Tony Gershlick
University Hospitals of Leicester UK
Tony Gershlick
University Hospitals of Leicester UK
The Angiosculpt Balloon:Does it have a role in interventional cardiology ?
The Angiosculpt Balloon:Does it have a role in interventional cardiology ?
Conflict of Interest
Pyramed
Speakers Bureau
Research Trial Involvement
Conflict of Interest
Pyramed
Speakers Bureau
Research Trial Involvement
3 nitinol spiral “scoring” wires (~0.005”)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
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 :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
o US Multi centre (FDA) study :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 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
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 (cont’d)Direct
(n=145)Pre-dilatation
(n=117)AngioSculpt
(n=37)P-value
IVUS Atheroma Morphology Soft plaque Fibrous plaque Calcific plaque Mixed plaqueLesion Length (mm)Pre-Dilatation Balloon LengthIVUS 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/A35 (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±9.113.5±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±9.215±4.2
10 (27.0%)3.6±2.8
20 (54.1%)7 (18.9%)4 (10.8%)3 (8.1%)3 (8.1%)
0.50.30.90.40.7
0.040.90.1
0.30.40.90.30.1
Results
On average DES achieved only 77%+13% of the predicted stent diameter and 70%+22% of the predicted final area
No difference between patients pre-treated with the Maverick and those with direct stent deployment (76%+13% vs. 76%+10%, p=0.8)
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)
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±0.40.9±0.2
0
0.2
0.4
0.6
0.8
1
1.2
1.4
Group I (Direct Stent) Group II (Pre-dilatation withsemi-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-dilatationwith semi-compliant
balloon)
Group III(AngioSculpt)
Conclusions Drug-eluting stent under-expansion was common, often
falling short of even minimum standards of stent expansion
Conventional balloon pre-dilatation did not improve final stent expansion compared to direct stenting
Compliance charts failed to reliably predict MSD and MSA after DES implantation
Pre-treatment with the AngioSculpt was safe and enhanced stent expansion, minimizing the difference between predicted and achieved stent dimensions
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
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
0102030405060708090
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 plaqueLesion Length (mm)Pre-Dilatation Balloon LengthIVUS 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/A35 (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±9.113.5±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±9.215±4.2
10 (27.0%)3.6±2.8
20 (54.1%)7 (18.9%)4 (10.8%)3 (8.1%)3 (8.1%)
0.50.30.90.40.7
0.040.90.1
0.30.40.90.30.1
• 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+0.40.9+0.2
0
0.2
0.4
0.6
0.8
1
1.2
1.4
Group I (Direct Stent) Group II (Pre-dilatation withsemi-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-dilatationwith semi-compliant
balloon)
Group III(AngioSculpt)
Drug-eluting stent underexpansion was common, often falling short of even minimum standards of stent expansion
Conventional balloon pre-dilatation did not improve final stent expansion compared to direct stenting
Compliance charts failed to reliably predict MSD and MSA after DES implantation
Pre-treatment with the AngioSculpt was safe and enhanced stent expansion, minimizing the difference between predicted and achieved stent dimensions
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
•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