An interventional study of Endoscopic vein harvest and Open vein harvest in Coronary Artery Disease, sponsored by Sheba Medical Center. Status unknown at 1 site in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-09-22.
Sponsored by Sheba Medical Center · Not applicable, Interventional, and Treatment
The aim of this study is to investigate the histological and immunohistochemical findings of the saphenous vein graft, to rule out endothelial damage as a direct result of manipulation or instrumentation by endoscopic and open conventional harvesting methods. Furthermore, to investigate if there are any differences in the surgical site infection, cardiac event and functional status between the two harvest strategies at 1-year of follow-up.
BACKGROUND Ischemic heart disease is the leading cause of death globally that accounts for about 7.4 million mortalities worldwide annually as published by the World Health Organization. Coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) are the options for revascularization in patients suffering from coronary artery disease (CAD). The choice of the most appropriate modality is affected by the clinical presentation, comorbidities, anatomical complexity of the CAD, and baseline characteristics of the patient. Although advances in PCI with drug-eluting stents have provide good outcomes, CABG remains an important revascularization strategy in the treatment of CAD.
The initial experience of using saphenous vein as coronary bypass conduits was first published from the Cleveland clinic in 1967. Minimally invasive endoscopic vein harvest (EVH) was first reported in 1996 as an alternative to open vein harvest (OVH). An endoscope is introduced adjacent to the vein, allowing its dissection under direct vision via a small incision. Over the last decade, EVH has become the preferred technique for conduit harvest in many cardiothoracic centers owing to the overall reduction in complications compared with OVH and the obvious cosmetic advantage. However, concerns persist regarding the risk of microscopic damage incurred during EVH, and the consequences of this for long-term graft patency.
OBJECTIVES The aim of this study is to investigate the histological and immunohistochemical findings of the saphenous vein graft, to rule out endothelial damage as a direct result of manipulation or instrumentation by endoscopic and open conventional harvesting methods. Furthermore, to investigate if there are any differences in the surgical site infection, cardiac event and functional status between the two harvest strategies at 1-year of follow-up.
METHODS This is a prospective, single-center randomized controlled trial conducted in the department of cardiac surgery at the Sheba Medical Center. It will include a sample size of 50 patients (randomization ratio 1:1), who are planned to undergo an elective isolated CABG surgery, and a vein graft is necessary for the revascularization.
5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.
This study's planned enrollment of 50 is below the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.
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Exclusion Criteria:
For the standard open conventional technique, the saphenous vein will be exposed by a longitudinal leg incision starting from the medial malleolus and ending at the upper medial thigh at the sapheno-femoral junction. The saphenous vein will be dissected free from its perivascular fat pedicle and visible side branches will be ligated and divided.
Other: Open vein harvest
We will use the Terumo VirtuoSaph® Plus Endoscopic Vessel Harvesting System for all endoscopic vein extractions, which is an open carbon dioxide (CO2) system. Approximately 6 l/min of CO2 will be continuously insufflated in the subcutaneous tunnel.
Device: Endoscopic vein harvest
An endoscope is introduced adjacent to the vein, allowing its dissection under direct vision via a small incision.
Open vein harvest
Microscopic vein damage by histology examination
The amount of preserved endothelium and endothelial stretching seen in the histology examination in the two different vein harvesting strategies.
Time frame: Immediate
Rehospitalization, myocardial infarction and all-cause mortality
Composite end point of rehospitalization, myocardial infarction and all-cause mortality up to 1-year.
Time frame: 12 months
New-York Heart Association (NYHA) functional class
New-York Heart Association (NYHA) functional class at 1-year
Time frame: 12 months
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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Sheba Medical Center