Dataset Information

Reverse slider technique using the Endurant stent graft for accurate proximal sealing in hostile neck endovascular aneurysm repair.

ABSTRACT: This report introduces the reverse slider technique to obtain proximal sealing effectively in endovascular aneurysm repair in short or angulated necks. It is the deployment process of the stent graft main body by repeatedly rotating and reversing the external slider with slight loosening of the suprarenal stent. This method helps obtain accurate placement of the proximal edge and effective sealing on the greater curvature side even in short and angulated necks. It is an effective method of extending the proximal sealing zone. It is gained by changing the deployment process with the Endurant stent graft (Medtronic, Santa Rosa, Calif) as an existing popular device.

SUBMITTER: Morikage N

PROVIDER: S-EPMC6614706 | biostudies-literature | 2019 Sep

REPOSITORIES: biostudies-literature

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Reverse slider technique using the Endurant stent graft for accurate proximal sealing in hostile neck endovascular aneurysm repair.

Morikage Noriyasu N Nishimura Junichi J Mizoguchi Takahiro T Takeuchi Yuriko Y Nagase Takashi T Samura Makoto M Harada Takasuke T Aga Kenichiro K Masuda Munetaka M Hamano Kimikazu K

Journal of vascular surgery cases and innovative techniques 20190629 3

This report introduces the reverse slider technique to obtain proximal sealing effectively in endovascular aneurysm repair in short or angulated necks. It is the deployment process of the stent graft main body by repeatedly rotating and reversing the external slider with slight loosening of the suprarenal stent. This method helps obtain accurate placement of the proximal edge and effective sealing on the greater curvature side even in short and angulated necks. It is an effective method of exten ...[more]

PMID: 31334412

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Project description:BackgroundEndovascular aneurysm sealing (EVAS), using the Nellix endovascular aneurysm sealing system, has been associated with high reintervention and migration rates. However, prior reports have suggested that EVAS might be related to a lower all-cause mortality compared with endovascular aneurysm repair (EVAR). In the present study, we examined the 5-year all-cause mortality trends after EVAS and EVAR.MethodsWe compared the 333 EVAS patients in the EVAS-1 Nellix U.S. investigational device exemption trial with 16,497 infrarenal EVAR controls from the Vascular Quality Initiative, treated between 2014 and 2016, after applying the exclusion criteria from the investigational device exemption trial (ie, hemodialysis, creatinine >2.0 mg/dL, rupture). As a secondary analysis, we stratified the patients by aneurysm diameter (<5.5 cm and ≥5.5 cm). We calculated propensity scores after adjusting for demographics, comorbidities, and anatomic characteristics and applied inverse probability weighting to compare the risk-adjusted long-term mortality using Kaplan-Meier and Cox regression analyses.ResultsAfter weighting, the EVAS group had experienced similar 5-year mortality compared with the controls from the Vascular Quality Initiative (EVAS vs EVAR, 18% vs 14%; hazard ratio [HR], 1.1; 95% confidence interval [CI], 0.71-1.7; P = .70). The subgroup analysis demonstrated that for patients with an aneurysm diameter of <5.5 cm, EVAS was associated with higher 5-year mortality compared with EVAR (19% vs 11%; HR, 2.4; 95% CI, 1.7-4.7; P = .013). In patients with an aneurysm diameter of ≥5.5 cm, EVAS was associated with lower mortality within the first 2 years (2-year mortality: HR, 0.29; 95% CI, 0.13-0.62; P = .002). However, compared with EVAR, EVAS was associated with higher mortality between 2 and 5 years (HR, 1.9; 95% CI, 1.2-3.0; P = .005), with no mortality difference at 5 years (18% vs 17%; HR, 0.82; 95% CI, 0.4-1.4; P = .46).ConclusionsWithin the overall population, EVAS was associated with similar 5-year mortality compared with EVAR. EVAS was associated with higher mortality for those with small aneurysms (<5.5 cm). For those with larger aneurysms (≥5.5 cm), EVAS was initially associated with lower mortality within the first 2 years, although this advantage was lost thereafter, with higher mortality after 2 years. Future studies are required to evaluate the specific causes of death and to elucidate the potential beneficial mechanism behind sac obliteration that leads to this potential initial survival benefit. This could help guide the development of future grafts with better proximal fixation and sealing that also incorporate sac obliteration.

Project description:OBJECTIVES:To evaluate the influence of baseline parameters on the occurrence of stent-graft surface movement after endovascular aneurysm repair (EVAR) and to investigate its association with migration and stent-graft-related endoleaks (srEL). METHODS:In this retrospective, cross-sectional study, three-dimensional surface models of the stent-graft, delimited by landmarks using custom-built software, were derived from the pre-discharge and last follow-up computed tomography angiography (CTA). Stent-graft surface movement in the proximal anchoring zone between these examinations was considered significant at a threshold of 9 mm. The Cox proportional hazards model was used to determine baseline variables associated with the occurrence of stent-graft surface movement. The association between migration and srEL with stent-graft surface movement was tested with the chi-square and the Fisher exact test, respectively. RESULTS:Stent-graft surface movement was observed in 54 (28.9%) of 187 patients. Multivariate analysis revealed that age ([HR] 1.05; p?=?0.017), proximal neck diameter ([HR] 5.07; p?<?0.001), infrarenal aortic neck angulation ([HR] 1.02, p?=?0.002), and proximal neck length ([HR] 0.62, p?<?0.001) were significantly associated with the occurrence of stent-graft surface movement. Migration and srEL occurred in 17 (31.5%) and 5 (9.3%) patients, with and 11 (8.3%) and 2 (1.5%) without stent-graft surface movement (p?<?0.001, p?=?0.022). CONCLUSIONS:Age, neck diameter, infrarenal neck angulation, and proximal neck length were significantly associated with the occurrence of stent-graft surface movement. Apart from possible use of adjunctive sealing systems, concerned patients may benefit from regular CTA surveillance, enabling timely diagnosis of subtle changes of stent-graft position. KEY POINTS:• Stent-graft surface movement, demonstrating subtle, three-dimensional changes in stent-graft position in the proximal anchoring zone, can be derived from CTA examinations. • Age, proximal neck diameter, and infrarenal neck angulation were significantly associated with an increased incidence of stent-graft surface movement. Stent-graft surface movement is significantly more frequent in patients with stent-graft migration and stent-graft-related endoleaks. • Consideration of risk factors for stent-graft surface movement may help to identify patients who might benefit from regular CTA surveillance and timely diagnosis of subtle changes of stent-graft position, enabling re-interventions to prevent migration and srEL.

Project description:BackgroundSince 2010, the Ovation Abdominal Stent Graft System has offered an innovative sealing option for abdominal aortic aneurysm (AAA) by including a sealing ring filled with polymer 13 mm from the renal arteries. In August 2020, the redesigned Ovation Alto, with a sealing ring 6 mm closer to the top of the fabric, received CE Mark approval.ObjectiveThis registry study aims to evaluate intraoperative, perioperative, and postoperative results in patients treated by the Alto stent graft (Endologix Inc.) for elective AAA repair in a multicentric consecutive experience.MethodsAll consecutive eligible patients submitted to endovascular aneurysm repair (EVAR) by Alto Endovascular AAA implantation will be included in this analysis. Patients will be submitted to EVAR procedures based on their own preferences, anatomical features, and operators experience. An estimated number of 300 patients submitted to EVAR with Alto stent graft should be enrolled. It is estimated that the inclusion period will be 24 months. The follow-up period is set to be 5 years. Full data sets and cross-sectional images of contrast-enhanced computed tomography scan performed before EVAR, at the first postoperative month, at 24 or 36 months, and at 5-year follow-up interval will be reported in the central database for a centralized core laboratory review of morphological changes. The primary endpoint of the study is to evaluate the technical and clinical success of EVAR with the Alto stent graft in short- (90-day), mid- (1-year), and long-term (5-year) follow-up periods. The following secondary endpoints will be also addressed: operative time; intraoperative radiation exposure; contrast medium usage; AAA sac shrinkage at 12-month and 5-year follow-up; any potential role of patients' baseline characteristics, valuated on preoperative computed tomography angiographic study, and of device configuration (number of component) in the primary endpoint.ResultsThe study is currently in the recruitment phase and the final patient is expected to be treated by the end of 2023 and then followed up for 5 years. A total of 300 patients will be recruited. Analyses will focus on primary and secondary endpoints. Updated results will be shared at 1- and 3-5-year follow-ups.ConclusionsThe results from this registry study could validate the safety and effectiveness of the new design of the Ovation Alto Stent Graft. The technical modifications to the endograft could allow for accommodation of a more comprehensive range of anatomies on-label.Trial registrationClinicalTrials.gov NCT05234892; https://clinicaltrials.gov/ct2/show/NCT05234892.International registered report identifier (irrid)PRR1-10.2196/36995.

Dataset Information

Reverse slider technique using the Endurant stent graft for accurate proximal sealing in hostile neck endovascular aneurysm repair.

Publications

Reverse slider technique using the Endurant stent graft for accurate proximal sealing in hostile neck endovascular aneurysm repair.

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