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