Abstract

Efficacy and safety assessment of lymphovenous anastomosis in patients with primary and secondary lymphoedema: A systematic review of prospective evidence

Katharina Rosian BSc, MSc1 | Michal Stanak AKC, MA1,2. Microsurgery. 2019;1–10

Introduction: Lymphoedema is a chronic, debilitating condition caused by an affected lymphatic system. Supermicrosurgical techniques like lymphovenous anastomosis (LVA) have gained popularity because of its minimal invasiveness, better aesthetic outcome, and lower costs in comparison to physical medicine. This systematic review aims to evaluate the clinical effectiveness and safety of LVA in comparison to conservative or other surgical treatments for primary or secondary lymphoedema patients.

Materials and Methods: A systematic literature search was performed in four databases in December 2017. We applied a methodological framework based on the HTA Core Model®. According to the grading of recommendations, assessment, development, and evaluation (GRADE) scheme, we synthesized the data on each selected outcome category. The studies were systematically assessed for risk of bias (RoB) using the Risk of Bias Assessment tool for Non-randomized controlled studies (RoBANS) and the Institute of Health Economics (IHE) Risk of Bias checklist for case series.

Results: A total of 629 citations were identified and five studies were assessed eligible for final inclusion (one non-randomized controlled trial and four prospective single-arm studies). Across the studies, 217 patients were enrolled. All studies showed a moderate to high RoB. The strength of evidence for the effectiveness and safety of LVA is “very low.” Due to the methodological shortcomings of the available evidence, no conclusions can be made about the effectiveness of the procedure.

Conclusion: LVA might be a safe technique for patients with primary and secondary lymphoedema—particularly because no serious complications were reported. Furthermore, LVA may have a role in the prevention of lymphoedema.

Main findings

• N = 217
• The included studies in this report demonstrate mixed results following the LVA procedures and the quality of these studies varies.
• A major concern of most of the identified prospective interventional single-arm studies is the low number of included patients (see Table 3). For instance, one study included only 10 patients (Damstra et al., 2009). In order to identify rare procedure related adverse events, low patient numbers are insufficient. Moreover, only one study had a longer follow-up period of 12 months (Chang et al., 2013). Therefore, reliable data of long-term safety and efficacy outcomes are missing.
• Patient-relevant outcomes, such as QoL were only described in uncontrolled studies and inconsistently reported (e.g., different measurement scales).
• with imaging modalities such as ICG lymphography the identification of suitable (healthy and functioning) lymphatic vessels for LVA procedures may be improved and the patency of the anastomosis can be improved.
• According to the literature, there seem to be two factors that determine the effectiveness of LVA: the identification of viable lymphatic vessels and the extent of tissue fibrosis related to lymphoedema (Chang, 2010).
• The present systematic review indicates that only limited evidence reporting the clinical effectiveness and safety of LVA procedures for patients with lymphoedema is presently available. Nevertheless, we identified three ongoing studies (two RCTs and one pilot study) that might show effects of LVA with a higher quality of evidence.
• The included studies showed poor quality of evidence and high risk of bias, and therefore makes it difficult to draw a reliable conclusion on the clinical effectiveness of LVA.
• There is a need for high-quality studies to confirm the consistent positive findings based on observational evidence with respect to limb volume reduction. Furthermore, there is a need to find the optimal lymphoedema management algorithm and to determine the exact patient group that would benefit most from the procedure. New study results based on a high-qualityRCT will potentially influence the effect estimate considerably.