Lydia Romano

Comparison of Surveillance Versus Aortic Endografting for Small Aneurysm Repair (CAESAR): Results from a Randomised Trial

BACKGROUND Randomised trials have failed to demonstrate benefit from early surgical repair of small abdominal aortic aneurysm (AAA) compared with surveillance. This study aimed to compare results after endovascular aortic aneurysm repair (EVAR) or surveillance in AAA <5.5 cm. METHODS Patients (50-79 years) with AAA of 4.1-5.4 cm were randomly assigned, in a 1:1 ratio, to receive immediate EVAR or surveillance by ultrasound and computed tomography (CT) and repair only after a defined threshold (diameter ≥5.5 cm, enlargement >1 cm /year, symptoms) was achieved. The main end point was all-cause mortality. Recruitment is closed; results at a median follow-up of 32.4 months are here reported. RESULTS Between 2004 and 2008, 360 patients (early EVAR = 182; surveillance = 178) were enrolled. One perioperative death after EVAR and two late ruptures (both in the surveillance group) occurred. At 54 months, there was no significant difference in the main end-point rate [hazard ratio (HR) 0.76; 95% confidence interval (CI) 0.30-1.93; p = 0.6] with Kaplan-Meier estimates of all-cause mortality of 14.5% in the EVAR and 10.1% in the surveillance group. Aneurysm-related mortality, aneurysm rupture and major morbidity rates were similar. Kaplan-Meier estimates of aneurysms growth ≥5 mm at 36 months were 8.4% in the EVAR group and 67.5% in the surveillance group (HR 10.49; 95% CI 6.88-15.96; p < 0.01). For aneurysms under surveillance, the probability of delayed repair was 59.7% at 36 months (84.5% at 54 months). The probability of receiving open repair at 36 months for EVAR feasibility loss was 16.4%. CONCLUSION Mortality and rupture rates in AAA <5.5 cm are low and no clear advantage was shown between early or delayed EVAR strategy. However, within 36 months, three out of every five small aneurysms under surveillance might grow to require repair and one out of every six might lose feasibility for EVAR. Surveillance is safe for small AAA if close supervision is applied. Long-term data are needed to confirm these results. CLINICAL TRIAL REGISTRATION INFORMATION This study is registered, NCT Identifier: NCT00118573.

Endovascular treatment of iliac aneurysm : Concurrent comparison of side branch endograft versus hypogastric exclusion

OBJECTIVE To analyze early and mid-term outcome of endovascular treatment in patients with iliac aneurysms, comparing the results of hypogastric revascularization by branch endografting with those of hypogastric occlusion. METHODS Consecutive patients with iliac aneurysms receiving side branch endograft (Group I) were compared with those receiving endograft with hypogastric exclusion (Group II) during the interval from January 2000 to May 2008. Procedural details and outcomes were prospectively collected and were analyzed at one year to avoid mismatch in follow-up length. RESULTS A total of 74 patients (mean age, 75.8 years, 95% males) were treated: 32 in Group I and 42 in Group II. No differences in baseline risk factors and aneurysm diameter (40.2 +/- 7.9 mm in Group I vs. 38.4 +/- 10.8 in Group II) were found. Concurrent treatment of aortic aneurysm was performed in 25/32 (78%) of Group I and 36/42 (86%) of Group II. Fluoro time was 48 minutes (interquartile range [IQR] 31-57) in Group I vs. 31 minutes (IQR 23-38) in Group II (P = .04). The amount of contrast was similar in both Groups: 184 ml (IQR 155-210) in Group I vs. 183 ml (IQR 155-200) in Group II. No intestinal ischemia or deaths occurred. There were no significant differences in failures of hypogastric side branch deployment (2/32) compared with hypogastric coiling (3/42). Limb occlusions all occurring in the external iliac artery side were 2/32 in Group I vs. 3/42 in Group II. Reintervention rates were similar (5/32 vs. 4/42) at one year. Shrinkage of 5 mm or more was detected in 7/23 (30%) of Group I and in 13/37 (34%) of Group II. Iliac endoleak was present in eight patients (19%) in Group II and in one patient in Group I (4%) (P = .1). Similarly, buttock claudication or impotence were more frequent after hypogastric exclusion, recorded in eight patients in Group II and in one patient in Group I (P = .1). CONCLUSIONS Endovascular treatment of iliac aneurysm with hypogastric revascularization through side branched endografts is feasible and safe in the mid-term. When compared with hypogastric embolization, this option leads to similar technical success and reintervention rates. Endoleak and buttock claudication occur frequently in patients with iliac aneurysm treated with hypogastric exclusion, while are uncommon in those with hypogastric revascularization. Side branch endografting for iliac aneurysm may be considered a primary choice in younger, active patients with suitable anatomy, but larger studies and longer postoperative observation periods are needed.

Quality of life in patients with small abdominal aortic aneurysm: the effect of early endovascular repair versus surveillance in the CAESAR trial.

OBJECTIVE To evaluate and compare changes over time in health-related quality of life reported by patients with small (4.1-5.4 cm) abdominal aortic aneurysms (AAAs) undergoing endovascular aortic aneurysm repair (EVAR) or surveillance. METHODS Participants were randomly assigned to receive either early EVAR or surveillance within a multicentre, randomised clinical trial on small AAA (Comparison of surveillance vs. Aortic Endografting for Small Aneurysm Repair, CAESAR). Patient-reported health-related quality of life was assessed before randomisation, at 6 months and yearly thereafter using the Short Form 36 (SF-36) Health Survey. RESULTS Between 2004 and 2008, 360 patients (345 males, mean age 68.9 years) were randomised, 182 to early EVAR and 178 to surveillance. There was one perioperative death. Mean follow-up was 31.8 months. No significant difference in survival was found. At baseline, comparable quality of life scores were recorded in both treatment groups: Total SF-36: 73.0 versus 75.5 (p = 0.18), Physical domain: 71.4 versus 73.3 (p = 0.33); Mental health domain: 70.9 versus 72.7 (p = 0.33), in the EVAR arm versus the surveillance arm, respectively. Six months after randomisation, Total SF-36 and Physical and Mental domain scores were all significantly higher with respect to baseline in the EVAR group, while patients of the surveillance group scored lower. The differences between EVAR and surveillance arms in score changes at 6 months were significant and in favour of EVAR: Total score: difference 5.4; p = 0.0017; Physical: difference 3.8; p = 0.02; and Mental: difference 6.0; p = 0.0005. Differences between EVAR and surveillance diminished over time. At the last assessment, patients in both groups had decreased scores with a significant drop with respect to the baseline (-3.9 in EVAR, -6.3 in surveillance). There were no significant differences between the EVAR and surveillance arms: Total score: p = 0.25; Physical: p = 0.47; and Mental: p = 0.38. CONCLUSIONS Patients with small AAA under surveillance compared with early EVAR had significant impaired functional health at 6 months after assignment. After a mean of 31.8 months, SF-36 health-related quality of life in patients allocated to early EVAR and surveillance was similar.

Second-generation Thienopyridine use is not Associated with Better Early Perioperative Outcome During Carotid Stenting

OBJECTIVE Management of anti-platelet therapy during carotid artery stenting (CAS) is mainly based on indirect evidence from coronary stenting experience. There is common agreement on the use of thienopyridine (mainly second-generation) during CAS, but some patients are unsuitable for clopidogrel treatment and data on the benefit of its use in large CAS populations are lacking. The aim of this study was to investigate whether clopidogrel was associated with reduced perioperative morbidity in patients undergoing CAS. METHODS Consecutive patients undergoing CAS for primary carotid stenosis from 2004 to 2009 were reviewed. The independent association of clopidogrel and perioperative morbidity was assessed using multivariable analysis. RESULTS A total of 1083 patients were treated (29% females, mean age 71.6 years); 825 (76%) patients were given clopidogrel starting before treatment. Clopidogrel use was associated with a non-significant reduction of perioperative stroke/death (4.3% vs. 2.4%; p = 0.13) and disabling stroke (1.2% vs. 1.0%; p = 1) rates. The non-significant stroke/death difference was similar in symptomatic (5.8% vs. 4.0%, p = 0.37) and asymptomatic (3.7% vs. 1.9%; p = 0.17) patients. After adjusting for demographics, co-morbidities and other therapies with multivariable analysis, clopidogrel use failed to show any significant independent association in decreasing operative risks. The only independent protective factor was use of statins (p = 0.010). The additional use of dual anti-platelet therapy did not add any advantage to the use of clopidogrel alone. CONCLUSIONS The suggested benefit of clopidogrel in decreasing the incidence of complications in patients undergoing CAS may be overestimated due to the overlapping effect of other more relevant factors (e.g., pleiotropy and plaque stabilisation from statins). More data and level I evidence are needed to understand which is the best medical management of CAS that will help improve outcomes of the procedure.

Fourteen-year outcomes of abdominal aortic endovascular repair with the Zenith stent graft

Objective: Long‐term results of abdominal aortic aneurysm (AAA) endovascular repair are affected by graft design renewals that tend to improve the performance of older generation prostheses but usually reset the follow‐up times to zero. The present study investigated the long‐term outcomes of endovascular AAA repair (EVAR) using the Zenith graft, still in use without major modification, in a single center experience. Methods: Between 2000 and 2011, 610 patients underwent elective EVAR using the Zenith endograft (Cook Inc, Bloomington, Ind) and represent the study group. Primary outcomes were overall survival, freedom from AAA rupture, and freedom from AAA‐related death. Secondary outcomes included freedom from late (>30 days) reintervention, freedom from late (>30 days) conversion to open repair, freedom from aneurysm sac enlargement >5.0 mm and freedom from EVAR failure, defined as a composite of AAA‐related death, AAA rupture, AAA growth >5 mm, and any reintervention. Results: Mean age was 73.2 years. Mean aneurysm diameter was 55.3 mm. There were five perioperative deaths (0.8%) and three intraoperative conversions. At a mean follow‐up of 99.2 (range, 0‐175) months, seven AAA ruptures occurred, all fatal except one. Overall survival was 92.8% ± 1.1% at 1 year, 70.1% ± 1.9% at 5 years, 37.8% ± 2.9% at 10 years, and 24 ± 4% at 14 years. Freedom from AAA‐rupture was 99.8% ± 0.02 at 1 year (one case), 99.4% ± 0.04 at 5 years (three cases), and 98.1% ± 0.07 at 10 and 14 years. Freedom from late reintervention and conversion was 98% ± 0.6 at 1 year, 87.7% ± 1.5 at 5 years, 75.7% ± 3.2 at 10 years, and 69.9% ± 5.2 at 14 years. Freedom from aneurysm sac growth >5.0 mm was 99.8% at 1 year, 96.6% ± 0.7 at 5 years, 81.0% ± 3.4 at 10 years, and 74.1% ± 5.8% at 14 years. EVAR failure occurred in 132 (21.6%) patients at 14 years. At multivariate analysis, independent predictors of EVAR failure resulted type I and III endoleak (hazard ratio [HR], 6.7; 95% confidence interval [CI], 4.6‐ 9.7; P < .001], type II endoleak (HR, 2.3; 95% CI, 1.6‐3.4; P < .001), and American Society of Anesthesiologists grade 4 (HR, 1.6; 95% CI, 1.0‐2.6; P = .034). Conclusions: EVAR with Zenith graft represents a safe and durable repair. Risk of rupture and aneurysm‐related death is low, whereas overall long‐term survival remains poor. Novel endograft models should be tested and evaluated considering that one‐fourth of the operated patients will still be alive after 14 years.