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

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
Why is Lesion
Preparation Essential?
POSTIT Trial : when using only the stent delivery balloon
over 70% of the pts. did not achieve optimal stent deployment.
Percent of Population
100
90
80
70
60
50
Patients who did not
achieve optimal stent
deployment with SDS
40
30
20
10
0
40
50
60
70
80
90
MSD as percent of RLD
100
120
130
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.
Manufacturer’s Predicted Minimal Stent Diameter (MSD)
is Usually Not Achieved With the Original Stent Balloon
4.5
IVUS Measured MSD (mm)
4.0
+
x
3.5
3.0
2.5
2.0
1.5
2.5
Manufacturer A
Manufacturer B
Manufacturer C
Manufacturer D
x x
+
+
+
+
+xx
+++
++
x+x+
x
x+
+x
+
x
x+xx
x
x
++
x
x
+
x
x
++++
x + +x
x++x
+
xxx++x + x
x x
x+x
+x +
3.0
3.5
4.0
4.5
Manufacturer’s Predicted MSD (mm)
Costa et al, Am J Cardiol 2005:96,74-78
R
E
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T
E
N
O
S
I
S
T
V
R
Non-uniform stent strut
distribution and
malapposition may result
in more intimal
hyperplasia after stenting
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
IVUS guidance may result
in more effective stent
expansion and results in
44% reduction in TVR
CRUISE study: Peter J. Fitzgerald et.al.
“Final Results of the Can Routine Ultrasound
Influence Stent Expansion (CRUISE) Study”
Circulation 2000 102:523-530
T
H
R
O
B
O
S
I
S
S
A
T
MSA and stent
under expansion
are major
predictors of stent
thrombosis
B.Brodie. Adjunctive balloon post dilatation
after stent deployment. J Interven Cardiol
2006;19:43-50
Only 22% of patients
that experience SAT
have an optimum PCI
result as assessed by
IVUS
.Cheneau Study: Edouard Cheneau,et al.
“Predictors of Subacute Thrombosis. Results
of a Systematic Intravascular Ultrasound
Study.” Circulation 2003; 108:43-47
Benefit of the AngioSculpt for
Pre-dilatation of DES
Group I (n=145)
Group II
(n=117)
Group III
(n=37)
p value
76% ± 10%
76% ± 13%
88% ± 18%
<0.001
67% ± 16%
70% ± 23%
88% ± 22%
<0.001
26.2%
25.6%
10.8%
0.03
MSD/PSD
MSA/PSA
Final stent CSA
< 5.0mm2
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
AngioSculpt Scoring Balloon
Catheter
Semi-compliant balloon with an external
nitinol shape memory helical scoring edge
Centrally Located Within the Arterial Lumen
The AngioSculpt is Comprised
of:
A
B
A - Rapid exchange or OTW semi-compliant balloon
B - Laser cut nitinol scoring element
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)
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
Aims of the Study
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 multivessel 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 - 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
AngioSculpt
Relative Contraindications
 Unprotected left main disease
 Non-calcified SVG lesion
 Thrombotic lesion
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)
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
Secondary Endpoints
 Flow limiting dissection
 Vessel perforation
Patient Demographics
221 pts, 279 lesions
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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%
Risk Factors
70
60
50
%
58.7%
40
41.2%
35.8%
30
NIDDM
20
10
IDDM
0
Hypercholesterolemia
5.7%
Diabetes
Family history of CAD
Vessel Distribution
40
36
35
30
30
25
% 20
17
15
15
10
5
0
4
2
LM protected
LAD
Diagonal
LCx
LCxM
RCA
Lesion Characteristics
ISR: 51/279 [18%],
 Bifurcation:
 Eccentric:
 Ulcerated:
 >30° angulation:
De-Novo: 228/279 [82%]
69/279 [25%]
117/279 [42%]
31/279 [11%]
154/279[55%]
Mean lesion angulation: 34.3±17˚
Lesions Classification (AHA/ACC)
31%
36%
19%
14%
A
B1
B2
C
Calcification Severity
29%
37%
34%
Mild
Moderate
Severe
Pre-Procedure QCA
Pre-Procedure Lesion Measurements
(QCA)
Length
(mm)
MLD
(mm)
17.1+11.4
0.26±0.29
RVD [d]
(mm)
2.69±0.35
Primary Endpoint Results
 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
QCA Results
Diameter Stenosis (%)
Pre-ASC
Post-ASC
Post-Stent
82.9+11.2
23.5+13.6
5.9+4.4
QCA Results (cont’d)
Minimum Luminal Diameter (mm)
Pre-ASC
Post-ASC
0.26+0.29 2.07+0.68
Post-Stent
2.43+0.72
IVUS Results
MLD (mm) and CSA (mm2)
MLD, CSA
Ref. Vessel (d)
MLD, CSA
Pre-dilatation
2.99±0.58
7.1±2.9
1.7±0.14
2.57±0.45
MLD, CSA
Post-ASC
P-Value*
2.1±0.35 p<0.0001
3.86±1.08 p<0.0001
MLD, CSA
Post-stent
P-Value*
2.82±1.1
5.5±2.03
p<0.002
p<0.0001
*Paired
t-Test
IVUS Results
Lesion Characteristics
Mod-Severe
Ca++
Eccentric
Post-ASC
“Controlled”
Dissections
72.4 %
39.1%
82.7 %
AngioSculpt Dimensions &
Inflation Pressures
ASC Diameter
(mm)
2.51+0.34
ASC Length
(mm)
Inflation Pressure
(atm)
16.4+3.3
15.1+2.4
range: 10-18
Reduction in Usage of
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 Crossability
Planned
POBA Pre-ASC
Successful
Primary ASC
POBA Predilatation After
Primary ASC
Failure to Cross
113/279
[40.5%]
104/279
[37.3%]
31/279
[11.1%]
Failure to Cross
with ASC After
POBA Predilatation
Predicted
Failure to Cross
(ASC not
attempted)
8/279
[2.9%]
1/279
[0.4%]
Device Slippage
Device slippage was observed in
4/271 [1.5 %] of ASC treated lesions
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
Stent Types Used in the Study
14%
21%
15%
33%
17%
Cypher
Taxus
Endeavor
Titan
Other stents
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 = 1.2mm
MLA = 1.5mm²
Plaque area = 5.72mm²
Plaque burden = 83%
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%
Angiogram and IVUS Post-Stent
MLD = 2.6 mm
MSA = 5.2 mm²
Severe calcified Lcx Lesion
Angiosculpt Dilation
Final Angiographic Result
[ Post Taxus Stent Insertion ]
Distal long RCA lesion
Pre dilated RCA lesion - Q.C.A Analysis
3.0/20 mm and 3.5/15 mm
Angiosculpt Predilation
3.5 mm Endeavor Stent Insertion
FINAL Angiographic RESULT
Cumulative MACE @ 30 day F/U 215/221
[97.2%] pts
Complication
Rate
Total MACE
Death at day 10 [ non cardiac ]
Sepsis ? P.E ?
M.I (Q or Non-Q wave)
6/221 [2.7 %]
Procedural complications (VF)
0.4% (1/221)
Chest pain, Re-cath, TIMI-2 , Patent
0.4% (1/221)
0.4% (1/221)
0.9% (2/221)
Re-Hospitalization
2.3 % (5/221)
Re-Catheterization
2.3 % (5/221)
TLR- PCI
0.9% (2/221)
TLR
Vessel and Aortic Root - Dissection
0.4% (1/221)
Procedural Complications
(per lesion)
Perforation
Distal embolism
0/279
5/279 [1.8%]
Moderate side branch occlusion
10/279 [3.6%]
Thrombus formation
1/279 [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.
Complication
Rate
Total MACE
4.9 % (11/221)
Death at day 10.
non cardiac.
MI (Q or Non-Q wave)
0.4% (1/221)
0.9% (2/221)
Re-Hospitalization
18.6% (41/221)
Re-Catheterization
15.4% (36/221)
CABG [>6 months]
Re-TLR/TVR - PCI
Vessel and aortic dissection
0.9% (2/221) [5.6%]
2.7% (5/221)
[13.8%]
0.4% (1/221)
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
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