This section describes safety outcomes from the published literature that the Committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the interventional procedure overview.
5.1 The systematic review and meta-analysis of 44 studies reported a lower incidence of 30‑day mortality in patients treated by endoscopic saphenous vein harvest than in patients who had open saphenous vein harvest (log-relative risk 0.71, 95% CI 0.56 to 0.90, p=0.005). This difference was no longer statistically significant when only randomised controlled trials were analysed (log-relative risk 0.75, 95% CI 0.27 to 2.11, p=0.58). In-hospital mortality was 1% after both endoscopic and open saphenous vein harvest in the non-randomised comparative study of 4709 patients (2665 propensity-matched patients [533 versus 2132]). Mortality within 30 days occurred in 2% of patients treated by endoscopic saphenous vein harvest and 4% of patients treated by open saphenous vein harvest in the non-randomised comparative study of 1988 patients (478 propensity-matched patients, p=0.26).
5.2 Wound infection was reported in a lower proportion of patients treated by endovascular vein harvest than in patients treated by open saphenous vein harvest in the systematic review of 44 studies (log-relative risk 0.31, 95% CI 0.23 to 0.42, p<0.0001, I2=43%). A similar result was reported from the analysis of randomised controlled trials only (log-relative risk 0.26, 95% CI 0.15 to 0.44, p<0.0001). Wound infection was reported in less than 1% of patients treated by endoscopic saphenous vein harvest and 2% of patients treated by open saphenous vein harvest in the non-randomised comparative study of 1988 patients (p=0.03).
5.3 Severe leg wound complications needing surgical revision were reported in 1% and 2% of patients treated by endoscopic and open saphenous vein harvest respectively (p=not significant) in the non-randomised comparative study of 885 patients.
5.4 Necrotising fasciitis was reported in 1 patient in a case report. The patient developed symptoms 3 weeks after the procedure, and surgical exploration of the wound showed extensive necrosis. Treatment included radical debridement, intravenous antibiotics followed by oral antibiotics, and a split-thickness skin graft.
5.5 Compartment syndrome was reported in 1 patient in a case report. Symptoms of leg tightness, swelling and tenderness occurred 4 days after the procedure. A fasciotomy was performed to decompress all 4 compartments of the lower leg. By 3 months, the patient had recovered without any neurological sequelae.
5.6 Massive carbon dioxide (CO2) embolisation was reported in 2 patients in a case series of 405 patients: 1 patient was successfully treated pharmacologically and the other needed emergency cardiopulmonary bypass support to complete the coronary artery bypass graft surgery.
5.7 A case report described scrotal distension due to CO2 and signs of cellulitis in 1 patient following endoscopic saphenous vein harvesting. The patient was treated with antibiotics and discharged after 14 days.
5.8 Pneumoperitoneum was reported in 1 patient in a case report. Postoperative chest X‑ray showed a complete resorption of CO2.
5.9 The specialist advisers described the possibility that endoscopic saphenous vein harvest might result in damage to the vein, which could decrease patency and lead to increased rates of postoperative myocardial infarction, mid-term myocardial infarction, mid-term mortality, recurrence of angina, repeat revascularisation rates and decreased survival over the long term.