MACCE After Endoscopic Vein Harvest for CABG

Completed

• Conditions: Complications Due to Coronary Artery Bypass Graft
• Interventions: Other: Quality of Life Questionnaire; Other: MACCE review

• Registration Number: NCT02471456
• Lead Sponsor: The Royal Wolverhampton Hospitals NHS Trust

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-06-09
• Study First Submitted QC: 2015-06-10
• Study First Posted: 2015-06-15
• Study Start: 2015-07
• Primary Completion: 2015-10-16
• Study Completion: 2015-10-16
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-20
• Last Update Posted: 2017-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
OVH	Quality of Life Questionnaire	Patients that have undergone open vein harvest (OVH)
EVH	Quality of Life Questionnaire	Patients that have undergone Endoscopic Vein Harvesting (EVH)
EVH	MACCE review	Patients that have undergone Endoscopic Vein Harvesting (EVH)
OVH	MACCE review	Patients that have undergone open vein harvest (OVH)

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

The Royal Wolverhampton NHS Trust; 🇬🇧 Wolverhampton, United Kingdom