Dr Mona Fawzy, a consultant in obstetrics and gynaecology, and labour ward lead at Barnsley Hospital NHS Foundation Trust, talks through the burden of pregnancy-related Venous Thromboembolism (VTE) - a leading cause of maternal death - and the study of an innovative new medical technology for high-risk maternity patients unable to be prescribed the standard care
Childbirth in the UK is the safest it has ever been, but it can bring with it more than morning sickness and fatigue.
It can also bring the risk of pregnancy‐related venous thromboembolism (VTE), a preventable medical condition that occurs when a blood clot that can form in the deep veins breaks off and travels through the bloodstream to the heart or lungs, causing a blockage called a pulmonary embolism (PE) – a life-threatening complication and the leading cause of maternal death in the in the UK.
While the absolute risk remains relatively low, pregnancy-related VTE effects two in every 1,000 patients, and is five times more common in pregnant women compared to non-pregnant women of a same age - increasing 20-fold in the 12 weeks after delivery, before dropping back to normal.
VTE risk factors, which can be hereditary and/or acquired, include a family history of VTE, age, obesity, immobility, and medical complications such as pre-eclampsia.
Caesarean delivery also carries a significantly-increased VTE risk, as does the associated prolonged hospital stay or complications during emergency delivery.
On top of this, the blood naturally clots more easily during pregnancy to lessen blood loss during childbirth, and later in pregnancy patients may experience less blood flow to the legs due to pressure on blood vessels in the pelvis by the growing baby.
VTE prevention strategies must therefore take into account potential adverse effects on the foetus, and employ clinical evaluation for risk factors, alongside optimal use of both mechanical and pharmacological prophylaxis to prevent blood clots.
NICE guidance and the Royal College of Obstetricians and Gynaecologists (RCOG) recommend low-molecular-weight heparin (LMWH) as the anticoagulant (drug) of choice due to its superior safety profile compared to other blood thinners, such as warfarin or unfractionated heparin.
But use of anticoagulant therapy, although highly effective, also carries an associated bleeding risk in maternity patients who are assessed at high risk of bleeding.
In circumstances where LMWH cannot be prescribed, guidance supports use of traditional mechanical compression, a boot-like cuff that squeezes the legs to move blood, called intermittent pneumatic compression (IPC).
Recognising the need for an alternative mechanical anti-stasis intervention the trust saw the potential to quantify our unmet need and to examine use of an innovative medical device to protect this unmet patient group, through an industry and NHS partnership
Use of IPC can, however, also present challenges as it decreases patient mobility, which makes it a non-practical option for patients who require protection for the few days of its use, for example during induction of labour.
In the absence of a suitable alternative, patients then receive no VTE prophylaxis and the risk of a fatal VTE remains.
Recognising the need for an alternative mechanical anti-stasis intervention the trust saw the potential to quantify our unmet need and to examine use of an innovative medical device to protect this unmet patient group, through an industry and NHS partnership.
Embracing innovation
We embraced the opportunity to quantify the level of our unmet need to determine whether use of the geko device would have a role in patients when LMWH and/or traditional mechanical compression could not be used.
We partnered with Sky Medical Technology (Sky) and its UK distributor partner, G&N, to carry out an in-hospital, prospective observational study to examine use of the geko, a neuromuscular electrostimulation device that prevents blood clots in the deep veins of the calf by activation of foot and calf muscle pumps, via stimulation of the common peroneal nerve at the side of the knee.
The size of a small wristwatch; the device uses a gentle electrical pulse, once every second, resulting in increased blood flow at a rate equal to 60% of continuous walking without the patient having to move.
The study focused on 90 patients over a period of 17 months and showed that all 90 patients required the geko device during some stage of labour, representing a 2% need overall.
More than half were prescribed the device as the only method of blood clot prevention. And, of these:
- 54% (49/90) postnatal women needed the geko device as their only method of thrombo-prophylaxis
- 94% (46/49), of the above 54%, had postpartum haemorrhage (PPH)
- 6% (3/49) had low platelets for which Dalteparin was contra-indicated
- 16% (15/90) with severe preeclampsia benefitted from the geko device antenatally during their admission as they were at risk of needing urgent delivery
- 14% (13/90) had severe oedema or high BMI resulting in TED stockings being impractical to use
- 8% (7/90) were deemed high risk therefore the geko device was used to aid their mobility
- 2% (2/90) women who had antenatal Daletparin used the geko device during labour
The geko device was used for maximum of 36 hours and the study also reported the device as easy to fit, safe, and well tolerated and, compared to pneumatic IPC sleeves, it allowed patients to be more mobile, thereby reducing the VTE risk further.
I feel extremely proud to be part of a trust that champions its clinicians to partner with industry to embrace innovation
The innovative device is now in routine use in our maternity unit, where other pharmacological methods are contraindicated or impractical, ensuring that all our high-risk patients can now receive pregnancy-related VTE prevention where previously no mechanical prophylaxis could be prescribed.
Importantly, the study, and our subsequent adoption of the geko device, has aligned our maternity unit to NICE guidance (MTG19), which recommends use of the geko device for VTE prevention in all at-risk hospital patients when standard of care is impractical or contraindicated.
I feel extremely proud to be part of a trust that champions its clinicians to partner with industry to embrace innovation.
And, as a result, our patients can be among the first to benefit from this hugely-exciting medical advance and we are delighted that other NHS maternity units are replicating use of the geko device to prevent pregnancy-related VTE in their high-risk patients also.
I am also proud that the study is recognised as award-winning, celebrating the high priority we place in industry partnering and the hard work of the Barnsley obstetrics team who, on top of their full-time jobs, and in a challenging environment, are willing to give-up additional time in pursuit of innovation for better patient outcomes.