The rig ight choice : : Endovascular Therapy vs vs Surgical - - PowerPoint PPT Presentation

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The rig ight choice : : Endovascular Therapy vs vs Surgical - - PowerPoint PPT Presentation

Aug 13, 2023 128 likes •341 views

The rig ight choice : : Endovascular Therapy vs vs Surgical Bypass for CLI Koen Deloose , MD Vascular Surgery, AZ Sint Blasius Dendermonde, Belgium Disclosure Statement of Financial Interest I, Koen Deloose, DO NOT have a financial

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The rig ight choice : : Endovascular Therapy vs vs Surgical Bypass for CLI

Koen Deloose, MD Vascular Surgery, AZ Sint Blasius Dendermonde, Belgium

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Disclosure Statement of Financial Interest

I, Koen Deloose, DO NOT have a financial interest/arrangement or affiliation with

  • ne or more organizations that could be

perceived as a real or apparent conflict of interest in the context of the subject of this presentation

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3 iD3 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

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4 iD3 Medical – 2016 |

THE LITERATURE

  • The only RCT directly comparing open bypass surgery

with endovascular therapy in CLI patients :

BASIL

429 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

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5 iD3 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

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6 iD3 Medical – 2016 |

BASIL secondary endpoints

Bradbury et al, Lancet 2005;366:1925-34

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7 iD3 Medical – 2016 |

BASIL authors’ conclusions

Bradbury et al, Lancet 2005;366:1925-34

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8 iD3 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…

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9 iD3 Medical – 2016 |

Indirect comparisons, meta- analysis….

  • Söderstrom, Ann Surg 2010;252:765-773
  • No statistical differences between Bypass/Endo
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10 iD3 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
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11 iD3 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
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12 iD3 Medical – 2016 |

Indirect comparisons, meta- analysis….

  • Xiaoyang et al. Int J Clin Exp Med 2015:8(7):10595-602
  • > overall survival @ 30 days
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13 iD3 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
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14 iD3 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
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15 iD3 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):549-55 Conte et al. Seminars of Vascular Surgery 2012 25:108-114 Goodney et al. J Vasc Surg 2011 : 54(1) ; 100-108

Open Surgery = Invasive for our CLI-patients

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Open Surgery = invasive for our CLI-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

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17 iD3 Medical – 2016 |

Fast evolution endovascular world

  • Spectacular advancement in technics
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Fast evolution endovascular world

  • Spectacular advancement in devices

50 100 150 200 250 10 20 30 40 50 60 70 80 90 100 Supera 500 LL Supera CWZ Tucson Restore Mc Quade Viper Viabahn 25 Viastar Leipzig Registry Zeller Registry Zilver PTX SAS Zilver PTX PMS Zilver PMS Japan Mean Lesion Length ( mm) Primary Patency Rates at 1 Year ( % )

N= N= 159 N= 147 N= 50 N= 119 N= 71 N= 72 N= 260 N= 228 N= 135 N= 45 N= 703

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19 iD3 Medical – 2016 |

Fast evolution endovascular world

  • Spectacular advancement in devices
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20 iD3 Medical – 2016 |

Our CLI treatment algorithm

CLI patient

  • Heavily calcified TASC

D+ (ATK+BTK)

  • “Frequent flyer”

Surgical candidate

  • RISK score

(PREVENT III criteria)

  • Vein availability

Venous bypass

Primary amputation/conservative R/

ENDOVASCULAR failure

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21 iD3 Medical – 2016 |

More clear view in the future…