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Tony Gershlick University Hospitals of Leicester UK

The Angiosculpt Balloon: Does it have a role in interventional cardiology ?. Tony Gershlick University Hospitals of Leicester UK. Conflict of Interest Pyramed Speakers Bureau Research Trial Involvement. 3 nitinol spiral “scoring” wires (~0.005”).

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Tony Gershlick University Hospitals of Leicester UK

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  1. The Angiosculpt Balloon: Does it have a role in interventional cardiology ? Tony Gershlick University Hospitals of Leicester UK

  2. Conflict of Interest Pyramed Speakers Bureau Research Trial Involvement

  3. 3 nitinol spiral “scoring” wires (~0.005”)

  4. Controlled “Floating” Technology Two axial polymeric spring Guide wire Catheter shaft Fixed distal bond Fixed proximal bond “Floating” intermediate bond The spiral element expansion is controlled by a combination of a fixed distal end and a semi-constrained proximal end

  5. Scoring Element Properties • Laser cut from a nitinol tube • Rectangular shaped “wires” • Electro-polished • Shape set • Assembled (“crimping”) Scanning EM of Scoring Element

  6. Non slip Ca 2+ Lesion preparation

  7. 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”

  8. The Data • 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

  9. 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%

  10. Primary Endpoint Results • Procedure Success: 98.5% (197/200) • Clinical Success: 97.5% (195/200)

  11. Pre-PCI AngioSculpt Post-AngioSculpt Post-Stent

  12. Severely Calcified Proximal LAD LAD Ca++ LAD Pre-AS AS Deployment LAD Post-AS LAD Post-Stent LAD Post-Stent

  13. In stent restenosis

  14. 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

  15. Lesion preparation American Journal of Cardiology, September, 2007

  16. Sonoda S et al., J Am Coll Cardiol. 2004;43(11):1959-63

  17. Fujii et al., J Am Coll Cardiol. 2005 Apr 5;45(7):995-8

  18. 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

  19. Measurements and Definitions *Measured in the tightest segment within the stent through the center of its lumen Minimum Stent Diameter (MSD)*

  20. Measurements and Definitions Stent Expansion (%) = IVUS MSD X 100 SD predicted by manufacturer’s compliance charts

  21. Compliance Chart Example: Taxus™

  22. Table 1. Patient, Angiographic, and Intravascular Ultrasound Lesion Characteristics (cont’d)

  23. 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)

  24. 1.4 1.2 1 0.8 0.6 0.4 0.2 0 Group I (Direct Stent) Group II (Pre-dilatation with Group III (AngioSculpt) semi-compliant balloon) Quantitative Analysis – Acute Gain (mm) *p<0.001 1.2±0.4 0.9±0.2 0.8±0.4 *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

  25. 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% Group I (Direct Stent) Group II (pre-dilatation Group III with semi-compliant (AngioSculpt) balloon) Quantitative Analysis Final Stent Area ≥5.0 mm² *p<0.001 89% 73.8% 74.4% *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

  26. 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

  27. 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?

  28. Lesion preparation Sonoda S et al., J Am Coll Cardiol. 2004;43(11):1959-63

  29. Fujii et al., J Am Coll Cardiol. 2005 Apr 5;45(7):995-8

  30. 100 87.2 90 Cypher 80 73.5 Taxus 70 63.2 60 50 36.8 40 26.4 30 20 12.8 10 0 Group I (direct stent) Group II (Pre- Group III dilatation with semi- (AngioSculpt) compliant balloon) • Stent Expansion (%) = IVUS MSD/MSA X 100 SD/SA predicted by manufacturer’s compliance charts

  31. Patient, Angiographic, and Intravascular Ultrasound Lesion Characteristics

  32. Patients pre-treated with AngioSculpt had significantly better stent expansion, reaching 88%+18% of the predicted final stent area (p<0.001)

  33. 1.4 1.2 1 0.8 0.6 0.4 0.2 0 Group I (Direct Stent) Group II (Pre-dilatation with Group III (AngioSculpt) semi-compliant balloon) Quantitative Analysis Acute Gain (mm) *p <0.001 1.2+0.4 0.9+0.2 0.8+0.4 *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

  34. 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% Group I (Direct Stent) Group II (pre-dilatation Group III with semi-compliant (AngioSculpt) balloon) Quantitative Analysis Final Stent Area ≥5.0 mm² *p <0.001 89% 74.4% 73.8% *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

  35. 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

  36. 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

  37. 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

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