Compare Endoscopic and Open Methods of Vein Harvesting for Coronary Artery Bypass Grafting

Meshalkin Research Institute of Pathology of Circulation

Status and phase: Completed; Phase 4

Conditions: Autovenous Conduit for Coronary Artery Bypass Grafting

Treatments: Procedure: Open vein harvesting; Procedure: Endoscopic vein harvesting

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT02446522

EVH vs OVH

Details and patient eligibility

About

There is no shared vision relating to integrity and quality of the conduit after the impact on the vein wall during vein harvesting. In this connection, the investigators studied the initial state of the venous conduit, interoperation damages of the vein and postoperative wound complications while using two methods of GSV harvesting.

Full description

The great saphenous vein (GSV) remains one of the most commonly used conduits due to its ease of harvest, availability and versatility [1] Traditional harvesting of GSV is open vein harvesting, which involves an extended leg incision. This technique is associated with a significant morbidity and wound complications occur in 2-24% of cases.

Minimally invasive techniques endoscopic vein harvesting (EVH), have therefore been developed to reduce post-CABG leg wound complications. Last time the endoscopic vein harvesting is the method of choice in many centers as it allowed reduction of post-surgical complications as compared to the open method. Although long-term graft patency following EVH has been questioned cohort studies have reported that the technique is safe and effective.

The possibility to use lymphoscintigraphy for evaluation of lower limb lymphatic system after vein harvesting for the coronary artery bypass surgeries was reported before. Nevertheless, the state of the lymphatic system after vein harvesting remains to be poorly studied.

Currently, there is no shared vision relating to integrity and quality of the conduit after the impact on the vein wall during vein harvesting. In this connection, the investigators studied the initial state of the venous conduit, interoperation damages of the vein and postoperative wound complications while using two methods of GSV harvesting.

Enrollment: 228 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• subjects with multivascular lesion of the coronary artery to whom coronary artery bypass surgery was indicated.

Exclusion criteria

• urgent coronary artery bypass surgery with unstable haemodynamics;
• previous coronary artery bypass surgery;
• chronic venous insufficiency С4-С6 under СЕAR classification;
• previous limb surgeries.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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228 participants in 2 patient groups

Open vein harvesting

Active Comparator group

Description:

Patients with IHD, who were underwent open vein harvest method (OVH)

Treatment:

Procedure: Open vein harvesting

Endoscopic vein harvesting

Active Comparator group

Description:

Patients with IHD, who were underwent edoscopic vein harvestingopen vein harvest method (EVH).

Treatment:

Procedure: Endoscopic vein harvesting