Intermediate-Term Outcomes of Endoscopic or Open Vein Harvesting for Coronary Artery Bypass Grafting: The REGROUP Randomized Clinical Trial.
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SUBMITTER: Zenati MA
PROVIDER: S-EPMC7961312 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:ImportanceValue-based purchasing creates pressure to examine whether newer technologies and care processes, including new surgical techniques, yield any economic advantage.ObjectiveTo compare health care costs and utilization between participants randomized to receive endoscopic vein harvesting (EVH) or open vein harvesting (OVH) during a coronary artery bypass grafting (CABG) procedure.Design, setting, and participantsThis secondary economic analysis was conducted alongside the 16-site Randomized Endo-Vein Graft Prospective (REGROUP) clinical trial funded by the Department of Veterans Affairs (VA) Cooperative Studies Program. Adults scheduled for urgent or elective bypass involving a vein graft were eligible. The first participant was enrolled in September 2013, with most sites completing enrollment by March 2014. The last participant was enrolled in April 2017. A total of 1150 participants were randomized, with 574 participants receiving OVH and 576 receiving EVH. For this secondary analysis, cost and utilization data were extracted through September 30, 2020. Participants were linked to administrative data in the VA Corporate Data Warehouse and activity-based cost data starting with the index procedure.InterventionsEVH vs OVH, with comparisons based on intention to treat.Main outcomes and measuresDischarge costs for the index procedure as well as follow-up costs (including intended and unintended events; mean [SD] follow-up time, 33.0 [19.9] months) were analyzed, with results from different statistical models compared to test for robustness (ie, lack of variation across models). All costs represented care provided or paid by the VA, standardized to 2020 US dollars.ResultsAmong 1150 participants, the mean (SD) age was 66.4 (6.9) years; most participants (1144 [99.5%] were male. With regard to race and ethnicity, 6 participants (0.5%) self-reported as American Indian or Alaska Native, 10 (0.9%) as Asian or Pacific Islander, 91 (7.9%) as Black, 62 (5.4%) as Hispanic, 974 (84.7%) as non-Hispanic White, and 6 (0.5%) as other race and/or ethnicity; data were missing for 1 participant (0.1%). The unadjusted mean (SD) costs for the index CABG procedure were $76 607 ($43 883) among patients who received EVH and $75 368 ($45 900) among those who received OVH, including facility costs, insurance costs, and physician-related costs (commonly referred to as provider costs in Centers for Medicare and Medicaid and insurance data). No significant differences were found in follow-up costs; per 90-day follow-up period, EVH was associated with a mean (SE) added cost of $302 ($225) per patient. The results were highly robust to the statistical model.Conclusions and relevanceIn this study, EVH was not associated with a reduction in costs for the index CABG procedure or follow-up care. Therefore, the choice to provide EVH may be based on surgeon and patient preferences.Trial registrationClinicalTrials.gov Identifier: NCT01850082.
| S-EPMC9214587 | biostudies-literature
Project description:We analyzed the clinical outcomes of open radial artery harvesting (OAH) and endoscopic radial artery harvesting (EAH) undergoing coronary artery bypass grafting (CABG). We designed this meta-analysis conducted using Pubmed, Medline, the Cochrane Library, and EMBASE. Articles with comparisons of OAH and EAH undergoing CABG were included. Primary outcomes included the wound infection rate, the wound complication rate, neurological complications of the forearm, in-hospital mortality, long-term survival, and the patency rate. The results of our study included six randomized controlled trials (RCTs), two non-randomized controlled trials (NRCTs) with matching, and 10 NRCTs. In total, 2919 patients were included in 18 studies, while 1187 (40.7%) and 1732 (59.3%) patients received EAH and OAH, respectively. EAH was associated with a lower incidence of wound infection (RR = 0.29, 95% confidence interval (CI) = 0.14 to 0.60, p = 0.03), and neurological complications over the harvesting site (RR = 0.41, 95% CI = 0.27 to 0.62, p < 0.0001). There was no significant difference in 30-day mortality, long-term survival (over one year), and the graft patency rate. According to our analysis, endoscopic radial artery harvesting can improve the outcome of the harvesting site, without affecting the mortality, long-term survival, and graft patency.
| S-EPMC7380611 | biostudies-literature
Project description:BackgroundTo compare the clinical outcomes, quality of saphenous vein (SV) grafts, and wound complications between endoscopic vein harvesting (EVH) technique and open vein harvesting (OVH) technique in patients with coronary artery bypass graft (CABG) surgery.MethodsWe reviewed one hundred patients with multi-vessel coronary artery disease who underwent elective CABG and agreed to preserve their SV specimens for study. Fifty patients (OVH group) underwent OVH, and the remaining (EVH group) underwent EVH. The median follow-up time was 12 months. Clinical outcomes, 1-year graft patency rates, endothelium integrity of SV grafts and wound complications were assessed.ResultsThe follow-up time was 12 [12-13] months. Recurrence of angina was observed in 5 patients, with 3 (6.1%) in EVH group and 2 (4%) in OVH group (P=0.68). The endothelium integrity of specimens before distension was similar in both the groups (EVH: 81.1%±6.11% vs. OVH: 80.8%±6.58%, P=0.83). After distension, the endothelium integrity was still similar (EVH: 70.7%±9.73%; OVH: 68.3%±9.60%; P=0.22). Grafts of 5 (11.6%) patients in EVH group were classified as occluded, and 4 (9.8%) patients in OVH group showed occlusion of SV grafts (P=1.0). After day 7, the postoperative leg pain was significantly milder in EVH group than OVH group (1.16±0.76 vs. 2.50±0.91, P<0.01).ConclusionsThese findings suggest that EVH is not associated with worse clinical outcomes or conduit quality. However, it may have advantage in wound healing.
| S-EPMC7330341 | biostudies-literature
Project description: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.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).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<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<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.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.URL: https://www.isrctn.com. International Standard Randomised Controlled Trial Registry Number: 91485426.
| S-EPMC5768238 | biostudies-literature
Project description:The incidence of surgical site infection (SSI) after open vein harvesting in coronary artery bypass grafting (CABG) patients ranges in different studies between 2 and 20%. Triclosan is an antibacterial substance that reduces the growth of bacteria by inhibiting fatty acid synthesis. We hypothesized that wound closure with triclosan-coated sutures would reduce SSI after open vein harvesting.An investigator-initiated prospective randomized double-blind single-centre study was performed with 374 patients, randomized to subcutaneous and intracutaneous leg-wound closure with either triclosan-coated sutures (Vicryl Plus and Monocryl Plus, Ethicon, Somerville, NJ, USA) (n = 184) or identical sutures without triclosan (n = 190) from the same manufacturer. All patients were followed up after 30 days (clinical visit) and 60 days (telephone interview). Primary endpoint was SSI within 60 days after surgery according to the definition of Center for Disease Control. Predefined secondary endpoints included culture-proven and antibiotic-treated SSI.The primary endpoint occurred in 23 patients (12.5%) with triclosan-coated sutures and in 38 patients (20.0%) in the group without triclosan (P = 0.0497, risk ratio 0.63, (95% confidence interval 0.39-1.00). Corresponding figures for culture-proven infections were 7.6 vs 12.1%, (P = 0.15), and for antibiotic-treated infections, 10.9 vs 18.4%, (P = 0.039). Staphylococcus aureus and coagulase-negative staphylococci were the most common pathogens in both groups. Insulin-treated diabetes and vein-harvesting time were associated with SSI after vein harvesting.Leg-wound closure with triclosan-coated sutures in CABG patients reduces SSIs after open vein harvesting. (ClinicalTrials.gov number NCT01212315).
| S-EPMC3794438 | biostudies-literature
Project description:Background and aim of the studyMany studies support that the no-touch (NT) procedure can improve the patency rate of vein grafts. However, it is not clear that the sequential vein graft early expansion in the NT technique during off-pump coronary artery bypass grafting (CABG). This study will explore this issue.MethodsThis was a prospective single-center randomized controlled clinical trial. A total of 100 patients undergoing off-pump CABG with the sequential saphenous graft were randomly assigned to two groups: the NT and conventional (CON) groups. Perioperative and postoperative data were collected during the hospital stay. The mean diameter of sequential grafts was measured using cardiac computed tomography angiography 3 months after the operation.ResultsThere was a significant difference in the average diameter of sequential grafts between the two groups (NT: [2.98 ± 0.42], CON: [3.26 ± 0.51], p = .005). There was no difference in occlusion of sequential venous grafts between the two groups (NT: 4/48 [8.3%], CON: 5/49 [10.2%], p = 1.000). There were differences in surgery time between the two groups (NT: 220 [188,240], CON: 190 [175,230], p = .009).ConclusionsThe sequential graft early expansion in the NT technique is not as pronounced as that in the conventional technique, which may have a long-term protective effect on the grafts.
| S-EPMC8252464 | biostudies-literature
Project description:BackgroundCoronary artery bypass grafting (CABG) using saphenous vein grafts (SVG) is vitiated by poor long-term patency of the vein grafts. Pedicled SVG harvested with the "no-touch" (NT) technique have demonstrated improved patency and could confer better outcomes. We aim to compare long-term results after CABG where NT or conventional technique was used for vein graft harvesting in a hypothesis-generating registry-based study.MethodsTwo propensity score matched cohorts (1349 patients) undergoing CABG with veins harvested with NT (NTT) or conventional (CT) technique in Sweden over the period 2005-2015 were used to compare long-term outcomes. Mortality, postoperative incidence of coronary angiography and need for reintervention was recorded and multivariable hazard ratios adjusted for risk factors were calculated.ResultsThe mean follow-up time (SD) was 6.8 (3.3) years for NTT and 6.6 (3.2) years for CT. The adjusted hazard ratios for death, first angiography and need for reintervention for NTT patients were (95% CI) 0.97 (0.80-1.19), 0.76 (0.63-0.93), 0.91 (0.78-1.05), and 0.91 (0.71-1.17), respectively. Failed grafts were found in 43.2% of NTT patients and 53.6% of CT patients at angiography.ConclusionsIn this study NT grafting was associated with a lower risk for repeat angiography, however no difference could be observed for mortality and need for reintervention. The earlier reported improvements in patency of NT veins could possibly be reflected in an improved clinical outcome during the first 10 years after surgery.
| S-EPMC6258143 | biostudies-literature
Project description:In coronary artery bypass grafting surgery, arterial conduits are preferred because of more favourable long-term patency and outcome. Anyway the greater saphenous vein continues to be the most commonly used bypass conduit. Minimally invasive endoscopic saphenous vein harvesting is increasingly being investigated in order to reduce the morbidity associated with conventional open vein harvesting, includes postoperative leg wound complications, pain and patient satisfaction. However, to date the short and the long-term benefits of the endoscopic technique remain controversial. This study provides an interesting opportunity to address this gap in the literature.Endoscopic Saphenous harvesting with an Open CO2 System trial includes two parallel vein harvesting arms in coronary artery bypass grafting surgery. It is an interventional, single centre, prospective, randomized, safety/efficacy, cost/effectiveness study, in adult patients with elective planned and first isolated coronary artery disease. A simple size of 100 patients for each arm will be required to achieve 80% statistical power, with a significant level of 0.05, for detecting most of the formulated hypotheses. A six-weeks leg wound complications rate was assumed to be 20% in the conventional arm and less of 4% in the endoscopic arm. Previously quoted studies suggest a first-year vein-graft failure rate of about 20% with an annual occlusion rate of 1% to 2% in the first six years, with practically no difference between the endoscopic and conventional approaches. Similarly, the results on event-free survival rates for the two arms have barely a 2-3% gap. Assuming a 10% drop-out rate and a 5% cross-over rate, the goal is to enrol 230 patients from a single Italian cardiac surgery centre.The goal of this prospective randomized trial is to compare and to test improvement in wound healing, quality of life, safety/efficacy, cost-effectiveness, short and long-term outcomes and vein-graft patency after endoscopic open CO2 harvesting system versus conventional vein harvesting.The expected results are of high clinical relevance and will show the safety/efficacy or non-inferiority of one treatment approach in terms of vein harvesting for coronary artery bypass grafting surgery.www.clinicalTrials.gov NCT01121341.
| S-EPMC3261821 | biostudies-literature
Project description:BACKGROUND:Advancements in surgical robotic technology over the last two decades have enabled coronary artery bypass grafting to be performed totally endoscopically, and have the potential to significantly change clinical practice in the future. METHODS:A systematic review of studies reporting clinical outcomes of total endoscopic coronary artery bypass grafting (TECABG) was performed. RESULTS:14 appraised studies included 880 beating heart TECABGs, 360 arrested heart TECABGs, 633 one-vessel operations and 357 two-vessel operations. Patients were generally low-risk. There was a significant learning curve. The weighted means for short-term beating heart and arrested heart TECABG results respectively were: intraoperative exclusion rate of 5.7% and 1.9%, intraoperative conversion rate of 5.6% and 15.0%, all-cause mortality of 1.2% and 0.4%, stroke of 0.7% and 0.8%, myocardial infarction of 0.8% and 1.8%, new onset atrial fibrillation of 10.7% and 5.1% and post-operative reintervention rate of 2.6% and 2.3%. The overall rate of short term postoperative graft patency for beating heart and arrested heart TECABG was 98.3% and 96.4% respectively. CONCLUSIONS:Appropriate patient selection was important in minimizing the risk of intraoperative and postoperative complications. Short-term outcomes of both beating and arrested heart TECABG were acceptable, but results so far have been heterogeneous. There were fewer studies reporting intermediate to long-term outcomes, but results were encouraging, and further investigation and development of the procedure is warranted.
| S-EPMC3741883 | biostudies-literature
Project description: Not available
| S-EPMC8690331 | biostudies-literature