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