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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
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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.
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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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Shammas 2007
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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Shammas 2007
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
Holm J, et al: Eur J Vasc Surg 1991;5:517-522.
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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.
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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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Shammas 2007
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,
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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
Holm J, et al: Eur J Vasc Surg 1991;5:517-522.
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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
Holm J, et al: Eur J Vasc Surg 1991;5:517-522.
Femoral Artery LesionsFemoral Artery Lesions
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Shammas 2007
ONE YEAR PATENCY
60% 62%
77%67%
0%
25%
50%
75%
100%
PA
TE
NC
Y
PRIMARY SECONDARY
PTA SURG
Holm J, et al: Eur J Vasc Surg 1991;5:517-522.
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.
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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.
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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
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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
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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
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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
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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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Shammas 2007
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
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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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Shammas 2007
Forces on the SFAContraction
Torsion
Flexion
Compression
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Shammas 2007
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
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Shammas 2007
Schillinger M.N Engl J Med.2006 May 4;354(18):1879-88
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Shammas 2007
Schillinger M.N Engl J Med.2006 May 4;354(18):1879-88
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Shammas 2007
Schillinger M.N Engl J Med.2006 May 4;354(18):1879-88
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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
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Shammas 2007
Copyright ©2007 American Heart Association
Krankenberg, H. et al. Circulation 2007;116:285-292
Odds ratios (ORs) of 12-month restenosis in selected patient subgroups
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Shammas 2007
Copyright ©2007 American Heart Association
Krankenberg, H. et al. Circulation 2007;116:285-292
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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Shammas 2007
Copyright ©2007 American Heart Association
Krankenberg, H. et al. Circulation 2007;116:285-292
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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Shammas 2007
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.