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.

Bhuvaneswari Bibleraaj, William Critchley, Alexander Thompson, Katherine Payne, Julie Morris, Rajamiyer Venkateswaran, Ann Caress, James Fildes, INizar Yonan

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Abstract

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<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<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. Conclusion: 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.
Original languageEnglish
Pages (from-to)1688-1702
JournalCirculation
Volume136
Early online date21 Jun 2017
DOIs
Publication statusPublished - 31 Oct 2017

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Coronary Artery Bypass
Veins
Randomized Controlled Trials
Quality-Adjusted Life Years
Health Status
Mammary Arteries
Hypertrophy
Cost-Benefit Analysis

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Bibleraaj, Bhuvaneswari ; Critchley, William ; Thompson, Alexander ; Payne, Katherine ; Morris, Julie ; Venkateswaran, Rajamiyer ; Caress, Ann ; Fildes, James ; Yonan, INizar. / 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. In: Circulation. 2017 ; Vol. 136. pp. 1688-1702.
@article{b1aac13851d540539a34e101e254b06a,
title = "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.",
abstract = "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<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<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. Conclusion: 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.",
author = "Bhuvaneswari Bibleraaj and William Critchley and Alexander Thompson and Katherine Payne and Julie Morris and Rajamiyer Venkateswaran and Ann Caress and James Fildes and INizar Yonan",
year = "2017",
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language = "English",
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pages = "1688--1702",
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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. / Bibleraaj, Bhuvaneswari; Critchley, William; Thompson, Alexander; Payne, Katherine; Morris, Julie; Venkateswaran, Rajamiyer; Caress, Ann; Fildes, James; Yonan, INizar.

In: Circulation, Vol. 136, 31.10.2017, p. 1688-1702.

Research output: Contribution to journalArticle

TY - JOUR

T1 - 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.

AU - Bibleraaj, Bhuvaneswari

AU - Critchley, William

AU - Thompson, Alexander

AU - Payne, Katherine

AU - Morris, Julie

AU - Venkateswaran, Rajamiyer

AU - Caress, Ann

AU - Fildes, James

AU - Yonan, INizar

PY - 2017/10/31

Y1 - 2017/10/31

N2 - 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<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<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. Conclusion: 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.

AB - 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<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<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. Conclusion: 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.

U2 - 10.1161/CIRCULATIONAHA.117.028261

DO - 10.1161/CIRCULATIONAHA.117.028261

M3 - Article

VL - 136

SP - 1688

EP - 1702

JO - Circulation

JF - Circulation

SN - 0009-7322

ER -