4/8/2017 BEST CLI Trial: Disclosures How is this Trial Impacting my Practice None Vincent L. Rowe, M.D., F.A.C.S. Professor of Surgery Division of Vascular Surgery and Endovascular Therapy Keck School of Medicine University of Southern California USC Practice • Reversed vein bypasses • Arm, SSV • Limited PTFE or Cryo • Early debridement • Endo – Balloon/Stent – Limited Atherectomy 1
4/8/2017 Open Vein Harvest Methods - Technique Open Harvest Endoscopic Harvest • Greater saphenous vein (GSV) conduit of choice for infrainguinal bypass Methods • Retrospective case-control study 76 bypasses: 35 EH, 41 OH • Mean age (P = .03) • BMI (P = NS) – Infrainguinal bypass – EH = 72 – EH =26 – 2000 – 2011 – OH = 67 – OH = 27 – Single segment vein bypass • Male (P = NS) • Diabetes (P = NS) – Frequency matched for diabetes and BMI – EH = 23 (66%) – EH = 17 (49%) – OH = 25 (61%) – Mean follow up 2.4 years – OH = 26 (63%) J Vasc Surg 2013 ; 57:1489-94 J Vasc Surg 2013 ; 57:1489-94 2
4/8/2017 Endoscopic Open Endoscopic Open Variable Harvest Harvest P-value Variable Harvest Harvest P-value Distal target vessel 0.6 Distal target vessel 0.6 Popliteal 14 (40) 14 (34) Popliteal 14 (40) 14 (34) Infrapopliteal 21 (60) 27 (66) Infrapopliteal 21 (60) 27 (66) Vein size (mm) 2.4 2.5 0.63 Vein size (mm) 2.4 2.5 0.63 Length of operation 252 248 0.80 Length of operation 252 248 0.80 Length of Hospital Stay 7 8 0.48 Length of Hospital Stay 7 8 0.48 Wound complications 10 (29) 11 (27) 0.87 Wound complications 10 (29) 11 (27) 0.87 Narcotic use (mg) 5 8 0.01 Narcotic use (mg) 5 8 0.01 Endoscopic Open Variable Harvest Harvest P-value P=0.9 30% Distal target vessel 0.6 P=0.4 Popliteal 14 (40) 14 (34) 20% EH Infrapopliteal 21 (60) 27 (66) P=0.9 OH P=0.3 Vein size (mm) 2.4 2.5 0.63 10% Length of operation 252 248 0.80 0% Length of Hospital Stay 7 8 0.48 Wound complications 10 (29) 11 (27) 0.87 Narcotic use (mg) 5 8 0.01 J Vasc Surg 2013 ; 57:1489-94 3
4/8/2017 Primary Patency Objective 100% 80% OH 60% P= 0.82 • Impact of vein harvest technique during 40% EH lower extremity bypass on: 20% • Incidence SSI 0% 0 30 90 180 270 365 730 1095 • Patency of bypass grafts Days J Vasc Surg 2013 ; 57:1489-94 Study Groups Results • 5,066 patients Continuous Skip Vein Harvesting Techniques Endoscopic Incision Incision 47% Continuous 40% Skip Endoscopic 13% J Vasc Surg 2015;61:1264-71 J Vasc Surg 2015;61:1264-71 4
4/8/2017 Surgical Site Infection Surgical Site Infection, Stratified by BMI 10% Continuous Skip Endoscopic P = .278 8% 20% P >.05 6% 15% 4.7% 4.0% 4% 3.4% 10% 7% 7% 7% 6% 2% 5% 5% 4% 3% 3% 3% 0% 0% Continuous Skip Endoscopic BMI<30 BMI 30-34 BMI >=35 J Vasc Surg 2015;61:1264-71 J Vasc Surg 2015;61:1264-71 Primary Patency Tourniquet Technique • Systemic heparin • Limb elevation P = .317 • Esmarck wrap P = .010 • Pneumatic tourniquet 250- 300 mmHg Surgery 1980;87:709-13 J Vasc Surg 2015;61:1264-71 5
4/8/2017 Completion Duplex Esmarck with elevation Technique • VQI Lower extremity bypass (LEB) module – January 2003 through October 2013 • Regions with <200 LEB excluded from regional analysis • Completion imaging – Duplex ultrasound – Angiogram – Both 6
4/8/2017 Results Regional Analysis 0% 100% • 14,284 LEB 7% 7% 90% 27% – Completion imaging missing n=144 80% 35% • 606 surgeons 70% Duplex 60% • 16 regions 92% Angiogram 51% 50% – 13 with n ≥ 200 57% No Completion 40% Imaging 30% 20% 30% 10% 0% A B C D E F G H I J K L M J Vasc Surg 2015;61:1258-63 Primary Patency at One Year Conduit 100 70% 58% 57% 60% 55% 50% 48% 80 50% 68 42% % p = 0.05 40% 31% 60 30% 63 No Completion Imaging % 20% 40 Completion Imaging 10% 0% 20 Prosthetic Composite Single GSV Biologic Single arm Single LSV Multiple (n=4401) Prosthetic (n=8207) (n=468) vein (n=89) vein & Vein (n=311) (n=375) 0 (n=195) 0 30 90 180 270 365 Days After Bypass J Vasc Surg 2015;61:1258-63 7
4/8/2017 Trial Overview Prospective, randomized, pragmatic, multicenter, � open label superiority trial 2,100 patients at 120 clinical sites in United States � and Canada Each patient will have at least 2 year follow-up � Sponsored by the National Heart Lung and Blood Institute Trial Objective BEST Trial Aim To compare treatment efficacy , functional outcomes and cost in patients with CLI undergoing best open surgical or best endovascular revascularization 8
4/8/2017 Cardiology • Combined services at County Hospital • Vascular Medicine • Opened doors of Cath Lab – Cases done – Vascular Fellows – Technical considerations • Appreciation for Vascular Surgery CLI Team • Vascular Surgeons • Interventional Cardiologist • Vascular Medicine • Nurse Practitioner • Research Coordinator • Vascular Surgery Fellows • Vascular Medicine Fellow 9
4/8/2017 CLI Team • Should limb salvage be offered 10
4/8/2017 CLI Team • Should limb salvage be offered • Vein availability • Alternative conduits • Co-morbidities (Coronary, Carotids…) • Reliability of patient • Discharge Planning 11
4/8/2017 Overcoming Treatment Bias • We feel comfortable as to which therapy to offer our patients • Each of us has developed personal algorithms that makes sense to us individually • Little scientific data exists to support our choice of therapy • Same patient would often be offered different treatment if seen by another specialist 12
4/8/2017 Diagnostic Angiogram Diagnostic Angiogram for Trial • Staged radiation exposure • Address Co-morbidities • Limit contrast (renal insufficiency) • “Informed” Informed consent • Endovascular planning (equipment, access…) • Cardiology agreed • Open surgical planning • Technique sharing • Length of stay??? 13
4/8/2017 VQI at USC Additional Lessons Learned 97 73 23 15 11.8 9 LOS %LOS >7d %statin at DC :10/2014- 2016 :2011-10/2014 Additional Lessons Learned • Data Management • Limb Salvage Center • Data-driven Practice Thank You • Keep Investigating 14
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