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The care of patients with varicose veins and associated chronic ...

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JOURNAL OF VASCULAR SURGERY<br />

Volume 53, Number 16S Gloviczki et al 7S<br />

Table I. Grading recommendations according to evidence a<br />

Grade<br />

Description <strong>of</strong><br />

recommendation Benefit vs risk <strong>and</strong> burdens<br />

1A Strong recommendation,<br />

high-quality evidence<br />

1B Strong recommendation,<br />

moderate quality<br />

evidence<br />

1C Strong recommendation,<br />

low-quality or very<br />

low-quality evidence<br />

2A Weak recommendation,<br />

high-quality evidence<br />

2B Weak recommendation,<br />

moderate-quality<br />

evidence<br />

2C Weak recommendation,<br />

low-quality or very<br />

low-quality evidence<br />

Benefits clearly outweigh<br />

risk <strong>and</strong> burdens, or vice<br />

versa<br />

Benefits clearly outweigh<br />

risk <strong>and</strong> burdens, or vice<br />

versa<br />

Benefits clearly outweigh<br />

risk <strong>and</strong> burdens, or vice<br />

versa<br />

RCT, R<strong>and</strong>omized controlled trial.<br />

a Adapted from Guyatt et al. 48 Used <strong>with</strong> permission.<br />

Benefits closely balanced<br />

<strong>with</strong> risks <strong>and</strong> burden<br />

Benefits closely balanced<br />

<strong>with</strong> risks <strong>and</strong> burden<br />

Uncertainty in the estimates<br />

<strong>of</strong> benefits, risks, <strong>and</strong><br />

burden; benefits, risk, <strong>and</strong><br />

burden may be closely<br />

balanced<br />

indicating the need for investigation <strong>and</strong> <strong>care</strong>. <strong>The</strong> term<br />

<strong>chronic</strong> venous disorder is reserved for the full spectrum <strong>of</strong><br />

venous abnormalities <strong>and</strong> includes dilated intradermal <strong>veins</strong><br />

<strong>and</strong> venules between 1 <strong>and</strong> 3 mm in diameter (spider <strong>veins</strong>,<br />

reticular <strong>veins</strong>, telangiectasia; CEAP class C 1).<br />

Varicose <strong>veins</strong> can progress to a more advanced form <strong>of</strong><br />

<strong>chronic</strong> venous dysfunction such as <strong>chronic</strong> venous insufficiency<br />

(CVI). 55,56 In CVI, increased ambulatory venous<br />

hypertension initiates a series <strong>of</strong> changes in the subcutaneous<br />

tissue <strong>and</strong> the skin: activation <strong>of</strong> the endothelial<br />

cells, extravasation <strong>of</strong> macromolecules <strong>and</strong> red blood<br />

cells, diapedesis <strong>of</strong> leukocytes, tissue edema, <strong>and</strong> <strong>chronic</strong><br />

inflammatory changes most frequently noted at <strong>and</strong><br />

above the ankles. 41,53 Limb swelling, pigmentation, lipodermatosclerosis,<br />

eczema, or venous ulcerations can<br />

develop in these <strong>patients</strong>.<br />

THE SCOPE OF THE PROBLEM<br />

In the adult Western population, the prevalence <strong>of</strong><br />

<strong>varicose</strong> <strong>veins</strong> is 20% (range, 21.8%-29.4%), <strong>and</strong> about 5%<br />

(range, 3.6%-8.6%) have venous edema, skin changes or<br />

venous ulcerations. Active venous ulcers are present in up<br />

to 0.5%, <strong>and</strong> between 0.6% <strong>and</strong> 1.4% have healed ulcers. 57<br />

On the basis <strong>of</strong> estimates <strong>of</strong> the San Diego epidemiologic<br />

study, more than 11 million men <strong>and</strong> 22 million women<br />

between the ages <strong>of</strong> 40 <strong>and</strong> 80 years in the United States<br />

have <strong>varicose</strong> <strong>veins</strong>, <strong>and</strong> 2 million adults have advanced<br />

Methodologic quality <strong>of</strong><br />

supporting evidence Implications<br />

RCTs <strong>with</strong>out important<br />

limitations or overwhelming<br />

evidence from observational<br />

studies<br />

RCTs <strong>with</strong> important limitations<br />

(inconsistent results,<br />

methodologic flaws, indirect,<br />

or imprecise) or exceptionally<br />

strong evidence from<br />

observational studies<br />

Observational studies or case<br />

series<br />

RCTs <strong>with</strong>out important<br />

limitations or overwhelming<br />

evidence from observational<br />

studies<br />

RCTs <strong>with</strong> important limitations<br />

(inconsistent results,<br />

methodologic flaws, indirect,<br />

or imprecise) or exceptionally<br />

strong evidence from<br />

observational studies<br />

Observational studies or case<br />

series<br />

Strong recommendation, can apply<br />

to most <strong>patients</strong> in most<br />

circumstances <strong>with</strong>out<br />

reservation<br />

Strong recommendation, can apply<br />

to most <strong>patients</strong> in most<br />

circumstances <strong>with</strong>out<br />

reservation<br />

Strong recommendation but may<br />

change when higher quality<br />

evidence becomes available<br />

Weak recommendation, best action<br />

may differ depending on<br />

circumstances or <strong>patients</strong>’ or<br />

societal values<br />

Weak recommendation, best action<br />

may differ depending on<br />

circumstances or <strong>patients</strong>’ or<br />

societal values<br />

Very weak recommendations; other<br />

alternatives may be equally<br />

reasonable<br />

CVD, <strong>with</strong> skin changes or ulcers. 1 <strong>The</strong> incidence <strong>of</strong> postthrombotic<br />

venous ulcers has not changed in the past 2<br />

decades for women, <strong>and</strong> it recently increased in men. 58 In<br />

the United States each year, at least 20,556 <strong>patients</strong> receive<br />

a new diagnosis <strong>of</strong> venous ulcers. 3<br />

<strong>The</strong> Bonn Vein Study, 59 which enrolled 3072 r<strong>and</strong>omly<br />

selected participants (1722 women <strong>and</strong> 1350 men),<br />

aged from 18 to 79 years, found symptoms <strong>of</strong> CVD in<br />

49.1% <strong>of</strong> men <strong>and</strong> in 62.1% <strong>of</strong> women. Also reported were<br />

<strong>varicose</strong> <strong>veins</strong> <strong>with</strong>out edema or skin changes in 14.3%<br />

(12.4% men, 15.8% women), edema in 13.4% (11.6% men,<br />

14.9% women), skin changes in 2.9% (3.1% men, 2.7%<br />

women), <strong>and</strong> healed or active ulceration in 0.6% or 0.1%,<br />

respectively. A French cross-sectional survey found <strong>varicose</strong><br />

<strong>veins</strong> in 23.7% <strong>of</strong> men <strong>and</strong> 46.3% <strong>of</strong> women. 60<br />

<strong>The</strong> National Venous Screening Program, under the<br />

auspices <strong>of</strong> the AVF, screened 2234 Americans for venous<br />

disease. 61 <strong>The</strong> participants’ mean age was 60 years, 77%<br />

were women, <strong>and</strong> 80% were white. <strong>The</strong> CEAP clinical<br />

classification <strong>of</strong> C 0 to C 6 was 29%, 29%, 23%, 10%, 9%,<br />

1.5%, <strong>and</strong> 0.5%, respectively. Reflux or obstruction was<br />

noted in 37% <strong>and</strong> 5% <strong>of</strong> participants, respectively.<br />

Progression <strong>of</strong> primary varicosity to severe CVI <strong>and</strong><br />

venous ulcer is not rare: in the North American subfascial<br />

endoscopic perforator surgery (SEPS) registry, more <strong>patients</strong><br />

<strong>with</strong> advanced CVI had primary venous disease than<br />

post-thrombotic syndrome (70% vs 30%). 62 Bauer 63 had

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