3 Committee considerations

3 Committee considerations

The evidence

3.1

NICE did a rapid review of the published literature on the efficacy and safety of this procedure. This comprised a comprehensive literature search and detailed review of the evidence from 12 sources, which was discussed by the committee. The evidence included 4 systematic reviews, 1 randomised controlled trial, 1 prospective study and 6 retrospective cohort studies. It is presented in the summary of key evidence section in the interventional procedures overview. Other relevant literature is in the appendix of the overview.

3.2

The professional expert and the committee considered the key efficacy outcomes to be: a reduction in secondary lymphoedema and technical success of lymphovenous anastomosis.

3.3

The professional expert and the committee considered the key safety outcomes to be: pain, bleeding, infection, overall survival and disease-free survival.

3.4

Patient commentary was sought but none was received.

Committee comments

3.5

Current treatments for lymphoedema, such as manual lymphatic drainage and compression garments, are often uncomfortable, time-consuming and need to be lifelong. This procedure has the potential to improve a person's quality of life and could have other benefits such as reduced hospitalisation.

3.6

There has been limited uptake of the lymphatic microsurgical preventive healing approach (LYMPHA) in the UK. The clinical expert explained that this is mainly because it needs to be done with specialist equipment by microsurgery-trained surgeons. There is a simplified version of the procedure (S‑LYMPHA) that can be done by the operating breast surgeon (without microsurgical training) and does not need specialist equipment. But most of the evidence is for LYMPHA and not S‑LYMPHA.

3.7

The clinical expert explained that lymphatic reconstruction may potentially increase the risk of metastatic disease if the procedure is done for lower limb (non-central) cancers such as malignant melanomas, and that more safety evidence is needed.

3.8

The clinical expert advised that studies with 5‑year follow up are needed to better establish the safety and efficacy of the procedure.

3.9

Patient consent should include that additional operating time is needed for this procedure, and that it is still possible that lymphoedema may develop.

ISBN: 978-1-4731-5887-0