Considerations in Evaluating Results of Endovascular Treatment

Risk Factor
Grade
Complication
Diabetes
0
1
2
3
None
Adult onset, diet controlled
Adult onset, insulin controlled
Juvenile onset
Tobacco usea
0
1
2
3
Never or none for last 10 years
None current, but smoked in last 10 years
Less than 1 pack/dayb
Greater than 1 pack/day
Hypertension
0
1
2
3
Nonec
Easily controlled with single drug
Controlled with two drugs
Requires more than 2 drugs or uncontrolled
Hyperlipidemia
0
1
2
3
Cholesterol/triglycerides within normal limits for age
Mild elevation, controlled by diet
Types II, III, IV requiring strict diet control
Requiring diet and drug control
Cardiac Status
0
1
2
3
Asymptomatic, normal ECG
Asymptomatic, h/o MI _6 mo, or occult MI by ECG
Stable angina, controlled ectopy, or asymptomatic
arrhythmia, drug compensated CHF
Unstable angina, symptomatic or poorly controlled
ectopy/arrhythmia, poorly compensated CHF, MI
within 6 months
Carotid Disease
0
1
2
3
No symptoms, bruit, or evidence of diseased
Asymptomatic but evidence of disease
Transient or temporary stroke
Completed stroke with permanent neurologic deficit
Renal Status
0
1
2
3
No known renal disease, serum creatinine _1.5 mg/dL, creatinine clearance _50 mL/min
Serum creatinine 1.5–3.0 mg/dL, creatinine clearance 30–50 mL/min
Serum creatinine 3.0–6.0 mg/dL, creatinine clearance 15–30 mL/min
Serum creatinine _6.0 mg/dL, creatinine clearance _15 mL/min, or on dialysis or with transplant
Pulmonary Status
0
1
2
3
Asymptomatic, normal CXR, PFT 20% of predicted
Asymptomatic or mild dyspnea on exertion, mild
CXR parenchymal changes, PFT 65–80% of predicted
Between 1 and 3
PFT: VC _1.85, FEV1 _1.2 L or _35% of predicted
Max. Vol. ventilation _28 L/min or _50% of
predicted, PCO2 _45 mm Hg, supplementary
oxygen needed, pulmonary hypertension
Note. ECG electrocardiography, MI myocardial infarction, CHF congestive heart failure, CXR chest radiograph (x-ray), PFT pulmonary function test, VC vital capacity, FEV1 forced expiratory volume in 1 s, PCO2 partial pressure of carbon dioxide. Reprinted with permission from [7]
a 0 _ absent, none, negligible; 1 _ mild; 2 _ moderate; 3 _ severe
b Includes abstinence less than 1 year
c Cutoff point, diastolic pressure regularly above or below 90 mm Hg
d Determined by noninvasive test or arteriography
Table 3.2
Classification of complications by outcome
Minor complications
•No therapy, no sequela
•Minor therapy or minor sequela, includes unplanned overnight hospital admission for observation only (<24 h)
Major complications
•Requires major therapy or unplanned hospitalization (24–48 h)
•Requires major therapy, unplanned increase in the level of care, prolonged hospitalization (>48 h)
•Permanent adverse sequela
•Death
Data adapted from: SIR Reporting Standards for the Treatment of Acute Limb Ischemia with Use of Transluminal Removal of Arterial Thrombus. N Patel et al. J Vasc Interv Radiol 2003; 14:S453–S465
Table 3.3
Clinical categories of acute limb ischemia
Category
 
Findings
Doppler signals
Description
Sensory loss
Muscle weakness
Arterial
Venous
I. Viable
Not immediately threatened
None
None
Audible
Audible
II. Threatened
(a) marginal
Salvageable if promptly treated
Minimal (toe) or none
None
Often inaudible
Audible
(b) immediately
Salvageable with immediate revascularization
More than toes, associated with rest pain
Mild, moderate
Usually inaudible
Audible
III. Irreversiblea
Major tissue loss or permanent nerve damage Inevitable
Profound, anesthetic
Profound, paralysis (rigor)
Inaudible
Inaudible
aWhen presenting early, the differentiation between category IIb and III may be difficult
Data adapted from: Recommended standards for reports dealing with lower extremity ischemia: Revised version, Rotherford R et al. J Vasc Surg 1997;26:517–38
Table 3.4
Clinical categories of chronic limb ischemia
Grade
Category
Clinical description
Objective criteria
0
0
Asymptomatic, no hemodynamically significant occlusive disease
Normal results of treadmill*/stress
I
1
Mild claudication
Treadmill exercise completed, postexercise AP is greater than 50 mm Hg but more than 25 mm Hg less than normal
2
Moderate claudication
Symptoms between those of categories 1 and 3
3
Severe claudication
Treadmill exercise cannot be completed, postexercise Ap is less than 50 mm Hg
II
4
Ischemic rest pain
Resting AP of 40 mm Hg or less, flat or barely pulsatile ankle or metatarsal plethysmographic tracing, toe pressure less than 30 mm Hg
III
5
Minor tissue loss, nonhealing ulcer, focal gangrene with diffuse pedal ischemia
Resting AP of 60 mm Hg or less, ankle or metatarsal plethysmographic tracing flat or barely pulsatile, toe pressure less than 40 mm Hg
6
Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable
Same as for category 5
Note.—AP  ankle pressure
Five minutes at 2 mph on a 12° incline.
Data adapted from: Standards for evaluating and reporting the results of surgical and percutaneous therapy for peripheral arterial disease. J Vasc Interv Radiol 1991;2:169–174
Table 3.5
Definitions of success for endoluminal revascularization devices
I.Technical: Meets the criteria for both anatomic and homodynamic success in the immediate post-procedure periods
A.Anatomic: <30% final residual stenosis measured at the narrowest point of the vascular lumen
Continued anatomic: < 50% recurrent stenosis
B.Hemodynamic: ABI or thigh/brachial index improved by 1.0 or greater above baseline and not deteriorated by >0.15 from the maximum early post-procedure level, or pulse volume recording distal to the reconstruction maintained at 5 mm above the preoperative tracing (only for patients with incompressible vessels)
II.Clinical: Immediate improvement by at least 1 clinical category, sustained improvement by at least 1 clinical category, patients with tissue loss (categories 5 and 6) must move up at least 2 categories and reach the level of claudication to be considered improved
Data adapted from: Reporting Standards for Clinical Evaluation of New Peripheral Arterial Revascularization Devices. Saks et al. J Vasc interv Radiol 2003;14:S395–S404
Table 3.6
Definitions of improvement of lower limb arterial diseases
Grade
Definition
+3
Markedly improved. Symptoms are gone or markedly improved. ABI increased to >0.90
+2
Moderately improved. Still symptomatic but with improvement in lesion category.a ABI increased by >0.10 but not normalized
+1
Minimally improved. Categorical improvement in symptoms without significant ABI increase (0.10 or less) or vice versa (but not both)
0
No change. No categorical shift and less than 0.10 changes in ABI
−1
Mildly worse. Either worsening of symptoms or decrease in ABI of >0.10
−2
Moderate worsening. Deterioration of the patient’s condition by one category or unexpected minor amputation
−3
Marked worsening. Deterioration of the patient’s condition by more than one category or major amputation
aCategories refer to clinical categories in Table 3.2 and 3.3.
Data adapted from: Standards for evaluating and reporting the results of surgical and percutaneous therapy for peripheral arterial disease. J Vasc Interv Radiol 1991;2:169–174
Table 3.7
Reporting requirements and recommendations for endoluminal revascularization devices

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Mar 20, 2016 | Posted by in INTERVENTIONAL RADIOLOGY | Comments Off on Considerations in Evaluating Results of Endovascular Treatment

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Data
Required
Highly recommended
Recommended
Pretreatment evaluationa
Risk factors/Comorbidities
X
   
Measures of disease severity
Stenosis of treated site
X
   
Runoff grade
X
   
Eccentricity
   
X
Noninvasive indices (ABI, TBI, PVR)
X
   
Treadmill (claudicants)
X
   
graded treadmill
 
X
 
Functional status
 
X
 
Quality of life
 
X
 
Treatment description
X
   
Posttreatment evaluationa
Follow-up angiogram
 
X
 
Technical success
     
Anatomic
     
Stenosis
X
   
Luminal gain
 
X
 
Hemodynamic
Noninvasive (ABI, TBI, PVR)
X
   
intravascular pressures
 
X
 
Clinical success
Improvement category
X
   
Functional status
 
X
 
Quality of life
 
X
 
Treadmill (claudicants)
X