Use Of EndoAnchors Research Articles

Effectiveness and Safety of Endoanchors in Abdominal and Thoracic Endovascular Aneurysm Repair: A Systematic Review and Meta-analysis

Purpose: This systematic review aimed to summarize the effectiveness and safety of endoanchor, a stabilizing device for the proximal endograft designed to prevent endoleak and stent migration in endovascular aneurysm repair (EVAR) and thoracic endovascular aneurysm repair (TEVAR). Materials and methods: A systematic review and meta-analysis was conducted per the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guideline. Literature up to May 31, 2023 was searched and independently screened from 4 databases. Data were pooled for meta-analysis. Primary outcomes included intraoperative and follow-up endoleak, stent migration, and reintervention rates; sac regression; and 30-day all-cause mortality. Results: Sixteen EVAR (n=1145) and 6 TEVAR studies (n=163) using the Heli-Fx EndoAnchor system were included from 2225 retrieved records. For EVAR patients (mean follow-up=11.9 months), the endoleak, graft migration, and reintervention rates were 3.97% (95% confidence interval [CI]=0.36%-1.99%), 0.004% (95% CI=0.00%-0.76%), and 5.43% (95% CI=0.86%-12.54%), respectively. The endoleak rates for primary and revision EVAR were 0.16% (95% CI=0.00%-1.65%) and 3.60% (95% CI=0.14%-9.72%), respectively. Only 4 cases of 30-day mortality (n=4) were reported in the literature. For TEVAR patients, the endoleak, stent migration, and reintervention rates were 7.4% (95% CI=0.03%-0.13%), 0.2% (95% CI=0.00%-0.06%), and 17.1% (95% CI=0.01%-0.45%), respectively. The 30-day mortality was 0.9% (95% CI=0%-0.12%). Conclusions: Endoanchor fixation in EVAR and TEVAR is effective and safe in preventing and treating endoleak and stent migration. The mortality is minimal in EVAR but higher in TEVAR. Clinical Impact Endoleak, graft migration, and reintervention in EVAR and TEVAR with endoanchor use were rare. Mortality in EVAR was low. The adjunctive deployment of endoanchors is an effective and safe means to prevent and treat endoleak and stent migration in EVAR and TEVAR. Yet, long-term efficacy and safety data and randomized controlled trials would be required to definitively recommend endoanchor use in routine clinical practice.

Endosutured Aneurysm Repair of Abdominal Aortic Aneurysms with Short Necks Achieves Acceptable Midterm Outcomes—Results from the Peru Registry

IntroductionThe study aims to describe midterm outcomes following treatment of infrarenal abdominal aortic aneurysms (AAAs) with short necks by endosutured aneurysm repair (ESAR) using the Heli-FX EndoAnchor system. MethodsThis is a retrospective study of prospectively collected data from nine vascular surgery departments between June 2010 - December 2019, including treated AAAs with neck lengths ≤ 10mm. The decision for the use of EndoAnchors was made by the treating surgeon or multidisciplinary aortic committee according to each centre’s practice. There were two subgroups further assessed according to neck length, A (≥4 and < 7mm) and B (≥7 and ≤10mm). The main outcomes analysed were technical success, freedom from type Ia endoleaks (TIaEL), sac size increase, all-cause (ACM) and aneurysm related mortality (ARM). Results76 patients were included in the study, 17 fell into Subgroup A and 59 into subgroup B. Median follow-up for the cohort was 40.5 (IQR 12-61) months. A median of 6 (IQR 3) EndoAnchors were deployed in each subject. Technical success was 86.8% for the total group, 82.4% and 88.1% (p=0.534) for subgroups A and B respectively. Six out of ten (60%) of TIaELs at the completion angiographies showed spontaneous resolution. Cumulative freedom from TIaEL at 3 and 5 years for the total group was 89% and 84% respectively; this was 93% and 74% for subgroup A and 88% at both intervals in subgroup B (p=0.545). In total, there were 7 (9.2%) patients presenting with type Ia endoleaks over the entire study period. Two (11.8%) in subgroup A and 5 (8.5%) in subgroup B (p=0.679). There were more patients with sac regression in subgroup B (subgroup A=6 - 35.3% versus subgroup B=34 - 57.6%, p=0.230) with no statistical significance. ACM was 19 (25%) patients, with no difference (4 – 23.5% versus 15 – 25.4%, p=0.874) between subgroups; whereas ARM occurred in one patient from subgroup A and 3 from subgroup B. ConclusionsThis study demonstrates reasonable outcomes for patients with short-necked AAAs treated by ESAR in terms of type Ia endoleaks up to 5 year follow up. EndoAnchor use should be judiciously evaluated in short necks and may be a reasonable option when anatomical constraints are encountered, mainly for those with 7-10mm neck lengths. Shorter neck length aspects, as indicated by the results from Group A, may be an alternative when no other options are available or feasible.

Use of EndoAnchors during index endovascular aortic aneurysm repair in patients with hostile proximal aortic neck anatomy.

Standard endovascular aortic aneurysm repair (EVAR) is sometimes the only treatment option for patients with hostile aortic neck anatomy, but it carries an increased risk of both early and late procedure-related complications. The aim of this study was to report on single-center experience with the Heli-FX EndoAnchors (Medtronic, Santa Rosa, CA) as an adjunctive procedure to endovascular aneurysm repair (EVAR) for prevention and perioperative treatment of proximal neck complications in patients with hostile neck anatomy. MATERIALS AND METHODS:Asingle-centre, retrospective study evaluating 24 consecutive patients treated with EndoAnchors during the index EVAR procedure between November 2018 and August 2021. EndoAnchor implantation was indicated for cases with hostile proximal aortic neck anatomy characterised by the presence of at least one of the following parameters: length of 28 mm, angle of >60°, circumferential thrombus/calcification involving ≥50%, and reverse taper. Median follow-up period was 22.5 months (IQR 2-31.5 months) with no aneurysm-related death, rupture, or conversion to open surgical repair during the follow-up. The procedural success rate was 100%, with no type Ia endoleak at the completion angiography. Amean of 7 EndoAnchors was used per patient (range 4-12). There were no EndoAnchor fractures and dislocations or stent graft fabric damage due to anchor implants.Twenty-three patients (95.8%) remained free of type Ia endoleak and migration on follow-up imaging. Aneurysm sac regression was observed in 13 patients (54.1%), while in 8 patients (33.3%) the sac remained stable. Sac enlargement was present in 1 patient (4.2%) due to late type Ia endoleak. Twopatients were lost to the follow-up immediately after the procedure.Between two groups of patients (sac regression versus failure to regress), the larger initial diameter of the proximal neck was the only significant independent factor associated with a lower possibility of sac regression (p= 0,021). The use of EndoAnchors during the index EVAR procedure in cases with challenging aortic neck anatomy with or without perioperative type Ia endoleak was associated with good midterm results and led to sac regression in most of the patients (Tab. 4, Fig. 3, Ref. 31).

The Effect of EndoAnchors on Aneurysm Sac Regression for Patients Treated With Infrarenal Endovascular Repair With Hostile Neck Anatomies: A Propensity Scored Analysis

Purpose: To analyze sac evolution patterns in matched patients with hostile neck anatomy (HNA) treated with standard endovascular aneurysm repair (sEVAR) and endosutured aneurysm repair (ESAR). Methods: Observational retrospective study using prospectively collected data between June 2010 and December 2019. ESAR group data were extracted from the primary arm of the PERU registry with an assigned identifier (NCT04100499) at 8 centers and those from the sEVAR came from 4 centers. Suitability for inclusion required: no proximal endograft adjuncts (besides EndoAnchor use), ≤15 mm neck length and minimum of 12-months follow-up imaging. Bubble-shaped neck (noncylindrical short neck with discontinuous seal) aspect was analyzed. Both groups were analyzed using propensity score matching (PSM) for aortic neck length, width, angulation, and device fixation type. Main outcome assessed was sac evolution patterns (sac expansion and regression were defined as >5mm increase or decrease, of the maximum sac diameter respectively; all AAAs within this ±5 mm range in diameter change were considered stable) and secondary outcomes were type-Ia endoleaks; other endoleaks and mortality. A power analysis calculation >80% was confirmed for sac regression evaluation. Results: After exclusions, PSM resulted in 96 ESAR and 96 sEVAR patients. Mean imaging follow-up (months) was 44.4±21.3 versus 43.0±19.6 (p=0.643), respectively. The overall number of patients achieving sac regression was higher in the ESAR group (n=57, 59.4% vs n=31, 32.3%; p<0.001) and the cumulative sac regression achieved at 5 years was 65% versus 38% (p=0.003) in favor of the ESAR group. There were no statistically significant differences in type-Ia endoleak and/or other endoleaks. Univariate analysis for sac regression patients in the sEVAR and ESAR group individually showed the bubble-shape neck as a predictor of sac regression failure. There were no statistical differences in overall and aneurysm-related mortality. Conclusion: Endosutured aneurysm repair provided improved rates of sac regression for patients with AAA and HNA when compared with sEVAR at midterm and up to 5 years, despite similar rates of type-Ia endoleaks, and the need to consider some important limitations. The presence of bubble-shaped neck was a predictor of sac regression failure for both groups equally. Clinical Impact The use of EndoAnchors aids and improves EVAR treatment in hostile neck anatomies by an increased rate of sac regression when compared to EVAR treatment alone in up to 5 year analysis. Moreover, a trend to reduced number of type Ia endoleaks is also achieved, although not significant in the present study. This data, adds to current and growing evidence on the usefulness of EndoAnchors for AAA endovascular treatment.

Coil Embolization Of Persistent Type 1 Endoleak

Type I endoleak is a well-known complication of endovascular repair which could be due to the patient or technical factors during the procedure. Every type I or type III endoleak should be repaired prior to completion of the endovascular repair procedure. In the case of type I endoleak aneurysm, the sac is still pressurized and will grow over time. Every attempt should be made to resolve endoleak prior to the completion of the procedure. Available strategies to treat type I endoleak include: (1) Repeat angioplasty of the seal zone; (2) Addition of an aortic cuff; (3) Use of balloon-expandable bare-metal stents to increase the radial force; (4) Use of endoanchors to obtain better graft/aorta apposition; (5) Extension of the graft with snorkel or fenestrated endograft to extend the seal zone beyond the visceral branches; and (6) Explantation and open repair.

Mid-term outcomes of the use of endoanchors during thoracic endovascular aortic repair in multicentre analysis.

To describe mid-term outcomes of the use of EndoAnchors as an adjunct for arch and thoracic endovascular aortic repair (TEVAR). A retrospective multicentre series from nine centres using the Heli-FX EndoAnchor System (Medtronic Inc, Minneapolis, USA) at TEVAR over May 2014-May 2019 is presented. The study is registered at ClinicalTrials.gov with number NCT04100499. The primary outcome was freedom from Type I endoleak at EndoAnchors deployments; secondary outcomes included evaluation of aortic wall penetration (AWP) at first computed tomography scan, EndoAnchor-related issues and mortality. 54high-risk patients (35males/19females, age 73 ± 11years) with arch, thoracic and thoracoabdominal aneurysmal disease (3 chronic post-dissection and one patch pseudoaneurysm), with a mean neck length 19.7 ± 6.6mm that were treated with multiple hybrid and endovascular techniques were included. A total of 329 EndoAnchors were used with a mean of 6.1 ± 2.5 per patient. Overall adequate AWP was 86%, whereas arch (Ishimaru's zones 0-2) deployments achieved 80.6% when compared to 87.3% in descending thoracic aorta (dTA); although there was no statistical significance. Freedom from type I endoleaks was 88% at 2year follow-up, due to 4 type IA endoleaks, two of them successfully treated, one with conservative treatment due to complexity of repair and remaining patient died 1year later due to endograft infection. There were reported five EndoAnchor-related issues; four losses and one renal stent-graft was crushed due to catheter deflection solved with balloon reinflation. None of the losses had clinical significance. Overall mortality is described for 7 (9.5%) patients, one of them aneurysm-related. The adjunctive use of EndoAnchors in TEVAR and complex TEVAR procedures achieved acceptable outcomes at midterm in a high-risk series with hostile seal zones. Still, they should be still judiciously used as there is lack of data to suggest a more liberal use; therefore, the landing zone should not be compromised in favour of their use.

Favorable Outcomes in Octogenarians With Hostile Neck Undergoing Endovascular Repair Using EndoAnchors

ObjectivesStandard endovascular repair (EVAR) is not suitable in patients with hostile aortic anatomy. Open aneurysm repair (OAR) has been the gold-standard approach in managing these patients. EndoAnchors have been introduced as a technique to make EVAR in patients with short and angulated necks possible. The use of EndoAnchors in managing hostile aneurysms in octogenarians has not been studied before. Thus, the purpose of this study is to evaluate both short and long-term outcomes in octogenarians versus nonoctogenarians patients with hostile aortic anatomy undergoing EVAR using EndoAnchors. MethodsOnly patients enrolled in the primary arm of the ANCHOR registry were included and stratified into octogenarians (80–89 years) and nonoctogenarians (<80 years). Standard univariate (chi-square, fisher's exact, student's t-tests) and multivariable (logistic, cox-regression) analysis was used to evaluate patients’ characteristics and outcomes between octogenarians versus nonoctogenarians as appropriate. ResultsOf 461 patients, 21% (N = 97) were octogenarians. Compared to nonoctogenarians, octogenarians were more likely to have a history of renal (32.0% vs. 18.4%) and genitourinary (30.9% vs. 21.2%) disease (both P < 0.05). They were also more likely to have an AAA diameter greater than 55 mm compared to nonoctogenarians (59% vs. 46%), had increased neck tortuosity index (mean [S.D.] 1.07 [0.08] vs. 1.05 [0.05]), greater proximal neck angulation (mean [S.D.]: 28.2 [17.3] vs. 23.7 [16] degrees) and were more likely to have localized (29.3% vs. 18.7%) and diffuse (25.6% vs. 20.7%) neck calcification (All P < 0.05). The overall procedural success was similar between both groups. However, octogenarians had higher rates of endoleaks at completion (32.0% vs. 21.2%, P = 0.03) and 30-day bleeding (12.4% vs. 5.8%) and cardiac (13.4% vs. 5.2%) complications (All P < 0.05). Additionally, compared to nonoctogenarians, octogenarians had lower freedom from all-cause mortality (87.90% vs. 96.50%) and type II endoleak (73.30% vs. 88.60%) based on Kaplan Meier estimates through one year (Both P < 0.05). In multivariable cox-regression analysis, octogenarians demonstrated a 5-fold increase in all cause mortality (HR [95% CI]: 5.19 [1.92–14], P = 0.001) and a 3-fold increase in type II endoleak (HR [95% CI]: 2.99 [1.54–5.81], P = 0.001) at 1-year. However, no significant difference was seen in aneurysm/device related mortality (HR [95% CI]: 1.42 [0.14–14.7], P = 0.77) and type I endoleak (HR [95% CI]: 1.71 [0.31–9.55], P = 0.54) at 1-year. ConclusionsDespite a worse aortic neck anatomy, octogenarians undergoing EVAR using EndoAnchors showed acceptable short and long-term outcomes. The results of our study could expand the utilization of EVAR in octogenarians with hostile neck.

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

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). 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. 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. 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.

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.

Increased type 1a endoleaks due to endo-anchors: ex vivo evaluation of the impact of anchors on the textile structure after explantation

The use of endo-anchors (EA) was proposed to treat type 1a endoleaks. The impact of these EA on the textile structure of explanted stentgrafts (ES) was never evaluated. We report the analysis of two cases of explantation of aortic SG associated with EA.

Endovascular repair of an abdominal aortic aneurysm involving the use of EndoAnchors in an aneurysmal left common iliac artery.

Endovascular repair of an abdominal aortic aneurysm involving the use of EndoAnchors in an aneurysmal left common iliac artery.

Predictors of inadequate EndoAnchors aortic wall penetration for the Endosutured therapy in hostile neck patients.

The use of EndoAnchors is increasing; however, not much about appropriate use in terms of aortic wall penetration (AWP) is described. We aim to evaluate the procedural and anatomical conditions related with borderline (b) or absence (ab) of AWP when checked on first CT-scan after the Endosutured aortic repair (ESAR) for hostile neck anatomies (HNA). This study with NCT04100499 is a single center prospective evaluation of patients receiving EndoAnchors for prevention or treatment of a proximal EVAR failure. AWP was evaluated on first CT-scan and findings correlated with neck anatomical features and procedural data. The sum of borderline and absence of AWP was considered as Inadequate - In-AWP (failure). Adjunctive procedures, reinterventions, all-cause mortality, absence of type Ia EL and aneurysm related mortality are also described. Forty-eight patients were treated during the study period and 43 high-surgical risk patients were finally included in the study for analysis with at least one HNA criteria (58%) and associating two in 21% or even three in 21%. A total of 250 EndoAnchors were deployed at a median 6 (range, 4-10) per case. From those, 31 (12.5%) achieved b-AWP and 11 (4.4%) ab-AWP, meaning 42 (16.8%) EndoAnchors with In-AWP. Univariate-analysis showed being an occasional user and a therapeutic case as predictor for at least one and more failures. The only predictor on multivariate analysis for two or more EndoAnchors with In-AWP was being an occasional user. Cumulative-survival and freedom from type-Ia EL at 2-years was 84% and 95%; respectively. Outcomes of the ESAR therapy should be validated according to their aortic wall penetration checked on first CT-scan. EndoAnchors use in HNA should not be considered an easy approach for the endovascular technique, especially for therapeutic cases. An individual and specific case analysis counterbalancing inadequate use of the device in unexperienced users should be evaluated against the increased risk of proximal failure as in standard EVAR alone during HNA treatment.

A Systematic Review of the Use of Endoanchors in Endovascular Aortic Aneurysm Repair

Objectives Endoanchor fixation might be a potential adjunct for the prevention and treatment of type Ia endoleak (TIaE) and graft migration in thoracic or abdominal endovascular aortic aneurysm repairs (TEVAR or EVAR). This review aimed to explore the safety and effectiveness of endoanchor fixation in TEVAR and EVAR. Methods A systematic review and random effects meta-analysis was conducted. Data sources were PubMed/MEDLINE, Embase, and the Cochrane Library. Results Seven EVAR and three TEVAR studies using the Heli-FX™ EndoAnchor™ system were included in the meta-analysis. A total of 455 EVAR patients underwent primary endoanchor fixation. Technical success was 98.4% (95% CI 95.7–99.8%). The rate of TIaE and graft migration was 3.5% (95% CI 1.7–5.9%) and 2.0% (95% CI 0.12–6.0%), respectively, after 15.4 months (95% CI 1.76–29.0) follow up. A total of 107 EVAR patients underwent secondary fixation with a technical success of 91.8% (95% CI 86.1–96.2%). Rates of TIaE and graft migration were 22.6% (95% CI 9.1–40.0%) and 0% after a mean 10.7 month (95% CI 7.8–13.6) follow up. Adverse events included three endoanchor fractures, three dislocated endoanchors, one entrapped endoanchor, and one common iliac artery dissection. All cause 30 day EVAR mortality was 0.82% (95% CI 0.20–1.85%). Sixty-six TEVAR patients underwent endoanchor fixation with a mean 9.8 month (95% CI 8.1–11.5) follow up. Technical success was 90.3% (95% CI 72.1–99.4%). The rates of TIaE and migration were 8.7% (95% CI 1.0–18.9%) and 0%, respectively. Adverse events included two misdeployed endoanchors with one fatal aortic dissection. All cause 30 day TEVAR mortality was 11.9% (95% CI 5.4–20.6%). Conclusion Endoanchor fixation in EVAR is technically feasible and safe, with at least comparable early outcomes to the latest generation of stent grafts. Endostapling in TEVAR is associated with lower technical success, higher peri-operative mortality, and potential serious adverse events. Current evidence lacks long term follow up and case controlled trials to recommend endoanchor use in routine practice.

Can Endoanchors be Used in Any Endovascular Aortic Procedure? Lessons Learned After 674 Endoanchors in 109 Patients in a Two-centre Experience

Introduction - Endovascular aortic aneurysm repair (EVAR) for thoracic, thoracoabdominal, pararenal, juxtarenal and abdominal aortic aneurysms has been troubled by complications during follow-up, mainly related to loss of seal and graft migration causing endoleaks and sac expansion. Different techniques have been applied ranging in grade of complexity, such as branched, fenestrated, chimney/periscope or standard EVAR/TEVAR or even hybrid surgery including arch/visceral debranching. The role and safety of EndoAnchors (Aptus Heli-FX, Medtronic, Minnesota, USA) as an adjunctive technique for supplementing fixation and seal in standard and complex EVAR/TEVAR needs to be addressed. Methods - We report on a two academic vascular centre experience with high volume of endovascular procedures with the use of EndoAnchors in different aortic anatomies and sectors. The number of total EndoAnchors deployed is described. Primary outcome is description of the safety of EndoAnchor deployments. Recommendations related to secondary outcomes such as complications, limitations and inadequate use are also described Results - 109 high-risk patients (male 81.7%, female 18.3%; ages 73.92 ± 10.9 years) were treated during the study period (2013-2018) with adjunctive EndoAnchors, 79 in centre A and 30 in centre B. Sixteen were treated with TEVAR (zone 1, n=4 (3 open debranching and 1 combined open/endo-debranching; zone 3, n=3; zone 4, n=12; 3 patients across 2 zones) 3 with Ch-EVAR (1 chimney each) and 90 with EVAR. All were considered complex due to anatomical constraints. 674 EndoAnchors were placed, 87 in TEVAR, 587 for EVAR/Ch-EVAR (2 in a bell-bottom iliac endograft) and a mean of 6.18 ± 2.2 per case. Ninety-eight were prophylactic (44 conical, 31 hyper-angulated > 60°, 30 short and 14 ‘bubble’ necks) and the remaining 11 were revision/type Ia endoleaks. Issues related to endoanchoring procedure were found in 17 (15.6%) cases. Thirteen (76%) occurred during the initial half of centres’ experience. Of the 17 cases we found 4 mal-deployment (0.5%), 4 fractures (0.5%, without clinical relevance), 3 (27.3%) type Ia endoleak persistence after endostapling (1 undersized diameter of endograft, 2 ruptured AAA unsuccessfully treated with cuff plus EndoAnchors - 1 solved with aortic banding, the other died due to unstability/3 patients with delayed type Ia sealing), 3 catheter ruptures/twisting (0.4%) and 3 (0.4%) losses (2 were retrieved and one caged by a sandwich technique using an aortic cuff). Eight (7.3%) patients received less than 4 endoanchors. Six (75%) occurred during the first half of centres experience. Four received only one EndoAnchor, two of these due to rupture of the catheter, in one other case further deployments were not possible due to severe sheath twists causing inability to pass the applicator and the remaining one due only iliac by-pass access limited manoeuvrability. Two received 2 EndoAnchors, due to extreme angulation and impossibility to get correct position, and remaining 2 patients received 3 endoanchors due to a loss during procedure Conclusion - Endovascular approach of complex aortic aneurysms with adjunctive use of EndoAnchors seems to be a safe ancillary procedure. Appropriate use of the device, including choice of adequate access, proper catheter manoeuvring, anatomical patient selection and increased expertise for technically demanding cases remain the most important issues to avoid misuse of the device or failure in the endovascular technique

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

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. 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. Neck length and diameter showed no statistical difference in preoperative measures, 9.1±6.9mm and 8.6±2.8mm and 25.4±4.7mm and 27.3±4.7mm, in group A and B, respectively. Aneurysm sac diameter decreased from 58.2±8mm and 57.9±9.8mm to 55.7±8.5mm and 53.8±10.4mm 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%. Our study shows that additional use of EndoAnchors can successfully improvethe sealing of abdominal endografts in case of intraoperative type Ia endoleaks in hostileneck 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.

Expanded Suitability of Ruptured Abdominal Aortic Aneurysms for Total Endovascular Repair Using the Endurant Endograft and Heli-FX EndoAnchors

Purpose: To assess if the suitability of endovascular aneurysm repair (EVAR) of ruptured abdominal aortic aneurysms (RAAAs) can be expanded by combining the Endurant stent-graft with the Heli-FX EndoAnchors. Materials and Methods: Contrast-enhanced computed tomography (CT) scans of 90 patients (mean age 73.2±9 years; 87 men) with RAAA admitted between January 2014 and January 2018 in 2 tertiary care centers were analyzed in a 3-dimensional workstation. Anatomical features of the aneurysms according to the instructions for use (IFU) for the Endurant endograft were evaluated and expansion of treatment with Heli-FX EndoAnchors was assessed. Results: Neck length <10 mm was present in 41 (45.6%) patients; 5 had neck diameters outside the IFU and 45 (50.0%) had conical necks. Thrombus and calcium were absent in 63 (70.0%) and 73 (81.1%), respectively. In the study cohort, 44 (48.9%) patients met all the neck criteria, although overall IFU compliance was found in only 35 (38.9%) patients due to iliac-related issues in 21 patients. The adjunctive use of EndoAnchors in the entire study group would enhance the therapeutic range to an additional 24 patients, 8 of whom would need an associated iliac procedure. This represents an expansion of the total EVAR approach from 48.9% to 75.6% of cases if some iliac issues are overcome and from 38.9% to 56.7% without correcting iliac deficiencies. Conclusion: The main reason of being unfit for endovascular treatment in this series was neck length <10 mm. Based on this analysis, nearly 40% of RAAA patients would have been candidates for EVAR based on the IFU neck criteria for the Endurant stent-graft. This suitability could be nearly doubled with the use of EndoAnchors and correction of unsuitable iliac anatomy. The use of EndoAnchors has the potential to offer a significant benefit in the endovascular treatment of RAAA patients.

The use of EndoAnchors in endovascular repair of abdominal aortic aneurysms with challenging proximal neck: Single-centre experience.

ObjectivesThe aim of this study was to present a single-centre experience with EndoAnchors in patients who underwent endovascular repair for abdominal aortic aneurysms with challenging proximal neck, both in the prevention and treatment of endograft migration and type Ia endoleaks.MethodsWe retrospectively analysed 17 consecutive patients treated with EndoAnchors between June 2015 and May 2018 at our institution. EndoAnchors were applied during the initial endovascular aneurysm repair procedure (primary implant) to prevent proximal neck complications in difficult anatomies (nine patients), and in the follow-up after aneurysm exclusion (secondary implant) to correct type Ia endoleak and/or stent-graft migration (eight patients).ResultsMean time for anchors implant was 23 min (range 12–41), with a mean of 5 EndoAnchors deployed per patient. Six patients in the secondary implant group required a proximal cuff due to stent-graft migration ≥10 mm. Technical success was achieved in all cases, with no complications related to deployment of the anchors. At a median follow-up of 13 months (range 4–39, interquartile range 9–20), there were no aneurysm-related deaths or aneurysm ruptures, and all patients were free from reinterventions. CT-scan surveillance showed no evidence of type Ia endoleak, anchors dislodgement or stent-graft migration, with a mean reduction of aneurysm diameter of 0.4 mm (range 0–19); there was no sac growth or aortic neck enlargement in any case.ConclusionsEndoAnchors can be safely used in the prevention and treatment of type Ia endoleaks in patients with challenging aortic necks, with good results in terms of sac exclusion and diameter reduction in the mid-term follow-up.

Indications for the Use of Endoanchors: State of the Art

Complications during follow-up - including loss of seal and graft migration with endoleakage - are the Achilles heel of endovascular abdominal and thoracic aneurysm repair (EVAR and TEVAR, respectively). At the level of the proximal and distal landing zones, the characteristics of aortic anatomy include length and shape, thrombus, calcification, kinking and progressive dilatation, and these may impact the long-term durability of endovascular repair. Endoanchors have been shown to mimic the stability of a hand sewn aortic anastomosis. This report gives an overview of current literature on the use of endoanchors in EVAR and TEVAR. Indications for use include primary implantation to secure the proximal or distal landing zone, in case of unfavourable anatomy or intraoperative type I endoleak/suboptimal apposition to the aortic wall, as well as secondary use for the treatment of type I endoleaks and stent-graft migration often in conjunction with a proximal or distal extension of the stent-graft. To conclude the report, we analysed perioperative results of the first 100 patients treated with TEVAR/EVAR and endoanchors - primarily or secondarily - during re-interventions in our department. From March 2011 to November 2015, 100 patients (85 men, 15 women; mean age 70 ± 9.7 years) were treated. 82 applications were carried out in the abdominal and 18 in the thoracic aorta. The implantation was performed during the primary EVAR/TEVAR procedure in 80 cases (group A); 20 patients were treated secondarily (group B). Technical success was 100%. Clinical success was 98%. No endoanchors were lost. Perioperative mortality was 4% and morbidity 7%. During 30-day follow-up, endoleaks were found in 8/96 surviving patients. 7/8 patients had type II endoleaks, and one patient with secondary proximal extension of the thoracic stent-graft had a persistent type I endoleak.

Influence of aortic neck characteristics on successful aortic wall penetration of EndoAnchors in therapeutic use during endovascular aneurysm repair

ObjectiveThis study sought to quantify EndoAnchor (Medtronic Vascular, Santa Rosa, Calif) penetration into the aortic wall in patients undergoing endovascular abdominal aortic aneurysm repair and to assess predictors of successful penetration and its relationship to postprocedural type IA endoleak. MethodsA subset of patients from the Aneurysm Treatment Using the Heli-FX Aortic Securement System Global Registry (ANCHOR) were included if they met the following criteria: the indication for EndoAnchor use was to treat a type IA endoleak, and postprocedure contrast-enhanced computed tomography (CT) scans of sufficient quality were available for core laboratory review. Patients undergoing implantation of cuffs or stents during the EndoAnchor implantation procedure were excluded. Baseline anatomic characteristics were recorded. The cohort was divided into patients with and without persistent type IA endoleaks at the first postoperative CT scan. Penetration of each EndoAnchor measured on this CT scan was defined as good penetration when the EndoAnchor penetrated ≥2 mm into the aortic wall, borderline penetration when EndoAnchor penetration was <2 mm or a gap remained between the endograft and aortic wall, or no penetration when the EndoAnchor did not penetrate into the aortic wall. Differences between the groups were analyzed with the Mann-Whitney U test or Fisher exact test. Multivariate analyses were performed to identify independent predictors of EndoAnchor penetration, and procedural success was defined by absence of type IA endoleak. ResultsEighty-six patients of the primary (n = 61 [71%]) and revision (n = 25 [29%]) arms of the ANCHOR registry were included. There were 53 (62%) without and 33 (38%) with persistent type IA endoleaks on the first postprocedural CT scan. The median number of EndoAnchors with good penetration was significantly greater in the cohort without endoleaks, 4 (interquartile range, 3-5) vs 3 (interquartile range, 1.5-4), respectively (P = .002). A multivariate model for EndoAnchor penetration identified use of a Medtronic Endurant endograft as a factor associated with good penetration (P = .001), whereas poor penetration was associated with a larger aortic neck diameter 10 mm distal to the lowest renal artery (P < .001) and greater proximal neck calcium thickness (P = .004). EndoAnchor penetration was the only variable that attained significance (P < .001) in the multivariate model for successful treatment of a type IA endoleak. ConclusionsAdequate EndoAnchor penetration into the aortic wall is less likely when the aortic neck diameter is large or when the neck contains significant mural calcium. No penetration of the EndoAnchor was the only factor predictive of postprocedural type IA endoleak. This study stresses the importance of careful selection of patients based on preoperative assessment of the infrarenal neck on CT angiography and emphasizes careful deployment of EndoAnchors into the aortic wall to improve successful treatment of type IA endoleaks.

P5495Postmarketing adverse events related to the use of endoanchors in abdominal aortic aneurysm repair

P5495Postmarketing adverse events related to the use of endoanchors in abdominal aortic aneurysm repair