European Expert Opinion on Infrarenal Sealing Zone Definition and Management in Endovascular Aortic Repair Patients: A Delphi Consensus.

PURPOSE: The purpose of the study was to provide a consensus definition of the infrarenal sealing zone and develop an algorithm to determine when and if adjunctive procedure(s) or reintervention should be considered in managing patients undergoing endovascular aortic repair (EVAR) for infrarenal abdominal aortic aneurysm (AAA). METHODS: A European Advisory Board (AB), made up of 11 vascular surgeons with expertise in EVAR for AAA, was assembled to share their opinion regarding the definition of preoperative and postoperative infrarenal sealing zone. Information on their current clinical practice and level of agreement on proposed reintervention paths was used to develop an algorithm. The process included 2 virtual meetings and 2 rounds of online surveys completed by the AB (Delphi method). Consensus was defined as reached when ≥ 8 of 11 (73%) respondents agreed or were neutral. RESULTS: The AB reached complete consensus on definitions and measurement of the pre-EVAR target anticipated sealing zone (TASZ) and the post-EVAR real achieved sealing zone (RASZ), namely, the shortest length between the proximal and distal reference points as defined by the AB, in case of patients with challenging anatomies. Also, agreement was achieved on a list of 4 anatomic parameters and 3 prosthesis-/procedure-related parameters, considered to have the most significant impact on preoperative and postoperative sealing zones. Furthermore, the agreement was reached that in the presence of visible neck-related complications, both adjunctive procedure(s) and reintervention should be contemplated (100% consensus). In addition, adjunctive procedure(s) or reintervention can be considered in the following cases (% consensus): insufficient sealing zone on completion imaging (91%) or on the first postoperative computed tomography (CT) scan (91%), suboptimal sealing zone on completion imaging (73%) or postoperative CT scan (82%), and negative evolution of the actual sealing zone over time (91%), even in the absence of visible complications. CONCLUSIONS: AB members agreed on definitions of the pre- and post-EVAR infrarenal sealing zone, as well as factors of influence. Furthermore, a clinical decision algorithm was proposed to determine the timing and necessity of adjunctive procedure(s) and reinterventions.

Preoperative Planning for EndoAnchor Use During Thoracic Endovascular Aortic Repair in the Distal Aortic Arch.

PURPOSE: To describe steps related to intraoperative C-arm orientations that can be taken during preoperative planning of thoracic stent-graft repair to facilitate the deployment of EndoAnchors in the distal aortic arch. TECHNIQUE: Previous experience from transcatheter aortic valve implantation (TAVI) may be helpful in addressing issues with C-arm orientation. In TAVI, preoperative computed tomography (CT) images are routinely obtained to generate a patient-specific curve that represents a virtually complete rotation of the C-arm perpendicular to the annulus. The curve clearly demonstrates that each adjustment in cranial or caudal view needs parallax correction in the left or right anterior oblique direction to remain perpendicular, and vice versa. This experience can be translated to the preoperative planning of EndoAnchor use in the aortic arch. By placing markers along the circumference of the proximal landing zone of the preoperative CT scan, the required C-arm orientations can be determined for each marker. CONCLUSION: Determining the optimal C-arm orientation during preoperative planning will facilitate successful EndoAnchor deployment and may contribute to improved durability of endovascular repair in hostile necks in the aortic arch.

Improved Midterm Outcomes Using Standard Devices and EndoAnchors for Endovascular Repair of Abdominal Aortic Aneurysms with Hyperangulated Necks.

PURPOSE: Loss of fixation and seal represent a key problem when undertaking endovascular repair of abdominal aortic aneurysms (AAA) with hyperangulated necks (HAN). This study assesses the outcomes following the use of adjunct endostapling to supplement proximal aorto-prosthetic fixation in patients who have AAAs with HAN. METHODS: A retrospective review of a prospective database of 42 patients with HAN (> 60°) who underwent endovascular aneurysm repair (EVAR) with supplementary endostapling was undertaken. Primary outcomes assessed were: change in post-EVAR neck angulation at first post-procedure scan, freedom from type 1 endoleaks, migration and reintervention for proximal seal complications. Secondary parameters included assessment for neck dilatation, sac size changes and EndoAnchor distribution patterns. RESULTS: In total, 42 patients underwent EVAR between 2013 and 2019. There was one 30-day mortality resulting in 41 patients (34 male, 7 females aged 76.8 ± 8.9 years)) being analysed; 251 EndoAnchors were deployed in total, averaging 6 ± 2 per patient; 38 such cases were primary deployments. Neck angulation was 76.9 ± 14 degrees pre-EVAR and 50.2 ± 14.5 degrees post-procedure (p < .001, paired T test). Mean follow-up time was 18.5 (95% CI 13.3-23.9) months. One patient had persistent type Ia endoleak, successfully banded. There was 6.8 ± 10.2 mm sac size reduction (p < .001, paired T test). There were no other neck-related reinterventions, despite continued neck dilatation (3.2 ± 3.7 mm, p < .001, paired T test). CONCLUSION: This study suggests successful EVAR with adjunct endostapling for AAA with hyperangulated necks, with significant sac shrinkage and low rates of endoleaks, migration and reinterventions. More data are needed to consider influencing current instructions for use.

Impact of the Aortic Graft on Arterial Stiffness and Inflammatory Biomarkers after Endovascular Aortic Repair or Open Surgical Repair in Abdominal Aortic Aneurysm Disease.

BACKGROUND: Abdominal aortic aneurysm (AAA) is an important cardiovascular (CV)-related disease that requires surgical treatment to prevent rupture. The elevation of arterial stiffness (AS) is an increasingly recognized independent determinant of CV morbidity and mortality and plays a special role in atherosclerosis. The importance of the surgical technique used for AAA repair in the long-term outcomes still needs to be clarified, and whether endovascular aortic repair (EVAR) or open surgical repair (OSR) confers high AS measurements and thus worse prognosis in terms of CV morbidity needs further investigation. METHODS: A prospective nonrandomized study that included consecutive patients requiring either EVAR or OSR for AAA disease between February 2015 and January 2016 was conducted. This study is registered on the National Institutes of Health website (ClinicalTrials.gov) and identified with NCT02642952. Several noninvasive measurements of AS and central aortic hemodynamics were obtained before surgery and in the first postoperative control (4-6 weeks), with change from baseline in heart rate-adjusted augmentation index (AIx@75) as main outcome. Likewise, inflammatory circulating biomarkers were also measured in the same time line. RESULTS: We included 44 patients, 25 in the EVAR group and 19 in the OSR group. Subjects who underwent EVAR were older and presented larger aneurysm diameter at baseline. There was a significant decrease in AIx@75 in the EVAR group after treatment (-4.1 ± 8.1%, P = 0.018), for a moderate effect size (d = 0.508), whereas the decreasing trend in the OSR group (-2.5 ± 6.7%, P = 0.127) was not statistically significant. No significant changes in carotid-radial pulse wave velocity (PWVCR) and central blood pressures were observed. The inflammatory markers increased after surgical repair, with significant changes in homocysteine in both EVAR (5.2 ± 6.9 µmol/L, P = 0.002) and OSR (1.8 ± 2.1 µmol/L, P = 0.002) groups. CONCLUSIONS: Our study suggests that both treatments confer better postoperative values of AS measured by AIx@75 and produces no changes in PWVCR, in the early term. Whether this situation is maintained during follow-up needs further investigation.

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.