Skeletonised Versus Pedicled Internal Thoracic Artery
- Conditions
- Heart Diseases
- Interventions
- Procedure: PedicledProcedure: Surgical skeletonisedProcedure: Thunderbeat skeletonised
- Registration Number
- NCT05562908
- Lead Sponsor
- Lars Peter Riber
- Brief Summary
It is to date unknown whether Thunderbeat has a place in harvesting the left internal mammary artery (LIMA) and whether skeletonisation is superior to pedicle harvested LIMA. Though, some studies have shown improved flow-rates in the skeletonised graft while others shows compromised blood flow to the thoracic wall after pedicle harvested LIMA.
The purpose of this study is to improve the quality of life for patients undergoing coronary artery bypass graft (CABG) operations.
The aim of this study is to compare three groups of LIMA harvesting techniques: Pedicled, surgical skeletonised and skeletonised with Thunderbeat to determine the best way to harvest LIMA during CABG operations.
The study design is an experimental randomized controlled trial in a single centre.
Study population: Adult patients enlisted for elective stand-alone CABG surgery at the Department of Cardiothoracic surgery, Odense University Hospital.
Study Unit: Test-days within subject and subject
The study will address two main hypotheses in CABG patients:
1. That both the surgical skeletonised and Thunderbeat skeletonised harvesting techniques of LIMA are superior to pedicled harvesting in regards to flowrates and pulsatility index (PI).
2. Skeletonized harvesting of LIMA graft compared to pedicled harvesting improves patient quality of life three days, 30 days, and six months postoperatively.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 165
- Stand-alone CABG (surgical removal of the left atrial appendage (LAAX) is accepted, since it doesn't affect the graft area)
- On-pump with cardioplegia (otherwise one cannot be sure of the pressure and perfusion during surgery of the graft)
- Patients aged >18
- Elective surgery (there is a known higher risk of postoperative complications with urgent surgery)
- CABG combined with other heart surgery, except from LAAX
- Previous heart surgery
- LVEF < 40% (there is a known higher risk of postoperative complications with low LVEF)
- Known cancers (there is a known higher risk of postoperative complication)
- Thoracic radiation therapy (there is a known higher risk of postoperative complication)
- Severe chronic obstructive pulmonary disease (COPD) (there is a known higher risk of postoperative complication)
- Patients not able to understand written consent
- Urgent and emergent surgery (there is a known higher risk of postoperative complication)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Pedicled Pedicled Harvesting of LIMA with its surrounding tissue: fascia, veins, etc Surgical skeletonised Surgical skeletonised Harvesting of LIMA in a "naked" fashion where you dissect the artery free of the surrounding tissue. Skeletonised with Thunderbeat Thunderbeat skeletonised Same as Surgical skeletonised but instead of closing the side branches with clips a surgical tool is used for coagulation of the side-branches.
- Primary Outcome Measures
Name Time Method Differences in flow in LIMA and pulssatility index between the three groups. Perioperative - After weaning off the extracorporeal circulation just before closing the thorax mL/ min With transit time flowmetry (Sono TT flowlab), the graft flow and peripheral index (PI) are measured after weaning off the extracorporeal circulation with a systolic pressure aimed at 100 mmHg. The measurements are done with probe size 3 or 4.
- Secondary Outcome Measures
Name Time Method Postoperative bleeding Postoperative bleeding is measured from the end of the operation to removal of the mediastinal drains in the intensive care unit Unit: mL
Rate of all-cause mortality - Early Early (≤30 days) Number of deaths in each group
Differences in pre and post operative regional oxygen saturation on the thorax. Measured 7 days prior to surgery and again 3 days after surgery Unit: oxygen saturation (rSO2)
Length of stay on ICU Day of surgery to the day of discharge from ICU. Up to 52 weeks Unit: Days
Rate of readmission to hospital due to Major adverse cardiac and cerebrovascular events (MACCE) - Intermediate Intermediate (≤180 days) Number of deaths in each group
Rate of mortality due to cardiac event - Early Early (≤30 days) Number of deaths in each group
Rate of mortality due to cardiac event - Iong Long (≤2 years) Number of deaths in each group
Re-operation due to ischemia Up to 48 hours calculated from the end of primaery surgery Number of patients in each group
Re-operation due to bleeding Up to 48 hours calculated from the end of primaery surgery Number of patients in each group
Myocardial injury - creatine kinase-MB (CK-MB) Routine bloodsample measured four hours after aortic cross clamp removal. Unit: (µg/L)
Myocardial injury - cardiac troponin (cTn) Routine bloodsample measured four hours after aortic cross clamp removal. Unit: (ng/L)
Length of stay in hospital Day of surgery to the day of discharge from hospital. Up to 52 weeks Unit: Days
Pleurocentesis Up to 10 days calculated from the end of primaery surgery Number of patients in each group
Rate of mortality due to cardiac event - Intermediate Intermediate (≤180 days) Number of deaths in each group
Rate of all-cause mortality - long Long (≤ 2 years) Number of deaths in each group
EQ-5D-5L questionnaire: differences in self reported assessment of patient quality of life between the 3 groups Questionnaires uptained the week before the date of surgery and again 3, 30, and 180 days after surgery. Developed by the EURO-QoF group in 1990 to describe five dimensions of quality of life: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five levels: no problems, slight problems, moderate problems, severe problems and extreme problems and a visual analogue scale recording the patient's self-rated health.
Telephone interview - Questions regarding pain, numbness and wound healing around the thoracic incision. 180 ± 7 days calculated from the date of surgery. All questions are closed questions and qualitative variables (yes/no)
Rate of readmission to hospital due to Major adverse cardiac and cerebrovascular events (MACCE) - early Early (≤30 days) Number of deaths in each group
Rate of readmission to hospital due to Major adverse cardiac and cerebrovascular events (MACCE) - Long Long (≤2 years) Number of deaths in each group
Rate of all-cause mortality - Intermediate Intermediate (≤180 days) Number of deaths in each group
Trial Locations
- Locations (1)
Department of Cardio, Vascular and Thoracic Surgery
🇩🇰Odense, Region Of Southern Denmark, Denmark