Impact of Hybrid Operating Rooms on Long-Term Clinical Outcomes Following Fenestrated and Branched Endovascular Aortic Repair.

PURPOSE: Evaluate the impact of hybrid operating room (HOR) guidance on the long-term clinical outcomes following fenestrated and branched endovascular repair (F-BEVAR) for complex aortic aneurysms. MATERIALS AND METHODS: Prospectively collected registry data were retrospectively analyzed to compare the procedural, short- and long-term outcomes of consecutive F-BEVAR performed from January 2010 to December 2014 under standard mobile C-arm versus hybrid room guidance in a high-volume aortic center. RESULTS: A total of 262 consecutive patients, including 133 patients treated with a mobile C-arm equipped operating room and 129 with a HOR guidance, were enrolled in this study. Patient radiation exposure and contrast media volume were significantly reduced in the HOR group. Short-term clinical outcomes were improved despite higher case complexity in the HOR group, with no statistical significance. At a median follow-up of 63.3 months (Q1 33.4, Q3 75.9) in the C-arm group, and 44.9 months (Q1 25.1, Q3 53.5, p=0.53) in the HOR group, there was no statistically significant difference in terms of target vessel occlusion and limb occlusion. When the endograft involved 3 or more fenestrations and/or branches (complex F-BEVAR), graft instability (36% vs 25%, p=0.035), reintervention on target vessels (20% vs 11%, p=0.019) and total reintervention rates (24% vs 15%, p=0.032) were significantly reduced in the HOR group. The multivariable Cox regression analysis did not show statistically significant differences for long-term death and aortic-related death between the 2 groups. CONCLUSION: Our study suggests that better long-term clinical outcomes could be observed when performing complex F-BEVAR in the latest generation HOR.

Experience With Unfavorable Iliac Access When Performing Fenestrated/Branched Endovascular Aneurysm Repair.

PURPOSE: To review a single-center experience with fenestrated and branched endovascular aneurysm repair (f/bEVAR) in patients with challenging iliac anatomies. MATERIALS AND METHODS: A retrospective review of the department's database identified 398 consecutive patients who underwent complex endovascular repair f/bEVAR between January 2010 and June 2018; of these, 67 had challenging accesses. The strategies implemented to overcome access issues were reviewed, using a dedicated scoring system to evaluate the access (integrating diameter, tortuosity, calcification, and previous open or endovascular repair). RESULTS: In this subgroup of patients, the most common graft design was a 4-vessel fenestrated endograft (27, 40.3%). Hostile access was due to small diameter (<7 mm) in 25 patients (37.3%) and/or concentric calcifications in 19 patients (26.9%). Mean iliac diameter was 5.5±2.6 mm on the right side and 6.0±2.5 mm on the left side. Previous open or endovascular aortoiliac repair had been performed in 15 patients (22.4%), and 20 patients (29.9%) had a stent previously implanted in at least 1 iliac artery, resulting in the inability to perform standard fenestrated repair with access from both sides. Five patients (7.5%) had a single patent iliac access. Eight distinctive strategies were identified to overcome these access issues, including the use of preloaded renal catheters in the endograft delivery system, angioplasty, graft modification (branches instead of fenestrations or 4 preloaded fenestrations), a conduit via a retroperitoneal approach, iliac artery recanalization, and/or the multiple puncture technique. Technical success was achieved in 62 cases (92.5%). Four patients had access complications and 1 died in the early postoperative period of multiorgan failure. Median follow-up was 24.6 months (IQR 7.2, 41.3). Clinical success at the end of follow-up was achieved in 57 patients (85.1%). During follow-up, 14 patients died, including 4 from an aorta-related cause. CONCLUSION: Dedicated strategies can be implemented to overcome hostile iliac access in patients with complex aneurysms when f/bEVAR is required. Typically, these maneuvers are associated with favorable outcomes.

Outcomes of Preventive Embolization of the Inferior Mesenteric Artery during Endovascular Abdominal Aortic Aneurysm Repair.

PURPOSE: To evaluate the impact of preemptive inferior mesenteric artery (IMA) embolization on outcomes of endovascular abdominal aortic aneurysm (AAA) repair (EVAR). MATERIALS AND METHODS: From January 2015 to July 2017, all patients undergoing elective EVAR or fenestrated EVAR (F-EVAR) for asymptomatic AAA in a single tertiary hospital were retrospectively included. Three groups of patients were defined: patients with a patent IMA who underwent embolization during EVAR/F-EVAR (group 1), those with a patent IMA who did not undergo embolization during EVAR/F-EVAR (group 2), and those with a chronically occluded IMA (group 3). Preoperative aortic morphology, demographics, and procedural details were recorded. Aneurysmal growth (≥5 mm), reintervention, and overall mortality rates were analyzed using multivariate proportional hazard multivariate modeling. Propensity scores were constructed, and inverse probability weighting was applied to a new set of multivariate analyses to perform a sensitivity analysis. RESULTS: A total of 266 patients (male, 95% [n = 249]) with a median age of 70 (65-77) years were included, with F-EVAR procedures comprising 87 (32.7%) of the interventions. There were 52, 142, and 72 patients in groups 1, 2, and 3, respectively. Changes in aneurysmal sac size did not differ between groups, nor did overall survival or reintervention rates at 24 months. IMA embolization was not identified as an independently protective factor for aneurysmal growth during follow-up (relative risk [RR] = 2.82/mm [0.96-8.28], P = .060), whereas accessory renal arteries (RR = 5.07/mm [1.72-14.96], P = .003) and a larger preoperative aneurysmal diameter (RR = 1.09/mm [1.03-1.15], P = .004) were independent risk factors for sac enlargement. CONCLUSIONS: Preventive embolization of the IMA during EVAR or F-EVAR did not promote aneurysmal sac shrinking or decrease the reintervention rate at 2-year follow-up.

Editor's Choice - Comprehensive Literature Review of Radiation Levels During Endovascular Aortic Repair in Cathlabs and Operating Theatres.

OBJECTIVE: Occupational exposure is a growing concern among the endovascular specialist community. Several types of imaging equipment are available, such as mobile C arms or hybrid rooms, and some have been shown to deliver higher levels of radiation. A literature review was conducted to identify studies reporting dose data during standard (EVAR) and complex abdominal aortic endovascular repair (fenestrated/branched EVAR [F/BEVAR]). METHODS: A search of the MEDLINE and the Cochrane databases was performed by two independent investigators using the medical subject heading terms "aortic aneurysms", "radiation", and "humans" over a search period of 10 years. Studies with full text available in English and reporting radiation data independently from the imaging equipment type were included. Experimental studies were excluded. RESULTS: The lowest dose-area product levels during EVAR and F/BEVAR were identified in hybrid rooms, while the highest were with fixed systems. When adherence to the as low as reasonably achievable principles was stipulated by the authors, dose reports tended to be among the lowest. Several studies, especially of F/BEVAR, report concerning levels of radiation for both patients and staff. CONCLUSION: Modern imaging equipment type, team involvement with radiation management, and the support of recent imaging technologies such as fusion help to reduce the dose delivered during standard and complex EVAR. Investment in modern imaging technology should be considered in every centre providing endovascular management of aortic aneurysms.

Risk factors for early and late mortality after fenestrated and branched endovascular repair of complex aneurysms.

BACKGROUND: The objective of this study was to evaluate outcomes after fenestrated and branched endovascular aneurysm repair (F-BEVAR) performed in high-risk patients to treat pararenal (PR) aneurysms and thoracoabdominal aortic aneurysms (TAAAs) and to identify those patients likely to benefit from this treatment. METHODS: A prospective single-center review of patients treated electively for PR aneurysm and TAAA using F-BEVAR between 2004 and 2016 was performed. Survival was estimated using the Kaplan-Meier method. Risk factors associated with 30-day morbidity and mortality during follow-up were determined using multivariate statistical techniques and a Cox regression model including all variables that were significant on univariate analysis (P < .05). RESULTS: There were 468 patients (median age, 71.6 years) identified, with American Society of Anesthesiologists score ≥3 in 94.7%. There were 221 (47.2%) type I to type III TAAAs and 247 (52.8%) type IV and type V TAAAs and PR aneurysms, with a median diameter of 58 mm. Technical success for target vessel stenting was 99.1% (1493/1506). The 30-day mortality rate was 4.9% (23 patients). The spinal cord ischemia rate was 3.8% (18 patients). Twenty patients (4.3%) required postoperative dialysis and four patients (0.8%) long-term dialysis after discharge. Median follow-up was 29 months. Survival at 1 year, 3 years, and 5 years was 86.7% (95% confidence interval [CI], 83.1-89.6), 73.3% (95% CI, 68.3-77.6), and 59.6% (95% CI, 53.4-65.2), respectively. Freedom from any target vessel occlusion and freedom from secondary procedures were 96.2% (95% CI, 93.8-97.7) and 88.2% (95% CI, 84.8-90.9) at 1 year and 90.0% (95% CI, 84.5-91.9) and 70.2% (95% CI, 63.9-75.6) at 5 years, respectively. In multivariate analysis, early mortality was associated with procedure time (hazard ratio [HR], 1.007 per minute; 95% CI, 1.003-1.010; P < .001), TAAA preoperative diameter (HR, 1.053 per millimeter; 95% CI, 1.020-1.087; P = .001), and chronic kidney disease (HR, 3.139; 95% CI, 1.369-7.196; P = .007). Mortality during the first 24 months of follow-up was associated with Crawford types I to III (HR, 1.526; 95% CI, 1.061-2.196; P = .023) compared with infradiaphragmatic repairs, chronic kidney disease (HR, 1.874; 95% CI, 1.294-2.712; P < .001), and TAAA preoperative diameter (HR, 1.027 per millimeter; 95% CI, 1.010-1.044; P = .002). In addition to these risk factors, mortality after 24 months of follow-up was also associated with age at repair (HR, 1.055 per year; 95% CI, 1.021-1.090; P = .001). CONCLUSIONS: F-BEVAR performed in high-risk patients is associated with favorable outcomes. Judicious selection of patients should take into consideration the reported risk factors associated with early and late mortality.

Radiation Dose Reduction During EVAR: Results from a Prospective Multicentre Study (The REVAR Study).

OBJECTIVE: To evaluate radiation exposure in standard endovascular aneurysm repair (EVAR) using intra-operative guidance with pre-operative computed tomographic angiography (CTA) fusion and strict ALARA guidelines in a modern hybrid room. MATERIAL AND METHODS: Between February and November 2016, consecutive patients with AAA undergoing EVAR with a bifurcated device in a hybrid room under fusion imaging guidance were prospectively enrolled in six aortic centres from the United States (n = 1), Europe (n = 4), and Japan (n = 1). Demographic data including body mass index (BMI), indirect dose area product (DAP), cumulative air kerma (CAK), variables influencing dose delivery, and contrast media volume were collected. RESULTS: 85 patients (90.4% males) were included. The median age was 75 (IQR 69-81), with a median BMI of 27.4 (IQR 24.7-30.6). Median DAP and CAK were 14.7 (IQR 10.0-27.7) Gy·cm2 and 107 (IQR 68.0-189.0) mGy, respectively. The median contrast volume was 47 mL (IQR 35-70) (equivalent to 14.1g of iodine [IQR 10.5-21.0]). Median DAP per centre was 28.1 (n = 16, IQR 12.6-47.1), 15.9 (n = 11, IQR 11.9-22.5), 14.2 (n = 12, IQR 10.9-25.7), 20.2 (n = 18, IQR 7.0-39.5), 10.3 (n = 27, IQR 8.2-14.7) and 26.5 (n = 1) Gy·cm2. In multivariable analysis, collimation was the only factor that was significantly associated with DAP reduction, (coefficient = -0.014 per percentage of collimation, 95% CI -0.019 to -0.008, p < .001). CONCLUSIONS: With adherence to the ALARA principle and routine application of fusion imaging guidance for EVAR, low radiation exposure compared with the published literature can be achieved in a real world setting.

Endovascular treatment of thoracoabdominal aortic aneurysms.

BACKGROUND: Development in endograft design has extended endovascular treatment to include thoracoabdominal aortic aneurysms (TAAA). We report our experience using fenestrated and branched endografts in the management of TAAA. METHODS: We analyzed a cohort of consecutive patients treated electively for TAAA using endovascular techniques between 2006 and 2011. All data were collected prospectively. The relationships between preoperative risk factors and clinical outcome were examined using univariate and multivariate statistical techniques. We also compared the outcomes between 33 previously published early cases (EC) with the last 56 later cases (LC). RESULTS: Eighty-nine patients (83 men) were treated. Median age was 69 years. All patients were deemed unfit for open surgery. The 30-day and in-hospital mortality rates were 8.9% and 10%, respectively. Multivariate analysis showed in-hospital mortality was associated with preoperative chronic renal failure and advanced age. Higher postoperative mean arterial blood pressure was a protective factor. Technical success rate was 96.6% (94% and 98% in the EC and LC groups, respectively; P = .14). The spinal cord ischemia (SCI) rate was 7.8% (15% and 3% in the EC and LC groups, respectively; P = .063) and was associated with chronic obstructive pulmonary disease and procedure duration. Six patients (6.7%) required temporary filtration, but none required permanent renal support (associated with left ventricular ejection fraction <40% and procedure duration). Median procedure duration decreased from 232 to 203 minutes (P = .01) in the EC and LC groups, respectively. Actuarial survival was 86.8% ± 3.7% at 1 year and 74.7% ± 6% at 2 years. CONCLUSIONS: Although we have treated a cohort at high operative risk, our midterm results compare favorably with the published series of conventional surgery. Accurate hemodynamic control represented by high-normal perioperative blood pressure seems to protect against severe postoperative complications.

Anatomic study of juxta renal aneurysms: impact on fenestrated stent-grafts.

BACKGROUND: Fenestrated stent-grafts allow for treatment of patients with juxtarenal aneurysms (JRA) when they present with contraindications for conventional treatment. The fenestrated module is a custom-made module, specially designed to fit a specific patient, using computed tomographic scan measurements, which entails manufacturing delay and high cost. The aim of our study was to evaluate the possibility to reproduce the interrenal aorta anatomy to design a standard fenestrated module that would fit the maximum number of patients with JRA. METHODS: On a three-dimensional working station, we analyzed 289 preoperative computed tomographic scan results of patients with JRA and who were treated with fenestrated stent-grafts comprising two fenestrations for the renal arteries and a scallop for the superior mesenteric artery (SMA). On curvilinear reconstructions, we successively measured the interrenal aorta diameter, its orientation, as well as the height of each renal ostium, taking the ostium center of the SMA as a reference mark. Later, a statistical analysis of these measures distribution was performed so as to design a fenestrated module that would fit the maximum number of patients. RESULTS: The center of the left renal artery presented with a median orientation of 82.5° (range, 37.5-150) and a median distance of 9 mm (range, 0-30), in relation to the SMA ostium. The ostium center of the right renal artery presented with a median orientation of 285° (range, 240-337.5) and a median distance of 8 mm (range, 3-30), in relation to the SMA ostium. By positioning the current renal fenestrations (6-mm wide), on the basis of the calculated median positions, in our series, only 20% of the patients could be treated with a standard fenestrated module. Should the diameter of these fenestrations be increased by 10 mm, it would then be possible to treat 50% of our patients. CONCLUSION: The anatomy of the interrenal aorta and its branches is quite reproducible to design standard fenestrated stent-grafts that could treat half of the patients with JRA.

Should we modify our indications after the EVAR-2 trial conclusions?

BACKGROUND: To compare the results of the endovascular aneurysm repair (EVAR) in patients considered as unfit for surgery in a "high volume" center with the EVAR-2 trial results. METHODS: In our center, between January 2006 and December 2008, 469 endovascular aorta treatments were performed in high-risk patients. All the data were prospectively collected in a database. Among 469 patients, we selected 191 patients considered as unfit for open surgery (group 1) corresponding to the EVAR trial criteria. Variables such as postoperative mortality at 30 days and 1 year, complications rates, as well as early and late redo surgery were evaluated. Long-term pharmacological treatment before surgery was listed. These results were compared with the EVAR trial (group 2). Survival during the follow-up was calculated according to the Kaplan-Meier method. RESULTS: Mortality at 30 days was 1.6% and 9% in groups 1 and 2, respectively (p = 0.002). Global complication rate was 44% and 43% in groups 1 and 2, respectively (p = 0.52). Over the follow-up period, the redo surgery rate was 13% and 26% in groups 1 and 2, respectively (p = 0.0102). In our cohort, the survival rate at 2 years was 84% with a residual number of 102 patients. Before surgery, a long-term antiplatelet treatment was prescribed in 89% and 58% of the patients and statins in 74% and 39% of the patients in groups 1 and 2, respectively (p < 0.0001). CONCLUSION: The EVAR-2 trial conclusions are in opposition to the practice of French vascular surgeons. Endovascular treatment of abdominal aortic aneurysms in high-risk patients is justified. This study confirms the importance of a multidisciplinary treatment for high-risk patients in high-volume centers.

Inverted limbs in fenestrated and branched endografts.

PURPOSE: To describe our experience with the use of custom-designed branched or fenestrated endoprostheses incorporating an inverted contralateral limb in the bifurcated component. METHODS: Retrospective analysis was performed of a prospectively maintained database of all patients undergoing endovascular aneurysm repair using modular branched or fenestrated devices at a university teaching hospital between January 2004 and February 2010. Of 102 cases, 7 male patients (mean age 69 years) were treated with modular devices that incorporated an inverted contralateral limb in the bifurcated component. Five patients had thoracoabdominal aortic aneurysm (4 type IV and 1 type II), 1 patient had a pararenal abdominal aortic aneurysm, and another had type I endoleak from a migrated AneuRx stent-graft. The technique was used primarily because of an existing bifurcated prosthesis (n=5), but in 2 patients without prior open surgery, this technique was needed because of anatomical constraints. RESULTS: All devices were implanted as planned. There was no mortality. One patient required temporary hemodialysis prior to discharge; another patient developed permanent paraplegia, likely related to extensive aortic coverage. No device migration, component separation, or type I or III endoleaks were detected during a mean follow-up of 25 months, and no reinterventions have been necessary. CONCLUSION: The use of an inverted limb in the bifurcated component of modular endografts may allow endovascular treatment in scenarios where there is insufficient space to deploy a standard bifurcated component. This design modification allows an adequate sealing zone between the iliac extension limbs and the bifurcated component.

Challenging treatment of a secondary endoleak in a fenestrated endograft.

PURPOSE: To describe the novel use of an Amplatzer occluder device to seal a secondary endoleak arising at a scallop in a fenestrated stent-graft. CASE REPORT: A 67-year-old man with comorbidities precluding standard endovascular repair of a pararenal aortic aneurysm was treated with a fenestrated endoprosthesis containing one fenestration for the left renal artery and one scallop for the celiac trunk; the right renal and superior mesenteric arteries were occluded at presentation. Interval imaging at 2 years showed a proximal type I endoleak at the celiac trunk scallop associated with expansion of the aneurysm sac. Attempted repair with an aortic extension cuff and a "chimney" stent was unsuccessful. An Amplatzer Patent Foramen Ovale occluder device was deployed across the endoleak to provide aneurysm sac exclusion, which has been maintained at 6-month follow-up. CONCLUSION: Treatment of a secondary type I endoleak after implantation of a fenestrated endoprosthesis is challenging. The novel use of an Amplatzer occluder in this setting may be applicable to other situations in which an endovascular solution is desirable for complications of complex endovascular aneurysm repair.