Quality of life before and after endovascular and retroperitoneal abdominal aortic aneurysm repair

PURPOSE: This study was undertaken to evaluate changes in quality of life and to compare conventional outcomes in patients undergoing endovascular and open retroperitoneal abdominal aortic aneurysm (AAA) repair. METHODS: Between October 2000 and May 2003, 129 patients underwent elective AAA repair, endovascular repair in 22 patients and open retroperitoneal repair in 107 patients. The Short-Form Health Survey, 12 items (SF-12) was administered preoperatively and at 3 weeks, 4 months, and 1 year after discharge. Quality of life, hospital and intensive care unit stay, perioperative complications, discharge disposition, readmission, and hospital cost were statistically evaluated. RESULTS: For the total group, significant differences were observed for both Physical Component Summary scores (P<.001) and Mental Component Summary scores (P=.001) between time points. There were no significant differences for either Component Summary score between open and endovascular procedures for any time period. Number of weeks required to return to baseline functional status was similar after either open or endovascular repair (7.22 vs 5.47 weeks, respectively; P=.09). Mean hospital and intensive care unit stay was 4.4 and 1 days, respectively, for open repair versus 1.9 and 0 days, respectively, for endovascular repair (P<.0001). No significant difference between groups was observed in terms of perioperative complications, discharge disposition, or hospital readmission (P> or =.54). Mean total hospital cost for endovascular repair was 1.60 times that for open repair (mean difference, $11,662; P<.0001; 95% confidence interval, $17,799-$5525). CONCLUSIONS: Hospital stay is significantly shorter after endovascular AAA repair. However, hospital cost is almost twice that for open retroperitoneal repair. Perioperative complications, discharge disposition, and hospital readmission are not statistically different between the two groups. Effect on health-related quality of life is similar after either open retroperitoneal or endovascular AAA 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.     

A statewide experience with endovascular abdominal aortic aneurysm repair: rapid diffusion with excellent early results

OBJECTIVE: The purpose of this study was to compare survival and outcomes of endovascular versus open repair of abdominal aortic aneurysms (AAAs) in New York State (NYS). METHODS: We used the NYS discharge dataset Statewide Planning and Research Cooperative System (SPARCS) to analyze the outcomes of elective admission for nonruptured (International Classification of Diseases-9th revision [ICD-9] 441.4) open aneurysm repair (38.44) and endovascular aneurysm repair (39.71) during the years 2000-2002. The ICD-9 code for endovascular repair was introduced in late 2000, thus capturing 3 months of empiric data for 2000. RESULTS: There has been a significant increase in the number of AAA procedures performed in NYS (comparing before and after 2000: average, 1419 vs 1701; P =.0001), temporally coinciding with the implementation of training programs after US Food and Drug Administration approval of endovascular grafts and the new payment code. From 2000 to 2002 the number of NYS hospitals performing endovascular repairs increased from 24 to 60. By 2002 there were more endovascular repairs being performed than open repairs (871 vs 783). The target population for these surgical interventions showed interesting differences. In 2002, women had a 43% chance of receiving an endograft, whereas men had a 55% probability. The use of endovascular repair over the observation period was relatively constant in patients younger than 65 years. In patients older than 65 years, and especially those older than 75 years, endovascular use increased substantially, so that by 2002 older patients were more likely to undergo endovascular repair than open repair. Patients who underwent endovascular repair had significantly more hypertension, coronary artery disease, diabetes, and hyperlipidemia than did patients who underwent open repair. Yet the mean length of stay for endovascular procedures was approximately 3.6 days, and for open procedures was about 10.3 days, across all 3 years (P = <.0001). Moreover, patients who underwent endovascular repair had statistically fewer postoperative complications and significantly lower mortality. In-hospital mortality in 2001 was 3.55% for open repair and 1.14% for endovascular repair (P =.0018), and in 2002 these rates were 4.21% versus 0.8% (P <.0001), respectively. CONCLUSION: This dataset suggests that endovascular AAA repairs are being performed in a patient population with a higher frequency of comorbidities. However, endovascular repairs still are associated with significantly lower in-hospital mortality, fewer postoperative complications, and a dramatically shorter length of stay. These results suggest that, despite the rapid diffusion of this new technique, early perioperative outcomes may be superior to those with conventional open repair. However, prospective clinical studies are needed to confirm these insights, and such studies may require the infrastructure of consortia of hospitals or society-based registries.     

Acute and chronic open conversion after endovascular aortic aneurysm repair: a 14-year review

OBJECTIVE: This study reviewed outcomes of patients requiring surgical conversion after endovascular abdominal aortic aneurysm (AAA) repair. METHODS: Records for all patients undergoing open conversion after endovascular AAA repair were reviewed. RESULTS: From 1993 to 2006, 574 patients underwent endovascular repair for AAA. Seventeen patients, including three patients who underwent prior endovascular repair at other centers, required surgical conversion with complete (n = 9) or partial graft removal (n = 8). Five patients required immediate conversion (acute), and 12 underwent delayed conversion 4 to 72 months after endovascular repair. Indications for acute conversion were large type I endoleak (n = 3, 60%), including one patient with graft migration, and retroperitoneal bleeding (n = 2, 40%). Indications for chronic conversion were endoleak with increasing aneurysm size (n = 9, 75%), stent fracture without endoleak (n = 1, 8%), delayed retroperitoneal bleeding (n = 1, 8%), and infection (n = 1, 8%). Suprarenal aortic cross-clamping was required in two patients (12%), and endograft components were retained in eight (47%). An aortic occlusion balloon placed through the body of the existing endograft facilitated proximal control in three patients. There were two perioperative deaths in the acute conversion group (2/5; 40%) and none in the delayed conversion group (P = .04). Five-year actuarial survival was 71.9%. Mean follow-up was 41.6 +/- 32.2 months. Retained endovascular components in patients with partial graft removal remained stable during follow-up. CONCLUSIONS: Surgical conversion after endovascular AAA repair can be performed without suprarenal clamping in most patients. Endovascular aortic control with a balloon avoids suprarenal exposure. Partial endograft removal in selected patients facilitates open conversion and appears durable. Acute conversion is associated with increased mortality.     

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.     

Symptomatic sac enlargement and rupture due to seroma after open abdominal aortic aneurysm repair with polytetrafluoroethylene graft: Implications for endovascular repair and endotension

OBJECTIVE: We report 5 patients in whom a symptomatic perigraft seroma developed within the aortic sac, without vascular endoleak, after open repair of an abdominal aortic aneurysm (AAA) with a polytetrafluoroethylene (PTFE) graft. We also discuss possible relationships of this phenomenon to endovascular repair of AAAs. PATIENTS AND METHODS: Over 18 years, 1156 patients underwent repair of an AAA by one of the authors (B.M.B.). Of these, 1084 underwent open repair, 256 with PTFE grafts. Five patients in the PTFE group (2.3%) returned at a mean of 4.5 years with acute abdominal or back pain and enlargement of the aortic sac. Mean diameter of the aneurysms was 5.9 cm preoperatively and 8.1 cm at readmission. There was no evidence of vascular endoleak on computed tomography scans, but 1 patient had a retroperitoneal hematoma. RESULTS: Laparotomy in 4 patients disclosed a seroma containing firm rubbery gelatinous material under tension, histologically identified as amorphous eosinophilic material containing thrombus and degenerate blood cells in all cases. Rupture of the sac was confirmed in the patient with a retroperitoneal hematoma. The sac contents were evacuated and the integrity of the underlying grafts and anastomoses was confirmed before sac reduction, with imbricating sutures, and closure was performed. One patient died at 8 months of an unrelated cause; the other 3 patients remain well at mean follow-up of 12 months. The fifth patient received conservative treatment and remains asymptomatic 3 years after acute presentation. CONCLUSIONS: These findings of sac enlargement without vascular endoleak after open AAA repair are reminiscent of sac enlargement in the absence of endoleak after endovascular AAA repair. This has been referred to as endotension. The comparatively benign outcome in 5 patients with symptomatic sac enlargement, including 2 patients with rupture, after open AAA repair provides data to support a circumspect approach to endotension, especially in patients with asymptomatic disease, which has been reported as occurring in almost half of patients who received a PTFE Excluder endograft.     

Rupture of abdominal aortic aneurysm: concurrent comparison of outcome of those occurring after endovascular repair versus those occurring without previous treatment in an 11-year single-center experience

OBJECTIVE: The purpose of this single-center study was to compare findings at presentation and surgical outcome in patients in whom abdominal aortic aneurysms (AAAs) ruptured after endovascular repair and patients in whom AAAs ruptured before any treatment, over a defined period. METHODS: From May 1992 to September 2003, 1043 patients underwent elective repair of intact infrarenal AAAs. Endovascular repair was performed in 609 patients, and open repair in 434 patients. Eighteen of 609 patients (3%) who underwent endovascular AAA repair required treatment because of rupture of the aneurysm after a mean of 29 months (group 1). During the same 11-year period, another 91 patients without previous treatment required urgent repair of a ruptured AAA (group 2). Rupture was diagnosed at contrast material-enhanced computed tomography or by presence of extramural extravasation of blood at open repair. Except for a higher incidence of women in group 2, patients in both groups were similar with regard to demographics and clinical characteristics but differed in findings at presentation. Eight patients in group 1 had a known endoleak before AAA rupture, whereas contrast-enhanced computed tomography, performed in 15 patients at presentation, demonstrated an endoleak in all. Hypotension (systolic blood pressure <100 mm Hg) was noted at presentation in 4 of 18 patients (22%) in group 1 and 76 of 91 patients (84%) in group 2. All patients underwent open repair via a transperitoneal approach, except for 4 patients in group 1 and 3 patients in group 2 who underwent endovascular repair of ruptured AAAs. RESULTS: The proportion of patients with hypotension at presentation in group 1 (4 of 18) was significantly less than in group 2 (76 of 91; P < .01). The difference in perioperative (30 day) mortality rate in group 1 (3 of 18; 16.6%) compared with group 2 (49 of 91; 53.8%) was also significant (P < .01). The outcome in group 1 was therefore superior to that in group 2. CONCLUSIONS: This study confirms that endovascular AAA repair complicated by endoleak does not prevent rupture. The data suggest, however, that rupture, when it occurs in these circumstances, may not be accompanied by such major hemodynamic changes and high mortality as rupture of an untreated AAA. Further long-term follow-up and analysis in a larger group of patients are required to confirm the apparent intermediate level of protection afforded by failed endovascular repair, which does not prevent rupture but enhances survival after operation to treat rupture, possibly by ameliorating the hemodynamic changes associated with the rupture process.     

Outcomes of secondary interventions after abdominal aortic aneurysm endovascular repair

PURPOSE: We assessed the distribution of secondary interventions after aortic stent grafting (EVAR) performed to treat infrarenal abdominal aortic aneurysm (AAA), and evaluated clinical success and survival in patients who underwent a secondary procedure (group 2) compared with patients who did not undergo a secondary procedure (group 1). METHODS: Two hundred fifty patients (mean age, 71.3 years) with asymptomatic AAAs (mean aneurysm diameter, 54.5 mm) underwent treatment with commercially available stent grafts. Mean follow-up was 28 months (median, 25 months). Secondary procedures were defined as any additional procedures performed after initial graft placement to treat endoleak, migration, kinking, stenosis, or occlusion. Overall clinical success was defined according to reporting standards of the Society for Vascular Surgery/American Association for Vascular Surgery. RESULTS: Sixty-eight patients (27%) required 112 secondary procedures, with a mean time from initial graft placement of 18.2 months. Patients who received grafts since removed from the market required more secondary procedures (59%, procedure:patient ratio) compared with patients who received devices still on the market (21%; P =.001). Thirty-six patients (53%) required a single secondary procedure, 24 patients (35%) required two procedures, 5 patients (10%) required three procedures, 2 patients (3%) required four procedures, and 1 patient required five secondary procedures. Ninety-eight procedures (87%) were performed with endovascular methods, including placement of 42 additional covered stent grafts (36 iliac, 6 aortic), with a success rate of 85%; 35 embolization procedures (21 lumbar, 9 internal iliac artery, 5 mesenteric), with only 23 (65%) successful; 14 angioplasty procedures, with 85% successful; 4 thrombolysis procedures, 2 of them successful (50%); and 3 successfully placed new endografts within a previous endovascular graft. Surgical secondary operations included nine femorofemoral bypass procedures and three femoral thromboendarterectomies, all of which remain patent; one cerclage of an external iliac limb; and one laparoscopic repair of a type II endoleak, which was successful. Overall clinical success rate for EVAR was 84% (211 of 250) in this series. Clinical success rate in groups 1 and 2 was 91% (166 of 182) versus 66% (45 of 68; P =.001) if all endoleaks on the most recent computed tomography scans are taken into account, and 94% (171 of 182) versus 76% (52 of 68; P =.001) if type II endoleak without aneurysm growth is not considered failure. The survival rate and rupture-free survival in groups 1 and 2 were, respectively, 97.7% +/- 1.0% and 98.5% +/- 1.4% at 1 month, 95.9% +/- 1.5% and 96.9% +/- 2.1% at 6 months, 94.4% +/- 2.0% and 93.2% +/- 3.4% at 1 year, and 80.8% +/- 5.2% and 88.5% +/- 5.0% at 3 years (P =.273, log-rank test). CONCLUSION: With close follow-up and a significant number of secondary operations, this 8-year experience has not included any aneurysm ruptures to date. Secondary operations did not lead to increased mortality, but were associated with more surgical conversions and with a higher clinical failure rate.     

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.     

Outcome of symptomatic, unruptured abdominal aortic aneurysms after endovascular repair with the Zenith stent-graft system

OBJECTIVE: Symptomatic abdominal aortic aneurysms (AAA) account for up to 20% of patients with unruptured AAA undergoing open repair. This condition is associated with an average postoperative mortality rate after open repair of about 16%. The aim of this study was to evaluate the outcome of a consecutive series of patients who underwent endovascular repair for symptomatic, unruptured AAA. MATERIAL AND METHODS: From January 2000 to October 2006, 14 patients underwent endovascular repair of intact AAA within 15 days since admission for AAA-related symptoms. In these patients, a Zenith stent-graft (Cook Incorporated, Bloomington, IN, USA) was deployed at the Oulu University Hospital, Kuopio University Hospital and Helsinki University Hospital, Finland. RESULTS: Stent-grafting was not successful in one patient because of access failure. The procedure was immediately converted to open repair and an aortobifemoral bypass with a Dacron prosthesis was performed. In the remaining 13 patients, bifurcated Zenith stent-grafts were deployed. After the procedure, type II endoleak was observed in three patients. The mean follow-up time was 1.9+/-1.4 years. The 2-year survival rate was 69%. The survival freedom from secondary procedure was 71% as one patient underwent stent-grafting for a distal type I endoleak 5 months after the procedure. Another patient underwent femoro-femoral cross-over bypass surgery because of right limb graft thrombosis which occurred 9 months after the procedure. CONCLUSIONS: These preliminary results suggest that endovascular repair of symptomatic, unruptured AAA is feasible and can be associated with a favourable outcome despite a very high operative risk.     

Life-table Analysis of Primary and Assisted Success Following Endoluminal Repair of Abdominal Aortic Aneurysms: the Role of Supplementary Endovascular Intervention in Improving Outcome

AIM: the aim of this study was to analyse the effect of supplementary endovascular intervention on the outcome of primary endoluminal repair of abdominal aortic aneurysm (AAA). METHODS: between May 1992 and December 1998, 266 patients underwent endoluminal repair of AAA. Minimum period of follow-up was 6 months. Those patients in whom the endoprosthesis could not be deployed were converted to open repair at the primary operation. Patients developing an early endoleak, within 31 days, were treated by a period of observation and secondary endovascular intervention in persistent cases. Patients developing a late endoleak were treated similarly, without a period of observation. Outcome was analysed by the life-table method. Primary success was defined as exclusion of the aneurysm from the circulation resulting from the original operation. Assisted success occurred when aneurysms with endoleaks became excluded from the circulation as a result of supplementary endovascular intervention. RESULTS: endoluminal repair failed in 17 patients requiring conversion to open repair at the original operation. Supplementary endovascular intervention was undertaken in 26 patients, with early endoleaks (n=6) and late endoleaks (n=20). Interventions involved deployment of secondary endoluminal grafts within the primary grafts (n=22), and coil embolisation (n=4). Successful exclusion of the aneurysm sac was achieved in 22 of 26 (85%) patients undergoing supplementary endovascular procedures. Conditional cumulative incidence of primary graft failure and secondary graft failure in the presence of all-cause mortality at 6 years was 47% and 25% respectively. CONCLUSIONS: supplementary endovascular intervention is an important adjunct to endoluminal AAA repair with the potential to improve outcome and avoid conversion to open repair. Successful supplementary endovascular intervention was achieved in 85% of patients in whom it was attempted. Life-table analysis showed these supplementary procedures to be durable in the long term.     

Delayed aortic aneurysm enlargement due to endotension after endovascular abdominal aortic aneurysm repair

Abdominal aortic aneurysm (AAA) enlarges after successful endovascular repair, because of persistent blood flow within the aneurysm sac, or endoleak. In the absence of detectable endoleak, AAA may still expand, in part because of persistent pressurization within the excluded aneurysm, or endotension. We report three patients who underwent successful endovascular AAA repair in whom postoperative surveillance showed aneurysm regression, yet delayed AAA enlargement without demonstrable endoleak developed in all three patients. Endotension was confirmed in all three patients at elective open conversion. Our study underscores the significance of endotension as a mechanism of delayed aneurysm enlargement after successful endovascular AAA repair.     

Impact of endovascular repair on early outcomes of ruptured abdominal aortic aneurysms

OBJECTIVE: Our purpose was to examine the impact of the introduction of endovascular treatment on the early outcomes of ruptured abdominal aortic aneurysms (AAAs) during 2 consecutive time periods at a single institution. METHODS: The hospital records of a single tertiary care center from 1997 to 2004 were retrospectively reviewed, and 36 consecutive patients who underwent treatment for acute ruptured AAA were identified. They were divided into 19 (53%) patients who were all treated with conventional open surgery from 1997 to 2001 (early) and 17 (47%) patients who were treated either with open (n = 4, 24%) or endovascular (n = 13, 76%) methods from 2002 to 2004 (late). All endovascular repairs were performed with commercially available bifurcated devices. Outcome measures included death, major complications, disposition at discharge (home or extended care facility), procedure time, blood loss, and hospital length of stay. RESULTS: Age, sex, and AAA size were similar between the 2 groups. Perioperative mortality in the early and late periods were 37% versus 12%, respectively (P =.13); rates of major complications were 84% versus 65%, respectively (P =.26); and discharge to home rather than extended care facility was 32% versus 59%, respectively (P =.18). Median procedure times (275 vs 149 minutes, P <.01), blood loss (3800 vs 138 mL, P <.0001), and length of stay (18 vs 6 days, P <.05) were all higher during the early period than in the late period. CONCLUSIONS: This preliminary study suggests that introduction of endovascular therapies may be potentially beneficial in the overall treatment scheme of patients with ruptured AAAs. However, longer follow-up and larger cohorts are needed to better establish its feasibility and efficacy compared with conventional open surgical repair.     

Endovascular Treatment of Failed Prior Abdominal Aortic Aneurysm Repair

Failure of endovascular or conventional abdominal aortic aneurysm (AAA) repair may occur as a result of attachment site endoleak (type I) or paraanastomotic aneurysm and pseudoaneurysm formation. This study examined the results of the use of secondary endovascular grafts for the treatment of failed prior infrarenal AAA repair procedures. Forty-seven patients were treated with endovascular grafts. These included 14 patients with type I endoleaks (5 proximal, 8 distal, 1 proximal and distal) and 33 patients with paraanastomotic aneurysms after standard open surgical AAA repair (3 proximal aorta, 5 distal aorta, 21 iliac, 4 proximal and distal). The interval between the primary aortic procedure and the endovascular repair was significantly shorter for failed endovascular procedures (mean, 18.2 months; range, 1-42 months) than for failed conventional procedures (mean, 108.9 months; range, 12-216 months) (p <0.01). The endovascular devices used for correction of the failed AAA repairs were Talent (23), physician-made (19), AneuRx (2), Vanguard (2), and Excluder (1). Transrenal fixation was used for repair of all proximal anastomotic failures. Mean follow-up after reintervention was 12.2 months in patients with failed endovascular grafts and 10.6 months in patients with failed conventional grafts. Patient demographics were as follows: average age, 78 years; 36 male and 11 female; and 4.1 comorbid medical conditions per patient. The endovascular graft was successfully deployed in all 47 cases; 1 patient experienced a persistent proximal attachment site endoleak after endograft deployment. Endovascular grafts may be used to treat previously failed endovascular and conventional AAA repair procedures with good short- and intermediate-term results. Endovascular treatments in these cases may avoid the difficulties of aortic reoperation or AAA repair in the setting of prior endovascular aortic grafting.     

Perioperative outcomes after open and endovascular repair of intact abdominal aortic aneurysms in the United States during 2001

OBJECTIVE: Small patient numbers, mixed data from clinical trials, and longitudinal series representing institutional learning curves have characterized previous studies of early outcomes after endovascular abdominal aortic aneurysm (AAA) repair. We compared the perioperative outcomes of endovascular and open surgical AAA repair in an unselected sample of patients in a single calendar year using a national administrative database. METHODS: The 2001 National Inpatient Sample database was retrospectively reviewed. This database represents 20% of all-payer stratified sample of non-federal US hospitals. Patients older than 49 years were identified by primary diagnostic codes (International Classification of Disease, ninth revision [ICD-9], 441.4, intact, nonruptured AAA) and procedure codes (ICD-9 38.44 for open, 39.71 for endovascular repair). Patient demographic data (age, sex), comorbid conditions (ICD-9 coded), inpatient complications (ICD-9 coded), length of stay, final discharge disposition (home vs institution vs death), and hospital charges were examined with univariate and multivariate analyses. RESULTS: In calendar year 2001, 7172 patients underwent either open (64%) or endovascular (36%) repair of intact, nonruptured AAAs. Despite comparable rates of preoperative comorbid conditions and a greater proportion of octogenarians (23% vs 16%%; P =.0001), morbidity (18% vs 29%; P =.0001) and mortality (1.3% vs 3.8%; P =.0001) were significantly lower for endovascular repair than for open repair. The median length of stay (2 vs 7 days; P =.0001) and the rate of discharge to an institutional facility versus home (6% vs 14%; P =.0001) were also much lower in the endovascular group than in the open repair group. At multivariate analysis, open AAA repair and age older than 80 years were strong independent predictors (P =.0001 for all) for death (open repair: odds ratio [OR], 3.3; 95% confidence interval [CI], 2.3-4.9; age: OR, 14.2; 95% CI, 3.5-58.1), complications (open repair: OR, 1.9; 95% CI, 1.7-2.1; age: OR, 1.9; 95% CI, 1.5-2.5), and not being discharged to home (open repair: OR, 3.4; 95% CI, 2.9-4.1; age: OR, 12.0; 95% CI, 7.0-20.4). Mean hospital charges were significantly greater (difference, $3337; P =.0009) for endovascular repair than for open repair. Extrapolated to the total number of endovascular AAA repairs performed during the single 2001 calendar year, this resulted in a staggering $50.3 million in additional hospital charges. CONCLUSIONS: Endovascular repair of intact AAAs results in a significantly lower number of complications and deaths, shorter hospital stay, and improved likelihood of discharge to home, even in older patients, when compared with open surgical repair. These impressive gains in clinical outcome, however, are achieved at similarly impressive increases in health care costs.     

Efficacy of a bifurcated endograft versus open repair of abdominal aortic aneurysms: a reappraisal

OBJECTIVE: Late complications and graft failures have recently cast serious doubts on the durability of endovascular repair of abdominal aortic aneurysms (AAA). The results of a multicenter trial comparing a bifurcated endograft (AB) with standard open repair (OR) were reviewed to assess the late findings of both methods of AAA treatment. PATIENTS AND METHODS: In a multicenter study of AB versus OR conducted from December 1995 to February 1998, 242 patients with AAA successfully treated with an AB and 111 control patients treated concurrently with OR were followed up at least yearly. Twenty-five immediate conversions were excluded from late follow-up. All imaging modalities obtained during follow-up were reviewed by a core laboratory for AAA size, endoleaks, migration, and device integrity. Clinical outcomes at the yearly visits were compared. All death reports were reviewed to classify the cause of death. RESULTS: Average follow-up for the AB group was 36 months, with 194 patients at 3 years and 55 patients at 4 years. The cumulative mortality rate was similar between the AB (15.7%) and OR groups (12.6%; P =.59). The significant early benefit to the AB group in cardiopulmonary complications was no longer evident by 3 years. However, the AB advantage in total and bowel complications, as well as the higher renal complication rates, persisted. At 3 years, 73.7% of patients showed a significant reduction of their AAA size, whereas 25.7% still had an endoleak. One migration and two single hook fractures were noted. Graftrelated reinterventions were performed in 50 patients (20%) without any deaths. Twenty-eight patients (11.6%) underwent interventions for limb flow compromise, whereas 25 were treated for endoleak. Late conversion to OR was required in five patients (2%). No AAA ruptures were encountered in either group. CONCLUSIONS: Rupture-free survival rates after treatment of AAA with the bifurcated AB are similar to those of the OR group. Notably the proximal attachment system is relatively stable and the AAA shrinks in three of four patients treated. Reinterventions are nonetheless required in nearly one of five patients. Although most late procedures are percutaneous, counseling regarding possible future interventions is necessary.     

Five-year interim comparison of the Guidant bifurcated endograft with open repair of abdominal aortic aneurysm

OBJECTIVE: This study was undertaken to compare 1-year and 5-year results of endovascular repair of abdominal aortic aneurysm (AAA) with the Guidant/EVT bifurcated graft system with results of open repair. METHODS: This was a prospective, nonrandomized, concurrent controlled study that compared results of endovascular versus open repair of AAA. The Phase II study with the EGS delivery system included 268 patients in 18 US medical centers; and the Phase III trial with the Ancure delivery system incuded 305 patients in 21 US institutions. Data were internally and externally audited and subjected to periodic review by the US Food and Drug Administration. The control group of 111 patients were excluded from endovascular repair with a tube graft because of anatomic considerations, but were otherwise comparable to the experimental group. Patients in the control group underwent conventional open surgical repair concurrently with patients who underwent EGS repair in 18 US institutions. RESULTS: Five hundred thirty-one of 573 patients (92.7%) underwent successful implantation of the Guidant/EVT bifurcated endograft. The combined major morbidity and mortality in the endograft group was 28.8%, compared with 44.1% in the open control group. Additional benefits in the endograft group included shorter hospital stay (2 days vs 6 days), less surgical blood loss (400 mL vs 800 mL), and less intensive care unit use (33% vs 94%). These early results are reported on an intent-to-treat basis; in all patients an attempt was made to treat with the endovascular graft, including those patients in whom conversion to standard open repair was necessary during the primary procedure. Three hundred nineteen patients were selected for long-term follow-up to 5 years, on the basis of date of implantation; ie, patients with the earliest implantations were followed up for 5 years. The primary purpose of long-term follow-up was to obtain data on long-term efficacy of the graft; thus only patients in whom implantation was successful were selected. No patient has experienced an aneurysm rupture to date. Survival (Kaplan- Meier method) in the experimental group was 68.1%, compared with 77.2% in the control group (P = NS). At 60 months, 74.4% of patients (32 of 43) were free of endoleak. There were no type I or type III endoleaks remaining. Aneurysm sac diameter decreased or remained stable in 97.6% of patients (41 of 42) and increased in only 1 patient. During the course of long-term follow-up, post-procedural conversion to open repair was required in only 9 patients (2.8%). CONCLUSION: The EVT/Guidant bifurcated graft is effective in preventing AAA rupture, and long-term survival is comparable to that with open repair.     

高危复杂腹主动脉瘤腔内修复术临床分析

目的 评估应用多种腔内技术治疗高危复杂腹主动脉瘤的可行性.方法 2001年1月至2010年12月,共138例腹主动脉瘤患者接受腹主动脉腔内修复术(EVAR),其中9例患者为高危复杂性腹主动脉瘤.男性8例,女性1例,年龄26～87岁,平均67岁.其中2例近肾腹主动脉假性动脉瘤,5例近肾腹主动脉瘤,1例腹主动脉瘤合并双髂总动脉瘤及左侧髂内动脉瘤,1例EVAR术后右髂内动脉瘤.所采用的腔内技术包括:主动脉支架开窗技术和扇形技术2例,烟囱技术5例,球囊辅助下髂内动脉瘤腔内治疗1例和球囊辅助反转支架技术1例.结果 所有腔内技术均获得成功.术中支架释放后即刻发现内漏4例,其中1例患者为Ⅰ型和Ⅲ型内漏,经大动脉球囊扩张后内漏消失;2例Ⅰ型内漏,其中1例行弹簧栓栓塞成功,另1例行近端裸支架成功.1例Ⅱ型内漏,经随访瘤腔直径未增大,未处理.随访4～79个月,平均25.9个月.无动脉瘤破裂,动脉瘤瘤体直径均有不同程度的缩小.随访过程中7例患者的靶血管(肾动脉、肠系膜上动脉和髂内动脉)均保持通畅.1例髂内动脉重建支架术后18个月血栓形成,但无盆腔缺血等症状.结论 对于不能耐受手术的高危复杂腹主动脉瘤患者,选择合适的腔内技术可以增加EVAR术的成功率,近、中期效果满意.     

Response of plasma matrix metalloproteinase-9 to conventional abdominal aortic aneurysm repair or endovascular exclusion: implications for endoleak

PURPOSE: Matrix metalloproteinases are enzymes capable of breaking down all of the components of the extracellular matrix and have been implicated in the development of aneurysm formation. Because matrix metalloproteinase-9 (MMP-9) levels are elevated in aortic aneurysmal tissue and in that patient plasma, we hypothesized that plasma MMP-9 levels should decrease significantly after conventional and endovascular infrarenal abdominal aortic aneurysm (AAA) repair but that plasma MMP-9 levels would remain elevated in patients with endoleaks. METHODS: A sandwich enzyme-linked immunosorbent assay was used to measure plasma levels of MMP-9 in patients with AAA who underwent conventional (n = 26; mean age, 71.5 years) and endovascular (n = 25; mean age, 76.4 years) AAA repair. Levels were drawn before surgery and at 1 month and 3 months after surgery. Eight patients for endovascular repair had endoleaks identified on postoperative computed axial tomographic scans. RESULTS: No correlation existed between preoperative plasma MMP-9 levels when compared with age, gender, or aneurysm diameter. No significant difference in preoperative plasma MMP-9 levels or AAA diameter was identified between patients with conventional repair compared with endovascular repair. Of the 51 patients, 33 had follow-up samples available for analysis. A significant increase in mean plasma MMP-9 levels was noted 1 month (149.5 +/- 40.1 ng/mL) after conventional AAA repair compared with preoperative levels (83.9 +/- 26.1 ng/mL; P <.05) and remained elevated 3 months after surgery (129.8 +/- 56.6 ng/mL). In those patients who underwent endovascular aneurysm exclusion without endoleak, a significant decrease in mean plasma MMP-9 levels was noted at 3 months (27.4 +/- 5.2 ng/mL) when compared with preoperative values (60.8 +/- 8.8 ng/mL; P <.01). In contrast, patients with endoleak after endovascular exclusion did not have a significant decrease in plasma MMP-9 levels at 3 months. CONCLUSION: Plasma MMP-9 levels remain elevated for as much as 3 months after conventional AAA repair, whereas successful endovascular exclusion of an AAA results in decreased plasma MMP-9 levels by 3 months. MMP-9 may have clinical value as an enzymatic marker for endoleak after endovascular AAA exclusion.     

Initial experience with endovascular aneurysm repair: Comparison of early results with outcome of conventional open repair

Purpose: To determine the safety, effectiveness, and problems encountered with endovascular repair of abdominal aortic aneurysm (AAA). Initial experience with endoluminal stent grafts was examined and compared with outcome for a matched concurrent control group undergoing conventional operative repair of AAA. Methods: Over a 3-year period, 30 patients underwent attempts at endovascular repair of infrarenal AAA. Of the 28 (93%) successfully implanted endografts, 8 were tube endografts, 8 bifurcated grafts, and 12 aortouniiliac grafts combined with femorofemoral bypass. Most of the procedures were performed in the past year because the availability of bifurcated and aortoiliac endografts markedly expanded the percentage of patients with AAA who might be treated with endoluminal methods. The follow-up period ranged from 1 to 44 months, with a mean value of 11 months. Results: Endovascular procedures demonstrated significant advantages with respect to reduced blood loss (408 versus 1287 ml), use of an intensive care unit (0.1 versus 1.75 days), length of hospitalization (3.9 versus 10.3 days), and quicker recovery (11 versus 47 days). Although the total number of postoperative complications was identical for the two groups, the nature of the complications differed considerably. Local and vascular complications characteristic of endovascular repair could frequently be corrected at the time of the procedure and tended to be less severe than systemic or remote complications, which predominated among the open surgical repair group. On an intent-to-treat basis, 23 (77%) of the 30 AAAs were successfully managed with endoluminal repair. The seven (23%) failures were attributable to two immediate conversions caused by access problems, three persistent endoleaks, one late conversion caused by AAA expansion, and one late rupture. Conclusions: Although less definitive than those for conventional operations, these early results suggest that endovascular AAA repair offers considerable benefits for appropriate patients. The results justify continued application of this method of AAA repair, particularly in the treatment of older persons at high risk. (J Vasc Surg 1998;27:992-1005.)