New research published in Anaesthesia (a journal of the Association of Anaesthetists) shows that VTEs, a known complication of surgery, are 50% more likely to occur in patients with current COVID-19 infection and almost twice as likely in those with recent infection. The study also found having a VTE was associated with 5-times increased risk of death within 30 days following surgery compared with patients with no VTE.

The study was delivered by the University of Birmingham-led GlobalSurg-COVIDSurg Collaborative: a global collaboration of over 15,000 surgeons working together to collect a range of data on the COVID-19 pandemic. The collaboration has already produced several studies, and this new analysis included 128,013 patients, from 1630 hospitals across 115 countries.

Patients were categorised as having VTE (pulmonary embolism or deep vein thrombosis) within 30 days of surgery. SARS-CoV-2 diagnosis was defined as peri-operative (7 days before to 30 days after surgery); recent (1–6 weeks before surgery); previous (7 weeks or more before surgery); or no diagnosis past or present.

The postoperative VTE rate was 0.5% (666/123,591) in patients without SARS-CoV-2; 2.2% (50/2317) in patients with peri-operative SARS-CoV-2; 1.6% (15/953) in patients with recent SARS-CoV-2; and 1.0% (11/1148) in patients with previous SARS-CoV-2.

After adjustment for confounding factors, patients with peri-operative SARS-CoV-2 were at a 50% higher risk of VTE and those with recent SARS-CoV-2 at a 90% increased risk. Patients with previous SARS-CoV-2 were at a 70% increased risk of VTE, but this result was of borderline statistical significance.

Overall, VTE was independently associated with 30-day mortality, increasing the risk of death during this period by 5.4 times. In patients with SARS-CoV-2, mortality without VTE was 7.4% (319/4342) and with VTE was again more than five times higher at 40.8% (31/76).

The authors note an important limitation to the study: that information on prophylaxis regimens for these blood clots in the veins or pre-operative anti-coagulation to prevent them was not available, and say that “further research is needed to define the optimal protocols for VTE prevention and treatment for surgical patients in the setting of SARS-CoV-2 infection”.

Co-author Elizabeth Li, General Surgery Registrar at University Hospital Birmingham, commented: “People undergoing surgery are already at higher risk of VTE than the general public, but we discovered that a current or recent SARS-CoV-2 infection was associated with greater risk of postoperative VTE. Surgical patients have risk factors for VTE, including immobility, surgical wounds and systematic inflammation — and the addition of SARS-CoV-2 infection may further increase this risk.”

Co-author Mr. Aneel Bhangu, Consultant Colorectal Surgeon from the University of Birmingham, commented: “Increased awareness and surveillance should be considered. At a minimum, we suggest close adherence to routine standard VTE prophylaxis for surgical patients, including the use of anti-clotting medication when bleeding risk is minimal, and increased vigilance and diagnostic testing in patients presenting with signs of VTE, such as swelling in one calf, right sided chest pain and shortness of breath.”

They conclude: “Routine postoperative care of surgical patients should include interventions to reduce VTE risk in general, and further research is needed to define the best protocols for VTE prevention and treatment in this setting.”

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The coronavirus pandemic placed additional demands on the VTE service as evidence concerning the use of anticoagulants in covid-19 emerged. Early evidence from China suggested that there might be some mortality benefit associated with the use of heparins due to their anti-inflammatory actions. Mr Power was responsible for leading a group in the Health Board that developed local thrombo-prophylactic policies. Over the past 18 months the policies and guidelines have been developed and modifed in response to new evidence.

“We’ve changed the guideline as the evidence has emerged – especially quite recently where the collaborative trial arms have now published their data…… What we’re actually seeing is that if we use therapeutic doses of low molecular weight heparin in what we classify as ‘moderately-unwell’ covid-19 patients – so these are the patients who were admitted requiring supplemental oxygen but [do] not require intensive oxygen therapy or organ support – ….there does seem to be a trend towards reduction in mortality or escalation to requiring organ support.  So, we’ve been able to shape our guidelines with that and this is what’s now in line with NICE [recommendations]. Conversely, in the critical care arm it seemed that there was no benefit in terms of using therapeutic anticoagulant therapy and in fact there was an increased bleeding risk”, says Mr Power

These findings have given rise to the hypothesis that early use of therapeutic doses of anticoagulant therapy may prevent the progression to disseminated intravascular coagulation (DIC), but the mechanism is still uncertain, he adds.

The case for a pharmacy-managed VTE service

The VTE service at Singleton Hospital expects to see 400-500 new VTE patients compared with about 150 three years ago, says Mr Power.

“One of the things we focused on in terms of benefits is the turnaround time for patients. So, the in the All Party Parliamentary Thrombosis Group report in 2018 they quoted the average figure from a patient being diagnosed with a VTE to the treatment being initiated to the patient [being] discharged as 16 hours. Within our service we’ve measured this and we’re actually 105 minutes – so we’re far below the national average. …..  In patients who could have the same-day scans there’s 137 minutes between the patient attending, having a scan, being seen by us, initiated on treatment and sent home with our treatment in their hand”, he explains.

Such a rapid turnaround depends on ready access to radiology services, he acknowledges. The major benefit of the service is fast turnaround with a safe service and built-in follow up.

“It is an efficient service that allows patients to be managed quickly but safely and then the knowledge that they’re also then part of the service where they’ll have follow-up and all of those treatment decisions will be undertaken under that one umbrella”, he says.

Next steps

With a projected workload of 450-500 patients this year, the service has outgrown its original resources and funding has been requested for additional pharmacists and for additional training resources. However, the pharmacy team could be taking on a diagnostic role in future.

Mr Power says, “We’ve already piloted this on a number of occasions. I’ve done training with the GPs and we’re just waiting on some funding to be able to cement our position there, but I’m pretty optimistic that we’ll then be taking on the assessment and diagnostic role with DVT (deep vein thrombosis) patients –  which is quite exciting”.

Call to action

Mr Power’s message to colleagues is that they should consider developing VTE management services. He says, “It’s primarily drug based, it’s complex and so it definitely requires somebody with specialist knowledge…… It’s one of the most common conditions that we see so if you’re working in health boards where there’s that gap ……  then I urge you to get involved with the area, develop your expertise, get your IP [and] develop your services …. the benefits are absolutely huge.”.

Mr Power adds that pharmacists or pharmacy technicians who are interested in developing VTE services are welcome to get in touch with him.

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One important development was the cancer thrombosis pathway.  This stemmed from the PELICAN (Patients’ Experiences of LIving with CANcer-associated thrombosis) study, led by Professor Simon Noble, in which patients receiving treatment for cancer-associated thrombosis (CAT) were interviewed about their experiences.

Many patients felt that the level of support they received for CAT compared unfavourably with their cancer care. This is a problem because 20% of cancer patients develop a thrombosis, notes Mr Power.

“We thought, “Well, we’ve got a VTE service, we’re seeing cancer patients how can we make this better for them?” and so what we did was we developed a specific cancer-associated thrombosis pathway whereby we had every single cancer thrombosis diagnosis come through our pathway within the health board and we would manage them from initiation to that six-month decision – because with cancer-associated thrombosis six months is generally the minimum duration – and much of our focus was around easing anxieties and improving patient education”, he explains.

When the service was evaluated anxiety scores and knowledge retention improved and patients were generally better informed.

Haematology clinic

A weekly haematology clinic is an integral part of the VTE service. This started as a DOAC (direct-acting oral anticoagulant) initiation clinic, when this process was started in secondary care, recalls Mr Power. Now that this is routinely undertaken in primary care in most of the UK, the clinic has developed to deal with patients with complex anticoagulant or thrombosis needs such as those with VTEs at unusual sites, patients with anti-phospholipid syndrome and those who require complex bridging arrangements, he says

Independent prescribers

Gaining independent prescriber (IP) qualifications has enabled the pharmacy VTE team members to function effectively as independent practitioners, says Mr Power.  In fact, they ran the service for several years before gaining their IP qualifications in 2018.

“I think the single most important thing that developed in terms of our service was that we all gained IP qualifications because it just allowed us to then become independent practitioners and develop the service as we wanted to, whereas prior to that it was quite difficult to make those independent decisions because you were fundamentally relying on somebody else to prescribe the medication for you”, he says.

De-skilling or up-skilling of junior doctors?

When asked whether the pharmacy-managed VTE service risks de-skilling of junior doctors in relation to anti-coagulant prescribing Mr Power argues that the education and guidelines that have been put in place have, in fact, up-skill junior doctors in this area.

“When we came in we identified numerous aspects of VTE care that weren’t in line with evidence or guidance and we’ve been able to improve on those things…….. I don’t feel like we’ve de-skilled the healthcare professionals, I think we’ve upskilled them ….  mainly through our education that we’ve undertaken [and] through the guidelines we’ve developed. ….  I was reflecting on this recently because I think one of the proudest [moments] I have is when I hear junior doctors quoting elements of management that I know that we’ve put into guidelines.  I kind of think, “Well, they weren’t saying those things three or four years ago!” “, says Mr Power.

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The management of VTE is complex because of the number of factors that need to be taken into account.  The first step is the selection of an appropriate anticoagulant and this is not a one-size-fits-all situation. There can be differences in the provoking factors, the locations of the VTE and patient factors such as renal function, weight, and presence of anti-phospholipid syndrome, for example.  The next important decision is about the duration of treatment. “We know now that recurrence rates are higher than we maybe previously thought and so far more now we’re assessing  patients, even after first-time events, for lifelong anticoagulant therapy”, says Mr Power. The third ‘complexity’ is concerned with long-term risks of complications, in particular post-thrombotic syndrome which affects some 30% of patients with VTE.

“Post thrombotic syndrome …..  is essentially where patients have the long term symptoms of VTE despite them not having recurrent thrombotic episodes. So patients will often have long-term leg swelling, cramping, pain. The difficulty with it is that there is no known effective treatment or cure for it and so much of it comes down to patient expectation management and maybe things like stockings that can help to support them”, explains Mr Power.

Similarly, pulmonary embolism (PE) can be associated with long-term complications. “One of the long-term complications of PE is CTEPH or chronic thromboembolic pulmonary hypertension. So, again, this can be quite a disabling condition [in which] you have chronic clots within your lung developing high pressures within the right side of your heart and ….. a lot of these patients have long-term dyspnoea and their performance in life is greatly reduced”, he says.

Direct-acting oral anticoagulants (DOACs)

From the patient’s perspective the introduction of DOACs has made anticoagulation a more straightforward process with fewer dietary impacts and interactions with other medication. From the pharmacist’s viewpoint, now that less time has to be spent on anticoagulant dosing and monitoring there is more time to spend on other important aspects of patient management. Furthermore, the improved safety profile of the DOACs has been important. “The bleeding data, especially in long-term patients, is very positive and I think that now –  because we’re far more comfortable with the idea of using long-term anticoagulant therapy – we are seeing far more people with first unprovoked VTE going on to receive lifelong anticoagulant therapy whereas I’m not so sure we would be as comfortable with warfarin”, says Mr Power. Nevertheless, there are nuances in treatment and DOACs are not suitable for everyone. “We need individuals to be able to identify the correct patients and …… I can’t see why that can’t be a pharmacist”, he adds.

A typical VTE patient swill be diagnosed by a physician and referred to the pharmacy team on the same day. The initial consultation is concerned with the selection of the correct anticoagulant regimen. At subsequent reviews the patient’s compliance with and tolerance of the treatment is assessed and additional investigations are arranged if necessary. At the three-month review the decision is made between lifelong treatment or discontinuation. Patients for whom lifelong treatment is recommended are then referred to their GP for ongoing management.

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Mr Power is responsible for leading, directing and overseeing the ongoing development of the VTE service at Singleton Hospital. He also has a hands-on role in the day-to-day operation of the service and runs a weekly haematology clinic for review of patients with complex thrombosis and anticoagulation issues.

The VTE service has grown steadily since pharmacists were first asked to assist with warfarin dosing for the ambulatory VTE service. This involved supporting patients “to get into [the therapeutic] range before being referred on to warfarin dosing clinics”, explains Mr Power. As warfarin usage diminished and was replaced by direct-acting oral anticoagulants (DOACs) the pharmacy team began to take a more prominent role in VTE management – and the service has continued to grow and develop.

“Over the past couple of years we’ve evolved our service so that we’re now the primary clinicians who look after VTE in the health board. What I mean by that is once the patient ‘s been diagnosed with a VTE, they get passed to us for a same day appointment where we will initiate therapy and the patient then will be under our care for the duration of their management until we make a decision at the at 3-6 month point and then we either stop the anticoagulant therapy or refer them on to primary care”, say Mr Power.

Whereas many pharmacy-led anticoagulation services are focused on stroke prevention in patients with atrial fibrillation (AF), the service at Singleton Hospital is VTE-focused. Mr Power attributes this to its historical origins and, more recently, to the complexity of VTE management. “I think there’s far more complexity in VTE management than there is in AF management when it comes to anticoagulant therapy – mainly because I think there’s a lot of supporting algorithms in terms of AF management whereas [in] VTE there’s a lot more variability in the type of patients you see, there‘s a lot more decision points t o undertake as you go along and, as such, it became an area that I thought worked very well with pharmacist independent prescribers – and as our interest grew the service grew with it”, he says.

VTE is estimated to affect one-two patients per 1000 patients each year in Europe. There are immediate risks and there can also be long-term complications.

“I think the complexity of management is also far more than people realise. It’s not a case of where we used think maybe we would just treat people for three to six months with anticoagulant therapy and that would be that. We’re now far more interested in long-term risks of recurrence [and] long-term complications, explains Mr Power.

One of the main benefits of the service for patients is consistency of decision-making and management, he says. “There are three of us currently who run the service as independent prescribers; most patients will see one of the three of us…….. we have a very tight system whereby all of these processes are undertaken and so that they can rest assured that once they’re under our service they will have all of those management decisions undertaken under one roof.

Read and watch the full series on our website or on YouTube.

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