Clinical Performance of the Low Profile Zenith Alpha Abdominal Endovascular Graft: 2 Year Results from the ZEPHYR Registry.

OBJECTIVE: The midterm outcomes of the low profile Zenith Alpha Abdominal Endovascular Graft from the ZEnith alPHa for aneurYsm Repair (ZEPHYR) registry are reported. METHODS: The ZEPHYR registry is a physician initiated, multicentre, non-randomised, core laboratory controlled, prospective registry. Inclusion criteria were patients with a non-ruptured abdominal aortic aneurysm with a maximum diameter ≥ 50 mm or enlargement > 5 mm within 6 months, with a site reported infrarenal neck length of ≥ 10 mm and with the intention to electively implant the Zenith Alpha abdominal endograft. Patients from 14 sites across Germany, Belgium, and the Netherlands were included. The primary endpoint was treatment success, defined as technical success and clinical success. Technical success was defined as successful delivery and deployment of the endograft in the planned position without unintentional coverage of internal iliac or renal arteries, with successful removal of the delivery system. Clinical success was defined as freedom from aneurysm sac expansion > 5 mm, type I or type III endoleaks, aneurysm rupture, stent graft migration > 10 mm, open conversion, and stent graft occlusion. RESULTS: Three hundred and forty-seven patients were included in the ZEPHYR registry. The median clinical follow up was 743 days (interquartile range [IQR] 657, 806) with a median imaging follow up of 725 days (IQR 408, 788). Treatment success at 6 months, 1, and 2 years was 92.5%, 90.4%, and 85.3%, respectively. Freedom from secondary intervention was 94.3%, 93.4%, and 86.9%, respectively. The predominant reason for secondary intervention was limb complications. Freedom from limb occlusion (per patient) at 6 months, 1, and 2 years was 97.2%, 95.8%, and 92.5%, respectively. Univariable and multivariable Cox regression analyses could not identify any independent predictor for limb complications. CONCLUSION: While treatment success is comparable with other commercially available grafts, the rate of limb complications at 2 years is of concern. The manufacturer's instructions for use should be followed closely. Further studies are necessary to investigate the root cause of the increased rate of limb complications with the Zenith Alpha Abdominal Endovascular Graft.

Editor's Choice - Endurant Stent Graft in Patients with Challenging Neck Anatomy "One Step Outside Instructions for Use": Early and Midterm Results from the EAGLE Registry.

OBJECTIVE: The aim of the Endurant for Challenging Anatomy: Global Experience (EAGLE) registry is to evaluate prospectively the technical and clinical success rate of a stentgraft used in patients with challenging neck anatomy outside the instructions for use (IFU) but within objective anatomical limits. METHODS: This was a prospective, international, multicentre, observational study. From 1 February 2012 to 1 September 2017, patients with an abdominal aortic aneurysm with a challenging infrarenal neck that were deemed suitable for endovascular aneurysm repair were included prospectively at 23 European centres. Patients were distributed by anatomy into three groups: short neck (SN; infrarenal neck 5 - 10 mm in combination with suprarenal angulation [α] ≤ 45° and infrarenal angulation [ß] ≤ 60°); medium neck (MN; infrarenal neck 10 - 15 mm with α ≤ 60° and ß 60° - 75° or α 45°- 60° and ß ≤ 75°; and long angulated neck (LN; infrarenal neck ≥ 15 mm with α ≤ 75° and ß 75°- 90° or α 60°- 75° and ß ≤ 90°. All computed tomography scans were reviewed by an independent core laboratory. Primary outcomes were technical and clinical success. Secondary endpoints were peri-operative major adverse events, all cause mortality, aneurysm related mortality, endoleaks, migration, and secondary intervention. RESULTS: One hundred and fifty patients (81.3% male) were included (SN = 55, MN = 16, LN = 79). The median follow up was 36 ± 12.6 months. In the overall cohort, the technical success rate was 93.3%. Estimated freedom from aneurysm related death was 97.3% at three years. Freedom from secondary interventions was 84.7% at three years. Estimated clinical success was 96.0%, 90.8%, and 83.2% at 30 days, one year, and three years, respectively. Estimated freedom from all cause mortality, late type IA endoleak, and migration at three years was 75.1%, 93.7%, and 99.3%, respectively. CONCLUSION: The early and midterm results of the EAGLE registry show that endovascular repair with the Endurant stentgraft in selected patients with challenging infrarenal neck anatomy yields results in line with large "real world" registries. Long term results are awaited for more definitive conclusions.

Thirty-day Results from the ZEPHYR Registry: Outcomes of EVAR Using the Zenith Alpha™ Abdominal Endovascular Graft for the Treatment of AAA in 347 Patients.

BACKGROUND: To report technical and clinical 30-day results following treatment with the Zenith Alpha™ abdominal stent graft from the ZEnith alPHa for aneurYsm Repair Registry (ZEPHYR). METHODS: Multicenter, nonrandomized, single arm, core laboratory-controlled, prospective registry collecting data on the Zenith Alpha Abdominal Endovascular Graft being used in subjects with abdominal aortic aneurysms (AAA) from sites in Germany, Belgium, and The Netherlands between December 2016 and December 2019. Inclusion criteria were non-ruptured AAAs with a maximum diameter ≥50 mm or enlargement >5 mm over 6 months with an AAA neck length ≥10 mm (site reported). Primary outcome measure was treatment success at 30 days. Treatment success was defined as a combined endpoint consisting of technical and clinical success. Technical success was defined as successful stent graft delivery and deployment as well as successful removal of the delivery system. Clinical success at 30 days was defined as freedom from type I and III endoleak, aneurysm rupture, conversion to open surgery and stent graft occlusion. RESULTS: Three hundred forty-seven subjects were included from 14 sites with a median age of 73.0 years (IQR 68.0-79.0). Thirty-four patients were female (9.8%). The median AAA diameter was 58.3 mm (IQR 55.0-63.5). The median proximal neck diameter was 23.6 mm (IQR 22.0-25.2) with a median proximal neck length of 24.4 mm (IQR 15.0-34.8) and a median infrarenal neck angulation of 24.5° (IQR 15.0-35.0). The right and left common iliac diameter were 16.1 mm (IQR 14.1-19.4) and 16.2 mm (IQR 14.1-19.1), respectively. The treatment success rate at 30 days was 94.8% (N = 329). Technical success was achieved in 333 patients (96.0%). The clinical success rate at 30 days was 98.8% (N = 343). Three patients had limb occlusions at 30 day follow up (0.9%). One patient had a type Ib endoleak (0.3%). Seventy percent of vascular access approaches were percutaneous. The reintervention rate was 1.7% (N = 6) within 30 days. Indications for reinterventions were a false aneurysm at puncture site (N = 1), limb complications (N = 2), stentgraft-associated renal artery occlusions (N = 2), and an external iliac artery thrombosis (N = 1). CONCLUSIONS: Endovascular aneurysm repair using the Zenith Alpha Abdominal Endovascular Graft is effective in the short term. Long term results will be reported in the future.

Pre-operative Patient Specific Flow Predictions to Improve Haemodialysis Arteriovenous Fistula Maturation (Shunt Simulation Study): A Randomised Controlled Trial.

OBJECTIVE: An arteriovenous fistula (AVF) needs to mature before it becomes suitable to cannulate for haemodialysis treatment. Maturation importantly depends on the post-operative flow increase. Unfortunately, 20-40% of AVFs fail to mature (FTM). A patient specific computational model that predicts immediate post-operative flow was developed, and it was hypothesised that providing information from this model for planning of fistula creation might reduce FTM rates. METHODS: A multicentre, randomised controlled trial in nine Dutch hospitals was conducted in which patients with renal failure who were referred for AVF creation, were recruited. Patients were randomly assigned (1:1) to the control or computer simulation group. Both groups underwent a work up, with physical and duplex ultrasonography (DUS) examination. In the simulation group the data from the DUS examination were used for model simulations, and based on the immediate post-operative flow prediction, the ideal AVF configuration was recommended. The primary endpoint was AVF maturation defined as an AVF flow ≥500 mL/min and a vein inner diameter of ≥4 mm six weeks post-operatively. The secondary endpoint was model performance (i.e. comparisons between measured and predicted flows, and (multivariable) regression analysis for maturation probability with accompanying area under the receiver operator characteristic curve [AUC]). RESULTS: A total of 236 patients were randomly assigned (116 in the control and 120 in the simulation group), of whom 205 (100 and 105 respectively) were analysed for the primary endpoint. There was no difference in FTM rates between the groups (29% and 32% respectively). Immediate post-operative flow prediction had an OR of 1.15 (1.06-1.26; p < .001) per 100 mL/min for maturation, and the accompanying AUC was 0.67 (0.59-0.75). CONCLUSION: Providing pre-operative patient specific flow simulations during surgical planning does not result in improved maturation rates. Further study is needed to improve the predictive power of these simulations in order to render the computational model an adjunct to surgical planning.

Midterm Results After Abandoning Routine Preemptive Coil Embolization of the Internal Iliac Artery During Endovascular Aneurysm Repair.

PURPOSE: To analyze the results of endovascular repair of common iliac artery (CIA) aneurysms without preemptive coil embolization of the internal iliac artery (IIA). MATERIALS AND METHODS: Between January 2010 and July 2016, 79 patients (mean age 74.3±8.4 years; 76 men) underwent endovascular repair extending into the external iliac artery owing to a CIA aneurysm. The procedure was performed for a ruptured aneurysm in 22 (28%) patients. Eighty-one IIAs were intentionally covered. The median CIA diameter was 37 mm (range 20-90). The primary outcomes were the occurrence of type II endoleaks and the incidence of buttock claudication. RESULTS: Five (6%) patients died within 30 days (4 with ruptured aneurysms and 1 elective case). Two type II endoleaks originating from a covered IIA were recorded; one required an endovascular intervention because of aneurysm growth. The other patient died of a rupture based on an additional type III endoleak. Mean follow-up was 37.6±26.3 months. Nineteen (26%) patients required a secondary intervention. Buttock claudication was reported in 21 (28%) of 74 patients and persisted after 1 year in 7. No severe ischemic complications as a result of IIA coverage were recorded, and no revascularization was required during follow-up. CONCLUSION: Treatment of CIA aneurysms by overstenting the IIA without preemptive coil embolization is safe and has a low risk of type II endoleak and aneurysm growth. Persisting buttock claudication is rare.

Overstenting the hypogastric artery during endovascular aneurysm repair with and without prior coil embolization: A comparative analysis from the ENGAGE Registry.

BACKGROUND: Endovascular aneurysm repair of aortoiliac or iliac aneurysms is often performed with stent graft coverage of the origin of the hypogastric artery (HA) to ensure adequate distal seal. It is considered common practice to perform adjunctive coiling of the HA to prevent a type II endoleak. Our objective was to question the necessity of pre-emptive coiling by comparing the outcomes of HA coverage with and without prior coil embolization. METHODS: Data from the Endurant Stent Graft Natural Selection Global Postmarket Registry (ENGAGE), which prospectively enrolled 1263 endovascular aneurysm repair patients between March 2009 and April 2011 from multiple centers worldwide, were used for this study. We identified patients in whom the Endurant stent graft (Medtronic Vascular, Santa Rosa, Calif) covered one or both HAs and grouped them into cases in which prior HA embolization-coils or plugs-was performed (CE) and cases in which HA embolization was not performed (NE). The occurrence of covered HA-related endoleak and secondary interventions were compared between groups. RESULTS: In 197 patients, 225 HAs were covered. Ninety-one HAs were covered after coil embolization (CE group), and 134 HAs were covered without prior coil embolization (NE group). Both groups were similar at baseline and had comparable length of follow-up to last image (665.2 ± 321.7 days for CE patients; 641.6 ± 327.6 days for NE patients; P = .464). Importantly, both groups showed equivalent iliac morphology concerning common iliac artery proximal, mid, and distal dimensions and tortuosity, making them suitable for comparative analysis. During follow-up, HA-related endoleaks were sparse and occurred equally often in both groups (CE 5.5% vs NE 3.0%; P = .346). Secondary intervention to resolve an HA-related endoleak was performed twice in the CE group and three times in the NE group. Late non-HA-related endoleaks occurred more often in the CE group compared with the NE group, (25.0% vs 15.0%; P = .080). Secondary interventions for other reasons than HA-related endoleaks occurred in 7.5% of NE cases and 15.4% of CE cases (P = .057), mostly for occlusions in the ipsilateral iliac limb. During follow-up, 19 NE patients and 9 CE patients died, which is not significantly different (P = .225), and no deaths were related directly or indirectly to HA coverage. Also, no reports of gluteal necrosis and bowel ischemia were made. CONCLUSIONS: This study shows that HA coverage with the Endurant endograft without prior coil embolization does not increase the incidence of endoleak or related secondary interventions. These findings together with the already available evidence suggest that omission of coil embolization may be a more resource-effective strategy whenever HA coverage is required.

Mycotic innominate artery aneurysm repair using a bovine pericardial bifurcation prosthesis.

We report the use of a bovine pericardial bifurcation prosthesis to repair a mycotic innominate artery aneurysm.

Comparison of midterm results for the Talent and Endurant stent graft.

OBJECTIVE: Stent graft evolution is often addressed as a cause for improved outcomes of endovascular aneurysm repair for patients with an abdominal aortic aneurysm. In this study, we directly compared the midterm result of Endurant stent graft with its predecessor, the Talent stent graft (both Medtronic, Santa Rosa, Calif). METHODS: Patient treated from January 2005 to December 2010 in a single tertiary center in The Netherlands with a Talent or Endurant stent graft were eligible for inclusion. Ruptured abdominal aortic aneurysms or patients with previous aortic surgery were excluded. The primary end point was the Kaplan-Meier estimated freedom from secondary interventions. Secondary end points were perioperative outcomes and indications for secondary interventions. RESULTS: In total, 221 patients were included (131 Endurant and 90 Talent). At baseline, the median aortic bifurcation was narrower for the Endurant (30 mm vs 39 mm; P < .001). Median follow-up was 64.1 ± 37.9 months and 59.2 ± 25.3 months for Talent and Endurant, respectively. The estimated freedom from secondary interventions at 30 days, 1 year, 5 years, and 7 years was 94.3%, 89.4%, 72.2%, and 64.1% for Talent and 96.8%, 89.3%, 75.2%, and 69.2% for Endurant (P = .528). The indication for secondary interventions does differ; more patients required an intervention for a proximal neck-related complication (type Ia endoleak or migration) in the Talent group (18.2% vs 4.8%; P = .001), whereas more interventions for iliac limb stenosis were seen in the Endurant group (0.0% vs 4.8%; P = .044). In a binomial regression analysis, suprarenal angulation, infrarenal neck length, and type of stent graft were independent predictors of neck-related complications. CONCLUSIONS: Evolution from the Talent stent graft into the Endurant has resulted in significant reduction of infrarenal neck-related complications; on the other hand, iliac interventions increased. The overall midterm secondary intervention rate was comparable.

Late single-center outcome of the Talent Abdominal Stent Graft after a decade of follow-up.

OBJECTIVE: Lifelong yearly surveillance is advised after endovascular aneurysm repair (EVAR) for abdominal aortic aneurysms. This follow-up requires a substantial amount of health care resources. The aim of this paper was to assess the occurrence of stent graft-related complications and secondary interventions during a minimum 10-year follow-up after elective EVAR. METHODS: Patients who were treated in a high-volume endovascular center in The Netherlands with the Talent infrarenal stent graft (Medtronic Vascular, Santa Rosa, Calif) between June 1999 and February 2005 were included. Patients with previous aortic surgery or emergency interventions were excluded. Our primary outcome was clinical success up to 10 years. Secondary end points were technical success and survival. RESULTS: A total of 149 patients were included; 91.9% were male. The mean age was 70.2 ± 7.8 years. A stent graft was implanted in 98% of patients; technical success was achieved in 89.9%. Clinical success after 30 days, 1 year, 5 years, and 10 years was 81.1%, 74.3%, 70.3%, and 65.5%, respectively. In 30 patients (20.7%), a secondary intervention was required; 80.0% of first secondary interventions occurred within the first 5 years. Six late conversions were necessary because of stent graft infection (2), migration (2), or persisting endoleak (2). The 5- and 10-year overall survival rates were 55.2% and 38.6%, respectively. CONCLUSIONS: The risk of EVAR-related complication is highest in the first 5 years. Consequently, the main focus should be on that period; further follow-up must not be neglected, as complications occur up to 10 years after treatment.

A ruptured abdominal aortic aneurysm that requires preoperative cardiopulmonary resuscitation is not necessarily lethal.

OBJECTIVE: A ruptured abdominal aortic aneurysm (RAAA) is associated with a high mortality rate. If cardiopulmonary resuscitation (CPR) is required before surgical repair, mortality rates are said to approach 100%. The aim of this multicenter, retrospective study was to study outcome in RAAA patients who required CPR before a surgical (endovascular or open) repair (CPR group). RAAA patients who did not need CPR served as controls (non-CPR group). METHODS: Over a 5-year time period, demographic and clinical characteristics and specifics of preoperative CPR if necessary were studied in all patients who were treated for a RAAA in three large, nonacademic hospitals. RESULTS: A total of 199 consecutive RAAA patients were available for analysis; 176 patients were surgically treated. Thirteen of these 176 patients (7.4%) needed CPR, and 163 (92.6%) did not. A 38.5% (5 of 13) survival rate was observed in the CPR group. Thirty-day mortality was almost three times greater in the CPR group compared with the non-CPR group (61.5% vs 22.7%; P = .005). Both CPR patients who received endovascular aortic repair survived. In contrast, survival in 11 CPR patients who underwent open RAAA repair was 27% (3 of 11; P = .128). A trend for higher Hardman index was found in patients who received CPR compared with patients who did not receive CPR (P = .052). The 30-day mortality in patients with a 0, 1, 2, or 3 Hardman index was 16.1%, 31.0%, 37.9%, and 33.3%, respectively (P = .093). CONCLUSIONS: An RAAA that requires preoperative CPR is not necessarily a lethal combination. Patient selection must be tailored before surgery is denied.

A 15-Year Single-Center Experience of Endovascular Repair for Elective and Ruptured Abdominal Aortic Aneurysms.

PURPOSE: To evaluate the differences in technical outcomes and secondary interventions between elective endovascular aneurysm repair (el-EVAR) procedures and those for ruptured aneurysms (r-EVAR). METHODS: Of the 906 patients treated with primary EVAR from September 1998 until July 2012, 43 cases were excluded owing to the use of first-generation stent-grafts. Among the remaining 863 patients, 773 (89.6%) patients (mean age 72 years; 697 men) with asymptomatic or symptomatic abdominal aortic aneurysms (AAAs) were assigned to the el-EVAR group; 90 (10.4%) patients (mean age 73 years; 73 men) were assigned to the r-EVAR group based on blood outside the aortic wall on preoperative imaging. The primary study outcome was technical success; secondary endpoints, including freedom from secondary interventions and late survival, were examined with Kaplan-Meier analyses. RESULTS: At baseline, r-EVAR patients had larger aneurysms on average (p<0.001) compared to el-EVAR patients. Technical success was comparable (p=0.052), but there were more type Ia endoleaks at completion angiography in the r-EVAR group (p=0.038). As anticipated, more patients died in the first month in the r-EVAR group (18.9% vs 2.2% el-EVAR, p<0.001). At 5 years, there was an overall survival of 65.1% for the el-EVAR patients vs 48.1% in the r-EVAR group (p<0.001). The freedom from AAA-related mortality was 95.7% for el-EVAR and 71.0% for r-EVAR (p<0.001). Five-year freedom from type I/III endoleaks was significantly lower in the r-EVAR group (78.7% vs 90.0%, p=0.003). Five-year freedom from secondary intervention estimates were not significantly different (el-EVAR 84.2% vs r-EVAR 78.2%, p=0.064). CONCLUSION: Within our cohort of primary EVAR patients, r-EVAR cases showed comparable stent-graft-related technical outcome. Although there was a higher incidence of type Ia endoleaks on completion angiography in the r-EVAR group, the overall secondary intervention rate was comparable to el-EVAR.

Performance of the Endurant stent graft in challenging anatomy.

OBJECTIVE: This study aimed to compare perioperative and postoperative outcomes after endovascular repair of abdominal aortic aneurysms (AAAs) in patients with various neck morphologic features. METHODS: Data from the Endurant Stent Graft Natural Selection Global Postmarket Registry (ENGAGE) were used for the analyses. Patients were categorized into three different groups according to proximal aortic neck anatomy: regular (REG), intermediate (INT), and challenging (CHA). REG was defined as AAAs with a proximal neck ≥15 mm combined with a suprarenal angulation (α) ≤45 degrees and an infrarenal neck angulation (ß) ≤60 degrees. INT was defined as AAAs with a proximal neck of 10 to 15 mm combined with α ≤45 degrees and ß ≤60 degrees or with a proximal neck of >15 mm combined with α ≤60 degrees and ß = 60 to 75 degrees or α = 45 to 60 degrees and ß ≤75 degrees. CHA was defined as infrarenal necks that exceed at least one of the three defining factors. RESULTS: Overall, 925 patients (75.9%) had REG anatomy, 189 patients (15.5%) had INT anatomy, and 104 patients (8.5%) had CHA anatomy. Patient demographics and risk factors were similar. There was a significant difference in AAA diameter between the REG and CHA groups (59.4 mm vs 65.2 mm; P < .001). Technical success was similar among groups (REG 99.1% vs INT 99.5% vs CHA 97.1%). There were no differences in mortality or the need for secondary procedures within 30 days or at 1 year. A significantly higher rate of type I endoleaks within 30 days was seen in CHA compared with REG (adjusted odds ratio, 0.15; 95% confidence interval, 0.05-0.46) and INT (adjusted odds ratio, 0.08; 95% confidence interval, 0.01-0.70), but there was no difference at 1-year follow-up. CONCLUSIONS: This real-world, global experience shows promising results and indicates that endovascular AAA repair with the Endurant stent graft (Medtronic Vascular, Santa Rosa, Calif) is safe and effective in patients with challenging aortic neck anatomy. However, long-term follow-up of patients is required to confirm results.

Effects of Anesthesia Type on Perioperative Outcome After Endovascular Aneurysm Repair.

PURPOSE: To examine outcomes of endovascular aortic aneurysm repair (EVAR) using general, regional, or local anesthesia. METHODS: From March 2009 to April 2011, patients were enrolled from 79 sites in 30 countries worldwide and treated with an Endurant Stent Graft System. Data were compared among 3 groups based on the method of anesthesia: general anesthesia (GA) was used in 785 (62%) patients, regional anesthesia (RA) in 331 (27%) patients, and local anesthesia (LA) in 145 (11%) patients. Multivariate logistic regression analysis was performed to adjust for possible confounding factors; outcomes are presented as the odds ratio and 95% confidence interval. RESULTS: There were intercontinental differences in the distribution of type of anesthesia used for EVAR. Higher ASA (American Society of Anesthesiologists) classification was associated with predominant use of GA. Procedure time was reduced in LA (80.4±40.0 minutes) compared with RA (94.2±41.6 min, adjusted p=0.001) and GA (105.3±46.0 minutes, adjusted p<0.001). Intensive care unit (ICU) admission was less frequent for RA than for GA (adjusted OR 0.71, 95% CI 0.53 to 0.97, p=0.030) and LA (adjusted OR 0.51, 95% CI 0.33 to 0.79, p=0.002). Postoperative hospital stay was significantly shorter for RA and LA compared with GA (adjusted p=0.003 and p=0.010, respectively). There were no significant differences in systemic and surgical complications. Mortality rates within 30 days did not differ among the groups. CONCLUSION: Type of anesthesia used during EVAR has no influence on perioperative mortality and morbidity. The use of local or regional anesthesia during EVAR appeared to be beneficial concerning procedure time, ICU admission, and postoperative hospital stay.

Long-term outcome of open or endovascular repair of abdominal aortic aneurysm.

BACKGROUND: For patients with large abdominal aortic aneurysms, randomized trials have shown an initial overall survival benefit for elective endovascular repair over conventional open repair. This survival difference, however, was no longer significant in the second year after the procedure. Information regarding the comparative outcome more than 2 years after surgery is important for clinical decision making. METHODS: We conducted a long-term, multicenter, randomized, controlled trial comparing open repair with endovascular repair in 351 patients with an abdominal aortic aneurysm of at least 5 cm in diameter who were considered suitable candidates for both techniques. The primary outcomes were rates of death from any cause and reintervention. Survival was calculated with the use of Kaplan-Meier methods on an intention-to-treat basis. RESULTS: We randomly assigned 178 patients to undergo open repair and 173 to undergo endovascular repair. Six years after randomization, the cumulative survival rates were 69.9% for open repair and 68.9% for endovascular repair (difference, 1.0 percentage point; 95% confidence interval [CI], -8.8 to 10.8; P=0.97). The cumulative rates of freedom from secondary interventions were 81.9% for open repair and 70.4% for endovascular repair (difference, 11.5 percentage points; 95% CI, 2.0 to 21.0; P=0.03). CONCLUSIONS: Six years after randomization, endovascular and open repair of abdominal aortic aneurysm resulted in similar rates of survival. The rate of secondary interventions was significantly higher for endovascular repair. (ClinicalTrials.gov number, NCT00421330.)

Retrograde catheterization of haemodialysis fistulae and grafts: angiographic depiction of the entire vascular access tree and stenosis treatment.

BACKGROUND: The European Best Practice Guidelines on Vascular Access propose magnetic resonance angiography (MRA) of dysfunctional dialysis fistulae and grafts if visualization of the complete arterial inflow and outflow vessels is needed. In a prospective multi-centre study we determined the technical success rate of complete vascular access tree depiction by digital subtraction angiography (DSA) as an alternative to MRA. Instead of a more invasive brachial artery of femoral artery approach, we performed a retrograde catheterization of the venous outflow or graft, and stenoses were treated in connection with DSA. METHODS: A catheter was advanced into the central arterial inflow after retrograde puncture of the venous outflow or graft for depiction of the complete inflow, access region and complete outflow. Access DSA through femoral artery puncture was done if the retrograde approach failed to depict the complete vascular access tree. Stenoses with a luminal diameter reduction >or=50% were treated, if possible, in connection with DSA. RESULTS: A total of 116 dysfunctional haemodialysis fistulae and 50 grafts were included. Retrograde DSA depicted the complete vascular tree in 162 patients (97.6%). The arteriovenous anastomosis of four fistulae could not be negotiated by a catheter. DSA demonstrated 247 significant stenoses: 30, 128 and 89 were located in the arterial inflow (12.1%), AV anastomosis and graft region (51.8%) and venous outflow (36.0%), respectively. Ten patients (6.0%) had no stenosis. Eight (4.8%), 55 (33.1%) and 33 (19.9%) patients demonstrated stenoses in only inflow, access region or outflow, respectively. Stenoses in two or three vascular territories were present in 53 (31.9%) and 7 (4.2%) patients, respectively. A technically successful endovascular intervention was obtained in 135 of the 139 patients (97.1%) who underwent angioplasty and/or stent placement. Additional sheath insertion by antegrade outflow puncture was needed in 46 patients (33.1%) for the treatment of coexisting venous outflow stenoses, located downstream from the retrograde positioned sheath. Two minor complications were observed at DSA/angioplasty. CONCLUSION: As an alternative to MRA, full retrograde DSA is safe and effective for stenosis detection and stenosis treatment. However, access evaluation by a non-invasive imaging modality such as colour duplex ultrasound will be sufficient in most cases as proximal inflow stenoses are encountered in a minority of patients. Full retrograde DSA, including complete arterial inflow depiction, may then be reserved for cases with an unsuccessful outcome following endovascular intervention of stenoses depicted at ultrasound.

A randomized trial comparing conventional and endovascular repair of abdominal aortic aneurysms.

BACKGROUND: Although the initial results of endovascular repair of abdominal aortic aneurysms were promising, current evidence from controlled studies does not convincingly show a reduction in 30-day mortality relative to that achieved with open repair. METHODS: We conducted a multicenter, randomized trial comparing open repair with endovascular repair in 345 patients who had received a diagnosis of abdominal aortic aneurysm of at least 5 cm in diameter and who were considered suitable candidates for both techniques. The outcome events analyzed were operative (30-day) mortality and two composite end points of operative mortality and severe complications and operative mortality and moderate or severe complications. RESULTS: The operative mortality rate was 4.6 percent in the open-repair group (8 of 174 patients; 95 percent confidence interval, 2.0 to 8.9 percent) and 1.2 percent in the endovascular-repair group (2 of 171 patients; 95 percent confidence interval, 0.1 to 4.2 percent), resulting in a risk ratio of 3.9 (95 percent confidence interval, 0.9 to 32.9). The combined rate of operative mortality and severe complications was 9.8 percent in the open-repair group (17 of 174 patients; 95 percent confidence interval, 5.8 to 15.2 percent) and 4.7 percent in the endovascular-repair group (8 of 171 patients; 95 percent confidence interval, 2.0 to 9.0 percent), resulting in a risk ratio of 2.1 (95 percent confidence interval, 0.9 to 5.4). CONCLUSIONS: On the basis of the overall results of this trial, endovascular repair is preferable to open repair in patients who have an abdominal aortic aneurysm that is at least 5 cm in diameter. Long-term follow-up is needed to determine whether this advantage is sustained.

Inflow stenoses in dysfunctional hemodialysis access fistulae and grafts.

BACKGROUND: The aim of the study is to prospectively determine the incidence of inflow stenoses in dysfunctional hemodialysis access arteriovenous fistulae (AVFs) and grafts (AVGs). METHODS: Contrast-enhanced magnetic resonance angiography (CE-MRA) was performed of 66 dysfunctional AVFs and 35 AVGs in 56 men and 45 women (mean age, 62 years; age range, 31 to 86 years). Complete inflow (from the subclavian artery), shunt region, and complete outflow (including subclavian vein) were shown at CE-MRA. In addition to standard digital subtraction angiography (DSA) of the shunt region and outflow, DSA of the complete inflow was obtained through access catheterization of all cases in which CE-MRA showed an inflow stenosis. Vascular stenosis is defined as greater than 50% decrease in luminal diameter compared with an uninvolved vascular segment located adjacent to the stenosis. Endovascular intervention of stenoses was performed in connection with DSA. RESULTS: CE-MRA showed 19 arterial stenoses in 14 patients (14%). DSA confirmed 18 of these lesions in 13 patients and showed no additional inflow lesions. Of the 13 patients, 7 patients had arterial stenoses only and 6 patients had accompanying stenoses in the shunt region and/or outflow. Referral criteria for the 13 patients to undergo access evaluation had been decreased flow rates (9 patients), steal symptoms (2 patients), and insufficient access maturation (2 patients). Access flow of the 9 patients with a low-flow access improved from 477 +/- 74 mL/min to 825 +/- 199 mL/min after angioplasty. One patient with steal symptoms became symptom free after angioplasty. Endovascular intervention in 3 patients proved to be unsuccessful. CONCLUSION: Inflow stenoses are not uncommon in dysfunctional hemodialysis access shunts. We suggest that radiological evaluation comprise assessment of the complete arterial inflow.

Infrarenal abdominal aortic aneurysm with concomitant urologic malignancy: treatment results in the era of endovascular aneurysm repair.

During diagnostic workup for urologic malignancies, an abdominal aortic aneurysm (AAA) is identified in a proportion of patients. In the era of open AAA repair, these patients presented a surgical dilemma with regard to the sequence of the operations: cancer treatment first or AAA repair first? Previous assessments have concluded that irrespective of the followed strategy, the early and mediumterm mortality from the two operative procedures in this patient category was significant. With the introduction of endovascular aneurysm repair (EVAR), the mortality and morbidity associated with the treatment of both pathologic conditions may be more favorable than with open aneurysm repair. The objective of this study was to assess, in an institutional series of patients receiving EVAR, the early and long-term survival and complication rates in patients with urologic malignancies. In a series of 385 patients receiving EVAR, 14 had a concomitant urologic malignancy: renal cell carcinoma (5 patients), prostate carcinoma (6 patients), and carcinoma of the bladder (3 patients). The first-month mortality was nil. Long-term survival was 80%, 83%, and 67% for the three tumor types, respectively. EVAR offers improved treatment in patients with concomitant AAA and urologic malignancy and should be considered the first choice for these patients.

Outpatient treatment of arterial inflow stenoses of dysfunctional hemodialysis access fistulas by retrograde venous access puncture and catheterization.

OBJECTIVE: To determine the feasibility of endovascular treatment of inflow stenoses in arteriovenous fistulae (AVFs) through retrograde venous access catheterization. METHODS: We included all 22 dysfunctional AVFs with arterial inflow stenoses at access imaging between January 2002 and September 2006. Following retrograde venous access puncture, an interventional radiologist intended to cross the arteriovenous anastomosis and advance a catheter into the aortic arch. After depiction of the complete vascular access tree, angioplasty and/or stent placement was aimed for stenoses with a >50% luminal diameter reduction at digital subtraction angiography (DSA). RESULTS: In one radiocephalic AVF, a catheter could not be positioned into the aortic arch after retrograde venous access puncture. DSA depicted 28 inflow stenoses in the remaining 21 patients (11 radiocephalic AVFs and 10 brachiocephalic AVFs). Clinical improvement was obtained in 18 out of 19 patients with a technically successful intervention (<30% residual stenosis after angioplasty or stent placement). Following endovascular therapy, access flow of 12 patients with a low flow access improved from 431 +/- 150 ml/min to 818 +/- 233 ml/min, and four patients with steal symptoms became symptom free. One nonmaturing fistula could be salvaged by angioplasty, and access cannulation problems were solved in another patient following angioplasty. Brachial artery stent placement did not reduce steal symptoms in one case, whereas two patients, in whom stent placement was not thought desirable, showed a >30% residual arterial stenosis after angioplasty. No complications were observed at DSA and endovascular intervention. CONCLUSION: Retrograde venous access puncture and catheterization, as an alternative to a potentially more hazardous brachial artery or more invasive femoral artery approach, should be considered for the visualization of the arterial inflow and endovascular treatment of inflow stenoses.

Peripheral arterial disease: clinical and cost comparisons between duplex US and contrast-enhanced MR angiography--a multicenter randomized trial.

PURPOSE: To prospectively determine the clinical and economic consequences of replacing duplex ultrasonography (US) with contrast material-enhanced magnetic resonance (MR) angiography for the initial imaging work-up of patients with peripheral arterial disease (PAD). MATERIALS AND METHODS: This randomized multicenter study was approved by the institutional review board of each hospital, and all patients signed written informed consent prior to randomization. Patients with PAD who needed to undergo imaging work-up and who had an ankle-brachial pressure index (ABPI) of less than 0.90 were recruited by vascular surgeons between January 2002 and September 2003. Patients were randomly assigned to undergo contrast-enhanced MR angiography or duplex US. The primary outcome measure was cost. Secondary outcome measures included therapeutic confidence, changes in disease severity, and changes in quality of life (QOL) assessed during 6 months of follow-up. Indicators for disease severity were based on the Rutherford classification, treadmill walking distance, ABPI at rest, and ABPI after exercise. QOL was assessed with the Rating Scale, Short Form 36, EuroQol-5D, and VascuQol questionnaires. The cost of (additional) imaging procedures, therapeutic interventions, and outpatient visits were calculated from a hospital perspective (ie, all costs incurred inside the hospital were estimated, including physician costs). Data were evaluated by using the Student t test and a multivariable linear regression analysis. RESULTS: At 6 months, 352 patients (239 [68%] men, 113 [32%] women; mean age, 65 years) were analyzed. The use of contrast-enhanced MR angiography versus duplex US reduced the number of additional vascular imaging procedures by 42%; contrast-enhanced MR angiography was also associated with higher therapeutic confidence. Diagnostic costs for contrast-enhanced MR angiography were 167 euros (186 dollars) higher than those for duplex US (P < .001). No statistically significant differences were found for total cost, changes in disease severity, or changes in QOL between patients examined with duplex US and those examined with contrast-enhanced MR angiography (P > .05). CONCLUSION: Replacing duplex US with contrast-enhanced MR angiography for the initial imaging work-up of patients with PAD reduces the need for additional imaging, although diagnostic costs are higher.