endovascular treatment vs open surgical bypass: what is...
TRANSCRIPT
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Endovascular Treatment vs Open Surgical Bypass: What is the BEST Revascularization
Option in CLI?
Alik Farber MDChief of Vascular and Endovascular Surgery
Boston Medical CenterProfessor of Surgery and Radiology
Boston University School of Medicine
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Disclosures
• BEST-CLI trial Co-Chair
– Supported by NHLBI: 1U01HL107407-01A1
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Critical Limb Ischemia (CLI)• Presents with intractable foot pain at rest and/or
tissue loss• Affects 2-3% of patients with PAD• Associated with impaired quality of life, high
morbidity and mortality • Costs > $4 billion/year
Hirsch AT et al. J Am Coll Cardiol 2006;47:1239-1312Conte MS and Farber A. BJS 2015;102:1007-1009
Norgren L et al. TASC II. J Vasc Surg 2007;45:S5-67. Biancari F. J Cardiovasc Surg (Torino) 2013;54:663-9.Fowkes FG et al. Lancet 2013;382:1329-40.Sachs T et al. J Vasc Surg 2011;54:1021-1031.
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Goals of CLI Treatment
• Improve limb perfusion – Relieve pain– Heal wounds– Preserve a functional limb–Maintain ambulatory status
–Perform above ankle amputation…if revascularization is futile
Hirsch AT et al. J Am Coll Cardiol 2006;47:1239-131 Conte MS and Farber A. BJS 2015;102:1007-1009
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Revascularization Options
• Open Vascular Surgery• Endovascular Therapy• Hybrid Procedure
How do we choose what option is best?
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Surgical Bypass
• 1948- 1st successful femoral popliteal bypass using rGSV in a patient with PAD (Kunlin J. Rev Chir Paris 70:206-236, 1951)
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1964
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Trends in PAD Therapy
Goodney et al. JAMA Surg 2015;150(1):84-86
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Open Vascular Surgery for CLI
Endarterectomy
Inflow Bypass InfrainguinalBypass
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Open Vascular Surgery for CLI
• Traditional treatment• Durable outcomes• Long follow up periods available
• Invasive• Is associated with – blood loss– morbidity– mortality– wound complications
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Endovascular Modalities
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Endovascular Therapy for CLI• Minimally invasive
• No incisions!• No general anesthesia• No hospitalization
• Can be done in office setting!• Reduced morbidity• Reduced mortality• Decreased durability
• Low patency rates in some vascular beds• Nephrotoxic contrast agents • Expensive• Driven by business interests
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Revascularization Options in CLI
Bypass Surgery
Endovascular Therapy
Which Treatment Strategy is Best?
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Current CLI Literature is not helpful!• Retrospective• Poorly controlled• Poorly powered• Suboptimal endpoints
o Amputation free survivalo Target lesion revascularizationo Target vessel revascularization
• Sponsor bias• Operator bias• Inclusion of claudicants• Short or incomplete follow up
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…There is paucity of high-quality data available to guideclinical decision making….
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0 %
1 0%
2 0%
3 0%
4 0%
5 0%
6 0%
7 0%
8 0%
9 0%
1 00 %
All VQI Centers Mean = 31%
% of Patients with CLI and Infrainguinal PAD treated using Surgical Bypass (vs. Endovascular Therapy)
0% Bypass
100% Bypass
Procedure Selection Variation
VQI Centers
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Sponsored by the National Heart Lung and Blood Institute
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BEST-CLI Trial: Overview
§ Prospective, randomized, multicenter, multispecialty, international, pragmatic open-label superiority trial
§ 2100 patients at 160 clinical sites
§ Funded by National Heart Lung and Blood Institute
§ Goal: to assess outcomes, quality of life and cost in patients with CLI who are candidates for both open vascular and endovascular surgery
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BASIL 2
Pragmatic, superiority RCT comparing clinical and cost-effectiveness outcomes of a ‘vein bypass first’ with a ‘best endovascular first’ revascularisation strategy for SLI
due to infra-popliteal (+/- femoro-popliteal) atherosclerotic disease
Bypass vs. Angioplasty in Severe Ischaemia of the Leg-2
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The Best Approach to CLI –Open vs. Endo?…
before Level I evidence becomes available!
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In “Broad Strokes” …
Old, frail, surgical high risk à Endo
Young, healthy, good vein àOpen
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Relevant Domains
Anatomy
LimbPatient
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Patient Factors
• Ambulatory Status• Comorbidities • Estimated life expectancy • Prior vascular interventions
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Limb Factors
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Relevant 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
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Generalized CLI Treatment Strategy • Ambulating patients with large wounds, few
comorbidities, longer life expectancy, multilevel, diffuse occlusive disease and SSGSV à open vascular surgery
• Patients with smaller wounds, at high surgical risk, shorter life expectancy, less extensive occlusive disease, no SSGSV à endovascular therapy
• Patients with poor functional status, multiple comorbidities, short life expectancy, extensive tissue loss à primary amputation
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Conclusions
• There is absence of good data to guide treatment of CLI
• BEST-CLI will provide a treasure trove of invaluable data on CLI and its management
• BASIL 2 will nicely complement BEST-CLI• Patient, limb and anatomical factors are used to
decide on CLI therapy in the current “data void”
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