Prospective Evaluation of the TIGRIS Vascular Stent Within a Modern Treatment Algorithm.

Purpose: To prospectively evaluate the safety and efficacy of the TIGRIS Vascular Stent in the superficial femoral artery (SFA) and proximal popliteal artery within a treatment algorithm that reserved stent usage for more challenging patients. Materials and Methods: This prospective, single-center study enrolled 97 patients (mean age 68.7 years; 66 men) who were treated for 100 de novo or nonstented restenotic femoropopliteal lesions (≥70% stenosis) and had recoil or dissection after plain balloon predilation. The average lesion length was 5.6±2.3 cm (maximum 8 cm per protocol). The composite primary efficacy outcome was 12-month primary patency, defined as a peak systolic velocity ratio ≤2.5 at the stented target lesion on duplex ultrasound, and no clinically-driven reintervention within the stented segment. The primary safety outcome was freedom from device- and procedure-related target vessel revascularization, target limb major amputation (above the metatarsals), or death through 30 days. Secondary outcomes included secondary patency, clinically-driven target lesion revascularization (TLR), Rutherford category change relative to baseline, and binary restenosis of the target lesion. Results: All devices were successfully implanted with no device-related complications at the time of implant or within the 30-day postimplant window. The average stented length was 7.0±2.5 cm; no stent elongation was observed during deployment. One patient was lost to follow-up before 12 months and another died of an unrelated cause, leaving 95 patients (98 lesions) available for 12-month follow-up and 77 patients/lesions for the 24-month preliminary analysis. The binary primary and secondary patency rates at 12 months were 92.9% and 100%. The binary freedom from TLR was 94.9%. At 24 months, the Kaplan-Meier estimate of primary patency was 90.0%. Conclusion: This prospective study demonstrated that the TIGRIS Vascular Stent is a safe and effective device in a modern treatment algorithm that reserved bare stent use for postangioplasty dissection or recoil in distal femoropopliteal arteries.

Safety and efficacy of direct acting oral anticoagulants and vitamin K antagonists in nonvalvular atrial fibrillation - a network meta-analysis of real-world data.

BACKGROUND: In randomized controlled trials (RCTs) direct acting oral anticoagulants (DOACs) showed a superior risk-benefit profile in comparison to vitamin K antagonists (VKAs) for patients with nonvalvular atrial fibrillation. Patients enrolled in such studies do not necessarily reflect the whole target population treated in real-world practice. MATERIALS AND METHODS: By a systematic literature search, 88 studies including 3,351,628 patients providing over 2.9 million patient-years of follow-up were identified. Hazard ratios and event-rates for the main efficacy and safety outcomes were extracted and the results for DOACs and VKAs combined by network meta-analysis. In addition, meta-regression was performed to identify factors responsible for heterogeneity across studies. RESULTS: For stroke and systemic embolism as well as for major bleeding and intracranial bleeding real-world studies gave virtually the same result as RCTs with higher efficacy and lower major bleeding risk (for dabigatran and apixaban) and lower risk of intracranial bleeding (all DOACs) compared to VKAs. Results for gastrointestinal bleeding were consistently better for DOACs and hazard ratios of myocardial infarction were significantly lower in real-world for dabigatran and apixaban compared to RCTs. By a ranking analysis we found that apixaban is the safest anticoagulant drug, while rivaroxaban closely followed by dabigatran are the most efficacious. Risk of bias and heterogeneity was assessed and had little impact on the overall results. Analysis of effect modification could guide the clinical decision as no single DOAC was superior/inferior to the others under all conditions. CONCLUSIONS: DOACs were at least as efficacious as VKAs. In terms of safety endpoints, DOACs performed better under real-world conditions than in RCTs. The current real-world data showed that differences in efficacy and safety, despite generally low event rates, exist between DOACs. Knowledge about these differences in performance can contribute to a more personalized medicine.

A randomized cross-over trial in patients suspected of PAD on diagnostic accuracy of ankle-brachial index by Doppler-based versus four-point oscillometry based measurements.

Background: For diagnosis of peripheral arterial occlusive disease (PAD), a Doppler-based ankle-brachial-index (dABI) is recommended as the first non-invasive measurement. Due to limitations of dABI, oscillometry might be used as an alternative. The aim of our study was to investigate whether a semi-automatic, four-point oscillometric device provides comparable diagnostic accuracy. Furthermore, time requirements and patient preferences were evaluated. Patients and methods: 286 patients were recruited for the study; 140 without and 146 with PAD. The Doppler-based (dABI) and oscillometric (oABI and pulse wave index - PWI) measurements were performed on the same day in a randomized cross-over design. Specificity and sensitivity against verified PAD diagnosis were computed and compared by McNemar tests. ROC analyses were performed and areas under the curve were compared by non-parametric methods. Results: oABI had significantly lower sensitivity (65.8%, 95% CI: 59.2%-71.9%) compared to dABI (87.3%, CI: 81.9-91.3%) but significantly higher specificity (79.7%, 74.7-83.9% vs. 67.0%, 61.3-72.2%). PWI had a comparable sensitivity to dABI. The combination of oABI and PWI had the highest sensitivity (88.8%, 85.7-91.4%). ROC analysis revealed that PWI had the largest area under the curve, but no significant differences between oABI and dABI were observed. Time requirement for oABI was significantly shorter by about 5 min and significantly more patients would prefer oABI for future testing. Conclusions: Semi-automatic oABI measurements using the AngER-device provide comparable diagnostic results to the conventional Doppler method while PWI performed best. The time saved by oscillometry could be important, especially in high volume centers and epidemiologic studies.

New oral anticoagulants in the treatment of acute venous thromboembolism - a systematic review with indirect comparisons.

BACKGROUND: For decades, heparins and vitamin K antagonists (VKAs) have been the gold standards in therapy of venous thromboembolism (VTE). The advent of factor IIa and Xa inhibitors provides new therapeutic options. The aim of this analysis is to compare the currently available new oral anticoagulants (NOACs) with VKAs and also indirectly the NOACs with each other, as it is unlikely that a head-to-head comparison will ever be available. PATIENTS AND METHODS: In total, 27,024 patients were included in the RE-COVER, RE-COVER II, EINSTEIN DVT and PE, AMPLIFY and HOKUSAI studies with 13,511 in the VKA arm and 13,513 in the NOAC arm. Efficacy and safety endpoints were assessed by relative risks (RR) and absolute risk reductions (ARR) relative to VKA. The indirect comparison between the NOACs was performed according to ISPOR guidelines. RESULTS: No differences between NOACs and VKA were found regarding recurrent VTE and death. Bleeding was significantly reduced by NOACs: major bleeding by rivaroxaban (RR 0.55; 0.38 - 0.81) and apixaban (RR 0.31; 0.17 - 0.55); major and clinically relevant non-major bleeding by dabigatran (RR 0.63; 0.51 - 0.77), apixaban (RR 0.44; 0.36 - 0.55) and edoxaban (RR 0.81; 0.71 - 0.93). The ARR for major bleeding was 1 % for rivaroxaban and apixaban; and for the composite bleeding endpoint 3.2 % for dabigatran, 5.4 % for apixaban, and 1.9 % for edoxaban. Regarding efficacy, no differences were found between NOACs. Apixaban reduced incidence of major bleeding more than dabigatran and edoxaban. Regarding occurrence of the composite bleeding endpoint, apixaban performed better than all other NOACs and dabigatran better than rivaroxaban and edoxaban. CONCLUSIONS: NOACs are as efficient in the treatment of VTE as VKA but with reduced risk of bleeding complications. Indirect comparisons indicate differences in the risk of clinically relevant bleeding events. Important issues such as monitoring and reversal of anticoagulation are still unresolved, but introduction of NOACs increased the therapeutic spectrum and thereby the potential for individualized therapy.

Carotid interventions and blood pressure.

Arterial baroreceptors are pressure sensors found in the carotid sinus near the bifurcation of the carotid artery and in the aortic arch. Carotid interventions, whether endovascular or surgical, affect this complicated control system and the post-interventional blood pressure behavior. Comparisons between the intervention techniques, however, are challenging due to the varying measurement methods, duration of observation, and patient populations. The question as to which interventional method is preferable, if undisturbed regulation of blood pressure is concerned, still remains unanswered. The fact that blood pressure events (i.e., hemodynamic instability, hypertension, unstable blood pressure) frequently occur both immediately after intervention and in the long term, mandates a particularly careful cardiopulmonary and blood pressure monitoring. Direct and indirect measurements of baroreceptor sensitivity can be helpful in identifying high-risk patients, although the association to hard clinical endpoints is rarely documented for methodological reasons.

Qualitative and quantitative assessment of nailfold capillaries by capillaroscopy in healthy volunteers.

BACKGROUND: Nailfold capillaroscopy (NVC) is a diagnostic tool particularly useful in the differential diagnosis of rheumatic and connective tissue diseases. Although successfully applied since many years, little is known about prevalence and distribution of NVC changes in healthy individuals. PROBANDS AND METHODS: NVC was performed in 120 individuals (57 men and 63 women; age 18 to 70 years) randomly selected according to predefined age and sex strata. Diseases associated with NVC changes were excluded. The nailfolds of eight fingers were assessed according to standardized procedures. A scoring system was developed based on the distribution of the number of morphologically deviating capillaries, microhaemorrhages, and capillary density. RESULTS: Only 18 individuals (15 %) had no deviation in morphology, haemorrhages, or capillary density on any finger. Overall 67 % had morphological changes, 48 % had microhaemorrhages, and 40 % of volunteers below 40 years of age and 18 % above age 40 had less than 8 capillaries/mm. Among morphological changes tortous (43 %), ramified (47 %), and bushy capillaries (27 %) were the most frequently altered capillary types. A semiquantitative scoring system was developed in such a way that a score above 1 indicates an extreme position (above the 90th percentile) in the distribution of scores among healthy individuals. CONCLUSIONS: Altered capillaries occur frequently among healthy individuals and should be interpreted as normal unless a suspicious increase in their frequency is determined by reference to the scoring system. Megacapillaries and diffuse loss of capillaries were not found and seem to be of specific diagnostic value.

Compression treatment in acute symptomatic proximal deep venous thrombosis - Results of a worldwide survey.

OBJECTIVES: The aim of this study was to illustrate how compression is performed worldwide in proximal DVT and if compression management has changed recently. METHODS: A global online survey, consisting of 36 questions, was used. The survey was solicited from membership lists of Union Internationale de Phlébologie (UIP) membership societies. For differences between the continents in comparison to Western Europe odds ratios and 95% Confidence Intervals (95%CI) where calculated. RESULTS: We received 626 answers from 41 countries. Compression is routinely used in proximal DVT in all regions (82.8%). 81.4% start compression immediately after diagnosis. In the acute phase of DVT reduction of pain and swelling (91.7%) and PTS prevention (66.2%) are the main reasons for compression. 33.2% recently changed their compression management with 43.5% starting compression earlier and 7.0% later. CONCLUSIONS: Compression is still used routinely in proximal DVT in addition to anticoagulation. The changes in international guidelines towards the non-routine use of compression in proximal DVT have not caused significant changes in DVT management.

The risk of recurrent venous thromboembolism in men and women.

BACKGROUND: Whether a patient's sex is associated with the risk of recurrent venous thromboembolism is unknown. METHODS: We studied 826 patients for an average of 36 months after a first episode of spontaneous venous thromboembolism and the withdrawal of oral anticoagulants. We excluded pregnant patients and patients with a deficiency of antithrombin, protein C, or protein S; the lupus anticoagulant; cancer; or a requirement for potentially long-term antithrombotic treatment. The end point was objective evidence of a recurrence of symptomatic venous thromboembolism. RESULTS: Venous thromboembolism recurred in 74 of the 373 men, as compared with 28 of the 453 women (20 percent vs. 6 percent; relative risk of recurrence, 3.6; 95 percent confidence interval, 2.3 to 5.5; P<0.001). The risk remained unchanged after adjustment for age, the duration of anticoagulation, and the presence or absence of a first symptomatic pulmonary embolism, factor V Leiden, factor II G20210A, or an elevated level of factor VIII or IX. At five years, the likelihood of recurrence was 30.7 percent among men, as compared with 8.5 percent among women (P<0.001). The relative risk of recurrence was similar among women who had had their first thrombosis during oral-contraceptive use or hormone-replacement therapy and women in the same age group in whom the first event was idiopathic. CONCLUSIONS: The risk of recurrent venous thromboembolism is higher among men than women.

Prediction of recurrent venous thromboembolism by measuring ProC Global.

In patients with venous thromboembolism (VTE) a laboratory assay that globally measures the overall thrombophilic tendency is not available. We hypothesized that determination of ProC((R)) Global, a plasma assay which tests the global function of the protein C pathway, could be used to stratify patients according to their risk of recurrent VTE. We prospectively followed 774 patients with first spontaneousVTE for a mean time of 52 months. ProC Global normalized ratio (NR) was measured in plasma by use of a commercially available assay based on activated partial thromboplastin time. Ninety-eight of the 774 patients had recurrentVTE. Patients with ProC Global NR > or = 0.75 had a relative risk of recurrence of 0.59 (95% CI 0.40-0.87) as compared with those with lower ratio. After four years, cumulative probability of recurrence was 8.6% in patients with ProC Global NR > or = 0.75 and 17.4% in patients with a lower ratio (p = 0.006). Patients with a high ProC Global NR have a low risk of recurrent VTE. ProC Global NR can be used to stratify patients with a first unprovoked VTE according to their risk of recurrence.

Efficacy and tolerability of liposomal heparin spraygel as an add-on treatment in the management of superficial venous thrombosis.

Superficial venous thrombosis usually resolves spontaneously in a few weeks. In most cases, treatment includes peroral analgesics or nonsteroidal anti-inflammatory drugs accompanied by the recommendation to wear elastic stockings and perform regular mild ambulation. In contrast to this "standard treatment," a recent ACCP guideline has recommended that patients affected by spontaneous superficial thrombophlebitis be treated with intermediate doses of unfractionated or low-molecular-weight heparin. This study was designed to assess the efficacy of topically applied heparin spraygel in terms of reduction of local symptoms and signs of superficial venous thrombosis.

Interleukin-6 and interleukin-6 promoter polymorphism (-174) G > C in patients with spontaneous venous thromboembolism.

Increased levels of interleukin-6 (IL-6) have been reported in patients with a history of venous thromboembolism (VTE); however, prospective studies did not confirm an association between inflammatory markers that are highly correlated with IL-6 and the risk ofVTE. It was the aim of our study to investigate the association of IL-6 and its promoter polymorphism (-174) G > C with the risk of spontaneousVTE. IL-6 was measured in 128 patients with deep venous thrombosis (DVT,70 w/58 m),105 with pulmonary embolism (PE, 58 w/47 m) and 122 healthy controls (60 w/62 m) with a highly sensitive ELISA (Quantikine HS Human IL-6 Immunoassay, RnDSystems). The promoter polymorphism was determined by genotyping, allele specific PCR was followed by high resolution gel-electrophoresis. Median concentrations [interquartile ranges] were 2.37 [1.51-3.89] (pg/ml) in patients with DVT, 2.83 [1.83-4.87] in those with PE and 2.51 [1.71-4.78] in controls (p = 0.6, p = 0.4). Hetero- or homozygous carriers of the C allele (71% in DVT, 67% in PE and 59% among controls) did not have higher IL-6 levels than homozygous carriers of the G allele (median 2.60 vs. 2.59 pg/ml, p = 0.7). In conclusion, we found no association of IL-6 and its promoter polymorphism (-174) G > C with the risk of spontaneous VTE.

Basal high-sensitivity-C-reactive protein levels in patients with spontaneous venous thromboembolism.

The role of C-reactive protein (CRP) in venous thromboembolism (VTE) is still under discussion because of controversial results in the literature. Conflicting data may have partly been due to bias by exogenous factors altering CRP levels. We investigated CRP concentrations in patients with spontaneous VTE applying a study design that allowed the measurement of basal high sensitivity (hs)-CRP levels. Patients with a history of deep vein thrombosis (DVT, n=117) and pulmonary embolism (PE, n=97) were compared to healthy individuals (n=104). Hs-CRP levels (mg/dl) were significantly higher in patients (n=214, median/interquartile range: 0.171/0.082-0.366) than in controls (0.099/0.053-0.245, p=0.001). The unadjusted odds ratio (OR) for VTE per 1 mg/dl increase of CRP was 2.8 [95% confidence interval (CI): 1.1-6.8, p=0.03]. This association remained significant after adjustment for factor V Leiden, prothrombin G20210A and factor VIII activity above 230% (OR = 2.9, 95% CI [1.1-7.5]), but became remarkably attenuated and lost its statistical significance after adjustment for BMI alone (OR = 1.7 [0.7-4.0]). CRP was also not independently associated with VTE in subgroups of patients (those with DVT without symptomatic PE, those with PE and patients without established risk factor) in multiple regression analysis. In summary, we observed significantly higher basal hs-CRP levels in patients with spontaneous VTE compared to healthy controls. This association was independent of hereditary and laboratory risk factors for VTE, but lost its significance after adjustment for BMI. Increased basal CRP levels do not appear to represent an independent risk factor for VTE.

Tissue factor pathway inhibitor and the risk of recurrent venous thromboembolism.

Tissue factor pathway inhibitor (TFPI) regulates factor X activation. Low TFPI is a risk factor for a first venous thrombosis. We evaluated whether low TFPI confers an increased risk of recurrent venous thromboembolism (VTE). TFPI-free antigen was measured in 611 patients with a first spontaneous VTE, and who were prospectively followed after withdrawal of anticoagulation. The endpoint was symptomatic recurrent VTE. The relative risk (RR) of recurrence increased from 1.0 (95% CI 0.4-2.6) in patients with TFPI levels < or = 5th percentile to 2.7 (95% CI 1.0-7.4) in patients with levels < or = 2nd percentile as compared with higher levels. At five years, the probability of recurrence was 48.6% (95th CI 19.0-78.1) among patients with TFPI < or = 2nd percentile and 16.8% (95th CI 13.8-19.8) among those with higher levels (p=0.04). Compared to patients with wild type factor V and high TFPI, the RR of recurrence was 1.1 (95% CI 0.7-1.7) in patients with factor V Leiden and high TFPI, 2.3 (95% CI 0.6-9.5) in patients with wild type factor V and low TFPI and 3.5 (95% CI 0.9-14.3) in patients with factor V Leiden and low TFPI. In a multivariate analysis,the high risk of recurrence in carriers of factor V Leiden and low TFPI slightly decreased [RR 2.8 (95% CI 0.6-9.5)]. We conclude that thrombosis patients with low levels of free TFPI are at an increased risk of recurrent VTE.

Haptoglobin phenotype 2-2 as a potentially new risk factor for spontaneous venous thromboembolism.

BACKGROUND AND OBJECTIVES: Haptoglobin (Hp) is a plasma protein that binds free hemoglobin and thus prevents catalysis of reactive oxygen species by the Fenton reaction. A genetic polymorphism has been described that leads to the generation of two distinct alleles, Hp1 and Hp2, which define three major haptoglobin phenotypes, denoted Hp1-1, Hp2-1 and Hp2-2. Hp2-2 has been reported to be associated with the risk of atherosclerosis and coronary heart disease. In our study we investigated the association of haptoglobin genotype and phenotype with the risk of spontaneous venous thromboembolism (VTE). DESIGN AND METHODS: One hundred and twenty-eight patients with a history of spontaneous deep vein thrombosis (70 women, 58 men), 105 with spontaneous symptomatic pulmonary embolism (58 women, 47 men) and 122 healthy controls (60 women, 62 men) were enrolled. Haptoglobin levels were measured immunonephelometrically and phenotypes were detected by polyacrylamide gel electrophoresis and subsequent immunoblotting. RESULTS: The Hp2-2 phenotype was significantly more prevalent in patients (42%) than in controls (30%) and significantly increased the risk for VTE in univariable (odds ratio=1.6, 95% confidence interval [1.0-2.6], p=0.04) and multivariable analyses (odds ratio=1.9 [1.0-3.4], p=0.04). Hp2-2 (n=134) was associated with significantly lower haptoglobin levels (median=89.7 mg/dL) than Hp2-1 (n=170, median = 123.5 mg/dL, p<0.001) or Hp1-1 (n=51, median=142.8 mg/dL, p<0.001). INTERPRETATION AND CONCLUSIONS: Our study gives the first evidence that Hp2-2 represents a risk factor for spontaneous VTE, presumably through a pathophysiological mechanism similar to that in arterial disease.

The risk of recurrent venous thromboembolism in heterozygous carriers of factor V Leiden and a first spontaneous venous thromboembolism.

BACKGROUND: Factor V (FV) Leiden is a risk factor for venous thrombosis (VT). Data on its influence on the risk of recurrent venous thromboembolism (VTE) are controversial owing to different study designs and patient cohorts. METHODS: We reevaluated the risk of recurrence among heterozygous carriers and noncarriers of FV Leiden with a first spontaneous proximal VT of the leg and/or pulmonary embolism. Patients with secondary VTE, homozygous FV Leiden, natural inhibitor deficiencies, lupus anticoagulant, cancer, or long-term anticoagulation were excluded. The study end point was objectively documented, symptomatic, recurrent VTE. RESULTS: After discontinuation of oral anticoagulant therapy for a first VTE, we prospectively observed 287 patients, 83 (29%) of whom were heterozygous for FV Leiden. Recurrent VTE was seen in 17 (20%) of 83 patients with and 44 (21.6%) of 204 without FV Leiden. The probability of recurrence among heterozygotes was 12% (95% confidence interval [CI], 8%-16%), 27% (95% CI, 21%-33%), and 27% (95% CI, 21%-33%) after 2, 4, and 6 years, respectively, and was not higher than that among patients without the mutation (16%, 23%, and 34%, respectively). The relative risk of recurrence in heterozygotes was 0.9 (95% CI, 0.5-1.6; P =.60) after adjustment for confounding variables. The risk of recurrence among patients with and without FV Leiden was not different when sex distribution or duration of anticoagulation therapy was taken into account. CONCLUSIONS: The risk of recurrence is similar among carriers and noncarriers of FV Leiden. Heterozygous patients should receive secondary thromboprophylaxis for a similar length of time as patients without FV Leiden.

Life-threatening acute pneumonitis in mixed connective tissue disease: a case report and literature review.

Mixed connective tissue disease (MCTD) is a rare connective tissue disease frequently involving the lungs. The main characteristic is a systemic sclerosis-like picture of slowly progressing interstitial lung disease consistent with lung fibrosis, while pulmonary arterial hypertension is rare. Herein, we present a case of a newly diagnosed MCTD patient developing life-threatening acute pneumonitis similar to lupus pneumonitis. Previous literature on this exceptionally rare complication of MCTD is reviewed and differential diagnosis and management discussed.

Blood pressure responses after carotid surgery: relationship to postoperative baroreceptor sensitivity.

BACKGROUND AND PURPOSE: Among hypertensive patients after carotid surgery, a group of patients with increased baroreflex sensitivity was identified. In the other group of hypertensive patients, blood pressure and reflex sensitivity were unchanged postoperatively. We hypothesized that a partial readjustment of baroreceptor sensitivity would produce more stable blood pressure profiles. METHODS: In order to test this hypothesis, a prospective, long-term follow-up study was designed. Blood pressure was monitored in 18 hypertensive and 6 normotensive patients during 6 months using a self-measurement technique. In addition, continuous 24-hour blood pressure monitoring was performed 6 months after surgery. The mean values and the ranges (amplitudes) of systolic and diastolic blood pressure were calculated as indicators for the stability of the circulatory system. RESULTS: Hypertensive patients with unchanged postoperative baroreceptor sensitivity showed significantly more pronounced instabilities of their blood pressure profiles (amplitudes of systolic and diastolic blood pressure p < 0.05 to p < 0.001). A relationship between baroreceptor function and antihypertensive therapy could also be demonstrated, with adequate therapy being much more difficult in patients with reduced or unchanged baroreceptor sensitivity. CONCLUSIONS: In contrast to vascular surgery on the aorta or in the region of the lower limbs, carotid surgery is frequently associated with blood pressure changes, demonstrating the essential role of the baroreceptors in the carotid sinus for the regulation of postoperative blood pressure. Since it seems to be the variability of blood pressure, and not the blood pressure level alone, that is critical, close blood pressure monitoring--allowing for an assessment of blood pressure variability--appears to be of particular importance in such patients.

Duplex sonographic predictors of restenosis, vascular and neurological events after carotid endarterectomy.

BACKGROUND: Although excellent short- and long-term results have been achieved with surgery in extracranial internal carotid artery stenosis, recurrent stenosis continues to play an important role in post-endarterectomy. Therefore, a close follow-up of patients is warranted. The value of postoperative duplex sonographic evaluations in postoperative follow-up is highly disputed. The study evaluates duplex sonographic parameters as predictors of carotid restenosis, general vascular events and ipsilateral neurological symptoms, in order to assess the role of duplex sonography in follow-up after carotid endarterectomy. METHODS: A retrospective cohort study with a follow-up period ranging from 7 months to 7.5 years was performed in 150 patients who underwent carotid endarterectomy. Pre- and postoperative duplex sonographic and clinical data were analyzed by life-table analysis and multivariate Cox regression with respect to carotid restenosis, vascular and ipsilateral neurological events. MAIN FINDINGS: Duplex sonographic predictors of carotid restenosis include the postoperative degree of stenosis (residual stenosis > or = 30% or more: relative risk (RR) = 1.56; 1.05-2.32), pre- to postoperative reduction of stenosis (higher than 50%: RR = 0.61; 0.45-0.83), and residual plaques in the operated carotid artery (RR = 1.96; 1.31-2.93). Some of these morphological parameters such as reduction of stenosis are also predictive of vascular events (RR = 1.25; 1.01-1.56) and ipsilateral neurological events (RR = 1.52; 1.05-2.19). In 12 cases restenosis was discovered by duplex sonography and in 3 cases by evaluation of clinical symptoms. In 5 cases restenosis was treated by repeat surgery. Contralaterally, progressive or newly developed carotid stenoses were observed in 17 cases, and only 5 were discovered on the basis of clinical symptoms. Fourteen contralateral stenoses required surgery. Overall, 12 patients underwent treatment for stroke prevention on the basis of duplex follow-up findings (8% of the study population). CONCLUSIONS: Postoperative duplex sonography allows for the identification of patients at risk for carotid restenosis as well as those at risk for other vascular events. As expected, regular examinations permit early detection of restenosis requiring surgical treatment. However, a large number of contralateral stenoses requiring surgical treatment were detected by routine duplex sonographic examinations. The timing of follow-up intervals may be oriented towards the perioperative outcome of duplex sonography.

D-dimer levels and risk of recurrent venous thromboembolism.

CONTEXT: Widespread screening of patients with venous thromboembolism (VTE) for thrombophilic risk factors has become common clinical practice. Because of the increasing number of risk factors, assessing the risk of recurrence in an individual patient is intricate; therefore, a laboratory method that measures multifactorial thrombophilia is required. OBJECTIVE: To prospectively study the relationship between the risk of recurrent VTE and D-dimer, a global marker of coagulation activation and fibrinolysis. DESIGN, SETTING, AND PARTICIPANTS: Prospective cohort study of 610 patients older than 18 years who were treated with oral anticoagulants for at least 3 months with a first spontaneous VTE, in whom D-dimer levels were measured shortly after discontinuation of oral anticoagulation. The study was conducted at the Department of Internal Medicine I, University Hospital, Vienna, Austria. Patients entered the study at time of discontinuation of oral anticoagulants and were observed at 3-month intervals during the first year and every 6 months thereafter from July 1992 to October 2002. MAIN OUTCOME MEASURE: Objectively documented symptomatic recurrent VTE. RESULTS: A total of 79 (13%) of 610 patients had recurrent VTE with a mean observation time of 38 months. Patients with recurrence had significantly higher D-dimer levels compared with those without recurrence (553 ng/mL vs 427 ng/mL, P =.01). Compared with patients with D-dimer levels of 750 ng/mL or higher, the relative risk (RR) of recurrence was 0.6 (95% confidence interval [CI], 0.3-1.4), 0.6 (95% CI, 0.3-1.2), and 0.3 (95% CI, 0.1-0.6) in patients with D-dimer levels of 500 to 749 ng/mL, 250 to 499 ng/mL, and less than 250 ng/mL, respectively. The cumulative probability of recurrent VTE at 2 years was 3.7% (95% CI, 0.9%-6.5%) among patients with D-dimer levels of less than 250 ng/mL compared with 11.5% (95% CI, 8.0%-15.0%) among patients with higher levels (P =.001). Patients with D-dimer levels of less than 250 ng/mL had a 60% lower RR of recurrence compared with patients with higher levels (RR, 0.4; 95% CI, 0.2-0.8). CONCLUSION: Patients with a first spontaneous VTE and a D-dimer level of less than 250 ng/mL after withdrawal of oral anticoagulation have a low risk of VTE recurrence.

Angio-Seal use in patients with peripheral arterial disease (ASPIRE).

PURPOSE: To investigate the incidence of complications after the use of an arterial closure device (Angio-Seal) in patients with peripheral arterial disease. METHODS: In 105 consecutive patients after transfemoral catheterization, the puncture site was closed using a closure device (Angio-Seal). Colour-flow-duplexsonography studies were conducted 1 to 4 days before, within 3 days after and 3 month after the intervention. RESULTS: All patients had peripheral arterial disease, 34 had calcification at the puncture site. Detection of calcification did not prevent device deployment. Complications (2 minor bleedings, 1 pseudoaneurysm) were not associated with high risk groups (these were: 69 antegrade punctures, 22 obese and 32 hypertensive patients). Three-month postinterventional diameter and blood velocity changes were <1%. CONCLUSIONS: Patients with peripheral arterial disease in the region of the puncture site and patients at higher complication risk can safely and effectively be closed with an Angio-Seal device. At the puncture site, no lumen change can be observed 3 months postinterventional.