Peripheral Arterial Disease Presentation Prevention Treatment Cardiovascular and Stroke Summit 1 June 2018 Mary MacDonald CD MD PhD FRCSC RPVI Vascular Surgeon Thunder Bay Regional Health Sciences Centre Assistant Professor Northern Ontario School of Medicine
Faculty/Presenter Disclosure Faculty: Dr. Mary MacDonald Relationships with commercial interests: none
Disclosure of Commercial Support Dr. Mary MacDonald, Vascular Surgeon, TBRHSC This program has received no financial or in-kind support Potential for conflict(s) of interest: I have no conflict of interest or affiliations that have influenced this presentation to disclose
Objectives 1. Review presentation of peripheral arterial disease 2. Evidence based prevention and risk factor management 3. Treatment options: indications for angiography and surgical bypass
Overview Chronic Peripheral Arterial Disease Presentation of PAD Prevention and Management of Risk Factors Guidelines for Treatment of Claudication Guidelines for Treatment of Critical Limb Ischemia Guidelines for Management of Diabetic Foot Ulcer Treatment: Indications for intervention
What is Peripheral Arterial Disease? Stenosis or occlusion of the aorta or limb arteries which leads to lack of tissue oxygenation (ischemia) Acute PAD most often caused by embolization Chronic PAD most often by atherosclerosis Either acute or chronic peripheral arterial disease can lead to death of tissues (nerve, muscle, bone) and loss of the limb
Peripheral Arterial Disease
Population (millions) The Aging Population 17% of the population 55-70 years of age has PAD 25 20 15 10 5 0 10 20 30 40 50 60 70 80 90 Age (years) 1980 1990 2000 2010 N=1592 PAD = peripheral arterial disease Fowkes FG, et al. Int J Epidemiol. 1991;20:384-392.
Independent Risk Factors for PAD* Relative Risk vs the General Population Reduced Increased Diabetes 4.05 Smoking 2.55 Hypertension Total cholesterol (10 mg/dl) 1.10 1.51 * PAD diagnosis based on ABI <0.90. Newman AB, et al. Circulation. 1993;88:837-845
Chronic Peripheral Arterial Disease
Causes of Chronic Peripheral Arterial Ischemia Popliteal Entrapment Syndrome Popliteal Adventitial Cyst 5% 85% Atherosclerosis 10% Popliteal Aneurysm Thromboangiitis Obliterans (Buerger s disease) Arteritis Fibromuscular Dysplasia
Atherosclerosis
Atherosclerosis Risk Factors
The Ankle-Brachial Index (ABI) Ankle systolic pressure Brachial systolic pressure Ankle pressure from Posterior Tibial and Dorsalis Pedis use highest
Chronic Peripheral Arterial Disease Clinical Ankle Brachial Index Normal ABI is 1.0 intermittent claudication <0.7 rest pain <0.5 tissue loss ulcers, gangrene <0.3
Critical Limb Ischemia Peripheral Arterial Disease w/ inadequate tissue oxygenation even at rest Rubor Rest Pain Tissue Loss ulcers, gangrene, infection
Chronic Peripheral Arterial Disease -- Natural History Of patients age 50 and older with PAD, only 1-2% will go on to develop critical limb ischemia but in patients who develop critical limb ischemia, after 1 year only 50% will be alive with both lower limbs
Case: Belinda B Belinda is a 70 year old who presents with intermittent, reproducible bilateral calf pain at 3 blocks (5-10 minutes). Symptoms have been present for approximately 6 months. She denies pain in her toes or feet at night There has been no tissue loss She has had no prior vascular interventions
Case: Belinda B What is your next action? A. Order a CT Angiogram B. Refer for conventional angiogram +/- angioplasty C. Start ASA, statin, and a walking program D. Do an ABI in the office
Clinical Presentation of PAD Initial PAD Presentation Asymptomatic PAD 20-50% Symptomatic PAD Atypical Leg Pain 40-50% Intermittent Claudication 10-35% Critical Limb Ischemia 1-2% Hirsch AT, Haskal ZJ, Hertzer NR, et al. Available at http://www.acc.org/clinical/guidelines/pad/summary.pdf. Accessed December 13, 2005.
Natural History of Claudication
Natural History of PAD: 5-year Outcomes Limb Morbidity Cardiovascular Morbidity and Mortality Stable Claudication70-80% Worsening Claudication10-20% Nonfatal CV Events 15-30% Mortality 15-30% Critical Limb Ischemia 1-2 % CV Causes 75% Non-CV Causes 25%
Fate of Patients With Critical Limb Ischemia After Initial Treatment Alive With Amputation 35% Dead 20% Alive Without Amputation 45% Summary of 19 studies on 6-month outcomes 5 year outcomes show increased mortality due to cardiovascular causes Dormandy JA, et al. J Vasc Surg. 2000;31:S1-S296.
Chronic Peripheral Arterial Disease Management Medical management: Risk factor modification Antiplatelet Statin Revascularization Open surgery: Endarterectomy Bypass anatomic extraanatomic Endovascular: Angioplasty transluminal subintimal Stent Other (Atherectomy, Cryoplasty)
Therapy of Intermittent Claudication: Magnitude of Functional Improvement Pentoxifylline (Trental) Cilostazol * antiplatelet not avail in Canada Supervised Exercise 0 50 100 150 200 Improvement Over Baseline After 90 to 180 Days (%) Gardner AW, Poehlman ET. JAMA. 1995;274:975-980; Girolami B, et al. Arch Intern Med. 1999;159:337-345. Hiatt WR. N Engl J Med. 2001; 344;1608-1621.
Change in Treadmill Walking Distance (%) Effects of Exercise Training on Claudication 200 180 160 140 Meta-analysis of 21 Studies Exercise Training Control 120 100 80 60 40 20 0 Onset of Claudication Pain Gardner AW, Poehlman ET. JAMA. 1995;274:975-980. Maximal Claudication Pain
Intermittent Claudication: Exercise Therapy Frequency: 3-5 supervised sessions/week Duration: 35 to 50 minutes of exercise/session Type of exercise: treadmill or track walking to near-maximal claudication pain Length: 6 months or more Results: 100%-150% improvement in maximal walking distance Improvement in quality of life Stewart KJ, et al. N Eng J Med. 2002;347:1941-1951.
Goals in Treating Patients With PAD Limb Outcomes Outcomes in Cardiovascular Morbidity and Mortality Improve ability to walk Increase walking distance Improvement in QOL Decrease mortality from MI, stroke, and cardiovascular death Decrease nonfatal MI and stroke Prevent progression to critical limb ischemia and amputation
2015 SVS Guidelines for the Management of Peripheral Arterial Disease Diagnosis
Diagnosis of PAD: The Ankle- Brachial Index Use ABI first to establish lower extremity PAD diagnosis Recommend against routine screening in the absence of symptoms or risk factors Use toe-brachial index in patients with non-compressible vessels Anatomic imaging if revascularization is being considered Hirsch AT, Haskal ZJ, Hertzer NR, et al. Available at http://www.acc.org/clinical/guidelines/pad/summary.pdf. Accessed December 13, 2005.
2015 SVS Guidelines for the Management of Peripheral Arterial Disease Risk Factor Management
Risk Factor Management: Asymptomatic Patient 1A Comprehensive Smoking Cessation intervention(s) 1C Educate re S&S of PAD progression 1C Recommend against invasive treatment in the absence of symptoms Hirsch AT, Haskal ZJ, Hertzer NR, et al. Available at http://www.acc.org/clinical/guidelines/pad/summary.pdf. Accessed December 13, 2005.
Risk Factor Management: Symptomatic Patient 1A Comprehensive Smoking Cessation intervention(s) 1A Statin therapy 1A ASA 81 mg PO OD 1B optimal diabetes control 1B B-blocker use as indicated 1B Plavix if ASA not tolerated
Risk Factor Management: Smoking Cessation Patient should discontinue use of cigarettes or other forms of tobacco Offer comprehensive smoking cessation interventions Behavior modification therapy, nicotine replacement therapy, and/or bupropion Hirsch AT, Haskal ZJ, Hertzer NR, et al. Available at http://www.acc.org/clinical/guidelines/pad/summary.pdf.
2015 SVS Guidelines for the Management of Peripheral Arterial Disease Treatment for Claudication
Claudication Treatment: Exercise Supervised exercise training should be the initial treatment 30-45 minute sessions 3 or more times per week At least 12 weeks Value of unsupervised exercise programs is not well established Hirsch AT, Haskal ZJ, Hertzer NR, et al. Available at http://www.acc.org/clinical/guidelines/pad/summary.pdf. Accessed December 13, 2005.
Claudication Treatment: Endovascular or Surgical Therapies Indicated only for patients with Vocational or lifestyle-limiting disability; Reasonable likelihood of symptomatic improvement; Prior failure of exercise therapy or pharmacological therapy; and Favorable risk-benefit ratio Not indicated as a prophylactic treatment for asymptomatic patients 1A Optimal Medical Management postintervention (Smoking cessation, ASA, Statin, glycemic and HTN control) Hirsch AT, Haskal ZJ, Hertzer NR, et al. Available at http://www.acc.org/clinical/guidelines/pad/summary.pdf. Accessed December 13, 2005.
PAD Indications for Intervention Persistent, lifestyle limiting claudication despite maximal medical therapy Rest pain Nonhealing ulcer Gangrene
Case: Belinda B Belinda is a 70 year old who presents with intermittent, reproducible bilateral calf pain at 3 blocks (5-10 minutes). Symptoms have been present for approximately 6 months. She denies pain in her toes or feet at night There has been no tissue loss She has had no prior vascular interventions
Case: Belinda B What is your next action? A. Order a CT Angiogram B. Refer for conventional angiogram +/- angioplasty C. Start ASA, statin, and a walking program D. Do an ABI in the office
Case: Clive C 78 year old man brought to clinic by his daughters, who describe progressive loss of mobility. At camp last summer, Clive could walk for at least 30 min, but now complains of severe pain in his left calf when walking to the mailbox (100m) and left foot pain that wakes him at night. PMHx: CAD with stents 10 yrs ago, HTN, ex-smoker. Not taking any medication. No prior leg-related complaints. On examination of the left leg he has dependent rubor without tissue loss in the left foot and no palpable pulses in either groin or the distal left leg.
Case 3: Clive C
Case: Clive C Initial management options: A. Give him a prescription for aspirin and tell him to walk it out -- reassess in a few months B. Start aspirin, a statin and an ACE Inhibitor and arrange an outpatient CT angiogram C. Admit him to hospital and continue the workup as an inpatient D. Start a heparin infusion and take him to the OR
Chronic Peripheral Arterial Insufficiency Clinical Ankle Brachial Index Normal ABI is 1.0 intermittent claudication <0.7 rest pain <0.5 tissue loss ulcers, gangrene <0.3
Rubor Tissue Loss
Major Tissue Loss
Selection of Treatment Acute or Chronic? Critical/Limb-threatening? Level, extent and severity of lesion(s)
Surgical Revascularization for Peripheral Arterial Disease Endarterectomy Bypass anatomic extra-anatomic autogenous (vein) or nonautogenous graft (Dacron, PTFE)
Peripheral Arterial Disease Endovascular Treatment Endovascular: Angioplasty Stent Other transluminal subintimal (Atherectomy, Cryoplasty)
Superficial Femoral Artery Occlusion
Superficial Femoral Artery Angioplasty
Stent Deployment ://www.youtube.com/watch?v=xrwi R7XUnvs
Surgical Bypass
Open Anatomic Bypass with Saphenous Vein Graft Popliteal-popliteal bypass with saphenous vein graft
Femoral Endarterectomy
Postintervention Surveillance 2C Clinical surveillance program to include interval history, ABI, Duplex scanning (for vein grafts), and 1C prophylactic reintervention for graft stenosis to promote long-term bypass patency
Case: Clive C 78 year old man with dependent rubor, left foot pain at night and no pulses in the groins or left leg. A. Give him a prescription for aspirin and tell him to walk it out -- reassess in a few months B. Start aspirin, a statin and an ACE Inhibitor and arrange an outpatient CT angiogram C. Admit him to hospital and continue the workup D. Start a heparin infusion and take him to the OR
Management of Peripheral Arterial Disease -- Summary Asymptomatic: CV Risk Factor Management Claudication: CV RF Mgt + Walking Program Consider Revascularization if disabling Critical Limb Ischemia: CV Risk Factor Management + Revascularization
Wound Healing after Revascularization
Ischemia and Diabetes
Risk Factor Management: Diabetes Therapies Encourage proper foot care Appropriate footwear, chiropody/podiatric medicine, daily foot inspection, skin cleansing, and topical moisturizing creams Urgently address skin lesions and ulcerations Target Hb A1C <7% to reduce microvascular complications and potentially improve cardiovascular outcomes Hirsch AT, Haskal ZJ, Hertzer NR, et al. Available at http://www.acc.org/clinical/guidelines/pad/summary.pdf. Accessed December 13, 2005.
Diabetic Foot Ulcer/Infection NEUROPATHY + ISCHEMIA = INFECTION 20-40% of healthcare resources spent on diabetes are related to diabetic feet 7-10% annual incidence ulcer formation if NO confounders 25-30% annual incidence if PAD, Charcot foot, prior ulcers or amputation
Diabetic Foot Ulcer/Infection 5-8% of patients with new ulcers require major amputation within a year Ischemia should be considered as a cause of DFU unless proven absent Neuroischemic and ischemic lesions should be considered together as both may require revascularization
Diabetic Foot Ulcer/Infection As intermittent claudication and rest pain are reported far less commonly in diabetics with ischemia compared to non-diabetics; early non-invasive vascular evaluation (ABI) recommended for patients with poor ulcer healing and a high risk for amputation; IWG for the Diabetic Foot recommends vascular studies if the DFU has not healed in 6 weeks even if initial diagnostics suggest only mild disease
Diabetic Foot Ulcer/Infection 2B Surgical intervention for moderate or severe infections is likely to decrease the risk of major amputation 2B open, endovascular or hybrid methods should be chosen depending on patient comorbidities, anatomy of the arterial lesion(s) and expertise of the centre 1A Negative-pressure wound therapy appears to be as, or more, effective than other local wound treatments in patients without significant infection
Summary: Peripheral Arterial Disease Chronic Limb Ischemia: clinical presentation, risk factors, medical, surgical and endovascular management Guidelines for care of Diabetic Foot Ulcers Acute Limb Ischemia: clinical presentation and treatment
Barriers to Practice Change Discussion What is the most prevalent barrier to change that you see in your practice? What can vascular surgery do to mitigate this barrier?
Rapid Access to Vascular Evaluation RAVE clinic weekly at TBRHSC we intend to expand clinic frequency, resources Rapid referral and assessment for patients with tissue loss and suspected vascular disease No imaging required we will arrange Fax referrals to 1-888-504-1696 (office)
References Cronenwett and Johnston (2012). Rutherford s Vascular Surgery 7 th ed, Elsevier, Philadelphia PA Dormandy JA, et al. J Vasc Surg. 2000;31:S1-S296. Fowkes FG, et al. Int J Epidemiol. 1991;20:384-392. Hirsch AT, Haskal ZJ, Hertzer NR, et al. Available at http://www.acc.org/clinical/guidelines/pad/summary.pdf. Newman AB, et al. Circulation. 1993;88:837-845 Norgren et al., (2007). Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II). JVS 45:1(S) 1A-65A. Pomposelli et al Society for Vascular Surgery Clinical Guidelines for Management of Peripheral Arterial Insufficiency JVS 66:3(S) Dec 2015 Schneider, PA (2009). Endovascular Skills: Guidewire and catheter skills for endovascular surgery 3 rd ed Informa, New York NY. Zarins and Gewertz (2005). Atlas of Vascular Surgery 2 nd ed, Elsevier, Philadelphia PA
Questions?
Acute limb ischemia
Case: Eric E 58 year old man presents to ED with 4 hours of right foot pain which woke him from sleep. The foot is pale, with no palpable pulses or Doppler signal. He now also has motor weakness at the ankle and toes, and numbness from the mid-shin down to the toes. He is a 1 PPD smoker with hypertension. He is otherwise healthy and has had no previous problems with either leg.
Case: Eric E Initial management options: A. Give the patient aspirin and get him to walk it out -- reassess in an hour B. Start a heparin infusion and obtain a CT scan C. Start a heparin infusion and obtain an urgent conventional angiogram (diagnostic, possibly therapeutic) D. Start a heparin infusion and take the patient to the Operating Room
Causes of Acute Limb Ischemia Acute limb ischemia is usually embolic -- a blood clot forms elsewhere in the body and travels to the limb Most (85%) emboli come from the heart; the remainder originate in proximal arteries (especially if these arteries are aneurysmal) Non embolic causes: thrombosis, dissection, trauma (including iatrogenic)
Cardiac Embolization Acute limb ischemia like a stroke, but for your leg
Clinical Presentation of Acute Limb Ischemia Acute limb ischemia: pain, progressive loss of motor and sensory function, diminished or absent pulses Clinical examination +/- imaging localize the level of occlusion Acute occlusion of a major artery is not well tolerated as there is little collateral flow, and the tissues will not typically survive longer than 4-6 hours
Rutherford Classification Clinical Presentation of Acute Limb Ischemia Sensory Motor Doppler Arterial Venous I Normal Normal Normal Audible IIa Toes only/ Normal Diminished Audible No change IIb Pain/ Weak Poor/no Audible sens loss III Pain/ No/Rigor None None insensate
Acute Limb Ischemia -- Treatment 1. Embolectomy 2. Thrombolysis IF the limb is viable, heparin infusion and catheter-directed TPA may be appropriate
Femoral Embolectomy for Acute Limb Ischemia Incision and exposure Proximal and distal control Transverse arteriotomy Embolectomy with Fogarty catheter of 1-3 vessels On-table angio if poor result Closure http://youtu.be/qbsgff4ysfk
Acute Ischemia: Embolus
Pre and Post Embolectomy
Case: Eric E 58 year old man presents acutely to ED with a pale, pulseless right foot, with progressive sensory and motor changes A. Give the patient aspirin and get him to walk it out - - reassess in an hour B. Start a heparin infusion and obtain a CT scan C. Start a heparin infusion and obtain an angiogram D. Start a heparin infusion and take the patient to the Operating Room
Classification of Recommendations Class I: Evidence and/or general agreement that procedure or treatment is beneficial, useful, and effective Class II: Conflicting evidence and/or divergence of opinion about usefulness or efficacy of a procedure or treatment Class IIa: Weight of evidence or opinion favors usefulness or efficacy Class IIb: Usefulness or efficacy is less well established by evidence or opinion Class III: Evidence and/or general agreement that procedure is not useful or effective and in some cases Hirsch AT, Haskal ZJ, may Hertzer NR, be et al. Available harmful at http://www.acc.org/clinical/guidelines/pad/summary.pdf. Accessed December 13, 2005.
Classification of Recommendations Class I: Evidence and/or general agreement that procedure or treatment is beneficial, useful, and effective Class II: Conflicting evidence and/or divergence of opinion about usefulness or efficacy of a procedure or treatment Class IIa: Weight of evidence or opinion favors usefulness or efficacy Class IIb: Usefulness or efficacy is less well established by evidence or opinion Class III: Evidence and/or general agreement that procedure is not useful or effective and in some cases Hirsch AT, Haskal ZJ, may Hertzer NR, be et al. Available harmful at http://www.acc.org/clinical/guidelines/pad/summary.pdf. Accessed December 13, 2005.
Peripheral Arterial Disease Aneurysms Rupture, thrombosis, embolization or mass effect Risk of rupture increases with size of aneurysm Treatment involves exclusion of the entire aneurysm sac with preservation of vascular supply to branch vessels and end organs Aneurysm thrombus may embolize distally, causing acute or chronic limb ischemia
Endovascular Complications Dissection: intimal tear +/- propagation, arterial occlusion Perforation: 1-3%, tx usually conservative Embolization: 3-5% distal embolization of which approx half is clinically significant. Anticoagulate early and minimize traversal of lesion(s) Access Site: Groin Hematoma Retroperitoneal Hematoma Pseudoaneurysm AV Fistula Axillary/Brachial Nerve Injury Axillary/Brachial Thrombosis Closure Device Complications Ischemic Infectious (EVAR 02-1.2% with 18-50% mortality)
Evidence Based Guidelines for Management of PAD ACC/AHA/TASC Guidelines for Treatment -- Class I Evaluate and treat conditions known to increase risk for primary amputation Onset of acute limb symptoms in an at-risk patient should be evaluated by a specialist in vascular disease Specialized wound care for skin breakdown Patients with CLI should be evaluated at least twice yearly by a specialist in vascular disease Evaluate patients with evidence of embolization for aneurysmal disease Hirsch et al 2005 Consensus Guidelines
Critical Limb Ischemia -- Evidence Based Guidelines ACC/AHA/TASC Guidelines for Treatment -- Class I Preop cardiac risk stratification prior to open repair Prompt antibiotics in patients with skin ulceration or evidence of limb infection Catheter-based thrombolysis for acute limb ischemia (class I or IIa) of less than 14 days duration Address inflow lesion(s) first in combined disease, then revascularize outflow for persistent symptoms or infection If there is uncertainty regarding inflow disease, measure intraarterial pressures before and after vasodilator administration Hirsch et al 2005 Consensus Guidelines
Thrombolysis Contraindications Absolute existing,very recent or high risk hemorrhage true allergy ie. active internal bleeding, recent (2 months) stroke, trauma or neurosurgery known intracranial neoplasm uncontrollable coagulopathy or hypertension, known allergic reaction Relative -- moderate risk for bleeding (recent biopsy, obstetric, GI surgery or bleeding, trauma, endocarditis, pancreatitis); severe renal or hepatic failure Peripheral artery thrombolysis led to significant hemorrhage in 5.7% (STILE) to 13% (TOPAS) of patients
Thrombolysis Complications Hemorrhagic -- local up to 25%, intracerebral 1-2% Antigenic -less than 0.01% with TPA Catheter-related -- up to 3% Embolic -- distal limb 9 to 13%, of which most (75%+) may be treated by advancing the catheter and continuing the infusion post DVT PE up to 10%, not all clinically significant
Thrombolytic Treatment of Critical Limb Ischemia Catheter-based thrombolysis is effective and beneficial for patients with Rutherford category I-IIa acute limb ischemia of less than 14 days duration Mechanical thrombectomy can be used as an adjunctive therapy for acute limb ischemia Catheter-based thrombolysis or thrombectomy may be considered for Rutherford category IIb acute limb ischemia of more than 14 days duration Hirsch AT, Haskal ZJ, Hertzer NR, et al. Available at http://www.acc.org/clinical/guidelines/pad/summary.pdf. Accessed December 13, 2005.
Thrombolytic Treatment of Critical Limb Ischemia Catheter-based thrombolysis is effective and beneficial for patients with Rutherford category I-IIa acute limb ischemia of less than 14 days duration Mechanical thrombectomy can be used as an adjunctive therapy for acute limb ischemia Catheter-based thrombolysis or thrombectomy may be considered for Rutherford category IIb acute limb ischemia of more than 14 days duration Hirsch AT, Haskal ZJ, Hertzer NR, et al. Available at http://www.acc.org/clinical/guidelines/pad/summary.pdf. Accessed December 13, 2005.