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10/4/2016
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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 AestheticsCox Health Systems and Ferrell-Duncan Clinic
The Future of Vascular Disease Therapeutics
Cox Health Heart and Vascular SummitOctober 14-15, 2016
Springfield, MO
• Disclosures:
• Cardiovascular Systems Inc., Medical Education Faculty Consultant
Objectives1. 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.
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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 2003.
• 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
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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”
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Endpoints
• Patency
• Amputation free survival
• Wound healing
• Functional status
• Quality of Life
The Challenge of Calcium:
Patient Implications of Calcium:
Contributes to Lower Success
Rates74% of flow limiting dissections occur in calcium1
• 1 yr. patency of ballooned arteries drops to 36%2
• Limb salvage drops to 56% at 1 year3
• Non-orbital atherectomy technologies not optimized for performance in calcium6
• 22% bail out stent rate7
Increased Adverse Events
Decreased Balloon Success
Decreased Stent Success
Non-Orbital Technologies Result in Higher Risk
• 28% fracture rate; presence of calcium is predictor4
• Stent malapposition5
1. Circulation 1992, Vol86, No. 1, Contribution of Localized Calcium Deposits to Dissection after Angioplasty2. Cardiovasc Intervent Radiol, 1996;19:317-322. The use of BTK Percutaneous Transluminal Angioplasty in Arterial Occlusive Disease causing CLI
3. Journ of Vasc Diseases 1994;45:797-804. Impact of Risk Factors on Limb Salvage after Balloon Angioplasty in CLI4. 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: 312-315.6. 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.
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Intervention in Unseen Calcium Can Result in
Dissection1
Calcium? Yes!
CSI-661 1. J Endovasc Ther 2008;15:117-125. 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 IVUS1
• 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
• Deep vessel injury leading to high restenosis rates2
• 38.6% binary restenosis at 12 mo in FAST Trial
1.Fitzgerald PJ, Ports TA, Yock PG. Contribution of localized calcium deposits to dissection after angioplasty. Circulation. 1992; 86(1):64-70.2.Krankenberg H, et al. Nitinol stent implantation versus percutaneous transluminal angioplasty in superficial femoral artery lesions up to 10 cm in length. Circulation. 2007;116:285-292.
STENT GROUP
0%
20%
40%
31.7
38.6
Binary Restenosis at 12 mo (p = 0.377)
PTA GROUP
FAST Trial
CSI-661
Balloon Angioplasty Can Cause
Dissections
Pre- ProcedureCalcified Lesion
Balloon Inflation8 atms of Inflation
Post BalloonDissection Occurred
Results May Vary
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High Pressure Inflation Does Not Always
Enable Balloon Expansion
Results May Vary
20 atm Balloon Inflation
Pre- ProcedureCalcified Lesion
Results May Vary
Stent Radial Force May Be
InadequateUnable to Maintain Lumen Post High-Pressure PTA
Results May Vary
Pre- ProcedureCalcified Lesion
Stent MalappostionDue to Calcium
Post Dilatation PTA12 atms of Inflation
Stent Lacked Radial ForceCalcium Prevented
Sufficient Apposition
Health Care Economics Implications:
Calcium Increases Costs• Increased lab time to manage adverse event
$100/minute1
• Increased bail-out stent rate at $700-$1,500/each2
• Increased re-intervention rate at $28,000/each3
• Amputation cost = $48,1523
• Annual cost to manage amputee = $49,0005
• Annual cost of nursing home = $80,0005
Day of Case
Durability
Wound Healing
Amputation
• Average cost to heal wound = $17,0963
1. Reimbursement Principles Inc. Data on record at CSI2. Average price paid for stents. Compiled from review of 100 UB40 case expense worksheets. Data on file at CSI.
3. Diabetes Care, 2000;2399):1333-38. A Cost Analysis of Diabetic Lower Extremity Ulcers.4. Diabetes Care, Vol 21, Number 8, 1998. Potential Economic Benefits of Lower Extremity Amputation Prevention in Diabetes.
5. J Endovasc Ther. 2009, 16. 24 Carat Gold, 14 Carat Gold or Platinum standards in the treatment of Critical Limb Ischemia: Bypass or Endovasc Intervention?
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Calcium Can Be Predicted
Independent Calcium Prediction Variables
1. ABI > 1.31
2. Critical Limb Ischemia2
3. Diabetes: Especially if neuropathy present3,4
4. Calcium found on forefoot X-Ray6
5. History of tobacco use2
6. Creatinine > 1.72
7. Glomerular Filtration Rate (GFR) < 605,7
1. Clev Clin Journ of Med 2006;73:s4. The magnitude of the problem of PAD: Epidemiology and Clinical Significance2. J Am Coll Cardiol, 2008,51;20:1967-1974. Tibial Artery Calcification as a Marker of Amputation Risk in Patients with PAD.
1. Diabetologia 1993, Jul;36(7):615-21. 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, 20:1453-1464. Vascular Calcification: The killer of patients with Chronic Kidney Disease5. Ritz Vascular calcification under maintenance hemodialysis. Journal of Mol. Med 55(8)(1977) 375-378
6. Definition and Classification of Chronic Kidney Disease Impairing Global outcomes Kidney Int. Vol. 67 (2005) 20089-2100
Which Patients are More Likely to
Have Calcium? PAD Patients with Metabolic Disorders Leading to Calcified Plaque and Media
Advanced Age
40.3M 65+yrs old in U.S.(1)
85+ age group is fastest growing in U.S.
Diabetics
Up to 26M in U.S.(2)
Diabetes is fastest growing health problem in U.S.(2)
Kidney Disease
Up to 31M in U.S. (3)
Diabetes is leading cause of kidney disease
1. U.S. Census Bureau, 20102. 2011 National Diabetes Fact Sheet Found on American Diabetes Association Website Searched on Dec. 26 , 2011
3. American Kidney Fund Website: News Release Oct. 17, 2011
Angiography Routinely Underestimates
Calcium 1
1. J Endovasc Ther 2008;15:117-125. Angiography Underestimates PAD
Calcium? Yes!
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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
List of Options for Atherectomy
• directional (Turbohawk)
• rotational (Rotoblader)
• orbital (Diamondback)
CLASSIC CROWN
SOLID CROWN
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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
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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
Crown Mass
Rotational Speed
Orbit Radius
Centrifugal Force = Mass x Rotational Speed2
The Physics of the MOA:
Centrifugal Force
Radius of the Orbit
Crown MassCentrifugal Force = Mass x Rotational Speed2
Radius of the Orbit
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
Solid Micro Crown
Classic Crown
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Rotational Speed
Centrifugal Force = Mass x Rotational Speed2
Radius of the Orbit
Speed exponentially impacts Centrifugal ForceAn increase in speed exponentially increases Centrifugal Force
• Classic Crown Speeds: 60, 90, 140K RPM• Solid Crown Speeds: 60, 90, 120K RPM
Orbit RadiusOffset Center of Mass Creates Orbital Motion
PlaquePlaque
Center of Mass is Offset from Driveshaft Axis
DRIVESHAFT Rotation Axis
Offset Distance = Orbit Radius
ORBIT Rotation Axis
Center of Mass
• Orbital motion produces 360° of contact• As Orbit Radius increases, Centrifugal Force decreases for inherent safety
Centrifugal Force = Mass x Rotational Speed2
Radius of the Orbit
Tibio-Pedal Artery Access
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Background
• Patients with critical limb ischemia typically have many co-morbidities.
• By virtue of the disease these patients are pre-disposed to complications:1. Groin access complications2. Acute Kidney Injury 3. Radiation exposure to the patient and the operator4. In case of complications, significant recovery time
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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.
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Technique
• Linear 15i7 MHz hockey stick probe for tibio-pedal access
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Anterior Tibial Artery AccessThe 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.
9CONFIDENTIAL - INTERNAL USE ONLY
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.
10CONFIDENTIAL - INTERNAL USE ONLY
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.
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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.
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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.
8CONFIDENTIAL - INTERNAL USE ONLY
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.
11CONFIDENTIAL - INTERNAL USE ONLY
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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.
12CONFIDENTIAL - INTERNAL USE ONLY
Final Step
• Inject contrast to confirm our intraluminal position.
• Inject 400-600 micrograms of nitroglycerin.
• 4 French micro sheath inserted into the tibial vessel.
13CONFIDENTIAL - INTERNAL USE ONLY
Body Floss
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Cases
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Case TL
74 year old gentleman with a long standing history of diabetes, who presented with a gangrenous left 2nd toe.
HTNCholNon smokerHgb A1c of 7Previously healed left 3rd toe amputation
Pedal Pulses non palpableABI non compressibleleft digital pressure 23 mm HgArterial Duplex demonstrated diffuse calcification and monophasic distal waveforms
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Comments Case TL1. PERC ATHERECTOMY, LEFT ANTERIOR TIBIAL ARTERY, DIAMONDBACK 1.25 WITH 4X60MM PTA @2ATM
2. RETROGRADE CANNULATION OF THE LEFT POPLITEAL ARTERY FROM THE LEFT ANTERIOR TIBIAL ARTERY AT THE ANKLE3. 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.
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Case 5tibio 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
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Comments Case DL1. 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..
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Comments Case SB1. PECR ATHERECTOMY, RIGHT SFA-POP, DIAMONDBACK 1.25, WITH 5X60MM PTA PROX, 4X120MM DISTAL2. RIGHT FEMORAL ANGIOGRAM, VIA PEDAL ACCESS3. 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
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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
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Comments Case JC 1. PERC ATHERECTOMY, LEFT PTA, DIAMONDBACK 1.25 PEDAL, WITH 3X220MM PTA@6ATM2. RIGHT TIBIAL ANGIOGRAM, NON SELECTIVE FROM LEFT PTA3. ULTRASOUND GUIDED ACCESS, RIGHT POSTERIOR TIBIAL ARTERY, 4FR, PRESSURE HEMOSTASIS
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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.SVascular and Endovascular SurgeryEndovenous Therapy and Vein Aesthetics
Ferrell-Duncan Clinic and Cox Health SystemsSpringfield, Missouri
Instagram @VascularVikingTwitter @FDCendovascular
[email protected] S. National Ave. Suite 160417-875-2627
