Keyhole technique for autologous brachiobasilic transposition arteriovenous fistula.

BACKGROUND: Autologous brachiobasilic transposition arteriovenous fistulas (AVFs) are desirable but require long incisions and extensive surgical dissection. To minimize the extent of surgery, we developed a catheter-based technique that requires only keyhole incisions and local anesthesia. METHODS: The technique involves exposure and division of the basilic vein at the elbow. A guidewire is introduced into the vein, and a 6F "push catheter" is advanced over the guidewire and attached to the vein with sutures. Gently pushing the catheter proximally inverts, or intussuscepts, the vein. Side branches that are felt as resistances when pushing the catheter forward are localized, clipped, and divided under direct vision. Throughout the procedure, the endothelium always remains intraluminal. The basilic vein is externalized at the axilla without dividing it proximally and is tunneled subcutaneously, where it is anastomosed to the brachial artery. RESULTS: Thirty-two patients underwent the procedure--31 as outpatients. The mean duration of operation was less than 90 minutes. All patients tolerated the procedure well, and 31 required only intravenous sedation and local anesthesia. At a mean follow-up of 8 months, the primary patency rate of AVFs in patients with basilic vein diameters of 4 mm or more on preoperative duplex ultrasonography was 80%, vs 50% for those with vein diameters less than 4 mm. Overall, 78% of patent AVFs were being successfully accessed and 22% were still maturing at last follow-up. CONCLUSIONS: Autologous brachiobasilic transposition AVFs can be created by using catheter-mediated techniques that facilitate the mobilization and tunneling of the basilic vein through small incisions. Medium-term data suggest that the inversion method results in acceptable maturation and functionality of AVFs created with this technique.

Aortoiliac angulation and the need for secondary procedures to secure stent graft fixation: which angle is important?

BACKGROUND: The purpose of this study was to quantify the degree of aortoiliac tortuosity and determine the relationship between aortoiliac angulation and the need for a secondary procedure following endovascular repair. METHODS: Among 206 patients treated with the AneuRx stent graft, 3-year follow up data were available in 71 patients. Twenty eight patients without duplex and CT angiograms (CT angiography) on follow-up were excluded. The anatomy of the preoperative proximal aortic neck was evaluated using 3D-CT angiography reconstructed images in: a) Group I: 15 patients who required secondary procedures and b) Group II: 18 patients without any endovascular leak during follow up. The groups did not differ in age (72.9+/-6.1 versus 73.3+/-9.1) or aneurysm diameter (60.1+/-9.1 versus 60.5+/-10.1). In order to determine the aortoiliac tortuosity, we measured: a) the suprarenal aorta-infrarenal aortic neck angle: angle of the aorta at the level of the renal arteries, b) infrarenal aortic neck-aneurysm angle: angle of the aorta at the start of aneurysm, c) right iliac angle, d) left iliac angle, e) aortic neck length, f) aortic neck diameter. RESULTS: Computer-based measurements on 3D-CT angiography reconstructed images were: a) suprarenal aorta-infrarenal aortic neck angle: group I: (22.6+/-16.2), group II: (11.9+/-6.9), p<0.05; b) infrarenal aortic neck-aneurysm angle: group I: 17.6+/-12.4, group II: 18.8+/-9.4, p=NS; c) right iliac angle: group I: 22.9+/-12.6, group II: 20.4+/-9.5, p=NS; d) left iliac angle: group I: 22.4+/-10.5, group II: 19.1+/-12.2, p=NS; e) aortic neck length: group I: 18.9+/-5.3 mm, group II: 20.4+/-5.3 mm, p=NS; f) aortic neck diameter: group I: 24.1+/-1.0 mm, group II: 23.3+/-1.6, p=NS. CONCLUSIONS: Aortoiliac angulation can be defined and quantified. In patients requiring secondary procedures, there is an increased angulation at the proximal aortic neck angle.

Impact of endovascular repair on open aortic aneurysm surgical training.

PURPOSE: The purpose of this study was to determine the impact of an endovascular stent-graft program on vascular training in open aortic aneurysm surgery. METHODS: The institutional and vascular surgery fellow experience in aortic aneurysm repair during a 6-year period was reviewed. The 3-year period before introduction of endovascular repair was compared with the 3-year period after introduction of endovascular repair. All patients undergoing abdominal aortic aneurysm (AAA) or thoracoabdominal aortic aneurysm repairs were entered prospectively into a vascular registry and retrospectively analyzed to evaluate the changing patterns in aortic aneurysm treatment and surgical training. RESULTS: Between July 1994 and June 2000, a total of 588 patients with AAA or thoracoabdominal aneurysms were treated at Stanford University Medical Center. There were 296 (50%) open infrarenal AAA repairs, 87 (15%) suprarenal AAA repairs, 47 (8%) thoracoabdominal aneurysm repairs, and 153 (26%) endovascular stent-grafts. The total number of aneurysms repaired per year by vascular fellows before the endovascular program was 71.3 +/- 4.9 (range, 68-77) and increased to 124.7 +/- 35.6 (range, 91-162) after introduction of endovascular repair (P <.05). This increase was primarily caused by the addition of endovascular stent-graft repairs by vascular fellows (51.0 +/- 29.0/year [range, 23-81]). There was no change in the number of open infrarenal aortic aneurysm repairs per year, 53.0 +/- 6.6 (range, 48-56) before endovascular repair versus 47.0 +/- 1.7 (range, 46-49) after (P = not significant). There was a significant increase in the number of suprarenal AAA repairs per year by vascular fellows, 10.0 +/- 1.0 (range, 9-11) before endovascular repair compared with 19.0 +/- 6.5 (range, 13-26) after (P <.05). There was no change in the number of thoracoabdominal aneurysm repairs per year between the two groups, 8.0 +/- 3.0 (range, 4-11) before endovascular repair compared with 7.6 +/- 2.3 (range, 5-9) after. CONCLUSIONS: Introduction of an endovascular aneurysm stent-graft program significantly increased the total number of aneurysms treated. Although the number of open aneurysm repairs has remained the same, the complexity of the open aneurysm experience has increased significantly for vascular fellows in training.

Type-II endoleaks following endovascular AAA repair: preoperative predictors and long-term effects.

PURPOSE: To determine the significance of persistent type-II endoleaks and whether they can be predicted preoperatively in patients with abdominal aortic aneurysms (AAA). METHODS: The charts of all AAA patients treated with the AneuRx stent-graft at a single center from 1996 to 1998 were reviewed. Patients with <12-month follow-up or type-I endoleaks were excluded. The presence or absence of type-II endoleaks was determined from duplex imaging and computed tomographic angiography. Three groups were identified and compared: 16 patients with persistent type-II endoleaks (PE), 14 patients with transient type-II endoleaks (TE), and 16 patients with no endoleak (NE). RESULTS: The groups did not differ with regard to age, preoperative comorbidities, follow-up time, and AAA neck diameter and length. AAA diameters were 57.1 +/- 9.0 mm for NE, 63.4 +/- 11.4 mm for TE, and 55.6 +/- 4.2 mm for PE. The inferior mesenteric artery (IMA) was patent in 5 (31%) NE patients, 6 (43%) TE patients, and 13 (81%) PE patients (p < 0.01). The number of patent lumbar arteries visualized preoperatively was 0.5 +/- 1.0 in NE, 1.3 +/- 0.8 in TE, and 2.4 +/- 0.6 in PE (p < 0.0001). Patent IMAs (RR 0.82, p < 0.01) and >2 lumbar arteries (RR 0.40, p < 0.0001) were identified as independent preoperative risk factors for persistent endoleaks. There were no changes in mean diameter or volume in aneurysms with persistent endoleaks. CONCLUSIONS: No adverse clinical events were related to the presence of type-II endoleaks, but there was no decrease in aneurysm size in patients with persistent type-II leaks. Patients with a large, patent IMA, or >2 lumbar arteries on preoperative CT angiography are at higher risk for persistent type-II endoleaks.

Impact of aortoiliac tortuosity on endovascular repair of abdominal aortic aneurysms: evaluation of 3D computer-based assessment.

OBJECTIVE: The purpose of this study was to examine the effect of aortoiliac tortuosity, as assessed by observers and 3-dimensional (3D) computer-based methods, on the conduct and outcome of endovascular repair of abdominal aortic aneurysms. METHODS: Infrarenal aortoiliac tortuosity was measured in 75 patients (mean follow-up, 14.8 +/- 10.4 months) who underwent endovascular repair of abdominal aortic aneurysms by using the following four methods: (1) grading by 2 experienced observers; (2) tortuosity index measured as the inverse radius of curvature (cm(-1)) at 1-mm intervals along the median luminal centerline (MLC) on 3D reconstructions of computed tomography (CT) angiograms and was calculated as the sum of values greater than 0.3 cm(-1); (3) MLC-straight line length ratio from renal to hypogastric arteries; (4) manual measurement of angles at points of angulation on anteroposterior and lateral projections of 3D CT reconstructions. In evaluating association between these measures, correlation between human observers was accepted as the gold standard. RESULTS: For rating of overall aortoiliac tortuosity, interobserver correlation (r = 0.67) was comparable with correlation of observers with tortuosity index (r = 0.67 and 0.56), whereas correlations of each observer with MLC-straight line ratio (r = 0.50 and 0.56) and cumulative angulation (r = 0.44 and 0.44) were significant but weaker. For determining the relative tortuosity of right and left aortoiliac access, agreement between observers and tortuosity index (54% and 58%; P < .05; kappa, 0.33 and 0.38) was not as good as between observers (68%; P < .001; kappa, 0.53). This difference was primarily related to evaluation of the aorta, where interobserver correlation (r = 0.71) was better than that between each observer and tortuosity index (r = 0.47 and 0.55), whereas correlations in the iliac arteries were comparable (r = 0.64 and 0.67) (all coefficients P < .01). Increased tortuosity was associated with a more complex endovascular repair, as reflected by longer fluoroscopy time (P = .05), use of more contrast material (P = .03), use of extender modules (P = .04), and more frequent use of arterial reconstruction (P = .01), but was not associated with a higher overall complication rate. Increased tortuosity, when it occurred in the aortic neck, was associated with predischarge endoleak (P = .03) but not with late endoleak, intervention, or aneurysm-related adverse events. CONCLUSION: Aortoiliac tortuosity is associated with increased complexity of endovascular aneurysm repair and with predischarge endoleak but does not appear to affect intermediate-term results. Computer-based 3D measurement of aortoiliac tortuosity is feasible and clinically meaningful. Its ultimate role in relation to human assessment must be further defined in future studies.

Outcome after unilateral hypogastric artery occlusion during endovascular aneurysm repair.

PURPOSE: The purpose of this study was to determine the long-term functional outcome after unilateral hypogastric artery occlusion during endovascular stent graft repair of aortoiliac aneurysms. METHODS: During a 41-month period, 157 consecutive patients underwent elective endovascular stent graft repair of aortoiliac aneurysms with the Medtronic AneuRx device. Postoperative computed tomography scans were compared with preoperative scans to identify new hypogastric artery occlusions. Twenty-three (15%) patients had unilateral hypogastric occlusion, and there were no cases of bilateral occlusions. Telephone interviews about past and current levels of activity and symptoms were conducted, and pertinent medical records were reviewed. All 23 (100%) patients were available for the telephone interview. A disability score (DS) was quantitatively graded on a discrete scale ranging from 0 to 10 corresponding to "virtually bed-bound" to "greater-than-a-mile" exercise tolerance. Worsening or improvement of symptoms was expressed as a difference in DS between two time points (-, worsening/+, improving). RESULTS: Among the 23 patients, two groups were identified: 10 patients (43%) had planned and 13 patients (57%) had unplanned or inadvertent occlusions. The patients in the two groups did not differ significantly in the mean age (73.4 vs 73.7 years), sex (male:female, 9:1 vs 10:3), and duration of follow-up (15.6 vs 14.4 months). Nine (39%) of the 23 patients, five patients in the planned and four patients in the unplanned group, reported significant symptoms of hip and buttock claudication ipsilateral to their occluded hypogastric arteries. The mean decrement from baseline of these nine patients in their DS postoperatively was -3.3. The symptoms were universally noted on postoperative day 1. Although most patients improved (89%), one (11%) never got better. Among those whose symptoms improved, the mean time to improvement was 15 weeks, but with a plateau thereafter resulting in a net decrement of DS of -2.3 from baseline. Finally, when questioned whether they would undergo the procedure again, all 23 patients unanimously answered, "Yes." CONCLUSIONS: A significant number (39%) of patients who sustain hypogastric artery occlusion after endovascular aneurysm repair have symptoms. Although most patients with symptoms have some improvement, none return to their baseline level of activity. Despite this, all patients in retrospect would again choose endovascular repair over conventional open repair.

Endovascular exclusion of descending thoracic aortic aneurysms and chronic dissections: Initial clinical results with the AneuRx device.

OBJECTIVE: The objective of this study was to analyze a single-center experience in which descending thoracic aortic aneurysms (TAAs) were treated with a new self-expanding endovascular prosthesis (Medtronic AVE). METHODS: Twenty-six patients (13 men, 13 women) with American Society of Anesthesiology grades II to IV and ages ranging from 53 to 92 years (average, 74 years) consented as part of a Phase I Food and Drug Administration-approved trial. Treated lesions included TAAs that were 5 to 10 cm in diameter, 12 diffuse dilations or fusiform aneurysms, and four saccular aneurysms. There were also nine chronic dissections (2 aneurysmal dilations and 7 symptomatic acute recurrent dissections). Three patients (2 with diffuse/fusiform and 1 with dissection) presented with hemothorax, contrast extravasation, or both. RESULTS: Twenty-five of the 26 patients who consented (96% technical success) were treated successfully with no surgical conversions. Eighteen patients have been followed up from 1 to 22 months (average, 9 months). One patient is lost to follow-up, and six patients have died (24%). One procedure-related death (4%) occurred within the 30-day postoperative period and was caused by diffuse embolization. There were no device-related deaths. Five additional patients (20%) have died during the study of comorbid conditions. Complications included one massive myocardial infarction 24 hours after the procedure requiring balloon counterpulsation and long-term dialysis, one cardiac tamponade resulting from central line placement before the procedure, one progression of aneurysm dilation proximal to the device at 1 year, and one bilateral lower extremity paralysis occurring 12 hours after successful deployment. Seven patients (5 women) had femoral artery reconstructions or iliac artery grafts to repair injuries during deployment catheter passage. Other significant parameters included average procedure time (2 hours 40 minutes; range, 1 hour 30 minutes to 5 hours 30 minutes), 450 cc average blood loss (n = 25; 100-3000 cc) being replaced by means of autotransfusion with only two patients receiving banked blood products, and an average 2 days to resumption of normal diet, 1 day in the intensive care unit, and 5 days' hospitalization postprocedure in uncomplicated cases (n = 22). One patient had an endoleak immediately after the procedure that sealed without treatment. Follow-up of all patients ranging from 1 to 22 months (average, 9 months; n = 18) demonstrates continued exclusion of the aneurysm with no endoleaks and either stable or decreasing aneurysm volume, except in one patient with volume increase and no obvious etiology who continues to be investigated. CONCLUSIONS: The study suggests that endovascular prosthesis exclusion of TAAs with an AneuRx self-expanding tubular device may be effective in many patients who are at significant risk for open surgical repair and substantiates further clinical investigation to confirm these findings.

Eccentric stent graft compression: an indicator of insecure proximal fixation of aortic stent graft.

PURPOSE: The purpose of this study was to determine whether radiographically demonstrated proximal stent graft contour can be used as a marker for security of proximal neck fixation after endovascular aneurysm repair. METHODS: Stent graft structure was examined in 100 consecutive patients with abdominal aortic aneurysms who were treated with the stent graft. Stent graft integrity, stent contour, angulation, compression, and position were assessed by use of plain abdominal radiography, and the results were correlated with contrast computed tomography (CT) scanning, clinical findings, and outcomes. Repeated imaging was carried out during follow-up of 3 to 38 (mean, 12) months. RESULTS: Stent graft repair was successful in all 100 patients. No stent fractures were identified. Concentric compression of the proximal portion of the stent graft was visible in 69% of patients and reflected deliberate oversizing of the stent graft at the time of implantation. In 5% of patients, a short eccentric compression deformity of the proximal stent was observed. This finding was associated with an increased risk of stent graft migration (P <.01) and with an increased risk for development of a late proximal (type I) endoleak (P <.01). Compared with CT scanning, abdominal radiography was less useful for assessment of short distances of migration (sensitivity 67%; specificity 79%). However, they provided better definition of the stent graft in relation to bony landmarks and better visualization of aortic calcification than CT with three-dimensional reconstruction. CONCLUSION: Plain abdominal radiographs are important in the postoperative evaluation of patients with aortic stent grafts. They allow for more precise evaluation of the structural elements of the stent graft than CT scanning and may disclose inadequate proximal fixation by demonstration of an eccentric compression deformity. They are less useful for assessment of migration.

The AneuRx stent graft: four-year results and worldwide experience 2000.

OBJECTIVE: The objective was to review the current results of endovascular abdominal aortic aneurysm repair with the AneuRx stent graft and to determine the effectiveness of the device in achieving the primary objective of preventing aneurysm rupture. METHODS: The outcome of all patients treated during the past 4 years in the U.S. AneuRx clinical trial was determined, and the worldwide clinical experience was reviewed. RESULTS: A total of 1192 patients were treated with the AneuRx stent graft during all phases of the U.S. Clinical Trial from June 1996 to November 1999, with follow-up extending to June 2000. Ten (0.8%) patients have had aneurysm rupture, with most ruptures (n = 6) occurring in 174 (3.4%) patients treated with an early stiff bifurcation stent graft design used in phase I and in the initial stages of phase II. Since the current, flexible, segmented bifurcation stent graft design was introduced, four (0.4%) ruptures have occurred among 1018 patients treated. Of these, one was during implantation, two were placed too far below the renal arteries, and one patient refused treatment of a type I endoleak. Kaplan-Meier analysis of all 1192 patients treated with the AneuRx stent graft including both stent graft designs revealed the patient survival rate to be 93% at 1 year, 88% at 2 years, and 86% at 3 years, freedom from conversion to open repair to be 98% at 1 year, 97% at 2 years, and 93% at 3 years, and freedom from secondary procedure to be 94% at 1 year, 92% at 2 years, and 88% at 3 years. Freedom from aneurysm rupture with the commercially available segmented bifurcation stent graft was 99.7% at 1 year, 99.5% at 2 years, and 99.5% at 3 years. The presence or absence of endoleak on contrast computed tomography scanning after stent graft placement was not found to be a significant predictor of long-term outcome measures. Worldwide experience with the AneuRx device now approaches 10,000 patients. CONCLUSIONS: Endovascular management of abdominal aortic aneurysms with the AneuRx stent graft has markedly reduced the risk of aneurysm rupture while eliminating the need for open aneurysm surgery in 98% of patients at 1 year and 93% of patients at 3 years. The device was effective in preventing aneurysm rupture in 99.5% of patients over a 3-year period. The overall patient survival rate was 93% at 1 year and 86% at 3 years.

Endovascular stent-grafts for the repair of infrarenal abdominal aortic aneurysms: a brief review.

In the United States nearly 1.5 million people have abdominal aortic aneurysms (AAAs). The natural history of AAAs is to enlarge and rupture. Rupture of an AAA results in an estimated 15,000 deaths per year. The major objective in the treatment of AAAs is to prevent aneurysm rupture and death. Endoluminal grafting for the treatment of aortic aneurysms is the most exciting topic in vascular surgery today. It is anticipated that approximately half of all aneurysms in the infrarenal abdominal and descending thoracic aorta will be repaired endovascularly in the future. Despite the enthusiasm for this technology, there are unanswered questions like the long-term fate of the device, management of endoleaks, and the ability to protect the patient from subsequent rupture. This article describes the two FDA approved devices in clinical use today and the indications, techniques, and potential pitfalls of endoluminal stent-grafting for the treatment of AAAs.

Increased flexibility of AneuRx stent-graft reduces need for secondary intervention following endovascular aneurysm repair.

PURPOSE: To evaluate the impact of a change in the manufacturing of the AneuRx stent-graft on the long-term results of endovascular abdominal aortic aneurysm (AAA) repair. METHODS: The first 70 AAA patients treated with the AneuRx stent-graft between October 1996 and December 1998 were reviewed. The early stiff bifurcated design (STIFF) was used in 23 patients (mean age 71.7 +/- 9.3 years, range 45-87) and the current flexible bifurcated design (FLEX) in 47 mean age 75.0 +/- 7.3 years, range 61-96). Data on patient demographics, aneurysm morphology, technical success, complications, secondary procedures, and outcomes were compared using Kaplan-Meier estimates to evaluate patient survival and freedom from surgical conversion, rupture, and secondary interventions at 6, 12, and 24 months. RESULTS: The 2 groups were equally matched with regard to age, preoperative comorbidities, proximal neck dimensions, and aneurysm diameter. Mean follow-up times were 22.42 +/- 11.72 months (range 1-46) for the STIFF cohort and 18.08 +/- 6.14 months (range 1-30) for the FLEX (p = 0.057). Eleven (48%) of 23 STIFF patients required secondary interventions versus 6 (13%) of 47 FLEX patients (p < 0.05). There were no ruptures. At the 24-month interval, survival estimates were 86% for STIFF and 76% for FLEX (p = NS); freedom from surgical conversion was 100% for STIFF and 97% for FLEX (p = NS) and freedom from secondary interventions was 18% for STIFF and 90% for FLEX (p < 0.05) at 24 months. CONCLUSIONS: The AneuRx stent-graft was effective in achieving the primary objective of preventing aneurysm rupture in all patients. However, increasing the flexibility of the bifurcated module significantly improved the primary success rate by reducing the need for subsequent secondary interventions.

Duplex ultrasound scanning versus computed tomographic angiography for postoperative evaluation of endovascular abdominal aortic aneurysm repair.

OBJECTIVE: The purpose of this study was to compare duplex ultrasound scanning and computed tomographic (CT) angiography for postoperative imaging and surveillance after endovascular repair of abdominal aortic aneurysm (AAA). METHODS: One hundred consecutive patients with AAA underwent endovascular (Medtronic AneuRx, stent graft) aneurysm repair and were imaged with both CT angiography and duplex ultrasound scanning at regular intervals after the procedure. Each imaging modality was evaluated for technical adequacy and for documentation of aneurysm size, endoleak, and graft patency. In concurrent scan pairs, accuracy of duplex scanning was compared with CT. RESULTS: A total of 268 CT scans and 214 duplex scans were obtained at intervals of 1 to 30 months after endovascular aneurysm repair (mean follow-up interval, 9+/-7 months). All CT scans were technically adequate, and 198 (93%) of 214 duplex scans were technically adequate for the determination of aneurysm size, presence of endoleak, and graft patency. Concurrent (within 7 days of each other) scan pairs were obtained in 166 instances in 76 patients (1-6 per patient). The maximal transverse aneurysm sac diameter measured with both methods correlated closely (r = 0.93; P <.001) without a significant difference on paired analysis. In 92% of scans, measurements were within 5 mm of each other. Diagnosis of endoleak on both examinations correlated closely (P <.001), and compared with CT, duplex scanning had a sensitivity of 81%, a specificity of 95%, a positive predictive value of 94%, and a negative predictive value of 90%. Discordant results occurred in 8% of examinations, and in none of these was the endoleak close to the attachment sites or associated with aneurysm expansion. An endoleak was demonstrated on both tests in all eight patients who had an endoleak judged severe enough to warrant arteriography. Graft patency was documented in each instance, without discrepancy, with both modalities. CONCLUSIONS: High-quality duplex ultrasound scanning is comparable to CT angiography for the assessment of aneurysm size, endoleak, and graft patency after endovascular exclusion of AAA.

Will endovascular repair replace open surgery for abdominal aortic aneurysm repair?

OBJECTIVE: To evaluate of the impact of endovascular aneurysm repair on the rate of open surgical repair and on the overall treatment of abdominal aortic aneurysms (AAAs). METHODS: All patients with AAA who were treated during two consecutive 40-month periods were reviewed. During the first period, only open surgical repair was performed; during the subsequent 40 months, endovascular repair and open surgical repair were treatment options. RESULTS: A total of 727 patients with AAA were treated during the entire period. During the initial 40 months, 268 patients were treated with open surgical repair, including 216 infrarenal (81%), 43 complex (16%), and 9 ruptured (3%) aortic aneurysms. During the subsequent 40 months, 459 patients with AAA were treated (71% increase). There was no significant change in the number of patients undergoing open surgical repair and no significant difference in the rate of infrarenal (238 [77%]) and complex (51 [16%]) repairs. A total of 353 patients were referred for endovascular repair. Of these, 190 (54%) were considered candidates for endovascular repair based on computed tomography or arteriographic morphologic criteria. Analyzing a subgroup of 123 patients, the most common primary reasons for ineligibility for endovascular repair were related to morphology of the neck in 80 patients (65%) and of the iliac arteries in 35 patients (28%). A total of 149 patients underwent endovascular repair. Of these, the procedure was successful in 147 (99%), and 2 (1%) patients underwent surgical conversion. The hospital death rate was 0%, and the 30-day death rate was 1%. During a follow-up period of 1 to 39 months (mean 12 +/- 9), 21 secondary procedures to treat endoleak (20) or to maintain graft limb patency (1) were performed in 17 patients (11%). There were no aneurysm ruptures or aneurysm-related deaths. CONCLUSIONS: Endovascular repair appears to have augmented treatment options rather than replaced open surgical repair for patients with AAA. Patients who previously were not candidates for repair because of medical comorbidity may now be safely treated with endovascular repair.

Endovascular repair of abdominal aortic aneurysms: eligibility rate and impact on the rate of open repair.

OBJECTIVE: The purpose of this study was to determine the rate of eligibility among patients with abdominal aortic aneurysms (AAAs) considered for endovascular repair and to examine the effect of an endovascular program on the institutional pattern of AAA repair. METHODS: All patients evaluated for endovascular AAA repair since the inception of an endovascular program were reviewed for determination of eligibility rates and eventual treatment. Open AAA repairs were categorized as simple (uncomplicated infrarenal), complex (juxtarenal, suprarenal, thoracoabdominal, infected), or ruptured, and their rates before and after initiation of an endovascular program were compared. RESULTS: Over 3 years, 324 patients were considered for endovascular AAA repair; 176 (54%) were candidates, 138 (43%) were not candidates, and 10 (3%) did not complete the evaluation. The rate of eligibility increased significantly from 45% (66/148 patients) during the first half of this period to 63% (110/176 patients) during the second half (P <. 001). Candidates were significantly younger (74.4 +/- 7.6 years) than noncandidates (78.3 +/- 6.7 years) (P <.01), and their aneurysm diameter tended to be smaller (57.6 +/- 9.2 mm compared with 60.8 +/- 12.3 mm; P =.06). The most common reason for ineligibility was an inadequate proximal aortic neck. Of 176 candidates, 78% underwent endovascular repair, and 6% underwent open repair. Of 138 noncandidates, 56% underwent surgical repair. Over a period of 6 years, 542 patients with AAAs (429 simple, 86 complex, 27 ruptured) underwent open repair. The total number and ratio of simple to complex open repairs for nonruptured aneurysms during the 3 years before the initiation of the endovascular program (213 simple, 44 complex) were not significantly different from the repairs over the subsequent 3-year period (216 simple, 42 complex). Similarly, no difference in the total number and the ratio of simple to complex open repairs was found between the first and the second 18-month periods since the initiation of the endovascular program. CONCLUSIONS: The rate of eligibility of patients with AAA for endovascular repair appears to be higher than previously reported. The presence of an active endovascular program has not decreased the number or shifted the distribution of open AAA repair.

Endoleak as a predictor of outcome after endovascular aneurysm repair: AneuRx multicenter clinical trial.

OBJECTIVE: The purpose of this study was to determine whether evidence of blood flow in the aneurysm sac (endoleak) is a meaningful predictor of clinical outcome after successful endovascular aneurysm repair. METHODS: We reviewed all patients in Phase II of the AneuRx Multicenter Clinical Trial with successful stent graft implantation and predischarge contrast computed tomographic (CT) imaging. The clinical outcome of patients with evidence of endoleak was compared with the outcome of patients without evidence of endoleak. The CT endoleak status before hospital discharge at 6, 12, and 24 months was determined by each clinical center as well as by an independent core laboratory. Endoleak status at 1 month was assessed with duplex scanning examination or CT at each center without confirmation by the core laboratory. RESULTS: Centers reported endoleaks in 152 (38%) of 398 patients on predischarge CT, whereas the core laboratory reported endoleaks in 50% of these patients (P <.001). The center-reported endoleak rate decreased to 13% at 1 month. Follow-up extended to 2 years (mean, 10 +/- 4 months). One patient had aneurysm rupture and underwent successful open repair at 14 months. This patient had a Type I endoleak at discharge but no endoleak at 1 month or at subsequent follow-up times. There were no differences between patients with and patients without endoleak at discharge in the following outcome measures: patient survival, aneurysm rupture, surgical conversion, the need for an additional procedure for endoleak or graft patency, aneurysm enlargement more than 5 mm, the appearance of a new endoleak, or stent graft migration. Despite a higher endoleak rate identified by the core laboratory, neither the endoleak rate reported by the core laboratory nor the endoleak rate reported by the center at discharge was significantly related to subsequent outcome measures. Patients with endoleak at 1 month were more likely to undergo an additional procedure for endoleak than patients without endoleaks. Patients with Type I endoleaks at discharge and patients with endoleak at 1 month were more likely to experience aneurysm enlargement at 1 year. However, there was no difference in patient survival, aneurysm rupture rate, or primary or secondary success rate between patients with or without endoleak. Actuarial survival of all patients undergoing endovascular aneurysm repair was 96% at 1 year and was independent of endoleak status. Primary outcome success was 92% at 12 months and 88% at 18 months. Secondary outcome success was 96% at 12 months and 94% at 18 months. CONCLUSIONS: The presence or absence of endoleak on CT scan before hospital discharge does not appear to predict patient survival or aneurysm rupture rate after endovascular aneurysm repair using the AneuRx stent graft. Although the identification of blood flow in the aneurysm sac after endovascular repair is a meaningful finding and may at times indicate inadequate stent graft fixation, the usefulness of endoleak as a primary indicator of procedural success or failure is unclear. Therefore, all patients who have undergone endovascular aneurysm repair should be carefully followed up regardless of endoleak status.

Rate of change in abdominal aortic aneurysm diameter after endovascular repair.

OBJECTIVE: Untreated abdominal aortic aneurysms (AAAs) enlarge at a mean rate of 3.9 mm/y with great individual variability. We sought to determine the effect of endovascular repair on the rate of change in aneurysm size. METHODS: There were 110 patients who underwent endovascular AAA repair at Stanford University Medical Center and who were followed up for 1 to 30 months (mean, 10 months) with serial contrast-infused helical computed tomography (CT). Maximal aneurysm diameter was determined using two independent methods: (1) measured manually, from cross-sectional computed tomography (XSCT) angiograms and (2) calculated from quantitative three-dimensional computed tomography (3DCT) data as orthonormal diameter. RESULTS: Maximal cross-sectional aneurysm diameter measured by hand (XSCT) and calculated as orthonormal values (3DCT) correlated closely (r = 0.915; P <.001). The XSCT-measured diameter was larger by 2.3 +/- 3. 75 mm (P <.001), and the 95% CI for SE of the bias was 1.85 to 2.75 mm. Preoperative aneurysm diameter (XSCT 59.1 +/- 8.4 mm; 3DCT 58.1 +/- 9.3 mm) did not differ significantly from the initial postoperative diameter. Considering all patients, XSCT diameter decreased at a rate of 0.34 +/- 0.69 mm/mo, and 3DCT diameter decreased at a rate of 0.28 +/- 0.79 mm/mo. Aneurysms in patients without endoleaks had a higher rate of decrease, an XSCT diameter by 0.50 +/- 0.74 mm/mo, and 3DCT diameter by 0.46 +/- 0.84 mm/mo. In these patients, mean absolute decrease in diameter at 6 months was 3. 4 +/- 4.5 mm (XSCT) and 3.3 +/- 5.9 mm (3DCT) and at 12 months, 5.9 +/- 5.7 mm (XSCT) and 5.4 +/- 5.7 mm (3DCT). Aneurysms in patients with persistent endoleaks did not change in mean XSCT diameter, and 3DCT diameter increased by 0.12 +/- 0.52 mm/mo (not significant). Aneurysm diameter remained within 4 mm of original size in 68% (3DCT) to 71% (XSCT) of patients. In one patient, aneurysm diameter increased (XSCT and 3DCT) more than 5 mm. Four patients who had a new onset endoleak had a much higher expansion rate than those with a chronic endoleak (P <.05). CONCLUSIONS: The rate of decrease in aneurysm size (annualized 3.4-4.1 mm/y) after endovascular repair of AAA approximates the reported expansion rate in untreated aneurysms. However, individual aneurysm behavior is unpredictable, and the presence of an endoleak is unreliable in predicting changes in diameter. New onset endoleaks are associated with an enlargement rate greater than that of untreated aneurysms.