Vacuumed Space Technology: A Far-fetched Dream or a Life Changing Technology?

Vacuumed Space Technology: A Far-fetched Dream or a Life Changing Technology?

Editorial Summary Intermittent Vacuum Therapy (IVT) has its origins in space and aeronautical medicine, taking flight from a collaboration between NASA and the Institute of Space Medicine of the German Aerospace Center (DLR). This article explores the potential clinical applications of this innovative treatment.

Introduction

P

eripheral Arterial Disease (PAD) is well known to affect between 15% and 20% worldwide and in Europe we have seen an estimate around 17.8% as described in the PANDORA prevalence study in 2011. In summary, PANDORA was a non-interventional European cross sectional study performed across Italy, Belgium, France, the Netherlands, Greece, and Switzerland, that examined the prevalence of PAD in 9816 subjects with moderate cardiovascular risk and the absence of diabetes or overt vascular disease.

We also know that incidence of chronic wounds has been increasing and is a silent epidemic impacting the quality of life of millions of people worldwide. According to Guest et al., 2015, in the UK alone there are an estimated 2.2 million people currently living with nonhealing wounds.

What Is a Chronic or Hard-To-Heal Wound?

Chronic wounds, or non-healing wounds, are defined as wounds that are slow to progress through the phases of healing, or display interrupted or delayed healing, due to intrinsic and extrinsic factors impacting on the wound and the individual (Sibbald et al., 2015, Woo et al., 2018). The impact of PAD on chronic wounds and their healing capabilities cannot be merely ignored. Taking into account all the other comorbidities and factors which influence healing, it paints a grim picture, especially for our older generation, when it comes to wound healing. Now the long-term effects postCOVID-19 have also joined the fray, leading to

more complex wound healing. Our biggest challenge with COVID-19 positive patients is systemic coagulopathy, which through hypercoagulation and microvascular occlusion can lead to ischemic stroke, myocardial infarction, venous thromboembolism, acute limb ischemia and pulmonary embolisms (Black et al 2020). This is perhaps where we need to consider adjunctive therapy focused on vascular flow regeneration and lymphatic drainage, to restore the balance of healing.

Why Use Vacuumed Space Technology?

Why then should we consider vacuumed space technology, also known as Intermittent Vacuum Therapy (IVT), as an adjunctive therapy? According to Weyergans, IVT has its technological origin in space medicine, through collaboration between NASA and the Institute of Space Medicine of the German Aerospace Center (DLR). In the absence of gravity, astronauts in space must undergo negative pressure application every ten hours, to avoid orthostatic complications due to an insufficient baroreflex; in a weightless environment this is the only way to ensure blood flow in the periphery. The development of a lower body negative pressure device (LBNPD) led to the development of the current device, known as the VACUMED® Flow Regeneration System.

How Does It Work?

Ms Liezl Naude Wound Management Specialist & Educator

The physiological principle behind the VACUMED® Flow Regeneration System is the positive influence of changing cycles of low and normal pressure on the vascular and lymphatic system of the body. The effects of

Johannesburg, South Africa

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Vacuumed Space Technology: A Farfetched Dream or a Life Changing Technology?

“If we can safe one more limb, improve a patient’s quality of life by improving blood flow, promoting revascularization, decreasing oedema and lymphoedema; why should we not consider space technology?”

the low pressure (negative pressure), results in capillary dilatation (enhancing vascular permeability), increased capillarization (formation of small new vessel branches and collateral flow), and therefore improvement in blood flow to the periphery and muscles. The effects of the normal pressure phase results in the increase of venous reflux, increased lymphatic flow, and increased lymphatic drainage. The effects of alternating low pressure with normal pressure causes rhythmic vascular dilation and vascular compression. The device literally functions as a second external heart in promoting arterial flow and venous and lymphatic reflux.

return, and lymph drainage, the ability of the body to successfully heal itself is severely compromised. In this regard, IVT might just be that lifesaving technology we have been looking for. IVT can decrease chronic oedema associated with secondary oedema in the long term, leading to a decrease in both venous oedema and lymphoedema, as well as secondary lymphoedema in the postoperative acute phase.

This is achieved through the mechanical passive lymph drainage of the device, and can be used in addition or as an alternative to manual lymph drainage. The implication herewith has a major impact on wound healing post operatively, but also in decreasing oedema prior to surgery.

This also explains why IVT with the VACUMED®/ VACUSPORT® device is so effective in sports medicine, and most data currently available is focused on the effect of IVT in sport rehabilitation and management.

The ability of IVT to create lymphatic drainage, promote blood circulation and venous outflow, results in oedema reduction as well as the rapid reduction of haematoma. This results in acceleration of wound healing, improved tissue management and shortening of rehabilitation time in athletes.

Perhaps the biggest impact possible is the implementation of IVT within the wound care environment. Within the diabetic foot our aim is to save limbs and prevent amputation. In aworld where not every patient has the means or ability to timeously see a vascular surgeon, IVT might just be that limb saving, lifesaving therapy that can change the future of vascular interventions.

It comes as no surprise that IVT is indicated for PAD (pAVD I-IV according to the Fontaine classification) as well as Diabetic Foot Syndrome (DFS). This is achieved through revascularisation, by stimulation of the endothelium (capillarisation and Nitrous Oxide (NO) release), blood flow promotion (flow increase), and tissue oxygenation (tissue management). If we can improve blood flow and revascularisation, promote venous outflow by active vascular dilatation and compression, and improve the physiological muscle pump by increasing collagen synthesis, we can decrease oedema, improve walking distance and restore the oxygen balance within the body; all of which has a significant impact on wound healing. This also means that IVT can have a significant impact on Chronic Venous Insufficiency (CVI) CEAP I-6, through the same mechanism of promoting blood circulation and venous outflow through active vascular dilatation and compression.

IVT has been effective in the management of fatigue-related pain, half muscle stiffness (Type 1 A); muscle fibre tear (Type 2A, 3A, 3B), (Sub-) total muscle tear; avulsion, and sinewy avulsion (Type 4), by shortening individual return to play by 30 to 50% while maintaining capillarization and shortening recuperation time. The device is used to shorten the rehabilitation period postoperatively or post-traumatically, as well as in cases of special indications. This also applies to all types of muscular injuries, and to the rapid recovery of full performance after training or competitions.

Everything in life is about blood flow and lymphatic drainage. Without the ability to have oxygen carrying arterial flow, active venous

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The European Medical Device Regulation

Vacuumed Space Technology: A Farfetched Dream or a Life Changing Technology?

(MDR) authority has recently approved more than 40 benefits/ indications for IVT with the VACUMED®/ VACUSPORT® device, and even though there have been some early studies such as Hageman et al., (2019), showing no significant evidence through a small randomized controlled trial (RCT), the overwhelming evidence ranges from a Class 1B to 4 is indicative of the opposite.

If we can save one more limb, improve a patient’s quality of life by improving blood flow, promoting revascularization, decreasing oedema and lymphoedema; why should we not consider space technology? Perhaps it is time that we look to the future and focus on prevention, by improving a patient’s vascular status to prevent associated diseases.

Conclusion Future studies on the impact of IVT on COVID-19 patients should be considered, and perhaps this would be the exploration of the great unknown. IVT space technology a farfetched dream or lifesaving technology? !e real question is what do we have to lose for us to decide? Perhaps its time that we sit up and take notice of what can be done without traumatic surgical interventions or as an adjunctive in improving our post-surgical outcomes.

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May - June 2022