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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- MACCE in patients undergoing CABG where the LSV is harvested by EVH as compared to OVH
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 85 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient underwent CABG (isolated or combined) during period Jan 2012 to Dec 2013
- •LSV harvested by EVH (Study group)
- •LSV Harvested by OVH matched with EVH group (Control group)
排除标准
- •Patient deceased at time of study start
结局指标
主要结局
MACCE in patients undergoing CABG where the LSV is harvested by EVH as compared to OVH
时间窗: approximately 1 year
The review of MACCE will occur at least 1 year after the patient's operation
次要结局
- Time taken to return to regular daily activities(approximately 1 year)
- Survival(at approximately 1 year)
- QOL as assessed by the SF12v2 questionnaire(approximately 1 year)
