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AVE Micro Stent KFSH & RC Experience with 6 months Angiographic Follow Up
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  1. AVE Micro StentKFSH & RC Experience with 6 months Angiographic Follow Up Layth A. Mimish, M. Bakhshi, F. Al-Nozha, A. Kinsara, O. Amoudi, J. Buraiki, K. Niazi, B. Dunn, B. Dajani, M.E. Fawzy

  2. AVE Micro Stent II • Arterial vascular engineering, Inc. Santa Rosa CA, USA • October 1994 sales commenced • FDA study approval Nov. 1995 • 2.5 mm stent introduced Dec. 1995 • Micro stent II XL (30, 39 mm) introduced January 1996

  3. AVE Micro Stent II • 316 L stainless steel • Moderate radio-opacity • Non- Ferromagnetic • Metallic surface area 8.4% • Sinusoidal ring • 0.065 inch un-expanded profile

  4. AVE Microstent II • Excellent longitudinal flexibility • Shortenining less than 2 % • Available diameters 2.5-4 mm • Available lengths 6-39 mm • Clinical trials on peripheral stents

  5. AVE Micro Stent II • PE ( moderately compliant ) balloon • Balloon mounted stent, no sheath • Minimal ID of guider 0.072 • Proximal and distal stent end markers • Nominal deployment at 9 Atmospheres • Excellent recrossability

  6. 1st stent deployed May 1995 • Until October 1997, 340 stents were deployed in 283 patients • By October 1997, 223 patients had completed 6 months post stent deployment, and underwent angiographic follow up

  7. Demographic/ Clinical Data • 340 Stents in 283 patients • 228 Males and 55 Females • Age 55+- 13 years • Smoking in 95 patients (33%) • Diabetes in 158 (56%) • Hypertension in 166 (59%) • Hyperlipidemia in 68%

  8. Demographic/ Clinical Data • History of MI in 180 (64%), 81% of which are Q- wave MI • Previous PTCA in 76 (27%) • History of CABG surgery in 9 patients • Mean CCS Class 2.2 +- 1.1

  9. AVE Micro Stent II • Elective stenting in 214 (63%) • Stenting for Dissection 126 (37%) • Mean Stent Size 3.1 +- 0.4 mm • Mean Length 16.2 +- 5.8 mm • Mean Deployment Pressure 15.7 +- 2.3 Atmospheres

  10. Vessel Stented • Left Main 1 • LAD 163 (48%) • Diagonal 2 • Circumflex 38 (11%) • OM 15 (4%) • Intermediate 7 (2%) • RCA 114 (33%)

  11. Antiplatelet/ Anticoagulation • ASA + Warfarin in 93 initial cases • ASA, Ticlopidine, 48 hrs Heparinization • ASA, Ticlopidine, Heparin bolus only • Mean hospital stay 3.6 +-2 days

  12. Successful Procedures • Recanalization with < 20% residual stenosis, without inhospital major events ( Death, Emergency CABG, Q-MI) • Success in 329/340 stents (96.8%)

  13. Major Complications • Death in 1 patient with Acute MI, poor LV function and salvage PTCA/Stenting • Q wave MI in 3 patients • Emergency CABG surgery in 5 patients

  14. Minor Complications • Non Q MI 10 • Hypotension 3 • Haematoma 4 • Pseudo aneurysm 1 • Subacute Occlusion 3 • Loss of stent 1 • Sepsis 1

  15. 6 month follow up • 222 /340 completed 6 months • 79/222 restenosed angiographicaqlly (35%) • Elective stenting restenosis 57/162 (35%) • Dissection stenting restenosis 22/60(37%) • restenotic lesion stenting restenosis 19/50 (38%) vs. (35%)

  16. Conclusion • All purpose stent • Excellent success rates • Easy deployment even in very complex lesions • Higher restenosis rate in this study compared to others !!!