Angiosculpt

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Angiosculpt

  1. 1. Tony Gershlick University Hospitals of Leicester UK The Angiosculpt Balloon: Does it have a role in interventional cardiology ?
  2. 2. Conflict of Interest Pyramed Speakers Bureau Research Trial Involvement
  3. 3. 3 nitinol spiral “scoring” wires (~0.005”)
  4. 4. 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
  5. 5. Scoring Element Properties <ul><li>Laser cut from a nitinol tube </li></ul><ul><li>Rectangular shaped “wires” </li></ul><ul><li>Electro-polished </li></ul><ul><li>Shape set </li></ul><ul><li>Assembled (“crimping”) </li></ul>Scanning EM of Scoring Element
  6. 6. Non slip Ca 2+ Lesion preparation
  7. 7. Proposed AngioSculpt Benefits <ul><li>Prepare Vessel for DES/BMS </li></ul><ul><ul><li>Non-slip (avoid “geographic miss”) </li></ul></ul><ul><ul><li>Full stent expansion/apposition at lower balloon pressures </li></ul></ul><ul><li>Calcified & Fibrotic Lesions </li></ul><ul><ul><li>Lesion expansion at lower balloon pressures </li></ul></ul><ul><ul><li>Less trauma/dissection leading to more predictable results </li></ul></ul><ul><li>Bifurcation Lesions </li></ul><ul><ul><li>Less elastic “recoil” in ostial side-branches or plaque-shifting </li></ul></ul><ul><ul><li>Lower rate of dissection and need for second stent in side-branch </li></ul></ul><ul><ul><li>Non-slip </li></ul></ul><ul><ul><li>Overcome “stent jail” of side-branch </li></ul></ul><ul><li>In-Stent Restenosis </li></ul><ul><ul><li>Non-slip (avoid “geographic miss”) </li></ul></ul><ul><ul><li>Less tissue “recoil” </li></ul></ul>
  8. 8. <ul><ul><ul><ul><li>US Multi centre (FDA) study </li></ul></ul></ul></ul><ul><ul><ul><ul><li>: PI – Marty Leon </li></ul></ul></ul></ul><ul><ul><ul><ul><li>Multi-center, non-randomized, single-arm, prospective trial </li></ul></ul></ul></ul><ul><ul><ul><ul><li>200 patients enrolled at 9 sites </li></ul></ul></ul></ul><ul><ul><ul><ul><li>IVUS sub-study in 80 patients </li></ul></ul></ul></ul><ul><ul><ul><ul><li>14-21 day clinical follow-up </li></ul></ul></ul></ul><ul><ul><ul><ul><li>Independent core labs </li></ul></ul></ul></ul>The Data
  9. 9. <ul><li>219 lesions treated </li></ul><ul><li>ISR: 16% </li></ul><ul><li>ACC B2/C lesions: 76% </li></ul><ul><li>Moderate/severe calcification: 35% </li></ul><ul><li>Bifurcation: 29% </li></ul><ul><li>Ostial: 13% </li></ul><ul><li>Lesion length: 17.79±8.94 mm (6.2-55.2) </li></ul><ul><li>RVD: 2.72±0.39 mm </li></ul><ul><li>MLD: 0.78±0.31 mm </li></ul><ul><li>Diameter Stenosis: 71.6±10.2% </li></ul>
  10. 10. Primary Endpoint Results <ul><li>Procedure Success : 98.5% (197/200) </li></ul><ul><li>Clinical Success : 97.5% (195/200) </li></ul>
  11. 11. Pre-PCI Post-AngioSculpt AngioSculpt Post-Stent
  12. 12. Severely Calcified Proximal LAD LAD Ca++ LAD Pre-AS AS Deployment LAD Post-AS LAD Post-Stent LAD Post-Stent
  13. 13. In stent restenosis
  14. 14. <ul><ul><li>Israeli Multi Centre Registry* </li></ul></ul><ul><ul><ul><li>9 centres </li></ul></ul></ul><ul><ul><ul><li>125 patients </li></ul></ul></ul><ul><ul><ul><li>Complex lesions (66% Type B2/C) </li></ul></ul></ul><ul><ul><ul><li>Successfully deployed in 94.4% of lesions </li></ul></ul></ul><ul><ul><ul><li>0% Perforations </li></ul></ul></ul><ul><ul><ul><li>Results evaluated by Angiographic QCA </li></ul></ul></ul><ul><ul><ul><li>No device slippage in de novo or in stent restenotic lesions </li></ul></ul></ul><ul><ul><ul><li>No perforations, MI, or deaths </li></ul></ul></ul><ul><ul><ul><li>* Accepted for publication American Journal of Cardiology 2006 </li></ul></ul></ul>
  15. 15. American Journal of Cardiology, September, 2007 Lesion preparation
  16. 16. Sonoda S et al., J Am Coll Cardiol . 2004;43(11):1959-63
  17. 17. Fujii et al., J Am Coll Cardiol . 2005 Apr 5;45(7):995-8
  18. 18. Study Methods <ul><li>299 lesions divided into 3 sub-groups: </li></ul><ul><ul><ul><li>Group I: Direct stenting (n=145) </li></ul></ul></ul><ul><ul><ul><li>Group II: Conventional pre-dilatation¹ (n=117) </li></ul></ul></ul><ul><ul><ul><li>Group III: Pre-dilatation with the AngioSculpt catheter (n=37) </li></ul></ul></ul>¹Conventional pre-dilatation used a regular semi-compliant balloon
  19. 19. <ul><li>Inclusion Criteria </li></ul><ul><li>>18 years old who signed the CIVT outcome database informed consent </li></ul><ul><li>Single de novo lesions (>50% by QCA) in native coronary arteries </li></ul><ul><li>Lesions with a reference vessel diameter 2.0 – 4.0 mm </li></ul><ul><li>Exclusion Criteria </li></ul><ul><li>Deployment of multiple stents (“overlapping”) </li></ul><ul><li>Post-dilatation pre-IVUS with a balloon other than the stent balloon </li></ul><ul><li>PCI of left main </li></ul><ul><li>PCI of restenotic lesions </li></ul><ul><li>PCI of grafts </li></ul><ul><li>Patient unable to take ASA and/or antiplatelet agents </li></ul>Study Inclusion/Exclusion Criteria
  20. 20. Measurements and Definitions <ul><li>*Measured in the tightest segment within the stent through the center of its lumen </li></ul>Minimum Stent Diameter (MSD)*
  21. 21. Measurements and Definitions <ul><li>Stent Expansion (%) = IVUS MSD X 100 </li></ul>SD predicted by manufacturer’s compliance charts
  22. 22. Compliance Chart Example: Taxus™
  23. 23. 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
  24. 24. 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
  25. 25. Table 2. IVUS Quantitative Assessment Direct (n=145) Pre-dilatation (n=117) AngioSculpt (n=37) P -value Reference Segment EEM cross sectional area, mm 2 Lumen cross sectional area, mm 2 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, mm 2 Lumen cross sectional area, mm 2 Minimum lumen diameter, mm Plaque and media, mm 2 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
  26. 26. Results <ul><ul><li>On average DES achieved only 77% + 13% of the predicted stent diameter and 70% + 22% of the predicted final area </li></ul></ul><ul><ul><li>No difference between patients pre-treated with the Maverick and those with direct stent deployment ( 76% + 13% vs. 76% + 10%, p=0.8) </li></ul></ul><ul><ul><li>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) </li></ul></ul>
  27. 27. Stent Expansion (IVUS measured MSD/Manufacturer’s Predicted MSD) as a Function of Plaque Morphology A IVUS Measured / Manufacturer’s Predicted MSD 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% IVUS Measured / Manufacturer’s Predicted MSD 100% 80% 60% 40% 20% 0% 76% Direct Pre dilate ASC 87% IVUS Measured / Manufacturer’s Predicted MSD 100% 80% 60% 40% 20% 0% 72% Direct Pre dilate ASC 87% IVUS Measured / Manufacturer’s Predicted MSD 100% 80% 60% 40% 20% 0% 75% 77% 20%
  28. 28. 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)
  29. 29. 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)
  30. 30. Conclusions <ul><li>Drug-eluting stent under-expansion was common, often falling short of even minimum standards of stent expansion </li></ul><ul><li>Conventional balloon pre-dilatation did not improve final stent expansion compared to direct stenting </li></ul><ul><li>Compliance charts failed to reliably predict MSD and MSA after DES implantation </li></ul><ul><li>Pre-treatment with the AngioSculpt was safe and enhanced stent expansion, minimizing the difference between predicted and achieved stent dimensions </li></ul><ul><li>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 </li></ul>
  31. 31. Coronary Bifurcation Study <ul><li>Single stent strategy (i.e. “provisional” side-branch stenting) </li></ul><ul><li>Prospective multi-center single-arm registry (4-5 sites) </li></ul><ul><li>Sample size: 50 patients? </li></ul><ul><li>Primary endpoints (safety, efficacy) </li></ul><ul><li>Secondary endpoints </li></ul><ul><li>Independent data management </li></ul><ul><li>Core labs: QCA, IVUS </li></ul><ul><li>Other issues? </li></ul>
  32. 34. Sonoda S et al., J Am Coll Cardiol . 2004;43(11):1959-63 Lesion preparation
  33. 35. Fujii et al., J Am Coll Cardiol . 2005 Apr 5;45(7):995-8
  34. 36. <ul><li>Stent Expansion (%) = IVUS MSD/MSA X 100 </li></ul>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
  35. 37. 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
  36. 38. <ul><li>Patients pre-treated with AngioSculpt had significantly better stent expansion, reaching 88% + 18% of the predicted final stent area (p<0.001) </li></ul>
  37. 39. 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)
  38. 40. 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)
  39. 41. <ul><li>Drug-eluting stent underexpansion was common, often falling short of even minimum standards of stent expansion </li></ul><ul><li>Conventional balloon pre-dilatation did not improve final stent expansion compared to direct stenting </li></ul><ul><li>Compliance charts failed to reliably predict MSD and MSA after DES implantation </li></ul><ul><li>Pre-treatment with the AngioSculpt was safe and enhanced stent expansion, minimizing the difference between predicted and achieved stent dimensions </li></ul><ul><li>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 </li></ul>
  40. 42. <ul><li>Pre-dilatation strategies (IVUS) study* </li></ul><ul><ul><ul><li>224 patients / 299 de novo lesions analysis </li></ul></ul></ul><ul><ul><ul><li>Group 1 – Direct Stenting (DES) </li></ul></ul></ul><ul><ul><ul><li>Group 2 – PTCA balloon + DES </li></ul></ul></ul><ul><ul><ul><li>Group 3 – AngioSculpt + DES </li></ul></ul></ul><ul><ul><ul><li>Patient and lesion characteristics similar in all groups </li></ul></ul></ul><ul><ul><ul><li>DES were commonly under expanded in Groups 1 and 2 </li></ul></ul></ul><ul><ul><ul><li>DES often failed to achieve minimum standards of expansion </li></ul></ul></ul><ul><ul><ul><li>Conventional pre-dilatation little difference to direct stenting </li></ul></ul></ul><ul><ul><ul><li>Pre-treatment with AngioSculpt enhanced stent expansion </li></ul></ul></ul><ul><ul><ul><li>*Circulation October 2006 Vol. 114, No, 18, Supplement II: 732 </li></ul></ul></ul>
  41. 43. <ul><li>Clinical indications </li></ul><ul><li>In-Stent Restenosis </li></ul><ul><ul><li>Non-slip (avoid “geographic miss”) </li></ul></ul><ul><ul><li>Less tissue “recoil” </li></ul></ul><ul><li>Calcified & Fibrotic Lesions </li></ul><ul><ul><li>Lesion expansion at lower balloon pressures </li></ul></ul><ul><ul><li>Less trauma/dissection leading to more predictable results </li></ul></ul><ul><li>Bifurcation Lesions </li></ul><ul><ul><li>Less elastic “recoil” in ostial side-branches </li></ul></ul><ul><ul><li>Non-slip </li></ul></ul>
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