Two-year outcome of patients after a first hospitalization for heart failure: A national observational study.

BACKGROUND: National population-based management and outcome data for patients of all ages hospitalized for heart failure have rarely been reported. AIM: National population-based management and outcome of patients of all ages hospitalized for heart failure have rarely been reported. The present study reports these results, based on 77% of the French population, for patients hospitalized for the first time for heart failure in 2009. METHODS: The study population comprised French national health insurance general scheme beneficiaries hospitalized in 2009 with a principal diagnosis of heart failure, after exclusion of those hospitalized for heart failure between 2006 and 2008 or with a chronic disease status for heart failure. Data were collected from the national health insurance information system (SNIIRAM). RESULTS: A total of 69,958 patients (mean age, 78 years; 48% men) were studied. The hospital mortality rate was 6.4%, with 1-month, 1-year and 2-year survival rates of 89%, 71% and 60%, respectively. Heart failure and all-cause readmission-free rates were 55% and 43% at 1 year and 27% and 17% at 2 years, respectively. Compared with a reference sample of 600,000 subjects, the age- and sex-standardized relative risk of death was 29 (95% confidence interval [CI] 28-29) at 2 years, 82 (95% CI 72-94) in subjects aged<50 years and 3 (95% CI 3-3) in subjects aged ≥ 90 years. For subjects aged < 70 years who survived 1 month after discharge, factors associated with a reduction in the 2-year mortality rate were: female sex; age < 55 years; absence of co-morbidities; and use of angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, beta-blockers, lipid-lowering agents or oral anticoagulants during the month following discharge. Poor prognostic factors were treatment with a loop diuretic before or after hospitalization and readmission for heart failure within 1 month after discharge. CONCLUSIONS: This large population-based study confirms the severe prognosis of heart failure and the need to promote the use of effective medications and management designed to improve survival.

Superficial venous thrombosis and compression ultrasound imaging.

BACKGROUND: A current debate concerning suspected superficial vein thrombosis (SVT) focuses on the need of performing a compression ultrasound (CUS) exploration for confirming the diagnosis of SVT. This study was conducted to determine the clinical relevance and optimal CUS exploration in patients with symptomatic SVT. METHODS: We analyzed the characteristics of SVT and concomitant deep vein thrombosis (DVT) in patients included in the Prospective Observational Superficial Thrombophlebitis (POST) multicenter, observational prospective study. All patients underwent complete bilateral lower limb CUS, exploring both the superficial and deep venous systems. RESULTS: A total of 844 patients with clinical symptoms of SVT were recruited, of which 99 isolated SVTs (21.4%) had saphenofemoral/popliteal junction involvement, and 198 (23.5%) had a concomitant DVT, with 41.8% of them proximal DVTs. In 83 patients (41.9%), DVT and SVT were not contiguous. Five of 639 patients (1%) had an isolated contralateral DVT (ie, not bilateral). Age ≥ 75 years (odds ratio [OR], 2.3; 95% confidence interval [CI], 1.6-3.4), inpatient status (OR, 5.4; 95% CI, 3.4-8.7), a personal history of DVT or pulmonary embolism (OR, 1.8; 95% CI, 1.2-2.8), and SVT on nonvaricose veins (OR, 3.3; 95% CI, 2.1-5.0) were significantly and independently associated with an increased risk of concomitant DVT. Half of the patients exhibited none of these risk factors, and the prevalence of concomitant DVT dropped to 11%. CONCLUSIONS: In patients with symptomatic SVT, a CUS exploration screening the whole venous system of the affected limb is useful because it provides information that has important consequences for the management of these patients.

A randomized double-blind trial of upward progressive versus degressive compressive stockings in patients with moderate to severe chronic venous insufficiency.

BACKGROUND: The present randomized double-blind multicenter study was designed to assess the efficacy of a progressive compressive stocking (new concept with maximal pressure at calf), compared to a degressive compressive stocking graded 30 mm Hg, evaluating the improvement of lower leg symptoms of chronic venous insufficiency (CVI) in ambulatory patients with moderate to severe chronic venous disease. METHODS: Both gender outpatients presenting symptomatic moderate to severe CVI were eligible for a treatment by compressive stockings. Patients were randomly assigned to receive either degressive compressive stockings (30 mm Hg at ankle, 21 mm Hg at upper calf) or progressive compressive stockings (10 mm Hg at ankle, 23 mm Hg at upper calf). The primary outcome, evaluated after 3 months, was a composite success outcome, including improvement of pain or heavy legs without onset of either ulcer, deep or superficial vein thrombosis of the lower limbs, or pulmonary embolism. The ease of application of the compressive stockings reported by patients was one of secondary outcome. RESULTS: Overall, 401 patients (199 in the progressive compressive stocking group and 202 in the degressive compressive stocking group) were randomized by 44 angiologists in France. Among them, 66% were classified in the C3 CEAP category. The rate of success was significantly higher in the progressive compressive stocking group compared to the degressive compressive stocking group (70.0% vs 59.6%; relative risk, 1.18; 95% confidence interval, 1.02-1.37; P = .03). This was mainly due to more frequent symptom improvement in the progressive compressive stocking group. The compressive stockings were considered easy to apply by 81.3% of patients in the progressive compressive stocking group vs 49.7% of patients in the degressive compressive stocking group (P < .0001). The rate of related serious adverse events was low and similar in both groups. CONCLUSIONS: This trial has demonstrated that progressive compressive stockings are more effective than usual degressive compressive stockings in the improvement of pain and lower leg symptoms in patients with CVI. Moreover, progressive compressive stockings were easier to apply, raising no safety concern at 3 months.

The risk of subsequent cancer and arterial cardiovascular events in patients with superficial vein thrombosis in the legs.

Although it has been clearly demonstrated that venous thromboembolism is associated with an increased risk of subsequent overt cancer and arterial cardiovascular events in comparison with control populations, whether this association also applies to patients with isolated (ie, without concomitant involvement of the deep vein system) superficial vein thrombosis (SVT) in the legs is unknown. In 737 consecutive patients with isolated SVT not involving the sapheno-femoral junction, we conducted a retrospective investigation to assess the rate of cancer and that of arterial cardiovascular events occurring during follow-up. The event rates were compared with those occurring in 1438 controls having comparable characteristics. Both cases and controls were followed-up for an average period of 26 ± 8 months (range, 3-45). Malignancy was diagnosed in 26 cases (3.5%) and 56 controls (3.9%), leading to a hazard ratio of 0.86 (95% confidence interval, 0.55%-1.35%). Arterial cardiovascular events occurred in 32 cases (4.3%) and 63 controls (4.4%), leading to a hazard ratio of 0.97 (95% confidence interval, 0.63%-1.50%). We conclude that the occurrence of isolated SVT in the legs does not place patients at an increased risk of malignancies or arterial cardiovascular events. Whether this conclusion also applies to patients whose thrombosis involves the sapheno-femoral junction remains to be demonstrated.

Superficial venous thrombosis and venous thromboembolism: a large, prospective epidemiologic study.

BACKGROUND: Superficial venous thrombosis (SVT) is perceived to have a benign prognosis. OBJECTIVE: To assess the prevalence of venous thromboembolism in patients with SVT and to determine the 3-month incidence of thromboembolic complications. DESIGN: National cross-sectional and prospective epidemiologic cohort study. (ClinicalTrials.gov registration number: NCT00818688) SETTING: French office- and hospital-based vascular medicine specialists. PATIENTS: 844 consecutive patients with symptomatic SVT of the lower limbs that was at least 5 cm on compression ultrasonography. MEASUREMENTS: Incidence of venous thromboembolism and extension or recurrence of SVT in patients with isolated SVT at presentation. RESULTS: Among 844 patients with SVT at inclusion (median age, 65 years; 547 women), 210 (24.9%) also had deep venous thrombosis (DVT) or symptomatic pulmonary embolism. Among 600 patients without DVT or pulmonary embolism at inclusion who were eligible for 3-month follow-up, 58 (10.2%) developed thromboembolic complications at 3 months (pulmonary embolism, 3 [0.5%]; DVT, 15 [2.8%]; extension of SVT, 18 [3.3%]; and recurrence of SVT, 10 [1.9%]), despite 540 patients (90.5%) having received anticoagulants. Risk factors for complications at 3 months were male sex, history of DVT or pulmonary embolism, previous cancer, and absence of varicose veins. LIMITATION: The findings are from a specialist referral setting, and the study was terminated before the target patient population was reached because of slow recruitment. CONCLUSION: A substantial number of patients with SVT exhibit venous thromboembolism at presentation, and some that do not can develop this complication in the subsequent 3 months. PRIMARY FUNDING SOURCE: GlaxoSmithKline, sanofi-aventis, and the Ministère Francais de la Santé et des Sports (Programme Hospitalier de Recherche Clinique).

Left atrial radiofrequency ablation during mitral valve surgery: a prospective randomized multicentre study (SAFIR).

BACKGROUND: Randomized studies evaluating left atrial radiofrequency ablation (RFA) in patients with persistent atrial fibrillation undergoing mitral valve surgery are scarce and monocentric. AIM: To evaluate the efficacy of left atrial RFA concomitant with mitral valve surgery to restore and maintain sinus rhythm. METHODS: The SAFIR is a multicentre, double-blinded, centrally randomized study involving four university hospitals. Between December 2002 and September 2005, 43 patients with mitral valve disease and long-standing, persistent atrial fibrillation (duration>6 months) were included. We compared valvular surgery alone (n=22) or with left atrial RFA (n=21). The main endpoint was sinus rhythm at 12 months without recurrence of arrhythmia during follow-up. Secondary endpoints were surgical adverse events, atrial fibrillation relapses, stroke and echocardiographic measurements after three and 12 months' follow-up. Analyses of the efficacy criteria were performed on an intention-to-treat basis. RESULTS: The primary endpoint occurred significantly more often in the RFA group than in the control group (respectively, 12/21 patients [57%] vs 1/22 patients [4%]; p=0.004). There were more patients with sinus rhythm in the RFA group than in the control group at discharge (72.7% vs 4.8%; p<0.005), 3-month follow-up (85.7% vs 23.8%; p<0.01) and 12-month follow-up (95.2% vs 33.3%; p<0.005). The patients in the RFA group had similar rates of postoperative complications and stroke during follow-up as those in the control group. CONCLUSIONS: This multicentre study suggests that left atrial RFA is effective and safe in patients with chronic atrial fibrillation and mitral valve disease.

Epidemiology of post-operative venous thromboembolism in Asian patients. Results of the SMART venography study.

BACKGROUND AND OBJECTIVES: The rate of post-operative asymptomatic deep-vein thrombosis in Asian patients remains uncertain. The aim of this study was to estimate the rate of venous thromboembolism, including asymptomatic deep-vein thrombosis, undergoing hip or knee surgery and not receiving pharmacological thromboprophylaxis. DESIGN AND METHODS: This was a prospective observational study of a cohort of consecutive Asian patients. The primary study outcome was the composite of venographically detected asymptomatic, or confirmed symptomatic venous thromboembolism, or sudden death at hospital discharge. Bilateral venography was to be performed in all patients between days 5 and 14 after surgery. Follow-up lasted 1 month. RESULTS: A total of 386 patients (median age: 65 years, female: 63.7%, body-mass index > or = 30 kg/m2: 15.4%) undergoing hip (n=160) or knee (n=226) replacement surgery satisfied the study selection criteria and 326 (84.5%) had evaluable venograms. The rate of the primary outcome was 36.5% (119 patients, 99% confidence interval: 29.7 to 43.7). The rate of symptomatic venous thromboembolism was 0.9% (3 patients, 99% confidence interval: 0.1 to 3.3). During follow-up (358 patients for a median duration of 33 days after surgery), two additional episodes of symptomatic venous thromboembolism occurred. Multivariate analysis identified that knee replacement surgery, duration of surgery and treatment with antibiotics within 1 week before surgery were independent risk factors (p<0.05) for venous thromboembolism or sudden death at hospital discharge. INTERPRETATION AND CONCLUSIONS: In Asian patients, the incidence of asymptomatic and symptomatic venous thromboembolism after major orthopedic surgery is high. These results suggest that thromboprophylaxis should be considered in these patients.

Predictors of cardiovascular events in patients with end-stage renal disease: an analysis from the Fosinopril in dialysis study.

BACKGROUND: Cardiovascular events (CVE) are a major cause of morbidity and mortality in end-stage renal disease (ESRD) patients. These patients are often excluded from CV clinical trials, and the prognostic factors associated with CVE in patients with ESRD have not been fully explored. A risk prediction model was created from the FOSIDIAL trial to identify factors predictive of CVE and to evaluate the relative strength of known predictors when considered together in a multivariate model. METHODS: FOSIDIAL was a prospective, randomized, double-blind study with 2-year follow-up and CVE adjudication. The study enrolled 397 patients with ESRD and left ventricular hypertrophy (LVH). CVE included cardiovascular death, non-fatal myocardial infarction, unstable angina, stroke, revascularization, heart failure hospitalization, resuscitated cardiac arrest and confirmed stroke. The model was built using a forward selection of all baseline variables. A structural equation model (SEM) was used to identify factors with an indirect association with CVE. RESULTS: CV history was the most important prognostic factor, followed by C-reactive protein (CRP), left ventricular mass index, diabetes and age. Smoking, low HDL, female gender and Kt/V were indirectly associated with CVE. CONCLUSION: Prior CV disease, elevated CRP, LVH, diabetes or advanced age identifies patients at the highest risk for CVE. These data may be useful to detect high risk patients, to define potential targets for pharmacologic intervention, and to plan future studies in ESRD. Further research is needed to identify effective approaches that reduce the rate of CVE in these patients.

Prevention of venous thromboembolism in medically ill patients: a clinical update.

The risk of venous thromboembolism (VTE) in hospitalised medically ill patients is often underestimated, despite the fact that it remains a major cause of preventable morbidity and mortality in this group. It is not well recognised that the risk of VTE in many hospitalised medically ill patients is at least as high as in populations after surgery. This may partly be attributed to the clinically silent nature of VTE in many patients, and the difficulty in predicting which patients might develop symptoms or fatal pulmonary embolism. Two large studies, Prospective Evaluation of Dalteparin Efficacy for Prevention of VTE in Immobilized Patients Trial and prophylaxis in MEDical patients with ENOXaparin, have shown that low-molecular-weight heparins provide effective thromboprophylaxis in medically ill patients, without increasing bleeding risk. Recent guidelines from the American College of Chest Physicians recommend that acutely medically ill patients admitted with congestive heart failure or severe respiratory disease, or those who are confined to bed and have at least one additional risk factor for VTE, should receive thromboprophylaxis.

Risk factors for venous thromboembolism in hospitalized patients with acute medical illness: analysis of the MEDENOX Study.

BACKGROUND: There is limited information about risk factors for venous thromboembolism (VTE) in acutely ill hospitalized general medical patients. METHODS: An international, randomized, double-masked, placebo-controlled trial (MEDENOX) has previously been conducted in 1102 acutely ill, immobilized general medical patients and has shown the efficacy of using a low-molecular-weight heparin, enoxaparin sodium, in preventing thrombosis. We performed logistic regression analysis to evaluate the independent nature of different types of acute medical illness (heart failure, respiratory failure, infection, rheumatic disorder, and inflammatory bowel disease) and predefined factors (chronic heart and respiratory failure, age, previous VTE, and cancer) as risk factors for VTE. RESULTS: The primary univariate analysis showed that the presence of an acute infectious disease, age older than 75 years, cancer, and a history of VTE were statistically significantly associated with an increased VTE risk. Multiple logistic regression analysis indicated that these factors were independently associated with VTE. CONCLUSIONS: Several independent risk factors for VTE were identified. These findings allow recognition of individuals at increased risk of VTE and will contribute to the formulation of an evidence-based risk assessment model for thromboprophylaxis in hospitalized general medical patients.

Factors predictive of venous thrombotic complications in patients with isolated superficial vein thrombosis.

OBJECTIVE: Superficial vein thrombosis may be complicated with venous thromboembolism. We examined factors predictive of venous thromboembolism in superficial vein thrombosis, which, to our knowledge, had not been prospectively studied before. DESIGN AND METHODS: We performed post hoc analysis of the STENOX trial, a prospective randomized controlled trial that investigated various antithrombotic therapies in 427 hospitalized patients with objectively confirmed symptomatic isolated superficial vein thrombosis. The value of various baseline characteristics as predictive factors of venous thrombotic complications at 3 months was studied with logistic regression. Venous thrombotic complications were defined as deep vein thrombosis or pulmonary embolism, or recurrence or proximal extension of superficial vein thrombosis. RESULTS: Venous thrombotic complications occurred in 78 patients. Independent predictive factors for complications were superficial vein thrombosis of recent onset (odds ratio [OR], 3.01; 95% confidence interval [CI], 1.44-6.27), severe chronic venous insufficiency (OR, 2.75; CI, 1.10-6.89), male gender (OR, 2.17; CI, 1.28-3.68), and history of venous thromboembolism (OR, 2.07; CI 1.06-4.04). Deep vein thrombosis or pulmonary embolism occurred in 19 patients. Only severe chronic venous insufficiency was an independent predictor of this complication (OR, 4.50; CI, 1.30-15.61). CONCLUSIONS: After symptomatic isolated superficial vein thrombosis, venous thrombotic complications are relatively frequent, and are more likely to occur in men, in patients with a history of venous thromboembolism or with severe chronic venous insufficiency, or in whom superficial vein thrombosis is recent. Knowledge of such predictive factors may be useful for determining appropriate treatment in patients with superficial vein thrombosis and for designing future phase III clinical trials.

Prevention of venous thromboembolism in medical patients with enoxaparin: a subgroup analysis of the MEDENOX study.

The Medical Patients with Enoxaparin (MEDENOX) trial was a randomized, placebo-controlled study that defined the risk of venous thromboembolism (VTE) in acutely ill, immobilized, general medical patients and the efficacy of the low-molecular-weight heparin, enoxaparin, in preventing thrombosis. We performed a post-hoc analysis to evaluate the effect of 40 mg enoxaparin once daily on MEDENOX patient outcome in different types of acute medical illness (heart failure, respiratory failure, infection, rheumatic disorder and inflammatory bowel disease) and pre-defined risk factors (chronic heart and chronic respiratory failure, age, immobility, previous VTE and cancer). The primary outcome was the occurrence of documented VTE between days 1 and 14. The relative risk reduction [95% confidence intervals (CI)] for VTE comparing 40 mg enoxaparin with placebo in the subgroups were: acute heart failure, 0.29 (95% CI, 0.10-0.84); acute respiratory failure, 0.25 (95% CI, 0.10-0.65); acute infectious disease, 0.28 (95% CI, 0.09-0.81); and acute rheumatic disorder, 0.48 (95% CI, 0.11-2.16). The relative risk reduction for VTE in the pre-defined risk factor subgroups were: chronic heart failure, 0.26 (95% CI, 0.08-0.92); chronic respiratory failure, 0.26 (95% CI, 0.10-0.68); age, 0.22 (95% CI, 0.09-0.51); immobility, 0.53 (95% CI, 0.14-1.72); previous VTE, 0.49 (95% CI, 0.15-1.68); and cancer, 0.50 (95%o CI, 0.14-1.72). The beneficial effects of enoxaparin extend to a wide range of acutely ill medical patients.

Systematic versus selective stent placement after superficial femoral artery balloon angioplasty: a multicenter prospective randomized study.

PURPOSE: Outcome with selective or systematic stenting with the Palmaz vascular stent was compared in patients with limb-threatening ischemia or persistent disabling claudication despite medical therapy, with less than 7 cm stenosis or occlusion of the superficial femoral artery. METHODS: This was a multicenter prospective randomized trial with centralized allocation of treatment and independent review of vascular events. The primary end point was presence of more than 50% stenosis at 1-year angiographic follow-up. Secondary end points were survival; occurrence of vascular events in the treated leg; and number of failed procedures, defined as more than 50% stenosis or death at 1 year. RESULTS: Two hundred twenty-seven patients were enrolled in the study, 112 in the selective stent group, and 115 in the systematic stent group. Seventeen patients (15%) in the selective stent group received a stent after suboptimal results of percutaneous transluminal angioplasty. Angiograms for 140 patients were available at 1-year follow-up and demonstrated no statistical difference between the two groups; more than 50% stenosis of the dilated site was noted in 21 of 65 patients (32,3%) in the selective stent group and 26 of 75 patients (34.7%) in the systematic stent group (P =.85, Fisher exact test). Survival in the percutaneous transluminal angioplasty and stent groups was, respectively, 92% and 96% at 1 year, 89% and 93% at 2 years, and 82% and 80% at 4 years (P =.40, log-rank test). Survival free of new vascular events in the treated limb was 77% and 65% at 1 year, 70% and 53% at 2 years, and 57% and 44% at 4 years (P =.017, log-rank test). Number of failed procedures at 1 year was 29 of 86 (33%) and 30 of 89 (34%) (P = 0.9). CONCLUSION: Systematic stenting of short stenosis or occlusion of the superficial femoral artery is not justified. Palmaz vascular stent placement should be reserved for use in patients with suboptimal results of balloon angioplasty.