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Efficacy and safety of novel mechanical thrombectomy systems
for iliofemoral DVT
Michael K. W. Lichtenberg MD, FESC
Conflict of Interest - Disclosure
Within the past 12 months, I or my spouse/partner have had a financial
interest/arrangement or affiliation with the organization(s) listed below.
Affiliation/Financial Relationship Company
1. Honoraria for lectures: CR Bard, Boston Scientific AB Medica, Volcano,
Optimed GmbH, Straub Medical, Terumo, Biotronik, Veryan
2. Honoraria for advisory board activities: Veniti, Optimed GmbH, Straub
Medical, Biotronik, Veryan, Boston Scientific, Philips
3. Participation in clinical trials: Biotronik, CR Bard, Veryan, Straub Medical,
Veniti, Boston Scientific, LimFlow,Terumo, Philips, Optimed, IPmedical
4. Research funding: Biotronik, Boston Scientific, Veryan, Veniti, AB Medica,
Philips, CRBard, Optimed
• Frequent, but underestimated chronic complication
after iliofemoral DVT
• > 25% at risk for developing PTS following an acute
iliofemoral DVT (ATTRACT 28%)
• 5-10% severe PTS
White RH. The epidemiology of venous thromboembolism. Circulation 2003;107 (23 Suppl 1): I4-8.
Akesson H, Brudin L, Dahlstrom JA, Eklöf B, Ohlin P, Plate G. Venous function assessed during a 5 year period after acute ilio-femoral venous thrombosis treated with anticoagulation. Eur J Vasc Surg 1990;4(1):43-48.
Meissner M, Gloviczki P, Comerota A, Dalsing MC, Eklof BG, Gillespie DL et al. Early thrombus removal strategies for acute deep venous thrombosis: Clinical practice guidelines of the society for vascular surgery and the American venous forum. J Vasc Surg 2012; 55:1449-462.
Post thrombotic syndrome…
ATTRACT subgroup analysis
Patient outcomes (efficacy analysis)
Villalta 24 months: PCTD 3.95 vs 5.54 non-PCTD, p = 0.0033
VCSS 24 months: PCTD 1.98 vs 2.80 non-PCDT, p = 0.018
Veines 24 months: PCTD 28.63 vs 23.02 non-PCDT, p = 0.029
Volume 8, Issue 1, January 2020, Pages 8-23.e18
Journal of Vascular Surgery: Venous and Lymphatic Disorders
VEINES-QOL change scores from baseline to all assessments were greater in the PCDT vs no PCDT group; this was statistically significant in the intention-to-treat analysis at 1 month (difference, 10.0; P < .0001) and 6 months (8.8; P < .0001) and in the per-protocol analysis at 18 months (difference, 5.8; P = .0086) and 24 months (difference, 6.6; P = .0067)
SF-36 PCS change scores were greater in PCDT vs no PCDT from baseline to 1 month (difference, 3.2; P = .0010) but not for other intervals.
Veines QoL change scores within different subgroups
SAFETY REPORTING
Bleeding complication
PEARL Registry: 4.5% (minor/major)
Venous Registry: 11% major,16% minor
CAVENT (CDT arm): 22% (minor/major)
Thrombolysis vs PMT for iliofemoral DVT:A systemic review and metaanalysis
M. Lichtenberg, R. de Graaf, K. Kolosa, D. Golicki (Arnsberg, Warsaw)
• Database: MEDLINE• Keywords:
– deep vein thrombosis, deep venous thrombosis– iliofemoral– Additionaly in updating search 2: AngioJet, Penumbra, Aspirex
• Publication years:– search 1: 1946 – 4th December 2018– search 2: 1946 – 12th December 2018
• Inclusion criteria:– deep vein thrombosis (DVT)– iliofemoral arteries– Interventions:
• Catheter-directed thrombolysis (CDT), systemic thrombolysis, ultrasound-accelerated CDT
• Pharmacomechanical thrombectomy (PMT) with AngioJet, Penumbra Indigo or Aspirex device
9
Safety: Major bleeding complications
Significantly
favours PMT
AngioVac Indigo Aspirex
Argon Penumbra Straub
no GW no GW 0,018 GW
Separator 0,025 GW
OTW
22F 3,4F, 5F, 6F, 8F 6F, 8F, 10F
75, 120 cm 85,115, 135, 150 cm 85, 95, 110 cm
Aspiration Aspiration Aspiration
Mechanical thrombectomy devices
Vortex principle Vaccum 737 mmHg Archimedic principle
Inclusion criteria:
Acute thrombotic or thromboembolic occlusion (onset of pain < 14 days)
FU: up to 24 months
Endpoints:
Assessment of the effectiveness and safety of the ASPIREX®S catheter
MAE, QoL, CEAP, VCSS
Patency FU 1 month: 95%
Patency FU 6 months: 94%
Patency FU 12 months: 87%
P-Max Study
Mechanical Thrombectomy For DVT With Aspirex
Prospective European multicenter single arm registry
Assessment of the effectiveness and safety of the ASPIREX®S catheter
Arnsberg patients
Freedom from CD-TLR
1 month: 100%
6 months: 100%
12 months: 94.7%
24 months: 93.8%
1 month 6 months 12 months 24 months
VCSS
VDS
Baseline pre-discharge 1 month 6 months 12 months 24 months
Baseline pre-discharge 1 month 6 months 12 months 24 months
M. Lichtenberg (Hrsg.), C. Tiefenbacher, M. Katoh, P. Minko, E. Minar, C. Wissgott, A. Storck, B. Hailer: Thrombektomie: medikamentös, mechnisch, operativ. Uni-med Verlag,
2013
Indigo System ® (Penumbra)Vaccum with 737 mmHg
8 F
catheter
After two Vetex Final result afterpassages MTS stenting
Study Overview
Objective: Demonstrate the safety and performance of Vetex Thrombectomy Device in the
treatment of patients with acute iliofemoral DVT.
1. Study Primary Performance Endpoints met in all cases;
“Procedural success, …. and SIR Grade II Lysis (50-95% thrombus removal) in the target vessel, with
freedom from procedural related adverse events”
2. No Device Related Adverse Events
3. No Thrombolytics used in 14 of 16 cases during the procedure
– Used from start of Procedure as a precaution in 2 cases
4. No adjunctive lytic therapy (overnight) in 13 out 16 cases
– Used post procedure to clear collateral veins in 3 cases
5. No IVC filter used in 12 of 16 cases
Device is
pulled
retrograde
from Iliac
to
Popliteal
Cage Separates
the Clot for
Extraction
Extraction
Screw
removes
Clot
Summary of Follow Ups - On-Going
Outcome
No. of
patients
Mean (Std. Dev)
Overall Change
from Baseline
VEINS QOL:At Baseline
At 1 Month FU
16
15
59.41 (12.67)
93.00 (9.49)
-
29.47 (11.64)
Villalta Score:At Baseline
At 1 Month FU
16
15
14.19 (7.60)
3.40 (3.76)
-
-10.07 (6.40)
VCSS:At Baseline
At 1 Month FU
13
13
8.62 (2.47)
3.15 (1.82)
-
-5.46 (2.40)
Questionnaires:Demographic/General:
OutcomeMean
(Std. Dev)
Gender4 Males
12 Females
Age55.1 (19.1)(21 – 74)
Index Leg5 Right11 Left
Device Passes(n=16)
2.50(0.63)
Device Runtime per
Case(n=16)
05:21 min(02:36 min)
Volume of Extract per
Case(n=16)
323 ml(171)
Calf Circumference:
Outcome
No. of patient
s
Mean (Std. Dev)
(cm)
Overall Change from
Baseline (Std. Dev)
(cm)
ATTRACT 2017(Std Error)
(cm)
At Baseline
1640.44 (7.24)
- -
At 24hr FU
1635.72 (6.34)
-4.72 (3.45) -
At 1 Month
FU15
35.97 (8.44)
-4.57 (4.84)Baseline to Day
30:-0.74 (±0.17)
Follow Ups – On-going (n=16):
Visits:1. 24hr – 16 Patients
Completed 2. 1 Month – 15 Patients
Completed
Duration of Hospital Stay Post Procedure: Duration (Days) (n=15):• Mean = 3.53• Std Dev. = 1.88
Vetex FIM Trial
16 patients
Study Primary
Performance Endpoint
was met in all cases
Lysis Grade II
No AE recorded
No concomitant lysis
in 14/16 patients
ClotTriever – mechanical thrombectomy
Technical success and short-term
outcomes after treatment of lower
extremity deep vein thrombosis with the
ClotTriever system: A preliminary
experience.
J Vasc Surg Venous Lymphat Disord. 2019
Dec 13.
JVIR 2019
Mechanical thrombectomy for descending iliofemoral DVT
Conclusion
• Real advantage for PMT is safety (significant lower bleeding complications)
– Trend towards lower pulmonary embolism
• PMT and CDT are quite similar in efficacy
– Trend towards lower overall PTS and reflux with PMT
CDT should be stopped for
treatment of iliofemoral DVT
Efficacy and safety of novel mechanical thrombectomy systems
for iliofemoral DVT
Michael K. W. Lichtenberg MD, FESC