Orbital Atherectomy. S. Jay Mathews, MD, MS, FACC Interventional Cardiologist, Bradenton Cardiology Center
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1 Orbital Atherectomy S. Jay Mathews, MD, MS, FACC Interventional Cardiologist, Bradenton Cardiology Center
2 Disclosures Clinical Investigator/Research Support Spectranetics, Terumo, Cordis, Abbott Vascular, Medtronic Speaker Astra Zeneca NO DISCLOSURES Related to Current Topic I will be mentioning commercial products as part of the discussion/presentation.
3 Atherectomy Options Excisional/Directional Phoenix Jetstream Turbohawk Ablation Excimer Laser Cryoablation Rotational Center Rotational (Rotablator) Offcenter Rotational (Orbital Atherectomy)
4 Orbital Atherectomy
5 Centrifugal Force Orbital Motion produces 360 of contact Create a smooth concentric lumen Increasing speed = Increases radius of orbit Conceptually allows for the treatment of multiple lumen diameters with the same device.
6 Differential Sanding 30 micron Diamond Coating 30 micron diamond coating for optimal catch of hard plaque Plaque provides resistance allowing diamond coating to sand away diseased tissue Elastic healthy tissue flexes minimizing the affect of the diamond coated surface on healthy tissue. Micro-particulate: 2 microns 1 99% < Capillary Diameter 93% < Red Blood Cell Diameter Micro-particulate >300 Histological Sections
7 Avoid Medial Damage Internal Elastic Lamina (IEL) Media Internal Elastic Lamina (IEL) Media External Elastic Lamina (EEL) External Elastic Lamina (EEL) Post-Balloon Angioplasty 74% dissection rate in non-compliant lesions. 1,2 Orbital Atherectomy Avoids medial damage Directional Atherectomy Non-concentric lumen Damages the Media 1. Image courtesy of Dr. Ed Pavillard, Phoenixville Hospital, PA 2. Fitzgerald, PJ. Contributions of localized calcium deposits to dissection after angioplasty. An observational study using intravascular ultrasound. Circulation 1992
8 Low Complications Across Trials Max. Inflation Pressure (atm) Bail-out Stent (due to complication) OASIS n = 201 CONFIRM I Diamondback n = 1146 CONFIRM II Predator n = 1734 CONFIRM III Outflow n = 1886 CALCIUM n = 29 COMPLIANCE n = 38 N/R % 3.8%* 5.8%* 5.2%* 6.9% 5.3% Perforation 1.5% 0.9% 0.6% 0.7% 0.0% 0.0% Embolization 0.5% N/R 2.2% 2.2% 0.0% 2.6% * Based on reported dissection treatments. Safian RD, et al. Orbital atherectomy for infrapopliteal disease: Device concept and outcome data for the OASIS trial. Catheter Cardiovasc Interv. 2009;73: Shammas NW, et al. Comparison of orbital atherectomy plus balloon angioplasty vs. Balloon angioplasty alone in patients with critical limb ischemia: Results of the CALCIUM 360 randomized pilot trial. J Endovasc Ther. 2012;19:480-8.
9 CONFIRM 360 Design Three consecutive prospective registries under a common protocol from All comers with three generations of OAS (Diamondback 360, Predator 360, and Stealth 360. >200 US Sites 3135 patients/4766 lesions Das T, et al. Technique, Optimiation of Orbital Atherectomy in Calcified Peripheral Lesions of the Lower Extremities: The CONFIRM Series, a Prospective Multicenter Registry. Cath Cardiovasc Interv. 2014;
10 Change in Practice Das T, et al. Technique, Optimiation of Orbital Atherectomy in Calcified Peripheral Lesions of the Lower Extremities: The CONFIRM Series, a Prospective Multicenter Registry. Cath Cardiovasc Interv. 2014;83:
11 Better Safety with Modifying Plaque Das T, et al. Technique, Optimiation of Orbital Atherectomy in Calcified Peripheral Lesions of the Lower Extremities: The CONFIRM Series, a Prospective Multicenter Registry. Cath Cardiovasc Interv. 2014;83:
12 Compliance 360 Trial Prospective, Multicenter, RCT Calcified ATK Lesions POBA vs. OAS + POBA Dattilo R. 12 Month Results of Compliance 360 : A Prospective, Multicenter, Randomized Trial Comparing Orbital Atherectomy to Balloon Angioplasty for Calcified Femoropopliteal Lesions. J Am Coll Cardiol. 2012;59(13s1):E2085.
13 Compliance 360 Trial Prospective, Multicenter, RCT Calcified ATK Lesions POBA vs. OAS + POBA Dattilo R. 12 Month Results of Compliance 360 : A Prospective, Multicenter, Randomized Trial Comparing Orbital Atherectomy to Balloon Angioplasty for Calcified Femoropopliteal Lesions. J Am Coll Cardiol. 2012;59(13s1):E2085.
14 Calcium 360 Trial Prospective, Multicenter, RCT Calcified BTK Lesions- POBA vs. OAS + POBA Shammas NW, et al. Comparison of Orbital Atherectomy plus Balloon Angioplasty vs. Balloon Angioplasty Alone in Patient with Critical Limb Ischemia: Results of The CALCIUM 360 Randomized Pilot Trial. J Endovasc Thera. 2012;19:480-8.
15 1.25 Micro/Solid for Trans-Pedal
16 CASES: Iliofemoral Disease Post-Turbohawk
17 CASES: Iliofemoral Disease Post-Turbohawk Post-OAD
18 CASES: SFA Disease Post-OAD
19 CASES: BTK/Critical Limb Ischemia 75 Year old Man Nonhealing Ulcer of the Right Lateral Forefoot Prior Fem-Fem Bypass Known Occluded Right Iliac Multiple Risk Factors Diabetic Hypertensive CKD Prior Smoker
20 CASES: BTK/Critical Limb Ischemia Angiosome Concept for Limb Salvage
21 CASES: BTK/Critical Limb Ischemia Angiosome Concept for Limb Salvage
22 CASES: BTK/Critical Limb Ischemia Angiosome Concept for Limb Salvage
23 CASES: BTK/Critical Limb Ischemia
24 CASES: BTK/Critical Limb Ischemia
25 CASES: BTK/Critical Limb Ischemia
26 CASES: BTK/Critical Limb Ischemia
27 CASES: BTK/Critical Limb Ischemia
28 CASES: BTK/Critical Limb Ischemia
29 CASES: BTK/Critical Limb Ischemia
30 CASES: BTK/Critical Limb Ischemia
31 CASES: BTK/Critical Limb Ischemia
32 CASES: BTK/Critical Limb Ischemia
33 Give Endovascular a Chance!
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