A Randomized Trial of External Stenting for Saphenous Vein Grafts in Coronary Artery Bypass Grafting

Taggart, David P.; Gal, Yanai Ben; Lees, Belinda; Patel, Niket; Webb, Carolyn; Rehman, Syed M.; DeSouza, Anthony; Yadav, Rashmi; Robertis, Fabio De; Dalby, Miles; Banning, Adrian P.; Channon, Keith M.; Mario, Carlo Di; Orion, Eyal

doi:10.1016/j.athoracsur.2015.01.060

Cited by 98 publications

(96 citation statements)

References 22 publications

(19 reference statements)

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“…The vortex count of areas with visibly complex flow was significantly higher in the non-stented group. Since local turbulence is generated mainly by lumen irregularities, these findings coincide with the fact that the stented SVGs demonstrate more uniform lumens and less ectatic segments (15).…”

Section: Systematic Methodology Was Developed For 3d Reconstruction Omentioning

confidence: 54%

“…As previously described (15), the Venous External Support Trial randomized 30 patients in a prospective, multi-center study. The study was approved by a UK Research Ethics Committee and all subjects gave informed consent.…”

Section: Methodsmentioning

confidence: 99%

“…Quantitative angiography analysis and IVUS As previously described (15), quantitative coronary angiography was performed for all patent SVGs.…”

Section: Methodsmentioning

confidence: 99%

“…We report here the application of Computational Fluid Dynamics (CFD) analysis to geometrical models of SVGs based on angiographic imaging and quantitative analysis data from the Venous External Support Trial (15). CFD coupled with imaging technologies have previously been employed to investigate blood flow patterns (16).…”

Section: Introductionmentioning

confidence: 99%

“…The VEST (Vascular Graft Solutions Ltd, Tel Aviv, Israel) is a kink resistant cobalt-chromium braided mesh, applied externally to the vein graft during surgery. The VEST was evaluated in both pre-clinical testing and a randomized controlled clinical study, and was shown to significantly reduce SVG's diffuse intimal hyperplasia and to improve lumen uniformity (14)(15).…”

Section: Introductionmentioning

confidence: 99%

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Flow patterns in externally stented saphenous vein grafts and development of intimal hyperplasia

Meirson

Orion²,

Mario

et al. 2015

The Journal of Thoracic and Cardiovascular Surgery

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Section: Systematic Methodology Was Developed For 3d Reconstruction Omentioning

confidence: 54%

Section: Methodsmentioning

confidence: 99%

“…Quantitative angiography analysis and IVUS As previously described (15), quantitative coronary angiography was performed for all patent SVGs.…”

Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Flow patterns in externally stented saphenous vein grafts and development of intimal hyperplasia

Meirson

Orion²,

Mario

et al. 2015

The Journal of Thoracic and Cardiovascular Surgery

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External Support for Saphenous Vein Grafts in Coronary Artery Bypass Surgery

Goldstein

Puskas²,

Alexander

et al. 2022

JAMA Cardiol

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and subsequent saphenous vein graft failure may have significant adverse clinical effects in patients undergoing coronary artery bypass surgery. External support of saphenous vein grafts has the potential to prevent vein graft dilation and hence slow the rate of intimal hyperplasia and increase long-term vein patency.OBJECTIVE To determine efficacy, as measured by intimal hyperplasia, and safety of an external saphenous vein graft support device in patients undergoing a coronary bypass graft procedure. DESIGN, SETTING, AND PARTICIPANTS This within-patient randomized, open-label, multicenter study was conducted at 17 Cardiothoracic Surgical Trials Network centers in North America. Between January 2018 and February 2019, 224 patients with multivessel coronary artery disease undergoing isolated bypass surgery were enrolled. For each patient, 1 of 2 vein grafts was randomized to receive external support or no support. INTERVENTIONS External vein graft support or no support. MAIN OUTCOMES AND MEASURESThe primary efficacy end point was intimal hyperplasia area assessed by intravascular ultrasound at 12 months postrandomization for each study graft. Secondary confirmatory end points were lumen diameter uniformity assessed by angiography and graft failure (Ն50% stenosis) by quantitative coronary angiography. Major cardiac and cerebrovascular events were collected through month 12.RESULTS Among 224 patients (mean [SD] age, 65.8 [8.3] years; 178 [79.5%] male), 203 (90.6%) were eligible for intravascular ultrasound, of which 85 (41.9%) had at least 1 study graft occluded or severely diseased at 12 months (55 supported, 56 unsupported). After imputation of data missing because of graft occlusion or severe disease, the estimated mean (SE) intimal hyperplasia area was 5.11 (0.16) mm 2 in supported grafts and 5.79 (0.20) mm 2 in unsupported grafts (P = .07). In a sensitivity analysis of 113 patients with both grafts imaged, the mean intimal hyperplasia area was 4.58 (0.18) mm 2 and 5.12 (0.23) mm 2 in supported and unsupported grafts, respectively (P = .04). By 12 months, 5 patients (2.2%) died and 16 patients (7.1%) experienced a major cardiac or cerebrovascular event.CONCLUSIONS AND RELEVANCE The 12-month difference in intimal hyperplasia area between supported and unsupported grafts did not achieve statistical significance. Cumulative mortality and major cardiac or cerebrovascular events rates were similar to those in other randomized coronary artery bypass trials. Further investigation to assess the effect of external graft support devices on long-term graft patency and clinical outcomes is warranted.

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3D Elastomeric Stent Functionalized with Antioxidative and Perivascular Tissue Regenerative Activities Ameliorated PVT Deprivation‐Induced Vein Graft Failure

Wang

Xiao

et al. 2023

Adv Healthcare Materials

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Clinically, arterial injuries are always accompanied with perivascular tissue damage, which may contribute to high failure rate of vein grafts due to intimal hyperplasia and acute thrombosis. In this study, a “perivascular tissue (PVT) deprivation” animal model is constructed to mimic clinical scenarios and identify the contribution of arterial PVT to the success of vein grafts. Proteomics analysis suggests that depriving PVT may exacerbate reactive oxygen species (ROS)‐induced endothelial apoptosis by up‐regulating inflammation response and oxidative stress. Locally administering metformin on vein grafts through 3D‐printed external stent (PGS‐PCL) shows antioxidative and anti‐inflammatory properties to protect cells from ROS invasion, thereafter decreasing acute thrombosis. Moreover, metformin induce rapid regeneration of perivascular adipose tissue in recipient regions, which improves patency by inhibiting intimal hyperplasia. Proteomics, western blot, and in vitro blocking tests reveal that metformin resists endothelial apoptosis through AMPK/mTOR and NFκB signaling pathways. To conclude, PVT deprivation exacerbates inflammatory response and oxidative stress in vein grafts bridging arterial circulation. Metformin‐loaded stent ameliorates “PVT damage” related vein graft failure, and enhances patency of through resisting endothelial apoptosis and regenerating arterial PVAT, offering a promising avenue to improve the success of vein grafts in clinic.

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A Randomized Trial of External Stenting for Saphenous Vein Grafts in Coronary Artery Bypass Grafting

Cited by 98 publications

References 22 publications

Flow patterns in externally stented saphenous vein grafts and development of intimal hyperplasia

Flow patterns in externally stented saphenous vein grafts and development of intimal hyperplasia

External Support for Saphenous Vein Grafts in Coronary Artery Bypass Surgery

3D Elastomeric Stent Functionalized with Antioxidative and Perivascular Tissue Regenerative Activities Ameliorated PVT Deprivation‐Induced Vein Graft Failure

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