Post on 28-Jul-2020
Tony Gershlick University Hospitals of Leicester UK
The Angiosculpt Balloon: Does it have a role in interventional cardiology ?
Conflict of Interest
Pyramed
Speakers Bureau
Research Trial Involvement
3 nitinol spiral “scoring” wires (~0.005”)
Two axial polymeric spring
Catheter shaft
Guide wire
Fixed distal bond “Floating” intermediate bond
Fixed proximal bond
Controlled “Floating” Technology
The spiral element expansion is controlled by a combination of a fixed distal end and a semi-constrained proximal end
Scoring Element Properties • Laser cut from a nitinol tube • Rectangular shaped “wires” • Electro-polished • Shape set • Assembled (“crimping”)
Scanning EM of Scoring Element
Non slip
Ca 2+
Lesion preparation
Proposed AngioSculpt Benefits • Prepare Vessel for DES/BMS
– Non-slip (avoid “geographic miss”) – Full stent expansion/apposition at lower balloon pressures
• Calcified & Fibrotic Lesions – Lesion expansion at lower balloon pressures – Less trauma/dissection leading to more predictable results
• Bifurcation Lesions – Less elastic “recoil” in ostial side-branches or plaque-shifting – Lower rate of dissection and need for second stent in side-branch – Non-slip – Overcome “stent jail” of side-branch
• In-Stent Restenosis – Non-slip (avoid “geographic miss”) – Less tissue “recoil”
o US Multi centre (FDA) study v :PI – Marty Leon
– Multi-center, non-randomized, single-arm, prospective trial
– 200 patients enrolled at 9 sites – IVUS sub-study in 80 patients – 14-21 day clinical follow-up – Independent core labs
The Data
• 219 lesions treated • ISR: 16% • ACC B2/C lesions: 76% • Moderate/severe calcification: 35% • Bifurcation: 29% • Ostial: 13% • Lesion length: 17.79±8.94 mm (6.2-55.2) • RVD: 2.72±0.39 mm • MLD: 0.78±0.31 mm • Diameter Stenosis: 71.6±10.2%
Primary Endpoint Results
• Procedure Success: 98.5% (197/200)
• Clinical Success: 97.5% (195/200)
Pre-PCI
Post-AngioSculpt
AngioSculpt
Post-Stent
Severely Calcified Proximal LAD
LAD Ca++ LAD Pre-AS AS Deployment
LAD Post-AS LAD Post-Stent LAD Post-Stent
In stent restenosis
– Israeli Multi Centre Registry*
• 9 centres • 125 patients • Complex lesions (66% Type B2/C) • Successfully deployed in 94.4% of lesions • 0% Perforations • Results evaluated by Angiographic QCA • No device slippage in de novo or in stent restenotic
lesions • No perforations, MI, or deaths * Accepted for publication American Journal of Cardiology 2006
American Journal of Cardiology, September, 2007
Lesion preparation
Sonoda S et al., J Am Coll Cardiol. 2004;43(11):1959-63
Fujii et al., J Am Coll Cardiol. 2005 Apr 5;45(7):995-8
Study Methods 299 lesions divided into 3 sub-groups:
• Group I: Direct stenting (n=145)
• Group II: Conventional pre-dilatation¹ (n=117)
• Group III: Pre-dilatation with the AngioSculpt catheter (n=37)
¹Conventional pre-dilatation used a regular semi-compliant balloon
Inclusion Criteria • >18 years old who signed the CIVT outcome database informed
consent • Single de novo lesions (>50% by QCA) in native coronary arteries • Lesions with a reference vessel diameter 2.0 – 4.0 mm
Exclusion Criteria • Deployment of multiple stents (“overlapping”) • Post-dilatation pre-IVUS with a balloon other than the stent balloon • PCI of left main • PCI of restenotic lesions • PCI of grafts • Patient unable to take ASA and/or antiplatelet agents
Study Inclusion/Exclusion Criteria
Measurements and Definitions
*Measured in the tightest segment within the stent through the center of its lumen
Minimum Stent Diameter (MSD)*
Measurements and Definitions
Stent Expansion (%) = IVUS MSD X 100 SD predicted by manufacturer’s
compliance charts
Compliance Chart Example: Taxus™
Table 1. Patient, Angiographic, and Intravascular Ultrasound Lesion Characteristics
Direct (n=145)
Pre-dilatation (n=117)
AngioSculpt (n=37) P-value
Age (yrs) 65.2±10.7 62.8±11.6 64.1±11.5 0.5
Gender (male/female) 92/53 80/37 25/12 0.7
Diabetes Mellitus Non-insulin treated diabetes Insulin-treated diabetes
45 (31%) 36 (24.8%)
9 (6.2%)
38 (32.5%) 31 (26.5%)
7(6.0%)
9 (24.1%) 6 (16.2%) 3 (7.9%)
0.08 0.2 0.2
Hypertension 116 (80%) 101 (86.3%) 27 (73%) 0.2
Hypercholesterolemia 120 (82.8%) 98 (85.4%) 30 (81.1%) 0.1
Clinical Presentation Silent Ischemia Stable Angina Unstable Angina
32 (22.1%) 80 (55.2%) 33 (22.8%)
27 (23.1%) 66(56.4%) 24 (20.5%)
7 (18.9%)
23 (62.2%) 7 (18.9%)
0.9 0.7 0.8
Vessel Treated Left anterior descending Left circumflex artery Right coronary artery
78 (53.5%) 36 (24.8%) 31 (21.4%)
62 (53.0%) 21 (17.9%) 34 (29.1%)
13 (35.1%) 5 (13.5%)
19 (51.4%)
N/A N/A N/A
Table 1. Patient, Angiographic, and Intravascular Ultrasound Lesion
Characteristics (cont’d) Direct
(n=145) Pre-dilatation
(n=117) AngioSculpt
(n=37) P-value
IVUS Atheroma Morphology Soft plaque Fibrous plaque Calcific plaque Mixed plaque Lesion Length (mm) Pre-Dilatation Balloon Length IVUS Detected Calcification at Lesion Site IVUS Superficial Calcification Length (mm) Arc of Ca at Lesion Site (degrees) No calcium < 90 > 90 ≤ 180 > 180 ≤ 270 > 270
46 (31.7%) 38 (26.2%) 22 (15.2%) 39 (26.9%) 15.6±9.5
N/A 35 (24.1%)
3.4±2.5
82 (56.6%) 29 (20%)
18 (12.4%) 11 (7.6%) 5 (3.4%)
40 (34.2%) 29 (24.8%) 20 (17.1%) 28 (23.9%) 15.9±9.1 13.5±3.8
28 (23.9%) 3.2±2.6
68 (58.1%) 20 (17.1%) 14 (12.0%)
4 (3.4%) 11 (9.4%)
10 (27%) 9 (24.3%) 6 (16.2%)
12 (32.5%) 16.5±9.2 15±4.2
10 (27.0%) 3.6±2.8
20 (54.1%) 7 (18.9%) 4 (10.8%) 3 (8.1%) 3 (8.1%)
0.5 0.3 0.9 0.4 0.7
0.04 0.9 0.1
0.3 0.4 0.9 0.3 0.1
Table 2. IVUS Quantitative Assessment
Direct (n=145)
Pre-dilatation (n=117)
AngioSculpt
(n=37)
P-value
Reference Segment EEM cross sectional area, mm2 Lumen cross sectional area, mm2 Lumen diameter, mm
10.8±4.4 8.5±2.2 3.3±0.7
10.1±4.3 8.0±2.3 3.2±0.7
10.6±6.5 9.0±2.9 3.6±0.9
0.4 0.1
0.09
Pre-Intervention – Lesion Site EEM cross sectional area, mm2 Lumen cross sectional area, mm2 Minimum lumen diameter, mm Plaque and media, mm2 Plaque burden, %
11.8±4.6 3.0±0.9 1.7±0.3 8.9±3.2 72±10
11.7±4.6 2.9±1.0 1.7±0.6 8.6±3.4 73±10
11.6±4.7 2.5±0.9 1.6±0.3 8.8±3.5 76±10
1.0
0.02 0.2 0.6
0.08
Results Ø On average DES achieved only 77%+13% of the
predicted stent diameter and 70%+22% of the predicted final area
Ø No difference between patients pre-treated with the Maverick and those with direct stent deployment (76%+13% vs. 76%+10%, p=0.8)
Ø Patients pre-treated with AngioSculpt had significantly better stent expansion, irrespective of plaque morphology, reaching 88%+18% of the predicted final stent area (p<0.001)
Stent Expansion (IVUS measured MSD/Manufacturer’s Predicted MSD) as a
Function of Plaque Morphology A
IVU
S M
easu
red
/ Man
ufac
ture
r’s
Pred
icte
d M
SD
B
C D
Soft Fibrotic
Calcific Mixed
P<0.001 P=0.01
P<0.001 P<0.001
Direct Pre dilate ASC
74%
100%
80%
60%
40%
20%
0%
75% 87%
77% 82%
Direct Pre dilate ASC
87%
IVU
S M
easu
red
/ Man
ufac
ture
r’s
Pred
icte
d M
SD
100%
80%
60%
40%
20%
0%
76%
Direct Pre dilate ASC
87%
IVU
S M
easu
red
/ Man
ufac
ture
r’s
Pred
icte
d M
SD
100%
80%
60%
40%
20%
0%
72%
Direct Pre dilate ASC
87%
IVU
S M
easu
red
/ Man
ufac
ture
r’s
Pred
icte
d M
SD
100%
80%
60%
40%
20%
0%
75% 77%
20%
Quantitative Analysis – Acute Gain (mm)
*P-value <0.001 when group III is compared to groups I and II No significant difference in the comparison between groups I and II
*p<0.001 1.2±0.4
0.8±0.4 0.9±0.2
0
0.2
0.4
0.6
0.8
1
1.2
1.4
Group I (Direct Stent) Group II (Pre-dilatation with semi-compliant balloon)
Group III (AngioSculpt)
Quantitative Analysis Final Stent Area ≥5.0 mm²
*P-value <0.001 when group III is compared to groups I and II No significant difference in the comparison between groups I and II
*p<0.001
73.8% 74.4% 89%
0% 10% 20% 30% 40% 50% 60% 70% 80% 90%
100%
Group I (Direct Stent) Group II (pre-dilatation with semi-compliant
balloon) Group III
(AngioSculpt)
Conclusions Ø Drug-eluting stent under-expansion was common, often falling
short of even minimum standards of stent expansion Ø Conventional balloon pre-dilatation did not improve final stent
expansion compared to direct stenting Ø Compliance charts failed to reliably predict MSD and MSA after
DES implantation Ø Pre-treatment with the AngioSculpt was safe and enhanced stent
expansion, minimizing the difference between predicted and achieved stent dimensions
Ø In the era of DES, pre-dilatation with the AngioSculpt may result in a reduced risk of stent thrombosis and a larger stent CSA at follow-up
Coronary Bifurcation Study • Single stent strategy (i.e. “provisional” side-branch stenting) • Prospective multi-center single-arm registry (4-5 sites) • Sample size: 50 patients? • Primary endpoints (safety, efficacy) • Secondary endpoints • Independent data management • Core labs: QCA, IVUS • Other issues?
Sonoda S et al., J Am Coll Cardiol. 2004;43(11):1959-63
Lesion preparation
Fujii et al., J Am Coll Cardiol. 2005 Apr 5;45(7):995-8
Ø Stent Expansion (%) = IVUS MSD/MSA X 100
SD/SA predicted by manufacturer’s compliance charts
87.2
63.2
26.4 12.8
36.8
73.5
0 10 20 30 40 50 60 70 80 90
100
Group I (direct stent) Group II (Pre- dilatation with semi- compliant balloon)
Group III (AngioSculpt)
Cypher Taxus
Patient, Angiographic, and Intravascular Ultrasound Lesion Characteristics
Direct (n= 145)
Pre-dilatation (n = 117)
AngioSculpt
(n = 37) P-value
IVUS Atheroma Morphology Soft plaque Fibrous plaque Calcific plaque Mixed plaque Lesion Length (mm) Pre-Dilatation Balloon Length IVUS Detected Calcification at Lesion Site IVUS Superficial Calcification Length (mm) Arc of Ca at Lesion Site (degrees) No calcium < 90 > 90 ≤ 180 > 180 ≤ 270 > 270
46 (31.7%) 38 (26.2%) 22 (15.2%) 39 (26.9%) 15.6±9.5
N/A 35 (24.1%)
3.4±2.5
82 (56.6%) 29 (20%)
18 (12.4%) 11 (7.6%) 5 (3.4%)
40 (34.2%) 29 (24.8%) 20 (17.1%) 28 (23.9%) 15.9±9.1 13.5±3.8
28 (23.9%) 3.2±2.6
68 (58.1%) 20 (17.1%) 14 (12.0%)
4 (3.4%) 11 (9.4%)
10 (27%) 9 (24.3%) 6 (16.2%)
12 (32.5%) 16.5±9.2 15±4.2
10 (27.0%) 3.6±2.8
20 (54.1%) 7 (18.9%) 4 (10.8%) 3 (8.1%) 3 (8.1%)
0.5 0.3 0.9 0.4 0.7
0.04 0.9 0.1
0.3 0.4 0.9 0.3 0.1
• Patients pre-treated with AngioSculpt had significantly better stent expansion, reaching 88%+18% of the predicted final stent area (p<0.001)
Quantitative Analysis Acute Gain (mm)
*P-value <0.001 when group III is compared to groups I and II No significant difference in the comparison between groups I and II
*p <0.001 1.2+0.4
0.8+0.4 0.9+0.2
0
0.2
0.4
0.6
0.8
1
1.2
1.4
Group I (Direct Stent) Group II (Pre-dilatation with semi-compliant balloon)
Group III (AngioSculpt)
Quantitative Analysis Final Stent Area ≥5.0 mm²
*P-value <0.001 when group III is compared to groups I and II No significant difference in the comparison between groups I and II
*p <0.001
73.8% 74.4% 89%
0% 10% 20% 30% 40% 50% 60% 70% 80% 90%
100%
Group I (Direct Stent) Group II (pre-dilatation with semi-compliant
balloon)
Group III (AngioSculpt)
Ø Drug-eluting stent underexpansion was common, often falling short of even minimum standards of stent expansion
Ø Conventional balloon pre-dilatation did not improve final stent expansion compared to direct stenting
Ø Compliance charts failed to reliably predict MSD and MSA after DES implantation
Ø Pre-treatment with the AngioSculpt was safe and enhanced stent expansion, minimizing the difference between predicted and achieved stent dimensions
Ø In the era of DES, pre-dilatation with the AngioSculpt may result in a reduced risk of stent thrombosis and a larger stent CSA at follow-up
• Pre-dilatation strategies (IVUS) study* • 224 patients / 299 de novo lesions analysis • Group 1 – Direct Stenting (DES) • Group 2 – PTCA balloon + DES • Group 3 – AngioSculpt + DES
• Patient and lesion characteristics similar in all groups
• DES were commonly under expanded in Groups 1 and 2
• DES often failed to achieve minimum standards of expansion • Conventional pre-dilatation little difference to direct stenting
• Pre-treatment with AngioSculpt enhanced stent expansion
*Circulation October 2006 Vol. 114, No, 18, Supplement II: 732
• Clinical indications
• In-Stent Restenosis – Non-slip (avoid “geographic miss”) – Less tissue “recoil”
• Calcified & Fibrotic Lesions – Lesion expansion at lower balloon pressures – Less trauma/dissection leading to more predictable results
• Bifurcation Lesions – Less elastic “recoil” in ostial side-branches – Non-slip