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5 year quality of life data after EKOS ® treatment in acute DVT Jochen Grommes MD European Vascular Center Aachen-Maastricht GxUS-EKO-2016-0006

5 year quality of life data after EKOS treatment in acute DVT › media › 1245_Jochen_Grommes_26_… · 5 year quality of life data after EKOS® treatment in acute DVT, Lunch meeting

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Page 1: 5 year quality of life data after EKOS treatment in acute DVT › media › 1245_Jochen_Grommes_26_… · 5 year quality of life data after EKOS® treatment in acute DVT, Lunch meeting

5 year quality of life data after EKOS®

treatment in acute DVT

Jochen Grommes MD

European Vascular Center Aachen-Maastricht

GxUS-EKO-2016-0006

Page 2: 5 year quality of life data after EKOS treatment in acute DVT › media › 1245_Jochen_Grommes_26_… · 5 year quality of life data after EKOS® treatment in acute DVT, Lunch meeting

LINC 2016

5 year quality of life data after EKOS® treatment

in acute DVT, Lunch meeting at LINC 2016 page 2

Disclosure of speaker’s interests

conflict of interest

See below

Potentially relevant company relationships

in connection with event 1

BTG

• Sponsorship or research funding2

• Fee or other (financial) payment3

• Shareholder4

• Other relationship, i.e. …5

Cook2

ab medica2,3

Page 3: 5 year quality of life data after EKOS treatment in acute DVT › media › 1245_Jochen_Grommes_26_… · 5 year quality of life data after EKOS® treatment in acute DVT, Lunch meeting

• Reason for early clot removal:

• Relief of acute symptoms • Swelling

• Pain

• Edema

• Risk reduction for posthrombotic syndrome (PTS) • residual venous obstruction

• residual thrombus

• valve incomptence

page 3 5 year quality of life data after EKOS® treatment

in acute DVT, Lunch meeting at LINC 2016

background methods results conclusion

Page 4: 5 year quality of life data after EKOS treatment in acute DVT › media › 1245_Jochen_Grommes_26_… · 5 year quality of life data after EKOS® treatment in acute DVT, Lunch meeting

• New endovascular techniques are becoming more popular

• US 2013: 300.000 catheter-directed thrombolysis for DVT

• New pharmacomechanical devices were developed

• Most experience derives from small case series addressing patency

• CaVent-trial is the only PRT who presented long-term results

page 4 5 year quality of life data after EKOS® treatment

in acute DVT, Lunch meeting at LINC 2016

background methods results conclusion

Page 5: 5 year quality of life data after EKOS treatment in acute DVT › media › 1245_Jochen_Grommes_26_… · 5 year quality of life data after EKOS® treatment in acute DVT, Lunch meeting

Seite 5 5 year quality of life data after EKOS® treatment

in acute DVT, Lunch meeting at LINC 2016

background methods results conclusion

• EkoSonic® Endovascular System: ultrasound-accelerated catheter-directed

thrombolysis (UACDT)

• Mechanical: high frequency, low energy ultrasound

• Drug: recombinant tissue plasminogen activator • Bolus 5mg, 1mg per hour

• Heparin PTT 40-60 seconds

Page 6: 5 year quality of life data after EKOS treatment in acute DVT › media › 1245_Jochen_Grommes_26_… · 5 year quality of life data after EKOS® treatment in acute DVT, Lunch meeting

Seite 6 5 year quality of life data after EKOS® treatment

in acute DVT, Lunch meeting at LINC 2016

background methods results conclusion

• Angiography

Start of UACDT

Page 7: 5 year quality of life data after EKOS treatment in acute DVT › media › 1245_Jochen_Grommes_26_… · 5 year quality of life data after EKOS® treatment in acute DVT, Lunch meeting

Seite 7 5 year quality of life data after EKOS® treatment

in acute DVT, Lunch meeting at LINC 2016

background methods results conclusion

• Angiography

24 hours 48 hours

Page 8: 5 year quality of life data after EKOS treatment in acute DVT › media › 1245_Jochen_Grommes_26_… · 5 year quality of life data after EKOS® treatment in acute DVT, Lunch meeting

Seite 8 5 year quality of life data after EKOS® treatment

in acute DVT, Lunch meeting at LINC 2016

background methods results conclusion

• Angiography

72 hours

Page 9: 5 year quality of life data after EKOS treatment in acute DVT › media › 1245_Jochen_Grommes_26_… · 5 year quality of life data after EKOS® treatment in acute DVT, Lunch meeting

Seite 9 5 year quality of life data after EKOS® treatment

in acute DVT, Lunch meeting at LINC 2016

background methods results conclusion

• Follow-up:

• Clinical examination

• Ultrasound

• Assessment of PTS: Villalta-Score (score 0-33)

• Quality of life:

• Generic measures using ShortForm Health Survey-36 (SF36)

Physical Component Summary (PCS)

Mental Component Summary (MCS)

• Disease-specific measures using Venous Insufficiency Epidemiological and Economic Study (Veines)-Qol/Sym

Veines-Qol 26-items Questionaire

Veines Sym subscale of the Veines-Qol measuring venous symptoms

Page 10: 5 year quality of life data after EKOS treatment in acute DVT › media › 1245_Jochen_Grommes_26_… · 5 year quality of life data after EKOS® treatment in acute DVT, Lunch meeting

Seite 10 5 year quality of life data after EKOS® treatment

in acute DVT, Lunch meeting at LINC 2016

background methods results conclusion

Our experience

•Since 2009: 40 patients with iliofemoral DVT (female: 21), 51 legs

•Recurrent DVT: 17/40

•Iliofemoral DVT with involvement of the inferior caval vein: 18/40

•Treatment time 79 ± 31 h (min 24 hours; max 120 hours)

•rtPA dosage 80.2 ± 35.9 mg

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Seite 11 5 year quality of life data after EKOS® treatment

in acute DVT, Lunch meeting at LINC 2016

background methods results conclusion

Primary Patency (n=51):

• >90% reduction of thrombus : 27

• 50-90% reduction of thrombus: 13

• < 50 % reduction of thrombus: 6

• no success: 5

• success: 79% (40/51)

50

-90 %

<50

%

No

su

ccess

> 9

0 %

red

ucti

on

of

thro

mb

us

0

20

40

60

Page 12: 5 year quality of life data after EKOS treatment in acute DVT › media › 1245_Jochen_Grommes_26_… · 5 year quality of life data after EKOS® treatment in acute DVT, Lunch meeting

Seite 12 5 year quality of life data after EKOS® treatment

in acute DVT, Lunch meeting at LINC 2016

background methods results conclusion

n=387 (male=197)

> 9

0 %

red

ucti

on

of

thro

mb

us

Page 13: 5 year quality of life data after EKOS treatment in acute DVT › media › 1245_Jochen_Grommes_26_… · 5 year quality of life data after EKOS® treatment in acute DVT, Lunch meeting

no PTS

mild

moder

ate

seve

re0

20

40

60

80

100

Data percentage

no PTS

mild

moderate

severe

Seite 13 5 year quality of life data after EKOS® treatment

in acute DVT, Lunch meeting at LINC 2016

background methods results conclusion

Follow-up Villalta-Score:

• low incidence of severe PTS after CDT

no PTS mild PTS moderate

PTS

severe

PTS

perc

enta

ge

successful EKOS/UACDT (n=21)

EKOS/UACDT without success (n=7)

no PTS

mild

moder

ate

seve

re0

20

40

60

80

100

Data percentage

no PTS

mild

moderate

severe

no PTS mild PTS moderate

PTS

severe

PTS perc

enta

ge

Kahn SR Determinants of health-related

Qol during the 2 years following DVT

J Thromb Haemost 2008 (n=387)

Page 14: 5 year quality of life data after EKOS treatment in acute DVT › media › 1245_Jochen_Grommes_26_… · 5 year quality of life data after EKOS® treatment in acute DVT, Lunch meeting

Seite 14 5 year quality of life data after EKOS® treatment

in acute DVT, Lunch meeting at LINC 2016

background methods results conclusion

Quality of life I: SF36 PCS and MCS

1 2 3 4 5

0

20

40

60

Data 2

PCS

MCS

UACDT

PCS

MCS

Korlaar

2004 Ashrani

2010

Roberts

2014 Kahn

2008

Page 15: 5 year quality of life data after EKOS treatment in acute DVT › media › 1245_Jochen_Grommes_26_… · 5 year quality of life data after EKOS® treatment in acute DVT, Lunch meeting

UACDT

Kah

n SR e

t.al.

0

20

40

60

Data 3

VeinesQol

VeinesSym

Seite 15 5 year quality of life data after EKOS® treatment

in acute DVT, Lunch meeting at LINC 2016

background methods results conclusion

Quality of life II VeinesSym/Qol

Kahn 2008 UACDT

VeinesQol

VeinesSym

Page 16: 5 year quality of life data after EKOS treatment in acute DVT › media › 1245_Jochen_Grommes_26_… · 5 year quality of life data after EKOS® treatment in acute DVT, Lunch meeting

Seite 16 5 year quality of life data after EKOS® treatment

in acute DVT, Lunch meeting at LINC 2016

background methods results conclusion

• Follow-up shows improved patency after EKOS/UACDT in comparison to

conservative treatment

• Low incidence of complications

• Improved Qol after EKOS/UACDT in comparison to the literature

• We need (more) results of prospective randomized trials

Page 17: 5 year quality of life data after EKOS treatment in acute DVT › media › 1245_Jochen_Grommes_26_… · 5 year quality of life data after EKOS® treatment in acute DVT, Lunch meeting

Seite 17 5 year quality of life data after EKOS® treatment

in acute DVT, Lunch meeting at LINC 2016

background methods results conclusion

•Thank you for attention!

[email protected]

Page 18: 5 year quality of life data after EKOS treatment in acute DVT › media › 1245_Jochen_Grommes_26_… · 5 year quality of life data after EKOS® treatment in acute DVT, Lunch meeting

5 year quality of life data after EKOS®

treatment in acute DVT

Jochen Grommes MD

European Vascular Center Aachen-Maastricht

GxUS-EKO-2016-0006