Diagnosis and treatment of venous leg ulcers: S2k Guideline of the German Society of Phlebology and Lymphology (DGPL) e.V.

This S2k guideline on venous leg ulcers was created on the initiative and under the leadership of the German Society of Phlebology and Lymphology (DGPL). The guideline group also consisted of representatives from the German Society for Phlebology and Lymphology, German Dermatological Society, German Society for General Medicine, German Society for Angiology, German Society for Vascular Surgery and Vascular Medicine, German Society for Surgery, German Society for Dermatosurgery, German Society for Wound Healing and Wound Treatment, Professional Association of Phlebologists and Lymphologists and Initiative Chronische Wunden. The aim of this guideline is to combine the different approaches and levels of knowledge of the respective professional groups on the basis of consensus, so that a basic concept for the best possible treatment of patients with venous leg ulcers can be provided. A total of 70 specific recommendations were formulated and agreed upon, divided into the subject areas of diagnostics, therapy, prevention of recurrences, and everyday challenges. The guideline thus reflects the current state of scientific knowledge and is intended to be widely used as the best available document for the treatment of patients with venous leg ulcers in everyday clinical practice.

The impact of treatment of periodic limb movements in sleep on blood pressure in patients with and without sleep apnea.

Improving sleep quality in patients with obstructive sleep apnea (OSA) by positive airway pressure therapy is associated with a decrease of blood pressure (BP). It remains elusive, whether treatment of sleep disturbances due to restless legs syndrome with symptomatic periodic limb movements in sleep (PLMS) affects BP as well. The present study provides first data on this issue. Retrospective study on patients undergoing polysomnography in a German University Hospital. Inclusion criteria were first diagnosis of restless legs syndrome with PLMS (PLM index ≥ 15/h and PLM arousal index ≥ 5/h) with subsequent initiation of levodopa/benserazide or dopamine agonists. Exclusion criterion was an initiation or change of preexisting positive airway pressure therapy between baseline and follow-up. BP and Epworth sleepiness scale were assessed at two consecutive polysomnographies. After screening of 953 PLMS data sets, 114 patients (mean age 62.1 ± 12.1 years) were included. 100 patients (87.7%) were started on levodopa/benserazide, 14 patients (12.2%) on dopamine agonists. Treatment was associated with significant reductions of PLM index (81.2 ± 65.0 vs. 39.8 ± 51.2, p < 0.001) and ESS (6 [interquartile range, IQR, 3-10.5] vs. 5 [IQR 3-10], p = 0.013). Systolic BP decreased from 132.9 ± 17.1 to 128.0 ± 15.8 mmHg (p = 0.006), whereas there was no significant change of diastolic BP (76.7 ± 10.9 vs. 75.1 ± 9.2 mmHg, p = 0.15) and heart rate (71.5 ± 11.9 vs. 71.3 ± 12.7, p = 0.84). The number of antihypertensive drugs remained unchanged with a median of 2 (IQR 1-3, p = 0.27). Dopaminergic treatment of PLMS is associated with an improvement of sleep quality and a decrease of systolic BP comparable to treatment OSA.

Cellular senescence at the saphenofemoral junction in patients with healthy, primary varicose and recurrent varicose veins - A pilot study.

OBJECTIVES: Cellular senescence could play a role in the development of venous disease. Superficial venous reflux at the saphenofemoral junction is a common finding in patients with primary varicose veins. Furthermore, reflux in this essential area is associated with higher clinical stages of the disease and recurrent varicose veins. Therefore, this pilot study aimed to investigate cellular senescence in the immediate area of the saphenofemoral junction in patients with healthy veins, primary varicose veins and additionally in patients with recurrent varicose veins due to a left venous stump. METHODS: We analyzed vein specimens of the great saphenous vein immediately at the saphenofemoral junction. Healthy veins were collected from patients who underwent arterial bypass reconstructions. Samples with superficial venous reflux derived from patients who received high ligation and stripping or redo-surgery at the groin, respectively. Sections were stained for p53, p21, and p16 as markers for cellular senescence and Ki67 as a proliferation marker. RESULTS: A total of 30 samples were examined (10 healthy, 10 primary varicose, and 10 recurrent varicose veins). We detected 2.10% p53+ nuclei in the healthy vein group, 3.12% in the primary varicose vein group and 1.53% in the recurrent varicose vein group, respectively. These differences were statistically significant (p = 0.021). In the healthy vein group, we found 0.43% p16+ nuclei. In the primary varicose vein group, we found 0.34% p16+ nuclei, and in the recurrent varicose vein group, we found 0.74% p16+ nuclei. At the p < 0.05 level, the three groups tended to be significant without reaching statistical significance (p = 0.085). There was no difference in respect of p21 and Ki67. CONCLUSION: We found significantly higher expression rates of p53 in primary varicose veins at the saphenofemoral junction than in healthy veins. p16 expression tended to be increased in the recurrent varicose vein group. These preliminary findings indicate that cellular senescence may have an impact in the development of varicose veins or recurrence. Further studies addressing this issue are necessary.

Functional repair of the great saphenous vein by external valvuloplasty reduces the vein's diameter: 6-month results of a multicentre study.

OBJECTIVES: External valvuloplasty (eVP) is a reconstructive surgical method to repair the function of the terminal and preterminal valves. We evaluated the 6-month outcomes of eVP regarding the diameter of the great saphenous vein (GSV). METHODS: Patients from five vein centres were included in this observational study. Follow-up involved detailed duplex sonography of the GSV. The venous clinical severity score (VCSS) and the C class of the clinical, aetiologic, anatomic and pathophysiologic (CEAP) classification were recorded. RESULTS: We enrolled 210 patients, with a follow-up rate of 58%; eVP was sufficient in 95.24% of the patients. The GSV diameters decreased significantly from 4.4 mm (standard deviation (SD): 1.39) to 3.9 (SD: 1.12), 4 cm distal to the saphenofemoral junction (SFJ); from 3.7 mm (SD: 1.10) to 3.5 mm (SD: 1.02) at the mid-thigh; from 3.6 mm (SD: 1.14) to 3.3 mm (SD: 0.94) at the knee and from 3.1 mm (SD: 0.99) to 2.9 mm (SD: 0.78) at the mid-calf. VCSS decreased significantly from 4.76 (SD: 2.13) preoperatively to 1.77 (SD: 1.57) 6 months postoperatively. CONCLUSIONS: GSV function can be restored by eVP; diameters over the total length of the GSV decreased significantly.

"Quality of Life after Varicose Vein Surgery in Patients with High-ligation and Stripping, External Valvuloplasty and Sapheno-femoral Redo Surgery".

BACKGROUND: High-ligation and stripping (HL/S) and external valvuloplasty (eVP) with the implantation of an external device to restore the valve's function, are surgical methods to eliminate reflux at the saphenofemoral junction. Furthermore, redo-surgery (RedoS) can be performed in terms of same side groin recurrences. It is unclear, if there is a difference in quality of life (QoL) between these 3 surgical treatment options. Therefore, it was the aim of our study to elucidate QoL in patients before and after surgical treatment at the saphenofemoral junction by comparing HL/S, eVP, and RedoS. METHODS: A total of 303 participants (156 HL/S, 81eVP, 64 RedoS) were recruited during the daily clinical routine. QoL was measured at admission and 6 weeks after the surgical procedure by means of SF-12 (12 item short form health survey) and Aberdeen Varicose Vein Questionnaire. RESULTS: The mean value of Aberdeen Varicose Vein Questionnaire was 14.5 (SD 2.1) preoperatively and 4.9 (SD 3.3) postoperatively in the HL/S group, 16.4 (SD 1.4) preoperatively and 6.8 (SD 2.5) postoperatively in the eVP group and 15.5 (2.2) preoperatively and 5.8 (SD 4.2) postoperatively in the RedoS group, which was statistically significant (P< 0.05) in all groups. Postoperatively, the mean values were statistically significant within the groups. Concerning physical aspects of the SF-12 we found a significant improvement in the RedoS group, while mental aspects were significantly better in the HL/S and eVP group postoperatively. Nevertheless, the clinical relevance of these SF-12 differences is questionable under consideration of the minimal important difference. CONCLUSIONS: Varicose vein surgery leads to a significant improvement of QoL in all groups. The implantation of an external patch could have a negative influence in QoL.

The differential impact of aerobic and isometric handgrip exercise on blood pressure variability and central aortic blood pressure.

BACKGROUND: Blood pressure variability and central SBP are independent markers of cardiovascular risk. Data on lifestyle-interventions to reduce these parameters are sparse. The present work reports the differential effects of aerobic vs. isometric handgrip exercise on blood pressure variability and central SBP in a prospective randomized trial. METHODS: Seventy-five hypertensive patients were randomized to one of the following 12-week programs: isometric handgrip training five times weekly; 'Sham-handgrip training' five times weekly; aerobic exercise training (30 min three to five times/week). Blood pressure variability was assessed by the coefficient of variation in 24-h ambulatory blood pressure monitoring (ABPM). Central SBP was measured noninvasively by the SphygmoCor device (AtCor Medical, Australia). RESULTS: The aerobic exercise program significantly decreased systolic daytime variability (12.1 ±â€Š2.5 vs. 10.3 ±â€Š2.8, P = 0.04), whereas diastolic daytime blood pressure variability was not significantly altered (P = 0.14). Night-time variability was not significantly affected (P > 0.05). Central SBP was reduced from 145±15 to 134 ±â€Š19 mmHg (P = 0.01). Isometric handgrip and sham-handgrip exercise did not significantly affect blood pressure variability (P > 0.05 each). Isometric exercise tended to reduce central SBP (142 ±â€Š19 to 136 ±â€Š17 mmHg, P = 0.06). ANCOVA revealed significant intergroup differences for the change of daytime SBP and DBP variability (P = 0.048 and 0.047, respectively). CONCLUSION: Aerobic exercise reduces blood pressure variability and central SBP. Isometric handgrip exercise does not reduce blood pressure variability but tends to lower central SBP in this hypertensive population.

Perioperative changes of response to antiplatelet medication in vascular surgery patients.

INTRODUCTION: Reduced antiplatelet activity of aspirin (ALR) or clopidogrel (CLR) is associated with an increased risk of thromboembolic events. The reported prevalence data for low-responders vary widely and there have been few investigations in vascular surgery patients even though they are at high risk for thromb-embolic complications. The aim of this prospective observational monocentric study was to elucidate possible changes in ALR or CLR after common vascular procedures. METHODS: Activity of aspirin and clopidogrel was measured by impedance aggregometry using a multiple electrode aggregometer (Multiplate®). Possible risk factors for ALR or CLR were identified by demographical, clinical data and laboratory parameters. In addition, a follow-up aggregometry was performed after completion of the vascular procedure to identify changes in antiplatelet response. RESULTS: A total of 176 patients taking antiplatelet medications aspirin and/or clopidogrel with peripheral artery disease (PAD) and/or carotid stenosis (CS) were included in the study. The prevalence of ALR was 13.1% and the prevalence of CLR was 32% in the aggregometry before vascular treatment. Potential risk factors identified in the aspirin group were concomitant insulin medication (p = 0.0006) and elevated C-reactive protein (CRP) (p = 0.0021). The overall ALR increased significantly postoperatively to 27.5% (p = 0.0006); however, there was no significant change in CLR that was detected. In a subgroup analysis elevation of the platelet count was associated with a post-procedure increase of ALR incidence. CONCLUSION: The incidence of ALR in vascular surgery patients increases after vascular procedures. An elevated platelet count was detected as a risk factor. Further studies are necessary to analyse this potential influence on patency rates of vascular reconstructions.

Minor tributary veins of the common femoral vein near the saphenofemoral junction - A postmortem study.

OBJECTIVES: Recurrent varicose veins after surgery are a frequent burden and the saphenofemoral junction is the most common source of reflux. Pre-existing branches of the common femoral vein near the saphenofemoral junction, which may increase due to haemodynamic or other reasons, could play a role in the development of recurrent varices. There exist only a few anatomical data about the prevalence of these minor venous tributaries of the common femoral vein near the saphenofemoral junction. Therefore, this study aimed to elucidate their frequency and distribution. METHOD: A total of 59 veins from 35 anatomical donors were dissected. The common femoral vein with the adherent parts of the profunda femoris vein and the great saphenous vein was exposed and analysed ex situ. The number of minor tributaries to the common femoral vein was counted and their distances to the saphenofemoral junction as well their diameters were measured. RESULTS: We could identify up to 10 minor tributaries of the common femoral vein below the level of the great saphenous vein as far as 6 cm distally and up to four veins above the level as far as 5 cm proximally. The mean diameters of these vessels ranged from 0.5 to 11.7 mm. Most of these vessels were located near the saphenofemoral junction and 3 cm distally. Directly opposite to the opening of the great saphenous vein we could find at least one minor tributary of the common femoral vein in 57%. CONCLUSIONS: There exist a vast number of minor tributaries of the common femoral vein and they are mainly located near the saphenofemoral junction. Nevertheless, their role in the development of recurrent varices is still unclear and further studies are necessary.

External valvuloplasty of the saphenofemoral junction in insufficient great saphenous veins - six weeks results of a prospective multicentre trial.

Background: Varicosis of the great saphenous vein (GSV) is a common disease. Most of the therapeutic concepts attempt to remove or destroy the truncal vein. However, the absence of the GSV could be harmful for further treatments of artherosclerotic disease as the GSV is often used as bypass graft in lower extremity or coronary artery revascularisations. External valvuloplasty (EV) is one of the vein-sparing treatment options. The aim of this clinical study was to describe the outcome, safety and complications of this procedure in a prospective multicentre trial. Patients and methods: The function of the terminal and preterminal valve was restored by external valvuloplasty. Furthermore, multiple phlebectomies of tributaries were performed. Patients were reinvestigated six weeks after surgery. Primary endpoint was the function of the external valvuloplasty measured by diameter of the GSV and the prevalence of reflux in the GSV. The eligibility of the vein as a potential bypass graft was noticed. CEAP class and VCSS scores were analysed. Results: A total of 359 patients were included in the study. After six weeks 297 patients could be reinvestigated. The function of the external valvuloplasty was sufficient in 284 patients (95.6%). Treatment failed in 8 patients (2.6%) due to an occlusion or junctional reflux despite valvuloplasty. The GSV was estimated as suitable as a bypass graft in 261 patients (87.8%). Reflux at the saphenofemoral junction was significantly reduced after treatment and the diameter of the GSV near the saphenofemoral junction significantly decreased from 4.4 mm to 3.8 mm (p < 0.05). The VCSS was significantly reduced from 4.6 preoperatively to 2.6 postoperatively. Conclusions: External repair of the great saphenous vein can reduce venous symptoms and may preserve the great saphenous vein as a bypass graft. Nevertheless, this treatment option is only suitable for a limited number of patients.

Surgical thrombectomy for iliofemoral deep vein thrombosis: Patient outcomes at 8.5 years.

INTRODUCTION: Deep vein thrombosis (DVT) is a frequent burden and a post-thrombotic syndrome (PTS) can be a serious long-term consequence. Iliofemoral DVT should be associated with severe forms of PTS. Therefore an early thrombus removal has been recommended in specific conditions. The aim of this study was to find out both, the long-term results after surgical thrombectomy of iliofemoral DVT in respect of the development of PTS as well as the venous hemodynamics after surgery concerning venous reflux and venous obstruction. METHODS: Sixty-seven patients who underwent surgical thrombectomy between the years 2000 and 2014 were included in this study; iliofemoral DVT was present in 52 of these patients. 35 patients could be reinvestigated after a mean follow-up of 8.5 years. CEAP (Clinical-Etiological-Anatomical-Pathophysiological) and Villalta scores were recorded in order to describe and assess PTS. Follow-up examinations included a detailed duplex mapping. Venous hemodynamics were measured by digital photoplethysmography and venous occlusion plethysmography. RESULTS: The primary patency rate of the iliofemoral segment was 88% after 8.5 years. 48% of all patients showed reflux in deep vein segments. Mild or moderate PTS occurred in 57% of all patients. Notably, there was no patient with an active ulcer or severe PTS. The mean venous outflow volume of all patients in the treated legs was 66.1 ml/100ml/min and significantly less than in the controlled contralateral non-treated legs (p<0.05). The mean venous refilling time was 16.3 seconds, while the mean value of the non-treated contralateral legs was 25.6 seconds and therefore significantly higher (p<0.05). CONCLUSION: Even though venous hemodynamics are significantly inferior in the treated legs, this study demonstrates excellent patency rates and good clinical outcome after surgical thrombectomy of iliofemoral veins.

Multimodal approach of venous recanalization in patients with a critical limb ischemia due to phlegmasia cerulea dolens: A case series of 17 patients in a single center.

OBJECTIVES: Advanced phlegmasia cerulea dolens can be a hazardous complication of a deep vein thrombosis and rapid recanalization of the deep venous system is the most important factor. METHOD: We describe the outcome of 17 patients with critical limb ischemia due to an advanced phlegmasia cerulea dolens. Venous thrombectomy was performed by a standardized operating procedure. RESULTS: Venous recanalization was successful in all patients. An additional fasciotomy was not necessary. There were five patients with an underlying malignancy and eight patients with a simultaneous pulmonary embolism. We had one amputation of a forefoot and one death within 30 days representing a 30-day mortality and an amputation rate of 6%. CONCLUSIONS: Early recanalization and recovery of the venous outflow is mandatory for success. A multimodal therapeutic approach of high urgency surgical thrombectomy in combination with endovenous strategies could be a successful treatment option for advanced phlegmasia cerulea dolens.

The anatomy of the small saphenous vein: fascial and neural relations, saphenofemoral junction, and valves.

PURPOSE: Varicose veins are a frequent burden, also in the small saphenous system. Yet its basic anatomy is not described consistently. We therefore investigated the fascial and neural relationships of the small saphenous vein (SSV) as well as the frequency and position of valves and the different junctional patterns, also considering the thigh extension. MATERIALS AND METHODS: We dissected the legs of 51 cadavers during the regular dissection course held in winter 2007 at Innsbruck Medical University, with a total of 86 SSVs investigable proximally and 94 SSVs distally. RESULTS: A distinct saphenous fascia is present in 93 of 94 cases. It starts with a mean distance of 5.1 cm (SD 1.2 cm) proximal to the calcaneal tuber, where the tributaries to the SSV join to form a common trunk. The neural topography at the level of the gastrocnemius muscle's origins shows the medial sural cutaneous nerve in 88% medially and in 12% laterally to the SSV, the tibial nerve in 64% medially and in 36% laterally, and the common fibular nerve in 98% medially and in 2% laterally to the vein. The saphenopopliteal junction (SPJ) resembled in about 37% type A (UIP-classification), 15% type B, and 24% type C. A total of 17% of specimens showed a venous web or star at the popliteal fossa and 6% had a doubled junction. A thigh extension could be demonstrated in about 84%. A most proximal valve was present in only 94% at a mean distance of 1.2 cm (SD 1.4 cm) to the SSVs orifice. A consecutive distal valve was only present in 65% with a mean distance of 5.1 cm (SD 2.3 cm). CONCLUSION: Two fascial points or regions can be described in the SSVs' course and its own saphenous fascia is demonstrated macroscopically in almost all cases. The neural topography is highly individual. The SPJ is highly individual where we found hitherto unclassified patterns in a remarkable number of veins. Venous valves are not as frequent as we supposed them to be. Furthermore, not all most proximal valves seem to be terminal valves.

Venous valves and major superficial tributary veins near the saphenofemoral junction.

BACKGROUND: Venous valves are still discussed controversially, mainly because it is still uncertain whether primarily missing or insufficient valves or the weakness of the venous walls cause varices. Furthermore, the distribution and frequencies of major superficial tributary veins (MSTVs), which should discharge the great saphenous vein (GSV) between the terminal (TV) and preterminal valve (PTV) gain in importance; a fortiori as remaining MSTVs during primary varicose vein treatment may be a reason of future recurrent varicose veins. Therefore, the aim of this study was to investigate both the frequency and position of the GSV valves and the distribution of MSTVs near the saphenofemoral junction (SFJ). METHODS: We investigated 114 formalin fixed bodies with 217 GSVs. The measurement of the position of the valves and the entrances of the MSTVs was performed in situ from the SFJ to the nodule of the valve or to the orifice of the tributary vein into the GSV, respectively. RESULTS: On average, the specimens possessed 2.26 valves on the left side and 2.07 valves on the right side. First, valves were present in all 217 legs in a range of 0.0 to 7.2 cm. Taking as a basis the strict definition of a TV that it lies between the orifice of the GSV and the most proximal MSTV we could find only 75 TVs (68.8%) on the left side and 77 (71.3%) on the right side. In total, we found 803 MSTVs entering the GSV, an average of 3.7 veins per GSV. The left GSVs had significantly more MSTVs (P = .000). Most frequently, the superficial external pudendal vein (SEPV) existed in 90.3%, joining the GSV from medial 16.9 mm distally to the SFJ. A complete "venous star" of the MSTVs, as it is described in several textbooks, was present in only 18.4%. CONCLUSIONS: Terminal and preterminal valves of the GSV do not always exist. Using a strict definition whether a valve should be called either "terminal valve" or "preterminal valve", we will find a lot of them completely missing. This means that in a considerable number of patients reflux from the common femoral vein (CFV) to the GSV and further on into the MSTVs might occur. Several major superficial tributary veins join the GSV within the first millimeters; therefore a thorough exposition and monitoring of these vessels during diagnostic procedures are obviously crucial for a long-lasting success.

An anatomical study of femoral vein valves near the saphenofemoral junction.

BACKGROUND: The relevance of venous valves in varicose veins is still discussed controversially as, among others, the veins' wall weakness is accused to be the initial trigger of varicose veins. Thorough knowledge of their positions and frequencies will support understanding the pathogenesis of varices. Contrary to the incidences of valves in the femoral vein, no sufficient data about the positions of valves, particularly in respect to the saphenofemoral junction, are available; specifically in conjunction with the fact that terminal and preterminal valves in the great saphenous vein are missing in 10% of cases. METHODS: The exact positions and distances of valves in both the common femoral and the femoral vein close to the saphenofemoral junction were studied macroscopically in 32 cadavers with a total of 63 veins. Measurements were performed from the saphenofemoral junction as reference point above and below. RESULTS: Valves in the common femoral vein exist in 71% of all cases with a mean distance of 3.8 cm proximally to the saphenofemoral junction. Distal valves are present in 87% of all cases with a mean distance of 5.0 cm. In more than a half, a second distal valve can be found at about 9 cm, which has not been described yet. Females have a significantly shorter mean distance of this second distal valve on the right side. CONCLUSION: Incorporating the study results on terminal and preterminal valves in the great saphenous vein, we have a well defined overview about the positions of the valves and frequencies in the coherent area of confluence of the superficial inguinal veins. More than ever, further studies, mainly about the real functions of valves, are necessary.