Performance of the Endurant stent graft in challenging anatomy

Pieter P H L Broos; Rutger A Stokmans; Steven M M van Sterkenburg; Giovanni Torsello; Frank Vermassen; Philippe W M Cuypers; Marc R H M van Sambeek; Joep A W Teijink

doi:10.1016/j.jvs.2015.03.024

Performance of the Endurant stent graft in challenging anatomy

J Vasc Surg. 2015 Aug;62(2):312-8. doi: 10.1016/j.jvs.2015.03.024. Epub 2015 May 1.

Authors

Pieter P H L Broos¹, Rutger A Stokmans¹, Steven M M van Sterkenburg², Giovanni Torsello³, Frank Vermassen⁴, Philippe W M Cuypers⁵, Marc R H M van Sambeek⁵, Joep A W Teijink⁶

Affiliations

¹ Department of Vascular Surgery, Catharina Hospital, Eindhoven, The Netherlands; Department of Epidemiology, CAPHRI Research School, Maastricht University, Maastricht, The Netherlands.
² Department of Vascular Surgery, Rijnstate Hospital, Arnhem, The Netherlands.
³ Department of Vascular Surgery, St. Franziskus-Hospital Münster, Münster, Germany.
⁴ Department of Vascular Surgery, Ghent University Hospital, Ghent, Belgium.
⁵ Department of Vascular Surgery, Catharina Hospital, Eindhoven, The Netherlands.
⁶ Department of Vascular Surgery, Catharina Hospital, Eindhoven, The Netherlands; Department of Epidemiology, CAPHRI Research School, Maastricht University, Maastricht, The Netherlands. Electronic address: joep.teijink@catharinaziekenhuis.nl.

PMID: 25937606
DOI: 10.1016/j.jvs.2015.03.024

Abstract

Objective: This study aimed to compare perioperative and postoperative outcomes after endovascular repair of abdominal aortic aneurysms (AAAs) in patients with various neck morphologic features.

Methods: Data from the Endurant Stent Graft Natural Selection Global Postmarket Registry (ENGAGE) were used for the analyses. Patients were categorized into three different groups according to proximal aortic neck anatomy: regular (REG), intermediate (INT), and challenging (CHA). REG was defined as AAAs with a proximal neck ≥15 mm combined with a suprarenal angulation (α) ≤45 degrees and an infrarenal neck angulation (ß) ≤60 degrees. INT was defined as AAAs with a proximal neck of 10 to 15 mm combined with α ≤45 degrees and ß ≤60 degrees or with a proximal neck of >15 mm combined with α ≤60 degrees and ß = 60 to 75 degrees or α = 45 to 60 degrees and ß ≤75 degrees. CHA was defined as infrarenal necks that exceed at least one of the three defining factors.

Results: Overall, 925 patients (75.9%) had REG anatomy, 189 patients (15.5%) had INT anatomy, and 104 patients (8.5%) had CHA anatomy. Patient demographics and risk factors were similar. There was a significant difference in AAA diameter between the REG and CHA groups (59.4 mm vs 65.2 mm; P < .001). Technical success was similar among groups (REG 99.1% vs INT 99.5% vs CHA 97.1%). There were no differences in mortality or the need for secondary procedures within 30 days or at 1 year. A significantly higher rate of type I endoleaks within 30 days was seen in CHA compared with REG (adjusted odds ratio, 0.15; 95% confidence interval, 0.05-0.46) and INT (adjusted odds ratio, 0.08; 95% confidence interval, 0.01-0.70), but there was no difference at 1-year follow-up.

Conclusions: This real-world, global experience shows promising results and indicates that endovascular AAA repair with the Endurant stent graft (Medtronic Vascular, Santa Rosa, Calif) is safe and effective in patients with challenging aortic neck anatomy. However, long-term follow-up of patients is required to confirm results.

Trial registration: ClinicalTrials.gov NCT00870051.

Publication types

Clinical Trial
Multicenter Study
Observational Study
Research Support, Non-U.S. Gov't

MeSH terms

Aged
Aged, 80 and over
Aortic Aneurysm, Abdominal / classification
Aortic Aneurysm, Abdominal / surgery*
Blood Vessel Prosthesis Implantation
Blood Vessel Prosthesis*
Endoleak / prevention & control
Endovascular Procedures
Female
Humans
Male
Middle Aged
Prosthesis Design
Registries
Retrospective Studies
Risk Factors
Stents

Associated data

ClinicalTrials.gov/NCT00870051