Compression Stockings

To provide guidance on the management of VTE, the authors developed a list of important management questions to be considered in this document (Table 1). Questions were developed by consensus of all the authors. To answer these questions, a literature search of MEDLINE and EMBASE from January 2004 to August 2014 was conducted. The following search terms were used and combined: anticoagulant treatment, anticoagulant therapy, antithrombotic treatment, heparin, low molecular weight heparin, enoxaparin, nadroparin, dalteparin, certoparin, bemiparin, tinzaparin, parnaparin, reviparin, vitamin K antagonists, warfarin, acenocoumarol, phenprocoumon, thrombolysis, thrombolytic treatment, fibrinolytic agent, fibrinolysis, urokinase, tenecteplase, alteplase, rtPA, tPA; aspirin, ticlopidine, clopidogrel; venous thromboembolism, venous thrombosis, deep venous thrombosis, deep vein thrombosis, superficial venous thrombosis, superficial venous thrombophlebitis; diagnosis. The search strategy was restricted to papers published in English. Detailed information on the results of the literature search is available upon request.Table 1

Guidance questions to be considered

How is the diagnosis of deep vein thrombosis and pulmonary embolism established?

Which patients require hospitalization versus initial outpatient therapy for the management of VTE?

What are the therapeutic options for the acute treatment of venous thromboembolism?

Which patients are candidates for a DOAC?

What is the role of vena cava filters if the patient is not a candidate for anticoagulation?

How is upper extremity VTE treated?

When is ambulation/exercise safe after DVT/PE?

Is the use of graduated compression stockings safe after acute DVT/PE?

What is the recommended duration of therapy for VTE?   What is the recommended duration of therapy for a patient with distal DVT?   What is the recommended duration of therapy for a patient with a surgically provoked VTE?   What is the recommended duration of therapy for a pregnancy or estrogen-associated VTE?   What is the recommended duration of therapy for a medical illness-associated VTE?   What is the recommended duration of therapy for a travel-associated VTE?   What is the recommended duration of therapy for a malignancy-associated VTE?   What is the recommended duration of therapy for a patient with unprovoked DVT/PE?

What are the therapeutic options for long term treatment of DVT/PE?

What is the best treatment of patients who have recurrent VTE in spite of anticoagulation?

How can you assess the risk of recurrent VTE and anticoagulant-associated bleeding?

For papers published before 2004, we only considered the most important studies that were likely to influence our responses to the questions. These studies were selected and suggested by the authors of this guidance document.

Parameters of vascular stiffness (carotid-femoral and aortic pulse wave velocities [cfPWV and aoPWV], brachial and aortic augmentation indices [brAIx and aoAIx], ankle-brachial index [ABI]) were recorded and calculated by Vascular Explorer software (Enverdis GmbH, Jena, Germany). Vascular Explorer implements single-point, suprasystolic brachial oscillometry pulse wave analysis for the assessment of PWV and AIx, was validated against other oscillometric, photoplethysmographic and Doppler devices and deemed feasible in epidemiologic studies [21 (link), 22 (link)]. Measurements were performed with appropriate arm and leg cuffs after at least 10 min resting in supine position. Pulse wave analysis, ankle and brachial blood pressures were automatically computed by software mediated analysis of photoplethysmographic signals from finger and toe and volume changes in the inflatable cuffs. The ABI was calculated by the software using the blood pressure readings in the lower and upper extremities. Participants were asked to refrain from speaking and advised to breathe calmly during the measurements. Exclusion criteria for this examination were amputations of limbs, open wounds at measurement sites, dialysis shunts, paralyses, lymph edema on arms or legs, bandages, or anti-embolism compression stockings which could not be removed.

The pelvic sLND template was defined as the removal of LN distal to the aortic bifurcation (Figure 1) (20 (link)):
The retroperitoneal sLND template was defined as the removal of para-aortic and inter-aorto-caval LN above the aortic bifurcation up to the inferior mesenteric artery (or up to the renal hilum in case of nodal recurrence above the inferior mesenteric artery on pre-operative imaging) (Figure 2). Paracaval LN were only removed in case of a positive LN in that area on preoperative imaging. Templates were not limited to the positive spots on imaging and could be modified slightly according to the nodal recurrence site on pre-operative imaging and the extent of the prior pelvic LN dissection during RP.
All procedures were performed by three experienced surgeons (H.V.P., S.J., and W.E.). For the robot-assisted procedures, the Xi Surgical System (Intuitive Surgical, Sunnyvale, CA, USA) was used with a six-port transperitoneal approach. Supplementary Figure 1 provides an overview of port placement in pelvic sLND and retroperitoneal sLND. In the open sLND group, pelvic LN were approached by extraperitoneal access and retroperitoneal LN by transperitoneal access.
Preoperative bowel preparation was not performed. All patients received postoperative compression stockings and subcutaneous injections with low-molecular weight heparins.

The primary outcome will be complete healing at 3 months follow-up: (yes/no), where complete healing is defined as complete epithelialisation maintained for at least 2 weeks and the time (in days) between the start of the study and complete wound healing.
Secondary variables are defined as complete healing at 6 months follow-up (yes/no), the degree of healing (Resvech 2. 0) which consists of 6 dimensions (depth, size, edges, wound bed, exudate and signs and symptoms of infection) with ascending scoring scales based on the severity of the dimension studied and a total score ranging from 0 to 35 [26 ]; the ulcer area (cm2), measured by digital photography and subsequent image processing using the open source Java image processing program “The ImageJ ecosystem” [27 (link)]; the VAS scale for perceived pain [28 ]; the level of adherence to the “Active Legs” intervention measured by the combined variable number of steps and time by means of the pedometer record (Yamax PZ270) and patients’ self-reported information on the home exercise program by means of the activity diary and the health-related quality of life measured with the CCVUQ-e, a questionnaire which in addition to an overall synthetic quality of life score, assesses the following dimensions: pain, depression, social relationships, impairment in performing activities of daily living and body image, with a score of 22 to 112 [29 ].
Variables related to the healing process are defined as Body Mass Index (kg/cm2); baseline pathology, diabetes mellitus (yes/no); last glycosylated haemoglobin (HbA1) value in the EHR; ABI score; tobacco and alcohol consumption; topical treatments used in existing ulcers; systemic treatments; adherence to multilayer compression therapy (yes/no); and physical activity level measured by the Minnesota Leisure Time Physical Activity Questionnaire, short version [30 (link)] and type of daily ambulation.
Prognostic variables are defined as location of the ulcer at the time of the study, number of ulcers at the time of the study, time (in days) of evolution of the venous ulcers before inclusion in the study and whether they are recurrent ulcers (yes/no).
Variables related to recurrence (measured at 6 months follow-up) are defined as occurrence of recurrence (yes/no), use of compression stockings (yes/no), light/normal/strong compression and hydration of the legs (yes/no).
Additionally, data such as age, sex, living alone (yes/no), employment status and level of education are collected.

A temporary filter was inserted via the nonaffected femoral or jugular vein into the inferior vena cava (IVC) prior to the next procedure for patients with an extensive thrombus in the proximal vein that was evaluated as potentially life-threatening and was retrieved after the proximal DVT was removed and potentially life-threatening conditions were relieved. Consistent with local routines based on published guidelines [9 ], anticoagulant treatment was initiated immediately when DVT was identified with the use of subcutaneous low molecular weight heparin (LMWH) at a bolus dose of 100 units/kg twice daily. PTA and/or stent placement was encouraged for lesions that caused 50% or greater diameter narrowing of the iliac and/or common femoral vein, robust collateral filling, and/or a mean pressure gradient of more than 2 mmHg. At the end of LMWH, oral rivaroxaban was directly commenced at a dosage of 15 mg twice a day over the subsequent 21 days and 20 mg once a day thereafter for at least 6 months. In addition, the use of compression stockings (ankle pressure was approximately 30–40 mmHg) for more than 1 year was recommended.

After surgery, elastic compression stockings and a mechanical compression device were applied to the lower limbs on both sides. For chemoprophylaxis for postoperative thromboembolism, 15 mg per day of edoxaban, an Xa-inhibitor, was orally administered until one week after surgery. At one week, ultrasonographic examination with pulsed Doppler, color Doppler (Toshiba Medical Systems, Japan) was performed for screening of DVT.
Postoperative drainage volume was recorded separately on the first day and second day, and the suction drain was removed on the second day. From the day after surgery, patients were given oral 60 mg of loxoprofen three times a day and 75 mg of pregabalin once a day. For patients with severe pain, additional prescription of tramadol hydrochloride acetaminophen was allowed as needed.
The postoperative rehabilitation regimens were the same for both groups, and range of motion exercise was initiated at postoperative day 1. Weight bearing of lower limbs on the surgical side was allowed at two weeks. We evaluated hemoglobin (Hb) at postoperative day 1, 3 and 7. Allogeneic blood transfusion was indicated for patients with Hb < 7.0 g/dl or those with Hb < 10.0 g/dl if they had symptoms related to anemia.