Large-Bore Mechanical Thrombectomy of Acute Pulmonary Embolism at a Community-Based Hospital: A Case Series
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MILITARY MEDICINE, 00, 0/0:1, 2022
Large-Bore Mechanical Thrombectomy of Acute Pulmonary
Embolism at a Community-Based Hospital: A Case Series
Maj Elissa R. Ballas, USAF, MC; Maj Christopher D. Sanders, USAF, MC;
Lt Col Jason D. Hoskins, USAF, MC
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ABSTRACT Acute pulmonary embolism (PE) is a common, and sometimes fatal, diagnosis that results in over 11,000
deaths in hospitalized patients in the USA annually. In patients with high-risk or high-intermediate-risk PE and espe-
cially in whom thrombolytic therapy is contraindicated, mechanical thrombectomy can be an effective treatment option.
This case series outlines three patients with PE who were successfully treated with large bore aspiration thrombectomy
by Interventional Radiology at a community-based military treatment facility (MTF). Two patients had presented to the
emergency department with acute PE and a third of patients with acute PE were transferred from an outside hospital
specifically for mechanical thrombectomy due to a complication from systemic anticoagulation. The patients were cate-
gorized as good candidates for immediate large-bore aspiration thrombectomy, a recently added capability at the MTF.
The patients showed immediate improvement post-procedure and required only one night admission for observation to
the intensive care unit. Implementation of this new capability for patients with acute high-risk or high-intermediate-risk
PE or with contraindications to thrombolysis provides an alternative treatment with immediate, life-saving capability.
INTRODUCTION may be considered whenever catheter-directed thrombolysis
Acute pulmonary embolism (PE) is a common diagnosis in (CDT) is indicated.
the emergency department (ED). In 2000 and 2017, PE was Catheter-directed thrombolysis is a standard treatment
recorded as the underlying cause of death in 11,000-12,000 consideration for PE in intermediate-risk and some high-
deaths in the USA annually.1 Furthermore, an estimated risk patients, especially in those with contraindications to
20-25% of PE cases present as sudden death.2 Pulmonary systemic thrombolysis since infusion are typically 50-90%
embolisms are categorized into three main risk categories: lower than systemic thrombolysis. This involves the infusion
low-risk, intermediate-risk (previously “submassive”), and of a thrombolytic agent intravascularly adjacent to the clot
high-risk (previously “massive”). Patients with high-risk PE burden through a percutaneous catheter. Drawbacks to this
are typically those in cardiac arrest or who are hypoten- treatment option are the requirement to administer throm-
sive (defined as systolic blood pressure less than 90 mm Hg). bolytics for approximately 6-24+ hours and observation in
Patients with intermediate-risk PEs are those with evidence the intensive care unit (ICU) for at least 24-48 hours as well
of right ventricular dysfunction (based on computed tomog- as continued risk for major bleeding.3,4
raphy findings such as right to left ventricle size ratio, brain Mechanical thrombectomy without thrombolytic drugs can
natriuretic peptide laboratory values, or electrocardiogram be accomplished in a variety of ways, some of which have
changes) or myocardial necrosis (based on elevated tro- inherent risks. The Amplatz thrombectomy device was an
ponins). Intermediate-risk PEs can be further sub-divided early option that dates back to the 1990s and has limited
into high-intermediate risk and low-intermediate risk. Patients data available.5–7 Thrombectomy via mechanical thrombus
with low-risk PE are those who are normotensive and with- fragmentation with rotational pigtail catheters or balloon
out evidence of right ventricular dysfunction or myocardial angioplasty catheters was also an early option but will pur-
necrosis. In patients with acute PE who are hemodynam- posely result in distal embolization.8 Clinical trials for the
ically unstable (high-risk), reperfusion is traditionally rec- Aspirex spiral rotating catheters (Straub Medical AG, Wangs,
ommended using systemic thrombolytic therapy. However, Switzerland) were terminated in 2007 although a case report
there is a subset of intermediate- and high-risk patients in demonstrating successful use of Aspirex in a patient with
whom thrombolytic therapy is contraindicated that may ben- massive PE was published in 2010.9 High-pressure saline
efit from mechanical thrombectomy. Additionally, newer jet injection such as the AngioJet Thrombectomy System
medium or large bore mechanical thrombectomy devices (Boston Scientific, Marlborough, MA, USA), with or without
additional pulsed thrombolytic, received a black box warn-
Department of Radiology, David Grant USAF Medical Center, Travis ing in 2008 related to adverse events such as bradycardia,
AFB, CA 94535, USA massive hemoptysis, and renal failure. The 22 French Angio-
The views expressed are solely those of the authors and do not reflect the Vac Cannula (AngioDynamics, Latham, NY, USA) has been
official policy or position of the U.S. Air Force, the Department of Defense, shown to effectively treat massive PE in several case reports
or the U.S. Government.
doi:https://doi.org/10.1093/milmed/usac046 and a case series in the 2010s; however, there has been
Published by Oxford University Press on behalf of the Association of
reported difficulty with navigation in the pulmonary artery
Military Surgeons of the United States 2022. This work is written by (a) US due to its large size and relative inflexibility. Furthermore,
Government employee(s) and is in the public domain in the US. the AngioVac Cannula includes an extracorporeal, filtered
MILITARY MEDICINE, Vol. 00, Month/Month 2022 1Mechanical Thrombectomy of Acute Pulmonary Embolism
bypass circuit and, therefore, requires resources that may not
be available at a community hospital.10–13 Medium-bore aspi-
ration thrombectomy with the 12 French Penumbra Indigo
Aspiration System (Penumbra Inc, Alameda, California) or
large-bore aspiration thrombectomy (LBAT) with the 20 and
24 French Inari FlowTriever System (Inari Medical, Irvine,
CA, USA) are newer technologies that both show promising
data in ongoing clinical trials.14–17
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In the recent FlowTriever Pulmonary Embolectomy Clin-
ical Study trial, the Inari FlowTriever System was shown to
be safe and effective in patients with acute intermediate-risk
PE, yielding significant improvement in right to left ventricle
size (RV/LV) ratio with minimal major bleeding.18 Addition-
ally, data from a single-institution study that included LBAT
performed on patients with both high-risk and intermediate-
risk PE yielded 100% technical and 88% clinical success
with the FlowTriever System.19 Another study attempted a
FIGURE 1. Coronal CT angiogram of the chest showing large pulmonary
retrospective comparison between CDT and LBAT, with 26 emboli involving the right upper lobe and lower lobe pulmonary arteries as
matched cases in each group. Results showed a similar reduc- well as the left main pulmonary artery.
tion in pulmonary artery pressure and heart rate; however,
the LBAT group demonstrated a higher rate of mortality,
ultimately concluding that larger studies are needed to truly for a D-dimer of 9.28, creatinine of 5.1 mg/dL (baseline
compare the options.20,21 Interim results from the FlowTriever 2.0 mg/dL), troponin of 0.202 ng/mL, and lactic acid level
All-Comer Registry for Patient Safety and Hemodynam- of 5.7 mmol/L. Clinically, he was diaphoretic with shallow
ics trial (NCT03761173) are particularly promising; of 500 respirations and significant dyspnea with speaking. His oxy-
patients enrolled in 26 sites within the USA, 93.8% pre- genation improved to 100% with a non-rebreather mask at
sented with intermediate-risk PE and the remaining patients 12-15 L/min and work of breathing slightly improved. A CT
presented with high-risk PE. Immediately post-procedure of angiogram of the chest revealed large pulmonary emboli in
mechanical thrombectomy, the FLASH trial showed signifi- the right and left main pulmonary arteries and findings con-
cantly improved clinical outcomes of heart rate, pulmonary sistent with right heart strain (Fig. 1). The patient also showed
artery pressure, and cardiac index. Long-term outcomes at evidence of early multiple organ system failure to include
6 months showed improvements in RV/LV function, and 91% acute kidney injury and type II non-ST-elevation myocar-
of patients had a decrease in severe dyspnea. Mortality risk dial infarction. Since the patient met the criteria for high-
was low: 0.2% at 48 hours, 1.1% at 30 days, and 4.9% at intermediate-risk PE with concerns for impending multiple
6 months. Additional research is forthcoming as enrollment organ system failure, the ED consulted Interventional Radiol-
will begin soon in the PEERLESS trial, which is a randomized ogy (IR) for consideration of thrombectomy versus thrombol-
controlled trial with up to 700 patients with intermediate– ysis. After consultation between providers in IR and Critical
high-risk PE in the USA and Europe comparing mechanical Care/Pulmonary per local policy, with input from providers
thrombectomy and CDT. in the ED, it was felt that urgent mechanical thrombectomy
would provide the most immediate benefit with the least risk.
CASE DESCRIPTION The patient initially presented to the ED at 13:21 hours, under-
went CT angiogram at 15:11 hours, and began mechanical
Case #1 thrombectomy in IR at 17:45 hours.
An 80-year-old male patient with a history of chronic kidney A 24 French FlowTriever system was advanced through
disease, diabetes mellitus, hypertension, and atrial tachy- a 24 French Gore Dry-seal sheath from the right common
cardia treated and well-controlled with diltiazem presented femoral vein into the right pulmonary artery. Extirpation
to the ED at the local military hospital with a chief com- of matter from the inferior right pulmonary artery was per-
plaint of shortness of breath on exertion for the past 3 weeks. formed. Post-embolectomy, there was near-complete filling
The patient had not recently been on anticoagulation for any of the right pulmonary artery inferior branch, where there had
medical conditions. The patient reported becoming short of previously been a filling defect (Figs. 2–3). Clinically, the
breath when he stood or walked short distances, resulting in patient’s oxygen saturation and pulse rate improved imme-
lightheadedness and dizziness. Upon initial presentation to diately after further, more complete, right pulmonary artery
the ED, the patient was tachycardic (210 bpm), tachypneic embolectomy. In total, large amounts of thrombotic material
(30 respirations/min), hypotensive (89/54 mm Hg), and were removed, primarily from the right pulmonary arter-
hypoxic (SpO2 94%). Laboratory data were significant ies with a small amount of matter removed from the left
2 MILITARY MEDICINE, Vol. 00, Month/Month 2022Mechanical Thrombectomy of Acute Pulmonary Embolism
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FIGURE 2. Pre-embolectomy filling. Notice the absence of contrast in the
right lower lobe.
FIGURE 4. Thrombus extracted from the main pulmonary arteries with the
FlowTriever System.
Case #2
A 65-year-old male with a history of renal failure, anemia,
and obesity was transferred from an outside hospital after
being diagnosed with a large saddle PE resulting in bilateral
near-complete obstruction of both main pulmonary arteries.
Upon presentation to the ED at the outside hospital 2 days
before transfer, the patient reported a history of persistent
shortness of breath over the past few weeks. Laboratory data
were significant for elevated troponin of 0.27 ng/mL. Electro-
cardiogram was remarkable for sinus tachycardia to 119 beats
per minute, inverted T waves in lead III, and flattened T waves
in augmented Vector Foot lead. In addition to a large saddle
PE, imaging at the outside hospital showed evidence of right
FIGURE 3. Post-embolectomy filling. Notice the large, significant increase
in right lower lobe filling. heart strain, to include an enlarged right ventricle and hepatic
reflux. The patient was hemodynamically stable on 5-6 L/min
oxygen by nasal cannula, which was a new oxygen require-
ment for him. He was initially treated with an unfractionated
pulmonary artery division (Fig. 4). The patient was admit- heparin drip at the outside hospital but developed lower gas-
ted to the ICU for overnight observation. The only minor trointestinal (GI) bleeding, which resulted in discontinuation
complication was a Category A (based on Society of Interven- of heparin. Based on the development of lower GI bleed-
tional Radiology Adverse Event Classification) right inguinal ing with systemic anticoagulation, IR at this local Northern
area hematoma associated with large bore access and a pre- California Department of Defense community-based hospital
existing fat-containing inguinal hernia, which was not medi- was consulted for mechanical thrombectomy. The patient was
cally significant. subsequently accepted and transferred.
MILITARY MEDICINE, Vol. 00, Month/Month 2022 3Mechanical Thrombectomy of Acute Pulmonary Embolism
Mechanical thrombectomy was performed with the Flow- or high-risk PE with contraindications to systemic throm-
Triever system. A 20 French FlowTriever was advanced bolysis would be offered lower-dose CDT and/or surgical
through a 24 French Gore dry seal sheath from the right options and usually require admission to the ICU for 7+
common femoral vein to the left pulmonary artery. Extir- days or may require transport to a higher level of care for
pation of matter from the left pulmonary artery was per- other treatment options. The local IR department recently
formed. The 20 French FlowTriever system was exchanged obtained and implemented use of the FlowTriever System
for a 24 French FlowTriever system, and extirpation of matter in order to expand capability and provide this life-saving
was performed from the right pulmonary arteries. Clinically, treatment option. Implementation included presentation of
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the patient’s shortness of breath improved immediately after capabilities and recent study results to the ED staff, Criti-
thrombectomy. The patient was admitted to the ICU for cal Care/Pulmonary staff, and Hematology/Oncology staff.
overnight observation. The patient was downgraded to the In this case series, the patients were quickly and effectively
general medicine floor the following day where he remained treated with immediate improved clinical outcomes and no
hospitalized for 3 days for further management of his GI requirement to transfer to a higher level of care at an outside
bleed. hospital. Admission to the ICU for acute PE after mechanical
thrombectomy was less than 24 hours (due to the novelty of
Case #3 the procedure at this hospital), and the ICU and critical care
A 57-year-old male patient with a history of polymyositis teams were significantly impressed with the quick recovery
on prednisone presented to the ED with a chief complaint and subsequent status downgrade compared to prior patient
of chest pain and shortness of breath that had begun the day outcomes.
prior. Upon presentation to the ED, the patient was tachypneic
(22 respirations/min) but otherwise hemodynamically stable LESSONS LEARNED
(heart rate 84 bpm; blood pressure 118/94 mm Hg; SpO2 99%) Mechanical thrombectomy is increasingly becoming a main-
and comfortable appearing on room air. His physical exam stay as a treatment option for high-intermediate and lysis-
was unremarkable. The patient’s troponin was elevated to contraindicated high-risk PE cases. Specifically, LBAT with
0.402 ng/mL, which was concerning for type II NSTEMI, the Inari FlowTriever System has significantly transformed
and D-dimer was elevated to 16.71. Remainder of laboratory PE treatment at this community-based hospital with three
data was unremarkable. A CT chest angiogram showed saddle recent cases producing similar positive outcomes. Penumbra
PE with extension into the right and left pulmonary arteries, Indigo launched a smaller, 12 French (Cat 12) system in July
as well as multiple segmental and subsegmental pulmonary 2020 in order to compete with the Inari 24 French FlowTriever
arteries bilaterally. There was also evidence of right heart system. Initial research has shown that mechanical thrombec-
strain to include an enlarged right ventricle with flattening of tomy can provide immediate hemodynamic improvement
the interventricular septum. Based on the size of the PE, IR without the bleeding risk involved with CDT. Furthermore,
was consulted for consideration of mechanical thrombectomy. mechanical thrombectomy involves a shorter hospital stay.
After multidisciplinary consultation confirmed that the While more prospective research directly comparing mechan-
patient was expected to benefit from mechanical thrombec- ical thrombectomy with CDT needs to be performed, initial
tomy, a 24 French FlowTriever system was advanced into research and the outcomes from this case series favor mechan-
the right pulmonary artery, and extirpation of matter from ical thrombectomy for some high-risk and intermediate-risk
the right pulmonary artery network was performed. The patients with PE.
FlowTriever system was then advanced into the left pul- With the implementation of this local treatment option,
monary artery, and extirpation of matter was performed several lessons are learned. First, identifying the appro-
within two inferior lobe branches. Post-embolectomy, there priate subset of patients that would benefit from mechani-
was near-complete filling of the right and left pulmonary cal thrombectomy is important. This treatment seems to be
artery branches where there had previously been filling most appropriate for high-risk and high-intermediate-risk PE
defects. Clinically, the patient’s chest pain and shortness of patients, particularly those who are unstable and/or decom-
breath improved immediately post-embolectomy. The patient pensating quickly. Second, the importance of educating front-
was admitted to the ICU for overnight observation and dis- line staff in the ED and in critical care settings about the
charged home the next morning with oral anticoagulation. The capability of mechanical thrombectomy and the appropri-
patient developed a right inguinal hematoma associated with ate patient population for this treatment is paramount. The
large bore access classified as Category A (based on Society sooner appropriate patients are identified, the faster they can
of Interventional Radiology Adverse Event Classification). be treated and possibly stabilized. Third, there have been two
large post-procedural inguinal hematomas, which were not
DISCUSSION medically significant; however, IR is now trialing the use of
The local Northern California Department of Defense 1 or 2 Perclose closure devices (Abbott Vascular, Chicago, IL,
community-based hospital has limited inpatient services. A USA) to help re-appose the common femoral vein access site
patient presenting to this hospital with high-intermediate due to the 24 French sheath size.
4 MILITARY MEDICINE, Vol. 00, Month/Month 2022Mechanical Thrombectomy of Acute Pulmonary Embolism
CONCLUSION thromboembolism: distal embolisation and pulmonary arterial pres-
Mechanical thrombectomy should be considered as a treat- sure elevation. Br J Radiol 2008; 81(971): 848–54.
9. Popovic P, Bunc M: Massive pulmonary embolism: percutaneous
ment option for patients with PE. Newer technology has
emergency treatment using an Aspirex thrombectomy catheter. Car-
shown promising data regarding effectiveness and limited risk diovasc Intervent Radiol 2010; 33(5): 1052–5.
of mechanical thrombectomy for patients with PE. Use of a 10. Behrens G, Bjarnason H: Venous thromboembolic disease: the use
large-bore device for three patients with high-intermediate- of the aspiration thrombectomy device AngioVac. Semin Intervent
risk PE has been demonstrated at a community-based DoD Radiol 2015; 32(4): 374–8.
11. Pasha AK, Elder MD, Khurram D, Snyder BA, Movahed MR: Suc-
hospital.
Downloaded from https://academic.oup.com/milmed/advance-article/doi/10.1093/milmed/usac046/6543981 by guest on 18 June 2022
cessful management of acute massive pulmonary embolism using
Angiovac suction catheter technique in a hemodynamically unstable
ACKNOWLEDGMENT patient. Cardiovasc Revasc Med 2014; 15(4): 240–3.
None declared. 12. Donaldson CW, Baker JN, Narayan RL, et al: Thrombectomy using
suction filtration and veno-venous bypass: single center experi-
FUNDING ence with a novel device. Catheter Cardiovasc Interv 2015; 86(2):
None declared. E81–7.
13. D’Ayala M, Worku B, Gulkarov I, Sista A, Horowitz J, Salemi A: Fac-
tors associated with successful thrombus extraction with the Angio-
CONFLICT OF INTEREST STATEMENT
Vac device: an institutional experience. Ann Vasc Surg 2017; 38:
None declared.
242–7.
14. Rali PM, Criner GJ: Submassive pulmonary embolism. Am J Respir
REFERENCES Crit Care Med 2018; 198(5): 588–98.
1. Barco S, Valerio L, Ageno W, et al: Age-sex specific pulmonary 15. Todoran TM, Petkovich B: Aggressive therapy for acute pulmonary
embolism-related mortality in the USA and Canada, 2000-18: an anal- embolism: systemic thrombolysis and catheter-directed approaches.
ysis of the WHO Mortality Database and of the CDC Multiple Cause Semin Respir Crit Care Med 2021; 42(2): 250–62.
of Death database. Lancet Respir Med 2021; 9(1): 33–42. 16. Aggarwal V, Nicolais C, Lee A, Bashir R: Acute management of pul-
2. Beckman MG, Hooper WC, Critchley SE, Ortel TL: Venous throm- monary embolism. Am Coll Cardiol 2017. Available at https://www.
boembolism: a public health concern. Am J Prev Med 2010; 38(4 acc.org/latest-in-cardiology/articles/2017/10/23/12/12/acute-manag
Suppl): S495–501. ement-of-pulmonary-embolism.
3. Brown KN, Devarapally SR, Lee LS, Gupta N: Catheter directed 17. Markovitz M, Lambert N, Dawson L, Hoots G: Safety of the
thrombolysis of pulmonary embolism. In: StatPearls. StatPearls Pub- Inari FlowTriever device for mechanical thrombectomy in patients
lishing; 2021: 1–9. Available at https://www.ncbi.nlm.nih.gov/boo with acute submassive and massive pulmonary embolism and con-
ks/NBK536918/. traindications to thrombolysis. Am J Interv Radiol 2020; 4(18):
4. Piazza G, Hohlfelder B, Jaff MR, et al: A prospective, single-arm, 1–6.
multicenter trial of ultrasound-facilitated, catheter-directed, low-dose 18. Tu T, Toma C, Tapson VF, et al: A prospective, single-arm, multicenter
fibrinolysis for acute massive and submassive pulmonary embolism: trial of catheter-directed mechanical thrombectomy for intermediate-
the SEATTLE II study. JACC Cardiovasc Interv 2015; 8(10): 1382–92. risk acute pulmonary embolism: the FLARE study. JACC Cardiovasc
5. Tadavarthy SM, Murray PD, Inampudi S, Nazarian GK, Amplatz K: Interv 2019; 12(9): 859–69.
Mechanical thrombectomy with the Amplatz device: human experi- 19. Wible BC, Buckley JR, Cho KH, Bunte MC, Saucier NA, Borsa JJ:
ence. J Vasc Interv Radiol 1994; 5(5): 715–24. Safety and efficacy of acute pulmonary embolism treated via large-
6. Coleman CC, Krenzel C, Dietz CA, Nazarian GK, Amplatz K: bore aspiration mechanical thrombectomy using the Inari FlowTriever
Mechanical thrombectomy: results of early experience. Radiology device. J Vasc Interv Radiol 2019; 30(9): 1370–5.
1993; 189(3): 803–5. 20. Graif A, Patel KD, Wimmer NJ, et al: Large-bore aspiration thrombec-
7. Uflacker R: Mechanical thrombectomy in acute and subacute throm- tomy versus catheter-directed thrombolysis for acute pulmonary
bosis with use of the Amplatz device: arterial and venous applications. embolism: a propensity score-matched comparison. J Vasc Interv
J Vasc Interv Radiol 1997; 8(6): 923–32. Radiol 2020; 31(12): 2052–9.
8. Nakazawa K, Tajima H, Murata S, Kumita SI, Yamamoto T, 21. Vedantham S: Pulmonary embolism: putting the horse back in front of
Tanaka K: Catheter fragmentation of acute massive pulmonary the cart. J Vasc Interv Radiol 2021; 32(3): 477–8.
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