Steven S. Gale

A randomized, controlled trial of endovenous thermal ablation using the 810-nm wavelength laser and the ClosurePLUS radiofrequency ablation methods for superficial venous insufficiency of the great saphenous vein.

BACKGROUND Great saphenous vein (GSV) incompetence is the most common cause of superficial venous insufficiency. Radiofrequency catheter ablation (RFA) is superior to conventional ligation and stripping, and endovenous laser treatment (EVL) has emerged as an effective alternative to RFA. This randomized study evaluated RFA and EVL for superficial venous insufficiency due to GSV incompetence and compared early and 1-year results. METHODS Between June 2006 and May 2008, patients with symptomatic primary venous insufficiency due to GSV incompetence were randomized to RFA or EVL. Patients with bilateral disease were randomized for treatment of the first leg and received the alternative method on the other. Pretreatment examination included a leg assessment using the Venous Clinical Severity Score (VCSS) and CEAP classification. Patients completed the Chronic Venous Insufficiency Questionnaire 2 (CIVIQ2). RFA was performed with the ClosurePlus system (VNUS Medical Technologies, Sunnyvale, Calif). EVL was performed with the EVLT system (AngioDynamics Inc, Queensbury, NY). Early (1-week and 1-month) postoperative results of pain, bruising, erythema, and hematoma were recorded. Duplex ultrasound (DU) imaging was used at 1 week and 1 year to evaluate vein status. VCSS scores and CEAP clinical class were recorded at each postoperative visit, and quality of life (QOL) using CIVIQ2 was assessed at 1 month and 1 year. RESULTS The study enrolled 118 patients (141 limbs): 46 (39%) were randomized to RFA and 48 (40%) to EVL, and 24 (20%) had bilateral GSV incompetence. At 1 week, one patient in the RFA group had an open GSV and was deemed a failure. More bruising occurred in the EVL group (P = .01) at 1 week, but at 1 month, there was no difference in bruising between groups. At 1 year, DU imaging showed evidence of recanalization with reflux in 11 RFA and 2 EVL patients (P = .002). The mean VCSS score change from baseline to 1 week postprocedure was higher for RFA than EVL (P = .002), but there was no difference between groups at 1 month (P = .07) and 1 year (P = .9). Overall QOL mean score improved over time for all patients (P < .001). CEAP clinical class scores of >or=3 were recorded in 21 RFA (44%) and 24 EVL patients (44%) pretreatment, but at 1-year, 9 RFA (19%) and 12 EVL patients (24%) had scores of >or=3 (P < .001). This represented a significant improvement in all patients compared with baseline. CONCLUSION Both methods of endovenous ablation effectively reduce symptoms of superficial venous insufficiency. EVL is associated with greater bruising and discomfort in the perioperative period but may provide a more secure closure over the long-term than RFA.

Carotid arterial ultrasound scan imaging: A direct approach to stenosis measurement

PURPOSE Management decisions regarding carotid artery disease are critically dependent on stenosis but have been made difficult because of conflicting methods used to determine such stenosis. The increasing use of duplex ultrasound scanning has conventionally depended on Doppler velocity measurement, an indirect method for calculating carotid stenosis. Recent technical advances have improved the quality of B-mode/color-flow ultrasound scan imaging (USI). We tested prospectively whether USI was clinically effective as the primary criterion for estimating carotid stenosis. METHODS Transverse and longitudinal USI, Doppler velocity, and arteriography data were obtained sequentially and independently for 713 carotid bifurcations. The internal carotid artery (ICA) residual lumen, the local outer diameter at the stenotic site, and the diameter distal to the bulb were measured in a representative USI longitudinal section. The peak systolic velocity and the end diastolic velocity (EDV) were measured at the stenosis. Local stenosis as determined with USI was compared with the x-ray arteriographic clinical radiology interpretation (XRI). As the primary method, radiologists compared the residual lumen with the distal ICA diameter, as recommended by the North American Symptomatic Carotid Endarterectomy Trial and the Asymptomatic Carotid Atherosclerosis Study. Analysis was by means of the USI positive predictive value (PPV) and negative predictive value (NPV) of the XRI findings, with the assumption that 80%, 70%, and 60% local stenosis with USI related to 70%, 60%, and 50% stenosis with XRI, respectively. RESULTS All 56 ICA occlusions as determined with USI were confirmed with XRI. When the USI showed 80% to 99% stenosis, the PPV of the XRI showing 70% to 99% stenosis was 94% (116/123). Two ICAs that were shown to be severely diseased with USI appeared to be occluded with XRI. For <50% stenosis shown with USI, the prediction of <50% stenosis shown with XRI was 94% (253/269). For borderline stenosis in the 50% to 79% range with USI, the addition of velocity criteria to USI data improved both the PPV and the NPV. In the range of 70% to 79% stenosis with USI, the PPV improved from 82% (76/93) to 91% (53/58) for the subgroup with an EDV of more than 80 cm/s. For the range of 60% to 69% stenosis with USI, the PPV improved from 75% (71/95) to 95% (21/22) for the subgroup with an EDV of more than 80 cm/s. In the range of 50% to 59% stenosis with USI, the NPV improved from 69% (53/77) to 93% (14/15) for the subset with a peak systolic velocity of less than 100 cm/s. CONCLUSION On the basis of the USI data alone, a prediction of arteriographic findings was possible at the 95% level for occlusion and severe stenosis and for ruling out hemodynamically significant stenosis. The addition of velocity data improved prediction in borderline degrees of stenosis. USI was effective for quantifying clinically significant degrees of stenosis.

Lower extremity arterial evaluation: are segmental arterial blood pressures worthwhile?

PURPOSE Physiologic observations with blood flow waveform analysis and pressure measurements can document the severity of lower extremity arterial disease. Segmental blood pressures (SEGPs) taken at the thigh, calf, and ankle are commonly used, but their utility has seldom been studied. We quantified improvements in accuracy compared with arteriography when ankle pressures alone (ABI) or SEGP data were added to velocity waveforms obtained by Doppler ultrasound. METHODS Continuous-wave Doppler velocity waveforms were recorded at common femoral (CFA), popliteal (POP), and dorsal pedal and posterior tibial (TIB) arterial levels. Systolic SEGP data were obtained with appropriately sized upper thigh, upper calf, and ankle cuffs. Waveforms, waveforms plus ABI, and waveforms plus SEGP data from 81 patients were randomly interpreted by 14 technologists or physicians from four institutions blinded to clinical and arteriographic data. Arteriograms were assigned negative or significant, severe (>75% diameter stenosis) values for four segments: iliofemoral (CFA), superficial femoral (SFA), popliteal (POP), and infrapopliteal (TIB) arteries. A total of 9072 segmental interpretations were analyzed. RESULTS Compared with arteriography, the accuracy of waveform analysis was 83% for severe disease at and proximal to the CFA, 79% for SFA disease, 64% for POP disease, and 73% for TIB disease. Adding ABI improved the accuracy significantly (p < 0.01) to 88% (CFA), 86% (SFA), 70% (POP), and 85% (TIB). Accuracy was inferior when SEGP data replaced ABI: 86% (CFA), 85% (SFA), 70% (POP), and 80% (TIB). CONCLUSIONS ABIs significantly improved Doppler waveform accuracy at all levels. Compared with ABI, the addition of segmental pressure to waveform data failed to improve accuracy. Pressure measurements above the ankle may lack cost effectiveness and clinical utility.

DEEP VEIN OBSTRUCTION AND LEG SWELLING CAUSED BY FEMORAL GANGLION

We present a case of a rare ganglion cyst originating from the hip joint and compressing the common femoral vein producing signs and symptoms that mimicked a deep vein thrombosis. Excision of the mass promptly restored normal venous return. This condition has not been previously reported in the English-language medical literature.

Gender bias in use of venous ultrasonography for diagnosis of deep venous thrombosis

PURPOSE We observed that ultrasound examinations for deep venous thrombosis (DVT) were more frequently requested for women than for men in our vascular laboratory serving a general outpatient population and referral 774-bed hospital. Because existing literature presents conflicting information about sex differences in occurrence of DVT, we investigated correlation in our population with positive ultrasound study results and risk factors for DVT. METHODS In 13 months, 2055 ultrasound examinations for DVT were requested. Of these, 300 patients (15%) were categorized in four subgroups: 75 ultrasonography-negative men, 75 ultrasonography-negative women, 75 ultrasonography (DVT)-positive men, and 75 ultrasonography (DVT)-positive women for risk factor analysis. RESULTS Women comprised 64% (1311 of 2055) and men 36% (744 of 2055) of ultrasound examinations requested, but men had significantly higher incidence of DVT-positive ultrasonography results (101 of 744 [14%]) compared with women (118 of 1311 [9%]) (p = 0.002 by chi-square testing). There were no significant sex differences in conventional DVT risk factors and no difference in aggregate number of risk factors. The anatomic distribution of DVT was the same in men as in women. Among those having negative ultrasonography results, significantly more outpatient examinations were performed in women (p = 0.018 by t testing). CONCLUSIONS Gender bias exists in use of ultrasonography for diagnosis of DVT. The greater incidence of women undergoing venous ultrasonography is not explained by higher prevalence of DVT risk factors or of higher occurrence of positive ultrasound examination results. Further investigation is needed to determine whether these differences indicate underuse of ultrasonography in men or overuse in women.

Percutaneous venous valve bioprosthesis: Initial observations

Chronic deep venous insufficiency remains a major health problem in the United States and worldwide. Selected patients benefit from direct deep vein valve repair or valve transplantation; however, most are not candidates for these procedures. Experience with the bovine monocusp venous valve surgically inserted into the common femoral vein (CFV) demonstrates potential benefit and good long-term patency. A venous valve placed distal to the CFV via percutaneous access has great appeal and potential for further improving venous hemodynamics, as well as reducing ambulatory venous hypertension and ulceration. Two patients were treated with a percutaneous venous valve bioprosthesis as part of a Phase I trial. The primary objective was to evaluate the safety, patency, and efficacy of the percutaneous venous valve bioprosthesis to restore competency to the deep venous system. Introduction

Chronic venous insufficiency due to great saphenous vein incompetence treated with radiofrequency ablation: an effective and safe procedure in the elderly.

Chronic venous insufficiency (CVI) with the resultant clinical sequelae significantly reduces quality of life. Most elderly patients with CVI are treated nonoperatively owing to concerns of increased operative risk and therefore suffer more advanced disease. Radiofrequency ablation (RFA) has emerged as a minimally invasive procedure to treat patients with superficial venous insufficiency (SVI) due to great saphenous vein (GSV) incompetence. The purpose of this study was to review our experience using RFA of the GSV to treat CVI due to superficial disease in elderly patients compared to younger patients in terms of procedure-related morbidity and severity of disease at time of treatment. RFA treatment of the GSV was performed in 490 extremities of 421 patients with SVI between March 2001 and December 2002. Indications, medical history, and outcome (operative complications and hospital stay) were compared between 2 groups: Group I: 41 extremities of 35 patients, 70 years if age or older (mean 75 ±4); and Group II: 449 limbs of 386 patients younger than 70 years (mean 47 ±11). The incidence of skin pigmentation and healed/nonhealed ulcers (CEAP 4–6) was significantly higher in the elderly than in the younger group (41% vs 16%, p <0.05). Hypertension, diabetes, and previous myocardial infarction were 2.8, 5.4, and 6.7 times more prevalent in the elderly (p <0.05), respectively. There were no major postoperative complications in either group; 97% of all patients were discharged on the day of operation and there was no difference between the 2 groups in overnight hospital stay. There is a treatment bias against operative management in elderly patients with SVI, as evidenced by their more advanced disease at the time of definitive treatment than their younger cohort. However, operative morbidity is no different compared to the younger subset. RFA is a safe and effective procedure for older patients; therefore, the threshold for operative management of older patients should be lowered.

Fate of great saphenous vein after radio-frequency ablation: detailed ultrasound imaging.

Radio-frequency ablation (RFA) of the great saphenous vein (GSV) is an endovascular alternative to stripping. To determine long-term effectiveness, the fate of GSV treated for valvular insufficiency with RFA was evaluated in detail with ultrasound imaging (US). One hundred lower extremities were examined with high-resolution color flow US, an average of 8 months after RFA treatment of an incompetent GSV. For every cm of the RFA-treated segment, the US observation was classified as follows: absent, occluded, or recanalized. Lengths of vein segments in each class were added and percentages of absent, occluded, or recanalized segments were calculated. Five groups were identified. Group I (n=15): segment of treated GSV was absent. Group II (n=4): segment of treated GSV was visualized and occluded (these vein segments had no flow and were shrunk and “fibrotic” or thrombosed without clear evidence of significant shrinkage). Group III (n=1): segment of treated GSV was recanalized. Group IV (n= 27): segment of treated GSV was obstructed (absent or occluded). Group V (n=53): segment of treated GSV was partially recanalized, on average being 53% absent, 32% occluded, and 15% recanalized. Maximum recanalization was 50% of treated segment. RFA was successful in obliterating all of the GSV treated segment in 46% of veins (groups I, 15%, plus II, 4%, plus IV, 27%) and obliterated more than half of the treated vein segment in 53% of the cases (group V). A dynamic process of recanalization and thrombosis warrants further evaluation to determine if and how a collateral network may develop.

Operative Venous Thrombectomy

Publisher Summary Based upon the available literature, patients with iliofemoral deep vein thrombosis (DVT) routinely should be considered for a management strategy designed to remove thrombus from the iliofemoral system to reduce postthrombotic sequelae. Many patients are now treated as outpatients for acute DVT. However, when common femoral vein thrombosis with occlusion is identified by venous duplex, it is recommended that the patient be hospitalized. If the patient is not a candidate for catheter-directed thrombolysis, the recommendation for venous thrombectomy (Grade 1B) should be followed. Successful thrombus removal results in improved quality of life and fewer postthrombotic sequelae. A randomized trial of catheter-directed thrombolysis versus anticoagulation has shown better patency and preserved valve function in those treated with thrombolytic therapy. Patients who have iliofemoral DVT and contraindications to lytic therapy should be considered for venous thrombectomy if they present within 10 days of the onset of their DVT. Aggressive anticoagulation combined with leg compression is the preferred treatment for patients who have a contraindication to thrombolysis, are poor operative candidates, have a prolonged duration of venous thrombosis, or are critically ill or bedridden. Contemporary venous thrombectomy has substantially improved the early and long-term results of patients with extensive DVT compared to the initial reports.

Subfascial Endoscopic Perforator Surgery Conserves Hospital Resources

Innovations in the management of venous disorders have included subfascial endoscopic perforator surgery (SEPS). Information on resource utilization of this procedure is limited. Comparison of sequential cohorts of patients treated for leg venous hypertension by SEPS versus open perforating vein ligation (OPL) was performed to quantify the impact on hospital resource utilization and length of stay. At the Jobst Vascular Center, the last OPL was performed in June 1995 and the first SEPS was performed in January 1994. The authors compared the last 34 consecutive OPL procedures with the first 33 consecutive SEPS operations. Both groups had similar clinical indications. Variables describing utilization of hospital resources were assessed from a computer database compiled at time of treatment and compared by use of t test and chi-square statistics. Charges were selected as representation of hospital resources. SEPS length of stay, 2.3 ±1.8 (sd) days was significantly less than OPL, 4.5 ±2.7 days (p < 0.001) with concomitant reduction in physician bedside visits, 4.8 ±3.9 for SEPS versus 8.0 ±5.3 for OPL (p = 0.007). Total hospital charges in dollars, adjusted for sequential annual increments, were similar: 8,093 +3,811 for OPL versus 7,278 ±1,716 for SEPS (p=0.27). When OPL and SEPS were compared respectively, there were no significant differences in patient age, 58 ±14 versus 53 ±12 years; gender distribution, 62% women versus 42%; active ulcer status, 88% versus 85%; advanced admission testing, 41% versus 58%; use of venography, 97% versus 88%; use of general anesthesia, both 82%; or concomitant vein stripping, 65% versus 58% (p >0.1). SEPS anesthesia time was longer, 136 ±10 versus 122 ±28 minutes (p = 0.01), but not clinically significant. SEPS reduced length of hospital stay and number of physician bedside visits compared with OPL. Total hospital charges may be further reduced as experience with this procedure accumulates.