Pre-stent plaque modification in complex, calcified coronary artery lesions

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AngioSculpt A New Scoring Balloon
Pre-stent plaque modification in complex,
calcified coronary artery lesions
Ehud Grenadier M.D Cardiac catheterization
Labs HaifaHerzlia ISRAEL

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Why is Lesion Preparation Essential?
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POSTIT Trial when using only the stent
delivery balloon over 70 of the pts. did not
achieve optimal stent deployment.
Percent of Population
Patients who did not achieve optimal stent
deployment with SDS
40 50 60 70 80
90 100 120 130
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.
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Manufacturers Predicted Minimal Stent Diameter
(MSD) is Usually Not Achieved With the Original
Stent Balloon
Costa et al, Am J Cardiol 200596,74-78
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(No Transcript)
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Benefit of the AngioSculpt for Pre-dilatation of
DES
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
Costa et al, AHA 2006
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AngioSculpt Scoring Balloon Catheter
Semi-compliant balloon with an external nitinol
shape memory helical scoring edge
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Centrally Located Within the Arterial Lumen
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The AngioSculpt is Comprised of
A
B
A - Rapid exchange or OTW semi-compliant
balloon B - Laser cut nitinol scoring element
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Histopathology of the AngioSculpt vs. POBA
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)
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Use of the Angiosculpt for Pre-dilation of
Challenging Coronary Lesions Prior to Stenting
Personal Experience

• Ehud Grenadier, Arthur Kerner, Nabeel Makhoul,
  Luis Gruberg, Ariel Roguin

Herzliya Rambam Med. Ctrs. Herzliya Haifa,
ISRAEL
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Aims of the Study

• To evaluate the Deliverability, Efficacy, and
  Safety of the
• AngioSculpt Scoring Balloon Catheter
• in patients with challenging and calcific CAD

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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

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I.V.U.S - Virtual Histology
Performed in 111/221 49.7 pts.
154/279 55.2 lesions

• Evaluated in 60/221 27.1 pts.
• 76/279 27.2 lesions
• Volcano Therapeutics
• IVG - 3 / S-5
• Eagle Eye Gold IVUS catheter

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AngioSculpt Relative Contraindications

• Unprotected left main disease
• Non-calcified SVG lesion
• Thrombotic lesion

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Primary Performance Endpoint

• 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)

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Primary Safety Endpoint

• 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

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Secondary Endpoints

• Flow limiting dissection
• Vessel perforation

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Patient Demographics221 pts, 279 lesions

• Age 63.819.4 yrs (range 34 88)
• Males 72
• Severe Angina (CCS class 3-4) 56
• Prior PCI 43
• Prior MI 34
• Prior CABG 6

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Risk Factors
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Vessel Distribution

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Lesion Characteristics

• ISR 51/279 18, De-Novo 228/279 82
• Bifurcation 69/279 25
• Eccentric 117/279 42
• Ulcerated 31/279 11
• gt30 angulation 154/27955
• Mean lesion angulation 34.317

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Lesions Classification (AHA/ACC)
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Calcification Severity
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Pre-Procedure QCA
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Pre-Procedure Lesion Measurements (QCA)
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Primary Endpoint Results

• Procedural Success 96.0 268/279
• Clinical Success 94.6 209/221

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AngioSculpt Only Procedural Success

• Diameter stenosis lt50 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

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QCA ResultsDiameter Stenosis ()
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QCA Results (contd)Minimum Luminal Diameter (mm)
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IVUS Results MLD (mm) and CSA (mm2)
Paired t-Test
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IVUS ResultsLesion Characteristics
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AngioSculpt Dimensions Inflation Pressures
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Reduction in Usage of NC Balloons
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AngioSculpt Crossability
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Device Slippage

• Device slippage was observed in
• 4/271 1.5 of ASC treated lesions

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Double 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

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Stent Types Used in the Study
Stents were implanted in 264/279 94.6 lesions


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Distal Left Main and Proximal LCx Lesions
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ANGIOSCULPT 2.0 x 15 mm
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POST-DES INSERTION
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IVUS Demonstrates Optimal Stent Apposition
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Angiogram and IVUS Pre-Intervention
MLD 1.2mm MLA 1.5mm² Plaque area
5.72mm² Plaque burden 83
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Angiogram and IVUS Post-AngioSculpt
Yellow arrows indicate scoring marks
MLD 1.4 mm MLA 3.1 mm² Plaque area 4.8
mm² Plaque burden 63
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Angiogram and IVUS Post-Stent
MLD 2.6 mm MSA 5.2 mm²
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Severe calcified Lcx Lesion
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Angiosculpt Dilation
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Final Angiographic Result Post Taxus
Stent Insertion
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Distal long RCA lesion
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Pre dilated RCA lesion - Q.C.A Analysis
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3.0/20 mm and 3.5/15 mm Angiosculpt Predilation
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3.5 mm Endeavor Stent Insertion
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FINAL Angiographic RESULT
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Cumulative MACE _at_ 30 day F/U 215/221 97.2 pts
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Procedural Complications(per lesion)
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Cumulative MACE _at_ 19.211.2 mon. 187/221
84.6 pts.
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Conclusions I

• The AngioSculpt is highly effective for the
  treatment of a broad spectrum of challenging
  coronary artery lesions
• It is very useful to avoid geographic miss due
  to device slippage
• A surprisingly low rate of TVR, no CARDIAC
  related DEATH and no Late Stent THROMBOSIS was
  observed during long term F/U in this study

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Conclusions II

• NC balloon usage was reduced by 46 in the
  lesions in which the AngioSculpt was successfully
  deployed
• Difficulty in device deliverability may be
  anticipated in severe, calcified lesions
  associated with pronounced vessel/lesion
  angulation (or when the IVUS catheter was unable
  to cross the lesion)
• Deliverability enhancements including an improved
  crossing profile and lubricious coating are in
  development