Comparative analysis of biofilm models to determine the efficacy of antimicrobials.

Biofilms are one of the greatest challenges in today's treatment of chronic wounds. While antimicrobials kill platonic bacteria within seconds, they are rarely able to harm biofilms. In order to identify effective substances for antibacterial therapy, cost-efficient, standardized and reproducible models that aim to mimic the clinical situation are required. In this study, two 3D biofilm models based on human plasma with immune cells (lhBIOM) or based on sheep blood (sbBIOM) containing S. aureus or P. aeruginosa, are compared with the human biofilm model hpBIOM regarding their microscopic structure (scanning electron microscopy; SEM) and their bacterial resistance to octenidine hydrochloride (OCT) and a sodium hypochlorite (NaOCl) wound-irrigation solution. The three analyzed biofilm models show little to no reaction to treatment with the hypochlorous solution while planktonic S. aureus and P. aeruginosa cells are reduced within minutes. After 48 h, octenidine hydrochloride manages to erode the biofilm matrix and significantly reduce the bacterial load. The determined effects are qualitatively reflected by SEM. Our results show that both ethically acceptable human and sheep blood based biofilm models can be used as a standard for in vitro testing of new antimicrobial substances. Due to their composition, both fulfill the criteria of a reality-reflecting model and therefore should be used in the approval for new antimicrobial agents.

[German national consensus on wound documentation of leg ulcer : Part 2: Routine care - classification of variable characteristics]. / Nationaler Konsensus zur Wunddokumentation beim Ulcus cruris : Teil 2: Routineversorgung ­ Klassifikation der Variablenausprägungen.

BACKGROUND: Standards in the assessment and documentation of disease processes are the basis of guideline-based care. For the treatment of chronic wounds, especially leg ulcers, no approved parameters are available. OBJECTIVES: Against this background, our aim was to develop standards for the documentation of leg ulcer in routine care. This article presents the recommendations for the classification and characteristics of the variables. MATERIALS AND METHODS: The development of the documentation standard was based on a systematic literature research and was performed in a Delphi-based consensus process. The national consensus process included meetings as well as web-based questionnaires. The Consensus Group is coordinated by the German Center for Health Services Research in Dermatology (CVderm). RESULTS: The documentation standards and their variables for leg ulcer routine care were developed in seven meetings of the consensus group. The consensus group consists of 38 delegates of wound care societies, health insurances, wound networks and associations. DISCUSSION: For each variable, recommended in routine care, a distinct response scheme (defined set of variable characteristics) was defined. As a next step, a structured implementation process is required, which was part of the resolutions of the consensus group.

[German national consensus on wound documentation of leg ulcer : Part 1: Routine care - standard dataset and minimum dataset]. / Nationaler Konsensus zu Wunddokumentation beim Ulcus cruris : Teil 1: Routineversorgung ­ "Standard-Dataset" und "Minimum-Dataset".

BACKGROUND: Standards for basic documentation and the course of treatment increase quality assurance and efficiency in health care. To date, no standards for the treatment of patients with leg ulcers are available in Germany. OBJECTIVES: The aim of the study was to develop standards under routine conditions in the documentation of patients with leg ulcers. This article shows the recommended variables of a "standard dataset" and a "minimum dataset". MATERIALS AND METHODS: Consensus building among experts from 38 scientific societies, professional associations, insurance and supply networks (n = 68 experts) took place. After conducting a systematic international literature research, available standards were reviewed and supplemented with our own considerations of the expert group. From 2012-2015 standards for documentation were defined in multistage online visits and personal meetings. RESULTS: A consensus was achieved for 18 variables for the minimum dataset and 48 variables for the standard dataset in a total of seven meetings and nine online Delphi visits. The datasets involve patient baseline data, data on the general health status, wound characteristics, diagnostic and therapeutic interventions, patient reported outcomes, nutrition, and education status. DISCUSSION: Based on a multistage continuous decision-making process, a standard in the measurement of events in routine care in patients with a leg ulcer was developed.

Editor's Choice - Assessment of International Outcomes of Intact Abdominal Aortic Aneurysm Repair over 9 Years.

BACKGROUND: Case mix and outcomes of complex surgical procedures vary over time and between regions. This study analyses peri-operative mortality after intact abdominal aortic aneurysm (AAA) repair in 11 countries over 9 years. METHODS: Data on primary AAA repair from vascular surgery registries in 11 countries for the years 2005-2009 and 2010-2013 were analysed. Multivariate adjusted logistic regression analyses were carried out to adjust for variations in case mix. RESULTS: A total of 83,253 patients were included. Over the two periods, the proportion of patients ≥80 years old increased (18.5% vs. 23.1%; p < .0001) as did the proportion of endovascular repair (EVAR) (44.3% vs. 60.6; p < .0001). In the latter period, 25.8% of AAAs were less than 5.5 cm. The mean annual volume of open repairs per centre decreased from 12.9 to 10.6 between the two periods (p < .0001), and it increased for EVAR from 10.0 to 17.1 (p < .0001). Overall, peri-operative mortality fell from 3.0% to 2.4% (p < .0001). Mortality for EVAR decreased from 1.5% to 1.1% (p < .0001), but the outcome worsened for open repair from 3.9% to 4.4% (p = .008). The peri-operative risk was greater for octogenarians (overall, 3.6% vs. 2.1%, p < .0001; open, 9.5% vs. 3.6%, p < .0001; EVAR, 1.8% vs. 0.7%, p < .0001), and women (overall, 3.8% vs. 2.2%, p < .0001; open, 6.0% vs. 4.0%, p < .0001; EVAR, 1.9% vs. 0.9%, p < .0001). Peri-operative mortality after repair of AAAs <5.5 cm was 4.4% with open repair and 1.0% with EVAR, p < .0001. CONCLUSIONS: In this large international cohort, total peri-operative mortality continues to fall for the treatment of intact AAAs. The number of EVAR procedures now exceeds open procedures. Mortality after EVAR has decreased, but mortality for open operations has increased. The peri-operative mortality for small AAA treatment, particularly open surgical repair, is still considerable and should be weighed against the risk of rupture.

Perioperative quality assessment of varicose vein surgery : Commission for quality assessment of the German Society for Vascular Surgery.

PURPOSE: An estimated 350,000 varicose vein (VV) surgical procedures are performed in Germany each year, with annual treatment costs amounting to about 800 million Euro. To evaluate the outcome quality of this treatment, we examined the intraoperative and postoperative complication rates on record in the VV surgery quality assessment (QA) registry of the German Society for Vascular Surgery (GSVS). METHODS: Data on 89,647 patients (27,463 men, 62,184 women; average age 52.8 years, range 15-96 years) collected in the GSVS varicose surgery QA registry between 2001 and 2009 were analyzed. In these patients, 95,214 surgical procedures were performed on 105,296 limbs. Complication rates were correlated with the type of VV surgical procedure, with whether surgery was performed on an inpatient or outpatient basis, and with the CEAP classification (C stage) and American Society of Anaesthesiologists' (ASA) stage at the time of surgery. Statistical analyses were performed using a chi-square test, a Cochrane-Armitage test, and an odds ratio calculation. RESULTS: Intraoperative and postoperative complication was low (0.18 and 0.43 %, respectively), being the lowest for radiofrequency ablation (0.25 %) but not differing significantly from those for endovenous laser therapy and high ligation and stripping. General complications occurred in 0.67 % of outpatients and in 0.25 % of inpatients, a highly significant statistical difference (p < 0.0001, chi-square test). With regard to C stage, the higher the stage, the higher the local complication rate. A clear correlation was also found between preoperative ASA stage and postoperative complication rates: for ASA stages I and II, the complication rates were 0.2 and 0.5 %, respectively, increasing for ASA stage III to 1.2 % and for ASA IV to 2.2 %. The differences between the ASA classes were highly statistically significant (p < 0.0001, Cochrane-Armitage test) CONCLUSIONS: Outcome quality as reflected in the intraoperative and postoperative complication rates was very good for all patients undergoing inpatient or outpatient VV surgery. Data from the GSVS QA registry shows that VV surgery is performed with very good perioperative results in specialized centers in Germany.

Editor's Choice - Subsequent Results for Arch Aneurysm Repair with Inner Branched Endografts.

OBJECTIVES: The aim was to evaluate the current results of aortic arch aneurysm repair using inner branched endografts performed in three high volume aortic endovascular centers and to compare them to the pioneering global experience with this technology. METHODS: Included patients underwent repair of aortic arch aneurysms >55 mm in diameter using inner branched endograft technology between April 2013 and November 2014. All patients were deemed unfit for open surgery. Inner branches were designed to perfuse the brachiocephalic trunk and the left common carotid artery in all cases. A left subclavian artery (LSA) revascularization was performed prior to the arch endovascular repair. Data were collected retrospectively in an electronic database. Parameters included length of procedure, fluoroscopy time, contrast volume, technical success, presence of endoleaks, early and late complications, and mortality. RESULTS: Twenty-seven patients were included in the study. Technical success was achieved in all cases. No patients died during the 30 day post-operative period. Early neurologic events included two major strokes (7.4%) and one minor stroke (3.7%). Transient spinal cord ischemia with full recovery was observed in two patients (7.4%). Four patients (14.8%) underwent early (<30 day) re-interventions; these were for an access complication, an ischemic limb and exploration of the left ventricle through a sternotomy in two patients. During follow up (median 12 months), one patient (3.7%) died from a remote thoraco-abdominal aneurysm rupture. There were three Type 2 endoleaks (11.1%). Two re-interventions (7.4%) were performed, one to treat a Type 2 endoleak and one to treat a septic false aneurysm. A significant decrease in overall mortality was observed when comparing patients from the early experience with patients from the current report. CONCLUSIONS: The early outcomes associated with this technology are favorable. Branched endografting of aortic arch aneurysms should be considered in patients unfit for open surgery.

[Vascular medicine needs more evidence: recent results and meta-analyses for the treatment of diabetic feet]. / Die Gefäßmedizin braucht mehr Evidenz: Aktuelle Ergebnisse und Metaanalysen zur Behandlung des diabetischen Fußes.

BACKGROUND: This overview comments on clinical trials and meta-analyses from the literature on the treatment of diabetic feet. METHODS: For the literature review, the MEDLINE database (PUBMED) was searched under the key words "diabetic foot". Publications of the last three years (2012 to 2014) were extracted. RESULTS: For patients with diabetic feet, both endovascular (ER) and open (OR) revascularisation techniques are possible. There are not sufficient data to demonstrate whether open bypass surgery or endovascular interventions are more effective in these patients. However, registries show that ER has now in terms of quantity become the preferred method. Angiosome-targeted revascularisation has to be considered in these situations. For the local treatment of a diabetic foot ulcer a variety of dressings are available, the evidence for their recommendation is low. Dressing cost and the wound management properties, e.g. exudate management therefore can influence the choice of dressing. There is no evidence that more expensive dressings as compared to basic dressings offer advantages in terms of healing. In plantar diabetic foot ulcers, non-removable off-loading devices regardless of type are more likely to result in ulcer healing than removable off-loading devices, presumably, because patient compliance with off-loading is facilitated. Meaningful pressure-relieving interventions for treating diabetic foot ulcers also include Achilles tendon lengthening, a plantar fascia release and percutaneous flexor tenotomy. The value of a standardised treatment protocol carried out by a specialist team could be proven in large registries based on decreasing amputation rates. CONCLUSION: This survey reveals a significant disparity between the large number of treatment recommendations and their evidence. For the future, therefore it is imperative to implement nationwide register surveys with respect to treatment and outcome of these patients.

[Transcardiac Access Routes for Endovascular Treatment of Ascending Aortic Pathologies]. / Transkardiale Zugangswege zur endovaskulären Versorgung der Aorta ascendens.

Gold standard for treatment of pathologies of the ascending aorta is still open surgery with extracorporal circulation in moderate to deep hypothermia. These procedures are associated with high morbidity and mortality, especially if performed in older patients or after previous cardiac surgery. Thoracic endovascular aortic repair (TEVAR) has become the preferred treatment option for thoracic aortic pathologies of the descending aorta even in high-risk patients with severe comorbidities resulting in reduced morbidity and mortality compared to open repair. Despite the continuous development of endograft technology an adequate arterial access still poses a relevant limitation of this treatment option accentuated in the proximal segments of the aorta. The transfemoral access may be limited due to severe kinking or arteriosclerotic plaque stenosis of femoral or iliac vessels. Furthermore, the long distance between femoral access vessels and the aortic lesion impairs device torsibility and exact deployment of the stent graft. To provide a practical alternative endovascular access to the ascending aorta, antegrade transcardiac access routes including transapical or transseptal techniques have recently gained increasing interest.

[Cost and cost-effectiveness in the treatment of peripheral arterial occlusion disease - what is proven?]. / Kosten und Kosteneffizienz bei der Behandlung der peripheren arteriellen Verschlusskrankheit - was ist gesichert?

BACKGROUND: This overview comments on the health-care relevance of peripheral arterial occlusive disease (PAOD) in patients with intermittent claudication (IC) and critical limb ischaemia (CLI). We evaluated different treatment modalities in terms of cost-effectiveness. METHOD: For the literature review, the Medline database (PubMed) was searched under the key words "critical limb ischemia AND cost", "critical limb ischemia AND economy", "peripheral arterial disease AND cost", "peripheral arterial disease AND economy". RESULTS: In the years 2005 to 2009, the hospitalisations of patients with PAOD rose disproportionately in Germany by 20 %, to 483,961 hospital admissions. By comparison, hospital admissions altogether increased by only 8 %. The average in-patient costs were estimated to be approximately € 5000 per PAOD-patient - a rather conservative estimate. For the patient with IC the economic data position is clear, supervised exercise training is by far the most cost-effective treatment option, followed by percutaneous transluminal angioplasty (PTA) and finally the peripheral bypass. In accordance with the guidelines of the UK, the latter is therefore indicated only if PTA fails or is technically not possible. In patients with CLI, the situation is not obvious. Indeed, a short-term economic advantage can be calculated for the PTA, the long-term comparison of both methods, however, is impossible due to insufficient data. In addition, the risk factors for the patient have to be included in the calculation. This was indeed demonstrated in the short-term, but could not be analysed in the long-term follow-up. CONCLUSION: The issue of greater cost-effectiveness of open or endovascular treatment in patients with CLI is uncertain, the studies and patient populations are too heterogeneous. Further studies are urgently needed to structure the sequence of the various treatment options in guidelines and clinical pathways.

[Wound networks in Germany: structure, functions and objectives 2014]. / Wundnetze in Deutschland: Struktur, Funktionen und Ziele 2014.

BACKGROUND: Wound networks are structured collaborations between various professions and medical disciplines in the field of treatment of patients with chronic wounds. In view of the complex chronic courses of such wounds with many relevant underlying diseases, comorbidities and a multitude of possible therapy options, the evidence-based structured treatment of patients with wound problems is of particular importance. However, this treatment is very heterogeneous and often uncoordinated. OBJECTIVE: This article describes a stocktaking of the active regional wound networks in Germany with characterization of their structures, activities and objectives. METHODS: A nationwide survey was carried out targeting wound specialists and wound societies as well as already established wound networks for which an updating was carried out. All identified networks were issued with a standardized questionnaire about the size of the network, extent of regional coverage, participating medical disciplines and professional groups and activities. In addition to the preformulated questions, free text information was also encouraged. RESULTS: A total of 35 wound networks could be identified. The majority of networks consisted of representatives of hospitals as well as physicians in private practice and nursing personnel. The most frequently represented medical disciplines were vascular surgeons (74%), general physicians (63%), diabetologists (60%), general surgeons (60%) and dermatologists (57%). The most frequent activities were informal meetings on further education (77%), exchange of experiences and second opinions (both 71%) and consultation on patient treatment (69%). Selective contracts were only implemented in very few cases. CONCLUSION: The wound networks established in Germany on self-initiatives represent strong interdisciplinary and interprofessional-oriented specialist platforms with a high potential for structured and efficient treatment. Incentives for systematic utilization of these structures in the course of improvements in quality and remuneration of treatment of patients with chronic wounds would be desirable.

[Future vascular medicine: inauguration of a cardiovascular hybrid concept]. / Gefäßmedizin von morgen: Vorstellung eines kardiovaskulären Hybrid-Care-Konzepts.

The demographic developments will lead to an exponential increase of cardiovascular diseases. Additionally, technical developments of conservative and invasive treatment modalities will be added to distinguished, organ-orientated therapeutic concepts. This will also require a new orientation of vascular services. This concept implies that specific contents are referred to and contained in partner specialties. Since the heart and vascular system function as an anatomic and functional union, implementation of vascular medicine within cardiovascular centres represents a logical consequence.

Advanced endovascular techniques for thoracic and abdominal aortic dissections.

Endovascular treatment of aortic dissection is still in its infancy and consists usually of implantation of thoracic tubular stent-grafts to cover the proximal entry tear and redirect flow into the true lumen. Large registries comparing endovascular treatment by thoracic endovascular aortic repair (TEVAR) with open surgery for aortic dissection of the descending aorta have demonstrated a clear benefit for endovascular treatment with lower mortality and morbidity rates turning TEVAR into the standard treatment for complicated type B aortic dissection. With this momentum of success endovascular techniques continue to challenge open surgical techniques also in the aortic arch and the ascending aorta. TEVAR for aortic dissection has become more complex requiring an individualized treatment strategy as endovascular techniques have developed with the advent of new devices and increased experience of the operators. In many cases straight implantation of a thoracic tubular stent-graft is sufficient. But as rerouting of the blood flow can also change perfusion of vital side-branches the endovascular operator needs to have a large armamentarium of techniques and adjunctive procedures in order to sufficiently address the individual patient morphology. This chapter reviews a variety of endovascular techniques including access techniques, proximal sealing, the Petticoat-technique, false lumen deployment, fenestration techniques, branch vessel stenting and false lumen obstruction by various techniques.

[Change in concept--from vascular centre to interdisciplinary organ-oriented clinic for vascular medicine]. / Vom Konzept Gefäßzentrum zur interdisziplinären Organklinik für Gefäßmedizin.

Demographic developments have led to an exponential increase of cardiovascular illness. Additionally, the technical development of conservative and invasive treatment modalities has added to an increase of differentiated therapy. The development of vascular centres led to optimised processes in diagnostic and therapy according to their essential requirements. A further development is an increased specialisation and new orientation of vascular specialties through a combination of vascular surgery, endovascular therapy and angiology. The concept of the Hamburg model implements this development by introduction of an organ-orientated clinic for vascular medicine, located within the heart centre of the University of Hamburg's Eppendorf Hospital.

New surgical and hybrid techniques for crural and pedal anastomoses.

Although there is currently a trend using endovascular methods to treat long and/or complex distal lesions, there are some interesting new approaches, technical modifications and simplifications in open surgery. Some of these are new, and some are older, but their effectiveness is now starting to be recognized. 1) Anatomical concepts: the lower leg/foot consists of 6 angiosomes, which are supplied by the 3 main arteries. It has been shown that the revascularization of the correct angiosome could lead to a higher rate of success when compared to the connection of an indirect artery. Other anatomical concepts describe the use of a flow-thru flap, and the advances in the use of homografts in peripheral bypass surgery. 2) New materials for implantation: while biological graft materials (tissue engineering) are still under development, no fundamental changes in clinical use have taken place. If autologous vein is missing, alloplastic materials made from polyester or polytetrafluorethylene (PTFE) are the available alternatives. On the basis of studies published so far, heparin coating does appear to offer advantages. 3) New aids for operative treatment: in contrast to rather slow (clinical) advancement with regard to bypass materials, there have been some interesting developments with regard to ancillary products. There are clips for stapled anastomoses, small shunts or thermosensitive polymers to avoid clamping. Furthermore some techniques perform anastomoses without sewing, like intraluminal protein tubes or ring anastomoses. The Viabahn Padova Sutureless (ViPS) technique anastomoses a stent-graft to the artery by placing it openly into the vessel and then releasing a stent by a simple pulling mechanism. In summary, peripheral bypass surgery remains a very standardized operation. Although not spectacular, there are some interesting new approaches, technical modifications and simplifications.