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