Jeffrey K. Raines

Radiofrequency Endovenous ClosureFAST versus Laser Ablation for the Treatment of Great Saphenous Reflux: A Multicenter, Single-blinded, Randomized Study (RECOVERY Study)

PURPOSE The present study was designed to address the hypothesis that radiofrequency (RF) thermal ablation, as represented by the ClosureFAST system, is associated with improved recovery and quality-of-life (QOL) parameters compared with 980-nm endovenous laser (EVL) thermal ablation of the great saphenous vein (GSV). MATERIALS AND METHODS Eighty-seven veins in 69 patients were randomized to ClosureFAST or 980-nm EVL treatment of the GSV. The study was prospective, randomized, single-blinded, and carried out at five American sites and one European site. Primary endpoints (postoperative pain, ecchymosis, tenderness, and adverse procedural sequelae) and secondary endpoints (venous clinical severity scores and QOL issues) were measured at 48 hours, 1 week, 2 weeks, and 1 month after treatment. RESULTS All scores referable to pain, ecchymosis, and tenderness were statistically lower in the ClosureFAST group at 48 hours, 1 week, and 2 weeks. Minor complications were more prevalent in the EVL group (P = .0210); there were no major complications. Venous clinical severity scores and QOL measures were statistically lower in the ClosureFAST group at 48 hours, 1 week, and 2 weeks. CONCLUSIONS RF thermal ablation was significantly superior to EVL as measured by a comprehensive array of postprocedural recovery and QOL parameters in a randomized prospective comparison between these two thermal ablation modalities for closure of the GSV.

Multicenter validation study of real-time (B-mode) ultrasound, arteriography, and pathologic examination.

The ability of high-resolution ultrasound, angiography, and pathologic examination of endarterectomy specimens to identify and quantitate atherosclerosis was compared in a five-center study. The carotid bifurcation in 900 patients was evaluated by angiography and ultrasound. In 216 cases, high-quality endarterectomy specimens were available for comparison with the preoperative images. All comparisons were made in a blinded fashion. Results indicate that ultrasound is able to differentiate angiographically normal from abnormal arteries with a sensitivity of 88% (1077 of 1233 arteries) and accuracy of 79% (1251 of 1578 arteries). Angiographic stenoses equal to or greater than 50% diameter were accurately identified by ultrasound imaging in 72% (1133 of 1578 arteries) of cases, and this was improved by the addition of other functional data (i.e., Doppler spectral analysis and oculoplethysmography). There was only modest correlation of absolute measurements of lesion width, minimal lumen, and standard lumen by the two imaging techniques (r = 0.28 to 0.55). Ultrasound measurements of lesion width were on the average 2 mm greater than those of angiography. The lumen averaged 1.5 mm larger when measured by ultrasound techniques. In the subset in which data were available from endarterectomy specimens, ultrasound showed the best correlation with lesion width (mean difference -1.1 mm) and angiography correlated best with minimal lumen (mean difference -0.1 mm). Neither examination consistently identified ulcerated plaques. Although ultrasound imaging alone has limited usefulness in quantitating luminal stenosis, this can be improved by the use of Doppler spectral analysis and oculoplethysmography. Ultrasound is superior to angiography for quantifying atherosclerotic plaque (lesion width) and will be an important tool for further study of atherosclerotic lesions.

Saphenous Laser Ablation at 1470 nm Targets the Vein Wall, Not Blood

The 2 primary objectives of this study were to investigate whether the 1470-nm wavelength can close a saphenous vein painlessly and determine safety, efficacy, and side effects of the 1470-nm laser. In all, 26 limbs were treated in the Dominican Republic, with a radially-emitting fiber at low energy ranging from 20 J/cm to 30 J/cm. Perivenous anesthesia was used selectively. Then 41 veins were treated with the 1470-nm laser at 30 J/cm at 5 watts, using standard perivenous tumescent anesthesia in Miami and compared to a historical control (980 nm, 80 J/cm, and 12 watts). We demonstrated that the 1470-nm wavelength endovenous laser system could not close saphenous veins without use of anesthesia. Closure with a dramatic reduction in energy when compared to a 980-nm wavelength control demonstrated a marked reduction in postoperative pain and ecchymosis; this implies that vein-wall perforations are minimized with this system.

Relationship of peripheral arterial compliance and standard cardiovascular risk factors.

Abnormalities of peripheral arterial compliance are clinically useful markers of atherosclerosis and risk of vascular events. Local peripheral arterial compliance can be easily and accurately assessed in the clinic by computer-controlled pulse volume recordings (air plethysmography). The purpose of this study was to investigate the relationship between clinical cardiovascular risk factors, a surrogate of atherosclerotic burden, and peripheral arterial compliance in the thigh and calf determined by quantification of local pulse volume recordings in patients undergoing coronary angiography. Peripheral arterial compliance in the thigh and calf was measured in 346 patients undergoing diagnostic cardiac catheterization at 4 centers. Demographic and cardiovascular risk factor data were collected, and their relationship to local arterial compliance examined using a new device that assesses maximal local arterial volume change in an extremity segment. Pulse volume recordings detected decreased local arterial compliance in the thigh associated with a history of hypertension (p< 0.0001), diabetes mellitus (p = 0.0001), and hyperlipidemia (p = 0.0007). In the calf, this arterial compliance measure was associated with a history of hypertension (p < 0.0001) and diabetes mellitus (p = 0.002). Females had lower arterial compliance than males in the thigh (p = 0.003) and calf (p <0.0001). Limited evidence of lower arterial compliance in the thigh was found for those with obesity (p = 0.07). This procedure also demonstrated that subjects with multiple cardiovascular risk factors had lower arterial compliance in the thigh than subjects with no or 1 risk factor (p = 0.0001). Peripheral arterial compliance determined by air plethysmography is strongly associated with standard cardiovascular risk factors. The noninvasive measurement of local arterial compliance by regional pulse volume recording may be a useful adjunct for cardiovascular risk stratification early in the course of the disease as well as for monitoring vascular response to therapy.

ClariVein Mechanochemical Ablation: Background and Procedural Details

Objectives: The 2 primary objectives of this publication are to provide a practical step-by-step procedure for the ClariVein system and a focused literature review of endovenous ablation. Materials and Methods: The ClariVein system is the first venous ablation technique to employ a hybrid (dual-injury) technique built into 1 catheter-based delivery system. Endomechanical abrasion is produced by the tip of the catheter’s rotating wire (mechanical component); and endovenous chemical ablation (EVCA) is via simultaneous injection of sclerosant over the rotating wire (chemical component). The author is an early adopter of this technique and via experience has developed a detailed step-by-step protocol. Discussion: To date, there have been 2 pivotal clinical studies published using the ClariVein system. These data are compared with the results using other methods of endovenous ablation. Conclusions: The ClariVein system is an exciting addition to the phlebologist’s toolbox and has the potential to become a first-line treatment.

Ambulatory Phlebectomy in the Office

Ambulatory phlebectomy is a minor, office-based surgical procedure designed to remove varicose veins. It is a perfect complement to endovenous thermal ablation of the saphenous vein. With this combination, patients can expect all varicose veins to vanish following a 1-hour procedure that employs only local anesthesia in the comfort of a physicians office. Advantages of office-based surgery are ease of scheduling for doctors and patients, less paperwork, elimination of travel time, and cost containment for the health care system. Furthermore, a procedure that is performed by the same staff daily is more streamlined and safe.

Ankle/Brachial Index in the Primary Care Setting

Peripheral arterial disease (PAD) is an underdiagnosed circulatory problem in the primary care setting. Individuals are at increased risk for cardiovascular disease; therefore, there is the need for a technique capable of early identification and detection of patients with PAD. The focus of this study was to compare the accuracy of a new operator-independent method of measuring ankle brachial index (ABI) with the traditional Doppler ultrasound method of determining ABI. In 246 limbs the authors compared ankle systolic pressures and ABI measured by a new automated oscillatory method called the ABIgram with those measured by standard Doppler ultrasound. In phase 1, the 2 methods for measuring ankle systolic pressure had a mean difference of 2 mm Hg with a standard deviation of 6.7 mm Hg. In phase 2 the mean difference was 3.1 mm Hg with a standard deviation of 5.1 mm Hg. Further, ABI as measured by the 2 methods fell within 1% and demonstrated a 5% error in reproducibility. These numbers pass the SP-10 standard for medical devices established by the FDA. The ABIgram module of the Vasocor ®Vascular Diagnostic Center offers primary care physicians the ability to rapidly obtain ABI measurements comparable to the standard technique. Further, the ABIgram may be operated by staff commonly found in the primary care setting.

Correlation of peripheral arterial compliance and Framingham coronary heart disease risk evaluation

An office-based air plethysmograph, with internal calibration (VasogramTM), was used to measure arterial compliance (AV/AP) at the thigh and calf in a 4 center clinical study, with 342 subjects (males aged 31 to 69 and females aged 41 lo 79). The subjects were stratified into 4 groups according to Framingham Cardiovascular Risk with 38-47 subjects in each gender/risk group. Group 1. Risk 20% or coronary equivalence but no documented coronary artery disease (CAD). Group 4. documented CAD. Arterial compliance was measured at the thigh and calf levels on each subject, on three different occasions, over a four-week period. Compliance was reported as the maximum volume change (ml) under the cuff occurring during a single cardiac cycle, normahzed lo a pulse pressure of 50 mmHg (MaxV50) with mean levels summarized in the table below: POSTER SESSION 1104 Platelets, Endothelium, and Thrombosis I

Reduced arterial compliance in patients with psychiatric diagnoses

BACKGROUND Peripheral arterial compliance is a measure of elasticity of the arteries that has been found to be a robust predictor of prevalent arteriosclerosis as well as incident stroke and myocardial infarction. Psychiatric diagnoses and second generation antipsychotics may contribute to cardiovascular risk and stroke, but effects on peripheral arterial compliance are unknown. This study compared peripheral arterial compliance in healthy male controls to male patients with psychiatric diagnoses who were treated with quetiapine or risperidone or off antipsychotics at time of testing. METHODS The groups consisted of 63 patients with mental illness taking quetiapine, risperidone, or no antipsychotics. There were 111 males in the control group. Mean thigh and calf arterial compliance among four groups were compared by ANCOVA, adjusting for body mass index and Framingham Risk Score. All patients were also compared to the control group. Compliance was measured with a computerized plethysmography device. RESULTS Patients (n=63) had significantly lower arterial compliance in both thigh and calf than the controls. Arterial compliance in the calf was significantly lower in the subgroups of quetiapine (n=16) and risperidone (n=19) treated, and in unmedicated (n=28) patients than in controls. In the thigh, patients taking either quetiapine or risperidone had significantly lower arterial compliance than controls. These subgroups did not differ from each other in arterial compliance. CONCLUSION The presence of psychiatric diagnoses is associated with reduced arterial compliance. A large study may be required to measure any specific affects of antipsychotics such as quetiapine and risperidone on compliance compared to controls.

Laser Ablation of Cutaneous Leg Veins

Patients presenting with lower-extremity telangiectasias, commonly known as spider veins, are a frequent presentation for vascular surgeons. The use of lasers in the treatment of lower-extremity spider veins has gained increased popularity during the past 5 years. This technology, driven by consumer demand, has been effective in treating vessels that are refractory to sclerotherapy treatment, vessels that arise from telangiectatic matting, and in patients who experience a phobia to needles. One laser wavelength per machine limits what the practitioner can do. That is, each type of vein responds best to a specific wavelength. Light skin is more forgiving to complications than dark skin. The devices are a complement to good sclerotherapy, not a substitute.