Specialist commentator comments

Comments on this technology were invited from clinical experts working in the field and relevant patient organisations. The comments received are individual opinions and do not represent NICE's view.

Comments were received from 3 specialists, all of whom had used this technology before. One had used it as part of a research trial.

Level of innovation

All commentators agreed that the technology is innovative, with 2 noting it represents a novel concept or design.

One commentator felt that while it is innovative, the L‑Dex U400 is not the only product that allows early detection of subclinical lymphoedema. This is because there is no consensus on the definition of subclinical lymphoedema and it could be argued that early changes can be detected with a tape measure or perometry.

Potential patient impact

One commentator stated the L‑Dex U400 may be of particular benefit for people with a significant risk of developing lymphoedema, such as people who have had axillary clearance. This is needed for fewer than 20% of women with breast cancer.

One commentator felt that using the L‑Dex U400 could lead to earlier and more effective treatment of lymphoedema. However, another commentator stated that there is currently no evidence that early treatment of subclinical lymphoedema has any impact on its development.

Another commentator added that if shown to be effective, the device could improve lymphoedema services and lead to fewer hospital visits for patients. However, another commentator suggested that it would lead to significantly more hospital visits for patients who were at risk of lymphoedema, and would only benefit a small number of patients at risk of arm swelling.

Potential system impact

Commentators agreed that training would be needed to use this technology; 2 stated that this would be minimal. One commentator clarified that a healthcare assistant or nurse would be able to use the device after around 60 to 90 minutes of training and observation.

One commentator noted that the L‑Dex U400 is a portable device and so it could be used in any clinic in primary or secondary care. A second commentator noted that use of the device adds around 15 minutes to each clinic appointment, but all commentators agreed that no changes to infrastructure would be needed.

One commentator suggested that the device would lead to cost savings in the NHS; however, another stated that the technology would only produce cost savings if it was used in a very select group of patients at higher risk of lymphoedema. They felt that if it was used for all patients with breast cancer then cost savings would not be generated. The third commentator was unsure whether the device would lead to cost savings.

General comments

One commentator noted that the device might be of benefit to patients at high risk of developing lymphoedema, but that even in these patients, the lymphoedema rate is low. They also commented that the time frame for developing lymphoedema varies, with some patients developing the condition many years after primary surgery or radiotherapy. Because of this, a surveillance programme would need to run for many years to identify patients with early-stage lymphoedema. Patients would need to return for regular clinical assessment which is at odds with the current NHS practice of early discharge to general practitioner care after breast cancer treatment. Additionally, the commentator reported that they had stopped using the device in their clinic because of low rates of detection of lymphoedema.

Another commentator added that bioimpedance currently lacks evidence for widespread introduction on the NHS, particularly in terms of the costs involved and whether it could result in cost savings, but that studies to address this are ongoing.

Patient organisation comments

The Lymphoedema Support Network and Breast Cancer Care provided the following comments on the L‑Dex U400.

The commentator from the Lymphoedema Support Network noted that early detection of lymphoedema would potentially prevent skin changes and increased swelling, which may reduce the need for more intensive care. However, despite early detection, current evidence does not support the idea that lymphoedema is reversible at any stage of development. Early diagnosis could delay development of the condition or maintain symptoms at a subclinical level.

They felt that bioimpedance could be a very valuable technology in patients with mid-line, head and neck or breast swelling (although these are not currently indicated for the L‑Dex U400), because there are currently no effective technologies for taking measurements in these groups. It was also noted that lymphoedema is now less common in breast cancer since sentinel node biopsy was introduced.

One commentator used more traditional limb volume measurements with a tape measure in their work as a lymphoedema specialist, and had not used the L‑Dex U400. They felt that the current evidence on this device was not sufficient to show that the device would be an accurate method to replace existing procedures.