Meta-Analysis of Duplex Surveillance Following Lower Limb Endovascular Intervention.

Abstract

The aim of this systematic review was to identify the evidence in the literature for limb salvage with the introduction of duplex surveillance. A systematic review and meta-analysis was performed using the Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines (PRISMA) methodology for all studies which compared a group undergoing clinical surveillance with a group undergoing combined clinical and duplex surveillance after endovascular therapy for peripheral arterial disease. MEDLINE, EMBASE, the Cochrane Database for Systematic Reviews, and ClinicalTrials.gov were searched for relevant studies by 2 reviewers. Studies were quality assessed using the ROBINS-I tool. An individual patient data survival analysis and meta-analysis for 1- and 2-year amputation outcomes using a random-effects model were performed. Two low-quality nonrandomized studies met the inclusion criteria. There was a statistically and clinically significant reduction in major amputation in patients undergoing combined clinical and duplex surveillance (log-rank p<0.001). The number needed to treat to prevent 1 amputation at 2 years was 5 patients. At 1 year, the odds ratio (OR) for amputation was 0.22, 95% confidence interval (CI)=0.10-0.48, with no statistical heterogeneity. At 2 years, the numbers of patients were low and the effect on amputation was less certain OR=0.25, 95% CI=0.04-1.58. Preliminary, low-quality data suggests that there may be a clinically significant reduction in major amputation with the introduction of duplex surveillance. It is recommended that a randomized controlled trial is performed to confirm these findings and identify the anatomical subgroups that benefit the most from surveillance. "Two low-quality studies reveal a significant clinical impact: combined clinical and duplex surveillance markedly reduces major amputations (log-rank p<0.001). At 1-year, the odds ratio for amputation is 0.22 (95% CI=0.10-0.48), emphasizing limb salvage benefits. Despite less certainty at 2-years, a notable absolute risk reduction of 19% is seen, with a number needed to treat of 5. This underscores the urgent need for a randomized controlled trial to validate findings and identify key subgroups. The meta-analysis strongly advocates implementing duplex surveillance for a year post-endovascular interventions, especially in patients fit for reintervention, with important considerations for cost-effectiveness and focused clinical trials."