ESOS (Endoscopic Saphenous Harvesting With an Open CO2 System) Trial

• Morbidity hypothesis [ Time Frame: six weeks ] [ Designated as safety issue: Yes ]

  When compared to Conventional vein-graft harvesting (CVH) in CABG surgery

  · Does Endoscopic vein-graft open CO2 system harvesting (EVOH) reduce postoperative wound complications (composite endpoint of all complications or individual complications) assessed with ASEPSIS score?

  
  
• Patient satisfaction hypothesis [ Time Frame: six weeks ] [ Designated as safety issue: Yes ]

  · Does EVOH improve patient satisfaction, postoperative leg pain and quality of life assessed with VAS score and EUROQol-5D?

  • To compare health-related quality of life for the two treatment arms (EVOH/CVH) by intention-to-treat
  • To identify factors in addition to treatment assignment that are associated with variations in quality of life outcomes
  
  
• Resource utilization hypothesis [ Time Frame: six weeks ] [ Designated as safety issue: Yes ]

  When compared to Conventional vein-graft harvesting (CVH) in CABG surgery

  · Does EVOH affect resource utilization?

  • Harvesting time related to the length of vein segments
  • Harvesting closure time
  • CABG time
  • Mobility time
  • Hospital length of stay
  • Re-exploration for bleeding due to vein-graft bleed
  • Readmission for leg wound complications
  • Need for outpatient wound management resources
  • To compare total medical costs for the two treatment arms (EVOH/CVH) by intention-to-treat
  
  
• Quality of vein harvesting hypothesis [ Time Frame: six weeks ] [ Designated as safety issue: Yes ]

  When compared to Conventional vein-graft harvesting (CVH) in CABG surgery

  • Do EVOH compromises the quality of venous conduit harvested?

    • Number of harvested veins requiring repair
    • Number of repairs to each vein
    • Re-exploration for bleeding due to vein-graft bleed
    • Histological integrity

  • Specific secondary subanalysis adjusted for:

    • Preparation solution of the vein conduit

      • 20 ml autologous blood
      • 0,5 ml heparin (5000UI/ml) = 2500 UI
      • 2 ml papavarine (30mg/ml) = 60 mg
    • Uncontrolled distension pressure/ no touch technique harvesting
  
  

• Vein-graft patency hypothesis [ Time Frame: six weeks ] [ Designated as safety issue: Yes ]

  Does EVH Open-CO2 system influence and improve vein-graft patency?

  • Assessment of systemic carbon dioxide absorption with respiratory and hemodynamic parameters

  • Assessment of vein-graft patency with:

    • vein conduit quality [diameter/well thickness]
    • vein segments above/below the knee
    • target coronary artery grafted territory
    • target coronary artery diameter
    • target coronary artery stenosis
    • target coronary artery severity disease
    • ascending aorta disease
    • composite /uncomposite graft
    • left ventricular function
  
  
• outcome hypothesis [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]

  § Detection of long-term outcomes:

  • MACE (major adverse cardiac events): death; myocardial infarction; revascularization (PCI or CABG) for ischemia or angina recurrence
  • MACE related to vein-graft failure
  • GF (vein-graft failure): at least 75% of stenosis;
  • GO (vein-graft occlusion) at angiographic study
  • to identify factors in addition to treatment assignment that are associated with variations in long-term outcomes and graft patency
  • baseline demographic characteristics and medications used of two treatment arms (EVOH/CVH)
  
  

The ESOS (Endoscopic Saphenous harvesting with an Open CO2 System) trial is a prospective randomized trial for coronary artery bypass grafting (CABG) surgery to compare and to test improvement in wound healing, quality of life, safety/efficacy, cost-effectiveness, short and long-term outcomes and vein-graft patency after endoscopic open CO2 harvesting system versus conventional vein harvesting.