Treatment of Ileo-femoral disease

Shammas 2007

Treatment of Ileo-femoral disease

Nicolas W. Shammas, MD, MS, FACC, FSCAIInterventional Cardiologist,

Cardiovascular Medicine, PC. Clinical Associate Professor,

University of Iowa Hospitals and ClinicsResearch Director,

Midwest Cardiovascular Research Foundation,Davenport, Iowa

Shammas 2007

Indications for Iliac Intervention

• Symptomatic limb ischemia.– Limiting claudication after failed conservative Rx.– Critical limb ischemia (acute and chronic).

• Vascular access.– Angiography or intervention is required.– Intra-aortic balloon counterpulsation.– Percutaneous LVAD.

• Treatment of access complications.

Shammas 2007

Randomized PTA to Surgery

0.45

0.77

0.46

0.67

BASELINE 1 YEAR

AB

I

PTA SURGP < 0.01P < 0.01

P = NS P = NS

Holm J, et al: Eur J Vasc Surg 1991;5:517-522.

Iliac Artery LesionsIliac Artery Lesions

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PTA vs SURGERY

0.50

0.78 0.80

0.50

0.820.78

Baseline Post-Rx 3 Year

AB

I

PTA SURG

P = NS for all.P = NS for all.

Wilson SE, et al. J Wilson SE, et al. J VascVasc SurgSurg 1989;9:11989;9:1--9.9.

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ONE-YEAR RESULTS

PTAn=53

SURGn=49

Am putation 3 (5.7 %) 8 (16 %)

Bleeding 4 2

Occlusion 2 3

Infe ction 0 4

Em boli zati on 0 4

Death 6 4

Randomized Trial of Chronic Lower-Limb IschemiaRandomized Trial of Chronic LowerRandomized Trial of Chronic Lower--Limb IschemiaLimb Ischemia


Shammas 2007

CONCLUSION

• PTA yields equivalent, if not slightly superior results compared to Surgery.

• Shorter hospital stay with PTA.

Holm J, et al: Holm J, et al: EurEur J J VascVasc SurgSurg 1991;5:5171991;5:517--522.522.

If either PTA or Surgery is appropriate, If either PTA or Surgery is appropriate, then PTA should be attempted first.then PTA should be attempted first.

Shammas 2007

Primary Iliac Stent vs PTA

Procedure 1-year 2-year 3-year 4-year

Stent (123) 95.2% 93.4% 92.1% 91.6%

PTA (124) 88.1% 85.1% 79.5% 74.3%

Cumulative PatencyCumulative PatencyCumulative Patency

Richter GM et al, In Richter GM et al, In LiermanLierman D. ed. Stents: State of the art and future D. ed. Stents: State of the art and future developments. Morin Heights, Canada, developments. Morin Heights, Canada, PolysciencePolyscience, 1995,30, 1995,30--35.35.

74.3%

91.6%

60%

80%

100%

PTA PTAS

4 - Year Patency

P < 0.05P < 0.05

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Nitinol or Stainless steel

• Nitinol and Stainless steel (Elgiloy) stents are equivalent at 12 months for both safety and efficacy endpoints.

• Iliac stent selection should be driven by:– operator preference.– ease of stent delivery.– device cost.

Ponec D, 28th Annual Meeting, Society of Interventional Radiology,

Shammas 2007

Indications for Fem-Pop PTA

• Is the patient sufficiently symptomatic?– Lifestyle limiting claudication that failed

conservative therapy.– Critical limb ischemia.

• Acute limb ischemia.• Chronic limb ischemia.

• Is the risk:benefit ratio acceptable?

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Femoral Popliteal:PTA vs SURG

• Prospective randomization of 102 pts.– Severe claudication.– Rest pain.– Limb-threatening ischemia.

• Stenoses (≥ 75%)/occlusions ≤ 6 cm length for iliac, femoral,or popliteal artery.

For Chronic Lower Limb IschemiaFor Chronic Lower Limb IschemiaFor Chronic Lower Limb Ischemia


Shammas 2007

Randomized PTA to Surgery

0.42

0.71

0.43

0.72

BASELINE 1 YEAR

AB

I

PTA SURGP < 0.01P < 0.01

P = NS P = NS


Femoral Artery LesionsFemoral Artery Lesions

Shammas 2007

ONE YEAR PATENCY

60% 62%

77%67%

0%

25%

50%

75%

100%

PA

TE

NC

Y

PRIMARY SECONDARY

PTA SURG


If patients are candidates for both surgery and angioplasty, angIf patients are candidates for both surgery and angioplasty, angioplasty should be tried first.ioplasty should be tried first.

Shammas 2007

SFA PTA Primary Patency

Kandarpa K, et al. J Vasc Interv Radiol. 2001;12:683-695.

45495254595 Years5 Years4 Years4 Years3 Years3 Years2 Years2 Years1 Year1 Year

% Primary Patency

Meta-analysis (N = 1003)

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Cryoplasty® Technology : Basic Premise

• Cryoplasty was designed to improve on the outcomes of PTA by combining dilation with simultaneous freezing of the artery

• Cryoplasty uses nitrous oxide instead of contrast and saline to achieve this goal.

Shammas 2007

CryoPlasty Therapy

1. Liquid nitrous oxide is used as the inflation media

2. Liquid expands into gas, inflating balloon to 8 ATM

3. Phase change from liquid to gas draws energy, driving balloon surface temperature to –10°C

CryoPlasty Therapy = Angioplasty + Cold Therapy

Shammas 2007

CryoPlasty® Therapy

•The PolarCath™ Peripheral Dilatation System is indicated for:

•Femoral arteries•Infrapopliteal arteries•Iliac arteries•Renal arteries•Subclavian arteries•ePTFE access grafts or native fistulae

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The System Components

• The Components

• Balloon Catheter• Inflation Unit• Nitrous Oxide Cartridge• Power Module

Fully Automated SystemEntire process takes takes less than a minute

Shammas 2007

Inner balloon:Contains the gas

and pressure

Middle layer:Insulates and has

RO markers

Outer balloon:PEBAX® balloon expands passively

The Balloon has 3 Layers

The System Components

Shammas 2007

CryoPlasty Therapy Pivotal TrialProspective study of 102 patients

with femoropopliteal lesions treated using stand-alone CryoPlasty Therapy

Prospective study of 102 patients with femoropopliteal lesions treated using

stand-alone CryoPlasty Therapy

Study ManagementStudy Management

Principal InvestigatorsPrincipal Investigators

Vascular UltrasoundCore Lab

Vascular UltrasoundCore Lab

John R. Laird, MDWashington Hospital Center

Giancarlo Biamino, MDHerzzentrum Leipsig

John R. Laird, MDWashington Hospital Center

Giancarlo Biamino, MDHerzzentrum Leipsig

Michael R. Jaff, DOMassachusetts GeneralMichael R. Jaff, DO

Massachusetts General

Shammas 2007

Patient Characteristics

Age=70.5+8.6 yrs61M/41F31% Diabetics73% Smokers87% Hypertension81% Hyperlipidemia

Age=70.5+8.6 yrs61M/41F31% Diabetics73% Smokers87% Hypertension81% Hyperlipidemia

DemographicsDemographics

84% SFA16% Popliteal15% CTO’s%DS=87+10%Length=4.7+2.6 cm

Runoff vessels=1.7+0.4

84% SFA16% Popliteal15% CTO’s%DS=87+10%Length=4.7+2.6 cm

Runoff vessels=1.7+0.4

LesionsLesions

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9 Month IDE Data

Procedural Success RateProcedural Success Rate

Stented LesionsStented Lesions

Mean Residual %DSMean Residual %DS

94%

9%

11 ± 11%

No unanticipated device related adverse eventsNo unanticipated device related adverse events

Shammas 2007

9 Month IDE Data

Primary Clinical PatencyPrimary Clinical Patency

Target LesionRevascularization

Target LesionRevascularization

ABI ImprovementABI Improvement

Claudication ImprovementClaudication Improvement

82.2%

17.8%

80%

89%

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Forces on the SFAContraction

Torsion

Flexion

Compression

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Historical Limitations

• Angioplasty alone is limited by a high frequency of dissection, significant recoil, and high restenosis rates.

• While stenting has made an acute impact on dissection and recoil, restenosis rates and walking distances have only modestly improved over time with no change in hard outcomes (death, amputation, need for urgent revascularization).

• More aggressive stent utilization has created other problems.– In stent restenosis and occlusion– Stent strut fracture

Shammas 2007

Schillinger M.N Engl J Med.2006 May 4;354(18):1879-88

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Shammas 2007


Shammas 2007

Copyright ©2007 American Heart Association

Krankenberg, H. et al. Circulation 2007;116:285-292

Absolute difference in restenosis rate ({Delta}RR) at 12 months between treatment modalities for men, women, diabetics, and smokers, as well as patients with total occlusions, patients with moderate to severe calcification, and patients with at least 1 distal runoff vessel (dist. ves.) occluded at baseline

Shammas 2007



Odds ratios (ORs) of 12-month restenosis in selected patient subgroups

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Change from baseline to 12 months in absolute walking distance (AWD) (A) and ABI (B) in patients who were able to undergo treadmill testing at both baseline and 12-month follow-up

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Change in Rutherford category in patients who were able to undergo treadmill testing at both baseline and 12-month follow-up

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Conclusion

• Iliac disease is best treated with Stenting with excellent long term outcome

• Cryoplasty of the SFA leads to good acute and long term outcome

• Stenting offers less restenosis rate with modest improvement in walking distance but not ABI or change in RB absolute difference. Hard outcomes are not changed. Long term outcomes are unknown. Can be used as a primary treatment or as a bail out treatment for dissection or suboptimal results.

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Treatment of Ileo-femoral disease