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