MACCE After Endoscopic Vein Harvest for CABG (MAQEH)

Major Adverse Cardiac and Cerebrovascular Event (MACCE) & Patients' Quality of Life (QOL) After Endoscopic Vein Harvesting as Compared to Open Vein Harvest for Coronary Artery Bypass Grafting

Most patients undergoing coronary artery bypass grafting (CABG) will require long saphenous vein (LSV) harvesting from the leg. This has been reported to be associated with a significant morbidity (leg swelling, pain, infection, bruising, wound discharge) in up to 50% of patients. Endoscopic vein harvesting (EVH) which has been reported to be associated with a reduction in these complications was implemented within the investigators' service in 2012. Although some initial reports of concerns regarding graft patency when the LSV is harvested by EVH, NICE and European Cardiology Society (ESC/EACTS) guidelines 2014 supported the use of the EVH technology. Last year a service evaluation in the investigators' department showed significant cost benefit of EVH as compared to open vein harvest (OVH) in a matched group (50 EVH and 50 OVH patients). The purpose of this study is to evaluate this group further to assess the incidence of MACCE (Major adverse cardiac and cerebrovascular event) and patient's quality of life (QOL) at least 1 year after their surgery. MACCE will be assessed by contacting the patient's GP and/or Cardiologist and QOL questionnaire (SF12v2) will be sent to patients along with a patient information sheet. It is estimated that data collection would be completed within 3 months of start.

Study Overview

• Status: Completed
• Conditions: Complications Due to Coronary Artery Bypass Graft
• Intervention / Treatment: Other: Quality of Life Questionnaire; Other: MACCE review

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• United Kingdom
  • Wolverhampton, United Kingdom, WV10 0QP
    • The Royal Wolverhampton NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Fifty patients who underwent EVH (Study group) were part of our service evaluation when EVH was introduced to our practice. These patients were matched with patients undergoing CABG during the same period but where the LSV was harvested by OVH (50 patients, control group).

This service evaluation showed a significant cost benefit when EVH was used in terms of reduction in the inhopsital stay, leg wound pain, leg wound infection and need to attend wound clinic. The current study is an extension of the service evaluation to assess how these patients are doing at least a year after their surgery in terms of MACCE, QOL,return to normal activities and survival

Description

Inclusion Criteria:

1. Patient underwent CABG (isolated or combined) during period Jan 2012 to Dec 2013
2. LSV harvested by EVH (Study group)
3. LSV Harvested by OVH matched with EVH group (Control group)

Exclusion Criteria:

1. Patient deceased at time of study start

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
EVH; Patients that have undergone Endoscopic Vein Harvesting (EVH)	Other: Quality of Life Questionnaire; Quality of Life Questionnaire will be completed at least 1 year after their surgery.; Other: MACCE review; MACCE will be assessed by contacting the patient's GP and/or Cardiologist at least 1 year after their surgery.
OVH; Patients that have undergone open vein harvest (OVH)	Other: Quality of Life Questionnaire; Quality of Life Questionnaire will be completed at least 1 year after their surgery.; Other: MACCE review; MACCE will be assessed by contacting the patient's GP and/or Cardiologist at least 1 year after their surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MACCE in patients undergoing CABG where the LSV is harvested by EVH as compared to OVH	The review of MACCE will occur at least 1 year after the patient's operation	approximately 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
QOL as assessed by the SF12v2 questionnaire	The review of QOL will occur at least 1 year after the patient's operation	approximately 1 year
Time taken to return to regular daily activities	The review of time taken to return to regular daily activities will occur at least 1 year after the patient's operation	approximately 1 year
Survival		at approximately 1 year

Collaborators and Investigators

• Sponsor: The Royal Wolverhampton Hospitals NHS Trust
• Collaborators: Maquet Cardiovascular
• Investigators: Principal Investigator: Heyman Luckraz, The Royal Wolverhampton NHS Trust

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2015
• Primary Completion (ACTUAL): October 16, 2015
• Study Completion (ACTUAL): October 16, 2015

Study Registration Dates

• First Submitted: June 9, 2015
• First Submitted That Met QC Criteria: June 10, 2015
• First Posted (ESTIMATE): June 15, 2015

Study Record Updates

• Last Update Posted (ACTUAL): June 21, 2017
• Last Update Submitted That Met QC Criteria: June 20, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 2015CAR76