Outcomes Of Endovascular Aneurysm Repair Research Articles

Endovascular Abdominal Aortic Aneurysm Repair: 5-Year Follow-Up Results

Endovascular aneurysm repair (EVAR) offers a minimally invasive alternative to open repair and has the benefits of reduced perioperative morbidity and mortality. There are potential complications specific to EVAR, including device failure, graft migration, and endoleak, which necessitate long-term follow-up. This remains a relatively novel technique, and therefore, little long-term data exist. This study reports 5-year EVAR outcome data from a single center. Five-year follow-up data for 58 patients at a single center who underwent EVAR using a variety of different commercial devices was reviewed. All patients were followed up with 6-monthly duplex ultrasound scanning and clinical assessment in a nurse-led clinic, in addition to yearly computed tomographic (CT) scans for those participating in the EVAR trial. All patients in this series were male, with a median age of 72 years (range 58-81). Mean preoperative aortic diameter was 5.95 cm, and this reduced following EVAR to 5.2 cm (mean diameter) at 5 years. Mean hospital stay was 7 days, and there were no perioperative deaths. There were 20 (34%) early and 15 (26%) late complications. There were 13 endoleaks confirmed on CT; four (31%) were type I and nine (69%) were type II. All-cause mortality was 26%. There were no late aneurysm-related deaths. EVAR has the advantages of shorter hospital stay and reduced perioperative morbidity and mortality. Long-term follow-up remains a priority following aortic stenting in order to detect late complications such as endoleak.

A Model to Predict Outcomes for Endovascular Aneurysm Repair Using Preoperative Variables

Models have been developed to predict the likely outcomes of endovascular aneurysm repair (EVAR) for patients, based on a longitudinal Australian audit. Mid-term progress of 961 Australian patients who underwent EVAR has been collected and used to develop predictive models for 17 outcomes. Stepwise forward logistic regressions determined the significant preoperative patient variables to be included in each outcome model. An interactive program was subsequently developed to allow surgeons to review the predicted success rates for patients about to undergo the procedure. Each model was assessed using a global goodness of fit test and was internally validated using bootstrapping. Eight pre-operative variables were included in the interactive model for 17 outcomes. The eight variables used were aneurysm size, age, ASA, gender, creatinine, aortic neck angle, infrarenal neck diameter and infrarenal neck length. The outcomes predicted included perioperative mortality, perioperative morbidity, mid-term survival and reintervention rates. All outcome models achieved reasonable goodness of fit, with the exception of the model for conversion to open repair (p=0.04). With respect to validation, survival, aneurysm related deaths, migrations, ruptures and conversions to open repair performed best in terms of predictive discrimination. Models for survival, migrations and conversions to open repairs performed best in terms of bias corrected R-squared index. The models with the smallest calibration error were 3 and 5 year survival, early deaths and mid-term type I endoleaks. An interactive model is available, which can assist vascular surgeons to evaluate the expected outcomes for a particular patient undergoing EVAR. The validated model is useful for counselling and pre-operative decision making.

Mid-term results of endovascular aneurysm repair with branched and fenestrated endografts

Mid-term results of endovascular aneurysm repair with branched and fenestrated endografts

Renal Transplantation After Endovascular Repair of Abdominal Aortic Aneurysm

An increasing number of abdominal aortic aneurysms (AAA) occur in renal failure patients because of strong association between atherosclerosis and chronic kidney disease. Endovascular aneurysm repair (EVAR) has proven to be an effective modality to treat AAA, particularly in patients with renal disease, because of its several advantages over the standard open procedure, including lower morbidity, shorter operative time, and shorter hospital stay. A Medline search showed a single publication on renal transplantation (RT) following EVAR of AAA. In this context, we report our case of successful RT in a patient who had undergone EVAR 2 years prior for a 5.7-cm AAA. No stent-related complications, such as graft occlusion, dislodgement, dissection, or endoleak, were observed in the perioperative period. The transplanted kidney had primary function leading to a stable serum creatinine of 115 μmol/L at 6 months. Although the long-term outcome of RT after endovascular repair of AAA remains unknown, currently available evidence shows favorable outcomes of EVAR in the normal population, in patients with renal diseases, and in RT recipients; hence, RT should not be denied to renal failure patients who have undergone EVAR in the past.

Thrombus and Calcium in Aortic Aneurysm Necks: Validation of a Scoring System in a Dutch Cohort Study

This study was conducted to validate a proposed classification system on the characteristics of the abdominal aortic aneurysm neck. The cohort comprised 100 consecutive patients who underwent open or endovascular aneurysm repair. Aneurysm neck characteristics of diameter, calcium, thrombus, and angulation were reviewed. The presence of calcium at the aortic aneurysm wall was associated with lower body mass index. Thrombus was found in 52% of the patients. Hypertension was correlated with the presence of aortic wall thrombus. At the renal artery level, angulation was anterior in 56%, right lateral in 39%, and left lateral in 27%. At the origin of the aneurysm, angulation was posterior in 76%, right lateral in 46%, and left lateral in 42%. A wide variety in these characteristics was found. A scoring system allows comparison of patient characteristics in studies describing the clinical outcome of endovascular aneurysm repair and should be included in study reports.

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

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. 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. 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. 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.

Mid-term results of endovascular aneurysm repair with branched and fenestrated endografts

The technique of fenestrated and branched endovascular aneurysm repair (EVAR) has been used for the treatment a variety of aortic aneurysms. Although technically successful, longer-term results have been lacking. This article reports on the mid-term results of aneurysm repair with fenestrated and branched endografts from a European center with a large endovascular experience. Between 2001 and 2005, 38 patients were prospectively enrolled in a single institution, investigational device protocol database. Indications for fenestrated or branched EVAR included unfavorable anatomy for traditional EVAR and an abdominal aortic aneurysm >5.5 cm in maximum diameter. Customized stent-grafts were either fenestrated or branched and based on the Zenith system. Data were analyzed on an intention-to-treat basis. Differences between groups were determined using analysis of variance with P < .05 considered significant. The mean (SD) follow-up was 25.8 +/- 12.7 months (median, 25.0 months; range, 9 to 46 months), and no patients were lost to follow-up. All cause mortality was 13% (5/38), with all deaths occurring within the first postoperative year; 30-day mortality was 2.6%. No patient died during the operation. Completion angiography demonstrated successful sealing in 37 of 38 patients and an overall operative visceral vessel perfusion rate of 94% (82/87). Cumulative visceral branch patency was 92% at 46 months. Stent occlusions, when they did occur, all happened within the first postoperative year. All postoperative occlusions occurred in unstented fenestrations or scallops. No occlusions occurred in stented vessels. The difference in serum creatinine preoperatively and postoperatively at 6 months, 1, 2, and 3 years was not significant (P = NS). No patient required dialysis. The aneurysm sac size decreased significantly during the first year and then remained stable (P < .05). Limb perfusion as assessed by the ankle/brachial index was not affected by the presence of a fenestrated or branched endograft. The intermediate-term results of fenestrated and branched endografts support their continued use in patients with anatomic contraindications for standard EVAR. Close surveillance is mandatory for early identification of visceral or branched vessel stenosis and preocclusion. All cases of failure appear to occur during the first year and then level off in subsequent longer-term follow-up. This includes death, secondary interventions, branch vessel patency, and complications. As the procedure matures, long-term results and randomized clinical trials will ultimately be required to determine the safety, efficacy, and stability of this system.

Midterm Follow-up of a Single-center Experience of Endovascular Repair of Abdominal Aortic Aneurysms with Use of the Talent Stent-Graft

To review the midterm results of endovascular aneurysm repair (EVAR) of abdominal aortic aneurysms (AAAs) with the Talent stent-graft. All patients who underwent EVAR of AAAs with Talent stent-grafts from February 1998 to April 2002 at a single institution were monitored for a minimum of 2 years or until an endpoint of death or rupture was reached. There were 68 eligible patients, who were monitored for a mean period of 39 months (range, 24-72 months). Forty-nine (72.9%) were alive at 2 years; among the 19 deaths, two resulted from aneurysm rupture and the other 17 were unrelated to EVAR. There was one immediate conversion to open repair and five primary proximal endoleaks; the remaining 62 patients (91.2%) all had a technically successful procedure. There were 33 endoleaks during follow-up: 23 (69.7%) were treated conservatively and 10 (30.3%) underwent secondary intervention in the form of embolization (n=2), attempted embolization (n=2), endovascular stent-graft placement (n=3), combined stent-graft placement and embolization (n=1), or surgical conversion (n=2). Overall, there were five persistent endoleaks, and the remaining patients were free of endoleak at their last review or endpoint. Three stent-grafts migrated and required further endovascular intervention. Wire fracture was seen in two stents but presented no clinical sequelae. There was one case of graft limb thrombosis that required surgical thrombectomy. EVAR of AAAs with use of the Talent stent-graft is a promising and acceptable alternative to open surgery. Our 30-day mortality rate of zero compares extremely well with historical data from open surgery and the findings of more recently published trials. The risk of endoleak and uncertainty over durability require long-term surveillance.

Endovascular Repair of Inflammatory Aortic Aneurysms: Long-Term Results

Our objective was to report the long-term follow-up results of endovascular aneurysm repair of inflammatory aortic aneurysms. Endovascular aneurysm repair of inflammatory aortic aneurysms excludes the aneurysm and seems to reduce the size of the aneurysmal sac and the extent of periaortic fibrosis with acceptable periinterventional and long-term morbidity.

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Early Elective Conversion for Failing Evar

The aim of the study was to assess the long term results of endovascular aneurysm repair (EVAR) of abdominal aortic aneurysms at the Helsinki University Central Hospital 1996-2004 with a special emphasis on elective conversion procedures and their outcome. Treatment results and follow-up data of all 110 elective EVAR procedures performed in our institution were gathered prospectively and evaluated. Conversion to open surgery was performed in 23 (21%) of 110 EVAR patients. 30-day mortality after elective stent-graft deployment was 0% as it was also on elective conversions (n = 20). Secondary elective conversions were performed due to infection in two and after failing stent-graft treatment in 12 patients. Six of the conversions were performed primarily. Three urgent conversions (3% overall) were performed: two of these patients died, corresponding to an overall mortality of 9% (2/23) in all conversions. Five-year aneurysm-related mortality after EVAR among patients with elective conversion was 0% and 19% in patients with secondary procedures other than elective conversions. As conversions seem to be hazardous only when performed in urgent situations, elective conversion could be an alternative treatment method in complex failing first-generation stent-grafts as it may reduce mortality associated with urgent conversions or repeated attempts to maintain graft integrity with endovascular procedures.

EVAR to reduce mortality and morbidity in treatment of ruptured abdominal aortic aneurysms: A 7-years single center experience with bifurcated stent grafts

Background: Morbidity and mortality of conventional open surgery for ruptured abdominal aortic aneurysm (rAAA) remained high during the last 50 years. Small studies have shown promising results of endovascular aneurysm repair (EVAR) for the treatment of rAAA. We report the results of the biggest series of EVAR for rAAA worldwide treated with bifurcated stentgrafts (SG).

Anesthesia Technique and Outcomes of Endovascular Aneurysm Repair

Anesthetic techniques vary widely in the endovascular repair of abdominal aortic aneurysms (EVAR). Previous studies have demonstrated the feasibility of using local anesthesia. However, the ideal anesthetic technique has not been determined. This study examines whether anesthetic technique influences the outcomes of EVAR. Data regarding demographics, risk factors, procedural characteristics, recovery characteristics, treatment complications, acute (<30 day) medical complications, mortality, and anesthetic type were prospectively collected during the AneuRx phase II aortic endograft trial. Patient cohorts receiving general, regional, or local anesthesia were compared. From 1997 to 1998, 424 patients underwent EVAR at 13 sites using the AneuRx Bifurcated endograft. There were 279 patients in the general anesthesia group, 95 patients in the regional group, and 50 patients in the local group. Risk factors were similar. There were no significant differences in age, gender, American Society of Anesthesiologists grade, length of anesthesia, branch artery occlusions, proximal endoleaks, failed implants, or open surgical conversions. Cardiac, renal, and wound-healing complications were all lower in the local group. Mortality was equivalent among the three groups. (p > 0.05, ANOVA). From these results we concluded that EVAR with local anesthesia is a safe and efficacious method that may reduce recovery times and postoperative medical morbidity compared to use of general or spinal/epidural anesthesia.

Overview of success of EVAR: Progress to date

Endovascular aneurysm repair (EVAR) of abdominal aortic aneurysms has been challenged by a number of groups, and the shortcomings of this procedure have been documented in the scientific literature. However, patients and physicians continue to pursue this procedure as a viable means of treating abdominal aortic aneurysms. Both device evolution and advancement of technical skills have led to dramatic improvements in the outcomes of EVAR within the last decade. These improvements and accomplishments have also been chronicled in the literature. This review looks at the successes of EVAR, based on both US Food and Drug Administration trials and independent studies comparing conventional open repair and endovascular repair.

Effect of improved endograft design on outcome of endovascular aneurysm repair

Objective This study was undertaken to identify factors that lead to improvements in the results of endovascular aneurysm repair, with particular focus on new endograft design. Methods We analyzed data for patients enrolled in the European Collaborators on Stent Graft Techniques for Abdominal Aortic Aneurysm Repair (EUROSTAR) registry, and compared those for endografts now withdrawn from the market with those for endografts currently in use. Patients in whom a variety of endograft types were used in small numbers were excluded. Postoperative and long-term outcomes were initially compared with univariate analyses, and subsequently multivariate tests were used to adjust for baseline differences between the 2 groups. The main outcome measures were freedom from a variety of secondary interventions, aneurysm rupture, and death. Results Some 1224 patients received “withdrawn” endografts, and 2768 patients received “current” endografts. The 2 groups were generally similar, but patients with current devices were more often men, significantly older, more frequently unfit for open surgery, and had larger aneurysms with wider necks. Of no surprise, current endografts were also more often used by experienced (>60 previous cases) surgical teams (44% vs 20%; P < .0001). Thirty-day clinical outcomes were comparable in the 2 groups, although patients with withdrawn devices were less likely to have type II endoleak (9.2% vs 5.5%; P < .0001), and those with current devices had a shorter mean hospital stay (5.4 vs 6.8 days; P < .0001). At 3 years more patients with current devices were free from secondary transfemoral intervention (88.4% vs 76%; P < .0001) and conversion to open repair (95.4% vs 93.4%; P = .007). Aneurysm-related mortality at 3 years, defined as death due to aneurysm rupture or within 30 days of a secondary intervention, was also less frequent with current endografts (2.7% vs 4.4%; P = .02). Aneurysm rupture at 3 years was infrequent (0.8% vs 1.8%; P = .07). At multivariate analysis the use of current devices was a protective factor against late conversion to open repair (hazard ratio, 0.49; 95% confidence interval, 0.28-0.86; P = .014) and aneurysm-related death (hazard ratio, 0.51, 95% confidence interval, 0.34-0.75; P = .0008). Larger aneurysm or neck diameter and shorter neck length were also associated with late conversion to open repair; larger aneurysm diameter, older age, and unfitness for open surgery were predictive of aneurysm-related death. Conclusion Modern endograft design has improved the results of endovascular aneurysm repair.

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The purpose of this study was to compare the branch morphology and short-term outcome of endovascular aneurysm repair using multibranched thoracoabdominal custom-made stent grafts (CSGs) vs standard stent grafts (SSGs).Data on patient demographics, aortic morphology, component use, and outcome were collected prospectively. Final branch length (cuff to target artery orifice) and branch angle (cuff orientation to target artery orientation) were determined using 3-D reconstruction of computed tomographic angiograms (CTAs).Between January 2008 and March 2010, 28 patients underwent endovascular aneurysm repair using 14 CSGs and 14 SSGs. Two patients were excluded from analysis: one patient in the CSG group had yet to undergo CTA, and one patient in the SSG group had crossed renal branches due to problems traversing a previously reconstructed aortic arch. All the stent grafts were implanted successfully. There were no perioperative deaths. There were no statistically significant differences between the CSG (n = 13) and SSG (n = 13) groups in terms of patient age (74.4 ± 7.9 years vs 73.5 ± 6.0 years), aneurysm diameter (66.1 ± 9.0 mm vs 71.2 ± 9.0 mm), operative time (311 ± 94 minutes vs 286 ± 57 minutes), fluoroscopy time (108 ± 43 minutes vs 101 ± 30 minutes), contrast volume (98 ± 39 minutes vs 91 ± 27 minutes), blood loss (458 ± 205 mL vs 433 ± 193 mL), mean branch angle (22.8 ± 19.0 degrees vs 22.0 ± 17.6 degrees), or branch length (25.3 ± 12.1 mm vs 23.4 ± 10.2 mm).The substitution of SSG for CSG had no effect on the complexity of the procedure, the branch morphology, or the perioperative outcome. The availability of an off-the-shelf SSG will broaden the application of endovascular thoracoabdominal aortic aneurysm repair by eliminating manufacturing delays.

Diameter of abdominal aortic aneurysm and outcome of endovascular aneurysm repair: does size matter? A report from EUROSTAR

ObjectivesThis study was undertaken to determine the effect of the preoperative diameter of abdominal aortic aneurysms on the midterm outcome after endovascular abdominal aneurysm repair (EVAR). MethodThe data for 4392 patients who had undergone EVAR were analyzed. Patients were enrolled over 6 years to June 2002 in the EUROSTAR database. Outcomes were compared between three groups defined by the preoperative diameter of the aneurysm: group A (n = 1962), 4.0 to 5.4 cm; group B (n = 1528), 5.5 to 6.4 cm; and group C (n = 902), 6.5 cm or larger. Patient characteristics, details of aortoiliac anatomy, operative procedures, old or current device generation, and postoperative complications in the three patient groups were compared. Outcome events included aneurysm-related death, unrelated death, conversion, and post-EVAR rupture of the aneurysm. Life table analysis and log-rank tests were used to compare outcome in the three study groups. Multivariate Cox models were used to determine whether baseline and follow-up variables were independently associated with adverse outcome events. ResultsPatients in group C were significantly older than patients in groups A and B (73 years vs 70 and 72 years, respectively; P = .003 – P < .0001 for different group comparisons), and more frequently were at higher operative risk (American Society of Anesthesiologists classification ≥3; 63% vs 48% and 54%; P = .0002–P <.0001). Device-related (type I) endoleaks were more frequently observed at early postoperative arteriography in group C compared with groups A and B (9.9% vs 3.7% and 6.8%; P = .01–P < .0001). Postoperatively systemic complications were more frequently present in group C (17.4% vs 12.0% in group A and 12.6% in group B; P < .0001 and .001). The first-month mortality was approximately twice as high in group C compared with the other groups combined (4.1% vs 2.1%; P < .0001). Late rupture was most frequent in group C. Follow-up results at midterm were less favorable in groups C and B compared with group A (freedom from rupture, 90%, 98%, and 98% at 4 years in groups C, B, and A, respectively; P < .0001 for group C vs groups A and B). Aneurysm-related death was highest in group C (88% freedom at 4 years, compared with 95% in group B and 97% in A; P = .001 and P < .0001, respectively; group B vs A, P = .004). The annual rate of aneurysm-related death in group C was 1% in the first 3 years, but accelerated to 8.0% in the fourth year. Incidence of unrelated death also was higher in groups C and B than in group A (76% and 82% freedom at 4 years vs 87%; P < .0001 for both comparisons). Ratio of aneurysm-related to unrelated death was 23%, 21%, and 50% in groups A, B, and C, respectively. Cox models demonstrated that the correlation between large aneurysms (group C) and all assessed outcome events was independent and highly significant. Older generation devices had an independent association with aneurysm-related and unrelated deaths (P = .02 and P = .04, respectively). However, this correlation was less strong than large aneurysm diameter (P = .0001 and P = .0009, respectively). ConclusionsThe midterm outcome of large aneurysms after EVAR was associated with increased rates of aneurysm-related death, unrelated death, and rupture. Reports of EVAR should stratify their outcomes according to the diameter of the aneurysm. Large aneurysms need a more rigorous post-EVAR surveillance schedule than do smaller aneurysms. In small aneurysms EVAR was associated with excellent outcome. This finding may justify reappraisal of currently accepted management strategies.

The Effect of Gender on Early and Intermediate Results of Endovascular Aneurysm Repair

Results of endovascular aneurysm repair (EVAR) may be gender dependent. Between September 1997 and September 2001, 118 AneuRx aortic grafts were placed for aneurysmal disease. During this period, 17 females and 101 males were treated with this device. A prospective database was maintained and supplemented with retrospectively gathered information to evaluate early and mid-term end points. A total of 113 devices were deployed in 118 attempts. Length of procedure was greater for females (3.3 +/- 1.75 vs. 2.3 +/- 0.8 hr, p = 0.05) and they were more likely to have significant arterial dissections (12% vs. 1%, p = 0.05). The mortality rates at 1 month were 12% for females and 0% for males ( p = 0.02); the complication rates at 1 month were 41% for females and 15% for males ( p = 0.02). Although technical success was not significantly different between the sexes, assisted primary technical success (requiring endovascular assistance) and assisted secondary technical success (requiring open surgical assistance) were significantly different (71% vs. 96%, p = 0.003; and 76% vs. 98%, p = 0.004, respectively). Clinical success at 1 month was 59% for females and 84% for males ( p = 0.02). This difference was also significant when assessing 1-month assisted primary clinical success (59% vs. 90%, p = 0.003) and assisted secondary clinical success as well (71% vs. 96%, p = 0.003). Clinical success and assisted primary clinical success were not different at 6- or 12-month intervals, however, assisted secondary clinical successes differed at both time intervals (56% vs. 83%, p = 0.02; and 56% vs. 81%, p = 0.05, respectively). As-yet undetermined factors appear to predispose females to complications and technical difficulties in the short term. Endovascular and open procedures required to achieve ongoing clinical success in the following months appear to favor males to a greater degree than females.

Introduction of endovascular aneurysm repair into community practice: Initial results with a new Food and Drug Administration-approved device

Purpose: The purpose of this study was to determine the outcome of endovascular aneurysm repair in a defined geographic region during the first 2 years after Food and Drug Administration approval of a new endovascular device. Method: Clinical results of all attempted endovascular aneurysm repairs from 1999 to 2001 with the AneuRx stent graft in the northern California/Nevada region were reviewed. All cases performed in 23 hospitals by 21 endovascular treatment teams were included on an intent-to-treat basis. Community physician training, proctoring, and assistance in case selection was provided by the manufacturer, with outcome monitored by external physician observers and clinical vascular specialists. Results in 22 community hospitals were compared with concurrent results in the regional university hospital training center and with results from the controlled, multicenter AneuRx clinical trial. Results: Endovascular aneurysm repair was attempted in 257 patients by 20 endovascular teams working in 22 community hospitals. The mean number of cases per team was 13 ± 2 (range, 1 to 36). Patient age was 74.1 ± 6.5 years (89% men and 11% women), and 29% of patients were not candidates for open surgical repair because of multiple medical comorbidities. Mean aneurysm diameter was 5.7 ± 0.8 cm. The endoluminal stent graft was successfully deployed in 254 patients (98.8%). In two patients, iliac access could not be obtained, and in one case, the iliac limb was misdeployed and the patient underwent successful open surgical repair. The surgical conversion rate was two of 257 patients (0.8%). The 30-day mortality rate was 1.2%, with one patient dying of stroke, one of multisystem organ failure, and one of cerebral hemorrhage. No device-related deaths occurred. Secondary procedures were performed in 8% of patients. Primary graft patency rate was 98%, and secondary graft patency rate was 100%. Concurrent university training center experience with 100 patients with similar characteristics and aneurysm size was not statistically different (deployment success rate, 100%; 30-day mortality rate, 0%; surgical conversion rate, 0%; secondary procedure rate, 8%). No aneurysm ruptures and no late surgical conversions have been seen in either the community or university experience, with follow-up periods extending to 2 years. Conclusion: Early results of endovascular aneurysm repair introduced into community practice are favorable. Initial community experience, with clinical support from the manufacturer, does not appear to differ significantly from concurrent results in the university training center or from results reported from the multicenter controlled clinical trial with the same device. (J Vasc Surg 2002;36:226-33.)

Abdominal aortic aneurysm repair with the Zenith stent graft: Short to midterm results

Purpose: The purpose of this study was to assess the short-term and mid-term results of endovascular aneurysm repair with the Zenith stent graft in a single-center prospective study. Method: Between October 1998 and July 2001, we used the Zenith stent graft for elective endovascular aneurysm repair in 116 patients, six of whom were women. The mean age was 75 years, and the mean aneurysm diameter was 60.3 ± 8.8 mm. Stent grafts were oversized 10% to 20% relative to computed tomographic (CT) scan-based diameter measurements. All repairs were performed in the operating room through surgically exposed femoral arteries. The results were assessed before discharge with three-phase, contrast-enhanced CT scan and plain abdominal radiograph. These studies were repeated at 1, 6, 12, and 24 months after operation. Follow-up periods ranged from 1 to 34 months. Results: No failed insertions and no conversions to open surgery occurred. The diameter of the main body of the stent graft was 28 mm or more in 73 patients (63%). Additional stents were inserted during surgery to treat kinking in eight patients (6.9%) and renal artery encroachment in two patients (1.7%). Mean fluoroscopy time was 35.1 ± 18.3 minutes, contrast load was 146 ± 53 mL (350 mg/mL), and estimated blood loss was 249 ± 407 mL. The major complication rate was 9.5%, and the minor complication rate was 10.3%. The perioperative complications were myocardial infarction in four patients, arrythmia in four patients, and pulmonary embolism, renal failure, stroke, small bowel obstruction, femoral stenosis, digital embolism, and graft limb thrombosis in one patient each. All 116 patients went home from the hospital, but one patient died 2 weeks later of a combination of pulmonary embolism and myocardial infarction. Endoleak was seen on the first CT scan in 16 patients (15%); 15 were type II, and one was type III. No endoleaks of type I or IV were seen. Additional interventions were performed for each of the following conditions: type II endoleak (n = 4), type III endoleak (n = 1), femoral clamp injury (n = 1), renal artery stenosis (n = 1), and graft limb occlusion (n = 1). One patient had acute aneurysm dilatation and rupture caused by a type II endoleak through the inferior mesenteric artery 6 months after stent graft implantation. No cases were seen of late graft occlusion, stent graft migration, stent fracture, barb fracture, or secondary endoleak. Conclusion: The Zenith device is safe, versatile, and effective in the short to medium term. Most patients need wide stent grafts (≥28 mm proximally and ≥16 mm distally) to achieve 10% to 20% oversizing to prevent type I endoleak. (J Vasc Surg 2002;36:217-25.)