Endovascular aortic repair with EndoAnchors demonstrate good mid-term outcomes in physician-initiated multicenter analysis-The PERU registry.

OBJECTIVES: We aim to describe real-world outcomes from multicenter data about the efficacy of adjunct Heli-FX EndoAnchor usage in preventing or repairing failures during infrarenal endovascular aneurysm repair (EVAR), so-called EndoSutured-aneurysm-repair (ESAR). METHODS: The current study has been assigned an identifier (NCT04100499) at the US National Library of Medicine (https://ClinicalTrials.gov). It is an observational retrospective study of prospectively collected data from seven vascular surgery departments between June 2010 and December 2019. Patients included in the ANCHOR registry were excluded from this analysis. The decision for the use of EndoAnchors was made by the treating surgeon or multidisciplinary aortic committee according to each center's practice. Follow-up imaging was scheduled according to each center's protocol, which necessarily included either abdominal ultrasound or radiography or computed tomographic scan imaging. The main outcomes analyzed were technical success, freedom from type Ia endoleaks (IaEL), all-cause and aneurysm-related mortality, and sac variation and trends evaluated for those with at least six months imaging follow-up. RESULTS: Two hundred and seventy-five patients underwent ESAR in participating centers during the study period. After exclusions, 221 patients (184 males, 37 females, mean age 75 ± 8.3 years) were finally included for analysis. Median follow-up for the cohort was 27 (interquartile range 12-48) months. A median 6 (interquartile range 3) EndoAnchors were deployed at ESAR, 175 (79%) procedures were primary and 46 (21%) revision cases, 40 associated with type IaEL. Technical success at operation (initial), 30-day, and overall success were 89, 95.5, and 96.8%, respectively; the 30-day success was higher due to those with subsequent spontaneous proximal endoleak seal. At two years, freedom from type IaEL was 94% for the whole series; 96% and 86% for the primary and revision groups, respectively; whereas freedom from all-cause mortality, aneurysm-related mortality, and reintervention was 89%, 98%, and 87%, respectively. Sac evolution pre-ESAR was 66 ± 15.1 vs. post ESAR 61 ± 17.5 (p < 0.001) and for 180 patients with at least six-month follow-up, 92.2% of them being in a stable (51%) or regression (41%) situation. CONCLUSIONS: This real-world registry demonstrates that adjunct EndoAnchor usage at EVAR achieves high rates of freedom from type IaEL at mid-term including in a high number of patients with hostile neck anatomy, with positive trends in sac-size evolution. Further data with longer follow-up may help to establish EndoAnchor usage as a routine adjunct to EVAR, especially in hostile necks.

Multicenter Registry about the Use of EndoAnchors in the Endovascular Repair of Abdominal Aortic Aneurysms with Hostile Neck Showed Successful but Delayed Endograft Sealing within Intraoperative Type Ia Endoleak Cases.

BACKGROUND: The durability of endovascular aortic aneurysms repair (EVAR) is highly related to several anatomical constraints. The term "hostile neck" describes several anatomical features that usually make EVAR treatment technically demanding despite having higher risk of failure. The aim of the study was to describe a multicenter experience with EVAR and an adjunctive use of EndoAnchors in hostile neck anatomies. METHODS: Data were prospectively collected from 4 academic vascular centers including 46 patients with a hostile neck treated by standard EVAR with the adjunctive use of EndoAnchors. Twenty-two of them (47.8%, group A) had an intraoperative type Ia endoleak, and 24 (52.2%) patients were treated in a preventive manner (group B). Primary endpoints were technical and procedural success. Secondary endpoints were regression of the aneurysm sac, freedom from type Ia endoleak, and reinterventions. RESULTS: Neck length and diameter showed no statistical difference in preoperative measures, 9.1 ± 6.9 mm and 8.6 ± 2.8 mm and 25.4 ± 4.7 mm and 27.3 ± 4.7 mm, in group A and B, respectively. Aneurysm sac diameter decreased from 58.2 ± 8 mm and 57.9 ± 9.8 mm to 55.7 ± 8.5 mm and 53.8 ± 10.4 mm in group A and B; respectively, at the last computed tomography scan. Technical and procedural success was 97.8% and 100%, respectively, for group B. Group A showed persistence of type Ia endoleak at completion angiogram in 9 (40.9%) patients. Five of them showed early spontaneous sealing at the first (30 days) computed tomography angiography (CTA), and in the remaining 4, a delayed spontaneous sealing was diagnosed at 12-month CTA. No neck-related secondary procedures were performed. Overall survival was 91%. CONCLUSIONS: Our study shows that additional use of EndoAnchors can successfully improve the sealing of abdominal endografts in case of intraoperative type Ia endoleaks in hostile neck anatomies, representing a safe and effective endovascular alternative in our armamentarium. However, meticulous radiological follow-up is necessary because complete resolution of all observed intraoperative type Ia endoleaks was not observed until the 12-month CTA follow-up.

Outcomes of open and endovascular repair of inflammatory abdominal aortic aneurysms.

Objective Reports on inflammatory aortic abdominal aneurysm treatment are scarce. Traditionally, open surgery has been validated as the gold standard of treatment; however, high technical skills are required. Endovascular aortic repair has been suggested as a less invasive treatment by some authors offering good results. The purpose of our study was to report our experience and outcomes in the treatment of inflammatory aortic abdominal aneurysm using both approaches. Material and methods A retrospective review and data collection of all patients treated for inflammatory aortic abdominal aneurysm between 2000 and 2015 was done in one academic center. Diagnosis of inflammatory aortic abdominal aneurysm was based on preoperative CT-scan imaging. Type of treatment, postoperative and long-term morbidity and mortality are described. Abdominal compressive symptoms (hydronephrosis) severity and relief after treatment are described. Results Thirty-four patients with intact inflammatory aortic abdominal aneurysm were included. Twenty-nine (85.3%) patients were treated by open means and the remaining five (14.7%) with endovascular aortic repair. Nearly 90% were considered high-risk patients. Median follow-up was 46 months (range 24-112). The two groups were comparable, except for the age and preoperative hydronephrosis. There was no statistical significance in blood transfusion requirements, intensive care hospitalization, 30-day and long-term mortality between the two groups. Preoperative hydronephrosis was diagnosed in four (13.8%) patients in the open surgery group and three (60%) patients in the endovascular aortic repair group. Improvement of hydronephrosis was recognized in three out of the four patients in the open repair group and two out of the three in the endovascular aortic repair group. Renal function remained stable in both groups during follow-up. Conclusions Open surgery remains a safe and valid option for the treatment of inflammatory aortic abdominal aneurysm. Although our study included a small number of patients with endovascular aortic repair treatment, results are promising. Further randomized controlled studies may be necessary to assess long-term effectiveness of endovascular aortic repair treatment in this disease.

Conical neck is strongly associated with proximal failure in standard endovascular aneurysm repair.

OBJECTIVE: Hostile proximal aortic neck (HN) challenges the suitability for standard endovascular aneurysm repair (EVAR) of patients at high risk for "open" repair. However, there has been little if any focus placed on the individual role of the "nonlength" HN features in EVAR outcomes. The aim of this study was to evaluate their individual and potentially predictive role in outcomes of EVAR under HN conditions. METHODS: Data of 156 consecutive EVAR patients with short (<15 mm) HN, treated with the Endurant device (Medtronic Cardiovascular, Santa Rosa, Calif) at three European academic vascular centers between 2007 and 2015, were collected and retrospectively analyzed. All patients had at least one of the four well-known nonlength HN criteria (width >32 mm or bulge, angulation >60 degrees, reverse taper anatomy, and circumferential thrombus or calcification >50%) and underwent standard EVAR without additional techniques, such as use of chimney grafts or endoanchors. Primary end points were absence of type IA endoleak at 1 month and midterm follow-up and aneurysm sac stabilization or shrinkage. Secondary end points were 30-day mortality, overall survival, and secondary interventions related to EVAR. The study cohort was classified in two subgroups related to neck length (length <10 mm and length between 10 and 14 mm) as well as in two subgroups according to on-label or off-label stent graft use. RESULTS: Mean clinical and radiologic follow-up was 41.1 ± 24.7 and 31.7 ± 19.0 months, respectively. Overall EVAR-related mortality was 1.9% (n = 3). The total type IA endoleak rate was 5.8% (n = 9). In four patients, the type IA endoleak was detected intraoperatively and solved by endovascular means. A type IA endoleak was detected in three patients at 1 month and in two patients at 2-year follow-up. During follow-up, five patients showed an increase of aneurysm diameter due to type II endoleak and were treated by secondary endovascular reinterventions. The total number of all EVAR-related secondary procedures in the midterm was 12 (7.7%). Univariate analysis showed that the center of treatment and the clinical or anatomic features were not associated with adverse outcomes. Multiple regression and Cox regression analysis of HN features revealed that reverse taper anatomy (conical neck) was the single and significantly associated predictor of proximal EVAR failure (P < .012). Width >32 mm, angulation >60 degrees, and calcification or thrombus were not associated with adverse outcomes. Analysis between HN length cohorts and between on-label and off-label subgroups revealed no difference in outcomes. CONCLUSIONS: A conical neck in hostile anatomies represents the single strongest factor associated with proximal failure of standard EVAR. This finding should be considered and highlighted apart from the length of the infrarenal neck to prevent midterm failure of standard EVAR.

Complementary Role of Fenestrated/Branched Endografting and the Chimney Technique in the Treatment of Pararenal Aneurysms After Open Abdominal Aortic Repair.

PURPOSE: To evaluate the totally endovascular techniques for treating complex pararenal aortic aneurysms after open repair of abdominal aortic aneurysm. METHODS: This retrospective study involved 34 men (mean age 74 years) with pararenal aortic aneurysms (22 pseudoaneurysms and 12 para-anastomotic aneurysms) that developed a median 11 years (range 4-22) after the primary surgical reconstruction. The median infrarenal neck length was 2 mm (range 0-9). Total endovascular aneurysm repair (EVAR) included the use of fenestrated (f-EVAR; n=17), branched (b-EVAR; n=11), combined f-EVAR/b-EVAR (n=1), and chimney (ch-EVAR; n=4) grafts and the "sandwich" technique (n=1). The primary outcome was aneurysm shrinkage >5 mm at latest follow-up. Secondary outcomes were target vessel patency, 30-day mortality, late survival, absence of type I and III endoleak, clinical success, and reintervention rate. RESULTS: Technical success was 97% (n=33/34), while clinical success was achieved in 32 (94%) patients. The 30-day mortality was 3% (n=1/34). Mean follow-up was 23.2±16.6 months. One patient was lost to follow-up, and 1 patient underwent late open conversion for endograft infection. Six (18%) of the 33 surviving patients required a reintervention. Primary patency of the target aortic branches was 98% (109/111). Mean aneurysm diameter decreased from 64.1±10.2 to 56.7±16.9 mm (p<0.001) at latest follow-up. Midterm mortality was 12.1% (4/33). Estimated survival rates at 1 and 2 years were 93.9% and 90.9, respectively. CONCLUSION: Use of f-EVAR, b-EVAR, and ch-EVAR allows effective treatment of postsurgical pararenal aneurysms based on a clear algorithm and patient selection, highlighting the complementary character of these less invasive approaches.

Usefulness of the H-Reflex for Intraoperative Monitoring of Thoracoabdominal Aneurysms.

PURPOSE: Intraoperative neurophysiologic monitoring in thoracoabdominal aneurysms (TAAA) is essential to avoid intraoperative spinal cord injury). Motor and somatosensory evoked potentials may be considered intraoperative tools for detecting spinal cord injury. H-reflex is a well-known neurophysiologic technique to evaluate L5-S1 root. Current evidence supports the observation that H-reflex changes may occur with spinal cord damage as high as the cervical level. This study aimed to evaluate the usefulness of the H-reflex in these surgeries. METHODS: The use of intraoperative H-reflex in TAAA monitoring was evaluated in 12 patients undergoing open or endovascular repair of TAAA for a period of four years (2016-2020) using somatosensory evoked potentials (SSEPs) and transcranial motor evoked potentials (TcMEPs) and bilateral H-reflex. RESULTS: Six neurophysiologic alarms were recorded in five of the 12 patients. Summarizing the neurophysiologic changes of our series, we considered a peripheral change when we detected a unilateral loss of SSEPs, TcMEPs, and H-reflex. Instead, we assumed a central change when we detected a unilateral or bilateral loss of TcMEPs and H-reflex with normal SSEPs, which we considered a sign of spinal cord ischemia. Interestingly H-reflex always changed significantly in combination with TcMEPs in the same fashion. CONCLUSIONS: According to our series, H-reflex can detect intraoperative changes with the same sensitivity as TcMEPs in TAAA surgeries. With the support of other techniques, it can be useful to localize the origin of the lesion (peripheral or central spinal cord), to help in surgical decision-making to avoid postoperative neurologic damage. Based on our results, we recommend the systematic use of H-reflex in TAAA surgeries.

Hypogastric Chimney Patency in Aortic Monoiliacal Endograft Thrombosis: A Life Saved by Collateral Pelvic Circulation.

Background To report a case of a high-risk patient treated with hypogastric chimney and aortic endograft for a native infrarenal aorta aneurysmal degeneration, 20 years after an aortobifemoral bypass procedure for severe iliac occlusive disease. Methods A two-stage procedure was planned. The first stage was right internal iliac artery (IIA) embolization and simple angioplasty of left IIA. The second stage consisted of aortouniiliac endograft with femoral crossover and left IIA chimney. Results Femoral crossover complicated with early thrombosis, but a decision on conservative medical treatment with anticoagulation was made based on no rest pain or severe claudication. After 3 months the patient presented with moderate claudication alone. Scheduled computed tomography scan showed femoral crossover graft and aortic endograft thrombosis with left IIA patency. The axillofemoral bypass was scheduled a week later, and the patient discharged home. Conclusion Preservation of pelvic circulation is mandatory to avoid life-threatening complications. The chimney technique demonstrates good patency and should be considered in the endovascular approach armamentarium for hypogastric artery revascularization.

Multicenter European Registry for Patients with AAA Undergoing EVAR Evaluating the Performance of the 36-mm-Diameter Endurant Stent-Graft.

INTRODUCTION: The use of and results with the Endurant stent-graft have been reported extensively. However, there has been little if any focus placed on performance and outcomes when a 36-mm-diameter device is used. METHODS: Data were collected and retrospectively analyzed on EVAR patients treated with a 36-mm-diameter Endurant device at 3 European academic vascular centers between 2007 and 2015. Primary endpoints were the absence of type Ia endoleak in the early and mid-term follow-up period, and aneurysm sac stabilization or shrinkage. Secondary endpoints were 30-day mortality, overall survival and secondary interventions. Subgroup analysis of outcomes in the on-label (ONL) versus off-label (OFL) device use cohorts was also performed. RESULTS: Seventy-three patients were included in the study. Mean follow-up was 30.1 ± 16.2 months. Mean aortic neck diameter was 29.5 ± 1.9. Primary technical success was achieved in 69 patients (94.5%). Five patients (6.8%) were found to have developed a type Ia endoleak, 3 during the first month, and the other 2 at 2 years. Overall EVAR-related mortality was 4.1% (n = 3). Subgroup analysis focused on the OFL cohort (n = 44) versus the ONL patients (n = 29). Two of the OFL patients (4.5%) had a type Ia endoleak, and 3 (10.3%) in the ONL group. CONCLUSION: The use of the largest diameter Endurant stent-graft device emerges as a reasonable option for EVAR treatment of AAA featuring a large-diameter proximal neck. Assessment of a larger group of patients followed in the long term will be necessary for a more definitive statement on such strategy.

No Difference in Neck Enlargement for Patients Treated With Double Proximal Self-Expandable Suprarenal Fixation Endografting.

INTRODUCTION: Neck enlargement is well described in patients treated with self-expandable endografts for abdominal aortic aneurysms. Double endografting (ie, overlapping of stent grafts) occurs in patients with proximal cuffs or bifurcated to monoiliacal configuration conversions. When the aortic neck of patients receives 2 suprarenal fixation endografts, it may behave differently in terms of radial force and interaction of additional suprarenal stents extending to the visceral aorta. METHODS: We performed a retrospective study comparing 2 groups. Group 1 included 18 patients treated with 2 proximal self-expandable endografts. Group 2 included 17 patients treated with 1 self-expandable endograft who were consecutively treated during the period of treatment in group 1. Neck measurements were analyzed in both groups preoperatively and in the last computed tomography scan during follow-up. Suprarenal, interrenal, juxtarenal, and infrarenal (at 5 and 10 mm) diameters, as well as interrenal and infrarenal (5 mm) areas, were measured. RESULTS: There was no significant difference in baseline characteristics, initial neck measurements, and aneurysmal sac evolution including endoleaks between the groups. Both groups showed neck enlargement. Group comparisons of all parameters in posttreatment neck measurements showed no statistical change. Univariate analysis showed oversizing to be significant in interrenal diameter and area and infrarenal at 10 mm diameter; however, 2-way analysis of variance analysis showed that the interaction between oversizing and the number of stent grafts was not significant. CONCLUSION: Neck enlargement occurs in patients with self-expandable endografts with a tendency to reach the size of the endograft in the long term. Double endografting seems to interact in the same way as simple endografting in the aortic neck. Although the main limitation of our study lies in the small sample size, the presence of an additional "double" stent graft does not appear to result in any differences in aortic neck dilatation when compared to a single stent graft.