P-015 - EARLY EXPERIENCE WITH OVATION ALTO STENT-GRAFT

TOPIC:
Abdominal Aortic Aneurysms
AUTHORS:
Cuozzo S. (Vascular Surgery Division Department of Surgery "Paride Stefanini" Policlinico Umberto I - "La Sapienza" University of Rome, Italy ~ Roma ~ Italy) , Martinelli O. (Vascular Surgery Division Department of Surgery "Paride Stefanini" Policlinico Umberto I - "La Sapienza" University of Rome, Italy ~ Roma ~ Italy) , Miceli F. (Vascular Surgery Division Department of Surgery "Paride Stefanini" Policlinico Umberto I - "La Sapienza" University of Rome, Italy ~ Roma ~ Italy) , Gattuso R. (Vascular Surgery Division Department of Surgery "Paride Stefanini" Policlinico Umberto I - "La Sapienza" University of Rome, Italy ~ Roma ~ Italy) , Sbarigia E. (Vascular Surgery Division Department of Surgery "Paride Stefanini" Policlinico Umberto I - "La Sapienza" University of Rome, Italy ~ Roma ~ Italy)
Introduction:
To report early clinical and technical outcomes, after CE Mark approval in August 2020, of endovascular aneurysm repair (EVAR) with the new Ovation Alto stent-graft in our University Hospital Center.
Methods:
Seven patients underwent EVAR with Ovation Alto stent-graft between June 2021 and February 2022. All EVAR procedures were performed by a vascular team of surgeons with EVAR experience with previous Ovation platform. All patients were male, with a mean age of 76,1±6.2 years. Hostile proximal aortic neck was present in all cases; narrow iliac arteries (<6 mm) were present in two patients. None of the enrolled patients was eligible to on-label EVAR with conventional devices. All patients had complex aortic neck anatomy that was judged feasible only for Ovation Alto stent-graft. Surgeons' preference was not considered as a reasonable criteria of graft selection. All procedures have been performed inside the instruction for use (IFU) of the device.
Results:
Technical success was achieved in all cases (100%). No type IA/III endoleak were registered at completion angiography. No distal migration occurred. Two distal displacements, defined as a landing distance ≥2 mm of the eight proximal markers of the stent-graft from the lowest renal artery, and/or as a distance ≥10 mm of the center of the proximal polymer-filled ring from the lowest renal artery, were observed, in absence of type IA endoleak at completion angiography and during the follow-up period. The median stent graft landing distance from the lowest renal artery was 1.5 mm (range 0-3,97). Any other graft-related complications occurred. Any significant variation of the proximal aortic neck diameter was observed at six months (p=ns).
Conclusion:
Our early experience shows promising technical and clinical success of the new Ovation Alto stent-graft. Technical improvements may allow to extend the eligibility to standard EVAR, but mid-to-long-term studies and prospective registries are mandatory to evaluate its efficacy and safety.
References:
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