an initial strategy of open disclosures bypass is better

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An initial strategy of open bypass is better for some CLI patients, and we can define

who they areFadi Saab, MD, FASE, FACC, FSCAI

Metro Heart & VascularMetro Health Hospital, Wyoming, MI

Assistant Clinical Professor of MedicineMichigan State University CHM & COM, E. Lansing, MI

Disclosures• Abbott Vascular – Consultant• Bard Peripheral Vascular - Research, Consultant, • Cardiovascular Systems, Inc. - Research, Consultant,• Cook Medical - Research, Consulting• Covidien – Consulting• Terumo – Consulting• Spectranetics – Research, Consulting

Talking Points

• Profile of CLI patients• Surgical Outcomes in CLI patients• Surgery vs EVT• Current Research

Understanding Objective PerformanceGoals for Critical Limb Ischemia TrialsMichael S. Conte, MD

Critical limb ischemia (CLI), the most advanced form of peripheral arterial disease, is

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CLI Patients• Surgery vs endovascular revascularization varies depending on:1. Disease pattern (Supra vs Infra popliteal2. Availability of a venous conduit3. Physician training and experience in clinical eval4. Surgical and endovascular skill sets5. Treatment biases6. There is selection bias in trials comparing surgery vs.

endovascular therapy

Basil Trial• The BASIL trial, in 1996 to compare the efficacy of balloon angioplasty-first (PTA) versus bypass

surgery-first (Bypass) treatment strategies in patients with severe limb ischemia.• The trial enrolled 452 patients over a 5-year period. Bypass was associated with significantly lower

immediate failure (3% vs 20%), • higher 30-day morbidity (57% vs 41%), and lower 12 month re-intervention (18% vs 26%) rates

than PTA.• Thirty day mortality was similar between the 2 groups (5% for Bypass and 3% for PTA). • There was no difference in the primary endpoint of amputation-free survival (AFS) by intention-

to-treat assignment between the two arms (57% for Bypass and 52% for PTA at 3 years). Post-hoc analysis, however, revealed that after 2 years, Bypass was associated with improved clinical outcomes.

Lancet, 2005. 366(9501): p. 1925-34.J Vasc Surg, 2010. 51(5 Suppl):

-In hospital Mortality: 2.78%- Highest mortality in gangrene patients

Best-CLI• The BEST-CLI Trial is a prospective, randomized, open label (two-

arm), multicenter, superiority trial comparing the effectiveness of best endovascular (EVT) to best surgical (OPEN) revascularization in 2,100 subjects with infrainguinal arterial occlusive disease and CLI.

• Treatment comparisons (EVT vs. OPEN) will be made separately in the two cohorts on an intention-to-treat (ITT) basis. Randomization to the two treatments will occur within cohort and within each of 4 strata defined by anatomic presentation and clinical classification (Rutherford category).

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N Engl J Med 2007; 356:1503-1516April 12, 2007

SurveySurgery EVT Equipoise

Flush SFA Occlusion

11% 36% 54%

Occluded Pop, +/-SFA

36% 22% 42%

Proximal TibialOcclusion

51% 11% 42%

Diffuse TibialDisease with Plantar preservation

43% 16% 42%

Open Surgical Procedures

CPT Code Description n* percent of all CPTs

35656 Bypass graft, with other than vein;femoral-popliteal 854 3.3

35566 Bypass graft, with vein;femoral-anterior tibial, posterior tibial, peroneal artery 762 3.0

35666 Bypass graft, with other than vein;femoral-anterior tibial, posterior tibial, or peroneal artery 526 2.0

35571 Bypass graft, with vein;popliteal-tibial, -peroneal artery or other distal vessels 454 1.8

35585 In-situ vein bypass;femoral-anterior tibial, posterior tibial, or peroneal artery 443 1.7

35371 Thromboendarterectomy, including patch graft, if performed;common femoral 408 1.6

35556 Bypass graft, with vein;femoral-popliteal 405 1.6

35372 Thromboendarterectomy, including patch graft, if performed;deep (profunda) femoral 232 0.9

35661 Bypass graft, with other than vein;femoral-femoral 196 0.8

35681 Bypass graft; composite, prosthetic and vein 180 0.7

Infra-popliteal Bypass

Rutherford Vascular Surgery. 2012

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Limb Salvage with Endovascular vs. Bypass Angiosome Directed Therapy

• The concept of Angiosome Directed Therapy (ADT)revolves around the fact that each vessel is responsible for supplying a particular anatomical location

• Critical limb ischemia patients tend to suffer from multiple comorbidities that limit their ability to tolerate multiple procedures

Saab et al. The AMP Group

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Tibial Vessel DistributionVessel Anatomical Area

Anterior Tibial

Artery

Supplies the anterior shin

Peroneal artery Supplies the lateral aspect of the heel. Providing the calcaneal

branches

Posterior tibial Supplies the medial aspect of the shin and the medial aspect of the

heel

Dorsalis Pedis Supplies the dorsal aspect of the foot to the digital arterioles

Medial Plantar

artery

Supplies the medial aspect of the foot sole

Lateral Plantar

artery

Supplies the lateral aspect of the foot sole


The value of ADT based revascularization

ADT Limb Salvage

Non ADTLimb Salvage

ADTWound Healing

Non ADTWound Healing

Neville et al 91% 61% 91% 62%

Iida et al 86% 69% N/A N/A

Varela et al 93% 72% 92% 73%

Alexandrescu et al

91% N/A 85% N/A

References: End of Talk

Courtesy of Dr Mustapha

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Saab et al

Saab et al

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Angiosome Distribution Case• 83 year old female presented with a non

healing ulcer• ABI R 0.85, L 1.5• Multiple Co-morbidities: HTN, DM, CKD• Ischemic Cardiomyopathy, EF 35%. Satble on

Medical therapy

Angiosome Assessment


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Treatment options

1. Is this a candidate for open surgery?2. Is this a Candidate for EVT?


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Saab et al. The AMP Group Saab et al. The AMP Group


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30 Day F/U


Complex Revascularization of Right Lower Extremity

Clinical Scenario• This is a 73 year old male

that presented with a non-healing ulcer of the R foot. Second toe

• ABI R 0.42, L 0.57• Diagnostic Angiogram was

performed

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R CFAHigh Grade

StenosisOccluded R SFA

No Flow at 9 seconds

Flow in Tibials ?

Treatment PlanThe patient undergoes R common femoral artery endaratectomyNo general anesthesia

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Clinical Course

• Rest pain improved• Wound worsening

Advancing the Sheath over the NAVI

Cross

Telescoping Technique

Targeting the R CTO

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Tibial AccessSchmidt Access

US GuidedAccess

Distal SFA Access (Schmidt Access)

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DEB In Popliteal

Vessel Preparation

Supera Deployment

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Stacking in CalcifiedSegments

Final Result

End of Procedure

But its not that simple….!!!


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Clinical Scenario• 49 year old male with PMH significant for DM. Long

standing history.• HTN, Hyperlipidemia• The patient developed an ulcer on the plantar aspect

of the left great toe• In four weeks, he presented to the office with…….

Selective Angiography

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No stenting optionsResistant to balloon angioplastySurgery vs EVT?Would this patient get enrolled?

Current Challenges• What are we going to learn from Randomized data:1. Which strategy is superior?2. Which patients would benefit?3. How are clinicians going to interpret the data?4. In my hands, I always get better outcomes ( We are

biased)?5. Its not only revascularization in CLI patients: Wound care,

Patient compliance, Follow up, Podiatry

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Current Evidence• The Peripheral Registry of Endovascular Clinical Outcomes

(PRIME Registry) is an ongoing CLI registry• Started enrolling patients in 2013.• Target to obtain data from 15 centers in the US and world

wide evaluating patients with advanced PVD and CLI• The registry covers all aspects of patient care including

patient evaluation, treatment modality and clinical follow up

PRIME Registry• Currently operated under

Michigan Clinical Outcomes Research and Reporting Program (MCORRP) at the university of Michigan

• Independent body to perform random audits and train new sites

The Impact of Amputation

30 days post revascularization-Physical exam-Schedule with PA-ABI( performed in vascular lab)-Wound assessment-Rutherford classification

Patient referred to Metro Heart and Vascular StAMP

program.

Patient scheduled with an Endovascular

Specialist per triage guidelines

Primary office visit to include:-Physical Exam-ABI (simple)-Wound assessment-Rutherford classification-Diagnostic Angiogram ordered-Multidisciplinary care team initiated as applicable

Diagnostic Angiogram performed.Referral to PAD program ordered.

Peripheral Vascular Intervention plan

outlined and scheduled within a week.

Intervention performed or

staged interventions scheduled as

necessary.

Once limb revascularization occurs, each limb,

specifically is entered into the

follow up protocol.

3 months post revascularization

-Physical exam-ABI (simple)-Wound assessment-Rutherford classification


-Physical exam-ABI (simple)-Wound assessment -Rutherford classification

Possible 9 months post revascularization-Physical exam-ABI (simple)-Wound assessment-Rutherford classification


-Physical exam-ABI(performed in vascular lab)-Wound assessment-Rutherford classification

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Conclusion• Surgery should be considered in patients that are

able to tolerate, with adequate venous conduit, acceptable risk profile

• EVT is evolving rapidly. As patients age, with significant co-morbidities, it’s the only option.

• The goal in CLI patients should be Amputation Free Survival not vessel or graft patency

Conclusion• If both approaches yield similar outcomes

would surgery still be the first option?• Establishing CLI centers that are Patient

centered not specialty centered is key to battling this deadly disease

Thank [email protected]

313-590-5902

ADT References

• Catheter Cardiovasc Interv. 2010;75:830–836• Ann Vasc Surg. 2009; 23:367-373• Vasc Endovasc Surg. 2010;44:654–660. • J Endovasc Ther. 2008;15:580–593

an initial strategy of open disclosures bypass is better

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