Pre-stent plaque modification in complex, calcified coronary

artery lesions

Pre-stent plaque modification in complex, calcified coronary

artery lesions

AngioSculpt®A New Scoring Balloon

Ehud Grenadier M.DEhud Grenadier M.D

Cardiac catheterization LabsCardiac catheterization LabsHaifa;Herzlia Haifa;Herzlia

ISRAEL ISRAEL

Why is Lesion Why is Lesion

Preparation Preparation

EssentialEssential??

MSD as percent of RLD

MSD as a percentage of RLD following stent deployment. Optimum stent deployment : (MSD 90% RLD).

Patients not achieving criteria with the stent delivery system (71%)

Brodie B. et al POSTIT Trial, Cath. Card. Int. 2003: 59,184-192.

Per

cen

t o

f P

op

ula

tio

n

40 50 60 70 80 90 100 120 130

Patients who did not achieve optimal stent deployment with SDS

POSTIT TrialPOSTIT Trial : when using only the stent delivery balloon : when using only the stent delivery balloon over 70% of the pts. did not achieve optimal stent deploymentover 70% of the pts. did not achieve optimal stent deployment..

++++++

++ ++++

++++

++++

+

++++ ++++ +

++xx x

xxxxxxxx

xxx

x xx

xxx

xxx

xxxx x

x

++

xxxx

2.5 3.0 3.5 4.0 4.5

1.5

2.0

2.5

3.0

3.5

4.0

4.5

Manufacturer’s Predicted MSD (mm)

IVU

S M

eas

ure

d M

SD

(m

m) Nominal S

tent Size

Manufacturer AManufacturer BManufacturer CManufacturer Dx

+

Costa et al, Am J Cardiol 2005:96,74-78

Manufacturer’s Predicted Minimal Stent Diameter Manufacturer’s Predicted Minimal Stent Diameter (MSD) is Usually Not Achieved With the Original (MSD) is Usually Not Achieved With the Original

Stent BalloonStent Balloon

IVUS guidance may result in more effective

stent expansion and results in 44% reduction

in TVR

Only 22% of patients that experience SAT have an optimum PCI result as assessed by

IVUS

CRUISE study: Peter J. Fitzgerald et.al. “Final Results of the Can Routine Ultrasound Influence Stent Expansion (CRUISE) Study”

Circulation 2000 102:523-530

.Cheneau Study: Edouard Cheneau,et al. “Predictors of Subacute Thrombosis. Results

of a Systematic Intravascular Ultrasound Study.” Circulation 2003; 108:43-47

T

V

R

S

A

T

Non-uniform stent strut distribution and

malapposition may result in more intimal

hyperplasia after stenting

MSA and stent under expansion

are major predictors of

stent thrombosis

RESTENOSIS

Takebayastri Study: Hideo Takebayastri et al. “Non-uniform Strent Strut Distribution

Correlates with More Neointimal Hyperplasia after Sirolimus-Elluting Stent Implantation”

Circulation 2004;110:3430-3434

B.Brodie. Adjunctive balloon post dilatation after stent deployment. J Interven Cardiol

2006;19:43-50

THROBOSIS

Benefit of the AngioSculpt Benefit of the AngioSculpt for Pre-dilatation of DESfor Pre-dilatation of DES

Benefit of the AngioSculpt Benefit of the AngioSculpt for Pre-dilatation of DESfor Pre-dilatation of DES

Group I (n=145)Group II (n=117)

Group III (n=37)

p value

MSD/PSD76% ± 10%76% ± 13%88% ± 18%<0.001

MSA/PSA67% ± 16%70% ± 23%88% ± 22%<0.001

Final stent CSA < 5.0mm226.2%25.6%10.8%0.03

Costa et al, AHA 2006

Group I = direct stenting

Group II = pre-dilatation with POBA

Group III = pre-dilatation with AngioSculpt

CSA = cross sectional area, MSA = minimum stent area, MSD = minimum stent diameter,

PSA = predicted stent area, PSD = predicted stent diameter

AngioSculpt Scoring Balloon AngioSculpt Scoring Balloon CatheterCatheter

Semi-compliant balloon with an Semi-compliant balloon with an external external

nitinol shape memory helical scoring nitinol shape memory helical scoring edgeedge

Semi-compliant balloon with an Semi-compliant balloon with an external external

nitinol shape memory helical scoring nitinol shape memory helical scoring edgeedge

Centrally Located Within the Arterial Lumen

The AngioSculpt is The AngioSculpt is Comprised ofComprised of : :

A - Rapid exchange or OTW semi-compliant A - Rapid exchange or OTW semi-compliant balloonballoon

B - Laser cut nitinol scoring elementB - Laser cut nitinol scoring element

A B

Acute histopathology specimen of a patient post conventional

balloon angioplasty demonstrating extensive dissection and laceration

(yellow arrows)

Post-AngioSculpt scoring of porcine ISR (yellow arrows)

Histopathology of the AngioSculpt vs. Histopathology of the AngioSculpt vs. POBAPOBA

Use of the Angiosculpt for Pre-dilation of Use of the Angiosculpt for Pre-dilation of Challenging Coronary Lesions Prior to Challenging Coronary Lesions Prior to

Stenting Stenting

Personal ExperiencePersonal Experience

Use of the Angiosculpt for Pre-dilation of Use of the Angiosculpt for Pre-dilation of Challenging Coronary Lesions Prior to Challenging Coronary Lesions Prior to

Stenting Stenting

Personal ExperiencePersonal Experience Ehud Grenadier, Arthur Kerner, Nabeel

Makhoul, Luis Gruberg, Ariel Roguin

Herzliya & Rambam Med. Ctrs. Herzliya & Haifa, ISRAEL

Aims of the StudyAims of the Study

To evaluate the Deliverability, Efficacy, and Safety of the

AngioSculpt Scoring Balloon Catheter

in patients with challenging and calcific CAD

To evaluate the Deliverability, Efficacy, and Safety of the

AngioSculpt Scoring Balloon Catheter

in patients with challenging and calcific CAD

Study Design

Two-center, prospective, consecutive, non-randomized single operator registry

Inclusion criteria: pts with single or multi-vessel coronary artery disease scheduled to undergo PCI

Population: 221 consecutive pts enrolled at 2 sites

Follow-up: outpatient visits, telephone interviews and re-catheterization if clinically indicated

Two-center, prospective, consecutive, non-randomized single operator registry

Inclusion criteria: pts with single or multi-vessel coronary artery disease scheduled to undergo PCI

Population: 221 consecutive pts enrolled at 2 sites

Follow-up: outpatient visits, telephone interviews and re-catheterization if clinically indicated

I.V.U.S - VirtualI.V.U.S - Virtual HistologyHistology

Evaluated in 60/221 [ 27.1 %] pts. 76/279 [ 27.2 %] lesions

“Volcano Therapeutics” IVG - 3 / S-5

Eagle Eye Gold IVUS catheter

Evaluated in 60/221 [ 27.1 %] pts. 76/279 [ 27.2 %] lesions

“Volcano Therapeutics” IVG - 3 / S-5

Eagle Eye Gold IVUS catheter

Performed in 111/221 [ 49.7 % ] pts. 154/279 [ 55.2 % ] lesionsPerformed in 111/221 [ 49.7 % ] pts. 154/279 [ 55.2 % ] lesions

AngioSculpt AngioSculpt Relative ContraindicationsRelative Contraindications

Unprotected left main diseaseUnprotected left main disease

Non-calcified SVG lesionNon-calcified SVG lesion

Thrombotic lesionThrombotic lesion

Unprotected left main diseaseUnprotected left main disease

Non-calcified SVG lesionNon-calcified SVG lesion

Thrombotic lesionThrombotic lesion

Primary Performance Primary Performance EndpointEndpoint

Procedural Success

Final diameter stenosis ≤10% in all AngioSculpt treated lesions following completion of the interventional procedure (including adjunctive stenting when used) without in-hospital major adverse cardiac events (MACE)

Procedural Success

Final diameter stenosis ≤10% in all AngioSculpt treated lesions following completion of the interventional procedure (including adjunctive stenting when used) without in-hospital major adverse cardiac events (MACE)

Primary Safety Primary Safety EndpointEndpoint

Clinical Success

Successful PCI and freedom from MACE at 30 day follow-up

MACE is defined as death, Q wave or non-Q wave MI, CABG or TLR of the index lesion

Clinical Success

Successful PCI and freedom from MACE at 30 day follow-up

MACE is defined as death, Q wave or non-Q wave MI, CABG or TLR of the index lesion

Secondary Secondary EndpointsEndpoints

Flow limiting dissectionFlow limiting dissection

Vessel perforationVessel perforation

Patient Patient DemographicsDemographics

221 pts, 279 lesions221 pts, 279 lesions Age: 63.8±19.4 yrs (range 34 – 88)Age: 63.8±19.4 yrs (range 34 – 88) Males: 72%Males: 72% Severe Angina (CCS class 3-4): 56%Severe Angina (CCS class 3-4): 56% Prior PCI: 43%Prior PCI: 43% Prior MI: 34%Prior MI: 34% Prior CABG: 6%Prior CABG: 6%

Age: 63.8±19.4 yrs (range 34 – 88)Age: 63.8±19.4 yrs (range 34 – 88) Males: 72%Males: 72% Severe Angina (CCS class 3-4): 56%Severe Angina (CCS class 3-4): 56% Prior PCI: 43%Prior PCI: 43% Prior MI: 34%Prior MI: 34% Prior CABG: 6%Prior CABG: 6%

Risk Factors

0

10

20

30

40

50

60

70

Hypercholesterolemia Diabetes Family history of CAD

5.7%5.7%

NIDDMNIDDM

58.7%58.7%

35.8%35.8%

41.2%41.2%%%

IDDMIDDM

Vessel DistributionVessel Distribution

2

36

4

1715

30

0

5

10

15

20

25

30

35

40

LM protected LAD Diagonal LCx LCxM RCA

%

Lesion CharacteristicsLesion Characteristics

ISR: 51/279 [18%], De-Novo: 228/279 [82%] Bifurcation: 69/279 [25%] Eccentric: 117/279 [42%] Ulcerated: 31/279 [11%] >30° angulation: 154/279[55%]

Mean lesion angulation: 34.3±17˚

ISR: 51/279 [18%], De-Novo: 228/279 [82%] Bifurcation: 69/279 [25%] Eccentric: 117/279 [42%] Ulcerated: 31/279 [11%] >30° angulation: 154/279[55%]

Mean lesion angulation: 34.3±17˚

Lesions Classification (AHA/ACC)

Calcification Severity Calcification Severity

Pre-Procedure QCAPre-Procedure QCA

Pre-Procedure Lesion Pre-Procedure Lesion Measurements (QCA)Measurements (QCA)

Length(mm)

MLD(mm)

RVD [d](mm)

17.1+11.40.26±0.292.69±0.35

Primary Endpoint Primary Endpoint ResultsResults

Procedural Success: 96.0% [268/279]

Clinical Success: 94.6% [209/221]

Procedural Success: 96.0% [268/279]

Clinical Success: 94.6% [209/221]

AngioSculpt “Only” Procedural Success

Diameter stenosis <50%: 224/279 [80%]

Diameter stenosis ≤20%: 158/279 [57%]

Final failure to cross with the AngioSculpt occurred in 8/279 lesions [2 .9%], all occurred in severe, calcified

lesions with pronounced vessel/lesion angulation

Diameter stenosis <50%: 224/279 [80%]

Diameter stenosis ≤20%: 158/279 [57%]

Final failure to cross with the AngioSculpt occurred in 8/279 lesions [2 .9%], all occurred in severe, calcified

lesions with pronounced vessel/lesion angulation

QCA ResultsQCA ResultsDiameter StenosisDiameter Stenosis)%( )%(

Pre-ASCPre-ASCPost-ASCPost-ASCPost-StentPost-Stent

82.982.9++11.11.2 2 23.523.5++13.613.65.95.9++4.4 4.4

QCA Results (cont’d)QCA Results (cont’d)Minimum Luminal Diameter Minimum Luminal Diameter

(mm)(mm)

Pre-ASCPre-ASCPost-ASCPost-ASCPost-Post-StentStent

0.260.26++0.20.299

2.072.07++0.680.682.432.43++0.70.722

IVUS Results IVUS Results MLD (mm) and MLD (mm) and CSA (mmCSA (mm22))

MLD, CSA Ref. Vessel

(d)

MLD, CSA Pre-

dilatation

MLD, CSAPost-ASC

P-Value*MLD, CSAPost-stent

P-Value*

2.99±0.587.1±2.9

1.7±0.142.57±0.45

2.1±0.353.86±1.0

8

p<0.0001

p<0.0001

2.82±1.15.5±2.03

p<0.002p<0.000

1

*Paired t-Test

IVUS ResultsIVUS ResultsLesion CharacteristicsLesion Characteristics

Mod-Severe Ca++Eccentric

Post-ASC “Controlled” Dissections

72.4 %39.1%82.7 %

AngioSculpt Dimensions & AngioSculpt Dimensions & Inflation PressuresInflation Pressures

ASC Diameter(mm)

ASC Length(mm)

Inflation Pressure(atm)

2.51+0.3416.4+3.315.1+2.4

range: 10-18

Reduction in Usage Reduction in Usage of NC Balloonsof NC Balloons

Usage of NC Balloons Pre-ASC

Usage of NC Balloons in ASC

Study

Reduction in Usage of NC

Balloons

89% 43% 46%

AngioSculpt CrossabilityAngioSculpt Crossability

Planned POBA Pre-

ASC

Successful Primary

ASC

POBA Pre-dilatation

After Primary ASC Failure to

Cross

Failure to Cross with ASC

After POBA Pre-dilatation

Predicted Failure to

Cross (ASC not

attempted)

113/279[40.5%]

104/279[37.3%]

31/279[11.1%]

8/279[2.9%]

1/279 [0.4%]

Device SlippageDevice Slippage

Device slippage was observed in 4/271 [1.5 %] of ASC treated lesions

Device slippage was observed in 4/271 [1.5 %] of ASC treated lesions

Double Wire TechniquesDouble Wire Techniques

In 11/279 [3.9 %] lesions the additional use of a buddy wire resulted in successful crossing of 6/11 lesions

The anchor wire [LCA] was used in 5/279 [1.8%] lesions resulting in successful crossing in 3/5 lesions

In 11/279 [3.9 %] lesions the additional use of a buddy wire resulted in successful crossing of 6/11 lesions

The anchor wire [LCA] was used in 5/279 [1.8%] lesions resulting in successful crossing in 3/5 lesions

Stent Types Used in the StudyStent Types Used in the Study

21%

33%17%

15%14%

Cypher Taxus Endeavor Titan Other stents

Stents were implanted in 264/279 [94.6%] lesions Stents were implanted in 264/279 [94.6%] lesions

Distal Left Main and Proximal LCx Lesions

ANGIOSCULPT 2.0 x 15 mm

POST-DES INSERTION

IVUS Demonstrates Optimal Stent Apposition

Angiogram and IVUS Pre-Intervention

MLD = 1.2mmMLA = 1.5mm²

Plaque area = 5.72mm²Plaque burden = 83%

Angiogram and IVUS Post-AngioSculpt

MLD = 1.4 mm

MLA = 3.1 mm²

Plaque area = 4.8 mm²

Plaque burden = 63%

Yellow arrows indicate “scoring marks”

Angiogram and IVUS Post-Stent

MLD = 2.6 mm

MSA = 5.2 mm²

Severe calcified Lcx LesionSevere calcified Lcx Lesion

Angiosculpt DilationAngiosculpt Dilation

Final Angiographic ResultFinal Angiographic Result [ Post Taxus Stent Insertion ] [ Post Taxus Stent Insertion ]

Distal long RCA lesion

Pre dilated RCA lesion - Q.C.A Analysis

3.0/20 mm and 3.5/15 3.0/20 mm and 3.5/15 mm Angiosculpt mm Angiosculpt

PredilationPredilation

3.53.5 mm Endeavor Stent Insertionmm Endeavor Stent Insertion

FINAL Angiographic RESULTFINAL Angiographic RESULT

Cumulative MACE @ 30 day F/U Cumulative MACE @ 30 day F/U 215/221 [97.2%] pts215/221 [97.2%] pts

ComplicationRateTotal MACE6/221 [2.7 %]

Death at day 10 [ non cardiac ] Sepsis ? P.E ?

0.4% (1/221)

M.I (Q or Non-Q wave)0.9% (2/221)

Procedural complications (VF)0.4% (1/221)Chest pain, Re-cath, TIMI-2 , Patent0.4% (1/221)

Re-Hospitalization2.3 % (5/221)

Re-Catheterization2.3 % (5/221)

TLR

TLR- PCI0.9% (2/221)Vessel and Aortic Root - Dissection 0.4% (1/221)

Procedural ComplicationsProcedural Complications(per lesion)(per lesion)

Procedural ComplicationsProcedural Complications(per lesion)(per lesion)

Perforation0/279

Distal embolism 5/279 [1.8%]

Moderate side branch occlusion

10/279 [3.6%]

Thrombus formation1/279 [0.36%]

Dissections (> type C), no flow limiting dissection.

6/271 [2.2%]

Cumulative MACE @ 19.2±11.2 mon. 187/221 [84.6%] pts.

ComplicationComplicationRateRate

Total MACETotal MACE4.9 % (11/221)4.9 % (11/221)

Death at day 10. Death at day 10.

non cardiac.non cardiac.0.4% (1/221)0.4% (1/221)

MI (Q or Non-Q wave)MI (Q or Non-Q wave)0.9% (2/221)0.9% (2/221)

Re-HospitalizationRe-Hospitalization18.6% (41/221)18.6% (41/221)

Re-CatheterizationRe-Catheterization15.4% (36/221)15.4% (36/221)

CABG [>6 months]CABG [>6 months]0.9% (2/221) [5.6%]0.9% (2/221) [5.6%]

Re-TLR/TVR - PCIRe-TLR/TVR - PCI2.7% (5/221) 2.7% (5/221) [13.8%][13.8%]

Vessel and aortic Vessel and aortic dissectiondissection

0.4% (1/221)0.4% (1/221)

The The ‘AngioSculpt’‘AngioSculpt’ is highly is highly effectiveeffective for for the treatment of a the treatment of a broad spectrumbroad spectrum of of challenging challenging coronary artery lesionscoronary artery lesions

It is very useful to It is very useful to avoidavoid ““geographic geographic miss”miss” due to due to device slippagedevice slippage

A surprisingly low rate of TVR, A surprisingly low rate of TVR, no CARDIAC no CARDIAC relatedrelated DEATHDEATH and and no Late Stent no Late Stent THROMBOSISTHROMBOSIS was observed during long was observed during long term F/U in this study term F/U in this study

The The ‘AngioSculpt’‘AngioSculpt’ is highly is highly effectiveeffective for for the treatment of a the treatment of a broad spectrumbroad spectrum of of challenging challenging coronary artery lesionscoronary artery lesions

It is very useful to It is very useful to avoidavoid ““geographic geographic miss”miss” due to due to device slippagedevice slippage

A surprisingly low rate of TVR, A surprisingly low rate of TVR, no CARDIAC no CARDIAC relatedrelated DEATHDEATH and and no Late Stent no Late Stent THROMBOSISTHROMBOSIS was observed during long was observed during long term F/U in this study term F/U in this study

Conclusions IConclusions I

NC balloonNC balloon usage was usage was reducedreduced by by 46%46% inin the lesions in whichthe lesions in which the the AngioSculptAngioSculpt was was successfully deployedsuccessfully deployed

Difficulty in device deliverability may be Difficulty in device deliverability may be anticipated in anticipated in severe, calcified lesions severe, calcified lesions associated with pronounced associated with pronounced vessel/lesion angulation vessel/lesion angulation (or when the (or when the IVUS catheter was unable to cross the IVUS catheter was unable to cross the lesion) lesion)

Deliverability enhancements including Deliverability enhancements including an improved crossing profile and an improved crossing profile and lubricious coating are in developmentlubricious coating are in development

NC balloonNC balloon usage was usage was reducedreduced by by 46%46% inin the lesions in whichthe lesions in which the the AngioSculptAngioSculpt was was successfully deployedsuccessfully deployed

Difficulty in device deliverability may be Difficulty in device deliverability may be anticipated in anticipated in severe, calcified lesions severe, calcified lesions associated with pronounced associated with pronounced vessel/lesion angulation vessel/lesion angulation (or when the (or when the IVUS catheter was unable to cross the IVUS catheter was unable to cross the lesion) lesion)

Deliverability enhancements including Deliverability enhancements including an improved crossing profile and an improved crossing profile and lubricious coating are in developmentlubricious coating are in development

Conclusions II