Skeletonised Versus Pedicled Internal Thoracic Artery

Lars Peter Riber165 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

165

Conditions

Heart Diseases

Interventions

PedicledPROCEDURE

Surgical procedure: A prior marking was made on both sides of the LIMA and its veins with bi-polar technique. Hereafter the LIMA and its veins were dissected free with scissor and forceps. Clips were added to all side branches. When the full length of LIMA was obtained, the LIMA and its veins were divided distally by adding clips on the peripheral part of the vessels and proximately dividing by scissor. A vessel-clamp was placed distally and the pedicled LIMA placed in the jugular cavity with a cloth containing papaverine.

Surgical skeletonisedPROCEDURE

Surgical procedure: The fascia of the LIMA was opened with a scissor. Hereafter the LIMA was dissected free with scissor and forceps, clips on all LIMA side-branches and divided by scissor. When the full length of LIMA was obtained, the LIMA was divided distally by adding clips on the peripheral part of the vessel and proximately dividing by scissor. A vessel-clamp was placed distally, and the skeletonised LIMA placed in the jugular cavity with a cloth containing papaverine.

Thunderbeat skeletonisedPROCEDURE

Surgical procedure: With Thunderbeat the fascia of LIMA was opened. The LIMA was dissected free with Thunderbeat including all side-branches. When the full length of the LIMA was obtained, the LIMA was divided distally by adding clips on the peripheral part of the vessel and proximately dividing by scissor. A vessel-clamp was placed distally, and the skeletonised LIMA placed in the jugular cavity with a cloth containing papaverine.

Outcomes

Primary Outcomes

Differences in flow in LIMA and pulssatility index between the three groups.

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.

Time frame: Perioperative - After weaning off the extracorporeal circulation just before closing the thorax

Secondary Outcomes

Postoperative bleeding

Unit: mL

Time frame: Postoperative bleeding is measured from the end of the operation to removal of the mediastinal drains in the intensive care unit

Re-operation due to bleeding

Number of patients in each group

Time frame: Up to 48 hours calculated from the end of primaery surgery

Re-operation due to ischemia

Number of patients in each group

Time frame: Up to 48 hours calculated from the end of primaery surgery

Pleurocentesis

Number of patients in each group

Time frame: Up to 10 days calculated from the end of primaery surgery

Myocardial injury - creatine kinase-MB (CK-MB)

Unit: (µg/L)

Time frame: Routine bloodsample measured four hours after aortic cross clamp removal.

Myocardial injury - cardiac troponin (cTn)

Unit: (ng/L)

Time frame: Routine bloodsample measured four hours after aortic cross clamp removal.

Differences in pre and post operative regional oxygen saturation on the thorax.

Unit: oxygen saturation (rSO2)

Time frame: Measured 7 days prior to surgery and again 3 days after surgery

Length of stay on ICU

Unit: Days

Time frame: Day of surgery to the day of discharge from ICU. Up to 52 weeks

Length of stay in hospital

Unit: Days

Time frame: Day of surgery to the day of discharge from hospital. Up to 52 weeks

EQ-5D-5L questionnaire: differences in self reported assessment of patient quality of life between the 3 groups

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.

Time frame: Questionnaires uptained the week before the date of surgery and again 3, 30, and 180 days after surgery.

Telephone interview - Questions regarding pain, numbness and wound healing around the thoracic incision.

All questions are closed questions and qualitative variables (yes/no)

Time frame: 180 ± 7 days calculated from the date of surgery.

Rate of readmission to hospital due to Major adverse cardiac and cerebrovascular events (MACCE) - early