EMBOLIC PROTECTION IN SVG, NATIVE CORONARY &

CAROTID ANGIOPLASTY

DR RAJ KUMAR,DM(Card).

NIMS,Hyderabad,AP,India.

Email:dr.rajkumarmd@yahoo.com

SAFER Trial – Comparison of SAFER Trial – Comparison of PercuSurge to Routine Stenting in SVG’sPercuSurge to Routine Stenting in SVG’s

801 Patients Randomized801 Patients Randomized

30 Day MACE

Reduced 42%

P<0.001

Baim et al. Circulation 2002; 105: 1285.

Routine PercuSurge

%

0

20

16.5%

9.6%

Fire Trial: Randomized BSC/EPI Fire Trial: Randomized BSC/EPI Filter vs. PercuSurge in SVGPCIFilter vs. PercuSurge in SVGPCI

650 patients in 65 sites650 patients in 65 sites

Conclusion: FW not inferior to GWConclusion: FW not inferior to GWStone et al. J Am Coll Cardiol 2003; 41: 43A

FWFW GWGW

TIMI 3 FlowTIMI 3 Flow 95.7%95.7% 97.7%97.7%

Device SuccessDevice Success 95.5%95.5% 97.2%97.2%

DeathDeath 0.9%0.9% 0.9%0.9%

MIMI 9.0%9.0% 10.0%10.0%

QMIQMI 0.9%0.9% 0.6%0.6%

30 day MACE30 day MACE 9.9%9.9% 11.6%11.6%

PROXIMAL OCCULUSION PROXIMAL OCCULUSION DEVICES DEVICES

• These devices occlude flow into the These devices occlude flow into the vessel using a balloon on the tip of or just vessel using a balloon on the tip of or just the tip of catheter the tip of catheter

• Two proximal occlusion catheters are in Two proximal occlusion catheters are in use:use:

Proxis catheterProxis catheter

Kerberos embolic protection systemKerberos embolic protection system

• With inflow occlusion , With inflow occlusion , retrograde flow generated by retrograde flow generated by distal collaterals or infusion distal collaterals or infusion through a ”rinsing “ catheter through a ”rinsing “ catheter can propel any liberated debris can propel any liberated debris back into the lumen of the back into the lumen of the guiding catheter guiding catheter

• These have potential These have potential advantage of providing advantage of providing embolic protection even before embolic protection even before the first wire crosses the the first wire crosses the lesion.lesion.

Proxis In VesselProxis In Vessel

Benefits to Proximal Benefits to Proximal ProtectionProtection

• Nothing crosses the lesion prior to Nothing crosses the lesion prior to protectionprotection

• Protection of main vessel Protection of main vessel andand side side branchesbranches

• Captures large and small particlesCaptures large and small particles• Can handle large embolic loadsCan handle large embolic loads

CATHETER-BASED APPROACHES TO CATHETER-BASED APPROACHES TO THROMBUS-RICHTHROMBUS-RICH

LESIONS LESIONS

• The negative impact of angiographically evident thrombi The negative impact of angiographically evident thrombi on PCI outcomes has prompted attempts to reduce clot on PCI outcomes has prompted attempts to reduce clot burden prior to intervention in order to minimize burden prior to intervention in order to minimize embolization and clinical complications.embolization and clinical complications.

• Novel catheter-based devices have been designed for Novel catheter-based devices have been designed for this purpose. this purpose.

• Devices operate either by debulking thrombi prior to PCI Devices operate either by debulking thrombi prior to PCI (active protection), or by creating a barrier to limit distal (active protection), or by creating a barrier to limit distal embolization (passive protection).embolization (passive protection).

The Transluminal Extraction The Transluminal Extraction Catheter (TEC)Catheter (TEC)

• The transluminal extraction catheter (TEC) was employed for the treatment of The transluminal extraction catheter (TEC) was employed for the treatment of thrombus-rich lesions in native coronary arteries and SVG’s.thrombus-rich lesions in native coronary arteries and SVG’s.

• Use of this device was restricted by its difficult set-up, large profile and Use of this device was restricted by its difficult set-up, large profile and propensity to cause dissections. propensity to cause dissections.

• Expanding clinical experience with these technologies suggests they may play Expanding clinical experience with these technologies suggests they may play an important role as adjuncts to PCI for thrombus-rich lesions.an important role as adjuncts to PCI for thrombus-rich lesions.

Rheolytic thrombectomyRheolytic thrombectomy

• Dissolution and removal of Dissolution and removal of clots from coronary and clots from coronary and peripheral arteries is achieved peripheral arteries is achieved by the creation of a flow-by the creation of a flow-mediated vacuum in the mediated vacuum in the vicinity of the treated lesion. vicinity of the treated lesion.

• High speed injection of saline High speed injection of saline fluid into an aspiration catheter fluid into an aspiration catheter forms a low pressure zone at forms a low pressure zone at its orifice (the Bernoulli effect). its orifice (the Bernoulli effect).

Hypo tube

Water jets

Exhaust lumen

• The pressure gradient between the thrombus The pressure gradient between the thrombus and the catheter tip draws clot particles into the and the catheter tip draws clot particles into the lumen of the device, where they are further lumen of the device, where they are further fragmented by the high speed saline jets and fragmented by the high speed saline jets and then aspirated. then aspirated.

• The double lumen device allows both saline The double lumen device allows both saline injection and aspiration of particulate matter into injection and aspiration of particulate matter into its collection system.its collection system.

• Two currently available devices that Two currently available devices that incorporate this principle have been incorporate this principle have been tested, namely the Possis Angiojet tested, namely the Possis Angiojet and Cordis Hydrolyser catheters.and Cordis Hydrolyser catheters.

• AngioJet thrombus scoring system AngioJet thrombus scoring system 

– Angiographic scoreAngiographic score• definite thrombus  3 ptdefinite thrombus  3 pt• probable thrombus  2 ptprobable thrombus  2 pt• possible thrombus  1 ptpossible thrombus  1 pt• unlikely   0 ptunlikely   0 pt

– Clinical ScoreClinical Score• acute (<24 hr)  2 ptacute (<24 hr)  2 pt• sub-acute (< 2wk)  1 ptsub-acute (< 2wk)  1 pt• chronic (> 2wk)  0 ptchronic (> 2wk)  0 pt

– Combined score = sum (0-5)Combined score = sum (0-5)

• Score Score >> 3 => 84%  3 => 84% substantial/complete resolution with substantial/complete resolution with AngioJetAngioJet

• In the VeGAS 2 trial, the In the VeGAS 2 trial, the Angiojet device was compared Angiojet device was compared with urokinase prior to with urokinase prior to percutaneous treatment of 346 percutaneous treatment of 346 patients with thrombus-rich patients with thrombus-rich lesions in native coronary lesions in native coronary arteries or SVG’s.arteries or SVG’s.

• In this high risk population, In this high risk population, procedural success and hospital procedural success and hospital course without a major adverse course without a major adverse cardiac event were achieved cardiac event were achieved with the Angiojet catheter in with the Angiojet catheter in 86% of cases, significantly more 86% of cases, significantly more frequently than with urokinase frequently than with urokinase (66%, P = 0.01)(66%, P = 0.01)

1.7%

15.0%13.9%

3.0%

33.1%30.8%

0%

10%

20%

30%

40%

Death MI MACE

Angiojet

Urokinase

3.3%0.6%3.3%

11.8%

3.0%

13.6%

0.0%

5.0%

10.0%

15.0%

20.0%

Any Surgical Repair Transfusion

Angiojet

Urokinase

• SILVA AND CO-WORKERS used the Angiojet used the Angiojet system in 70 AMI patients prior to angioplasty of the system in 70 AMI patients prior to angioplasty of the culprit lesion. culprit lesion.

• The procedure was successful in more than 90% of The procedure was successful in more than 90% of patients. patients.

• In-hospital survival exceeded 90%, and 87% of this In-hospital survival exceeded 90%, and 87% of this group remained free of MACE throughout their hospital group remained free of MACE throughout their hospital course, course,

• 16% had CS at the time of the procedure.16% had CS at the time of the procedure.

““CLASSIC” USES OF ANGIOJETCLASSIC” USES OF ANGIOJET  

– SVG thrombusSVG thrombus– Native vessel thrombusNative vessel thrombus– Acute MI   ---- AIMI trialAcute MI   ---- AIMI trial– Stent thrombosisStent thrombosis– Peripheral arterial thrombosisPeripheral arterial thrombosis– Clotted dialysis access fistulaClotted dialysis access fistula– Deep venous thrombosisDeep venous thrombosis– Pulmonary embolusPulmonary embolus

  

• The largest study with the The largest study with the Cordis Hydrolyser in Cordis Hydrolyser in coronary PCIcoronary PCI included 31 pts . included 31 pts .

• TIMI 2-3 flow was achieved with the Hydrolyser in 58% TIMI 2-3 flow was achieved with the Hydrolyser in 58%

of initially occluded vessels.of initially occluded vessels.

• 90%of the pts received additional PCI (PTCA and stent). 90%of the pts received additional PCI (PTCA and stent).

• A major adverse cardiac event occurred in 3 pts (in-A major adverse cardiac event occurred in 3 pts (in-hospital mortality in two, non-Q AMI in one).hospital mortality in two, non-Q AMI in one).

ASPIRATION THROMBECTOMYASPIRATION THROMBECTOMY

• The X-Sizer (EndicCOR The X-Sizer (EndicCOR Medical, Inc.,) is a Medical, Inc.,) is a thromboatherectomy catheter thromboatherectomy catheter of varying dimensions. of varying dimensions.

• Rotation of a distal helical Rotation of a distal helical cutter results in thrombus cutter results in thrombus maceration and extraction into maceration and extraction into a distal vacuum collection a distal vacuum collection bottle. bottle.

• Experience in several hundred Experience in several hundred pts has shown this catheter to pts has shown this catheter to be effective in debulking be effective in debulking thrombus and degenerating thrombus and degenerating SVG lesions . SVG lesions .

• THE X-TRACT TRIAL THE X-TRACT TRIAL demonstrated that the demonstrated that the X-X-SizerSizer may be safely used as an  may be safely used as an adjunct to PCI of diseased adjunct to PCI of diseased SVGs and thrombus-laden SVGs and thrombus-laden native coronary arteries. native coronary arteries.

• Less need for GP IIb/IIIa Less need for GP IIb/IIIa inhibitor bail-out in patients inhibitor bail-out in patients treated with the treated with the X-SizerX-Sizer, , suggesting a reduction in suggesting a reduction in periprocedural complications. periprocedural complications.

• MACE rates at 30 days were MACE rates at 30 days were similar in both groupssimilar in both groups

• There was a significantly lower There was a significantly lower incidence of large incidence of large postprocedural MI at 30-day postprocedural MI at 30-day follow-up among patients follow-up among patients treated with the treated with the X-SizerX-Sizer device.  device.

17.0 17.4

1.0

15.8

1.8 1.5

16.9

0.30

5

10

15

20

25

Cardiacdeath

MI TVR MACEInc

idenc

e (%)

X-SIZER Control

Role of distal protection for Role of distal protection for thrombus-rich lesionsthrombus-rich lesions

Two classes of devices designed to trap embolic matter downstream Two classes of devices designed to trap embolic matter downstream from the site of intervention are the occlusive type (e.g., from the site of intervention are the occlusive type (e.g., PercuSurge, USA) and the filter wires type (e.g., Angioguard, USA).PercuSurge, USA) and the filter wires type (e.g., Angioguard, USA).

With the PercuSurge system, a balloon is incorporated into a 0.014'' With the PercuSurge system, a balloon is incorporated into a 0.014'' wire, passed across the lesion and then inflated, occluding the distal wire, passed across the lesion and then inflated, occluding the distal vessel.vessel.

Angioplasty and/or stenting is then performed over the guidewire. Angioplasty and/or stenting is then performed over the guidewire. Following intervention, an aspiration catheter is introduced over the Following intervention, an aspiration catheter is introduced over the device wire, aspirating embolized material trapped by the distal device wire, aspirating embolized material trapped by the distal balloon. balloon.

• The 800 patient multicenter randomized SAFER The 800 patient multicenter randomized SAFER trial demonstrated a 50% reduction in in-hospital trial demonstrated a 50% reduction in in-hospital adverse events with PercuSurge distal adverse events with PercuSurge distal protection during SVG stenting, when compared protection during SVG stenting, when compared to stenting without protectionto stenting without protection

• Preliminary experiences with the Preliminary experiences with the PercuSurge PercuSurge in AMI patients in AMI patients undergoing percutaneous undergoing percutaneous intervention suggest that normal myocardial intervention suggest that normal myocardial blush may be achieved in more than 60%blush may be achieved in more than 60%

PercuSurge SystemPercuSurge System

AdvantagesAdvantages

• Captures smaller Captures smaller particles and particles and “humoral” mediators“humoral” mediators

• Frequently applicable Frequently applicable

DisadvantagesDisadvantages

• Transient occlusionTransient occlusion

• Long “parking” Long “parking” segmentsegment

• Side branches Side branches unprotectedunprotected

• Two operatorsTwo operators

• In Filter wire-type devices, An emboli entrapment net is In Filter wire-type devices, An emboli entrapment net is mounted on a 0.014" guidewire and expanded distally to mounted on a 0.014" guidewire and expanded distally to the lesion. the lesion.

• Intervention is then performed over the guidewire.Intervention is then performed over the guidewire.

• Filters do not block distal blood flow when first deployed Filters do not block distal blood flow when first deployed unlike occlusive devices.unlike occlusive devices.

• Dislodged material is caught by the distal filter, which is Dislodged material is caught by the distal filter, which is then closed and retracted only at the end of the then closed and retracted only at the end of the procedure.procedure.

• A limitation of these devices in thrombus-rich lesions is that A limitation of these devices in thrombus-rich lesions is that thrombotic emboli can partially block the filter and accelerate thrombotic emboli can partially block the filter and accelerate thrombus accumulation on it, thereby diminishing flow. thrombus accumulation on it, thereby diminishing flow.

• The efficacy of all distal protection systems in native coronary The efficacy of all distal protection systems in native coronary arteries is potentially limited by side branches originating arteries is potentially limited by side branches originating proximally to the location of the device, which may not be proximally to the location of the device, which may not be protected from embolizationprotected from embolization..

• More data are required before the use of distal protection devices is More data are required before the use of distal protection devices is indicated in the treatment of thrombus-rich lesions.indicated in the treatment of thrombus-rich lesions.

• PREPARE (proximal embolic protection in acute mi & resolution of st elevation)study

• PREMIAR (protection of distal embolisation in high risk pts with acute stemi)

• EMERALD (enhanced myocardial efficacy and removal by aspiration of liberated debris) guardwire

EMBOLIC PROTECTION IN CAROTID

ANGIOPLASTY

Neuroprotection systems•Embolisation occurs in all percutaneous cardiovascularInterventions.•It acquires more significance in the neurovascular territory.

• Carotid lesions contain friable ulcerated plaque and thrombotic material that can embolise during endovascular or open surgery.

•Embolic particles are classified as either macroemboli (>100 μm) or microemboli (<100 μm).

•Macroemboli, especially >200 μm, are usually associated withclinical events;

DISTAL PROTECTION DEVICES

• Filter devices can be classified based on the relationship to the 0.014” guidewire.

“wire-mounted filters”.“bare-wire filter systems”.

• Filters are positioned in a straight portion of the ICA(“landing-zone”) in order to optimise adaptation of the frame to thevessel wal

LIMITATIONS OF DISTAL PROTECTION DEVICES

• 1.Unprotected crossing of the lesion in order to deploy the device,especially in tight stenoses.

• 2.Not effective in trapping microemboli, limited by pore size.

• 3. In tortuous, large or diseased distal ICA anatomies incomplete wall apposition may allow even macroemboli to bypass the system.

4. Debris may be dislodged during the recapture phase (“squeezing effect”) of the procedure.

5. Filters may be an embolic source themselves due to intimal damage at the landing zone.

Schematic of (A) concentric and (B) eccentric filtersillustrating the position of the wire in relation to

the basket.

PROXIMAL PROTECTION DEVICES

• Proximal occlusion devices interrupt or reverse blood-flow in the ICA by preventing antegrade flow from the CCA to the ICA and retrograde flow from the ECA into the ICA.

• they offer the following ADVANTAGES:1. Crossing the lesion under protection with the

preferred guidewire.

2. Blocking both macro- and microemboli.

3.Navigation of the device in the distal ICA is not required, thus reducing the risk of intimal damage, spasm or dissection.

NEUROPROTECTION SYSTEM™ (NPS) (GORE, NEWARK,DE, USA)

(A) Global view of the system. The detail shows the “balloon-sheath” and the “balloon-wire” both inflated in the CCAand ECA

B) The filter is positioned between the NPS-sheath and the venous sheath. (C) TheNPS “balloon-sheath”.

MO.MA™ (INVATEC S.P.A., RONCADELLE, ITALY

9FR sheath with integrated baloon in CCA

EXTENDED INTEGRATED BALOON IN ECA.

Following postdilatation blood is aspirated and checked for debris before deflatingthe balloons

LIMITATIONS OF PROXIMAL PROTECTION DEVICES

PROXIMAL PROTECTION DURING CAS: CLINICAL OUTCOMES

• The ARMOUR study is a pivotal US trial evaluating the safety and effectiveness of the Mo.Ma system.

– 30-day major adverse cardiac and cerebrovascular events, was 2.3%. The device success rate was 98.2%.

• The DESERVE study(europe) is a Diffusion Weighted-MRI based evaluation of the effectiveness of the Mo.Ma system..

• EMPIRE is a prospective controlled single-arm multicentre trial to evaluate the performance of the NPS system.

• It enrolled 122 patients .• The primary endpoint of 30-day stroke and death rate

was 1.6%.

• CREST (carotid revascularisation endarterectomy versus stenting trial)

• EVA-3S (endarterectomy versus angioplastyin pts with symp, sev CAS )

• SPACE (stent supported percutaneous angioplasty of the carotid artery versus endarterectomy)

• ICSS (international carotid stenting study)

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