Thrombectomy Update

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Thrombectomy Update

• Faz Ordoubadi
• Manchester Heart Centre

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Why do we need Thrombectomy Devices

• When looking at more sensitive indicators of
  myocardial perfusion such as Myocardial Blush
  Score and ST segment resolution restoration of
  TIMI 3 flow by PCI may not result in rescue of
  jeopardised myocardium in up to 1/3 of the cases
• Main reason is occurrence of distal embolisation

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Why do we need Thrombectomy Devices

• DE occurs in gt15 of patients following primary
  PCI and is associated with highly significant 5
  yr mortality of up to 44 compared to 9 when
  there is no evidence of distal embolisation
• Clot is not always visible on angiography and may
  be missed in more than a third of the acute cases

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Impact of Macroscopic Distal Emboli
PLCX filling defect at primary PCI site

• DE occurred in 27 of 178 (15) pts after primary
  PTCA

Distal thromboemboli
Henriques JPS et al. EHJ 2002231112-7
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Impact of Macroscopic Distal Emboli
DE no DE p value Anterior MI 63
36 0.01 Blush 0/1 68
7 lt0.001 Complete ST res. 9
60 lt0.001 LDH Q72 1612 847 lt0.05 Pre-d/c
LVEF () 42 14 51 9 lt0.01 5-year
mortality 44 9 lt0.001
Multivariate analysis DE was an independent
predictor of 5-year mortality (OR 95 CI 8.6
3.7, 20.1)
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Interventionalist
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Type of Devices

• Thrombus Extraction Device
• Simple
• Complex (Mechanical)
• Distal Protection Device
• Occlusion
• Filtration
• Proximal Occlusion Device

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Thrombus Extraction DeviceSimple
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Randomised Studies in AMI
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Guide Catheter Aspiration
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• Pros
• Simple to use
• No Learning Curve
• 6F compatible
• Quick to deploy
• Enables distal drug delivery
• Data is general ve in AMI in Native vessels

• Cons
• No data for SVG
• ? Effectiveness when there is large clot burden

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Type of Devices

• Thrombus Extraction Device
• Simple
• Complex (Mechanical)
• Distal Protection Device
• Occlusion
• Filtration
• Proximal Occlusion Device

AngioJet X-sizer
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In native or SVG with angiographic thrombus
N346
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X-Sizer
1.5 or 2.0 mm cutter connected to 4.5 or 5.5F
dual bore catheter shaft Works on Archimedes
Principle with rotating screw at 2100 rpm
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• 201 patients with acute STEMI, Randomised,
  multicentre study
• Only included patients with TIMI 0/1 flow
• Primary endpoint ST resolution 1 hour post-PCI
• Secondary endpoints STRgt50, MBG, TIMI frame
  count, composite slow flow, no reflow, distal
  embolisation, MACE

Results for MBG and MACE were similar
No X-Sizer X-Sizer p value Patients
(N197) 100 97 - Slow flow
or no reflow () 16.0 4.1
0.012 Distal embolization () 10.0
2.1 0.006 Procedural time (min)
4525 5528 0.003
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• Easy set-up Spike infusate, power up, prime
  pump
• 5.5F Crossing Profile Atraumatic, flexible rubber
  tip
• Rapid exchange design (10 cm wire lumen)
• Helix rotation speed 95,000 RPM
• Vacuum strength 700 mmHg
• Enclosed helix for no direct vessel wall contact
• Compatible with 7F guide catheters and 6F sheaths
  (? 0.078)
• Completely disposable no capital equipment
  required

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• Pros
• Good for Large Clot Burden

• Cons
• Some skill involved
• High Profile
• Over the wire
• Up to 10 failure to deploy
• Requires Temporary Pacing wire (Angiojet)
• Data Not very strong

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Type of Devices

• Thrombus Extraction Device
• Simple
• Complex (Mechanical)
• Distal Protection Device
• Occlusion
• Filtration
• Proximal Occlusion Device

• Medtronic (PercuSurge) GuardWire
• Kensey Nash TriActiv system

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The PercuSurge GuardWire System
Consists of 4 components the GuardWire, the
EZ-Flator, the MicroSeal Adapter, and the
Export catheter
MicroSeal Adapter
EZ-Flator

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Balloon Occlusion Based Distal Protection
Concept

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Safer Trial
801 pts undergoing SVG stenting randomizedto
PercuSurge distal protection (0.036 GuardWire)
vs. standard technique1 EP 30 day MACE
composite rate of death, Q MI, non-Q MI, CABG,
or TLRMean graft age 10.7 7.1, 13.5
yearsLesion length 16 mm Thrombus 39
Technical Success 90, Balloon Inflation time
4.5-10.5
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The EMERALD Trial
Enhanced Myocardial Efficacy and Recovery by
Aspiration of Liberalized Debris
1) Resolution of ST segment elevation 2)
Infarct size by tc-99m- sestamibi at 5-14 days
PCI without protection
2º Endpoints Blush, MACE
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Average Procedural Delays using GW 14
mins Average vessel occlusion with GW Additional
10 mins
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650 randomised patient demonstrating
non-inferiority to established distal
protection devices
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• Pros
• Complete control of the microcirculation
• Small as well as large particles retrieved
• Neurohumoral substances aspirated
• No limit to amount of retrieved material
• Efficacy proven in SVG RCT

• Cons
• Ischemia
• Prolongs procedure/ischaemic time
• Needs certain skill/ Learning curve
• PCI can be difficult with no forward flow
• Directs flow toward side branches
• Cant protect lesions in distal vessel
• Efficacy not proven in native vessels

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Type of Devices

• Thrombus Extraction Device
• Simple
• Complex (Mechanical)
• Distal Protection Device
• Occlusion
• Filtration
• Proximal Occlusion Device

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Filter Based Distal Protection Concept
deployment and PTCA
insertion
retrieval
stent
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New DPD
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• Cons
• Relatively high profile, crossing can ?
  embolization
• Small particle and vasoactive substances can
  pass
• Debris can block flow ? ischemia
• Directs flow toward side branches (esp. when
  occluded)
• Capacity limit retrieval challenges
• Cant protect lesions in small or distal vessels
• Each filter is unique
• Not shown to be effective when used in native
  vessels during AMI

• Pros
• Continuous perfusion in most patients
• First choice for the hemodynamically compromised
  patient
• Contrast flow facilitates accurate PCI
• Relatively Simple to use
• Data ve for SVG

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Type of Devices

• Thrombus Extraction Device
• Simple
• Complex (Mechanical)
• Distal Protection Device
• Occlusion
• Filtration
• Proximal Occlusion Device

• Proxis (Velocimed- St. Jude)
• Kerberos Rinspirator (Kerberos)

• Parodi (ArteriA)
• MO.MO (Invatec)

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PROXIMAL Randomised Trial of 600 patients for SVG
intervention is ongoing
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• Pros
• Does not cross lesion No embolisation
• Effective for Side branches
• Can be used for distal lesions

• Cons
• Bulky 7 8F
• Not able to use for proximal lesions
• More technically challenging
• Requires fast actions
• No Data

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Summary

• When clot is present and distal embolisation
  occurs this is associated with high procedural
  and cardiac event rate
• There is now good evidence for routine use of
  some kind of protection in all SVG cases
• However, there is no evidence for their routine
  use in native vessels
• Centres performing acute intervention should be
  familiar with use of thrombectomy / protection
  devices
• Simple thromectomy extraction devices should be
  considered in acute cases when there is evidence
  of clot presence and more complex devices such as
  x-sizer should be reserved for cases with high
  clot burden in relatively large arteries

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Thank You
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Mechanical Approaches to Thrombus
Thrombectomy
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T
ransluminal extraction catheter (IVT)
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AngioJet (Possis)
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X-Sizer (EndiCOR), etc.
Thromboablation
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Laser (holmium, excimer)
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Hot balloon
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Ultrasound thrombolysis (Acolysis, etc.)
Distal protection
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PercuSurge,
AngioGuard, EPI, MedNova, EV3
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FilterWire Distal Protection in AMI

• 53 pts with STEMI lt6 with IRA gt3.0mm and TIMI lt3
  stented with FilterWire distal protection,
  compared to 53 matched pts

FilterWire Control p Success FW 47 (89) (bw in
7, pre-dil in 4) Final TIMI-3 98.1 84.9 0.03 Fin
al cTFC 22 14 31 19 0.005 Final blush
3 66 36 0.006 ST res. gt70 80 54 0.006 Distal
emboli 1.9 14.1 0.03 RWM 0-4 wks 0.30
0.20 0.18 0.22 0.008
Limbruno U et al. Circulation 200318171-6
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DIPLOMAT Randomized Trial

• 60 pts at 5 French sites
• PI Thierry Lefevre
• Primary PCI lt12 hrs
• ST? gt2 mm in 2 leads
• Rand to PCI AngioGuard
• Primary EP Absolute resolution of the sum of ST
  segment 1 post PCI (mm)

Presented at
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DIPLOMAT Results (n56)

• AngioGuard Control P
• N 30 26
• Device delivered 100 -
• Debris retrieved 82 -
• TIMI-3 post 93 96 NS
• cTFC 30 17 29 11 NS
• SST Res (mm) 15.8 15.3 9.6 6.7 0.048
• ST Res gt70 67 54 NS