Interventional procedure overview of endoanchoring systems in endovascular aortic aneurysm repair
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Appendix
The following table outlines the studies that are considered potentially relevant to the IP overview but were not included in the summary of the key evidence. It is by no means an exhaustive list of potentially relevant studies.
Single case reports have been excluded.
Article | Number of patients/ follow-up | Direction of conclusions | Reasons for non-inclusion in summary of key evidence section |
|---|---|---|---|
Arko FR, Stanley GA, Pearce BJ et al. (2019) Endosuture aneurysm repair in patients treated with Endurant II/IIs in conjunction with Heli-FX EndoAnchor implants for short-neck abdominal aortic aneurysm. Journal of Vascular Surgery 70: 732–40 | Cohort study n=70 FU=12 months | In this analysis of the short-neck cohort from ANCHOR, the procedure appears to be a safe and effective treatment option with a high technical success rate and low incidence of type 1a endoleaks and secondary interventions. The short-term outcomes suggest that it could be complementary to therapies currently available for treatment of hostile anatomy and a viable off-the-shelf endovascular treatment option for patients with short-neck abdominal aortic aneurysms, although long-term follow-up is critically important. | Subgroup analysis of ANCHOR registry, included in Karaolanis (2020) systematic review. |
Avci M, Vos JA, Kolvenbach RR et al. (2012) The use of endoanchors in repair EVAR cases to improve proximal endograft fixation. The Journal of Cardiovascular Surgery 53: 419–26 | Case series n=11 FU=mean 10 months | One endoanchor dislodged but was successfully retrieved using an endovascular snare. During follow-up there were no endoanchor-related complications or renewed migration of the endografts. Two patients had repeat intervention for persistent type 1a endoleak. | Small case series, included in Qamhawi (2020) systematic review. |
Bail DH, Walker T, Giehl J (2013) Vascular endostapling systems for vascular endografts (T) EVAR—systematic review—current state. Vascular and Endovascular Surgery 47: 261–6 | Systematic review | With endostaple systems, patients with difficult anatomic features and high risk can potentially be treated. These systems might reduce the high reintervention rates after endovascular aneurysm repair. Controlled randomised trials with larger number of patients are warranted. | More recent systematic reviews are included. |
Chaudhuri A, Kim HK, Valdivia AR (2020) Improved midterm outcomes using standard devices and EndoAnchors for endovascular repair of abdominal aortic aneurysms with hyperangulated necks. Cardiovascular and Interventional Radiology 43: 971–80 | Case series n=42 FU=mean 18.5 months | There was 1 death within 30 days. One patient had persistent type 1a endoleak, successfully banded. There was 6.8 mm sac size reduction (p<0.001). There were no other neck-related reinterventions, despite continued neck dilatation. | Small case series. |
Deaton DH (2012) Improving proximal fixation and seal with the HeliFx Aortic EndoAnchor. Seminars in Vascular Surgery 25: 187–92 | Review | The device's most immediate application will most likely be in the address of the failing endograft and in the extension of current technology to challenging anatomy where current endograft fixation technology has been demonstrated to have a higher rate of failure. | Review |
Deaton DH, Mehta M, Kasirajan K et al. (2009) The phase I multicenter trial (STAPLE-1) of the Aptus Endovascular Repair System: Results at 6 months and 1 year. Journal of Vascular Surgery 49: 851–8 | Case series n=21 FU=1 year | Three secondary interventions were done in 2 patients for limb thrombosis. There were no EndoStaple-related adverse events, device integrity failures, migrations, or conversions. | Small case series, included in Qamhawi (2020) and Karaolanis (2020) systematic reviews. |
de Vries J-PPM, Ouriel K, Mehta M et al. (2014) Analysis of EndoAnchors for endovascular aneurysm repair by indications for use. Journal of Vascular Surgery 60: 1460-7e1 | Cohort study (ANCHOR registry) n=319 FU=1 year | The most challenging subset was revision patients treated for type 1a endoleak; type 1a endoleaks were evident during follow-up in 34% (10/29) of patients. Sac regression >5 mm in patients with 1-year imaging was observed 39% (26/66) of patients and was highest in the primary prophylaxis subset (20/43; 47%). | A different publication from the same registry is included (Jordan W et al., 2014). Included in Qamhawi (2020) systematic review. |
Donas KP, Torsello G (2010) Midterm results of the Anson Refix Endostapling Fixation system for aortic stent-grafts. Journal of Endovascular Therapy 17: 320–3 | Case series n=8 FU=mean 18 months | There were no device failures, migrations, endoleaks, conversions, or secondary procedures. | Larger studies are included. |
DuBois BG, Houben IB, Khaja MS et al. (2020) Thoracic endovascular aortic repair in the setting of compromised distal landing zones. The Annals of Thoracic Surgery. 111: 237–45 | Case series n=51 (6 with endoanchors) | Thoracic endovascular aortic repair is a viable alternative for the treatment of thoracoabdominal aortic aneurysms in patients with compromised distal landing zones. | Endoanchors were only used in a small proportion of the patients. |
Galiñanes EL, Hernandez‐Vila EA, Krajce Z (2019) EndoAnchors minimize endoleaks in chimney‐graft endovascular repair of juxtarenal abdominal aortic aneurysms. Texas Heart Institution Journal 46:183–8 | Case series n=5 FU=11 to 18 months | It was feasible to use endoanchors with the chimney-graft technique to prevent type 1a endoleaks in the treatment of juxtarenal abdominal aortic aneuryms. Further studies are needed to validate this adjunctive technique and to determine its durability. | Small case series. |
Galinanes EL, Hernandez E, Krajcer Z (2016) Preliminary results of adjunctive use of endoanchors in the treatment of short neck and pararenal abdominal aortic aneurysms. Catheterization and Cardiovascular Interventions 87: e154-9 | Case series n=9 FU=mean 8 months | Technical success=100% In 2 patients, type 1a endoleaks were noted before the deployment of any endoanchors. In both cases, a final angiogram depicted resolution of the type 1a endoleak after insertion of the endoanchors. All the endografts remained patent and free from type 1a endoleaks. There were no adverse renal complications or mortality. | Small case series, included in Qamhawi (2020) systematic review. |
Giudice R, Borghese O, Sbenaglia G et al. (2019) The use of EndoAnchors in endovascular repair of abdominal aortic aneurysms with challenging proximal neck: Single-centre experience. JRSM Cardiovascular Disease 8: 1–8 | Case series n=17 FU=median 13 months | Technical success=100% There were no aneurysm-related deaths or aneurysm ruptures, and all patients were free from reinterventions. CT-scan surveillance showed no evidence of type 1a endoleak, anchors dislodgement or stent-graft migration, with a mean reduction of aneurysm diameter of 0.4 mm (range 0 to 19); there was no sac growth or aortic neck enlargement in any case. | Small case series, included in Qamhawi (2020) systematic review. |
Goudeketting SR, van Noort K, Vermeulen JJM et al. (2019) Analysis of the position of EndoAnchor implants in therapeutic use during endovascular aneurysm repair. Journal of Vascular Surgery 69: 1726–35 | Cohort study n=86 | 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 gaps bigger than 2 mm, EndoAnchor implants alone may not provide the intended sealing, and additional devices should be considered. | Subgroup analysis of ANCHOR registry. |
Goudeketting SR, Wille J, van den Heuvel DAF et al. (2019) Midterm single-center results of endovascular aneurysm repair with additional EndoAnchors. Journal of Endovascular Therapy 26: 90–100 | Cohort study n=51 FU=median 24 months | Kaplan-Meier estimates of freedom from type 1a endoleak, proximal neck-related reinterventions, and aneurysm-related mortality at 2 years were 87.3%, 92.2%, and 94.0%, respectively | Larger studies are included. |
Goudeketting SR, van Noort K, Ouriel K et al. (2018) Influence of aortic neck characteristics on successful aortic wall penetration of EndoAnchors in therapeutic use during endovascular aneurysm repair. Journal of Vascular Surgery 68: 1007–16 | Cohort study n=86 | Adequate 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 1a endoleak. | Subgroup analysis of ANCHOR registry. |
Ho VT, George EL, Dua A et al. (2020) Early real-world experience with EndoAnchors by indication. Annals of Vascular Surgery 62: 30–34 | Case series n=37 | Early experience suggests that endoanchors effectively treat intraoperative type 1a endoleaks and high-risk seal zones, with sac regression and no proximal endoleaks on follow-up. In patients treated for prior EVAR with postoperative type 1a endoleaks, fewer than half resolved after endoanchor attempted repair. | Small case series, included in Qamhawi (2020) systematic review. |
Jordan WD Jr, de Vries J-PPM, Ouriel K et al. (2015) Midterm outcome of EndoAnchors for the prevention of endoleak and stent-graft migration in patients with challenging proximal aortic neck anatomy. Journal of Endovascular Therapy 22: 163–70 | Cohort study n=208 FU=mean 14 months | Technical success=98% (204/208). The frequency of fracture was 0.3% (3/1118); there were no clinical sequelae associated with the fractures. Over the follow-up, 95% of patients were alive, and no deaths were attributable to EndoAnchors. There were no ruptures, migrations, or open surgical conversions. Aneurysm-related reinterventions were performed in 8 (4%) patients. Among 130 patients with postprocedure contrast CT studies, 2 had type 1a endoleaks. Aneurysm sac diameter decreased >5 mm in 43% of patients with CT scans at or beyond 1 year; 2% of patients had sac enlargement >5 mm. | Subgroup analysis of ANCHOR registry (prophylactic use only) |
Jordan WD Jr, Ouriel K, Mehta M et al. (2015) Outcome-based anatomic criteria for defining the hostile aortic neck. Journal of Vascular Surgery 61: 1383–90 | Cohort study n=221 | A limited number of independent anatomic variables are predictive of type 1a endoleak after EVAR, including aortic neck diameter and aortic neck length, whereas mural thrombus in the neck is protective. | Subgroup analysis of ANCHOR registry |
Jordan WD, Mehta M, Ouriel K et al. (2016) One-year results of the ANCHOR trial of EndoAnchors for the prevention and treatment of aortic neck complications after endovascular aneurysm repair. Vascular 24: 177–86 | Cohort study n=100 FU=1 year | 6% (6/100) of patients had aneurysm-related reinterventions during follow up. There were no aneurysm ruptures. Freedom from type 1a endoleak was 95% in the Primary Arm and 77% in the Revision Arm (p=0.006). Aneurysm sacs regressed >5 mm within 1 year in 45% of the Primary cases and in 25% of the Revisions. Aneurysm expansion >5 mm occurred in 1 revision patient. | Subgroup analysis of ANCHOR registry |
Kasprzak P, Pfister K, Janotta M et al. (2013) EndoAnchor placement in thoracic and thoracoabdominal stent-grafts to repair complications of nonalignment. Journal of Endovascular Therapy 20: 471–80 | Case series n=6 FU=mean 11 months | A patient with thoracoabdominal aortic aneurysm with a fenestrated aortic arch stent-graft had multiple visceral and cerebral infarctions and died 4 weeks after the procedure. During follow-up, there was no stent-graft migration or EndoAnchor dislocation. There were no periaortic haematomas or side branch complications. | Small case series, included in Qamhawi (2020) systematic review. |
Locham S, Mathlouthi A, Dakour-Aridi H et al. (2021) Favorable outcomes in octogenarians with hostile neck undergoing endovascular repair using EndoAnchors. Annals of Vascular Surgery 74: 194–203 | Cohort study (ANCHOR registry) n=461 FU=1 year | Despite a worse aortic neck anatomy, octogenarians undergoing EVAR using EndoAnchors showed acceptable short and long-term outcomes. The results of this study could expand the use of EVAR in octogenarians with hostile neck. | Analysis of ANCHOR registry data, focusing on patients aged 80 years and over. |
Ongstad SB, Miller DF, Panneton JM (2016) The use of EndoAnchors to rescue complicated TEVAR procedures. The Journal of Cardiovascular Surgery 57: 716–29 | Case series n=54 FU=mean 9.6 months | Endoanchors were used for therapeutic indications in 32% of patients and for prophylactic indications in 68%. The overall initial technical success was 98%. There were no instances of graft migration. The overall endoleak rate was 5% with prophylactic use and 12% with therapeutic use. Aortic-related reintervention was needed in 14% of patients who had prophylactic placement and 24% of patients who had therapeutic placement; 1 reintervention was done for endoanchor failure. | Small case series, included in Qamhawi (2020) systematic review. |
Perdikides T, Melas N, Lagios K et al. (2012) Primary endoanchoring in the endovascular repair of abdominal aortic aneurysms with an unfavorable neck. Journal of Endovascular Therapy 19: 707–15 | Case series n=13 FU=median 7 months | Primary technical success=85% Perioperatively, there were 2 type 2 endoleaks, which needed no intervention. During follow-up, there were no further complications apart from an asymptomatic internal iliac artery occlusion and a non-lethal myocardial infarction at 9 months. The type 2 endoleaks spontaneously sealed. There was no endograft migration or loss of endoanchor integrity. There were no deaths. | Small case series, included in Karaolanis (2020) systematic review. |
Perini P, Bianchini Massoni C, Mariani E, et al. (2019) Systematic review and meta‐analysis of the outcome of different treatments for type 1a endoleak after EVAR. Ann Vasc Surg 60: 435–46 | Systematic review n=714 (35 with endostapling) | Different treatments are available for type 1a endoleak, and the choice should be based on endoleak characteristics, aortic anatomy, and the patient's surgical risk. | Only a small proportion of patients had endostapling. |
Reyes Valdivia A, Busto Suarez S, Duque Santos A et al. (2020) Evaluation of EndoAnchor aortic wall penetration after thoracic endovascular aortic repair. Journal of Endovascular Therapy 27: 240–7 | Case series n=25 FU=mean 16.6 months | EndoAnchors have a higher risk of maldeployment in the arch, though this may be attributable to the small learning curve experience in this location. The best aortic wall penetration for this series was in the descending thoracic aorta, where EndoAnchors proved useful for distal endograft fixation during TEVAR. | Larger studies are included. |
Reyes Valdivia A, Duque Santos A, Pitoulias G et al. (2020) Predictors of inadequate EndoAnchors aortic wall penetration for the Endosutured therapy in hostile neck patients. The Journal of cardiovascular surgery 61: 738–44 | Case series n=43 | EndoAnchors use in hostile neck anatomies 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 hostile neck anatomy treatment. | Larger studies are included. |
Reyes Valdivia A, Beropoulis E, Pitoulias G et al. (2019) 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. Annals of Vascular Surgery 60: 61–69 | Case series n=46 FU=12 months | The study shows that additional use of EndoAnchors can successfully improve the sealing of abdominal endografts in case of intraoperative type 1a endoleaks in hostile neck anatomies, representing a safe and effective endovascular alternative. However, meticulous radiological follow-up is necessary because complete resolution of all observed intraoperative type 1a endoleaks was not observed until the 12-month CT follow-up. | Larger studies are included. |
Spanos K, Rohlffs F, Panuccio G et al. (2019) Outcomes of endovascular treatment of endoleak type Ia after EVAR: a systematic review of the literature. Journal of Cardiovascular Surgery 60:175–85 | Systematic review n=356 | A multitude of techniques for endovascular repair for type 1a endoleak exists. No strong evidence supports one specific technique. The early and mid-term outcomes are encouraging in terms of type 1a endoleak resolution, mortality and morbidity rates. | More recent systematic reviews are included. |
Tassiopoulos AK, Monastiriotis S, Jordan WD et al. (2017) Predictors of early aortic neck dilatation after endovascular aneurysm repair with EndoAnchors. Journal of Vascular Surgery 66: 45–52 | Cohort study n=209 | Aortic diameter and graft oversizing appear to be independent risk factors for early aortic neck dilatation. Endoanchors have a protective effect on neck dilatation at their usual level of deployment. | Subgroup analysis of ANCHOR registry, included in Karaolanis (2020) |
van Noort K, Vermeulen JJM, Goudeketting SR et al. (2019) Sustainability of individual EndoAnchor implants in therapeutic use to treat type Ia endoleak after endovascular aneurysm repair. Journal of Endovascular Therapy 26: 369–77 | Cohort study n=54 FU=median 13 months | Despite the small number of endoanchors analysed, this study showed that the sustainability of implants with initially good penetration is satisfactory at 1-year follow-up. The vast majority of endoanchor implants with good penetration initially remained in good position; <3% of implants became borderline or nonpenetrating, without any clinical consequence. | Subgroup analysis of ANCHOR registry. |
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