None Vincent L. Rowe, M.D., F.A.C.S. Professor of Surgery Division - - PowerPoint PPT Presentation

4/8/2017 1

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

BEST CLI Trial: How is this Trial Impacting my Practice

None

Disclosures USC Practice

• Reversed vein bypasses
• Arm, SSV
• Limited PTFE or Cryo
• Early debridement
• Endo

– Balloon/Stent – Limited Atherectomy

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Open Vein Harvest

• Greater saphenous vein

(GSV) conduit of choice for infrainguinal bypass

Methods - Technique

Open Harvest Endoscopic Harvest

Methods

• Retrospective case-control study

– Infrainguinal bypass – 2000 – 2011 – Single segment vein bypass – Frequency matched for diabetes and BMI – Mean follow up 2.4 years

J Vasc Surg 2013; 57:1489-94

• Mean age (P = .03)

– EH = 72 – OH = 67

• Male (P = NS)

– EH = 23 (66%) – OH = 25 (61%)

• BMI (P = NS)

– EH =26 – OH = 27

• Diabetes (P = NS)

– EH = 17 (49%) – OH = 26 (63%)

76 bypasses: 35 EH, 41 OH

J Vasc Surg 2013; 57:1489-94

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Variable Endoscopic Harvest Open Harvest P-value Distal target vessel 0.6 Popliteal 14 (40) 14 (34) Infrapopliteal 21 (60) 27 (66) Vein size (mm) 2.4 2.5 0.63 Length of operation 252 248 0.80 Length of Hospital Stay 7 8 0.48 Wound complications 10 (29) 11 (27) 0.87 Narcotic use (mg) 5 8 0.01 Variable Endoscopic Harvest Open Harvest P-value Distal target vessel 0.6 Popliteal 14 (40) 14 (34) Infrapopliteal 21 (60) 27 (66) Vein size (mm) 2.4 2.5 0.63 Length of operation 252 248 0.80 Length of Hospital Stay 7 8 0.48 Wound complications 10 (29) 11 (27) 0.87 Narcotic use (mg) 5 8 0.01 Variable Endoscopic Harvest Open Harvest P-value Distal target vessel 0.6 Popliteal 14 (40) 14 (34) Infrapopliteal 21 (60) 27 (66) Vein size (mm) 2.4 2.5 0.63 Length of operation 252 248 0.80 Length of Hospital Stay 7 8 0.48 Wound complications 10 (29) 11 (27) 0.87 Narcotic use (mg) 5 8 0.01

0% 10% 20% 30%

EH OH P=0.9 P=0.3 P=0.4 P=0.9

J Vasc Surg 2013; 57:1489-94

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0% 20% 40% 60% 80% 100% 30 90 180 270 365 730 1095

Primary Patency

P= 0.82

Days

OH EH

J Vasc Surg 2013; 57:1489-94

Objective

• Impact of vein harvest technique during

lower extremity bypass on:

• Incidence SSI
• Patency of bypass grafts

Continuous Incision Skip Incision Endoscopic

Study Groups

J Vasc Surg 2015;61:1264-71

Results

47% 40% 13% Vein Harvesting Techniques Continuous Skip Endoscopic

• 5,066 patients

J Vasc Surg 2015;61:1264-71

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Surgical Site Infection

4.7% 4.0% 3.4% 0% 2% 4% 6% 8% 10%

Continuous Skip Endoscopic

P = .278

J Vasc Surg 2015;61:1264-71

Surgical Site Infection, Stratified by BMI

4% 7% 7% 3% 6% 7% 3% 3% 5% 0% 5% 10% 15% 20%

BMI<30 BMI 30-34 BMI >=35

Continuous Skip Endoscopic

P >.05 J Vasc Surg 2015;61:1264-71

Primary Patency

P = .317 P = .010

J Vasc Surg 2015;61:1264-71

Surgery 1980;87:709-13

Tourniquet Technique

• Systemic heparin
• Limb elevation
• Esmarck wrap
• Pneumatic

tourniquet 250- 300 mmHg

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Esmarck with elevation

Completion Duplex 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

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Results

• 14,284 LEB

– Completion imaging missing n=144

• 606 surgeons
• 16 regions

– 13 with n ≥ 200

J Vasc Surg 2015;61:1258-63

Regional Analysis

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% A B C D E F G H I J K L M Duplex Angiogram No Completion Imaging

57% 27% 0% 51% 7% 92% 30% 7% 35%

Conduit

31% 42% 48% 50% 55% 57% 58% 0% 10% 20% 30% 40% 50% 60% 70% Prosthetic (n=4401) Composite Prosthetic & Vein (n=195) Single GSV (n=8207) Biologic (n=468) Single arm vein (n=311) Single LSV (n=89) Multiple vein (n=375)

Primary Patency at One Year

68 63

20 40 60 80 100 30 90 180 270 365

No Completion Imaging Completion Imaging p = 0.05 % % Days After Bypass

J Vasc Surg 2015;61:1258-63

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Sponsored by the National Heart Lung and Blood Institute

• Prospective, randomized, pragmatic, multicenter,
• pen 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

Trial Overview BEST Trial Aim

To compare treatment efficacy, functional

• utcomes and cost in patients with CLI

undergoing best open surgical or best endovascular revascularization

Trial Objective

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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

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CLI Team

• Should limb salvage be offered

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CLI Team

• Should limb salvage be offered
• Vein availability
• Alternative conduits
• Co-morbidities (Coronary, Carotids…)
• Reliability of patient
• Discharge Planning

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Overcoming Treatment Bias

• We feel comfortable as to which therapy to
• ffer our patients
• Each of us has developed personal algorithms

that makes sense to us individually

• Little scientific data exists to support our choice
• f therapy
• Same patient would often be offered different

treatment if seen by another specialist

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Diagnostic Angiogram

• Staged radiation exposure
• Limit contrast (renal insufficiency)
• Endovascular planning (equipment, access…)
• Open surgical planning

Diagnostic Angiogram for Trial

• Address Co-morbidities
• “Informed” Informed consent
• Cardiology agreed
• Technique sharing
• Length of stay???

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VQI at USC

11.8 23 73 9 15 97

LOS %LOS >7d %statin at DC

:2011-10/2014 :10/2014- 2016

Additional Lessons Learned Additional Lessons Learned

• Data Management
• Limb Salvage Center
• Data-driven Practice
• Keep Investigating

Thank You