Bivalirudin Versus Heparin During PCI in NSTEMI: Individual Patient Data Meta-Analysis of Large Randomized Trials.

BACKGROUND: The benefit:risk profile of bivalirudin versus heparin anticoagulation in patients with non-ST-segment-elevation myocardial infarction undergoing percutaneous coronary intervention (PCI) is uncertain. Study-level meta-analyses lack granularity to provide conclusive answers. We sought to compare the outcomes of bivalirudin and heparin in patients with non-ST-segment-elevation myocardial infarction undergoing PCI. METHODS: We performed an individual patient data meta-analysis of patients with non-ST-segment-elevation myocardial infarction in all 5 trials that randomized ≥1000 patients with any myocardial infarction undergoing PCI to bivalirudin versus heparin (MATRIX [Minimizing Adverse Hemorrhagic Events by Transradial Access Site and Systemic Implementation of Angiox], VALIDATE-SWEDEHEART [Bivalirudin Versus Heparin in ST-Segment and Non-ST-Segment Elevation Myocardial Infarction in Patients on Modern Antiplatelet Therapy in the Swedish Web System for Enhancement and Development of Evidence-Based Care in Heart Disease Evaluated According to Recommended Therapies Registry Trial], ISAR-REACT 4 [Intracoronary Stenting and Antithrombotic Regimen: Rapid Early Action for Coronary Treatment 4], ACUITY [Acute Catheterization and Urgent Intervention Triage Strategy], and BRIGHT [Bivalirudin in Acute Myocardial Infarction vs Heparin and GPI Plus Heparin Trial]). The primary effectiveness and safety end points were 30-day all-cause mortality and serious bleeding. RESULTS: A total of 12 155 patients were randomized: 6040 to bivalirudin (52.3% with a post-PCI bivalirudin infusion), and 6115 to heparin (53.2% with planned glycoprotein IIb/IIIa inhibitor use). Thirty-day mortality was not significantly different between bivalirudin and heparin (1.2% versus 1.1%; adjusted odds ratio, 1.24 [95% CI, 0.86-1.79]; P=0.25). Cardiac mortality, reinfarction, and stent thrombosis rates were also not significantly different. Bivalirudin reduced serious bleeding (both access site-related and non-access site-related) compared with heparin (3.3% versus 5.5%; adjusted odds ratio, 0.59; 95% CI, 0.48-0.72; P<0.0001). Outcomes were consistent regardless of use of a post-PCI bivalirudin infusion or routine lycoprotein IIb/IIIa inhibitor use with heparin and during 1-year follow-up. CONCLUSIONS: In patients with non-ST-segment-elevation myocardial infarction undergoing PCI, procedural anticoagulation with bivalirudin and heparin did not result in significantly different rates of mortality or ischemic events, including stent thrombosis and reinfarction. Bivalirudin reduced serious bleeding compared with heparin arising both from the access site and nonaccess sites.

Immature Platelet Fraction Predicts Adverse Events in Patients With Acute Coronary Syndrome: the ISAR-REACT 5 Reticulated Platelet Substudy.

BACKGROUND: Immature or reticulated platelets are associated with impaired efficacy of antiplatelet drugs and adverse events in cardiovascular patients. Their role as a predictive biomarker in patients with acute coronary syndrome treated with potent P2Y12 receptor inhibitors is not fully understood. We aimed to prospectively evaluate reticulated platelets as a predictor of the primary end point of the ISAR-REACT 5 trial consisting of death, myocardial infarction, or stroke at 1 year in patients with acute coronary syndrome randomized to prasugrel or ticagrelor. METHODS: Immature platelet fraction (IPF) was assessed within 48 hours after randomization. Patients were divided based on the IPF median values: the IPFhigh group included patients with IPF>median and the IPFlow group included patients with IPF≤median. Platelet aggregation was assessed using the Multiplate Analyzer and was correlated to IPF. RESULTS: Five hundred seventy-seven patients were included in the study. IPF values in % (median [interquartile range]) within the first 48 hours did not differ between the two study groups: 3.6 (2.5-5.2)% in the prasugrel group and 3.6 (2.5-5.4)% in the ticagrelor group (P=0.882). The incidence of the primary end point was significantly higher in the IPFhigh (IPF>3.6%) group compared with the IPFlow (IPF≤3.6%) group: 13.0% versus 7.2% (HRadj, 1.74 [1.02-3.00]; P=0.044), independently from the assigned drug (Pint=0.159). No significant association between IPF and BARC 3 to 5 bleeding was observed. ADP-induced platelet aggregation correlated significantly with IPF in patients treated with prasugrel (r=0.22; P=0.005) while no correlation was detected in patients treated with ticagrelor (r=0.09; P=0.257). CONCLUSIONS: Independently from drug treatment, IPF was associated with the primary end point and therefore is a promising biomarker for the prediction of adverse cardiovascular events in patients with acute coronary syndrome treated with prasugrel or ticagrelor. REGISTRATION: https://www. CLINICALTRIALS: gov; Unique identifier: NCT01944800.

Optimal sample size allocation for two-arm superiority and non-inferiority trials with binary endpoints.

The sample size of a clinical trial has to be large enough to ensure sufficient power for achieving the aim the study. On the other side, for ethical and economical reasons it should not be larger than necessary. The sample size allocation is one of the parameters that influences the required total sample size. For two-arm superiority and non-inferiority trials with binary endpoints, we performed extensive computations over a wide range of scenarios to determine the optimal allocation ratio that minimizes the total sample size if all other parameters are fixed. The results demonstrate, that for both superiority and non-inferiority trials the optimal allocation may deviate considerably from the case of equal sample size in both groups. However, the saving in sample size when allocating the total sample size optimally as compared to balanced allocation is typically small.

Ticagrelor or Prasugrel in Patients with Acute Coronary Syndromes.

BACKGROUND: The relative merits of ticagrelor as compared with prasugrel in patients with acute coronary syndromes for whom invasive evaluation is planned are uncertain. METHODS: In this multicenter, randomized, open-label trial, we randomly assigned patients who presented with acute coronary syndromes and for whom invasive evaluation was planned to receive either ticagrelor or prasugrel. The primary end point was the composite of death, myocardial infarction, or stroke at 1 year. A major secondary end point (the safety end point) was bleeding. RESULTS: A total of 4018 patients underwent randomization. A primary end-point event occurred in 184 of 2012 patients (9.3%) in the ticagrelor group and in 137 of 2006 patients (6.9%) in the prasugrel group (hazard ratio, 1.36; 95% confidence interval [CI], 1.09 to 1.70; P = 0.006). The respective incidences of the individual components of the primary end point in the ticagrelor group and the prasugrel group were as follows: death, 4.5% and 3.7%; myocardial infarction, 4.8% and 3.0%; and stroke, 1.1% and 1.0%. Definite or probable stent thrombosis occurred in 1.3% of patients assigned to ticagrelor and 1.0% of patients assigned to prasugrel, and definite stent thrombosis occurred in 1.1% and 0.6%, respectively. Major bleeding (as defined by the Bleeding Academic Research Consortium scale) was observed in 5.4% of patients in the ticagrelor group and in 4.8% of patients in the prasugrel group (hazard ratio, 1.12; 95% CI, 0.83 to 1.51; P = 0.46). CONCLUSIONS: Among patients who presented with acute coronary syndromes with or without ST-segment elevation, the incidence of death, myocardial infarction, or stroke was significantly lower among those who received prasugrel than among those who received ticagrelor, and the incidence of major bleeding was not significantly different between the two groups. (Funded by the German Center for Cardiovascular Research and Deutsches Herzzentrum München; ISAR-REACT 5 ClinicalTrials.gov number, NCT01944800.).

Prognostically relevant periprocedural myocardial injury and infarction associated with percutaneous coronary interventions: a Consensus Document of the ESC Working Group on Cellular Biology of the Heart and European Association of Percutaneous Cardiovascular Interventions (EAPCI).

A substantial number of chronic coronary syndrome (CCS) patients undergoing percutaneous coronary intervention (PCI) experience periprocedural myocardial injury or infarction. Accurate diagnosis of these PCI-related complications is required to guide further management given that their occurrence may be associated with increased risk of major adverse cardiac events (MACE). Due to lack of scientific data, the cut-off thresholds of post-PCI cardiac troponin (cTn) elevation used for defining periprocedural myocardial injury and infarction, have been selected based on expert consensus opinions, and their prognostic relevance remains unclear. In this Consensus Document from the ESC Working Group on Cellular Biology of the Heart and European Association of Percutaneous Cardiovascular Interventions (EAPCI), we recommend, whenever possible, the measurement of baseline (pre-PCI) cTn and post-PCI cTn values in all CCS patients undergoing PCI. We confirm the prognostic relevance of the post-PCI cTn elevation >5× 99th percentile URL threshold used to define type 4a myocardial infarction (MI). In the absence of periprocedural angiographic flow-limiting complications or electrocardiogram (ECG) and imaging evidence of new myocardial ischaemia, we propose the same post-PCI cTn cut-off threshold (>5× 99th percentile URL) be used to define prognostically relevant 'major' periprocedural myocardial injury. As both type 4a MI and major periprocedural myocardial injury are strong independent predictors of all-cause mortality at 1 year post-PCI, they may be used as quality metrics and surrogate endpoints for clinical trials. Further research is needed to evaluate treatment strategies for reducing the risk of major periprocedural myocardial injury, type 4a MI, and MACE in CCS patients undergoing PCI.

Ticagrelor or Prasugrel in Patients With ST-Segment-Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention.

BACKGROUND: Data on the comparative efficacy and safety of ticagrelor versus prasugrel in patients with ST-segment-elevation myocardial infarction undergoing primary percutaneous coronary intervention are limited. We assessed the efficacy and safety of ticagrelor versus prasugrel in a head-to-head comparison in patients with ST-segment-elevation myocardial infarction undergoing primary percutaneous coronary intervention. METHODS: In this prespecified subgroup analysis, we included 1653 patients with ST-segment-elevation myocardial infarction randomized to receive ticagrelor or prasugrel in the setting of the ISAR REACT-5 trial (Intracoronary Stenting and Antithrombotic Regimen: Rapid Early Action for Coronary Treatment 5). The primary end point was the incidence of death, myocardial infarction, or stroke at 1 year after randomization. The secondary end point was the incidence of bleeding defined as BARC (Bleeding Academic Research Consortium) type 3 to 5 bleeding at 1 year after randomization. RESULTS: The primary end point occurred in 83 patients (10.1%) in the ticagrelor group and in 64 patients (7.9%) in the prasugrel group (hazard ratio, 1.31 [95% CI, 0.95-1.82]; P=0.10). One-year incidence of all-cause death (4.9% versus 4.7%; P=0.83), stroke (1.3% versus 1.0%; P=0.46), and definite stent thrombosis (1.8% versus 1.0%; P=0.15) did not differ significantly in patients assigned to ticagrelor or prasugrel. One-year incidence of myocardial infarction (5.3% versus 2.8%; hazard ratio, 1.95 [95% CI, 1.18-3.23]; P=0.010) was higher with ticagrelor than with prasugrel. BARC type 3 to 5 bleeding occurred in 46 patients (6.1%) in the ticagrelor group and in 39 patients (5.1%) in the prasugrel group (hazard ratio, 1.22 [95% CI, 0.80-1.87]; P=0.36). CONCLUSIONS: In patients with ST-segment-elevation myocardial infarction undergoing primary percutaneous coronary intervention, there was no significant difference in the primary end point between prasugrel and ticagrelor. Ticagrelor was associated with a significant increase in the risk for recurrent myocardial infarction. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01944800.

Age- and Weight-Adapted Dose of Prasugrel Versus Standard Dose of Ticagrelor in Patients With Acute Coronary Syndromes : Results From a Randomized Trial.

BACKGROUND: The efficacy and safety of a reduced dose of prasugrel versus a standard dose of ticagrelor in elderly patients or those with a low body weight presenting with an acute coronary syndrome (ACS) are unknown. OBJECTIVE: To investigate the effect of an age- and weight-adapted dose of prasugrel versus a standard dose of ticagrelor in patients with ACS. (ClinicalTrials.gov: NCT01944800). DESIGN: Prespecified analysis of the multicenter, randomized ISAR-REACT 5 trial. SETTING: 23 centers in Germany and Italy. PATIENTS: 3997 patients with ACS planned for invasive management. INTERVENTION: Participants were randomly assigned to receive a standard dose of ticagrelor or prasugrel (reduced dose in the elderly or low-weight group and standard dose in the neither elderly nor low-weight group). MEASUREMENTS: The efficacy end point was a composite of death, myocardial infarction, or stroke, and the safety end point was bleeding, both at 12 months. RESULTS: In the elderly or low-weight group, the efficacy end point occurred in 12.7% of patients assigned to receive prasugrel and 14.6% of those assigned to receive ticagrelor (hazard ratio [HR], 0.82 [95% CI, 0.60 to 1.14]); in the neither elderly nor low-weight group, the efficacy end point occurred in 4.8% of patients assigned to receive prasugrel and 7.3% of those assigned to receive ticagrelor (HR, 0.65 [CI, 0.48 to 0.88]; P for interaction > 0.2). In the elderly or low-weight group, Bleeding Academic Research Consortium type 3 to 5 bleeding occurred in 8.1% of patients assigned to receive prasugrel and 10.6% of those assigned to receive ticagrelor (HR, 0.72 [0.46 to 1.12]), and in 3.7% and 3.8%, respectively, of patients in the neither elderly nor low-weight group (HR, 0.98 [CI, 0.65 to 1.47]; P for interaction > 0.2). LIMITATION: The study is a subgroup analysis. CONCLUSION: In elderly or low-weight patients with ACS, a reduced dose of prasugrel compared with the standard dose of ticagrelor is associated with maintained anti-ischemic efficacy while protecting these patients against the excess risk for bleeding. PRIMARY FUNDING SOURCE: German Center for Cardiovascular Research and Deutsches Herzzentrum München.

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.

Safety of a compression stocking for patients with chronic venous insufficiency (CVI) and peripheral artery disease (PAD).

BACKGROUND: With increasing age, it is increasingly common for patients to develop both chronic venous insufficiency (CVI) and peripheral artery disease (PAD). While there are special compression bandage systems commercially available for individuals thus affected, appropriate compression stockings have previously not been available. In the present study, we investigated the safety and effectiveness of a type of compression stocking specifically designed for this patient group (VenoTrain® angioflow, Bauerfeind Germany, German compression class 1 with high stiffness). PATIENTS AND METHODS: In a prospective case series, we included patients with both CVI (C3-C5 disease according to CEAP classification) and PAD (ankle-brachial index of < 0.9 and > 0.5; absolute ankle systolic pressure of > 60 mmHg). Primary outcome measures consisted of 1) safety in terms of PAD, as determined by measuring acral pressure using acral photoplethysmography (APPG), and 2) effectiveness in terms of CVI symptoms, as assessed by using a suitable questionnaire (VVSymQ). RESULTS: Fifty patients were evaluated (mean age: 67.1; mean ankle-brachial index: 0.75 ± 0.77). Fifteen patients had stage IIa PAD (according to Fontaine); 15, stage IIb; the remainder, stage I disease. Thirty-one patients had stage C3 CVI (according to CEAP classification); 16 patients, stage C4; and three patients, stage C5 disease. Immediately after donning the medical compression stocking, systolic arterial pressure in the big toe increased significantly (from 83.3 mmHg ± 27.6 mmHg to 90.8 mmHg ± 24.1 mmHg) (p = 0.026). The VVSymQ score dropped significantly from 5.0 ± 4.95 points to 1.4 ± 2.26 points (p < 0.001), thus reflecting an improvement in CVI symptoms. CONCLUSIONS: The compression stocking tested herein is safe for individuals with an ankle brachial index ≥ 0.5. Skin damage was not observed.

Round-knit or flat-knit compression garments for maintenance therapy of lymphedema of the leg? - Review of the literature and technical data.

To date, there have been no studies comparing flat-knit and round-knit compression garments for maintenance therapy of lymphedema of the leg. According to expert opinion, flat-knit fabrics are generally recommended for this purpose. Given the differences in the clinical presentation of lymphedema in terms of disease stage and location as well as patient adherence, and, last but not least, for economic reasons, it seems questionable whether all patients with lymphedema of the leg actually do require flat-knit compression garments. Considering technical aspects, published data and our own clinical experience, it seems reasonable that the choice of compression stockings be based on clinical findings and not on the diagnosis. Typical indications for flat-knit garments include significant differences in leg circumference as well as deep skin folds and edema of the toes/forefoot. However, there are also patients with lymphedema who benefit from round-knit fabrics with a high degree of stiffness. In any case, prior to maintenance therapy, it is essential to adequately decongest the legs using compression bandages and/or adaptive compression systems.

Real clinical experiences of dual versus triple antithrombotic therapy after percutaneous coronary intervention.

OBJECTIVES: We aimed to assess the impact of omitting aspirin on clinical outcomes in a real-world collective of patients receiving oral anticoagulation (OAC) therapy who were treated with a current-generation drug-eluting stent (DES) or an everolimus-eluting bioresorbable vascular scaffold (BVS). BACKGROUND: Limited data are available regarding the clinical benefit of triple antithrombotic therapy (TAT) with aspirin compared with dual antithrombotic therapy (DAT) without aspirin in patients undergoing percutaneous coronary intervention (PCI) and requiring OAC. METHODS: In total, 237 patients were analyzed. The primary outcome was a composite of major adverse cardiac and cerebrovascular events (MACCE) within 1 year after PCI. Secondary outcomes were the individual components of the primary endpoint, cardiovascular death, and any bleeding according to Bleeding Academic Research Consortium (BARC) or Thrombolysis in Myocardial Infarction (TIMI) criteria. RESULTS: Eighty-nine patients (37.6%) received DAT, and 148 (62.4%) received TAT. The rate of MACCE was significantly higher in DAT patients than in TAT patients (16 (18%) vs. 11 (7.4%); hazard ratio [HR] 2.73, 95% confidence interval [CI] 1.24-6.03; P = 0.01). The results of the multivariable Cox proportional hazards model including corrections for imbalances in baseline characteristics confirmed a significant independent association between DAT and MACCE (HRadj 3.14, 95% CI 1.31-7.54; P = 0.01). Major bleeding did not differ significantly between treatment groups. CONCLUSION: DAT was associated with a significantly higher rate of MACCE than TAT after DES or BVS implantation. Further studies are required to evaluate the safety and efficacy of dual versus TAT after PCI in clinical practice.

Impact of design of coronary stents and length of dual antiplatelet therapies on ischaemic and bleeding events: a network meta-analysis of 64 randomized controlled trials and 102 735 patients.

AIMS: The differential impact on ischaemic and bleeding events of the type of drug-eluting stent [durable polymer stents [DES] vs. biodegradable polymer stents vs. bioresorbable scaffolds (BRS)] and length of dual antiplatelet therapy (DAPT) remains to be defined. METHODS AND RESULTS: Randomized controlled trials comparing different types of DES and/or DAPT durations were selected. The primary endpoint was Major Adverse Cardiovascular Events (MACE) [a composite of death, myocardial infarction (MI), and target vessel revascularization]. Definite stent thrombosis (ST) and single components of MACE were secondary endpoints. The arms of interest were: BRS with 12 months of DAPT (12mDAPT), biodegradable polymer stent with 12mDAPT, durable polymer stent [everolimus-eluting (EES), zotarolimus-eluting (ZES)] with 12mDAPT, EES/ZES with <12 months of DAPT, and EES/ZES with >12 months of DAPT (DAPT > 12 m). Sixty-four studies with 150 arms and 102 735 patients were included. After a median follow-up of 20 months, MACE rates were similar in the different arms of interest. EES/ZES with DAPT > 12 m reported a lower incidence of MI than the other groups, while BRS showed a higher rate of ST when compared to EES/ZES, irrespective of DAPT length. A higher risk of major bleedings was observed for DAPT > 12 m as compared to shorter DAPT. CONCLUSION: Durable and biodegradable polymer stents along with BRS report a similar rate of MACE irrespective of DAPT length. Fewer MI are observed with EES/ZES with DAPT > 12 m, while a higher rate of ST is reported for BRS when compared to EES/ZES, independently from DAPT length. Stent type may partially affect the outcome together with DAPT length.

Systemic therapies for leg ulcers.

Successful management of patients with leg ulcers requires identification of the underlying etiology, with subsequent initiation of causal treatment, if feasible. Supplementary measures of first choice include stage-adjusted wound treatment, usually combined with compression therapy. The significance of systemic drugs has been the subject of controversial debate, depending on the underlying cause of the condition. The present review article is therefore meant to highlight current aspects of systemic drug therapies for the treatment of leg ulcers associated with chronic venous insufficiency, peripheral arterial disease, livedoid vasculopathy, vasculitis, necrobiosis lipoidica, calciphylaxis and pyoderma gangrenosum. In summary, the majority of therapeutic options presented herein are used off-label. While systemic drugs are promising options for the more common types of wounds such as venous, mixed or arterial leg ulcers, they do not represent the current standard of treatment. By contrast, systemic agents play a key role in the management of many of the other disorders presented herein. These agents primarily include immunomodulatory and rheological drugs used to expedite wound healing.

S1 Guidelines - Dermatoses associated with dermal lymphostasis.

The objective of the present S1 guidelines is to present current knowledge about dermatologically relevant diseases associated with localized dermal lymphostasis, thus facilitating their early detection, diagnostic workup, and targeted treatment. Whenever possible, treatment should be based on stage-appropriate and clearly defined algorithms. The numerous issues regarding differential diagnosis and treatment clinicians are confronted with in everyday clinical practice seem to warrant the publication of up-to-date guidelines. These guidelines focus on patients of all age groups and genders exhibiting skin lesions caused by dermal lymphostasis. Specific recommendations are provided with respect to the diagnosis and differential diagnosis of the various clinical manifestations. In this context, comorbid skin diseases such as atopic dermatitis, psoriasis, hidradenitis suppurativa, urticaria, and contact dermatitis will be highlighted, including their treatment and associated specific risks. Several other relevant current guidelines are referenced as regards the distinction from and treatment of common cofactors and comorbid conditions.

S1-Leitlinie - Dermatosen bei dermaler Lymphostase.

Das Ziel dieser S1-Leitlinie ist es, aktuelles Wissen über dermatologisch relevante Krankheitsbilder bei lokal begrenzter dermaler Lymphostase an allen Lokalisationen des Hautorgans zu vermitteln, um diese frühzeitig zu erkennen, diagnostisch zu sichern und gezielt zu behandeln. Wann immer möglich, sollte diese Therapie anhand klar definierter Algorithmen stadiengerecht erfolgen. Die im klinischen Alltag häufig auftauchenden differenzialdiagnostischen und therapeutischen Fragen lassen eine aktuelle Leitlinie notwendig erscheinen. Diese Leitlinie fokussiert auf Patienten jeglichen Alters und Geschlechts mit Hautveränderungen, die im kausalen Zusammenhang mit dermaler Lymphostase stehen. In konkreten Handlungsempfehlungen werden die Diagnostik und Differenzialdiagnostik der verschiedenen Manifestationsformen bei gleichzeitig auftretender dermatologischer Komorbidität wie beispielsweise atopische Dermatitis, Psoriasis vulgaris, Acne inversa, Urtikaria, Kontaktekzeme sowie ihre Therapien unter Berücksichtigung besonderer Risiken veranschaulicht. Für die Abgrenzung und Behandlung häufiger therapierelevanter Kofaktoren und Komorbidität wird auf mehrere andere hierfür relevante aktuelle Leitlinien verwiesen.

Impact of Gram-negative bacteria on the treatment of venous leg ulcers.

Gram-negative germs with and without multi-resistance are garnering more and more importance. The aim of this study was to investigate the frequency and rate of resistance against antibiotics and to clarify the impact of Gram-negative bacteria, especially with high rates of resistance, for the treatment of venous leg ulcers. This is a retrospective, monocentric, non-randomised open study. Included were all data within 1 year of bacterial swabs of venous leg ulcers. We performed summarization, pooling, and descriptive analysis for frequencies and crossover. We analysed 679 swabs of 285 patients with venous leg ulcers. The mean patient age was 69.78 years. There were 76.1% Gram-positive and 58.2% Gram-negative germs detected; 56.5% of the swabs showed multi-resistance. Gram-negative bacteria were associated with more pain. Exacerbation and relevant aggravation of wounds that led to stationary treatment occurred more frequently. With polihexanid treatment, we saw less Gram-negative flora. This study showed an immediate impact of Gram-negative germs on the patient's pain, the risk for aggravation, and the choice of treatment. Further studies for prophylaxis and treatment of Gram-negative germs in venous leg ulcer therapy are needed.

S1 guidelines: Lipedema.

The present, revised guidelines on lipedema were developed under the auspices of and funded by the German Society of Phlebology (DGP). The recommendations are based on a systematic literature search and the consensus of eight medical societies and working groups. The guidelines contain recommendations with respect to diagnosis and management of lipedema. The diagnosis is established on the basis of medical history and clinical findings. Characteristically, there is a localized, symmetrical increase in subcutaneous adipose tissue in arms and legs that is in marked disproportion to the trunk. Other findings include edema, easy bruising, and increased tenderness. Further diagnostic tests are usually reserved for special cases that require additional workup. Lipedema is a chronic, progressive disorder marked by the individual variability and unpredictability of its clinical course. Treatment consists of four therapeutic mainstays that should be combined as necessary and address current clinical symptoms: complex physical therapy (manual lymphatic drainage, compression therapy, exercise therapy, and skin care), liposuction and plastic surgery, diet, and physical activity, as well as psychotherapy if necessary. Surgical procedures are indicated if - despite thorough conservative treatment - symptoms persist, or if there is progression of clinical findings and/or symptoms. If present, morbid obesity should be therapeutically addressed prior to liposuction.

S1-Leitlinie Lipödem.

Die vorliegende überarbeitete Leitlinie zum Lipödem wurde unter der Federführung der Deutschen Gesellschaft für Phlebologie (DGP) erstellt und finanziert. Die Inhalte beruhen auf einer systematischen Literaturrecherche und dem Konsens von acht medizinischen Fachgesellschaften und Berufsverbänden. Die Leitlinie beinhaltet Empfehlungen zu Diagnostik und Therapie des Lipödems. Die Diagnose ist dabei auf der Basis von Anamnese und klinischem Befund zu stellen. Charakteristisch ist eine umschriebene, symmetrisch lokalisierte Vermehrung des Unterhautfettgewebes an den Extremitäten mit deutlicher Disproportion zum Stamm. Zusätzlich finden sich Ödeme, Hämatomneigung und eine gesteigerte Schmerzhaftigkeit der betroffenen Körperabschnitte. Weitere apparative Untersuchungen sind bisher besonderen Fragestellungen vorbehalten. Die Erkrankung ist chronisch progredient mit individuell unterschiedlichem und nicht vorhersehbarem Verlauf. Die Therapie besteht aus vier Säulen, die individuell kombiniert und an das aktuelle Beschwerdebild angepasst werden sollten: komplexe physikalische Entstauungstherapie (manuelle Lymphdrainage, Kompressionstherapie, Bewegungstherapie, Hautpflege), Liposuktion und plastisch-chirurgische Interventionen, Ernährung und körperliche Aktivität sowie ggf. additive Psychotherapie. Operative Maßnahmen sind insbesondere dann angezeigt, wenn trotz konsequent durchgeführter konservativer Therapie noch Beschwerden bestehen bzw. eine Progredienz des Befundes und/oder der Beschwerden auftritt. Eine begleitend zum Lipödem bestehende morbide Adipositas sollte vor einer Liposuktion therapeutisch angegangen werden.