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1.
Br J Surg ; 105(1): 68-74, 2018 Jan.
Article in English | MEDLINE | ID: mdl-29265406

ABSTRACT

BACKGROUND: This study aimed to assess how the prevalence and growth rates of small and medium abdominal aortic aneurysms (AAAs) (3·0-5·4 cm) have changed over time in men aged 65 years, and to evaluate long-term outcomes in men whose aortic diameter is 2·6-2·9 cm (subaneurysmal), and below the standard threshold for most surveillance programmes. METHODS: The Gloucestershire Aneurysm Screening Programme (GASP) started in 1990. Men aged 65 years with an aortic diameter of 2·6-5·4 cm, measured by ultrasonography using the inner to inner wall method, were included in surveillance. Aortic diameter growth rates were estimated separately for men who initially had a subaneurysmal aorta, and those who had a small or medium AAA, using mixed-effects models. RESULTS: Since 1990, 81 150 men had ultrasound screening for AAA (uptake 80·7 per cent), of whom 2795 had an aortic diameter of 2·6-5·4 cm. The prevalence of screen-detected AAA of 3·0 cm or larger decreased from 5·0 per cent in 1991 to 1·3 per cent in 2015. There was no evidence of a change in AAA growth rates during this time. Of men who initially had a subaneurysmal aorta, 57·6 (95 per cent c.i. 54·4 to 60·7) per cent were estimated to develop an AAA of 3·0 cm or larger within 5 years of the initial scan, and 28·0 (24·2 to 31·8) per cent to develop a large AAA (at least 5·5 cm) within 15 years. CONCLUSION: The prevalence of screen-detected small and medium AAAs has decreased over the past 25 years, but growth rates have remained similar. Men with a subaneurysmal aorta at age 65 years have a substantial risk of developing a large AAA by the age of 80 years.


Subject(s)
Aortic Aneurysm, Abdominal/diagnostic imaging , Aortic Aneurysm, Abdominal/epidemiology , Mass Screening , Aged , Aortic Aneurysm, Abdominal/pathology , Disease Progression , Follow-Up Studies , Humans , Male , Models, Statistical , Prevalence , Ultrasonography , United Kingdom/epidemiology
2.
Br J Surg ; 105(9): 1135-1144, 2018 08.
Article in English | MEDLINE | ID: mdl-30461007

ABSTRACT

BACKGROUND: The aim of this study was to develop a 48-h mortality risk score, which included morphology data, for patients with ruptured abdominal aortic aneurysm presenting to an emergency department, and to assess its predictive accuracy and clinical effectiveness in triaging patients to immediate aneurysm repair, transfer or palliative care. METHODS: Data from patients in the IMPROVE (Immediate Management of the Patient With Ruptured Aneurysm: Open Versus Endovascular Repair) randomized trial were used to develop the risk score. Variables considered included age, sex, haemodynamic markers and aortic morphology. Backwards selection was used to identify relevant predictors. Predictive performance was assessed using calibration plots and the C-statistic. Validation of the newly developed and other previously published scores was conducted in four external populations. The net benefit of treating patients based on a risk threshold compared with treating none was quantified. RESULTS: Data from 536 patients in the IMPROVE trial were included. The final variables retained were age, sex, haemoglobin level, serum creatinine level, systolic BP, aortic neck length and angle, and acute myocardial ischaemia. The discrimination of the score for 48-h mortality in the IMPROVE data was reasonable (C-statistic 0·710, 95 per cent c.i. 0·659 to 0·760), but varied in external populations (from 0·652 to 0·761). The new score outperformed other published risk scores in some, but not all, populations. An 8 (95 per cent c.i. 5 to 11) per cent improvement in the C-statistic was estimated compared with using age alone. CONCLUSION: The assessed risk scores did not have sufficient accuracy to enable potentially life-saving decisions to be made regarding intervention. Focus should therefore shift to offering repair to more patients and reducing non-intervention rates, while respecting the wishes of the patient and family.


Subject(s)
Aortic Aneurysm, Abdominal/mortality , Aortic Rupture/mortality , Decision Support Techniques , Endovascular Procedures/methods , Palliative Care/methods , Risk Assessment/methods , Aged , Aortic Aneurysm, Abdominal/surgery , Aortic Rupture/surgery , Female , Follow-Up Studies , Hospital Mortality/trends , Humans , Male , ROC Curve , Retrospective Studies , Risk Factors , Survival Rate/trends , Time Factors , Treatment Outcome , United Kingdom/epidemiology
3.
Br J Surg ; 104(12): 1656-1664, 2017 Nov.
Article in English | MEDLINE | ID: mdl-28745403

ABSTRACT

BACKGROUND: The UK abdominal aortic aneurysm (AAA) screening programmes currently invite only men for screening because the benefit in women is uncertain. Perioperative risk is critical in determining the effectiveness of screening, and contemporary estimates of these risks in women are lacking. The aim of this study was to compare mortality following AAA repair between women and men in the UK. METHODS: Anonymized data from the UK National Vascular Registry (NVR) for patients undergoing AAA repair (January 2010 to December 2014) were analysed. Co-variables were extracted for analysis by sex. The primary outcome measure was in-hospital mortality. Secondary outcome measures included mortality by 5-year age groups and duration of hospital stay. Logistic regression was performed to adjust for age, calendar time, AAA diameter and smoking status. NVR-based outcomes were checked against Hospital Episode Statistics (HES) data. RESULTS: A total of 23 245 patients were included (13·0 per cent women). Proportionally, more women than men underwent open repair. For elective open AAA repair, the in-hospital mortality rate was 6·9 per cent in women and 4·0 per cent in men (odds ratio (OR) 1·48, 95 per cent c.i. 1·08 to 2·02; P = 0·014), whereas for elective endovascular AAA repair it was 1·8 per cent in women and 0·7 per cent in men (OR 2·86, 1·72 to 4·74; P < 0·001); the results in HES were similar. For ruptured AAA, there was no sex difference in mortality within the NVR; however, in HES, for ruptured open AAA repair, the in-hospital mortality rate was higher in women (33·6 versus 27·1 per cent; OR 1·36, 1·16 to 1·59; P < 0·001). CONCLUSION: Women have a higher in-hospital mortality rate than men after elective AAA repair even after adjustment. This higher mortality may have an impact on the benefit offered by any screening programme offered to women.


Subject(s)
Aortic Aneurysm, Abdominal/mortality , Aortic Aneurysm, Abdominal/surgery , Hospital Mortality , Age Factors , Aortic Rupture/mortality , Aortic Rupture/surgery , Elective Surgical Procedures/mortality , Endovascular Procedures/mortality , Female , Humans , Length of Stay , Male , Registries , United Kingdom/epidemiology
4.
Br J Surg ; 103(9): 1097-104, 2016 Aug.
Article in English | MEDLINE | ID: mdl-27346306

ABSTRACT

BACKGROUND: Although women represent an increasing proportion of those presenting with abdominal aortic aneurysm (AAA) rupture, the current prevalence of AAA in women is unknown. The contemporary population prevalence of screen-detected AAA in women was investigated by both age and smoking status. METHODS: A systematic review was undertaken of studies screening for AAA, including over 1000 women, aged at least 60 years, done since the year 2000. Studies were identified by searching MEDLINE, Embase and CENTRAL databases until 13 January 2016. Study quality was assessed using the Newcastle-Ottawa scoring system. RESULTS: Eight studies were identified, including only three based on population registers. The largest studies were based on self-purchase of screening. Altogether 1 537 633 women were screened. Overall AAA prevalence rates were very heterogeneous, ranging from 0·37 to 1·53 per cent: pooled prevalence 0·74 (95 per cent c.i. 0·53 to 1·03) per cent. The pooled prevalence increased with both age (more than 1 per cent for women aged over 70 years) and smoking (more than 1 per cent for ever smokers and over 2 per cent in current smokers). CONCLUSION: The current population prevalence of screen-detected AAA in older women is subject to wide demographic variation. However, in ever smokers and those over 70 years of age, the prevalence is over 1 per cent.


Subject(s)
Aortic Aneurysm, Abdominal/epidemiology , Mass Screening , Adult , Age Factors , Aged , Aged, 80 and over , Aortic Aneurysm, Abdominal/diagnosis , Aortic Aneurysm, Abdominal/etiology , China/epidemiology , Europe/epidemiology , Female , Humans , Middle Aged , Prevalence , Risk Factors , Smoking/adverse effects , United States/epidemiology
5.
Br J Surg ; 101(6): 623-31, 2014 May.
Article in English | MEDLINE | ID: mdl-24664537

ABSTRACT

BACKGROUND: A number of published economic evaluations of elective endovascular aneurysm repair (EVAR) versus open repair for abdominal aortic aneurysm (AAA) have come to differing conclusions about whether EVAR is cost-effective. This paper reviews the current evidence base and presents up-to-date cost-effectiveness analyses in the light of results of four randomized clinical trials: EVAR-1, DREAM, OVER and ACE. METHODS: Markov models were used to estimate lifetime costs from a UK perspective and quality-adjusted life-years (QALYs) based on the results of each of the four trials. The outcomes included in the model were: procedure costs, surveillance costs, reintervention costs, health-related quality of life, aneurysm-related mortality and other-cause mortality. Alternative scenarios about complications, reinterventions and deaths beyond the trial were explored. RESULTS: Models based on the results of the EVAR-1, DREAM or ACE trials did not find EVAR to be cost-effective at thresholds used in the UK (up to £30,000 per QALY). EVAR seemed cost-effective according to models based on the OVER trial. These results seemed robust to alternative model scenarios about events beyond the trial intervals. CONCLUSION: These analyses did not find that EVAR is cost-effective compared with open repair in the long term in trials conducted in European centres. EVAR did appear to be cost-effective based on the OVER trial, conducted in the USA. Caution must be exercised when transferring the results of economic evaluations from one country to another.


Subject(s)
Aortic Aneurysm, Abdominal/economics , Endovascular Procedures/economics , Aged , Aortic Aneurysm, Abdominal/mortality , Aortic Aneurysm, Abdominal/surgery , Cost-Benefit Analysis , Endovascular Procedures/mortality , Female , Hospital Costs , Humans , Male , Markov Chains , Postoperative Care/methods , Quality of Life , Quality-Adjusted Life Years , Randomized Controlled Trials as Topic , Survival Analysis , Treatment Outcome
6.
Br J Surg ; 101(8): 976-82, 2014 Jul.
Article in English | MEDLINE | ID: mdl-24862963

ABSTRACT

BACKGROUND: Implementation of the National Health Service abdominal aortic aneurysm (AAA) screening programme (NAAASP) for men aged 65 years began in England in 2009. An important element of the evidence base supporting its introduction was the economic modelling of the long-term cost-effectiveness of screening, which was based mainly on 4-year follow-up data from the Multicentre Aneurysm Screening Study (MASS) randomized trial. Concern has been expressed about whether this conclusion of cost-effectiveness still holds, given the early performance parameters, particularly the lower prevalence of AAA observed in NAAASP. METHODS: The existing published model was adjusted and updated to reflect the current best evidence. It was recalibrated to mirror the 10-year follow-up data from MASS; the main cost parameters were re-estimated to reflect current practice; and more robust estimates of AAA growth and rupture rates from recent meta-analyses were incorporated, as were key parameters as observed in NAAASP (attendance rates, AAA prevalence and size distributions). RESULTS: The revised and updated model produced estimates of the long-term incremental cost-effectiveness of £5758 (95 per cent confidence interval £4285 to £7410) per life-year gained, or £7370 (£5467 to £9443) per quality-adjusted life-year (QALY) gained. CONCLUSION: Although the updated parameters, particularly the increased costs and lower AAA prevalence, have increased the cost per QALY, the latest modelling provides evidence that AAA screening as now being implemented in England is still highly cost-effective.


Subject(s)
Aortic Aneurysm, Abdominal/economics , Aortic Rupture/economics , State Medicine/economics , Aortic Aneurysm, Abdominal/diagnostic imaging , Aortic Aneurysm, Abdominal/prevention & control , Aortic Rupture/diagnostic imaging , Aortic Rupture/prevention & control , Cost-Benefit Analysis , Early Diagnosis , England , Humans , Male , Mass Screening/economics , Models, Economic , Quality-Adjusted Life Years , Ultrasonography
7.
Br J Surg ; 101(3): 216-24; discussion 224, 2014 Feb.
Article in English | MEDLINE | ID: mdl-24469620

ABSTRACT

BACKGROUND: Single-centre series of the management of patients with ruptured abdominal aortic aneurysm (AAA) are usually too small to identify clinical factors that could improve patient outcomes. METHODS: IMPROVE is a pragmatic, multicentre randomized clinical trial in which eligible patients with a clinical diagnosis of ruptured aneurysm were allocated to a strategy of endovascular aneurysm repair (EVAR) or to open repair. The influences of time and manner of hospital presentation, fluid volume status, type of anaesthesia, type of endovascular repair and time to aneurysm repair on 30-day mortality were investigated according to a prespecified plan, for the subgroup of patients with a proven diagnosis of ruptured or symptomatic AAA. Adjustment was made for potential confounding factors. RESULTS: Some 558 of 613 randomized patients had a symptomatic or ruptured aneurysm: diagnostic accuracy was 91·0 per cent. Patients randomized outside routine working hours had higher operative mortality (adjusted odds ratio (OR) 1·47, 95 per cent confidence interval 1·00 to 2·17). Mortality rates after primary and secondary presentation were similar. Lowest systolic blood pressure was strongly and independently associated with 30-day mortality (51 per cent among those with pressure below 70 mmHg). Patients who received EVAR under local anaesthesia alone had greatly reduced 30-day mortality compared with those who had general anaesthesia (adjusted OR 0·27, 0·10 to 0·70). CONCLUSION: These findings suggest that the outcome of ruptured AAA might be improved by wider use of local anaesthesia for EVAR and that a minimum blood pressure of 70 mmHg is too low a threshold for permissive hypotension.


Subject(s)
Aortic Aneurysm, Abdominal/surgery , Aortic Rupture/surgery , Endovascular Procedures/methods , After-Hours Care/statistics & numerical data , Aged , Aged, 80 and over , Aortic Aneurysm, Abdominal/mortality , Aortic Rupture/mortality , Blood Pressure/physiology , Endovascular Procedures/mortality , Female , Fluid Therapy/statistics & numerical data , Health Facility Size/statistics & numerical data , Humans , Male , Middle Aged , Patient Transfer/statistics & numerical data , Preoperative Care/statistics & numerical data
8.
Eur J Vasc Endovasc Surg ; 46(2): 171-2, 2013 Aug.
Article in English | MEDLINE | ID: mdl-23683395

ABSTRACT

Different national screening programmes use a variety of surveillance intervals for patients identified with small abdominal aortic aneurysm. An individual patient meta-analysis of >15000 persons with small aneurysm has provided a strong scientific basis for safe surveillance frequency. In many screening programmes the number of surveillance visits for men could be reduced by up to half. The higher rate of aneurysm rupture in women leads to different recommendation for women.


Subject(s)
Aortic Aneurysm, Abdominal/diagnosis , Mass Screening/methods , Watchful Waiting , Aortic Aneurysm, Abdominal/complications , Aortic Aneurysm, Abdominal/therapy , Aortic Rupture/etiology , Aortic Rupture/prevention & control , Disease Progression , Female , Humans , Male , Meta-Analysis as Topic , Predictive Value of Tests , Prognosis , Risk Assessment , Risk Factors , Sex Factors , Time Factors
9.
Br J Surg ; 99(5): 655-65, 2012 May.
Article in English | MEDLINE | ID: mdl-22389113

ABSTRACT

BACKGROUND: Surveillance is a common management strategy for small abdominal aortic aneurysm (AAA) (3.0-5.4 cm in diameter). Individual characteristics, other than diameter, may influence aneurysm growth or rupture rates. METHODS: Individual data were collated from 15 475 people under follow-up for a small aneurysm in 18 studies. The influence of co-variables (including demographics, medical and drug history) on aneurysm growth and rupture rates (analysed using longitudinal random-effects modelling and survival analysis with adjustment for aneurysm diameter) were summarized in an individual patient meta-analysis. RESULTS: The mean aneurysm growth rate of 2.21 mm/year was independent of age and sex. Growth rate was increased in smokers (by 0.35 mm/year) and decreased in patients with diabetes (by 0.51 mm/year). Mean arterial pressure had no effect and antihypertensive or other cardioprotective medications had only small, non-significant effects on aneurysm growth, consistent with the observation that calendar year of enrollment was not associated with growth rate. Rupture rates were almost fourfold higher in women than men (P < 0.001), were double in current smokers (P = 0.001) and increased with higher blood pressure (P = 0.001). CONCLUSION: Follow-up schedules for individuals with a small AAA may need to consider diabetes and smoking, in addition to aneurysm diameter. The differing risk factors for growth and rupture suggest that a lower threshold for surgical intervention in women may be justified. No single drug used for cardiovascular risk reduction had a major effect on the growth or rupture of small aneurysms.


Subject(s)
Aortic Aneurysm, Abdominal/pathology , Aortic Rupture/pathology , Aged , Aortic Aneurysm, Abdominal/epidemiology , Aortic Rupture/epidemiology , Cardiovascular Agents/therapeutic use , Diabetes Mellitus/pathology , Female , Humans , Male , Prevalence , Risk Factors , Smoking/pathology
10.
Br J Surg ; 99(12): 1649-56, 2012 Dec.
Article in English | MEDLINE | ID: mdl-23034729

ABSTRACT

BACKGROUND: The long-term effects of abdominal aortic aneurysm (AAA) screening were investigated in extended follow-up from the UK Multicentre Aneurysm Screening Study (MASS) randomized trial. METHODS: A population-based sample of men aged 65-74 years were randomized individually to invitation to ultrasound screening (invited group) or to a control group not offered screening. Patients with an AAA (3·0 cm or larger) detected at screening underwent surveillance and were offered surgery after predefined criteria had been met. Cause-specific mortality data were analysed using Cox regression. RESULTS: Some 67 770 men were enrolled in the study. Over 13 years, there were 224 AAA-related deaths in the invited group and 381 in the control group, a 42 (95 per cent confidence interval 31 to 51) per cent reduction. There was no evidence of effect on other causes of death, but there was an overall reduction in all-cause mortality of 3 (1 to 5) per cent. The degree of benefit seen in earlier years of follow-up was slightly diminished by the occurrence of AAA ruptures in those with an aorta originally screened normal. About half of these ruptures had a baseline aortic diameter in the range 2·5-2·9 cm. It was estimated that 216 men need to be invited to screening to save one death over the next 13 years. CONCLUSION: Screening resulted in a reduction in all-cause mortality, and the benefit in AAA-related mortality continued to accumulate throughout follow-up. REGISTRATION NUMBER: ISRCTN37381646 (http://www.controlled-trials.com).


Subject(s)
Aortic Aneurysm, Abdominal/mortality , Aortic Rupture/mortality , Aged , Aortic Aneurysm, Abdominal/diagnosis , Aortic Aneurysm, Abdominal/surgery , Aortic Rupture/diagnosis , Aortic Rupture/surgery , Cause of Death , Early Diagnosis , Follow-Up Studies , Humans , Male
11.
Br J Surg ; 98(7): 935-42, 2011 Jul.
Article in English | MEDLINE | ID: mdl-21484775

ABSTRACT

BACKGROUND: The aim was to compare rates of myocardial infarction, stroke and cardiovascular death in patients with a large abdominal aortic aneurysm who had endovascular (EVAR) or open repair to determine whether cardiovascular mortality explains the convergence in survival curves after these procedures. METHODS: Between 1999 and 2004, 1252 patients were randomized to EVAR or open repair in the UK EVAR trial 1. All patients were followed for death, myocardial infarction or stroke until September 2009. Cox regression was used to compare cardiovascular events and deaths between the randomized groups during different time intervals. RESULTS: Over 5 years of follow-up, a total of 187 first non-fatal or fatal cardiovascular events (98 myocardial infarctions and 89 strokes) and 256 cardiovascular deaths occurred. Although the endovascular group had a lower cardiovascular event rate than the open repair group (2·6 versus 3·2 per 100 person-years respectively) this was not statistically significant (adjusted hazard ratio (HR) 0·83, 95 per cent confidence interval 0·62 to 1·10; P = 0·199). Overall, there was little difference in cardiovascular mortality between the randomized groups (adjusted HR 1·06, 0·83 to 1·36; P = 0·638), but a non-significant excess of cardiovascular deaths was apparent in the endovascular group during the 6-24-month interval (adjusted HR 1·44, 0·79 to 2·62; P = 0·237). CONCLUSION: Patients who had EVAR appeared to have a lower subsequent cardiovascular event rate during all time intervals. Cardiovascular mortality was similar between the two groups overall, but more cardiovascular deaths in the EVAR group appeared to contribute to the convergence in all-cause mortality during the first 2 years.


Subject(s)
Aortic Aneurysm, Abdominal/surgery , Endovascular Procedures/mortality , Myocardial Infarction/etiology , Postoperative Complications/etiology , Stroke/etiology , Aged , Aortic Aneurysm, Abdominal/mortality , Female , Humans , Kaplan-Meier Estimate , Male , Middle Aged , Myocardial Infarction/mortality , Postoperative Complications/mortality , Stroke/mortality
12.
Br J Surg ; 98(5): 609-18, 2011 May.
Article in English | MEDLINE | ID: mdl-21412998

ABSTRACT

BACKGROUND: Small abdominal aortic aneurysms are usually asymptomatic and managed safely in ultrasound surveillance programmes until they grow to a diameter threshold where intervention is considered. The aim of this study was to synthesize systematically the published data on growth rates for small aneurysms to investigate the evidence basis for surveillance intervals. METHODS: This was a systematic review of the literature published before January 2010, which identified 61 potentially eligible reports. Detailed review yielded 15 studies providing growth rates for aneurysms 3·0-5·5 cm in diameter (14 in millimetres per year, 1 as percentage change per year). These studies included 7630 people (predominantly men) enrolled during 1976-2005. RESULTS: The pooled mean growth rate was 2·32 (95 per cent confidence interval 1·95 to 2·70) mm/year but there was very high heterogeneity between studies; the growth rate ranged from - 0·33 to + 3·95 mm/year. Six studies reported growth rates by 5-mm diameter bands, which showed the trend for growth rate to increase with aneurysm diameter. Simple methods to determine growth rate were associated with higher estimates. Meta-regression analysis showed that a 10-mm increase in aneurysm diameter was associated with a mean(s.e.m.) 1·62(0·20) mm/year increase in growth rate. Neither mean age nor percentage of women in each study had a significant effect. On average, a 3·5-cm aneurysm would take 6·2 years to reach 5·5 cm, whereas a 4·5-cm aneurysm would take only 2·3 years. CONCLUSION: There was considerable variation in the reported growth rates of small aneurysms beyond that explained by aneurysm diameter. Fuller evidence on which to base surveillance intervals for patients in screening programmes requires a meta-analysis based on individual patient data.


Subject(s)
Aortic Aneurysm, Abdominal/pathology , Aged , Aortic Aneurysm, Abdominal/etiology , Female , Humans , Male , Middle Aged , Prospective Studies , Randomized Controlled Trials as Topic
13.
Eur J Vasc Endovasc Surg ; 41(1): 2-10, 2011 Jan.
Article in English | MEDLINE | ID: mdl-20952216

ABSTRACT

BACKGROUND: Small aneurysms of the abdominal aorta (3.0-5.5 cm in diameter) often are managed by regular surveillance, rather than surgery, because the risk of surgery is considered to outweigh the risk of aneurysm rupture. The risk of small aneurysm rupture is considered to be low. The purpose of this review is to summarise the reported estimates of small aneurysm rupture rates. METHODS AND FINDINGS: We conducted a systematic review of the literature published before 2010 and identified 54 potentially eligible reports. Detailed review of these studies showed that both ascertainment of rupture, patient follow-up and causes of death were poorly reported: diagnostic criteria for rupture were never reported. There were only 14 studies from which rupture rates (as ruptures per 100 person-years) were available. These 14 published studies included 9779 patients (89% male) over the time period 1976-2006 but only 7 of these studies provided rupture rates specifically for the diameter range 3.0-5.5 cm, which ranged from 0 to 1.61 ruptures per 100 person-years. CONCLUSIONS: Rupture rates of small abdominal aortic aneurysms would appear to be low, but most studies have been poorly reported and did not have clear ascertainment and diagnostic criteria for aneurysm rupture.


Subject(s)
Aortic Aneurysm, Abdominal/epidemiology , Aortic Aneurysm, Abdominal/pathology , Aortic Rupture/epidemiology , Humans , Research Design , Risk Assessment
14.
Br J Surg ; 97(8): 1207-17, 2010 Aug.
Article in English | MEDLINE | ID: mdl-20602502

ABSTRACT

BACKGROUND: It is uncertain which baseline factors are associated with graft-related complications and reinterventions after endovascular aneurysm repair (EVAR) in patients with a large abdominal aortic aneurysm. METHODS: Patients randomized to elective EVAR in EVAR Trial 1 or 2 were followed for serious graft-related complications (type 2 endoleaks excluded) and reinterventions. Cox regression analysis was used to investigate whether any prespecified baseline factors were associated with time to first serious complication or reintervention. RESULTS: A total of 756 patients who had elective EVAR were followed for a mean of 3.7 years, by which time there were 179 serious graft complications (rate 6.5 per 100 person years) and 114 reinterventions (rate 3.8 per 100 person years). The highest rate was during the first 6 months, with an apparent increase again after 2 years. Multivariable analysis indicated that graft-related complications increased significantly with larger initial aneurysm diameter (P < 0.001) and older age (P = 0.040). There was also evidence that patients with larger common iliac diameters experienced higher complication rates (P = 0.011). CONCLUSION: Graft-related complication and reintervention rates were common after EVAR in patients with a large aneurysm. Younger patients and those with aneurysms closer to the 5.5-cm threshold for intervention experienced lower rates.


Subject(s)
Aortic Aneurysm, Abdominal/surgery , Blood Vessel Prosthesis Implantation , Blood Vessel Prosthesis , Postoperative Complications/etiology , Adult , Aged , Aortic Aneurysm, Abdominal/mortality , Aortic Aneurysm, Abdominal/pathology , Elective Surgical Procedures , Endarterectomy/methods , Endarterectomy/mortality , Female , Graft Survival , Humans , Kaplan-Meier Estimate , Male , Middle Aged , Reoperation
15.
Stat Med ; 29(12): 1298-311, 2010 May 30.
Article in English | MEDLINE | ID: mdl-20209660

ABSTRACT

Genetic markers can be used as instrumental variables, in an analogous way to randomization in a clinical trial, to estimate the causal relationship between a phenotype and an outcome variable. Our purpose is to extend the existing methods for such Mendelian randomization studies to the context of multiple genetic markers measured in multiple studies, based on the analysis of individual participant data. First, for a single genetic marker in one study, we show that the usual ratio of coefficients approach can be reformulated as a regression with heterogeneous error in the explanatory variable. This can be implemented using a Bayesian approach, which is next extended to include multiple genetic markers. We then propose a hierarchical model for undertaking a meta-analysis of multiple studies, in which it is not necessary that the same genetic markers are measured in each study. This provides an overall estimate of the causal relationship between the phenotype and the outcome, and an assessment of its heterogeneity across studies. As an example, we estimate the causal relationship of blood concentrations of C-reactive protein on fibrinogen levels using data from 11 studies. These methods provide a flexible framework for efficient estimation of causal relationships derived from multiple studies. Issues discussed include weak instrument bias, analysis of binary outcome data such as disease risk, missing genetic data, and the use of haplotypes.


Subject(s)
Bayes Theorem , Meta-Analysis as Topic , Biostatistics , C-Reactive Protein/genetics , C-Reactive Protein/metabolism , Fibrinogen/metabolism , Genetic Markers , Humans , Models, Statistical , Phenotype , Polymorphism, Single Nucleotide
16.
Eur J Vasc Endovasc Surg ; 39(4): 396-402, 2010 Apr.
Article in English | MEDLINE | ID: mdl-20096611

ABSTRACT

OBJECTIVES: To investigate whether endovascular aneurysm repair (EVAR) influences the rate of cardiovascular events (fatal or non-fatal myocardial infarction or stroke) in patients with abdominal aortic aneurysm (AAA) considered unfit for open repair. DESIGN: Randomised controlled trial. MATERIALS: Between 1999 and 2004, 404 patients with large AAA considered unfit for open repair were randomised to EVAR or no surgical intervention across 33 UK hospitals and followed until July 2009. METHODS: The Customised Probability Index was used to determine fitness for each patient and Cox regression was used to compare time to first cardiovascular event between randomised groups and levels of fitness. RESULTS: During an average of 2.8 years of follow-up, 67 first cardiovascular events occurred with a non-significantly higher event rate in the EVAR group compared to the no intervention group (6.6 versus 5.1 events per 100 person years); adjusted hazard ratio 1.42 [95% CI 0.87-2.34], p=0.156. There was no evidence to suggest that the hazard ratio between randomised groups changed with level of fitness (p=0.378). CONCLUSIONS: Cardiovascular event rates were high in these unfit patients and medical therapy was sub-optimal. Events rates were slightly higher in the EVAR group but this was not statistically significant.


Subject(s)
Aortic Aneurysm, Abdominal/surgery , Blood Vessel Prosthesis Implantation/adverse effects , Myocardial Infarction/etiology , Stroke/etiology , Aged , Aged, 80 and over , Aortic Aneurysm, Abdominal/diagnostic imaging , Aortic Aneurysm, Abdominal/mortality , Aortography/methods , Blood Vessel Prosthesis Implantation/mortality , Chi-Square Distribution , Female , Humans , Kaplan-Meier Estimate , Male , Myocardial Infarction/mortality , Patient Selection , Proportional Hazards Models , Risk Assessment , Risk Factors , Severity of Illness Index , Stroke/mortality , Time Factors , Tomography, X-Ray Computed , Treatment Outcome , United Kingdom
17.
Science ; 151(3710): 562-8, 1966 Feb 04.
Article in English | MEDLINE | ID: mdl-17809494

ABSTRACT

Solid-state devices developed primarily for nuclear gamma spectroscopy have many potential uses in x-ray analysis.

18.
Acta Chir Belg ; 109(6): 678-80, 2009.
Article in English | MEDLINE | ID: mdl-20184048

ABSTRACT

BACKGROUND: Systematic reviews have suggested a survival advantage for patients with ruptured abdominal aortic aneurysm (AAA), who are managed by endovascular repair. These reviews are based on single centre experiences of selected patients. OBJECTIVE: To determine whether a policy of endovascular repair improves the survival of all patients with ruptured AAA. METHODS: A randomized controlled trial, IMPROVE (ISRCTN 48334791) will randomize patients with a clinical diagnosis of rAAA, made in hospital, either to immediate CT scan and endovascular repair whenever anatomically suitable (endovascular first), or to open repair, with CT scan being optional (normal care), The trial is set on a background of guidelines for emergency care, CT scanning and anaesthesia, which incorporate the protocol of permissive hypotension. Recruitment started in October 2009 and 600 patients are required to show a 14% survival benefit at 30 days (primary outcome) for the endovascular first policy. Recruitment will be from the UK and Europe. Secondary outcomes include 24h, in-hospital and 1 year survival, complications, major morbidities, costs and quality of life. DISCUSSION: This is a "real life" trial that will answer the fundamental relevant clinical dilemma, namely, do patients who present with ruptured AAA derive benefit from treatment in a system, which offers a preferential strategy of endovascular repair? The trial addresses whether the anticipated reduced mortality and morbidity associated with endovascular repair is offset by the relatively greater ease of access and speed to conventional surgery. This issue is pivotal to future patient care and provision of services.


Subject(s)
Aortic Aneurysm, Abdominal/mortality , Aortic Aneurysm, Abdominal/surgery , Blood Vessel Prosthesis Implantation/mortality , Hospital Mortality , Humans , Research Design , Treatment Outcome , Vascular Surgical Procedures
20.
Br J Surg ; 95(2): 183-90, 2008 Feb.
Article in English | MEDLINE | ID: mdl-17876749

ABSTRACT

BACKGROUND: Recent randomized trials have shown that endovascular abdominal aortic aneurysm repair (EVAR) has a 3 per cent aneurysm-related survival benefit in patients fit for open surgery, but it also has uncertain long-term outcomes and higher costs. This study assessed the cost-effectiveness of EVAR. METHODS: A decision model was constructed to estimate the lifetime costs and quality-adjusted life years (QALYs) with EVAR and open repair in men aged 74 years. The model includes the risks of death from aneurysm, other cardiovascular and non-cardiovascular causes, secondary reinterventions and non-fatal cardiovascular events. Data were taken largely from the EVAR trial 1 and supplemented from other sources. RESULTS: Under the base-case (primary) assumptions, EVAR cost 3800 pounds sterling (95 per cent confidence interval (c.i.) 2400 pounds sterling to 5200 pounds sterling) more per patient than open repair but produced fewer lifetime QALYs (mean -0.020 (95 per cent c.i. -0.189 to 0.165)). These results were sensitive to alternative model assumptions. CONCLUSION: EVAR is unlikely to be cost-effective on the basis of existing devices, costs and evidence, but there remains considerable uncertainty.


Subject(s)
Aortic Aneurysm, Abdominal/surgery , Endoscopy/economics , Aged , Aortic Aneurysm, Abdominal/economics , Aortic Aneurysm, Abdominal/mortality , Cost-Benefit Analysis , Decision Support Techniques , Disease-Free Survival , Endoscopy/mortality , Humans , Male , Models, Economic , Quality-Adjusted Life Years , Randomized Controlled Trials as Topic , Risk Factors
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