CLINICALEVIDENCE
SUMMARY
CLINICALEVIDENCE
SUMMARY

Pressure Injury
Preventing Venous
Prevention
SolutionsThromboembolism with
Intermittent Pneumatic Compression

Welcome
Arjo, has over 40 years’ experience as a trusted global leader invenous thromboembolism prevention. Our journey began in the
1970s with the Flowtronaire® device, when clinical VTE studies
clearly demonstrated the protective benefit associated withintermittent pneumatic compression (IPC) of the deep veins of
the leg. Arjo have been instrumental in developing easy to use,clinically effective IPC systems to support facilities across theglobe with their VTE programmes.
Our Flowtron Active Compression System (ACS) range isdesigned, by prioritising comfort, compliance, affordability andease of use. The Flowtron Active Compression System with ourrange of garments is; comfortable for the patient, convenient
for the healthcare provider and clinically effective at deliveringintermittent pneumatic compression – helping to contribute toimproved patient compliance.
We recognise that clinical decision-making is complex andshould be based upon the best available clinical evidence.
We invite you to review this clinical resource providing examples
of some of the key evidence supporting the use of IPC andspecifically the Flowtron ACS as part of a VTE prevention
programme.

What is Venous Thromboembolism (VTE)?
Blood clotting is essential to life but only when it is appropriate, such as sealing awound or after a cut. However, when the blood clots in the wrong place and/or thewrong time, the results can be life changing and often fatal.

Blood flow

Valve

EmbolusDeep Vein Thrombosis (DVT)
If a blood clot (thrombosis) develops in the
deep veins of the leg (less commonly in thearm) it is referred to as a Deep Vein Thrombosis
or DVT

Deep vein

Pulmonary Embolism (PE)If part of the clot becomes dislodged it isreferred to as an embolus and can travel
through the venous circulation until it reaches
the lungs: a pulmonary embolism or PE

Venous Thromboembolism (VTE)
Venous thromboembolism or VTE is thecollective term for both DVT and PE (Figure 1)

Valve

Blood clot

Figure 1: Venous Thromboembolism
10 million people around the world develop VTE each year.1

Why is VTE so important?
With healthcare demand at unprecedented
levels, and budgets struggling to keep
pace, attention is increasingly focussed
upon adverse clinical events. Of particularinterest are incidents, such as VTE, thatare common, have a high economic andhumanitarian cost and are largely considered
preventable. 2
Unfortunately, robust economic data is
not routinely published, but there issufficient evidence to show that when
VTE does occur, it is frequently fatal and,
if not, is often associated with costly andlife changing long-term complications.
Good enough reason to target prevention.

VTE is the most common cause of preventable death in
hospitalised patients3
The cost of treating preventable VTE has been estimatedto be up to US$ 14.2 billion per annum, rising to US$ 39.3
billion as cost and incidence rises 2$

Up to US$ 19.1 billion is spent each year in thetreatment of longterm complications following VTE 2

30%

1/3

Around 30% of patients will die within 30 days of VTE
while 25% of unexpected inpatient deaths are diagnosed
with PE at autopsy 4
Around 1/3 of patients with DVT develop
Post-thrombotic syndrome suffering swelling and pain4
and for 25%,5 the resultant chronic ulceration is associatedwith substantial on-going treatment cost 6

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The pathophysiology of VTE is complex and the condition is triggered when multiple risk factors, collectively
described by ‘Virchow’s Triad’ (Figure 2), tip the balance of homeostasis leading to clot formation 7

Venous stasis
Circumstances that cause the blood flow to slow (stasis) in the
deep veins will increase the risk of VTE.

Figure 2: Virchow's Triad• Immobility, perhaps due to age, frailty or prescribed bed 		
rest is a clear risk factor.
• Physical obstruction of the deep vessels, either due to 		
external forces or pressure from tumours and lymph 		nodes, is also implicated, as are previous DVTs.

VenousstasisHypercoagulation

VTE

Changes in blood density and chemistry can increase thetendency for the blood to clot. This is associated with conditions
such as simple dehydration to hypoxia, malignancy, trauma,
hormone therapy, systemic inflammatory disease and genetic
predisposition.

(DVT & PE)
Hypercoagulation

VesselinjuryVessel Injury
Injury may occur through accidental trauma or though medical
interventions such as surgical or invasive procedures. Even the actof stretching a vessel can trigger the clotting cascade.
Once injury occurs, an orchestrated series of events initiate
platelet adhesion and the eventual formation of a blood clot; thisprotective mechanism seals the damage and begins the healing
process: sometimes this process is exaggerated or inappropriate.

Who is at risk of VTE?

Figure 3: VTE risk factors9
Stasis> 50%

of hospital patientsare at risk 8< 50%

have recommended
prophylaxis 8

•
•
•
•
•
•

Muscle relaxants used during surgery
Surgery, trauma, immobility, paresis
Increasing age
Pregnancy and postpartum
Heart or respiratory failure
Obesity

Vessel injury
When one or more risk factors are present (Figure 3),9 anybody, froma new mother to a frail elder with reduced mobility, is at risk of VTE.
At particular risk, are surgical inpatients10 as surgery itself causes thegreatest increase in risk, because of the anaesthetic (hypercoagulability),
muscle relaxants (stasis) and surgical intervention(vessel damage).
It is now clear that non surgical patients are also
at high risk of VTE. Awareness of the need forprophylaxis in high risk groups such as criticalcare, cancer, obstetrics, bariatrics, stroke andolder paediatric patients has been steadily
increasing over recent years.

4

7 foldincrease in VTE
incidence for patientswith malignancy 11

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•
•
•
•
•

Surgery
Previous deep vein thrombosis
Smoking
Varicose veins
Central venous catheterisation

Hypercoagulability•••

Increasing age
Malignancy or cancer therapy
Oestrogen therapy (contraception
or hormone replacement)

•
•
•
•

Acute medical illness
Inflammatory bowel disease
Nephrotic syndrome
Myeloproliferative disorders

Preventing VTE
Prevention strategies commonly incorporate the use ofpharmacological prophylaxis and mechanical methods including:• Intermittent Pneumatic Compression (IPC)• Passive Graduated Compression Stockings (GCS)• The addition of Inferior Vena Cava (IVC) Filters have also been increasing for a number of patients at very high risk

Figure 4: IPC addresses 2 of the principle causes of DVT formation:
Venous Stasis and Hypercoagulation

Intermittent PneumaticCompression and GraduatedCompression Stockings

VenousstasisVTE(DVT & PE)
VesselinjuryHypercoagulation

Some risk factors are difficult or impossible to address, forexample, vessel injury arising from trauma, surgery or invasive
procedures. These incidental risk factors, along with underlying
co-morbidities such as age, obesity, malignancy and genetic
thrombophilia, can all trigger hypercoagulation and this is often
managed with oral or injected anticoagulation therapy.
Anti-coagulation is not without risk and not all patients are
suitable candidates e.g. heightened bleeding risk.
Complications, including heparin-induced thrombocytopaenia,12dosing error13 and haemorrhage14 are not uncommon andanticoagulants do nothing to address stasis in the deep veins
where most thrombi develop.

Intermittent PneumaticCompression (IPC) devices

plantar plexus (beneath the sole of the foot) is compressed
during weight bearing. Theses bio-pumps eject blood in a
proximal direction towards the heart, while venous valvesprevent backflow.
When walking is not possible, the benefits of the muscle
pump can be simulated by mechanical means.
Figure 5: Natural Muscle Pump
ValvesclosedValvesopen

Natural Muscle Pump:
Venous stasis is naturally avoided through the biomechanicalaction of the calf and foot muscle pump, (Figure 5). Which iswhy early ambulation is the treatment of choice for patientsat lower risk of VTE.10
During walking and ankle flexion, the deep veins of the calf
are compressed by muscle contraction, while the blood-filled

Deep veins
under highpressure

Relaxation

Contraction

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Mechanical prophylaxis
Mechanical prophylaxis is the term used to differentiate
VTE prevention strategies from pharmacological methods;
it falls into two main categories: passive graduatedcompression stockings and active intermittent pneumatic
compression devices.

Passive graduated Compression Stockings
This is typically achieved through the use of calf-length
or thigh-length compression hosiery (Figure 6) commonly
designed to apply a graduated pressure decrease, from18 mmHg at the ankle and gently reducing towards thethigh (8 mmHg).15 These graduated compression stockings(GCS) are worn throughout the period of immobilisationand often for several weeks after discharge from hospital.

GCS wereincorrectly fitted in29%
of patients 16

Mode of action
It is thought that by applying pressure to the limb, thediameter of the deep vessels is reduced and the velocity ofblood flow may increase.15
GCS are often used in combination with other prophylactic
measures but, like anticoagulation, their use has been
associated with side effects. Incorrect application16 can leadto a significant increase in complications, some of which(skin ulcers and necrosis) can be serious.17

Figure 6: Thigh-length GCS

Intermittent Pneumatic Compression Systems
IPC is a very well established, and proven intervention witha convincing evidence base and few side effects; as such it isindicated for use across a wide range of hospitalised patientsat risk of VTE.
As a non-invasive mechanical method of VTE prophylaxis it iseffective when used either as a sole prevention modality such as

for those patients at high risk of bleeding or is very commonlyused in combination with pharmacological prophylaxis forhigh risk patients.
These powered devices use inflatable calf-length, thighlength and/or foot compression garments (Figure 7) used tosimulate the natural protective mechanism of walking.
Figure 7

All IPC systems have a single
common purpose – to propel
blood from the deeper veinsthrough the intermittent
inflation and deflationof a garment.

6

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Type of compression: sequential & uniform
Active compression comes in many different configurations.
There are different garments, compression profiles and cycle
times, but all have a common therapeutic purpose – todisplace blood from the deep veins and move it in a proximal
direction18 back into the central venous system. How this isachieved may differ, but the end result is the same and no
single type of compression can be considered superior interms of clinical benefit.18 19
The most commonly used garments are calf or thigh lengthand each will deliver either uniform compression through asingle air bladder in each segment or sequential compression(Figure 8), through a series of air bladders, which inflatein a proximal direction. When it is not possible to fit a leg
garment, a foot garment can be used instead.

IPC is aneffective
prophylaxis,
irrespective ofmode of action 18

Figure 8a:
Flowtron Uniform Garment

Figure 8b:
Flowtron Sequential Garment

Neither the
garment, nor thetype of compression(uniform/sequential),
makes a significant
difference to haematologicaloutcomes19

Mode of action
Prior to compression, there is a slow steady flow of blood in thelumen of the deep veins. When compression is applied there isa sudden increase in blood flow, which causes distension of thevein and flushes the valve pockets where thrombi are thought
to originate. There is an overall decrease in venous hypertension
and interstitial oedema.20 On deflation of the garment, theveins refill and the cycle is repeated.

pressure gradient, or hyperaemia caused by the veno-arteriolar
reflex or the release of nitric oxide.

The compression cycles and cell pressures vary according to
the type of application (Table 1), but are designed to be strong
enough to propel the blood, frequent enough to maximise thebenefit, but with sufficient deflation time to allow the vessels
to refill.

Table 1: Flowtron systems compression profile

The positive effects of Active Intermittent PneumaticCompression are not limited to the venous system. Improved
emptying of the lower extremity veins increases arterial bloodflow in patients with arterial disease, without compressing thearteries. This may be due to changes in the arterial-venous (AV)The augmented (increased or enhanced) blood flow, inducedby the pulsatile compression wave, can be visualised andmeasured objectively using Doppler ultrasound.

Flowtron
Calf & ThighLength
garments

FlowtronFoot
Garments

Cycles per minute1

2

Inflation: deflation ratio

12 : 48 secs

3 : 27 secs

Compression pressure

40 mmHg

130 mmHg

Inflation rate

Moderate

Fast

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Intermittent Pneumatic Compression– a multi modal approach to prophylaxis
Perhaps surprisingly, Intermittent pneumatic
compression therapy not only reduces venous
stasis, but also has a measurable anticoagulant
effect.
So, unlike other methods of prophylaxis, IPC
mitigates two of the pathological processes
that lead to VTE (Figure 9).

Intermittent PneumaticCompression and GraduatedCompression Stockings

VenousstasisVTE(DVT & PE)
Hypercoagulation

VesselinjuryIntermittent PneumaticCompression (IPC) devices

Figure 9:

Figure 10:
Haematological effect of IPC

Haematological Balance

Haematological effect of IPC

There is a very fine homeostatic balance between the procoagulant(‘clot making’) and fibrinolytic (‘clot breaking’) biochemical
pathways and IPC has been shown to produce changes thatboth inhibit clot formation and promote fibrinolysis.21

The mechanical effects of IPC in increasing blood flow, not only
reduces venous stasis but also has a measurable anticoagulant
effect. Figure 10 shows the mechanical force of compression
producing shear and strain, which brings about the release of
key chemical mediators from the endothelial cells (EC) lining thedeep veins.21

Fibrinolytic effect22•••

Tissue plasminogen activator (tPA)21
Urokinase plasminogen activator (uPA)23
Plasminogen activator inhibitor 21, 24

Antithrombotic effect••Tissue factor pathway inhibitor (TFPI)25
Thrombin-Antithrombin Complex (TAT)26

Other effects••

Prostacyclin Platelet disaggregation 21
Nitric oxide vessel dilatation & platelet disaggregation 21, 26

8

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SafetyBecause IPC mimics natural physiological processes, it is one of
the safest methods of prophylaxis available. IPC is not associatedwith the severe complications seen with anticoagulation therapy
nor the foot ulcers of GCS.17 Adverse events are rare and can be
avoided by following good clinical practice and the manufacturer’s
instructions for use.

Flowtron IPC: Clinical EffectivenessLaboratory studies
Many of the early investigative studies that underpinIntermittent Pneumatic Compression as a generic form of
VTE prophylaxis, were conducted using predecessors to thecontemporary Flowtron range. Although the technology has

been updated, the underlying design principles such as cycle
pressure, inflation rate and cycle intervals, remain the same.
The following studies demonstrate the antithrombotic andprofibrinolytic effect of Flowtron IPC.

The influence of inflation
rate on haematological andhaemodynamic effects of IPC.
Morris et al 2006 22

Both fast (comparator) and slow
inflation (Flowtron device) reduced
procoagulant activity
Only Flowtron significantly
increased global fibrinolysis
Haematological Studies
Effect of Flowtron IPC on
haemostasis and endothelial
function in claudicants
Sutkowska et al 2009 26

Compression increased nitric oxidelevels from the endothelium
Flowtron IPC decreased
thrombin-antithrombin complex (TAT)
Flowtron IPC reduced platelet activity
Systemic haemostasis after IPC
Giddings et al 2004 23

Flowtron IPC elicited a beneficial
haematological effect, supressing
procoagulant activation whilstenhancing fibrinolytic mechanisms
Fibrinolytic effects of IPC in
post-thrombotic patients

Key Summary:Comerota et al 1997 24• IPC reduces pro-coagulant activity(makes clots less likely to form)

Compression was associated withdecreased Plasminogen Activator
Inhibitor (PAI)
Fibrinolytic activity was significantly
increased in both normal (control) andpost-thrombotic patients• IPC increases inhibition of coagulation activation(increases the suppression of clot formation)• IPC increases fibrinolytic activity(breaks up clots once they begin to form)

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The reversal of venous stasis is key to prevention and the Flowtron IPC range has been subject to a number of comparativelaboratory tests and consistently demonstrated favourable results 27, 28 (Table 2).
Figure 11: Doppler Ultrasound Machine and Blood Flow Images

Table 2: Evidence from the laboratory

10

AuthorStudy

DesignKey Findings

Woodcock &Morris29

Doppler bloodflow analysis

Thigh-Length Compression• Flowtron [uniform] compression• Sequential compression(other brand)• The Flowtron system demonstrated
venous refill (not observed with sequential
compression) and so was considered to bea more efficient device

Flam et al 30 42

Prospective
randomised
cross-overstudy

Calf Compression• Flowtron [uniform] compression• Sequential compression (other brand)

Average flow augmentation• 107% Flowtron IPC (superior)• 77% Sequential Peak velocity• 39.5 cm/sec Flowtron IPC (significant)• 34.2 cm/sec Sequential

Flam et al 31

Comparative
femoral bloodflow study

Foot Compression• Flowtron [FP5000] foot compression• Comparator A• Comparator B• Low-cost comparator C• All systems except Comparator C device
delivered an average of 32% augmentationin supine position• Flowtron FP5000 delivered 219.5% in thedependent position compared toComparator C at 36.5%

Flam et al 32

Comparative
blood flow
study

Thigh-Length Compression• Flowtron [uniform] compression• Sequential compression (other brand)• Peak compression velocity was similar• Flowtron IPC produced significantly 		
higher blood flow augmentation = 23%

Morris &Woodcock 33

Bariatric
garment
evaluation

Calf Compression (Bariatric)• The DVT 60 (bariatric) garment• Blood flow augmentation = 83% to 120%
• DVT 60 likely to be equally effective
compared to standard fit garments

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Clinical EffectivenessOver the past 30 years, independent specialists have conducted
a number of clinical studies. Subjects have been recruited fromthe highest risk patient populations and across a range of clinicalspecialities. The results have consistently demonstrated theprophylactic capability of the Flowtron IPC range when used
with, or in place of, other methods of prophylaxis (Table 3).
Although IPC is now widely accepted as a valid form of prophylaxis,3
these legacy studies continue to have value.

Table 3: Flowtron Clinical Outcome Studies
AuthorStudy

Design & Results

Key Findings

Delince et al2011 34

149 patients randomised
to either Flowtron IPC or
Enoxaparin + graduatedcompression stockings

Flowtron IPC was associated with 		lower VTE rate (1.2% compared to 		2.9%) and fewer post-operative		transfusions required

Flowtron IPC considered to
be a cost effective and safe
option when used as the
only means of prophylaxis

Ginzburg et al2003 35

442 trauma patientsrandomisedGroup 1: Flowtron calf garments• DVT = 0.5% & $6,272
Group 2: Low Molecular Weight Heparin• DVT = 2.7% & $73,000

Flowtron IPC provides a lowcost and effective methodof prophylaxis for trauma
patients

Montgomery& Wolf 2005 36

344 patient charts
reviewed

Patients received either Flowtron thighlength compression or low molecularweight Heparin

LMWH group hassignificant risk of major
bleed (p=0.045)
for no additional benefit

VTE rates the same in both groups =1.2%
Brooks et al200737Comparative chart
review

Group 1: Spinal anaesthesia +anticoagulants + Flowtron calf garments
Group 2: Epidural anaesthesia + Flowtron calf

• Similar VTE rates• Flowtron IPC provides
effective prophylaxis
in this very high risk group

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Table 4: Flowtron Evidence in Speciality Groups
AuthorStudy

DesignKey Findings

Kurtoglu
et al 2005 38

Prospective Study.
High risk trauma andsurgical ICU patients

38 patients with multiple trauma
were provided with a Flowtron Excel
System. Venous duplex ultrasonography
performed on days 3 & 7
and at discharge. Chest radiology
conducted to screen for PE

No patient developed a DVT.
One patient had a symptomatic PE.
IPC safe and effective modality inpreventing both DVT and PE in high risk ICU
patients. IPC should be used when there is aclear contraindication to chemoprophylaxis

Kurtoglu
et al 200439

Prospective RCT.
Head and spinal
trauma patients

Group 1: IPC (Flowtron)

Group 1: 4 patients developed DVT
and 2 patients a fatal PE

Group 2: LMWH (Enoxaparin)
Daily leg circumference plus Doppler
ultrasound on admission and weekly
until 1 week post dischargeGroup 2: 3 patients developed a DVT
and 4 patients a fatal PE. The VTE
results were not statistically significant.
IPC group required statistically significant(p=<0.03) fewer blood transfusions
compared to the LMWH group

Kamranet al 1998 40

Retrospective &prospective study
in stroke patients

Three phase study:
Group 1: Retrospective review of
233 stroke patients – sub-cutaneous
heparin & AES

Using additional IPC for non-ambulatory
stroke patients reduced the incidence ofVTE by more than 40 times

Group 2: Prospective study 432 patients. Received same prophylaxis asgroup 1, plus IPC (calf garments) for
non-ambulatory patients
Group 3: Prospective study 16
patients given same therapy as group 1

Capperet al 1998 41

Retrospective andprospective audit.
Elective hip andknee replacements

Retrospective group:
825 patients received LDH,
LMWH or hydroxycholroquine
Prospective Group: 375 patients
received Flowtron IPC calf garments
warn pre-operatively until discharge

Eskanderet al 1997 42

Randomised control
trial: Traumatic Hip
FractureGroup 1: IPC (Calf) until 48 hours

Retrospective group:
VTE rate = 2.6%
Prospective group:
VTE rate was 1.06%
The benefits of IPC warrant serious
consideration

Group 1: VTE = 14% of patients

post-op, then LMWH to day 7

Group 2: VTE = 17% of patients
Group 2: LMWH from admission
to day 7

12

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IPC avoids the complications associatedwith pharmacological agents

IPC Evidence from Meta-analysis and Systematic Reviews
As with all preventative interventions, IPC can only be effective if
it is used with the right patient at the right time and that means
identifying patients at risk before a VTE incident occurs.
At the same time, the risk of side effects must be considered, inparticular, the risk of haemorrhage associated with the use of
anticoagulation. Meta analyses and systematic reviews (Table 5),
where multiple evidence sources are combined to determine
the overall clinical utility of ACT, are useful sources of

information and can guide prescription.
As an extension of the systematic review, the publication of national
and international clinical practice guidelines translate robust
and contemporary research into discrete recommendations(Table 6): knowledge gaps are filled by international consensus
panels. While the wording varies, the recommendations arelargely consistent and all accept IPC as an effective and safeintervention.

Table 5: IPC Evidence from Systematic Reviews
AuthorStudy

Key Findings

Kakkos 201643

Cochrane review: IPC with orwithout chemical prophylaxis• IPC + pharmacological prophylaxis reduces the risk of VTE• Chemical prophylaxis increases the risk of bleeding, this 		side effect is not seen for IPC

Eppsteiner 201044

Review of 16 RCTs;
n=c.4,000 subjects• No difference between mechanical prophylaxis & heparin• Significantly increased post-operative bleeding with heparin

Morris & Woodcock45
20106810 trials. GraduatedCompression Stockings vs. ACT• Both methods known to be effective but trend in favour of IPC

Nice uk 201846

IPC is indicated:• For many high risk populations e.g. bariatric,
gastrointestinal, cardiac and orthopaedic surgery• As the modality of choice for patients with a high riskof bleeding• For stroke patients within 3 days of the event and for
up to 30 days or when mobile• To be worn for as many hours as possible, and in manycases from admission• Featured systematic reviews reinforce no superiority
between uniform or sequential compression and calf
or thigh length garments with regards to efficacy• Choice is influenced by comfort, saftey, intended
application and clinical preference

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Table 6 – Selected ACCP (9th Edition)
Guideline Recommendations Related to Indications for IPC47

Population

Prophylaxis

Orthopaedic Surgery:
Major Orthopaedic Surgery: Total Hip Arthroplasty
Total Knee Arthroplasty, Hip Fracture Surgery

Dual prophylaxis with an antithrombotic agent and
IPC during hospital stayWith bleeding risk

IPC

Total Hip or Knee Arthroplasty

Recommend IPC plus pharmacological agent

Hip Fracture Surgery

Recommend IPC plus pharmacological agent

General Surgical Patients (Non Orthopaedic):
At low risk of VTE

Suggest mechanical prophylaxis preferably with IPC,
over no prophylaxis

At moderate risk for VTE, who are not at high risk for
major bleeding complications

Pharmacological: LMWH or LDUH over no prophylaxis.
Suggest mechanical prophylaxis preferably with IPC overno prophylaxis

At moderate VTE risk who are at high risk for major
bleeding complications or those whom the consequencesof bleeding are thought to be particularly severe

Mechanical prophylaxis preferably with IPC over no prophylaxis

At high risk for VTE, who are not at high risk for major
bleeding complications

Recommended Pharmacological: LMWH or LDUH over noprophylaxis. Suggest that mechanical prophylaxis with elastic
stockings or IPC should be added to pharmacologic prophylaxis

At high risk for VTE who are at high risk of major bleeding
complications or those in whom the consequences of
bleeding are thought to be particularly severe

Suggest use of mechanical compression prophylaxis, preferablywith IPC over no prophylaxis, until the risk of bleeding diminishes
then pharmacological prophylaxis may be initiatedAt high risk for VTE whom both LMWH and unfractionatedHeparin are contraindicated or unavailable and who are not
at high risk for major bleeding complications

Suggest mechanical prophylaxis preferably with IPC,
over no prophylaxis

Medical Patients:
Acutely ill hospitalised medical patients who arebleeding or at high risk for major bleeding

Optimal use of mechanical thromboprophylaxis with GCS.
Suggest IPC rather than no mechanical compression, until
bleeding risk decreases. If VTE risk persists suggest thatpharmacological thromboprophylaxis be substituted formechanical thromboprophylaxis

Critical Care Patients:
Critically ill patients who are bleeding or are at high riskof major bleeding

Mechanical thromboprophylaxis with GCS or IPC until bleeding risk
decreases, rather than no mechanical compression. When bleedingrisk decreases, suggest that pharmacological thromboprophylaxis be
substituted for mechanical thromboprophylaxis

Cardiac surgery:

14

Patients with an uncomplicated postoperative course

Mechanical prophylaxis, preferably with optimally applied IPC
over no prophylaxis

Prolonged hospital course by one or more non
haemorrhagic surgical complications

Add pharmacological prophylaxis with LDUH or LMWH tomechanical prophylaxis

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Population

Prophylaxis

Thoracic surgery:At moderate risk for VTE who are not at highrisk for perioperative bleeding

Pharmacological: LDUH or LMWH over no prophylaxis.
Mechanical prophylaxis with optimally applied IPC overno prophylaxis

At high risk for VTE who are not at high riskfor perioperative bleeding

Pharmacological: LDUH or LMWH over no prophylaxis
Mechanical compression with elastic stockings or IPC should be
added to pharmacological prophylaxis, until bleeding diminishes
then pharmacologicalAt high risk for major bleeding

Mechanical prophylaxis preferably with optimally applied IPC
over no prophylaxis, until the risk of bleeding diminishes andpharmacological prophylaxis may be initiatedCraniotomy:
Craniotomy patients

Mechanical prophylaxis, preferably with IPC used over noprophylaxis Mechanical prophylaxis, preferably with IPC
used over pharmacological prophylaxis

At very high risk of VTE (e.g. those undergoing
craniotomy for malignant disease)

Suggest adding pharnacological prophylaxis to mechanicalprophylaxis. Once adequate haemostasis established andbleeding risk decreases

Spinal Surgery:
Spinal surgery

Mechanical compression preferably with IPC over no prophylaxis
Mechanical prophylaxis preferably with IPC over pharmacological
LDUH or LMWH

Patients undergoing spinal surgery at high risk forVTE (including those with malignant disease or thoseundergoing surgery with a combined anterior – posterior
approach

Add pharmacological prophylaxis to mechanical prophylaxis.
Once adequate haemostasis established and bleeding risk
decreases

Major Trauma Patients:
Major Trauma patients

Pharmacological: LDUH, LMWH over no prophylaxis. Suggest useof mechanical prophylaxis with IPC over no prophylaxis.

When LMWH & LDUH are contraindicatedMechanical prophylaxis, preferably with IPC over no prophylaxis
when not contraindicated by lower extremity injury.
Pharmacological when risk of bleeding diminishes orcontraindication to heparin resolves

Traumatic brain injury, acute spinal injury and traumaticspine injury

Add mechanical prophylaxis to pharmacologic prophylaxis when
not contraindicated by lower limb extremity injury

LDUH = Low Dose Unfractionated Heparin
LMWH = Low Molecular Weight Heparin
IPC = Intermittent Pneumatic Compression
GCS = Graduated Compression Stockings

Note: Table 6 provides only a very limited selection and summarised version of
the ACCP (9th edition) guideline recommendations related to the indications for
IPC. Please refer to the full ACCP published guidelines for full details not includedin this table.

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Convenience
As with any method of prophylaxis, IPC is only beneficial when it
is correctly administered and tolerated by the patients who use
it; comfort and usability are key considerations and concordance
can vary.48 In a busy clinical environment the device benefits
from an intuitive user interface and appropriate safety features

to minimise the risk of harm. Some of these aspects have been
evaluated in usability trials (Table 7) and through independent
technology assessments, these feature safety, quality, ease ofuse in addition to cost-effectiveness.

Table 7: Evidence from Usability Studies

16

AuthorStudy

DesignKey Findings

ECRI 49

Independent
Product Evaluation

Evaluation of
IPC devices and garments

Copies of the most recent report are available
on the ECRI website

Van Blerk50

Usability andacceptance study

Calf And Foot Compression• Flowtron [v0] foot compression• Flowtron [DVT 10]
calf compression• The Flowtron device was quiet, lightweight,
with good safety features• Garments were comfortable leading to goodcompliance and positive outcomes:
30 patients, no VTE

Pagella 51

Comfort andconcordance(wear time)

Calf Compression• Flowtron IPC• Sequential compression(other brand)• Flowtron IPC was associated with greaterconcordance and patient satisfaction• Lower incidence of VTE after implementing
Flowtron IPC across the facility

Proctor 52

Comparative
study:
effectiveness,
comfort, usability

Calf Compression• Flowtron IPC• Four other brands of IPC• Flowtron IPC with calf garments had
lowest incidence of VTE = 1.1%
highest nurse & patient satisfaction
highest level of concordance (wear time)

ARJO V TE E VIDENCE RE VIEW V 1

Flowtron IPC: Choosing the right solution
Table 8: Key considerations for effective prophylaxis are efficacy and safety
IPC

Chemicalprophylaxis

Graduatedcompression stockings

Does the device
prevent venous stasis?

✓✗

Passive

Does the device
reduce coagulation?

✓

✓

✗

Does the device
increase fibrinolysis?

✓

✓

✗

Can the method induce
serious side effects

Rare
Rare incidents of skin/nerve damage avoided
by correct application

Frequent
Haemorrhage
Heparin-induced
thrombocytopaenia

Some
No longer recommended for immobile
stroke patients due to increased risk oftissue damage. NOTE: Stroke patients
share numerous characteristics with otherimmobile patients

The latest clinical guidelines now recommend battery-powered, portabledevices so that VTE prophylaxis can be continued without interruption47(Table 9) and, while the clinical and technical aspects of a device areimportant, so is patient acceptability.

Table 9: ACCP (9th edn.) Recommendations
Recommendation

Flowtron AC900

Portability✓

Battery-powered✓

Proper wear-time recording and reporting capability✓

18 hours of daily compliance✓

Choice of garment
For convenience, there is a choice of Flowtron garments, withcalf or thigh-length versions offering either sequential or uniform
compression, available in a range of sizes from small throughbariatric. Foot compression is available in regular or large foot size.
It is not clear whether there is any advantage in the use of thighcompression and, irrespective of compression profile,28 all
methods deliver a measurable (and clinically important) pulseof blood flow; the choice of garment depends simply uponclinician preference.

For safety and convenience, Smartsense Auto GarmentRecognition (Figure 12) ensures that the correcttherapy is applied.
The pause phase of each cycle is sufficient to refill the deepveins. At Arjo we prefer to keep things simple and cost-effective,
only adding features if there is a proven benefit.

PRE VENTING V TE WITH INTERM ITENT PN EU MATIC COM PRESSION   17  Figure 12: SmartsenseTM Auto Garment Recognition

Foot garment
A foot garment might be chosen when access to the calf is notpossible and patients may use a combination of leg and footgarments (on different legs).
However, given the nature of the smaller plantar reservoir,
the pulse required to propel blood through the femoral vein
is more abrupt, more frequent and higher pressure is needed.
Though producing the necessary blood flow,18 some patientscan find this sensation less comfortable than the ‘massage’sensation of leg garments.

Calf and Thigh Garment (DVT 30 & DVT 40)
Compress the calf and thigh area

Figure 13:

Calf Garment (DVT 10 & DVT 20)
Compress the calf

18

Foot Garment (FG100 FG200)
Compress the arch of the foot. Foot garments can be usedin combination with calf and calf and thigh garments.

PRE VENTING V TE WITH INTERM ITENT PN EU MATIC COM PRESSION

The Combination therapy
While the 9th ACCP guidelines 47 (Table 6) has found sufficientevidence to recommend IPC in combination with pharmacologicalprophylaxis in higher risk patients, the same cannot be said
for combining mechanical methods. In particular, there is little
rationale for adding graduated compression stockings beneath
IPC garments. The cost-benefit is not proven and, in the past,this may have been recommended simply to improve comfort
when using non-breathable fabrics.
Flowtron IPC delivers active compression and is not dependent
on the calf-muscle pump to reverse venous pooling andpromote haemostasis.

Figure 14: Flowtron garments in use

Single Patient Use
Arjo garments are all indicated for single-patient use.
We don’t believe it is safe, hygienic or desirable to ask patientsto share garments that are worn for prolonged periods directlyagainst the skin, particularly as the garments will becomecontaminated with moisture, skin debris and microorganisms,
some of which may be drug resistant. Studies have shown thateven short wear time increases the bioload to unacceptablelevels.53

Comfort and compliance
In order to achieve optimum VTE prevention, continuous use ofintermittent pneumatic compression therapy is recommended
for a minimum of 72 hours or until the patient is mobile and has
been suggested for as long as 10-14 days47 in patients following
major Orthopaedic surgery.
In the latest guideline published by the American College of
Chest Physicians (ACCP) in 2012,47 it is recommended to aim
for 18-24 hours of use per day. This can result in the patient
wearing the garments for long periods during the day and night;
in various climates within the hospital. The condition of thepatient can also have an effect on core temperature, which can
influence the patient’s normothermic state.

Comfort is a critical factor in patientcompliance with IPC
Comfortable VTE garments are important in improving the patient
experience and therefore concordance with prevention therapy.
Better concordance with therapy is linked with reduced VTE event
rates as studies reviewing reminder tools have shown.54

Improving Patient Comfort
One method of improving patient comfort is to focus on thegarments’ ability to allow the passage of heat, air or moisturevapour away from the skin through the fabric.

This can result in patients perspiring in the lower limb area, leading
to discomfort whilst wearing an IPC garment.

Patients are more compliant with therapy
when a comfortable VTE prevention
garment is used
A randomised trial evaluating patient compliance with IPC therapy
demonstrated that a garment, which was more comfortable, wasworn for longer periods. The study concluded that “patientsare more compliant with a pneumatic compression device that
promotes patient comfort when worn”.51
Specifically in this study, differences in compliance were seen
when patients reported that ‘the device was hot’ (p=0.14) andthe ‘device made my legs sweat’ (p=.029).

Figure 15: Example of Flowtron TriPulse Garment Fabric Construction

PRE VENTING V TE WITH INTERM ITENT PN EU MATIC COM PRESSION   19  

Flowtron Garments have been
designed to provide:

In order to demonstrate Flowtron® DVT garments properties, they were
tested at an accredited independent laboratory to assess heat, air andwater vapour characteristics following recognised test standards.

• Low thermal rating (Figure 16)• Heat and moisture vapour transfer throughthe material (Figure 17)• Water Vapour Permeability WVP Index BS7209:1990 (1997)• Quick drying of the fabric (Figure 18)• Thermal Resistance (TOG) BS4745• RET Water Vapour Resistance EN31092

0.80

Low is better

Example of TriPulse Garment Testing
0.8

0,78

Figure 16: Low Thermal Rating (TOG)
To minimise the risk of perspiration or increased heat production during wear
time, VTE prevention garments should be nonthermal – this means that they
do not generate additional heat.

0,76
0.76
0,74
TargetA single plate procedure is used to determine the thermal
resistance of the fabric.

TriPulse40

Low is better

Tog

40

30
20

Resistance Evaporation Permeability (RET) measures the resistance to water
vapour transmission through a barrier.

20
5.6

10
0

Figure 17: Breathable Fabric (RET)

NonBreathble

Breathble

5,6

5.0
5

TriPulse

CottonIndustry standards (EN31092) state that a fabric which scores > 40 is nonbreathable, 20-40 is semi-breathable and < 20 is breathable.

0.05
0,04

Low is better

R. Value

0.05

0,03
0,02
0,01
0,00

0,0018Target

TriPulse

Figure 18: Drying Time
Perspiring is one of the body’s methods of thermoregulation. Water canabsorb a high amount of heat energy when it evaporates, and this creates acooling effect. A fast drying time indicates that liquid such as perspiration
can evaporate away from a garment quickly. This can help the body cool.
A dry vs. wet weight variance of 0.05 over 8 hours shows how quickly fluid
has evaporated away from the material.

100
80
60

80

76.1

40
20
0

TargetFigure 19: Water Vapour Permeability
The transfer of water vapour away from the patient’s skin is a criticalfactor in patient comfort — this process refers to a fabric’s breathability.
Water Vapour Permeability (WVP) and RET are 2 measures that are used
to evaluate the breathability of a fabric. WVP describes the water vapour
permeability of a fabric and therefore the degree of perspiration transported
to the outside air.

TriPulse% Permeability

20

Low is better

Weight Variance

The higher the value, the more breathable the fabric.

PRE VENTING V TE WITH INTERM ITENT PN EU MATIC COM PRESSION

A final thought…
We recognise that you have a choice of provider for your VTE prophylaxis andthat IPC devices represents only a small part of your overall VTE prevention
strategy. With Arjo’s many years of knowledge and experience in VTE prevention.
We can support your facility with a range of education, assessment and service
solutions to support your VTE prevention strategy.
For further information please visit www.arjo.com

PRE VENTING V TE WITH INTERM ITENT PN EU MATIC COM PRESSION   21  

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PRE VENTING V TE WITH INTERM ITENT PN EU MATIC COM PRESSION   23  

DVT.CEB.01.GB-INT.1.ARJO - Arjo VTE Evidence Review V1. July 2018.
Only Arjo designed parts, which are designed specifically for the purpose, should be used on the equipment and products supplied by Arjo. As our policy is one of continuous development we reserve the right to modify designs and specifications without prior notice.
At Arjo, we are committed to improving the everyday lives of people affected by reduced mobility and age-related health challenges. With products and solutions that ensureergonomic patient handling, personal hygiene, disinfection, diagnostics, and the effective prevention of pressure injury and venous thromboembolism, we help professionals
across care environments to continually raise the standard of safe and dignified care. Everything we do, we do with people in mind.
Arjo AB • Hans Michelsensgatan 10 • 211 20 Malmö • Sweden • +46 10 335 4500
www.arjo.com