Traitement endovasculaire des AAA- EndoVascular Aortic Replacement
1. (2005). "Endovascular aneurysm repair and outcome in patients unfit for open repair of abdominal aortic aneurysm (EVAR trial 2): randomised controlled trial." Lancet 365(9478): 2187-92.
BACKGROUND: Endovascular aneurysm repair (EVAR) to exclude abdominal aortic aneurysm (AAA) was introduced for patients of poor health status considered unfit for major surgery. We instigated EVAR trial 2 to identify whether EVAR improves survival compared with no intervention in patients unfit for open repair of aortic aneurysm. METHODS: We did a randomised controlled trial of 338 patients aged 60 years or older who had aneurysms of at least 5.5 cm in diameter and who had been referred to one of 31 hospitals in the UK. We assigned patients to receive either EVAR (n=166) or no intervention (n=172). Our primary endpoint was all-cause mortality, with secondary endpoints of aneurysm-related mortality, health-related quality of life (HRQL), postoperative complications, and hospital costs. Analyses were by intention to treat. FINDINGS: 197 patients underwent aneurysm repair (47 assigned no intervention) and 80% of patients adhered to protocol. The 30-day operative mortality in the EVAR group was 9% (13 of 150, 95% CI 5-15) and the no intervention group had a rupture rate of 9.0 per 100 person years (95% CI 6.0-13.5). By end of follow up 142 patients had died, 42 of aneurysm-related factors; overall mortality after 4 years was 64%. There was no significant difference between the EVAR group and the no intervention group for all-cause mortality (hazard ratio 1.21, 95% CI 0.87-1.69, p=0.25). There was no difference in aneurysm-related mortality. The mean hospital costs per patient over 4 years were UK pound sterling 13,632 in the EVAR group and pound sterling 4983 in the no intervention group (mean difference pound sterling 8649, SE 1248), with no difference in HRQL scores. INTERPRETATION: EVAR had a considerable 30-day operative mortality in patients already unfit for open repair of their aneurysm. EVAR did not improve survival over no intervention and was associated with a need for continued surveillance and reinterventions, at substantially increased cost. Ongoing follow-up and improved fitness of these patients is a priority.
2. (2005). "Endovascular aneurysm repair versus open repair in patients with abdominal aortic aneurysm (EVAR trial 1): randomised controlled trial." Lancet 365(9478): 2179-86.
BACKGROUND: Although endovascular aneurysm repair (EVAR) has a lower 30-day operative mortality than open repair, the long-term results of EVAR are uncertain. We instigated EVAR trial 1 to compare these two treatments in terms of mortality, durability, health-related quality of life (HRQL), and costs for patients with large abdominal aortic aneurysm (AAA). METHODS: We did a randomised controlled trial of 1082 patients aged 60 years or older who had aneurysms of at least 5.5 cm in diameter and who had been referred to one of 34 hospitals proficient in the EVAR technique. We assigned patients who were anatomically suitable for EVAR and fit for an open repair to EVAR (n=543) or open repair (n=539). Our primary endpoint was all-cause mortality, with secondary endpoints of aneurysm related mortality, HRQL, postoperative complications, and hospital costs. Analyses were by intention to treat. FINDINGS: 94% (1017 of 1082) of patients complied with their allocated treatment and 209 died by the end of follow-up on Dec 31, 2004 (53 of aneurysm-related causes). 4 years after randomisation, all-cause mortality was similar in the two groups (about 28%; hazard ratio 0.90, 95% CI 0.69-1.18, p=0.46), although there was a persistent reduction in aneurysm-related deaths in the EVAR group (4%vs 7%; 0.55, 0.31-0.96, p=0.04). The proportion of patients with postoperative complications within 4 years of randomisation was 41% in the EVAR group and 9% in the open repair group (4.9, 3.5-6.8, p<0.0001). After 12 months there was negligible difference in HRQL between the two groups. The mean hospital costs per patient up to 4 years were UK pound sterling 13,257 for the EVAR group versus pound sterling 9946 for the open repair group (mean difference pound sterling 3311, SE 690). INTERPRETATION: Compared with open repair, EVAR offers no advantage with respect to all-cause mortality and HRQL, is more expensive, and leads to a greater number of complications and reinterventions. However, it does result in a 3% better aneurysm-related survival. The continuing need for interventions mandates ongoing surveillance and longer follow-up of EVAR for detailed cost-effectiveness assessment.
3. Blankensteijn, J. D., S. E. de Jong, et al. (2005). "Two-year outcomes after conventional or endovascular repair of abdominal aortic aneurysms." N Engl J Med 352(23): 2398-405.
BACKGROUND: Two randomized trials have shown better outcomes with elective endovascular repair of abdominal aortic aneurysms than with conventional open repair in the first month after the procedure. We investigated whether this advantage is sustained beyond the perioperative period. METHODS: We conducted a multicenter, randomized trial comparing open repair with endovascular repair in 351 patients who had received a diagnosis of abdominal aortic aneurysm of at least 5 cm in diameter and who were considered suitable candidates for both techniques. Survival after randomization was calculated with the use of Kaplan-Meier analysis and compared with the use of the log-rank test on an intention-to-treat-basis. RESULTS: Two years after randomization, the cumulative survival rates were 89.6 percent for open repair and 89.7 percent for endovascular repair (difference, -0.1 percentage point; 95 percent confidence interval, -6.8 to 6.7 percentage points). The cumulative rates of aneurysm-related death were 5.7 percent for open repair and 2.1 percent for endovascular repair (difference, 3.7 percentage points; 95 percent confidence interval, -0.5 to 7.9 percentage points). This advantage of endovascular repair over open repair was entirely accounted for by events occurring in the perioperative period, with no significant difference in subsequent aneurysm-related mortality. The rate of survival free of moderate or severe complications was also similar in the two groups at two years (at 65.9 percent for open repair and 65.6 percent for endovascular repair; difference, 0.3 percentage point; 95 percent confidence interval, -10.0 to 10.6 percentage points). CONCLUSIONS: The perioperative survival advantage with endovascular repair as compared with open repair is not sustained after the first postoperative year.
4. Greenhalgh, R. M., L. C. Brown, et al. (2004). "Comparison of endovascular aneurysm repair with open repair in patients with abdominal aortic aneurysm (EVAR trial 1), 30-day operative mortality results: randomised controlled trial." Lancet 364(9437): 843-8.
BACKGROUND: Endovascular aneurysm repair (EVAR) is a new technology to treat patients with abdominal aortic aneurysm (AAA) when the anatomy is suitable. Uncertainty exists about how endovascular repair compares with conventional open surgery. EVAR trial 1 was instigated to compare these treatments in patients judged fit for open AAA repair. METHODS: Between 1999 and 2003, 1082 elective (non-emergency) patients were randomised to receive either EVAR (n=543) or open AAA repair (n=539). Patients aged at least 60 years with aneurysms of diameter 5.5 cm or more, who were fit enough for open surgical repair (anaesthetically and medically well enough for the procedure), were recruited for the study at 41 British hospitals proficient in the EVAR technique. The primary outcome measure is all-cause mortality and these results will be released in 2005. The primary analysis presented here is operative mortality by intention to treat and a secondary analysis was done in per-protocol patients. FINDINGS: Patients (983 men, 99 women) had a mean age of 74 years (SD 6) and mean AAA diameter of 6.5 cm (SD 1). 1047 (97%) patients underwent AAA repair and 1008 (93%) received their allocated treatment. 30-day mortality in the EVAR group was 1.7% (9/531) versus 4.7% (24/516) in the open repair group (odds ratio 0.35 [95% CI 0.16-0.77], p=0.009). By per-protocol analysis, 30-day mortality for EVAR was 1.6% (8/512) versus 4.6% (23/496) for open repair (0.33 [0.15-0.74], p=0.007). Secondary interventions were more common in patients allocated EVAR (9.8% vs 5.8%, p=0.02). INTERPRETATION: In patients with large AAAs, treatment by EVAR reduced the 30-day operative mortality by two-thirds compared with open repair. Any change in clinical practice should await durability and longer term results.
5. Lottman, P. E., R. J. Laheij, et al. (2004). "Health-related quality of life outcomes following elective open or endovascular AAA repair: a randomized controlled trial." J Endovasc Ther 11(3): 323-9.
PURPOSE: To assess health-related quality of life outcomes after endovascular versus open abdominal aortic aneurysm repair. METHODS: Participants were randomly assigned to receive either endovascular or open abdominal aortic aneurysm (AAA) surgery according to a rate of 3 endovascular patients to 1 with open repair. Data on patient characteristics, operative aspects, and procedural and device-related complications were compiled at a single center. Health-related quality of life was assessed before treatment and 1 and 3 months following operation using the Medical Outcomes Study Short-Form 36-item Health Survey (SF-36) and the EuroQol questionnaire. RESULTS: Between 1996 and 1999, 57 patients (54 men; mean age 69 years, range 52-82) underwent endovascular and 19 patients (16 men; mean age 68 years, range 52-81) underwent open AAA repairs. Preoperatively, comparable scores were recorded in both treatment groups. One month after operation, patients of both groups scored significantly lower on the SF-36 domains of Role Limitations due to physical problems and Pain compared to preoperative scores. Three months after operation, both groups had scores in all domains comparable to preoperative levels of functioning. There was a significant benefit for the endovascular group 1 month after operation in the SF-36 domains of Physical Functioning, Role Limitations due to physical problems, Vitality, and Pain; their score on the EuroQol Usual Activities item was also significantly better. After 3 months, there were no longer differences between groups. CONCLUSIONS: Short-term health-related quality of life benefits were found after endovascular repair compared with standard open surgery.
6. Prinssen, M., E. Buskens, et al. (2004). "Quality of life endovascular and open AAA repair. Results of a randomised trial." Eur J Vasc Endovasc Surg 27(2): 121-7.
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.
7. Prinssen, M., E. Buskens, et al. (2004). "Sexual dysfunction after conventional and endovascular AAA repair: results of the DREAM trial." J Endovasc Ther 11(6): 613-20.
PURPOSE: To assess sexual function in the first postoperative year after elective endovascular aneurysm repair (EVAR) and open repair (OR) of abdominal aortic aneurysm (AAA). METHODS: In the Dutch Randomized Endovascular Aneurysm Management (DREAM) trial, 153 patients (141 men; mean age 71 years, range 53-85) were randomly allocated to EVAR (n=77) or OR (n=76). Sexual functioning was evaluated preoperatively and at 5 times in the first postoperative year (3, 6, 13, 26, and 52 weeks) using a questionnaire derived from the Medical Outcomes Study. The proportions of patients reporting sexual dysfunction for any of 5 aspects (interest, pleasure, engagement, orgasm, and erection) and any increase in the magnitude of dysfunction were compared between EVAR and OR. RESULTS: Preoperatively, the proportion of patients reporting sexual dysfunction in at least 1 aspect was 66% for the OR group and 74% in the EVAR group (p=NS). Surgery had a clear impact on sexual dysfunction. The proportion of patients reporting sexual dysfunction on at least 1 aspect increased to 79% in the OR group and 82% in the EVAR group. The magnitude of sexual dysfunction increased in both groups on all 5 aspects at 3 weeks postoperatively, but this was more pronounced in the OR group (interest: OR p=0.038 vs. EVAR p=0.071; pleasure: OR p=0.009 vs. EVAR p=0.065; engagement: OR p=0.006 vs. EVAR p=0.054; orgasm OR p=0.023 vs. EVAR p=0.112, and erection: OR p=0.046 vs. EVAR p=0.030). At 6 weeks, the OR group still reported a significant increase in 3 aspects (pleasure p=0.031, engagement p=0.010, and orgasm p=0.003), whereas the EVAR group no longer showed a significant difference. From 3 months on, both groups had returned to baseline. CONCLUSIONS: EVAR and open elective AAA repair both have an impact on sexual function in the early postoperative period. After EVAR, recovery to preoperative levels is faster than after open repair, but at 3 months, sexual dysfunction levels are similar in both groups.
8. Prinssen, M., E. L. Verhoeven, et al. (2004). "A randomized trial comparing conventional and endovascular repair of abdominal aortic aneurysms." N Engl J Med 351(16): 1607-18.
BACKGROUND: Although the initial results of endovascular repair of abdominal aortic aneurysms were promising, current evidence from controlled studies does not convincingly show a reduction in 30-day mortality relative to that achieved with open repair. METHODS: We conducted a multicenter, randomized trial comparing open repair with endovascular repair in 345 patients who had received a diagnosis of abdominal aortic aneurysm of at least 5 cm in diameter and who were considered suitable candidates for both techniques. The outcome events analyzed were operative (30-day) mortality and two composite end points of operative mortality and severe complications and operative mortality and moderate or severe complications. RESULTS: The operative mortality rate was 4.6 percent in the open-repair group (8 of 174 patients; 95 percent confidence interval, 2.0 to 8.9 percent) and 1.2 percent in the endovascular-repair group (2 of 171 patients; 95 percent confidence interval, 0.1 to 4.2 percent), resulting in a risk ratio of 3.9 (95 percent confidence interval, 0.9 to 32.9). The combined rate of operative mortality and severe complications was 9.8 percent in the open-repair group (17 of 174 patients; 95 percent confidence interval, 5.8 to 15.2 percent) and 4.7 percent in the endovascular-repair group (8 of 171 patients; 95 percent confidence interval, 2.0 to 9.0 percent), resulting in a risk ratio of 2.1 (95 percent confidence interval, 0.9 to 5.4). CONCLUSIONS: On the basis of the overall results of this trial, endovascular repair is preferable to open repair in patients who have an abdominal aortic aneurysm that is at least 5 cm in diameter. Long-term follow-up is needed to determine whether this advantage is sustained.
9. Cuypers, P. W., M. Gardien, et al. (2001). "Randomized study comparing cardiac response in endovascular and open abdominal aortic aneurysm repair." Br J Surg 88(8): 1059-65.
BACKGROUND: The aim was to compare the cardiac response and the incidence of adverse cardiac events during and after endovascular (EVAR) and open (OR) repair of abdominal aortic aneurysms (AAAs). METHODS: Seventy-six patients with an AAA suitable for EVAR, and in a general condition allowing open surgery were randomized to EVAR (57 patients) or OR (19 patients). The analysis was on an intention-to-treat basis. Haemodynamic variables were assessed intraoperatively before, during and after aortic occlusion. During the procedure myocardial ischaemia was identified with use of electrocardiography (ECG) and transoesophageal echocardiography (TEE). After operation, cardiac complications were diagnosed by clinical observation, 12-lead ECG at 1 h, 1 day and 7 days, echocardiography at 1 month and measurement of cardiac enzymes. RESULTS: After aortic occlusion, a greater decrease in systemic vascular resistance compared with baseline was observed with OR than with EVAR (- 396 and - 70 dyne s/cm5 respectively; P = 0.03). The stroke work index, as a direct measure of myocardial performance, demonstrated a decrease during OR and an increase during EVAR during aortic occlusion (- 6.6 and + 1.7 g m/m2 respectively; P = 0.03) as well as after aortic occlusion (- 7.6 and + 3.4 g m/m2 respectively; P < 0.01), compared with baseline. The incidence of postoperative clinical cardiac complications was comparable in the two study groups; however, myocardial ischaemia, as observed by ECG and TEE, was observed more frequently in the OR group (ten of 19 versus 15 of 57 patients; P = 0.05). CONCLUSION: Haemodynamic changes were less severe and there was a lower incidence of myocardial ischaemia during EVAR than during OR. Studies are needed to demonstrate whether this may reduce the operative mortality rate.
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