Endoscopic Saphenous harvesting with an Open CO2 System (ESOS) trial for coronary artery bypass grafting surgery: study protocol for a randomized controlled trial

<p>Abstract</p> <p>Background</p> <p>In coronary artery bypass grafting surgery, arterial conduits are preferred because of more favourable long-term patency and outcome. Anyway <it>the greater saphenous vein </it>continues to be the most commonly used bypass conduit. <it>Minimally invasive endoscopic saphenous vein harvesting </it>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.</p> <p>Methods/Design</p> <p><b>Endoscopic Saphenous harvesting with an Open CO₂System </b>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.</p> <p>Discussion</p> <p>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 CO₂harvesting system versus conventional vein harvesting.</p> <p>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.</p> <p>Trial registration</p> <p>www.clinicalTrials.gov <a href="http://www.clinicaltrials.gov/ct2/show/NCT01121341">NCT01121341</a>.</p

Prospective randomized study comparing the Teleflex Medical SaphLITE Retractor to the Ethicon CardioVations Clearglide Endoscopic System

BACKGROUND: Several minimally invasive saphenous vein harvesting techniques have been developed to reduce morbidities associated with coronary artery bypass grafting. This prospective, randomized study was designed to compare two commonly used minimally invasive saphenous vein harvesting techniques, the SaphLITE Retractor System (Teleflex Medical) and the Clearglide Endoscopic Vessel Harvesting System (Ethicon CardioVations, Inc.). METHODS: Between January 2003 and March 2004, a total of 200 patients scheduled for primary, nonemergent coronary artery bypass grafting, with or without concomitant procedures were randomized into two groups: SaphLITE (n = 100) and Clearglide (n = 100). Pre-, intra- and postoperative data was collected and subjected to statistical analysis. Randomization provided homogenous groups with respect to preoperative risk factors. RESULTS: Harvest location for the SaphLITE group was thigh (n = 40), lower leg (n = 5) and both lower leg and thigh (n = 55). The location of harvest for the Clearglide group was thigh (n = 3), lower leg (n = 16) and both lower leg and thigh (n = 81). The mean incision length was 3.6 cm (range, 2–6) in the SaphLITE group versus 2.1 cm (range, 1–4) in the Clearglide group (p < 0.05). The total incision length was 12.9 cm versus 8.9 (p < 0.05) in the SaphLITE and Clearglide groups. Conversion to the open technique occurred in 5 SaphLITE patients and 7 Clearglide patients. Intraoperative leg exploration for bleeding occurred in two of the Clearglide patients and none of the SaphLITE patients. Post-operative complications specifically related to minimally invasive harvesting technique, including a two-week post-discharge visit, were not statistically different between the groups. CONCLUSION: The saphenous vein can be safely harvested utilizing the SaphLITE and Clearglide systems. While the Clearglide system allows for fewer incisions (number and length) and less harvest time, these benefits may be outweighed by the increased cost of the Clearglide system compared to the SaphLITE retractor