Early abdominal aortic endografts: a decade follow-up results.

OBJECTIVES: To report the results of long-term follow-up of abdominal aortic aneurysms (AAAs) treated with endografts more than a decade ago. DESIGN: Retrospective analysis of estimated long-term follow-up, mortality and morbidity in terms of complications and re-interventions, using the Kaplan-Meier survival analysis. MATERIALS/METHODS: Between March 1997 and January 2000, 61 patients with AAA (53 asymptomatic, four symptomatic and three ruptured) were treated with aortic endografts. All preoperative, operative and follow-up data were recorded according to the EUROpean collaborators on Stent graft Techniques for abdominal aortic Aneurysm (EUROSTAR) criteria. RESULTS: The primary technical success rate was 98.4%. The majority of used devices were Vanguard (65.0%), and in a bifurcated configuration (86.7%). At 10-year follow-up, the estimated cumulative follow-up rate was 82.0%; complications occurred in 74.6% of the patients and re-interventions were required in 56.9%. The Vanguard endograft was related to a higher incidence of re-interventions (P=0.012). The combined in-hospital or AAA-related mortality rate was 5.0% at 30 days and 8.2% at a 10-year follow-up (1.8% and 5.0% in elective cases, respectively). CONCLUSIONS: Early abdominal endografts are associated with high incidence of complications (74.6%) and re-interventions (56.9%) at a 10-year follow-up; however, the mortality rate related to the procedure or aneurysm is low (5.0% in elective cases). Early endografts need lifelong strict surveillance.

Endovenous management of saphenous vein reflux. Endovenous Reflux Management Study Group.

PURPOSE: This study assessed clinical outcomes of two catheter-based endovenous procedures to eliminate or greatly mitigate saphenous vein reflux. MATERIALS AND METHODS: A computer-controlled, dedicated generator and two catheter designs were used to treat 210 patients at 16 private clinic and university centers in Europe. The Closure catheter applied resistive heating over long vein lengths to cause maximum wall contraction for permanent obliteration; the Restore catheter induced a short subvalvular constriction to improve the competence of mobile but nonmeeting leaflets. RESULTS: Closure treatment caused acute obliteration in 141 (93%) of 151 limbs; Restore treatment, shrinking one or more valves, acutely reduced reflux to less than 1 second in 41 (60%) of 68 limbs. Closure treatments were associated with early recanalization (6%), paresthesias (thigh, 9%; leg, 51%; P <.001), 3 skin burns, and 3 deep-vein thrombus extensions, with 1 embolism. Restore treatments were thrombogenic (16%) despite prophylactic anticoagulation, and treated valves enlarged over 6 weeks, becoming less competent. Clinical Efficacy Assessment Project clinical class was significantly improved after both treatments, up to 1 year. At 6 months, 87% of 53 Closure patients were class 0 or 1, 75% were symptom-free, and 96% of 55 treated limbs were completely free of reflux. Fourteen of 31 Restore patients (45%) had no symptoms, but 55% were class 2 or lower and only 19% had less than 1-second reflux. CONCLUSION: Closure treatment is clinically effective, albeit with offsetting complications and early failures; these are being addressed through four procedural modifications. Restore valve shrinking, although conceptually attractive, is too problematic to be competitive with Closure treatment or saphenectomy.

Combination of a clinical risk assessment score and rapid whole blood D-dimer testing in the diagnosis of deep vein thrombosis in symptomatic patients.

PURPOSE: The clinical diagnosis of deep vein thrombosis (DVT) is unreliable in more than 50% of cases, and, in recent years, plasma D-dimer assays have been used to predict the presence of DVT with high sensitivity and negative predictive values. This study investigated the use of a rapid whole blood test that could be performed and interpreted by the bedside in addition to a clinically derived risk assessment score (RAS) to determine whether a practical and cost-effective clinical model could be developed for the diagnosis and exclusion of DVT in symptomatic patients. METHODS: Two hundred consecutive patients who were referred to the vascular laboratory with clinically suspected DVT underwent the following procedures: (1) clinical assessment and stratification into low, moderate, or high risk for DVT on the basis of an RAS related to history, symptoms, and physical examination findings; (2) rapid (5-minute) whole blood D-dimer testing with a semi-qualitative agglutination technique on a fingerprick blood sample; and (3) color flow duplex ultrasound scanning with standard criteria for the diagnosis of proximal and calf DVT. RESULTS: Forty-six patients (23%) had acute DVT on duplex ultrasound scanning. Of these cases, 28 (61%) had proximal DVT and 18 (39%) were confined to the calf. A total of 88 patients were classified as low risk, 67 were classified as moderate, and 45 were classified as high risk on the basis of the RAS method. Of the patients who were classified at low risk, 4.5% (4/88) had DVT, as compared with 17.9% (12/67) in the moderate clinical risk group and 66.7% (30/45) in the high risk group. Isolated calf DVT was found in 30% (9/30), 50% (6/12), and 75% (3/4) of the high, moderate, and low risk groups, respectively. The sensitivity (8.7%, 26.1%, 65.2%), specificity (45.5%, 64.3%, 90.3%), positive predictive value (4.5%, 17.9%, 66.7%), and overall accuracy rate (37%, 55.5%, 84.5%) of the low, moderate, and high risk groups, respectively, in the diagnosis of DVT increased significantly with increasing risk score stratification. The sensitivity, specificity, positive and negative predictive value, and overall accuracy of the rapid D-dimer test for all DVT were 91.3%, 81.9%, 60%, 96.9%, and 84%, respectively, with a 100% sensitivity and negative predictive value for proximal DVT. A combination of the RAS and D-dimer identified a low risk group with a negative D-dimer as having less than a 1% likelihood of DVT and a high risk group with positive D-dimer as having a likelihood of more than 90%. CONCLUSION: A combination of clinical assessment and rapid D-dimer testing provides an effective means of excluding proximal DVT in symptomatic patients. The application of a clinical diagnostic model on the basis of these parameters has the potential for saving a large proportion of unnecessary duplex scans with the associated time and costs.