Clinical and Morphological Outcomes in Endovascular Aortic Repair of Abdominal Aortic Aneurysm Using GORE C3 EXCLUDER: Comparison between Patients Treated within and Outside Instructions for Use

Nishibe, Toshiya; Iwahashi, Toru; Kamiya, Kentaro; Kano, Masaki; Maruno, Keita; Fujiyoshi, Toshiki; Iwahori, Akinari; Suzuki, Shun; Kawago, Koji; Takahashi, Satoshi; Ogino, Hitoshi; Koizumi, Jun; Dardik, Alan

doi:10.1016/j.avsg.2018.12.090

Cited by 7 publications

(4 citation statements)

References 13 publications

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“…Group 2 also showed more in-hospital days and more perioperative complications (p = 0.01 and 0.041, respectively), although the complications were all access-related rather than proximal-neck-related. The influence of the adherence to the IFU on sac shrinkage has been investigated for the Endurant stent graft as well as other commercially available endografts, and as in our experience, no statistically significant difference has been reported on sac shrinkage or expansion rates [10,11]. Interestingly, although the small number of aorticrelated deaths makes it difficult to obtain a statistically significative difference, it appears that aneurysm-related mortality is not affected by the adherence to the IFU; it is worth considering, however, that the aneurysm-related mortality rate and the 30-days mortality rate of Group 2 is more than double that of Group 1.…”

Section: Discussionmentioning

confidence: 83%

Endurant Stent Graft for Treatment of Abdominal Aortic Aneurysm Inside and Outside of the Instructions for Use for the Proximal Neck: A 14-Year, Single-Center Experience

Accarino,

De Vuono,

Accarino

et al. 2024

JCM

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Aim: To assess the medium and long-term performance of the Endurant stent graft in a cohort of consecutive patients treated with this device for an abdominal aortic aneurysm (AAA) both inside and outside of the instructions for use (IFU) and to find factors influencing the outcomes. Methods: Our observational, retrospective, single-center study included all patients who consecutively underwent endovascular aneurysm repair with the Endurant stent graft from February 2009 to January 2023. Patients with an AAA to treat according to current guidelines were included. Patients were divided into two groups: Group 1 inside of the IFUs and Group 2 outside of the IFUs for the proximal aortic neck. Patients were followed up after the procedure with computed angiography tomography, ultrasound examination, and interviews. Aneurysm-related mortality, procedure-related reinterventions, and type IA and III endoleaks were considered primary endpoints. Secondary endpoints included aneurysmal sac variations and graft thrombosis. Results: A total of 795 patients were included, 650 in Group 1 and 145 in Group 2; 732 were males, and the mean age was 74 ± 8. Anamnestic baseline did not differ between the two groups. Neck length, width, and angulation were different between the two groups (all p < 0.001). A total of 40 patients had a ruptured AAA, while 56 were symptomatic. At a mean follow-up of 43 ± 39 months, aneurysm-related mortality was less than 1%, and 82 endoleak (10.5%) were observed. Overall endoleak rate and type 1A endoleak, as well as procedure-related reintervention, were significantly more frequent in Group 2. Sac regression of at least 5 mm was observed in 65.9% of cases. AAAs larger than 60.5 mm carried a higher risk of endoleak (HR: 1.025; 95% CI: 1.013–1.37; p < 0.001) and proximal necks shorter than 13.5 mm carried a higher type 1A risk (HR: 0.890; 95% CI: 0.836–0.948; p < 0.001). Patients without chronic obstructive pulmonary disease and taking lipid-lowering drugs had an overall more consistent sac-shrinking rate. Conclusions: The Endurant stent graft proves safe and reliable. Out-of-IFU treatment has poorer medium and long-term outcomes. Some conditions influence medium and long-term reintervention risk and sac behavior. Patients with bigger aneurysms, proximal necks shorter than 13.5 mm, and chronic obstructive pulmonary disease should be more carefully evaluated during follow-up. Consistent follow-up is in keeping low aneurysm-related mortality. Personalized risk profiles and peri and postoperative management strategies are needed.

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Section: Discussionmentioning

confidence: 83%

Endurant Stent Graft for Treatment of Abdominal Aortic Aneurysm Inside and Outside of the Instructions for Use for the Proximal Neck: A 14-Year, Single-Center Experience

Accarino,

De Vuono,

Accarino

et al. 2024

JCM

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“…As previously stated, all procedures were carried out under general or regional anesthesia by or under the supervision of certified cardiovascular surgeons (TN, MK, et al) in an operating room with a portable imaging system. 17,18) Technical success was defined as a satisfactory stent graft insertion that included successful passage of the delivery system, correct deployment of the stent graft, complete withdrawal of the delivery system, freedom from open conversion, and absence of type I or III endoleak.…”

Section: Surgical Techniquesmentioning

confidence: 99%

“…Patients were monitored according to the institutional policy, as reported previously. 17,18) Patients were observed through the database until death or the end of the followup period in November 2021, whichever happened first. Postoperative results included any causes of death.…”

Section: Mortalitymentioning

confidence: 99%

Prognostic Value of Nutritional Markers for Long-Term Mortality in Patients Undergoing Endovascular Aortic Repair

Nishibe

Kano

Matsumoto

et al. 2023

Annals of Vascular Diseases

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Objective:The relationship between nutritional status and morbidity and death in a number of diseases and disorders has garnered considerable attension. In patients having endovascular aneurysm repair (EVAR) for abdominal aortic aneurysms (AAA), we assessed the prognostic value of nutritional markers of albumin (ALB), body mass index (BMI), and geriatric nutritional risk index (GNRI) for long-term mortality. Materials and Methods: Retrospective data analysis was done on patients who had undergone elective EVAR for AAA more than 5 years earlier.Results: A total of 176 patients underwent EVAR for AAA between March 2012 and April 2016. The optimal cutoff value of ALB, BMI, and GNRI for predicting long-term mortality was calculated as 3.75 g/dL (area under the curve [AUC] 0.64), 21.4 kg/m 2 (AUC 0.65), and 101.4 (AUC 0.70), respectively. Low ALB, low BMI, and low GNRI as well as age ≥75 years, chronic obstructive pulmonary disease, chronic kidney disease, and active cancer were independent risk factors for long-term mortality. Conclusion: Malnutrition, which is measured by ALB, BMI, and GNRI, is an independent risk factor for long-term mor-tality in patients receiving EVAR for AAA. Of the nutritional markers, the GNRI can be the most reliable nutritional indicator to identify a potentially high-risk group of mortality after EVAR.

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“…Over recent years, endovascular repair of abdominal aortic aneurysms (EVAR) has progressively expanded to more complex anatomies, often requiring implantation outside IFU (oIFU). 1 Whilst some researchers have reported no major differences between treatment oIFU and inside the IFU (iIFU) with respect to patient outcome, 2,3 others have described higher rates of type I endoleaks, representing treatment failure. 4–6 Furthermore, increased rates of reintervention (RI) have been described in oIFU–EVAR 7 .…”

Section: Introductionmentioning

confidence: 99%

Outcomes of thoracic endovascular aortic repair in thoracic aortic aneurysm and penetrating aortic ulcer using the Conformable Gore TAG within and outside the instructions for use

et al. 2020

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Objective To describe the outcome of thoracic endovascular aortic repair (TEVAR) in thoracic aortic aneurysm and penetrating aortic ulcer with respect to instructions for use status. Methods Between October 2009 and September 2017, a total of 532 patients underwent TEVAR; of which 195 have been treated using the Conformable GORE® TAG® thoracic endoprosthesis (CTAG). Fifty-six patients of this cohort underwent TEVAR for thoracic aortic aneurysm/penetrating aortic ulcer using the CTAG. Depending on the preoperative computed tomography angiography findings, patients were classified as inside or outside the device’s instructions for use. All inside instruction for use patients underwent postoperative reclassification regarding the instructions for use status. Study endpoints included TEVAR-related reintervention, exclusion of the pathology (endoleak type I/III), TEVAR-related mortality, and graft-related serious adverse events. The median duration of follow-up was 29.7 months (range: 0–109.4 months). Results Of the 56 patients, 17 were primarily classified as outside instruction for use, and in additional 13 patients, TEVAR was performed outside instruction for use, leading to 30 outside instruction for use patients (53.6%). Twenty-six patients (46.4%) were treated inside instruction for use. Reintervention-free survival was lower in outside instruction for use patients ( P = 0.016) with a hazard ratio of 9.74 (confidence interval 1.2–80.2; P = 0.034) for TEVAR-related reintervention. With respect to endoleak type I/III, relevant difference was detected between inside/outside instruction for use status ( P = 0.012). The serious adverse event rate was 30.4%, mainly in outside instruction for use patients ( P = 0.004). Logistic regression analysis indicated an association between graft-related serious adverse event/instructions for use status (odds ratio 6.11; confidence interval 1.6–30.06; P = 0.012). In-hospital death was seen more frequently in outside instruction for use patients ( P = 0.12) as was procedure-related death (log-rank test: P = 0.21). Conclusion TEVAR for thoracic aortic aneurysm/penetrating aortic ulcer is frequently performed outside instruction for use despite preoperative inside instruction for use eligibility, leading to important consequences for technical/clinical outcome. Instructions for use adherence in TEVAR should be of interest for further large-scale studies.

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Clinical and Morphological Outcomes in Endovascular Aortic Repair of Abdominal Aortic Aneurysm Using GORE C3 EXCLUDER: Comparison between Patients Treated within and Outside Instructions for Use

Cited by 7 publications

References 13 publications

Endurant Stent Graft for Treatment of Abdominal Aortic Aneurysm Inside and Outside of the Instructions for Use for the Proximal Neck: A 14-Year, Single-Center Experience

Endurant Stent Graft for Treatment of Abdominal Aortic Aneurysm Inside and Outside of the Instructions for Use for the Proximal Neck: A 14-Year, Single-Center Experience

Prognostic Value of Nutritional Markers for Long-Term Mortality in Patients Undergoing Endovascular Aortic Repair

Outcomes of thoracic endovascular aortic repair in thoracic aortic aneurysm and penetrating aortic ulcer using the Conformable Gore TAG within and outside the instructions for use

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