Peripheral Arterial Disease and Limb Salvage: An Odyssey to Value-Based Care. Jon Matsumura and Travis Engelbert Division of GIM December 11, 2013

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1 Peripheral Arterial Disease and Limb Salvage: An Odyssey to Value-Based Care Jon Matsumura and Travis Engelbert Division of GIM December 11, 2013

2 Agenda What is vascular surgery? Describe interaction of market focus, procedures, and evidence in journey to value-based care: Examples of vascular collaborative, service, communication, access, quality, clinical trials Peripheral Artery Disease (PAD) Definitions: Asymptomatic, claudication, limb salvage/critical limb ischemia (CLI) Treatment options Evidence Future work Extended effort of limb salvage

3 What is Vascular Surgery? Diagnosis and management of diseases of the peripheral arteries, veins, lymphatics, nerves, and muscles. Noninvasive vascular lab Medical treatment Endovascular therapies Classic open operations Cosurgeon and Rescue The Fugitive

4 Vascular is a Big Team Nine Faculty Surgeons 32 Division Associates Midlevels, vascular technologists, residents Countless Partners at UWHC, Middleton VAMC, UWMF, UWSMPH, Affiliates and Outreach sites 8 locations in Dane County 65 clinic days outside of Dane County

5 Orszag & Ellis, Congressional Budget Office Our country s financial health will in fact be determined primarily by the growth rate of per capita health care costs. Total health care costs are about 16% of GDP and are projected to reach nearly 20% by Bulk of growth is from the development and diffusion of new medical technologies and therapies. NEJM 2007

Orszag & Ellis, Congressional Budget Office Costs affected by: fee-for-service reimbursements declining proportion of costs paid by recipient Substantial geographic

6 Orszag & Ellis, Congressional Budget Office Costs affected by: fee-for-service reimbursements declining proportion of costs paid by recipient Substantial geographic differences in health care spending without higher life expectancies or improvement of other health care measures. By hospital referral region Interstate International NEJM ;18

8 My Patients are Sicker Health status does matter---it accounts for $593 of the $3,280 difference between the lowest and highest-intensity regions, or just about 18% We should be able to reorganize and improve care to eliminate wasteful and unnecessary services. Sutherland JM, Fisher ES, Skinner JS. Getting past denial the high cost of health care in the United States. NEJM 361Sept 2009.

9 Non-profits Profit motives by commercial and non-profits NEJM 2008 In the face of increasingly constrained resources, there is a realistic way of achieving better health results: conduct careful analysis to identify evidence-based opportunities for more efficient delivery of health care whether prevention or treatment and then restructure the system to create incentives that encourage the appropriate delivery of efficient interventions. Cohen JT, Neumann PJ, Weinstein MC. Does Preventive care save money? Health economics and the presidential candidates. NEJM Feb, 2008.

10 Contextual Change Placing 160,00 employees into a private exchange offering 25 separate health plans One of the 9000 Walgreens stores is within 2 miles of 90% of Americans 40,000,000 Americans will be in a private exchange next year Cost structure must cope with unpredicatble revenue

11 Endovascular AAA Repair (EVR) Minimally invasive alternative to open operation Timeline 1993 First US IDE implant 1999 US FDA approval of first generation devices 2013 Eight approved systems in US Each original device has been modified and/or recalled

12 Typical Industry-Sponsored Trial

13 Early Benefits of EVR Variable Open EVR P Procedure time (min) <.001 Blood Loss (ml) <.001 Transfusion 88 (89%) 32 (14% ) <.001 ICU (%) 86 (87%) 56 (24%) <.001 ICU Stay (h) 67 ± ± 0.8 <.001 Hospital Length of Stay (d) <.001 Return to Normal Activity (d) Incomplete recovery at 6 m 20% 5%

14 Early (<30d) Major AE Type Control EVR P Any 57% 14% <.0001 Bleeding 32% 4% <.0001 Pulmonary 12% 1% <.0001 Cardiac 14% 3% <.0001 Renal 3% 1%.16 Wound 4% 3%.75 Bowel 16% 2% <.0001 Vascular 6% 1%.02 Neurologic 2% 0.4%.21 Genitourinary 1% 0.4%.51 Neoplasm 0% 0.4%.99

15 New Medical Technology The role of new medical technology deserves special attention it is fiscally irresponsible to continue to accept innovations regardless of cost, even if they pass tests of safety and efficacy and it is particularly irresponsible when the interventions are provided at public expense. Fuchs V, Stanford U, NEJM March 18, 2010

16 The Open Vs. Endovascular Repair Trial for AAA, VA Cooperative Study #498 (OVER) RCT at 42 VAMC, 881 elective AAA 30 day Mortality (P=.006) EVR 0.2% Open 2.3% 2 Year Mortality (P=.13) EVR 7.0% Open 9.8% JAMA 2009, NEJM 2012 Hospital admission costs $38,365 for EVR, $45,594 for Open (P=.11) Total 2 year healthcare costs $74,265 for EVR, $80,845 for Open (P=.11) QALY for EVR, for Open (P=.78) 2012 J Vasc Surgery

17 Vascular Collaborative Multidisciplinary D4/5, OR, case managers, midlevels, surgeons, purchasing, decision support Review global efficiencies, patient satisfaction, O/E mortality outcomes Targets of opportunity Heterogeneity CEA OR time, Major amputations, device usage

18 CEA Heterogeneity Carotid Endartectomy Cases May, April, Avg Time in Room Avg Cut to Close Volume 7

19 CEA Heterogeneity FY2011 Q1 and 2 cases Avg Cost $11,232 $11,544 $12,188 $12,834 $9,659 $11,315 $10,414 $11,180

Healthlink Same day reads, call for positive reports Image Share: Image based consults SLC: Same day swollen leg

20 Service and Communication Vascular surgeon availability cell phones and add-on appointments Add-on testing same day Later hours at West open until 6PM, need patient to arrive by 5:20 Digital Reporting: Vascular reports delivered in Healthlink Same day reads, call for positive reports Image Share: Image based consults SLC: Same day swollen leg consults Acute symptoms Unilateral swelling One stop clinical risk assessment, test ordering, f/u on testing, and initiate therapy

21 Urgent Surgical Consult

22 Quality

23 VTE Prophylaxis Quality Improvement Surgical Care Improvement Project (SCIP), the Center for Medicare and Medicaid Services (CMS) considers appropriate VTE prophylaxis to be a pay-for-performance quality measure for specific procedures Agency for Health Care Research and Quality (AHRQ): Prevention of VTE is the number one strategy to improve patient safety in hospitals AHRQ Patient safety indicator PSI- 12 post operative VTE. Standardized indicator using coded data One VTE event costs $18,800 and 3.5 days extra length of stay

24 VTE at UWHC in 2009 PSI-12 events third quarter Observed VTE/ 1000 discharges 11.2 Expected VTE/ 1000 discharges O/E ratio: 1.32 University Health System Consortium (UHC) Rank 73rd of 117 hospitals

25 VTE Improvement Project Goals Multidisciplinary group led by Dr. John R. Hoch: 1. Enhance VTE prophylaxis knowledge 2. Develop a system for monitoring VTE risk and prophylaxis treatment regimen 3. Achieve 90% compliance with patients receiving appropriate VTE prophylaxis 4. Reduce preventable hospital acquired VTE events 5. Reduce health care cost by reducing hospital acquired VTE events

26 Cost Savings with Implementation of Anticoagulation Improvement Project Number of VTE Ave added cost of VTE $18,695 $11870 $16385 $17631 Actual Costs $1,869,500 $902,120 $1,097,842 $791,999 Cost savings Baseline $967,380 $771,658 $1,077,501 Operating Expenses N/A $157,112 $164,967 $181,876 Return on Investment N/A 6.1:1 4.7:1 5.9:1

27 Capture 2 Risk Adjusted National Standards 5297 consecutive subjects by 459 physicians at 186 sites before Jan, day stroke, independent neuro exam 2.7% [95% CI: ] Parsimonious model uses symptom status and age: Pi=1/(1+e ( (symptomatic) (age 80)+0.62 (age 80 x symptomatic ) )

28 Examples of how a model-expected stroke rate is derived and compared with observed stroke rate (actual data from two study sites) Pi=1/(1+e ( (symptomatic) (age 80)+0.62 (age 80 x symptomatic ) ) Expected Stroke Rate For Each Population Asy < % Asy % Sy < % Sy % Site A Population Mix Site A Fractional Stroke Site A Observed Stroke Rate 4.6% Asy < % = Rate Asy % Asy <80 1.2% Vs. Sy < % Asy % Sy % Sy <80 1.1% Sum Site A Expected Sy % Stroke Rate 2.9% Site B Population Mix Asy < % Asy % Sy < % Sy % = Site B Fractional Stroke Rate Asy <80 0.8% Asy % Sy <80 1.5% Sy % Sum Site B Expected Stroke Rate 3.4% Vs. Site B Observed Stroke Rate 1.9%

29 Interpretation of Results Observed to Expected (O/E) Ratio Represents the hospital s outcomes compared to the other ACS NSQIP hospitals, adjusted for inter-hospital differences in patients characteristics, comorbidities, and preoperative laboratory values 2 LOW Overall OUTLIER: (Multispecialty) If the upper bound 30-Day of the Morbidity O/E O/E Ratios confidence 1/1/2007 interval - 12/31/2007 is <1.0, the hospital s outcomes are statistically better than expected. Thus, the hospital s outcomes are Exemplary. O/E Ratio 99% Confidence interval Low Outlier High Outlier AS EXPECTED HIGH OUTLIER: If the lower bound of the O/E ratio is >1.0, the hospital s outcomes are statistically worse than expected. Thus, the hospital s outcomes Need ACS NSQIP Hospital ID Number Report Identification Improvement. Number

30 Vascular Surgery Quality NSQIP 30-Day Mortality Observed Rate: 1.66% Expected Rate: 6.45% O/E Ratio: 0.26 Status: Exemplary

31 Travis Engelbert, M.D.

32 Objectives Outcomes and PAD Definitions and Natural History Screening for PAD Medical Therapy Revascularization Options Ongoing/Upcoming Trials Amputation for PAD

33 Readmissions as an Outcomes Measure

34 Readmissions in Vascular Surgery. Engelbert TL, [ ], Matsumura J. JVS, 2013 Largest single institution review of readmissions within vascular surgery population All procedures by the vascular surgery service for 3.5 years N=2,505 Exclusion: planned readmission, death during primary hospitalization, and discharge against medical advice Primary outcome of interest was unplanned 30-day readmission to the same institution

35 Sources of Readmission Category Procedure Procedure Volume % Readmitted Abdominal % EVAR % oaaa % Occlusive % Head/Neck % Carotid endarterectomy % Carotid stent % Lower Extremity % Lower extremity endo % Lower extremity open % Thoracic % TEVAR % TAA/TAAA % Upper extremity % Upper extremity reconstruction % Upper extremity 1st rib % Amputations % BK amputation % AK amputation % Foot amputation % Amputation other %

36 Sources of Readmission Lower extremity revascularization and amputations combine for 63% of readmissions.

37 Readmissions in Vascular Surgery N % Readmitted to Vascular Service % Readmission LOS (Days) 244 5(6) Readmitting Diagnosis Wound infection or complication % Vascular complication (ulcer, atherosclerosis, etc.) % Gastrointestinal % Device or graft % Cardiac complication % Respiratory complication % Renal complication % Hematoma % Other % 37% of readmissions were for wound infection/complication Improved outpatient wound monitoring, earlier follow-up

38 Definitions and Natural History

39 Claudication Discomfort in the legs that occurs during walking and is relieved by rest Claudicare (Latin) meaning to limp Arterial perfusion inadequate to meet working muscle demand Reproducible: duration and location Etiology Ischemic neuropathy Local intramuscular acidosis

40 Critical Limb Ischemia (CLI) Reduction in distal tissue perfusion below resting metabolic requirements Manifestation Rest pain Ischemic ulceration/gangrene Objective confirmation Ankle pressure <50 mmhg Toe pressure <30 mmhg ABI <.40

41 PAD Prevalence National Health and Nutrition Examination Survey (NHANES). Circulation, % prevalence of PAD (ABI <0.9) 0.9% <50 yo, 14.5% >70 yo

42 Global Estimates of Prevalence and Risk Factors for PAD Comparison of global estimates of prevalence and risk factors for peripheral artery disease in 2000 and 2010: a systematic review and analysis. F Gerald R Fowkes et al. Lancet 2013; 382:

43 Natural History: Asymptomatic PAD Edinburgh Artery Study Cross-sectional survey N=1592 9% with asymptomatic PAD (ABI <0.9) No significant decrease in ABI over 5 years Asymptomatic PAD: 1.6 RR [CI: ] ischemic heart disease than the normal population Conclusion: Small risk of progression to limb-threatening ischemia Increased risk of cardiovascular disease in patients with PAD

44 U.S. Preventative Services Task Force and ABI Low ABI, asymptomatic patients with no diagnosis of CVD or diabetes ASA does not improve health outcomes and may increase bleeding Other interventions (lipid-lowering therapy) No reduction in CVD morbidity No delay in onset of lower-extremity symptoms Downstream harms Anxiety, labeling, opportunity costs Exposure to gadolinium or contrast (MRA, CTA)

45 USPSTF and ABI No evidence that screening and treatment of PAD in asymptomatic patients leads to clinically important benefits Known CVD or diabetes already at risk and interventions (antiplatelet, lipid-lowering therapy) recommended 2009: Class D recommendation changed to I statement (insufficient evidence)

46 Natural History: Claudication Predictors of progression from claudication to CLI 1 Insulin dependent diabetes Low initial ABI High pack-years smoking Claudication in Non-diabetics: 6-year f/u 2 Smoking cessation: 8% progression to CLI Continued smoking: 79% progression to CLI 5-year rate of amputation <5% 3 1. Aquino R, Johnides C, Makaroun M, et al: Natural history of claudication: long-term serial follow-up study of 1244 claudicants. J Vasc Surg 2001; 34: Jonason J, Ringqvist I: Factors of prognostic importance for subsequent rest pain in patients with intermittent claudication. Acta Med Scand 1985; 218: Leng GC, Lee AJ, Fowkes FGR, et al: Incidence, natural history, and cardiovascular events in symptomatic and asymptomatic peripheral arterial disease in the general population. Int J Epidemiol 1996; 25:

47 Natural History: CLI Amputation rate: 1 year Inverse relationship to ABI ABI >0.5 = 15% ABI <0.5 = 34% Patient outcomes at 6 months Marston WA, Davies SW, Armstrong B, et al: Natural history of limbs with arterial insufficiency and chronic ulceration treated without revascularization. J Vasc Surg 2006; 44: Norgren L, Hiatt WR, Dormandy JA, et al. TASC II Working Group. Inter- Society Consensus for the Management of Peripheral Arterial Disease (TASC II). J Vasc Surg. 2007;45:S9A

48 Medical Management of PAD: Preventing Cardiovascular Events

49 Heart Outcomes Prevention Evaluation (HOPE) Study. 2000, Ramipril vs Placebo RCT High risk for CVE patients NEJM CAD, previous stroke, clinical PVD Diabetes + (smoking, HTN, HCL, or low HDL) Endpoint: stroke, MI, cardiovascular death Clinical PVD highest baseline CVE rate Ostergren J et al. Eur Heart J 2004; 25:

50 HOPE Study. 2000, NEJM Absolute risk reduction Greatest in the patients with clinical PVD Highest overall event rates Relative Risk reduction similar in all high risk patients despite ABI PAD: 22% risk reduction stroke, MI, cardiovascular-related mortality Ostergren J et al. Eur Heart J 2004; 25:

51 Heart Protection Study. Lancet, 2002 Simvastatin reduction in cardiovascular events Hx of PAD, CAD, cerebrovascular disease, DM, or treated HTN PAD cohort (claudication, revasc procedure, amputation) Absolute reduction greater in PAD patients 22% reduction in major vascular events HPS Collaborative Group. J Vasc Surg. 2007; 45:

52 Antithrombotic Trialists Collaboration. BMJ, 2002 Meta-analysis of RCTs Antiplatelet vs placebo Patients with cardiovascular disease (MI, stroke, PAD, other vascular disease) Reduced fatal and nonfatal cardiovascular events by one quarter No adverse effects on other deaths Subgroup analysis: PAD 23% reduction in CVE Similar benefit for claudicants, bypass and angioplasty patients

53 CAPRIE. Lancet, 1996 Recent ischemic stroke or MI, symptomatic PAD 75 mg clopidogrel vs 325 mg ASA (control) Endpoint: stroke, MI, or death Clopidogrel 8.7% relative risk reduction PAD subgroup 24% relative risk reduction Safety profile similar Conclusion: Clopidogrel is more effective in reducing the combined outcome for PAD patients

54 CHARISMA. NEJM, 2006 Clopidogrel + low-dose ASA vs low-dose ASA + placebo Established CVD or multiple atherothrombotic risk factors No difference in primary endpoint (MI, stroke, or CV death)

55 CHARISMA. NEJM, 2006 Trend toward more severe bleeding (fatal or ICH) P=.09, and significant increase in moderate bleeding P<.001. PAD post hoc analysis No difference in Primary endpoint Higher rate of minor bleeding P<.001

56 Revascularization for PAD

57 National Trends In Lower Extremity Revascularization Goodney, et al. JVS, 2009 Total number of lower extremity intervention nearly doubled More than three-fold increase in in endovascular interventions Bypass surgery decreased by 42% 29% decrease in amputation rates

58 National Trends In Lower Extremity Revascularization Goodney, et al. JVS, 2009 This change has occurred in the setting of limited and often conflicting evidence.

59 RCT: Angioplasty (PTA) vs Exercise for Claudication Perkins et al. EJVES, patients with claudication 37 with long term (6 year) f/u PTA versus Exercise ABI better in PTA up to 15 months Claudication better in exercise group Best in those with isolated SFA disease No late differences in ABI Only 2 (4%) late amputations Conclusion: Exercise is superior to PTA

60 RCT: Primary vs Selective Balloon Expandable (BE) Stent Becquemin et al JVS patients with claudication and CLI, short s/o </= 7 cm 115 BE Stent versus 112 selective stent (15% had stent) 1, 2, 4 Year Survival 96/93/80% primary stent vs 92/89/82% selective stent (P=.40) 1, 2, 4 Year Survival free of new vascular event in treated limb 65/53/44% primary stent vs 77/70/57% selective stent (P=.017) Conclusion: Primary stenting is not justified and stent should be reserved for suboptimal PTA.

61 RCT: Primary vs Selective Self-Expandable (SE) Stent Schillinger et al NEJM patients with claudication (87%) and CLI (13%) 51 Primary SE stent vs 53 PTA and selective stent in 32% 6 month angiographic restenosis 24% primary stent vs 43% PTA (P=.05) 12 month duplex restenosis 37% primary stent vs 63% PTA (P=.01) Treadmill walking further in primary stent group at 6 and 12 months Conclusion: Primary SE stenting is superior at 1 year

62 A report of 1000 percutaneous interventions. Annals of Surgery, 2007 DeRubertis BG, [ ], Kent KC. Single institution, infrainguinal PAD Debilitating claudication 46.3%, CLI 52.7% (72% tissue loss) 2-year primary/secondary patency and limb salvage Claudication: 62.4%, 79.3%, 99.5% CLI: 37.4%, 55.4%, 79.3%

63 A report of 1000 percutaneous interventions. Ann Surg, 2007 Conclusion: Low risk of morbidity (10.4%) and mortality (0.5%) Should be considered first line in patients with chronic lower extremity ischemia

64 BASIL: Infrainguinal CLI. Lancet, JVS, patients CLI Bypass first vs Angioplasty first Amputation-free survival No difference at 2 years Adjusted hazard ratio % CI [ ] No significant difference in health-related QOL First year hospital costs one-third higher with bypass first ($8469) Initial conclusion: Endovascular first strategy for CLI

65 BASIL: Infrainguinal CLI. Lancet, JVS, 2010 Late f/u: Improved overall and amputation free survival in bypass first group Conclusion Bypass better if pt survival >2 years, lower mortality Prosthetic fared much more poorly that tx with vein bypass

66 Ongoing/Upcoming Trials

67 CLEVER (Claudication: Exercise Vs. Endoluminal Revascularization) Unblinded, 3-arm, RCT. Ongoing 119 patients, 22 sites Treatment effectiveness and safety for aortoiliac PAD with claudication Optimal medical care (smoking cessation, walking and diet advise, cilostazol) Stent placement (+ optimal medical care) Supervised exercise (+ optimal medical care)

68 CLEVER Peak walking time at 6 months Stent group Mean stenosis: 83% +/- 19% ABI improvement / Minutes

69 CLEVER Conclusion Better walking performance with supervised exercise vs stent revascularization (p<0.05) Both stenting and supervised improve walking distance vs optimal medical care (p<0.05) Aortoiliac stent = better QOL scores (p<0.001)

70 BEST Trial: Best Endovascular vs Best Surgical Why? Therapy in Patients with CLI CLI 1-year amputation 40% w/o revasc CLI 1-year mortality >20% w/o revasc Most suitable therapy unknown New endovascular technology with improved patency rates Randomized, two-arm, multicenter, superiority trial 2 cohorts EVT vs OPEN with autogenous vein EVT vs OPEN with prosthetic conduit

71 BEST-CLI Trial N=2,100 Duration=5 years Primary endpoint: Major adverse limb event-free survival rates Secondary endpoints: Freedom from MI, stroke, secondary interventions, QoL, Cost effectiveness

72 BEST-CLI Trial Inclusion: Infrainguinal PAD with rest pain or nonhealing ischemic ulcer Candidate for open or endovascular therapy Adequate inflow and distal revascularization target Exclusion Life expectancy < 2 years

73 Alternative Therapies for Lower Extremity Limb Salvage?

74 Gene Based Therapy for CLI Angiogenic Growth and Transcription Factors Delivery: recombinant protein, non-viral or viral system encoding angiogenic protein VEGF, HGF, FGF, HIF-1alpha (transcription factor), SDF-1 (chemokine) Negative Phase II and III trials (VEGF, FGF) HGF + Phase II tcpo2 at 6 months Phase III inititated, 2012 From Bench to Bedside: Review of Gene and Cell-Based Therapies and the Slow Advancement into Phase 3 Clinical tiral, with a Focus on Aastrom s Ixmyelocel-T. Bartel RL, et al. Stem Cell Rev June; 9(3):

75 Cell-Based Therapy for CLI Cellular Therapies Adult bone marrow and peripheral blood cell separation techniques Endothelial progenitor cells (mononuclear cells), mesenchymal stromal cells Hone to sites of ischemia and incorporate into capillaries Actively recruiting studies, but no published results in peer-reviewed journals From Bench to Bedside: Review of Gene and Cell-Based Therapies and the Slow Advancement into Phase 3 Clinical tiral, with a Focus on Aastrom s Ixmyelocel-T. Bartel RL, et al. Stem Cell Rev June; 9(3):

76 Amputation for PAD

77 Amputation Jones WS et al., J Am Coll Cardiol 2012; 60: CMS , PAD patients 7,258/100,000 to 5,790/100,000 (p<0.001) Predictors: male, black race, DM, renal disease Why? Improved medical therapy and wound management Improved screening and detection of PAD Increased revascularization procedures

78 Amputation Up to 85% caused by CLI BKA primary healing rate 60-85% 30-day Mortality 7-15%

Jones WS et al., Am Heart J 2013; 165: 809-815.e1.

79 Jones WS et al., Am Heart J 2013; 165: e1. Double mortality rate vs CLI no amputation 30-day 13.5% vs 6.9%, P < year 48.3% vs 24.2%, P < year 70.9% vs 43.2% Amputation

80 Poor Surgical Risk Poor Surgical Risk Patients with limited life expectancy Poor distal target vessels Lack of adequate vein for conduit Significant co-morbid conditions Non-ambulatory patients Massive tissue loss

81 ELS Introduction Extended efforts at Limb Salvage (ELS) combines revascularization (usually distal bypass) and free flap Groups of patients are not amenable to conventional bypass procedures: I No outflow vessel II Exposed target vessel III Significant hind/midfoot tissue loss Only alternative is major amputation

82 Free flaps and extended effort at limb salvage Patients with hindfoot gangrene, extensive tissue loss, or lack of suitable outflow vessels have traditionally had below knee amputation Ideal for calcaneus osteomyelitis, midfoot exposure, and immunosuppressed patient Long cases

83 Angio OR/One Stop Care

84 Angiography: Complete Subtraction, magnification, vasodilators Attention to donor sites

85 Defining Extent of Tissue Loss Operative exploration and debridement Stabilize wound, control infection

86 UW Case 1 57 year old smoker, noncompliant Nonhealing left anterior leg wound with infected tendon Left SFA revascularization Debridement, IV abx

87 UW Case

88 Case 1

89 Case 1

90 ELS: Selected Series G r o u p 1 st Author Year I II/III Patency F/U May % 19m Briggs % 7m Mimoun % 14m Cronenwett 86, % 24m Shenaq % 4m Shestak % 18m Greenwald % 20m

91 ELS: Selected Series G r o u p 1 st Author Year I II/III Patency F/U Chowdary 91, % 22m Ciresi % 10m Marzelle % 12m Serletti 91, % 22m Lepantalo % 12m Matsumura % 6m All %

92 Extended Efforts for Limb Salvage: Conclusion Limb Salvage can be expanded by the use of free tissue transfer 85% short term success in selected patients Patients face near 100% amputation rate without Extended Efforts for Limb Salvage Vascular Surgeon + Plastic Surgeon= MORE LIMBS SAVED

93 Conclusions: Integrated Approach Medical therapy for all PAD patients Amputation for nonambulatory patients and massive tissue loss For patients with CLI and disabling claudication: Endovascular first strategy has become predominant for CLI and disabling claudication Shorter lesions, no vein, limited life expectancy?? use of expensive technology: stent, stent-graft, cryo, cutting, DES, atherectomy, laser, remote endarterectomy, reentry, growth factors Bypass first with long occlusions, good vein, adequate target, long expected patient longevity. More research needed

94 Durability II

Durability II uses VIVA PG to test the strategy of a single long stent (up to 200 mm) for long femoropopliteal disease Editorial Comment: FDA Perspective on Clinical Trial Design for Femoropopliteal

95 Durability II uses VIVA PG to test the strategy of a single long stent (up to 200 mm) for long femoropopliteal disease Editorial Comment: FDA Perspective on Clinical Trial Design for Femoropopliteal Stent Correction of Peripheral Vascular Insufficiency Cardiovascular Devices Jennifer Goode, BS Wolf Sapirstein, MD Bram Zuckerman, MD Food and Drug Administration, Center for Devices and Radiological Health, Office of Device Evaluation, Rockville, Maryland

96 DURABILITY II Study Design Prospective, multi-center, non-randomized 287 subjects enrolled (the largest nitinol SFA stent PMA trial) Primary Safety Major Adverse Event (MAE) rate at 30 days, defined as clinically-driven target lesion revascularization, amputation of treated limb, or all-cause mortality. Primary Effectiveness Primary stent patency rate at 1 year, defined as a binary duplex ultrasound ratio PSVR < 2.0 at the stented target lesion with no clinically-driven reintervention within the stented segment. Clinical follow-up at 30 days, 6 months, 1, 2 and 3 years post procedure Independent CEC, DSMB and Core laboratory analysis

97 Key Inclusion and Exclusion Criteria Inclusion Criteria 1. Rutherford Clinical Category Score of 2, 3 or % stenosis or restenosis 3. Target lesion(s) total length is 4 cm and 18 cm 4. Target vessel diameter is 4.5 mm and < 7.5 mm Exclusion Criteria 1. Previous implantation of stent/stent graft in the target vessel 2. Presence of significant ipsilateral common femoral stenosis 3. Aneurysmal target vessel

Baseline Clinical Characteristics Subject Characteristics N= (287) Rutherford Clinical Category Mean age (yrs.) 67.7 ± 10.7 Male 66.2% Diabetes 42.5% Hyperlipidemia 86.

98 Baseline Clinical Characteristics Subject Characteristics N= (287) Rutherford Clinical Category Mean age (yrs.) 67.7 ± 10.7 Male 66.2% Diabetes 42.5% Hyperlipidemia 86.1% Hypertension 88.2% Renal insufficiency 9.8% Angina 16.7% Myocardial infarction 20.9% Smoker 39.0% Rutherford 4 4.5% Rutherford % Rutherford % *Rutherford 5 0.3% * Protocol Deviation

99 Safety: Major Adverse Event Rate at 30 Days MAE within 30 Days N = 284* Subjects with MAE 0.0% (0/284) [0] Death 0.0% (0/284) [0] Amputation of treated limb 0.0% (0/284) [0] Clinically driven target lesion revascularization 0.0% (0/284) [0] *Denominator includes subjects who have completed the 30-day follow-up visit (N=280) and those who did not complete the 30-day visit but came back for later follow up visits (N=4)

100 Safety: Major Adverse Event Rate at 1, 2 and 3 Years MAE 1-Year (N=273) 2-Year (N=261) 3-Year (N=257) Subjects with MAE 17.2% (47/273) 33.0% (86/261) 40.9% (105/257) Death 2.9% (8/273) 7.7% (20/261) 10.1% (26/257) Amputation of treated limb 0.0% (0/273) 0.4% (1/261) 0.8% (2/257) Clinically driven target lesion revascularization 14.3% (39/273) 25.7% (67/261) 31.1% (80/257)

101 Freedom From Target Lesion Revascularization at 3 Years Freedom from TLR 1-Year (N= 287) 2-Year (N= 287) 3-Year (N= 287) All Subjects (n=287) 86% 75% 70% Lesion 80 mm (n=133) Mean lesion length 48.7 mm Lesion > 80 mm (n=154) Mean lesion length mm 92% 89% 80% 81% 64% 61%

102 Sustained Improvement in Ankle Brachial Index (ABI) at 3 Years 100 % with Change in ABI from Baseline to Follow-up Visits Year 2 Year 3 Year 0 Decrease No Change Improvement

103 Summary Long-term follow-up data support continued safety and effectiveness of the EverFlex stent in long complex femoropopliteal lesions. No MAEs at 30 days and acceptable MAE rate through 3 years Primary patency at 3 years: 60% Lesions 80 mm: 71% Lesions > 80 mm: 51% Freedom from TLR at 3 years: 70% Lesions 80 mm: 80% Lesions >80 mm: 61% Excellent stent durability Stent fracture rate at 3 years: 0.9%

104 Vascular Vision Vascular Care will be outpatient, local anesthesia, percutaneous, no anticoagulants Image guided intervention is sweeping all surgical specialties Expansive clinical research National trial leadership Ten new trials have enrolled at UWHC DOR, DOM, DON, DONS are coinvestigators Four RO1 investigators Greater integration Unified EMR and PACS, Remote consultation, Swollen leg clinic Midlevel takeover Weekends and night coverage, vertical Quality improvement and Accountability NSQIP, Compare, Avatar, Readmissions

John E. Campbell, MD Assistant Professor of Surgery and Medicine Department of Vascular Surgery West Virginia University, Charleston Division

John E. Campbell, MD Assistant Professor of Surgery and Medicine Department of Vascular Surgery West Virginia University, Charleston Division John Campbell, MD For the 12 months preceding this CME activity,