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MACCE After Endoscopic Vein Harvest for CABG

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02471456
Acronym
MAQEH
Enrollment
100
Registered
2015-06-15
Start date
2015-07-31
Completion date
2015-10-16
Last updated
2017-06-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Complications Due to Coronary Artery Bypass Graft

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.

Interventions

OTHERQuality of Life Questionnaire

Quality of Life Questionnaire will be completed at least 1 year after their surgery.

OTHERMACCE review

MACCE will be assessed by contacting the patient's GP and/or Cardiologist at least 1 year after their surgery.

Sponsors

Maquet Cardiovascular
CollaboratorINDUSTRY
The Royal Wolverhampton Hospitals NHS Trust
Lead SponsorOTHER_GOV

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
40 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
MACCE in patients undergoing CABG where the LSV is harvested by EVH as compared to OVHapproximately 1 yearThe review of MACCE will occur at least 1 year after the patient's operation

Secondary

MeasureTime frameDescription
QOL as assessed by the SF12v2 questionnaireapproximately 1 yearThe review of QOL will occur at least 1 year after the patient's operation
Time taken to return to regular daily activitiesapproximately 1 yearThe review of time taken to return to regular daily activities will occur at least 1 year after the patient's operation
Survivalat approximately 1 year

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026