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Multicenter European Registry for Patients with AAA Undergoing EVAR Evaluating the Performance of the 36-mm-Diameter Endurant Stent-Graft

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Abstract

Introduction

The use of and results with the Endurant stent-graft have been reported extensively. However, there has been little if any focus placed on performance and outcomes when a 36-mm-diameter device is used.

Methods

Data were collected and retrospectively analyzed on EVAR patients treated with a 36-mm-diameter Endurant device at 3 European academic vascular centers between 2007 and 2015. Primary endpoints were the absence of type Ia endoleak in the early and mid-term follow-up period, and aneurysm sac stabilization or shrinkage. Secondary endpoints were 30-day mortality, overall survival and secondary interventions. Subgroup analysis of outcomes in the on-label (ONL) versus off-label (OFL) device use cohorts was also performed.

Results

Seventy-three patients were included in the study. Mean follow-up was 30.1 ± 16.2 months. Mean aortic neck diameter was 29.5 ± 1.9. Primary technical success was achieved in 69 patients (94.5%). Five patients (6.8%) were found to have developed a type Ia endoleak, 3 during the first month, and the other 2 at 2 years. Overall EVAR-related mortality was 4.1% (n = 3). Subgroup analysis focused on the OFL cohort (n = 44) versus the ONL patients (n = 29). Two of the OFL patients (4.5%) had a type Ia endoleak, and 3 (10.3%) in the ONL group.

Conclusion

The use of the largest diameter Endurant stent-graft device emerges as a reasonable option for EVAR treatment of AAA featuring a large-diameter proximal neck. Assessment of a larger group of patients followed in the long term will be necessary for a more definitive statement on such strategy.

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Authors and Affiliations

  1. Department of Vascular and Endovascular Surgery, Ramón y Cajal´s University Hospital, Madrid, Spain

    Andrés Reyes Valdivia & Claudio Gandarias

  2. Division of Vascular Surgery, 2nd Department of Surgery, Aristotle University of Thessaloniki “G. Gennimatas” Hospital, Thessaloniki, Greece

    Georgios Pitoulias & Apostolos G. Pitoulias

  3. Vascular Surgery Department, Union Memorial Hospital-MedStar Health, Baltimore, MD, USA

    Frank J. Criado

  4. Department of Vascular Surgery, St Franziskus Hospital Münster. Clinic for Vascular and Endovascular Surgery, Münster University Hospital, Münster, Germany

    Giovanni Torsello, Martin Austermann & Konstantinos Donas

Authors
  1. Andrés Reyes Valdivia
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  2. Georgios Pitoulias
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  3. Frank J. Criado
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  4. Giovanni Torsello
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  5. Claudio Gandarias
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  6. Martin Austermann
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  7. Apostolos G. Pitoulias
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  8. Konstantinos Donas
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Correspondence to Andrés Reyes Valdivia.

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The authors declare no conflicts of interest.

Ethical Approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.

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Informed consent was obtained from all individual participants included in the study.

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Reyes Valdivia, A., Pitoulias, G., Criado, F.J. et al. Multicenter European Registry for Patients with AAA Undergoing EVAR Evaluating the Performance of the 36-mm-Diameter Endurant Stent-Graft. Cardiovasc Intervent Radiol 40, 1514–1521 (2017). https://doi.org/10.1007/s00270-017-1665-6

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  • DOI: https://doi.org/10.1007/s00270-017-1665-6

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