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Neovalve construction in postthrombotic syndrome.

OBJECTIVE: The purpose of this study was to evaluate a new neovalve construction technique in postthrombotic syndrome. The surgical procedure is described, and preliminary results of the first case series are given. METHODS: From December 2000 to June 2004, neovalve construction in 18 limbs was performed on 16 patients (8 male and 8 female; median age, 55.5 years; range, 34-79 years) to treat severe chronic venous insufficiency in cases of postthrombotic syndrome. Surgical treatment was recommended in cases of nonhealing or recurrent ulcers (CEAP classification class C6). Preoperative duplex scanning, ascending/descending venography, and air plethysmography were routinely performed. Valvular cusps were created by dissecting the thickened venous wall to obtain material with which to fashion a new monocuspid or bicuspid valve. Mean follow-up was 22 months (range, 1-42 months). Postoperative duplex scanning and air plethysmography were performed in all patients. Descending venography was performed after surgery in 15 limbs. RESULTS: In 16 lower extremities (89%), the ulcer healed within 4 to 25 weeks (median, 12 weeks), and no recurrences occurred. Neovalve competence was confirmed in 17 cases (95%). Postoperative duplex scan and air plethysmography showed a significant improvement in hemodynamic parameters (P < .001), especially in younger patients with good muscle pump function. In 17 limbs (95%), the treated segments remained primarily patent at median follow-up of 22 months. Early thrombosis below the neovalve site occurred in two patients (12%). No perioperative pulmonary embolism was observed. A late occlusion occurred in one patient (6%), 8 months after surgery. Minor postoperative complications occurred in three patients (17%). CONCLUSIONS: Neovalve construction seems to be effective in restoring femoral competence in postthrombotic reflux. Although these preliminary results are encouraging, long-term follow-up and a larger series are required to validate the technique.

Adult↗

The site of residual abnormalities in the leg veins in long-term follow-up after deep vein thrombosis and their relationship to the development of the post-thrombotic syndrome.

Two major sequelae of deep vein thrombosis (DVT), obstruction to outflow due to the presence of residual thrombus and reflux due to valvular damage, may contribute to the development of the post-thrombotic syndrome (PTS). We studied the nature and site of residual abnormality, non-invasively with duplex ultrasound, in the veins of 69 limbs in 66 patients, 1 to 6 years after primary acute DVT. There were clinical features of the PTS in 27 limbs and 42 legs were asymptomatic. The pattern of duplex abnormalities was complex and varied for both the PTS and asymptomatic groups. The proportion of abnormal common and external iliac veins and abnormal common, deep and superficial femoral veins was similar for limbs with the PTS and asymptomatic limbs. Twenty-six per cent of legs with the PTS had reflux at the saphenofemoral junction compared with 19% asymptomatic legs (difference not significant). The PTS was associated with proportionally more abnormal popliteal veins (81% vs 55%) and posterior tibial veins (PTV), PTV#1 (41% vs 21%) and PTV#2 (41% vs 14%) when compared with asymptomatic limbs. The odds ratio for a popliteal vein abnormality being associated with the PTS was 3.63 (95% CI 1.16 to 11.43). The odds ratios for PTV#1 and PTV#2 abnormalities in association with the PTS compared to asymptomatic limbs were 2.52 (95% CI 0.87 to 7.31) and 4.13 (95% CI 1.30 to 13.11). In conclusion, residual venous abnormalities after DVT are common and when present in the popliteal and tibial veins are associated with an increased likelihood of PTS expression.

Case-Control Studies↗

[Prospective study of the risk factors for the development of post-thrombotic syndrome after proximal deep venous thrombosis].

BACKGROUND AND OBJECTIVE: The incidence and risk factors for the development of post-thrombotic syndrome (PTS) are not well known, so the aim of our study is to evaluate the development of PTS after proximal deep vein thrombosis (DVT) and its relationship with several clinical, laboratory and therapeutic factors. PATIENTS AND METHOD: Prospective, observational study. INCLUSION CRITERIA: consecutive patients with acute symptomatic proximal DVT in the lower extremities diagnosed between February 2000 and July 2002. EXCLUSION CRITERIA: life expectancy < 12 months, impossibility for follow-up, renal or hepatic failure, previous PTS or varicosis and recurrent thrombosis during follow up. Endpoint: PTS at 12 months. Explicative variables: clinical risk factors for DVT, D-dimer value, hypercoaguable state, anticoagulant therapy and compression stockings compliance. Multivariable analysis (logistic regression) was performed. RESULTS: One hundred and seventy two patients with DVT were evaluated for inclusion. Sixty nine were excluded and 87 patients completed follow-up. PTS appeared in 47 patients (54%). Compliance of compression stockings was adequate in 57% of patients and decreased 45% the risk for PTS (p = 0.01). No significant associations were observed between PTS and others variables. Multivariable analysis confirmed the protective effect of compression stockings (RR = 0.3; p < 0.01) and previous ipsilateral DVT appeared significatively associated with PTS development (RR = 8; p = 0.01) CONCLUSIONS: About 50% of patients with proximal DVT develop PTS within 1 year. Previous ipsilateral DVT is the strongest risk factor for PTS. Regular compression stocking use decreases the risk of PTS by 50%.

Aged↗

The post-thrombotic syndrome: current knowledge, controversies, and directions for future research.

The post-thrombotic syndrome (PTS) is a long-term complication of deep venous thrombosis (DVT) that is characterized by chronic, persistent pain, swelling and other signs in the affected limb. PTS is common, burdensome and costly. It is likely to increase in prevalence, since despite widespread use of and improvements in the efficacy of thromboprophylaxis, the incidence of DVT has not decreased over time. About 20-50% of patients develop PTS within 1-2 years of symptomatic DVT, and severe PTS, which can include venous ulcers, occurs in 5-10% of cases. Although there is no gold standard for the diagnosis of PTS, the presence of typical clinical features in a patient with previous DVT provides strong supporting evidence. Objective evidence of venous valvular incompetence helps to confirm the diagnosis in symptomatic patients. Preventing ipsilateral recurrence of DVT, by ensuring an adequate duration and intensity of anticoagulation for the initial DVT and by prescribing situational thromboprophylaxis after discontinuation of oral anticoagulants, is likely to reduce the risk of developing PTS. There is no proven role for thrombolysis of the initial DVT to prevent PTS. Daily use of graduated compression stockings after DVT may reduce the risk of PTS, and may prevent worsening of established PTS. Pending the results of ongoing studies, stockings are recommended in patients with persistent symptoms or swelling after DVT. Future research should focus on standardizing criteria for PTS diagnosis, identification of DVT patients at high risk for PTS, and rigorously evaluating the effectiveness of stockings, thrombolysis, and venoactive drugs in preventing or treating PTS.

Disease Management↗

[Surgery for deep venous reflux in the lower limb].

UNLABELLED: The effectiveness of the deep venous reconstructive surgery (DVRS) for reflux remains controversial. The more common etiology in deep venous reflux (DVR) is the postthrombotic syndrome, but primary deep vein insufficiency is frequently overshadowed. Valve agenesis is very rare. Clinical examination frequently does not allow distinguishing between superficial and deep venous insufficiency. In addition primary reflux is difficult to identify from secondary deep reflux. INVESTIGATIONS: Duplex scanning provides etiologic, anatomic and hemodynamic information. Plethysmography gives information on the overall severity of the venous disease, but not on the etiology and is not reliable for identifying the predominant component when superficial and deep insufficiencies are combined. It would seem logical to go beyond these investigations only in those patients in whom surgery for DVR may be considered. In absence of contraindication (uncorrectable coagulation disorder, ineffective calf pump) complementary investigations must be carried out: ambulatory venous pressure measurement and venography including ascending and descending phlebography. The goal of DVR surgery is to correct the reflux related to deep venous insufficiency at subinguinal level. But it must be kept in mind that DVR is frequently combined with superficial and perforator reflux, consequently all these mechanisms have to be corrected in order to reduce the ambulatory venous pressure. Surgical techniques can be classified into 2 groups: those with phlebotomy and those without. Outcomes DVRS for reflux are difficult to assess as this surgery is frequently combined with superficial and perforator vein surgery, but both have been usually performed before as first step. Indication for DVRS relies on clinical, hemodynamic and imaging criteria. Etiology is also a decision factor as surgery is more often proposed in primary reflux. DVRS must be performed on specialized and high-trained centers.

Humans↗

A cost analysis of the treatment of patients with post-thrombotic syndrome in Brazil.

INTRODUCTION: Post-thrombotic syndrome (PTS) occurs in 15-50% of patients with deep vein thrombosis (DVT), and is associated with substantial medical costs. This prospective observational study investigated the costs associated with the treatment of PTS in Brazil. MATERIALS AND METHODS: A total of 157 patients diagnosed with PTS and with a history of DVT were recruited from nine centers in Brazil. The costs of investigations and treatment for PTS over a 1-year follow-up period were analyzed. Ninety patients were available for this analysis. RESULTS: Of the 90 patients, 17 had mild-to-moderate PTS, and 73 had severe PTS. The patients with severe PTS tended to undergo more investigations and hospitalizations for PTS than those with mild-to-moderate PTS, although the differences between the two groups did not reach statistical significance. The mean annual cost of treating PTS in Brazilian Reais was 1214 R dollars (426 US dollars) for mild-to-moderate PTS and 3386 R dollars (1188 US dollars) for severe PTS. The difference was mainly due to significantly higher hospitalization costs in patients with severe PTS (704 R dollars/247 US dollars vs. 0 R dollars; p=0.044). CONCLUSION: These results suggest that PTS imposes substantial demands on health care resources in Brazil. The implementation of effective thromboprophylactic strategies could significantly reduce the incidence of DVT, and hence of PTS, potentially resulting in significant cost savings.

Brazil↗

Relation between quality of anticoagulant treatment and the development of the postthrombotic syndrome.

BACKGROUND: About 30% of patients with an episode of adequately treated deep venous thrombosis (DVT) develop the postthrombotic syndrome (PTS) within 2 years. During treatment with vitamin K antagonists (VKA) patients spend only 60% of time between an International Normalized Ratio (INR) of 2.0 and 3.0. We hypothesized that patients who spend a large amount of their time beneath this range will have an increased risk of the PTS. OBJECTIVE: To investigate the relation between the quality of anticoagulant therapy with VKA and the risk of the development of the PTS. METHODS: The time spent beneath the therapeutic range was calculated for patients with a first episode of DVT, who were treated with VKA for at least 3 months. At follow-up assessments for a maximum of 5 years, presence and severity of signs and symptoms of PTS were recorded. RESULTS: A total of 244 patients, with a median duration of follow-up of 4.9 years were included for analysis. Of these, 81 patients (33%) developed the PTS. The multivariate model showed that patients who spend more than 50% of their time beneath an INR level of 2.0 are at higher risk for PTS [odds ratio (OR): 2.71, 95% CI: 1.44-5.10]. CONCLUSIONS: Low quality treatment with VKA, which is a common condition, is related to the occurrence of the PTS in patients with DVT. Strategies aimed at improving the quality of long-term anticoagulation might have the potential to reduce the incidence of this complication.

Aged↗

Quality-of-life improvement using thrombolytic therapy for iliofemoral deep venous thrombosis.

Patients with iliofemoral deep venous thrombosis suffer the most severe postthrombotic morbidity. Techniques that effectively remove thrombus from the venous system eliminate venous obstruction and potentially preserve valvular function. This will likely reduce or avoid the postthrombotic syndrome and improve long-term quality of life. To evaluate whether catheter-directed thrombolysis is associated with improved quality of life compared with anticoagulation alone and whether outcome in the thrombolysis group is related to lytic success, 98 patients with iliofemoral deep venous thrombosis who were treated at least 6 months earlier were identified and queried with a validated health-related quality-of-life questionnaire. Sixty-eight patients were identified through the Venous Registry (a national, multicenter venous registry) and were treated with catheter-directed thrombolysis with urokinase, and 30 patients were identified by means of medical record review and were treated with anticoagulation alone. All patients were candidates for thrombolysis; however, the treatment decision was made according to physician preference. The two treatment groups did not differ significantly in average time between the reference hospitalization and first contact. No difference was found in physical functioning and well-being between the groups before the development of deep venous thrombosis. Following treatment, patients receiving catheter-directed thrombolysis reported better overall physical functioning, less stigma, less health distress, and fewer postthrombotic symptoms compared to those patients treated with anticoagulation alone. Within the thrombolysis group, successful lysis correlated with health-related quality of life. Catheter-directed thrombolysis for the management of patients with iliofemoral deep venous thrombosis significantly improves health-related quality of life compared to similar patients treated with anticoagulation alone. Improved quality of life is related to successful thrombolysis. These data offer a compelling argument for a prospective randomized study.

Adult↗

Surgical removal of an inferior vena cava thrombus.

Studies on the management of inferior vena cava (IVC) thrombosis have rarely focused upon the risk of later development of post-thrombotic syndrome of the lower limbs. From 1983-1989, 52 patients with ilio-femoral thrombosis with an extension of thrombus into the IVC were treated. In addition to lower limb pain and swelling, 12 (23%) patients had symptomatic pulmonary embolism on admission. Perfusion/ventilation pulmonary scans were positive in 63%. Twelve patients received only anti-coagulant treatment. Thrombectomy was attempted in 40 patients, but failed in 13 patients due to old thrombi. Twenty-seven patients had surgical removal of thrombus combined with anti-coagulation [temporary arterio-venous fistula (AVF) and IVC interruption (n = 15); AVF alone (n = 9); and without fistula n = 3)]. The mortality and morbidity were low and hospital stay was not prolonged. Thirty-eight legs were examined at 7-66 months (mean: 23 +/- 3) after initial treatment. The limbs in which the IVC thrombus could not be removed (n = 20) were symptomatic in 25% of patients, venous ulcer developed in 4 of 20 limbs. The ilio-femoral segment was patent in only 35%. The thrombectomised limbs (n = 18) were asymptomatic in 56%; none had developed ulcer and iliac patency was 72%. Doppler investigations and refilling times were normal in 39% of the thrombectomised limbs. All patients without surgical IVC thrombus removal developed contralateral deep venous thrombosis during the follow-up period. This study shows that femoro-ilio-caval thrombectomy is successful only in patients with a short history and fresh clot, and can be safely performed with low morbidity and mortality.(ABSTRACT TRUNCATED AT 250 WORDS)

Adolescent↗

Post-thrombotic syndrome, recurrence, and death 10 years after the first episode of venous thromboembolism treated with warfarin for 6 weeks or 6 months.

BACKGROUND: The influence of the duration of anticoagulant therapy after venous thromboembolism (VTE) on the long-term morbidity and mortality is unclear. AIM: To investigate the long-term sequelae of VTE in patients randomized to different duration of secondary prophylaxis. METHODS: In a multicenter trial comparing secondary prophylaxis with vitamin K antagonists for 6 weeks or 6 months, we extended the originally planned 2 years follow-up to 10 years. The patients had annual visits and at the last visit clinical assessment of the post-thrombotic syndrome (PTS) was performed. Recurrent thromboembolism was adjudicated by a radiologist, blinded to treatment allocation. Causes of death were obtained from the Swedish Death Registry. RESULTS: Of the 897 patients randomized, 545 could be evaluated at the 10 years follow-up. The probability of developing severe PTS was 6% and any sign of PTS was seen in 56.3% of the evaluated patients. In multivariate analysis, old age and signs of impaired circulation at discharge from the hospital were independent risk factors at baseline for development of PTS after 10 years. Recurrent thromboembolism occurred in 29.1% of the patients with a higher rate among males, older patients, those with permanent triggering risk factor - especially with venous insufficiency at baseline - signs of impaired venous circulation at discharge, proximal deep vein thrombosis, or pulmonary embolism. Death occurred in 28.5%, which was a higher mortality than expected with a standardized incidence ratio (SIR) of 1.43 (95% CI 1.28-1.58), mainly because of a higher mortality than expected from cancer (SIR 1.83; 95% CI 1.44-2.23) or from myocardial infarction or stroke (SIR 1.28; 95% CI 1.00-1.56). The duration of anticoagulation did not have a statistically significant effect on any of the long-term outcomes. CONCLUSION: The morbidity and mortality during 10 years after the first episode of VTE is high and not reduced by extension of secondary prophylaxis from 6 weeks to 6 months. A strategy to reduce recurrence of VTE as well as mortality from arterial disease is needed.

Aged↗

The postthrombotic syndrome in relation to venous hemodynamics, as measured by means of duplex scanning and strain-gauge plethysmography.

PURPOSE: Venous hemodynamics were evaluated in relation to the postthrombotic syndrome (PTS) 7 to 13 years after deep venous thrombosis (DVT). METHODS: The presence of flow, reflux, and compressibility of 1394 vein segments in 82 patients was assessed by means of duplex scanning. The venous outflow resistance was measured by means of strain-gauge plethysmography. The venous hemodynamics were related to the clinical severity of the PTS, characterized by the CEAP (clinical, etiologic, anatomic, pathophysiologic) classification. RESULTS: In patients with severe clinical symptoms of PTS, the prevalence of reflux was significantly higher. There was no relationship between the severity of the PTS and the noncompressibility or the combination of reflux and noncompressibility or an increased venous resistance. By means of multiple regression analysis with the variables of age, gender, reflux, and venous resistance, age and reflux were shown to be the main contributors to the severity of PTS. Significantly more patients (64%) with severe signs of PTS had a combination of deep and superficial reflux. In each of the traceable vein segments, the mean of the CEAP classification was calculated for the vein segments with and without reflux. In the proximal superficial femoral vein (P <.001), distal superficial femoral vein (P <.05), and popliteal vein (P <.05), a significantly higher mean CEAP classification was found in the veins with reflux, whereas in the distal, long, and short saphenous veins, no such relationship was found. CONCLUSION: Most patients with severe PTS had a combination of deep and superficial reflux. Reflux in the deep proximal veins contributes significantly to the PTS.

Adult↗

Incidence of post-thrombotic syndrome and its association with various risk factors in a cohort of Spanish patients after one year of follow-up following acute deep venous thrombosis.

Post-thrombotic syndrome (PTS) is a frequent complication of deep venous thrombosis (DVT). However, neither the incidence nor the moment of PTS appearance are known. The main reason are the criteria used to define PTS, the characteristics of the patients, the study design and the time of follow-up. Our aims were to estimate the early incidence of PTS and its associated factors in a cohort of carefully defined DVT patients. 135 patients with a previous episode of acute idiopathic, phlebographically confirmed DVT, in the lower limbs, were followed up over 12 months. Phlebography was then repeated to determine the appearance of PTS. In addition, we used a validated clinical scale in order to assess the correlation between the clinical and phlebographical diagnosis of the PTS. This scale was applied at 6 and 12 months. The incidence of phlebographically confirmed PTS within the first year was 56.3% for the isolated PTS and 5.9% for PTS plus recurrent DVT, regardless of age, sex, platelet count, INR, or anticoagulation. None of these patients could be diagnosed as having PTS using the clinical validated scale. However, those patients with phlebographically diagnosed PTS had a higher clinical score than those without (P=0.012). The only factor related to a higher risk of developing a PTS was the localization of the DVT, subjects with both proximal and distal DVT having the highest incidence (P=0.001). In conclusion, although patients had appropriate anticoagulation, early incidence of PTS was very high, thus making it necessary to develop better diagnostic methods in order to evaluate the PTS impact.

Adult↗

Acute effects of exercise in patients with previous deep venous thrombosis: impact of the postthrombotic syndrome.

BACKGROUND: The postthrombotic syndrome (PTS) occurs frequently after deep venous thrombosis (DVT) and is believed to worsen with upright posture and physical activity. However, the effects of exercise in patients with previous DVT have not been studied. STUDY OBJECTIVES: To determine whether previous DVT and PTS limit the ability to exercise, and whether exercise increases the severity of venous symptoms and signs. DESIGN AND SETTING: A repeated-measures cohort study that was conducted at a university-affiliated teaching hospital, 1999-2000. PARTICIPANTS: Subjects with a first episode of unilateral DVT at least 1 year earlier were recruited from the Thrombosis Clinic (total, 41 subjects; with PTS, 19 subjects). INTERVENTION: Treadmill exercise session. MEASUREMENTS AND RESULTS: Venous symptoms, calf muscle fatigability, flexibility, and leg volume before and after treadmill exercise were measured and compared. Exercise did not worsen venous symptoms, despite a higher gain in affected leg volume in subjects with PTS vs subjects without PTS (mean difference: affected leg, 53 mL; unaffected leg, -15 mL; p = 0.018). Calf flexibility significantly improved after exercise in subjects with PTS (gastrocnemius: affected-unaffected, PTS vs no PTS + 4.5 degrees, p = 0.0029; soleus: affected-unaffected, PTS vs no PTS + 5.7 degrees, p = 0.0011). CONCLUSIONS: Exercise did not acutely exacerbate symptoms and, in subjects with PTS, resulted in improved flexibility in the affected leg. Our findings suggest that treadmill or similar exercise is unlikely to make symptoms of PTS worse, and may improve flexibility. Further study is indicated to determine whether a regular exercise-training program might have a role in the management of patients with PTS, since, to date, the treatment options for this condition are limited.

Adult↗

Postthrombotic syndrome after hip or knee arthroplasty: a cross-sectional study.

BACKGROUND: Although the incidence of the postthrombotic syndrome (PTS) has been addressed in patients with symptomatic deep vein thrombosis (DVT), less information is available on the incidence in patients who develop asymptomatic DVT after major hip or knee arthroplasty. OBJECTIVES: To determine whether symptomatic PTS occurs more frequently in patients who develop DVT after hip or knee arthroplasty than those who are free of DVT and to provide an estimate of the incidence of PTS in patients who had undergone major hip or knee arthroplasty and had proximal DVT, distal (calf) DVT, or no DVT. DESIGN AND SETTING: A cross-sectional study conducted at the Hamilton Health Sciences Corporation, Hamilton, Ontario, and the Academic Medical Centre, Amsterdam, the Netherlands. SUBJECTS AND METHODS: Two hundred fifty-five subjects who had undergone major hip or knee arthroplasty 2 to 7 years previously and had routine predischarge venography showing proximal DVT (n = 25), distal DVT (n = 66), or no DVT (n = 164) were enrolled from March 1993 through December 1998. The presence of symptomatic PTS confirmed by the presence of objectively confirmed venous valvular incompetence was ascertained. RESULTS: The rates of PTS were low and not significantly different among the 3 subgroups: 1 (4.0%, 95% confidence interval [CI] = 0.1%-20.4%) of 25 patients with proximal DVT, 4 (6.1%, 95% CI = 1.7%-14.8%) of 66 patients with distal DVT, and 7 (4.3%, 95% CI = 1.7%-8.6%) of 164 patients with no DVT. CONCLUSIONS: Symptomatic PTS is an uncommon complaint after major hip or knee arthroplasty. Patients who develop postoperative proximal or distal DVT and who receive 6 to 12 weeks of anticoagulant therapy are not predisposed to PTS.

Aged↗

The post-thrombotic syndrome: incidence and prognostic value of non-invasive venous examinations in a six-year follow-up study.

The ability to predict severity of the post-thrombotic syndrome (PTS) early after acute deep-vein thrombosis (DVT) is limited. The aim of our study was to examine the incidence of PTS prospectively and to evaluate the predictive value of non-invasive venous examinations shortly after DVT for the development of PTS. In 93 patients with DVT thrombosis score (TS), reflux, venous outflow resistance (VOR) and calf muscle pump dysfunction (CMP) were examined prospectively. After one, two and six years patients were evaluated for PTS using the clinical scale of the CEAP-classification (PTS present > or = 3 on a scale from 0 to 6). Area under the curves (AUC) were used to evaluate the predictive value of the non-invasive examinations at one and three months after diagnosis of DVT for future PTS. The cumulative incidence of PTS increased from 49% (32/65) after one year to 55% (36/65) and 56% (27/48) after two and six years, whereas the incidence of patients with PTS class 4 progressed from 20% after two years to 33% after six years. The prognostic value to predict PTS was highest for the combination of TS, VOR and reflux measured three months after diagnosis and showed an AUC of 0.77 (0.65-0.90) for PTS after one year. In conclusion, the incidence of PTS after DVT did not increase significantly after one year, whereas during longer follow-up the severity of PTS rose in patients with PTS. Moreover, measurement of TS, VOR and reflux three months after DVT could predict, with reasonable accuracy, the risk of PTS after one year of follow-up.

Adolescent↗

The post-thrombotic syndrome: risk factors and impact on the course of thrombotic disease.

BACKGROUND: The post-thrombotic syndrome (PTS) is a frequent complication of deep vein thrombosis (DVT). Patients with recurrent ipsilateral DVT have an increased risk of PTS; other risk factors are unknown. OBJECTIVES: To establish risk factors of PTS and its impact on venous thrombotic disease. PATIENTS: We prospectively followed 406 patients after a first symptomatic DVT for a median of 60 months. Patients with recurrent DVT, a natural inhibitor deficiency, the lupus anticoagulant, cancer, long-term anticoagulation, an observation time < 18 months and DVT-recurrence prior PTS-assessment were excluded. Study outcomes were occurrence of PTS and recurrent symptomatic DVT. RESULTS: PTS was assessed after 44 +/- 23 months (mean +/- SD) using a clinical classification score. PTS developed in 176 of 406 patients (43.3%). Severe PTS was rare (1.4%). Proximal DVT was the strongest risk factor of PTS [odds ratio (OR) 2.1, 95% confidence interval (CI) 1.3-3.7]. Male gender (OR 1.6, 95% CI 1.0-2.8) and elevated D-dimer levels (OR 1.9, 95% CI 1.0-3.9) were weaker risk factors. Factor V Leiden, factor II G20210A or high factor VIII did not confer an increased risk of PTS. At 4 years, the cumulative probability of recurrence was 7.4% (95% CI 3.2-11.7) among patients with PTS when compared with 1.6% (95% CI 0-3.5; P < 0.02) among patients without PTS. The risk of recurrence was 2.6-fold (95% CI 1.2-5.9) increased when PTS was present. CONCLUSIONS: Proximal DVT, male gender, and high D-dimer levels are independently associated with the development of PTS in patients with a first DVT. Patients with PTS have an increased risk of recurrent venous thromboembolism.

Adult↗

The development of postthrombotic syndrome in relationship to venous reflux and calf muscle pump dysfunction at 2 years after the onset of deep venous thrombosis.

OBJECTIVE: Postthrombotic syndrome (PTS) develops in 40% to 60% of patients with deep venous thrombosis. Factors that are important in the development of PTS include venous reflux, deep vein obstruction, and calf muscle pump dysfunction (CMD). METHODS: Reflux and CMD in relationship to the severity of PTS were evaluated in a 2-year follow-up study of patients with acute deep venous thrombosis. Duplex scanning was used to measure reflux. The supine venous pump function test (SVPT) measures CMD with strain-gauge plethysmography. The base-line examination was performed within 1 to 5 days after diagnosis. The next examinations were scheduled at 3, 6, 12, and 24 months. RESULTS: The study included 86 legs, and the 2-year follow-up period was completed for 70 legs. Significantly more reflux was found in previously thrombosed vein segments, with an odds ratio of 1.8 after 3 months, of 2.1 after 6 months, of 2.5 after 12 months, and of 3.2 after 24 months. Multiple regression results showed that the most important risk factor for early clinical signs of PTS was superficial reflux in months 3, 6, and 12 (P < or =.02). Deep reflux did not have a synergistic relationship with superficial reflux in correlation with the clinical signs of PTS. The SVPT was not able to predict the development of PTS. CONCLUSION: More reflux develops in previously thrombosed vein segments. As early as after the third month, patients with superficial reflux have an increased risk of development of the first clinical signs of PTS. Within 2 years, the SVPT shows no relationship with clinical signs of PTS.

Female↗

Economic burden of deep-vein thrombosis, pulmonary embolism, and post-thrombotic syndrome.

PURPOSE: Deep-vein thrombosis (DVT) and pulmonary embolism (PE) are associated with major morbidity and mortality, with their burden often extending to longer-term complications such as event recurrence and post-thrombotic syndrome (PTS). Few data exist on the overall economic burden of DVT and PE and their sequelae. A retrospective observational cohort study was conducted to determine the direct medical costs of a DVT or PE patient across the entire continuum of care. SUMMARY: Administrative claims data for patients with a DVT or PE diagnosis (ICD-9-CM code) and patients with possible evidence of PTS between January 1, 1997, and March 31, 2004, were extracted from the PharMetrics Patient-Centric Database, which comprises fully adjudicated medical and pharmaceutical claims for U.S. health care-plan enrollees. Resource utilization and annualized direct medical costs of care for patients with DVT and/or PE were calculated and compared with matched controls. A total of 26,958 patients met the study inclusion criteria. Of the 17,634 patients evaluable for the PTS cohort, 663 (3.8%) patients experienced PTS. Patients with DVT, PE, or DVT and PE had higher annualized direct medical costs before the index (initial) DVT and/or PE event (median: $7227, $6381, and $6771, respectively) than controls (median: $1045). During and after the DVT/PE event, annualized median costs rose to $17,512, $18,901, and $25,554, respectively, compared with $680 in the control group. Annualized median total costs for the PTS group were $20,569 compared with $15,843 in matched controls with DVT and/or PE and no PTS. CONCLUSION: These data suggest that the initial acute DVT or PE event is associated with high total health care costs and that these costs are further increased by subsequent events such as recurrent DVT or PE and PTS. Early detection and appropriate treatment of this high-risk population have the potential for both clinical and economic benefits.

Cost of Illness↗