Aneurysm enlargement following endovascular aneurysm repair: AneuRx clinical trial

OBJECTIVE: The purpose of this study was to determine the incidence and significance of aneurysm enlargement, with or without treatment, in relation to the primary end points of rupture, surgical conversion, aneurysm-related death, and survival following endovascular repair. METHOD: Aneurysm (AAA) size changes and clinical outcome of all patients treated from 1997 through 1998 during the Phase II AneuRx multicenter clinical trial of endovascular AAA repair were reviewed. Aneurysm dimensions and the presence or absence of endoleak were determined by an independent core laboratory, with enlargement or shrinkage defined as a diameter change of 5 mm or more compared with baseline. RESULTS: Among 383 patients (89% men, 11% women, age 73 +/- 9 years), with a mean device implant time of 36 +/- 11 months (median = 39 months), aneurysm diameter decreased from 5.7 +/- 1.0 at baseline to 5.2 +/- 1.0 at 3 years (P =.0001). A total of 46 patients (12%) experienced AAA enlargement, 199 patients (52%) had no change in AAA diameter, and 138 patients (36%) had a decrease in AAA diameter of 5 mm or more. Significant risk factors for enlargement included age (enlargement patients were 4 years older on average than patients with aneurysms that decreased in size; P =.002) and the presence of an endoleak (P <.001). Among patients with endoleak at any time, 17% had aneurysm enlargement, whereas only 2% of patients without endoleak had aneurysm enlargement (P <.001). Patients with enlargement were more likely to undergo secondary endovascular procedures and surgical conversions (P <.001). Twenty patients (43%) with enlargement underwent treatment, and 26 patients were untreated. There were two deaths following elective surgical conversion and one death in a patient with untreated enlargement and a type I endoleak. Three aneurysms ruptured: one with enlargement, one with no change, and one with a decrease in aneurysm size; all three aneurysms were larger than 6.5 cm. Kaplan-Meier analysis showed that freedom from rupture at 3 years was 98% with enlargement, 99% with no change, and 99% with decrease in AAA size (log-rank test, not significant). Freedom from AAA death at 3 years was 93% in patients with enlargement, 99% in no increase, and 99% in decrease (P =.005). Survival at 3 years was 86% with increase, 82% with no change, and 93% with decrease (P =.02). CONCLUSIONS: Aneurysm enlargement following endovascular repair was not associated with an increased risk of aneurysm rupture or decrease in patient survival during a 3-year observation period. Aneurysm size rather than enlargement may be a more meaningful predictor of rupture. Close follow-up and a high re-intervention rate (43%) may account for the low risk of rupture in patients with enlargement. The long-term significance of aneurysm enlargement following endovascular repair remains to be determined.     

Growth rate and associated factors in small abdominal aortic aneurysms.

OBJECTIVE: To study the growth rate and factors influencing progression of small infrarenal abdominal aortic aneurysms (AAA). DESIGN: Observational, longitudinal, prospective study. PATIENTS AND METHODS: We followed patients with AAA <5 cm in diameter in two groups. Group I (AAA 3-3.9 cm, n = 246) underwent annual ultrasound scans. Group II (AAA 4-4.9 cm, n = 106) underwent 6-monthly CT scans. RESULTS: We included 352 patients (333 men and 19 women) followed for a mean of 55.2+/-37.4 months (6.3-199.8). The mean growth rate was significantly greater in group II (4.72+/-5.93 vs. 2.07+/-3.23 mm/year; p<0.0001). Group II had a greater percentage of patients with rapid aneurysm expansion (>4 mm/year) (36.8 vs. 13.8%; p<0.0001). The classical cardiovascular risk factors did not influence the AAA growth rate in group I. Chronic limb ischemia was associated with slower expansion (< or = 4 mm/year) (OR 0.47; CI 95% 0.22-0.99; p = 0.045). Diabetic patients in group II had a significantly smaller mean AAA growth rate than non-diabetics (1.69+/-3.51 vs. 5.22+/-6.11 mm/year; p = 0.032). CONCLUSIONS: The expansion rate of small AAA increases with the AAA size. AAA with a diameter of 3-3.9 cm expand slowly, and they are very unlikely to require surgical repair in 5 years. Many 4-4.9 cm AAA can be expected to reach a surgical size in the first 2 years of follow-up. Chronic limb ischemia and diabetes are associated with reduced aneurysm growth rates.     

Statins are associated with a reduced infrarenal abdominal aortic aneurysm growth.

OBJECTIVE: To evaluate the effect of statins on aneurysm growth in a group of consecutive patients under surveillance for infrarenal aortic aneurysms (AAA). MATERIALS AND METHODS: All patients (59 statin users, 91 non-users) under surveillance between January 2002 and August 2005 with a follow-up for aneurysm growth of at least 12 months and a minimum of three diameter evaluations were retrospectively included in the analysis. Multiple regression analysis, weighted with the number of observations, was performed to test the influence of statins on AAA growth rate. RESULTS: During a median period of 3.1 (1.1-13.1) years the overall mean aneurysm growth rate was 2.95+/-2.8 mm/year. Statin users had a 1.16 mm/year lower AAA growth rate compared to non-users (95% CI 0.33-1.99 mm/year). Increased age was associated with a slower growth (-0.09 mm/year per year, p = 0.003). Female gender (+1.82 mm/year, p = 0.008) and aneurysm diameter (+0.06 mm/year per mm, p = 0.049) were associated with increased AAA growth. The use of non-steroidal anti-inflammatory drugs, chronic lung disease, or other cardiovascular risk factors were not independently associated with AAA growth. CONCLUSIONS: Statins appear to be associated with attenuation of AAA growth, irrespective of other known factors influencing aneurysm growth.     

Endovascular aneurysm repair at 5 years: does aneurysm diameter predict outcome?

OBJECTIVE: The appropriate size threshold for endovascular repair of small abdominal aortic aneurysms (AAA) is unclear. We studied the outcome of endovascular aneurysm repair (EVAR) as a function of preoperative aneurysm diameter to determine the relationship between aneurysm size and long-term outcome of endovascular repair. METHODS: We reviewed the results of 923 patients treated in a prospective, multicenter clinical trial of EVAR. Small aneurysms were defined according to two size thresholds of 5.5 cm and 5.0 cm. Two-way analysis was used to compare patients with small aneurysms (<5.5 cm, n = 441) to patients with large aneurysms (> or =5.5 cm, n = 482). An ordered three-way analysis was used to compare patients with small AAA (<5.0 cm, n = 145), medium AAA (5.0 to 5.9 cm, n = 461), and large AAA (> or =6.0 cm, n = 317). The primary outcome measures of rupture, AAA-related death, surgical conversion, secondary intervention, and survival were compared using Kaplan-Meier estimates at 5 years. RESULTS: Median aneurysm size was 5.5 cm. The two-way comparison showed that 5 years after EVAR, patients with small aneurysms (<5.5 cm) had a lower AAA-related death rate (1% vs 6%, P = .006), a higher survival rate (69% vs 57%, P = .0002), and a lower secondary intervention rate (25% vs 32%, P = .03) than patients with large aneurysms (> or =5.5 cm). Three-way analysis revealed that patients with small AAAs (<5.0 cm) were younger (P < .0001) and were more likely to have a family history of aneurysm (P < .05), prior coronary intervention (P = .003), and peripheral occlusive disease (P = .008) than patients with larger AAAs. Patients with smaller AAAs also had more favorable aortic neck anatomy (P < .004). Patients with large AAAs were older (P < .0001), had higher operative risk (P = .01), and were more likely to have chronic obstructive pulmonary disease (P = .005), obesity (P = .03), and congestive heart failure (P = .004). At 5 years, patients with small AAAs had better outcomes, with 100% freedom from rupture vs 97% for medium AAAs and 93% for large AAAs (P = .02), 99% freedom from AAA-related death vs 97% for medium AAAs and 92% for large AAAs (P = .02) and 98% freedom from conversion vs 92% for medium AAAs and 89% for large AAAs (P = .01). Survival was significantly improved in small (69%) and medium AAAs (68%) compared to large AAAs (51%, P < .0001). Multivariate Cox proportional hazards modeling revealed that aneurysm size was a significant independent predictor of rupture (P = .04; hazard ratio [HR], 2.195), AAA-related death (P = .03; HR, 2.007), surgical conversion (P = .007; HR, 1.827), and survival (P = .001; HR, 1.351). There were no significant differences in secondary intervention, endoleak, or migration rates between small, medium, and large AAAs. CONCLUSIONS: Preoperative aneurysm size is an important determinant of long-term outcome following endovascular repair. Patients with small AAAs (<5.0 cm) are more favorable candidates for EVAR and have the best long-term outcomes, with 99% freedom from AAA death at 5 years. Patients with large AAAs (> or =6.0 cm) have shorter life expectancy and have a higher risk of rupture, surgical conversion, and aneurysm-related death following EVAR compared to patients with smaller aneurysms. Nonetheless, 92% of patients with large AAAs are protected from AAA-related death at 5 years. Patients with AAAs of intermediate size (5 to 6 cm) represent most of the patients treated with EVAR and have a 97% freedom from AAA-related death at 5 years.     

Aortic necks of ruptured abdominal aneurysms dilate more than asymptomatic aneurysms after endovascular repair

BACKGROUND: Endovascular repair of abdominal aortic aneurysm (AAA) is increasingly used. We evaluated if a difference exists in the rate of change of the aortic neck diameter between non-ruptured and ruptured AAAs after endovascular aneurysm repair (EVAR). METHODS: Details of patients undergoing elective (group I) and emergency (group II) EVAR using Talent stents between October 1999 and September 2005 were reviewed. Top neck diameters were prospectively recorded on the hospital database from computed tomography scans preoperatively and at 1, 3, 12, and 24 months postoperatively. The aortic neck diameter rate of change was calculated for each group. RESULTS: Endovascular repair was performed on 110 elective and 41 emergency patients, of which 100 (80 male) elective and 29 (26 male) emergency patients were included in this analysis. Mean age was similar in each group. Stents were oversized by 20.9% +/- 13.6% in group I and by 24.7% +/- 16.3% in group II (P = .37). The preoperative mean proximal aortic neck was larger in group II (25.0 +/- 3.3 mm vs 23.5 +/- 2.8 mm; P = .029). The growth rate of the top neck diameter was significantly greater at 12 months (1.48 +/- 2.4 mm/year vs 3.89 +/- 6.24 mm/year; P = .04) and 24 months (.99 +/- 1.1 mm/year vs 2.61 +/- 3.3 mm/year; P = .04) in group II than in group I. A decreasing sac size was found in 68.2% of patients whose neck dilated. The complication rate was similar in each group. CONCLUSION: Aneurysm necks in patients with ruptured aneurysms are larger and dilate at a greater rate than those with nonruptured aneurysms. The accelerated rate of expansion in some patients must be borne in mind during follow-up and in secondary endovascular interventions and conversion to open surgery.     

Biomechanical properties of ruptured versus electively repaired abdominal aortic aneurysm wall tissue

OBJECTIVE: The purpose of this study was to evaluate and compare the biomechanical properties of abdominal aortic aneurysm (AAA) wall tissue from patients who experienced AAA rupture with that of those who received elective repair. METHODS: Rectangular, circumferentially oriented AAA wall specimens (approximately 2.5 cm x 7 mm) were obtained fresh from the operating room from patients undergoing surgical repair. The width and thickness were measured for each specimen by using a laser micrometer before testing to failure with a uniaxial tensile testing system. The force and deformation applied to each specimen were measured continuously during testing, and the data were converted to stress and stretch ratio. The tensile strength was taken as the peak stress obtained before specimen failure, and the distensibility was taken as the stretch ratio at failure. The maximum tangential modulus and average modulus were also computed according to the peak and average slope of the stress-stretch ratio curve. RESULTS: Twenty-six specimens were obtained from 16 patients (aged 73 +/- 3 years [mean +/- SEM]) undergoing elective repair of their AAA (diameter, 7.0 +/- 0.5 cm). Thirteen specimens were resected from nine patients (aged 73 +/- 3 years; P = not significant in comparison to the electively repaired AAAs) during repair of their ruptured AAA (diameter, 7.8 +/- 0.6 cm; P = not significant). A significant difference was noted in wall thickness between ruptured and elective AAAs: 3.6 +/- 0.3 mm vs 2.5 +/- 0.1 mm, respectively (P < .001). The tensile strength of the ruptured tissue was found to be lower than that for the electively repaired tissue (54 +/- 6 N/cm2 vs 82 +/- 9.0 N/cm2; P = .04). Considering all specimens, no significant correlation was noted between tensile strength and diameter (R = -0.10; P = .55). Tensile strength, however, had a significant negative correlation with wall thickness (R = -0.42; P < .05) and a significant positive correlation with the tissue maximum tangential modulus (R = 0.76; P < .05). CONCLUSIONS: Our data suggest that AAA rupture is associated with aortic wall weakening, but not with wall stiffening. A widely accepted indicator for risk of aneurysm rupture is the maximum transverse diameter. Our results suggest that AAA wall strength, in large aneurysms, is not related to the maximum transverse diameter. Rather, wall thickness or stiffness may be a better predictor of rupture for large AAAs.     

Abdominal aortic aneurysms following orthotopic heart transplantation

The purpose of these authors' study was to analyze their center's experience with orthotopic heart transplantation (OHT) and abdominal aortic aneurysms (AAA) with particular attention to corticosteroid dosing, hemodynamic parameters, and aneurysm growth rate. A retrospective review of all patients (453) who underwent OHT at their university-affiliated medical center over an 18-year period (1981-1999) was undertaken. Nine (2%) patients who developed AAAs were identified and aneurysm growth was correlated with corticosteroid immunosuppression and hemodynamic parameters. The mean age of OHT patients was 44.5 +/-15 years and the majority were males (371 males, 82%). Median follow-up was 5.7 years. Ischemic cardiomyopathy (IC) was the most common indication for transplantation (45.5% of patients). All AAA patients were male (p=0.157), with a mean age of 58.4 +/-4.8 years (p=0.001), and had undergone OHT for IC (p=0.001). Mean arterial blood pressure and ejection fraction in the AAA patients had increased from pretransplant values of 107 mm Hg and 14.3 +/-5.7% to 142 mm Hg (p=0.017) and 54.1 +/-14.1% (p<0.001), respectively, before aneurysm repair. Mean aneurysm diameter at the time of repair was 6.0 +/-0.8 cm, and the average growth rate was 1.2 +/-0.4 cm/year in the 4 patients in whom it could be measured. Aneurysm repair was performed urgently in 2 patients and electively in 7 patients with 1 early postoperative death (11%). The extent of corticosteroid immunosuppression, corticosteroid pulses, and total corticosteroid dosing did not correlate with the rate of aneurysm growth. Improved hemodynamics and progressive posttransplant hypertension may contribute to aneurysm formation and growth in this group of patients.     

Endovascular abdominal aortic aneurysm repair: long-term outcome measures in patients at high-risk for open surgery

PURPOSE: The study was conducted to determine the outcome in the United States after endovascular repair (EVAR) of infrarenal abdominal aortic aneurysms (AAAs) in patients at high-risk for open surgery by using independently audited, high-compliance, chart-verified data sets, and to compare those results with open surgery. METHODS: High-risk was defined to match a recent European trial (EVAR2) and included age of > or =60 years with aneurysm size of > or =5.5 cm, plus at least one cardiac, pulmonary, or renal comorbidity. Data from five multicenter investigational device exemption clinical trials leading to Food and Drug Administration (FDA) approval were analyzed. Of 2216 EVAR patients, 565 met the high-risk criteria. Of 342 surgical controls (OPEN), 61 met high-risk criteria. Primary outcome comparisons included AAA-related death, all-cause death, and aneurysm rupture. Secondary measures were endoleak, AAA sac enlargement, and migration. RESULTS: Average age of the high-risk EVAR subset was 76 +/- 7 years vs 74 +/- 6 years OPEN (P = 0.07), mean EVAR AAA size was 6.4 +/- 0.8 cm vs 6.6 +/- 1.0 cm OPEN (P = .33), and average EVAR follow-up was 2.7 years vs 2.5 years OPEN. The 30-day operative mortality was 2.9% in EVAR vs 5.1% in OPEN (P = .32). The AAA-related death rate after EVAR was 3.0% at 1 year and 4.2% at 4 years compared with 5.1% at both time points after OPEN (P = .58). Overall survival at 4 years after EVAR was 56% vs 66% in OPEN (P = .23). After treatment, EVAR successfully prevented rupture in 99.5% at 1 year and in 97.2% at 4 years. CONCLUSIONS: Endovascular repair of large infrarenal AAAs in anatomically suited high-surgical-risk patients using FDA-approved devices in the United States is safe and provides lasting protection from AAA-related mortality. EVAR mortality remained comparable with OPEN up to 4 years. The decision to treat AAAs in patients with advanced age and significant comorbidities must be individualized and carefully considered, but repair provides excellent protection from AAA-related death.     

The role of aortic neck dilation and elongation in the etiology of stent graft migration after endovascular abdominal aortic aneurysm repair with a passive fixation device

OBJECTIVE: Endovascular repair of abdominal aortic aneurysm (AAA) is complicated by the potential for stent graft migration over time. Factors including the type of fixation, initial proximal fixation length, and dilation and elongation of the infrarenal aortic neck may contribute to device migration. We sought to determine when device migration is a real phenomenon with actual device movement that compromises aneurysm exclusion. METHODS: Computed tomographic (CT) scans and computer reconstructions of all patients undergoing endovascular AAA repair with a passive fixation device at our institution from June 1996 to October 2004 were retrospectively reviewed. The distance from the distal renal artery to the proximal end of the stent graft at the time of initial deployment was determined for each patient. Migration was defined as a distance increase greater than 5 mm in the follow-up period; proximal fixation length, aortic neck enlargement and elongation, and neck angle were then measured. Data were further analyzed with respect to AAA growth, development of endoleak, AAA rupture, and the need for reintervention. RESULTS: A total of 308 patients with endovascular AAA repairs using a passive fixation device had complete postoperative imaging data sets; 48 patients (15.6%) with stent graft migration of 5 mm or more were identified, and 25 (8.1%) of these had a migration of 10 mm or more. Seventeen (35.4%) of 48 migration patients had a total loss of the proximal seal zone (loss patients); their average migration distance was 17.7 +/- 12.0 mm, with a mean neck shortening of 13.6 +/- 14.2 mm, and the average proximal fixation length loss was 14.0 +/- 7.6 mm. Those 31 patients with an intact proximal seal zone (nonloss patients) showed an average migration of 9.4 +/- 3.7 mm, with a mean neck lengthening of 9.6 +/- 8.4 mm and an average proximal fixation length change of 0.7 +/- 8.0 mm. Univariate analysis demonstrated significant differences between the loss and nonloss patients in follow-up duration (65.9 +/- 20.4 months vs 45.9 +/- 26.4 months; P = .01), neck dilatation at the distal renal artery (4.6 +/- 4.5 mm vs 1.8 +/- 1.9 mm; P = .026), stent graft migration distance (17.7 +/- 12.0 mm vs 9.4 +/- 3.7 mm; P = .001), change in aortic neck length (-13.6 +/- 14.2 mm vs 9.6 +/- 8.4 mm; P < .0001), change in proximal fixation length (-14.0 +/- 7.6 mm vs 0.7 +/- 8.0 mm; P < .0001), change in AAA size (1.8 +/- 7.1 mm vs -3.6 +/- 9.7 mm; P = .033), and use of a stiff body stent graft (47.1% vs 19.4%; P = .043). However, only change in aortic neck length was statistically significant on multivariate analysis (odds ratio, 0.75; 95% confidence interval, 0.591-0.961; P = .022). There were no differences between the loss and nonloss patients in time to migration discovery, initial AAA size, initial aortic neck diameter or length, initial device oversizing, initial neck angle, neck angle increase, type II endoleak, or AAA rupture. Eight of the 17 loss patients have been treated with proximal aortic cuffs; the remainder have refused reintervention, died of unrelated causes, or elected to have open repair. CONCLUSIONS: Postoperative elongation of the infrarenal aortic neck may create the radiographic perception of migration without necessarily causing a loss of proximal stent graft fixation. Patients with a total loss of the proximal seal zone actually have infrarenal aortic neck shortening, with a degree of neck dilatation beyond initial device oversizing that may compromise proximal fixation length. Conversely, those with an intact proximal seal zone demonstrate aortic neck elongation equivalent to migration, with no loss of proximal fixation length; these patients have a benign natural history without intervention. Thus, aortic neck dilatation beyond oversizing, aortic neck shortening, and loss of proximal fixation length are more clinically relevant predictors of proximal stent graft failure than simple migration distance.     

Influence of sex on expansion rate of abdominal aortic aneurysms

BACKGROUND: The UK Small Aneurysm Trial suggested that female sex is an independent risk factor for rupture of abdominal aortic aneurysm (AAA). This study assessed the effect of sex on the growth rate of AAA. METHODS: Between January 1985 and August 2005 all patients who were referred to the Royal Infirmary of Edinburgh with an AAA who were not considered for early aneurysm repair were assessed by serial abdominal ultrasonography. Maximum anteroposterior and transverse diameters of the AAAs were measured. RESULTS: A total of 1255 patients (824 men and 431 women) were followed up for a median of 30 (range 6-185) months. A median of six examinations (range 2-37) was performed for each patient. Median diameter on initial examination was 41 (range 25-83) mm. Median growth rate overall was 2.79 (range - 4.80-37.02) mm per year. Median growth rate of AAA was significantly greater in women than men (3.67 (range - 1.2-37.02) versus 2.03 (range - 4.80-21.00) mm per year; P < 0.01). Weighted linear regression analysis revealed that large initial anteroposterior AAA diameter and female sex were significant predictors of faster aneurysm growth rate (P < 0.001 and P = 0.006 respectively). CONCLUSION: The growth rate of AAA was significantly greater in women than in men. This may have implications for the frequency of follow-up and timing of repair of AAA in women.     

Ten-year outcome of patients with very small abdominal aortic aneurysm

BACKGROUND: The long-term fate of very small abdominal aortic aneurysms (AAA) is not well known. METHODS: Forty-one patients with asymptomatic small AAA (range 25 to 40 mm) underwent ultrasonographic surveillance. RESULTS: The median follow-up period was 7.3 years. The median linear aneurysm expansion rate was 2.0 mm/year (range 0 to 8.4). Three patients experienced aneurysm rupture (7.3%) which resulted in 1 patient'death. Thirteen patients underwent aneurysm repair (31.7%) and 1 patient died postoperatively (7.7%). The survival rate at 10-year follow-up was 59.0%. The survival rate free from aneurysm rupture and repair at 10-year follow-up was 69.9%. The median time for occurrence of aneurysm rupture was 4.9 years (range 1.8 to 10.5) and the need for aneurysm repair was 4.5 years (range 1.4 to 10.4). CONCLUSIONS: The fate of very small AAA is to slowly enlarge in size, sometimes threatening the patient's life. These observations underline the importance of continuous surveillance and the potential benefits of any medical treatment in this patient population.     

Long-term surveillance is paramount after implantation of the Vanguard stent-graft for abdominal aortic aneurysms

AIM: The aim of this study was to describe the results and long-term follow-up of the Vanguard endovascular graft for infrarenal abdominal aortic aneurysm (AAA) repair. METHODS: Between February 1997 and October 1999, 76 patients were treated with a median aneurysm diameter of 52 mm (39-90 mm). All were followed up according to the Eurostar criteria. RESULTS: The primary technical success rate was 100%. Perioperative mortality was 1.3%. During follow-up (median 75 months, 6-112 months) 9 aneurysm related deaths occurred. A total of 79 late complications occurred in 45 patients (64%). Complications were noticed more frequently in the group of aneurysms larger than 5.5 cm (P=0.014). Patients who ultimately developed aneurysm rupture after endovascular repair had more postoperative complications compared to the majority who did not rupture their aneurysm. (P=0.001) Secondary interventions were mandatory in 23 patients, surgical conversion in 9. At 72 months this has resulted in an overall survival rate of 57%, an aneurysm rupture free survival of 88%, a conversion free survival of 95%, an endoleak free survival of 83% and a secondary intervention free survival of 82% (Kaplan Maier). CONCLUSION: The importance of life-long strict surveillance of patients treated with a Vanguard endograft was confirmed. Patients with graft-related complications should be treated accordingly.     

Endovascular repair or surveillance of patients with small AAA.

OBJECTIVE: To compare the outcome of patients with small abdominal aortic aneurysms (AAA) treated in a prospective trial of endovascular aneurysm repair (EVAR) to patients randomized to the surveillance arm of the UK Small Aneurysm Trial. METHOD: All patients with small AAA (< or = 5.5 cm diameter) treated with a stent graft (EVARsmall) in the multicenter AneuRx clinical trial from 1997 to 1999 were reviewed with follow up through 2003. A subgroup of patients (EVARmatch) who met the age (60-76 years) and aneurysm size (4.0-5.5 cm diameter) inclusion criteria of the UK Small Aneurysm Trial were compared to the published results of the surveillance patient cohort (UKsurveil) of the UK Small Aneurysm Trial (NEJM 346:1445, 2002). Endpoints of comparison were aneurysm rupture, fatal aneurysm rupture, operative mortality, aneurysm related death and overall mortality. The total patient years of follow-up for EVAR patients was 1369 years and for UK patients was 3048 years. Statistical comparisons of EVARmatch and UKsurveil patients were made for rates per 100 patient years of follow up (/100 years) to adjust for differences in follow-up time. RESULTS: The EVARsmall group of 478 patients comprised 40% of the total number of patients treated during the course of the AneuRx clinical trial. The EVARmatch group of 312 patients excluded 151 patients for age < 60 or > 76 years and 15 patients for AAA diameter < 4 cm. With the exception of age, there were no significant differences between EVARsmall and EVARmatch in pre-operative factors or post-operative outcomes. In comparison to the UKsurveil group of 527 patients, the EVARmatch group was slightly older (70 +/- 4 vs. 69 +/- 4 years, p = 0.009), had larger aneurysms (5.0 +/- 0.3 vs. 4.6 +/- 0.4 cm, p < 0.001), fewer women (7 vs. 18%, p < 0.001), and had a higher prevalence of diabetes and hypertension and a lower prevalence of smoking at baseline. Ruptures occurred in 1.6% of EVARmatch patients and 5.1% of UKsurveil patients; this difference was not significant when adjusted for the difference in length of follow up. Fatal aneurysm rupture rate, adjusted for follow up time, was four times higher in UKsurveil (0.8/100 patient years) than in EVARmatch (0.2/100 patient years, p < 0.001); this difference remained significant when adjusted for difference in gender mix. Elective operative mortality rate was significantly lower in EVARmatch (1.9%) than in UKsurveil (5.9%, p < 0.01). Aneurysm-related death rate was two times higher in UKsurveil (1.6/100 patient years) than in EVARmatch (0.8/100 patient years, p = 0.03). All-cause mortality rate was significantly higher in UKsurveil (8.3/100 patient years) than in EVARmatch (6.4/100 patient years, p = 0.02). CONCLUSIONS: It appears that endovascular repair of small abdominal aortic aneurysms (4.0-5.5 cm) significantly reduces the risk of fatal aneurysm rupture and aneurysm-related death and improves overall patient survival compared to an ultrasound surveillance strategy with selective open surgical repair.     

Does the presence of an iliac aneurysm affect outcome of endoluminal AAA repair? An analysis of 336 cases.

OBJECTIVE: To determine whether the presence of an iliac aneurysm compromises outcome of endovascular exclusion of AAA and to ascertain the fate of the iliac aneurysmal sac. PATIENTS AND METHODS: Between April 1997 and March 2001, data on 336 consecutive patients undergoing endovascular repair for AAA were entered in a prospective database. Suitability for endovascular repair was assessed by preoperative contrast-enhanced computed tomography. A maximum common iliac artery (CIA) diameter > or = 20 mm was defined as iliac aneurysm. Patients with and without iliac aneurysms were compared to early (immediate conversion or perioperative death) and late failure (increase in aneurysm diameter or persisting graft-related endoleak, or late AAA rupture or conversion). RESULTS: Fifty-nine patients (18%) had iliac aneurysms, 19 were bilateral, for a total of 78 aneurysmal iliac arteries (median diameter 23 mm; range 20-50 mm). A distal seal was achieved by landing in 33 external iliac arteries, in 20 ectatic CIAs, and in 25 normal CIAs. Operating time differed significantly between patients with and without CIA aneurysms (153 +/- 71 vs 123 +/- 55 min, p = 0.0001), whereas no statistically significant differences were found with respect to early and late failure (2% vs 3%, p = 0.5 and 14% vs 8%, p = 0.11, respectively). There were no cases of buttock or colon necrosis. At a median follow-up of 14 months (range 0-46; i.q.r. 7-27 months) common iliac diameter decreased > or = 2 mm in 49 cases, remained stable in 25, and increased > or = 2 mm in 3. CONCLUSION: The presence of iliac aneurysm rendered endoluminal AAA repair more complex but did not affect feasibility and long-term outcome of the procedure. In our experience internal iliac exclusion was never associated with significant morbidity. These data may be useful when considering endovascular repair in high-risk patients with challenging anatomy.     

Mid-term results of a second generation bifurcated endovascular graft for abdominal aortic aneurysm repair: the French Vanguard trial.

PURPOSE: The purpose of this study was to evaluate prospectively the results of the bifurcated Vanguard endovascular graft for abdominal aortic aneurysm (AAA) repair. METHODS: Seventy-five patients, with a median age of 69.6 years (range, 48 to 88 years) and asymptomatic AAAs, were recruited in 14 French vascular institutions. An independent committee validated the indications for endovascular repair, and all the implantations were supervised by a well-trained medico-technical assistant. Further independent committees reviewed patient data, clinical data, and imaging follow-up examination. The main endpoints were implantation success, mortality, morbidity, reinterventions, and aneurysm evolution assessed with serial computed tomographic (CT) scanning. RESULTS: All the grafts were successfully implanted, resulting in a 100% success rate on an intent-to-treat basis. At discharge, there were no deaths, six significant local complications (8%) that necessitated surgery, no vascular complications, and six systemic complications (8%). The average durations of intensive care unit and hospital stays were 26 +/- 6 hours and 6 +/- 2.54 days, respectively. Predischarge CT scan results showed five type I and 18 type II endoleaks (total, 30%). At the end of the follow-up period (mean duration, 18.35 +/- 4.12 months; range, 17 days to 24 months), seven patients (9%) had died: one from sepsis, five from unrelated causes, and one from aneurysm rupture. The 2-year cumulative survival rate was 86% +/- 5.9%. Twenty-one subsequent endovascular or vascular procedures were necessitated (28%) in 17 patients (23%) to treat graft limb occlusion or stenosis (n = 9 patients) or to seal an endoleak (n = 8 patients). The 2-year cumulative survival rate free of reintervention was 67% +/- 7%. On CT scans, the mean AAA diameter decreased from 54 mm +/- 8.9 (range, 45 to 80 mm) before surgery to 51.6 mm +/- 9.1 at 6 months and to 43.4 mm +/- 4.4 at the end of the follow-up period (P =.001). Persistent endoleak was significantly associated with an increase in diameter (4 of 5 [80%] vs 1 of 47 [2%]; P =.001). CONCLUSION: In selected patients, the bifurcated Vanguard endovascular graft may be implanted with a low mortality and morbidity rate and a favorable mid-term survival rate. The decrease of the aneurysm size is a strong argument in favor of the efficiency of the device. However, lasting endoleaks with increased aneurysm diameter and occurrence of limb graft stenosis or occlusion raise concerns and justify a careful long-term follow-up monitoring of all patients who undergo treatment with endovascular technique.     

Prediction of rupture risk in abdominal aortic aneurysm during observation: wall stress versus diameter

OBJECTIVES: We previously showed that peak abdominal aortic aneurysm (AAA) wall stress calculated for aneurysms in vivo is higher at rupture than at elective repair. The purpose of this study was to analyze rupture risk over time in patients under observation. METHODS: Computed tomography (CT) scans were analyzed for patients with AAA when observation was planned for at least 6 months. AAA wall stress distribution was computationally determined in vivo with CT data, three-dimensional computer modeling, finite element analysis (nonlinear hyperelastic model depicting aneurysm wall behavior), and blood pressure during observation. RESULTS: Analysis included 103 patients and 159 CT scans (mean follow-up, 14 +/- 2 months per CT). Forty-two patients were observed with no intervention for at least 1 year (mean follow-up, 28 +/- 3 months). Elective repair was performed within 1 year in 39 patients, and emergent repair was performed in 22 patients (mean, 6 +/- 1 month after CT) for rupture (n = 14) or acute severe pain. Significant differences were found for initial diameter (observation, 4.9 +/-.1 cm; elective repair, 5.9 +/-.1 cm; emergent repair, 6.1 +/-.2 cm; P <.0001) and initial peak wall stress (38 +/- 1 N/cm(2), 42 +/- 2 n/cm(2), 58 +/- 4 N/cm(2), respectively; P <.0001), but peak wall stress appeared to better differentiate patients who later required emergent repair (elective vs emergent repair: diameter, 3% difference, P =.5; stress, 38% difference, P <.0001). Receiver operating characteristic (ROC) curves for predicting rupture were better for peak wall stress (sensitivity, 94%; specificity,81%; accuracy, 85% [with 44 N/cm(2) threshold]) than for diameter (81%, 70%, 73%, respectively [with optimal 5.5 cm threshold). With proportional hazards analysis, peak wall stress (relative risk, 25x) and gender (relative risk, 3x) were the only significant independent predictors of rupture. CONCLUSIONS: For AAAs under observation, peak AAA wall stress seems superior to diameter in differentiating patients who will experience catastrophic outcome. Elevated wall stress associated with rupture is not simply an acute event near the time of rupture.     

Persistent type 2 endoleak after endovascular repair of abdominal aortic aneurysm is associated with adverse late outcomes

OBJECTIVE: Type 2 endoleak occurs in up to 20% of patients after endovascular aneurysm repair (EVAR), but its long-term significance is debated. We reviewed our experience to evaluate late outcomes associated with type 2 endoleak. METHODS: During the interval January 1994 to December 2005, 873 patients underwent EVAR. Computed tomography (CT) scan assessment was performed < or =1 month of the operation and at least annually thereafter. Sequential 6-month CT scan follow-up was adopted for those patients with persistent type 2 endoleaks, and reintervention was limited to those with sac enlargement >5 mm. Study end points included overall survival, aneurysm sac growth, reintervention rate, conversion to open repair, and abdominal aortic aneurysm (AAA) rupture. Preoperative variables and anatomic factors potentially associated with these endpoints were assessed using multivariate analysis. RESULTS: We identified 164 (18.9%) patients with early (at the first follow-up CT scan) type 2 endoleaks. Mean follow-up was 32.6 months. In 131 (79.9%) early type 2 endoleaks, complete and permanent leak resolution occurred < or =6 months. Endoleaks persisted in 33 patients (3.8% of total patients; 20.1% of early type 2 endoleaks) for >6 months. Transient type 2 endoleak (those that resolved < or =6 months of EVAR) was not associated with adverse late outcomes. In contrast, persistent endoleak was associated with several adverse outcomes. AAA-related death was not significantly different between patients with and without a type 2 endoleak (P = .78). When evaluating patients with no early endoleak vs persistent endoleak, freedom from sac expansion at 1, 3, and 5 years was 99.2%, 97.6%, and 94.9% (no leak) vs 88.1%, 48.0%, and 28.0% (persistent) (P < .001). Patients with persistent endoleak were at increased risk for aneurysm sac growth vs patients without endoleak (odds ratio [OR], 25.9; 95% confidence interval [CI] 11.8 to 57.4; P < .001). Patients with a persistent endoleak also had a significantly increased rate of reintervention (OR, 19.0; 95% CI, 8.0 to 44.7); P < .001). Finally, aneurysm rupture occurred in 4 patients with type 2 endoleaks. Freedom from rupture at 1, 3, and 5 years for patients with a persistent type 2 endoleak was 96.8%, 96.8%, and 91.1% vs 99.8%, 98.5%, and 97.4% for patients without a type 2 endoleak. Multivariate analysis demonstrated persistent type 2 endoleak to be a significant predictor of aneurysm rupture (P = .03). CONCLUSIONS: Persistent type 2 endoleak is associated with an increased incidence of adverse outcomes, including aneurysm sac growth, the need for conversion to open repair, reintervention rate, and rupture. These data suggest that patients with persistent type 2 endoleak (>6 months) should be considered for more frequent follow-up or a more aggressive approach to reintervention.     

Endovascular aneurysm repair: gender-specific results

OBJECTIVES: The outcome for a wide variety of diseases and treatment methods varies by gender. In an effort to determine whether gender has a role in the outcome of endovascular aortic aneurysm repair, we analyzed data from consecutive patients treated at a single institution over 6 years. METHODS: Over 6 years ending in March 2002, 704 patients underwent endovascular repair of an infrarenal abdominal aortic aneurysm at The Cleveland Clinic. Six hundred six patients (86.1%) were men and 98 patients (13.9%) were women. Preprocedure and postprocedure imaging studies were evaluated to determine the frequency of aneurysm sac shrinkage or growth, defined as diameter change equal to or greater than 5 mm. Presence and type of endoleak was assessed with non-contrast material-enhanced, post-contrast-enhanced, and delayed post-contrast-enhanced computed tomography scans. These and other clinical variables were assessed with the Kaplan-Meier method and the Cox-Mantel log-rank test, and values were expressed as mean +/- SE. RESULTS: Male and female patients were comparable with respect to baseline comorbid conditions. Women, however, were slightly older (76.7 +/- 0.7 years vs 74.4 +/- 0.3 years; P =.009), and had slightly smaller aneurysms (5.2 +/- 0.1 cm vs 5.4 +/- 0.04 cm; P =.033). There were no gender-specific differences in perioperative mortality (men, 1.3%; women, 3.1%; P =.197) or mid-term (24 months) survival (men, 80% +/- 2.6%; women, 78% +/- 8.1%). Similarly, there were no differences at 24 months in risk for graft migration (7.5% +/- 2.0% vs 5.4% +/- 3.2%), need for secondary remedial procedures (24% +/- 2.9% vs 21% +/- 6.3%), conversion to open surgery (3.9% +/- 1.5% vs 3.8% +/-2.7%), or post-repair aneurysm rupture (1.1% +/- 0.9% vs 2.2% +/-2.2%) in male and female patients, respectively. In contrast, risk for graft limb occlusion at 24 months was significantly higher in women than in men (11% +/- 5.2% vs 3.3% +/- 1.1%; P =.022). While frequency of endoleak of any type did not differ among male and female patients, aneurysm sac shrinkage at 24 months was more rapid in women (76% +/- 8.1% vs 57% +/- 3.5%; P =.019). CONCLUSIONS: With the exception of slightly older age and somewhat smaller aneurysm, female patients are similar to male patients undergoing endovascular aneurysm repair. A greater frequency of graft limb occlusion was observed in female patients, but no statistically significant differences were detected in survival, rupture risk, or need for secondary procedures. Moreover, a more rapid rate of aneurysm sac shrinkage was detected in women. These observations suggest that endovascular aneurysm repair should be offered to suitable candidates irrespective of gender.     

Endovascular repair of abdominal aortic aneurysms: risk stratified outcomes

OBJECTIVE: The impact of co-morbid conditions on early and late clinical outcomes after endovascular treatment of abdominal aortic aneurysm (AAA) was assessed in concurrent cohorts of patients stratified with respect to risk for intervention. SUMMARY BACKGROUND DATA: As a minimally invasive strategy for the treatment of AAA, endovascular repair has been embraced with enthusiasm for all prospective patients who are suitable anatomical candidates because of the promise of achieving a durable result with a reduced risk of perioperative morbidity and mortality. METHODS: From April 1994 to March 2001, endovascular AAA repair was performed in 236 patients using commercially available systems. A subset of patients considered at increased risk for intervention (n = 123) were categorized, as such, based on a preexisting history of ischemic coronary artery disease, with documentation of myocardial infarction (60%) or congestive heart failure (35%), or due to the presence of chronic obstructive disease (21%), liver disease, or malignancy. RESULTS: Perioperative mortality (30-day) was 6.5% in the increased-risk patients as compared to 1.8% among those classified as low risk (P = NS). There was no difference between groups in age (74 +/- 9 years vs. 72 +/- 6 years; mean +/- SD), surgical time (235 +/- 95 minutes vs. 219 +/- 84 minutes), blood loss (457 +/- 432 mL vs. 351 +/- 273 mL), postoperative hospital stay (4.8 +/- 3.4 days vs. 4.0 +/- 3.9 days), or days in the ICU (1.3 +/- 1.8 days vs. 0.5 +/- 1.6 days). Patients at increased risk of intervention had larger aneurysms than low-risk patients (59 +/- 13 mm vs. 51 +/- 14 mm; P <.05). Stent grafts were successfully implanted in 116 (95%) increased-risk versus 107 (95%) low-risk patients (P = NS). Conversion rates to open operative repair were similar in increased-risk and low-risk groups at 3% and 5%, respectively. The initial endoleak rate was 22% versus 20%, based on the first CT performed (either at discharge or 1 month; P = NS). To date, increased-risk patients have been followed for 17.4 +/- 15 months and low-risk patients for 16.3 +/- 14 months. Kaplan-Meier analysis for cumulative patient survival demonstrated a reduced probability of survival among those patients initially classified as at increased risk for intervention (P <.05, Mantel-Cox test). Both cohorts had similar two-year primary and secondary clinical success rates of approximately 75% and 80%, respectively. CONCLUSIONS: Early and late clinical outcomes are comparable after endovascular repair of AAA, regardless of risk-stratification. Notably, 2 years after endovascular repair, at least one in five patients was classified as a clinical failure. Given the need for close life-long surveillance and the continued uncertainty associated with clinical outcome, caution is dictated in advocating endovascular treatment for the patient who is otherwise considered an ideal candidate for standard open surgical repair.     

The impact of gender on presentation, therapy, and mortality of abdominal aortic aneurysm in the United States, 2001-2004

INTRODUCTION: The elective repair of abdominal aortic aneurysms (AAA) may decrease a patient's risk of rupture and confers a significantly lower in-hospital mortality rate than emergency repair. Previous works have shown that AAA rupture rates are higher in women compared to men, and that women have higher associated in-hospital mortality rates. This study was performed to evaluate, currently, to what extent patient gender influences presentation and treatment of AAA and the associated outcomes in the United States. METHODS: The Nationwide Inpatient Sample was used, with pertinent ICD-9 codes, to identify all patient-discharges that occurred with the primary diagnosis of intact (iAAA) or ruptured/dissecting (rAAA) abdominal aortic aneurysms between the years 2001 and 2004. Univariate and multiple logistic regression analyses of variables were performed. RESULTS: An estimated 220,403 AAA patient-discharges were identified during the study period. 37,016 (17%) patients presented with rAAA. A higher percentage of women with AAA presented with rupture compared to men (21% vs 16%; odds ratio [OR] 1.40, 95% confidence interval [CI], 1.27-1.54). This rupture rate did not significantly change from 2001 to 2004 (P = .85 for trend). For iAAA, women had higher odds of in-hospital mortality than men (OR 1.60; 95% CI, 1.24-2.07). Compared to men, in-hospital mortality rates for women with iAAA were higher for both endovascular (2.1% vs 0.83%, P < .0001) and open repairs (6.1% vs 4.0%, P < .0001). For iAAA, fewer women underwent endovascular repair (32.4% vs 46.7%, P < .0001; O.R. 0.59, 95% CI, 0.52-0.67). For patients who presented with rAAA, women were less likely to undergo surgical intervention compared to men (59% vs 70%, P < .0001). For those that underwent repair, women had higher in-hospital mortality rates than men (43% vs 36%, P < .0001; OR 1.49, 95% CI, 1.16-1.91). CONCLUSION: A higher percentage of women currently present with aneurysm rupture. They have higher in-hospital mortality rates for both iAAA and rAAA. This gender difference in the outcomes following repair of abdominal aortic aneurysm has persisted over time, the cause of which is not explained by these or previous data, a fact that warrants further investigation.