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The optimal treatment for patients with asymptomatic carotid artery stenosis is under debate. Since best medical treatment (BMT) has improved over time, the benefit of carotid endarterectomy (CEA) or carotid artery stenting (CAS) is unclear. Randomised data comparing the effect of CEA and CAS versus BMT alone are absent. We aimed to directly compare CEA plus BMT with CAS plus BMT and both with BMT only.SPACE-2 was a multicentre, randomised, controlled trial at 36 study centres in Austria, Germany, and Switzerland. We enrolled participants aged 50-85 years with asymptomatic carotid artery stenosis at the distal common carotid artery or the extracranial internal carotid artery of at least 70%, according to European Carotid Surgery Trial criteria. Initially designed as a three-arm trial including one group for BMT alone (with a randomised allocation ratio of 2·9:2·9:1), the SPACE-2 study design was amended (due to slow recruitment) to become two substudies with two arms each comparing CEA plus BMT with BMT alone (SPACE-2a) and CAS plus BMT with BMT alone (SPACE-2b); in each case in a 1:1 randomisation. Participants and clinicians were not masked to allocation. The primary efficacy endpoint was the cumulative incidence of any stroke or death from any cause within 30 days or any ipsilateral ischaemic stroke within 5 years. The primary safety endpoint was any stroke or death from any cause within 30 days after CEA or CAS. The primary analysis was by intention-to treat, which included all randomly assigned patients in SPACE-2, SPACE-2a, and SPACE-2b, analysed using meta-analysis of individual patient data. We did two-step hierarchical testing to first show superiority of CEA and CAS to BMT alone then to assess non-inferiority of CAS to CEA. Originally, we planned to recruit 3640 patients; however, the study had to be stopped prematurely due to insufficient recruitment. This report presents the primary analysis at 5-year follow-up. This trial is registered with ISRCTN, number ISRCTN78592017.513 patients across SPACE-2, SPACE-2a, and SPACE-2b were recruited and surveyed between July 9, 2009, and Dec 12, 2019, of whom 203 (40%) were allocated to CEA plus BMT, 197 (38%) to CAS plus BMT, and 113 (22%) to BMT alone. Median follow-up was 59·9 months (IQR 46·6-60·0). The cumulative incidence of any stroke or death from any cause within 30 days or any ipsilateral ischaemic stroke within 5 years (primary efficacy endpoint) was 2·5% (95% CI 1·0-5·8) with CEA plus BMT, 4·4% (2·2-8·6) with CAS plus BMT, and 3·1% (1·0-9·4) with BMT alone. Cox proportional-hazard testing showed no difference in risk for the primary efficacy endpoint for CEA plus BMT versus BMT alone (hazard ratio [HR] 0·93, 95% CI 0·22-3·91; p=0·93) or for CAS plus BMT versus BMT alone (1·55, 0·41-5·85; p=0·52). Superiority of CEA or CAS to BMT was not shown, therefore non-inferiority testing was not done. In both the CEA group and the CAS group, five strokes and no deaths occurred in the 30-day period after the procedure. During the 5-year follow-up period, three ipsilateral strokes occurred in both the CAS plus BMT and BMT alone group, with none in the CEA plus BMT group.CEA plus BMT or CAS plus BMT were not found to be superior to BMT alone regarding risk of any stroke or death within 30 days or ipsilateral stroke during the 5-year observation period. Because of the small sample size, results should be interpreted with caution.German Federal Ministry of Education and Research (BMBF) and German Research Foundation (DFG).

ZusammenfassungDie Versorgungsqualität bei Eingriffen an der extrakraniellen A. carotis wird von der Expertise des Operateurs, indirekt somit auch von Mindestmengen und außerdem von Strukturmerkmalen der behandelnden Einrichtungen beeinflusst. In einer kurzen Übersicht werden aktuelle Analysen aus dem Bereich der Versorgungsforschung sowie die aktuellen Leitlinien-Empfehlungen dargelegt. Die Mindestmenge von 20 Eingriffen pro Jahr bei Operationen (CEA) und 10 Eingriffen bei Stentangioplastien (CAS) sollte nach derzeitiger Empfehlung nicht unterschritten werden. Eine 24-Stunden-Verfügbarkeit von Fachärzten sowie der Bildgebungsverfahren (CT, MRA) wird empfohlen, optimalerweise auch eine organisierte enge Kooperation mit Neuro-Interventionalisten sowie einer Stroke Unit.

Die Karotisstenose ist im Fachbereich Gefaschirurgie das einzige Krankheitsbild, fur das eine bundesweite gesetzlich verpflichtende Qualitatssicherung (QS) durchgefuhrt wird. Im Folgenden werden die Qualitatsziele zur Karotisrevaskularisation (Karotisendarteriektomie und Stentimplantation) mit den erhobenen Qualitatsindikatoren (QI) im QS-Verfahren beschrieben. Die QIs wurden zusammengefasst und in Kontext mit der Literatur gesetzt. Zur Uberprufung von Qualitatszielen werden verschiedene Mase wie QIs, Transparenzkennzahlen und Sentinel-Event-Indikatoren verwendet. Hiervon haben nur QIs einen festgelegten Referenzbereich. Das Ziel der Karotisrevaskularisation ist die Schlaganfallprophylaxe. Beim gesetzlichen QS-Verfahren „Karotisrevaskularisation“ werden daher zwei Qualitatsziele verfolgt, die mithilfe von QIs uberpruft werden: Die Indikationsstellung und eine niedrige Komplikationsrate des primaren Endpunkts Schlaganfall und Tod. Fur die Komplikationsrate wird als QI das risikoadjustierte Verhaltnis der beobachteten zur erwarteten Rate an periprozeduralen Schlaganfallen oder Todesfallen berechnet. Bundesweit lag das adjustierte Risiko fur CEA uber die Jahre zwischen 2,1 und 2,9 % und fur CAS zwischen 3,1 und 4,5 %. Die Karotisrevaskularisation ist die einzige gefaschirurgische Prozedur, bei der eine gesetzlich vorgeschriebene QS mit Uberprufung der Indikationsstellung und periprozeduralem Schlaganfall- und Letalitatsrisiko erfolgt. Damit besteht ein wichtiges Tool zur Sicherung der Versorgungsqualitat bei der invasiven Behandlung von Karotisstenosen in Deutschland. Mit zunehmender wissenschaftlicher Evidenz ist eine konstante Anpassung der QIs notwendig.

Purpose: To report the outcomes of bypass grafting (BG) vs endovascular therapy (EVT) in patients with non-dialysis-dependent chronic kidney disease (CKD) and chronic limb-threatening ischemia (CLTI). Materials and Methods: The CRITISCH Registry is a prospective, national, interdisciplinary, multicenter registry evaluating the current practice of all available treatment options in 1200 consecutive CLTI patients. For the purposes of this analysis, only the 337 patients with non-dialysis-dependent CKD treated by either BG (n=86; median 78 years, 48 men) or EVT (n=251; median age 80 years, 135 men) were analyzed. The primary composite outcome was amputation-free survival (AFS); secondary outcomes were overall survival (OS) and amputation-free time (AFT). All outcomes were evaluated in Cox proportional hazards models; the results are reported as the hazard ratio (HR) and 95% confidence interval (CI). Results: The Cox regression analysis revealed a significantly greater hazard of amputation or death after BG (HR 1.78, 95% CI 1.05 to 3.03, p=0.028). The models for AFT and overall survival also suggested a higher hazard for BG, but the differences were not significant (AFT: HR 1.66, 95% CI 0.78 to 3.53, p=0.188; OS: HR 1.41, 95% CI 0.80 to 2.47, p=0.348). The absence of runoff vessels (HR 1.73, 95% CI 1.15 to 2.60, p=0.008) was associated with a decreased AFS. The likelihood of amputation was higher in male patients (HR 2.21, 95% CI 1.10 to 4.45, p=0.027) and was associated with a lack of runoff vessels (HR 1.95, 95% CI 0.96 to 3.95, p=0.065) and myocardial infarction (HR 3.74, 95% CI 1.23 to 11.35, p=0.020). Death was more likely in patients without runoff vessels (HR 1.76, 95% CI 1.11 to 2.80, p=0.016) and those with a higher risk score (HR 1.73, 95% CI 1.03 to 2.91, p=0.038). Conclusion: This analysis suggested that BG was associated with poorer AFS than EVT in patients with non-dialysis-dependent CKD and CLTI. Male sex, previous myocardial infarction, and the absence of runoff vessels were additionally identified as predictors of poorer outcomes.

Summary Background Among asymptomatic patients with severe carotid artery stenosis but no recent stroke or transient cerebral ischaemia, either carotid artery stenting (CAS) or carotid endarterectomy (CEA) can restore patency and reduce long-term stroke risks. However, from recent national registry data, each option causes about 1% procedural risk of disabling stroke or death. Comparison of their long-term protective effects requires large-scale randomised evidence. Methods ACST-2 is an international multicentre randomised trial of CAS versus CEA among asymptomatic patients with severe stenosis thought to require intervention, interpreted with all other relevant trials. Patients were eligible if they had severe unilateral or bilateral carotid artery stenosis and both doctor and patient agreed that a carotid procedure should be undertaken, but they were substantially uncertain which one to choose. Patients were randomly allocated to CAS or CEA and followed up at 1 month and then annually, for a mean 5 years. Procedural events were those within 30 days of the intervention. Intention-to-treat analyses are provided. Analyses including procedural hazards use tabular methods. Analyses and meta-analyses of non-procedural strokes use Kaplan-Meier and log-rank methods. The trial is registered with the ISRCTN registry, ISRCTN21144362. Findings Between Jan 15, 2008, and Dec 31, 2020, 3625 patients in 130 centres were randomly allocated, 1811 to CAS and 1814 to CEA, with good compliance, good medical therapy and a mean 5 years of follow-up. Overall, 1% had disabling stroke or death procedurally (15 allocated to CAS and 18 to CEA) and 2% had non-disabling procedural stroke (48 allocated to CAS and 29 to CEA). Kaplan-Meier estimates of 5-year non-procedural stroke were 2·5% in each group for fatal or disabling stroke, and 5·3% with CAS versus 4·5% with CEA for any stroke (rate ratio [RR] 1·16, 95% CI 0·86–1·57; p=0·33). Combining RRs for any non-procedural stroke in all CAS versus CEA trials, the RR was similar in symptomatic and asymptomatic patients (overall RR 1·11, 95% CI 0·91–1·32; p=0·21). Interpretation Serious complications are similarly uncommon after competent CAS and CEA, and the long-term effects of these two carotid artery procedures on fatal or disabling stroke are comparable. Funding UK Medical Research Council and Health Technology Assessment Programme.

ZusammenfassungDie periphere arterielle Verschlusskrankheit ist eine häufige, chronische Störung der arteriellen Durchblutung v. a. der unteren Extremitäten, wobei fibröse Plaques der Gefäßwand zu Stenosen und Thrombenbildung führen. Bei betroffenen Patienten besteht ein hohes Risiko für kardiovaskuläre Komplikationen im gesamten arteriellen Gefäßsystem, auch nach dortigen Eingriffen. Daher besteht Optimierungsbedarf bei der antithrombotischen Therapie. Zur Mehrfach-Thrombozytenaggregationshemmung durch neue Arzneimittelklassen werden in den nächsten Jahren Studiendaten erwartet. Aktuelle Studien zeigten bei Hemmung der Gerinnungskaskade durch direkte orale Antikoagulanzien klinische Vorteile bei vertretbarem Sicherheitsprofil. Grundlage medikamentöser Therapie bleibt das Management von Risikofaktoren wie Übergewicht und Nikotin sowie die Korrektur metabolischer Störungen. Diese Aspekte sollten den behandelnden Ärzten bekannt sein, um eine optimale Versorgung und Motivation der Patienten zu erreichen.

Popliteal artery aneurysm (PAA) is a rare disease with a prevalence of 0.1% to 1%. Within previous years, endovascular repair (ER) of PAAs has been performed more frequently despite the lack of high-level evidence compared with open surgical repair (OSR). In 2014, the POPART registry was initiated to validate the current treatment options for PAA repair.POPART is a multinational multicenter registry of the peri- and postoperative outcomes of ER and OSR for PAAs. Data sets were recorded using the online survey tool SurveyMonkey (available at: https://www.surveymonkey.com/). Regular monitoring and plausibility checks of the data sets are performed to ensure reliability. The aim of the present study was to report the findings from the POPART registry, which includes data from 41 centers.From June 2014 to August 2019, 794 cases had been recorded in the POPART registry. OSR had been performed in 662 patients and ER in 106 patients; 23 patients had been treated conservatively. Of the 106 patients in the primary ER group, 4 had required conversion to OSR. The ER patients were significantly older (ER, median, 71 years; OSR, median, 67 years; P .05). No other significant differences were present in the demographic data, comorbidities, or aneurysm morphology between the two groups. Of the 662 patients in the OSR group, 50.3% were symptomatic compared with 29.2% of the 106 patients in the ER group (P .05). Emergency treatment because of acute ischemia, critical ischemia, or rupture was necessary for 149 patients (22.5%) in the OSR group and 11 patients (10.3%) in the ER group. The most frequent postoperative complications were impaired wound healing (OSR, n = 47 [7.1%]; ER, n = 3 [2.8%]; P.05) and major bleeding (OSR, n = 26 [3.9%]; ER, n = 3 [2.8%]; P.05). The in-hospital length of stay was significantly longer for the OSR group than for the ER group (median, 10 days; range, 3-65 days; vs median, 7 days; range, 1-73 days). The overall patency for the OSR and ER groups after 12 and 24 months was 83.2% and 44.7% (P .005) and 74.2% and 29.1% (P .005), respectively. The outcomes with a prosthetic graft vs an autologous vein were significantly poorer in the OSR group (primary patency, 71.4% vs 88.1% at 12 months).To evaluate new treatment techniques such as ER for PAAs, real-world data are of essential importance. The present analysis of the first results for the POPART registry shows good perioperative results for endovascular treatment of PAA in asymptomatic patients with good outflow vessels. The perioperative complication rate is low and the postoperative hospital stay is shorter than after OSR. However, the patency rates after 12 and 24 months are low in the ER group compared to patients treated with open repair. More follow-up data is required for further interpretation; the completion of the data sets in the registry is ongoing.

BACKGROUND: Around 15% of cerebral ischemias are caused by lesions of the extracranial carotid artery. The goal of this guideline is to provide evidence- and consensus-based recommendations for the management of patients with extracranial carotid stenoses throughout Germany and Austria. METHODS: A systematic literature search (1990–2019) and methodical assessment of existing guidelines and systematic reviews; consensus-based answers to 37 key questions with evidence-based recommendations. RESULTS: The prevalence of extracranial carotid artery stenoses is around 4% overall, higher from the age of 65 years. The most important examination modality is duplex sonography. Randomized trials have shown that carotid endarterectomy (CEA) significantly reduces the 5-year risk of stroke in patients with 60–99 % asymptomatic stenoses (absolute risk reduction [ARR] 4.1% over 5 years, number needed to treat [NNT] 24) or 50–99% symptomatic stenoses (50–69%: ARR 4.6 % over 5 years, NNT 22; 70–99%: 15.9 % over 5 years, NNT 6). With the aid of intensive conservative treatment, the carotid artery-associated risk of stroke can be reduced to as little as 1% per year. Critical determination of indications and strict quality criteria are therefore necessary for CEA and carotid artery stenting (CAS). Systematic reviews of controlled trials comparing CEA and CAS show that the procedural risk of stroke is higher for CAS (asymptomatic: 2.6% versus 1.3%; symptomatic: 6.2% versus 3.8%). There are no differences in the long term. CEA is recommended as standard procedure for high-grade asymptomatic and moderate to high-grade symptomatic carotid artery stenoses; CAS may be considered as an alternative. For both procedures, the periprocedural combined rate of stroke or death should not exceed 2% for asymptomatic stenoses or 4% for symptomatic stenoses. CONCLUSION: Future studies should evaluate even better selection criteria for optimal individualized treatment, whether conservative, surgical, or endovascular.

Graphical Abstract This online structured survey has demonstrated the global impact of the COVID-19 pandemic on vascular services. The majority of centres have documented marked reductions in operating and services provided to vascular patients. In the months during recovery from the resource restrictions imposed during the pandemic peaks, there will be a significant vascular disease burden awaiting surgeons. Graphical Abstract One of the most affected specialties

The Kerecis™ Omega3 Wound matrix is a decellularized skin matrix derived from fish skin and represents an innovative concept to achieve wound healing. The aim of this study was to report the cumulative experience of three centers for vascular surgery regarding use of the Omega3 Wound matrix in selected patients with complicated wounds. In this study 23 patients with 25 vascular and/or diabetes mellitus-associated complicated wounds and partially exposed bony segments were treated with the Omega3 Wound matrix in three vascular centers. In several patients, conventional wound treatment with vacuum therapy had previously been carried out sometimes over several weeks without durable success. Following initial debridement in the operating room, the matrix was applied and covered with a silicone mesh. In the further course, wound treatment was conducted on an outpatient setting if possible. In total 25 wounds were treated with localization at the level of the thigh (n = 2), the distal calf (n = 7), the forefoot (n = 14) and the hand (n = 2). The time to heal varied between 9 and 41 weeks and between 3 and 26 wound matrices were applied per wound. Interestingly, a reduction of analgesics intake was noted when the treatment with the Omega3 Wound matrix was initiated. The novel Omega3 Wound matrix in this study represented an effective treatment option in 25 complicated wounds. Further studies are necessary to evaluate the impact of the wound matrix on stimulation of granulation tissue and re-epithelialization as well as the potential antinociceptive and analgetic effects.

Die Omega-3-Wundmatrix (Kerecis®) stellt eine innovative Wundauflage dar, die aus der Haut des Kabeljaus durch entsprechende Verfahren wie Dezellularisierung gewonnen wird und seit Kurzem in Deutschland verfugbar ist. Die Intention der vorliegenden Studie ist die Zusammenstellung der Behandlungserfahrungen aus 3 gefaschirurgischen Zentren mit dem Einsatz der Omega-3-Wundmatrix bei selektierten Wundpatienten. In einem multizentrischen Erfahrungsbericht haben wir die Ergebnisse von insgesamt 23 Patienten mit 25 vaskularen und diabetes- bzw. vaskulitisassoziierten Problemwunden zusammengestellt. Bei mehreren Patienten war zuvor eine konventionelle Wundbehandlung mit Vakuumtherapie teils uber mehrere Wochen ohne durchgreifenden Erfolg durchgefuhrt worden. Die Erstapplikation der Omega-3-Wundmatrix erfolgte im OP unter stationaren Bedingungen, danach wurden die Patienten nach Moglichkeit einmal wochentlich ambulant versorgt. Insgesamt behandelten wir 25 Problemwunden sowohl nach Amputationen als auch bei primarer Wunde (Oberschenkel n = 2, Unterschenkel n = 7, Fus n = 14, Hand = 2). Die Abheilungszeiten variierten von 9 bis 41 Wochen, die Anzahl der pro Wunde verwendeten Omega-3-Wundmatrizes von 3 bis 26. Zusatzlich war im Rahmen der Behandlung mit Omega-3-Wundmatrizes eine Verminderung der lokalen Wundschmerzen zu verzeichnen. Die Behandlung mit der innovativen marinen Omega-3-fettsaurehaltigen Wundmatrix stellt in dieser Untersuchung einen wirksamen Ansatz in der Behandlung von 25 Problemwunden dar. Weitere Untersuchungen sind notwendig, um die Granulations- und Reepithelialisierungsfunktion sowie die zusatzlich vorhandene analgetische bzw. antinozizeptive Wirkung dieses Praparates genauer zu evaluieren.

Chronische Wunden stellen in Deutschland mit einer Pravalenz von 0,26 bis 0,64 % entsprechend 400.000 bis 1,8 Mio. Betroffener eine medizinische und soziookonomische Herausforderung dar. Die uberwiegende Anzahl chronischer Wunden sind vaskularer Genese, einschlieslich des diabetischen Fussyndroms (DFS). Somit ist der Gefaschirurg im besonderen Mase gefordert, eine professionelle und adaquate Diagnostik und Therapie chronischer Wunden als auch der vaskularen Versorgung durchzufuhren. Nach Daten der Barmer GEK erfahren jedoch nur rund 25 % aller Patienten eine gefasmedizinische Diagnostik. Eine interventionelle oder operative Versorgung findet dadurch nur im unzureichenden Mase statt. Nicht zuletzt ist die facharztliche Betreuung, die ein wesentliches Qualitatsmerkmal in einer interdisziplinaren und interprofessionellen Wundversorgung darstellt und nur in rund der Halfte aller Behandelten mit chronischen Wunden erfolgt, weiterhin unterreprasentiert. Masnahmen zur Qualitatssteigerung, an der die Wundkommission der Deutschen Gesellschaft masgeblich beteiligt ist, stellen die Teilnahme an den Bundeskonsensuskonferenzen chronischer Wunden, der Deutsche Wundrat und nicht zuletzt die Implementierung des Wundsiegels zur Zertifizierung von Wundzentren mit dem Schwerpunkt einer leitliniengerechten gefasmedizinischen Therapie und Wundversorgung dar. Im Rahmen der Bundeskonsensuskonferenzen konnte ein minimaler Datensatz erarbeitet werden, der die Parameter Allgemeinstatus, Wundanamnese und -status, diagnostische und therapeutische Parameter sowie Ernahrung und Edukation beinhaltet. Diese Standards sollen die qualitatsgesicherte Versorgung in der Praxis unterstutzen und zu einer effizienteren Versorgung chronischer Wunden in Deutschland beitragen.

Die Kompressionstherapie ist eine nebenwirkungsarmarme physikalische Therapie, die insbesondere bei Patienten mit Odemen der unteren Extremitaten angewendet wird. Die Indikationen fur diese Kompressionstherapie sind Odeme sehr unterschiedlicher Genese wie beispielsweise venose oder lymphatische Krankheitsbilder ebenso wie Niereninsuffizienz, Adipositas oder Inflammation. Allerdings mussen bei diesen Patienten verschiedene Kontraindikationen beachtet werden. Von besonderer Bedeutung sind hier die fortgeschrittene periphere arterielle Verschlusskrankheit und eine Polyneuropathie, die einer besonderen Beachtung bedurfen. Aufgrund der Vielzahl der heute zur Verfugung stehenden Kompressionsmaterialien und -systeme, kann trotz dieser Kontraindikationen bei einem Grosteil der Patienten mit Odemen der unteren Extremitaten eine Kompressionstherapie durchgefuhrt werden. Diese kann sich heute als patientengerechte Versorgung an den Komorbiditaten und individuellen Bedurfnisse sowie Fahigkeiten der Patienten orientieren.

Klinische Pfade dienen optimalerweise zur Standardisierung von Behandlungsablaufen in Bezug auf eine bestimmte Erkrankung und bezwecken eine Verbesserung der Prozessqualitat. Grundsatzliches Ziel bleibt dabei die generelle Qualitatsverbesserung und die Moglichkeit des Monitorings von Abweichungen. Fur Eingriffe an der A. carotis gelten dabei Besonderheiten, da es sich hier einerseits um prophylaktische Eingriffe handelt, andererseits aus okonomischen Grunden die Gefahr einer inadaquaten Therapieausweitung droht, und nicht zuletzt, weil verschiedene Disziplinen gemeinsam oder unabhangig voneinander in Diagnostik und Therapie agieren. Die vorhandene Literatur wurde durchgesehen und gepruft, ob die Verwendung klinischer Pfade neben dem bisherigen Qualitatsmanagement zu einer weiteren Verbesserung der Ergebnisqualitat fuhren kann. Es existiert keine randomisierte Studie mit dieser Fragestellung. Die Literatur ist kaum vergleichbar und stammt haufig aus einer Zeit vor der Publikation vieler Leitlinien und vor Einfuhrung des DRG-Systems. In den meisten Analysen wurden aber neben anderen Aspekten die Therapiekosten und die Verweildauer deutlich reduziert. Zur Erreichung einer guten Ergebnisqualitat sind – neben der bereits existierenden gesetzlichen Qualitatssicherung mit ihren bekannten Limitationen eines fehlenden 30-Tage-Follow-up – sowohl die ublichen Instrumente eines effektiven Qualitatsmanagements als auch zukunftig zu definierende klinische Pfade sinnvoll. Dabei kann die Formulierung eines klinischen Pfades hilfreich bei der Koordination der an Diagnostik und Therapie beteiligten Disziplinen sein. Ein direkter Nachweis zur Ergebnisverbesserung bei der Versorgung von Patienten mit extrakranieller Karotisstenose lasst sich methodisch bedingt und nicht zuletzt auch aufgrund ethischer Bedenken durch prospektiv-randomisierte Studien vermutlich nicht erbringen.

Objectives The most effective first-line treatment between endovascular therapy and bypass surgery for patients with critical limb ischemia (CLI) is still not well defined. The primary aim of the interim analysis of CRITISCH (Registry of First-Line Treatments in Patients With Critical Limb Ischemia) was to compare both treatment options in a prospective confirmatory manner. Background Only 1 randomized controlled trial between endovascular therapy and bypass surgery has been published yet. Several retrospective studies showed comparable outcomes between the 2 treatment strategies, but in the majority of them, current endovascular technologies have not been included. Methods Between January 2013 and September 2014, 1,200 CLI patients (Rutherford 4 to 6) from 27 vascular centers were enrolled. The selection of the first-line treatment was left completely to the discretion of the responsible physician. The primary composite endpoint was amputation-free survival (AFS), that is, time to major amputation and/or death from any cause. A pre-specified interim analysis aimed at showing noninferiority of the endovascular therapy versus bypass surgery as to the hazard ratio (HR) of AFS (noninferiority bound = 1.33; interim α = 0.0058). Time-to-event analyses of major amputation, death, and the composite endpoint of reintervention and/or above-ankle amputation were also conducted. Results Endovascular therapy was applied to 642 (54%) and bypass surgery to 284 (24%) patients. Median follow-up time was 12 months in both groups. One-year AFS was 75% and 72%, respectively. The noninferiority of endovascular therapy versus bypass surgery for AFS was confirmed (HR: 0.91; upper bound of 1-sided (1 − 0.0058) confidence interval [CI]: 1.29; p = 0.003). An impact of the treatment strategy on time until death (HR: 1.14; 95% CI: 0.80 to 1.63; p = 0.453), major amputation (HR: 0.86; 95% CI:0.56 to 1.30; p = 0.463), and reintervention and/or above-ankle amputation (HR: 0.89; 95% CI: 0.70 to 1.14; p = 0.348) was not observed. Conclusions The interim analysis confirmed that when physicians are free to individualize therapy to CLI patients, the endovascular-first approach achieved a noninferior AFS rate compared with bypass surgery. (Registry of First-Line Treatments in Patients With Critical Limb Ischemia [CRITISCH]; NCT01877252)

Peripheral arterial occlusive disease is a frequent and chronic vascular disorder mostly affecting the lower limbs and caused by fibrous plaques in arteries that can result in stenoses and thrombi. Patients suffering from this condition show a high risk for cardiovascular complications of the complete arterial vascular system, especially post-procedural. Thus, there is a need to optimize anti-thrombotic therapy. Data on multiple antiplatelet aggregation therapy including new drug classes are expected in the coming years. In addition, recent studies showed that direct oral anticoagulation provided clinical advantages combined with a reasonable safety profile. Management of risk factors such as overweight and nicotine and correction of metabolic disorders are not to be ignored and the background to further therapy. All treating physicians should be aware of these aspects to guarantee an optimal care and motivation of their patients.Die periphere arterielle Verschlusskrankheit ist eine häufige, chronische Störung der arteriellen Durchblutung v. a. der unteren Extremitäten, wobei fibröse Plaques der Gefäßwand zu Stenosen und Thrombenbildung führen. Bei betroffenen Patienten besteht ein hohes Risiko für kardiovaskuläre Komplikationen im gesamten arteriellen Gefäßsystem, auch nach dortigen Eingriffen. Daher besteht Optimierungsbedarf bei der antithrombotischen Therapie. Zur Mehrfach-Thrombozytenaggregationshemmung durch neue Arzneimittelklassen werden in den nächsten Jahren Studiendaten erwartet. Aktuelle Studien zeigten bei Hemmung der Gerinnungskaskade durch direkte orale Antikoagulanzien klinische Vorteile bei vertretbarem Sicherheitsprofil. Grundlage medikamentöser Therapie bleibt das Management von Risikofaktoren wie Übergewicht und Nikotin sowie die Korrektur metabolischer Störungen. Diese Aspekte sollten den behandelnden Ärzten bekannt sein, um eine optimale Versorgung und Motivation der Patienten zu erreichen.

Background and Purpose— Guidelines recommend that carotid endarterectomy should be performed within 2 weeks in patients with a symptomatic carotid stenosis. Because a Swedish register study indicated that patients treated within the first days after a stroke or transient ischemic attack might have an increased perioperative stroke and mortality risk, this study aimed to find out whether these findings are also true under everyday conditions in Germany. Methods— Secondary data analysis including 56 336 elective carotid endarterectomy procedures performed for symptomatic carotid stenosis under everyday conditions between 2009 and 2014. The patient cohort was divided into 4 groups according to time interval between index event and surgery (I: 0–2, II: 3–7, III: 8–14, and IV: 14–180 days). Primary outcome was any in-hospital stroke or death. For risk-adjusted analyses, a multilevel multivariable regression model was used. Results— Mean patients’ age was 71.1±9.6 years; 67.5% were men. Overall rate of any stroke or death was 2.5% (n=1434). Risk of any in-hospital stroke or death was 3.0% in group I, 2.5% in group II, 2.6% in group III, and 2.3% in group IV. Multivariable regression analysis revealed that the time interval was not significantly associated with the primary outcome. Conclusions— The time interval between the index event and carotid endarterectomy was not associated with the risk of any in-hospital stroke or death in patients with symptomatic carotid stenosis in Germany. In clinically stable patients, carotid endarterectomy might, therefore, be performed safely as soon as possible after the neurological index event.

Purpose: To examine the outcomes of all first-line strategies for the treatment of critical limb ischemia (CLI), identify factors that influenced the treatment choice, and determine the risk of amputation or death after each treatment. Methods: CRITISCH ( ClinicalTrials.gov identifier NCT01877252) is a multicenter, national, prospective registry evaluating all available treatment strategies applied in 1200 consecutive CLI patients in 27 vascular centers in Germany. The recruitment started in January 2013 and was completed in September 2014. Treatment options were endovascular revascularization (642, 53.5%), bypass surgery (284, 23.7%), femoral artery patchplasty (126, 10.5%) with or without concomitant peripheral intervention, conservative treatment (118, 9.8%), and primary major amputation (30, 2.5%). The primary endpoint of this study was amputation-free survival (AFS). The Society of Vascular Surgery’s suggested objective performance goal (OPG) for AFS (71%) was used as the effectiveness criterion. Multivariable regression methods were employed to identify variables that influenced the treatment selection and AFS after each treatment; results are presented as the hazard ratio (HR) and 95% confidence interval (CI). Results: The 12-month AFS estimates following endovascular therapy, bypass grafting, femoral patchplasty, and conservative treatment were 75%, 72%, 73%, and 72%, respectively. Factors influencing treatment choice were age, chronic kidney disease (CKD), diabetes, smoking, prior vascular procedures in the index leg, TransAtlantic Inter-Society Consensus II C/D lesions, and absence of runoff vessels. Cox regression analysis identified CKD (HR 2.07, 95% CI 1.26 to 3.41, p=0.004), the use of a prosthetic bypass conduit (HR 1.97, 95% CI 1.23 to 3.14, p=0.004), and previous vascular intervention in the index limb (HR 1.52, 95% CI 0.94 to 2.43, p=0.085) as independent risk factors for diminished AFS after bypass surgery. CKD (HR 1.47, 95% CI 1.09 to 1.99, p=0.012) and Rutherford category 6 (HR 1.81, 95% CI 1.30 to 2.52, p

This article summarizes the current study situation on treatment of asymptomatic carotid artery stenosis and discusses the evidence situation in the literature. The 10-year results of the ACST study have shown that in comparison to conservative treatment, carotid endarterectomy (CEA) has retained a positive long-term effect on the reduction of all forms of stroke. All multicenter randomized controlled trials comparing CEA with carotid artery stenting (CAS) and, in particular the SAPHIRE and CAVATAS studies, have in common that despite a basic evidence level of Ib, the case numbers of asymptomatic patients are too small for a conclusive therapy recommendation. In the overall assessment of the CREST study the resulting difference in the questionable endpoint of "perioperative myocardial infarction" in favor of the CAS methods, could not be confirmed for exclusively asymptomatic patients. In the long-term course of the CREST study, both methods were classified as equivalent, even when the 4‑year results of periprocedural and postprocedural stroke rates in the separate assessment of the asymptomatic study participants clearly favored the CEA. The results of the ACST-1 study showed an equivalent effect of both treatment methods with respect to all investigated endpoints; however, the unequal sizes of the groups in addition to the statistically insufficient case numbers put a question mark on the validity of the study results. The results of the ASCT-2 and CREST-2 studies are to be awaited, which also investigate the significance of "CEA versus CAS" (ASCT-2) and "CEA/CAS + best medical treatment (BMT) versus BMT alone" in only asymptomatic stenoses. The current S3 guidelines allow operative therapy to be considered in patients with a 60-99% asymptomatic carotid artery stenosis, because the risk of stroke is statistically significantly reduced.Der folgende Artikel fasst die aktuelle Studienlage zur Therapie der symptomfreien Karotisstenose zusammen und diskutiert deren Evidenzlage in der Literatur. Die 10-Jahres-Ergebnisse der ACST-1-Studie haben gezeigt, dass die Karotisendaretrektomie (CEA) im Vergleich zur konservativen Therapie ihren positiven Langzeiteffekt in der Reduktion jedweder Schlaganfälle beibehalten hat. Alle multizentrisch randomisiert kontrollierten Studien mit dem Vergleich CEA versus Stent (

Medizinisches Qualitatsmanagement (ob in der Arztpraxis oder im Krankenhaus) hat die Aufgabe, gute bzw. hervorragende Medizin planbar, vorhersehbar und nachweisbar zu machen. Der zentrale Ansatz medizinischen Qualitatsmanagements ist mithin nicht die „totale dauerhafte Verbesserung“, sondern vielmehr das Bestreben, das eigene medizinische Handeln frei von Zufalligkeiten fur alle Beteiligten und die Gute des eigenen medizinischen Handelns transparent zu machen. Nukleus medizinischer Qualitatssicherung ist damit das der eigenen Krankenhausabteilung angepasste, selbst entwickelte Qualitatsmanagement. Was sich um dieses herum gruppiert, sind Hilfswissenschaften.

Hintergrund Seit 2002 besteht in Deutschland eine verpflichtende Dokumentation aller operativen Rekonstruktionen der extrakraniellen Karotisbifurkation. Dies ermoglicht die Analyse etwaiger Trends in der Karotischirurgie. In 2012 haben wir erste Daten zur perioperativen Schlaganfallrate und Letalitat veroffentlicht, nun sollen Entwicklungen im Bereich der apparativen Diagnostik und des intra- und perioperativen Managements hinsichtlich der Umsetzung evidenzbasierter Empfehlungen aus der nationalen S3-Leitlinie zur Karotisstenose analysiert werden.

Zielsetzung In einer Pilotstudie sollte das gefaschirurgische Krankengut bei peripherer arterieller Verschlusskrankheit (PAVK) stadienabhangig definiert und die wichtigsten Behandlungsverfahren in ihrer Haufigkeit dargestellt werden. Praoperative Risikofaktoren, perioperative Morbiditat und Letalitat bei endovaskularem (ER) und offenem (OR) Vorgehen waren zu analysieren.

The aim of the study was to analyze clinical, morphological and structural predictors of the outcome of open and endovascular surgery on non-ruptured (nr) and ruptured (r) abdominal aortic aneurysms (AAA) in a quality assurance registry of the German Vascular Society (Deutsche Gesellschaft fur Gefaschirurgie und Gefasmedizin, DGG). The study focused in particular on a possible relationship between annual hospital caseload and outcome. Between 1999 and 2010 a total of 36,594 surgical procedures for nrAAA and 4859 surgical procedures for rAAA were recorded in 201 hospitals. Categorical and quantitative characteristics are summarized in descriptive statistics. To analyze a relationship between annual hospital caseload and in-hospital mortality, the hospitals were divided into volume groups. A mixed logistic regression model was used to compare the groups. Additionally, a univariate model with volume groups as an influencing variable was adjusted to the data, as well as multivariate models with volume groups, type of surgery, age, AAA size, ASA score and presence of an additional iliac aneurysm or inflammatory AAA as independent variables. The mean age was 71.0 years (± 8.1) in nrAAA and 73.8 years (± 9.1) in rAAA. In total, 66.7 % of patients with nrAAA and 88.3 % in rAAA presented with ASA ≥ 3. In nrAAA, 37 % of patients received endovascular aortic repair (EVAR), 11.8 % for rAAA. In-hospital mortality for nrAAA was 2.7 % [open aortic repair (OAR) 3.6 %, EVAR 1.3 %], for rAAA 39 % (OAR 41.2 %, EVAR 21.8 %). Univariate analysis showed increasing age, ASA ≥ 3, increasing aneurysm size, inflammatory AAA and OAR to be significant predictors of higher in-hospital mortality in both nrAAA, and rAAA. A significant survival benefit for the treatment of nrAAA could be shown for patients treated in hospitals with a caseload of ≥ 31 operative procedures per year (compared to 1–20 operative procedures/year). Hospitals with higher annual caseloads also showed a trend towards decreased mortality in rAAA. Multivariate analysis showed increasing age, AAA diameter ≥ 6 cm, ASA ≥ 3 and OAR to be independent predictors of perioperative fatality in nrAAA and rAAA. In nrAAA, an annual AAA volume of 50–62 cases was an independent predictor of lower in-hospital mortality. Comorbidities (ASA score) and increasing age are significant predictors of increased in-hospital mortality in nrAAA and rAAA. A higher annual volume is associated with lower in-hospital mortality in nrAAA. For both elective and emergency AAA treatment, a referral to a hospital with a high annual AAA caseload should be considered.

An analysis was conducted of intermediate outcomes and possible influencing factors in patients with end-stage renal disease (ESRD) and critical limb ischemia after lower limb revascularization compared with patients with regular renal function (non-ESRD).Data collection was performed by inquiry of the German multicenter registry of First-Line Treatments in Patients with Critical Limb Ischemia (CRITISCH); 102 ESRD patients and 674 non-ESRD patients were included. Four different therapy modalities were analysed: bypass surgery, endovascular therapy (EVT), femoral artery endarterectomy, and no vascular intervention (conservative treatment or primary major amputation). Predefined end points were amputation-free survival (AFS), death, major amputation, and reintervention. Cox regression models were built to analyze independent risk factors for outcome parameters.ESRD patients showed inferior results at 2 years in the rate of AFS (ESRD, 35.4%; non-ESRD, 67.2%; P .001). Similarly, death rate (ESRD, 55.0%; non-ESRD, 20.7%; P .001) and major amputation rate (ESRD, 24.5%; non-ESRD, 15.8%; P = .029) were significantly elevated for ESRD patients. The choice of therapeutic approach in ESRD did not influence the incidence of the investigated end points (death or major amputation: EVT, 56.9% vs bypass, 76.9% [P = .225]; death: EVT, 46.2% vs bypass, 61.5% [P = .372]; amputation: EVT, 15.4% vs bypass, 15.4% [P = 1.000]; reintervention: EVT, 32.3% vs bypass, 15.4% [P = .324]). Cox regression analysis indicated that dialysis patients carry a twofold increased hazard of death or major amputation (hazard ratio, 2.27; 95% confidence interval, 1.67-3.10; P .001), and open surgical treatment (all patients combined) was associated with reduced risk of death compared with EVT (hazard ratio, 0.58; 95% confidence interval, 0.37-0.91; P = .017). Comorbidities were not found to have a noticeable impact on AFS, survival, reintervention, or major amputation.Two-year AFS, overall survival, and freedom from major amputation were decreased in ESRD patients compared with non-ESRD patients with critical limb ischemia. Cardiovascular comorbidities were without significant impact on outcome parameters, whereas choice of treatment modality within the ESRD group did not influence AFS. Decision-making in ESRD as to choice of therapeutic approach in dialysis patients should notably account for the individual's lesion characteristics and vascular disease; surgical revascularization and EVT may be used as complementary options.

BACKGROUND Female patients are underrepresented in most stent-graft (EVAR) trials due to a reduced anatomical eligibility for endovascular treatment. The purpose of this analysis was to determine the performance of the Ovation® and Ovation Prime® stent graft in women versus men for elective abdominal aortic aneurysm (AAA) repair. METHODS From May 2011 to December 2013, 501 patients (86% men, mean age 73 years) from 30 sites were prospectively enrolled in the OVATION Registry and electively treated with endovascular aneurysm repair. Patients returned for clinical and imaging follow-up at 1 month, 6 months, and 1 year. A post-hoc analysis was performed to assess the influence of gender on patient outcomes. RESULTS Women were older (median 77 vs. 73 years, P

Compression therapy is a physical therapy with few side effects, which is used especially in patients with edema of the lower extremities. The indication for compression therapy is given here for edema of very different origins such as, for example, venous or lymphatic disease symptoms as well as renal insufficiency, obesity or inflammation. However, different contraindications must be considered in these patients. Of particular importance are the advanced peripheral arterial occlusive disease and the polyneuropathy, which need special attention.Due to the large number of different compression materials and systems available today, in spite of these contraindications, compression therapy can be carried out with a large proportion of patients with edema of the lower extremities. The therapy should be adapted to the comorbidities and individual needs as well as personal abilities in the context of a patient-oriented care.

Secondary prevention in patients with critical limb ischemia (CLI) is crucial for the reduction of cardiovascular morbidity and mortality. Nonetheless, current recommendations are extrapolated from other high-risk populations because of the lack of CLI-dedicated trials. The aim of this explorative study was to evaluate the association of statin therapy with the outcomes of CLI patients.The First-Line Treatments in Patients With Critical Limb Ischemia (CRITISCH) registry is a prospective multicenter registry analyzing the effectiveness of all available treatment strategies in 1200 CLI patients. For the purposes of this analysis, patients were divided into two groups based on statin administration. Treatment crossovers and nonadherent patients were excluded from analysis. The primary composite end point of this study was the amputation-free survival (AFS). Major adverse cardiovascular and cerebral events (MACCEs), time to death, and time to major amputation were also analyzed.Statin therapy was applied in 445 individuals (37%), 371 (31%) patients received no statins, and 384 subjects were excluded from analysis (treatment crossovers). Patients receiving statins were more likely to be younger (P .001) and to have a history of coronary heart disease (P .001) or previous intervention at index limb (P .001). Patients receiving statin therapy had a lower hazard regarding AFS (hazard ratio [HR], 0.45; 95% confidence interval [CI], 0.34-0.63; P .001) and death (HR, 0.40; 95% CI, 0.24-0.66; P .001) as well as lower odds of MACCE (odds ratio, 0.41; 95% CI, 0.23-0.69; P = .001). However, statin therapy was not associated with reduced amputation rates (HR, 1.02; 95% CI, 0.67-1.56; P = .922). Statin effect on AFS was consistent among diabetics (HR, 0.47; 95% CI, 0.31-0.70; P .001), patients with chronic kidney disease (HR, 0.53; 95% CI, 0.32-0.87; P = .012), and patients older than 75 years (HR, 0.40; 95% CI, 0.26-0.60; P .001). Statin administration was also associated with an improved AFS in patients with antiplatelet medication (HR, 0.64; 95% CI, 0.41-0.99; P = .049) and without antiplatelet medication (HR, 0.26; 95% CI, 0.12-0.57; P = .001) and after both endovascular therapy (HR, 0.51; 95% CI, 0.34-0.76; P = .001) and bypass revascularization (HR, 0.38; 95% CI, 0.21-0.68; P = .001).Statin therapy in CLI patients is associated with an increased AFS and lower rates of mortality and MACCEs without improving, however, the salvage rates of the affected limb.

Zielsetzung Analyse der Daten des Qualitatssicherungsprojekts „Bauchaortenaneurysma“ der Deutschen Gesellschaft fur Gefaschirurgie und Gefasmedizin (DGG) im Hinblick auf klinische, morphologische und strukturelle Pradiktoren fur ein erhohtes perioperatives Risiko offener und endovaskularer Operationen bei nicht rupturierten (nr) und rupturierten (r) abdominalen Aortenaneurysmen (AAA). Der mogliche Zusammenhang zwischen Krankenhausfallzahl/Jahr und perioperativer Letalitat war von besonderem Interesse.

Zielsetzung Die Daten fur das Jahr 2013 des Registers „Abdominelles Aortenaneurysma“ (AAA) des DIGG der Deutschen Gesellschaft fur Gefaschirurgie und Gefasmedizin sollen vorgestellt und die Ergebnisse mit denen anderer Register verglichen werden.

Die Arteriosklerose ist eine der wichtigsten Krankheits- und Todesursachen in Industrielandern. Risikofaktoren sind neben Alter und mannlichem Geschlecht Rauchen, Hypertonie, erhohte Blutfette, Diabetes, Ubergewicht und Adipositas. Typische Manifestationen sind koronare Herzerkrankung (KHK), Arteriosklerose der Halsschlagader und der hirnversorgenden Arterien mit nachfolgendem Schlaganfall oder transitorischen ischamischen Attacken (TIA) sowie periphere arterielle Verschlusskrankheit (pAVK) und Bauchaortenaneurysma. Allein die Pravalenz der KHK betragt in Deutschland insgesamt 7 % bei Frauen und 10 % bei Mannern. Vor allem die Pravalenz der pAVK nimmt seit einigen Jahren deutlich zu, wahrend die des Bauchaortenaneurysmas offenbar abnimmt. Haufig wird trotz aller Aufklarungskampagnen der Stellenwert der Pravention unterschatzt. Grose Bevolkerungsstudien konnten aber zeigen, dass Praventionsprogramme die arteriosklerotisch bedingten Folgen zum Teil drastisch reduzieren. Die wichtigsten Masnahmen sind Rauchverzicht, gesunde Ernahrung, Vermeidung von Ubergewicht, Blutdruckeinstellung und eine lipidsenkende Therapie. Die Primarpravention sollte unbedingt bereits im Kindes- und Jugendalter beginnen.

Seit 2002 besteht fur alle deutschen Krankenhauser die Verpflichtung zur Teilnahme an der Qualitatssicherung (QS) fur die operative extrakranielle Karotisrekonstruktion. Veranderungen der Patientenpopulation, der klinischen Stadien und der klinischen Ergebnisse von 2003–2011 sollten ermittelt werden. Die Analyse der praoperativen Diagnostik, der Operationsmethoden und des prozeduralen Managements folgt in einer spateren Publikation. Die Jahresberichte 2003–2011 des QS-Registers wurden systematisch ausgewertet. Patientenbezogene Parameter und pradefinierte Qualitatsindikatoren wurden statistisch evaluiert (Cochran-Armitage-Trend-Test, Korrelationskoeffizient nach Pearson, 2-seitiges Signifikanzniveau von α = 5 %). Es wurden 229.304 operative Karotisrekonstruktionen (mannliche/weibliche Patienten 68/32 %) dokumentiert. Der Anteil an uber 80-jahrigen Patienten stieg signifikant an (p

Die unter dem Begriff der Arteriosklerose zusammengefassten arteriellen Gefaserkrankungen sind durch fibrose Umbauprozesse in der Gefaswand gekennzeichnet. In der vorliegenden Ubersicht sollen die Risikofaktoren, die Epidemiologie und die Manifestationen der Arteriosklerose dargestellt werden. Grundlage der Ubersicht ist einer Literaturrecherche, die wichtige Studien zur Arteriosklerose einschliest. Die Atherosklerose ist die am haufigsten vorkommende Form der Arteriosklerose. Das Gewicht der Atherosklerose fur das Gesundheitssystem machen folgende Zahlen deutlich: In der Altersgruppe der ab 65-Jahrigen liegt bei uns die Erkrankungshaufigkeit der Frauen an koronarer Herzkrankheit (KHK) bei 18 %, die der Manner bei 28 %. Die Sterblichkeit wegen KHK wurde fur das Jahr 2004 mit 80,57 auf 100.000 Frauen und 149,21 auf 100.000 Manner berechnet. Nach der Gesundheitsberichterstattung des Bundes waren 1998 ca. 3 Mio. Menschen in Deutschland von der peripheren arteriellen Verschlusskrankheit (PAVK) betroffen. Die Pravalenz der Atherosklerose hat im letzten Jahrzehnt dramatisch zugenommen, in Landern mit hohem Einkommen (wie bei uns) um 13,1 %. Was die Risikofaktoren einer PAVK angeht, so hat in Landern mit hohem Einkommen das Rauchen den hochsten Einfluss auf die Entwicklung der Erkrankung, die Hypercholesterinamie relativ gesehen den geringsten. Im Gegensatz zur PAVK muss nach Daten aus dem UK davon ausgegangen werden, dass die Inzidenz des Bauchaortenaneurysmas (BAA) eher rucklaufig ist. Danach hat die altersadjustierte Sterblichkeit des BAA in England und Wales zwischen 1997 und 2009 von 40,4 auf 25,7 pro 100.000 Einwohner abgenommen.