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The right choice : Endovascular Therapy
vsSurgical Bypass
for CLIKoen Deloose, MD
Vascular Surgery, AZ Sint Blasius
Dendermonde, Belgium
Disclosure Statement of Financial Interest
I, Koen Deloose, DO NOT have a financial
interest/arrangement or affiliation with
one or more organizations that could be
perceived as a real or apparent conflict of
interest in the context of the subject of
this presentation
3iD3 Medical – 2016 |
The right choice is….
•At least doing something….20 464 PAD pts who underwent major amputation(2003-2006)
Goodney et al, Circ : Cardiovasc Qual Outcomes, 2012;5:94-102
No Revasc/no Angio no Angio Angio only
4iD3 Medical – 2016 |
THE LITERATURE
• The only RCT directly comparing open bypass surgerywith endovascular therapy in CLI patients :
BASIL429 pts, @ 27 UK hospitals, followed 5 years
*primary endpoints : overall survival/amputation
free survival
*secondary endpoints : 30d mortality, MI,
hematoma, woundinfection,
reinterventions
Bradbury et al, Lancet 2005;366:1925-34
5iD3 Medical – 2016 |
BASIL primary endpoints
@ 2 yr : NO DIFFERENCE BETWEEN BOTH GROUPS
amputation free survival overall survival
After 2 yrs, diverging curves in favor of surgery
Bradbury et al, Lancet 2005;366:1925-34
6iD3 Medical – 2016 |
BASIL secondary endpoints
Bradbury et al, Lancet 2005;366:1925-34
7iD3 Medical – 2016 |
BASIL authors’ conclusions
Bradbury et al, Lancet 2005;366:1925-34
8iD3 Medical – 2016 |
BASIL criticism
• SLI = CLI ??? : several subcohorts based on ankle/toe pressure measurements, Tcp02…
• Best Medical Therapy ??
• Best Endovascular Therapy ?? Experience,
materials, techniques (ex. 9 stents were placed…)
• Endpoints? Not ideal for a direct comparison of revascularization strategies
• Relatively late superiority of open surgery is quite irrelevant due to high overall mortality rates of CLI-patients…
9iD3 Medical – 2016 |
Indirect comparisons, meta-analysis….• Söderstrom, Ann Surg 2010;252:765-773
• No statistical differences between Bypass/Endo
10iD3 Medical – 2016 |
Indirect comparisons, meta-analysis….• Romiti et al. J Vasc Surg 2008:47(5):975-81 : >2500 pts
• No statistical differences between Bypass/Endo in LSR
11iD3 Medical – 2016 |
Indirect comparisons, meta-analysis….• Xiaoyang et al. Int J Clin Exp Med 2015:8(7):10595-602
-> amputation free survival @ 1, 3 & 5 yrs
12iD3 Medical – 2016 |
Indirect comparisons, meta-analysis….• Xiaoyang et al. Int J Clin Exp Med 2015:8(7):10595-602
-> overall survival @ 30 days
13iD3 Medical – 2016 |
Indirect comparisons, meta-analysis….• Xiaoyang et al. Int J Clin Exp Med 2015:8(7):10595-602
-> overall survival @ 1, 3 & 5 yrs
14iD3 Medical – 2016 |
Indirect comparisons, meta-analysis….• Xiaoyang et al. Int J Clin Exp Med 2015:8(7):10595-602
-> Limb Salvage @ 1, 3 & 5 yrs
15iD3 Medical – 2016 |
• 1 - 5% mortality rates
• 10-20% of bypasses develop incisional wound complications
• Large prospective NSQIP analysis of >2500 patients revealed bypass has ~20% peri-procedural complication rate, and 49% readmission rate at 6 months (65% are bypass related)
• Meta-analysis showed 12% decline in ambulation and 15% loss of independent living post bypass surgery
La Muragglia et al. Eur J Vasc Endovasc Surg 2012; 43(5):549-55Conte et al. Seminars of Vascular Surgery 2012 25:108-114Goodney et al. J Vasc Surg 2011 : 54(1) ; 100-108
Open Surgery = Invasivefor our CLI-patients
16iD3 Medical – 2016 |
Open Surgery = invasive for ourCLI-patients
• High risk category classification :ESRD with HD
Extensive tissue loss
>75yr
Coronary disease
Low Hct (<30%)
• Available venous conduit : >3-4mm
Conte et al. Results of the PREVENT III trial. J Vasc Surg 2006;43:742-751
17iD3 Medical – 2016 |
Fast evolution endovascular world
• Spectacular advancement in technics
18iD3 Medical – 2016 |
Fast evolution endovascular world
• Spectacular advancement in devices
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Supera 500LL
SuperaCWZ
TucsonRestore
Mc Quade Viper Viabahn 25 Viastar LeipzigRegistry
ZellerRegistry
Zilver PTXSAS
Zilver PTXPMS
Zilver PMSJapan
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N= N=159
N=147
N=50
N=119
N=71
N=72
N=260
N=228
N=135
N=45
N=703
19iD3 Medical – 2016 |
Fast evolution endovascular world
• Spectacular advancement in devices
20iD3 Medical – 2016 |
Our CLI treatment algorithmCLI patient
• Heavily calcified TASC D+ (ATK+BTK)
• “Frequent flyer”
Surgical candidate
• RISK score (PREVENT III criteria)
• Vein availability
Venous bypass Primary amputation/conservative R/
ENDOVASCULARfailure
21iD3 Medical – 2016 |
More clear view in the future…
