Bibleraaj, Bhuvaneswari

Caress, Ann

Critchley, William

Fildes, James

Morris, Julie

Payne, Katherine

Thompson, Alexander

Venkateswaran, Rajamiyer

Yonan, INizar

BACKGROUND: Current consensus statements maintain that endoscopic vein harvesting (EVH) should be standard care in coronary artery bypass graft surgery, but vein quality and clinical outcomes have been questioned. The VICO trial (Vein Integrity and Clinical Outcomes) was designed to assess the impact of different vein harvesting methods on vessel damage and whether this contributes to clinical outcomes after coronary artery bypass grafting. METHODS: In this single-center, randomized clinical trial, patients undergoing coronary artery bypass grafting with an internal mammary artery and with 1 to 4 vein grafts were recruited. All veins were harvested by a single experienced practitioner. We randomly allocated 300 patients into closed tunnel CO 2 EVH (n=100), open tunnel CO 2 EVH (n=100), and traditional open vein harvesting (n=100) groups. The primary end point was endothelial integrity and muscular damage of the harvested vein. Secondary end points included clinical outcomes (major adverse cardiac events), use of healthcare resources, and impact on health status (quality-adjusted life-years). RESULTS: The open vein harvesting group demonstrated marginally better endothelial integrity in random samples (85% versus 88% versus 93% for closed tunnel EVH, open tunnel EVH, and open vein harvesting; P&lt;0.001). Closed tunnel EVH displayed the lowest longitudinal hypertrophy (1% versus 13.5% versus 3%; P=0.001). However, no differences in endothelial stretching were observed between groups (37% versus 37% versus 31%; P=0.62). Secondary clinical outcomes demonstrated no significant differences in composite major adverse cardiac event scores at each time point up to 48 months. The quality-adjusted life-year gain per patient was 0.11 (P&lt;0.001) for closed tunnel EVH and 0.07 (P=0.003) for open tunnel EVH compared with open vein harvesting. The likelihood of being cost-effective, at a predefined threshold of £20 000 per quality-adjusted life-year gained, was 75% for closed tunnel EVH, 19% for open tunnel EVH, and 6% for open vein harvesting. CONCLUSIONS: Our study demonstrates that harvesting techniques affect the integrity of different vein layers, albeit only slightly. Secondary outcomes suggest that histological findings do not directly contribute to major adverse cardiac event outcomes. Gains in health status were observed, and cost-effectiveness was better with closed tunnel EVH. High-level experience with endoscopic harvesting performed by a dedicated specialist practitioner gives optimal results comparable to those of open vein harvesting. </p

Edge Hill University Research Information Repository

Study comparing vein integrity and clinical outcomes in open vein harvesting and 2 types of endoscopic vein harvesting for coronary artery bypass grafting:The VICO randomized clinical trial (vein integrity and clinical outcomes)

Background: Current consensus statements maintain that endoscopic vein harvesting (EVH) should be standard care in coronary artery bypass graft surgery, but vein quality and clinical outcomes have been questioned. The VICO trial (Vein Integrity and Clinical Outcomes) was designed to assess the impact of different vein harvesting methods on vessel damage and whether this contributes to clinical outcomes after coronary artery bypass grafting.Methods: In this single-center, randomized clinical trial, patients undergoing coronary artery bypass grafting with an internal mammary artery and with 1 to 4 vein grafts were recruited. All veins were harvested by a single experienced practitioner. We randomly allocated 300 patients into closed tunnel CO2 EVH (n=100), open tunnel CO2 EVH (n=100), and traditional open vein harvesting (n=100) groups. The primary end point was endothelial integrity and muscular damage of the harvested vein. Secondary end points included clinical outcomes (major adverse cardiac events), use of healthcare resources, and impact on health status (quality-adjusted life-years).Results: The open vein harvesting group demonstrated marginally better endothelial integrity in random samples (85% versus 88% versus 93% for closed tunnel EVH, open tunnel EVH, and open vein harvesting; P&lt;0.001). Closed tunnel EVH displayed the lowest longitudinal hypertrophy (1% versus 13.5% versus 3%; P=0.001). However, no differences in endothelial stretching were observed between groups (37% versus 37% versus 31%; P=0.62). Secondary clinical outcomes demonstrated no significant differences in composite major adverse cardiac event scores at each time point up to 48 months. The quality-adjusted life-year gain per patient was 0.11 (P&lt;0.001) for closed tunnel EVH and 0.07 (P=0.003) for open tunnel EVH compared with open vein harvesting. The likelihood of being cost-effective, at a predefined threshold of £20 000 per quality-adjusted life-year gained, was 75% for closed tunnel EVH, 19% for open tunnel EVH, and 6% for open vein harvesting.Conclusions: Our study demonstrates that harvesting techniques affect the integrity of different vein layers, albeit only slightly. Secondary outcomes suggest that histological findings do not directly contribute to major adverse cardiac event outcomes. Gains in health status were observed, and cost-effectiveness was better with closed tunnel EVH. High-level experience with endoscopic harvesting performed by a dedicated specialist practitioner gives optimal results comparable to those of open vein harvesting.Clinical trial registration: URL: https://www.isrctn.com. International Standard Randomised Controlled Trial Registry Number: 91485426

Krishnamoorthy, Bhuvaneswari

Critchley, William R.

Thompson, Alexander J.

Venkateswaran, Rajamiyer V.

Caress, Ann L.

Fildes, James E.

Yonan, Nizar

The University of Manchester - Institutional Repository

Study Comparing Vein Integrity and Clinical Outcomes in Open Vein Harvesting and 2 Types of Endoscopic Vein Harvesting for Coronary Artery Bypass Grafting:The VICO Randomized Clinical Trial (Vein Integrity and Clinical Outcomes)


            Background:
            Current consensus statements maintain that endoscopic vein harvesting (EVH) should be standard care in coronary artery bypass graft surgery, but vein quality and clinical outcomes have been questioned. The VICO trial (Vein Integrity and Clinical Outcomes) was designed to assess the impact of different vein harvesting methods on vessel damage and whether this contributes to clinical outcomes after coronary artery bypass grafting.
          
          
            Methods:
            
              In this single-center, randomized clinical trial, patients undergoing coronary artery bypass grafting with an internal mammary artery and with 1 to 4 vein grafts were recruited. All veins were harvested by a single experienced practitioner. We randomly allocated 300 patients into closed tunnel CO
              2
              EVH (n=100), open tunnel CO
              2
              EVH (n=100), and traditional open vein harvesting (n=100) groups. The primary end point was endothelial integrity and muscular damage of the harvested vein. Secondary end points included clinical outcomes (major adverse cardiac events), use of healthcare resources, and impact on health status (quality-adjusted life-years).
            
          
          
            Results:
            
              The open vein harvesting group demonstrated marginally better endothelial integrity in random samples (85% versus 88% versus 93% for closed tunnel EVH, open tunnel EVH, and open vein harvesting;
              P
              &lt;0.001). Closed tunnel EVH displayed the lowest longitudinal hypertrophy (1% versus 13.5% versus 3%;
              P
              =0.001). However, no differences in endothelial stretching were observed between groups (37% versus 37% versus 31%;
              P
              =0.62). Secondary clinical outcomes demonstrated no significant differences in composite major adverse cardiac event scores at each time point up to 48 months. The quality-adjusted life-year gain per patient was 0.11 (
              P
              &lt;0.001) for closed tunnel EVH and 0.07 (
              P
              =0.003) for open tunnel EVH compared with open vein harvesting. The likelihood of being cost-effective, at a predefined threshold of £20 000 per quality-adjusted life-year gained, was 75% for closed tunnel EVH, 19% for open tunnel EVH, and 6% for open vein harvesting.
            
          
          
            Conclusions:
            Our study demonstrates that harvesting techniques affect the integrity of different vein layers, albeit only slightly. Secondary outcomes suggest that histological findings do not directly contribute to major adverse cardiac event outcomes. Gains in health status were observed, and cost-effectiveness was better with closed tunnel EVH. High-level experience with endoscopic harvesting performed by a dedicated specialist practitioner gives optimal results comparable to those of open vein harvesting.
          
          
            Clinical Trial Registration:
            
              URL:
              https://www.isrctn.com
              . International Standard Randomised Controlled Trial Registry Number: 91485426.
            
          </jats:sec

Bhuvaneswari Krishnamoorthy

William R. Critchley

Alexander J. Thompson

Katherine Payne

Julie Morris

Rajamiyer V. Venkateswaran

Ann L. Caress

James E. Fildes

Nizar Yonan

Crossref

Circulation

Study Comparing Vein Integrity and Clinical Outcomes in Open Vein Harvesting and 2 Types of Endoscopic Vein Harvesting for Coronary Artery Bypass Grafting

BACKGROUND—: Current consensus statements maintain that endoscopic vein harvesting (EVH) should be standard care in coronary artery bypass surgery (CABG) but vein quality and clinical outcomes have been questioned. The Vein Integrity and Clinical Outcome (VICO) trial was designed to assess the impact of different vein harvesting methods on vessel damage and if this contributes to clinical outcomes following CABG. METHODS—: A single centre, randomised clinical trial of patients undergoing CABG with an internal mammary artery, and with one to four vein grafts were recruited. All the veins were harvested by a single experienced practitioner. We randomly allocated n=300 patients into: closed tunnel CO2 EVH (CT-EVH) (n=100), open tunnel CO2 EVH (OT-EVH) (n=100) and traditional open vein harvesting (OVH) (n=100) groups. The primary end-point was endothelial integrity and muscular damages of the harvested vein. Secondary end-points included clinical outcomes (major adverse cardiac events, MACE), use of healthcare resources and impact on health status (quality-adjusted life years, QALYs). RESULTS—: The OVH group demonstrated marginally better endothelial integrity in random samples (85% vs. 88% vs. 93% for CT-EVH, OT-EVH and OVH, p&lt;0.001). CT-EVH displayed the lowest longitudinal hypertrophy (1% vs. 13.5% vs. 3%, p=0.001). However, no differences in endothelial stretching were observed between groups (37% vs. 37% vs. 31%, p=0.62). Secondary clinical outcomes demonstrated no significant differences in composite MACE scores at each time point up to 48 months. The QALY gain per patient was: 0.11 (p&lt;0.001) for closed tunnel CO2 EVH and 0.07 (p=0.003) for open tunnel CO2 EVH compared with open vein harvesting. The likelihood of being cost-effective, at a pre-defined threshold of £20,000 per QALY gained was: 75% for closed tunnel, 19% for open tunnel and 6% for open vein harvesting. CONCLUSIONS—: Our study demonstrates that harvesting techniques do impact upon integrity of different vein layers, albeit with only a small effect. Secondary outcomes suggest that histological findings do not directly contribute to MACE outcomes. Gains in health status were observed and cost-effectiveness was better with CT-EVH. High level experience with endoscopic harvesting performed by a dedicated specialist practitioner gives optimal results which is comparable to open vein harvesting. CLINICAL TRIAL REGISTRATION—: URL: https://www.isrctn.com Unique Identifier: ISRCTN: 91485426</p

English

A Study Comparing Vein Integrity and Clinical Outcomes (VICO) in Open Vein Harvesting and Two Types of Endoscopic Vein Harvesting for Coronary Artery Bypass Grafting:The VICO Randomised Clinical Trial

https://research.edgehill.ac.uk/ws/files/20204836/Final%20submission%201%20for%20publication%20VICO.pdf

Study comparing vein integrity and clinical outcomes in open vein harvesting and 2 types of endoscopic vein harvesting for coronary artery bypass grafting:The VICO randomized clinical trial (vein integrity and clinical outcomes)

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The University of Manchester - Institutional Repository

Crossref

The University of Manchester - Institutional Repository