Standardized ultrasound evaluation of carotid stenosis for clinical trials: University of Washington Ultrasound Reading Center

<p>Abstract</p> <p>Introduction</p> <p>Serial monitoring of patients participating in clinical trials of carotid artery therapy requires noninvasive precision methods that are inexpensive, safe and widely available. Noninvasive ultrasonic duplex Doppler velocimetry provides a precision method that can be used for recruitment qualification, pre-treatment classification and post treatment surveillance for remodeling and restenosis. The University of Washington Ultrasound Reading Center (UWURC) provides a uniform examination protocol and interpretation of duplex Doppler velocity measurements.</p> <p>Methods</p> <p>Doppler waveforms from 6 locations along the common carotid and internal carotid artery path to the brain plus the external carotid and vertebral arteries on each side using a Doppler examination angle of 60 degrees are evaluated. The UWURC verifies all measurements against the images and waveforms for the database, which includes pre-procedure, post-procedure and annual follow-up examinations. Doppler angle alignment errors greater than 3 degrees and Doppler velocity measurement errors greater than 0.05 m/s are corrected.</p> <p>Results</p> <p>Angle adjusted Doppler velocity measurements produce higher values when higher Doppler examination angles are used. The definition of peak systolic velocity varies between examiners when spectral broadening due to turbulence is present. Examples of measurements are shown.</p> <p>Discussion</p> <p>Although ultrasonic duplex Doppler methods are widely used in carotid artery diagnosis, there is disagreement about how the examinations should be performed and how the results should be validated. In clinical trails, a centralized reading center can unify the methods. Because the goals of research examinations are different from those of clinical examinations, screening and diagnostic clinical examinations may require fewer velocity measurements.</p

Vein graft lesions: Time of onset and rate of progression

AbstractPurpose: The objectives of this study were to determine the time of onset, location, severity, rate of progression, and subsequent fate of infrainguinal vein graft lesions.Methods: Sixty-one infrainguinal vein grafts were studied serially with duplex ultrasonography to document the location and severity of each lesion. Grafts were studied at 1, 2, 3, 4, 6, 9, 12, and 18 months and then annually.Results: The cumulative secondary graft patency rate at 3 years (life-table analysis) was 93.2%. A total of 158 lesions were detected in 55 of the 61 grafts studied. The degree of diameter reduction at the time of initial detection was as follows: 1% to 19% (29.6%), 20% to 49% (51.0%), 50% to 75% (17.3%), and greater than 75% (3.1%). Forty-eight percent were detected at the first examination, 59.2% within 2 months, and 85.7% within 6 months. Progression was detected in 31.2% of the lesions by 6 and in 39.1% of the lesions by 18 months (life-table analysis). Thrombosis, in the absence of significant changes in ankle-brachial index (≥0.15) or return of symptoms, was not observed in grafts that had lesions with less than 75% diameter reduction.Conclusions: The data support the performance of a duplex scan either during surgery or before discharge from the hospital in addition to frequent surveillance for the first 6 months. Frequent surveillance is appropriate for lesions with less than 75% diameter reduction as long as they remain asymptomatic and without a significant reduction in the ankle-brachial index. (J VASC SURG 1995;22:466-75.

Venous valvular reflux in veins not involved at the time of acute deep vein thrombosis

AbstractPurpose: The aim of this study was to determine whether, in lower extremities with documented episodes of acute deep venous thrombosis (DVT), incompetence develops in veins that were not the site of thrombosis.Methods: Patients were monitored with serial duplex ultrasonography at 1 day, 1 week, 1, 3, 6, 9, and 12 months, and then annually after detection of acute DVT. The following venous segments were analyzed: common femoral, greater saphenous, proximal superficial femoral, deep femoral, popliteal, and posterior tibial. The incidence of reflux development in both thrombosed and uninvolved segments was determined. Reflux was categorized as either transient or permanent.Results: A total of 227 limbs in 188 patients were serially studied. Mean follow-up was 19.9 months (range 1 to 88 months). Overall, 403 of the 1423 segments (28.3% ± 2.3%) developed reflux during the study, of which 118 (29.3% ± 4.4%) had no prior or concurrent history of thrombosis. Considering only the segments that developed incompetence, the percent without prior thrombosis at each level was as follows: common femoral vein (40.0%), greater saphenous vein (53.1%), deep femoral vein (20.6%), proximal superficial femoral vein (23.9%), popliteal vein (8.9%), and posterior tibial vein (31.9%). Valvular insufficiency developing in segments uninvolved with thrombus was more likely to be transient (40.2%) than was the reflux in thrombosed segments (22.6%). This difference was statistically significant (p < 0.05).Conclusions: Permanent venous valvular damage can occur in the absence of thrombosis after DVT. Reflux in uninvolved venous segments has a different anatomic distribution and is more likely to be transient than the incompetence associated with thrombosis.(J VASC SURG 1995;22:524-31.

Early outcome after isolated calf vein thrombosis

AbstractPurpose: The clinical significance of isolated calf vein thrombosis (CVT), particularly with respect to development of the postthrombotic syndrome, remains controversial. The purpose of this study was to define the early natural history of CVT in relation to persistent lower extremity symptoms, propagation, recanalization, and the development of valvular incompetence.Methods: Over a 116-month period, 499 patients with acute deep venous thrombosis (DVT) were referred to our research laboratory, of whom 58 (12%) had thrombosis confined to the calf veins of at least one extremity. The lower extremities of 268 patients (29 with isolated CVT) were followed-up clinically and with duplex ultrasonography at intervals of 1 day, 7 days, 1 month, every 3 months for the first year, and yearly thereafter.Results: Seventy percent of extremities with CVT were symptomatic at presentation. Although the prevalence of clinical signs and symptoms decreased to 29% by 1 month, 23% of patients had persistent pain, edema, or both at 12 months. In contrast, 9% of uninvolved extremities contralateral to a CVT and 54% of extremities with proximal DVT remained symptomatic at 1 year (p = 0.004). Recanalization proceeded rapidly such that the mean thrombus load was reduced by 50% at 1 month and to zero at 1 year. The prevalence of valvular incompetence progressively increased such that reflux was present in 24% of extremities at 1 year. Although its investigation was not a primary goal of this study, pulmonary embolism was diagnosed at presentation and during follow-up in 11% and 3% of patients, respectively.Conclusions: The natural history of CVT is complicated by persistent symptoms and the development of valvular incompetence in approximately one-quarter of patients. This potential for persistent lower extremity symptoms should be considered in evaluating the clinical relevance of isolated calf vein DVT. (J Vasc Surg 1997 26:749-56.