Disclosures. Objectives. Bypass vs. Endo for SFA Disease: Reaching Consensus on a Rational Approach. Christopher D. Owens, MD 4/23/2009

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1 Disclosures Bypass vs. Endo for SFA Disease: Reaching Consensus on a Rational Approach No disclosures No conflicts of interest Christopher D. Owens, MD Objectives Changing face of our patients presenting for lower extremity revascularization Demographics of the population with PAD Relative strengths and weakness of vein, prosthetic, and endovascular procedures within the SFA Highlight recommendations from the 2007 TASC II document Practice Perspectives of the post-basil trial era DM1 CRI 2 Prior 3 CABG ESRD 4 S2 2000s 1980s S1 Ann Surg March

2 Comparative comorbidities between lower extremity revascularization and cardiac revasularization Survival times in patients presenting with intermittent claudication and critical limb ischemia. Vascular medicine 2008 Feb;13(1):63-74 J Vasc Surg 2007 TASC II document The problem: Medicine is more broadly competent than ever before rendering vascular surgeons with a more comorbid patient population with increasing lifespan Goals of revascularization: the solution Durable procedure to restore function in the lower extremity with minimal morbidity allowing for patient independence and quality of life 2

3 VascuQol Data from PREVENT III. Patients who experienced graft occlusion had lower scores across all domains and loss of benefit of revascularization No GRE 1 GRE 2 P<.0001 JVS 2006; 44: Flaws In Current Literature: hindrance to consensus Nonrandomized studies, or no controls Small numbers, single center, single operator Poorly defined patient demographics and interventions Intermittent claudication and CLI combined Suprainguinal and infrainguinal disease combined Short or incomplete follow up Retrospective analysis 16 professional societies Met in 2004 Published in recommendations Three grades A-RCT B-well conducted clinical studies C-expert opinions 227 references What is the best femoro-popliteal bypass conduit, vein or prosthetic? 3

4 Claudication Patency rates for saphenous vein and PTFE above the knee and Recommendation 40 below the knee bypass grafts Femoral below knee popliteal and distal bypass An adequate long (greater) saphenous vein is the optimal conduit in femoral CLI below-knee popliteal and distal bypass [C]. In its absence, another good quality vein should be used [C]. Med Dec Making 1994, 14:71-81 What about the absence of ipsilateral GSV? Meta-analysis of secondary patency for alternative autogenous vein (black), PTFE (gray), and umbilcal vein (yellow) and cryopresserved vein blue J Vasc Surg 2005; 42:

5 Meta-analysis of major amputation for alternative autogenous vein (black), PTFE (gray), and umbilcal vein (yellow) J Vasc Surg 2005; 42: J Vasc Surg 2002;35:48-55 Not all vein is created equal! Recommendation 38 Inflow artery for femorodistal bypass Any artery, regardless of level (i.e. not only the common femoral artery), may serve as an inflow artery for a distal bypass provided flow to that artery and the origin of the graft is not compromised [C]. JVS 2007;45:740-3 & JVS 2007;45(suppl):S5-67 5

6 Hazard Ratio (loss of primary patency at 1 year) by Bypass graft diameter ( ) 1.56 ( ) 1.0 (ref) Hazard Ratio (loss of primary patency at 1 year) for patients in the PREVENT III cohort for different type of vein constructions (ref) 1.47 ( ) 1.59 ( ) 0 <3mm 3 to 3.5mm > 3.5mm GSV-SS composite SSV or ARM graft diameter conduit type Hazard Ratio (loss of primary patency at 1 year) for different bypass graft length (ref) 1.26 ( ) 1.50* ( ) <40cm 40 to 50cm 50 to 60cm graft length 1.33* ( ) >60cm Recommendation 35 Choosing between techniques with equivalent short and long term clinical outcomes In a situation where endovascular revascularization and open repair/bypass of a specific lesion causing symptoms of peripheral arterial disease give equivalent short-term and long-term symptomatic improvement, endovascular techiques should be used first [B]. 6

7 There is no therapy whatsoever which diminishes the incidence or prevalence of restenosis following peripheral endoluminal interventions. Therefore, identification of the right patients for the right procedure is key. Independent Effect of Diabetes on Patency of Lower Extremity Percutaneous Intervention. First Author (ref.) N Time frame of enrollment Strength of association (if reported) Bakkan (62) NS NS Constanza (57) NS NS Kudo (31) NS on UV; no MV NS Conrad (34) MV not reported NS Black (33) NS MV NS Surowiec (30) Not reported NS P-value Clark (32) ( ).0009 DeRubertis (59) ( ).205 DeRubertis (58) ( ).029 Ryer (60) UV; no MV.001 on UV Scott (61) ( ).20 Schillinger (75) 89 Not reported 2.4 (.8-7.4).1 Significant Technical/Anatomic Factors Influencing Outcome After Percutaneous Intervention. Recommendation 37 Risk Factor (referent) Test of Association Adjusted point estimate φ Multilevel (single level) OR Tibial intervention (femoral) CLI (claudication) OR OR, HR, OR, HR 1.75, 2.54, 1.680, 2.27 Reference TASC C (TASC A) HR, HR 2.95, , 34 TASC D (TASC A) (A,B,C)* HR, HR 4.40, 1.32* 30, 58 Tibial runoff score RR, RR 5.8, 2.8, 32, 33 Lesion calcification (none) RR , 58, 59, 61 Treatment of femoral popliteal lesions TASC A and D lesions. Endovascular therapy is the treatment of choice for type A lesions and surgery is the treatment of choice for type D lesions [C]. TASC B and C lesions. Endovascular treatment is the preferred treatment for type B lesions and surgery is the preferred treatment for good-risk patients with type C lesions. The patient s co-morbidities, fully informed patient preference and the local operator s long-term success rates must be considered when making treatment recommendations for type B and type C lesions [C]. 7

8 Amputation Free Survival RCT PTA vs bypass mainly in TASC B and C lesions Enrolled patients with CLI technically suited for both interventions No stents used Only 1/3 were eligible to be randomized. Randomized 8.2% of patients screened ½ of all patients screened deemed unfit for any revascularization High number of cigarette smokers 40% were not receiving antiplatelet therapy 1/3 were on statin. Lesion characteristic by TASC II in BASIL A B C D?? Major findings of BASIL Vein quality and anatomical extent of the lesion are the two biggest contributing variables in the decision of endo vs. open 1. Similar to ACAS, ACST, EVAR trials surgery first is associated with higher up-front morbidity, and greater LOS and no difference in AFS. 1. No difference in mortality 2. After 2 years surgery first was associated with reduced risk of future amputation, death, or both. (post hoc but more to come) 3. No difference in self-reported HRQL at 2 years Vein quality Availability of ipsilateral GSV vs alternative vein Lumen diameter Pre-existing vein disease Decision Anatomy TASC category Degree of calcification runoff Involvement of the popliteal, distal SFA, profunda, etc 8

9 Summary Our patients are sicker and they live longer. Treatments must be durable. Patients deemed to live longer than 2 years with advanced SFA disease, TASC C and D, and with available vein, should undergo bypass surgery Especially true with CLI as stakes of failure are higher Employ strategies to optimize the vein, e.g DOGs, and other hybrid operations Success of bypass surgery is related to vein quality whereas endovascular procedure related to the extent of disease Reaching a rational consensus? Projected lifespan Disease presentation Lesion characteristic TASC A&B Endo < 2 yr & CLI Few Available ipsilateral vein N Prosthetic vs. endo TASC C&D Projected lifespan Y About 9/16 by BASIL! Y Y Vein bypass > 2 yr Available IL vein Any autogenous vein N Y N CLI N Reconsider nothing or endo. No simple algorithm substitutes for surgical judgment in managing complex PVD. Surgeons must understand the strengths and weakness of each intervention in their hands and in their patients, have an honest assessment of results, understand the device specific patterns of failure, and have diligent surveillance against failure. 9

10 Thank you Science is the belief in the ignorance of experts. R. Feynman 10