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.     

Long-term results of endovascular abdominal aortic aneurysm treatment with the first generation of commercially available stent grafts

HYPOTHESIS: Little information about the long-term results of endovascular abdominal aortic aneurysm repair is available. This study was performed to evaluate the long-term data of patients treated with the first generation of commercially available stent grafts. DESIGN: Multicenter registry. SETTING: Sixty-two European centers that participated in the EUROSTAR (EUROpean collaborators on Stent-graft Techniques for abdominal aortic Aneurysm Repair) registry. PATIENTS: A total of 1190 patients with a follow-up of up to 8 years, who underwent endovascular abdominal aortic aneurysm repair with a stent graft (Stentor or Vanguard). INTERVENTION: Elective endovascular abdominal aortic aneurysm repair. MAIN OUTCOME MEASURES: The morbidity and mortality data of patients treated with the first-generation stent graft who enrolled in the EUROSTAR registry were analyzed. Incidence rates of complications were calculated to quantify annual risks. Life-table analyses and multivariate Cox proportional hazards models were used for the survival analysis. RESULTS: Conversion to open repair, aneurysm rupture, all-cause death, and aneurysm-related death occurred in 7.1%, 2.4%, 19.9%, and 3.0% of the patients, respectively. The cumulative percentage of the combined outcome event, conversion-free and rupture-free survival, after 8 years was 48.0%. Procedure-related complications that frequently occurred were endoleak (13.0 cases per 100 patient-years), stenosis/thrombosis (4.6 cases per 100 patient-years), and stent migration (4.3 cases per 100 patient-years). CONCLUSIONS: Patients treated with the first generation of stent grafts will need lifelong surveillance because of a considerable risk of late complications. How these findings translate to the outcome of newer-generation stent grafts is unknown. For this reason, vigilant surveillance remains indicated in all patients who undergo endovascular abdominal aortic aneurysm repair.     

Aneurysm rupture after endovascular repair using the AneuRx stent graft

OBJECTIVE: The purpose of this study was to determine the cause and frequency of aneurysm rupture after endovascular aneurysm repair. METHODS: We reviewed each patient who sustained aneurysm rupture among all patients enrolled for endovascular aortic aneurysm repair in phases I, II, and III of the US AneuRx Multicenter Clinical Trial from June 1996 through October 1999. RESULTS: A total of 1067 patients were enrolled for endovascular aneurysm repair. The AneuRx stent graft was successfully implanted in 1046 patients (98%). Endovascular repair was unsuccessful in 21 patients (2%); 13 patients (1%) were converted to open aneurysm repair. Among these, two patients (0.2%) sustained aneurysm rupture due to procedure-related instrumentation and underwent open surgical conversion. Aneurysm rupture has occurred in seven patients (0.7%) 3 weeks to 24 months (mean, 16 months) after successful endovascular repair. Four patients survived open surgical repair, and three patients died within 30 days. Overall rupture-related mortality was 0.5% and included late deaths after rupture. Before rupture, two patients had endoleak and aneurysm enlargement, and five patients had no endoleak and no aneurysm enlargement. After aneurysm rupture all seven patients had evidence suggesting that there was poor fixation of the stent graft at the proximal distal, or iliac junction fixation sites. The two patients with endoleak declined recommended open surgical or endovascular repair, which could have prevented aneurysm rupture. In retrospect, the five patients without endoleak could potentially have avoided rupture with better patient selection, better stent graft positioning, or reinforcement of fixation points with stent graft extenders. The probability of no aneurysm rupture for all patients undergoing endovascular repair is 0.996 +/- 0.002 at 1 year and 0.974 +/- 0.011 at 2 years by life table analysis with the longest follow-up of 41 months. CONCLUSION: The early risk of aneurysm rupture after endovascular aneurysm repair is low. However, the possibility of rupture persists even in patients with no endoleak after the procedure. Therefore, all patients treated with endovascular aneurysm repair should continue to be monitored after the procedure. Patients with evidence suggesting insecure stent graft fixation should undergo further endovascular treatment or open surgical repair.     

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.     

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.     

Endovascular repair of para-anastomotic aortic aneurysms

BACKGROUND: Para-anastomotic aneurysms involving the aorta and iliac arteries can occur years after aortic surgery and are at risk for rupture and erosion into surrounding structures. We report on our continued experience with patients who have been treated for these lesions with endovascular management as an alternative to traditional open repair. METHODS: Patients who underwent endovascular repair of para-anastomotic aneurysms involving the distal aortic arch, descending thoracic aorta, abdominal aorta, or iliac arteries were prospectively followed up in a database. Patient comorbidities, initial aortic pathology, initial graft configuration, aneurysm characteristics, evidence of infection, type and configuration of endograft used, and follow-up were analyzed. RESULTS: From 1997 to 2006, 53 patients with 65 para-anastomotic aneurysms were treated with endovascular stent grafts. Patients who were originally treated for aortoiliac occlusive disease presented significantly later than those treated for aneurysmal disease (15.8 vs 8.9 years, P < .01) The initial technical success rate was 98%. Endoleaks were identified in six patients (11%) < or =1 month of surgery, and three required reintervention, including open conversions. Endoleak complications were significantly associated with patients who had symptomatic para-anastomotic aneurysms (P = .01). Perioperative mortality after endovascular repair was 3.8%. Overall mortality within a mean follow-up of 18 months was 49% and was significantly associated with older age at the time of endovascular treatment (P = .03). CONCLUSION: Endovascular repair of para-anastomotic aneurysms involving the aorta and iliac arteries is technically feasible and is associated with a low perioperative morbidity and mortality. Close follow-up is required to identify endoleaks. Long-term survival is limited in older patients. We recommend endovascular stent graft repair for para-anastomotic aneurysms in anatomically suitable patients.     

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.     

A prospective study of medically treated acute type B aortic dissection.

OBJECTIVE: To study prospectively aneurysm formation, need of surgery, incidence of rupture and mortality in patients with conservatively treated acute type B aortic dissection. METHODS: All patients referred to us with acute type B dissection between January 1990 and December 2001 were candidates for this prospective treatment and follow-up study. Patients deemed not to be in need of acute surgical repair were included after aggressive antihypertensive treatment. The follow-up protocol included close blood pressure control, clinic visits with physical examination, chest x-ray and spiral CT or MRI at 3 and 6 months and annually thereafter. RESULTS: Sixty-six patients were followed for a mean of 79 months (range 22-179). The actuarial survival rate was 82% at 5 years and 69% at 10 years. Eighty-five percent remained free from dissection-related death at 5 years and 82% at 10 years. Ten patients (15%) developed aneurysm (>6 cm) of the dissected aorta. Three of these 10 patients died from aortic rupture and 2 underwent elective surgical repair. Of the 56 patients without aneurysm, one died from rupture and one died suddenly for causes unknown. One patient was treated with endovascular stent-graft. Five patients sustained a new type A aortic dissection which in all but one were fatal. In 26 patients the initial dissection was categorized as intramural hematoma. Twelve of these patients had, in addition to the hematoma, areas with localized dissection/ulcer-like projection. The latter was found to be a predictor of aortic event (dissection-related death, rupture, new type A aortic dissection, aneurysm formation) during follow-up, as was an initial diameter of >4.0 cm at first CT-scan during the acute event. CONCLUSIONS: Conservatively treated acute type B dissection has a low incidence of aneurysm formation and rupture during the chronic phase. These results must be matched or improved upon before endovascular stent-grafting or early aortic surgical repair can be regarded as the primary treatment of choice.     

Isolated iliac artery aneurysms: a contemporary comparison of endovascular and open repair

OBJECTIVE: Iliac artery aneurysms are rare but associated with significant morbidity and mortality when ruptured. This study compares recent open and endovascular repairs of iliac aneurysms at a single institution. METHODS: Patients were identified and charts reviewed using ICD-9 and CPT codes for iliac artery aneurysm and open or endovascular repair performed between January 2000 and January 2006. Baseline characteristics, procedure-related variables, and follow-up data were retrospectively reviewed. RESULTS: A total of 71 patients were treated with isolated iliac artery aneurysms. There were 19 open and 52 endovascular repairs. Seven presented with acute ruptures and were treated by open (4) or endovascular (3) repair. Preoperative comorbidities were similar between the two groups. Major perioperative (30 day) complications included three deaths in the open group from cardiovascular complications, all after ruptured aneurysm repair, and one death in the endovascular group (after rupture; one additional perioperative death occurred after 30 days due to colonic infarction) (P = NS). Postoperative complications were less frequent in the endovascular group, although this did not reach statistical significance. The mortality was 50% in the open group and 33% in the endovascular group for patients presenting with a ruptured aneurysm (P = NS). Transfusion requirement was significantly higher in the open group (47%) than in the endovascular group (6%) (P = .03). The mean follow-up was 20 +/- 5 months in the open group and 17 +/- 2 months in the endovascular group (P = NS). Long-term complications included two limb thromboses following repair with a bifurcated stent graft that were treated with thrombolysis plus stenting or a fem-fem bypass. Three endoleaks were identified on postop CT scans, all of which were successfully managed with endovascular techniques. There were no postoperative ruptures or aneurysm-related death. The mean postoperative length of stay was 5.2 +/- 2.3 days (open) and 1.3 +/- 1.0 days (endovascular) (P = .04). CONCLUSIONS: This is the first large, case control study comparing open vs endovascular repair of isolated iliac artery aneurysms. Endovascular repair of iliac artery aneurysms is safe and results in decreased length of stay, lower requirement for perioperative blood transfusion, and similar intermediate term outcomes as open repair.     

Lessons learned in adopting endovascular techniques for treating abdominal aortic aneurysm

HYPOTHESIS: Endovascular exclusion of abdominal aortic and common iliac aneurysms can be performed safely, and in the short term represents a feasible alternative to traditional, open aneurysm repair. PATIENTS AND METHODS: Forty-one patients were treated with endovascular grafts for 39 abdominal aortic and 2 common iliac artery aneurysms. RESULTS: All devices were successfully deployed. The size of the abdominal aortic aneurysms varied from 4.9 to 11.9 cm (average, 6.13 cm). The median procedure time was 195 minutes. There was one iliac artery rupture, which required celiotomy for repair. The hospital stay varied from 2 to 39 days (average, 6.7 days). The perioperative mortality rate was 2.4%. Sixteen patients (39%) had groin wound complications. Ten patients (24%) had evidence of contrast (endoleak) within the aneurysm sac on completion of the procedure. There were no obvious direct leaks from either the point of proximal or distal fixation. Seven of these endoleaks have resolved spontaneously. Two patients required additional procedures in the postoperative period to treat endoleak. The final patient has evidence of persistent endoleak on 3-month surveillance computed tomography scan. Major late problems occurred in 3 patients. CONCLUSION: Patients with large abdominal aortic aneurysms and considerable cardiac comorbidity can safely undergo endovascular aneurysm repair. Femoral groin wound complications resulting in prolonged hospitalization remain the major cause of perioperative morbidity. In contradistinction to open aneurysm repair, long-term surveillance is essential to detect migration of the device and identify flow within the residual aneurysm sac-complications that could lead to aneurysm rupture following endovascular repair.     

Zenith AAA endovascular graft: intermediate-term results of the US multicenter trial

PURPOSE: The intent of this study was to assess the safety and effectiveness of the Zenith AAA Endovascular Graft compared with conventional aneurysm repair. MATERIAL AND METHODS: The study was conducted in a prospective, multicenter, nonrandomized, concurrent control manner. Physiologically similar patients with infrarenal abdominal aortic aneurysms (AAAs) underwent either open surgery or repair with the Zenith AAA Endovascular Graft. Separate analyses of physiologically challenged patients were performed. Follow-up was conducted at hospital discharge and at 1, 6, and 12 months (endovascular repair group) or 1 and 12 months (open surgical repair group). Evaluation included computed tomography, abdominal radiography, laboratory tests, and physical examination. Mortality (AAA-related and overall), morbidity, in-hospital recovery, renal function, and secondary interventions were assessed. Patients in the endovascular repair group were evaluated for change in aneurysm size, endoleak, graft migration, conversion, rupture, and device integrity. Statistical analyses were performed with the Kaplan-Meier method, Blackwelder test, propensity score assessment, two-sample t test, Yates-corrected Pearson chi(2) test, and Fisher exact test. RESULTS: Conventional open surgery was used in 80 patients, and 200 patients underwent repair with the Zenith AAA Endovascular Graft. Technical success was accomplished in 98.8% of patients in the open repair group and 99.5% in the endovascular repair group. Patients in the endovascular repair group had fewer significant adverse events within 30 days (80% vs 57%; P <.001). All-cause mortality was similar (endovascular, 3.5%; open surgery, 3.8%). Aneurysm-related mortality was higher with conventional surgery at 12 months (3.8% vs 0.5%; P =.04). In-hospital recovery and procedural measures were better for endovascular repair in all categories (P <.001). The incidence of endoleak was 17% at 30 days, 7.4% at 12 months, and 5.4% at 24 months. Aneurysm shrinkage (>5 mm) was noted in more than two thirds of patients at 12 months and three fourths of patients at 24 months. Renal dysfunction rate did not differ between groups. Migration (>5 mm) was detected in four (2%) patients through 12 months; none was greater than 10 mm or associated with adverse events through 24 months. Three conversions were performed within 12 months, one because of aneurysm rupture. Secondary procedures were more common in the endovascular group (11% vs 2.5%; P =.03). In total, 351 patients had endografts implanted, and 6 patients were noted to have barb separations through 12-month follow-up. No stent fractures were noted. CONCLUSIONS: The Zenith AAA Endovascular Graft is safe and effective for treatment of infrarenal AAAs. The high likelihood of decrease in aneurysm size provides evidence that treatment of aneurysms with this device reverses the natural history of aneurysmal disease. The importance of long-term follow-up is underscored by the small but defined incidence of barb separation and the potential for unforeseen failure modes.     

Endovascular management of isolated iliac artery aneurysms

OBJECTIVE: We reviewed our experience with endovascular treatment of isolated iliac artery aneurysms (IAAs). METHODS: Medical records for consecutive patients undergoing endovascular IAA repair from 1995 to 2004 were reviewed. Computed tomography (CT) angiograms were used to assess IAA location, size, and presence of endoleaks after endovascular repair. Rates of primary patency and freedom from secondary interventions were estimated using the Kaplan-Meier life-table method. RESULTS: From July 1995 to November 2004, 45 patients (42 men), with a mean age of 75 years, underwent endovascular repair of 61 isolated IAAs: 41 common iliac, 19 internal iliac, and one external iliac. Five patients (11%) were symptomatic, although none presented with acute rupture. The mean preoperative IAA diameter was 4.2 +/- 1.7 cm. Fifteen patients (33%) had prior open abdominal aortic aneurysm repair. Local or regional anesthesia was used in 28 cases (62%). Thirty-four patients (75%) were treated with unilateral iliac stent-grafts, eight (18%) with bifurcated aortic stent-grafts, and three (7%) with coil embolization alone. Perioperative major complications included one early graft thrombosis that eventually required conversion to open repair and one groin hematoma that required operative evacuation. On follow-up, late complications included one additional graft thrombosis and one late death after amputation. No late ruptures occurred after endovascular repair, with a mean follow-up of 22 months (range, 0 to 60 months). The mean postoperative length of stay was 1.3 +/- 1.0 days. On postoperative CT scans obtained at 1, 6, 12, 24, and 36 months, aneurysm shrinkage was noted in 18%, 29%, 57%, 67%, and 83% of IAAs, respectively, compared with the baseline diameter. One hypogastric aneurysm enlarged in the presence of a later identified type II endoleak. Five endoleaks were noted (4 type II, 1 indeterminate) at 1 month, with four other endoleaks (1 type II, 1 type III, 2 indeterminate) identified on later CT scans. At 2 years, primary patency was 95%, and freedom from secondary interventions was 88%. CONCLUSIONS: Endovascular repair of isolated IAAs appears safe and effective, with initial results similar to those after endovascular abdominal aortic aneurysm repair.     

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.     

Splenic artery aneurysms: postembolization syndrome and surgical complications

BACKGROUND: This study assessed the endovascular embolization of splenic artery aneurysms and false aneurysms with special consideration given to postoperative complications. METHODS: Fifteen patients (11 women; mean age, 56 y; range, 39-80 y) with splenic artery aneurysm (n = 13) or false aneurysm (n = 2) were treated with coil embolization. The lesion was asymptomatic in 9 patients, symptomatic in 5 patients, and ruptured in 1 patient. The mean aneurysm diameter was 33 +/- 23 mm (range, 15-80 mm). Postoperative follow-up evaluation included a clinical visit and spiral computed tomography at 1, 4, and 12 months, and yearly thereafter. RESULTS: Endovascular treatment was possible in 14 patients (93%) (1 failure: neck cannulation). Perioperative mortality was not observed. Morbidity included postembolization syndrome in 5 patients (30%). Neither pancreatitis nor spleen abscess occurred. The mean follow-up period was 36 months (range, 3-60 mo). During follow-up evaluation we detected 1 sac reperfusion that was sealed successfully with additional coils. Surgical conversion or open repair were never required. CONCLUSIONS: At our institute, endovascular treatment represents the first-line treatment for splenic artery aneurysms. Postembolization syndrome and infarcts are common events but generally resolve without sequelae.     

Endovascular treatment of the descending thoracic aorta.

OBJECTIVES: to report our initial experience with endovascular stent graft repair of a variety of thoracic aortic pathology. DESIGN: retrospective single center study. MATERIAL AND METHODS: between February 2000 and January 2002, endovascular stent graft repair was performed in 26 patients: traumatic aortic isthmus rupture (n=3), Type B dissection (n=11) and descending thoracic aortic aneurysm (n=12). The deployed stent graft systems were AneuRx-Medtronic (n=1), Talent-Medtronic (n=13) and Excluder-Gore (n=12). RESULTS: successful deployment of the stent grafts in the intended position was achieved in all patients. No hospital mortality neither paraplegia were observed. Late, non procedure related, death occurred in four patients (15%). Access artery complications with rupture of the iliac artery occurred in two patients and were managed by iliac-femoral bypass. The left subclavian artery was overstented in seven patients (27%). Only the first patient received a carotido-subclavian bypass. The mean maximal aortic diameter decreased significantly in patients treated for descending thoracic aneurysm. Only one patient had an endoleak type II after 6 months without enlargement of the aneurysm. Complete thrombosis of the thoracic false lumen occurred in all but one patient treated for Type B dissection 6 months postoperatively. Two patients underwent a consecutive stent graft placement, due to a large re-entry tear distal to the first stent graft. CONCLUSIONS: endovascular stent graft repair for Type B dissection, descending thoracic aneurysm and aortic isthmus rupture is a promising less-invasive alternative to surgical repair. Further studies are mandatory to determine its long-term efficacy.     

Endovascular treatment for para-anastomotic abdominal aortic and iliac aneurysms following aortic surgery

AIM: The aim of this study was to report our experience with endovascular repair of anastomotic aneurysms occurring after graft replacement for abdominal aortic aneurysms or aorto-iliac obstructive disease. METHODS: Between January 2000 and April 2006, 19 consecutive male patients (median age 73 years) underwent endovascular repair for 22 anastomotic aneurysms [proximal aortic (n=15), iliac (n=4), concomitant aortic and iliac (n=3)], occurring 3 months to 18 years (mean 8.6 years) after open surgery. Three patients (15.7%) underwent emergency treatment for rupture. No patient had symptoms or positive blood tests for infection of the original graft. Twelve patients were treated with a bifurcated stent-graft, 4 patients with a proximal stent-graft cuff, 2 patients with a tube iliac stent-graft, and 1 patient with a mono-iliac stent-graft. RESULTS: Stent-grafts were successfully deployed in all patients. Procedure-related complications or death were not observed; open conversion was never required. Median hospitalisation was 9 days (range 3-45). During a median follow-up of 16 Euro-months (range, 2-44) all anastomotic aneurysms maintained excluded: 4 patients (21%) died. We observed 1 major complication (5.2%): an iliac branch occlusion occurred 1 month after the procedure, successfully treated with catheter-directed thrombolysis. Overall, survival rates at 6, 12, 18 and 36-months were 92.8%, 84.4%, 72.3%, and 57.8% respectively. CONCLUSION: Our experience confirms that endovascular stent-grafts can be used successfully to exclude anastomotic aortic aneurysms after open surgery. Endovascular repair seems to be effective at mid-term follow-up.     

Lessons learned from midterm follow-up of endovascular repair for traumatic rupture of the aortic isthmus

OBJECTIVE: The aim of this study was to evaluate the short- and midterm results following endovascular repair of a traumatic rupture of the aortic isthmus. METHODS: Between January 2001 and January 2007, 27 patients underwent endovascular repair for acute traumatic rupture of the aortic isthmus (8 women, 19 men, mean age 40.2 +/- 16.7 years [19-78]). All patients underwent a computed tomography scan resulting in the preoperative diagnosis of aortic disruptions. Twenty-one patients were treated within the first 5 days following diagnosis. Follow-up computed tomography scans were performed at 1 week, at 3 and 6 months, and annually thereafter. The median follow-up was 40 months. RESULTS: All endografts were successfully deployed (Excluder-TAG [16], Talent [10], Zenith [2]). Three patients required common iliac artery access. The morbidity rate was 14.8%: two cases of inadvertent coverage of supra-aortic trunks occurred peroperatively, a proximal type I endoleak was successfully treated by a proximal implantation of a second endograft, and one collapse of an endograft was successfully treated by open repair and explantation. No patient suffered transient or permanent paraplegia, cerebral complication, endograft migration, or secondary endoleak. The overall mortality rate was 3.7%. CONCLUSIONS: Short and midterm results following endovascular treatment for traumatic rupture of the aortic isthmus favor the proposition of endovascular repair as the first-line treatment in hemodynamically unstable patients. In hemodynamically stable patients, the preoperative morphological evaluations aim to assess aortic anatomy and thereby detect possible technical limitations (aortic diameter <20 mm, severe aortic isthmus angulation, short proximal aortic neck <20 mm, conical aorta). In the presence of any one of these technical restrictions, open surgical treatment should be discussed to avoid major per- or postoperative complications related to endovascular repair. Further studies and long-term survival studies are mandatory to determine the efficacy and durability of this technique.     

肾动脉下腹主动脉瘤腔内治疗后并发症的防治

目的　总结肾动脉下腹主动脉瘤腔内治疗后常见并发症的预防与处理。　方法对已施行腔内治疗的 71例肾下腹主动脉瘤患者的临床资料进行回顾性分析 ,讨论常见并发症发生的原因、处理、结果及预后。　结果　 71例接受腔内治疗的肾动脉下腹主动脉瘤患者技术成功率1 0 0 % ,无中转开腹手术者。原发性内漏 8例 ,神经并发症合并急性血栓形成 1例。一过性缺血性肠炎 2例。无肾动脉梗死、肢体栓塞等并发症。平均随访时间 (2 6± 5)个月。围手术期病死率 1 3 % (1 /71 ) ,总病死率 4 2 % (3/ 71 )。死亡原因 2例为急性心肌梗死 ,1例为急性心功能衰竭。随访过程中发现 3例原发性内漏转为持续性内漏 ,另发现继发性内漏 4例。本组患者 1个月后内漏发生率 9 8%(7/ 71 )。 2例继发性Ⅰ型内漏随访中瘤体增大 ,1例进行二期腔内治疗。　结论　动脉瘤的腔内治疗具有创伤小、技术操作可行、效果肯定的优点 ,内漏血是该技术主要并发症。对漏血量及瘤体有增大趋势的内漏应积极处理     

Significance of endoleaks after endovascular repair of abdominal aortic aneurysms: The EUROSTAR experience

OBJECTIVE: The purpose of this study was to assess the incidence, risk factors, and consequences of endoleaks after endovascular repair of abdominal aortic aneurysm. METHODS: Data on 2463 patients were collected from 87 European centers and recorded in a central database. Preoperative data were compared for patients with collateral retrograde perfusion (type II) endoleak (group A), patients with device-related (type I and III) endoleaks (group B), and patients in whom no endoleak was detected (group C). Only endoleaks observed after the first postoperative month of follow-up were taken into consideration. Regression analysis was performed to investigate statistical relationships between the occurrence and type of endoleak and preoperative patient and morphologic characteristics, operative details, type of device, and experience of the operating team. In addition, postoperative changes in aneurysmal morphology, the need for secondary interventions, conversions to open repair, aneurysmal rupture, and mortality during follow-up were compared between these study groups. RESULTS: Patients in group A had a higher prevalence of a patent inferior mesenteric artery compared with patients without endoleak. Patients in group B were treated more frequently than patients in group C by an operating team with experience of less than 30 procedures. The mean follow-up period was 15.4 months. Secondary interventions were needed in 13% of the patients. Rupture of the aneurysm during follow-up occurred in 0.52% (1/191) in group A, 3.37% (10/297) in group B, and 0.25% (5/1975) in group C. Life table analysis comparing the three study groups demonstrated a significantly higher rate of rupture in group B than in group C (P =.002). The incidence of conversion to open repair during follow-up was higher in group B than in the other two study groups (P <.01). Death was related to the aneurysm or to endovascular repair of the aneurysm in 7% of patients. Secondary outcome success, defined as absence of rupture and conversion, was significantly higher in group A and C compared with that in group B (P =.006 and P =.0001, respectively). CONCLUSIONS: The presence of device-related endoleaks correlated with a higher risk of aneurysmal rupture and conversion compared with patients without type I or III endoleaks. Type II endoleak was not associated more often with these events. Consequently, intervention in type II endoleak should only be performed in case of increase of aneurysm size.