Konstantinos Katsanos Joseph Mills Sigrid Nikol Jim Reekers Robert Hinchliffe Rachael Forsythe Jan Apelqvist Ed Boyko Robert Fitridge Joon Pio Hong Konstantinos Katsanos Joseph Mills Sigrid Nikol Jim Reekers Maarit Venermo Eugene Zierler Nicolaas Schaper www.iwgdfguidelines.org

Peripheral artery disease Slides courtesy IWGDF; available at: www.iwgdfguidelines.org Peripheral artery disease Any atherosclerotic arterial occlusive disease below the inguinal ligament, resulting in a reduction in blood flow to the lower extremity Diagnosis Prognosis Treatment Definition of PAD from 2012 guidance

Focus of PAD guidelines Slides courtesy IWGDF; available at: www.iwgdfguidelines.org Focus of PAD guidelines Patients with ulceration (highest risk) Patient Intervention Comparator Outcome Recommendation What outcomes did we select and why?

Do we need specific PAD guidelines in people with diabetes? Slides courtesy IWGDF; available at: www.iwgdfguidelines.org Do we need specific PAD guidelines in people with diabetes? Associated with poor outcomes both in terms of wound healing (failure), salvage of the limb and prevention of amputation but also in terms of overall patient prognosis and mortality both all-cause and CV related There is a real variation in the management – in part because to depends who you ask but also because we have a host of different specialists managing these patients – angiologists, surgeons, radiologists, cardiologists One of the key problems is that they are often managed by non-vascular specialists at least initially who may not be expert or comfortable either having access to the necessary investigative modalities or interpreting their outcomes The other fundamental problem is that there really is a lack of evidence with few high quality RCTs to influence clinical practice – and those that do exist are in a mixed population of people wit and without diabetes and hence the guidelines that do exist are really not focussed on people with diabetes but the generality of the population of PAD – and why is that important – principally because this population of patients are quite different to the general PAD population

Poor prognosis (wound, limb, patient) Slides courtesy IWGDF; available at: www.iwgdfguidelines.org Common in DFU (50%) Poor prognosis (wound, limb, patient) Managed by non-vascular specialists (variation) PAD is a spectrum of disease Weak evidence to underpin clinical practice (No RCTs) PAD vascular guidelines – no diabetes focus Associated with poor outcomes both in terms of wound healing (failure), salvage of the limb and prevention of amputation but also in terms of overall patient prognosis and mortality both all-cause and CV related There is a real variation in the management – in part because to depends who you ask but also because we have a host of different specialists managing these patients – angiologists, surgeons, radiologists, cardiologists One of the key problems is that they are often managed by non-vascular specialists at least initially who may not be expert or comfortable either having access to the necessary investigative modalities or interpreting their outcomes The other fundamental problem is that there really is a lack of evidence with few high quality RCTs to influence clinical practice – and those that do exist are in a mixed population of people wit and without diabetes and hence the guidelines that do exist are really not focussed on people with diabetes but the generality of the population of PAD – and why is that important – principally because this population of patients are quite different to the general PAD population

Fundamental questions Slides courtesy IWGDF; available at: www.iwgdfguidelines.org Fundamental questions PAD?

Fundamental questions Slides courtesy IWGDF; available at: www.iwgdfguidelines.org Fundamental questions PAD? Who revascularise?

Fundamental questions Slides courtesy IWGDF; available at: www.iwgdfguidelines.org Fundamental questions PAD? Who revascularise? When?

Fundamental questions Slides courtesy IWGDF; available at: www.iwgdfguidelines.org Fundamental questions PAD? Who revascularise? When? How?

Guidelines for clinical practice Slides courtesy IWGDF; available at: www.iwgdfguidelines.org Guidelines for clinical practice Relevant to generalist and specialist Variation in severity / mode of presentation Variation in distribution of PAD Variation in fitness of patients Revascularisation is beneficial & potentially harmful Focus is on the generalist – why – they see far more patient with PAD than a so called specialist – and specialist soften carry on and do what they want anyway – even thought it is incorrect But you are going to need some specialist kit I am afraid to treat these patients effectively – inspection, palpation, percussion and auscultation are not going to be enough………….

Guidelines for clinical practice Slides courtesy IWGDF; available at: www.iwgdfguidelines.org Guidelines for clinical practice Diagnosis (1-3) Clinical exam Non-invasive tests Prognosis (4-9) Non-invasive tests Classification Decision making Treatment (10-17) Vascular imaging Revasc technique Organisation General principles 1 more than the guidance document published in 2015/6 So – what has changed since 2015/6? There are no new RCTs in the field – so guidance base don solid principles and largely uncontrolled observational data In essence we have 1 more guideline – we have made some minor adaptations for the sake of clarity or where the evidence has changed as a result of contemporary publications or where we have received feedback requesting change. The major change is the adoption of WIFI system to help inform the decision to revascularise

Diagnosis (excluding PAD) Slides courtesy IWGDF; available at: www.iwgdfguidelines.org Diagnosis (excluding PAD) Clinical examination unreliable Pedal Doppler waveforms + ankle pressure / ABI or toe pressure / TBI measurement. No single modality / threshold optimal Triphasic pedal Doppler waveforms Toe brachial index ≥0.75. ABI 0.9-1.3 (Strong; Low) Better identify patients who do well or poorly with standard approaches Is there any evidence that earlier intervention improves outcomes Do some of the novel approaches and therapies do any better?

Prognosis (classification) Slides courtesy IWGDF; available at: www.iwgdfguidelines.org Prognosis (classification) Use the WIfI classification system - Wound - Ischaemia - foot Infection stratify amputation risk revascularisation benefit (Strong; Moderate) Better identify patients who do well or poorly with standard approaches Is there any evidence that earlier intervention improves outcomes Do some of the novel approaches and therapies do any better?

Prognosis (be prepared to change strategy) Slides courtesy IWGDF; available at: www.iwgdfguidelines.org Prognosis (be prepared to change strategy) Despite optimal wound and medical care Ulcer not healing in 4-6 weeks → vascular imaging (Strong; Low) PAD + no healing in 4-6 weeks → revascularise (Strong; Low) Better identify patients who do well or poorly with standard approaches Is there any evidence that earlier intervention improves outcomes Do some of the novel approaches and therapies do any better?

Treatment Aim - direct blood flow to ≥1 foot arteries Slides courtesy IWGDF; available at: www.iwgdfguidelines.org Treatment Aim - direct blood flow to ≥1 foot arteries preferably to anatomical region of ulcer post procedure → objective measurement of perfusion. (Strong; Low) Revascularisation technique based on individual factors. (Strong; Low) Patient access to expertise and facilities diagnosis PAD revascularisation (endovascular and bypass surgery). (Strong; Low) Better identify patients who do well or poorly with standard approaches Is there any evidence that earlier intervention improves outcomes Do some of the novel approaches and therapies do any better?

Future research priorities Slides courtesy IWGDF; available at: www.iwgdfguidelines.org Future research priorities Improve identificaiton of those who benefit from revascularisation Role of novel methods of perfusion assessment? Earlier revascularisation? Angiosome concept Venous arterialisation Novel medical therapies Better identify patients who do well or poorly with standard approaches Is there any evidence that earlier intervention improves outcomes Do some of the novel approaches and therapies do any better?

Conclusions Clinical examination is unreliable Slides courtesy IWGDF; available at: www.iwgdfguidelines.org Conclusions Clinical examination is unreliable Bedside tests helpful – limitations Optimise other aspects of care Revascularisation decisions complex (heal spontaneously) Be prepared to change strategy if no improvement Better identify patients who do well or poorly with standard approaches Is there any evidence that earlier intervention improves outcomes Do some of the novel approaches and therapies do any better?