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PubMed1997

Efficacy of Daflon 500 mg in venous leg ulcer healing: a double-blind, randomized, controlled versus placebo trial in 107 patients.

The objective of this study was to evaluate the efficacy of Daflon 500 mg (Dios)* in venous ulcers. A multicenter, double-blind, randomized, controlled versus placebo (Plac) trial was conducted, with stratification according to the size of ulcer (< or = 10 cm and > 10 cm). The protocol called for a two-month treatment with Dios (one tablet = 450 mg micronized purified Diosmin) or a placebo, two tablets/day, in addition to compression therapy. Evaluations were performed every fifteen days, from D0 to D60. The primary endpoint, in accordance with Alexander House group requirements were: percentage of patients with complete ulcer healing, ie, comparison between Dios and Plac group at D60, and comparison of survival curves in each group between D0 and D60 (log rank test). Secondary endpoints included ulcer surface area assessed by computerized planimetric measurements, qualitative evaluation of ulcers, and symptoms. The patients were 105 men and women ranging in age from eighteen to eighty-five years, with standard compression stocking, who were undergoing standardized local care of ulcer and had no significant arterial disease (ankle/arm systolic pressure index > 0.8). Fifty-three patients received Dios, and 52 received Plac. The 2 groups were well matched for age (m +/- 1 SD = seventy-one +/- eleven years), gender, ulcer size, and associated disorders. Among patients with ulcer size < or = 10 cm (Dios = 44, Plac = 47) a significantly larger number of patients had a complete ulcer healing at two months in the Dios group (n = 14) in comparison with the Plac group (n = 6) (32% vs 13%, P = 0.028) with a significantly shorter time duration of healing (P = 0.037). No difference was shown for the secondary criteria, except for sensation of heavy legs (P = 0.039) and a less atonic aspect of ulcer (P = 0.030) in favor of Dios. Among the 14 patients with ulcer size > 10 cm (Dios = 9, Plac = 5), subjected to a descriptive analysis only, no ulcer healed. This study showed that a two-month course of Daflon 500 mg at a daily dose of two tablets, in addition to conventional treatment, is of benefit in patients with venous ulcer < or = 10 cm by accelerating complete healing.

Adolescent↗

PubMed1998

Long-term outcomes after deep venous thrombosis of the lower extremities.

Few natural history studies are available which describe long-term outcomes after venous thromboembolism. However, symptomatic deep-vein thrombosis (DVT) of the lower extremities carries a high risk for recurrent venous thromboembolism that persists for many years. This risk is higher among patients with permanent risk factors including inherited abnormalities of hemostasis than among patients who have suffered trauma or who are postoperative. The development of recurrent ipsilateral DVT carries a high risk for severe post-thrombotic syndrome, an otherwise rare problem in patients with a first episode of DVT adequately treated with anticoagulant drugs and wearing vascular compression stockings. Long-term survival following DVT is generally good in the absence of malignancy. Carefully designed randomized trials are needed to determine whether chronic anticoagulation can reduce further the risks of recurrent DVT and symptoms of post-thrombotic syndrome.

Anticoagulants↗

PubMed2004

Traumatic deep vein thrombosis in a soccer player: A case study.

A 42 year-old male former semi-professional soccer player sustained a right lower extremity popliteal contusion during a soccer game. He was clinically diagnosed with a possible traumatic deep vein thrombosis (DVT), and sent for confirmatory tests. A duplex doppler ultrasound was positive for DVT, and the patient was admitted to hospital for anticoagulation (unfractionated heparin, warfarin). Upon discharge from hospital the patient continued oral warfarin anticoagulation (six months), and the use of compression stockings (nine months). He followed up with his family doctor at regular intervals for serial coagulation measurements, and ultrasound examinations. The patient's only identified major thrombotic risk factor was the traumatic injury. One year after the initial deep vein thrombosis (DVT) the patient returned to contact sport, however he continued to have intermittent symptoms of right lower leg pain and right knee effusion.Athletes can develop vascular injuries in a variety of contact and non-contact sports. Trauma is one of the most common causes of lower extremity deep vein thrombosis (DVT), however athletic injuries involving lower extremity traumatic DVT are seldom reported. This diagnosis and the associated risk factors must be considered during the initial physical examination. The primary method of radiological diagnosis of lower extremity DVT is a complete bilateral duplex sonography, which can be augmented by other methods such as evidence-based risk factor analysis. Antithrombotic medication is the current standard of treatment for DVT. Acute thrombolytic treatment has demonstrated an improved therapeutic efficacy, and a decrease in post-DVT symptoms.There is a lack of scientific literature concerning the return to sport protocol following a DVT event. Athletic individuals who desire to return to sport after a DVT need to be fully informed about their treatment and risk of reoccurrence, so that appropriate decisions can be made.

Journal Article↗

PubMed2002

Venous leg ulcer recurrence: prevention and healing.

After a leg ulcer has healed, well-fitting compression stockings, patient education and regular check-ups are the basis for preventing recurrence. This article examines patterns in recurrence and subsequent healing among patients at an ulcer clinic.

Bandages↗

PubMed2004

Deep vein thrombosis among patients entering cardiac rehabilitation after coronary artery bypass surgery.

BACKGROUND: Little information is available about the prevalence of deep vein thrombosis (DVT) after discharge from cardiac surgery units and its impact on rehabilitation programs. OBJECTIVES: To estimate the rate of DVT, in relation to different thromboprophylaxis strategies, in patients with a recent coronary artery bypass graft (CABG) entering cardiac rehabilitation. METHODS: Two hundred seventy consecutive patients admitted to three rehabilitation facilities after CABG surgery from 19 cardiac surgery units (male patients, 81%; mean +/- SD age, 64 +/- 9 years; interval after operation, 4 to 19 days) underwent serial leg venous ultrasound examination on admission to three rehabilitative units. RESULTS: At admission, antiplatelet treatment was present in all patients except 10 with absolute contraindications. In 171 patients (63%), heparin prophylaxis (low-molecular-weight heparin once daily, 87%; unfractionated heparin twice daily, 13%) was reported, limited to the early postoperative period (< or = 3 days) in 102 patients (38%). DVT was detected in 47 patients (17.4%). The rate of proximal and isolated distal DVT was 2.6% (7 cases) and 14.8% (40 cases), respectively. DVT was complicated in two cases (0.7%) by symptomatic pulmonary embolism, fatal in one case (0.4%). Clots were found in the leg contralateral to the saphenous vein harvest site in half of all DVT cases. Forty-three DVT cases (91%) were diagnosed at admission, while serial ultrasound testing allowed diagnosis of an additional 4 distal DVT cases. At multivariate analysis, female sex (p < 0.001) and length of stay in the surgery unit > 8 days (p < 0.05) were independently associated with risk of DVT in the rehabilitation setting. The adoption of heparin prophylaxis until discharge predicted the absence of DVT after adjustment for immobility (p < 0.05). CONCLUSIONS: This study showed a high rate of DVT in patients entering cardiac rehabilitation after CABG surgery. Wearing unilateral graded compression stockings after CABG surgery had limited efficacy, as clots were often localized in legs contralateral to the saphenous vein harvest site.

Coronary Artery Bypass↗

PubMed2004

Antithrombotic therapy for venous thromboembolic disease: the Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy.

This chapter about antithrombotic therapy for venous thromboembolic disease is part of the seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy: Evidence Based Guidelines. Grade 1 recommendations are strong and indicate that the benefits do, or do not, outweigh risks, burden, and costs. Grade 2 suggests that individual patients' values may lead to different choices (for a full understanding of the grading see Guyatt et al, CHEST 2004; 126:179S-187S). Among the key recommendations in this chapter are the following: for patients with objectively confirmed deep vein thrombosis (DVT), we recommend short-term treatment with subcutaneous (SC) low molecular weight heparin (LMWH) or, alternatively, IV unfractionated heparin (UFH) [both Grade 1A]. For patients with a high clinical suspicion of DVT, we recommend treatment with anticoagulants while awaiting the outcome of diagnostic tests (Grade 1C+). In acute DVT, we recommend initial treatment with LMWH or UFH for at least 5 days (Grade 1C), initiation of vitamin K antagonist (VKA) together with LMWH or UFH on the first treatment day, and discontinuation of heparin when the international normalized ratio (INR) is stable and > 2.0 (Grade 1A). For the duration and intensity of treatment for acute DVT of the leg, the recommendations include the following: for patients with a first episode of DVT secondary to a transient (reversible) risk factor, we recommend long-term treatment with a VKA for 3 months over treatment for shorter periods (Grade 1A). For patients with a first episode of idiopathic DVT, we recommend treatment with a VKA for at least 6 to 12 months (Grade 1A). We recommend that the dose of VKA be adjusted to maintain a target INR of 2.5 (INR range, 2.0 to 3.0) for all treatment durations (Grade 1A). We recommend against high-intensity VKA therapy (INR range, 3.1 to 4.0) [Grade 1A] and against low-intensity therapy (INR range, 1.5 to 1.9) compared to INR range of 2.0 to 3.0 (Grade 1A). For the prevention of the postthrombotic syndrome, we recommend the use of an elastic compression stocking (Grade 1A). For patients with objectively confirmed nonmassive PE, we recommend acute treatment with SC LMWH or, alternatively, IV UFH (both Grade 1A). For most patients with pulmonary embolism (PE), we recommend clinicians not use systemic thrombolytic therapy (Grade 1A). For the duration and intensity of treatment for PE, the recommendations are similar to those for DVT.

Evidence-Based Medicine↗

PubMed2000

Current practices in the prophylaxis of venous thromboembolism in bariatric surgery.

BACKGROUND: Morbidly obese patients undergoing bariatric surgery have commonly been concluded to be at high risk for the development of perioperative venous thromboembolism. Due to its clinically silent nature, primary prevention is the key to reduce morbidity and mortality. There is no clear consensus in the literature regarding the optimum approach to minimize this preventable phenomenon. METHODS: Members of the American Society for Bariatric Surgery were surveyed regarding their current practices in the prophylaxis of venous thromboembolism in their bariatric patients. RESULTS: 31% of the members completed the survey. 62% were in private practice, and 38% practiced in an academic hospital. The number of bariatric surgeries done per year ranged from 5 to 325, with a mean of 85 procedures per member. The gastric bypass was the most commonly performed procedure at 61.7%, followed by vertical banded gastroplasty at 23.3%, biliary pancreatic diversion at 9.3%, laparoscopic gastroplasty at 4.0%, laparoscopic gastric bypass at 1.6%, and horizontal banded gastroplasty at 0.1%. 86% felt that their bariatric patients were at high risk for developing deep vein thrombosis (DVT) and pulmonary embolism (PE) with a self-reported incidence of 2.63% and 0.95%, respectively. 48% had at least one death due to PE. Routine prophylaxis is used by over 95% of members. 62% ranked the various methods of prophylaxis from most preferred to least preferred, while 38% used a combination of 2 or more prophylactic methods simultaneously. Low-dose heparin was the most preferred prophylaxis by 50% of members, followed by intermittent pneumatic compression stockings at 33%, low molecular weight heparins at 13%, and other methods at 4%. Over 83% indicated that safety with few complications, ease of administration, and effectiveness were the most important criteria for selecting their most preferred prophylactic method. Only 2% routinely performed testing to rule out venous thromboembolism before discharge, and 11% routinely discharged patients with prophylaxis. CONCLUSIONS: The prevailing opinion of members of the American Society for Bariatric Surgery is that morbidly obese patients are at high risk for developing perioperative venous thromboembolism. A vast majority routinely use prophylaxis. Despite these measures, fatal PE is still widespread. A lack of consensus in the method of prophylaxis was seen. A multicentric randomized controlled study comparing the efficacy of the various methods of prophylaxis will be the only manner to determine the best prophylaxis and its usefulness. This study will be costly and probably not warranted due to the low incidence of this condition in the morbidly obese patient.

Data Collection↗

PubMed2000

[A new optoelectronic measuring device for assessment of leg circumference in comparison with manual measurement].

For compression treatment to be effective in patients with chronic venous insufficiency, it is vital that leg circumference be measured accurately. If compression stockings are custom fit and appropriate for the medical indications, patient compliance will be high. Exact measurements of circumference and length are prerequisites for a good fit. The aim of the present study was to compare an opto-electronic device for the contact-free measurement of calf circumference with the conventional manual method using a tape measure. We investigated the differences between the results obtained with the two methods, and also their reproducibility. Circumferences were measured at defined heights on an anatomically shaped non-yielding leg model and on the leg of a healthy volunteer by 10 different experimenters both with the tape measure and with the opto-electronic device. The calf circumferences measured manually with the tape measure varied significantly more than those measured opto-electronically, both in the leg model and in the leg of the volunteer. A systematic error in the opto-electronic method appears unlikely, since the manual measurements on the leg model were both larger and smaller than those obtained with the opto-electronic device. Reproducibility was exceptionally high with the opto-electronic device (standard deviation 0.11-0.42 cm). The opto-electronic method yields rapid accurate measurements of circumference with excellent intra- and inter-operator reproducibility.

Anthropometry↗

PubMed1998

Rational antithrombotic therapy and prophylaxis in elderly, immobile patients.

The aging process is associated with increased coagulation and fibrinolysis parameters, resulting in an overall 'prethrombotic state'. This probably explains the increased baseline susceptibility of elderly patients to the development of thromboembolic disease. Additional factors such as major surgery or malignant disease multiply the risk of thromboembolism in this population. Even when adequate antithrombotic therapy is instituted, the mortality associated with thromboembolic disease remains considerable; this underlines the importance of adequate thromboembolic prophylaxis. At present, the use of low molecular weight heparins (LMWHs) in elderly immobile patients appears to be the most effective approach to prophylaxis. The use of compression stockings seems to be effective in the prevention of venous thrombosis, at least in moderate risk surgical patients. In patients undergoing orthopaedic surgery, additional prophylaxis (e.g. with an LMWH) is necessary. In the management of venous thrombosis, patients can initially be treated with a bodyweight-adjusted dosage of an LMWH. In patients with deep vein leg thrombosis or pulmonary embolism, oral anticoagulant therapy should be started as soon as possible, and should be continued for 6 months. However, before starting prophylaxis or therapy, an individual risk assessment should be performed in which the benefits and disadvantages are balanced. Most of the large trials that have studied the effects of thromboembolic prophylaxis have focused on postsurgical patients. However, it will be of great interest to develop more specific prophylactic and therapeutic regimens for different nonsurgical high risk subgroups of patients, particularly the elderly.

Aged↗

PubMed1989

Thromboprophylaxis in hip arthroplasty. Dextran with graded compression or preoperative dextran compared in 150 patients.

Totally, 150 patients, subjected to total hip arthroplasty, were randomly allocated into three prophylactic groups with either conventional dextran alone or with additional graded compression stockings or with additional preoperative administration of dextran. The overall frequency of deep venous thrombosis (DVT), as studied by radioactive fibrinogen uptake test and ascending phlebography of the operated on thigh was in the conventional dextran group 46 percent, the additional stockinged group 30 percent, and in the additional preoperative dextran group 52 percent. In the stockinged group, there was a lower frequency of DVT in the nonoperated on leg as well as, on an average, about 350 mL less peroperative bleeding as compared with the other two groups. No adverse reaction occurred from dextran administration. Increased and prolonged postoperative administration of dextran decrease the number of femoral DVTs.

Aged↗

PubMed1990

Lower thrombosis risk with epidural blockade in knee arthroplasty.

Thirty-six patients scheduled for knee arthroplasty were randomized to general or epidural anesthesia that was prolonged into the postoperative period. All the patients wore graded compression stockings until full ambulation. No other thrombo-prophylactic treatment was given. In diagnosing deep venous thrombosis, bilateral ascending venography was performed 9-11 days after surgery. The incidence of thrombosis was 2/13 in the epidural group versus 10/16 in the general anesthesia group (P less than 0.05).

Adult↗

PubMed1991

Prevention of thromboembolism in 190 hip arthroplasties. Comparison of LMW heparin and placebo.

Prophylactic efficacy and safety of a low molecular weight (LMW) heparin against postoperative thromboembolic complications were investigated in a double-blind, randomized study. Totally, 210 consecutive patients undergoing total hip replacement were allocated to two groups. Patients in the heparin group received 50 IU anti-Xa per kilo body weight of Logiparin once daily, and patients in the placebo group received one daily injection of saline. Additional prophylaxis in all the patients was thigh-length compression stockings beginning on the day of the operation. Deep vein thrombosis was diagnosed by bilateral ascending phlebography between Days 8 and 10 after the operation. Twenty patients were excluded from the evaluation. Thirty of 93 patients in the heparin group compared with 45 of 97 patients in the placebo group suffered a thromboembolic complication during the study (P = 0.02). The postoperative blood loss and total number of blood transfusions in the heparin group were higher than in the placebo group. However, the observed differences were of no clinical importance. Adverse effects, including bleeding complications and wound hematomas, were observed in 13 heparin patients and 7 placebo patients (NS). One patient in each group died. Thrombo-prophylaxis with LMW heparin once daily was safe and more effective than the placebo in patients undergoing total hip replacement.

Adult↗

PubMedDate not supplied

Approach to leg edema of unclear etiology.

A common challenge for primary care physicians is to determine the cause and find an effective treatment for leg edema of unclear etiology. We were unable to find existing practice guidelines that address this problem in a comprehensive manner. This article provides clinically oriented recommendations for the management of leg edema in adults. We searched on-line resources, textbooks, and MEDLINE (using the MeSH term, "edema") to find clinically relevant articles on leg edema. We then expanded the search by reviewing articles cited in the initial sources. Our goal was to write a brief, focused review that would answer questions about the management of leg edema. We organized the information to make it rapidly accessible to busy clinicians. The most common cause of leg edema in older adults is venous insufficiency. The most common cause in women between menarche and menopause is idiopathic edema, formerly known as "cyclic" edema. A common but under-recognized cause of edema is pulmonary hypertension, which is often associated with sleep apnea. Venous insufficiency is treated with leg elevation, compressive stockings, and sometimes diuretics. The initial treatment of idiopathic edema is spironolactone. Patients who have findings consistent with sleep apnea, such as daytime somnolence, loud [corrected] snoring, or neck circumference >17 inches, should be evaluated for pulmonary hypertension with an echocardiogram. If time is limited, the physician must decide whether the evaluation can be delayed until a later appointment (eg, an asymptomatic patient with chronic bilateral edema) or must be completed at the current visit (eg, a patient with dyspnea or a patient with acute edema [<72 hours]). If the evaluation should be conducted at the current visit, the algorithm shown in Figure 1 could be used as a guide. If the full evaluation could wait for a subsequent visit, the patient should be examined briefly to rule out an obvious systemic cause and basic laboratory tests should be ordered for later review (complete blood count, urinalysis, electrolytes, creatinine, blood sugar, thyroid stimulating hormone, and albumin).

Algorithms↗

PubMed2004

Prophylaxis for deep venous thrombosis in neurosurgical oncology: review of 2779 admissions over a 9-year period.

OBJECT: Management of disease in patients undergoing neurosurgical treatment for tumors requires balancing the competing risks of hemorrhage and thrombosis. The authors compared the incidence of clinically apparent deep venous thrombosis (DVT) and pulmonary embolism (PE) in patients admitted for treatment of intracranial and spinal tumors at three institutions. At the public hospital (the Royal North Shore Hospital [RNSH]) nonsequential calf compression was used, and at the other two private neurosurgery services sequential calf compression with low-molecular-weight heparin was used in patients undergoing spinal surgery. All patients wore compression stockings and underwent follow-up scanning after surgery. METHODS: The authors identified from their neurosurgery databases 2779 discharges of patients with tumor from the RNSH and private hospitals between January 1, 1995 and December 31, 2003. Patient admissions were relatively well matched for age, sex, duration of stay, and tumor type. For patients who underwent spinal surgery, the incidence of DVT was higher in the RNSH (2.6% of admissions) than in private hospitals, where no case of DVT was seen (p = 0.02). The incidence of PE was higher in admissions patients who had been treated for cranial tumors in the RNSH (2.9%) than in those treated in the private hospitals (1.3%, p = 0.01). Possible reasons for these discrepancies include a higher proportion of ambulatory patients before and after surgery in the group treated at private hospitals. More emergency and semi-emergency surgery was performed in the RNSH than in the private hospitals. Nevertheless, fewer patients discharged from the RNSH had undergone surgery, which is a known risk factor for DVT. CONCLUSIONS: Patients with intracranial tumors had a higher incidence of PE than those with spinal tumors. The incidence of DVT and PE was higher in patients admitted to the public hospital. The incidence of DVT in patients undergoing spinal procedures was lower when low-molecular-weight heparin was used judiciously, but the incidence of PE in patients undergoing cranial procedures was lower with the private hospital protocol, which did not include prophylaxis with anticoagulating agents.

Anticoagulants↗

PubMed1995

Nursing care of elders with leg edema.

1. Leg edema is a common problem in the elderly, with diverse etiologies. 2. Raised-leg exercise is only effective for the leg edema due to venous insufficiency. 3. Compression stockings have been shown to be effective only for a limited time and may not be useful for individuals with disproportionately large thighs and/or who are noncompliant to usage.

Aged↗

PubMed1999

Issues and controversies in venous thromboembolism.

This paper gives specific recommendations on a number of issues in venous thromboembolism: how to evaluate idiopathic deep vein thrombosis (DVT); how to treat calf vein thrombosis and upper-extremity DVT; how to use low-molecular-weight heparin, vena cava filters, catheter-directed thrombolytic therapy, and compression stockings; how long to continue anticoagulation therapy; and how to manage recurrent DVT.

Adult↗

PubMed1991

Venous ulceration: factors influencing recurrence after standard surgical procedures.

Ninety patients with chronic venous ulceration were investigated to determine the extent of the incompetence of the venous valves. They were then treated by established surgical methods to control reflux. All wore fitted compression stockings and were regularly followed up. Forty-two patients had valvular incompetence confined to the perforating and superficial veins. All their ulcers healed and only one developed a minor recurrence during the three year follow-up. Nineteen patients had additional but limited incompetence of the deep veins; all their ulcers healed, but three developed a recurrence. Twenty-nine patients had extensive deep vein valvular incompetence including incompetence of the popliteal valve; in 12 of these patients either the ulcer failed to heal or the patient developed a recurrent ulcer within 18 months. Thirty-two other patients developed further venous reflux from the opening of new channels, including the perforating veins of the foot, and required sclerosants or local ligation. It was concluded that established surgical techniques, thoroughly performed, were very effective for the treatment of chronic venous ulceration provided the popliteal valves were competent. When the popliteal valves were incompetent the recurrence rate was unacceptably high and additional methods, including vein valve transplants, excision of the ulcer with skin grafting and lumbar sympathectomy, were considered. Nine of 11 patients who received a vein valve transplant had falls in their ambulant venous pressures, improvement in the nutrition of their skin and healing of their recurrent ulcers.

Bandages↗

PubMed1998

Clinical therapeutic conference: recurrent venous thrombotic and thromboembolic disease.

Recurrent venous thrombotic and thromboembolic disease, once thought to be an uncommon entity, is increasingly being recognized. Etiologies of recurrent deep venous thrombosis usually include elements of Virchow's triad. Venous stasis (e.g., immobilization, congestive heart failure, acute myocardial infarction, obesity), hypercoagulability (e.g., malignancy, inflammatory bowel disease, hyperhomocysteinemia, protein C resistance, antithrombin III, protein C or S deficiency) and endothelial trauma (e.g., surgical trauma, venous trauma, in-dwelling venous instrumentation) are risk factors. Diagnosis is dependent on objective testing, including venography duplex Doppler (color) ultrasonography and impedance plethysmography. Treatment is usually started with heparin or low-molecular-weight heparin and advanced to warfarin (adjusted to international normalized ratio). Prophylaxis may continue using low-molecular-weight heparin, warfarin, venacaval interruption (Greenfield filter), or concomitant use of the platelet-active agent indobufen and graduated compression stockings.

Anticoagulants↗