External Support for Saphenous Vein Grafts in Coronary Artery Bypass Surgery

Abstract

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.

External stenting for saphenous vein grafts in coronary artery bypass grafting: A meta‐analysis

“…We further analysed the different SVG territories, and the results showed that the graft failure rates in the right territory were higher in the external stented group compared to the non-stented group (RR: 1.73, 95% CI: 1.07 to 2.80, p = 0.02, I 2 = 8%, Figure 3B). 17,19 However, in the left territory, the difference did not reach statistical significance in two groups (RR: 0.85, 95% CI: 0.58 to 1.25, p = 0.41, I 2 = 19%, Figure 3A). The heterogeneity was not obvious, and sensitivity analyses were not performed to detect the source of this statistical heterogeneity.…”

“…Two studies 17,19 reported SVG failure rates (≥ 50% stenosis); the results showed that the external support device for SVGs did not increase the overall SVG failure rate compared with non-stented group (RR: 1.14, 95% CI: 0.85 to 1.52, p = 0.38, I 2 = 0%, Figure 2D). The heterogeneity was low based on the heterogeneity test (I 2 = 0%).…”

“…All three included studies 16,17,19 reported the intimal hyperplasia area and thickness assessed by IVUS. According to the meta-analysis, the external support devices for SVGs showed a significant reduction in intimal hyperplasia area (MD:−0.78, 95% CI: −1.11 to −0.45, p < 0.001, I 2 = 0%, Figure 2A) and thickness (MD:−0.06, 95% CI: −0.08 to −0.04, p < 0.001, I 2 = 0%, Figure 2B) compared to nonstented SVGs, and the heterogeneity of the statistically significant evidence was low (I 2 = 0.0%).…”

“…15,16 However, the latest RCT with the largest sample reported that the difference in the intimal hyperplasia area did not reach statistical significance. 17 For this reason, the efficacy of the external support devices remains controversial, and, to date, there has been no systematic review or metaanalysis on the use of external support devices for SVGs in CABG. Therefore, we collected data from previous RCTs and performed a meta-analysis to investigate the efficacy and safety of external support devices for SVGs in CABG.…”

Effect of Prehabilitation on Patient’s Undergoing Coronary Artery Bypass Graft Outcomes

“…Patients who have three-diseased vessel, with left ventricular ejection fractions (LVEF) > 3%, or severe disease in the left main corona artery are candidates for the CABG operation. Compared to medicinal therapy or percutaneous procedures like angioplasty or stents, surgical revascularization (CABG) has lower longterm morbidity and mortality rates, (Goldstein et al, 2022). The degree of issues linked to CABG surgery can shed light on patients' and nurses' opinions regarding that leg and chest wounds, drugs, and complications were the most critical learning needs for the patients relative to other domains.…”