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

PURPOSE: 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: A single-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. RESULTS:  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. A mean 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. Two patients 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). CONCLUSIONS:  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).

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.

[Secondary ruptures of an abdominal aortic aneurysm treated with a physician-modified fenestrated endograft, endoanchors and finally with open repair]. / Hasi aorta aneurysma másodlagos rupturáinak kezelése orvos által módosított fenesztrált grafttal, endocsavarozással, majd nyitott mutéttel.

Secondary rupture is a late complication of endovascular aneurysm repair (EVAR). Open surgery is a technically feasible treatment option in most cases, however, late conversion carries a significant risk of morbidity and mortality, as it usually requires at least partial explantation of the in situ device, which is of major concern especially if suprarenal fixation is present. Endovascular treatment of these cases is usually challenging, especially since the custom-made devices that are often needed are not readily available but having a production time of several weeks. To overcome this limitation, physician-modified stent grafts are getting accepted to treat such urgent cases. We present the case of a patient receiving EVAR who later experienced two ruptures, treated first with a physician-modified endograft and adjunctive endoanchoring, later with open ligation of the lumbar arteries. Orv Hetil. 2023; 164(36): 1426-1431.

Five-year outcomes of endosuture aneurysm repair in patients with short neck abdominal aortic aneurysm from the ANCHOR registry.

OBJECTIVE: Hostile aortic neck anatomies such as proximal short necks are known to put patients at an increased risk for type IA endoleaks, migration, and need for reinterventions. The Heli-FX EndoAnchor System was designed to improve seal of aortic stent grafts. Endosuture aneurysm repair (ESAR) using EndoAnchors with the Endurant stent graft has been shown to be safe and effective for the treatment of patients with short necks through one year. This study reports the 5-year patient outcomes of the Aneurysm Treatment using the Heli-FX EndoAnchor System Global Registry (ANCHOR) short neck regulatory cohort. METHODS: The 70 patients from the ANCHOR Registry were cohort submitted to regulators for approval of the Endurant short neck indication. Patients had an infrarenal neck length of ≥ 4 mm and <10 mm. At 5 years, this short neck cohort had clinical and imaging follow-up compliance rates of 85% (28/33) and 70% (23/33), respectively. RESULTS: The short neck cohort had a mean age of 71.3±8.1 years and was 27.1% (19/70) female. Kaplan Meier freedom from all-cause mortality was 68.5 ± 6.2%, freedom from aneurysm-related mortality was 90.1 ± 4.5%, freedom from any endovascular or surgical secondary procedure was 76.9 ± 7.2%, and freedom from rupture was 95.6 ± 3.2%. Eight patients had a total of nine type IA endoleaks detected through 5 years, of which three resolved spontaneously by the next follow-up visit. There were two patients with renal complications who did not undergo reintervention and there were no device migrations reported through 5 years. After 5 years, 68.2% of patients (15/22) had sac regression, 13.6% (3/22) had stable sacs, and 18.2% (4/22) had increased sac diameter as compared with their 1-month measurements. CONCLUSIONS: After ESAR treatment using Heli-FX EndoAnchors with Endurant, the 5-year outcomes of the short neck cohort from the ANCHOR registry had encouraging results with regards to proximal neck-related complications, secondary procedures, and sac regression. This review of ESAR in patients with short proximal necks showed positive outcomes through 5 years although follow-up of a larger cohort is necessary.

Device profile of EndoAnchors for aortic stent graft implantation: overview of their safety and efficacy.

INTRODUCTION: Endovascular aneurysm repair (EVAR) and thoracic endovascular aneurysm repair (TEVAR) are established techniques to treat abdominal aortic aneurysms (AAA) and thoracic aortic aneurysms (TAA). However, there are limitations when challenging proximal neck anatomy is present. Heli-FX EndoAnchors have been used in addition to EVAR and TEVAR to improve proximal sealing of a stent-graft, but there are limited data available on their outcomes, safety, and efficacy. AREAS COVERED: The properties and development of Heli-FX EndoAnchors are evaluated. The evidence of various clinical outcomes, safety, and efficacy is interrogated with the augmented use of Heli-FX EndoAnchors with EVAR or TEVAR. EXPERT OPINION: Challenging proximal neck anatomy can be problematic during EVAR or TEVAR. EndoAnchors may be part of the solution - used either prophylactically or therapeutically. The safety and efficacy databases are building but long-term data are still not available for this device and there remains inadequate data to support its routine use. Judicious patient selection is still needed.

EndoSuture aneurysm repair versus fenestrated aneurysm repair in patients with short neck abdominal aortic aneurysm.

OBJECTIVE: The aim of this study was to compare midterm results of EndoAnchors in EndoSuture aneurysm repair (ESAR) versus fenestrated endovascular aneurysm repair (FEVAR) in short neck abdominal aortic aneurysm (AAA). METHODS: All patients who underwent an ESAR procedure for a short neck AAA at our center between September 2017 and May 2020 were considered for analysis. To form the control group, preoperative computed tomography angiography of patients who underwent FEVAR for juxtarenal AAA between April 2012 and May 2020 were reviewed and patients who met short neck criteria selected. A propensity-matched score on neck length and neck diameter was calculated, resulting in 18 matched pairs. AAA shrinkage, type Ia endoleaks (EL), AAA-related reinterventions, and AAA-related deaths were compared. RESULTS: The median AAA diameter was 54 mm (interquartile range [IQR], 52-61 mm) versus 58 mm (IQR, 53-63 mm) with a median neck length of 8 mm (IQR, 6-12 mm) vs 10 mm (IQR, 6-13 mm) in ESAR and FEVAR patients, respectively. Technical success was 100% in both groups. Procedural success was 94% in the ESAR group versus 100% in the FEVAR group. The median procedure duration was 138 mm (IQR, 113-182 mm) vs 240 mm (IQR, 199-293 mm) ( P < .001) and the median length of stay was 2 days (IQR, 2-3 days) vs 7 days (IQR, 6-7 days) (P < .001) in ESAR and FEVAR patients, respectively. No major hospital complications were observed in ESAR patients compared with two in FEVAR patients (11%) with one transient acute kidney injury and one transient paraplegia. The median follow-up was 23 months (IQR, 19-33 months) vs 36 months (IQR, 22-57 months) with 67% versus 61% AAA shrinkage in the ESAR and FEVAR groups, respectively (P = .73). No type Ia EL, proximal neck-related reinterventions, or AAA-related deaths were observed in either group. No AAA-related reintervention was observed in the ESAR group versus three reinterventions in the FEVAR group (P = .23). CONCLUSIONS: ESAR seems to be a safe technique with no major postoperative complications or reinterventions observed during follow-up. It seems to offer similar midterm results as FEVAR in terms of type Ia EL, aneurysm shrinkage, and aneurysm-related mortality. ESAR seems to be a good off-the-shelf alternative to FEVAR in case of technical constraints.

Technological Advances to Address the Challenging Abdominal Aortic Aneurysm Neck.

There have been significant technologic advances in endovascular aortic therapies since the introduction of conventional infrarenal endovascular aortic aneurysm repair (EVAR). These advances have sought to address the weaknesses of conventional EVAR- particularly the difficult or "hostile" infrarenal aortic aneurysm neck. We review anatomical features that create a hostile neck and the most recent advancements to overcome these limitations. EndoAnchors replicate open suture fixation to seal endograft to aortic tissue and have been shown to be useful as a prophylactic measure in short, angulated necks as well as therapeutic for type Ia endoleaks. Fenestrated EVAR (FEVAR) devices such as the Z-fen (Cook Medical, Bloomington, IN, USA) raises the seal zone to the suprarenal segment while maintaining renal perfusion. Finally, multibranch aortic grafts such as the Thoracoabdominal Branch Endoprosthesis (Tambe; W. L. Gore & Associates, Flagstaff, AZ, USA) raise the seal zone above the visceral segment and can be used off the shelf with promising results.

Ruptured juxtarenal abdominal aortic aneurysm managed with endosuture aneurysm repair.

The use of Heli-FX EndoAnchors (Medtronic CardioVascular, Santa Rosa, CA) with the Endurant II stent graft (Medtronic CardioVascular) has been approved by the Food and Drug Administration for juxtarenal abdominal aortic aneurysms with neck lengths ≤4 mm. The use of this technique of endosuture aneurysm repair has not been previously described in the setting of rupture. We have presented two cases of successful endosuture aneurysm repair of ruptured juxtarenal AAAs.

Computational analysis of endovascular aortic repair proximal seal zone preservation with endoanchors: A case study in cylindrical neck anatomy.

BACKGROUND: Endovascular aortic repair is the common approach for abdominal aortic aneurysms, but endoleaks remain a significant problem with long-term success. Endoanchors have been found to reduce the incidence of type 1A endoleaks and can treat intraoperative type 1a endoleaks. However, little is known about the optimal number and position of endoanchors to achieve the best outcome. METHODS: Using image segmentation and a computational model derived from a reconstructed native patient abdominal aortic aneurysm geometry, the stability of the proximal seal zone was examined through finite element analysis in Abaqus (Dassault Systèmes, Providence, RI). The biomechanical parameter of contact area was compared for varying numbers (0, 2, 4, 8) and positions (proximal, medial, distal) of endoanchors under different adhesion strengths and physiologic pressure conditions. RESULTS: In every simulation, an increase in adhesion strength is associated with maintenance of proximal seal. For biologically plausible adhesion strengths, under conditions of normal blood pressure (120 mm Hg), the addition of any number of endoanchors increases the stability of the endograft-wall interface at the proximal seal zone by approximately 10% compared with no endoanchors. At hypertensive pressures (200 mm Hg), endoanchors increase the stability of the interface by 20% to 60% compared with no endoanchors. The positioning of endoanchors within the proximal seal zone has a greater effect at hypertensive pressures, with proximal positioning increasing stability by 15% compared with medial and distal positioning and 30% compared with no endoanchors. CONCLUSIONS: Endoanchors improve fixation within the proximal seal zone particularly under conditions of high peak systolic pressure. Seal zone stabilization provides a mechanism through which endoanchor addition may translate into lower rates of type 1a endoleaks for patients.

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.

Use of Gore C-TAG with active control to treat a complex infrarenal abdominal aortic aneurysm.

Complex abdominal aortic aneurysms (AAAs) can preclude the use of endovascular aortic repair. In patients unable to undergo open surgical repair (OSR), the use of endografts outside the instructions for use might be the only option. We present the case of a woman with a highly angulated infrarenal AAA neck who was unsuitable for OSR and was successfully treated using a Gore C-TAG conformable thoracic stent graft (W.L. Gore and Associates, Inc, Flagstaff, Ariz) with active control, Medtronic Heli-FX EndoAnchors (Medtronic Vascular, Minneapolis, Minn), and a bifurcated Gore Excluder endoprosthesis W.L. Gore and Associates). The repair was successful without evidence of an endoleak. Using a thoracic endograft outside of the instructions for use to treat infrarenal AAAs might be feasible for patients unable to undergo OSR.

Outcomes of endosutured aneurysm repair with the Heli-FX EndoAnchor implants.

OBJECTIVE: Endovascular aneurysm repair has gained field over open surgery for the treatment of abdominal aortic aneurysm. However, type Ia endoleak represents a common complication especially in hostile neck anatomy that is recently faced using endoanchors. We conducted a systematic review and meta-analysis to collect and analyse all the available comparative evidence on the outcomes of the endosuture aneurysm repair in patients with or without hostile neck in standard endovascular aneurysm repair. METHODS: The current meta-analysis was conducted using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. All the prospective and retrospective studies reporting primary use of the Heli-FX EndoAnchor implants were considered eligible for inclusion in this study. The main study outcomes (technical success of endoanchor implantation, incidence of type Ia endoleak, aortic stent graft migration and the percentage of patients who presented regression or expansion of aneurysm sac throughout the follow-up) were subsequently expressed as proportions and 95% confidence intervals. RESULTS: Eight studies with a total of 968 patients were included in a pooled analysis. The technical success of the primary endoanchor fixation was 97.12% (95%CI: 92.98-99.67). During a mean six months follow-up period, a pooled rate of 6.23% (95%CI: 0.83-15.25) of the patients developed a persistent type Ia endoleak despite the primary implantation. Migration of the main graft was reported in five studies, in which a 0.26% (95%CI = 0.00-1.54) of the patients required an additional proximal aortic cuff. Regression of the aneurysm sac was observed at 68.82% (95%CI: 51.02-84.21). An expansion of the aneurysm sac was found in 1.93% (95%CI: 0.91-3.24) of the participants. The overall survival rate was 93.43% (95%CI: 89.97-96.29) at a mean six months follow-up period. CONCLUSIONS: Endosuture aneurysm repair with the Heli-FX EndoAnchor implants seems to be technically feasible and safe either for prevention or for repair of intraoperative type Ia endoleak. Despite the primary implants of endoanchors, few cases of persistent type Ia endoleak and migration are still conspicuous. Long-term follow up is needed to determinate the role of this therapeutic option in the treatment of aortic aneurysms.

Editor's Choice - Systematic Review of the Use of Endoanchors in Endovascular Aortic Aneurysm Repair.

OBJECTIVE: 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.

Effect of Different EndoAnchor Configurations on Aortic Endograft Displacement Resistance: An Experimental Study.

Purpose: This study investigated the effect of different EndoAnchor configurations on aortic endograft displacement resistance in an in vitro model. Materials and Methods: An in vitro model was developed and validated to perform displacement force measurements on different EndoAnchor configurations within an endograft and silicone tube. Five EndoAnchor configurations were created: (1) 6 circumferentially deployed EndoAnchors, (2) 5 EndoAnchors within 120° of the circumference and 1 additional, contralateral EndoAnchor, (3) 4 circumferentially deployed EndoAnchors, (4) 2 rows of 4 circumferentially deployed EndoAnchors, and (5) a configuration of 2 columns of 3 EndoAnchors. An experienced vascular surgeon deployed EndoAnchors under C-arm guidance at the proximal sealing zone of the endograft. A constant force with increments of 1 newton (N) was applied to the distal end of the endograft. The force necessary to displace a part of the endograft by 3 mm was defined as the endograft displacement force (EDF). Two video cameras recorded the measurements. Videos were examined to determine the exact moment 3-mm migration had occurred at part of the endograft. Five measurements were performed after each deployed EndoAnchor for each configuration. Measurements are given as the median and interquartile range (IQR) Q1, Q3. Results: Baseline displacement force measurement of the endograft without EndoAnchors resulted in a median EDF of 5.1 N (IQR 4.8, 5.2). The circumferential distribution of 6 EndoAnchors resulted in a median EDF of 53.7 N (IQR 49.0, 59.0), whereas configurations 2 through 5 demonstrated substantially lower EDFs of 29.0 N (IQR 28.5, 30.1), 24.6 N (IQR 21.9, 27.2), 36.7 N, and 9.6 N (IQR 9.4, 10.0), respectively. Decreasing the distance between the EndoAnchors over the circumference of the endograft increased the displacement resistance. Conclusion: This in vitro study demonstrates the influence EndoAnchor configurations have on the displacement resistance of an aortic endograft. Parts of the endograft where no EndoAnchor has been deployed remain sensitive to migration. In the current model, the only configuration that rivaled a hand-sewn anastomosis was the one with 6 EndoAnchors. A circumferential distribution of EndoAnchors with small distances between EndoAnchors should be pursued, if possible. This study provides a quantification of different EndoAnchor configurations that clinicians may have to adopt in clinical practice, which can help them make a measured decision on where to deploy EndoAnchors to ensure good endograft fixation.

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

OBJECTIVES: The 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. METHODS: We 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). RESULTS: Mean 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. CONCLUSIONS: EndoAnchors 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.

Endosuture aneurysm repair in patients treated with Endurant II/IIs in conjunction with Heli-FX EndoAnchor implants for short-neck abdominal aortic aneurysm.

OBJECTIVE: Endovascular repair of abdominal aortic aneurysm (AAA) remains a challenging clinical scenario when there is a short or nonexistent segment of healthy infrarenal aorta. This study sought to determine the safety and effectiveness of endosuture aneurysm repair (ESAR) using the Endurant II/IIs endograft (Medtronic Vascular, Santa Rosa, Calif) in conjunction with Heli-FX EndoAnchors (Medtronic Vascular) in the treatment of short-neck AAA. METHODS: In this subgroup analysis, 70 patients were identified from the Aneurysm Treatment Using the Heli-FX EndoAnchor System Global Registry (ANCHOR) who had an infrarenal neck length <10 mm down to 4 mm based on core laboratory measurements. Primary outcomes included technical success of the index procedure, rate of type IA endoleak at 1 month and 12 months, and rate of secondary procedures at 12 months. RESULTS: In this short-neck cohort (n = 70), the average neck length and diameter were 6.9 ± 1.6 mm and 25.7 ± 4.0 mm, respectively. Investigators reported an overall procedural success rate of 97.1% and a technical success rate of 88.6%. The duration of the implant procedure, EndoAnchor implantation, and total fluoroscopy time was 148.0 ± 80.0 minutes, 17.1 ± 11.5 minutes, and 35.3 ± 22.0 minutes, respectively, and an average of 5.5 ± 2.1 EndoAnchors were implanted per patient. Through the 30-day follow-up, type IA endoleaks were reported in four patients, of which three resolved spontaneously by the 12-month follow-up. There was an additional type IA endoleak through the 12-month follow-up that has not resulted in AAA enlargement or required a secondary procedure. The Kaplan-Meier estimate for freedom from secondary endovascular procedures and all-cause mortality is 95.4% and 92.7% through 365 days, respectively. No patient in the short-neck cohort experienced main body stent migration, increase in maximum aneurysm diameter, or aneurysm rupture or required conversion to open surgical repair through 12 months. CONCLUSIONS: In this analysis of the short-neck cohort from ANCHOR, the Endurant II/IIs endograft in conjunction with Heli-FX EndoAnchor implants (ESAR) appears to be a safe and effective treatment option with a high technical success rate and low incidence of type IA endoleaks and secondary interventions. Despite the complex and hostile anatomies, the ESAR method required short procedure and fluoroscopy times. These short-term outcomes suggest that ESAR could be complementary to therapies currently available for treatment of hostile AAA anatomy and a viable off-the-shelf endovascular treatment option for patients with short-neck AAAs, although long-term follow-up is critically important.

Analysis of the position of EndoAnchor implants in therapeutic use during endovascular aneurysm repair.

OBJECTIVE: The aim of this study was to analyze the penetration depth, angles, distribution, and location of deployment of individual EndoAnchor (Medtronic Vascular, Santa Rosa, Calif) implants. METHODS: Eighty-six primary and revision arm patients (procedural success, 53; persistent type IA endoleak, 33) treated for type IA endoleaks with a total of 580 EndoAnchor implants from a subset of the Aneurysm Treatment Using the Heli-FX Aortic Securement System Global Registry (ANCHOR) were included in this study. Procedural success was defined as the absence of a type IA endoleak on the first postprocedural computed tomography scan after the EndoAnchor implantation procedure. Endograft malapposition along the circumference was assessed at the first postoperative computed tomography scans and expressed as clock-face range and width in degrees and normalized such that the center was translated to 0 degrees. The position and penetration of each EndoAnchor implant were measured as the clock-face orientation. EndoAnchor implant penetration into the aortic wall was categorized as follows: good penetration, ≥2 mm; borderline penetration, <2 mm or ≥2-mm gap between the endograft and aortic wall; or no penetration. The orthogonal and longitudinal angles between the EndoAnchor implant and the interface plane of the aortic wall were determined. Location of deployment was investigated for each EndoAnchor implant and classified as maldeployed when it was above the fabric or in a gap >2 mm between the endograft and aortic wall due to >2-mm thrombus or positioning of the EndoAnchor implant below the aortic neck. RESULTS: A total of 170 (29%) EndoAnchor implants had maldeployment and were therefore beyond recommended use and not useful. After EndoAnchor implantation, the procedural success and persistent type IA endoleak groups had 3 (1%) and 4 (2%) EndoAnchor implants positioned above the fabric as well as 60 (18%) and 103 (42%) placed in a gap >2 mm, respectively. The amount of EndoAnchor implants with good, borderline, and no penetration was significantly different between both groups (success vs type IA endoleak) after exclusion of maldeployed EndoAnchor implants (235 [87.4%], 14 [5.2%], and 20 [7.4%] vs 97 [68.8%], 18 [12.8%], and 26 [18.4%], respectively; P < .001). Good penetration EndoAnchor implants were more closely aligned with a 90-degree orthogonal angle than the borderline penetration and nonpenetrating EndoAnchor implants. The longitudinal angle was more distributed, which was observed through all three penetration groups. CONCLUSIONS: In this subcohort of ANCHOR patients, almost 30% of the EndoAnchor implants had maldeployment, which may be prevented by careful preoperative planning and measured intraoperative deployment. If endoleaks are due to >2-mm gaps, EndoAnchor implants alone may not provide the intended sealing, and additional devices should be considered.

Midterm Single-Center Results of Endovascular Aneurysm Repair With Additional EndoAnchors.

PURPOSE: To review midterm clinical outcomes of EndoAnchor placement during or after endovascular aneurysm repair (EVAR) or chimney EVAR (ch-EVAR). MATERIALS AND METHODS: A retrospective analysis was conducted of 51 consecutive patients [median age 75 years; 38 men] who underwent EVAR/ch-EVAR with EndoAnchor placement between June 2010 and December 2016 to prevent seal failures (31, 61%) or to treat type Ia endoleak and/or migration (20, 39%). Median aortic neck diameter was 27.7 mm and median neck length was 9.0 mm. Thirty-three (65%) had a conical neck; 48 (94%) had at least 1 hostile neck characteristic. Thirty-two (63%) patients had severe comorbidities (ASA score ⩾III). Eight patients had a single ch-EVAR procedure. Baseline patient characteristics, anatomic variables, procedure details, early and late complications, reinterventions, and aneurysm-related and all-cause mortality rates were recorded. Follow-up imaging was performed with computed tomography angiography (CTA) or duplex ultrasonography. RESULTS: Median procedure time was 100 minutes; a median of 6 EndoAnchors were implanted. There were 10 (10%) residual type Ia endoleaks at the end of the procedure; 9 had resolved by the first postoperative CTA. One residual and 2 new type Ia endoleaks were identified at the first postoperative imaging. Median follow-up for the entire cohort was 24.0 months, during which 3 new type Ia endoleaks were identified. Five of the 6 type Ia endoleaks were treated, 1 resolved spontaneously. There was 1 endograft limb occlusion without clinical consequences, 1 chimney graft occlusion without possibilities for a reintervention, 1 rupture after type IV endoleak (a Nellix device was successfully deployed within the main device), and 1 complete graft explantation for infection. There was no new-onset hemodialysis. Kaplan-Meier estimates of freedom from type Ia endoleak, proximal neck-related reinterventions, and aneurysm-related mortality at 2 years were 87.3%, 92.2%, and 94.0%, respectively. CONCLUSION: EndoAnchors are helpful in the endovascular treatment of unfavorable proximal aortic necks, with fair midterm results.