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.
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.
Women and elderly at higher risk
Objectives Uncomplicated acute type B aortic dissection (AD) treated conservatively has a 10% 30-day mortality and up to 25% need intervention within 4 years. In complicated AD, stent grafts have ...been encouraging. The aim of the present prospective randomised trial was to compare best medical treatment (BMT) with BMT and Gore TAG stent graft in patients with uncomplicated AD. The primary endpoint was a combination of incomplete/no false lumen thrombosis, aortic dilatation, or aortic rupture at 1 year. Methods The AD history had to be less than 14 days, and exclusion criteria were rupture, impending rupture, malperfusion. Of the 61 patients randomised, 80% were DeBakey type IIIB. Results Thirty-one patients were randomised to the BMT group and 30 to the BMT+TAG group. Mean age was 63 years for both groups. The left subclavian artery was completely covered in 47% and in part in 17% of the cases. During the first 30 days, no deaths occurred in either group, but there were three crossovers from the BMT to the BMT+TAG group, all due to progression of disease within 1 week. There were two withdrawals from the BMT+TAG group. At the 1-year follow up there had been another two failures in the BMT group: one malperfusion and one aneurysm formation ( p = .056 for all). One death occurred in the BMT+TAG group. For the overall endpoint BMT+TAG was significantly different from BMT only ( p < .001). Incomplete false lumen thrombosis, was found in 13 (43%) of the TAG+BMT group and 30 (97%) of the BMT group ( p < .001). The false lumen reduced in size in the BMT+TAG group ( p < .001) whereas in the BMT group it increased. The true lumen increased in the BMT+TAG ( p < .001) whereas in the BMT group it remained unchanged. The overall transverse diameter was the same at the beginning and after 1 year in the BMT group (42.1 mm), but in the BMT+TAG it decreased (38.8 mm; p = .062). Conclusions Uncomplicated AD can be safely treated with the Gore TAG device. Remodelling with thrombosis of the false lumen and reduction of its diameter is induced by the stent graft, but long term results are needed.
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.
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.
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.
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.
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.
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.
Abstract Objectives The Endurant Stent Graft System (Medtronic Vascular, Santa Rosa, CA) is specifically designed to treat patients with abdominal aortic aneurysm, including those with difficult ...anatomies. This is the 1-year report of a prospective, non-randomised, open-label trial at 10 European centres. Methods Between November 2007 and August 2008, 80 patients were enrolled for elective endovascular aneurysm repair (EVAR) with the Endurant; 71 with moderate (≤60°) and nine with high (60–75°) infrarenal aortic neck angulation. Safety and stent-graft performance were assessed throughout a 1-year follow-up period. Results The device was successfully delivered and deployed in all cases. All-cause mortality was 5% (4/80), with one possibly device-related death. Serious adverse events were comparable between the high and moderate angulation groups. There were no device migrations, stent fractures, aortic ruptures or conversions to open repair. Maximal aneurysm diameter decreased >5 mm in 42.7% of cases. A total of 28 endoleaks were observed (26 type II, two undetermined). Three secondary endovascular procedures were performed for outflow vessel stenosis, graft limb occlusion and iliac extension, resulting in a secondary patency rate of 100%. No re-interventions were required in the high angulation group. Conclusions The Endurant Stent Graft was successfully delivered and deployed in all cases and performed safely and effectively in all patients, including those with unfavourable proximal neck anatomy.
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.
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. Reported in‐hospital stroke or death rates might underestimate true risks after carotid endarterectomy.
Half the strokes occurred after the day of surgery
An abdominal aortic aneurysm (AAA) is a balloon-like dilation of the aorta, which is potentially fatal in case of rupture. Computational finite element (FE) analysis is a promising approach to a more ...accurate and patient-specific rupture risk prediction. AAA wall strength and rupture potential index (RPI) calculation are implemented in our FE software. Static structural FE simulations are performed on n = 30 non-ruptured asymptomatic, n = 9 non-ruptured symptomatic, and n = 14 ruptured AAAs. We calculate maximum values for diameter, wall displacement, strain, stress, and RPI as well as minimum wall strength for every AAA. All investigated quantities, except minimum strength, show statistically significant differences between non-ruptured asymptomatic and symptomatic/ruptured AAAs. Maximum wall stress and especially the RPI are notably increased for symptomatic and ruptured AAAs. The biggest difference is found to be the RPI (Δ = 44.9%, p = 8.0e−5). Lowest RPI obtained for symptomatic or ruptured AAAs is 0.3. The RPI of more than 55% of the investigated asymptomatic AAAs falls below this value. Maximum wall stress and maximum RPI criteria enable a reliable rupture risk evaluation for AAAs. Especially in the diameter range where surgical indication is not obvious, the RPI holds great potential for improvement of clinical decisions.
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