Hormonal Contraception. Guideline of the DGGG, OEGGG and SGGG (S3 Level, AWMF Registry Number 015/015, January 2020).

Aims This is an official interdisciplinary guideline published and coordinated by the German Society for Gynecology and Obstetrics (DGGG), the Austrian Society for Gynecology and Obstetrics (OEGGG) and the Swiss Society for Gynecology and Obstetrics (SGGG). The guideline was developed for use in German-speaking regions and is backed by numerous professional societies and organizations. The aim of this guideline is to provide an evidence- and consensus-based overview of the diagnostic approach and the management of hormonal contraception based on a systematic evaluation of the relevant literature. Methods To compile this S3-guideline, a systematic search for evidence was carried out in PubMed and the Cochrane Library to adapt existing guidelines and identify relevant reviews and meta-analyses. A structured evaluation of the evidence was subsequently carried out on behalf of the Guidelines Commission of the DGGG, and a structured consensus was achieved based on consensus conferences attended by representative members from the different specialist societies and professions. Recommendations Evidence-based recommendations about the advice given to women requesting contraception were compiled. The guideline particularly focuses on prescribing contraceptives which are appropriate to women's individual needs, take account of her personal circumstances, and have few or no side effects.

Prevention of thromboembolism in spinal cord injury -S1 guideline.

INTRODUCTION: Traumatic and non-traumatic spinal cord injury bears a high risk for thromboembolism in the first few months after injury. So far, there is no consented guideline regarding diagnostic and prophylactic measures to prevent thromboembolic events in spinal cord injury. Based on a Pubmed research of related original papers and review articles, international guidelines and a survey conducted in German-speaking spinal cord injury centers about best practice prophylactic procedures at each site, a consensus process was initiated, which included spinal cord medicine experts and representatives from medical societies involved in the comprehensive care of spinal cord injury patients. The recommendations comply with the German S3 practice guidelines on prevention of venous thromboembolism. RECOMMENDATIONS: Specific clinical or instrument-based screening methods are not recommended in asymptomatic SCI patients. Based on the severity of neurological dysfunction (motor completeness, ambulatory function) low dose low molecular weight heparins are recommended to be administered up to 24 weeks after injury. Besides, mechanical methods (compression stockings, intermittent pneumatic compression) can be applied. In chronic SCI patients admitted to the hospital, thromboembolism prophylactic measures need to be based on the reason for admission and the necessity for immobilization. CONCLUSIONS: Recommendations for thromboembolism diagnostic and prophylactic measures follow best practice in most spinal cord injury centers. More research evidence needs to be generated to administer more individually tailored risk-adapted prophylactic strategies in the future, which may help to further prevent thromboembolic events without causing major side effects. The present article is a translation of the guideline recently published online (https://www.awmf.org/uploads/tx_szleitlinien/179-015l_S1_Thromboembolieprophylaxe-bei-Querschnittlaehmung_2020-09.pdf).

Sex hormones and venous thromboembolism - from contraception to hormone replacement therapy.

The use of sex hormones such as combined oral contraceptives (COC) or hormone replacement therapy (HRT) increases the risk for venous thromboembolism (VTE) considerably, especially in patients with an increased intrinsic risk for thromboembolic complications. Despite public and media attention and increasing scientific evidence, prescription patterns seem to be hard to change. It is well recognized that the patient's baseline risk is the most relevant factor in the absolute risk for developing VTE. The relative risk increase associated with sex hormones, depends on the type and dosage of hormones, the route of application (oral, vaginal, transdermal), and for COC, on the specific combination of oestrogen and gestagen components. Consequently, a careful decision for or against any specific type of hormone treatment needs to be based on an assessment of the patient's risk profile (disposition) as well as on the treatment-associated risks and benefits (exposition). This review discusses the most common sex hormone treatments in contraception and HRT, the relevance for VTE risk patients, and strategies to counsel patients with regard to hormone use according to their risk profiles. Keywords: Oral contraceptives, hormonal contraception, hormone replacement therapy, venous thromboembolism.

Post-thrombotic syndrome 3 years after deep venous thrombosis in the Thrombosis and Pulmonary Embolism in Out-Patients (TULIPA) PLUS Registry.

BACKGROUND: Reported post-thrombotic syndrome (PTS) rates may be confounded by including patients with a history of deep venous thrombosis (DVT) before the index event, varicose veins, or chronic venous insufficiency independent of PTS. We were interested in assessing PTS incidence rates of patients without these pre-existing disease conditions. METHODS: A prospective registry with a 3-year follow-up after an initial DVT was assessed. Available for analysis were 135 ambulatory patients without a history of DVT (before the index DVT), signs of varicose veins, or chronic venous insufficiency affecting the ipsilateral or contralateral leg, and Villalta score. RESULTS: PTS was detected in 24.5% of patients, with 17.0% having mild (Villalta score, 5-9), 6.0% moderate (score, 10-14), and 1.5% severe PTS (score ≥15) after a first DVT. Of these, 52.6% had proximal and 47.4% distal DVT; 63.7% were provoked and 35.6% unprovoked (one patient missing). Patients with proximal DVT (32.4%) significantly more often developed any PTS compared with patients with distal DVT (15.6%; P = .024); however, groups were similar with regard to severity of PTS by the four-level Villalta score (P = .109). In univariate analysis, PTS was more frequent (odds ratio, 95% confidence interval) with higher age (1.06 per year; 1.02-1.09), a body mass index of 25 to 30 kg/m(2) (2.38; 0.71-7.97) and ≥30 kg/m(2) (6.08; 1.75-21.14), proximal vs distal DVT (2.59; 1.12-5.98), and calf swelling ≥3 cm larger than the asymptomatic leg (3.77; 1.66-8.55). In a multivariate analysis, age (1.05; 1.01-1.09) and calf swelling ≥3 cm larger than the asymptomatic leg (2.94; 1.20-7.20) remained predictive for PTS. Compression therapy was used by 78.5% of patients at the 1-year follow-up and by 46.7% at the 3-year follow-up. Both rates were higher in patients with PTS (93.9%) vs no PTS (66.7%). CONCLUSIONS: This prospective survey demonstrates a low rate of PTS in patients with a first DVT and no pre-existing DVT, varicose veins, or chronic venous insufficiency, and a high adherence rate to compression therapy, within the first 3 years of follow-up. Age and marked calf swelling were independent predictors of PTS.

Impact of gender on the clinical presentation and diagnosis of deep-vein thrombosis.

It is uncertain whether gender influences the clinical presentation of deep-vein thrombosis (DVT) and the discriminative value of the Wells diagnostic pretest probability score. The aim of the study was to determine whether gender impacts the clinical presentation and diagnosis of DVT. The study analysed a cohort of 4,976 outpatients with clinically suspected DVT of the leg prospectively recruited by 326 vascular medicine physicians in the German ambulatory care sector between October and December 2005. The diagnosis of DVT was based on compression ultrasonography in 96% of patients. Among 4,777 patients who had a diagnostic work-up for DVT there were more women (n=2,998) than men (n=1,779). However, the prevalence of confirmed DVT was 37.0% (658/1779) in men vs. 24.3% (730/2,998) in women (p<0.001). Among patients with confirmed DVT, proximal DVT was more common in men (59.6% vs. 44.5% in women, p<0.001). Swelling of the leg, pitting oedema and dilated superficial veins were more frequently reported by men (p<0.001). The percentage of patients with a high probability Wells clinical pretest score was higher in men than in women (67.0% vs. 57.0%, p<0.001). However, overall, the score equally discriminated risk groups for DVT in both sexes. In conclusion, women were more frequently referred for a diagnostic work-up for DVT than men, but the prevalence of DVT was higher in men and their thrombotic events were more severe. Nevertheless, the Wells clinical pretest probability score correctly identified low- and high-risk groups in both genders.

Diagnosis of deep-vein thrombosis: adherence to guidelines and outcomes in real-world health care.

Current guidelines recommend optimised algorithms for diagnosis of suspected deep-vein thrombosis (DVT). There is little data to determine to what extent real-world health care adheres to guidelines, and which outcome in terms of diagnostic efficiency and safety is achieved. This registry involved patients with clinically suspected DVT of the leg recruited in German ambulatory care between October and December 2005. Registry items were: diagnostic methods applied, diagnostic categories at day 1, and venous thromboembolic events up to 90 days in patients without firmly established DVT. A total of 4,976 patients were recruited in 326 centres. Venous ultrasonography was performed in 4,770 patients (96%), D-dimer assay in 1,773 patients (36%) and venography in 288 patients (6%). At day 1, DVT was confirmed in 1,388 patients (28%), and ruled out in 3,389 patients (68%), and work-up was inconclusive in 199 patients (4%). The rate of venous thromboembolism at 90 days was 0.34% (95% confidence interval [CI]: 0.09 to 0.88) in patients in whom the diagnosis of DVT had been ruled out, and 2.50% (95% CI: 0.69 to 6.28) in patients with inconclusive diagnostic workup. This nationwide evaluation in German ambulatory care revealed that the diagnostic work-up for suspected DVT did not adhere to current guidelines. However, the overall diagnostic safety was excellent, although there is potential for improvement in a well defined minority of patients.

[Treatment of deep vein thrombosis in the leg and pelvis]. / Die Behandlung der tiefen Bein- und Beckenvenenthrombose.

The most important step for the treatment of deep vein thrombosis in the leg and pelvis is the immediate and sufficient anticoagulation by subcutaneous application of low-molecular-weight heparins or fondaparinux. Prevention of a relapse can be achieved by subsequent oral anticoagulation with vitamin K antagonists, whereas treatment duration is based on localisation of the thrombus and underlying risk factors. Immediate mobilisation of the patient is a fundamental step. Treatment with a compression bandage and subsequent use of compression stockings is a further effective step in reducing pain and swelling, preventing pulmonary embolism and a postthrombotic syndrome (PTS).

The treatment of deep vein thrombosis in the pelvis and leg.

INTRODUCTION: Deep vein thrombosis is associated with a risk of pulmonary embolism and post thrombotic syndrome (PTS). METHODS: Selective literature review with special reference to the American College of Chest Physicians' current guidelines and the German S2 interdisciplinary guideline. RESULTS AND DISCUSSION: The most important therapeutic measure is prompt and adequate anticoagulation with heparin or fondaparinux. Thrombolysis or thrombectomy is only indicated in highly selected severe cases. The risk of PTS can be reduced by immediate ongoing treatment with compression stockings. Prevention of relapse is achieved using vitamin K antagonists with a target INR of 2.0 to 3.0. The duration of anticoagulation should be tailored to the localisation and etiology of the thrombosis, from at least three months to indefinite treatment. The ongoing risk of bleeding secondary to anticoagulation should be reevaluated at regular intervals as a cost-benefit analysis. New anticoagulants for acute and long term treatment will soon be available for clinical use.

An evaluation of venous thromboembolic risk in acutely ill medical patients immobilized at home: the AT-HOME Study.

Many risk factors for venous thromboembolism (VTE) in hospitalized medical patients are also present in medical outpatients. VTE prevention represents an important challenge for physicians treating patients at home. The AT-HOME study was a prospective cross-sectional observational study designed to assess awareness of the risk of VTE in immobilized acutely ill medical outpatients among German physicians, many of whom were participating in a national Continuing Medical Education (CME) program designed to raise awareness of VTE. The study involved 1210 medical patients who were acutely confined to bed at home. Physicians performed a subjective assessment of VTE risk, which was rated on a 10-point scale (1 = very low risk; 10 = very high risk). The risk of VTE was also assessed retrospectively by using a scorecard developed for use in hospitalized medical patients. Of the 1210 patients, 198 (16%) had risk scores of 0-4, 319 (26%) had scores of 5 or 6, and 693 (57%) had scores > or =7. Overall, 966 patients (80%) received thromboprophylaxis. The proportion of patients receiving thromboprophylaxis was 0% to 47% in risk score groups 0-4, 76% to 85% in groups 5 and 6, and 90% to 100% in risk score groups 7-10. In the retrospective assessment of VTE risk, 74% of patients were at high risk, 15% were at intermediate risk, and 11% were at low risk. The proportions of patients receiving thromboprophylaxis in these groups were 87%, 61%, and 55%, respectively. The involvement of physicians in educational activities focusing on VTE awareness appeared to create awareness of the risks of VTE in acutely ill medical outpatients.

Mobilization versus immobilization in the treatment of acute proximal deep venous thrombosis: a prospective, randomized, open, multicentre trial.

OBJECTIVE: The aim of prescribing strict bed rest for acute deep venous thrombosis is to reduce the risk of pulmonary embolism and pain in the legs, as well as swelling. This study was performed in order to compare outcome of mobilization against 5 days of strict bed rest in patients with acute proximal deep venous thrombosis (DVT). METHODS: 103 in-patients with proximal DVT or patients admitted to the hospital because of proximal DVT were recruited to a randomized study. All patients were treated in hospital and given a lower leg and thigh compression bandage as well as therapeutic doses of the low molecular weight heparin, dalteparin-sodium (Fragmin). RESULTS: Seven of 52 patients (13.5%) in the mobile group versus 14 of 50 patients (28.0%) in the immobile group suffered at least one of the outcomes defined under the combined primary endpoint (clinically relevant pulmonary embolisms, pulmonary embolisms detectable by scintigraphy or computer tomography, progression of thrombosis or new thrombosis, nosocomial infections and/or serious adverse events) (p = 0.088), whereby serious adverse events occurred once in the mobile group and three times in the immobile group. New pulmonary embolisms over the course were seen in 10 of 50 patients (20%) with a perfusion disorder at baseline scintigraphy, while such was ascertained only in one of 52 patients (1.9%) without a perfusion disorder at baseline scintigraphy. Leg pain was reduced from 54.1 (+/-30.4) to 20.7 (+/-19.2) in the mobilized group and from 41.0 (+/-26.8) to 14.0 (+/-11.1) in the immobilized patients. Leg pain was assessed using the visual analogue scale (0 = no pain, 100 = maximum pain). More immobilized patients complained of increasing back pain (23% versus 6%) and disturbed micturition (10% versus 2%) as well as defecation (13% versus 6%) on day 5. More patients in the mobile group reported increased stress from the thrombosis and its treatment (15% versus 6%). CONCLUSIONS: No benefit of prescribing bed rest in patients with deep venous thrombosis could be detected in this study. Based on data available, strict bed rest for at least 5 days is not justified if adequate therapy with low molecular weight heparin and adequate compression is assured. It remains open whether patients with initial signs of pulmonary embolism might profit from a brief immobilization.