Disclosures. Talking Points. An initial strategy of open bypass is better for some CLI patients, and we can define who they are

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1 An initial strategy of open bypass is better for some CLI patients, and we can define who they are Fadi Saab, MD, FASE, FACC, FSCAI Metro Heart & Vascular Metro Health Hospital, Wyoming, MI Assistant Clinical Professor of Medicine Michigan 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 Performance Goals for Critical Limb Ischemia Trials Michael S. Conte, MD Critical limb ischemia (CLI), the most advanced form of peripheral arterial disease, is 1

2 CLI Patients Surgery vs endovascular revascularization varies depending on: 1. Disease pattern (Supra vs Infra popliteal 2. Availability of a venous conduit 3. Physician training and experience in clinical eval 4. Surgical and endovascular skill sets 5. Treatment biases 6. 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 intentionto-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, (9501): p J Vasc Surg, (5 Suppl): -In hospital Mortality: 2.78% - Highest mortality in gangrene patients Best-CLI The BEST-CLI Trial is a prospective, randomized, open label (twoarm), 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). 2

3 Survey Surgery EVT Equipoise Flush SFA Occlusion 11% 36% 54% Occluded Pop, +/- SFA 36% 22% 42% Proximal Tibial Occlusion 51% 11% 42% N Engl J Med 2007; 356: April 12, 2007 Diffuse Tibial Disease with Plantar preservation 43% 16% 42% Infra-popliteal Bypass Open Surgical Procedures CPT Code Description n * percent of all CPTs Bypass graft, with other than vein;femoral-popliteal Bypass graft, with vein;femoral-anterior tibial, posterior tibial, peroneal artery Bypass graft, with other than vein;femoral-anterior tibial, posterior tibial, or peroneal artery Bypass graft, with vein;popliteal-tibial, -peroneal artery or other distal vessels In-situ vein bypass;femoral-anterior tibial, posterior tibial, or peroneal artery Thromboendarterectomy, including patch graft, if performed;common femoral Bypass graft, with vein;femoral-popliteal Thromboendarterectomy, including patch graft, if performed;deep (profunda) femoral Bypass graft, with other than vein;femoral-femoral Bypass graft; composite, prosthetic and vein Rutherford Vascular Surgery

4 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 4

5 Tibial Vessel Distribution Vessel Anatomical Area Anterior Tibial Supplies the anterior shin Artery The value of ADT based revascularization ADT Limb Salvage Non ADT Limb Salvage ADT Wound Healing Non ADT Wound Healing Peroneal artery Posterior tibial Dorsalis Pedis Medial Plantar artery Supplies the lateral aspect of the heel. Providing the calcaneal branches Supplies the medial aspect of the shin and the medial aspect of the heel Supplies the dorsal aspect of the foot to the digital arterioles Supplies the medial aspect of the foot sole Neville et al 91% 61% 91% 62% Iida et al 86% 69% N/A N/A Varela et al 93% 72% 92% 73% Lateral Plantar artery Supplies the lateral aspect of the foot sole Alexandrescu et al 91% N/A 85% N/A Saab et al. The AMP Group References: End of Talk Courtesy of Dr Mustapha 5

6 Saab et al Saab et al 6

7 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 Saab et al. The AMP Group 7

8 Treatment options 1. Is this a candidate for open surgery? 2. Is this a Candidate for EVT? Saab et al. The AMP Group 8

9 Saab et al. The AMP Group Saab et al. The AMP Group Saab et al. The AMP Group 9

10 30 Day F/U Complex Revascularization of Right Lower Extremity Saab et al. The AMP Group Clinical Scenario This is a 73 year old male that presented with a nonhealing ulcer of the R foot. Second toe ABI R 0.42, L 0.57 Diagnostic Angiogram was performed 10

11 R CFA High Grade Stenosis Occluded R SFA No Flow at 9 seconds Treatment Plan Flow in Tibials? The patient undergoes R common femoral artery endaratectomy No general anesthesia 11

12 Clinical Course Rest pain improved Wound worsening Advancing the Sheath over the NAVI Cross Targeting the R CTO Telescoping Technique 12

13 Tibial Access Schmidt Access US Guided Access Distal SFA Access (Schmidt Access) 13

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15 DEB In Popliteal Vessel Preparation Supera Deployment 15

16 Stacking in Calcified Segments Final Result But its not that simple.!!! End of Procedure Saab et al. The AMP Group 16

17 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 17

18 No stenting options Resistant to balloon angioplasty Surgery 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 18

19 Current Evidence PRIME Registry The Peripheral Registry of Endovascular Clinical Outcomes (PRIME Registry) is an ongoing CLI registry Started enrolling patients in 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 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 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. 30 days post revascularization -Physical exam -Schedule with PA -ABI( performed in vascular lab) -Wound assessment -Rutherford classification 3 months post revascularization -Physical exam -ABI (simple) -Wound assessment -Rutherford classification 6 months post revascularization -Physical exam -ABI (simple) -Wound assessment -Rutherford classification Possible 9 months post revascularization -Physical exam -ABI (simple) -Wound assessment -Rutherford classification 12 months post revascularization -Physical exam -ABI(performed in vascular lab) -Wound assessment -Rutherford classification 19

20 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 ADT References Thank You Fadi.saab@metrogr.org Catheter Cardiovasc Interv. 2010;75: Ann Vasc Surg. 2009; 23: Vasc Endovasc Surg. 2010;44: J Endovasc Ther. 2008;15: