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

2. Why is Lesion Preparation Essential?

3. 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
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 : 59,

4. Manufacturer’s Predicted MSD (mm)
Manufacturer’s Predicted Minimal Stent Diameter (MSD) is Usually Not Achieved With the Original Stent Balloon + x
1.5
2.0
2.5
3.0
3.5
4.0
4.5
Manufacturer’s Predicted MSD (mm)
IVUS Measured MSD (mm)
Nominal Stent Size
Manufacturer A
Manufacturer B
Manufacturer C
Manufacturer D
Costa et al, Am J Cardiol 2005:96,74-78

5. MSA and stent under expansion are major predictors of stent thrombosis
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 R E S T N O I
Takebayastri Study: Hideo Takebayastri et al. “Non-uniform Strent Strut Distribution Correlates with More Neointimal Hyperplasia after Sirolimus-Elluting Stent Implantation” Circulation 2004;110:
B.Brodie. Adjunctive balloon post dilatation after stent deployment. J Interven Cardiol 2006;19:43-50 H B
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 :
.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

6. Benefit of the AngioSculpt for Pre-dilatation of DES
Group I (n=145)
Group II (n=117)
Group III (n=37)
p value
MSD/PSD
76% ± 10%
76% ± 13%
88% ± 18%
<0.001
MSA/PSA
67% ± 16%
70% ± 23%
88% ± 22%
Final stent CSA
< 5.0mm2
26.2%
25.6%
10.8%
0.03
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

7. AngioSculpt Scoring Balloon Catheter
Semi-compliant balloon with an external
nitinol shape memory helical scoring edge

8. Centrally Located Within the Arterial Lumen

9. The AngioSculpt is Comprised of:B
A - Rapid exchange or OTW semi-compliant balloon
B - Laser cut nitinol scoring element

10. 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)

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

12. Aims of the Study
To evaluate the Deliverability, Efficacy, and Safety of the
AngioSculpt Scoring Balloon Catheter
in patients with challenging and calcific CAD

13. 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

14. 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

15. AngioSculpt Relative Contraindications
Unprotected left main disease
Non-calcified SVG lesion
Thrombotic lesion

16. 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)

17. 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

18. Secondary Endpoints
Flow limiting dissection
Vessel perforation

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

20. Risk Factors
5.7%
NIDDM
58.7%
35.8%
41.2% %
IDDM

21. Vessel Distribution %

22. Lesion 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˚

23. Lesions Classification (AHA/ACC)

24. Calcification Severity

25. Pre-Procedure QCA

26. Pre-Procedure Lesion Measurements (QCA)
Length
(mm)
MLD
RVD [d]
0.26±0.29
2.69±0.35

27. Primary Endpoint Results
Procedural Success: 96.0% [268/279]
Clinical Success: 94.6% [209/221]

28. 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

29. QCA Results Diameter Stenosis (%)
Pre-ASC
Post-ASC
Post-Stent

30. QCA Results (cont’d) Minimum Luminal Diameter (mm)
Pre-ASC
Post-ASC
Post-Stent

31. IVUS Results MLD (mm) and CSA (mm2)
MLD, CSA
Ref. Vessel (d)
Pre-dilatation
Post-ASC
P-Value*
Post-stent
2.99±0.58
7.1±2.9
1.7±0.14
2.57±0.45
2.1±0.35
3.86±1.08
p<0.0001
2.82±1.1
5.5±2.03
p<0.002
*Paired t-Test

32. IVUS Results Lesion Characteristics
Mod-Severe Ca++
Eccentric
Post-ASC “Controlled” Dissections
72.4 %
39.1%
82.7 %

33. AngioSculpt Dimensions & Inflation Pressures
ASC Diameter
(mm)
ASC Length
Inflation Pressure
(atm)
range: 10-18

34. Reduction in Usage of NC Balloons
Pre-ASC
Usage of NC Balloons in ASC Study
Reduction in Usage of NC Balloons
89%
43%
46%

35. AngioSculpt 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%]

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

37. 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

38. Stent Types Used in the Study
Stents were implanted in 264/279 [94.6%] lesions

39. Distal Left Main and Proximal LCx Lesions

40. ANGIOSCULPT 2.0 x 15 mm

41. POST-DES INSERTION

42. IVUS Demonstrates Optimal Stent Apposition

43. Angiogram and IVUS Pre-Intervention
MLD = 1.2mm
MLA = 1.5mm²
Plaque area = 5.72mm²
Plaque burden = 83%

44. 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%

45. Angiogram and IVUS Post-Stent
MLD = 2.6 mm
MSA = 5.2 mm²

46. Severe calcified Lcx Lesion

47. Angiosculpt Dilation

48. Final Angiographic Result [ Post Taxus Stent Insertion ]

49. Distal long RCA lesion

50. Pre dilated RCA lesion - Q.C.A Analysis

51. 3.0/20 mm and 3.5/15 mm Angiosculpt Predilation

52. 3.5 mm Endeavor Stent Insertion

53. FINAL Angiographic RESULT

54. Cumulative MACE @ 30 day F/U 215/221 [97.2%] pts
Complication
Rate
Total MACE
6/221 [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 , Patent
Re-Hospitalization
2.3 % (5/221)
Re-Catheterization
TLR
TLR- PCI
0.9% (2/221)
Vessel and Aortic Root - Dissection

55. Procedural Complications (per lesion)
0/279
Perforation
5/279 [1.8%]
Distal embolism
10/279 [3.6%]
Moderate side branch occlusion
1/279 [0.36%]
Thrombus formation
6/271 [2.2%]
Dissections (> type C), no flow
limiting dissection.

56. Cumulative MACE @ 19.2±11.2 mon. 187/221 [84.6%] pts.
Complication
Rate
Total MACE
4.9 % (11/221)
Death at day 10.
non cardiac.
0.4% (1/221)
MI (Q or Non-Q wave)
0.9% (2/221)
Re-Hospitalization
18.6% (41/221)
Re-Catheterization
15.4% (36/221)
CABG [>6 months]
0.9% (2/221) [5.6%]
Re-TLR/TVR - PCI
2.7% (5/221) [13.8%]
Vessel and aortic dissection

57. 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

58. 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