The Correlation Of Aortic Neck Length To Late Outcomes Following EVAR with the Ovation Stent Graft

Descending thoracic aneurysms can be treated with a stent graft provided that there is sufficient proximal and distal aortic neck length above the celiac axis. One of the options for the treatment of thoracic aneurysms with a too short distal neck is described in this report. For this purpose, a stent graft was constructed with a scallop for the celiac axis. Three cases are presented, and the technical details are described.

Download Full-text

The Correlation of Aortic Neck Length to Late Outcomes After Endovascular Aneurysm Repair With the Ovation Stent Graft

Journal of Vascular Surgery ◽

10.1016/j.jvs.2020.04.136 ◽

2020 ◽

Vol 72 (1) ◽

pp. e72-e73

Author(s):

Asma Mathlouthi ◽

Andrew Barleben ◽

Omar Al-Nouri ◽

Mahmoud B. Malas

Keyword(s):

Stent Graft ◽

Endovascular Aneurysm Repair ◽

Neck Length ◽

Aortic Neck ◽

Aneurysm Repair

Download Full-text

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

Journal of Endovascular Therapy ◽

10.1177/1526602816685581 ◽

2017 ◽

Vol 24 (2) ◽

pp. 191-197 ◽

Cited By ~ 21

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.

Download Full-text

Effect Of Stent-Graft Active Fixation And Oversizing On Aortic Neck Dilation After Endovascular Aneurysm Exclusion For Infrarenal Aortic Aneurysm

Annals of Vascular Surgery ◽

10.1016/j.avsg.2021.08.026 ◽

2021 ◽

Author(s):

Lillian Malach ◽

Nader Tehrani ◽

Shilpa Kolachina ◽

Karolina Krawczyk ◽

Amy Wozniak ◽

...

Keyword(s):

Aortic Aneurysm ◽

Stent Graft ◽

Infrarenal Aortic Aneurysm ◽

Active Fixation ◽

Aortic Neck

Download Full-text

Anatomical Predictors of Endoleaks or Migration After Endovascular Aneurysm Sealing

Journal of Endovascular Therapy ◽

10.1177/1526602818808296 ◽

2018 ◽

Vol 25 (6) ◽

pp. 719-725 ◽

Cited By ~ 7

Author(s):

Kim van Noort ◽

Johannes T. Boersen ◽

Aleksandra C. Zoethout ◽

Richte C. L. Schuurmann ◽

Jan M. M. Heyligers ◽

...

Keyword(s):

Regression Analysis ◽

Large Scale ◽

High Volume ◽

Control Group ◽

Neck Length ◽

Aortic Neck ◽

Distal Migration ◽

Aneurysm Growth ◽

Instructions For Use ◽

Neck Diameter

Purpose: To identify preoperative anatomical aortic characteristics that predict seal failures after endovascular aneurysm sealing (EVAS) and compare the incidence of events experienced by patients treated within vs outside the instructions for use (IFU). Methods: Of 355 patients treated with the Nellix EndoVascular Aneurysm Sealing System (generation 3SQ+) at 3 high-volume centers from March 2013 to December 2015, 94 patients were excluded, leaving 261 patients (mean age 76±8 years; 229 men) for regression analysis. Of these, 83 (31.8%) suffered one or more of the following events: distal migration ⩾5 mm of one or both stent frames, any endoleak, and/or aneurysm growth >5 mm. Anatomical characteristics were determined on preoperative computed tomography (CT) scans. Patients were divided into 3 groups: treated within the original IFU (n=166), outside the original IFU (n=95), and within the 2016 revised IFU (n=46). Categorical data are presented as the median (interquartile range Q1, Q3). Results: Neck diameter was significantly larger in the any-event cohort vs the control cohort [23.7 mm (21.7, 26.3) vs 23.0 mm (20.9, 25.2) mm, p=0.022]. Neck length was significantly shorter in the any-event cohort [15.0 mm (10.0, 22.5) vs 19.0 mm (10.0, 21.8), p=0.006]. Maximum abdominal aortic aneurysm (AAA) diameter and the ratio between the maximum AAA diameter and lumen diameter in the any-event group were significantly larger than the control group (p=0.041 and p=0.002, respectively). Regression analysis showed aortic neck diameter (p=0.006), neck length (p=0.001), and the diameter ratio (p=0.011) as significant predictors of any event. In the comparison of events to IFU status, 52 (31.3%) of 166 patients in the inside the original IFU group suffered an event compared to 13 (28.3%) of 46 patients inside the 2016 IFU group (p=0.690). Conclusion: Large neck diameter, short aortic neck length, and the ratio between the maximum AAA and lumen diameters are preoperative anatomical predictors of the occurrence of migration (⩾5 mm), any endoleak, and/or aneurysm growth (>5 mm) after EVAS. Even under the refined 2016 IFU, more than a quarter of patients suffered from an event. Improvements in the device seem to be necessary before this technique can be implemented on a large scale in endovascular AAA repair.

Download Full-text

Stent-Graft Migration following Endovascular Repair of Aneurysms with Large Proximal Necks: Anatomical Risk Factors and Long-term Sequelae

Journal of Endovascular Therapy ◽

10.1177/152660280200900517 ◽

2002 ◽

Vol 9 (5) ◽

pp. 652-664 ◽

Cited By ~ 37

Author(s):

James T. Lee ◽

Jason Lee ◽

Ihab Aziz ◽

Carlos E. Donayre ◽

Irwin Walot ◽

...

Keyword(s):

Stent Graft ◽

Endovascular Repair ◽

Morphological Changes ◽

Morphological Characteristics ◽

Anatomical Characteristic ◽

Computed Tomographic ◽

Aortic Neck ◽

Distal Migration ◽

Graft Migration ◽

Over Time

Purpose: To evaluate the outcome of aortic endografts deployed in large infrarenal necks and to identify any association of preoperative aneurysm characteristics and postoperative morphological changes with the incidence of neck dilatation and device migration in this patient subset. Methods: The records of 47 patients (41 men; mean age 74, range 55–84) with large aortic neck diameters treated with Talent stent-grafts from 1998 to 2001 were reviewed. Patients with anatomical criteria that precluded aneurysm exclusion with currently available devices were preferentially selected. Mean baseline aneurysm morphology included 27.6-mm (range 18–33.4) suprarenal and 28.1-mm (range 24–34) infrarenal neck diameters; the infrarenal neck length was 26 ± 16 mm with angulation of 37° ± 18°. Computed tomographic (CT) angiograms up to 3 years were analyzed using specialized interactive software; migration was defined as >1-cm change in the distance from the lower renal artery to the top of the device. Pre- and postoperative morphological characteristics of the aneurysm were compared between patients with and without migration. Results: Of the 45 patients successfully treated, 40 had complete CT data for analysis. During a mean 17-month follow-up, 7 (17.5%) of the 40 devices exhibited distal migration. Six patients required secondary procedures; 5 were in the migration cohort. No preoperative anatomical characteristic or degree of neck dilatation over time was predictive of stent-graft migration. Aneurysm sac regression was significant at 1 (–0.09 ± 4.90 mm) and 2 (–1.48 ± 2.56 mm) years in endografts without migration (p<0.001). Distal endograft migration >1 cm predicted the need for secondary interventions (p<0.001), with 83% sensitivity and 94% specificity. Conclusions: Endovascular repair is successful in patients with large infrarenal necks and complex neck morphology. Changes in aneurysm remodeling over time were similar to reported observations in patients with more favorable neck criteria. Although no anatomical factor associated with migration could be identified from this analysis, distal displacement >1 cm correlated with the need for a secondary intervention.

Download Full-text

Clinical Application of a Curved Nitinol Stent-Graft for Thoracic Aortic Aneurysms

Journal of Endovascular Therapy ◽

10.1177/152660280301000106 ◽

2003 ◽

Vol 10 (1) ◽

pp. 20-28 ◽

Cited By ~ 27

Author(s):

Junichiro Sanada ◽

Osamu Matsui ◽

Noboru Terayama ◽

Satoshi Kobayashi ◽

Tetsuya Minami ◽

...

Keyword(s):

Aortic Arch ◽

Stent Graft ◽

Neurological Complications ◽

Polyester Fabric ◽

Aortic Aneurysms ◽

The Other ◽

Neck Length ◽

Nitinol Stent ◽

Proximal Neck ◽

Thoracic Aortic Aneurysms

Purpose: To evaluate the clinical efficacy of a curved nitinol stent-graft for repair of thoracic aortic aneurysms. Methods: The Matsui-Kitamura stent-graft (MKSG), composed of a self-expanding nitinol stent and polyester fabric, was shaped to match the aortic curvature of 11 patients (6 men; mean age 72.6 years, range 33–90) with 6 true and 5 false aneurysms of the distal arch or proximal descending aorta. The delivery system was an 18 or 20-F J-shaped sheath combined with a preloader-type introducer. The original mean proximal neck length was 16.4 mm, but 4 patients received an axilloaxillary bypass to lengthen the neck. Although the mean corrected proximal neck length was 21.9 mm (overall), 5 cases still had proximal necks <15 mm long. Results: All curved MKSGs were successfully deployed in the correct position and fitted to the curvature of the aortic arch, achieving complete aneurysm exclusion in 8 (73%) cases. The other 3 repairs displayed early endoleaks; 1 received an additional MKSG, but the other 2 are being observed. Thirty-day mortality was 0%. One patient developed transient renal failure requiring hemodialysis; no neurological complications were observed. Conclusions: Endovascular repair of thoracic aortic aneurysms using curved MKSGs appears to be feasible and clinically effective. A tighter fit of the device to the curvature of the aortic arch may exclude distal arch aneurysms despite a short proximal neck.

Download Full-text

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

Journal of Endovascular Therapy ◽

10.1177/1526602819828377 ◽

2019 ◽

Vol 26 (2) ◽

pp. 245-249 ◽

Cited By ~ 2

Author(s):

Andrés Reyes Valdivia ◽

Francisco Álvarez Marcos ◽

África Duque Santos ◽

Julia Ocaña Guaita ◽

Claudio Gandarias Zúñiga

Keyword(s):

Endovascular Treatment ◽

Stent Graft ◽

Tertiary Care ◽

Abdominal Aortic Aneurysms ◽

Aortic Aneurysms ◽

Study Cohort ◽

Neck Length ◽

Entire Study ◽

Abdominal Aortic ◽

Ruptured Abdominal Aortic Aneurysms

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.

Download Full-text

Endoluminal AAA Repair Using Intravascular Ultrasound for Graft Planning and Deployment: A 2-Year Community-Based Experience

Journal of Endovascular Therapy ◽

10.1177/152660280301000311 ◽

2003 ◽

Vol 10 (3) ◽

pp. 463-475 ◽

Cited By ~ 11

Author(s):

David P. Slovut ◽

Lewis C. Ofstein ◽

J. Michael Bacharach

Keyword(s):

Intravascular Ultrasound ◽

Stent Graft ◽

Atherosclerotic Plaque ◽

Aortic Aneurysms ◽

Graft Occlusion ◽

High Grade ◽

Aortic Neck ◽

Abdominal Aortic ◽

Increased Risk ◽

Stent Graft Repair

Purpose: To examine the effectiveness of intravascular ultrasound (IVUS) and digital subtraction angiography (DSA) for preoperative planning and intraoperative deployment of stent-grafts to treat abdominal aortic aneurysms. Methods: One hundred seventy patients (143 men; mean age 73.6±7.2 years, range 51–89) underwent successful DSA and IVUS to determine suitability for stent-graft repair. Patients subsequently received the AneuRx (n=157) or Ancure (n=13) device; intraprocedural IVUS was used to survey the proximal endograft for proper apposition to the aortic wall. Results: Reliable preoperative IVUS measurements were obtained in all patients. Plaque morphology was assessed in 140 (82.3%) aortic necks; in 36 (25.7%), preoperative IVUS showed high-grade atherosclerotic plaque in the nonaneurysmal abdominal aortic neck. The procedure was successful in 168 (98.8%) cases (1 [0.6%] acute conversion and 1 access failure). There were 2 (1.2%) periprocedural deaths related to bowel ischemia. Four (2.3%) patients developed graft occlusion/kinking and 2 (1.2%) developed renal failure requiring dialysis within 30 days. Multivariate logistic regression analysis revealed that female gender (p=0.0247), a short nonaneurysmal aortic neck (p=0.0185), and presence of high-grade atherosclerotic plaque (p=0.0185) correlated with major acute complications. Over a mean 10.4-month follow-up (range 1–25), 11 patients died of unrelated causes; there was no known AAA rupture or device failure. The Kaplan-Meier estimate of survival at 1 year was 91.0%±2.8%. Sixteen (9.4%) patients underwent 17 secondary procedures for endoleak or graft limb occlusion at a mean 5.4 months after stent-graft repair (freedom from secondary intervention at 1 year 86.5%±3.2%). Conclusions: Our findings suggest that IVUS may identify patients at increased risk of major adverse complications following endovascular repair. The combination of IVUS and DSA for endoluminal stent-graft planning and placement provides excellent short- and mid-term patient outcomes.

Download Full-text