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Diagnosing
Peripheral Arterial Disease,
Critical Limb Ischemia and
Non-healing Wounds
PeriFlux 6000 | intelligence combined
44-00318-01
Disclaimer
The information contained in this document is intended to provide general
information only. It is not intended to be, nor does it constitute, medical advice.
Under no circumstances is the information contained in this document to be
interpreted as a recommendation for a particular treatment for specific
individuals. In all cases it is recommended that clinicians perform their own
interpretations of data in conjunction with the clinical assessment of their patient.
Due to Perimed’s commitment to continuous improvement of our products, all
specifications are subject to change without notice.
All information and content in this document is protected by copyright. All rights
are reserved. Users are prohibited from modifying, copying, distributing,
transmitting, displaying, publishing, selling, licensing, creating derivative works,
or using any information available in or through the document for commercial or
public purposes. All responsibility for any liability, loss or risk, personal or
otherwise, which is incurred as a consequence, directly or indirectly, of the use
and application of any of the material in this document is specifically disclaimed.
• Diagnosing Peripheral Arterial Disease
(PAD), Critical Limb Ischemia (CLI) and Non-
healing Wounds
• Hands on, Tips and Tricks
• Maintenance and Calibration
• Interpreting Curves and Results
Introduction
The aim of this document is to describe Peripheral
Arterial Disease (PAD), its complications and how to
diagnose PAD with objective vascular tests.
Facts…
Worldwide there is:
• An increasing number of diabetics
• An aging population
Resulting in…
More patients with:
• Peripheral Arterial Disease (PAD)
• Critical Limb Ischemia (CLI)
• Complicated chronic wounds
• Amputations
Peripheral Arterial Disease PAD
What is PAD?
• Occlusions in the peripheral arteries causing
ischemia in the lower extremities
Risk factors:
• Smoking, diabetes, high blood pressure, obesity,
increasing age …
Prevalence:
• 3-10% in general, 15-20% people aged > 70
Problem: 2/3 of all patients with PAD show no symptoms!
Underestimation of disease!
Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASCII). Eur J Vasc and Endovasc Surgery, Vol 33, suppl 1 2007
Peripheral Arterial Disease PAD
Symptoms:
• Walking pain - Intermittent Claudication (IC)
– Pain upon walking which disappear at rest
– Cold legs and feet
– Discoloration
• Critical Leg Ischemia (CLI)
– Severe form of PAD
– Rest pain
– Ischemic ulcers and gangrene
– High incidence of amputation and mortality
• Non-healing wounds
– Often caused by Ischemia (PAD/CLI)
– 15 % of all diabetics develop ulcers
– 14-24% with a foot ulcer require amputation, 85% of these
amputations could be prevented with early diagnosis
Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASCII). Eur J Vasc and Endovasc Surgery, Vol 33, suppl 1 2007
ESVS Guidelines for Critical Limb Ischaemia and Diabetic Foot, 2011
“Ischemia should not
be excluded as a
cause of a diabetic
foot ulcer unless
proven absent.”
Objective Vascular Tests
It is recommended to confirm PAD/CLI with objective
vascular tests:
• Ankle pressure – ABI
• Toe pressure - TBI
• tcpO2
• PVR
• Segmental pressure
• Imaging techniques (Duplex, angiogram)
Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASCII). Eur J Vasc and Endovasc Surgery, Vol 33, suppl 1 2007
Why is objective diagnosis useful?
Crucial to Make the Right Decision
Objective vascular tests support clinical decisions
Diagnosing PAD/CLI
• Diagnose if a patient is suffering from PAD/CLI
• Assess severity of disease
• Predict wound healing potential
Decide treatment plan
Prioritize between patients
• Define optimal amputation level
• Qualify for Hyperbaric Oxygen Therapy (HBOT)
Better “success rate” for the doctor
• Evaluate treatment success
Follow up on treatment, plan for next step
Complications with diabetes
• Peripheral Arterial Disease (PAD) is more aggressive
• Increased prevalence for Critical Limb Ischemia (CLI)
• Neuropathy – reduces pain perception, feet are ”warm”
• Calcified vessels – falsely elevated ABI
• Non-healing, diabetic foot ulcers
• Impaired microvascular functions
• High risk for amputations
More complex diagnosis
Common Objective Vascular Tests
Ankle Pressure, Ankle Brachial Index
• Most commonly used vascular test
• Simple and cheap
• ABI = Ankle pressure/Brachial pressure
Is ABI accurate enough?
• Risk for falsely high ABI values due to calcified vessels
– Common in diabetics and end-stage renal disease patients
– May result in underestimation of PAD/CLI
• Macrocirculatory measurement only
– Skin microcirculation important factor for wound healing,
macrocirculation is not enough
Toe pressure – Toe Brachial Index
“Trust ABI when low but not when high.”
• Toe pressures have proven to be an excellent option for the
diagnosis of PAD in patients at risk for falsely elevated ABI
values (ABI>1.4)
• Toe arteries are smaller and more easy to occlude
• Accurate toe pressures require sensitive techniques such as
laser Doppler
PeriFlux 6000 solution
• Laser Doppler used for detection
– Sensitive at low pressures
– Solution for cold ischemic feet – in-built local heating
– Small probes easy to affix on all digits
International Consensus on the Diabetic Foot and Practical Guidelines on the Management and Prevention of
the Diabetic Foot, International Working Group on the Diabetic Foot, 2012
Transcutaneous oxygen (tcpO2 / TCOM)
Measures the local oxygen tension in the skin deriving from the
local capillary (nutritive) blood perfusion.
• Predicts wound healing potential
• Helps define degree of small vessel disease
• Accurately determines amputation level
• Monitors efficacy of patients ongoing therapy
• Establishes candidacy for HBO treatment
PeriFlux 6000 solution
• Clarke type electrodes for detection
• Possibility to combine with pressure measurements
Pulse Volume Recording (PVR)
• Measures changes in pressure, reflecting arterial
pulsatility (air plethysmography)
• The shape of the signal is affected by calcification of
the arteries as well as occlusions
Normal Mildly abnormal Moderate abnormal Severely abnormal
Pulse Volume Recording (PVR)
PVR can be performed at different positions of
the leg, localizing significant occlusive lesions
in limbs
Segmental Pressures
• Similar to toe and ankle pressure, but different positioning of
the cuffs
• Provide an initial indication of anatomical location of arterial
occlusive lesions (often replaced with imaging techniques)
• Often combined with segmental pulse volume recordings
(PVR).
Combine test for best diagnosis!
PeriFlux 6000
All recommended vascular tests in one instrument!
• Ankle pressure – ABI
• Toe pressure - TBI
• tcpO2
• PVR
• Segmental pressure
PeriFlux 6000 Solution
Adapt tests and workflow to patient
Diabetic ABI Toe pressure
Claudicant, no diabetes ABI Treadmill
Diabetic with wound ABI Toe pressure tcpO2
Critical Limb Ischemia ABI Toe pressure tcpO2
Right foot:
Ankle pressure = 146 mmHg
ABI = 1.22
Toe pressure = 42 mmHg
Baseline tcpO2 = 43 mmHg
Combine Tests for Best Diagnosis
Example: Male with painful left foot and amputated toes.
Results from several
tests will give a better
overview of the limb
circulation.
Here : Patient with clear
PAD but no CLI.
Left foot:
Ankle pressure = incompressible arteries
Toe pressure = no toes
Baseline tcpO2 = 42 mmHg
Normal Ankle Pressure
and ABI. Is this really
reliable or the beginning
of media sclerosis and
falsely elevated ABIs?
Falsely normal ABIs!
PeriFlux 6000 intelligence combined
A unique combination
of simultaneous vascular
tests to speed up your
diagnosis
PeriFlux intelligence combined
Accurate ABI and toe pressure
Segmental pressure and PVR
Adapt tests and workflow to patient
Microvascular tests – tcpO2
Parallel testing to save time
Step-by-step instructions, operator independent
Reference Values for Diagnosis
Reference Values PAD/CLI – TASC II
Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASCII). Eur J Vasc and Endovasc Surgery, Vol 33, suppl 1 2007
Peripheral Arterial Disease Critical Limb Ischemia
Reference Values PAD/CLI - IWGDF
Clinical history:
History to identify symptoms of PAD.
Palpation of pulses in the lower limb.
Non-invasive screening tests:
Hand-held Doppler evaluation of flow signals from both
foot arteries
Ankle-Brachial Index (ABI)
Toe-Brachial Index when ABI is uncertain
PAD is likely when:
The patient has claudication or rest pain.
Both foot pulses are absent to palpation.
Absent or monophasic Doppler signals from one or both foot arteries
TBI < 0.7
ABI < 0.9
Assess severity of PAD (wound healing potential)
Mild PAD:
Palpable foot pulses
Toe pressure > 55 mmHg
tcpO2 > 50 mm Hg
ABI > 0.6*
Evaluate the effect of maximum 6 weeks optimal wound
care. Reassess perfusion and consider duplex
ultrasound or angiography when wound healing
response is poor.
*Note: ABI > 0.6 has less predictive value, and in these
patients, tcpO2 or toe pressure should be measured.
Severe PAD
Significant ischemia, severely impaired wound healing:
Toe pressure < 50 mmHg
tcpO2 < 30 mm Hg
ABI < 0.6
Consider revascularization
International Consensus on the Diabetic Foot and
Practical Guidelines on the Management and
Prevention of the Diabetic Foot, International Working
Group on the Diabetic Foot, 2012
Reference Values tcpO2 / TCOM
Reference values
50-70 mmHg Normal
< 40 mmHg Impaired Wound Healing
< 30 mmHg Critical Limb Ischemia
Transcutaneous Oximetry in Clinical Practice: Consensus statements from an expert panel based on evidence. C. E FIFE, D. R. SMART,
P. J. SHEFFIELD, H. W. HOPF, G. HAWKINS , D CLARKE , J Undersea and Hyp Med Vol. 36, No. 1 p 43-53, 2009
For a more extensive summary of diagnostic
guidelines, please visit:
http://www.perimed-
instruments.com/guidelines-diagnosis-PAD
For more detailed information about tcpO2,
please visit:
http://www.perimed-
instruments.com/upl/files/106348.pdf
Thank You!
PeriFlux 6000 | intelligence combined
www.perimed-instruments.com

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Diagnosing peripheral arterial disease and assessing degree of ischemia

  • 1. Diagnosing Peripheral Arterial Disease, Critical Limb Ischemia and Non-healing Wounds PeriFlux 6000 | intelligence combined 44-00318-01
  • 2. Disclaimer The information contained in this document is intended to provide general information only. It is not intended to be, nor does it constitute, medical advice. Under no circumstances is the information contained in this document to be interpreted as a recommendation for a particular treatment for specific individuals. In all cases it is recommended that clinicians perform their own interpretations of data in conjunction with the clinical assessment of their patient. Due to Perimed’s commitment to continuous improvement of our products, all specifications are subject to change without notice. All information and content in this document is protected by copyright. All rights are reserved. Users are prohibited from modifying, copying, distributing, transmitting, displaying, publishing, selling, licensing, creating derivative works, or using any information available in or through the document for commercial or public purposes. All responsibility for any liability, loss or risk, personal or otherwise, which is incurred as a consequence, directly or indirectly, of the use and application of any of the material in this document is specifically disclaimed.
  • 3. • Diagnosing Peripheral Arterial Disease (PAD), Critical Limb Ischemia (CLI) and Non- healing Wounds • Hands on, Tips and Tricks • Maintenance and Calibration • Interpreting Curves and Results
  • 4. Introduction The aim of this document is to describe Peripheral Arterial Disease (PAD), its complications and how to diagnose PAD with objective vascular tests.
  • 5. Facts… Worldwide there is: • An increasing number of diabetics • An aging population
  • 6. Resulting in… More patients with: • Peripheral Arterial Disease (PAD) • Critical Limb Ischemia (CLI) • Complicated chronic wounds • Amputations
  • 7. Peripheral Arterial Disease PAD What is PAD? • Occlusions in the peripheral arteries causing ischemia in the lower extremities Risk factors: • Smoking, diabetes, high blood pressure, obesity, increasing age … Prevalence: • 3-10% in general, 15-20% people aged > 70 Problem: 2/3 of all patients with PAD show no symptoms! Underestimation of disease! Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASCII). Eur J Vasc and Endovasc Surgery, Vol 33, suppl 1 2007
  • 8. Peripheral Arterial Disease PAD Symptoms: • Walking pain - Intermittent Claudication (IC) – Pain upon walking which disappear at rest – Cold legs and feet – Discoloration • Critical Leg Ischemia (CLI) – Severe form of PAD – Rest pain – Ischemic ulcers and gangrene – High incidence of amputation and mortality • Non-healing wounds – Often caused by Ischemia (PAD/CLI) – 15 % of all diabetics develop ulcers – 14-24% with a foot ulcer require amputation, 85% of these amputations could be prevented with early diagnosis Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASCII). Eur J Vasc and Endovasc Surgery, Vol 33, suppl 1 2007 ESVS Guidelines for Critical Limb Ischaemia and Diabetic Foot, 2011 “Ischemia should not be excluded as a cause of a diabetic foot ulcer unless proven absent.”
  • 9. Objective Vascular Tests It is recommended to confirm PAD/CLI with objective vascular tests: • Ankle pressure – ABI • Toe pressure - TBI • tcpO2 • PVR • Segmental pressure • Imaging techniques (Duplex, angiogram) Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASCII). Eur J Vasc and Endovasc Surgery, Vol 33, suppl 1 2007
  • 10. Why is objective diagnosis useful?
  • 11. Crucial to Make the Right Decision Objective vascular tests support clinical decisions
  • 12. Diagnosing PAD/CLI • Diagnose if a patient is suffering from PAD/CLI • Assess severity of disease • Predict wound healing potential Decide treatment plan Prioritize between patients • Define optimal amputation level • Qualify for Hyperbaric Oxygen Therapy (HBOT) Better “success rate” for the doctor • Evaluate treatment success Follow up on treatment, plan for next step
  • 13. Complications with diabetes • Peripheral Arterial Disease (PAD) is more aggressive • Increased prevalence for Critical Limb Ischemia (CLI) • Neuropathy – reduces pain perception, feet are ”warm” • Calcified vessels – falsely elevated ABI • Non-healing, diabetic foot ulcers • Impaired microvascular functions • High risk for amputations More complex diagnosis
  • 15. Ankle Pressure, Ankle Brachial Index • Most commonly used vascular test • Simple and cheap • ABI = Ankle pressure/Brachial pressure Is ABI accurate enough? • Risk for falsely high ABI values due to calcified vessels – Common in diabetics and end-stage renal disease patients – May result in underestimation of PAD/CLI • Macrocirculatory measurement only – Skin microcirculation important factor for wound healing, macrocirculation is not enough
  • 16. Toe pressure – Toe Brachial Index “Trust ABI when low but not when high.” • Toe pressures have proven to be an excellent option for the diagnosis of PAD in patients at risk for falsely elevated ABI values (ABI>1.4) • Toe arteries are smaller and more easy to occlude • Accurate toe pressures require sensitive techniques such as laser Doppler PeriFlux 6000 solution • Laser Doppler used for detection – Sensitive at low pressures – Solution for cold ischemic feet – in-built local heating – Small probes easy to affix on all digits International Consensus on the Diabetic Foot and Practical Guidelines on the Management and Prevention of the Diabetic Foot, International Working Group on the Diabetic Foot, 2012
  • 17. Transcutaneous oxygen (tcpO2 / TCOM) Measures the local oxygen tension in the skin deriving from the local capillary (nutritive) blood perfusion. • Predicts wound healing potential • Helps define degree of small vessel disease • Accurately determines amputation level • Monitors efficacy of patients ongoing therapy • Establishes candidacy for HBO treatment PeriFlux 6000 solution • Clarke type electrodes for detection • Possibility to combine with pressure measurements
  • 18. Pulse Volume Recording (PVR) • Measures changes in pressure, reflecting arterial pulsatility (air plethysmography) • The shape of the signal is affected by calcification of the arteries as well as occlusions Normal Mildly abnormal Moderate abnormal Severely abnormal
  • 19. Pulse Volume Recording (PVR) PVR can be performed at different positions of the leg, localizing significant occlusive lesions in limbs
  • 20. Segmental Pressures • Similar to toe and ankle pressure, but different positioning of the cuffs • Provide an initial indication of anatomical location of arterial occlusive lesions (often replaced with imaging techniques) • Often combined with segmental pulse volume recordings (PVR).
  • 21. Combine test for best diagnosis! PeriFlux 6000 All recommended vascular tests in one instrument! • Ankle pressure – ABI • Toe pressure - TBI • tcpO2 • PVR • Segmental pressure
  • 22. PeriFlux 6000 Solution Adapt tests and workflow to patient Diabetic ABI Toe pressure Claudicant, no diabetes ABI Treadmill Diabetic with wound ABI Toe pressure tcpO2 Critical Limb Ischemia ABI Toe pressure tcpO2
  • 23. Right foot: Ankle pressure = 146 mmHg ABI = 1.22 Toe pressure = 42 mmHg Baseline tcpO2 = 43 mmHg Combine Tests for Best Diagnosis Example: Male with painful left foot and amputated toes. Results from several tests will give a better overview of the limb circulation. Here : Patient with clear PAD but no CLI. Left foot: Ankle pressure = incompressible arteries Toe pressure = no toes Baseline tcpO2 = 42 mmHg Normal Ankle Pressure and ABI. Is this really reliable or the beginning of media sclerosis and falsely elevated ABIs? Falsely normal ABIs!
  • 24. PeriFlux 6000 intelligence combined A unique combination of simultaneous vascular tests to speed up your diagnosis
  • 25. PeriFlux intelligence combined Accurate ABI and toe pressure Segmental pressure and PVR Adapt tests and workflow to patient Microvascular tests – tcpO2 Parallel testing to save time Step-by-step instructions, operator independent
  • 26. Reference Values for Diagnosis
  • 27. Reference Values PAD/CLI – TASC II Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASCII). Eur J Vasc and Endovasc Surgery, Vol 33, suppl 1 2007 Peripheral Arterial Disease Critical Limb Ischemia
  • 28. Reference Values PAD/CLI - IWGDF Clinical history: History to identify symptoms of PAD. Palpation of pulses in the lower limb. Non-invasive screening tests: Hand-held Doppler evaluation of flow signals from both foot arteries Ankle-Brachial Index (ABI) Toe-Brachial Index when ABI is uncertain PAD is likely when: The patient has claudication or rest pain. Both foot pulses are absent to palpation. Absent or monophasic Doppler signals from one or both foot arteries TBI < 0.7 ABI < 0.9 Assess severity of PAD (wound healing potential) Mild PAD: Palpable foot pulses Toe pressure > 55 mmHg tcpO2 > 50 mm Hg ABI > 0.6* Evaluate the effect of maximum 6 weeks optimal wound care. Reassess perfusion and consider duplex ultrasound or angiography when wound healing response is poor. *Note: ABI > 0.6 has less predictive value, and in these patients, tcpO2 or toe pressure should be measured. Severe PAD Significant ischemia, severely impaired wound healing: Toe pressure < 50 mmHg tcpO2 < 30 mm Hg ABI < 0.6 Consider revascularization International Consensus on the Diabetic Foot and Practical Guidelines on the Management and Prevention of the Diabetic Foot, International Working Group on the Diabetic Foot, 2012
  • 29. Reference Values tcpO2 / TCOM Reference values 50-70 mmHg Normal < 40 mmHg Impaired Wound Healing < 30 mmHg Critical Limb Ischemia Transcutaneous Oximetry in Clinical Practice: Consensus statements from an expert panel based on evidence. C. E FIFE, D. R. SMART, P. J. SHEFFIELD, H. W. HOPF, G. HAWKINS , D CLARKE , J Undersea and Hyp Med Vol. 36, No. 1 p 43-53, 2009
  • 30. For a more extensive summary of diagnostic guidelines, please visit: http://www.perimed- instruments.com/guidelines-diagnosis-PAD For more detailed information about tcpO2, please visit: http://www.perimed- instruments.com/upl/files/106348.pdf
  • 31. Thank You! PeriFlux 6000 | intelligence combined www.perimed-instruments.com