Quality of life from a randomized trial of open and endovascular repair for abdominal aortic aneurysm.

BACKGROUND: Long-term survival is similar after open or endovascular repair of abdominal aortic aneurysm. Few data exist on the effect of either procedure on long-term health-related quality of life (HRQoL) and health status. METHODS: Patients enrolled in a multicentre randomized clinical trial (DREAM trial; 2000-2003) in Europe of open repair versus endovascular repair (EVAR) of abdominal aortic aneurysm were asked to complete questionnaires on health status and HRQoL. HRQoL scores were assessed at baseline and at 13 time points thereafter, using generic tools, the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36®) and EuroQol 5D (EQ-5D™). Physical (PCS) and mental component summary scores were also calculated. Follow-up was 5 years. RESULTS: Some 332 of 351 patients enrolled in the trial returned questionnaires. More than 70 per cent of questionnaires were returned at each time point. Both surgical interventions had a short-term negative effect on HRQoL and health status. This was less severe in the EVAR group than in the open repair group. In the longer term the physical domains of SF-36® favoured open repair: mean difference in PCS score between open repair and EVAR -1·98 (95 per cent c.i. -3·56 to -0·41). EQ-5D™ descriptive and EQ-5D™ visual analogue scale scores for open repair were also superior to those for EVAR after the initial 6-week interval: mean difference -0·06 (-0·10 to -0·02) and -4·09 (-6·91 to -1·27) respectively. CONCLUSION: In this study EVAR appeared to be associated with less severe disruption to HRQoL and health status in the short term. However, during longer-term follow-up to 5 years, patients receiving open repair appeared to have improved quality of life and health status.

Renal function 5 years after open and endovascular aortic aneurysm repair from a randomized trial.

BACKGROUND: Deterioration of renal function after major vascular surgery is an important complication, and may vary between patients undergoing endovascular (EVAR) or open surgical (OR) repair of an abdominal aortic aneurysm (AAA). The objective was to determine the impact of OR and EVAR on renal function after 5 years. METHODS: This was a post hoc analysis of data collected prospectively from the Dutch Randomized Endovascular Aneurysm Management (DREAM) trial. Five years after surgery, creatinine levels were available for 189 patients (94 after OR and 95 after EVAR). The severity of renal disease was staged using the chronic kidney disease classification of the US National Kidney Foundation clinical guidelines. RESULTS: Using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation, the estimated glomerular filtration rate (eGFR) for the entire group declined over time, with a mean(s.d.) preoperative value of 80·0(7·6) ml per min per 1·73 m(2) compared with 75·7(9·7) ml per min per 1·73 m(2) after 5 years (mean difference 4·2 (95 per cent confidence interval 3·2 to 5·3) ml per min per 1·73 m(2) ; P < 0·001). Five years after surgery, the mean eGFR (CKD-EPI equation) was not significantly different between the OR and EVAR groups: 76·3(9·3) versus 75·1(10·0) ml per min per 1·73 m(2) (mean difference 1·2 (-1·6 to 3·9) ml per min per 1·73 m(2) ; P = 0·410). CONCLUSION: Renal function 5 years after OR and EVAR for AAA was similar. Neither surgical procedure accelerated the loss of renal function.

Residual infrarenal aortic neck following endovascular and open aneurysm repair.

BACKGROUND: The effectiveness of open and endovascular aneurysm repair of aortic abdominal aneurysms (AAAs) can be jeopardised by deterioration of the residual infrarenal neck of the aneurysm. OBJECTIVE: The study aims to determine the length of the residual infrarenal aortic segment after endovascular and open aneurysm repair. METHODS: In a multicentre randomised controlled trial comparing open and endovascular AAA repair, 165 patients were discharged after open AAA repair (OR) and 169 after endovascular repair (EVAR). Immediately after the operation, surgeons were asked to enter in the case record form whether the level of their anastomosis after open repair was within or beyond 10 mm of the caudal renal artery. Postoperative computed tomography (CT) scans that were obtained within 6 months after surgery were used for comparative analysis. The distance between the caudal renal artery and the proximal anastomosis of the (endo-) graft was measured using axial CT slices and a standardised protocol. CT images were available and suitable for analysis in 156 (95%) of 165 OR patients and in 160 (95%) of 169 EVAR patients. Data are presented as median (range). Differences were analysed using the Mann-Whitney test. RESULTS: The distance from the caudal renal artery to the proximal anastomosis was 24 mm (16-30 mm) in the OR group versus 0 mm (0-6 mm) in the EVAR group (p < 0.0001, Mann-Whitney). In 140 of 156 (90%) patients, at least 1 cm of untreated infrarenal neck persisted after OR and in 17 of 160 (10%) after EVAR. In 84 of the 156 open repair patients (54%), the surgeon had indicated that the proximal anastomosis was within 10 mm of the caudal renal artery. Only five surgeons (6%) were accurate in this respect. CONCLUSION: After open repair, a longer segment of the infrarenal aortic neck is left untreated compared with endovascular repair and this length is underestimated by most surgeons. Long-term studies are required to determine the consequences of this difference.

The impact of endovascular treatment on in-hospital mortality following non-ruptured AAA repair over a decade: a population based study of 16,446 patients.

OBJECTIVES: We hypothesised that over the past decade, the nation-wide outcome of infrarenal abdominal aortic aneurysm (AAA) repair has improved with the introduction of endovascular treatment. The aim of the study was to identify endovascularly-treated patients in a national registry and to assess the impact on in-hospital mortality of non-ruptured AAA repair, if any, after the introduction of endovascular repair. MATERIALS AND METHODS: We retrospectively studied the nation-wide outcome of non-ruptured AAA repair over the past decade. Variables studied were age and gender of the patients, hospital size and type and the year in which treatment was performed and the outcome on in-hospital mortality. The in-hospital mortality of non-ruptured AAA repair in 16,446 patients in the 10-year period from 1991 to 2000 was 7.3% (6.2-8.2%). In the 15,589 (95%) patients that underwent conventional treatment, in-hospital mortality was 7.6% (7.0-8.1%), whereas in the endovascular group it was 1.9% (0.6-3.5%). In the multivariate analysis, age and endovascular repair were the most important independent predictors of in-hospital mortality. CONCLUSION: With the limitations of a national registry aside, the introduction of endovascular aneurysm repair seems to have had a small but significant impact on in-hospital mortality following infrarenal AAA repair.

Quality of life endovascular and open AAA repair. Results of a randomised trial.

AIM: To compare the quality of life (QoL) in the first postoperative year after elective endovascular abdominal aortic aneurysm repair (EVAR) and open repair (OR) in a randomised study. METHODS: In the Dutch Randomised Endovascular Aneurysm Management (DREAM) trial, patients are randomly allocated to EVAR or OR. QoL questionnaires (SF-36 and EuroQoL-5D) were sent to all patients preoperatively (PREOP) and at five time points in the first postoperative year (3W, 6W, 3M, 6M and 12M). Between November 1999 and August 2002, 153 patients (141 male; 12 female) were randomised (78 EVAR and 75 OR; one crossover from OR to EVAR). The EuroQoL-5D scores and the eight domains of the SF-36 for the two groups were compared using the Mann-Whitney test. Changes over time were analysed using the Wilcoxon sign test. RESULTS: There were no statistically significant differences in baseline characteristics (age, gender and SVS risk factors). The preoperative QoL scores of the study group were similar to the QoL scores of the general population of the same age. After 3W the OR group showed a significant decrease on the EuroQol-5D (p=0.022) and in six of the eight SF-36 domains. The EVAR group also showed a significant decrease on the EuroQol-5D (p=0.004) and in 5 of the 8 domains of the SF-36. At 6W the EuroQol-5D had recovered to baseline in the OR group and the decreased domains of the SF-36 had partially recovered. In the EVAR group the EuroQol-5D and three of the five decreased SF-36 domains, had returned to baseline. From 6M on, the OR group reported a significantly higher score on the EuroQoL-5D than the EVAR group (p=0.045 (6M) and p=0.001 (12M)). CONCLUSION: In the early postoperative period there is a small, yet significant QoL advantage for EVAR compared to OR. At 6 months and beyond, patients reported better QoL after OR than after EVAR.

Decision-making in follow-up after endovascular aneurysm repair based on diameter and volume measurements: a blinded comparison.

OBJECTIVE: to assess whether volume, in addition to diameter, measurements facilitate decision-making after endovascular aneurysm repair (EVAR). MATERIAL/METHODS: patients (n = 82) with an immediately post-EVAR, and at least one follow-up (3-60 months), computed tomographic angiogram (CTA) were studied. The actual and all preceding proportional sac size changes were recorded. The resulting 347 diameter and 347 volume data were placed in random order and reviewed by three blinded observers who then recommended one of three treatment policies: "good/wait", "uncertain/intensify follow-up" or "not good/further diagnostics (Dx) or intervention (Rx)". The observers were instructed to consider changes of 10% relevant. One observer reviewed the graphs twice. RESULTS: the interobserver agreements (kappa) for the diameter were 0.92, 0.81 and 0.76 and for volumes 0.91, 0.88 and 0.86. The intra-observer agreement was 0.93 for both diameter and volume. Volume data resulted in significantly more "good/wait" decisions out to 36 months. Diameter data resulted in more "not good/Dx or Rx"-decisions out to 36 months (all p < 50.005). CONCLUSION: post-EVAR aneurysm sac volume data appears to provide earlier reassurance, reduce unnecessary interventions and to be more sensitive to secondary problems than diameter data alone.

The Dutch Randomised Endovascular Aneurysm Management (DREAM) trial. Background, design and methods.

After the introduction of endovascular repair of abdominal aortic aneurysms (AAA), both benefits and drawbacks of this new technique have been reported. To assess whether the new technique is an adequate substitute of conventional AAA repair, a randomised study is due. The Dutch Randomised Endovascular Aneurysm Management (DREAM) trial is a randomised multicenter trial enrolling patients eligible for elective treatment of infrarenal AAAs. In this study, the cost-effectiveness of endovascular aneurysm repair (EAR) is compared with that of conventional transabdominal surgery, in patients that are considered suitable for both types of treatment. The primary endpoint is combined operative mortality and morbidity. Secondary endpoints and additional assessments include event free survival, quality of life, length of hospital stay and costs. It is expected that the DREAM-trial will lead to a safe and controlled introduction of a new technology. Also, the medical community will obtain valid scientific evidence of the merits of endovascular AAA repair. Finally, policy makers will be provided with accurate cost-effectiveness data for the Dutch healthcare system. The aim of the present paper is to describe the background, methods and design of the DREAM-trial.

The sac shrinking process after EAR does not start immediately in most patients.

OBJECTIVE: the aim of this study was to determine the pattern of shrinkage after endovascular aneurysm repair (EAR) using logarithmic, exponential and linear models and to calculate a lag time is present. PATIENTS AND METHODS: patients with a complete CTA follow-up of 2 years and a primary shrinking aneurysm were included, resulting in a study group of 29 patients. Six functions, logarithmic, exponential and linear, all with and without lag time, were fitted to the thrombus volume obtained from measurements postoperative and after 6, 12 and 24 months. The correlation coefficient was used to determine the association between the calculated and measured values. A correlation coefficient >0.95 was considered a good fit. RESULTS: a logarithmic model produced the best fits. From the 29 patients, two patients could not be described by any model. The remaining 27 patients could be fitted using a logarithmic function with a correlation coefficient of >0.95 (median 0.99, range 0.95-1.00). Twenty-two of these patients had a lag time (median 63.4 days, range 5.8-252.3). Only five of the initial 44 patients (11%) showed immediate sac shrinkage. CONCLUSION: almost all shrinkage processes could be described by a logarithmic function. In over 75% of patients a lag time to shrinkage could be calculated. In only a small proportion did the shrinking process start immediately after EAR.

Concerns for the durability of the proximal abdominal aortic aneurysm endograft fixation from a 2-year and 3-year longitudinal computed tomography angiography study.

OBJECTIVE: To provide a long-term perspective on the durability of the proximal abdominal aortic aneurysm endograft fixation from a single device series with perpendicular neck measurements in two groups of patients with complete 2- and 3-year follow-up. DESIGN: This was a prospective study of postoperative, radiologic images. SETTING: The study used a referral center, institutional practice, and ambulatory patients. SUBJECTS: From January 1994 until May 1998, 37 endografts were implanted for abdominal aortic aneurysm. In the first postoperative year, there were four unrelated deaths and six conversions, leaving 27 patients with complete 24-month data and 13 with complete 36-month data. MAIN OUTCOME MEASURE: Computed tomography angiograms were processed on a work station to measure the neck perpendicular to the central lumen line of the aorta. The surface area at the proximal endovascular anastomosis was recorded at each follow-up interval and related to the postoperative size at the same level. RESULTS: Significant dilatation of the surface area was found: 20% (16% to 27%) at 24 months (c2 = 30; P < .001, Friedman) and 23% (18% to 28%) at 36 months (c2 = 27; P < .001, Friedman). This increase in neck size was continuous and linear, with a yearly rate of approximately 10% surface area; translated into diameter, this approximates 1 mm/y. CONCLUSION: A continuous aortic enlargement of approximately 1 mm/y at the level of the proximal endovascular anastomosis was found. Because of the practice of oversizing the endograft relative to the infrarenal aortic neck, a loss of the endovascular seal may not become apparent until several years after endovascular abdominal aortic aneurysm repair is performed.