Excluder Stent Graft-Related Outcomes in Patients with Aortic Neck Anatomy Outside of Instructions For Use (IFU) within the Global Registry for Endovascular Aortic Treatment (GREAT): Mid-term Follow-Up Results

2021 ◽  
Author(s):  
Ian P Barry ◽  
Mitchell Barns ◽  
Eric Verhoeven ◽  
Jackie Wong ◽  
Steven Dubenec ◽  
...  
Keyword(s):  
Stent Graft ◽  
Aortic Neck ◽  
Neck Anatomy ◽  
Instructions For Use ◽  
Global Registry

scholarly journals Midterm Results of Proximal Aneurysm Sealing With the Ovation Stent-Graft According to On- vs Off-Label Use

2017 ◽  
Vol 24 (2) ◽  
pp. 191-197 ◽  
Author(s):  
Gianmarco de Donato ◽  
Francesco Setacci ◽  
Luciano Bresadola ◽  
Patrizio Castelli ◽  
Roberto Chiesa ◽  
...  
Keyword(s):  
Stent Graft ◽  
Morphological Changes ◽  
Endovascular Aneurysm Repair ◽  
Neck Length ◽  
Off Label ◽  
Aortic Neck ◽  
Type Ia ◽  
Instructions For Use ◽  
Aneurysm Repair

Purpose: To compare the use of the Ovation stent-graft according to the ≥7-mm neck length specified by the original instructions for use (IFU) vs those treated off-label (OL) for necks <7 mm long. Methods: A multicenter retrospective registry (TriVascular Ovation Italian Study) database of all patients who underwent endovascular aneurysm repair with the Ovation endograft at 13 centers in Italy was interrogated to identify patients with a minimum computed tomography (CT) follow-up of 24 months, retrieving records on 89 patients (mean age 76.4±2.4 years; 84 men) with a mean follow-up of 32 months (range 24–50). Standard CT scans (preoperative, 1-month postoperative, and latest follow-up) were reviewed by an independent core laboratory for morphological changes. For analysis, patients were stratified into 2 groups based on proximal neck length ≥7 mm (IFU group, n=57) or <7 mm (OL group, n=32). Outcome measures included freedom from type Ia endoleak, any device-related reintervention, migration, and neck enlargement (>2 mm). Results: At 3 years, there was no aneurysm-related death, rupture, stent-graft migration, or neck enlargement. There were no differences in terms of freedom from type Ia endoleak (98.2% IFU vs 96.8% OL, p=0.6; hazard ratio [HR] 0.55, 95% CI 0.02 to 9.71 or freedom from any device-related reintervention (92.8% IFU vs 96.4% OL, p=0.4; HR 2.42, 95% CI 0.34 to 12.99). In the sealing zone, the mean change in diameters was −0.05±0.8 mm in the IFU group and −0.1±0.5 mm in the OL group. Conclusion: Use of the Ovation stent-graft in patients with neck length <7 mm achieved midterm outcomes similar to patients with ≥7-mm-long necks. These midterm data show that the use of the Ovation system for the treatment of infrarenal abdominal aortic aneurysm is not restricted by the conventional measurement of aortic neck length, affirming the recent Food and Drug Administration–approved changes to the IFU.

Midterm Outcome of EndoAnchors for the Prevention of Endoleak and Stent-Graft Migration in Patients With Challenging Proximal Aortic Neck Anatomy

2015 ◽  
Vol 22 (2) ◽  
pp. 163-170 ◽  
Author(s):  
William D. Jordan ◽  
Jean-Paul P. M. de Vries ◽  
Kenneth Ouriel ◽  
Manish Mehta ◽  
David Varnagy ◽  
...  
Keyword(s):  
Stent Graft ◽  
Midterm Outcome ◽  
Aortic Neck ◽  
Neck Anatomy ◽  
Graft Migration

One-year results of the ANCHOR trial of EndoAnchors for the prevention and treatment of aortic neck complications after endovascular aneurysm repair

Vascular ◽  
2015 ◽  
Vol 24 (2) ◽  
pp. 177-186 ◽  
Author(s):  
William D Jordan ◽  
Manish Mehta ◽  
Kenneth Ouriel ◽  
Frank R Arko ◽  
David Varnagy ◽  
...  
Keyword(s):  
Endovascular Aneurysm Repair ◽  
Neck Length ◽  
Aortic Neck ◽  
Hostile Neck ◽  
Type Ia ◽  
Study Population ◽  
Neck Anatomy ◽  
One Year ◽  
Aneurysm Repair

Objectives EndoAnchors have been used to address proximal aortic neck complications including type Ia endoleaks and endograft migration after endovascular aortic aneurysm repair (EVAR). Methods The study population included 100 patients with one-year follow-up in the ANCHOR study. A primary cohort ( N = 73) comprised patients who underwent EndoAnchor implantation at the time of an initial EVAR and a Revision cohort ( N = 27) included patients treated remote from EVAR. A hostile neck was defined for neck length <10 mm, neck diameter >28 mm, angulation >60°, conical configuration or significant mural thrombus or calcium. Results Baseline anatomy included neck length of 17 ± 14 mm, diameter of 27 ± 5 mm, and angulation of 35 ± 18°; 83% of patients had hostile necks. Over 18 ± 4 months of clinical follow-up, six patients (6%) underwent aneurysm-related reinterventions. There were no aneurysm ruptures. Over 13 ± 2 months of imaging follow-up, freedom from type Ia endoleak was 95% in the Primary Arm and 77% in the Revision Arm ( P = .006). Aneurysm sacs regressed > 5 mm within one year in 45% of the Primary cases and in 25% of the Revisions. Aneurysm expansion > 5 mm occurred in one revision patient. Conclusion Despite a high frequency of hostile neck anatomy, proximal neck complications were relatively infrequent after EndoAnchor use.

scholarly journals Geometric Remodeling of the Perirenal Aortic Neck at and Adjacent to the Double Sealing Ring of the Anaconda Stent-Graft After Endovascular Aneurysm Repair

2019 ◽  
Vol 26 (6) ◽  
pp. 855-864
Author(s):  
Maaike A. Koenrades ◽  
Marianne R. F. Bosscher ◽  
Jouke T. Ubbink ◽  
Cornelis H. Slump ◽  
Robert H. Geelkerken
Keyword(s):  
Stent Graft ◽  
Endovascular Aneurysm Repair ◽  
Average Diameter ◽  
Main Body ◽  
Area Change ◽  
Average Area ◽  
Aortic Neck ◽  
Sealing Ring ◽  
Diameter Change

Purpose: To evaluate if the radial force of the double sealing ring of the Anaconda stent-graft induces dilatation in the perirenal aortic neck adjacent to the rings. Materials and Methods: This study evaluated the serial electrocardiogram-gated computed tomography scans of 15 abdominal aortic aneurysm patients (mean age 72.8±3.7 years; 14 men) who were treated electively using an Anaconda stent-graft. Follow-up scans were conducted before discharge and at 1, 6, 12, and 24 months after endovascular repair. Diameter and area were assessed perpendicular to the aortic centerline along the perirenal aortic neck, which was subdivided into 3 zones: the suprastent, the stent, and the infrastent zones. Measurements were performed independently by 2 experienced observers using dedicated 3-dimensional image processing software. Results: Between discharge and the 2-year follow-up the diameter and area remained stable in the suprastent zone [average diameter change: −0.1±0.4 mm (−0.4%±1.7%), p=0.893; average area change: −2.9±17.2 mm2 (−0.7%±3.4%), p=0.946], increased in the stent zone [average diameter change: +1.9±1.0 mm (+7.3%±4.0%), p<0.001; average area change: +84.3±48.3 mm2 (+15.5%±8.7%), p<0.001], and diverged in the infrastent zone [average diameter change: −0.8±2.2 mm (−2.3%±7.4%), p>0.99; average area change: −34.6±102.3 mm2 (−4.1%±14.8%), p>0.99; increased in 4 patients, decreased in 9 patients]. Conclusion: After Anaconda implantation the infrarenal aortic neck accommodated to the expansion of the sealing rings at the stent zone. Below the stent zone the neck diameter decreased in the majority of patients, while an increase was related to downstream displacement of the main body. A decrease in size in the infrastent zone may contribute to durable sealing and fixation. A personalized follow-up scheme based on geometric neck remodeling should be feasible if our observations are confirmed in larger, long-term studies.

scholarly journals Spontaneous Sealing of a Type Ia Endoleak after Ovation Stent Graft Implantation in a Patient with On-Label Aortic Neck Anatomy

2016 ◽  
Vol 34 ◽  
pp. 270.e19-270.e24 ◽  
Author(s):  
Chiara Pranteda ◽  
Pasqualino Sirignano ◽  
Laura Capoccia ◽  
Wassim Mansour ◽  
Nunzio Montelione ◽  
...  
Keyword(s):  
Stent Graft ◽  
Aortic Neck ◽  
Type Ia ◽  
Neck Anatomy ◽  
Stent Graft Implantation ◽  
Graft Implantation

scholarly journals Endovascular repair of de novo post-stenotic aortic coarctation aneurysms with complex collateral supply: two cases with long and medium term follow-up

2021 ◽  
Vol 4 (1) ◽  
Author(s):  
Omar Abdel-Hadi ◽  
John Thomson ◽  
Simon J. McPherson
Keyword(s):  
Stent Graft ◽  
Endovascular Repair ◽  
Aortic Coarctation ◽  
De Novo ◽  
Aortic Aneurysms ◽  
Medium Term ◽  
First Case ◽  
Case Presentations ◽  
Selective Embolisation

Abstract Purpose To report the technical details and outcomes of the endovascular repair of two cases of de novo post-stenotic aortic coarctation aneurysms complicated by complex collateral supply. Case presentations Two patients with thoracic aortic aneurysms complicated by complex aneurysm sac collaterals distal to a previously untreated thoracic aortic coarctation have been treated at our institution. Open surgical intervention was deemed to carry a high risk of haemorrhage due to the degree and complexity of arterial collateralisation. In the first case, selective embolisation of collateral vasculature was performed prior to successful exclusion of the aneurysm with a thoracic endovascular stent-graft and then balloon-expandable stent dilatation of the coarctation stenosis. In the second case, the additional technique of using a jailed sheath within the aneurysm sac allowed for selective embolisation of previously inconspicuous collaterals after deployment of the stent-graft and stent combination. Results Technical success was achieved in both patients with successful occlusion of the aneurysm, with no recorded complications or aneurysm sac perfusion in the long and medium term follow up periods respectively. Conclusion De novo post stenotic aortic coarctation aneurysms are rare. Endovascular repair is a safe and durable technique that provides a less invasive alternative to open surgical repair. The use of a jailed sheath allows for complete selective embolisation of complex collaterals avoiding a type II aneurysm endoleak.

scholarly journals National Bariatric Surgery Registries: an International Comparison

2021 ◽  
Author(s):  
Erman O. Akpinar ◽  
Perla J. Marang- van de Mheen ◽  
Simon W. Nienhuijs ◽  
Jan Willem M. Greve ◽  
Ronald S. L. Liem
Keyword(s):  
Standard Of Care ◽  
Population Based ◽  
Substantial Agreement ◽  
Perfect Agreement ◽  
Moderate Agreement ◽  
Real World Evidence ◽  
International Collaborations ◽  
Global Registry ◽  
Registry Report

Abstract Introduction Pooling population-based data from all national bariatric registries may provide international real-world evidence for outcomes that will help establish a universal standard of care, provided that the same variables and definitions are used. Therefore, this study aims to assess the concordance of variables across national registries to identify which outcomes can be used for international collaborations. Methods All 18 countries with a national bariatric registry who contributed to The International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO) Global Registry report 2019 were requested to share their data dictionary by email. The primary outcome was the percentage of perfect agreement for variables by domain: patient, prior bariatric history, screening, operation, complication, and follow-up. Perfect agreement was defined as 100% concordance, meaning that the variable was registered with the same definition across all registries. Secondary outcomes were defined as variables having “substantial agreement” (75–99.9%) and “moderate agreement” (50–74.9%) across registries. Results Eleven registries responded and had a total of 2585 recorded variables that were grouped into 250 variables measuring the same concept. A total of 25 (10%) variables have a perfect agreement across all domains: 3 (18.75%) for the patient domain, 0 (0.0%) for prior bariatric history, 5 (8.2%) for screening, 6 (11.8%) for operation, 5 (8.8%) for complications, and 6 (11.8%) for follow-up. Furthermore, 28 (11.2%) variables have substantial agreement and 59 (23.6%) variables have moderate agreement across registries. Conclusion There is limited uniform agreement in variables across national bariatric registries. Further alignment and uniformity in collected variables are required to enable future international collaborations and comparison. Graphical abstract

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