Peter Neglén

Classification and Grading of Chronic Venous Disease in the Lower Limbs-A Consensus Statement-

Classification and grading of chronic venous disease in the lower limbs : A consensus statement

Venous outflow obstruction: an underestimated contributor to chronic venous disease

OBJECTIVE To assess the importance of iliac venous outflow obstruction in limbs with and without concomitant deep or superficial reflux, we performed a retrospective analysis of data contemporaneously entered into a set time-stamped electronic medical records program. MATERIAL AND METHOD Four hundred forty-seven limbs underwent iliac vein stenting of chronic, nonmalignant obstruction when greater than 50% morphologic stenosis was found at transfemoral venography or intravascular ultrasonography. Group 1 (female-male ratio, 3.4:1; left limb-right limb, 2.7:1; nonthrombotic-thrombotic, 1.8:1) included 187 stented limbs in 176 patients with absence of deep and superficial reflux as identified at erect duplex Doppler scanning. Group 2 (female-male, 1.7:1; left-right, 1.9:1, nonthrombotic-thrombotic limb, 1:2.1) included 260 limbs in 253 patients with combination obstruction and reflux. Reflux was left untreated during the observation period. Clinical outcome (ulcer healing and recurrence rate, degree of pain per visual analog scale, swelling grade) and hemodynamic effects (ambulatory venous pressure, venous refilling time, venous filling index at 90 seconds) of iliac venous stenting were assessed. RESULT Patients with reflux and obstruction had more severe disease (clinical class 4-6, 53% in group 2 vs 24% in group 1; P <.001). Similarly, rate of active ulcer was low in limbs with obstruction only (3% vs 24%, groups 1 and 2, respectively). Mean clinical follow-up was 13 +/- 12 months (SD) in 86% of limbs. Because of the presence of reflux in group 2, venous pressure was higher, venous filling time was shorter, and venous filling index at 90 seconds increased, compared with group 1. Multisegment scores were 2.6 +/- 1.6 and 0, respectively. Of greater interest, there was no deterioration in venous hemodynamics in group 2 after stenting. There was substantial clinical improvement in both groups after stenting. Approximately half of patients were completely relieved of pain after stenting, and a third were completely relieved of swelling. In addition, 55% of ulcerated limbs healed. CONCLUSION Iliac venous outflow obstruction appears to have an important role in clinical expression of chronic venous insufficiency, particularly in producing pain, and is easily overlooked, mainly because of diagnostic difficulty. The combination of reflux and obstruction is seen more frequently with severe clinical disease than is obstruction alone. Ulcer prevalence is clearly associated with reflux, with a low incidence in patients with obstruction alone. Removal of iliac vein outflow obstruction does not result in increased axial reflux, with clinical deterioration in limbs with combined reflux and obstruction.

A comparison between descending phlebography and duplex Doppler investigation in the evaluation of reflux in chronic venous insufficiency: A challenge to phlebography as the “gold standard”

To evaluate venous reflux in 56 lower limbs of 32 consecutive patients, hemodynamic tests, ascending and descending phlebography, and supine and erect quantitative duplex scanning were performed and the clinical severity was classified (class 0 = 15, class 1 = 19, class 2 = 8, and class 3 = 14). Of the 56 lower limbs, 22 (40%) had severe swelling and hyperpigmentation with or without ulcer (classes 2 and 3). Adequacy of the clinical severity classification was supported by the hemodynamic results. Radiologic and ultrasound findings were described by axial grading, multilevel/multisystem point, and multisegment scoring systems. Applying these evaluation systems, the phlebographic and scan results correlated poorly. There was no relationship between the radiologically obtained average reflux grade or points and the clinical severity. An erect quantitative duplex Doppler test assessed by the multisegment scoring system correlated best with the severity classification. The predictive value of this test to diagnose severe reflux leading to severe symptoms (classes 2 and 3) was 77% compared with 35% to 44% for descending phlebography. The study suggests that erect quantitative segmental duplex Doppler reflects the degree and distribution of venous reflux more accurately than does descending venography.

Balloon Dilation and Stenting of Chronic Iliac Vein Obstruction: Technical Aspects and Early Clinical Outcome

Purpose: To describe the technical aspects of percutaneous balloon dilation and stenting for the treatment of venous outflow obstruction in chronic venous insufficiency. Methods: Between March 1997 and December 1998, 94 consecutive patients (median age 48 years, range 14 to 80) with suspected iliac vein obstruction in 102 limbs were studied prospectively with the intent to treat any venous occlusion or stenosis verified during femoral vein cannulation. Data from the history, clinical examination, procedure, and follow-up were recorded. Preoperative indicators of obstruction were venographic evidence of occlusion, stenosis, or pelvic collateral vessels; increased arm-foot venous pressure differential; and abnormal hyperemia-induced venous pressure elevation. Results: Cannulation and technical success rates were 98% and 97%, respectively, with 118 Wallstents deployed in 77 veins. Primary, assisted primary, and secondary patency rates at 1 year were 82%, 91%, and 92%, respectively. Clinical improvement in pain and swelling was significant. Conclusions: Stenting of benign iliac vein obstruction is a safe method with good short-term results. Venous lesions should always be stented; when treating iliocaval junction lesions, stents should be inserted well into the inferior vena cava. Absence of collateral vessels does not exclude the existence of significant obstruction, and their presence may indicate an obstruction not visualized. No gold standard for accurate pre- or intraoperative patient selection is currently available.

Venous stenting across the inguinal ligament

BACKGROUND Arterial stenting across joints is not recommended because of increased risk of in-stent focal neointimal hyperplasia and compression or fracture of the stent by joint motion with decreased long-term patency. The aim of this study was to assess the risk of placing stents in the venous system across the inguinal ligament. MATERIALS AND METHODS From 1997 to 2006, 177 limbs with chronic non-malignant obstructive lesions had stents placed in the iliofemoral venous outflow across the inguinal ligament into the common femoral vein. Transfemoral venograms and duplex ultrasound scans to assess cumulative patency rates, cumulative rates, site of in-stent restenosis (ISR), and structural integrity of the stents were performed during follow-up. The results were compared to the findings in 316 limbs with stents terminating cephalad to the inguinal ligament. RESULTS Overall cumulative secondary patency (CSP) rate at 54 months was greater in the limbs with cephalad than in those caudad stent termination in relation to the inguinal ligament (95% and 86%, respectively; P = .0001). Although CSP of limbs with non-thrombotic obstruction was 100% regardless of the site of stent termination, that of the limbs stented for thrombotic obstruction was greater for stents terminating cephalad than for those caudad to the ligament (90% and 84%, respectively; P = .0378). However, a comparison of CSP rates between limbs treated for thrombotic occlusion and those with thrombotic non-occlusive obstruction at 32 months revealed no difference whether or not the stent was placed across the inguinal ligament (occlusion 77% and 77%, P = .7540, non-occlusive obstruction 96% and 95%, P = .7437). Severe ISR (> or =50%) were rare, 5%. The cumulative rate was, however, not significantly different in limbs stented cephalad and caudad to the inguinal ligament (7% and 11%, respectively, P = .6393). Focal in-stent recurrent stenosis at the site of the inguinal ligament occurred in only 7% of limbs (all <50%). None of the braided stainless steel stents were compressed or fractured. CONCLUSION Contrary to arterial stenting, braided stainless stents can be safely placed in the venous system across the inguinal crease with no risk of stent fractures, narrowing due to external compression, focal development of severe in-stent restenosis, and no effect on long-term patency. The patency rate is not related to the length of stented area or the placement of the stent across the inguinal ligament, but is dependent upon the etiology and whether the treated postthrombotic obstruction is occlusive or non-occlusive.

A rational approach to detection of significant reflux with duplex Doppler scanning and air plethysmography

PURPOSE Several techniques are currently available for the detection of venous reflux. We have attempted to determine the relative value and accuracy of available techniques to develop a logical strategy of investigation in reflux venous insufficiency. METHODS The morphologic distribution of venous incompetence (erect duplex and descending venography); the results of ambulatory venous pressure measurement, venous refilling time, the Valsalva test, and air-plethysmography (venous refilling index, VFI); and the clinical severity were described in 118 consecutive limbs. In an attempt to validate the tests, results were correlated with the clinical severity classification (class 0, n = 34; class 1, n = 42; class 2, n = 11; class 3, n = 31) and with a standardized quantification of reflux (multisegment score) as seen on standing duplex Doppler scanning with rapid deflation cuffs. RESULTS Twenty-nine percent of limbs with severe venous disease (class 2/3) had pure deep insufficiency, only 6% had pure superficial disease, and the remainder had a combination. A history of previous thrombosis and the presence of posterior tibial vein incompetence were markedly common with ulcer disease (84% and 42%, respectively). The duplex Doppler multisegment score correlated strongly with clinical severity classification (r = 0.97). The venous refilling time and VFI had the highest sensitivity in identifying severe venous disease (class 2/3), and the ambulatory venous pressure had excellent specificity. CONCLUSIONS For noninvasive determination of reflux, the combination of VFI and duplex scanning not only localized reflux but also separated severe clinical vein disease from mild, with high sensitivity and specificity. Air plethysmography may also provide valuable information regarding calf muscle pump and outflow obstruction.

Percutaneous recanalization of total occlusions of the iliac vein

BACKGROUND Venovenous bypass has been the standard in relieving chronic total occlusions of iliac veins. The technical feasibility of percutaneous recanalization was previously reported. Routine applicability of this technique in a wide spectrum of lesions and patients, stent patency, and clinical outcome forms the basis of this presentation. METHODS During a 9-year period, 167 limbs in 159 unselected patients in a consecutive series with post-thrombotic chronic total occlusions of the iliac and adjacent vein segments underwent percutaneous attempts at recanalization. Patients were not selected based on venographic appearance or extent of the lesion, or excluded because of a preemptive choice of open venovenous bypass surgery. RESULTS Percutaneous recanalization was successful in 139 of 167 limbs (83%), including patients with bilateral occlusions and 14 patients with inferior vena cava filters incorporated in the treated occlusion. Median age was 53 years (range, 18-84 years). Thrombophilia was identified in 44 patients. Venous dermatitis/ulcer was found in 46% of the treated limbs. Recanalization involved three or more totally occluded vein segments in 42% of the limbs. The cumulative secondary stent patency rate at 4 years was 66%. The cumulative marked relief of pain and swelling at 3 years was 79% and 66%, respectively. Cumulative healing of venous ulcer at 33 months was 56%. Quality of life metrics improved significantly. CONCLUSIONS Most femoroiliocaval chronic total occlusions lesions can be successfully recanalized percutaneously with very little morbidity, minimal downtime, sustained long-term stent patency, and substantial clinical improvement. The procedure has wide applicability in a broad spectrum of symptomatic patients, including those with extensive lesions, and can be considered for routine use.

Secondary chronic venous disorders

Secondary chronic venous disorders (CVD) usually follow an episode of acute deep venous thrombosis (DVT). Most occluded venous segments recanalize over the first 6 to 12 months after an episode of acute DVT, leading to chronic luminal changes and a combination of partial obstruction and reflux. Such morphological changes produce venous hypertension with the highest levels of ambulatory venous pressure occurring in patients with combined outflow obstruction and distal reflux. The clinical manifestations of secondary CVD, including pain, venous claudication, edema, skin changes, and ulceration are commonly referred to as the post-thrombotic syndrome. Such sequelae are best avoided by early and aggressive treatment of proximal DVT. The diagnostic evaluation of secondary CVD is similar to primary CVD and is based upon duplex ultrasound. However, the definition of hemodynamically significant venous stenosis remains obscure and there are no reliable tests to confirm the presence of such lesions. Diagnosis depends more on anatomic rather than hemodynamic criteria, and IVUS is superior to venography in estimating the morphological degree and extent of iliac vein stenosis. The fundamental role of compression in the treatment of CVD is well recognized. Compliance with compression is essential to heal ulcers and minimize recurrence. The efficacy of various adjuncts to ulcer treatment, including complex wound dressings and medications have been variable. Although superficial venous surgery has not been demonstrated to improve ulcer healing rates, it does decrease ulcer recurrence. Deep venous valve reconstruction is performed in only a few specialized centers, and the results are better for primary than for secondary CVD. Treatment of incompetent perforating veins remains controversial. Although artificial venous valves are promising, most early experimental models have failed. With respect to venous obstruction, iliocaval angioplasty and stenting has emerged as the primary treatment for proximal iliofemoral venous obstruction with surgical bypass assuming a secondary role.

Chronic Venous Insufficiency and Varicose Veins

A 52-year-old receptionist presents with an ulcer on her ankle that has persisted for a year. The use of narcotic analgesics once or twice a day and elevation of the leg reduce the pain. She does not have a history of diabetes and does not smoke. Physical examination reveals an ulcer, approximately 5 cm in diameter, above the medial malleolus. The ulcer has a clean bed of granulation and is surrounded by hyperpigmented skin. Pedal pulses are easily palpable. How should she be evaluated and treated?

In-stent recurrent stenosis in stents placed in the lower extremity venous outflow tract

PURPOSE This study was undertaken to describe development of in-stent recurrent stenosis (ISR) in stents placed in the iliocaval outflow tract and to examine possible contributing factors. METHOD After iliocaval balloon angioplasty and stent insertion to treat chronic nonmalignant obstruction, single-plane transfemoral venography was performed at least once in 324 limbs, twice in 123 limbs, three times in 40 limbs, and four times in 4 limbs. ISR was measured with a caliper, and expressed as percentage diameter reduction of patent lumen on the venograms. Left-right limb ratio was 2.3:1; thrombotic-nonthrombotic disease ratio, 1.2:1; negative-positive thrombophilia test ratio, 1.6:1; and above-below inguinal ligament stent placement ratio, 4.5:1. Median stent length was 9 cm (range, 4-35 cm), and median lumen area before and after stenting was 0.41 cm(2) (range, 0-1.65 cm(2)) and 1.70 cm(2) (range, 0.65-4.00 cm(2)), respectively. Limbs were divided into groups with no ISR, any degree of ISR, greater than 20% diameter reduction, and greater than 50% diameter reduction. Cumulative ISR and patency rates were analyzed. Possible contributing factors were examined. RESULTS At 42 months, only 23% of limbs demonstrated no ISR. Cumulative rate of limbs with greater than 20% diameter reduction was 61%, and of limbs with greater than 50% diameter reduction was 15%. Patient gender or sidedness of the treated extremity did not affect outcome. At 36 months, limbs with thrombotic disease had higher ISR rates than did limbs without thrombotic disease (63% and 41% of limbs with >20% narrowing, and 23% and 4% of limbs with >50% narrowing, respectively; P <.01). Similarly, higher rates of ISR were found in patients with thrombophilia and long stents extending below the inguinal ligament. Primary, assisted primary, and secondary patency rates for the entire population at 3 years were 75%, 92%, and 93%, respectively. There was a significant increase in ISR in individual limbs, but analysis of groups of stents did not unequivocally show progression. CONCLUSION Severe (>50%) ISR of iliofemoral venous stents is uncommon over the short term. The three major risk factors appear to be presence of thrombotic disease, positive thrombophilia test results, and stent extending below the inguinal ligament (long stents). Although stented limbs that eventually became occluded during the study demonstrated similar risk factors, no conclusion regarding a cause-effect relationship can be drawn from the present data. Whether late occlusion is due to acute thrombosis or to gradual development of true intimal hyperplasia requires further study.