Endovascular aortic repair with EndoAnchors demonstrate good mid-term outcomes in physician-initiated multicenter analysis-The PERU registry.


Journal

Vascular
ISSN: 1708-539X
Titre abrégé: Vascular
Pays: England
ID NLM: 101196722

Informations de publication

Date de publication:
Feb 2022
Historique:
pubmed: 12 2 2021
medline: 23 2 2022
entrez: 11 2 2021
Statut: ppublish

Résumé

We aim to describe real-world outcomes from multicenter data about the efficacy of adjunct Heli-FX EndoAnchor usage in preventing or repairing failures during infrarenal endovascular aneurysm repair (EVAR), so-called EndoSutured-aneurysm-repair (ESAR). The current study has been assigned an identifier (NCT04100499) at the US National Library of Medicine (https://ClinicalTrials.gov). It is an observational retrospective study of prospectively collected data from seven vascular surgery departments between June 2010 and December 2019. Patients included in the ANCHOR registry were excluded from this analysis. The decision for the use of EndoAnchors was made by the treating surgeon or multidisciplinary aortic committee according to each center's practice. Follow-up imaging was scheduled according to each center's protocol, which necessarily included either abdominal ultrasound or radiography or computed tomographic scan imaging. The main outcomes analyzed were technical success, freedom from type Ia endoleaks (IaEL), all-cause and aneurysm-related mortality, and sac variation and trends evaluated for those with at least six months imaging follow-up. Two hundred and seventy-five patients underwent ESAR in participating centers during the study period. After exclusions, 221 patients (184 males, 37 females, mean age 75 ± 8.3 years) were finally included for analysis. Median follow-up for the cohort was 27 (interquartile range 12-48) months. A median 6 (interquartile range 3) EndoAnchors were deployed at ESAR, 175 (79%) procedures were primary and 46 (21%) revision cases, 40 associated with type IaEL. Technical success at operation (initial), 30-day, and overall success were 89, 95.5, and 96.8%, respectively; the 30-day success was higher due to those with subsequent spontaneous proximal endoleak seal. At two years, freedom from type IaEL was 94% for the whole series; 96% and 86% for the primary and revision groups, respectively; whereas freedom from all-cause mortality, aneurysm-related mortality, and reintervention was 89%, 98%, and 87%, respectively. Sac evolution pre-ESAR was 66 ± 15.1 vs. post ESAR 61 ± 17.5 (p < 0.001) and for 180 patients with at least six-month follow-up, 92.2% of them being in a stable (51%) or regression (41%) situation. This real-world registry demonstrates that adjunct EndoAnchor usage at EVAR achieves high rates of freedom from type IaEL at mid-term including in a high number of patients with hostile neck anatomy, with positive trends in sac-size evolution. Further data with longer follow-up may help to establish EndoAnchor usage as a routine adjunct to EVAR, especially in hostile necks.

Identifiants

pubmed: 33568007
doi: 10.1177/1708538121992596
doi:

Banques de données

ClinicalTrials.gov
['NCT04100499']

Types de publication

Journal Article Multicenter Study

Langues

eng

Sous-ensembles de citation

IM

Pagination

27-37

Auteurs

Andrés Reyes Valdivia (A)

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

Arindam Chaudhuri (A)

Bedfordshire - Milton Keynes Vascular Centre, Bedfordshire Hospitals Foundation Trust, Bedford, UK.

Ross Milner (R)

Section of Vascular Surgery and Endovascular Therapy, Department of Surgery, University of Chicago Medicine, Chicago, IL, USA.

Giovanni Pratesi (G)

Vascular Surgery Unit, Department of Biomedicine and Prevention, University of Rome Tor Vergata, Rome, Italy.

Michel Mpj Reijnen (MM)

Department of Surgery, Rijnstate, Arnhem and the Multi-Modality Medical Imaging Group, TechMed Centre, University of Twente, Enschede, The Netherlands.

Giovanni Tinelli (G)

Unit of Vascular Surgery, Fondazione Policlinico Universitario Gemelli IRCCS - Università Cattolica del Sacro Cuore, Rome, Italy.

Richte Schuurmann (R)

Department of Vascular Surgery, St. Antonius Hospital, Nieuwegein, The Netherlands, and Department of Surgery, Division of Vascular Surgery, University Medical Centre Groningen, Groningen, The Netherlands.

Matteo Barbante (M)

Vascular Surgery Unit, Department of Biomedicine and Prevention, University of Rome Tor Vergata, Rome, Italy.

Trissa A Babrowski (TA)

Section of Vascular Surgery and Endovascular Therapy, Department of Surgery, University of Chicago Medicine, Chicago, IL, USA.

Georgios Pitoulias (G)

Faculty of Medicine, 2nd Department of Surgery, Division of Vascular Surgery, Thessaloniki General Hospital, Aristotle University of Thessaloniki, "G. Gennimatas," Greece.

Yamume Tshomba (Y)

Unit of Vascular Surgery, Fondazione Policlinico Universitario Gemelli IRCCS - Università Cattolica del Sacro Cuore, Rome, Italy.

Claudio Gandarias (C)

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

Ayman Badawy (A)

Bedfordshire - Milton Keynes Vascular Centre, Bedfordshire Hospitals Foundation Trust, Bedford, UK.

Jean-Paul Pm de Vries (JP)

Department of Vascular Surgery, St Antonius Hospital, Nieuwegein, the Netherlands.
Department of Surgery, Division of Vascular Surgery, University Medical Centre Groningen, Groningen, The Netherlands.

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