Distal balloon occlusion devices and distal filter devices are the main types of embolic protection devices (EPDs) used during percutaneous coronary intervention (PCI). Distal balloon occlusion devices use a balloon to occlude blood flow distal to the lesion during PCI, while distal filter devices use a nitinol mesh filter to capture debris without interrupting blood flow. Major trials have shown the benefits of EPDs for saphenous vein graft interventions and for STEMI patients undergoing PCI. EPD selection depends on lesion location and vessel characteristics. EPDs are recommended for saphenous vein graft PCI but their routine use is not supported for native coronary artery PCI.

1. Embolic protection device
1) Distal balloon occlusion/ aspiration system
2) distal filter system
3) proximal occlusion/ aspiration system

3. Distal occlusive device
• Percusurge GuardWire (Medtronic, Inc), and
• TriActiv FX system (Kensey Nash,).
• First EPD to be FDA approved after SAFER trial.
• Consist of 0.014” wire with distal balloon.
• Mechanism- balloon passed distal to lesion and
inflated before intervention, to occlude flow so as
to create a column of stagnant blood which
collects plaque debris that is subsequently
removed with an aspiration catheter

4. Distal occlusive device
Advantage Disadvantage
Easy to cross lesion Cessation of antegrade flow which can
lead to hemodynamic worsening
Small landing zone, 20mm 5-8% are intolerant
Complete protection Can not be used for ostial lesion (risk of
embolization to aorta)
Aspirate large & small particles Cannot be used for distal lesion
Reliably trap debris Balloon induced injury
Entraps soluble mediators Not as steerable as PTCA wire
Easy device retrieval Difficult to image during procedure
Compatible with device Balloon can move during PCI
More steerable & lower profile than filter
wires

8. Filter devices
• Filter wire EX/EZ (Boston Scientific
Corporation)
• Spider/Spider FX (ev3 Inc., Plymouth, MN),
• Rubicon filter (Rubicon Medical Corporation),
• Interceptor wire (Medtronic AVE, );

9. Equipment
Distal filter device (FilterWire EZ)
FilterWire device is composed of a protection wire and a delivery and a
retraction catheter
 Protection wire - composed of a nitinol mesh filter with a distal
radiopaque spring tip, mounted on a 190 cm or a convertible 300/190 cm
cm PTFE-coated 0.014 inch stainless steel wire
Reproduced with permission from Boston Scientific Corporation

10. Equipment
Distal filter device (SpiderFX® Embolic Protection Device )
SpiderFX device is composed of a Capture wire and a SpiderFX Catheter
 Capture wire - composed of a nitinol mesh filter with a distal floppy tip,
mounted on a 190 cm or a convertible 320/190 cm PTFE-coated 0.014 in
stainless steel wire pre-loaded through the delivery end of the SpiderFX
catheter
Reproduced with permission from eV3 Inc.

11. • Mechanism- : uses a filter basket as opposed
to a balloon, traps debris but maintains distal
perfusion and ability for contrast imaging
during the procedure

12. Technique for spider FX
 6F guide catheter to engage the coronary ostium
 Standard 0.014 inch guidewire to cross the lesion (with the Spider)
 Identify the location where the filter will be deployed, preferably
2.5 to 3 cm distal to the lesion site
 Measure the vessel diameter in this location and choose the
appropriate filter diameter size
 Do not undersize (inadequate vessel wall apposition resulting in
embolization of debris) or oversize (vessel wall damage and or
slow/no-flow)

13. Technique
Deploying the device
 Cross the lesion with standard 0.014 in guidewire,
 load the distal tip of the EPD catheter on to the proximal
part of the guidewire
 Advance the EPD catheter over the primary guidewire,
cross the lesion until the radiopaque marker at the distal tip
of the delivery end is at least 4-5 cm beyond the distal edge
of the lesion
 Withdraw the primary guidewire, leaving the delivery
catheter with the capture wire in place
 Under fluoroscopy ensure that the proximal radiopaque
marker band is at least 2 cm distal to the lesion treated.
 Remove the EPD catheter to expose and deploy the filter.

14. Technique
Recovery and removal of the device
 PCI is completed using the capture wire as the primary
guidewire.
 Load the recovery end of the catheter.
 Gently advance the recovery end over the filter until the
proximal portion of the filter is inside the catheter (partial
enclosure recovery) or until all radiopaque markers on the
filter are within the catheter (full enclosure recovery)
 Carefully remove the catheter and the capture wire together
as a unit

15. Technique
FilterWire
 The deployment of FilterWire is similar, except the
protection wire serves as the guidewire and a
conventional guidewire is not used prior to deployment
of the FilterWire

20. Proximal occlusion devices
• Proxis (St. Jude Medical),
• Parodi
• Gore flow reversal
• and F.A.S.T. Funnel Catheter.
Mechanism- inflow balloon occlusion proximal
to the lesion

21. Proximal vs. Distal Protection
Ideal case for proximal protection
 Distal lesion with <4-5 cm
length of vessel beyond the
lesion
 Minimal proximal
atherosclerosis
Ideal case for distal protection
 Lesion with at least 4-5 cm length
of vessel beyond the lesion as a
landing zone
 Minimal landing zone
atherosclerosis

25. EPD Types: Strengths and Limitations
Distal
Occlusion
Distal Filter Proximal Occlusion
Embolization on wiring / pre-
dilatation/device crossing
+ + -
Failure to capture debris <
100μm
- + -
Failure to capture soluble
mediators
- + -
Ischemia during balloon
occlusion
+ - +
Limited contrast
opacification
+ - +
Unlimited debris capture + - +
Shunting of debris into
proximal side branches
+ - -

26. Major Trials of EPDs in SVG Intervention
Trial Device No. of
Patients
30-Day
MACE, %
P-
Value
Design
Distal occlusion device
SAFER GuardWire vs. Conventional guidewire 801 9.6 vs. 16.5 0.004 Superiority
PRIDE TriActiv vs. GuardWire 631 11.2 vs. 10.1 0.02 Non-inferiority
Distal filter device
FIRE FilterWire vs. GuardWire 651 9.9 vs. 11.6 0.0008 Non-inferiority
CAPTIVE CardioShield vs. GuardWire 652 11.4 vs. 9.1 NS Non-inferiority
TRAP TRAP vs. Conventional guidewire 358 12.7 vs. 17.3 0.24 Superiority
SPIDER SPIDER vs. FilterWire or GuardWire 732 9.1 vs. 8.4 0.012 Non-inferiority
AMEthyst Interceptor PLUS vs. FilterWire or
GuardWire
797 8.0 vs. 7.3 0.025 Non-inferiority
Proximal occlusion device
PROXIMAL Proxis vs. FilterWire or GuardWire 594 9.2 vs. 10 0.006 Non-inferiority

27. Major Trials of EPDs in Native Coronary STEMI
Trial Device No. of
Patients
Primary Endpoint Result, % P-
Value
Distal occlusion device
EMERALD GuardWire Plus vs.
Conventional guidewire
501 ST-segment resolution
at 30 mins
Infarct size
63.3 vs. 61.9
12.0 vs. 9.5
0.78
0.34
Tahk et al.* GuardWire Plus vs.
Conventional guidewire
116 TIMI grade-3 flow
TMP grade-3
Hyperemic Average
Peak Velocity
96 vs. 81
65 vs. 38
39.2 ± 16.7
vs. 30.6 ±
10.8 cm/s
0.016
0.001
0.014
MICADO GuardWire Plus vs.
Conventional guidewire
167 No-reflow
TIMI grade-3 flow
TMP grade-3
4 vs. 3
80 vs. 76
58 vs. 44
0.73
0.182
0.054
Ochala et al. GuardWire Plus vs.
Abciximab
120 TIMI grade-3 flow 89 vs. 89 NS
ASPARAGUS GuardWire Plus vs.
Conventional guidewire
329 TIMI grade-3 flow 77 vs. 78 0.73

28. Major Trials of EPDs in Native Coronary STEMI
Trial Device No. of
Patients
Primary Endpoint Result, % P-
Value
Distal filter device
PROMISE FilterWire EX vs.
Conventional guidewire
200 Maximum adenosine-
induced flow velocity
34±17 vs.
36±20 cm/s
0.46
UpFlow MI FilterWire EZ vs.
Conventional guidewire
100 TIMI grade-3 flow
Blush score-3
ST-segment resolution
at 60 mins
88.2 vs. 93.9
68.1 vs. 66
9.4 vs. 10.7
NS
NS
NS
DEDICATION FilterWire vs. Conventional
PCI
626 ST-segment resolution
at 90 mins
72 vs. 76 0.29
PREMIAR SpiderRX vs. Conventional
PCI
140 ST-segment resolution
at 60 mins
60 vs. 60 0.99
Proximal occlusion devices
PREPARE Proxis vs. Conventional PCI 284 Complete ST-segment
resolution at 60 mins
80 vs. 72 0.14

29. Selection of EPD
• Ostial lesion
-Filter type EPD
(Guardwire can lead to proximal embolization
into aorta)(.
• Shaft lesion
-Any device
• Distal lesion
-Proxis device
** For graft <2years old lesion due to ISR, EPD are
not required as embolization risk is less.

30. Class I
• Distal embolic protection devices be used with PCI to saphenous vein
grafts when technically feasible
Indications
Smith SC Jr, et al. ACC/AHA/SCAI 2005 guideline
update for percutaneous coronary intervention.

31. • Carotid artery stenting
• Data to date do not support the routine use of EPDs for native
coronary artery PCI (either stable CAD or acute MI setting)
• Other vascular beds - EPDs have been studied for renal artery stenting
and other peripheral stenting. There are no robust data to attest to
their efficacy at present
Other Indications

32. • Avoid distal EPDs in vessels with excessive
tortuosity
• Do not deploy EPDs in the region of stent
• Do not over- or under-size the EPD
Contraindications / Caution

33. Adjunctive therapy
• GP 2b 3a Inhibitors
– Donot result in improvement in epicardial blood
flow or MACE.
• Vasodilators
– Promising result in reversing so-flow or no-flow
phenomena.
– In comparison to adenosine & verapamil,
nicardipine was the most potent coronary
vasodilators with the fewest systemic side effects

34. LIMA graft interventions
• M/C distal anastomotic site stenosis.

35. Conclusions
• SVGs have poor long term patency rates & recurrent
ischemia is a common clinical problem.
• Early PCI is frequently very durable
• Results of late SVG PCI are suboptimal compared to
native PCI
• Distal protection should be used in ALL cases of SVG
PCI (ACC/AHA/SCAI class I indication) – reduces
risk of no reflow, distal embolization and peri
procedural MI

36. Conclusions
• Distal protection devices are underutilized
• Covered stents do not reduce MACE in SVG PCI
• Direct stenting and slightly undersizing may
improve outcomes
• DES treatment reduces angiographic and clinical
restenosis but does not alter death or MI
• Native vessel PCI is preferred whenever possible as
as an alternative therapy