Infrainguinal inflow assessment and endovenous stent placement in iliofemoral post-thrombotic obstructions.

PURPOSE: To assess the technical success, patency, and clinical outcome, following assessment of inflow and infrainguinal endovenous stent placement in patients with iliofemoral post-thrombotic obstruction with infrainguinal involvement. METHODS: A retrospective analysis of 39 patients with iliofemoral post-thrombotic venous obstruction accepted for infrainguinal stent placement in the period November 2009-December 2016. The clinical status was categorized according to the Clinical Etiological Anatomical Pathophysiological (CEAP) classification and symptom severity was assessed using Venous Clinical Severity Score (VCSS). The inflow was categorized as "good", "fair", or "poor" depending on vein caliber and extent of post-thrombotic changes in the inflow vessel(s). Stent patency was assessed by duplex ultrasound. Median follow-up was 44 months (range 2-90 months). RESULTS: Stent placement was successful in all 39 patients. Primary patency after 24 months was 78%. Thirty of 39 patients (77%) had open stents at final follow-up. Re-interventions were performed in four patients and included catheter-directed thrombolysis (CDT) in all and adjunctive stenting in two. Twenty-eight of 39 patients (72%) reported a sustained clinical improvement. Patients with "good" inflow had better patency compared to those with "fair"/"poor" (p = 0.01). One patient experienced acute contralateral iliofemoral thrombosis; this segment was successfully treated with CDT and stenting. No other complications required intervention. CONCLUSION: Infrainguinal endovenous stent placement was a feasible and safe treatment with good patency and clinical results, and should be considered in patients with substantial symptoms from post-thrombotic obstructions with infrainguinal involvement. Stents with good inflow have better patency and inflow assessment is essential in deciding the optimal stent landing zone.

Post-thrombotic syndrome after catheter-directed thrombolysis for deep vein thrombosis (CaVenT): 5-year follow-up results of an open-label, randomised controlled trial.

BACKGROUND: Post-thrombotic syndrome is a common complication after acute proximal deep vein thrombosis (DVT) and is associated with reduced quality of life and a substantial cost burden. In the 2-year results of the CaVenT study, additional catheter-directed thrombolysis reduced the risk of post-thrombotic syndrome by 14% compared with conventional therapy, but did not affect quality of life. In this study we report results at the 5-year follow-up, aiming to assess whether findings for post-thrombotic syndrome and quality of life have persisted. METHODS: Between Jan 3, 2006, and Dec 22, 2009, we recruited patients aged 18-75 years with a first-time high proximal leg DVT from 20 hospitals in the Norwegian southeastern health region. With sealed envelopes, participants were randomly assigned (1:1) to standard treatment with compression stockings and anticoagulants (control group) or to standard treatment plus catheter-directed thrombolysis with alteplase within 21 days from symptom onset. Pre-specified outcomes in this analysis were post-thrombotic syndrome at 5 years as assessed with the Villalta score and scores for quality of life at 5 years with EQ-5D and the disease-specific VEINES-QOL/Sym. Analyses were by intention to treat. The trial is registered with ClinicalTrials.gov, number NCT00251771. FINDINGS: At 5 year follow-up (last date Oct 14, 2014), data were available for 176 patients (84% of the 209 patients originally randomised)--87 originally assigned to catheter-directed thrombolysis and 89 originally assigned to the control group. 37 patients (43%; 95% CI 33-53) allocated to catheter-directed thrombolysis developed post-thrombotic syndrome, compared with 63 (71%; 95% CI 61-79) allocated to the control group (p<0·0001), corresponding to an absolute risk reduction of 28% (95% CI 14-42) and a number needed to treat of 4 (95% CI 2-7). Four (5%) patients assigned to catheter-directed thrombolysis and one (1%) to standard treatment had severe post-thrombotic syndrome (Villalta score ≥ 15 or presence of an ulcer). Quality-of-life scores with either assessment scale did not differ between the treatment groups. INTERPRETATION: Additional catheter-directed thrombolysis resulted in a persistent and increased clinical benefit during follow-up for up to 5 years, supporting the use of additional catheter-directed thrombolysis in patients with extensive proximal DVT. However, allocation to this therapy did not lead to better quality of life. The optimal endovascular thrombolytic approach needs further investigation. FUNDING: Southeastern Norway Regional Health Authority, the Research Council of Norway, University of Oslo, Oslo University Hospital.

Hereditary lymphedema, characteristics, and variations in 17 adult patients with lymphedema cholestasis syndrome 1/Aagenaes syndrome.

BACKGROUND: The characterizations of primary lymphedemas in different hereditary diseases are often published as case reports. In this study, 17 out of 20 Norweigian adult patients with lymphedema cholestasis syndrome 1 (LCS1)/Aagenaes syndrome were examined. The patients exhibited lymphedema and sporadic cholestasis. Individual clinical variations are described. METHODS AND RESULTS: Lymphedema was classified from Grade I to IV by clinical examinations and ultrasound B-mode scanning. To support the clinical findings, direct segmental multifrequency bioelectrical impedance analysis (DSM-BIA) was included and was compared to healthy matched controls. The lymphedema was similar to other hereditary lymphedemas, with more pronounced fluid retention in the lower extremities. It was generally more extensive, as it also included lymphedema in the arms, face, and trunk. Limited tissue fibrosis was observed, even after long-standing lymphedema. CONCLUSIONS: Approximately one-third of the patients had severe forms of lymphedema in the limbs (grades III and IV) and their conditions required close followup. A more frequent use of compression in the upper extremities is advised.

Residual rates of reflux and obstruction and their correlation to post-thrombotic syndrome in a randomized study on catheter-directed thrombolysis for deep vein thrombosis.

BACKGROUND: Deep vein thrombosis (DVT) often results in venous valvular incompetence and incomplete recanalization, followed by post-thrombotic syndrome (PTS). Treatment with additional catheter-directed thrombolysis (CDT) in patients with an iliofemoral DVT has been shown to reduce the frequency of PTS. The objective of this study was to assess the effect of CDT on venous reflux and patency and to identify possible predictors for the development of PTS. METHODS: Open, multicenter, randomized, controlled clinical trial. Patients (18-75 years) with a first-time iliofemoral DVT were randomized to receive conventional treatment with anticoagulation and compression stockings or CDT in addition to conventional treatment. Follow-up after 6 and 24 months included ultrasound and air plethysmography for evaluation of venous reflux and patency. PTS was assessed with the Villalta score. Possible predictors of PTS were analyzed in multivariate logistic regression models. RESULTS: Following additional CDT, deep venous reflux was detected in 65.2% (95% confidence interval [CI], 54.8-74.2) of patients at 6 months and 66.7% (95% CI, 56.4-75.6) at 24 months. The absolute risk reduction of deep venous reflux was 11.9% (95% CI, 1.1-24.9) after 6 months and 16.5% (95% CI, 4.2-28.8) after 24 months in the CDT arm compared with controls. Correspondingly, venous patency was regained in 65.9% (95% CI, 55.5-75.0) of patients at 6 months and 74.7% (95% CI, 64.9-82.6) after 24 months. Patency was regained in 18.5% (95% CI, 4.4-32.6) more patients after 6 months and 15.1% (95% CI, 1.8-28.5) more patients after 24 months compared with controls. Independent of treatment allocation, patients with fully recanalized and competent deep veins at 6-month follow-up had a 40.5% (95% CI, 26.4-54.7) absolute risk reduction of developing PTS compared with patients with abnormal vein assessment. Reflux and lack of patency at 6 months were found to be independent predictors of PTS development in patients treated with CDT (odds ratio, 8.3; 95% CI, 2.6-26.8 for patients with reflux, and odds ratio, 0.17; 95% CI, 0.06-0.49 for patients with patency). CONCLUSIONS: Additional CDT improved patency and reduced reflux. Both parameters were found to be strong predictors of PTS in patients treated with CDT. Noninvasive vein assessments of patency and reflux may be helpful to identify and monitor patients at high risk of PTS. Our findings provide evidence for the importance of early recanalization with CDT for acute iliofemoral DVT.

Review of postoperative CT and ultrasound for endovascular aneurysm repair using Talent stent graft: can we simplify the surveillance protocol and reduce the number of CT scans?

BACKGROUND: Simplifying a postoperative surveillance protocol for endovascular aneurysm repair (EVAR) requires quality control comparing computerized tomography (CT) and ultrasound (US) results of abdominal aortic aneurysm (AAA) diameter measurements and endoleaks. PURPOSE: To test if US is comparable to CT, then assess a simplified follow-up with our conventional surveillance to assess patient safety. MATERIAL AND METHODS: During 2001-2006, data on 56 patients treated with Talent stent graft were prospectively registered. Median follow-up was 41.5 months (range, 2-94 months), with CT, US, and plain film abdomen X-rays (PFA) at 1, 6, and 12 months, then yearly. Bland-Altman plot was used to assess the agreement between CT and US measuring the AAA diameters and mixed model by the time effect to assess the difference in diameter over time. Sensitivity and specificity for detection of endoleaks by US, with CT as 'gold standard' were calculated. A simplified surveillance protocol with US/PFA at 6 and 8 weeks, CT/US/PFA at 1 year, and yearly US/PFA thereafter, was evaluated. CT was carried out when poor visibility, endoleak detected, AAA diameter increase (≥5 mm) on US or migration (≥10 mm) on PFA. This regime was compared with our conventional follow-up protocol. RESULTS: Diameter measurements on US appear comparable to CT with 91% specificity and 85% sensitivity for endoleaks detected by US. Using the simplified surveillance protocol no endoleaks, migrations, or endotension requiring treatment were overlooked. The simplified protocol generated 53 selective CT scans, avoiding approximately 144 CT scans. If further simplified by omitting the 1-year CT scan, one type II endoleak would be missed with a 1-year delay, eliminating a further 45 CT scans. CONCLUSION: US appears comparable to CT in the follow-up of Talent stent grafts in our institution. The proposed simplified surveillance protocol seems safe and can lead to a significant reduction in the number of CT scans.

Determinants of early and long-term efficacy of catheter-directed thrombolysis in proximal deep vein thrombosis.

PURPOSE: Catheter-directed thrombolysis (CDT) for proximal deep vein thrombosis (DVT) effectively enhances clot removal and recently has been shown to reduce the development of postthrombotic syndrome (PTS). This study was performed to identify potential markers for early and long-term efficacy of CDT, adverse events, and their interrelationship. MATERIALS AND METHODS: Patients aged 18-75 years (mean, 54 y; 33 women) with first-time proximal DVT and symptoms up to 21 days were included in subanalyses in an open, multicenter, randomized, controlled trial. Early efficacy was assessed with a thrombus score based on daily venography. Six-month and 2-year follow-up included iliofemoral patency assessed with duplex ultrasound and air plethysmography, and PTS was assessed with the Villalta scale. RESULTS: A mean clot resolution of 82%±25 was achieved in 92 patients. Successful lysis (ie,≥50%) was obtained in 83 patients. Early efficacy was equal for femoral and iliofemoral thrombus and not related to thrombus load before CDT, symptom duration, or predisposing risk factors. Lower thrombus score at completion of CDT was associated with increased patency at 24 months (P = .040), and increased patency after 6 and 24 months was correlated with reduced development of PTS after 24 months (P<.001). Bleeding complications were mainly related to the puncture site, and popliteal vein access led to fewer bleeding incidents. CONCLUSIONS: Comp, this is a Clinical Study article, so, as noted on the TOC, the Conclusions section of the abstract gets listed on the TOC. CDT via popliteal access was safe, effectively removed clots, and restored iliofemoral patency. Preprocedure evaluation did not identify patients who did not benefit from treatment. Early efficacy and follow-up patency are of importance to reduce the risk for PTS.

Long-term outcome after additional catheter-directed thrombolysis versus standard treatment for acute iliofemoral deep vein thrombosis (the CaVenT study): a randomised controlled trial.

BACKGROUND: Conventional anticoagulant treatment for acute deep vein thrombosis (DVT) effectively prevents thrombus extension and recurrence, but does not dissolve the clot, and many patients develop post-thrombotic syndrome (PTS). We aimed to examine whether additional treatment with catheter-directed thrombolysis (CDT) using alteplase reduced development of PTS. METHODS: Participants in this open-label, randomised controlled trial were recruited from 20 hospitals in the Norwegian southeastern health region. Patients aged 18-75 years with a first-time iliofemoral DVT were included within 21 days from symptom onset. Patients were randomly assigned (1:1) by picking lowest number of sealed envelopes to conventional treatment alone or additional CDT. Randomisation was stratified for involvement of the pelvic veins with blocks of six. We assessed two co-primary outcomes: frequency of PTS as assessed by Villalta score at 24 months, and iliofemoral patency after 6 months. Analyses were by intention to treat. This trial is registered at ClinicalTrials.gov, NCT00251771. FINDINGS: 209 patients were randomly assigned to treatment groups (108 control, 101 CDT). At completion of 24 months' follow-up, data for clinical status were available for 189 patients (90%; 99 control, 90 CDT). At 24 months, 37 (41·1%, 95% CI 31·5-51·4) patients allocated additional CDT presented with PTS compared with 55 (55·6%, 95% CI 45·7-65·0) in the control group (p=0·047). The difference in PTS corresponds to an absolute risk reduction of 14·4% (95% CI 0·2-27·9), and the number needed to treat was 7 (95% CI 4-502). Iliofemoral patency after 6 months was reported in 58 patients (65·9%, 95% CI 55·5-75·0) on CDT versus 45 (47·4%, 37·6-57·3) on control (p=0·012). 20 bleeding complications related to CDT included three major and five clinically relevant bleeds. INTERPRETATION: Additional CDT should be considered in patients with a high proximal DVT and low risk of bleeding. FUNDING: South-Eastern Norway Regional Health Authority; Research Council of Norway; University of Oslo; Oslo University Hospital.

[Surgical treatment of chronic venous insufficiency]. / Kirurgi ved kronisk venøs insuffisiens.

BACKGROUND: Patients with chronic venous insufficiency (CVI) may develop serious symptoms such as pain, oedema, venous claudication and leg ulcers. Conventional therapy includes compression therapy, elevation of the extremities, and in some cases surgical elimination of superficial varicose veins. This article presents and discusses surgical treatment (reconstructive deep venous surgery and transplantation) and endovascular therapy (percutaneous recanalization of post-thrombotic deep venous occlusions). MATERIAL AND METHODS: The article is based on literature identified through non-systematic searches in the PubMed and Cochrane databases. RESULTS: After reconstructive deep venous surgery, ulcer healing is reported in 60-78 % of cases and clinical improvement in 90 %. After such surgery, the median ulcer-free period seems to be longer in primary (congenital, familial), 54 months, than in secondary (after deep vein thrombosis) chronic venous insufficiency (18 months). Recanalization of deep venous occlusions is successful in 90 % of patients who have undergone endovascular treatment of venous claudication and leg ulcer. INTERPRETATION: Reconstructive deep venous surgery constitutes a real treatment choice for patients with chronic venous insufficiency for whom conventional measures have failed. The benefits are ulcer-free periods, clinical improvement, return to work and improved quality of life.

[Venous insufficiency in the lower limbs]. / Venøs insuffisiens i underekstremitetene.

BACKGROUND: Venous insufficiency is a common condition that presents with various symptoms and is often treated inadequately. The purpose of the article is to provide an overview of the prevalence, recommended investigations and indications for treatment of venous insufficiency. MATERIAL AND METHOD: The literature reviewed was identified through a non-systematic search in PubMed based on the authors' experience in research, investigations and treatment of this patient group. RESULTS: Venous insufficiency is a common condition with a prevalence of about 30 %. Some patients will develop distal dystrophic skin changes (prevalence

Catheter-directed Venous Thrombolysis in acute iliofemoral vein thrombosis--the CaVenT study: rationale and design of a multicenter, randomized, controlled, clinical trial (NCT00251771).

BACKGROUND: The conventional treatment of acute deep vein thrombosis (DVT) is anticoagulation and compression therapy, as recommended in the international guidelines. Anticoagulation prevents recurrent venous thrombosis, pulmonary embolism, and death. Compression therapy reduces the risk of developing long-term sequelae, that is, postthrombotic syndrome (PTS). Evaluation of systemic thrombolysis has shown effective thrombolysis and a likely reduction in PTS but at the cost of increased risk of bleeding complications. Catheter-directed thrombolysis (CDT) was introduced for rapid removal of thrombi and salvage of venous valves with less systemic thrombolytic effect, and is being offered to selected patients with iliofemoral DVT to prevent development of PTS. Case series have shown technical and thrombolytic success; however, no randomized studies have evaluated the long-term clinical effects of venous CDT. The aim of the CaVenT study is to investigate the role of adjunctive CDT by evaluating its clinical efficacy and safety compared with conventional treatment alone in patients with acute iliofemoral DVT. METHODS: The CaVenT study is an open, randomized, controlled, clinical trial. We plan to include 200 patients who will receive either CDT, in addition to conventional treatment, or conventional treatment alone. The primary outcome measures are patency at 6 months and prevalence of PTS at 2 years. CONCLUSION: Implementation of the CaVenT study will be a contribution toward evidence-based medicine in the treatment of acute proximal DVT of the leg. Any documentation of improved functional outcome will have a significant impact on clinical practice for this patient group and may lead to a modification of existing international guidelines.

Edema in the lower limb of patients operated on for proximal femoral fractures.

BACKGROUND: Patients with proximal femoral fracture (PFF) often develop postoperative edema in the operated limb. This may lead to reduced mobilization, increasing the length of hospitalization. It is therefore relevant to gain information about the extent and pathogenesis of this edema formation. METHODS: Forty-one patients with PFF (30 women and 11 men) were studied pre- and postoperatively. Patients were grouped into pertrochanteric fractures and femoral cervical fractures, according to the AO/ASIF classification of PFF. Thigh and calf volumes were calculated in both fractured and contralateral limbs preoperatively and on postoperative days 3, 5, 7, and 30. RESULTS: All patients with PFF developed edema in the operated limb. The greatest volume increase occurred on postoperative day 7 (p < 0.0005). The magnitude of edema in the thigh and the leg of patients with pertrochanteric fractures as compared with the nonoperative side was approximately twice as great as in those with femoral cervical fractures (p < 0.0001). There was a statistically significant daily increase in the volume of the operative limb as compared with the nonoperative side. Age and sex were not correlated with the extent of edema formation. Functionally significant deep venous thrombosis and local infection could be excluded as causative factors. CONCLUSIONS: Postoperative edema in the thigh and leg of the operated limb was considerable. The magnitude of edema formation was related to the severity of primary trauma and the type of osteosynthesis. Therefore, the operation performed for PFF should be minimally traumatic.

[Venous leg ulcers]. / Venøse leggsår.

Patients with venous leg ulcers usually have extensive symptoms both related to their venous insufficiency and to the wound itself, often combined with a reduced quality of life. Prevalence of venous leg ulcers varies from 0.1 to 1.0%. Treatment costs are high and may amount to 1.5% of a nation's total spending on health care. Venous hypertension is the common denominator for all patients with venous leg ulcers. Isolated superficial as well as deep or combined venous insufficiency with or without insufficient perforators may cause ulceration. In the microcirculation, inflammation is involved, but the exact mechanisms behind the ulcer formation remain unresolved. During the examination, a presence of superficial venous insufficiency accessible for superficial resection must be established. In addition to a clinical examination, venous pressure measurements/plethysmography and colour duplex scanning is recommended in order to locate and evaluate the significance of the venous insufficiency. The key element in the treatment of venous ulcers is to reduce oedema and venous hypertension by adequate compression and elevation. If primary superficial venous insufficiency is established, venous resection is recommended. This may improve healing and reduce recurrences. In selected patients, deep venous reconstruction is an alternative approach.

[Arterial ischemic ulcers]. / Arterielle sår i underekstremiteten.

Arterial ischaemic ulcers develop because of inadequate perfusion leading to local ischaemia in the skin and underlying tissue. The most common cause is peripheral arterial disease, giving rise to symptoms like intermittent claudication, rest pain and gangrene, in addition to local ulceration. Diabetes mellitus increases the risk of ulcer formation; admittedly mainly neuropathic ulcers with a low component of peripheral arterial disease. Yet a combination of neuropathy and ischaemia is common ("neuro-ischaemic ulcer"). A thorough patient history and clinical examination can help discriminate arterial ulcers from venous, pressure, traumatic and vasculitis ulcers. Reduction of ankle systolic pressure and calculated ankle/brachial index, sometimes additional other non-invasive laboratory tests, confirm peripheral arterial disease. The primary treatment of arterial ischaemic ulcer is to increase blood supply to the affected area, primarily by endovascular treatment or open arterial reconstruction. Endovascular treatment (balloon angioplasty) is the method of choice because of graft infection risk in patients with open ulcers. Most arterial ischaemic ulcers will progress to healing if the blood supply is reestablished.

[Catheter-directed thrombolysis of iliofemoral venous thrombosis]. / Kateterbasert trombolytisk behandling av bekkenvenetrombose.

BACKGROUND: Although a success rate of 80% has been reported in patients with iliofemoral venous thrombosis treated with catheter-based thrombolysis, the possible long-term benefit of this treatment is not known. MATERIAL AND METHOD: 28 consecutive patients referred for catheter-based thrombolysis of iliofemoral venous thrombosis were treated with infusion of alteplase into the thrombus for two to five days. Following thrombolysis, warfarin was given for at least one year. All patients were examined every six months with colour duplex scanning and air pletysmography. RESULTS: 100% thrombolysis was achieved in eight patients, 75-99% in ten, 50-74% in nine and < 50% in one patient. Angioplasty (four) or stent implantation (four) was successful in eight out of twelve patients with stenosis of the left common iliac vein. Early recurrence of thrombosis (< 7 days) occurred in three patients, pulmonary embolism in one, and bleeding at the insertion site in six. After a mean follow-up of 2.5 years, 17 patients were free of symptoms, seven had a mild degree and four a moderate degree of postthrombotic syndrome. Eighteen patients had normal venous physiology, nine deep venous reflux, and three functional obstruction of deep veins. Postthrombotic syndrome was associated with deep venous reflux and/or functional obstruction of the iliofemoral segment. INTERPRETATION: Catheter-based thrombolysis is a safe and effective treatment of proximal deep venous thrombosis and might reduce the occurrence of postthrombotic syndrome compared to treatment with anticoagulation alone.

[Increased cortisol levels, frostbite and effects on the muscles and skeleton during extreme polar conditions]. / Økt kortisolnivå, frostskader og påvirkning av muskler og skjelett under ekstreme polarforhold.

BACKGROUND: We wanted to record physiological changes, injuries and illnesses during a long sledge expedition in North Canada. MATERIAL AND METHODS: The expedition consisted of four men aged 41 to 50, and 16 polar dogs. Measurements of cortisol in saliva were performed before, during and after the expedition. Frostbites and other injuries were registered continuously. Body weight and muscle, fat and bone mass were measured by dual X-ray absorptiometry scanning, and strength and endurance of shoulders, knees and back were tested. The group encountered extreme frost (-30 to -42 degrees C day temperature), wind, unexpected amounts of pack ice, and poorly motivated dogs. RESULTS AND INTERPRETATION: The participants showed increased free cortisol levels during their stay on the ice, probably because of increased mental stress. Three got first degree and two second-degree frostbites, but the affected areas were normal on vascular examination five months later. All members increased their muscle mass, but muscle strength and endurance remained unchanged.