Percutaneous Mechanical Thrombectomy for Acute Iliofemoral DVT with the Aspirex Catheter:

The Dijon Experience

JFICV 2018, BeauneJFICV 2018, Beaune

Prof. Romaric LOFFROY, MD, PhD, FCIRSEProf. Romaric LOFFROY, MD, PhD, FCIRSE

Chief, Department of Vascular and Interventional RadiologyChief, Department of Vascular and Interventional Radiology

ImageImage--Guided Therapy CenterGuided Therapy Center

FranFranççoisois--Mitterrand University HospitalMitterrand University Hospital

Dijon, FranceDijon, France

Endovascular therapeutic optionsEndovascular therapeutic options

•• ThrombolysisThrombolysis

–– LocalLocal

–– CDT CDT

•• Manual aspirationManual aspiration

•• Thrombus fragmentationThrombus fragmentation

–– TrerotolaTrerotola®®

•• PMT or lysisPMT or lysis--assisted MTassisted MT

–– EKOSEKOS®® = US= US--enhanced lysisenhanced lysis

–– TrellisTrellis®® = pharmaco= pharmaco--MTMT

–– AngiojetAngiojet®® = rheolytic pharmaco= rheolytic pharmaco--MTMT

•• Pure MTPure MT

–– IndigoIndigo®® = aspiration MT= aspiration MT

–– AspirexAspirex®®S = rotational MTS = rotational MT

Thrombectomy devices for DVT treatmentThrombectomy devices for DVT treatment

•• AspirexAspirex®®

–– Pure mechanical thrombectomyPure mechanical thrombectomy

–– No thrombolyticsNo thrombolytics

–– Age of thrombus not so relevantAge of thrombus not so relevant

–– Chance to finish in the angioChance to finish in the angio--roomroom

–– No RCT dataNo RCT data

•• EKOSEKOS®® / Trellis/ Trellis®® / Angiojet/ Angiojet®®

–– Time consumingTime consuming

–– Additional thrombolyticsAdditional thrombolytics

–– Bleeding risksBleeding risks

–– ReRe--angio after finishing treatment angio after finishing treatment for stent placement (EKOS)for stent placement (EKOS)

–– Organized thrombus > 4 weeks = Organized thrombus > 4 weeks = possible ineffectivenesspossible ineffectiveness

–– Additional ICU stay with EKOSAdditional ICU stay with EKOS

–– No RCT data, only registry dataNo RCT data, only registry data

The perfect system ?The perfect system ?

•• Minimally invasiveMinimally invasive

•• Easy to useEasy to use

•• Reduced procedural timeReduced procedural time

•• Treat all veinsTreat all veins

•• Reduces thrombus burdenReduces thrombus burden

•• Lowest complication rateLowest complication rate

•• No vessel wall damageNo vessel wall damage

•• Successful in restoring vein patencySuccessful in restoring vein patency

•• Preserves valvular function Preserves valvular function

•• Unmask underlying lesionUnmask underlying lesion

•• Targeted treatmentTargeted treatment

•• No need for lysis drugNo need for lysis drug

•• Overall costOverall cost--effectiveeffective

PurePure

RotationalRotational

MechanicalMechanical

Thrombectomy ?Thrombectomy ?

Purpose

• To assess the safety and efficacy of percutaneous mechanical thrombectomy (PMT) for acute symptomatic iliofemoral deep vein thrombosis (DVT) using the AspirexS device (Straub Medical AG, Wangs, Switzerland)

Study population

• Retrospective study

• Period of inclusion– December 2015-January 2018

• 25 patients– 19F/6M

• Mean age

– 45.519.9 yrs (range, 17-76)

• History– DVT history: 13/25 (52%)

– Thrombophilic abnormality: 5/25 (20%)

– Cancer: 4/25 (16%)

– IVC surgery: 1/25 (4%)

• Treatment before diagnosis– Anticoagulants=6/20

– Antiplatelets=3/20

• Symptomatic ilio-femoral DVT– Oedema/pain in all

patients

– PE in 2 patients

DVT characteristics

• Localisation– Left=21/right=4

– Bilateral=1

• Extension– LET 3=21/25

• Involvement of popliteal vein=5/21

– LET 4=4/25

• Duration of symptoms before treatment– 5.5 days (range, 2-11)

• May-Thurner syndrome– 15/25 (60%)

• Pre-operative CT scan in all patients

Procedural data

• Under local anesthesia

• Cook Flexor 10-Fr long sheath

• Endovascular approach

– Jugular: 7

– Popliteal: 17

– Both: 1

• Aspirex®S 10-Fr 110 cm

• Self-expandable stents (10-16 mm)

– Sinus-XL Flex Stent or Sinus Superflex-635

• Optimed, Ettlingen, Germany

– Protégé GPS

• eV3-Covidien, Plymouth, MN

• Bolus of 100IU/kg of heparin every 45 min

• « ALN » IVC temporary filter

– 9/25

• Systematic exams at day 1

– Chest CT scan

– Duplex US

• Post-operative medication for 3 months

– Anticoagulants

• 1 mo: LMWH

• 2 mo: NOAC

– Antiplatelets

• 3 mo

Aspirex®S technical data

Size m

atters

!

Key concepts

• Age of thrombus

• Coagulation

• Infusion mix

• Flow

• Guidewire

• Correct movement

• Motor

Age of thrombus

• Optimal moment to treat proximal vein occlusion– Goal: safe valve function

– Age of thrombus is key of success

• Best results achieved with really fresh thrombus:– 10 days: National Venous Registry

– 14 days: ATTRACT trial

– 21 days: CaVent trial

< 14 days is optimal but as early as possible is better

Coagulation

• Always consider the coagulation

– Bolus of 100UI/kg of heparin every 45 min

• If a proper anticoagulation is not achieved

– The helix may be blocked

– Guidewire could be stuck in the catheter

Infusion mix

• Technique– 250ml saline + 250ml

contrast + 5000UI heparin

– Put the mix in a pressure bag

– Adjust the flow

• To avoid collapse of the vein during the aspiration

– Start the infusion until visualization of the vein

– Start the aspiration

– Stop the flow when the motor is off

• Benefits– Get real-time information

during the procedure about

• Status of the vein

• Vessel wall behavior

• Thrombus status

• Efficiency of the aspiration

• Vessel patency

– Contrast: no systemic effect because permanently aspirated by the Aspirex

Flow

• If the vein is collapsing on the Aspirex head, it means that the flow is not enough– Pull back the catheter and wait for the vein to fill up again

– Stop the motor and wait for the vein to fill up again

• Keep in mind during run of catheter– System is cooled by blood flow: warming of catheter indicates

insufficient blood flow/cooling• Consider saline infusion in occluded venous segments

– High aspiration capacity: keep an eye on collecting bag

– Flush catheter after usage

Guidewire

• Aspirex 10-Fr

– 0.035’’ guidewire is always fine

• Aspirex 8-Fr / 6-Fr

– 0.018’’ guidewire is not always fine

– Keep it straight

– Don’t hesitate to take another one

Correct movement

• How to reach eccentric thrombus

– Used long angled 10/12-Fr sheath to increase the radius of catheter

Motor

Immediate results

• Technical success=100%– Restoration of proximal ilio-

femoral blood flow

– Residual thrombus < 20%

• No lytic therapy infusion– Additional IV bolus of

Actilyse in 5 of 25 patients

• Stenting rate– 100%

– Iliac and/or femoral

• Implanted stents– Mean = 2.3/patient

– Range: 1-4

• Number of runs=2-4 (mean = 2.6/patient)

• Amount of blood/thrombus aspirated

– Mean = 307.866.1 mL

– Range: 190-410 mL

• Mean procedural time– PMT run

• 4.90.99 min (3.2-6.7)

– Total procedure

• 107.333.9 min (70-180)

• Mean scopy time

– 20.27.7 min (8-44)

Outcomes

• Complications– No MAE (bleeding, PE)

– 3 minor

• 1 wire lost: snared

• 1 helix broken outside the patient

• Hospital stay– Mean = 2.6 days

– Discharge ≤ 2 days in 84%

– No ICU stay

• Follow-up

– Mean: 13.38.2 mo

– Range: 6-30 mo

• Relief of acute symptoms within 3 days– 23/25 = 92%

• Patency rate at 6 months– Primary: 23/25 = 92%

• Early in-stent re-thrombosis within 1 week in 2 patients

– Secondary: 22/24 (88%)

• Failure of recanalization: 2

– PTS at 6 months

• 4/25 = 16%

• Moderate ++

Fast thrombus removalFast thrombus removal

No ICU stayNo ICU stay

No angiographic controlNo angiographic control

No lytics requiredNo lytics required

No bleeding complicationsNo bleeding complications

Outpatient procedure ?Outpatient procedure ?

Catheter costCatheter cost

Why is pure MT costWhy is pure MT cost--effective ?effective ?

LET 4 DVT: outpatient procedure

9:20 am: angiologist call1:30 pm: CT scan

2:10 pm: angio-suite entrance3:20 pm: angio-suite exit

5:15 pm: go home10:40 pm (day 1): US

Technical limitations

• Subintimal position of the guidewire

• Chronic venous occlusion

• Proper anticoagulation not achieved

• Impossibility to pass the lesion completely with the guidewire

• Undersized or oversized vessel diameter

• With radius of curvature less than 2 cm

• If the catheter, the guidewire or the sheath are damaged, kinked or present unsolved resistance

IVUS role ?

Study limitations

On-going P-Max study

Conclusion

• Thrombectomy using the Aspirex®S device is a safe, fast and effective therapeutic option in patients presenting with acute symptomatic iliofemoral DVT:– Effective in venous thrombus removal +++

• Fast relief of acute symptoms

– Restores vein patency in lower limb +++

– Has low risk and less side effects +++

• No ICU stay

• End it in the angiolab

• No need for lytic infusion

• No bleeding complications

– Prevention of PTS ++

– Preserves valve function…?

Still debated…

• Jugular/popliteal approach ?

• IVC filter ?

• Necessity of 100% thrombus removal ?

• Landing zone of stenting ?

• Treatment of superficial femoral/popliteal vein ?

• Type/duration of post-operative medication ?