Patient Assessment: Physical evaluation
Pulses. Indicate the characteristics of pulses in the following locations: - Femoral - Popliteal - Dorsalis pedis - Posterior tibial Indicate if pulses are: 0: Absent 1: Diminished 2: Normal 3: Bounding
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Bruits. Indicate the presence or absence of bruits on auscultation in the following: - Carotid - Abdominal - Femoral - Subclavian
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Elevation pallor. Indicate the presence of pallor of the forefoot after elevating the leg 60° for 1 min.
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Reperfusion delay (>40 s)
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Dependent rubor. Indicate if rubor of the foot is present when held in dependence after an elevation pallor maneuver.
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Acute limb ischemia is characterized by - Pallor - Pulselessness - Poikilothermia - Paralysis One of the following categories should be assigned: I: Viable—Limb is not immediately threatened; no sensory loss; no muscle weakness; audible arterial and venous Doppler II: Threatened—Mild to moderate sensory or motor loss; inaudible arterial Doppler; audible venous Doppler III: Irreversible—Major tissue loss or permanent nerve damage inevitable; profound sensory loss, anesthetic; profound muscle weakness or paralysis (rigor); inaudible arterial and venous Doppler
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Tissue loss (ischemic wound or gangrene): characteristics Tissue loss is characterized by - Dryness - Necrosis - Granulation
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Tissue loss (ischemic wound or gangrene): affected limb
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Tissue loss (ischemic wound or gangrene): location Specify the location of tissue loss. Choose all that apply: - Distal aspect of leg or foot - Over bony prominence - Toe - Others
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Tissue loss (ischemic wound or gangrene): wound area Indicate the measured area of the wound in centimeters.
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Tissue loss (ischemic wound or gangrene): infection
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Tissue loss (ischemic wound or gangrene): type
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Tissue loss (ischemic wound or gangrene): depth/Wagner grade
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Diagnostic Testing: Noninvasive Procedures
Ankle Brachial Index/Toe Brachial Index Date of procedure Indicate the date the procedure was performed. Ankle systolic pressure Indicate the ankle systolic pressure of the right and left legs and whether it is recorded from the posterior tibial or dorsalis pedis arteries. ABI value Indicate the ABI value for each leg. Choose 1 of the following: - Normal (ABI 1.00–1.40) - Abnormal (ABI <0.90) - Borderline (ABI 0.91–0.99) - Noncompressible arteries (ABI >1.40) Great toe systolic pressure: Indicate the right and left great toe systolic pressures. TBI value: Indicate the TBI value for each leg. A TBI value of <=0.7 is abnormal.
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Exercise Testing: Treadmill Exercise Date of procedure Indicate the date exercise testing was performed. Protocol Specify the symptom-limited exercise protocol used (constant load/graded). Postexercise ankle pressure and/or ABI Indicate if immediate postexercise ankle pressure and/or ABI measurement were performed. Choose 1 of the following: - Yes. If so, indicate value. - No Walking time Indicate the following walking time in minutes: - Claudication onset time - Peak walking time Distance: Indicate the walking distance in meters or feet: - Claudication-onset walking distance - Peak walking distance METS 1 MET is defined as 3.5 mL O2*kg^-1*min^-1. Indicate METS at peak exercise. Alternative method A 6-min walk is the distance walked in 6 min on flat surface using standardized measurement procedures. It is reported in meters or feet.
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Segmental Pressure Examination Date of examination Segmental pressure measurements - Right and left brachial pressures - Right and left thigh pressures - Right and left low thigh pressures - Right and left thigh calf pressures - Right and left dorsalis pedis pressures - Right and left posterior tibial pressures Indicate if there is a >20 mm Hg drop between the contiguous segments of the same leg, which can suggest the location of stenosis.
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Pulse Volume Recording (PVR) Date of recording Amplitude reduction - Indicate the leg and location of PVR: - Right/left high thigh - Right/left low thigh - Right/left calf - Right/left ankle - Right/left metatarsal Choose 1 of the following to describe pulse wave amplitude: - Normal - Abnormal - Mildly reduced - Moderately reduced - Severely reduced
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Transcutaneous Oxygen Pressure Date of measurement TcPO2 measured: Measurement of the pressure of oxygen on the surface of the skin. Indicate the TcPO2 value in the right foot and left foot.
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Duplex Ultrasound Date of procedure Artery imaged: - Aorta - Right/left CIA - Right/left EIA - Right/left common femoral artery - Right/left proximal profunda femoris artery - Right/left superficial femoral artery - Right/left popliteal artery - Right/left tibioperoneal trunk - Right/left anterior tibial artery - Right/left posterior tibial artery - Right/left peroneal artery
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Peak systolic velocity. Specify for - Aorta - Right/left CIA - Right/left EIA - Right/left common femoral artery - Right/left proximal profunda femoris artery - Right/left superficial femoral artery - Right/left popliteal artery - Right/left tibioperoneal trunk - Right/left anterior tibial artery - Right/left posterior tibial artery - Right/left peroneal artery
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Category of stenosis. Specify for - Aorta - Right/left CIA - Right/left EIA - Right/left common femoral artery - Right/left proximal profunda femoris artery - Right/left superficial femoral artery - Right/left popliteal artery - Right/left tibioperoneal trunk - Right/left anterior tibial artery - Right/left posterior tibial artery - Right/left peroneal artery Indicate the category of stenosis: - Normal - 1%–49% - 50%–99% - Occlusion
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Bypass graft. Indicate location of proximal and distal anastomosis and type (eg, in situ saphenous vein, reverse saphenous vein, PTFE).
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Peak systolic velocity of bypass graft Indicate peak systolic velocity at proximal anastomosis, along conduit, and at distal anastomosis.
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Ratios of peak systolic velocities along bypass graft Indicate ratio of peak systolic velocity of 2 contiguous segments at proximal anastomosis, along conduit, and at distal anastomosis
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Category of bypass graft stenosis
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Magnetic Resonance Angiography Date of procedure Indicate if gadolinium was used Indicate the artery imaged. Choose all that apply: - Abdominal aorta - Right/left iliac (common, internal, external) artery - Right/left femoral (common, superficial, deep) artery - Right/left popliteal (above knee, below knee, both) artery - Right/left tibial/peroneal (anterior tibial, posterior tibial, peroneal) arteries Specify the location of the lesion. Indicate the severity of stenosis by quantitative analysis using the formula 100x(1-minimum lumen diameter)/maximum diameter of reference segment Indicate if reconstitution was seen (yes/no)
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CT Angiography: Date of procedure. Type of contrast: Ionic contrast, Nonionic contrast (specify: Monomer, Dimer). Indicate the volume of contrast used in milliliters. Indicate the slice thickness in millimeters. Indicate if raw images were reviewed: yes/no Indicate if reconstructed images were reviewed: - Yes (specify: Shaded surface images or Maximum intensity projection) - No Indicate the artery imaged. Choose all that apply: - Abdominal aorta - Right/left iliac (common, internal, external) artery - Right/left femoral (common, superficial, deep) artery - Right/left popliteal (above knee, below knee, both) artery - Right/left tibial/peroneal (anterior tibial, posterior tibial peroneal) arteries Specify the location of the lesion. Indicate if calcification is present: None / Mild / Moderate / Severe If present, specify the location Indicate the severity of stenosis by quantitative analysis using the formula 100x(1-minimum lumen diameter)/maximum diameter of reference segment Indicate if reconstitution was seen (yes/no)
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Diagnostic Testing: Invasive procedures
Catheter Angiography Date of procedure Operator name Type of anesthesia: - General - Local, sedation yes/no - Regional, sedation yes/no Specify the vascular access site. Indicate the contrast agent used: - Iodinated: Ionic / Nonionic (Monomer / Dimer) - Noniodinated (CO2) Specify the contrast volume given. Indicate the field size in centimeters or inches. Indicate the Frame rate [FPS]. Indicate the image type: Cine / Digital images Digital subtraction: yes/no Indicate total fluoroscopy time recorded to the nearest 0.10 min. The time recorded should include the total time for the procedure. Indicate the artery imaged. Choose all that apply: - Abdominal aorta - Right/left iliac (common, internal, external) artery - Right/left femoral (common, deep, superficial) artery - Right/left popliteal (above knee, below knee, or both) artery - Right/left tibial/peroneal (anterior tibial, posterior tibial, peroneal) arteries Specify the location of the lesion (ostial, proximal third, middle third, and distal third). Indicate if calcification is present: None / Mild / Moderate / Severe If present, specify the location. Indicate the severity of stenosis by quantitative analysis using the formula 100x(1-minimum lumen diameter)/maximum diameter of reference segment Indicate if the artery is reconstituted by collaterals: Yes (If yes, indicate level) / No Translesional pressure gradient: Indicate the pressure measured proximal to the stenosis minus the pressure measured distal to the stenosis. Also indicate the following: - Baseline pressure gradient: Systolic, Mean, Diastolic - Enhanced (hyperemic, postvasodilator) pressure gradient: Systolic, Mean, Diastolic - Measurement timing: Simultaneous / Pullback Indicate any technical complications encountered during the diagnostic procedure: Choose all that apply: - Pseudoaneurysm - Atrioventricular fistula - Hematoma - Dissection - Vessel thrombosis - Vessel perforation - Atheromatous embolization - Contrast nephropathy - Contrast hypersensitivity - Requirement of intervention to prevent permanent impairment/damage
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Pharmacological Therapy for Symptoms of Claudication
Indicate if cilostazol has been prescribed for the patient: - Yes (If yes, indicate Dose and Duration of treatment) - No
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Indicate if pentoxifylline has been prescribed for the patient: - Yes (If yes, indicate Dose and Duration of treatment) - No
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Exercise Rehabilitation for Intermittent Claudication
Exercise Program Assessment Functional status/quality of life: Document functional ability at initiation and completion of the exercise program based on the following: - Claudication onset walking distance - Peak walking distance - METS achieved at peak exercise - 6-min walking test - Questionnaires Document the total exercise time during the exercise session at initiation and completion of the exercise program. Document the total rest time spent during the exercise session at initiation and completion of the exercise program. Document the duration of walking time at initiation and completion of the exercise program.
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Exercise Prescription Indicate the place where exercise is done: Supervised facility / Home based Indicate the mode of exercise prescribed: - Treadmill: Indicate initial speed and grade, final speed and grade - Track walking: Indicate initial speed, final speed - Cycling: Indicate initial speed and watts, final speed and watts Indicate the recommendation for progression of exercise. Intensity level: Indicate the recommended claudication pain intensity level before resting. Indicate the recommended range of RPE. Indicate the duration of the exercise session in minutes. Frequency of session: Indicate the number of days of exercise session per week Duration of prescription: Indicate how long the exercise prescription should be performed in number of sessions or number of weeks
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Therapeutic Procedures: Endovascular and Open Surgical Revascularization
Endovascular Revascularization Date of procedure Operator name Limb revascularized: Right / Left / Both Procedure: - Balloon angioplasty - Cutting balloon - Stent (drug eluting yes/no, type of drug-eluting stent) - Stent graft - Atherectomy - Laser - Cryoplasty Indicate the target vessel for revascularization. Choose all that apply: - Aorta - CIA - EIA - IIA - Common femoral artery - Superficial femoral artery - Deep femoral artery - Popliteal (above the knee) - Popliteal (below the knee) - Anterior tibial artery - Posterior tibial artery - Peroneal artery - Pedal arteries Indicate the manufacturer of the device. Indicate the model number of the device. Indicate the maximum diameter of the device in millimeters. Indicate the maximum length of the device in millimeters. Indicate the time of patient arrival in the catheterization lab in hours:minutes. Last catheter removed: Indicate the date and time the last catheter was removed. Indicate the thrombolytic agent used. Specify the following: - Specific thrombolytic agent used - Route of delivery - Dosage - Duration of infusion Indicate the antithrombotic agent used. Specify the following: - Specific antithrombotic agent used: Unfractionated heparin / Low–molecular-weight heparin / Fondaparinux / Direct thrombin inhibitor - Route of delivery - Dosage - Duration of infusion Antiplatelet agent Indicate the antiplatelet agent used. Specify Dosage Indicate if a closure device was used: yes (specify Manufacturer and Model) / no Indicate type of contrast used: - Iodinated: Ionic / Nonionic / Monomer / Dimer / Noniodinated (CO2) Indicate the devices used for the procedure. Choose all that apply: - Guidewires - Guiding catheters - Intravascular ultrasound - Angioplasty balloons - Cutting balloon - Infusion catheter - Laser catheter - Thrombectomy device - Atherectomy device - Reentry device - Thermal balloon - EPD - Stent - Drug-eluting stent - Stent graft Indicate the technical outcome of the procedure. Specify the following: - Postprocedure translesional gradient - Residual percent stenosis Indicate any technical complications encountered during the procedure: Choose all that apply: - Vessel perforation - Embolization (loss of runoff vessel) - Dissection - Vasospasm - Access site bleeding
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Open Surgery Date of procedure Operator name Indicate which limb the procedure was done: Right / Left / Both Indicate the type of procedure performed. Choose 1 of the following: - Primary/secondary - Bypass -- Inflow/outflow -- Anatomic/extra-anatomic - Endarterectomy - Thrombectomy - Graft revision Indicate the proximal anastomotic site and side. Choose 1 of the following: - Thoracic aorta - Abdominal aorta - CIA - EIA - Common femoral artery - Proximal superficial femoral artery - Distal superficial femoral artery - Profunda femoral artery - Proximal popliteal artery - Distal popliteal artery - Tibioperoneal artery - Proximal anterior tibial artery - Distal anterior tibial artery - Proximal posterior tibial artery - Distal posterior tibial artery - Proximal peroneal artery - Distal peroneal artery - Dorsalis pedis/tarsal artery Indicate the distal anastomotic site. Choose 1 of the following: - CIA - EIA - Common femoral artery - Proximal superficial femoral artery - Distal superficial femoral artery - Profunda femoral artery - Proximal popliteal artery - Distal popliteal artery - Tibioperoneal artery - Proximal anterior tibial artery - Distal anterior tibial artery - Proximal posterior tibial artery - Distal posterior tibial artery - Proximal peroneal artery - Distal peroneal artery - Dorsalis pedis/tarsal artery Graft material Indicate the type of graft material used for the procedure. Choose 1 of the following: - Autogenous -- Harvest site Left / Right -- Specify the vein used: --- Great saphenous vein, in situ --- Great saphenous vein, nonreversed --- Great saphenous vein, reversed --- Arm vein --- Small saphenous vein --- Composite vein --- Vein patch - Autogenous-prosthetic composite - Prosthetic -- Specify the type. Choose 1 of the following: --- PTFE --- Heparin-coated PTFE --- Dacron --- Other (specify) Specify graft diameter: - Prosthetic - Vein Indicate type of anesthesia used. Choose 1 of the following: - General - Local, sedation yes/no - Regional, sedation yes/no -- Epidural -- Spinal Indicate the technical outcome of the procedure. Specify the following: - Postprocedure translesional gradient - Residual percent stenosis Indicate the type of study performed after the procedure. Choose 1 of the following: - Angiogram - Duplex ultrasound Estimated blood loss in milliliters. Indicate the blood products transfused to the patient. Choose all that apply: - Auto transfused blood (specify volume used) - Packed RBCs - Fresh frozen plasma - Platelets - Other (specify) Indicate the total time of the procedure in hours:minutes.
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Outcomes of Endovascular/Open Surgery Procedures
Indicate the period at which outcome measures are assessed
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Indicate major clinical complications arising from the management or treatment of the disease.
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Indicate postoperative clinical events or conditions associated with the endovascular procedure
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Complications of open surgery
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Clinical Outcomes: Limb-Related Outcomes
Indicate the period at which outcome measures are assessed
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Limb-related outcomes: symptoms - Claudication -- None -- Unchanged -- Improved -- Worsened - Ischemic rest pain - Ischemic tissue loss - Amputation
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Walking ability - Pain-free walking distance (in meters) or time (in minutes) - Maximum walking distance (in meters) or time (in minutes) Functional status/quality of life - Questionnaire assessment -- Community-based walking (PAD specific): Walking Impairment Questionnaire, others -- Generic health status: SF-36, Nottingham Health Profile, EuroQol, Sickness Impact Profile, and others -- PAD-specific quality of life: VascuQOL Questionnaire, PADQOL, and others - Patient anecdote
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Noninvasive assessment of outcome - Limb perfusion pressure and/or ABI - Graft scan - Other imaging (CTA or MRA)
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Procedure-related outcomes: Patency
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Wound healing characteristics - Description of dressing - 1-wk change in area - 4-wk change in area - Presence and amount of granulation tissue - Presence of reepithelialization - Presence of fibrin slough
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Cardiovascular outcomes
New cardiovascular ischemic event
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