Coronary Artery Bypass Grafting Surgery
Conditions
Keywords
Endoscopic vein harvesting, Saphenous vein, Conventional vein harvesting
Brief summary
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 endoscopic open CO2 harvesting system versus conventional vein harvesting.
Detailed description
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.
Interventions
PROCEDUREVein harvesting
Endoscopic versus conventional vein harvesting
Sponsors
LivaNova
Azienda Ospedaliera San Giovanni Battista
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Elective planned CABG surgery * First isolated CABG surgery
Exclusion criteria
* Emergency revascularization: patients with hemodynamic instability or requiring inotropic or intra-aortic balloon support * Previous cardiac surgery * Planned concomitant valve surgery * Very varicous veins * Previous saphenectomy * History of deep vein thrombosis * History of suffered trauma on the lower extremity * Preoperative legs immobilization * Previous leg wound complications * Coexisting illness with life expectancy \< five years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Morbidity hypothesis | six weeks | 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 | six weeks | · 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 | six weeks | 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 | six weeks | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Vein-graft patency hypothesis | six weeks | 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 | 18 months | § 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) |
Countries
Italy
Contacts
Primary ContactAntonio Campanella, MD
Outcome results
None listed