The Current State of Critical Limb...
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Endovascular Treatment versus Open Surgical Bypass: What Is the “BEST” Revascularization Option? Matthew Menard, MD Brigham and Women’s Hospital
Transcript of The Current State of Critical Limb...
Endovascular Treatment versus Open Surgical Bypass: What Is the “BEST”
Revascularization Option?
Matthew Menard, MD
Brigham and Women’s Hospital
DISCLOSURE
Matthew Mell, MD
• No relevant financial relationship reported
Revascularization Options
• Open Vascular Surgery
• Endovascular Therapy
• Hybrid procedures
J Vasc Surg 2015; 62:965-73
27 centers
J Vasc Surg 2015; 62:965-73
Initial revascularization for CLI
- Critisch Registry: 45% bypass
- Recent VQI Data: 40% bypass
(N= 38,470)
Relevant questions
• Is Endovascular-first a valid strategy?
– For All Comers?
• What about surgery-first?
Amputation free survival Overall survival
Primary bypass
AFS and OS worse after secondary bypass for failed PBA
Outcomes after primary bypass and
secondary bypass after failed PBA in BASIL-1
Primary bypass
Secondary bypass Secondary bypass
P = 0.04 P = 0.06
D20%D17%
Eur J Vasc Endovasc Surg (2019) 57, 382e391
30-Day Amputation & Graft Occlusion
Primary Patency & Secondary Patency
Data is compelling
• There is no free lunch!
• Emboli
• Thrombosis, with loss of domain
• Altered bypass targets
• Lost time – sometimes you have one chance
to get it right
• Everyone likes to think they’re not that guy/gal!
• Newsflash: You’re not not that guy/gal
Data is compelling
• This is not an anti-endo message
• Rather a… Use endo and open
sensibly and rationally message
Goals of PAD Treatment
• Improve limb perfusion
– Restore ambulatory function
– Relieve pain
– Heal wounds
– Preserve a functional limb
– Maintain ambulatory status
Hirsch AT et al. J Am Coll Cardiol 2006;47:1239-131 Conte MS and Farber A. BJS 2015;102:1007-1009
General mantra
Old, frail, surgical high risk → Endo
Young, healthy, good vein → Open
Relevant Domains
Anatomy
LimbPatient
Patient Factors
• Ambulatory Status
• Age, comorbidities
• Estimated life expectancy
• Prior vascular interventions
Risk Stratification Models
WFVS
Risk stratification tools
PIII risk category predicts survival
Causey MW et al J Vasc Surg 2016; 63:1563-73.c
Limb Factors
Rutherford →
Society for Vascular Surgery Lower Extremity Threatened Limb Classification: WIfI Index
• Wound: extent and depth• Ischemia: perfusion/flow• Foot Infection: presence and extent
SVS Lower Extremity Threatened Limb Classification - WIfI Index
• Wound: extent and depth
• Ischemia: perfusion/flow
• foot Infection: presence and extent
Anatomical Factors
• Extent of occlusive disease• Location of disease• Lesion length• Size of treated artery• Degree of calcification• Quality of runoff• Quality of target• Availability of good vein• Angiosome
Anatomic Classification Schemas
TASC
WFVS
Global Vascular Guideline for the
Management of Chronic Limb-Threatening
Ischemia
Michael S. Conte MD, Andrew W. Bradbury MBA, MD, FRCS
Philippe Kolh MD, PhD (Co-Editors)
GLASS*: Assumptions and Approach
WFVS
• Focus on Infrainguinal Disease (SFA origin to foot)
• Clinician defines the primary Target Artery Path (TAP)
• Femoro-popliteal (FP) and Infra-popliteal (IP) segments separately graded (0-4), then combined into Three GLASS Stages for the limb (I-III)
• Infra-malleolar (pedal) disease graded; used as a modifier only
• Calcification graded as Severe or not; simplified system
• *Global Limb Anatomic Staging System
Vascular Bypass
Vascular Bypass
➢ Traditional, “gold standard” treatment➢ Excellent, durable results➢ Long follow up periods available
➢ Invasive➢ Significant morbidity➢ Blood loss➢ Wound complications➢ Technically demanding
“It’s all about the vein”
Schanzer AS et al J Vasc Surg 2007;46:1180-90
Influence of Vein Quality
5-year
Primary
Graft
Patency
5-year
Secondary
Graft
Patency
5-year
Limb
Salvage
Taylor et al.(JVS 1990)
80% 84% 90%
Shah et al.(Ann Surg 1995)
72% 81% 95%
Greater Saphenous Vein
Endovascular Modalities
Endovascular Treatment Options for PAD
➢ Plain Balloon Angioplasty (PTA)➢ Stenting➢ Atherectomy➢ Laser assisted PTA➢ Brachytherapy➢ Stent grafts➢ Drug eluting stents➢ Drug coated balloons➢ Bioabsorbable stents➢ Lithoplasty➢ ………
Benefits of Endovascular Therapy
➢ Minimally invasive➢ No incisions!
➢ No general anesthesia
➢ No hospitalization➢ Can be done in office setting!
➢ Financial incentives
➢ Reduced morbidity
➢ Reduced mortality
SFA-Popliteal DCB Trials6-month Late Lumen Loss in SFA-Popliteal DEB Trials
J Lammer LINC 2014
64.1%
83.4%
10 Patency: Provisional Zilver PTX vs. BMS
Dake MD, et al. Circulation. 2016;133:1472-1483.
72.4%
Three-Year Outcomes; The SPINACH Study
Lida et al., 2017, Circ Cardiovasc Interv. 2017 Dec; 10(12): e005531.
•3-year amputation-free survival was not different between surgical reconstruction and endovascular
therapy in the overall CLI population.
CRITISCH REGISTRY
Bisdas et al. J Vasc Surg 2015 Oct;62(4):965-973
➢ 27 Sites
➢ 1200 patients
Study Design
Amputation-free survivalMatched populations
Bypass:72%
Endo:75%
Statistical significantnon-inferiority of endovascular
versus bypass surgery(at 2.5% level of significance)
Bisdas et al. JACC Cardiovasc Interv 2016
• “Durability of ..(endovascular revascularization)… decreases with greater lesion length, occlusion rather than stenosis, presence of multiple and diffuse lesions, (and) poor quality runoff...”
Circulation 2017
Scenarios when I favor surgical bypass
• TASC C and D
• Prior endo failure • “Bad actors”
• Really need good, sustained flow!•Rest pain
•Heel ulcer
• Lots of tissue loss
Scenarios when I might favor endovascular
• Prohibitive groin
• Obese leg
• Extensive venous disease
• Redo bypass scenario – really don’t want to operate (e.g. densely scarred targets)
• Truly no vein (i.e. you actually looked!)
Health Care Spending as Share of GDP, 1980-2013
Which FIRST Revascularization
Option in CLI Has the BEST Value?
VS
Bypass
Surgery
(LEB)
Endovascular
Therapy (Endo)
Enrollment Update – May 22, 2019
▪ 1,716 subjects randomized (82%)
Case Presentation
• 86 y.o. F with debilitating BL rest pain
• CABG: 2/2017
Case Presentation
• PE:•Slightly diminished femoral pulses•Non-palpable BL popliteal, distal pulses
• ABIs: .31/.35
• TBIs: 0/0
Conclusions
• Open surgical bypass and endovascular therapy are COMPLIMENTARY modalities.
• Learn to do both really well
Robert Linton, M.D
• “Do the right thing”
• “Do it right”
