Timing of procedural stroke and death in asymptomatic patients undergoing carotid endarterectomy: individual patient analysis from four RCTs.

BACKGROUND: The effectiveness of carotid endarterectomy (CEA) for stroke prevention depends on low procedural risks. The aim of this study was to assess the frequency and timing of procedural complications after CEA, which may clarify underlying mechanisms and help inform safe discharge policies. METHODS: Individual-patient data were obtained from four large carotid intervention trials (VACS, ACAS, ACST-1 and GALA; 1983-2007). Patients undergoing CEA for asymptomatic carotid artery stenosis directly after randomization were used for the present analysis. Timing of procedural death and stroke was divided into intraoperative day 0, postoperative day 0, days 1-3 and days 4-30. RESULTS: Some 3694 patients were included in the analysis. A total of 103 patients (2·8 per cent) had serious procedural complications (18 fatal strokes, 68 non-fatal strokes, 11 fatal myocardial infarctions and 6 deaths from other causes) [Correction added on 20 April, after first online publication: the percentage value has been corrected to 2·8]. Of the 86 strokes, 67 (78 per cent) were ipsilateral, 17 (20 per cent) were contralateral and two (2 per cent) were vertebrobasilar. Forty-five strokes (52 per cent) were ischaemic, nine (10 per cent) haemorrhagic, and stroke subtype was not determined in 32 patients (37 per cent). Half of the strokes happened on the day of CEA. Of all serious complications recorded, 44 (42·7 per cent) occurred on day 0 (20 intraoperative, 17 postoperative, 7 with unclear timing), 23 (22·3 per cent) on days 1-3 and 36 (35·0 per cent) on days 4-30. CONCLUSION: At least half of the procedural strokes in this study were ischaemic and ipsilateral to the treated artery. Half of all procedural complications occurred on the day of surgery, but one-third after day 3 when many patients had been discharged.

ANTECEDENTES: La efectividad de la endarterectomía carotídea (carotid endarterectomy, CEA) en la prevención de un accidente cerebrovascular depende de que este procedimiento tenga pocos riesgos. El objetivo de este estudio fue evaluar la frecuencia y el momento de aparición de las complicaciones tras una CEA, lo que podría clarificar los mecanismos subyacentes y ayudar a establecer una política de altas hospitalarias segura. MÉTODOS: Se utilizaron los datos de los pacientes incluidos en cuatro grandes ensayos de intervención carotídea (VACS, ACAS, ACST-1 y GALA; 1983-2007). Para el presente análisis se utilizaron los datos de pacientes sometidos a CEA por estenosis de la arteria carótida asintomática recogidos inmediatamente tras la aleatorización. Se consideraron diferentes intervalos entre el procedimiento, la muerte o el accidente cerebrovascular: intraoperatorio día 0, postoperatorio día 0, postoperatorio días 1-3 y postoperatorio días 4-30. RESULTADOS: En el análisis se incluyeron 3.694 pacientes. Se detectaron complicaciones graves relacionadas con el procedimiento en 103 (2,8%) pacientes (18 accidentes cerebrovasculares fatales, 68 accidentes cerebrovasculares no fatales, 11 infartos de miocardio fatales y 6 muertes por otras causas). De los 86 accidentes cerebrovasculares, 67 (78%) fueron ipsilaterales, 17 (20%) contralaterales y dos (2%) vertebrobasilares. Los accidentes cerebrovasculares fueron isquémicos en 45 (52%) casos, hemorrágicos en 9 (10%) y no se pudo determinar el subtipo de ictus en 32 (37%). La mitad de los accidentes cerebrovasculares ocurrieron el día de la CEA. De todas las complicaciones graves registradas, 44 (43%) ocurrieron en el día 0 (20 intraoperatorias, 17 postoperatorias y 7 en períodos poco definidos), 23 (22%) entre los días 1-3 y 36 (35%) entre los días 4-30. CONCLUSIÓN: En este estudio, al menos la mitad de los accidentes cerebrovasculares relacionados con la CEA fueron isquémicos e ipsilaterales respecto a la arteria tratada. La mitad de todas las complicaciones de la CEA ocurrieron el día de la cirugía, pero un tercio de los casos se presentaron después del día 3, cuando muchos pacientes ya habían sido dados de alta.

Angioplasty in asymptomatic carotid artery stenosis vs. endarterectomy compared to best medical treatment: One-year interim results of SPACE-2.

BACKGROUND: Treatment of individuals with asymptomatic carotid artery stenosis is still handled controversially. Recommendations for treatment of asymptomatic carotid stenosis with carotid endarterectomy (CEA) are based on trials having recruited patients more than 15 years ago. Registry data indicate that advances in best medical treatment (BMT) may lead to a markedly decreasing risk of stroke in asymptomatic carotid stenosis. The aim of the SPACE-2 trial (ISRCTN78592017) was to compare the stroke preventive effects of BMT alone with that of BMT in combination with CEA or carotid artery stenting (CAS), respectively, in patients with asymptomatic carotid artery stenosis of ≥70% European Carotid Surgery Trial (ECST) criteria. METHODS: SPACE-2 is a randomized, controlled, multicenter, open study. A major secondary endpoint was the cumulative rate of any stroke (ischemic or hemorrhagic) or death from any cause within 30 days plus an ipsilateral ischemic stroke within one year of follow-up. Safety was assessed as the rate of any stroke and death from any cause within 30 days after CEA or CAS. Protocol changes had to be implemented. The results on the one-year period after treatment are reported. FINDINGS: It was planned to enroll 3550 patients. Due to low recruitment, the enrollment of patients was stopped prematurely after randomization of 513 patients in 36 centers to CEA (n = 203), CAS (n = 197), or BMT (n = 113). The one-year rate of the major secondary endpoint did not significantly differ between groups (CEA 2.5%, CAS 3.0%, BMT 0.9%; p = 0.530) as well as rates of any stroke (CEA 3.9%, CAS 4.1%, BMT 0.9%; p = 0.256) and all-cause mortality (CEA 2.5%, CAS 1.0%, BMT 3.5%; p = 0.304). About half of all strokes occurred in the peri-interventional period. Higher albeit statistically non-significant rates of restenosis occurred in the stenting group (CEA 2.0% vs. CAS 5.6%; p = 0.068) without evidence of increased stroke rates. INTERPRETATION: The low sample size of this prematurely stopped trial of 513 patients implies that its power is not sufficient to show that CEA or CAS is superior to a modern medical therapy (BMT) in the primary prevention of ischemic stroke in patients with an asymptomatic carotid stenosis up to one year after treatment. Also, no evidence for differences in safety between CAS and CEA during the first year after treatment could be derived. Follow-up will be performed up to five years. Data may be used for pooled analysis with ongoing trials.

Regional frequency variation of revascularization procedures for carotid stenosis in Germany: Secondary data analysis of DRG data from 2012 to 2014.

BACKGROUND: For Germany, regional variation of procedure rates of carotid endarterectomy (CEA) and carotid artery stenting (CAS) performed for carotid stenosis have so far not been analyzed at a national level. The aim of this study was to assess small area estimates of procedure rates among German regions, and to identify regional characteristics, which are associated with the regional frequency of procedures. METHODS: German diagnosis-related groups (DRG) statistics (2012-2014) were analyzed. Inclusion and exclusion criteria for procedural codes were set according to German quality assurance measures in combination with the diagnosis of carotid stenosis (I65.2). Rates of CEA and CAS were indirectly standardized for sex and age. RESULTS: In total, 88,182 procedures were performed (73,042 CEA; 15,367 CAS). The overall procedure rate varied between 13.2 per 100,000 (Augsburg) and 89.2 per 100,000 (Wilhelmshaven). Spatial analysis revealed that regional distribution was significantly clustered. CONCLUSION: The rates of CEA, and especially of CAS showed high regional variation. The spatial distribution was significantly clustered. In addition to the regional prevalence of diabetes mellitus, smoking and obesity, socioeconomic factors, such as income and debts were correlated with the overall frequency of CEA and CAS. No significant association was found between indicators of health infrastructure (e. g. density of hospital beds, vascular surgeons and angiologists) and the overall procedure rate.

[Operative treatment of diabetics with vascular complications : Secondary data analysis of diagnosis-related groups statistics from 2005 to 2014 in Germany]. / Operative Versorgung von Diabetikern mit vaskulären Komplikationen : Sekundärdatenanalyse der DRG-Statistik von 2005 bis 2014 in Deutschland.

BACKGROUND: In Germany approximately 40,000 amputations per year are performed on patients with diabetes mellitus, often with accompanying vascular complications. OBJECTIVE: The aim of this study was to present the various degrees of severity of the vascular complications and the temporal changes of the treatment options in diabetics with vascular complications in Germany. MATERIAL AND METHODS: The microdata of the diagnosis-related groups (DRG) statistics of the Federal Statistical Office were analyzed over the period from 2005 to 2014. All cases were included in which the main or secondary diagnosis of diabetes mellitus with concurrent vascular complications (diabetic angiopathy and peripheral arterial disease) was encrypted. RESULTS: The median age of the 1,811,422 cases was 73 years and 62% were male. While the total number of amputations remained stable over time, there was a 41% reduction in knee-preserving and a 31% reduction in non-knee preserving major amputations with an 18% increase in minor amputations. Revascularization increased by 33% from 36 procedures in 2005 to 48 procedures per 100,000 inhabitants. The increase in revascularization was evident in the area of endovascular therapy alone where there was an increase of 78%. CONCLUSION: Due to the significant increase in endovascular revascularization measures, there was a significant increase in the proportion of diabetes patients with vascular pathologies in whom revascularization was carried out. As a result, improved limb preservation was achieved despite equally high amputation rates due to increasing minor amputation rates.

Nationwide analysis of risk factors for in-hospital mortality in patients undergoing abdominal aortic aneurysm repair.

BACKGROUND: There is increasing awareness that women may have worse outcomes following repair of abdominal aortic aneurysm (AAA). The aim of this study was to analyse the association between sex, age and in-hospital mortality after AAA using hospital episode data collected routinely at the nationwide level. METHODS: Data were extracted from the nationwide statutory Diagnosis Related Group statistics provided by the German Federal Statistical Office. Patients with a diagnosis of intact (non-ruptured) AAA (ICD-10 GM I71.4) and procedure codes (OPS; 2005-2013) for endovascular aneurysm repair (EVAR) (5-38a.1*) or open aneurysm repair (5-384.5, 5-384.7), treated from 2005 to 2013, were included. A multilevel multivariable regression model was applied to adjust for medical risk (using the Elixhauser co-morbidity score), type of procedure, type of admission, and to account for clustering of patients within centres. The primary outcome was in-hospital mortality. RESULTS: Some 84 631 patients were identified, of whom 10 039 (11·9 per cent) were women. Women were significantly older than men at admission (median 74 (i.q.r. 69-80) versus 72 (66-77) years; P < 0·001). EVAR was used less frequently in women (48·1 versus 54·7 per cent; P < 0·001). The in-hospital mortality rate was higher in women, overall (5·0 versus 3·1 per cent; relative risk 1·60, 95 per cent c.i. 1·45 to 1·75), and for EVAR (2·8 versus 1·5 per cent; RR 1·90, 1·60 to 2·30) and open repair (6·8 versus 5·0 per cent; RR 1·36, 1·22 to 1·52). In-hospital mortality increased with age and was highest in patients aged over 80 years. In multivariable regression analysis, female sex (RR 1·20, 1·07 to 1·35) and age per 10-year increase (RR 1·83, 1·73 to 1·95) were independent risk factors for higher in-hospital mortality. CONCLUSION: In Germany, women were older when undergoing AAA repair and were less likely to receive EVAR. Mortality rates were higher in older patients and in women, irrespective of the surgical technique used.

Outcomes of Endovascular Abdominal Aortic Aneurysm Repair in Octogenarians: Meta-analysis and Systematic Review.

OBJECTIVES: This meta-analysis and systematic review aimed to highlight the results of endovascular aneurysm repair (EVAR) for abdominal aortic aneurysm (AAA) to assess safety and effectiveness in patients older than 80 years of age compared with younger patients. METHODS: PRISMA guidelines were used; quality was appraised, and data were extracted and analysed following the Cochrane collaboration. The MEDLINE and Embase databases were searched on December 31, 2016. All studies related to clinical outcomes following EVAR for AAA treatment in octogenarians compared with those in younger patients were included for a meta-analysis and systematic review of short- and midterm outcomes. Data were analysed using a fixed or random effects model by pooling and calculating odds ratios (ORs) or hazard ratios (HRs) and weighted mean differences, to investigate the safety and feasibility of endoluminal treatment in octogenarians. RESULTS: Published literature search identified nine observational studies, comprising 25,723 patients with AAA (5989 octogenarians and 19,734 younger patients). More males (OR 0.621, p=.002) and smokers (OR 0.457, p<.001) were observed in the younger group. Frequent concomitant diseases were associated with advanced age, thus, the procedural duration, blood loss estimation, and length of stay were considerably higher among octogenarians. Although elderly patients have a higher 30 day mortality (2.7% vs. 1.5%, p<.001), endoleak, pulmonary, and renal diseases, no significant difference was found in the technical success of the procedure. As expected, the HR for octogenarians was markedly higher than that of younger patients (HR 1.946, p<.001) for midterm all-cause mortality. However, the re-intervention rate to maximum follow-up period of 5 years was not significantly different (HR 1.148, p=.408) between the groups. CONCLUSION: Compared with younger patients, EVAR in octogenarians is associated with a significantly higher but still acceptable peri-operative and midterm mortality rate. Because of similar midterm re-intervention rates, these findings suggest that EVAR remains an appropriate therapeutic approach in the elderly group if comprehensive pre-operative evaluation and post-operative surveillance are incorporated.

MR Imaging of Individual Perfusion Reorganization Using Superselective Pseudocontinuous Arterial Spin-Labeling in Patients with Complex Extracranial Steno-Occlusive Disease.

BACKGROUND AND PURPOSE: Patients with multiple stenoses or occlusions of the extracranial arteries require an individualized diagnostic approach. We evaluated the feasibility and clinical utility of a novel MR imaging technique for regional perfusion imaging in this patient group. MATERIALS AND METHODS: Superselective pseudocontinuous arterial spin-labeling with a circular labeling spot enabling selective vessel labeling was added to routine imaging in a prospective pilot study in 50 patients (10 women, 70.05 ± 10.55 years of age) with extracranial steno-occlusive disease. Thirty-three had infarct lesions. DSC-MR imaging was performed in 16/50 (32%), and cerebral DSA, in 12/50 patients (24%). Vascular anatomy and the distribution of vessel stenoses and occlusions were defined on sonography and TOF-MRA. Stenoses were classified according to the NASCET criteria. Infarct lesions and perfusion deficits were defined on FLAIR and DSC-MR imaging, respectively. Individual perfusion patterns were defined on the superselective pseudocontinuous arterial spin-labeling maps and were correlated with vascular anatomy and infarct lesion localization. RESULTS: The superselective pseudocontinuous arterial spin-labeling imaging sequence could be readily applied by trained technicians, and the additional scan time of 12.7 minutes was well-tolerated by patients. The detected vessel occlusions/stenoses and perfusion patterns corresponded between cerebral DSA and superselective pseudocontinuous arterial spin-labeling maps in all cases. Perfusion deficits on DSC-CBF maps significantly correlated with those on superselective pseudocontinuous arterial spin-labeling maps (Pearson r = 0.9593, P < .01). Individual collateral recruitment patterns were not predictable from the vascular anatomy in 71% of our patients. CONCLUSIONS: Superselective pseudocontinuous arterial spin-labeling is a robust technique for regional brain perfusion imaging, suitable for the noninvasive diagnostics of individual perfusion patterns in patients with complex cerebrovascular disease.

Association of Matrix Metalloproteinase Levels with Collagen Degradation in the Context of Abdominal Aortic Aneurysm.

OBJECTIVE/BACKGROUND: Matrix metalloproteinases (MMPs) have already been identified as key players in the pathogenesis of abdominal aortic aneurysm (AAA). However, the current data remain inconclusive. In this study, the expression of MMPs at mRNA and protein levels were investigated in relation to the degradation of collagen I and collagen III. METHODS: Tissue samples were obtained from 40 patients with AAA undergoing open aortic repair, and from five healthy controls during kidney transplantation. Expression of MMPs 1, 2, 3, 7, 8, 9, and 12, and tissue inhibitor of metalloproteinase (TIMP)1, and TIMP2 were measured at the mRNA level using quantitative reverse transcription polymerase chain reaction. At the protein level, MMPs, collagen I, and collagen III, and their degradation products carboxy-terminal collagen cross-links (CTX)-I and CTX-III, were quantified via enzyme linked immunosorbent assay. In addition, immunohistochemistry and gelatine zymography were performed. RESULTS: In AAA, significantly enhanced mRNA expression was observed for MMPs 3, 9, and 12 compared with controls (p ≤ .001). MMPs 3, 9, and 12 correlated significantly with macrophages (p = .007, p = .018, and p = .015, respectively), and synthetic smooth muscle cells with MMPs 1, 2, and 9 (p = .020, p = .018, and p = .027, respectively). At the protein level, MMPs 8, 9, and 12 were significantly elevated in AAA (p = .006, p = .0004, and p < .001, respectively). No significant correlation between mRNA and protein was observed for any MMP. AAA contained significantly reduced intact collagen I (twofold; p = .002), whereas collagen III was increased (4.6 fold; p < .001). Regarding degraded collagen I and III relative to intact collagens, observations were inverse (1.4 fold increase for CTX-1 [p < .001]; fivefold decrease for CTX-III [p = .004]). MMPs 8, 9, and 12 correlated with collagen I (p = .019, p < .001, and p = 0.003, respectively), collagen III (p = .015, p < .001, and p < .001, respectively), and degraded collagen I (p = .012, p = .049, and p = .001, respectively). CONCLUSION: No significant relationship was found between mRNA and protein and MMP levels. MMPs 9 and 12 were overexpressed in AAA at the mRNA and protein level, and MMP-8 at the protein level. MMP-2 was detected in synthetic SMCs. Collagen I and III showed inverse behaviour in AAA. In particular, MMPs 8, 9, and 12 appear to be associated with collagen I, collagen III, and their degradation products.

[Radiotherapeutic management of lymphatic fistulas : An effective but disregarded therapy option]. / Strahlentherapeutisches Management von Lymphfisteln : Eine effektive, aber wenig beachtete Therapieoption.

BACKGROUND: Lymphatic fistulas and lymphoceles are known complications after vascular surgery of the groin and after extended surgical interventions in the pelvic region. Unfortunately, conservative standard therapies are not always successful. OBJECTIVES: Evaluation of the therapeutic efficacy and related side effects of percutaneous low-dose irradiation in patients with lymphorrhea and definition of its importance. MATERIAL AND METHODS: Current presentation of previously published case series, reviews and guidelines. RESULTS: The use of low-dose irradiation therapy with single doses of 0.3-0.5 Gy leads to a cessation of the lymphatic flow in a high percentage of patients when standard therapies do not show a sufficient effect. With cessation of lymphorrhea irradiation should be terminated. Acute side effects have not been reported and the risk of tumor induction is almost negligible. CONCLUSION: Low-dose irradiation is an effective and very well-tolerated therapeutic alternative in the treatment of lymphatic fistulas and lymphorrhea when conservative therapies are unsuccessful.

Trends in Patient Safety of Intact Abdominal Aortic Aneurysm Repair: German Registry Data on 36,594 Procedures.

OBJECTIVE/BACKGROUND: The study aim was to determine whether patient safety for non-ruptured abdominal aortic aneurysm (nrAAA) repair has changed between 1999 and 2010 in a large German cohort. METHODS: The data source was the prospective quality assurance registry of the German Vascular Society from 1999 to 2010. Patient characteristics, surgical techniques (open aortic repair [OAR], endovascular aortic repair [EVAR]), procedural time and outcomes, including the length of hospital stay (LOS), were analysed using the Cochran-Armitage test for binary parameters and Spearman's correlation coefficient for quantitative parameters. RESULTS: A total of 36,594 operations (23,037 OAR, 13,557 EVAR) for infrarenal nrAAA in 201 hospitals in Germany were investigated. Patients' mean age increased from 69.6 to 72.0 years (p < .001). The rate of patients with American Society of Anesthesiologists scores of 3 or 4 increased (p < .001). Use of EVAR increased (1999: 16.7%; 2010: 62.7%; p < .001), and since 2009, EVAR has been more frequently used than OAR. The overall in hospital mortality decreased from 3.1% in 1999 to 2.3% in 2010 (p < .001). There were no temporal trends for mortality rates for EVAR (p = .233) or OAR (p = .281) when considered separately. Cardiac (1999: 8.1%; 2010: 5.1%; p < .001) and pulmonary (1999: 7.8%; 2010: 4.8%; p < .001) complications decreased. The rate of post-operative renal failure increased (1999: 3.6%; 2010 4.1%; p = .017), without increasing the rate of patients needing dialysis (1999: 1.7%; 2010: 1.7%; p = .171). The median LOS decreased from 17 days in 1999 to 10 days in 2010 (p < .001). CONCLUSION: This study shows significantly improved post-procedural in hospital outcomes and decreased use of resources for nrAAA repair. This trend can probably be attributed to the implementation of EVAR as a standard technique, but some trends could also possibly be explained by a change in the remuneration system. The main limitation of the registry is the lack of internal and external validation. However, in hospital patient safety for AAA repair seems to have improved significantly in the participating hospitals.

[Locoregional solutions for groin defects : Coverage after vascular surgery]. / Lokoregionale Lösungen bei Leistendefekten : Deckung nach gefäßchirurgischen Eingriffen.

INTRODUCTION: Vascular surgery through a groin incision may be associated with severe wound healing disorders in this sensitive area. There are many options to reconstruct the defect surgically. The choice of surgical reconstruction depends mainly on the individual status of vasculature, which is most often compromised in these patients. There are random pattern flaps, as well as perforator, pedicled flaps or microvascular flaps to choose from. AIM: We give an overview of plastic surgical solutions for groin defects, with a special focus on complex wounds after vascular surgical complications. We discuss advantages and disadvantages of different flaps with two case reports and also show alternatives. PATIENTS AND METHODS: We demonstrate in two cases how the reconstruction of the groin defect was planned, taking into account the vascular status, and why we chose an innovative and seldom-used option in each case. RESULTS: The selected flaps, a pedicled fasciocutaneous ALT propeller flap and a perforator-based, pedicled abdominal advancement flap reconstructed the defects successfully. DISCUSSION: The surgical therapy for the reconstruction of groin defects should be chosen according to the individual vascular status to ensure safe and reliable blood supply. To guarantee the best possible reconstruction and avoid postoperative healing disorders and infections, less common flaps should also be considered.

Measurements After Image Post-processing Are More Precise in the Morphometric Assessment of Thoracic Aortic Aneurysms: An Intermodal and Intra-observer Evaluation.

OBJECTIVES: Precise pre-procedural anatomical analysis of aneurysmal anatomy is essential for successful thoracic endovascular aortic repair (TEVAR). Since surgeons and radiologists have to perform multiple measurements in the same patient, high intra-observer reliability of any imaging method is mandatory. Commercially available three dimensional (3D) post-processing techniques are expected to be superior to conventional two dimensional multiplanar reconstructions (MPRs) derived from computed tomography angiograms (CTAs). However, few data exist to support this view. This study aims to evaluate the intermodal and intra-observer differences using 3D software (3surgery) in descending thoracic aortic aneurysms (dTAAs). METHODS: Pre-operative CTAs (performed between 2004 and 2010) of 30 dTAAs (mean maximum diameter 61.4 ± 13 mm) were assessed by three independent investigators with different experience in the measurement of aortic pathologies. Intra-observer reliability and intermodal differences (3D vs. 2D) were investigated using pre-specified measurement points (distances of total length, maximum diameter, proximal and distal landing zones). Statistical analyses were performed using the Bland-Altman method and a mixed regression model. RESULTS: Intermodal comparison showed that 2D measurements significantly underestimate the measured distances (maximum diameter 3.7 mm [95% CI -5.3 to -2.1] and landing zone maximum 1.4 mm [95% CI -2.0 to -0.2] shorter with 2D, p < .05). In almost all 3D measurements, all investigators showed lower variability comparing the intra-observer differences, most notably in the measuring point total length (reduction of the SD up to 7.9 mm). CONCLUSIONS: These data show that both techniques led to significant measurement disparity. This occurs especially at the point of indication (maximum diameter) and the total length of the aneurysm (important for correct stent graft selection). But overall the variability is reduced with the 3D technique, which also tends to measure greater distances. The use of post-processing software therefore leads to more precise device selection for TEVAR in TAA.

Epidemiology and inpatient treatment of vascular diseases in Germany: English Version.

BACKGROUND: Non-cardiac vascular diseases account for approximately 10 % of the total burden of disease in the German population as measured in disability-adjusted life years (DALY). Thus, from the social perspective, much attention should be paid to optimization of the provision of vascular services especially in elderly people. OBJECTIVES: This article describes the structure of inpatient care and the provision of vascular treatment as well as age- and gender-specific hospital incidence rates of vascular diseases in Germany between 2005 and 2013. MATERIALS AND METHODS: Secondary data analysis is based on basic data from German hospitals as well as nationwide aggregated data from the diagnosis-related groups' statistics from the Federal Statistical Office. RESULTS: Since 2005, the incidence of non-cardiac vascular diseases has increased and showed a significant dependency on sex and age. In general, men were affected consistently more frequently by vascular diseases. In contrast, hospital admission rates due to varicose veins or acute ischemia of the legs were higher in women. Treatment of arterial diseases was performed predominantly in general surgery units or departments for vascular surgery. From 1991 to 2013, the number of hospitals employing specialists for vascular surgery almost doubled, and the number of vascular surgeons working full-time in German hospitals was nearly tripled. Endovascular approaches were used particularly for revascularization of peripheral arteries as well as aortic aneurysm repair. In contrast, carotid surgery as well as peripheral embolectomy were predominately performed using open surgical techniques. CONCLUSIONS: Since 1991, the increasing need for vascular services for patients has been met by continuously growing structures for the provision of vascular surgical treatment; however, the suitability and efficiency of provision of vascular services could only be assessed in an appropriate way by using more differentiated and disaggregated data. ADDITIONAL MATERIAL AVAILABLE ONLINE: Additional information is available in the online version of this article (doi:10.1007/s00772-015-0095-5).

SPACE-2: A Missed Opportunity to Compare Carotid Endarterectomy, Carotid Stenting, and Best Medical Treatment in Patients with Asymptomatic Carotid Stenoses.

BACKGROUND: Because of recent advances in best medical treatment (BMT), it is currently unclear whether any additional surgical or endovascular interventions confer additional benefit, in terms of preventing late ipsilateral carotid territory ischemic stroke in asymptomatic patients with significant carotid stenoses. The aim was to compare the stroke-preventive effects of BMT alone, with that of BMT in combination with carotid endarterectomy (CEA) or carotid artery stenting (CAS) in patients with high grade asymptomatic extracranial carotid artery stenosis. METHODS: SPACE-2 was planned as a three-armed, randomized controlled trial (BMT alone vs. CEA plus BMT vs. CAS plus BMT, ISRCTN 78592017). However, because of slow patient recruitment, the three-arm study design was amended (July 2013) to become two parallel randomized studies (BMT alone vs. CEA plus BMT, and BMT alone vs. CAS plus BMT). RESULTS: The change in study design did not lead to any significant increase in patient recruitment, and trial recruitment ceased after recruiting 513 patients over a 5 year period (CEA vs. BMT (n = 203); CAS vs. BMT (n = 197), and BMT alone (n = 113)). The 30 day rate of death/stroke was 1.97% for patients undergoing CEA, and 2.54% for patients undergoing CAS. No strokes or deaths occurred in the first 30 days after randomization in patients randomized to BMT. There were several potential reasons for the low recruitment rates into SPACE-2, including the ability for referring doctors to refer their patients directly for CEA or CAS outwith the trial, an inability to convince patients (who had come "mentally prepared" that an intervention was necessary) to accept BMT, and other economic constraints. CONCLUSIONS: Because of slow recruitment rates, SPACE-2 had to be stopped after randomizing only 513 patients. The German Research Foundation will provide continued funding to enable follow up of all recruited patients, and it is also planned to include these data in any future meta-analysis prepared by the Carotid Stenosis Trialists Collaboration.

[Indications and results of endovascular therapy of critical limb ischemia]. / Indikationen und Ergebnisse der endovaskulären Therapie der kritischen Extremitätenischämie.

BACKGROUND: Critical limb ischemia (CLI) is the most severe form of peripheral artery occlusive disease and is characterized by high amputation, morbidity and mortality rates. Therefore, revascularization is the essential step in therapy for retention of the affected limb. OBJECTIVES: Although for a long time bypass surgery represented the gold standard in the treatment of CLI, in recent years there has been a disproportionate increase of endovascular treatment despite the lack of level-data. In this review the indications and results of endovascular therapy of CLI are presented on the basis of published data. METHODS: A literature search was carried out to identify publications that compared the results of endovascular and surgical therapy as well as observational studies about different endovascular techniques. RESULTS: The BASIL study provided the highest quality data comparing endovascular and surgical treatment of CLI. The long-term data of the BASIL trial showed that apart from patients with a suitable vein and a life expectancy of more than 2 years, first line endovascular therapy is equivalent to surgical treatment. The equivalence could also be demonstrated in a meta-analysis comparing operative and endovascular treatment of CLI. CONCLUSION: The CLI is a disease with high mortality and morbidity risks. Due to the comparable amputation-free survival times with lower complication rates in the published data, in most patients an endovascular first strategy in experienced centers can be justified.

Patient characteristics and outcomes of carotid endarterectomy and carotid artery stenting: analysis of the German mandatory national quality assurance registry - 2003 to 2014.

AIM: In Germany, every surgical or endovascular procedure on the extracranial carotid artery is documented in a mandatory quality assurance registry. The purpose of this study is to describe the patient characteristics, the indications for treatment, and the short-term outcomes as well as to analyse the corresponding trends from 2003 to 2014. METHODS: Data on demographics, peri-procedural measures, and outcomes were extracted from the annual quality reports published by the Federal Agency for Quality Assurance and the Institute for Applied Quality Improvement and Research in Health Care. Data were available from 2003 to 2014 for carotid endarterectomy (CEA) and from 2012 to 2014 for carotid artery stenting (CAS). The primary outcome event of this study is any stroke or death until discharge from hospital. Temporal trends of categorical variables were statistically analysed using the Cochran-Armitage test for trend. RESULTS: Between 2003 and 2014, 309,405 CEAs and 18,047 CAS procedures were documented in the database; 68.1% of all patients were male. The mean age of patients treated with CEA increased from 68.9 years in 2003 to 70.9 years in 2014. The proportion of patients with ASA stages III to V increased from 65% to 71% in CEA, whereas it decreased from 44% to 41% in CAS patients. 53.1% of all CEAs were performed for asymptomatic patients (group A), 34.4% for symptomatic patients treated electively (group B), and 11.2% a in a collective group including other indications for CEA or CAS (such as recurrent stenosis, carotid aneurysms, emergency treatment due to stroke-in-evolution). The corresponding data for CAS are 49.3%, 26.1% and 26.3% respectively. In group B, the interval between the neurological index event and CEA decreased from 28 to 8 days (P<0.001). In patients treated with CAS, this interval was 9 days in 2012 (no further data available). On average, 67.1% and 48.2% of surgically treated patients as well as 77.8% and 69.8% of CAS patients were neurologically assessed before and after the procedure, respectively. From 2003 to 2014, CEA procedures were performed more frequently in locoregional anesthesia (10.1% to 29.1%, P<0.001). The same trend was observed for the application of the eversion technique (37.0% to 41.6%, P<0.001), the neurophysiological monitoring (49.8% to 61.8%, P<0.001), and the intra-procedural assessment of the treated artery (44.5% to 69.7%, P<0.001). In contrast, shunting was used less frequently (48.1% to 43.0%, P<0.001). Averagely 95.7% of all endovascular procedures were performed using stent-angioplasty. In 54.2% a protection device was used. Nitinol and bare metal stents were used in 74.1% and 21.4% of cases, respectively. The in-hospital rate of any stroke or death decreased from 2.0% to 1.1% in asymptomatic patients treated with CEA without a contralateral stenosis ≥75% or occlusion, P<0.001). In patients treated with CAS this rate did not increase (1.7% to 1.8%, p=0.909). The corresponding rates in CEA and CAS patients with severe contralateral stenosis or occlusion varied between 1.9%-3.1% and 2.2%-2.6%, respectively. In symptomatic patients (group B) with a stenosis of 50 percent or more, the rate of any stroke or death decreased significantly after CEA from 4.2% to 2.4% (P<0.001) and remained stable after CAS (3.9% to 3.5%, P=0.577). CONCLUSION: This report on 327,452 carotid procedures analysed one of the largest quality registries on CEA and CAS worldwide. Data indicate that treated patients became older and sicker, whereas in contrast, the in-hospital rates of stroke or death are decreasing over time.

CXCR4: A Potential Marker for Inflammatory Activity in Abdominal Aortic Aneurysm Wall.

OBJECTIVES: The aim of the study was to evaluate the potential role of chemokine receptor CXCR4 and its ligand CXCL12 in the pathogenesis of abdominal aortic aneurysm (AAA). METHODS: AAA tissue specimens were obtained from the anterior or lateral aneurysm sac of patients (n = 32, 26 males, 6 females; 66.8 ± 11.2 years, diameter 64.4 ± 17.0 mm), who underwent elective open surgical repair. Twelve non-aneurysmal aortic specimens from transplant donors served as controls. Expression analysis of CXCR4 and CXCL12 at mRNA and protein level was determined by quantitative reverse transcription-polymerase chain reaction (RT-PCR) and western blot. Immunohistochemical staining of corresponding histological sections for CD3 (T-cells), CD20 (B-cells), and CD68 (macrophages) was performed to determine the cellular localization of CXCR4 and CXCL12. Data were analyzed with SPSS 20.0 using Mann-Whitney U test and Spearman's rank correlation coefficient. RESULTS: Gene expression of CXCR4 and CXCL12 was 9.6 and 4.6 fold higher in AAA than in non-aneurysmal aorta (p = .0004 and p < .0001, respectively). Likewise, the protein level of CXCR4 was increased 3.2 fold in AAA wall compared with non-aneurysmal aortic tissue (p < .0001), although CXCL12 could not be detected. Immunohistochemical analysis revealed that CXCR4 was expressed in B and T lymphocytes and macrophages, and CXCL12 was observed only in plasma cells. CONCLUSIONS: This study confirmed the over expression of CXCR4 in human AAA tissue. CXCR4 was detected both at the mRNA and the protein level and by immunohistochemistry, especially in inflammatory cells. In contrast, CXCL12 expression was observed only at the mRNA level, with the exception of plasma cells. The exact role of CXCR4/CXCL12 in AAA has to be further elucidated.