Objectives 10/4/2016. Percutaneous Atherectomy and Tibio-Pedal Access. The Art of Body Floss. 1. Appreciate the scope of PAD and Amputation.

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1 The Future of Vascular Disease Therapeutics Percutaneous Atherectomy and Tibio-Pedal Access The Art of Body Floss Robert W. Vorhies, M.D., F.A.C.S. Vascular and Endovascular Surgery Endovenous Therapy and Vein Aesthetics Cox Health Systems and Ferrell-Duncan Clinic Cox Health Heart and Vascular Summit October 14-15, 2016 Springfield, MO Disclosures: Cardiovascular Systems Inc., Medical Education Faculty Consultant Objectives 1. Appreciate the scope of PAD and Amputation. 2. Define the goals of therapy 3. Recognize the available options for treatment 4. Understand the mechanism of action for orbital atherectomy 5. Learn about the value of tibia-pedal artery access for peripheral interventions. 1

2 outline introduction, demographics of amputation cost of calcium general list of therapeutic options list of options for atherectomy itself MOA of orbital atherectomy Concepts surrounding tibia pedal access Cases with body floss. Conclusions introduction and demographics of amputation Peripheral arterial disease (PAD), atherosclerosis, is present in up to 29% of the US population Critical Limb Ischemia (CLI) was diagnosed in more than 2.5 million Americans in Patients with critical limb ischemia have an overall poor prognosis 1 year mortality = 25% 5 year mortality = 50% introduction and demographics of amputation Patients presenting with CLI: Initial Treatment 50% revascularized 25% medical management only 25% receive a primary amputation 1 year later 25% CLI resolved 30% alive with amputation 20% continue to have CLI 25% have died 2

3 introduction and demographics of amputation 25% of patients with the worst stage of PAD will have an amputation approximately 120,000 LE amputations are performed annually in the US the lifetime direct healthcare cost for an amputee patient is $794,027. when aggregated for the total number of LE amputations, the expected lifetime cost is roughly $95.2 billion introduction and demographics of amputation following an initial LE amputation, 27% will have 1 or more re-amputations within 1 year 40% progressed to a higher level of limb loss within a year 62% if patient has DM 55% of those with PAD will have the other limb amputated within 2-3 years. How endovascular surgeons are trained Endovascular approach first, open surgery second. Requirements for a successful revascularization Inflow, Conduit, Outflow Faucet, hose, sprinkler Role of Outflow in Wound Healing More flow to the wound should result in better wound healing Endovascular technique allows attempts at three vessel treatments and may reach vessels too small for open surgery Role of stents in Endovascular Surgery Primarily bail-out, with exceptions DO NOT cover your Surgical Zones, aka no stent territories 3

4 Endpoints Patency Amputation free survival Wound healing Functional status Quality of Life The Challenge of Calcium: Patient Implications of Calcium: Contributes to Lower Success Rates Increased Adverse Events 74% of flow limiting dissections occur in calcium 1 Decreased Balloon Success 1 yr. patency of ballooned arteries drops to 36% 2 Limb salvage drops to 56% at 1 year 3 Decreased Stent Success 28% fracture rate; presence of calcium is predictor 4 Stent malapposition 5 Non-Orbital Technologies Result in Higher Risk Non-orbital atherectomy technologies not optimized for performance in calcium 6 22% bail out stent rate 7 1. Circulation 1992, Vol86, No. 1, Contribution of Localized Calcium Deposits to Dissection after Angioplasty 2.Cardiovasc Intervent Radiol, 1996;19: The use of BTK Percutaneous Transluminal Angioplasty in Arterial Occlusive Disease causing CLI 3. Journ of Vasc Diseases 1994;45: Impact of Risk Factors on Limb Salvage after Balloon Angioplasty in CLI 4.TCT 2008, Abstract, D. Scheinert, MD, Department of Clinical and Interventional Angiology, Heart Center and Park Hospital, University of Leipzig Hospital 5. Journ of American College of Cardiology, 2005;45: Review of Atherectomy devices. Information on file at CSI. 7. Cardiac Catheter Interventions, June, 2009, Poster A-32. Percutaneous Lower extremity Arterial Interventions Using Balloon Angioplasty Versus SilverHawk: Results of the SMARTHAWK Randomized Trial. 4

5 Intervention in Unseen Calcium Can Result in Dissection 1 Calcium? Yes! CSI J Endovasc Ther 2008;15: Angiography Underestimates PAD 2.Images courtesy of Dr. Raymond Dattilo, MD, FACC, Director of Peripheral Interventions Kansas Heart and Vascular Center, Cardiology Consultants of Topeka, KS High Pressure Balloons Increase Risk of Adverse Events in Calcified Lesions Significant subintimal dissection confirmed by IVUS 1 Up to 74% dissections related to calcified plaque Dissections significantly larger in calcified vs. non-calcified plaque (p<0.002) Need for bail-out stenting 40% 20% FAST Trial Binary Restenosis at 12 mo (p = 0.377) % Deep vessel injury leading to high restenosis rates % binary restenosis at 12 mo in FAST Trial STENT GROUP PTA GROUP CSI Fitzgerald PJ, Ports TA, Yock PG. Contribution of localized calcium deposits to dissection after angioplasty. Circulation. 1992; 86(1): Krankenberg H, et al. Nitinol stent implantation versus percutaneous transluminal angioplasty in superficial femoral artery lesions up to 10 cm in length. Circulation. 2007;116: Balloon Angioplasty Can Cause Dissections Pre- Procedure Calcified Lesion Balloon Inflation 8 atms of Inflation Post Balloon Dissection Occurred Results May Vary 5

6 High Pressure Inflation Does Not Always Enable Balloon Expansion Pre- Procedure Calcified Lesion 20 atm Balloon Inflation Results May Vary Results May Vary Stent Radial Force May Be Inadequate Unable to Maintain Lumen Post High-Pressure PTA Pre- Procedure Calcified Lesion Stent Malappostion Due to Calcium Post Dilatation PTA 12 atms of Inflation Stent Lacked Radial Force Calcium Prevented Sufficient Apposition Results May Vary Health Care Economics Implications: Calcium Increases Costs Day of Case Increased lab time to manage adverse event $100/minute 1 Increased bail-out stent rate at $700-$1,500/each 2 Durability Increased re-intervention rate at $28,000/each 3 Wound Healing Average cost to heal wound = $17,096 3 Amputation Amputation cost = $48,152 3 Annual cost to manage amputee = $49,000 5 Annual cost of nursing home = $80, Reimbursement Principles Inc. Data on record at CSI 2.Average price paid for stents. Compiled from review of 100 UB40 case expense worksheets. Data on file at CSI. 3. Diabetes Care, 2000;2399): A Cost Analysis of Diabetic Lower Extremity Ulcers. 4.Diabetes Care, Vol 21, Number 8, Potential Economic Benefits of Lower Extremity Amputation Prevention in Diabetes. 5.J Endovasc Ther. 2009, Carat Gold, 14 Carat Gold or Platinum standards in the treatment of Critical Limb Ischemia: Bypass or Endovasc Intervention? 6

7 Calcium Can Be Predicted Independent Calcium Prediction Variables 1. ABI > Critical Limb Ischemia 2 3. Diabetes: Especially if neuropathy present 3,4 4. Calcium found on forefoot X-Ray 6 5. History of tobacco use 2 6. Creatinine > Glomerular Filtration Rate (GFR) < 60 5,7 1. Clev Clin Journ of Med 2006;73:s4. The magnitude of the problem of PAD: Epidemiology and Clinical Significance 2. J Am Coll Cardiol, 2008,51;20: Tibial Artery Calcification as a Marker of Amputation Risk in Patients with PAD. 1. Diabetologia 1993, Jul;36(7): Medial arterial calcification in the feet of diabetic patients. 3. Ann Vasc Surg 2008; 22:6. Arterial calcification increases in distal arteries. 4. J Am Soc Nephrol 2009, 20: Vascular Calcification: The killer of patients with Chronic Kidney Disease 5. Ritz Vascular calcification under maintenance hemodialysis. Journal of Mol. Med 55(8)(1977) Definition and Classification of Chronic Kidney Disease Impairing Global outcomes Kidney Int. Vol. 67 (2005) Which Patients are More Likely to Have Calcium? PAD Patients with Metabolic Disorders Leading to Calcified Plaque and Media Advanced Age Diabetics Kidney Disease 40.3M 65+yrs old in U.S. (1) 85+ age group is fastest growing in U.S. Up to 26M in U.S. (2) Diabetes is fastest growing health problem in U.S. (2) Up to 31M in U.S. (3) Diabetes is leading cause of kidney disease 1. U.S. Census Bureau, National Diabetes Fact Sheet Found on American Diabetes Association Website Searched on Dec. 26, American Kidney Fund Website: News Release Oct. 17, 2011 Angiography Routinely Underestimates Calcium 1 Calcium? Yes! 1. J Endovasc Ther 2008;15: Angiography Underestimates PAD 7

8 Results May Vary General List of Therapeutic Options conservative management risk factor management walking Cilostazol endovascular interventions angioplasty stent atherectomy open surgical procedures endarterectomy bypass with vein graft bypass with synthetic graft bypass with biograft gene therapy angiogenesis directional (Turbohawk) List of Options for Atherectomy rotational (Rotoblader) orbital (Diamondback) SOLID CROWN CLASSIC CROWN 8

9 List of Options for Atherectomy photoablative (Laser) aspirational (Pathway) hybrid (Phoenix) contact (Crosser) Orbital Atherectomy Mechanism of Action The Orbital Atherectomy Mechanism of Action is based on two elements 1. Differential Sanding 2. Centrifugal Force 9

10 Differential Sanding Targets Diseased Tissue 30 micron grit for optimal catch of hard plaque surfaces Diseased tissue provides resistance and allows grit to sand away plaque Elastic healthy tissue gives and is not affected by diamond surface Orbit motion creates smooth, even surface Diamond Grit The Physics of the MOA: Centrifugal Force Crown Mass Centrifugal Force = Mass x Rotational Speed 2 Rotational Speed Radius of the Orbit Orbit Radius Centrifugal Force = Mass x Rotational Speed 2 Radius of the Orbit Crown Mass Classic Crown Solid Micro Crown Solid Crown Solid Crown Mass > Classic Crown Mass Solid Micro Crown: tapered design of Solid Crown, but less mass and a shorter surface for additional flexibility Classic Crown: Shorter sanding surface for increased flexibility Solid Crown: Longer sanding surface created more overall crown mass; tapered design for frontal sanding 10

11 Centrifugal Force = Mass x Rotational Speed 2 Radius of the Orbit Rotational Speed Speed exponentially impacts Centrifugal Force An increase in speed exponentially increases Centrifugal Force Classic Crown Speeds: 60, 90, 140K RPM Solid Crown Speeds: 60, 90, 120K RPM Centrifugal Force = Mass x Rotational Speed 2 Radius of the Orbit Orbit Radius Offset Center of Mass Creates Orbital Motion Plaque Plaque Center of Mass is Offset from Driveshaft Axis Offset Distance = Orbit Radius Center of Mass ORBIT Rotation Axis DRIVESHAFT Rotation Axis Orbital motion produces 360 of contact As Orbit Radius increases, Centrifugal Force decreases for inherent safety Tibio-Pedal Artery Access 11

12 Background Patients with critical limb ischemia typically have many co-morbidities. By virtue of the disease these patients are predisposed to complications: 1. Groin access complications 2. Acute Kidney Injury 3. Radiation exposure to the patient and the operator 4. In case of complications, significant recovery time 3 Background Tibio-pedal arterial access is one of the cornerstones of advanced endovascular therapies for patients with CLI Familiarity with ultrasound imaging and especially understanding the spacial relationships of localizing needle entry and manipulating wires under ultrasound is ESSENTIAL to successful access and treatment of these difficult patent anatomies. 4 Technique Linear 15i7 MHz hockey stick probe for tibiopedal access 6 12

13 Anterior Tibial Artery Access The tibial vessels are accessed in the following fashion:. The orientation of the foot is adjusted depending on the target tibial vessel. In cases of the dorsalis pedis (DP) or the distal anterior tibial artery (AT), the foot is maintained in natural orientation with the heel of the foot on the table with slight dorsiflexion. CONFIDENTIAL - INTERNAL USE ONLY 9 Posterior Tibial Artery Access To access the posterior tibial artery (PT) the foot is rotated laterally and the leg will be bent slightly at the knee level for patient comfort. CONFIDENTIAL - INTERNAL USE ONLY 10 Technique Assessing the ideal spot for retrograde tibiopedal arterial access site is mainly done by ultrasound. This decreases the likelihood of venous puncture, venous sheath placement, AV fistulas, and tibial artery spasm. 5 13

14 Technique As we move the probe cranially, it is easy to visualize how the tibial veins start to separate from the tibial arteries, allowing easier cannulation of the tibial vessels in a spot where the veins are not located in the planned needle trajectory. However, while moving cranially, keep in mind the four major anatomical compartments below the knee. These compartments lay within the gastrocnemius muscle and most of the time end at the insertion points of the distal gastrocnemius heads. 7 Technique Avoid accessing beyond the gastrocnemius heads in order to decrease the likelihood of a complication which may result in compartment syndrome, which in turn can lead to emergent surgical intervention and in rare occasions even amputation. Arterial access below the gastrocnemius heads, allows the operator to have complete control to address potential bleeding complications during and after tibial access procedures. A vascular technologist is very beneficial during the access process, but is not required if the interventionist is skilled in ultrasound localization. CONFIDENTIAL - INTERNAL USE ONLY 8 Technique The short and long access views of these vessels will reveal the access point. Retrograde tibial access identifies a hibernating lumen of these vessels not otherwise identified with traditional angiography due to proximal vessel occlusion. Tibial lesions also can be distal and easy to identify on US evaluation. CONFIDENTIAL - INTERNAL USE ONLY 11 14

15 Technique Visualize the wire under US guidance while traveling inside the vessel. Once access is gained into the tibial vessel, the micro sheath is introduced into the vessel. CONFIDENTIAL - INTERNAL USE ONLY 12 Final Step Inject contrast to confirm our intraluminal position. Inject micrograms of nitroglycerin. 4 French micro sheath inserted into the tibial vessel. CONFIDENTIAL - INTERNAL USE ONLY 13 Body Floss 15

16 Cases 16

17 Case TL 74 year old gentleman with a long standing history of diabetes, who presented with a gangrenous left 2nd toe. HTN Chol Non smoker Hgb A1c of 7 Previously healed left 3rd toe amputation Pedal Pulses non palpable ABI non compressible left digital pressure 23 mm Hg Arterial Duplex demonstrated diffuse calcification and monophasic distal waveforms 17

18 18

19 19

20 Comments Case TL 1. PERC ATHERECTOMY, LEFT ANTERIOR TIBIAL ARTERY, DIAMONDBACK 1.25 WITH 4X60MM 2. RETROGRADE CANNULATION OF THE LEFT POPLITEAL ARTERY FROM THE LEFT ANTERIOR TIBIAL ARTERY AT THE ANKLE 3. ULTRASOUND GUIDED ACCESS, LEFT ANTERIOR TIBIAL, 4FR, PRESSURE HEMOSTASIS Flush tibial occlusions seen from above can be crossed from below using Tibio-Pedal Access. Angiosome directed therapy is important Lesions isolated to the tibial arteries can by treated from the foot without the additional risks of groin access. 20

21 Case 5 tibio pedal access assisted interventions. 5a; Daniel Liston AT intervention 5b; Sandra Boland SFA intervention from the foot 5c; John Callaway 5d; James Hutchins Case DL 85 year old gentleman with DM and severe RA referred for recurrent non healing foot and toe ulcers bilaterally non palpable pulses, ABI 0.6 right, 0.55 left with monophonic waveforms Case DL Diagnostic angio showing flush occlusion of the right SFA with AK reconstruction and 3 vessel tibial disease with ATA/DP available for pedal access. patient unable to hold still in the cath lab, so rescheduled for Hybrid OR 21

22 22

23 23

24 Comments Case DL 1. Percutaneous angioplasty, 6 x 220 mm balloon, atherectomy, Diamondback 1.5 solid crown, and stent placement, Viabahn 6 x 150 mm, 6 x 150 mm, 6 x 50 mm, right superficial femoral artery (percutaneous fem-pop bypass). 2. Percutaneous atherectomy of the right anterior tibial artery, Diamondback 1.25 with post-angioplasty 3 x 200 mm balloon by retrograde tibial artery access. 3. Ultrasound-guided vascular access to the right anterior tibial artery, 4-French sheath pressure hemostasis. 4. Ultrasound-guided vascular access to the left common femoral artery 6-French sheath, Mynx closure. Case SB 70 year old lady with a history of right SFA stents, coronary stents, ongoing tobacco use, hypertension and hypercholesterolemia is referred by her podiatrist for foot pain. She has known spine disease s/p multiple injections without relief. She has no palpable pulses below the groin. no ulcers. worsened with exercise which she says is mostly limited by her back. She has worsening bilateral LE rest pain especially on the left. ABI 0.45 right and 0.2 left. no ulcers. CTA showing diffusely small vessels with iliac disease on the left and flush occlusion on the right SFA. Right tibial vessels are patent.. 24

25 25

26 26

27 Comments Case SB 1. PECR ATHERECTOMY, RIGHT SFA-POP, DIAMONDBACK 1.25, WITH 5X60MM PTA PROX, 4X120MM DISTAL 2. RIGHT FEMORAL ANGIOGRAM, VIA PEDAL ACCESS 3. ULTRASOUND GUIDED ACCESS, RIGHT PTA AT THE ANKLE, 4FR, PRESSURE HEMOSTASIS Case JC 87 year old gentleman with bilateral dependent rubber and edema with a gangrenous right first toe tip. popliteal pulses faintly palpable, not aneurysmal Right ABI is 0.5 in the PT and 0.1 in the AT Left ABI is 0.6 in PT and DP 27

28 Case JC Antegrade access angio showing defuse disease and TPT occlusion. PT reconstruction mid and distal tibia. Lateral plantar patent to arch medial plantar very small and occludes mid foot 28

29 29

30 Comments Case JC 1. PERC ATHERECTOMY, LEFT PTA, DIAMONDBACK 1.25 PEDAL, WITH 3X220MM 2. RIGHT TIBIAL ANGIOGRAM, NON SELECTIVE FROM LEFT PTA 3. ULTRASOUND GUIDED ACCESS, RIGHT POSTERIOR TIBIAL ARTERY, 4FR, PRESSURE HEMOSTASIS 30

31 Conclusions: Amputation is still far too frequent and costly Orbital Atherectomy is designed to treat calcified vascular disease Tibio-Pedal artery access can produce successful interventions with low risk Advanced endovascular techniques continue to improve outcomes while reducing patient risk and discomfort. Thank you Robert W. Vorhies, M.D., F.A.C.S Vascular and Endovascular Surgery Endovenous Therapy and Vein Aesthetics Ferrell-Duncan Clinic and Cox Health Systems Springfield, Missouri S. National Ave. Suite

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