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224 Chapter 20 Catheter-directed thrombolysis for acute iliofemoral deep vein thrombosis
https://t.me/med1917
such studies from January1996 to February2020 to perform a meta-analysis of the outcomes of CDT against anticoagulation alone in 8737 patients with acute DVT over
a weighted mean follow-up of 30.5 ± 28 months. While
there was no signicant difference in age, gender, baseline comorbidities, and risk factors of DVT, patients who
underwent CDT were more likely to present with iliofemoral (48.9% vs 39.3%, p-value < .001) and less likely with
femoropopliteal (50.1% vs. 56.1%, p-value=.021) DVT.
At 6 months follow-up, CDT was associated with higher
venous patency (71.1% vs 37.7%; OR 5.49, 95% CI [2.63,
11.5], p-value < .001) and lower PTS (27% vs. 40.7%; OR
0.44, 95% CI [0.22, 0.86], p-value=.02).
14
Of the few randomized data assessing the efcacy of
CDT in acute iliofemoral DVTs, one of the most inuential
is the CaVenT trial. It randomized 189 patients between 18
and 75years of age presenting with acute iliofemoral DVT
within 21 days of symptoms from January2006 to December2009 within eight Norway hospitals to receive either
anticoagulation with low-molecular-weight heparin transitioned to coumadin only or CDT in addition to standard
anticoagulation. All DVTs were conrmed using ultrasound, or by venography or CT if ultrasound was inconclusive, and followed for patency and development of PTS at
6 and 24 months. At 6 months, there was no difference in
the incidence of PTS between the two groups, but iliofemoral venous patency was signicantly higher in the CDT
group (66% vs 47%, p-value=0.012). At later time points
there was a considerable reduction in PTS for the CDT
group, as PTS was present in 41% of patients in the CDT
group vs 56% of patients in the anticoagulation group at
2years and 43% vs 71% at 5years, respectively. The CDT
group reported 20 bleeding complications, 3 of which were
classied as major (abdominal wall hematoma necessitating blood transfusion, one compartment syndrome needing
surgery, access site hematoma) and 5 as clinically relevant.
There were no deaths, pulmonary embolisms, or cerebral
hemorrhages related to CDT. These ndings represent the
rst large, randomized trial demonstrating benet to CDT
as an effective adjunct for iliofemoral DVT.
26
Another important study that looked at the use of
thrombolytic therapy and other aggressive thrombus
removal strategies was the ATTRACT trial. ATTRACT
was an NIH-funded multicenter trial that randomized 692
patients to systemic anticoagulation alone or pharmacomechanical thrombolysis (PCDT) in conjunction with
anticoagulation, which included catheter-directed lysis,
percutaneous mechanical thrombectomy, or both. Of those
randomized to PCDT, 58% were treated with a catheter-directed-lysis-rst or infusion-rst strategy, while the remainder utilized thrombectomy or fragmentation devices during
initial treatment. As such, the ndings are not necessarily
immediately generalizable to CDT treatment options, but
instead reect current-day practice that includes the complementary use of CDT and thrombectomy devices dependent on specic patient characteristics and presentation.
This study failed to show a difference in the primary endpoint of development of PTS between 6 and 24 months
and did show an increase in major bleeding rate among the
patients randomized to PCDT (1.7% for PCDT vs 0.3%
for anticoagulation alone, p-value = 0.049). However,
while there was no difference in the rate of development of
any PTS in the entire study group, there was a signicant
reduction in the development of moderate or severe PTS at
24 months in those treated with PCDT compared to those
randomized to anticoagulation alone (17.9% vs 23.7%,
p-value=0.035), as well as reductions across Villalta and
Venous Clinical Severity Scores, which reect patient quality of life. Additionally, largely due to patient recruitment
and enrollment reasons, this study included patients with
isolated femoropopliteal venous thrombosis, which are
generally recognized to benet less from aggressive thrombus removal strategies. When looking at subset analyses
from the ATTRACT trial, it is evident that those with more
proximal venous thrombosis of the iliofemoral segments
had more substantial benet from PCDT than those with
isolated femoropopliteal segments (moderate/severe PTS of
18.4% in PCDT group compared to 28.2% in anticoagulation group for iliofemoral segments; 17.1% vs 18.1%,
respectively, for femoropopliteal segments).
27
The rapid restoration of venous patency offered by
aggressive strategies of thrombus removal make CDT and
PMT especially applicable to patients with PCD. PCD is a
highly morbid condition involving complete venous outow obstruction, ultimately translating to arterial malperfusion.
28
This condition is more common in settings of
underlying malignancy and heparin-induced thrombocytopenia and is highly correlated with perioperative death and
high rates of amputation.
29–31
Systemic anticoagulation with heparin has long been
shown to be ineffective in treating PCD because of its therapeutic extent being limited to arresting thrombus progression
and not in addressing profound venous outow obstruction
seen in PCD or venous gangrene.
5
The relative rarity of the
clinical presentation has made reports of PCD management
with catheter-directed thrombolysis or PMT sparse in the
available medical literature. Despite the lack of high-quality
evidence, the reported efcacy of these options in limiting
and even reversing the effects of PCD, along with the relative
inefcacy of systemic anticoagulation in reducing the morbidity and mortality associated with limb-threatening PCD,
make CDT and PMT attractive options for this condition,
and they have therefore been given strong recommendation
(grade 1A) in societal guidelines.
32
The most updated guidelines established by the Society of Vascular Surgery (SVS) and the American Venous
Forum (AVF) offer evidence-based guidelines for the diagnosis and treatment of acute venous thrombosis.
33
In these
guidelines, early thrombus removal strategies are recommended for patients with a rst episode of iliofemoral
deep venous thrombosis who have symptoms <14 days in
duration, have a low risk of bleeding, and who are ambulatory with good functional capacity and an acceptable
life expectancy (grade 2C). Early thrombus removal strategies are also recommended for patients with PCD due
to the limb-threatening nature of this condition and the
need for immediate restoration of patency (grade 1A).
Those with isolated femoropopliteal DVTs, on the other
hand, are recommended to undergo systemic anticoagulation alone due to the lack of data supporting the use
of CDT or PMT in these patients (grade 1C). Although
early strategies of thrombus removal can include either
open surgical thrombectomy or percutaneous techniques,
the guidelines recommend percutaneous therapies over
20.6 Clinical evidence and guidelines for lytic therapy
https://t.me/med1917
225
surgical thrombectomy due to the demonstrated efcacy
and favorable risk prole of these devices (grade 2C).
When choosing between types of percutaneous therapies,
mechanical thrombectomy catheter use is favored over
CDT in centers where the appropriate expertise exists, due
largely to the potential bleeding risks of ongoing multiday
CDT (grade 2C). For selected patients with contraindications to thrombolytic therapy who are candidates for anticoagulation (i.e., a patient with PCD at a center without
expertise in PMT procedures), open thrombectomy is recommended (grade 2C). Asummary of the SVS/AVF guidelines is noted in Table20.3.
TABLE 20.3 Society of Vascular Surgery/American Venous Forum guidelines for early thrombus removal strategies in
acute deep venous thrombosis
Guideline Grade
Recommendation FOR:
• CT venogram, or
• Contrast venography, or
• MRvenography
In patients with suspected DVT not conrmed by standard duplex ultrasonography
Suggestion FOR:
• Early thrombus removal in patients with a rst episode of acute iliofemoral deep venous thrombosis,
symptoms <14 days in duration, a low risk of bleeding, and ambulatory with good functional capacity
and an acceptable life expectancy
Recommendation AGAINST:
• Early thrombus removal in patients with isolated
femoropopliteal deep venous thrombosis
(Use of conventional anticoagulation therapy alone in
these patients)
Recommendation FOR:
• Early thrombus removal in patients with
limb-threatening venous ischemia due to iliofemoral
deep venous thrombosis with or without associated
femoropopliteal venous thrombosis (phlegmasia
cerulea dolens)
Recommendation FOR:
• Percutaneous catheter-based techniques over open
thrombectomy in aforementioned patients
Suggestion FOR:
• Pharmacomechanical thrombectomy device usage
over CDT alone if expertise and resources are
available
Recommendation AGAINST:
• Routine use of inferior vena cava lters (IVCFs)
during early thrombus removal
Recommendation FOR:
• The use of self-expanding metallic stents for treatment of chronic iliocaval compressive or obstructive
lesions that are uncovered by any of the thrombus
removal strategies
Suggestion AGAINST:
• Use of stents in the femoral and popliteal veins
Recommendation FOR:
• Anticoagulation after treatment with PMT or CDT
Recommendation FOR:
• Knee-high compression stockings (30–40 mmHg) for
at least 2years after the procedure
1: Strong
2: Weak
1 C
2 C
1 C
1 A
1 C
2 C
1 C
1 C
2 C
1 A
1 C
Quality
A. High
B. Moderate
C. Low or
very low 1A
Type of DVT
Iliofemoral Isolated fem-
oropopliteal
✓ ✓ ✓
✓ ✓
✓
✓ ✓
✓ ✓
✓ ✓ ✓
✓ ✓ ✓
✓ ✓
✓ ✓ ✓
✓ ✓ ✓
Phlegmasia
✓
20
226 Chapter 20 Catheter-directed thrombolysis for acute iliofemoral deep vein thrombosis
https://t.me/med1917
20.7 CONCLUSION
The currently available evidence and understanding of the
natural history of acute iliofemoral DVTs, in conjunction
with appreciation of the morbidity and costs associated,
both direct health care and QALY-based, suggest CDT as
an early treatment modality with or without PMT, and
this contention is supported by current societal guidelines
for most functional patients with acute iliofemoral venous
thrombosis. This is especially true in patients with severe
venous outow obstruction and PCD, where aggressive
and early thrombus removal remains the primary treatment of choice. Based on current medical literature, CDT
is safe with appropriate facility resources and efcacious
in achieving complete recanalization and prevention of
PTS over systemic anticoagulation alone. Despite the available evidence and society recommendations, use of CDT
remains underutilized in both tertiary care and outpatient
settings, and further awareness within the greater practitioner community remains necessary.
34,35
Guidelines 20.0 of the American Venous Forum on catheter-directed thrombolysis for acute iliofemoral deep vein
thrombosis
No. Guideline Strength of recommendation Grade of evidence
20.1 We suggest early thrombus removal in patients with a rst episode of acute iliofemoral deep venous thrombosis, symptoms
<14 days in duration, a low risk of bleeding, and ambulatory
with good functional capacity and an acceptable life expectancy.
20.2 In patients with limb-threatening venous ischemia (phlegmasia
cerulea dolens) due to iliofemoral deep venous thrombosis with
or without associated femoropopliteal venous thrombosis, we
recommend early thrombus removal.
20.3 In patients with acute iliofemoral DVT, we suggest pharmacomechanical thrombectomy over CDT alone if expertise and
resources are available.
2
(weak)
1
(strong)
2
(weak)
C
(low to very low)
A
(high)
C
(low to very low)
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20
https://t.me/med1917
CHAPTER
21
https://t.me/med1917
Percutaneous mechanical thrombectomy
for treatment of acute iliofemoral
deep vein thrombosis
Kayla J. Krause, Ahsan Zil-E-Ali, Faisal Aziz, and Peter Gloviczki
21.1 INTRODUCTION
In 2018, venous thromboembolism (VTE) disease affected
over 1million individuals in the United States.
mated 389,000 patients had pulmonary embolism (PE)
and 626,000 had deep vein thrombosis (DVT). Thirty-day
mortality was 5.1% and 1-year mortality was 19.6% in
Medicare beneciaries.
RIETE registry that included 116,655 patients, 30-day
mortality was 2.57% for lower extremity DVT and 5.07%
3
for PE.
The main goal of VTE treatment is to reduce the
risk of PE, for which anticoagulation is the mainstay of
treatment.
inammation and swelling, and the late complication of
post-thrombotic syndrome (PTS). Standard anticoagulation used heparin or a derivative as the initial choice and
bridging to warfarin as a long-term oral anticoagulant.
The newer direct oral anticoagulants (DOACs), however,
are now the agents of choice for both initial and longterm anticoagulation. Chapter19 discusses in detail the
best medical therapy of VTE. Anticoagulation is effective
to decrease PE, but the most signicant late complication
of VTE, PTS, cannot be prevented or treated with anticoagulation alone, with estimates suggesting 20%–50% of
patients develop PTS after an acute DVT, despite adequate
anticoagulation.
of chronic venous insufciency (CVI) that occur after acute
DVT; it is generally evident within the rst few months
after the acute event. Patients with PTS may present with
pain, edema, cramps, venous claudication, pigmentation,
lipodermatosclerosis, eczema, dermatitis, varicose veins,
and atrophie blanche, and in severe cases ulcerations, leading to signicant pain, disability, and an impairment in the
quality of life.
with abnormal microcirculation, plays a central role in
the development of PTS, which results in destruction of
the valves, venous incompetence, and/or chronic luminal
obstruction and vein wall brosis, driven by thrombus-induced inammation or physical scarring that causes venous
valve dysfunction.
4–7
The secondary goal is to reduce early pain,
PTS is dened as a constellation of signs and symptoms
8,12
2
In recent data of the international
8–11
Ambulatory venous hypertension, along
13–15
1
An esti-
21.2 RATIONALE FOR REMOVAL OF
THROMBUS
The rationale for thrombus removal in patients with iliofemoral DVT is based on the underlying pathophysiology of
chronic venous disease, which leads to valvular incompetence and venous obstruction.
the severity and extent of DVT, delay in treatment, or
use of anticoagulation alone are risks of post-thrombotic
morbidity. Early thrombus removal is especially important in patients with severe symptoms of proximal venous
obstruction and in those with phlegmasia cerulea dolens
or venous gangrene. Strategies of thrombus removal in
patients with iliofemoral DVT will reduce chronic venous
obstruction, resulting in reduction, although not elimination, of PTS.
dolens or venous gangrene, however, it may salvage the
limb or the life of the patients.
Chapter20 discusses the most frequently used technique of thrombus removal, catheter-directed thrombolysis (CDT). During CDT, patients need to be monitored
in an intensive care unit. Major bleeding complications
still can occur, and this has hampered the widespread use
of CDT. ACochrane review of 19 randomized controlled
trials (RCTs) of 1943 patients who underwent treatment
for VTE found that complete clot lysis was more frequent
(RR 4.75; 95% CI 1.83–12.33) and PTS slightly less frequent (50% vs 53%, RR 0.78, 95% CI 0.66–0.93) after
using thrombolytic strategies vs anticoagulation alone.
Bleeding complications, however, were signicantly more
frequent with thrombolysis (6.7% vs 2.2%, RR 2.45,
95% CI 1.58–3.78) than with anticoagulation. The longawaited ATTRACT trial randomized 692 patients with
acute DVT to receive either anticoagulation alone or
anticoagulation plus pharmacomechanical thrombolysis
(PMT) (catheter-mediated or device-mediated intrathrombus delivery of recombinant tissue plasminogen activator [TPA] and thrombus aspiration or maceration, with
or without stenting).
was no signicant between-group difference in patients
with PTS (47% vs 48%). PMT, however, led to more
12,17–19
In patients with phlegmasia cerulea
22
Between 6 and 24 months, there
16
Studies have shown that
20
21
DOI: 10.1201/9781003328971-24
229229
230 Chapter 21 Percutaneous mechanical thrombectomy for treatment of acute iliofemoral deep vein thrombosis
https://t.me/med1917
major bleeding events within 10 days (1.7% vs 0.3% of
patients, P=0.049). Severity scores for PTS were lower
in the PMT group up to 24 months, but quality of life
(QOL) was similar between groups. In recent years, therefore, percutaneous mechanical thrombectomy (MT) has
been used with increasing frequency to avoid or shorten
lytic therapy, decrease drug dose, shorten overall treatment time, decrease bleeding complications, and reduce
early symptoms and the incidence of late PTS.
21.3 ULTRASOUND-ASSISTED
THROMBOLYSIS AND
PHARMACOMECHANICAL
AND MECHANICAL
THROMBECTOMY
Currently, more than 45 peripheral venous MT or thrombolysis devices are approved in the United States by the
Food and Drug Administration.
ultrasonic or mechanical techniques has rapidly become
the standard for catheter-based management of extensive venous thrombosis, and MT, without the use of lytic
agents, has been gaining signicant popularity.
21.3.1 Ultrasound-assisted thrombolysis
CDT can be performed with ultrasound-assisted thrombolytic catheters that facilitate dispersion of the TPA to
shorten the time needed for lysis. Ultrasound waves generated during infusion of the plasminogen activator increase
the surface area of brin and speed lysis. This concept was
studied by Engelberger et al.
xed-dose, low-intensity, ultrasound-assisted thrombolysis was a safe and effective treatment for PE. The same
authors reported on ultrasound-accelerated thrombolysis for iliofemoral DVT followed by routine stenting.
They randomized 48 patients with DVT to receive CDT
or ultrasound-accelerated thrombolysis.
of treatment, the authors found that patients had 54%
and 55% (P=0.91) thrombus load reductions with CDT
and ultrasound-accelerated thrombolysis, respectively.
There were no differences between treatment groups in
any of the other outcomes. Follow-up at 1year conrmed
that the addition of intravascular ultrasound to conventional CDT did not have any impact on relevant clinical
or duplex sonographic outcomes, which were favorable
in both groups.
The 2020 Ultrasound-Accelerated Catheter-Directed
Thrombolysis Versus Anticoagulation for the Prevention
of Post-Thrombotic Syndrome (CAVA) trial compared 115
patients with iliofemoral DVT randomly assigned to either
ultrasound-accelerated CDT or standard therapy alone.
The trial showed that early reperfusion with CDT did not
reduce the incidence of PTS compared with standard therapy alone. Follow-up in 2021 showed that ultrasound-accelerated CDT prevented PTS increases with time, but there
was still no change to the patients’ QOL.
27
23
The adjunctive use of
24
In a single-center RCT,24
26
After 15hours
29
25
28
21.3.2 Pharmacomechanical and
mechanical thrombectomy
Percutaneous MT can be performed with drug injection but
also without the use of any lytic treatment. MT devices are
distinguished based on their action of thrombus removal:
oscillation/maceration, suction aspiration, or augmented
aspiration.
22.3.2.1 Oscillation/maceration
Examples of devices that work with oscillation/maceration include the Cleaner device (Argon Medical),
Arrow-Trerotola Over-the-Wire Percutaneous Thrombolytic Device (Teleex, Inc.) (recalled in 2021), and the Trellis device (Medtronic, Inc.).
an important RCT showed some advantages of this technique.
22.3.2.2 Suction aspiration
This group includes, among others, the Indigo Cat-18 and
the Lightning Intelligent devices (Penumbra, Inc.),
JETi device (WALK Vascular),
dynamics, Inc.) device,
bypass for use.
22.3.2.3 Augmented aspiration
Devices with augmented aspiration, among others, include
the AngioJet (Solent Proxi, Zelante) rheolytic devices (Boston Scientic),
Treaver basket (Inare Medical, Inc.).
22.3.2.4 Results of clinical trials
In a RCT22 that included 692 patients with acute proximal DVT, anticoagulation alone was compared to anticoagulation plus PMT (catheter-mediated or device-mediated
intrathrombus delivery of recombinant TPA and thrombus
aspiration or maceration, with or without stenting). The
AngioJet Rheolytic Thrombectomy System (Boston Scientic) or the Trellis Peripheral Infusion System (Covidien)
was used in addition to CDT. No difference was noted
in the incidence of PTS at 6 and 24 months between the
groups (48% vs 47 %), but PMT was associated with
more major bleeding events at 10 days (1.7% vs 0.3%
of patients, P=0.049). Severity scores for PTS after PMT
were lower at all intervals, up to 24 months. There was no
QOL improvement, however.
Multiple registries reported on outcomes after different pharmacomechanical and mechanical thrombectomies
(Table21.1).
investigated the AngioJet Rheolytic Thrombectomy device
in 329 patients with lower extremity DVT and found
that AngioJet treatment signicantly shortened procedure
time (Figure21.1). Major bleeding events occurred in 12
patients (3.6%), but none were related to the AngioJet
procedure.
tomy with CDT treatment of DVT is safe and effective and
potentially reduces procedure time and intensive care unit
stay. These results were conrmed in a systematic review
and meta-analysis of clinical trials comparing AngioJet
30
33
Trellis was discontinued, but
33
35
36
22,37
the FlowTriever discs, and the Clot-
36,37,39,40
The PEARL registry by Garcia et al.37
and the AngioVac (Angio-
which also needs a venovenous
38,39
The study concluded that rheolytic thrombec-
31,32
34
the
the
21.3 Ultrasound-assisted thrombolysis and pharmacomechanical and mechanical thrombectomy 231
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TABLE 21.1 Prospective registries of pharmacomechanical and mechanical thrombectomies for acute lower extremity
deep vein thrombosis
Registry First
author,
year
PEARL Garcia,
ARNSBERG Lichtenberg
RAPID Moriarty,
CLOUT Dexter, 2022 250 ClotTreaver
2015
2019
2021
37
40
36
N of
Treatment Primary efficacy
pts
329 AngioJet Rheo-
lytic Thrombectomy + CDT
56 AngioJet Rheo-
lytic Thrombectomy, Trellis, Indigo
System
234 AngioVac for
caval thromboemboli, right
heart masses,
catheter-related
thrombi and PE
system for lower
extremity DVT
outcome
Procedure time signicantly reduced with RT,
clot removal grade (not
different in groups)
PTS: at 1, 6, and 12
months, rVCSS, CEAP
score
% Removal or thrombus
or right heart mass
Because of the limited use
to remove PE, AngioVac
was not recommended for
this indication
>75% Thrombus removal
(Marder score): achieved
in 86% of limbs
Secondary efficacy
outcome
Freedom from rethrombosis, reintervention
Loss of benet of
thrombectomy
HRQOL
Iliofemoral patency
higher at 6 months
after MT vs CDT
PTS: severity, symptoms, pain, HRQOL
PTS: Villalta scale >5,
pain scale (NPRS),
rVCSS, HRQOL:EQ5D
Patency assessed
with Duplex At 6
months signicant
and sustained clinical
improvement
Primary or secondary
safety outcome
Acute renal failure, bradycardia
Death
Bleeding (major in 3.6%,
none due to AngioJet)
VTE recurrence
Device- and procedure-related complications,
rethrombosis.
Bleeding less after MT than
after CDT
There is a risk of hemolysis
after MT
Death, bleeding, PE, vessel
injury, arrhythmia, stroke,
distal embolization
Device-related adverse
event
VTE recurrence, bleeding,
death
At 30 days one serious
adverse event
21
21.1 AngioJet peripheral thrombectomy system. (From Boston Scientic, Marlborough, MA, with permission.)
232 Chapter 21 Percutaneous mechanical thrombectomy for treatment of acute iliofemoral deep vein thrombosis
https://t.me/med1917
thrombectomy with CDT.41 AngioJet did not result in a
signicant difference in efcacy and complications, but it
decreased the incidence of PTS and improved the Villalta
score. It also decreased the duration of the treatment and
the drug dose.
The ARNSBERG Registry data was reported by Licht-
enberg et al.
40
who used the Aspirex catheter (BD, Franklin Lake, NJ) as a rotational MT device for treatment of
iliofemoral DVT in 56 patients. All patients received stents.
Procedure-related complications were seen in 14% of
patients, 12-month patency was 87%. Patients seemed to
have substantial prevention of moderate-to-severe PTS and
had few device-related complications including bleeding.
The RAPID registry investigated the safety and efcacy of the AngioVac System in 234 patients with caval
thromboemboli (36%), right heart masses (48%), catheter-related thrombi (8.5%), and PEs (2%). Extracorporeal
bypass time was <1hour in three of four patients. There
were 36 procedure-related complications, including one
death. The AngioVac System was judged to remove vascular thrombi and cardiac masses safely and effectively, but
the number of PEs was limited, and no recommendation
was made for this indication.
Promising interim data were reported on the prospective, single-arm CLOUT Registry by Dexter et al.
39
Two-hundred and fty patients with lower extremity DVT
were treated with the ClotTreaver system (Figure21.2). No
patients received thrombolytic treatment, and all but one
were treated in a single session. Median blood loss was
estimated to be 50 mL. Stents were placed in 46.5% of
the patients. Only six patients (2.4%) were treated in an
intensive care unit. One patient had a fatal PE during the
procedure. There were no acute renal injuries. Complete or
near-complete (>75%) thrombus removal was achieved in
86% of limbs. At 6 months, 24% of patients had PTS, but
there was overall a signicant improvement in PTS, symptoms, pain, and QOL.
39
A computer-aided mechanical aspiration thrombectomy device (Indigo System with Lightning 12 Intelligent
Aspiration, Penumbra, Inc., Alameda, CA) was used in 16
patients with iliofemoral DVT by Robertson et al.
34
(Fig-
ure21.3). Thrombus reduction of ≥70% was achieved in
all patients. Eight patients (50%) were stented. All had
symptom resolution before discharge. The median blood
loss was 155mL, and no patient required a blood transfusion. One patient received adjunctive CDT. No patient
developed acute kidney failure, and no complications
occurred. At 1–8 months, iliofemoral vein patency was
93.8%, and 87.5% of the patients were free of symptoms.
These data support the safety and efcacy of a single-session treatment of iliofemoral DVT without bleeding complications using MT.
34
A meta-analysis of percutaneous MT with and without CDT for the treatment of lower extremity DVT
included 1323 patients from 35 studies.
42
The perioperative incidence of major bleeding and PE was 4.6%
(95% CI, 2.9%–7.3%) and 3.8% (95% CI, 2.5%–6.7%),
respectively. The average follow-up ranged from 2.8 to
32.1months. About 15% of patients developed PTS. In
comparing the results of PMT± CDT with CDT alone,
the partial thrombolysis rate was higher in the PMT ±
CDT group (odds ratio [OR], 2.64; 95% CI, 1.34–5.21;
P= .005), whereas the complete lysis rate was not. Villalta
scores were similar. The thrombolytic drug dose in the
PMT± CDT group was less and the procedural time was
shorter than in the CDT group. There was no signicant
difference in major bleeding or PE between the groups.
The study concluded that PMT with or without CDT is a
relatively effective and safe approach for lower extremity
DVT patients.
Another, more recent meta-analysis of six trials in
2019 found that PMT for iliofemoral DVT signicantly
reduced the severity of PTS by reducing the Villalta score.
It also reduced thrombus score, hospital length of stay, and
thrombolysis time.
43
There was no signicant difference
between valve incompetence, minor bleeding, stent events,
or clot reduction grade Ievents.
New rigorous RCTs, enrollment of larger numbers of
patients in prospective registries, and analysis of both early
and long-term results will help us conrm the clinical efcacy of pharmacomechanical and completely mechanical
thrombectomy in patients with acute iliofemoral DVT.
A recent Trustworthy Delphi consensus-based statement reported by Vedantham et al.
44
addressed the need for
21.2 ClotTreaver mechanical thrombectomy device. (From Inari Medical, Irvine, CA, with permission.)
21.3 Ultrasound-assisted thrombolysis and pharmacomechanical and mechanical thrombectomy 233
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21.3 Indigo Aspiration System with Lightning Aspiration Tubing. (From Penumbra Inc., Alameda, CA, with permission.)
TABLE 21.2 Reporting standards for endovascular interventions for acute iliofemoral DVT
No. Consensus statement
1. We strongly encourage using multicenter RCTs to assess the efcacy of endovascular interventions.
2. The population description should include (1) characteristics of the index DVT-presenting symptoms, PE, or a temporary
provoking risk factor; (2) symptom duration and DVT history; (3) the most cephalad anatomic extent of the DVT; (4) whether
the patients present initially with DVT, had early treatment failure, or had acute limb-threatening circulatory compromise.
3. The protocol should specify thrombus removal techniques, stand-alone use of the device, and its use along with brinolysis
or with other treatments. Any brinolytic drug (systemic or catheter directed), the sequence of use (thrombectomy device
rst, drug rst, simultaneous), the drug dose, and other thrombus removal methods should be reported.
4. Immediate anatomic efcacy requires demonstration of thrombus volume reduction by an independent blinded assessment
of venograms performed before and after the intervention, ideally using established assessment scales. For stand-alone
devices, the post-treatment venogram must be performed before other interventions.
5. Early anatomic efcacy at 1 month should always be reported.
6. We suggest early patient follow-up at 7–10 days, 1 month, and 6 months to evaluate adverse events, early anatomic efcacy,
and early clinical efcacy. Follow-up of 1–2years will identify PTS. In some studies, follow-up of 3–5years will denitively
assess PTS, the need for reintervention, and severe clinical manifestations (ulcers).
7. Demonstration of clinical efcacy at 1–6 months compared with nonintervened controls should include early anatomic efcacy and improvement in patient-centered sequelae of venous disease (limb pain, ambulatory/functional capacity, and QOL) or
objective clinical signs of venous disease (swelling by measurement of limb circumference/volume).
8. The risks of bleeding (device-related blood loss, access site bleeding, distant bleeding), PE, early rethrombosis, vascular
injury, bradycardia, renal failure, and any additional risks that stem from the nature and mechanism of action of any specic
device must be reported.
21
Source: Based on Vedantham S, Gloviczki P, Carman TL, et al. Delphi consensus on reporting standards in clinical studies for endovascular treatment of
acute iliofemoral venous thrombosis and chronic iliofemoral venous obstruction. Circ Cardiovasc Interv. 2023;16(7):e012894.
sufcient rigor to conduct future studies to support conclusions on safety, efcacy, durability, and risks and benets
of endovascular treatment of acute and chronic venous disease. Of the 30 statements on reporting clinical outcome, 8
dealt specically with MT (Table21.2.)
The CLOUT registry
ences with both mechanical and aspiration-assisted thrombus removal
34,46–48
outcomes because thrombectomy is performed without
systemic or catheter-directed thrombolytic therapy that is
responsible for most major bleeding complications. Recent
data also suggest that at current cost and outcomes, MT
38,39,45
and other reported experi-
suggest that MT has excellent early
44
is the most cost-effective intervention for iliofemoral DVT
compared with anticoagulation or CDT.
that some of these devices will be useful for patients with
subacute or chronic DVT as well.
50,51
49
It is also possible
The 2012 SVS/AVF guidelines already suggested a
strategy of early thrombus removal with percutaneous
catheter-based techniques in patients in whom it is the rst
episode of iliofemoral DVT, if symptoms lasted under 14
days, the patient had a low risk of bleeding, and they were
ambulatory with good functional capacity and an acceptable life expectancy (grade 2C). It was strongly recommended that thrombus be removed in phlegmasia cerulea
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