Early complications and long-term outcome after open surgical treatment of popliteal artery aneurysms: is exclusion with saphenous vein bypass still the gold standard?

BACKGROUND: Popliteal artery aneurysms (PAAs) are rare, but thromboembolic complications may result in limb loss. To define complications and outcomes after open surgical repairs, we reviewed our experience. METHODS: Clinical data of patients with PAA seen between 1985 and 2004 at Mayo Clinic, Rochester, Minnesota, were reviewed and outcomes in 289 patients with open revascularization were analyzed. Kaplan-Meier method with log-rank tests, chi(2), and Wilcoxon rank sum tests were used for analysis. RESULTS: A total of 358 PAAs were treated in 289 patients, consisting of 281 (97%) men and eight (3%) women. There were 133 (46%) unilateral and 156 (54%) bilateral PAAs with a mean diameter of 2.9 cm (range, 1.5 to 9 cm). Abdominal aortic aneurysm (AAA) was more frequent with bilateral than unilateral PAAs (65% [101/156] vs 42% [56/133] P = .001). There were 144 (40%) asymptomatic limbs (group 1), 140 (39%) had chronic symptoms (group 2), and 74 (21%) had acute ischemia (group 3). Great saphenous vein (GSV) was used in 242 limbs (68%), polytetrafluoroethylene (PTFE) in 94 (26%), and other types of graft in 22 (6%). Early mortality was 1% (3/358), all in group 3 (4% [3/74]). Six of seven patients with perioperative myocardial infarctions belonged to group 3 (8%). The 30-day graft thrombosis rate was 4%, with 1% in group 1 (1/144), 4% in group 2 (5/140), and 9% in group 3 (7/74). All six early amputations (8%) were in group 3, five with failed bypass (4 PTFE, 1 GSV). Mean follow-up was 4.2 years (range, 1 month to 20.7 years). The 5-year primary and secondary patency rates were 76% and 87%, respectively, higher with GSVs (85% and 94%) than PTFE (50% and 63%, P < .05). Seven recurrent PAAs (2%) required reintervention. The 5-year freedom from reintervention was 100% after endoaneurysmorrhaphy vs 97% after ligations (P = .03). Five-year limb salvage rate was 97% (85% in group 3). There was no limb loss in group 1 and none in group 2 with GSV. In group 3, preoperative thrombolysis reduced the amputation rate in class II patients with marginally threatened limbs (96% vs 69%, P = .02). CONCLUSION: Acute presentation of PAA continues to carry high mortality and cardiac morbidity; although preoperative thrombolysis appears to improve results, the 8% early and 15% late amputation rates remain ominous. Early elective repair is recommended because these patients had no surgical mortality, a low rate of complications, and asymptomatic patients had no limb loss at 5 years. GSV and endoaneurysmorrhaphy continues to be the gold standard for open repair of PAA.

Aortic neck dilation after endovascular abdominal aortic aneurysm repair: should oversizing be blamed?

Long-term durability after endovascular abdominal aortic aneurysm repair (EVAR) is dependent upon the maintenance of an effective seal between the endograft and the proximal landing zone. Continuous neck dilation might lead to the loss of such a seal. This study aims at evaluating the incidence, risk factors, and clinical consequences of post-EVAR aneurysm neck dilation in patients treated with two types of endografts: AneuRx and Ancure. We reviewed data concerning all consecutive patients submitted to primary EVAR using the AneuRx and Ancure devices. Preoperative neck anatomic characteristics (diameter, calcification, and thrombus load) were evaluated, and device oversize percentage was calculated. Postoperative same-level neck diameter was measured on all postoperative computed tomographic (CT) scans. Probabilities of neck dilation (> or = 10% and > or = 15%) relative to preoperative diameter and first postoperative diameter were estimated with the Kaplan-Meier method and compared between patients using both types of endograft. The impact of anatomic characteristics on neck dilation incidence was evaluated using Cox proportional hazards models. Mean neck dilation was compared between patients with and without device migration and proximal type I endoleak. Both groups had similar probabilities of dilating > 10% relative to preoperative diameter and to first postoperative diameter. Proximal necks in AneuRx-treated patients had higher probabilities of dilating > or = 15% relative to preoperative diameter than Ancure-treated patients (45.5% vs. 18.7% at 1.5 years, p = 0.025), but the probability of such dilation relative to the first postoperative diameter was not different between the two groups (12.4% vs. 9.1% at 1.5 years, p = 0.832). None of the preoperative neck characteristics was associated with neck dilation risk. Device oversize percentage was correlated with the percentage of neck dilation at first postoperative CT scan relative to preoperative diameter in both the AneuRx (correlation coefficient = 0.469, p < 0.0001) and the Ancure (correlation coefficient = 0.464, p < 0.011) groups, but it was not correlated with the percentage of neck dilation at 1 or 1.5 years relative to first postoperative CT scan in either group. Patients with and without caudad device migration (> or = 5 mm) had similar percentages of neck dilation at 1.5 years relative to preoperative diameter, but migrators had higher mean percentages of dilation at 1.5 years relative to first postoperative neck diameter (11.4% vs. 5.6, p = 0.012). Two phenomena may be differentiated: an immediate postimplant dilation, strongly correlated with the percentage of oversize and more likely to reach values > or = 15% with an AneuRx device than with an Ancure graft, and a subsequent dilation, relative to the first postoperatively measured diameter, equally probable with either type of device, not correlated with the percentage of oversizing but associated with caudad device migration. Our study does not support any adverse role for the degree of oversize.

Evolution from axillofemoral to in situ prosthetic reconstruction for the treatment of aortic graft infections at a single center.

OBJECTIVE: The primary purpose of this study was to analyze the clinical outcome in patients treated for aortic graft infections with in situ reconstruction (ISR). As a secondary aim, the outcomes were compared between patients who had similar clinical characteristics and extent of infection, needed total graft excision, and had either ISR or axillofemoral reconstruction (AXFR). METHODS: 117 consecutive patients treated for aortic graft infection over a 20 year period from January 1981 to December 2001 were identified. 52 patients had prosthetic ISR, 49 had AXFR, and 16 had other reconstructions. The ISR patients treated with total (n = 35) or partial (n = 17) graft excision comprised the primary analysis. A second analysis was done between 34 ISR and 43 AXFR patients (non-concurrent groups), as stated above. Primary outcome measures were early and late procedure-related death, primary graft patency and limb loss. Secondary outcomes were operative morbidity, patient survival, and graft reinfection rates. RESULTS: There were 40 males and 12 females with a mean age of 69 years treated with ISR. 43 patients had Rifampin-soaked grafts and 39 had omental flap or other autogenous coverage. Operative morbidity occurred in 23 patients (44%). There were 4 early and no late procedure-related deaths after a median follow up of 3.4 years (range, 2 months to 9.6 years). Primary patency and limb salvage rates at 5 years were 89% and 100%, respectively. Graft reinfection occurred in 6 patients (11.5%) and was not associated with procedure-related death. In the comparative analysis, the procedure-related death rate for patients treated with ISR was not different than those treated with AXFR (9% versus 23%; P = 0.11). There was a significant improvement in primary patency between ISR and AXFR at 5 years (89% versus 48%; P = .01). Limb salvage was 100% for ISR and 89% for AXFR at 5 years (P = .06). The incidence of graft reinfection was similar in both groups: 11% for ISR and 17% for AXFR (P = .28). Major complications or procedure-related deaths occurred in 12 patients after ISR (30%) and 26 patients (60%) after AXFR (P < .04). CONCLUSION: ISR is a safe and effective alternative in the treatment of select patients with aortic graft infection. Graft reinfection occurred in 11.5% of the patients. The graft patency and limb salvages rates are excellent.

Factors affecting outcomes of open surgical repair of pararenal aortic aneurysms: a 10-year experience.

PURPOSE: Few large series document surgical outcomes for patients with pararenal abdominal aortic aneurysms (PAAAs), defined as aneurysms including the juxtarenal aorta or renal artery origins that require suprarenal aortic clamping. No standard endovascular alternatives presently exist; however, future endovascular branch graft repairs ultimately must be compared with the gold standard of open repair. To this end, we present a 10-year experience. METHODS: Between 1993 and 2003, 3058 AAAs were repaired. Perioperative variables, morbidity, and mortality were retrospectively assessed. Renal insufficiency was defined as a rise in the concentration of serum creatinine by > or = 0.5 mg/dL. Factors predicting complications were identified by multivariate analyses. Morbidity and 30-day mortality were evaluated with multiple logistic regression analysis. RESULTS: Of a total of 3058 AAA repairs performed, 247 were PAAAs (8%). Mean renal ischemia time was 23 minutes (range, 5 to 60 minutes). Cardiac complications occurred in 32 patients (13%), pulmonary complications in 38 (16%), and renal insufficiency in 54 (22%). Multivariate analysis associated myocardial infarction with advanced age (P = .01) and abnormal preoperative serum creatinine (>1.5 mg/dL) (P = .08). Pulmonary complications were associated with advanced age (P = .03), renal artery bypass (P = .02), increased mesenteric ischemic time (P = .01), suprarenal aneurysm repair (P < .0008), and left renal vein division (P = .01). Renal insufficiency was associated with increased mesenteric ischemic time (P = .001), supravisceral clamping (P = .04), left renal vein division (P = .04), and renal artery bypass (P = .0002), but not renal artery reimplantation or endarterectomy. New dialysis was required in 3.7% (9/242). Abnormal preoperative serum creatinine (>1.5 mg/dL) was predictive of the need for postoperative dialysis (10% vs 2%; P = .04). Patients with normal preoperative renal function had improved recovery (93% vs 36%; P = .0002). The 30-day surgical mortality was 2.5% (6/247) but was not predicted by any factors, and in-hospital mortality was 2.8% (7/247). Median intensive care and hospital stays were 3 and 9 days, respectively, and longer stays were associated with age at surgery (P = .007 and P = .0002, respectively) and any postoperative complication. CONCLUSIONS: PAAA repair can be performed with low mortality. Renal insufficiency is the most frequent complication, but avoiding renal artery bypass, prolonged mesenteric ischemia time, or left renal vein transection may improve results.

Beyond the instructions for use: pushing the limits of infrarenal device application for abdominal aortic aneurysms.

Endograft devices are used to treat 40% to 80% of patients with abdominal aortic aneurysms. A much smaller percentage of patients have ideal anatomy, for which the devices were designed. Vascular surgeons and interventionalists have become increasingly creative in endograft placement to exclude aneurysms, despite the presence of complex aortoiliac anatomy. Arterial diameter and angulation are the most common barriers to successful endograft placement. In response to this need, graft manufacturers are increasing graft size choices, improving device flexibility, and providing improved arterial wall fixation. Despite newer devices, providers still must push the limits of defined anatomy based on the manufacturers recommended instructions to repair most infrarenal aneurysms.

Takayasu's arteritis: operative results and influence of disease activity.

OBJECTIVES: To determine the short- and long-term outcomes of patients treated operatively for Takayasu's arteritis and the effect of disease activity on results. METHODS: Forty-two (17%) of the 251 patients enrolled in our Takayasu's arteritis registry between 1975 and 2002 required operation for symptomatic disease. Data were obtained from the registry, patient records, phone correspondence, and written surveys. RESULTS: There were 38 females and 4 males with a median age of 29 years (range, 12 to 56 years), and 32 (76%) were white. Sixty operations were performed for symptomatic disease. The mean duration of symptoms before operation was 5.6 months (range, 0 to 25 months). Thirteen (31%) patients had active disease and underwent operation for acute presentation or failure of medical management. Thirty-nine patients (93%) had operation for occlusive disease. Twenty-two (52%) patients had involvement of both the great and abdominal aortic branch vessels; 10 (24%) had great vessel disease alone; 9 (21%) had involvement of abdominal arteries; and 1 (2%) had coronary artery disease. There was no operative death, myocardial infarction, major stroke, or renal failure. Three patients had early graft thrombosis, two had a minor stroke, and two developed hyperperfusion syndrome. The median follow-up was 6.7 years (range, 1 month to 19.3 years). Eleven (26%) patients required 15 graft revisions; five of the patients had active disease at the time of initial operation. All early revisions (<1 year) were in patients with active disease. By Kaplan-Meier analysis, freedom from revision at 5 and 10 years was 100% in patients with quiescent disease not requiring steroids (group I, n = 5, 12%), 95% and 81% in patients whose disease was quiescent on steroids (group II, n = 24, 57%), 57% in patients with active disease on steroids (group III, n = 7, 17%), and 33% in patients with active disease and no long-term steroids (group IV, n = 6, 14%) (P < .006). The rate of revision or progression of disease at another site in 5 years was 0% in group 1, 10% in group 2, 57% in group 3, and 67% in group 4 (P < .001) The differences were even more pronounced when an analysis was done on the basis of disease activity alone, irrespective of steroid use. During the follow-up period, 3 of 39 great vessel, 2 of 18 mesenteric/renal, and 1 of 9 aortofemoropopliteal reconstructions occluded. The predicted mortality for patients was 4% at both 5 and 10 years (95% CI) respectively (confidence interval [CI], 0% to 11%) and 10 (CI, 0% to 14%) years, respectively. CONCLUSIONS: The minority of patients with Takayasu's arteritis require operation. In our predominantly white female patient population, occlusive symptoms were the most common indication for operation. Operation for these selected patients was safe, with no operative mortality, myocardial infarction, major stroke, or renal failure. Patients with active disease requiring operation are more likely to require revision or develop progressive symptomatic disease at another site. Long-term survival is excellent, regardless of disease activity at the time of operation.

Prosthetic vascular graft infection: a risk factor analysis using a case-control study.

OBJECTIVES: Several factors have been anecdotally reported to increase the risk of prosthetic vascular graft infection (PVGI), a serious complication with high mortality and limb amputation rates. The goal of this study is to confirm purported risk factors using a well-designed statistical model. METHODS: Patients undergoing vascular graft placement at Mayo Clinic Rochester between January 1, 1982 and December 31, 2002 were retrospectively evaluated, excluding redo cases. PVGI cases had to meet one of the following criteria: perigraft air or fluid >8 weeks postoperatively, positive Gram stain or cultures of graft or perigraft material, intraoperative gross purulence, failure of graft incorporation, or exposed graft. Each case had two controls matched for age, gender and date of surgery. Duration of follow-up for a given control had to be at least equal to the time to infection of the corresponding case. Demographic and other clinical data were collected for each patient. RESULTS: Fifty-one cases and 102 controls met the inclusion criteria. Median age was 68 years. Staphylococcal species were identified in 45% of the total number of cases, and 60% of cases with a recovered organism. Univariate analysis identified groin incision, wound complication and wound infection as significant risk factors for PVGI (p<0.005 for all three factors). After adjusting for age and surgery date, multivariate analysis confirmed the statistical significance of groin incision and wound infection as risk factors for PVGI. CONCLUSIONS: This is the first published risk factor analysis that includes statistical evaluation in a case-control study of PVGI. Groin incision, wound complication, and wound infection are significantly associated with developing PVGI. These findings will assist in identifying patients at increased risk of developing subsequent infection. SUMMARY: In order to confirm purported risk factors of prosthetic vascular graft infections (PVGI), a well designed case-control study was conducted at Mayo Clinic, Rochester, MN. Univariate and multivariate analyses of 51 cases and 102 controls identified three statistically significant risk factors for the development of PVGI: groin incision, wound complication, and wound infection.

The spectrum, management and clinical outcome of Ehlers-Danlos syndrome type IV: a 30-year experience.

PURPOSE: Ehlers-Danlos syndrome type IV (EDS-IV) results from abnormal procollagen III synthesis and leads to arterial, intestinal, and uterine rupture. The purpose of this study was to review the spectrum, management, and clinical outcome of EDS-IV patients. METHODS: We retrospectively reviewed the clinical data of 31 patients (15 male and 16 female) with a clinical diagnosis of EDS-IV treated over a 30-year period (1971 to 2001). Biochemical confirmation was obtained in 24 patients, and mutation of the COL3A1 gene was confirmed in 11 patients. The study excluded patients with other connective tissue dysplasias. RESULTS: The mean age at the time of diagnosis was 28.5 +/- 11 years (range, 10 to 53 years). Twenty-four patients developed 132 vascular complications; of these, 85 were present either before or at the time of the initial evaluation, and 47 complications occurred during a median follow-up of 6.3 years (range, 0.5 to 26 years). Survival free of vascular complications was 90% at age 20 years, 39% at 40 years, and 20% at age 60 years. Fifteen patients underwent 30 operative interventions for vascular complications, including arterial reconstruction (n = 15), simple repair or ligation (n = 4), coil embolization (n = 3), splenectomy (n = 2), and abdominal decompression, nephrectomy, graft thrombectomy, vein stripping and thoracoscopy (n = 1 each). Three hospital deaths occurred from exsanguinating hemorrhage: two after operative interventions and one because of a ruptured splenic artery. Procedure-related morbidity was 46%, including a 37% incidence of postoperative bleeding and a 20% need for re-exploration. The incidence of late graft-related complications was 40% of arterial reconstructions, including 4 anastomotic aneurysms, 1 fatal anastomotic disruption, and 1 graft thrombosis. Patient survival was 68% at age 50 years and 35% at age 80 years. Of the 12 deaths during the study period, 11 were associated with vascular or graft-related complications. CONCLUSION: Operative mortality in patients with vascular complications of EDS-IV was not excessively high, but the incidence of postoperative bleeding complications and late graft-related problems was significant. Despite successful repair of vascular complications, survival was shortened because of secondary vascular or graft-related complications.

Surgical management of renal fibromuscular dysplasia: challenges in the endovascular era.

Percutaneous transluminal renal angioplasty (PTRA) is the primary treatment for renal fibromuscular dysplasia (RFMD). Surgical revascularization is limited to patients who fail or are unsuitable for PTRA. All patients who were operated on with RFMD since the indications for renal PTRA were expanded in our institution were retrospectively reviewed. Outcome included patency, hypertension, and renal function. Twenty-six patients had reconstruction of 32 renal arteries between 1998 and 2004. The mean age was 47.1 +/- 14 years; the majority (81%) were female. Six patients had bilateral disease and three had a solitary kidney. Operations were done for hypertension in 25 patients, renal artery aneurysm in 8, and chronic dissection in 1, alone or in combination. Six patients had a failed PTRA and 20 were unsuitable for it. Aortorenal bypass was done most often (n = 28) and saphenous vein was the preferred conduit (n = 25). The distal anastomosis was to the main renal artery in 13 patients and to the branch arteries in 19. Ex vivo repair was needed in five patients. Five intraoperative revisions were done because of abnormalities on duplex scan. One patient died unexpectedly 42 days after operation from myocardial infarction. Extrarenal complications occurred in five patients. Median follow-up was 2.4 (range, 42 days to 6.3) years and was available in all but one patient (96%). Two bypasses occluded at 3 and 376 days, which resulted in loss of the kidneys. One graft stenosis was treated successfully with PTRA at 239 days. All failures occurred in men. One-year cumulative primary patency was 89 +/- 8% and was not adversely affected by prior PTRA or complex repair. Hypertension at 1 year was cured in 27% of the patients and improved in 60%. No patient developed acute or chronic renal failure. Surgical reconstruction for RFMD has excellent short-term patency. Failed PTRA or complex reconstructions did not adversely affect outcome.

AneuRx device migration: incidence, risk factors, and consequences.

Success after endovascular abdominal aortic aneurysm repair (EVAR) is dependent on device positional stability. The quest for such stability has motivated different endograft designs, and the risk factors entailed remain the subject of debate. This study aims at defining the incidence, risk factors, and clinical implications of device migration after EVAR with the AneuRx endograft. In this study we included all consecutive 109 patients submitted to primary AneuRx placement for infrarenal aortic or aortoiliac aneurysms. Preoperative computed tomography (CT) scans were reviewed for the following anatomic characteristics: neck length, diameter, angulation, calcification, and thrombus load; and sac diameter and thrombus load. Percentage of device oversizing relative to the proximal neck diameter was determined. All postoperative CT scans were reviewed, and the distance between the lowest renal artery and the craniad end of the device was measured. A >/=5-mm increase in such distance was considered indicative of device migration. Migration cumulative incidence was estimated by the Kaplan-Meier method, and its association with any of the preoperative anatomical characteristics was tested using Cox proportional hazards models. Median follow-up time was 9 (range, 1-31) months. Migration occurred in nine patients, corresponding to a 15.6% estimated probability of migration at 30 months (SE = 5.1%). Migration was associated with the risk of proximal type I endoleak (hazard ratio = 3.39, 95% confidence interval = 1.46-7.87; p = 0.007). This type of endoleak occurred in three of the migration-affected patients (33.3%); all of them were resolved by additional cuff placement at the proximal landing zone. No other migration-related reinterventions were performed. The only significant associations between anatomic factors and device migration probability were the protective effects of longer necks (odds ratio [OR] = 0.71 for each additional 5 mm, p = 0.045) and longer overlapped portions of neck and device (OR = 0.56 for each additional 5 mm, p = 0.003). There was a trend toward higher probability of migration among reverse-tapered necks (OR = 1.75, p = 0.109). Percentage of device oversizing correlated with early neck dilation (between preoperative and first postoperative diameters, correlation coefficient = 0.4, p < 0.0001), but not with late neck dilatation (between first postoperative and 1.5-year scan diameters, correlation coefficient = 0.29, p = 0.112). There was a trend toward higher mean percentage of late dilation among migrators (11.4%, standard error of the mean [SEM] 2.6) than nonmigrators (5.7%, SEM = 1) (p = 0.08), but both groups had similar mean percentages of early dilation (3%, SEM = 1.6%, vs. 5.5%, SEM = 0.6%; p = 0.365). This result indicates that device migration is not a rare event after AneuRx implantation. This phenomenon is associated with proximal type I endoleaks. Deployment of the endograft immediately below the renal arteries might help to prevent migration, since use of greater lengths of overlapped device relative to the proximal neck has a protective effect. Migration seems to be independent of the degree of device oversizing.

Comparison of precuffed and vein-cuffed expanded polytetrafluoroethylene grafts for infragenicular arterial reconstructions: a case-matched study.

Distal vein cuff interposition is often added to prosthetic infragenicular arterial reconstruction in an attempt to improve hemodynamics and patency rates. The purpose of this study was to compare the outcome of a precuffed expanded polytetrafluroethylene (ePTFE) graft with a vein-cuffed ePTFE graft for infragenicular bypass. We reviewed the clinical outcome of 77 patients with critical limb ischemia without available autologous vein conduits who underwent arterial reconstruction of 80 limbs to below-knee popliteal or tibioperoneal vessels using either ePTFE precuffed graft (precuffed group, 38 patients 40 limbs) or ePTFE vein-cuffed graft (vein-cuffed group, 39 patient, 40 limbs). Precuffed group patients were enrolled in a prospective cohort study. Vein-cuffed group patients consisted of consecutive case-matched patients operated on during the same study period. End points were primary graft patency and limb salvage rates. There were 42 males and 35 females with a mean age of 73.4 years (range, 44-92 years). Both groups were matched to demographics, risk factors for atherosclerosis, previous ipsilateral reconstruction, and location of the distal anastomosis. Proximal anastomosis was to the common (n = 68) or superficial (n = 12) femoral arteries. Distal anastomosis was to the below-knee popliteal (n = 28), anterior tibial (n = 12), posterior tibial (n = 15) and peroneal (n = 25) arteries. Operative mortality was 1.3%. Graft patency at dismissal was 90% and 95% in the precuffed and vein-cuffed groups, respectively. The mean follow-up was 25.7 months (range, 2.4-61 months). Primary patency rates at 1 and 3 years were 70% and 57% in the precuffed group, and 78% and 54% in the vein-cuffed group (p = 0.32). Limb salvage rates at 1 and 3 years were 97% and 70% in the precuffed group, and 95% and 81% in the vein-cuffed group (p = 0.49). Overall patient survival at 1 and 3 years was 81 % and 57%, respectively. In this case-control study, results of precuffed ePTFE graft were similar to those obtained with vein-cuffed ePTFE grafts. The precuffed ePTFE graft is an adequate alternative conduit for infragenicular arterial reconstruction in patients with critical limb ischemia and no available autologous veins.

Proximal type I endoleak after endovascular abdominal aortic aneurysm repair: predictive factors.

Proximal type I endoleaks after endovascular abdominal aortic aneurysm repair (EVAR) are associated with a high risk of rupture. Risk factors for developing this complication are not fully elucidated. We aimed to define preoperative predictors for proximal type I endoleak and describe its clinical outcome. From a consecutive series of 257 patients who underwent EVAR, we selected 202 who had available pre- and postoperative CT scan studies. Proximal neck diameter, length, angulation, calcification, thrombus load (thickness, percentage of neck circumference coverage, percentage of neck area occupancy), and maximum aneurysm diameter were evaluated on preoperative CT scans. All postoperative CT and duplex ultrasound scans, supplemented with angiograms in selected cases, were reviewed for the presence or absence of endoleak. Device overlap and oversizing (relative to the proximal neck) were also determined. Type I proximal endoleak rates were estimated using the Kaplan-Meier method. The associations between the variables listed above and proximal type I endoleak were evaluated by use of Cox proportional hazards models. Proximal type I endoleak occurred in eight patients, corresponding to a 3-year incidence rate of 4% (SE = 1.5%). The median follow-up was 340 days (range, 22-1954). Univariate analyses found significant associations between proximal type I endoleak and the following variables: percentage of calcified neck circumference (hazards ratio = 2.19 for a 25% increase, p = 0.019), aneurysm maximum diameter (hazards ratio = 1.98 for a 1-cm increase, p = 0.006) and proximal neck and device overlap (hazards ratio = 0.53 for a 5-mm increase, p = 0.007). The mean overlap among cases with and without type I proximal endoleak was 15.6 mm and 29.3 mm, respectively. When these variables were included in a multivariate model, all remained statistically significant. No significant association could be documented for neck thrombus-related variables. Thirty-nine (19.3%) patients had a beta neck angle inferior to 120 degrees . There was a trend toward a higher incidence of proximal type I endoleaks in these patients (p = 0.057). Device oversize relative to proximal neck diameter did not affect the probability of this type of endoleak. One patient survived an emergency open repair of a ruptured aneurysm after significant expansion. Six patients underwent endovascular reinterventions (4 additional proximal cuff placements, 2 proximal angioplasties). The mean interval for reintervention was 389 days. Distal migration (>or=5 mm) was identified in four cases (50%). Proximal type I endoleak is a rare complication after EVAR, but it is associated with a high number of reinterventions and potentially serious consequences. Patients with short and heavily calcified aneurysmal necks and large aneurysms are at increased risk of proximal type I endoleaks.

Endovascular abdominal aortic aneurysm repair: does gender matter?

Substantial differences across genders have been documented for the natural history and clinical course of cardiovascular diseases. This study's objective is to compare preoperative characteristics, intraoperative events, and postoperative outcomes in men and women undergoing endovascular abdominal aortic aneurysm repair (EVAR). We hypothesized that despite gender anatomic specificities, EVAR may achieve similar results across genders. We included 241 consecutive patients who underwent elective EVAR at our institution from December 1996 through May 2003. Demographic variables and comorbidities were collected by chart review, and intraoperative events were from surgical notes. Baseline anatomic characteristics were evaluated on the last preoperative computed tomography (CT) scan. Radiologic outcomes were evaluated on all postoperative CT scans, and clinical follow-up information was abstracted from charts. Women constituted 12% (n = 29) of our cohort and were older than men (79.9 vs. 74.9 years, p = 0.0003). When compared to men, they had aneurysms with similar diameter (54.1 vs. 55.5 mm, p = 0.491) but narrower (23.1 vs 25.5 mm, p < 0.0001) and shorter (18.9 vs. 30.4 mm, p < 0.0001) proximal necks. Female iliac arteries were narrower (9.6 vs. 11.4 mm, p < 0.0001), with higher calcification scores (2.5 vs. 2.3, p = 0.047) but lower tortuosity indexes (1.2 vs. 1.3, p = 0.0001). Additional access maneuvers were more frequent in women: iliac access angioplasty (31% vs. 10.9%, = p = 0.007), uni-iliac conversion (13.8% vs. 1.4%, p = 0.005), and iliac "chimney" conduit (12.1% vs. 1.2%, p = 0.0001). There was a trend toward longer fluoroscopy time in women (34.6 vs. 26.9 min, p = 0.056). The following postoperative outcomes at 24 months were similar in women and men: freedom from endoleak (63.4% vs. 72.7%, p = 0.74), reintervention rate (28% vs. 24.5%, p = 0.878), aneurysm shrinkage (24.3% vs. 68.7%, p = 0.199), aneurysm expansion (0% vs. 3%, p = 0.213), and survival (92.9% vs. 84.3%, p = 0.341). There was a trend toward higher rates of neck dilation relative to preoperative diameter in women (48.5% vs. 16% at 12 months, p = 0.059) and toward lower limb patency rates in men (100% vs. 92.8%, p = 0.098). In sum, women have shorter proximal necks and smaller and more calcified iliac arteries, which increases the necessity of access-related additional maneuvers. Despite being older and having a less favorable anatomy, women can expect similar technical and clinical outcomes after EVAR.

Most patients with abdominal aortic aneurysm are not suitable for endovascular repair using currently approved bifurcated stent-grafts.

Strict morphologic criteria must be used for patient selection to achieve durable success with endovascular aortic aneurysm repair (EVAR). The goal of this study was to assess morphologic suitability (MS) of abdominal aortic aneurysms (AAAs) for 2 currently approved bifurcated stent grafts and identify reasons for exclusion from EVAR. The authors reviewed the electronic charts of 1,795 consecutive patients who were diagnosed as having AAA between January 1999 and July 2001 at their institution. Three hundred and twenty patients had an AAA with a diameter of > or = 5.0 cm, measured on computed tomography (CT). The records of 301 patients, 254 men, 47 women, with a mean age of 74 years were available for review, and these patients constituted the study cohort. Criteria used for MS included a proximal neck length > or = 15 mm; neck diameter between 18 and 26 mm; neck angulation < or = 60 degrees ; common or external iliac artery (CIA or EIA) diameters of 7-16 mm and 8-13 mm, respectively, for AneuRx (Medtronic Ave, Santa Rosa, CA) and Ancure (Guidant Cardiac and Vascular Division, Menlo Park, CA) bifurcated grafts. AAAs were suitable for AneuRx device in 14% of patients (43 of 301; 95% CI = 11-19%) and for Ancure in 5% (16 of 301; 95% CI = 3.1-9%). The main reason for exclusion was an inadequate proximal aortic neck (73%). The neck was too short in 49.5%, too wide in 64% and badly angulated in 12% of the patients. Iliac artery morphology precluded EVAR with AneuRx and Ancure devices in 52% and 80%. Both CIAs were too wide for EVAR in 43% and 77%, respectively. When iliac artery diameter < or = 20 mm was accepted, iliac suitability for AneuRx increased from 49% to 70% and overall suitability increased from 14% to 20%. When more permissive criteria were used for MS (neck length > or = 10 mm, neck diameter < or = 30 mm, CIA < or = 20), 39% of patients became candidates for EVAR. More than three fourths of the patients with an AAA > or = 5.0 cm in size, seen in a tertiary referral center, are morphologically not suitable for EVAR using 2 currently approved bifurcated endografts. The main reasons for exclusion are a short or wide proximal aortic neck. Considerable changes in size of the devices and in proximal attachment techniques have to occur before most AAAs will be suitable for EVAR.

Computed tomography and ultrasound in follow-up of patients after endovascular repair of abdominal aortic aneurysm.

The purpose of this study was to compare our experience with duplex ultrasonography (US) and computed tomography (CT) for the routine follow-up of patients after endovascular repair (EVAR) of abdominal aortic aneurysm (AAA). We reviewed the electronic charts and radiologic exams of the first 125 patients (113 males, 12 females, median age of 76 years, range 48-98 years) with AAA treated by EVAR from June 1996 to November 2001. Our follow-up protocol included serial CT and US at regular intervals after the procedure (before discharge, at 1 month, and then every 6 months). Adequacy of each exam, ability to detect endoleaks, measurements of AAA diameter, and ability to determine graft patency were compared. For endoleak detection, comparison between CT and US was done using CT as the gold standard. A total of 608 exams, 337 CTs and 271 US, were performed 1 day to 5 years after endovascular aneurysm repair; 98% of CT and 74% of US were technically adequate. Contrary to CT, the proportion of adequate US exam was significantly less in patients with higher body mass index (BMI > or = 30 = 54% vs. BMI < 30 = 81%, p < 0.001) and for pre-discharge US compared to the post-discharge US (54% vs. 88%, p = 0.0005). Concurrent scan pairs were obtained in 252 instances in 107 patients (1-8 pairs per patient). Excellent correlation between AAA diameter measured on CT and US was noted (correlation coefficient of 0.9, p < 0.0001). However, agreement was poor. CT anteroposterior (AP) and transverse measurements were on average 2.9 mm (95% limits of agreement = -7 to 13 mm) and 1.8 mm (95% limits of agreement = -9 to 12 mm) greater than US. For AAA diameter change, there was no case of increase AP diameter on CT. However, in 23% (29/128 pairs of sets) of US, an increase in AAA size that could have influenced patient management (> or = 4 mm) was reported despite no change demonstrated on CT. For endoleak detection, sensitivity and specificity of US compared to that of CT was 25% and 89%. Similar sensitivity and specificity were noted when we excluded the first set (25% and 95%), sets done prior to 2000 (30% and 89%), inadequate CT or US scans (31% and 98%), or duplicate sets of results for each patient (28% and 81%). Of the 27 endoleaks missed on US in 17 patients, 2 were type I endoleaks. None of the four endoleaks seen only on US were type I endoleak. US usefulness prior to discharge was reduced by the high rate of inadequate exam, especially in obese patients. Despite the excellent correlation in AAA diameter between US and CT, there was significant disagreement in AAA diameter measurement and diameter change. Sensitivity of nonstandardized US for endoleak was low compared to CT. CT remains our primary imaging study after EVAR, but standardization of post-EVAR US technique may improve its accuracy.

Stapled aortic anastomoses: a minimally invasive, feasible alternative to videoscopic aortic suturing?

Widespread applications of totally laparoscopic aortic reconstructions have been limited by the long cross-clamp time required to suture the aortic anastomosis despite improvement in instrumentation. The authors' hypothesis was that a "one-step anastomosis concept" using an intraluminal stapler would allow shorter cross-clamp time but similar patency and imperviousness as videoscopic suturing techniques. An intraluminal stapler (Endopath-ILS, Ethicon) with a modified anvil was used to perform videoscopic-assisted thoracic aorta-to-iliac artery bypass with a 21 mm by 8 mm polytetrafluoroethylene (PTFE) graft in 22 sheep through a minimally invasive approach using a 5 cm thoracotomy. The graft-to-iliac artery anastomoses were hand sutured through a flank incision. Twelve sheep were used to establish the technique and 10 subsequent animals constituted the study group. Aortic cross-clamp time, imperviousness, and need for additional sutures were recorded and compared to previously reported data using videoscopic suturing in pigs. Patency was assessed by comparing lower limb arterial pressures. Macroscopic and microscopic examinations of the anastomoses were performed at different time-points within the first 3 months. Videoscopic-assisted stapled anastomoses were also performed on atherosclerotic aortas of 3 human cadavers. Stapled anastomoses between the thoracic aorta and PTFE graft were completed in 8 of 10 animals. Two animals were euthanized after stapler failure and anastomotic bleeding. Sutures to strengthen the anastomosis had to be used in 4 cases. Mean aortic cross-clamp time in 8 successful cases was 4.3 +/-2.9 minutes (range 2-11 minutes) and was significantly shorter than clamp time of videoscopic suturing technique (48.7 +/-9.4 minutes, p < 0.0001). Imperviousness was good or excellent in 4 animals and fair in 4 animals. All anastomoses were patent at the end of the procedure. Examination of the anastomosis of the 2 failed interventions showed medial aortic tear surrounding the anastomosis in 1 case and misfired staples in the other. No graft occlusion was noted during follow-up ranging from 0 to 12 weeks. At the time of harvest, no bleeding was noted after epinephrine and volume infusion to increase mean arterial pressure to 200 mm Hg for 15 minutes. Macroscopic examination of the anastomoses revealed adequate healing with circumferential stapling of the prosthesis to the aortic wall and no stenosis or thrombus except in 1 false aneurysm (1/7, 14%). Surface electron microscopy showed cells coverage of the anastomosis surface. When applied on human cadaver thoracic and abdominal aorta with atherosclerotic changes, clamping times of less than 5 minutes were achieved. However, imperviousness tested with saline was poor. An automatic stapling device allows performance of a graft-to-aorta anastomosis through a minimally invasive approach with shorter clamping time than a videoscopic suturing technique. However, the current technique of aortic stapling is unreliable and further improvements are needed.

Hand-assisted laparoscopic aorto-aortic bypass: initial experience in a porcine model.

Videoscopic surgical techniques have been developed to reduce morbidity of open aortic reconstructions. The advantage of hand-assisted laparoscopic surgery (HALS) technique is the introduction of the surgeon's hand into the peritoneal cavity. The aims of this study were to assess the feasibility and to examine the learning curve, limitations, and pitfalls of the HALS technique to perform aortic reconstruction in a porcine model for training purposes. HALS aorto-aortic 8 mm polytetrafluoroethylene (PTFE) interposition grafts were placed in 12 pigs. Proficiency was judged by measuring operative time points, satisfactory completion of the operation, and the need to convert to open procedure. The strength of the relationship between order number in which a procedure was performed and the various surgical time point measures was described with the Spearman rank correlation. HALS aortic grafting was successful in the last 8 pigs. The first 2 pigs required conversion to open repair, and the graft of the third and fourth animals occluded early. Median operative time was 115 minutes (range: 75 to 205), median intestinal retraction time was 28 minutes (range: 10 to 40), median aortoiliac dissection time was 30 minutes (range: 20 to 60), and median aortic cross-clamp time was 48 minutes (range: 35 to 82). The Spearman rank correlations and p values between the order of the procedure and the intestinal retraction time, aortoiliac dissection time, clamping time, and total operative time were -0.62 (0.06), -0.47 (0.17), -0.69 (0.03), and -0.83 (0.03), respectively. HALS facilitates intestinal retraction and completion of laparoscopic aortoiliac dissection. It offers adequate exposure in pigs for aortic grafting and allows open sutured aortic anastomosis. The learning curve for HALS aortic surgery in a porcine model is short and within reach of surgeons with standard laparoscopic surgery skills, since no laparoscopic suturing is required. Training on this porcine model may be an efficient and safe way to introduce surgeons to HALS for aortoiliac reconstruction.

Iatrogenic operative injuries of abdominal and pelvic veins: a potentially lethal complication.

PURPOSE: Epidemiologic studies of vascular injuries are usually limited to those caused by trauma. The purpose of this study was to review the management and clinical outcome in patients with operative injuries to abdominal and pelvic veins. METHODS: Clinical data and outcome in all patients with iatrogenic venous injuries during abdominal and pelvic operations between 1985 and 2002 were reviewed. RESULTS: Forty patients (21 men, 19 women; mean age, 51 years [range, 27-87 years]) sustained 44 venous injuries. Injuries occurred during general (30%), colorectal (23%), orthopedic (20%), gynecologic (15%), and other (12%) operations. Factors leading to injury included oncologic resection (65%), difficult anatomic exposure (63%), previous operation (48%), recurrent tumor (28%), and radiation therapy (20%). All patients had substantial bleeding (mean, 3985 mL; range, 500-20,000 mL). Injuries were located in the inferior vena cava (n = 6), portal vein (n = 7), renal vein (n = 1), and iliac vein (n = 30). Repair was performed with venorrhaphy (64%), end-to-end anastomosis (14%), interposition graft (20%), and vessel ligation (2%). Seven patients (18%) died of injury-related causes, including multisystem organ failure (n = 4), uncontrollable bleeding (n = 2), and pulmonary embolism (n = 1). Thirteen patients (32.5%) had major injury-related complications, including repeat exploration because of bleeding (n = 6), multisystem organ failure (n = 6), and venous thrombosis (n = 4). In two patients (5%) unilateral lower extremity edema developed, with no evidence of thrombosis. There was no late graft or venous thrombosis. Variables associated with increased risk for death were massive bleeding, acidosis, hypotension, and hypothermia (P <.05). CONCLUSION: Operative injuries of abdominal and pelvic veins occur in patients undergoing oncologic resection and those with difficult anatomic exposure, owing to previous operation, recurrent tumor, or radiation therapy. Massive blood loss, acidosis, hypotension, and hypothermia are associated with increased risk for death. Repair of venous injuries offers durable results with low incidence of graft or venous thrombosis.

Carotid endarterectomy in SAPPHIRE-eligible high-risk patients: implications for selecting patients for carotid angioplasty and stenting.

OBJECTIVES: Carotid angioplasty and stenting (CAS) has been proposed as an alternative to carotid endarterectomy (CEA) in patients excluded from the North American Symptomatic Carotid Endarterectomy Trial and the Asymptomatic Carotid Atherosclerosis Study and in those considered at high risk for CEA. In light of recently released CAS data in patients at high risk, we reviewed our experience with CEA. METHODS: The records for consecutive patients who underwent CEA between 1998 and 2002 were retrospectively reviewed, and risk was stratified according to inclusion and exclusion criteria from a "high-risk" or CAS-CEA trial, The Stenting and Angioplasty with Protection in Patients at High Risk for Endarterectomy (SAPPHIRE) trial. RESULTS: Of 776 CEAs performed, 323 (42%) were considered high risk, on the basis of criteria including positive stress test (n = 109, 14%), age older than 80 years (n = 85, 11%), contralateral carotid occlusion (n = 66, 9%), pulmonary dysfunction (n = 56, 7%), high cervical lesion (n = 36, 5%), and repeat carotid operation (n = 27, 3%). Other high-risk criteria included recent myocardial infarction (MI), cardiac surgery, or class III or IV cardiac status; left ventricular ejection fraction less than 30%; contralateral laryngeal palsy; and previous neck irradiation (each <1.5%). Clinical presentation was similar in the high-risk and low-risk groups: asymptomatic (73% versus 73%), transient ischemic attack (23% vs 22%), and previous stroke (4% vs 5%). The overall postoperative stroke rate was 1.4% (symptomatic, 2.9%; asymptomatic, 0.9%). Comparison of high-risk and low-risk CEAs demonstrated no statistical difference in the stroke rate. Factors associated with significantly increased stroke risk included cervical radiation therapy, class III or IV angina, symptomatic presentation, and age 60 years or younger. Overall mortality was 0.3% (symptomatic, 0.5%; asymptomatic, 0.2%), not significantly different between the high-risk (0.6%) and low-risk groups (0.0%). Non-Q-wave MI was more frequent in the high-risk group (3.1 vs 0.9%; P <.05). A composite cluster of adverse clinical events (death, stroke, MI) was more frequent in the symptomatic high-risk group (9.3% vs 1.6%; P <.005), but not in the asymptomatic cohort. There was a trend for more major cranial nerve injuries in patients with local risk factors, such as high carotid bifurcation, repeat operation, and cervical radiation therapy (4.6% vs 1.7%; P <.13). In 121 patients excluded on the basis of synchronous or immediate subsequent operations, who also would have been excluded from SAPPHIRE, the overall rates for stroke (1.65%; P =.69), death (1.65%; P =.09), and MI (0.83%; P =.71) were not significantly different from those in the study population. CONCLUSIONS: CEA can be performed in patients at high risk, with stroke and death rates well within accepted standards. These data question the use of CAS as an alternative to CEA, even in patients at high risk.

Perioperative complications and early outcome after endovascular and open surgical repair of abdominal aortic aneurysms.

BACKGROUND: Open repair (OR) of abdominal aortic aneurysms (AAAs) is a major surgical procedure with elevated morbidity and a low but definite mortality. Advocates of endovascular repair (EVAR) claim decreased complication rates and outcome equal to OR. METHODS: Data of all patients with infrarenal AAA that was treated electively, both with OR and EVAR, at Mayo Clinic Rochester between December 1, 1999 and December 1, 2001 were retrospectively reviewed. Thirty-day morbidity and mortality and early clinical outcomes were assessed and compared. RESULTS: Three hundred fifty-five patients underwent treatment: 261 patients, including 229 males and 32 females (mean age: 73 years; range: 52 to 90 years) underwent OR, and 94 patients including 85 males and 9 females (mean age: 77 years; range: 61 to 98 years) underwent EVAR (AneuRx: 53, Ancure: 38, Endologix: 3). Median AAA size was 57 mm in both groups. There were more high-risk patients in the EVAR group (27% vs 14%, P =.007). Thirty-day mortality rates were 1.1 % (3/261) for OR and 0 for EVAR (P = NS). Cardiac and pulmonary complications were less frequent after EVAR (11% vs 22%, P =.02, and 3% vs 16%, P =.001, respectively), but graft-related complications were more frequent (13% vs 4%, P =.002). The association between type of repair and cardiac, pulmonary, and graft complications remained statistically significant after adjusting for age, gender, and high-risk status. The multivariate odds ratios (EVAR vs OR) for cardiac, pulmonary, and graft complications were 0.35 (95% confidence interval [CI]: 0.17 to 0.74), 0.14 (95% CI: 0.04 to 0.47), and 3.81 (95% CI: 1.51 to 9.58), respectively. Primary and secondary patency and freedom-from-reintervention rates at 1 year were lower after EVAR (83% vs 98%, P <.001; 96% vs 99%, P =.02; 65% vs 93%, P <.001, respectively). CONCLUSIONS: Both elective OR and EVAR can be performed with low mortality, but cardiac and pulmonary complications are less frequent and less severe after EVAR. The tradeoff of EVAR is a higher rate of graft-related complications, with more reinterventions and a lower graft patency rate at 1 year. These results should be considered before EVAR is offered to patients with AAA.