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.

Overweight, obesity, and the risk of recurrent venous thromboembolism.

BACKGROUND: Excess body weight is a risk factor for a first venous thromboembolism. The impact of excess body weight on risk of recurrent venous thrombosis is uncertain. METHODS: We studied 1107 patients for an average of 46 months after a first unprovoked venous thromboembolism and withdrawal of anticoagulant therapy. Excluded were pregnant patients, those requiring long-term antithrombotic treatment, and those who had a previous or secondary thrombosis, natural coagulation inhibitor deficiency, lupus anticoagulant, or cancer. Our study end point was symptomatic recurrent venous thromboembolism. RESULTS: A total of 168 patients had recurrent venous thromboembolism. Mean (SD) body mass index (BMI) (calculated as weight in kilograms divided by height in meters squared) was significantly higher among patients with recurrence than among those without recurrence: 28.5 (6.0) vs 26.9 (5.0) (P = .01). The relationship between excess body weight and recurrence was linear; the adjusted hazard ratio for each 1-point increase in BMI was 1.044 (95% confidence interval [CI], 1.013-1.076) (P < .001). Four years after discontinuation of anticoagulant therapy, the probability of recurrence was 9.3% (95% CI, 6.0%-12.7%) among patients of normal weight and 16.7% (95% CI, 11.0%-22.3%) and 17.5% (95% CI, 13.0%-22.0%) among overweight and obese patients, respectively. Compared with patients of normal weight, the hazard ratio of recurrence adjusted for age, sex, factor V Leiden, prothrombin G20210A mutation, high factor VIII levels, and type of initial venous thromboembolic event was 1.3 (95% CI, 0.9-1.9) (P = .20) among overweight patients and 1.6 (95% CI, 1.1-2.4) (P = .02) among obese individuals. The population attributable risk corresponding to excess body weight was 26.8% (95% CI, 5.3%-48.2%). CONCLUSION: Excess body weight is a risk factor of recurrent venous thromboembolism.

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.

Family history for venous thromboembolism and the risk for recurrence.

PURPOSE: The relevance of a family history for venous thromboembolism with regard to the likelihood for recurrence is unknown. SUBJECTS AND METHODS: We studied 826 patients for an average of 36 months after a first unprovoked venous thromboembolism and withdrawal of oral anticoagulation. Patients with cancer, lupus anticoagulant, or deficiency of antithrombin, protein C, or protein S were excluded. The study endpoint was objective evidence of recurrent symptomatic venous thromboembolism. RESULTS: Recurrence for venous thromboembolism was recorded in 23 of 190 patients (12.1%) with a family history (at least one affected first-degree family member) and in 79 of 636 patients (12.4%) without familial thrombosis (relative risk for recurrence 1.0; 95% confidence interval, 0.7-1.6; P=.9). At 5 years, the likelihood for recurrence was 20% among patients with a family history for venous thromboembolism and 18% among those without a family history for venous thromboembolism (P=.9). Risk determinants for venous thromboembolism including factor V Leiden, factor II G20210A, and high factor VIII were not statistically different between the 2 groups. CONCLUSION: A family history for venous thromboembolism does not segregate patients into high- or low-risk categories and is not suitable to identify patients at increased risk for recurrent venous thromboembolism.

Low level laser therapy in primary Raynaud's phenomenon--results of a placebo controlled, double blind intervention study.

OBJECTIVE: To assess the efficacy of low level laser therapy in patients with primary Raynaud's phenomenon and predict the success of laser therapy by clinical characteristics. METHODS: Forty-eight patients were included in a randomized placebo controlled, double blind crossover study. Laser and sham therapy each were applied 5 days a week for 3 weeks. Clinical symptoms, exposure to triggers, and frequency and intensity of attacks were recorded in diaries. Results of infrared thermography before onset and at the end of both irradiation sequences were evaluated. Primary endpoint was the average intensity of attacks; secondary endpoints were average number of attacks and thermography results. Age, sex, duration of symptoms, age at onset of symptoms, evoking conditions other than cold, maximum temperature drop after cold provocation, and rewarming time after cold provocation were tested as potential predictors. RESULTS: Number of attacks and their intensity were significantly reduced during laser therapy compared to sham treatment. Thermographic parameters did not reach statistical significance. In a stepwise multiple regression analysis, evoking conditions other than cold (stress, wetness as additional triggers), rewarming time, and temperature decrease after cold provocation were significant predictors of therapeutic efficacy. CONCLUSION: Low level laser therapy reduces frequency and severity of Raynaud attacks. The effect is most pronounced in patients with signs of decreased threshold for vasospasm and less effective in patients with delayed hyperemia.

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.

Degree of atherosclerosis predicts short-term commitment for smoking cessation therapy.

BACKGROUND: Only little is known about factors that influence the smokers' propensity to start smoking cessation therapy and stay within such programs. METHODS: One hundred fifteen subjects that were current smokers and presented at the angiologic outpatient unit were enrolled in a prospective cohort study. All patients were invited to take part in a smoking cessation program. Patients' history, noninvasive vascular, cardiac, and pulmonary parameters, state of atherosclerotic disease (SMART-score), smoking history, and Fagerström index were obtained and the carbon monoxide breathing test was performed. RESULTS: Lower age and heavy smoking were associated with less propensity to start smoking cessation therapy. The degree of atherosclerosis significantly predicted short-term commitment to smoking cessation therapy (relative risk for discontinuation: 0.82; 95% CI: 0.70-0.96). Single factors predictive for staying within the therapy were peripheral arterial occlusive disease and hyperlipidemia, while neither prior myocardial infarction nor pulmonary function was associated with compliance. Fifty-four percent of patients that completed 3 months of therapy quit smoking. CONCLUSIONS: Counseling in smokers with preexistent or newly diagnosed atherosclerotic diseases or risk factors should include their specific vascular condition and information on positive consequences on the progress of these conditions. Counseling for initiation of smoking cessation therapy should apply different strategies as used in the maintenance phase of therapy.

Superficial thrombophlebitis and risk for recurrent venous thromboembolism.

OBJECTIVE: Superficial thrombophlebitis (ST) is a frequent and potentially serious disease if complicated with venous thromboembolism (VTE). Data on risk factors and incidence rates for ST are scarce. It is also unknown whether ST is a risk factor for recurrence of VTE. METHODS: After discontinuation of secondary thromboprophylaxis for a first spontaneous VTE, we prospectively observed 615 patients on average for 30 +/- 26 months. Patients with natural coagulation inhibitor deficiency, lupus anticoagulant, or cancer, who were pregnant, or were receiving long-term antithrombotic therapy were excluded. The study outcomes were occurrence of symptomatic ST or objectively documented recurrent symptomatic VTE. RESULTS: ST developed in 45 patients (7.3%) with a first VTE. High factor VIII concentration emerged as an independent risk factor for ST (relative risk [RR], 2.0; 95% confidence interval [CI], 1.0-5.2), compared with lower levels after adjustment for age and sex; factor V Leiden and prothrombin G20210A concentration; hyperhomocysteinemia; high body mass index; and duration of oral anticoagulation therapy. VTE recurred in 12 (27%) of 45 patients with ST and in 67 (12%) of 570 patients without ST. In patients with VTE, subsequent ST emerged as an independent risk factor for recurrent VTE. Patients with ST had twofold higher RR (2.1; 95% CI, 1.0-4.2) for recurrence than did patients without ST after adjustment for putative confounding variables. CONCLUSION: Patients with a first spontaneous VTE and subsequent ST are at increased risk for recurrent VTE. High factor VIII concentration is an independent risk factor for ST.

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.

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.

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.