence-based practice guidelines. Chest 2012;141: 2 suppl 7S-47S.
88. devices and techniques
Pigtail rotation
Cheap, easy, accessible, can debulk proximal emboli
Aspiration thrombectomy
8F guide catheter
Balloon maceration
Sized smaller than target artery
Angiojet
Used in 11% of cases but accounts for 76% of major complications
28% major complication rate
Bradyarrhythmia, heart block, hemoglobinuria, hemoptysis,death
Ekos
Ultrasound-aided lysis infusion
Others not available at UCLA: Amplatz thrombectomy device,
Straub Aspirex catheter, Helix ClotBuster, etc
89. Catheter-guided lysis
25 patients with massive PE had 33 catheter interventions
EKOS in 15
Standard CDT in 18
EKOS showed more effective thrombus removal
EKOS group had complete thrombus removal in 100%
CDT group had complete thrombus removal in 50%, partial
thrombus removal in 14%
EKOS group had lower mean time of lysis (17 vs. 25 hours)
Treatment-related hemorrhagic complication rate lower for
EKOS (0% vs. 21%)
Mortality similar (9.1% for EKOS, 14.2% for CDT)
Lin PH, et al. Comparison of percutaneous ultrasound-accelerated thrombolysis versus catheter-directed thrombolysis in patients with acute
massive pulmonary embolism. Vascular 2009;17 Suppl 3:S137-47.
91. Intrapulmonary administration of Lytics
A study from 1992 found no signification difference between IV
and PA administration of tPA 1
Patients received 100 mg tPA IV or in the PA
No significant difference in outcomes
Conclusion: IV and PA administration of tPA equally effective in PE
BUT
Administration of tPA was NOT directly into the clot
Current preferred administration of lytics into thrombosed vessels
is through multisidehole infusion catheters placed directly into clot
Increases the surface area of the clot exposed to lytics
Avoids lost dose from preferential flow of lytic into
nonthrombosed vessels
Goldhaber
92. tPA Contraindications
Active internal bleeding
History of CVA in last 6 months?
Recent neurosurgery or head trauma
Intracranial AVM, aneurysm or tumor
Known bleeding diathesis
Severe uncontrolled HTN
93. Relative CI to tPA
Recent major surgery
CV disease
Recent GI or GU bleeding
Recent trauma
SBP >175 or DBP >110
Acute pericarditis
Subacute bacterial endocarditis
Severe hepatic or renal disease
Pregnancy
Hemorrhagic ophthalmic conditions
Septic thrombophlebitis
Advanced age >75
Patients on oral anticoagulants
94. Major hemorrhage from tPA
Independent predictors of major hemorrhage in PE
patients treated with systemic tPA
Cancer
Elevated INR
DM
Hemodynamic instability
Fiumara et al. Predictors of major hemorrhage following fibrinolysis for acute pulmonary embolism. Am J Cardiol 2006;97:127-129..
95. Major hemorrhage from tPA
Acute MI: 5% major, 1% intra-cerebral
Acute PE (Fiumura): 19% major, 5% intra-cerebral
Acute PE (Goldhaber): 22% major, 3% intra-cerebral
Bovill EG et al. Ann Int Med 1991;115:256-265
Fiumara et al. Predictors of major hemorrhage following fibrinolysis for acute pulmonary embolism. Am J Cardiol 2006;97:127-129.
Goldhaber et al. Lancet 1999;353:1386-89.
96. Controversies
Bradyarrhthymia and hemolysis from rheolytic
thrombectomy
Fears of vascular perforation
“A double-edged sword” chest 2007 vs. shining
saber chest 2008
97. Meta-analysis
0 RCTs
6 prospective trials
29 retrospective reviews
594 patients
All level 2 and 3 evidence
Reported indications were severe shock,
cardiopulmonary arrest, contraindication to IV tPA,
failure of IV tPA
99. Role for catheter treatment of submassive
PE requires an answer to these questions
How important is rapid clearance of thrombus?
Role of thrombolysis
How does the effectiveness of catheter directed
thrombolysis compare to systemically delivered lytic
agents?
Can catheter directed therapy achieve the same
results as systemic lytic therapy at a lower dose of the
lytic agent?
Reduce hemorrhage?
100. thrombolysis and hemorrhage
Half of patients have a contraindication to thrombolysis
20% major hemorrhage rate when systemic lytics
administered
3-5% hemorrhagic stroke
Case series of ten patients with massive PE treated with
catheter directed ultrasound-accelerated thrombolysis
Reteplase (0.5 mg)
Heparin not simultaneously delivered
No major complications
1 patient with nonfatal hemoptysis
1 patient with small groin hematoma
101. OnGOING CLINICAL TRIALS
PERFECT 1
Pulmonary Embolism Response to Fragmentation,
Embolectomy, & Catheter Thrombolysis
A prospective observational study to evaluate the safety and effectiveness
data of catheter-directed therapy (CDT) including percutaneous mechanical
thrombectomy (PMT) for treatment of acute pulmonary embolism (PE)
NCT01097928
102. ACCP 2012 recommendations
In patients with acute PE associated with
hypotension (eg, systolic BP <90 mmHg) who do not
have a high bleeding risk, we suggest systemically
administered thrombolytic therapy over no such
therapy (Grade 2C)
In most patients with acute PE not associated with
hypotension, we recommend against systemically
administered thrombolytic therapy (Grade 1C)
In patients with acute PE when a thrombolytic agent
is used, we suggest administration through a
peripheral vein over a pulmonary artery catheter
(Grade 2C)
Guyatt GH, et al. Executive summary: antithrombotic therapy and prevention of thrombosis, 9th ed: American College of Chest Physicians
evidence-based practice guidelines. Chest 2012;141: 2 suppl 7S-47S.