Key points from the evidence
Scottish Health Technologies Group (SHTG)
- We identified 15 studies on the use of the VB device for people with PE. Thirteen were retrospective reviews of medical records, one was a prospective case series and one was a small randomised controlled trial (RCT). The studies were heterogeneous and prone to bias. The retrospective studies were mostly small, patients self-reported their daily wear time, and only people who completed the treatment were included in the final analyses. It is not clear from most of the studies if the treatment benefits that are reported are maintained in the longer term.
- The largest (n=259) and most recent study (2024), from The Netherlands, reported that 86 out of 165 people who completed treatment with the VB device considered it a success (52.1%). Treatment was considered successful if patients, parents and a surgeon regarded the result as aesthetically pleasing.
- Eleven of the 15 studies reported on the effectiveness of the VB device. The outcomes and how they were measured varied across the studies. In the four oldest studies the sternum was raised to a normal level in 13.5% to 31.5% of participants following treatment for up to 18 months. The remaining seven studies, published since 2018, reported a positive treatment outcome in approximately 20% to 50% of patients selected for treatment with the VB device.
- Evidence suggests that a younger age at treatment onset (approximately ≤11 years) and a flexible chest wall are factors associated with successful treatment outcomes with the VB device. A smaller pre-treatment chest wall depth may also be associated with improved outcomes. One small, preliminary RCT (n=26) reported that treatment with the VB device may be further optimised if patients are also offered a standardised physiotherapy programme.
- Three of the studies reported improved patient outcomes in people who wore the VB device for longer periods of time
- Optimal daily wear time cannot be determined from the available literature, and it is likely to differ depending on the age of the patient and the nature of their PE. Younger patients (aged ≤11 years) with a pliable chest wall may only require, and tolerate, shorter daily wear times. Two studies did not find evidence of improved outcomes with longer wear times (>60 minutes and >150 minutes), with one reporting that successful treatment outcomes were observed in several people who chose to wear the VB device for less than 60 minutes per day.
- Five of the studies reported that total duration of treatment was associated with improved patient outcomes. Two studies suggested that use of the VB device should last at least 12 months, and another two studies reported that treatment should last 24 months. The optimal total duration of treatment is likely to vary according to the age of the patient and the nature of the PE.
- The VB device may not be suitable for some people with asymmetrical PEs if this means the device cannot be attached to the chest wall (that is, a vacuum cannot be created). Breast development may also impede use of the VB device.
- No safety concerns with the VB device were identified. Most people are able to tolerate treatment with the VB device, and the side effects and complications reported in the literature do not appear to be permanent or severe. Side effects noted in the literature include chest wall pain, back pain, skin irritation, haematoma, upper extremity paraesthesia, petechiae, thickening/darkening of the skin and blistering. As the VB device is typically used to treat PE in children and young people, support and supervision by a parent or carer is required.
- A patient organisation told us how people can be negatively affected by a difference in their chest wall appearance, with some people experiencing significant psychological and/or physiological consequences. Some people with PE become self-conscious and withdraw from activities that they would otherwise enjoy. For people with more pronounced PEs, the compression in the chest can impede normal functions such as walking, exercising and swallowing. No literature was identified on the patient experience of using the VB device.
- We estimated and compared the total costs of first line conservative management for PE (an initial in-clinic appointment followed by virtual appointments with a physiotherapist, quarterly for up to 18 months), surgical management and treatment with the VB device. The cost of treatment with the VB device (estimated between £468 and £503 per patient) was higher than the cost of conservative management alone (£192), but far lower than the costs of surgical management (£15,003 modified Ravitch procedure; £13,513 Nuss procedure).
- We were unable to conduct a cost-effectiveness analysis comparing use of the VB device with usual care options because of a paucity of evidence for key parameters. Gaps in the evidence included efficacy of VB compared with usual care, and evidence relating to health-related quality of life following VB device or usual care.