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Venous Thromboembolism

and You!

Global Distributor Summit

Las Vegas, 3rd June 2013

• Aetiology of VTE and where DJO fits

• DJO Product Offering

– VenaFlow Elite

– VenaPure

• Key Clinical Aspects for Combined Prophylaxis

• Implications for Pharmacological Prophylaxis

• VTE: A Hospital Acquired Condition

– Is it just Orthopaedics?

• VenaFlow S Mode

– What is it and Why

So How Big is The Problem?

• UK

– 25,000 people die from VTE each year 1

• Europe

– 543,454 estimated VTE deaths per annum 2

• US

– 200,000 VTE related deaths per annum

• Australia

– 5,000 VTE related deaths per annum 3

• Asia

– Korea: Annual incidence of VTE shown to be 13.8 per 100,000 4

– Singapore: Acute DVT found in 15.8 per 10,000 5 , total deaths to PE at 1.8% 17

– Thailand: In a large study of non-surgical hospital patients, 0.59% VTE with mortality of 26% 18

– India: 17.46 per 10,000 hospitalised admissions & separately 14% DVT rate in surgical patients 15,16

– Incidence of DVT in 7 Asian countries was 41% post major orthopaedic surgery 8

VTE is still a major cause of preventable deaths globally

• PROVE registry compared VTE events in Europe/Australia with those in Asia 9: – Asian patients younger – More proximal DVTs – Fewer patients received prophylaxis

• Piovella and his review work from 2005 showed 7: – Using Venography, incidence of DVT following orthopaedic surgery was

higher than in Western populations – Lack of awareness in Asian countries – slow to adopt new techniques

• Multinational study involving 32 countries proved that high percentage of hospitalised patients were at risk of VTE but too few received appropriate prophylaxis22: – Surgical patients: 64.4% at risk – only 58.5% received correct

prophylaxis – Medical patients: 41.5% at risk – only 39.5% received correct

prophylaxis

Under-diagnosed - Under-prophylaxed!

Low rate of thromboprophylaxis in Asian population despite their high risk of VTE.

• Hospital versus Community acquired – 10% of patients will develop VTE in hospital, with 0.5% developing immediately

post-discharge! – 74% of VTE present in outpatients 10

• 42% of VTE outpatients have had hospital admissions • Only 40% received prophylaxis in hospital

– 2/3 of VTE deaths occur post-discharge • Lack of clinical studies in certain areas

– Highest risk groups: Obs & Gyn, Medical, Oncology • National differences not recognised

– Health systems – Income growth & distribution

• Varying levels of VTE awareness • Underestimate risk

– No risk assessment at admission or prior to surgery – 72.9% patients demonstrate 1 or more risk factors for DVT 17

– Patients readmitted into other departments – lost in system • Lack of acceptance of guidelines

Why is there still VTE?

Risk assessment is critical for all patients not just to assess risk of VTE but to identify other possible co-morbidities.

• Personal Health Cost

– 30% greater cumulative risk of recurrent VTE after 1st case

– Sequelae of post-thrombotic syndrome, PE, PAH

– Loss of work, social mobility, lack of confidence

• Financial Burden

– Cost of treating VTE • Hospitalisation

• Drugs

• Care givers

• Long term sequelae

• National pressures for effective VTE management

– Public reporting

– Accountability

– #1 potentially preventable death in hospitalised patients

– VTE management rated #1 most effective safety policy in US hospitals

– Health systems may stop paying for hospital induced VTE

Why VTE Prophylaxis?

Prophylaxis works: Reduced risk of VTE from

1.8 to 1.1! 19

General Risk Factors for DVT

• Age > 60 years

• Obesity (BMI >30kg/m2)

• Oestrogen-containing contraceptive therapy

• Pregnancy

• Use of HRT (Hormone Replacement Therapy)

• Critical care admission

• Travel for extended periods of time (plane, train, truck, car)

• Personal history or first degree relative with history of VTE

• Active cancer or cancer treatment

• Severe asthma

• One or more significant medical comorbidities (eg. Heart disease, metabolic, endocrine or respiratory pathologies, acute infectious diseases, inflammatory conditions)

• Varicose veins with phlebitis

• Known thrombophilias

• DVT is often asymptomatic, however if symptoms do exist: – Calf pain or tenderness, or both – Swelling with pitting oedema – Swelling below knee in distal DVT and up to groin in proximal DVT – Increased skin temperature – Superficial venous dilatation – Cyanosis can occur with severe obstruction – Coughing and/or chest pain

• The Silent Killer

– The clinical signs can be unreliable especially in early thrombosis. In up to 50% of cases, there are few or no significant signs and symptoms. (Turner & Turner 1982)

– Only 25% of patients with DVT display clinical signs (O’Meara 1990)

Clinical signs and symptoms of VTE

• What caused it?

– 2 recent surgeries on her foot in March 2011

– Later complained of pain in her leg

– DVT & PE!

• Why was it missed?

– Slower heart rate – increased risk of stasis

– Misdiagnosis

So who is at risk?

Stasis

Vessel Wall Damage

Hypercoagulation

Cause of VTE: Virchow’s Triad

1856

The presence of at least two of the above factors will cause a DVT/PE to form.

Methods of Preventing DVT

A. Prevention of Stasis and Endothelial Damage (Mechanical)

Leg elevation and early ambulation

Graduated elastic compression

Intermittent pneumatic compression

Plantar foot compression B. Prevention of Hypercoaguable State (Pharmaceutical) Oral anticoagulants Low dose Subcutaneous Heparin Low Molecular Weight Heparin (LMWH) Pentasaccharides- Fondaparinux Oral LMWH C. Combination of Methods from A and B

Pharmaceutical Prophylaxis

• Use of drugs to prevent VTE by affecting the ability of the blood to clot

– Vitamin K antagonists (warfarin/coumadin) long term, now mostly used for treatment (oral use) • Block synthesis of vitamin K-dependent coagulation factors

– Heparins

• Unfractionated heparin (UFH) injections short term

– Low molecular weight heparins (LMWH), such as Clexane/Lovenox (enoxaparin & dalteparin) indicated for VTE prophylaxis in medical & surgical patients. Injection only.

– Fondaparinux – synthetic sugar (pentassacharide) that binds to Factor Xa.

– New synthetic oral anticoagulants:

• Pradaxa (dabigatran) launched March 2009 – direct thrombin inhibitor, IIa

• Xarelto (rivaroxaban) and Eliquis (apixaban) – Factor Xa

Advantages Disadvantages

Pharmacological:

LMWH Longer ½ life Improved efficacy Wide indications Cost effective Widely studied/clinically proven

Injection only – trained healthcare professionals Ongoing lab monitoring Poor compliance post-discharge Increased bleeding risk Poor reversibility (Protamine) Variable effect in renal failure, obesity Regimen commences post-surgery Epidural haematoma - Black box warning Porcine based Risk of HIT (heparin induced thrombocytopenia)

Novel oral anticoagulants

Oral formulation - ideal for home use No monitoring required Similar efficacy to LMWH Shorter ½ life (5-9 hrs Rivaroxaban, 12-17 dabigatran) Synthetic drugs

Very limited indications Bleeding risks resulting in some deaths Increased risk with renal insufficiency, elderly, obese Therapy commences post-op No antidote

Pros & Cons Pharmaceuticals

External pressure has the effect of:

• Reducing the diameter of the superficial and deep veins.

• Reestablishing the functionality of the valves by narrowing vein diameter

• Retaining the interstitial fluid in the vessels.

• Improve lymphatic microcirculation.

• Increase circulation at the level of the skin.

Venous Compression: Mode of Action

No compression With compression

Relaxing of walls, valve reflux

Excess pressure standing & slow down of return

Pressure exerted by compression opposed to hydrostatic pressure & reflux

Pressure exerted at ankle more important than calf or thigh

• Recumbent/immobile

– Patients laying in bed require low levels of pressure (>10mmHg) to control venous stasis

– This is sufficient to prevent thrombus formation

– Pressures in excess of 30 mmHg do not have beneficial effect if patient is laying down

• Ambulatory/standing

– Far higher levels of pressure required to influence blood flow

– Pressure during walking fluctuates between 20-100mmHg

– Working pressures of 40-50mmHg are required to influence this

Why different levels of compression?










Where Do We Fit In?

Stasis

Vessel Wall Damage

Coagulation Changes

Intermittent Pneumatic Compression

Graduated Compression Stockings

Intermittent Pneumatic Compression

Pharmacological modalities

Graduated Compression Stockings

VenaFlow VenaPure

VenaFlow VenaPure

Mechanism of Action: VenaPure & VenaFlow

• VenaPure

- Reduce venous dilation preventing endothelial damage

- Graduated compression profile increases blood flow velocity (138.4%) Sigel 1975

• VenaFlow

- Increases venous velocity by 112% above baseline, empties veins bringing vein walls into opposition

• Tissue Factor Pathway Inhibitors & Tissue Plasminogen Activators – released by body in response to vessel damage

• Only device to truly replicate normal ambulation and the mechanism of action of the calf muscle pump

– Demonstrated by the Doppler comparisons

• Very easy to set up device

• Compliance meter is standard

– Essential to ensure that the correct therapy is being administered

• Integrated Sequential Flow System ensures that the minimal amount of tubing is used to administer maximum benefit

– Reduces the risk of pressure points on leg

• Clinically proven with recent studies to reduce DVTs

– Eisele 2007, Westrich 2006, Silbersack 2004

• Clinically proven to be more effective than competitors in reducing DVT

– Lachiewicz 2004

• One device for all situations

– Delivers the same clinically proven compression profile

VenaFlow Elite

• Design and manufacture has been based on the market leader (TED)

• Uses the same clinically proven compression profile that has demonstrated a reduction in the rate of DVTs

• Inspection toe on top of the stocking facilitates nurse observations

– Less risk of the patient picking up dirt etc from the ward floor

• Range of sizes available ensure the majority of the population are covered

• All the dispenser boxes contain tape measures – enough for every patient

– No need to reuse tape measure and risk cross infection

VenaPure

VenaFlow Elite

Bed hanger release button

Pump indicator lights (green = on, flashing red = alarm)

Telescoping bed hanger

Graphical display

Single /Dual Leg Operation

On/Off/Reset Button

Patient compliance meter

• Digital display with Alarm prompts

• Green/Red lights seen from any angle

• Alarm volume can be adjusted from high to normal

• Telescoping bed hook (up to 9cm)

• Mains only or Mains/Battery models

– Battery runs approximately 2 hours

– Takes 4 hours to charge

• Pressures are preset

• Cycle is preset

• Auto detects cuff type

• Microprocessors monitor and prevent overinflation

• 4 lengths of tubing available

All-In-One System (Foot, Calf, Thigh)

• Leg Cuffs

– Seamless duplex cells

• Distal inflation at 73 mmHg (+/- 15)

• Proximal inflation at 63 mmHg (+/- 15)

• Holds at 45 mmHg

– The distal aircell inflates first within 0.5 seconds. Then at a certain pressure or “pinch” point the air flows into the proximal aircell.

• Total cycle time 6 seconds

• After 54 secs, cycle recommences

– Alternate legs

• Foot cuffs

– One cell

• 130 mmHg for 0.5 secs

• Holds at 45 mmHg

– Cycle 6 secs, after 54 secs cycle recommences

– Alternate feet

Rapid Inflation

• Cool, lightweight, breathable sleeves

– Durable fabric

– Brushed nylon & polyester

• 3 sizes of calf cuff and 1 size for thigh

– Minimal inventory required

– Can be trimmed to size

• Bariatric calf cuff available (up to 76cm)

– Bariatric doppler results unchanged

• Cuffs are Single Patient Use

• Aircells can be placed anterior, posterior, medial, lateral on leg

– Does not affect performance

• Safe connectors, durable tubing, anti-kinking

• Can be applied with or without anti-embolism stockings

– Medical decision

Cuffs and Tubing

VenaFlow Doppler Comparisons

Standard VenaFlow System 110% increase in venous velocity over baseline

VenaFlow Elite System 112% increase in venous velocity over baseline

Plantar/dorsiflexion 111% increase in venous velocity over baseline

Competitive Dopplers

Slow inflation, SCD device

50% increase in venous velocity over

baseline

Slow inflation, uniform compression device

33% increase in venous velocity over

baseline

VenaFlow Elite System

112% increase in venous velocity

over baseline

• Sleeves or Foot cuffs should be worn throughout the immobilsation period, pre-op, intra-op and post-op

• Cuffs should be kept on for 24 hours and for as many days as prescribed until the patient is fully mobile

• At sleep – device should not be disconnected – risk of DVT forming if no prophylaxis used

• Remove daily and inspect skin for signs of pressure damage

• Become familiar with the fault alarms both visual and audible with corresponding coding.

In Service Recommendations

VenaPure Anti-Embolism Stockings

8 mmHg

10 mmHg

8 mmHg

14 mmHg

18 mmHg

In-Service Recommendations

• Stockings should be worn throughout immobilisation period, pre-operatively, intra-operatively, and post-operatively.

• Stockings should be kept on for 24 hours and should not be left off for more than 30 minutes when bathing etc.

• Ensure the proper fit. Re-measure if decrease/increase in œdema and reapply correct size

• It is recommended that stockings continue to be worn for at least 6 weeks post surgery

Review

• DVT is real and lethal!!

• Hospital based disease.

• Preventable cause of death.

• Massively under diagnosed.

• Under treated.

• Multimodal treatments efficient.

The Good News!

Control Group Treatment Group

Author Patient

pop

Modalities DVT rate Modalities DVT rate Significance

Eisele 2007 Orthopaedic LMWH 1.7% LMWH & VenaFlow

0.4% Yes

Westrich 2006 TKA VenaFlow & Aspirin

17.8% VenaFlow & Enoxaparin

14.1% No

Silbersack 2004

THR/TKR LMWH & Comprinet

28.6% LMWH & VenaFlow

0% Yes

Roderick Review 2005

125 trials, surgical & medical

Control Control

21.2% 23.4%

GCS IPC

8.6% 10.1%

66% risk reduction

Pharma 18.1% Mechanical & Pharma

10% 53% risk reduction

Kakkos, Cochrane

Review 2009

7,000 patients from 11 RCTs

Mechanical compression

DVT 4% Sympt PE 3%

Mechanical plus pharmacological

DVT 1% Sympt PE 1%

NA

Pharmacolog-ical

DVT 4.21%

Pharmcological plus Mechanical

DVT 0.65% NA

• High risk patients: – Bleeding – Wound hematoma – Renal insufficiency – HIT

• Type of surgery – High risk orthopaedic procedures – CABG – Spinal – Neurosurgery

• Type of anaesthesia – Neuraxial, spinal or epidural risk of haematoma

• Virchow Triad – All 3 factors covered

When Mechanical is Enough!

• In a Japanese study looking at hip surgery 11

– Mechanical prophylaxis only – Incidence of VTE:

• Fatal PE 0% • Symptomatic PE 0.03% • Symptomatic DVT 0.1%

• Review of the use of pharmaprophylaxis in the OR and ICU 12

– Effective no more than 2/3 of the time – Only protects against hypercoagulation – Importance of IPC placement pre-anaesthesia, peri-op and post-op

location – Disconnection of IPC is not recommended until patient fully

ambulatory • Review of gynaecological procedures in benign surgery 13

– Use of IPC alone demonstrated VTE event of <1%

Where’s The Clinical Proof?

• In cervical spine patients, where there is an increased risk of wound haematoma when using pharmacologicals 20

– IPC was used alone

– Single level trial showed 1-2% VTE, multi-level trial 7% DVT & 2% PE

– Data is comparable to that achieved with drug regimen, but without the associated high bleeding risk

• Review of the use of mechanical prophylaxis generally 21

– Clinically proven to reduce incidence of VTE, also stimulates fibrinolysis and physiologic inhibitors of coagulation

– Important to initiate mechanical before, during and after surgery to limit venous stasis and endothelial damage from venous distention

• Meta-analysis in variety of clinical settings14

– IPC alone reduced DVT incidence 60%

1. NICE Clinical Guidance 92 January 2010

2. Cohen, Thromb & Haemost. 2007

3. National Health & Medical Research Council, Australia 2011

4. Jang Thromb Haemost. 2010

5. Lee Ann Acad Med Singapore 2002

6. Prasannan, AJS 2005

7. Piovella, J.Thromb Haemost. 2005

8. Angchaisuksiri, Thromb Haemost 2011

9. Tupie, J.Thromb Haemost 2005

10. Spencer, Arch Intern Med 2007

11. Sugano, J. Arthroplasty, 2009

12. Burns, AORN 2012

13. Rahn. Obs & Gyn 2011

14. Urbankova, J Throm Haemost 2004

15. Lee , Eur J Vas Endovas Surg 2009

16. Tauro , J Clin Diag Research 2010

17. Sule , Int J Angiol 2011

18. Aniwan , Blood Coag & Fibrinolysis 2010

19. Cheng, Thrombosis 2011

20. Epstein , Spine 2005

21. Caprini, Clin Appl Thromb Hemost 2010

22. Cohen AT, Lancet 2008

Clinical References

It’s Not Just About Orthopaedics!

44

VTE and the Patient in Obstetrics & Gynaecology

Questions

• Is the pregnant patient at higher risk of VTE

• What gynaecological conditions are highest risk

• What are some of the common risk factors in this population

• What are the possible complications during pregnancy and gynaecological surgery

• What types of prophylaxis are clinically efficacious

Setting

• 9% of all maternal deaths in US attributed to VTE 1

• Incidence of VTE is 4 times greater in pregnant women that non-pregnant2

• 1/3 of all maternal deaths in UK are attributed to VTE2

• VTE incidence rate following cesarean section was approximately 4 times higher than other delivery methods3

• In benign gynaecological population overall incidence of VTE is between 0-2%4

• In gynaecological oncology incidence of VTE is between 1.2%-6.8%5

Risk Factors in Obstetrics

Score 1 Factor Score 2 Factors Score 3 Factors

• Age at delivery >35 • Obesity (BMI >30) • Pregnancy or postpartum (<1 month) • Prolonged immobility • Parity • History of multiple births • Smoking

• Caesarean section • Assisted reproduction technique (inc IVF)

• History of DVT, personal and/or family • Thrombophilias (acquired or inherited) • Postpartum hemorrhage

Total Score: -----------

Low Risk (1 factor)

Moderate Risk (2 factors)

High Risk (3-4 factors)

Highest Risk (5 or more factors)

No specific measures

AES or LMWH or LDUH

IPC and LMWH/LDUH and/or AES

IPC and AES with LMWH for extended period

Adapted from Caprini Risk Assessment

Risk Factors in Gynaecology


• Age 41-60 • Obesity (BMI >30) • Oral contraceptives/ hormone replacement therapy • Prolonged immobility • Infection • Smoking • Cardiac disease

• Age >60 • Major surgery (>60mins) • Previous malignancy

• History of DVT, personal and/or family • Thrombophilias (acquired or inherited) • Present cancer or chemotherapy • Major surgery over 3 hours


Low Risk (1 factor)




No specific measures Early ambulation

AES or LMWH or LDUH or IPC


IPC until fully ambulatory and AES with LMWH


Complications/Concerns

• Use of heparin preferred during pregnancy BUT1:

– 40-50% increase in maternal blood volume

– ↑ in renal excretion of heparin

– ↑ in protein binding of heparin

– Shorter ½ life and lower peak plasma concentrations mean higher dose and more frequent administration

• According to Asian guidelines, use of new oral anticoagulants is not recommended during pregnancy, puerperium & during breast feeding

• Risk of epidural or spinal haematoma with regional anaesthesia1

• Bleeding risk

• Higher incidence of illiac vein DVT in pregnancy, but harder to diagnose2

• Approximately 70% of patients with fatal PE are only diagnosed at autopsy6

The Solution

Obstetrics

• Risk assessment in early pregnancy essential and then repeat if admitted to hospital

• ACOG guidelines recommend the use of IPC pre-Caesarean delivery, especially due to the bleeding risk with thromboprophylaxis1

• AES recommended ante- and post-partum for all women who have had prior VTE2

Gynaecology

• IPC & AES post gynaecologic pelvic surgery vs AES alone reduced DVT rates to 4.8% versus 12.5%7

• Use of IPC for benign procedures reduced incidence of VTE and decreased the potential morbidities associated with heparin prophylaxis4

• In gynaecological cancer surgery, VTE decreased from 6.5% with IPC alone to 1.9% in combination with unfractionated heparin5

• Moderate risk patients should recieve anticoagulant or IPC8

• High risk patients should receive combined prophylaxis with pharma and mechanical 8

References

1. ACOG, Thromboembolism in Pregnancy, Sept 2011

2. Marik, New England J of Medicine, 2008:359

3. Simpson, Brit J of Obstetrics & Gynaecology Jan 2001 Vol 108

4. Rahn, Obstetrics & Gynecology Nov 2011 Vol 118 No 5

5. Einstein, Obstetrics & Gynecology Nov 2008 Vol 112 No 5

6. Maxwell, Obstetrics & Gynecology Dec 2001 Vol 98 No 6

7. Gao, Chin Med J(Eng) 2012 Dec 125(23)

8. Asian venous thromboembolism guidelines, Int Angio 2012 (31)

VTE and the Patient in Neurosurgery

Questions

• With the shortage of epidemiological data on VTE incidence in this patient population, what are the risks

• What risks do pharmacological agents pose in neurosurgery

• What are some of the common risk factors in this population

• What are the possible complications

• What types of prophylaxis are clinically efficacious

Setting

• 40% DVT rates within first 3 weeks post stroke, identified by MRI1

• 15.5% of patients have DVT following spinal surgery, if no prophylaxis administered2

• Calf DVT may be as high as 40-80% in patients following major trauma and spinal cord injury2

• Increased use of pharmacologial prophylaxis increases risk of haematoma and cauda equina syndrome2

• Use of low dose heparin in cranial & spinal procedures risks minor & major postop haemorrhage3

• Incidence of VTE in patients undergoing neurosurgery could be as high as 25%4

Risk Factors in Neurosurgery/Neurology


• Age >60 • Obesity (BMI >30) • Dehydration • Expected reduction in mobility • Pre-op leg weakness • Leg paresis • Smoking • Hormone replacement therapy •Varicose veins

• Age >60 • Major surgery (>90mins) • Previous malignancy • Medical co-morbidities •Post-op ventilation

• History of DVT, personal and/or family • Thrombophilias (acquired or inherited) •Active cancer or chemotherapy •Large tumour • Major surgery over 3 hours

52



53

Low Risk (1 factor)




Mechanical prophylaxis

IPC/AES with LMWH or LDUH


IPC & AES with LMWH until fully ambulatory

Low Risk (1 factor)




Mechanical prophylaxis (AES or IPC)

AES or IPC IPC and/or AES and LMWH/LDUH

IPC & AES until fully ambulatory with LMWH (caution)

Low Risk of Bleeding

High Risk of Bleeding

Complications/Concerns

• Use of anticoagulants in the peri-operative period limited due to fear of intracranial bleeding

• Patients are at risk of VTE throughout the surgery, therefore the initiation of prophylaxis is critical

• In CLOTS 1 trial on post-stroke patients, the use of AES alone showed no clinical benefit in reducing the risk of VTE5

• Stroke patients present with a variety of co-morbidities, a number of factors can be associated with VTE

• Benefits of using pharmacological prophylaxis needs to be considered relative to the risks of bleeding

The Solution

• In patients with intracerebral haemorrhage, the use of AES plus IPC to reduce VTE was significantly reduced versus AES alone: 4.7% vs 15.9%6

• Haemorrhagic stroke patients admitted to hospital were monitored for DVT7:

– 9.2% DVT and 2.4% PE on heparin alone

– 0.23% DVT and 0 PE on combination IPC & heparin

• Mechanical prophylaxis provided effective prophylaxis against VTE, the added efficacy of pharmacologicals needs to be weighed against risk of bleeding3

• Mechanical prophylaxis is integral part of neurological practice, used pre-, peri- and post-operatively8

• Recent CLOTS 3 study in post stroke patients showed reduction from 12.1% in no prophylaxis group to 8.5% with IPC9

Estimated that about 3,000 patients could avoid a DVT and 1,500 lives saved, just with the use of IPC in post stroke patients! 9

References

1. Naccarato, Cochrane Review 2010

2. Bryson, Journal of Ortho Surg & Research 2012, 7:14

3. Epstein, Surg Neurol 2005 Oct 64(4) 295-301

4. Browd, Neurosurg Focus 2004, 17(4) E1

5. CLOTS 1, Lancet 2009

6. Lacut, Neurology 2005 65:865-869

7. Kamran Neurology June 1998 Vol 50 No 6

8. Auguste, Neurosurg Focus 2004, 17(4) E3

9. CLOTS 3, Press Report from BBC News , 31st May 2013 (trial not yet published)

VenaFlow S Mode

• Internationally, concerns have been raised in some centres by:

– The noise of the pump, especially at night

– The startle effect of leg movement, especially during surgery

– Perceived pain of “rapid” inflation

• The objective is to add a function “S Mode” to the Elite to allow the user to select a slower compression mode, which will significantly reduce the “Startle Effect”

Project Rationale

• To build a new, separate pump with standard rapid inflation plus the additional S mode function

• S mode equates to slow compression of a lower pressure profile during a slightly longer cycle

• The design change is reflected primarily by:

– Software change

– Replacement of a current icon for S mode icon

Project Design

Feature Benefit

Rapid inflation mode will be standard mode of operation (0.6 sec and 6 sec inflation total) until S Mode selected

Clinically proven VTE reduction Mimic normal ambulation

S Mode will introduce slow compression –inflation over 10 secs

Less startle effect Less leg movement during surgery Improved compliance

New pressure profile in S Mode: 45-50mmHg in calf & thigh in 8-10 secs

No peak and settle pressure

Slow compression will facilitate the reduced startle effect, improve patient and clinician compliance

Button/icon on front to select S mode Easy to toggle between modes Easy to identify which mode of action selected

LCD display will indicate pump is functioning in S mode Clear identification of clinical parameters

Slight reduction in noise during S mode The parts used in the construction of the Elite remain the same, however the pressure in the reservoir is slightly less in S mode and should be marginally quieter

Simultaneous leg compression in S mode only (Rapid inflation inflates legs alternately)

No patient movement due to impulse inflation

Foot cuff not available in S mode If foot is attached, mode will automatically revert to Rapid inflation, but will also alarm CHECK TUBES

Locked function – it will be possible to disarm the S mode function if required

If the icon is pressed, it will show LOCKED (or similar). May be beneficial in study situations or if clinician has preference

VenaFlow S Mode Only

• Will there be any new clinical studies on the S mode?

• Will there be a new part number for the S mode pump?

• Will there be a battery option in the S mode as well as mains only

• What will happen with standard Elite

• We do not want to perform any clinical studies to prove that slow compression reduces DVT. The key rationale for introducing this function is compliance, both patient and clinician.

• Yes, the codes will be different for the Normal and S mode pumps

• Yes, we will offer battery & mains pump and mains only. Launch timing will differ

• This is the mainstay of our business and we will continue manufacturing

Other Possible Questions & Answers

• The S Mode icon will use the current Single/Dual leg selection button. What will happen if I want to select only one leg?

• Will the new pump require new accessories?

• What is the life expectancy of the pump

• How long can we guarantee service and repair

• The machine, whether in S Mode or Normal mode will now automatically detect whether one or two legs are attached. No need to choose.

• No the accessories are exactly the same for both pumps

• The maximum life of the pump is expected to be 3-5 years (the same for the Elite)

• We will continue to service and repair the pumps for the life of the warranty and up to 3 years following any discontinuation

More Q&As

Let’s Keep the Blood Flowing!

Compression Therapy



• What is Compression Therapy

– How does it differ from VTE prevention

• A tour through our DJO factory

• Veinax Programme

– Rationale

– Product Specification

– Marketing Support

• Our Expertise

• Case Study

External pressure has the effect of:

• Reducing the diameter of the superficial and deep veins.

• Reestablishing the functionality of the valves by narrowing vein diameter

• Retaining the interstitial fluid in the vessels.

• Improve lymphatic microcirculation.

• Increase circulation at the level of the skin.

Venous Compression: Mode of Action

No compression With compression

Relaxing of walls, valve reflux

Excess pressure standing & slow down of return

Pressure exerted by compression opposed to hydrostatic pressure & reflux

Pressure exerted at ankle more important than calf or thigh



















• Affects blood vessels of circulatory system • Various terms used

– Post-thrombotic syndrome – Chronic venous insufficiency – Chronic venous disease

• Can be as a result of: – DVT / PE – Phlebitis (inflammation of the vein) – Higher than normal blood pressure in the veins leading to damage to

the valves (incompetent valves) – Family history of varicose veins – Environmental/behavioural factors

• Prolonged standing or sitting

– Personal factors • Overweight • Pregnancy • Smoking • Lack of exercise

Venous Diseases – What are they?

• Swelling at the ankles

• Calves feel tight

• Legs may feel heavy, tight, restless or achy

• May be painful to walk

• Discolouration of the skin

• Varicose veins

• Itchiness of skin

Symptoms

• In venous disease, large veins become incompetent

• Blood refluxes back towards feet instead of passing smoothly towards heart

• Blood oscillates between damaged segments of valves

• Leads to gradual rise in pressure in venous circulation

– Walking no longer effective at reducing pressure

– Changes occur in microcirculation • Oedema formation

• Tissue changes (lipodermatosclerosis)

• Possibly ulceration

Venous Circulation

Pressure Variation Caused by Chronic Venous Insufficiency

In a normal human, pressure measured at the ankle: -Standing 80-90mmHg -Sitting 45mmHg -Laying down 10mmHg

Takes around 1 minute for blood to completely circulate the body

Variation in venous pressure during ambulation

Venous pressure at foot mmHg

------ Severe venous insufficiency

------- Moderate venous insufficiency

------ Healthy person

Ambulatory venous pressure - - - - Venous refill time - - -

Time

• 1st Stage

– Venous dilation without oedema

– Legs feel heavy, pain in calf, night cramps, skin feels hot and burning

• 2nd Stage

– Venous dilation with oedema in feet and ankles, especially at night, during warm weather and then eventually permanently

• 3rd Stage

– Complications of chronic venous insufficiency (CVI)

– Varicose eczema, skin pigmentation, hyperdermatitis, leg ulcers

Stages of Venous Insufficiency

Skin discolouration Swollen legs Leg ulcers

Sequelae of Venous Insufficiency

Phlebitis

Varicose Veins

• Conservative:

– Exercise

– Compression therapy • Stockings

• Layered bandages

• Garments

– Wound and skin care

– Pharmacological therapy

• Interventional: – Sclerotherapy

– Ablative therapy with endovenous radiofrequency and laser

– Endovascular therapy

• Surgical: – Ligation and stripping

– Subfascial endoscopic perforator surgery

– Valve reconstruction

Treatment Options

Compression therapy is the application of controlled graduated external pressure to the limb to reduce venous pressure within the limb.

It is strongest at the ankle, decreasing proximally

Compression Therapy

So What is the Fuss?

• Prevalence of varicose veins estimated at between 5 – 30% of adults:

– Female : Male 3:1

• CVI been estimated in:

– 21.2% of men >50yrs

– 12.0% of women >50yrs

• Estimated prevalence of venous ulcers of ≈ 0.3%

• US estimates that ≈ 2.5m have CVI

– Of which 20% will develop venous ulcers

• > 50% of venous ulcers require prolonged therapy lasting >1yr

The effects of varicose veins and CVI are devastating both for the patient, but also the family and the healthcare system

Welcome to Asheboro

Headquarters in Asheboro, North Carolina Established 1989 Started with 25 employees and 30 knitting machines. Jan 2011 DJO acquired ETI Now employs 235 personnel

We are the world’s largest manufacturer of medical graduated compression hosiery for the private label industry.

ETI (Elastic Therapy Inc.) Now DJO

233 Knitting Machines 140,00 pairs knitted per week > 7 million pairs per year

Knitting

•

Compression Testing Devices

HATRA

NAHM MST Professional

CEN MST Mark III

Chatilon

Dyeing

Boarding

Sewing

75 sewing machines

> 6,000 SKUs

Asheboro Capabilities

Style Description mmHg Colours

Mens Socks Dress sock Microfibre

20-30

Black, Navy

Athletic sock with Coolmax

20-30 White

Microfibre rib pattern dress sock

20-30 Black, Navy

Microfibre pin dot pattern 15-20 Black, Navy

Ladies Socks Trouser sock with comfort top

15-20 Black, Tan, Navy

Microfibre diamond pattern

15-20 Black, Brown, Navy

Natural comfort, 71% rayon, 25% nylon, 5% spandex

15-20 Black, Brown, Navy

Asheboro Capabilities

Description Colours

Microfibre Surgical Weight 20 -25 mmHg

Below Knee, Closed Toe Black, Sand

Below Knee, Open Toe, Open Heel Sand

Below Knee, Open Toe Black, Sand

Thigh Holdups with dotted silicone band, Closed Toe Black, Sand

Panty Hose, Closed Toe Black, Sand

Classifications of Medical Compression Hosiery

UK

BSI 40

German

RAL-GZ 387/1 DIN58133

French

FD CEN/TR 15831

Indications

Class 1 14-17 mmHg

18-21 mmHg 10-15 mmHg •Varicose veins during pregnancy

•Superficial or early varices.

Class 2 18-24 mmHg

23-32 mmHg 15-20 mmHg •Varices of medium severity.

•Ulcer treatment and prevention of recurrent ulcers.

•Mild oedema varicose during pregnancy.

•Superficial phlebitis

Class 3 25-35 mmHg

34-46 mmHg 20-36 mmHg •Gross varices.

• Post thrombotic venous insufficiency.

•Gross oedema.

• Ulcer treatment and prevention of recurrent ulcers

Class 4 N/A 49 mmHg & higher

•Made to measure stockings

•Lymphoedema Stage III

• 2011 Revenue $190m

• 8 million pairs of stockings sold

• Only 25% of people who need compression hosiery actually wear it

French Compression Market

French Competition

• Below knee $29

• Thigh/Holdup $39

• Tights $55

Reimbursement

France & Compression Hosiery

Veinax France

• Old

– 228 SKUs

– One length

– Mediocre quality

– Healthy sales

• New

– 360 SKU

– 2 lengths

– Exceptional quality

– Modern design

– Major push on sales

... Presenting a complete range

Ankle Pressure: Class VEINAX Solution

10 to 15 mm Hg Class I Veinax class I Microtrans

15 to 20 mm Hg Class II Veinax class II Transparent or Microtrans

1st Level 20 to 36 mmHg

Class III Veinax class III Transparent

2nd Level 20 to 36 mmHg

Class III Veinax class III Microtrans

Superposition Equivalent to Class IV Veinax class I Microtrans + Veinax class III Transparent

• Medical:

– Range of products designed to meet all stages of venous disease, as defined by CEAP

• Functional:

– Asethetic

– Comfortable

– Highest quality

– Easy to don

CEAP Classification

C0s No visible or palpable sign of venous disease

C1s Telangiectasies or reticular veins

C2 Varicose veins (diameter of >3mm)

Veinax Positioning

Microtrans Class I Microtrans Class II Transparent Class II Fantaisie Class II Cotton Class II

Microtrans Class II Transparent Class II Fantaisie Class II Cotton Class II Transparent Class III

Where does Veinax Fit in?

C3 Oedema

C4 Changes in skin

and subcutaneous

tissue:

C4a Pigmentation or

eczema

C4b Lipodermato -

sclerosis or atrophie

blanche

C5 Healed venous ulcer C6 Active venous ulcer

Transparent Class III

Microtrans Class III Superposition: Microtrans Class I + Transparent Class III

Superposition: Microtrans Class I + Transparent Class III

• Quality of manufacture

• Softness of yarn

• Softness on skin

• Easy to don

• Robust yarn but softness maintained

• Modern, attractive packaging

Subjective Aspects

• Extra flat seams:

– Toe box

– Self fixating band

• Extendable toe box which adapts to all morphologies.

• Reinforced section at level of toe.

• Reinforced sole.

• Reinforced heel.

• Wide hem for knee high.

• Panty area of the tights provides additonal support without extra compression.

• Unequalled transparency.

• Edge to edge stitching on the top band.

Objective Aspects

Microtrans/Microfibre

Class 1

Class 2

Class 3

Fantaisie / Diamond Pattern (Microfibre)

Class 2

Transparent

Class 2

Class 3

Cotton

• May be worn by men or women - Unisex

Class 2

Modern Packaging

Available in English & French: - Box - IFU

Your Team in Asheboro

Welcome

• ETI Compression Stocking

• In Hospital & Retail Channels

• Limfix Japan

Japan

Population 130M GDP per capita >$30K USD Healthcare expend. 8% of GDP Per person 2600 $

RxFit (Limfix/ETI) for Varicose veins (hospital)

• Potential patient no. in Japan: 10million

• Prescription market: 150K pairs/yr

• Limfix 110K pairs (75% share) – regarded as the highest quality in an extremely competitive market

• Channels: mainly prescribed by >100 phlebologists and some of vascular surgeons

• Other 100K pairs recommend by nurse

• ¥3,000.-~¥5,500. (USD$40-60)

• Knee High – Panty hose

• Asian sizes, fitting, colors

Current hospital channels: Society of Phlebology College of Angiology Society for Vascular Surgery Society for Lymphology

Developing hospital channels:

Sales Trend of Rxfit at Hospital Market Varicose Veins Only

No sales growth in the thirds and fourth quarters of 2012 than previous year Where to GROW??

Characteristics of Consumer Markets

(Varicose Veins, Fatigue, Edema and Slimness)

• OTC – No sales at over US$ 20.00 / pair

Dr. Scholl

• Mail Order (popular 10 years ago) and TV Shopping

• Internet Sales

- Market size >> x10 of hospital market

- There is no prominent player in the market

- > 20 competitors, nobody >5%

- Amazon, Rakuten portal…

TV Shopping

Strategies by LimFix

• Internet sales - starts advertising as of June 1, 2013

• New Company, New Brand, New Packing, New Pricing… for selling stockings as consumer products

• 15-20mmHg, beige and black, knee length and panty hose

• Target middle price range (>USD30)

- New Brand : Leg polus Fit New Company: Comprize Inc.

Satisfied

Very Satisfied

Nurses

Satisfied

Very Satisfied

Aircrew

• Increased awareness of varicose vein

• Large potential in E-channels

• ETI stockings has the highest quality, endorsed by healthcare professionals

• Leverage on Limfix local experties & experience

• Asian sizes, fitting, colors

• New venture for future GROWTH

Thank you!

Dr Comfort Diabetic Foot Care



Dr Roy Lidtke

• Clinical associate professor of Podiatric Medicine specialising in lower extremity biomechanics

• Currently Assistant Professor, Department of Internal Medicine Section of Rheumatology at Rush University Medical Centre, Chicago

– Ranked among the top 50 hospitals in the US

• Published extensively on lower extremity biomechanics, often associated with osteoarthritis and the effect with therapeutic footwear

• Co-inventor on patent for the new Dr Comfort Flex-OA shoe

What has driven the US Dr Comfort Business?

• Driven by the cost & level of amputations in the US

• 1993 Therapeutic Shoes for Persons with Diabetes (TSPD) Act came into force

• Since 1996 number of foot and let amputations in the US fell by more than half

– Since Medicare started paying for blood sugar monitoring & protective shoes and other medical devices

– Increase in number of diabetics who had annual foot exam

• 2006 Therapeutic footwear for consumers with diabetes provided framework for specialist companies to receive reimbursement

– 1 pair of extra depth shoes plus 3 pairs of inserts per year

– Patients must present with diabetes and related foot condition

Shoe Manufacturer Requirements

• Shoes must be made of breathable or other suitable material

• Shoes must come in whole and half sizes and a minimum of 3 widths (Medium / Wide / Extra Wide)

• Shoes must have a spacer, which when removed provides a minimum of 4mm (3/16th inch) extra depth

• Shoes must have a closure (Velcro/laces etc)

Padded Heel Counter: Reduces irritation

Padded Tongue: Reduces friction and improves fit

Non-skid, Non-wearing

Outsole: Increases traction

Protective Toe Box: Reduces potential for injury

Lightweight Construction: Reduces daily fatigue

Quality Top Grain Leather: Shapes to your foot for superior comfort

Firm Heel Counter: Provides enhanced support

Smooth Leather Lining: Keeps feet cool and dry while reducing chances for irritation

against seams

Extra Width & Depth in the

Toe Box & Forefoot Area: Reduces pressure on problem feet

Extra 11 mm Deep

Lightweight Outsole: Coring keeps soles light

Shankpiece: Give shoe structure and

makes the shoe bend only where your foot bends

Ortho Sandal Range

Superior Wet/Dry Performance

(Microfiber /Mesh)

Dual-Density Midsole

Encourages healthy foot motion by reducing shock

to your heel & toes.

Ultra Lightweight

Adjustable Velcro Closing

Built-in Orthosis:

Supports your natural arch and relieves

symptoms of plantar fasciitis

Integrated Post:

Prevents pronating and promotes proper foot

alignment while walking

Integrated Shank

Stabilize you foot with every step

you take

Rubber Outsole

for improved traction

• Most of the range can be modified:

– Addition of rocker bars

– Sole lift for leg length discrepancies

– Lateral heel wedge

– etc

Modifiable Shoes

Easy to adapt to calipers

• Roy H. Lidtke • Assistant Professor of Internal Medicine

• Rush University Medical Center • Chicago, IL

DJO Global’s Vision

How do I get my patients moving without

causing tissue damage?

• 347 million people worldwide have diabetes.

• 80% of people with diabetes live in low- and middle-income

countries.

• WHO projects that diabetes deaths will double between 2005 and 2030.

What seems to be the problem?

Percent of Obese (BMI > 30) in U.S. Adults

WHO Fact Sheet; Diabetes

International Working Group on the Diabetic Foot Diabetes Metab Res Rev 2000; 16 (Suppl 1): S84±S92.

National Diabetes Information Clearinghouse NIH Publication No. 09–3185

Firm 20-30 mmHg Moderate 15-20 mmHg Gentle 10-15 mmHg

Metatarsal head area cut out lower

than toe

Anterior Rock Outsole Ball Depression

Elevated Proximal Area

Insole area elevated at central metatarsal shafts

Choices!

Men’s and Women’s Range

All Seasons

• USPs: – 3 widths

– Extra depth in toe box

– Lightweight

– Removeable insole

– Easily modifiable

– Modern design

• Advantages over competition: – Individual orders possible

– No minimum quantities

– Full fitting service available

– Short delivery times

– Product range maintained

Therapeutic shoes designed with comfort in mind

European Positioning

European Positioning

Casual Line Active Line Smart Line

Womens Betty Annie Patty

Refresh Spirit Plus Move Kelly

Kristin Delight Paradise

Mens Fisherman Douglas Justin

Performance Endurance Champion Plus Ranger

Captain Wing

Women’s Range

Betty Black

Move Black

Annie Black Annie Acorn

Delight Walnut Kristin Black

Patty Beige

Kelly Camel

Paradise Black

Refresh Pink Spirit Plus White

Delight Black

Betty Beige

Paradise Saddle Tan

Smart

Casual

Active

Douglas Chestnut Douglas Black

Wing Chestnut

Patrick Multi

Wing Black

Captain Chestnut

Ranger Black

Justin Chestnut Nubuck

Captain Black

Performance Black Champion Plus Black

Fisherman Black

Justin Black

Endurance Black

Men’s Range

Smart

Casual

Active

Summer Sandals - Women

Karen

Liz

Sharon Rachel

Agathe

Lydie

Marina

Sandrine Sabine

Ingrid

Elodie

Alice

Lea

Estelle

Adriana

Men’s Sandals

Pascal Benat

Competitor Overview Features DJO

Dr Comfort Klaveness Finn Comfort Schein

LucRo FLD

Nationality American Norwegian German German French

Factory location China Portugal & Poland Germany France

Size range Women’s 34 – 41, Men’s 39-50

Women 35-48 Men 39-47

Women 34-43, Men 35-50

Womens 34-45, Mens 37-

50

Women 35-42 Men 35-48

Widths N,M,W,XW 3 widths Slender, Normal, Wide

S,M,W,+10 (depth)

N,XL

Material construction

Leather

Leather, inc Pig Leather, FinnStretch

Leather Leather, Fabric

Styles Available Athletic, Casual, Smart, Ortho,

Boots, OA, Washable

Ortho, Children, Comfort, Sports

>240 & Golf shoes & Finnamic

51 Classic & Kinetic (slim

foot)

CHUT/CHUP, Ortho

Removable insoles Yes Yes Yes, Classic Comfort Footbed

Yes Yes

No of Women’s vs Men’s

14 Women’s 14 Men’s


20 Womens, 31 Mens

Positioning Therapeutic Shoe Comfort / Medical Shoes

Comfort Shoe Diabetic / Comfort Shoe

Medical & Paramedical

Competitor Overview Features DJO

Dr Comfort The Bennie

Group Ken Hall

Buchanan Orthotics Steprite

Chaneco Kenward Orthopaedic

Nationality American British British British British

Factory location China Britain Britain Britain

Size range Women’s 34 – 41, Men’s 39-50

Women Men

Women, Men Womens Mens

Women 35-42 Men 35-48

Widths N,M,W,XW Careware – 4 Carefree – 3 NuStyle - 2

N,XL

Material construction

Leather

Leather, inc Pig Leather, Fabric

Styles Available Athletic, Casual, Smart, Ortho,

Boots, OA, Washable

Careware, Carefree, Nustyle,

Children

Diabetic Diabetic

Removable insoles Yes Yes Yes Yes

No of Women’s vs Men’s


Positioning Therapeutic Shoe Orthopaedic Shoes Modular footwear

Hand made stock &

bespoke shoes