Early multicentric outcomes of the on-label and CE-marked combination of the Endurant with the Radiant chimney graft for the chimney endovascular aortic repair (EnChEVAR): The LaMuR Registry

J Cardiovasc Surg (Torino). 2024 Apr;65(2):106-109. doi: 10.23736/S0021-9509.24.13056-X. Epub 2024 Apr 18.

Abstract

Background: The aim of this study was to evaluate the early results of the CE-marked standardized device combination consisting of Endurant and the Radiant chimney graft (En-ChEVAR) for the treatment of juxtarenal aortic aneurysms.

Methods: We analyzed multicentric non-industry sponsored case series evaluating the EnChEVAR technique for patients treated between December 2022 and February 2024. Clinical, perioperative procedure-related and radiological data were collected. The primary outcome measure was the freedom of a type Ia gutter-related endoleak at postoperative computed tomography angiography (CTA). Secondary outcome measures included early type Ia endoleak-related reinterventions, target vessel complications including dissection or loss of target vessel, major adverse events, and mortality. Continuous variables were presented as median (interquartile range [IQR]) and categorical variables as count and percentage.

Results: Ten patients were included in the present study. Eight (80%) were males, in nine cases a single chimney was implanted, and the other one was a double chimney graft placement. The treated aneurysms had an infrarenal neck length of 3.4 (1.2) mm. The rate of main body oversizing was 30%. The new neck length after chimney graft placement was 18 (3) mm. The median procedural time was 130 (17) mm, contrast medium use was 109 (26) mL, radiation time was 45 (12) min. The technical success was 100%. No type Ia endoleak was detected at the postoperative CTA. There were no target vessel issues. No major adverse events or death were observed.

Conclusions: First reported cohort of patients treated with EnChEVAR demonstrated reproducible clinical and procedural outcomes within the 3 vascular centers with total exclusion of the aneurysms, patent renal arteries, and no evidence of gutter-related type IA endoleak. Further evidence with larger sample size of treated patients and longer follow-up are needed.

Publication types

  • Multicenter Study

MeSH terms

  • Aged
  • Aged, 80 and over
  • Aortic Aneurysm, Abdominal* / diagnostic imaging
  • Aortic Aneurysm, Abdominal* / mortality
  • Aortic Aneurysm, Abdominal* / surgery
  • Blood Vessel Prosthesis Implantation* / adverse effects
  • Blood Vessel Prosthesis Implantation* / instrumentation
  • Blood Vessel Prosthesis Implantation* / mortality
  • Blood Vessel Prosthesis*
  • Endoleak* / etiology
  • Endovascular Aneurysm Repair / adverse effects
  • Endovascular Aneurysm Repair / instrumentation
  • Female
  • Humans
  • Male
  • Product Labeling
  • Prosthesis Design*
  • Registries
  • Retrospective Studies
  • Risk Factors
  • Stents
  • Time Factors
  • Treatment Outcome