Peripheral interventions

Endovascular aortic repair in patients with challenging anatomies: the EXTREME study

EuroIntervention 2021;16:e1544-e1550. DOI: 10.4244/EIJ-D-19-00547

Pasqualino Sirignano
Pasqualino Sirignano1, MD; Wassim Mansour1, MD, PhD; Laura Capoccia1, MD, PhD; Simone Cuozzo1, MD; Stefano Camparini2, MD; Gianmarco de Donato3, MD; Nicola Mangialardi4, MD; Sonia Ronchey5, MD; Francesco Talarico6, MD; Carlo Setacci3, MD; Francesco Speziale1, MD
1. Vascular and Endovascular Surgery Unit, Department of Surgery “Paride Stefanini”, Policlinico Umberto I of Rome, “Sapienza” University of Rome, Rome, Italy; 2. Vascular and Endovascular Surgery Unit, Department of Thoraco-Vascular Surgery, Azienda Ospedaliera Brotzu, Cagliari, Italy; 3. Vascular and Endovascular Surgery Unit, Department of Medicine, Surgery, and Neuroscience, University of Siena, Siena, Italy; 4. Department of Vascular Surgery, “San Camillo Forlanini” Hospital, Rome, Italy; 5. Department of Vascular Surgery, “San Filippo Neri” Hospital, Rome, Italy; 6. Division of Vascular and Endovascular Surgery, Ospedale Civico, Palermo, Italy

Aims: The aim of this study was to report the 30-day technical and clinical success with endovascular repair using the ultra-low-profile Ovation stent graft in patients judged to be outside the instructions for use (IFU) for conventional endografts, while amenable to treatment within the IFU for Ovation.

Methods and results: One hundred and twenty-two patients (78.65±7.67 years; 111 male) were enrolled. Patients were evaluated as being outside the IFU for standard endografts because of the absence of a suitable proximal aortic neck in 109 cases (89.3%), of inadequate access vessels in 13 (10.7%), or both in 111 (90.9%). Mean aneurysm (abdominal aortic aneurysm [AAA]) diameter was 52.96±10.1 mm; mean aortic neck length was 7.75±6.05 mm. Technical success (98.4%) was achieved in all but two patients due to a type Ia endoleak. At completion angiography, 15 (12.3%) patients presented a type II endoleak. All patients underwent 30-day follow-up. Primary clinical success at one month was 96.8%, assisted clinical success 98.4%. There were no type I endoleaks, while 12 (9.8%) type II endoleaks were still evident, in the absence of sac expansions. Two patients (1.6%) presented an asymptomatic limb occlusion.

Conclusions: Our experience suggests that, in a selected population of patients with challenging anatomy outside the IFU for conventional endografts, endovascular aneurysm repair (EVAR) using the Ovation stent graft can be performed safely with satisfactory immediate outcomes.

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clinical trialsabdominal aortic aneurysm stent/prosthesisabdominal aorta aneurysm
Peripheral interventionsAAA
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