Vorhies Hrt and Vasc Summit 2017 Final PPT11/16/2017 2 introduction and demographics of amputation • Peripheral arterial disease (PAD), atherosclerosis, is present in up to 29% of

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Percutaneous Revascularization

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 SummitNovember 17-18, 2017

Springfield, MO

• Disclosures:

• Cardiovascular Systems Inc.

• Bard Peripheral Vascular

• Endologix, Inc.

Objectives

1. Appreciate the scope of PAD and Amputation.

2. Define the goals of therapy

3. Recognize the available options for endovascular treatment

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introduction and demographics of amputation

• Peripheral arterial disease (PAD), atherosclerosis, is present in up to 29% of the US population and estimated 202 Million people world wide

• Critical Limb Ischemia (CLI) was diagnosed in more than 3.4 million Americans in 2015 and predicted to increase to more than 4 million by 2030.

• Patients with critical limb ischemia have an overall poor prognosis

• 1 year mortality = 25%

• 5 year mortality = 50%

thesagegroup.us, Amputation Prevention Symposium 2016


• Patients presenting with CLI:

• Initial Treatment

• 50% revascularized

• 25% medical management only

• 25% receive a primary amputation

“Prevalence, Incidence, and Outcomes of Critical Limb Ischemia in the US Medicare Population”, Vascular Disease Management, 2013:10(2):E26-E36


• CLI patient 1 year later

• 25% CLI resolved

• 30% alive with amputation

• 20% continue to have CLI

• 25% have died


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• 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



• 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

Rutherford classification

• Stage 0 – Asymptomatic

• Stage 1 – Mild claudication

• Stage 2 – Moderate claudication

• Stage 3 – Severe claudication

• Stage 4 – Rest pain

• Stage 5 – Ischemic ulceration not exceeding ulcer of the digits of the foot

• Stage 6 – Severe ischemic ulcers or frank gangrene

General List of Therapeutic Options

• conservative management

• risk factor management

• walking

• Cilostazol

• endovascular interventions

• angioplasty

• atherectomy

• stent

• open surgical procedures

• endarterectomy

• bypass with vein graft

• bypass with synthetic graft

• bypass with biograft

• gene therapy

• angiogenesis

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General List of Therapeutic Options

• endovascular interventions

• angioplasty

• atherectomy

• stent

Plain Old Balloon Angioplasty (POBA)

• Angioplasty was first described by the US interventional radiologist Charles Dotter in 1964.

• On January 16, 1964, Dotter percutaneously dilated a tight, localized stenosis of the superficial femoral artery (SFA) in an 82-year-old woman with painful leg ischemia and gangrene who refused leg amputation.

• The first percutaneous coronary angioplasty on an awake patient was performed in Zurich by the German radiologist Andreas Gruentzig on September 16, 1977.

Dotter CT, Judkins MP (November 1964). "Transluminal treatment of arteriosclerotic obstruction". Circulation. 30 (5): 654–70.

Rösch, Josef; et al. (2003). "The birth, early years, and future of interventional radiology". J Vasc Interv Radiol. 14 (7): 841–853."Andreas R. Gruentzig – Biographical Sketch". ptca.org. Retrieved February 22, 2016.

Plain Old Balloon Angioplasty (POBA)

• Results:

• 5 year patency , 36% for class A and B lesions, 12% for class C and D lesions

• 4 year limb salvage, 70-80%

• 37% require “bail-out” stent

“Late outcomes of balloon angioplasty and angioplasty with selective stenting for superficial femoral-popliteal disease are equivalent”

Journal of Vascular SurgeryVolume 54, Issue 4, October 2011, Pages 1051-1057.e1

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Cryo-Balloon

• Cryoplasty uses nitrous oxide as the dilation medium at -10°C • apoptosis of the smooth muscle cells in the vessel wall,• plaque modification,• reduces elastic recoil of the vessels by altering elastin fibers in the wall.

• Outcomes were initially good with up to 75% 3 year patency. • Reduced amount of “Bail-out” stenting but did not change 1 year patency from POBA • Meta-analysis in 2013 was inconclusive for benefit of Cryoplasty• Cryotherapy is now being marketed as an alternative to RF ablation in chronic Afib.

2. “Cryoballoon angioplasty broadens the role of primary angioplasty and reduces adjuvant stenting in complex superficial femoral artery lesions.”J Am Coll Surg. 2008 Mar;206(3):524

1. “Practical Uses of Cryoplasty” Endovascular Today , October 2008.

Cutting Balloons

• Atherotomes deliver a controlled fault line by scoring the plaque longitudinally rather than an uncontrolled dissection.

• micro-surgical blades extend 0.005”

• Allows for decreased risk of barotrauma and neointimal hyperplasia

• Typically used in 2-4 mm vessels

J Invasive Cardiol. 2002 Sep;14(9):552-6.

Cutting balloon angioplasty.

Chocolate Balloon

• Standard balloons are wrapped with pleated folds. This can create rotational torque on a plaque when they open.

• Nitinol constraining structure of the Chocolate balloon creates “pillows” and “grooves” with uniform expansion to improve plaque modification and reduce dissection.

• Maintains a cylindrical shape to allow for more controlled expansion and rapid deflation; reduces need for cutting balloons.

“Novel Use of Pillows and Grooves: The Chocolate® PTA Balloon Catheter”, Endovascular Today, May 2014

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Drug Coated Balloon Angioplasty(DCB)

Company Name

Product Name

Drug Type

Drug Concentration (µg/mm2)

Excipient Type

Wire Compatibility (inch)

Shaft Length (cm)

Sheath Sizing Size (F)

Balloon Diameters (mm)

Balloon Lengths (mm)

FDA Indicated Use

Bard Peripheral Vascular, Inc.

Lutonix 035 (AV indication)

Paclitaxel 2 Polysorbate and sorbitol

0.035 40, 75, 100

5–9 4–12 40, 60, 80, 100

Indicated for percutaneous transluminal angioplasty, after predilatation, for treatment of stenotic lesions of dysfunctional native arteriovenous dialysis fistulas that are 4–12 mm in diameter and up to 80 mm in length

Bard Peripheral Vascular, Inc.

Lutonix 035 (SFA/popliteal indication)

Paclitaxel 2 Polysorbate and sorbitol

0.035 75, 130 5 (all sizes)

4–7 40, 60, 80, 100, 120, 150

Indicated for percutaneous transluminal angioplasty, after appropriate vessel preparation, of de novo, restenotic, or in-stent restenotic lesions up to 300 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4–7 mm

Medtronic In.Pact Admiral

Paclitaxel 3.5 Urea 0.035 80, 130 5 (4 mm), 6 (5, 6 mm), 7 (7 mm)

4–7 40, 60, 80, 120, 150

Indicated for PTA, after appropriate vessel preparation, of de novo, restenotic or in-stent restenotic lesions with lengths up to 180 mm in superficial femoral or popliteal arteries with reference vessel diameters of 4–7 mm

Spectranetics, a Philips company

Stellarex Paclitaxel 2 Polyethylene glycol (PEG)

0.035 80, 135 6 4, 5, 6 40, 60, 80, 120

De novo and restenotic lesions in the superficial femoral or popliteal arteries

2017 BUYER'S GUIDE > DRUG-COATED BALLOONS


• Drug eluting devices inhibit neointimal growth of vascular smooth muscle cells and therefore potentially prevent restenosis

• Paclitaxel bound to different agents and dripped onto standard balloons in different strengths.

• anti proliferative

• rapid cellular uptake

• Downstream losses can inhibit wound healing and rare cases of vasculitis reported.

“Drug-eluting balloon catheters for lower limb peripheral arterial disease: the evidence to date” , Vasc Health Risk Manag. 2016; 12: 199–208. Published online 2016 May 12.


• General Results fem-pop lesions:

• 1 year patency 65% to 82% DCB vs 52% POBA

• Freedom from TLR 87% DCB vs 83% POBA

• no significant difference in amputation or mortality

• Similar conclusions from the below knee trials

“Drug-eluting balloon catheters for lower limb peripheral arterial disease: the evidence to date” , Vasc Health Risk Manag. 2016; 12: 199–208. Published online 2016 May 12.

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Atherectomy

• Ather-

• -ectomy

athero-Combining form meaning gruellike, soft, pasty mater ials; atheroma, atheromatous.[G. athērē, gruel, porridge ]

-ectomyword element [Gr.], excision; surgical removal.

List of Options for Atherectomy

• directional (Turbohawk)

• rotational (Rotoblader)

• orbital (Diamondback)

CLASSIC CROWN

SOLID CROWN

List of Options for Atherectomy

• photoablative (Laser)

• aspirational (Pathway)

• hybrid (Phoenix)

• contact (Crosser)

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Crown Mass

Rotational Speed

Orbit Radius

Centrifugal Force = Mass x Rotational Speed2

The Physics of the MOA:

Centrifugal Force

Radius of the Orbit

Crown Mass

Solid CrownSolid Micro Crown

Classic Crown

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

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Atherectomy Results

• Orbital

• Freedom from TLR or restenosis 80% (patency)

• “bail out” stenting 5 % (vs. 78% with PTA alone)

• MAE

• perforation 0%

• dissection 16%

• embolization 2.6%

Dattilo R, Himmelstein SI, Cuff RF. The COMPLIANCE 360° Trial: a randomized, prospective, multicenter, pilot study comparing acute and long-term results of orbital atherectomy to ball

Atherectomy Results

• Directional

• 12 month patency 78%

• Freedom from major amputation 95%

• “bail out” stenting 3.2 %

• MAE

• perforation 5%

• dissection 2.3%

• embolization 3.8%

McKinsey JF, Zeller T, Rocha-Singh KJ, Jaff MR, Garcia LA. Lower extremity revascularization using directional atherectomy: 12-month prospective results of the DEFINITIVE LE study. JACC Cardiovasc Interv 2014;7:923

Atherectomy Results

• Photoablative , study of In-Stent Restenosis

• 6 month freedom from TLR 73% (patency)

• Freedom from major amputation 95%

• “bail out” stenting 4.1 %

• MAE

• perforation 5%

• dissection 7.7 %

• embolization 8.3 %

Dippel EJ, Makam P, Kovach R, et al. Randomized controlled study of excimer laser atherectomy for treatment of femoropopliteal in-stent restenosis: initial results from the EXCITE ISR trial (EXCImer Laser Randomized Controlled Study for Treatment of Femor

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Atherectomy ChoicesAtherectomy Type Directional Rotational Photo-Ablative Orbital

Device SilverHawk/ TurboHawk Jetstream Laser Diamondback 360

Eccentric, focal calcification XX X

Thrombotic lesion XX X

BTK lesion X X X

Highly calcific, diffuse plaque X XX

In-stent restenosis XX

In-stent restenosis with thrombus X X

Chronic total occlusion X XX

Table 1: Atherectomy Devices and Where Each Device is Most AdvantageousBTK = below the knee

“Atherectomy for Lower Extremity Intervention: Why, When, and Which Device?”

American College of Cardiology Jun 16, 2015 | Konstantinos Charitakis, MD, FACC; Dmitriy N. Feldman, M.D., FACC

Endovascular Stents

• Bare Metal: balloon expandable, self expanding

• Covered: balloon expandable, self expanding

• Drug Eluting

• What’s new

the first intraluminal stent was developed by Julio Palmaz, in 1985

Bare Metal Endovascular Stents

• Bare Metal: balloon expandable, self expanding

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Endovascular Stents: Results

• Iliac stents, covered vs uncovered

• patency 18 months 95% vs. 73%

• biggest difference in TASC C and D

• however no difference in rate of amputation

“Durability of the balloon-expandable covered versus bare-metal stents in the Covered versus Balloon Expandable Stent Trial (COBEST) for the treatment of aortoiliac occlusive disease.” J Vasc Surg. 2016 Jul;64(1):83

Endovascular Stents: Results

• Femoral -Popliteal lesion >100mm

• self-expanding stent vs. plain PTA

• 1 year patency 87 % vs 45 %

• Covered self expanding vs. bare metal SE

• 1 year patency 78% vs. 53%Nitinol stent implantation vs. balloon angioplasty for lesions in the superficial femoral and proximal popliteal arteries of patients with claudication: three-year follow-up from the RESILIENT randomized trial. J Endovasc Ther. 2012;19:1

Heparin-bonded covered stents versus bare-metal stents for complex femoropopliteal artery lesions: the randomized VIASTAR trial (Viabahn endoprosthesis with PROPATEN bioactive surface [VIA] versus bare nitinol stent in the treatment of long lesions in s

Endovascular Stents

• Drug Eluting above the knee

• initial enthusiasm dampened by 31 % stent fractures and no advantage

• Paclitaxel coated, self expanding vs. POBA

• 2 year patency 74% vs. 26%

• provisional DES 83% vs provisional BMS 64%

“Sustained safety and effectiveness of paclitaxel-eluting stents for femoropopliteal lesions: 2-year follow-up from the Zilver PTX randomized and single-arm clinical studies.” J Am Coll Cardiol. 2013 Jun 18; 61(24):2417

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Endovascular Stents• Drug eluting vs. POBA below the knee

• 1 year patency 75% vs. 57%

• However no difference in amputation or TLR

• DES vs. BMS

• Significantly better patency 85% vs. 54%

• fewer amputations 2% vs 12%

“A prospective randomized multicenter comparison of balloon angioplasty and infrapopliteal stenting with the sirolimus-eluting stent in patients with ischemic peripheral arterial disease: 1

“Sirolimus-eluting stents for treatment of infrapopliteal arteries reduce clinical event rate compared to bare-metal stents: long-term results from a randomized trial.” J Am Coll Cardiol. 2012 Aug 14; 60(7):587

Follow up: generally all endovascular interventions

• Aspirin

• Clopidogrel

• Statin

• CV risk factor modification

• Ultrasound and ABI at 1 month, 6 months

“Endovascular Intervention for Peripheral Artery Disease” Circ Res. 2015 Apr 24; 116(9): 1599–1613.

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

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..

Conclusions:• Amputation is still far too frequent and costly

• Advanced endovascular techniques continue to improve outcomes while reducing patient risk and discomfort.

• Drug coated balloon angioplasty promises to reduce recurrence of peripheral occlusive lesions.

• Orbital Atherectomy is designed to treat calcified vascular disease

• Endovascular Stents can be used in a wide variety of applications.

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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

References1. thesagegroup.us, Amputation Prevention Symposium 20162. Dotter CT, Judkins MP (November 1964). "Transluminal treatment of arteriosclerotic obstruction". Circulation. 30 (5): 654–70.3. Rösch, Josef; et al. (2003). "The birth, early years, and future of interventional radiology". J Vasc Interv Radiol. 14 (7): 841–853.4. "Andreas R. Gruentzig – Biographical Sketch". ptca.org. Retrieved February 22, 2016.“Prevalence, Incidence, and Outcomes of Critical Limb Ischemia in the US Medicare

Population”, Vascular Disease Management, 2013:10(2):E26-E365. “Late outcomes of balloon angioplasty and angioplasty with selective stenting for superficial femoral-popliteal disease are equivalent”6. Journal of Vascular Surgery Volume 54, Issue 4, October 2011, Pages 1051-1057.e1 1992, Vol86, No. 1. 7. “Practical Uses of Cryoplasty” Endovascular Today , October 2008. “Cryoballoon angioplasty broadens the role of primary angioplasty and reduces adjuvant stenting in complex

superficial femoral artery lesions.”J Am Coll Surg. 2008 Mar;206(3):524-32. doi: 10.1016/j.jamcollsurg.2007.09.008. Epub 2007 Nov 26.8. “Cutting balloon angioplasty.” Invasive Cardiol. 2002 Sep;14(9):552-6.9. “Novel Use of Pillows and Grooves: The Chocolate® PTA Balloon Catheter”, Endovascular Today, May 201410.“Drug-eluting balloon catheters for lower limb peripheral arterial disease: the evidence to date” , Vasc Health Risk Manag. 2016; 12: 199–208. Published online 2016 May

12.Cardiovasc Intervent Radiol, 1996;19:317-322. 11.The use of BTK Percutaneous Transluminal Angioplasty in Arterial Occlusive Disease causing CLI12.Journ of Vasc Diseases 1994;45:797-804. Impact of Risk Factors on Limb Salvage after Balloon Angioplasty in CLI13.TCT 2008, Abstract, D. Scheinert, MD, Department of Clinical and Interventional Angiology, Heart Center and Park Hospital, University of Leipzig Hospital14.Journ of American College of Cardiology, 2005;45: 312-315.15.Review of Atherectomy devices. Information on file at CSI.16.Cardiac Catheter Interventions, June, 2009, Poster A-32. Percutaneous Lower extremity Arterial Interventions Using Balloon Angioplasty Versus SilverHawk: Results of the

SMARTHAWK Randomized Trial.17.Dattilo R, Himmelstein SI, Cuff RF. The COMPLIANCE 360° Trial: a randomized, prospective, multicenter, pilot study comparing acute and long-term results of orbital atherectomy to

balloon angioplasty for calcified femoropopliteal disease. J Invasive Cardiol 2014;26:355-60.J Endovasc Ther 2008;15:117-125.18.McKinsey JF, Zeller T, Rocha-Singh KJ, Jaff MR, Garcia LA. Lower extremity revascularization using directional atherectomy: 12-month prospective results of the DEFINITIVE LE

study. JACC Cardiovasc Interv 2014;7:923-33.19.“Atherectomy for Lower Extremity Intervention: Why, When, and Which Device?”American College of Cardiology Jun 16, 2015 | Konstantinos Charitakis, MD, FACC; Dmitriy N. Feldman, M.D., FACC20.Angiography Underestimates PAD21.Images courtesy of Dr. Raymond Dattilo, MD, FACC, Director of Peripheral Interventions Kansas Heart and Vascular Center, Cardiology Consultants of Topeka, KS22.Clev Clin Journ of Med 2006;73:s4. The magnitude of the problem of PAD: Epidemiology and Clinical Significance23.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.24.Ann Vasc Surg 2008; 22:6. Arterial calcification increases in distal arteries.25.J Am Soc Nephrol 2009, 20:1453-1464. Vascular Calcification: The killer of patients with Chronic Kidney Disease26.Ritz Vascular calcification under maintenance hemodialysis. Journal of Mol. Med 55(8)(1977) 375-378 27.Definition and Classification of Chronic Kidney Disease Impairing Global outcomes Kidney Int. Vol. 67 (2005) 20089-210028.“Durability of the balloon-expandable covered versus bare-metal stents in the Covered versus Balloon Expandable Stent Trial (COBEST) for the treatment of aortoiliac occlusive

disease.” J Vasc Surg. 2016 Jul;64(1):83-94.e1. doi: 10.1016/j.jvs.2016.02.064. Epub 2016 Apr 28.29.Nitinol stent implantation vs. balloon angioplasty for lesions in the superficial femoral and proximal popliteal arteries of patients with claudication: three-year follow-up from the

RESILIENT randomized trial. J Endovasc Ther. 2012;19:1–9.30.“Sustained safety and effectiveness of paclitaxel-eluting stents for femoropopliteal lesions: 2-year follow-up from the Zilver PTX randomized and single-arm clinical studies.” J Am

Coll Cardiol. 2013 Jun 18; 61(24):2417-242731.“A prospective randomized multicenter comparison of balloon angioplasty and infrapopliteal stenting with the sirolimus-eluting stent in patients with ischemic peripheral arterial

disease: 1-year results from the ACHILLES trial.” J Am Coll Cardiol. 2012 Dec 4; 60(22):2290-532.“Sirolimus-eluting stents for treatment of infrapopliteal arteries reduce clinical event rate compared to bare-metal stents: long-term results from a randomized trial.” J Am Coll Cardiol.

2012 Aug 14; 60(7):587-9133.“Endovascular Intervention for Peripheral Artery Disease” Circ Res. 2015 Apr 24; 116(9): 1599–1613.

Vorhies Hrt and Vasc Summit 2017 Final PPT11/16/2017 2 introduction and demographics of amputation • Peripheral arterial disease (PAD), atherosclerosis, is present in up to 29% of

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