JFICV 2018, Beaune Percutaneous Mechanical Thrombectomy for Acute Iliofemoral DVT with the Aspirex Catheter: The Dijon Experience Prof. Romaric LOFFROY, MD, PhD, FCIRSE Chief, Department of Vascular and Interventional Radiology Image-Guided Therapy Center François ois-mitterrand University Hospital Dijon, France
Endovascular therapeutic options Thrombolysis Local CDT Manual aspiration Thrombus fragmentation Trerotola PMT or lysis-assisted MT EKOS = US-enhanced lysis Trellis = pharmaco-mt Angiojet = rheolytic pharmaco-mt Pure MT Indigo = aspiration MT Aspirex S = rotational MT
Thrombectomy devices for DVT treatment Aspirex Pure mechanical thrombectomy No thrombolytics Age of thrombus not so relevant Chance to finish in the angio- room No RCT data EKOS / Trellis / Angiojet Time consuming Additional thrombolytics Bleeding risks Re-angio after finishing treatment for stent placement (EKOS) Organized thrombus > 4 weeks = possible ineffectiveness Additional ICU stay with EKOS No RCT data, only registry data
The perfect system? Minimally invasive Easy to use Reduced procedural time Treat all veins Reduces thrombus burden Lowest complication rate No vessel wall damage Successful in restoring vein patency Preserves valvular function Unmask underlying lesion Targeted treatment No need for lysis drug Overall cost-effective Pure Rotational Mechanical Thrombectomy?
Purpose To assess the safety and efficacy of percutaneous mechanical thrombectomy (PMT) for acute symptomatic iliofemoral deep vein thrombosis (DVT) using the Aspirex S device (Straub Medical AG, Wangs, Switzerland)
Study population Retrospective study Period of inclusion December 2015-January 2018 25 patients 19F/6M Mean age 45.5 19.9 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 Antiplatelets 1 mo: LMWH 2 mo: NOAC 3 mo
Aspirex S technical data Size matters!
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 iliofemoral 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 = 307.8 66.1 ml Range: 190-410 ml Mean procedural time PMT run 4.9 0.99 min (3.2-6.7) Total procedure 107.3 33.9 min (70-180) Mean scopy time 20.2 7.7 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: 13.3 8.2 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 rethrombosis within 1 week in 2 patients Secondary: 22/24 (88%) Failure of recanalization: 2 PTS at 6 months 4/25 = 16% Moderate ++
Why is pure MT cost-effective? Fast thrombus removal No ICU stay No angiographic control No lytics required No bleeding complications Outpatient procedure? Catheter cost
LET 4 DVT: outpatient procedure 9:20 am: angiologist call 1:30 pm: CT scan 2:10 pm: angio-suite entrance 3:20 pm: angio-suite exit 5:15 pm: go home 10:40 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?