Long-term outcomes after fenestrated endovascular aortic repair for juxtarenal aortic aneurysms.

OBJECTIVE: Fenestrated endovascular aortic aneurysm repair (FEVAR) for juxtarenal aortic aneurysm (jAAA) disease is safe and effective with good short- and mid-term outcomes. The durability issues have mainly focused on the proximal and distal seal and target vessel (TV) instability, and long-term data are scarce. In previous studies, we have reported the short-term outcomes after FEVAR and compared our early and late experience and the long-term results for the early cohort. In the present report, we have provided the long-term outcomes for our late experience cohort who had undergone FEVAR at the Vascular Center (Skåne University Hospital, Malmö, Sweden). METHODS: Consecutive patients who had undergone FEVAR for jAAAs from 2007 to 2011 were included in the present study. Data were collected retrospectively from the medical and imaging records. The follow-up protocol consisted of a clinical examination 1 month postoperatively and computed tomography angiography combined with plain abdominal radiography at 1 and 12 months and annually thereafter. The primary endpoints were TV instability, reinterventions, and survival. Changes in the aneurysm diameter and renal function and the incidence and type of endoleaks were also analyzed. RESULTS: A total of 94 patients were included in the present study. The median follow-up time was 89 months (range, 0-152 months). A total of 280 fenestrations or scallops were used, of which 205 were stented. Technical success was 89.4%. Primary TV patency was 94% ± 1% at 1 year, 90% ± 2% at 3 years, and 89% ± 2% at 5 years. Of the 94 patients, 37 (39.4%) had required a total of 70 reinterventions. The mean time to the first reintervention was 21 ± 3.97 months. Five patients (5.3%) had died of aneurysm-related causes. Overall survival was 95.7% ± 2.1% at 1 year, 87.1% ± 3.5% at 3 years, and 71.0% ± 4.7% at 5 years. A stable or decreasing aortic diameter after treatment was seen in 91% of the cases. The mean glomerular filtration rate had decreased from 59.2 ± 14.9 mL/min/1.73 m2 preoperatively to 50.0 ± 18.6 mL/min/1.73 m2 at the end of follow-up. CONCLUSIONS: The results of the present study have shown that the long-term results after treatment of jAAAs with FEVAR remain good and the treatment is safe and effective. Although the need for reintervention remained high, long-term renal function and survival support the use of FEVAR as a valid treatment option for jAAA disease.

Five Year Results of Off the Shelf Fenestrated Endografts for Elective and Emergency Repair of Juxtarenal Abdominal Aortic Aneurysm.

OBJECTIVE: Fenestrated endovascular aneurysm repair (FEVAR) is a well established treatment for complex abdominal aortic aneurysms (AAAs). FEVAR with custom made devices (CMDs) has limitations in both the emergency and elective settings due to time consuming manufacture. "Off the shelf" (OTS) fenestrated stent grafts are a potential solution. The primary goal was to evaluate the five year outcome of the COOK Zenith p-Branch OTS device at a single centre. METHODS: Patients with juxtarenal AAA meeting the inclusion criteria for the COOK Zenith p-Branch device were enrolled in a prospective, non-randomised, non-comparative trial from July 2012 to September 2015. Demographic, anatomical, procedure related, and five year follow up data were collected, analysed, and adjudicated by a core laboratory. The primary aims were to assess intervention free survival and overall survival at five years. RESULTS: Twenty-three patients were treated and 21 completed follow up. Mean time to p-Branch implantation after patient presentation was 28 hours (range 0-122 hours) in emergency cases and 67 days (range 20-112 days) in elective cases. Median procedure time was 283 minutes (range 161-475 minutes) and technical success was 91%. Mean follow up was 45 months (standard deviation ± 24.4 months). The most common adverse events were renal injuries. Primary target vessel patency was 96.4% and 94.0% after one and five years respectively. Mean time to first re-intervention was 469 days (range 0-1 567 days). Survival during the follow up period was 76%, with no aneurysm related deaths. CONCLUSION: FEVAR with the COOK Zenith p-Branch device is safe and effective for juxtarenal AAA in a selected patient population, in both elective and emergency settings. Long term outcomes are acceptable although inferior to CMDs. Mid and long term outcomes emphasise the p-Branch as a possible endovascular treatment for juxtarenal aortic pathology where CMD is not an option. Further innovation to address target vessel complications is needed, as these seem more prevalent than after repair with CMDs.

Juxtarenal endovascular therapy with fenestrated and branched stent grafts after previous infrarenal repair.

BACKGROUND: The treatment strategy for proximal aortic disease or type I endoleak after previous infrarenal repair has traditionally been open surgery. As endovascular treatment options with fenestrated and branched stent grafts increasingly rival open surgery for juxtarenal and pararenal aortic aneurysms, secondary proximal repair may similarly be performed endovascularly. Fenestrated stent grafts are individually tailored to each patient, whereas a more readily available "off-the-shelf" branched stent graft is often suitable in more urgent settings. METHODS: All patients who had been reoperated on with a proximal fenestrated or branched cuff after previous infrarenal endovascular or open repair from two tertiary referral centers between 2002 and 2015 were included in the analysis. Patients were retrospectively enrolled in a digital database. Data were collected from chart review and digital imaging. RESULTS: There were 43 patients, 37 (86%) male and six (14%) female, who were treated. The indications for proximal endovascular repair were type I endoleak (58%), proximal aneurysm formation (30%), and stent graft migration (12%). Median follow-up time was 33 months (range, 3-120 months); 34 patients (79%) received a fenestrated cuff, and branched stent grafts were used in 8 (19%) cases. The majority of grafts had three (47%) or four (49%) fenestrations or branches. Technical success was accomplished in 93% of cases. In two cases, the celiac trunk occluded; in one case, the hepatic artery was overstented, and a renal artery could not be cannulated in one case. Median hospital stay was 5 days (range, 2-57 days). The 30-day mortality was 0%, and 1-year mortality was 5%. One patient died of an aneurysm-related cause during the study period. CONCLUSIONS: An endovascular approach with fenestrated or branched stent grafts for treatment of proximal endoleak, proximal aneurysm formation, or pseudoaneurysms after previous infrarenal repair seems to be a valid alternative to open surgery.

Aneurysm Shrinkage Is Compatible With Massive Endoleak in the Presence of an Aortocaval Fistula: Potential Therapeutic Implications for Endoleaks and Spinal Cord Ischemia.

PURPOSE: To present a patient with ruptured abdominal aortic aneurysm (AAA) and aortocaval fistula who was successfully treated with endovascular aneurysm repair in spite of developing a massive endoleak. CASE REPORT: A 70-year-old man with ruptured AAA and aortocaval fistula was treated with endovascular aneurysm repair (EVAR). During 8 years of follow-up, he had massive perfusion of the aneurysm sac by retrograde flow from the inferior mesenteric artery into the caval vein through the aortocaval fistula. The aneurysm diameter decreased continuously in spite of the type II endoleak. This observation illustrates the mechanisms of sac expansion and may have therapeutic implications for complicated type II endoleaks and prevention of spinal cord ischemia in thoracic stent-grafting. CONCLUSION: EVAR can be applied in this rare setting because the ensuing high-flow endoleak is associated with sac shrinkage owing to depressurization by the caval shunt.

Early versus late experience in fenestrated endovascular repair for abdominal aortic aneurysm.

OBJECTIVE: The objective of this study was to evaluate operative results and 1-year outcomes in early vs late experience after fenestrated endovascular aortic repair. METHODS: All patients treated in Malmö, Sweden, and in Lille, France, with fenestrated endovascular repair for abdominal aortic aneurysm were prospectively enrolled in a computerized database. Early experience was defined as the first 50 patients treated at each center. Data from early and late experience were retrospectively analyzed and compared for differences in operative results and 1-year outcomes. RESULTS: Early experience covered 4.7 years in Malmö and 4.5 years in Lille; late experience covered 5.6 years in Malmö and 3.7 years in Lille. A total of 288 patients were included. In the later phase, stent graft configuration was more complex because of increased number of fenestrations/scallops incorporated in the graft design (2.7 ± 0.8 vs 3.2 ± 0.7; P < .001). Despite this, volume of contrast material and radiation time decreased by 27% and 20%, respectively, whereas procedure time remained unchanged. At 1 year, a trend toward decreasing abdominal aortic aneurysm diameter was observed in the late group, but no differences were found in mortality, endoleaks, or target vessel patency between the groups. CONCLUSIONS: With increasing experience, fenestrated endovascular aneurysm repair design has become more complicated, with more visceral vessels targeted for better proximal seal, while operative risk still remains low. Simultaneously, radiation time and volume of contrast material have been reduced, with possible long-term benefits for the patient.

Suitability of the Zenith p-Branch Standard Fenestrated Endovascular Graft for Treatment of Ruptured Abdominal Aortic Aneurysms.

PURPOSE: To evaluate the anatomic suitability of the Zenith pivot branch (p-branch) fenestrated device in ruptured abdominal aortic aneurysms (rAAA). METHODS: Contrast-enhanced computed tomography (CT) images of 206 patients (mean age 75±8 years; 175 men) with rAAA were evaluated in a dedicated 3-dimensional vascular workstation. All aneurysms found unsuitable for standard infrarenal repair were evaluated for Zenith p-branch suitability according to the Investigational Device Exemption protocol for both device configurations (A, pivot fenestrations at the same level; B, right renal fenestration located more cranially). RESULTS: The suitability of the p-branch (A or B configuration) for short neck aneurysms (<15 mm; n=89) was 49%; of the 26 different combinations of exclusion criteria, a mismatch between a renal artery takeoff and the positioning of the corresponding fenestration was the most common. For juxta- and pararenal aneurysms (neck length <10 mm; n=66), suitability was 48%. Suitability assessed by target vessel positioning only (excluding all other limiting factors) was 58% for short neck aneurysms (n=52) and 55% for juxta- and pararenal aneurysms (n=36). CONCLUSION: Approximately half of patients with short neck rAAAs would be suitable for the Zenith p-branch fenestrated device according to the instructions for use. In almost 60%, the pivot fenestrations can accommodate the corresponding target vessels. More studies are needed to confirm these findings.

Impact of renal chimney grafts on anatomical suitability for endovascular repair in ruptured abdominal aortic aneurysm.

PURPOSE: To evaluate the impact of renal chimney grafts on anatomical suitability for endovascular aneurysm repair (EVAR) in ruptured abdominal aortic aneurysm (rAAA). METHODS: Contrast-enhanced computed tomography images of 206 patients with rAAA [175 men (mean age 75 ± 7.8 years) and 31 women (mean age of 76 ± 7.5 years)] were evaluated in a dedicated 3-dimensional vascular workstation. Assessment of infrarenal EVAR suitability was based on predefined anatomical variables reflecting the Instructions for Use of commercially available stent-grafts. In patients where aneurysm neck length was the only limiting factor for suitability, reevaluation of the proximal sealing zone was done, accounting for chimney grafts in one or both renal arteries. RESULTS: Seventy (34%) rAAA patients were anatomically suitable for EVAR: 65 (37%) of 175 men and 5 (16%) of 31 women (p < 0.01). Eighty-nine (65%) of the 136 unsuitable patients had aneurysm necks < 15 mm long; short neck was the only exclusion criterion in 33 (24%) cases. In the 33 short-necked aneurysms without other limiting factors, a proximal sealing zone > 15 mm could potentially be achieved with one or two renal chimney grafts in 12 (36%) and 25 (76%) patients, respectively, increasing overall suitability to 40% and 46%. If access issues could also be solved and a similar strategy with chimneys for the renal arteries was applied, the EVAR suitability would increase further to 58%. CONCLUSION: Roughly one third of patients with rAAA are anatomically suitable for EVAR; short aneurysm neck is the most common exclusion criteria. In appropriate cases, chimney grafts in one or both renal arteries may increase overall suitability by 12%. Suitability increases to ~ 60% when iliac access issues are additionally overcome.