Flushing of the GSV tunnel with bupivacaine plus adrenaline significantly reduces postoperative pain and haematoma formation in patients undergoing GSV stripping for varicose veins.
Background: Critical limb ischemia (CLI) is the most severe manifestation of peripheral vascular disease. Revascularization is the preferred therapy, but it is not achievable in 25%À40% of patients due to diffuse anatomic distribution of the disease or medical comorbidities. No-option CLI represents an unmet medical need. Mesenchymal stromal cells (MSCs) may provide salvage therapy through their angiogenic and tissue-trophic properties. This article reports a phase 1b clinical study examining the safety and feasibility of intramuscular transplantation of autologous bone-marrow MSCs for patients with no-option CLI. Methods: Twelve patients were enrolled in the clinical trial, and nine proceeded to bone marrow aspiration and culture expansion of MSCs. Results: A high rate of karyotype abnormality (>30%) was detected in the produced cell batches, resulting in failure of release for clinical administration. Four patients were treated with the investigational medicinal product (IMP), three with a low dose of 20 £ 10 6 MSCs and one with a mid-dose of 40 £ 10 6 MSCs. There were no serious adverse events related to trial interventions, including bone marrow aspiration, IMP injection or therapy. Conclusions: The results of this trial conclude that an autologous cell therapy approach with MSCs for critical limb ischemia is limited by the high rate of karyotype abnormalities.
WHAT THIS PAPER ADDS Debate continues regarding the timing of adjunctive interventions for superficial varicose tributaries following truncal ablative techniques. These data coalesce a large, heterogenous evidence base, for a widely performed intervention, suggesting that concomitant treatment of truncal and superficial varicose tributaries potentially offers lower rates of re-intervention with similar rates of complications. Furthermore, treatment results in improvements in both disease severity and quality of life. However, data from randomised trials assessing this hypothesis are limited, and further well designed trials are required to definitively address this challenge.Objective: This review compares the outcomes of both concomitant and staged superficial varicose tributary (SVT) interventions as an adjunct to endovenous truncal ablation. Methods: A systematic search of Medline through Pubmed, Embase, and the Cochrane Central Register of Controlled Trials was last performed in November 2019. All studies comparing the outcomes of both concomitant and staged treatments for SVT as an adjunct to endovenous truncal ablation were included. Each included study was subject to an evaluation of methodological quality using the Downs and Black assessment tool. Outcomes assessed included rates of re-intervention, complications, and thrombotic events. Quality of life (QOL) and disease severity were also analysed. Data were pooled with a random effects model. Results: Fifteen studies (6 915 limbs) were included for analysis. Included studies were of reasonable methodological quality. Re-intervention rates were significantly lower in the concomitant group (6.3% vs. 36.1%) when compared with staged intervention (relative risk [RR] 0.21 [95% CI 0.07e0.62], p ¼ .004, I 2 ¼ 90%, p .001). Reported complications (RR 1.14 [95% CI 0.67e1.93], p ¼ .64) and rates of deep venous thrombosis (RR 1.41 [95% CI 0.72e2.77] p ¼ .31) were similar in each group. Overall disease severity (Venous Clinical Severity Score) was lower in the concomitant group (À1.16 [95% CI, À1.97e À0.35] p ¼ .005), while QOL, assessed using the Aberdeen Varicose Vein Questionnaire, favoured concomitant treatment when measured at less than three months (weighted mean difference [WMD] À3.6 [95% CI, À7.17e À0.03] p ¼ .050) and between three and 12 months (WMD -1.61 [95% CI, À2.99e À0.23] p ¼ .020). Conclusion:Concomitant and staged treatments are safe and effective. Improvements in early disease severity and QOL scores were better in the concomitant group. While meta-analysis suggests that concomitant intervention offers significantly lower rates of re-intervention, studies assessing its merits are subject to some biases. This benefit was not reflected by the randomised trial subgroup analysis, which identified no difference in re-intervention.
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