Dataset Information

Global Post-Market Clinical Follow-up of the Treovance Stent-Graft for Endovascular Aneurysm Repair: One-Year Results From the RATIONALE Registry.

ABSTRACT: PURPOSE::To evaluate the safety and performance of the Treovance stent-graft. METHODS::The global, multicenter RATIONALE registry ( ClinicalTrials.gov; identifier NCT03449875) prospectively enrolled 202 patients (mean age 73.0±7.8 years; 187 men) with abdominal aortic aneurysms (AAA) suitable for endovascular aneurysm repair (EVAR) using the Treovance. The composite primary safety endpoint was site-reported all-cause mortality and major morbidity. The primary efficacy outcome was clinical success. Further outcomes evaluated included technical success; stent-graft migration, patency, and integrity; endoleak; and aneurysm size changes. RESULTS::Technical success was 96% (194/202); 8 patients had unresolved type I endoleaks at the end of the procedure. There was no 30-day mortality and 1% major morbidity (1 myocardial infarction and 1 bowel ischemia). Clinical success at 1 year was confirmed in 194 (96%) patients; 6 of 8 patients had new/persistent endoleaks and 2 had aneurysm expansion without identified endoleak. A total of 8 (4%) reinterventions were required during the mean 13.7±3.1 months of follow-up (median 12.8). At 1 year, the Kaplan-Meier estimate for freedom from reintervention was 95.6% (95% CI 91.4% to 97.8%). Other estimates were 95.5% (95% CI 91.7% to 97.6%) for freedom from endoleak type I/III and 97.4% (95% CI 94.2% to 98.9%) for freedom from aneurysm expansion. Thirteen (6.4%) patients died; no death was aneurysm related. CONCLUSION::The RATIONALE registry showed favorable safety and clinical performance of the Treovance stent-graft for the treatment of infrarenal AAAs in a real-world setting.

SUBMITTER: Uberoi R

PROVIDER: S-EPMC6238168 | biostudies-literature | 2018 Dec

REPOSITORIES: biostudies-literature

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Global Post-Market Clinical Follow-up of the Treovance Stent-Graft for Endovascular Aneurysm Repair: One-Year Results From the RATIONALE Registry.

Uberoi Raman R Setacci Carlo C Lescan Mario M Lorido Antonio A Murray David D Szeberin Zoltán Z Zubilewicz Tomasz T Riambau Vincent V Chartrungsan Angsu A Tessarek Jörg J

Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists 20181003 6

<h4>Purpose:</h4>To evaluate the safety and performance of the Treovance stent-graft.<h4>Methods:</h4>The global, multicenter RATIONALE registry ( ClinicalTrials.gov; identifier NCT03449875) prospectively enrolled 202 patients (mean age 73.0±7.8 years; 187 men) with abdominal aortic aneurysms (AAA) suitable for endovascular aneurysm repair (EVAR) using the Treovance. The composite primary safety endpoint was site-reported all-cause mortality and major morbidity. The primary efficacy outcome was ...[more]

PMID: 30280649

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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.

Dataset Information

Global Post-Market Clinical Follow-up of the Treovance Stent-Graft for Endovascular Aneurysm Repair: One-Year Results From the RATIONALE Registry.

Publications

Global Post-Market Clinical Follow-up of the Treovance Stent-Graft for Endovascular Aneurysm Repair: One-Year Results From the RATIONALE Registry.

Similar Datasets

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