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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.

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)

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

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.

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.

Background Neurofibromatosis type 1 (NF1) is one of the most frequently inherited diseases. Vascular manifestations have been reported, mostly concerning stenosis of the renal artery or spontaneous rupture of single arteries. Also, venous aneurysms have been reported. Methods We present clinical and pathological findings of a young patient with NF1 with lethal bleeding due to spontaneous rupture of a lumbal and renal artery. Results High fragility of several arteries as well as veins in the abdominal and pelvic arterial and venous system resulted in a destroyed vessel structure caused by invading neurogen fibres. Conclusions In rare cases, NF1 is associated with a severe systemic vasculopathy concerning the arterial and venous vascular system.

Objective Analysis of in-hospital outcomes in patients treated for critical limb ischemia (CLI) and end-stage renal disease (ESRD) compared to CLI patients with normal renal function. Methods A subgroup analysis of the German CRITISCH registry, a prospective multicenter registry, assessing the first-line treatment strategies in CLI patients in 27 vascular centers in Germany was performed. The study cohort was divided into ESRD patients (n = 102) and patients with normal renal function (n = 674; glomerular filtration rate >60/mL/min/1.73 m 2 ). The following first-line treatment strategies were assessed: endovascular therapy (EVT), bypass surgery, patch plasty, and no vascular intervention (conservative treatment, primary amputation). Uni- and multivariate analyses were performed to identify differences between groups as to six end points: amputation or death (composite end point), amputation, death, hemodynamic failure, major adverse cardiac and cerebrovascular events, and reintervention. Results Differences between the ESRD and non-ESRD group were found regarding the applied first-line therapy ( P = .016): The first-line treatment strategies in ESRD patients were EVT in 64% (n = 65), bypass surgery in 13% (n = 13), patch plasty in 11% (n = 11), and no vascular intervention in 13% (n = 13). In non-ESRD patients, EVT was applied in 48% (n = 326), bypass surgery in 27% (n = 185), patch plasty in 13% (n = 86), and no vascular intervention in 11% (n = 77). For ESRD patients, a noticeably increased risk of the composite end point (odds ratio [OR], 2.62; 95% confidence interval [CI], 1.19-5.79; P = .017), amputation (OR, 3.14; 95% CI, 1.35-7.31; P = .008), and hemodynamic failure (OR, 2.19; 95% CI, 1.19-4.04; P = .012) was observed. Conclusions CLI patients on dialysis represent a challenging cohort prone to in-hospital death, amputation, and hemodynamic failure. Two-thirds of these high-risk patients are treated with EVT. Present data suggest that this modality is generally considered as the most favorable treatment option in this patient subgroup.

Fragestellung Diese Datenerhebung wurde mit dem Ziel durchgefuhrt, beurteilen zu konnen, ob die In-situ-Rekonstruktion bei Gefasprotheseninfektion mit einem silberacetatbeschichten Dacrongraft ein sicheres und vertretbares Konzept ist. Wir etablierten ein fragebogenbasiertes prospektives, multizentrisches offenes Register. Die Teilnehmer waren zum Einsenden aller entsprechend therapierten Falle verpflichtet.

ZusammenfassungEin Screening der Population für das abdominelle infrarenale Bauchaortenaneurysma ist nur grenzwertig kosteneffektiv. Ein Screening der Subpopulation von männlichen Rauchern zwischen 60 und 75 Jahren und von Männern und rauchenden Frauen mit positiver Familienanamnese oder vaskulären Krankheiten anderer Lokalisation und Ursache ist jedoch kosteneffektiv. Es kann die steigende Mortalität halbieren. Die Indikation zum Handeln ist bei Männern ab einem Aneurysmadurchmesser von 5,5 cm gegeben, bei Frauen ist dieser Grenzwert noch zu bestimmen, dürfte aber bei 4,5 bis 5 cm liegen.Die Surveillance noch nicht für eine Aneurysmaausschaltung in Frage kommender Patienten darf nicht nur den Aneurymadurchmesser berücksichtigen, sondern sollte auch bei Überschreiten einer jährlichen Wachstumsrate von 0,5 cm zur Behandlung führen.

ZusammenfassungDie endovaskuläre Therapie der Arteria femoralis superficialis (AFS) erfolgt zunehmend mit der Stent-Technologie: Kurzstreckige Stenosen und langstreckige Verschlüsse werden primär endovaskulär behandelt. In randomisierten Studien wurde gezeigt, dass der Stent in der AFS das Ergebnis nach PTA kurz- bis mittelstreckiger Läsionen nicht verbessert. Seine Indikation hat der Stent als sekundäre Maßnahme zur Bewahrung eines PTA-Ergebisses im Falle einer Komplikation (z. B. bei Gefäßlumenverlegender Dissektion). Neue technische Entwicklungen zielen auf die Behandlung komplexer AFS-Läsionen (TASC Typ C). Stents aus Nitinol, Sirolimus-beschichtete oder PTFE-ummantelte Stents weisen zwar therapeutische Möglichkeiten zur Therapie dieser Läsionen auf, jedoch fehlen randomisierte Studien zu Langzeitergebnissen. Zur Kosten/Nutzenanalyse dieser Verfahren liegen keine Daten vor. Adjunktive Techniken, z. B. Lasertherapie und Brachytherapie, verbesserten die endovaskulären AFS-Therapieergebnisse nicht überzeugend. Komplexe Interventionen bergen das Risiko, einen für den Erhalt der Extremität meist eher harmlosen AFS-Verschluss durch Verletzung des Profundaabgangs oder des Popliteasegments in eine die Extremität bedrohende Läsion zu verwandeln. Hinzu kommt, das die endovaskuläre Therapie mit zunehmender Komplexität der AFSLäsion und bei Diabetes mellitus deutlich schlechtere Ergebnisse als die Bypass-Chirurgie erzielt. Unter Berücksichtigung von evidenzbasierten Kriterien für eine Therapieempfehlung erscheint eine primäre Stent-PTA der AFS meistens nicht gerechtfertigt, weder aus medizinischen noch aus ökonomischen Überlegungen.

Critical limb ischemia (CLI) is growing in global prevalence and is associated with high rates of limb loss and mortality. However, a relevant gap of evidence about the most optimal treatment strategy still exists. The aim of this study of the prospective, multicenter First-Line Treatments in Patients With Critical Limb Ischemia (CRITISCH) registry was to assess the current practice of all first-line treatments strategies in CLI patients in German vascular centers.Between January 2013 and September 2014, five first-line treatment strategies-endovascular revascularization (ER), bypass surgery (BS), femoral/profundal artery patchplasty (FAP), conservative treatment, and primary amputation-were determined among CLI patients in 27 vascular tertiary centers. The main composite end point was major amputation or death, or both, during the hospital stay. Secondary outcomes were hemodynamic failure, major adverse cardiovascular and cerebral events, and reintervention. Univariate logistic models were additionally built to preselect possible risk factors for either event, which were then used as candidates for a multivariate logistic model.The study included 1200 consecutive patients. First-line treatment of choice was ER in 642 patients (53.4%), BS in 284 (23.7%), FAP in 126 (10.5%), conservative treatment in 118 (9.8%), and primary amputation in 30 (2.5%). The composite end point was met in 24 patients (4%) after ER, in 17 (6%) after BS, in 8 (6%) after FAP, and in 9 (8%) after conservative treatment (P = .172). The highest rate of in-hospital death was observed after primary amputation (10%) and of hemodynamic failure after conservative treatment (91%). Major adverse cardiovascular and cerebral events developed in 4% of patients after ER, in 5% after BS, in 6% after FAP, in 5% after conservative treatment, and in 13% after primary amputation. The reintervention rate was 8%, 14%, 6%, 5%, and 3% in each group, respectively. In the multivariate regression model, coronary artery disease (odds ratio [OR], 2.96; 95% confidence interval [CI], 1.42-6.17) and previous myocardial infarction (PMI)6 months (OR, 3.67, 95% CI, 1.51-8.88) were identified as risk factors for the composite end point. Risk factors for amputation were dialysis (OR, 3.31, 95% CI, 1.44-7.58) and PMI (OR, 3.26, 95% CI, 1.23-8.36) and for death, BS compared with ER (OR, 3.32; 95% CI, 1.10-10.0), renal insufficiency without dialysis (OR, 6.34; 95% CI, 1.71-23.5), and PMI (OR, 7.41; 95% CI, 2.11-26.0).The CRITISCH registry revealed ER as the most common first-line approach in CLI patients. Coronary artery disease and PMI6 months were independent risk factors for the composite end point. Special attention should be also paid to CLI patients with renal insufficiency, with or without dialysis, and those undergoing BS.

Prospective in vivo experiments to test the morphogenic power of increased fluid shear stress on collateral vessel growth (arteriogenesis) are rare. Therefore, the present study was designed to determine the arteriogenic potency of increased fluid shear stress and elucidate the underlying mechanism. Methods: Domestic pigs (n = 20) underwent bilateral proximal ligature of both superficial femoral arteries. At 1 week, a side-to-side anastomosis was created unilaterally between the distal femoral stump and the accompanying vein. Another week later, pressure and flow measurements in presence and absence of reactive hyperemia were performed to determine the fractional collateral flow (FCF). Quantitative arterial angiography was utilized for morphometric analysis of the collateral vessels. Subsequently, the vessels were excised and confocal immunohistochemistry (PCNA, eNOS, a-actin, lectin), as well as 2D-PAGE, differential expression analysis and Northern-blotting for destrin, cofilin-1, cofilin-2 and transgelin-2 was performed. Results: The number and size of collateral vessels was significantly increased in the shunted (S) as compared to the non-shunted (C) limb (p < 0,001; t-test). The mean fractional collateral flow was also significantly elevated (p

Die Gewinnung der Vena saphena magna ist ein entscheidender Operationsschritt im Zuge der peripheren Gefasrekonstruktion. Wundkomplikationen der dabei durchgefuhrten Inzisionen konnen jedoch zu einer erheblichen Erhohung der perioperativen Morbiditat beitragen. Aus diesem Grunde wird zunehmend die minimal-invasive Dissektion der Vena saphena magna („endoscopic vein harvesting”) diskutiert. Die Insufflation von Kohlendioxid (CO2) zur Gewebsretraktion scheint dabei eine sinnvolle Erganzung des endoskopischen Verfahrens darzustellen.

Background Although endovascular treatment of abdominal aortic aneurysms with a stent graft has been employed since 1990, safety is still controversial since type 1 endoleaks lead to reperfusion of the aneurysmal sac. The effect of small endoleaks on pressure in the aneurysmal sac with subsequent rupture risk has not been fully investigated. This study examines average pressure and pressure amplitude in the aneurysmal sac of abdominal aortic aneurysm models with a stent graft, depending on the diameter of a type 1 endoleak.

Im Vergleich zum offenen Vorgehen ist in der laparoskopischen Chirurgie die Moglichkeit der Instrumentenfuhrung signifikant eingeschrankt. Durch Einsatz von Robotic-Systemen lassen sich Instrumente mit allen Freiheitsgraden verwenden. Durch zusatzliche Filterung der Bewegungsubertragung vom Chirurgen auf die Instrumente ist so ein erheblicher Prazisionsgewinn gegeben. Die Effektivitat solcher Telemanipulatoren in der laparoskopischen Chirurgie ist mittlerweile auch fur die klinische Praxis belegt. Wir berichten hier uber die - nach unserer Kenntnis — erste laparoskopische Operation an der Vena cava inferior (V. cava inf.) unter Verwendung eines solchen Telemanipulators. Patient und Methode: Zugewiesen wurde uns eine 21jahrige Frau mit einem rechtsseitigen retroperitonealen Tumor, der zu einer kompletten Thrombose der V. cava inf. und zur ventralen Verlagerung des rechten Ureters gefuhrt hatte. Trotz mehrfacher Punktionsversuche war im Vorfeld keine eindeutige Histologiegewinnung moglich. Es wurde ein retroperitonealer Weichteiltumor ausgehend von glatten Muskelzellen der V. cava inf. vermutet.