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HH610-Flowtron DVT_HH 7/10/08 15:03 Page b

CLINICAL EVIDENCE

FLOWTRON DVTPROPHYLAXIS SYSTEMS

HH610-Flowtron DVT_HH 7/10/08 15:03 Page c

2•

From the experts…

Pagella et al (Orthopaedic Nursing 2007)1

“In comparing the two [Intermittent pneumatic compression - IPC] devices, the

results of this project suggest that patients were more satisfied and comfortable with

Product Y [Huntleigh] than Product X [Tyco]”.

Brooks et al (Journal of Arthroplasty 2007)2

“Our data suggest that postoperative use of epidural analgesia with IPC alone is an

extremely effective method of postoperative pain control without a significant increase

in deep vein thrombosis (DVT) as compared with spinal anaesthesia followed by low

molecular weight herparin (LMWH) administration”.

ECRI Institute (2007)3

The ECRI Institute acknowledge that no single type of IPC (uniform / sequential; calf /

thigh etc) is more or less effective than the other at preventing DVT. Therefore the

key factors to consider when purchasing such products are; ease of use; patient

comfort; performance; product safety features and build quality.

The ECRI institute rated the Huntleigh FLOWTRON® Universal as the best overall

product tested.

National Institute for Health and Clinical Excellence (NICE) (2007)4

IPC or foot impulse devices may be used instead of, or as well as, graduated

compression stockings while patients are in hospital. These devices should be used

for as much time as is possible and practical”.

“[IPC] is cost effective compared with no prophylaxis”.

Morris et al (Journal of Vascular Surgery 2006)5

“Rapid inflation clearly produced no extra benefit in increasing global fibrinolysis and

may be less haematologically effective”.

Ginzburg et al (British Journal of Surgery 2003)6

The data indicated that the use of IPC in trauma patients was low cost and was

effective in preventing thromboembolic events.

A total of US $73,000 was spent on LMWH in this study compared with $6,272 in

the IPC device group. This represented a cost saving of $67,300 in the IPC group.

Proctor et al (Journal of Vascular Surgery 2001a)7

Devices W (Huntleigh), X (sequential) and Y (sequential) had comparable DVT rates.

Vendor W (Huntleigh) had the highest level of acceptance, especially with respect to

comfort and quietness.

Proctor et al (Journal of Vascular Technology 2001b)8

“We were unable to show a difference in DVT incidence based on length of the

device or method of compression.

…too much force may actually injure the endothelium, exposing the thrombogenic

basement membrane and potentially resulting in DVT.”

HH610-Flowtron DVT_HH 7/10/08 15:03 Page 2

3•

DVT and pulmonary embolism (PE) are major health

problems.

PE arising from DVT is the commonest avoidable cause

of death and occurs at approximately five times the rate

in hospital patients compared to the general population9.

In the long term DVT can lead to post-thrombotic

syndrome which affects patient quality of life, as well as

having significant healthcare costs.

IPC is a non-invasive mechanical method of both

increasing venous blood flow in the legs and stimulating

endogenous fibrinolytic activity. IPC is a safe and proven

alternative to the use of anticoagulants to assist in the

prevention of DVT and represents significantly lower

costs per patient episode6.

This booklet has been written for the healthcare

professional. It provides abstracts of key clinical papers

and evidence based guidelines relating to the use of IPC

systems for DVT prophylaxis.

IntroductionContents

Introduction 3

The scale of the problem 4

Recommendations for the use of IPC:

consensus statements and guidelines 5

Meta-analyses and literature reviews 7

IPC – mechanisms of action 9

Physiological measurement studies

using FLOWTRON Systems 11

Comparative clinical and outcome

studies using FLOWTRON Systems 15

Summary 22

References 23


4•

The scale of the problem

Up to 200,000 patients die from DVT and or PE each

year in the United States10, while in the United Kingdom it

is estimated that venous thromboembolism (VTE) kills

25,000 patients per annum. This equates to more

deaths than from breast cancer, HIV AIDS and road

traffic accidents combined and more than 25 times the

number who die from MRSA11.

PE is the immediate cause of death in 10% of hospital

patients and until recently was the leading cause of

peri-natal death11.

Direct and indirect cost of VTE is estimated at £640

million per year in the UK and over 50% of leg ulcers

arise as a direct result of DVT – which were probably

preventable given adequate prophylaxis11.

The factors associated with VTE are well established but,

if the risk is proactively managed, this distressing

condition is largely avoidable, however … up to 40% of

patients undergoing major surgery in the UK may not

receive adequate prophylaxis, with legal settlements for

negligence awarding up to £500,000 per claimant12.

Venous thromboembolism risk and prophylaxis in

the acute hospital care setting (ENDORSE study):

a multinational cross-sectional study (Cohen et al

2008)

• A multinational epidemiological study (>68,000

patients across 32 countries) looking at patient VTE

risk profile and the proportion of these patients

receiving adequate prophylaxis.

• Worldwide, more than half of all hospitalised patients

are at risk of VTE however, only half of these at risk

patients receive an American College of Chest

Physcians (ACCP) recommended form of prophylaxis.

• 10% of all patients at risk of VTE were also at high risk

of bleeding and not able to have anticoagulants.

These patients could have had ACCP recommended

forms of mechanical prophylaxis.

• The use of recommended VTE prophylaxis was

particularly poor in medical patients; only 37% of

patients with diagnoses of active malignancy and

ischaemic stroke (two of the highest risk groups for

VTE) received adequate prophylaxis13.


A number of consensus statements have been produced

following both national and international conferences

involving experts from a variety of specialities who have

reviewed the published evidence on aspects of VTE

prevention. Guidelines have been produced from many

of these consensus statements which recommend the

most effective forms of prophylaxis relative to the patient

group.

The Seventh ACCP conference on antithrombotic and

thrombolytic therapy14 identified the frequency of DVT in

hospitalised patients in the absence of prophylaxis.

Table 1 illustrates the high incidence of DVT and the

requirement for effective prophylactic measures.

Risk factors identified from within the literature have

enabled several consensus groups14,15,16,17,18 to classify

patients into levels of risk for development of VTE.

Table 2 presents a summary from the ACCP Consensus

Conference which outlines the thromboembolism risk

levels in different surgical patients without prophylaxis

and the recommended evidence based prevention

strategies.

In 2007, NICE released the VTE prophylaxis clinical

guidelines4 for surgical in patients across England and

Wales. A summary of the NICE recommendations for

VTE prophylaxis is given in the Table 3.

Recommendations for the use of IPC: consensus statements and guidelines

Level of risk Successful recommendedprevention strategies

Low risk – minor surgery in patients<40 years with no additional risk factors

No specific measuresEarly and aggressive mobilisation

Moderate risk – minor surgery inpatients with additional risk factors;surgery in patients 40-60 years with noadditional risk factors

IPCLow dose unfractionated heparin(LDUH) every 12 hours LMWHdaily. Graduated compressionstockings (GCS)

High risk – surgery in patients >60years; surgery in patients 40–60 yearswith additional risk factors (prior VTE,cancer, molecular hypercoagulability)

IPCLDUH every 8 hoursLMWH daily

Highest risk – surgery in patients withmultiple risk factors (e.g. age >40 years,cancer, prior VTE), hip or kneearthroplasty, hip fracture surgery, majortrauma and spinal cord injury

IPC / GCS + LDUH / LMWH oradjusted dose heparinLMWH daily, oral anticoagulants,vitamin K antagonists (VKAs)

Surgicalspeciality -excluding daycase surgery

No patient related riskfactors

One or more patient related riskfactors

Elective HipReplacement

Mechanical prophylaxis+ LMWH/ Fond

Mechanical prophylaxis + LMWH/Fond continued for 4 weeks

Hip Fracture Mechanical prophylaxis+ LMWH/ Fondcontinued for 4 weeks

Mechanical prophylaxis + LMWH/Fond continued for 4 weeks

OtherOrthopaedic

Mechanical prophylaxis+ LMWH/ Fond

Mechanical prophylaxis + LMWH/Fond

General Mechanical prophylaxis Mechanical prophylaxis + LMWH/Fond

Gynaecological Mechanical prophylaxis Mechanical prophylaxis + LMWH

Cardiac Mechanical prophylaxis Mechanical prophylaxis + LMWH*

Thoracic Mechanical prophylaxis Mechanical prophylaxis + LMWH

Urological Mechanical prophylaxis Mechanical prophylaxis + LMWH

Neurosurgery Mechanical prophylaxis Mechanical prophylaxis +LMWH**

Vascular Mechanical prophylaxis Mechanical prophylaxis + LMWH

Table 1

Table 2

Table 3

Fond = Fondaparinux, *= if not otherwise anticoagulated, ** except patients with ruptured

cranial or spinal vascular malformations if the lesion has not been secured, Mechanical =

graduated compression stockings, IPC devices or foot impulse devices

Patient Group DVT Prevalence

Medical Patients 10-20%

General Surgery 15 – 40%

Major Gynaecologic Surgery 15 – 40%

Major Urologic Surgery 15 – 40%

Neurosurgery 15 – 40%

Stroke 20 – 50%

Hip or Knee Arthroplasty

Hip Fracture Surgery40 – 60%

Major Trauma 40 – 80%

Spinal Cord Injury 60 – 80%

Critical Care Patients 10 – 80

5•


6•

Summary of outcomes from consensus papers and guidelines

Consensus statement Methodology Recommendations relating to IPC

NICE Clinical Guideline 46 (2007)4 An evidence-based clinical guideline based upon the

methodology of a systematic review. The guidelines

focus specifically on the prevention of VTE in surgical in-

patients and recommend the optimal patient treatment.

CG46 is designed to be adopted and implemented

across England and Wales.

IPC or foot impulse devices may be used instead of, or as

well as, GCS while patients are in hospital. These devices

should be used for as much time as is possible and

practical.

IPC is cost effective compared with no prophylaxis.

The Australia and New Zealand

Working Party on the Management

and Prevention of Venous

Thromboembolism19

Best Practice Guidelines 4th Edition

(2007)

National guidelines developed by a working party to

assist in the identification and treatment of patients at risk

of developing DVT.

IPC reduces the incidence of DVT and is more effective than

GCS in high risk patients in combination with anticoagulants

or when anticoagulants are contraindicated. IPC should be

used when the patient is immobile and continue until patient

is fully mobile. IPC should not be used in patients with

critical ischaemia.

International Consensus Statement

(2006)18

An international group of experts reviewed levels of risk

and recommended prophylactic and treatment measures

in surgical, medical and obstetric patients.

IPC is effective for moderate and high risk patients.

IPC is recommended for patients undergoing neurosurgical

procedures.

Health Technology Assessment

(2005)20

Evidence-based guidelines for the prevention of VTE

produced to influence key decision making bodies in the

UK to help raise standards of care.

IPC produces a highly significant reduction in DVT when

used as monotherapy or adjunctive therapy.

7th ACCP Conference on

Antithrombotic Therapy (2004)14

North American consensus statement from the American

College of Chest Physicians (ACCP). Evidence based

risk stratification; recommendations and expert opinion /

advice given where insufficient evidence exists.

IPC is an attractive method of prophylaxis as there are no

bleeding complications. Combined prophylaxis of IPC and

pharmacological methods may be advantageous in very high

risk patients.

Prophylaxis of Venous

Thromboembolism.

SIGN Guidelines (2002)17

A guideline drawn up by the Scottish Intercollegiate

Guidelines Network to incorporate current best evidence

for all patient specialities with respect to VTE prophylaxis.

IPC devices are effective in reduction of asymptomatic DVT

in surgical patients with a risk reduction of around 68%.

Salvati et al (1998)21 American and UK experts reviewed methods of screening

and prophylactic measures for patients undergoing total

hip replacement.

IPC reduces the incidence of DVT and is more effective than

GCS in high risk patients in combination with anticoagulants

or when anticoagulants are contraindicated.

IPC should be used from the time of immobility to the return

of full ambulation.

THRiFT II (1998)16 THRiFT I experts (from England, Scotland, Ireland) plus

public health physicians, hospital managers, pharmacists,

clinical risk managers reviewed new evidence published

between 1991-1997.

IPC is recommended for moderate and high risk patients.

IPC is recommended for elective hip and knee surgery.

IPC is free of haemorrhagic complications.

THRiFT (1992)22 UK experts reviewed the risk of thromboembolic disease

to hospital patients. Specific recommendations were

made for surgical and medical patients.

All inpatients should be assessed and prophylaxis continued

at least until discharge.

European Consensus Statement

(1992)15

Meeting of experts from 12 European countries, USA,

Canada and Australia held in London in 1991. Evidence

and expert opinion on DVT prophylaxis was reviewed and

later published in 1994.

IPC is effective and suitable for moderate and high risk

patients in both medical and surgical specialities until

ambulant. Patients at high risk of bleeding and neurosurgical

patients should receive mechanical forms of prophylaxis.

USA National Institute of Health

Consensus Conference (1986)23

An expert panel reviewed evidence supporting the use of

different methods of DVT prophylaxis in medical and

surgical patients during this conference and

recommendations were made

IPC is recommended for: general and orthopaedic surgery,

neurosurgery, urology, trauma, obstetrics and gynaecology.

IPC is the method of choice where the risk of haemorrhagic

complications exists.


7•

Meta-analyses and literature reviews

Evidence based compression. Prevention of stasis

and deep vein thrombosis (Morris and Woodcock

2004)

Years: 1970 – 2002

Objectives:

To review published evidence on the venous flow effects

of mechanical compression devices to answer some

common questions on flow properties and determine

their relevance in relation to DVT prevention.

Outcomes:

• Use of IPC is simple and complication free and

compares favourably with pharmacological

prophylaxis.

• Evidence does not support the view that the higher

the peak velocity the more effective the IPC system.

• Both thigh and calf compression systems are effective

in preventing DVT.

• Foot compression requires significantly higher

pressures to augment blood flow as there is less

blood in the plantar plexus compared to the calf and

the muscles are less compressible.

• There is no evidence that graded sequential

compression is better than uniform compression in

terms of DVT incidence.

• Distal venous trapping can occur, but there is no

evidence it happens consistently or with a particular

type of system. It cannot be considered an important

feature of IPC generally.

• Although compression stockings are effective in DVT

prevention, they are not as effective as IPC or

anticoagulants. It is imperative the correct size and

shape are used as poorly fitted stockings increase the

risk of thrombosis.

• There is insufficient evidence to support the view that

the combined use of compression stockings and IPC

increases venous velocity augmentation over and

above that achieved by IPC alone24.

Prophylaxis of perioperative venous thrombosis:

role of venous compression (Silleran-Chassany and

Safran 2000)

Objectives:

A literature review to examine the effectiveness of IPC

devices in prevention of DVT following general and

orthopaedic surgery.

Outcomes:

• Mechanical methods of prevention are inexpensive,

easy to use, with few contraindications and are not

associated with bleeding complications compared to

pharmacological methods. They offer an effective and

satisfactory alternative in patients unsuitable for

anticoagulation.

• The venous haemodynamic effects of compression

include a reduction in the calibre of superficial and

deep veins with acceleration of blood flow, reduction

of oedema by draining interstitial fluid and reduction of

venous reflux.

• Randomised trials have shown compression and

anticoagulation used together to be better than the

respective methods alone (25% DVT in combination,

compared to 38% in LMWH alone).

• IPC is particularly relevant in neurosurgery where

anticoagulants are not used in the perioperative

period25.


8•

FLOWTRON DVT Prophylaxis Systems

A meta-analysis of thromboembolic prophylaxis

following elective hip arthroplasty (Freedman et al

2000)

No. of papers reviewed: 52 (10,929 patients)

Years: 1966 – 1998

Objective:

To define the efficacy and safety of agents used for DVT

prophylaxis in total hip arthroplasty patients – LMWH,

warfarin, aspirin, low does heparin (LDH) and IPC. No

combination therapies were included.

Outcomes:

• Risk of DVT was lowest with LMWH (17.7%), IPC

(20.7%) and warfarin (23.2%). These were the only

agents that significantly decreased the risk of

symptomatic PE.

• LMWH, LDH and warfarin were associated with the

highest risk of minor and major wound bleeding.

• IPC and warfarin each provide the best balance of

efficacy and safety.

• Use of IPC had lowest risk of distal DVT (7.7%)

compared to other methods. Risk of proximal DVT

when using IPC was 13.3%. Overall, IPC gave the

second lowest risk of total DVT at 20.7%.

• IPC had the second lowest risk of symptomatic PE

(0.26%) and lowest risk of minor wound bleeding

(1.1%) and major wound bleeding (0%)26.

Meta-analysis of effectiveness of intermittent

pneumatic compression devices with a comparison

of thigh-high to knee-high sleeves (Vanek 1998)

No. of papers reviewed: 57

Years: 1966 – 1996

Objectives:

To examine the effectiveness of IPC devices in the

prevention of DVT and PE. To compare the results of

knee-high versus thigh-high sleeves.

Outcomes:

• IPC was more effective than placebo, GCS and LDH

in preventing DVT. It was not able to be shown if IPC

was protective against PE as only 2 studies performed

routine ventilation / perfusion scans. IPC devices

reduced the relative risk of DVT by 62% when

compared with placebo, 47% compared with GCS

and 48% compared with heparin.

• IPC reduced the relative risk by 28% when compared

with warfarin, although this is not statistically

significant.

• IPC significantly decreased proximal and calf DVT in

neurosurgery and major orthopaedic surgery.

• Knee-high sleeves had a slightly greater reduction in

relative risk (64%) compared to thigh-high garments

(56%). There is no evidence that one method is

superior to another.

• Meta-analysis clearly reveals that IPC devices are

effective in reducing incidence of DVT in patients at

moderate to high risk of DVT, and are probably more

efficacious than GCS or LDH. A much larger number

of patients would need to be studied to demonstrate

the effect of IPC on PE incidence27.


Mechanical

In healthy ambulatory subjects, there is active propulsion

of blood in the deep veins towards the heart via the

action of the calf and foot pumps. IPC seeks to mimic

these effects in those patients that are non-ambulatory

and affects the venous circulation by:

1 Increasing blood flow velocity in the deep veins and

reducing stasis.

2 Decreasing venous hypertension.

3 Flushing valve pockets where it is thought thrombi

originate.

4 Decreasing interstitial oedema28.

Biochemical

The mechanical forces of shear and stress within the

venous system as described above are linked to

physiological responses in the endothelial cells that are

thought to contribute to the anti-thrombotic and pro-

fibrinolytic effects of IPC29.

Anti-thrombotic

IPC has been found to increase tissue factor pathway

inhibitor (TFPI) which is an important regulator of the

initiating event in the blood coagulation system30, 31.

Another pathway which IPC has been suggested to

affect is that of platelet disaggregation via the action of

prostacyclin29.

Pro-fibrinolytic

Studies have demonstrated that IPC increases tissue

plasminogen activator (tPA) and urokinase-plasminogen

activator (UPA) with a corresponding decrease in

plasminogen activator inhibitor-1 (PAI-1). These actions

have the overall effect of suppressing the pro-coagulant

activity whilst enhancing the fibrinolytic mechanism31, 32.

IPC – mechanisms of action

Mechanical and biochemical effects of IPC on a vein. Diagram adapted from Chen at al (2001)29.

Compression

Compression

Flow

Shear

tPA

ProstacyclinNO TFPI S

trai

n

9•


Maintaining haemostatic balance

In a study of 21 healthy male subjects, Giddings et al

(2004)33 examined specific markers of blood coagulation

and fibrinolysis before (control) and after 60 and 120

minutes of IPC using the FLOWTRON Excel System.

The results were in keeping with the concept that

physiological blood flow plays a significant role in

maintaining a haemostatic balance and reflects the

potential value of relatively simple procedures such as

IPC in clinical thrombosis management.

Compression type

The FLOWTRON DVT Prophylaxis System range of

garments is designed either to compress the calf, thigh

or the foot, augmenting blood flow to a level proven to

minimise formation of DVT.

The FLOWTRON Excel System is a single pulse IPC

system which delivers an intermittent pressure in a distal

to proximal direction via usage of either calf or thigh-

length garments.

When standard calf or thigh garments are inappropriate,

the FLOWTRON Universal System is an effective

alternative delivering external intermittent pneumatic

compression to the foot. The FLOWTRON Universal

System, superseding the FP5000™ foot pump, is a

three-in-one design system providing a choice of calf,

thigh or foot compression from a single pump.

Haemodynamic studies have been undertaken

comparing Huntleigh calf and thigh garments against so-

called multi-chamber 'sequential' systems. Comparable

outcomes were achieved with respect to blood velocity

and there was a trend towards greater peak flow

augmentation with the FLOWTRON System7, 34, 35, 36, 37.

Comparative patient studies have been undertaken and

are discussed later in this booklet.

FLOWTRON Excel System with calf garments

FLOWTRON Universal System with foot garments

FLOWTRON Universal System with foot and calf garments

10•


The influence of inflation rate on the hematologic

and hemodynamic effects of intermittent pneumatic

calf compression for deep vein thrombosis

prophylaxis (Morris et al 2006)

• A rapidly inflating IPC device (Aircast Venaflow™) was

compared to a more gentle IPC device (Huntleigh

FLOWTRON system) in a group of 20 male volunteers

to determine if there were any differences in the

haematological and haemodynamic profiles of the two

IPC devices.

• Blood samples for fibrinolytic and blood coagulation

components were obtained without using a tourniquet

from the antecubital vein immediately before and after

each of the IPC sessions. Doppler ultrasound flow

velocity measurements were also taken to quantify the

hemodynamic impact of the IPC devices.

• Both IPC systems reduced procoagulant activity. Only

the gentle IPC device (FLOWTRON system) was able

to significantly increase global fibrinolysis.

• Rapid inflation devices cannot claim to increase

fibrinolysis. Devices with rapid inflation profiles may

not provide optimal DVT prophylaxis5.

Systemic haemostasis after intermittent pneumatic

compression. Clues for investigation of DVT

prophylaxis and travellers thrombosis (Giddings et al

2004)

This study sought to study the effects of the FLOWTRON

Excel System on haematological markers. The

FLOWTRON System, used with the DVT10 calf

compression garments, was applied for 120 minutes on

21 male, non-smoking volunteers ranging in age from 19

to 47 years. Peripheral blood samples were obtained

from the subjects before and after 60 and 120 minutes of

IPC. Blood samples were also obtained from the same

subjects when they were resting for these time periods

without IPC, which acted as controls.

The method of taking the blood samples was carefully

controlled and performed; no tourniquet was used and

cannulae were not left indwelling, as these factors had

previously been shown to significantly alter coagulation

markers.

The outcomes of this study were that:

• The FLOWTRON Excel System exerted a beneficial

haematological effect, suppressing pro-coagulant

activation whilst enhancing fibrinolytic mechanisms.

• Measurement of specific fibrinolytic components does

not reflect overall fibrinolytic activity.

• What is measured is highly dependent upon how

blood is sampled and processed in the laboratory33.

Intermittent pneumatic compression for bariatric

patients – the Huntleigh DVT60 compression

garment (Morris and Woodcock 2003a)

This haemodynamic evaluation took place in 3 subjects

using DVT60 Bariatric Fit™ garments from Huntleigh. 1

evaluation took place at the University of Wales College

of Medicine and 2 subjects were evaluated at Yale

University, USA.

• The 3 subjects weighed between 150 kg and 210 kg.

• Augmentations between 83% and 120% were

obtained in the femoral and popliteal veins which

correspond well with those reported for the DVT10

garment.

• The compressibility of fat is not very different to that of

most other body constituents and it is unlikely that the

layer of fat would absorb the effects of cuff

compression and prevent emptying of the veins.

Physiological measurement studies using FLOWTRON Systems

FLOWTRON DVT60 Bariatric Fit calf garments

11•


• Evidence from these evaluations suggests that the

DVT60 garment would provide as effective prophylaxis

as the DVT10 or DVT20 garments38.

Haematological and haemodynamic comparison of

the Kendall A-V Impulse™ and the Huntleigh

FP5000 Intermittent Pneumatic Foot Compression

Systems (Morris et al 2003b)

• The A-V Impulse and the FP5000 Systems were

compared. The 2 systems differ in their method of

compression, with the A-V Impulse System

administering a sharp pulse by inflating to 60-200

mmHg within 0.4 seconds, every 20 seconds. The

FP5000 System inflates to 130-170 mmHg over a 3

second period every 30 seconds.

• The haematological and haemodynamic effects of the

2 systems were compared using 20 healthy

volunteers.

• Despite differences in cuff design and inflation

patterns, both systems increase fibrinolysis and

prevention of venous stasis with no statistically

significant differences39.

The effect of the Kendall (Tyco) SCD™ and

Huntleigh DVT30 garments on femoral and popliteal

vein blood flow measurements (Woodcock and Morris

2002)

Popliteal and femoral vessels were scanned using duplex

Doppler ultrasound in healthy volunteers with both

FLOWTRON Excel DVT30 thigh-length and Tyco SCDTM

thigh-length garments.

• Little difference was detected between the 2 systems

with respect to the response in the femoral vein or the

volume flow rate of blood ejected from the lower limb.

• The FLOWTRON Excel System combined with the

DVT30 garment reduced venous flow to very low

levels, indicating refilling of veins. This was not

observed with the Tyco SCD System. The findings

indicate that the FLOWTRON Excel System with

DVT30 (thigh-length garment) is more efficient than the

Tyco SCD System at emptying veins37.

Venous hemodynamic characteristics of pneumatic

compression devices (Proctor et al 2001a)

15 healthy volunteers tested 9 different IPC pumps and

15 different compression garments from a total of 5

different suppliers. Venous haemodynamic parameters

were assessed at the common femoral vein using duplex

ultrasound.

• Although baseline velocities all changed, there was no

significant difference in the haemodynamic outcomes

with respect to compression cycle, type and length of

garment.

• Neither the length of garment nor the type of

compression affected the haemodynamic parameters

of peak and mean velocity and peak volume flow.

This was also true for the 3 types of compression

cycles: rapid graduated sequential, graduated

sequential and intermittent compression7.

A clinical study was also carried out by the same

investigators evaluating DVT rate, patient and staff

acceptability8. See page 18.

Intermittent pneumatic compression devices of the

foot: a comparison of various systems on femoral

vein blood flow velocity augmentation in the supine

and dependent, non-weight bearing positions (Flam

et al 2000)

In this randomised study, 4 commercially available foot

compression systems were evaluated in 4 healthy adult

subjects: Kendall A-V Impulse, KCI PlexipulseTM System,

Currie ALPTM and Huntleigh FP5000 Systems. Blood

velocity augmentation was measured at the femoral vein.

• Huntleigh FP5000 System, Kendall A-V Impulse

System, and KCI Plexipulse System were similar with

an average velocity augmentation of 32% in supine

positioning. Currie ALP System performed poorly

compared to the other products.

• The Huntleigh FP5000 System average velocity

augmentation was 219.5% while the Currie ALP

System was just 36.5% in a dependent non-weight

bearing position40.

12•


FP5000 Pump System – the impact of comfort on

efficacy (Huntleigh 2000)

In this study, blood velocity augmentation was evaluated

by duplex ultrasound imaging in 8 healthy adults using

the Huntleigh FP5000 Foot Compression System,

Kendall A-V Impulse System and the KCI Plexipulse

System. Using a randomised order, 5 consecutive

measurements were undertaken.

• Results showed that blood flow velocity augmentation

of the FP5000 System was proven to be comparable

to the Kendall A-V Impulse and the KCI Plexipulse

Systems41.

Venous haemodynamics after total knee

arthroplasty: evaluation of active dorsal to plantar

flexion and several mechanical compression

devices (Westrich et al 1998)

The purpose of this study was to evaluate the

haemodynamic effect of active dorsal to plantar flexion

with 7 different pneumatic compression devices

(including the FLOWTRON Excel System with calf

garments) in 10 patients who had a total knee

arthroplasty at the Hospital for Special Surgery in New

York City.

• After evaluating the 7 different IPC devices, it was

found that calf compression is sufficient and thigh-high

compression is not necessary.

“Based upon the results of our study, we doubt

whether the addition of thigh compression is

necessary. Pulsatile calf compression appears to be

sufficient for augmentation of venous velocity.”36

The fibrinolytic effects of intermittent pneumatic

compression. Mechanism of enhanced

compression (Comerota et al 1997)

This study was undertaken to quantify and clarify the

mechanisms of fibrinolytic enhancement with IPC.

Additionally the investigators evaluated whether post-

thrombotic subjects had the same capacity for fibrinolytic

enhancement as normal subjects when using IPC.

• After 180 minutes of IPC, there was a significant

increase in fibrinolytic activity in both normal and post-

thrombotic subjects. tPA levels only increased in

normal subjects.

• Decreases in PAI-1 were seen in both groups after

IPC.

• Fibrinolytic activity was reduced significantly at

baseline in post-thrombotic subjects compared with

normal subjects.

• Following IPC, fibrinolytic activity of the post-

thrombotic subjects only increased to the equivalent of

the baseline level seen in the normal subjects.

• It is the balance of PAI-1 to tPA which determines

fibrinolytic activity. IPC induces a reduction in PAI-1

which in turn increases the availability of tPA32.

Blood flow augmentation of intermittent pneumatic

compression systems used for the prevention of

deep vein thrombosis prior to surgery (Flam et al

1996)

This study was designed as a prospective, randomly

assigned, crossover study, using duplex ultrasonography

to compare the FLOWTRON DVT calf compression

System to the Tyco SCD thigh compression System in

terms of blood velocity.

• 26 healthy volunteers were studied.

• The average flow augmentation was 107% with the

FLOWTRON DVT calf compression System and 77%

with the Tyco SCD thigh-high System.

• Peak compression velocity was significantly higher

with the FLOWTRON DVT calf compression System

than with the Tyco SCD thigh-high sequential System

(39.5 cm/sec vs. 34.2 cm/sec)35.

SYSTEM AVERAGE RESULTS OFBLOOD VELOCITY

Huntleigh FP5000 System 45%

A-V Impulse System 45%

Plexipulse System 49%

13•


DVT prophylaxis: comparison of two thigh-high

intermittent pneumatic compression systems (Flam

et al 1993)

This study was conducted to directly compare 2 thigh-

high IPC devices, the Huntleigh FLOWTRON DVT

Prophylaxis System and the Tyco SCD System.

• Duplex ultrasonography was used to measure the

femoral blood flow in 20 healthy subjects.

• Peak compression velocity was equal in the

FLOWTRON DVT thigh-high System and the Tyco

SCD thigh-high System.

• Augmentation of femoral venous blood flow was 23%

higher with the FLOWTRON System than with the

Tyco SCD System.

• The FLOWTRON thigh-high single pulse IPC System

produced a significantly higher venous blood flow

augmentation than the thigh-high vinyl sequential

pulse system34.

14•

Blood flow velocity (measured with Doppler ultrasound) versustime in the femoral vein of a recumbent 65 kg healthy male,with a FLOWTRON DVT10 calf garment and compression of 40mmHg. Augmentation is expressed as the maximum increasein blood velocity above baseline as a percentage of thebaseline. Note the sustained increase in velocity aftercompression and the reduction after deflation due to refilling ofdistal veins.

2 4 6 8 10 12 14 16

Onset of compressionTime (s) End of compression

Augmentation180%

Peak42cm/s

Baseline15cm/s

Left femoral vein

80

60

40

20

0

–20


Comparative clinical and outcome studies using

FLOWTRON Systems. A randomised trial to

evaluate compliance in terms of patient comfort

and satisfaction of two pneumatic compression

devices (Pagella et al 2007)

Design: Randomised controlled trial.

Objective: To evaluate whether patient comfort and

satisfaction correlated to concordance in wearing IPC

devices.

Setting: Trauma unit / orthopaedic medical-surgical unit.

Method: Two different types of effective IPC devices

were randomly evaluated in 65 patients to determine

whether the comfort and satisfaction were correlated to

compliance in wearing of the garments. Product X (Tyco

SCD compression system) was used in the hospital at

the time of the evaluation and consisted of thick plastic

sleeves that anecdotally patients removed due to them

being hot and uncomfortable. Product Y (FLOWTRON

Excel system) introduced into this study, utilised

breathable calf sleeves allowing moisture to escape and

air to circulate.

Results: The Tyco SCD compression system group

reported less desirable scores than the FLOWTRON

Excel system group for all questions. This outcome was

the same for nurse evaluations of the products. The

FLOWTRON system was associated with a greater

amount of wear time than the Tyco SCD compression

system.

Conclusion: At the end of the evaluation, the hospital

discontinued use of the Tyco SCD compression system

and implemented the use of the FLOWTRON Excel

system hospital wide. There was also a downward trend

of DVT and PE diagnosis after the implementation of the

FLOWTRON Excel system despite a rise in the number

of hospital admissions1.

Thromboembolism in patients undergoing total

knee arthroplasty with epidural analgesia (Brooks et

al 2007)

Design: A retrospective, consecutive chart review.

Objective: To compare the early post-operative VTE

rates between patients with indwelling epidural catheters

and no chemoprophylaxis to those patients with spinal

anaesthesia combined with LMWH.

Setting: Orthopaedics – unilateral or bilateral primary TKA.

Method: Retrospective chart review of 381 patients who

underwent primary total knee arthroplasty where all

patients utilised calf length IPC garments (FLOWTRON

Excel System) for DVT prophylaxis and all had early post-

operative lower extremity ultrasound.

Results: 157 patients had epidural anaesthesia (+IPC as

only form of VTE prophylaxis), of these 6 (3.8%)

developed DVT; all these patients had had bilateral knee

arthroplasty.

224 patients had spinal anaesthesia (IPC + LMWH as

prophylaxis) and 5 patients (2.2%) had a DVT.

There were no reported PE’s in either group.

Conclusion: The data suggest that epidural analgesia

with IPC alone is an effective method of post-operative

pain control without a significant increase in DVT as

compared to spinal anaesthesia followed by LMWH

administration2.

International clinical studies by independent

specialists have taken place over the past 30 years

examining Huntleigh’s IPC systems in comparison

to other methods of DVT prophylaxis.

The results demonstrate that Huntleigh’s IPC

systems are able to provide an excellent method of

DVT prophylaxis; they also offer many clinical and

cost advantages over other types of prophylaxis.

Comparative clinical and outcome studies using FLOWTRON Systems

15•


Venous thrombosis prophylaxis for urological

laparoscopy: Fractionated heparin versus

sequential compression devices (Montgomery and

Wolf 2005)

Design: Retrospective chart review.

Objectives: To examine the rate of post-operative

haemorrhagic and thrombotic complications after

laparoscopic urological procedures in patients treated

with LMWH or mechanical lower extremity compression

(FLOWTRON DVT Prophylaxis System).

Setting: Urological laparoscopic surgery.

Method: Patients treated over a 30 month period

received either 40 mg LMWH daily, commencing during

the peri-operative period, or thigh-length mechanical

compression applied immediately pre-operatively.

Symptomatic VTE was confirmed by ultrasound /

radiology; patients were followed up for 3 months post-

operatively.

Results: A total of 344 patients were included (172 in

each group). VTE outcomes were the same at 1.2%.

The rate of haemorrhage in the LMWH group was

significantly higher (p = 0.045), they were more likely to

experience a major bleed and required more

transfusions.

Conclusion: LMWH is associated with significantly

increased haemorrhagic complications without a

reduction in VTE. Mechanical compression devices are

the prophylaxis of choice in this patient speciality42.

Intermittent pneumatic compression in the

prevention of venous thromboembolism in high-risk

trauma and surgical ICU patients (Kurtoglu et al

2005)

Design: Prospective study.

Objectives: To evaluate the efficacy of IPC (FLOWTRON

Excel System) in the prevention of VTE in high risk

patients (major abdominal surgery or multiple trauma) for

whom anticoagulation is contraindicated.

Setting: Surgical Intensive Care Unit.

Method: Patients were provided with a FLOWTRON

Excel System. Venous duplex ultrasonography was

performed on days 3 and 7 and again at discharge.

Chest radiology was undertaken to screen for PE.

Results: Within a 9 month period 38 patients were

evaluated. Patients presented with multiple trauma

(n=21), major surgery (n=11) or gastrointestinal bleeding

(n=6).

Routine scans showed no DVT development during the

course of the study while one patient (2.6%) was found

to have an asymptomatic PE.

Conclusion: IPC is a safe and effective modality in

preventing both DVT and PE in high risk ICU patients

with severe trauma and for those undergoing major

surgery. IPC should be used when there is a clear

contraindication to pharmacologic therapy43.

Venous thromboembolism prophylaxis after head

and spinal trauma: Intermittent pneumatic

compression devices versus low molecular weight

heparin (Kurtoglu et al 2004)

Design: Prospective randomised controlled clinical trial.

Objective: To compare the safety and efficacy of IPC

and LMWH for DVT prophylaxis in patients with serious

head and spinal trauma.

Setting: Trauma – Intensive Care Unit (ICU).

Method: 120 patients admitted to ICU with head or

spinal trauma, were allocated either IPC (e.g.

FLOWTRON Excel) or LMWH (enoxaparin). Patients

showing signs of continued cerebral bleeding were

excluded from the study.

Patients were screened for VTE by Doppler ultrasound

on admission, then on a weekly basis and 1 week post

discharge. In addition, daily leg circumference was

measured with an increase of >10% prompting further

investigation.

Results:

IPC group: 4 patients with DVT and 2 patients with

fatal PE

16•


17•

LMWH group: 3 patients with DVT and 4 patients with

fatal PE

These results were not statistically significant.

The IPC group required statistically significant (p = <0.03)

fewer blood transfusions (0.9 ± 1.7) compared to the

LWMH group (2.8 ± 1.3).

Conclusion: The data suggests that IPC was as

effective as LMWH in decreasing the risk of DVT and PE.

However, IPC carries no risk to the patient

(haemorrhage), is non invasive and has a lower cost than

LMWH and therefore may be the preferred option in

head and spinal trauma44.

Evaluating an intermittent compression system for

thromboembolism prophylaxis (Van Blerk 2004)


Objectives: To evaluate use and acceptance of the

FLOWTRON Universal System.

Setting: Trauma & Orthopaedic Unit: elective joint

replacement surgery.

Method: Patients at high risk of VTE were provided

with either a calf or foot garment, with or without

anticoagulation and/or compression stockings.

The combination was determined by the surgeon, whilst

the choice of garment was guided by limb size and

surgical site.

Results: 30 patients were recruited: 19 received calf

garments, 10 had foot garments, and a single patient

used a foot garment on the operative leg and a calf

garment on the other. Half of the patients received

mechanical prophylaxis alone. There were no VTE

episodes reported.

Patients: Most (85%) found the FLOWTRON Universal

System to be comfortable or very comfortable, with calf

garments preferred over foot garments. This finding is

not device specific45 and reflects the higher pressures

required to empty the plantar plexus in foot compression.

Nurses: All 20 nurses rated the device highly positively

due to its favourable ergonomics, light weight, low

vibration and noise and safety features.

Conclusion: Patient satisfaction led to good compliance

and positive clinical outcomes in this high risk group.

Compared with chemical prophylaxis, the FLOWTRON

Universal System offers a cost-effective solution while

avoiding the potential complications of altered

coagulation46.

Randomized clinical trial of intermittent pneumatic

compression and low molecular weight heparin in

trauma (Ginzburg et al 2003)


Objective: To compare the effects of LMWH versus IPC

(using the FLOWTRON Excel System with DVT10 calf

garments) for thromboembolic prophylaxis in trauma

patients.

Setting: Trauma – patients with severe injuries with an

Injury Severity Score (ISS) of ≥9.

Method: 442 patients were prospectively randomised to

receive either LMWH (enoxaparin 30 mg BD) or the

FLOWTRON Excel System with DVT10 calf garments.

Thromboprophylaxis was continued until patients were

walking independently or discharged. Duplex study of

lower extremities was conducted on admission and

weekly until discharge or at 30 days.

Results: A comparable level of thromboembolic

prophylaxis between the 2 groups was demonstrated.

1 PE occurred in each group. Incidence of DVT was

2.7% in the FLOWTRON Excel System group, and 0.5%

in the group using enoxaparin, with no statistical

difference. A total of US $73,000 was spent on LMWH

compared to $6,272 for the FLOWTRON Excel Systems

representing a cost saving of $67,300 in the FLOWTRON

Excel System group.

Conclusion: The low rate of thromboembolic events in

the FLOWTRON Excel System group supports the use of

IPC as a low cost alternative method of DVT prophylaxis

in trauma patients6.


Avoiding haemorrhage and wound infection in total

arthroplasty whilst maintaining deep venous

thrombosis prophylaxis (Cameron 2001)

Design: Retrospective study.

Objective: To compare LMWH and foot compression

(FC) as DVT prophylaxis for patients undergoing total hip

(THR) or knee replacements (TKR) particularly in relation

to nurse / patient compliance, therapeutic and cost

benefits.

Setting: Orthopaedics.

Method: An audit of 57 patient notes was carried out to

extract data on DVT rates, wound bleeding, limb

swelling, bruising of tissues and erythema.

Results: There was no difference in DVT rates between

the two methods. In TKR patients there was 25% less

dressing soakage at 48 hours post-operation using FC

than LMWH and 35% less on the fifth day post-

operation. 26% of patients receiving LMWH had

soakage on discharge, compared to 0% using FC.

Average discharge time with LMWH was 10.7 days,

compared to only 8.4 days with FC. No difference was

noted in swelling and bruising. In THR, 27% more

soakage was observed using LMWH on the fifth post-

operative day compared to FC. Discharge time was 10

days with LMWH and 8.35 days with FC.

Conclusion: The FP5000 System was chosen as the

preferred method of foot compression as it enabled

better patient compliance with less sleep disturbance,

was operationally quieter with an easier tubing

connection and was less likely to alarm than other

systems47.

Intermittent pneumatic foot compression for

prophylaxis against thromboembolic disease in

total hip replacement (Richards et al 2001)


Objective: To compare the effectiveness of a foot

compression system with LMWH in preventing DVT and

other secondary outcomes.

Setting: Orthopaedics – elective primary hip

replacements.

Method: 81 patients were screened, with 27 entering

the trial. Patients were randomised to receive either foot

compression (FP5000 System) pre-operatively and until

mobile / 3 days post-operatively, or LMWH until

ambulant.

Post-operative duplex ultrasound scans were performed

at 7 days and 6 weeks. Secondary outcomes measured

included blood loss, haemoglobin levels, and skin

integrity.

Results: 1 DVT was recorded in each group. Blood loss

was significantly lower in the foot compression group

(p<0.003), and post-operative haemoglobin was higher.

No skin problems were identified in the IPC group.

Conclusion: Use of the FP5000 System reduced blood

loss and minimised haemoglobin changes, whilst offering

a level of prophylaxis comparable to LMWH. This makes

it a suitable alternative for patients contraindicated to

pharmacological prophylaxis48.

A clinical comparison of pneumatic compression

devices: The basis for selection (Proctor et al 2001b)

Design: Comparative evaluation.

Objective: To evaluate 5 IPC devices with respect to

effectiveness, compliance, patient and nursing

satisfaction, and potential clinical selection.

Setting: Surgery.

Method: 1350 patients were evaluated, using 5

manufacturers’ devices, including the FLOWTRON Excel

System and FP5000 System. Each manufacturer’s

device was tested for a 4 week period. Tests included

venous duplex ultrasound, DVT risk assessment, device

evaluation, compliance using pump meters, and ranking

matrix for compression pattern. Patients were asked to

complete 7 questions about acceptability including

comfort, mobility, sleep interference and noise.

Similarly, nurses also completed a questionnaire with

questions including frequency of alarms, patient

complaints and ease of use.

18•


Results: The FLOWTRON Excel System with calf

garments was ranked the best with respect to DVT rate

with only a 1.1% incidence. It also ranked highest in the

patient and nurse satisfaction surveys and gained the

highest compliance rates.

Conclusion: This is the largest known study to have

evaluated all marketed IPC devices. Huntleigh was

awarded the contract for IPC at the University of

Michigan hospitals based upon clinical outcomes and

patient / nurse satisfaction8.

External pneumatic compression therapy for DVT

prophylaxis (Capper 1998)

Design: Retrospective & prospective audit.

Objective: To evaluate the effectiveness of the

FLOWTRON Excel System in the prophylaxis of DVT in

hip and knee surgery, compared to the previous use of

anticoagulants.

Setting: Orthopaedic – elective hip and knee

replacements.

Method: Retrospectively 825 elective surgery patients

received LDH, LMWH or hydroxychloroquine as the

method of DVT prophylaxis. Prospectively, 375 patients

undergoing elective surgery had FLOWTRON calf

garments applied prior to surgery, and were worn until

discharge; patients were mobilised after 48 hours.

Results: The rate of thromboembolic complication using

anticoagulants was found to be 2.6%, compared to a

rate of only 1.06% when using FLOWTRON garments as

the method of prophylaxis. The FLOWTRON garments

were also found to be well tolerated by patients with no

risk of haematoma or bruising, whilst proving to be cost-

effective.

Conclusion: When selecting a method of DVT

prophylaxis, clinical effectiveness, patient comfort,

reduction of the risk of infection, and compliance with

treatment all need to be considered. The benefits of IPC

warrant serious consideration49.

Pneumatic sequential compression reduces the risk

of deep vein thrombosis in stroke patients (Kamran

et al 1998)

Design: Three phased study.

Objective: To determine if IPC combined with sub-

cutaneous heparin and GCS reduces the risk of

thromboembolic disease.

Setting: Acutely hospitalised patients with non-

haemorrhagic stroke.

Method: 3 patient groups were studied. Group 1

patients were studied retrospectively over 3 years and

comprised 233 stroke patients who were treated

prophylactically with sub-cutaneous heparin and GCS’s.

Group 2 patients were studied prospectively over 5 years

and comprised 432 subjects who received the same

prophylaxis as group 1 but in addition, those who were

non-ambulatory were given FLOWTRON Systems with

calf garments. Group 3 patients (n=16) were given the

same therapy as group 1.

Results: Using an additional DVT prophylactic method

(FLOWTRON System with calf garments) for non-

ambulatory stroke patients reduced the incidence of

thromboembolic disease significantly by more than 40

times.

Conclusion: Non-ambulatory stroke patients have an

increased risk for DVT and PE. Use of the FLOWTRON

System can significantly reduce this risk without

appreciably increasing patient care cost. Use of

FLOWTRON Systems should be considered for

adjunctive DVT prophylaxis in all non-ambulatory stroke

patients50.

19•


20•

Sequential mechanical and pharmacological

thromboprophylaxis in the surgery of hip fractures

(Eskander et al 1997)


Objective: To compare a combination of IPC (using

FLOWTRON Excel System) and LMWH, with LMWH only.

Setting: Trauma – femoral neck fractures.

Method: 238 patients admitted with a fractured neck of

femur were screened, with 45 fulfilling the criteria for the

trial. Patients were randomised to receive either IPC with

the FLOWTRON Excel System and calf garments until 48

hours post-operatively, then only enoxaparin to day 7

(group 1), or enoxaparin only from admission to day 7

(group 2). Blood transfusions, wound drainage and

haemoglobin levels pre-operation, day 2 and day 7 were

recorded. Colour duplex Doppler scans of the femoral

and popliteal venous system were carried out at week 1

and 6 post-operation.

Results: Thromboembolic rates were comparable

between the two groups with 14% in the FLOWTRON

System group and 17% in the enoxaparin group. There

was no significant fall in haemoglobin, or difference in

operative field, but group 1 had less wound drainage

(mean 314 ml), compared to group 2 (mean 402 ml).

Conclusion: The study demonstrated that the use of the

FLOWTRON Excel System in the peri-operative period,

followed by pharmacological treatment during

mobilisation can be successful. The use of the

FLOWTRON Excel System allowed the operation to be

carried out without the problems that can occur with

pharmacological agents51.

A comparison of intermittent calf compression and

enoxaparin for thromboprophylaxis in total hip

replacement (Stone et al 1996)


Objective: To compare a pharmacological method using

enoxaparin with a mechanical IPC method (FLOWTRON

System) for thromboprophylaxis.

Setting: Orthopaedics – elective primary hip

replacement.

Method: 50 patients were studied and randomised to

either group 1 (FLOWTRON System with calf garment) or

group 2 (enoxaparin 40 mg daily). The operative field

was monitored during the surgical procedure, as were

haemoglobin levels pre-operatively, on day 2 and day 5.

Blood loss into drains, and blood transfusions required

were also recorded. Signs of infection and haematoma

were checked for when drains were removed. All

patients underwent a colour duplex ultrasound scan at

weeks 1 and 6 post-operatively to assess for popliteal

and femoral thrombus.

Results: 1 DVT was detected in each group. The

operative field was judged by the surgeons to be drier in

the FLOWTRON System group in comparison to the

enoxaparin group, with no significant wound drainage or

haemoglobin difference. 3 patients required blood

transfusions in the FLOWTRON System group compared

to 7 patients in group 2.

Conclusion:

“The use of intermittent calf compression garments

is a safe method of prophylaxis for general use in a unit

performing total hip replacement.”52


21•

Comparison of thigh and calf-length intermittent

pneumatic compression devices for venous

thrombosis prophylaxis in trauma patients (Fedullo

et al 1994)


Objective: To determine whether a systematic approach

to DVT prophylaxis was effective in reducing the

incidence, compared to historical controls, and whether

sequential thigh-length and single pulse calf-length IPC

devices were equivalent in terms of DVT prophylaxis.

Setting: Trauma – head and spinal injuries, pelvic and

lower extremity fracture, penetrating wounds.

Method: 106 patients were randomised to receive either

calf-length compression (FLOWTRON System), or thigh-

length sequential compression (Tyco SCD System) for 4

weeks. Patients had serial impedance plethysmography

and Doppler ultrasound at least weekly in the first 3

weeks and then on study completion.

Results: A DVT rate of 3.9% occurred in the

FLOWTRON System calf-length group, compared to 2%

in the thigh-length group.

Conclusion: The study demonstrated that a systematic

approach to DVT prophylaxis reduced overall proximal

DVT to 2.9% and PE to 1%. The calf- and thigh-length

IPC devices appear to be equally effective in preventing

proximal DVT.

However, it was easier for patients to correctly place and

fit the calf garment compared to the thigh-length

garment. Compliance with the device is important to

ensure correct function53.

A prospective study on intermittent pneumatic

compression in the prevention of deep vein

thrombosis in patients undergoing total hip or total

knee replacement (Pidala et al 1992)


Objective: To evaluate the effectiveness of IPC

(FLOWTRON Systems) as a cost effective method for

preventing DVT.

Setting: Orthopaedics – elective hip and knee

replacements.

Method: The study used 346 consecutive patients

admitted for elective total hip replacement (112 patients),

and total knee replacement (234 patients). All patients

had the FLOWTRON Excel System applied pre and post-

operatively until discharge. Venous Doppler ultrasound

and impedance plethysmography were performed pre-

operatively on day 4 and day 7 post-operatively. The

control group was abandoned, as the study was unable

to ethically continue to withhold prophylaxis.

Results: DVT was found in 8/112 total hip replacement

patients, and 6/234 total knee replacement patients,

giving an incidence of 4%. No PE were diagnosed.

Conclusion: The study supports the use of the

FLOWTRON System in patients undergoing total hip and

total knee replacements. A dramatic decrease in the rate

of DVT was shown in joint replacements with the use of

the FLOWTRON System (4%) compared to numerous

reports showing a high rate of DVT without prophylaxis

(40–70%)54.


IPC Technology Review

Intermittent pneumatic compression devices –

ECRI evaluation (2007)

• ECRI (www.ecri.org) is a US based independent

unbiased research organisation that undertakes

medical device evaluations as well as offering

guidance on patient safety, quality and risk

management issues. The ECRI mission is to research

the best approaches for safety, quality and cost-

effectiveness in healthcare.

• In June 2007, a 28 page detailed evaluation report of

IPC devices was published. The following devices

were tested and rated:

– Aircast VenaFlow system

– Huntleigh Healthcare FLOWTRON Excel system and

FLOWTRON Universal system

– KCI Plexipulse all-in-1 system and Pulse SC™

system

– Tyco S.C.D EXPRESS™ system and S.C.D

Response™ system

• Each product was evaluated using specific and

detailed parameters: patient safety, ease of use,

patient comfort, performance, quality of construction

and battery (if applicable). Detailed reports are given

of the testing procedures and ratings achieved as well

as an overall recommendation.

• The Huntleigh FLOWTRON Universal was the “Top

Choice”, best overall product tested and is the (single)

preferred IPC product on the market. Patient safety

and ease of use were evaluated as excellent. Patient

comfort, product performance and construction of the

product were rated as good. The FLOWTRON Excel

system was rated as “worth considering” offering

good performance with only minor disadvantages.

• The report highlights that there is currently no reason

to believe that one type of IPC therapy (uniform or

sequential; calf or thigh) is more effective than any

other in preventing deep vein thrombosis. Therefore,

the type of therapy a device provides is not

necessarily a significant factor when deciding among

models. Instead, choice should be based on the

other factors such as product performance, ease of

use, patient comfort, adequate safety features and

quality of construction3.

Summary

Clinical efficacy, cost effectiveness, patient acceptability

and staff ease of use are fundamental factors in

determining product selection. This brochure presents a

summary of clinical studies that provides this key

information.

Huntleigh Healthcare’s range of FLOWTRON DVT

Prophylaxis Systems are able to offer you and your

patients a safe, efficacious, user friendly system that will

also help in saving healthcare resource.

Please contact Huntleigh if you require any further

information. www.Huntleigh.co.uk

Abbreviations

Abbreviation Full term

ACCP American College of Chest Physicians

DVT Deep vein thrombosis

FC Foot compression

FOND Fondaparinux

GCS Graduated compression stockings

ICU Intensive care unit

IPC Intermittent pneumatic compression

LDH Low dose heparin

LDUH Low dose unfractionated heparin

LMWH Low molecular weight heparin

NICE National Institute for Health and Clinical Excellence

NO Nitric oxide

PAI-1 Plasminogen activator inhibitor

PE Pulmonary embolism

SCD Sequential compression device

TFPI Tissue factor pathway inhibitor

THR Total hip replacement

TKR Total knee replacement

tPA Tissue plasminogen activator

uPA Urokinase plasminogen activator

VKA Vitamin K antagonist

VTE Venous thromboembolism

22•


1. Pagella P, Cipolle M, Sacco E et al (2007). A randomised trial to evaluate compliancein terms of patient comfort and satisfaction of two pneumatic compression devices.Orthopaedic Nursing; 26(3): 169-174

2 Brooks PJ, Keramati M, Wickline A (2007). Thromboembolism in patients undergoingtotal knee arthroplasty with epidural analgesia. Journal of Arthroplasty; 22(5): 641-643

3. ECRI Institute (2007). Intermittent pneumatic compression device evaluation. HealthDevices. USA; 36(6): 177-204

4. National Institute for Health and Clinical Excellence (NICE) (2007). Clinical Guideline46 Venous thromboembolism: reducing the risk of venous thromboembolism (deepvein thrombosis and pulmonary embolism) in patients undergoing surgery.www.nice.org.uk

5. Morris RJ, Giddings JC, Ralis HM et al (2006). The influence of inflation rate on thehematologic and hemodynamic effects of intermittent pneumatic calf compression fordeep vein thrombosis prophylaxis. Journal of Vascular Surgery; 44: 1039-1045

6. Ginzburg E, Cohn S, Lopez J et al (2003). Randomised clinical trial of intermittentpneumatic compression and low molecular weight heparin in trauma. British Journalof Surgery; 90: 1338-1344

7. Proctor MC, Zajkowski PJ, Wakefield TW et al (2001a). Venous hemodynamic effectsof pneumatic compression devices. The Journal of Vascular Technology; 25(3): 141-145

8. Proctor MC, Greenfield LJ, Wakefield TW et al (2001b). A clinical comparison ofpneumatic compression devices: the basis for selection. Journal of Vascular Surgery;34(3): 459-464

9. McAndrew S and O’Neill C (2002). Preventing deep vein thrombosis and pulmonaryembolism: anticoagulation v intermittent pneumatic compression. The Healthcare RiskResource; 4(1): 2-9

10. American Public Health Association (APHA) (2003). Deep Vein Thrombosis:Advancing awareness to protect patient lives. White paper. Presented at PublicHealth Leadership Conference on Deep Vein Thrombosis: Feb 26th, Washington, DC

11. The House of Commons: Health Committee (2005). The prevention of venousthromboembolism in hospitalised patients. HC99. London.

12. Scurr JRH & Scurr JH (2007). Is failure to provide venous thromboprophylaxisnegligent? Phlebology; 22(4): 186-191

13. Cohen A, Tapson V, Bergmann J et al (2008). Venous thromboembolism risk andprophylaxis in the acute hospital care setting (ENDORSE study): a multinational cross-sectional study. The Lancet; 371: 387-394

14. Geerts WH, Heit JA, Clagett GP et al (2004). Prevention of venous thromboembolism.Chest; 126: 3385-4005

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