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

Sirignano, Pasqualino; Mansour, Wassim; Capoccia, Laura; Cuozzo, Simone; Camparini, Stefano; Donato, Gianmarco de; Mangialardi, Nicola; Ronchey, Silvia; Talarico, Francesco; Setacci, Carlo; Speziale, Francesco

doi:10.4244/eij-d-19-00547

Cited by 5 publications

(3 citation statements)

References 31 publications

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“…All but three studies [ 43 , 60 , 70 ] reported a follow-up period longer than 30 days. Follow-up duration was evaluated by polling the data of the considered study: mean follow-up was 27.38 months (range 1–120, SD ± 23,12; Figure 2 ).…”

Section: Resultsmentioning

confidence: 99%

Is Evar Feasible in Challenging Aortic Neck Anatomies? A Technical Review and Ethical Discussion

Sirignano

Ceruti

Aloisi

et al. 2022

JCM

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Background: Endovascular aneurysm repair (EVAR) has become an accepted alternative to open repair (OR) for the treatment of abdominal aortic aneurysm (AAA) despite “hostile” anatomies that may reduce its effectiveness. Guidelines suggest refraining from EVAR in such circumstances, but in clinical practice, up to 44% of EVAR procedures are performed using stent grafts outside their instruction for use (IFU), with acceptable outcomes. Starting from this “inconsistency” between clinical practice and guidelines, the aim of this contribution is to report the technical results of the use of EVAR in challenging anatomies as well as the ethical aspects to identify the criteria by which the “best interest” of the patient can be set. Materials and Methods: A literature review on currently available evidence on standard EVAR using commercially available endografts in patients with hostile aortic neck anatomies was conducted. Medline using the PubMed interface and The Cochrane Library databases were searched from 1 January 2000 to 6 May 2021, considering the following outcomes: technical success; need for additional procedures; conversion to OR; reintervention; migration; the presence of type I endoleaks; AAA-related mortality rate. Results: A total of 52 publications were selected by the investigators for a detailed review. All studies were either prospective or retrospective observational studies reporting the immediate, 30-day, and/or follow-up outcomes of standard EVAR procedures in patients with challenging neck anatomies. No randomized trials were identified. Fourteen different endo-grafts systems were used in the selected studies. A total of 45 studies reported a technical success rate ranging from 93 to 100%, and 42 the need for additional procedures (mean value of 9.04%). Results at 30 days: the incidence rate of type Ia endoleak was reported by 37 studies with a mean value of 2.65%; 31 studies reported a null migration rate and 32 a null conversion rate to OR; in 31 of the 35 studies that reported AAA-related mortality, the incidence was null. Mid-term follow-up: the incidence rate of type Ia endoleak was reported by 48 studies with a mean value of 6.65%; 30 studies reported a null migration rate, 33 a null conversion rate to OR, and 28 of the 45 studies reported that the AAA-related mortality incidence was null. Conclusions: Based on the present analysis, EVAR appears to be a safe and effective procedure—and therefore recommendable—even in the presence of hostile anatomies, in patients deemed unfit for OR. However, in order to identify and pursue the patient’s best interest, particular attention must be paid to the management of the patient’s informed consent process, which—in addition to being an essential ethical-legal requirement to legitimize the medical act—ensures that clinical data can be integrated with the patient’s personal preferences and background, beyond the therapeutic potential of the proposed procedures and what is generically stated in the guidelines.

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Section: Resultsmentioning

confidence: 99%

Is Evar Feasible in Challenging Aortic Neck Anatomies? A Technical Review and Ethical Discussion

Sirignano

Ceruti

Aloisi

et al. 2022

JCM

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“…Since its appearance in the market in 2010, the Ovation endograft has offered an innovative sealing concept involving a nonexpansive circumferential apposition of inflatable rings filled by a low-viscosity polymer [ 20 ]. The polymer-filled system adapts to the patients’ aortic neck, thus ensuring a continuous, customized concentric seal.…”

Section: Discussionmentioning

confidence: 99%

Endovascular Abdominal Aortic Aneurysm Repair With Ovation Alto Stent Graft: Protocol for the ALTAIR (ALTo endogrAft Italian Registry) Study

Donato¹,

Pasqui²,

Sirignano³

et al. 2022

JMIR Res Protoc

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Background Since 2010, the Ovation Abdominal Stent Graft System has offered an innovative sealing option for abdominal aortic aneurysm (AAA) by including a sealing ring filled with polymer 13 mm from the renal arteries. In August 2020, the redesigned Ovation Alto, with a sealing ring 6 mm closer to the top of the fabric, received CE Mark approval. Objective This registry study aims to evaluate intraoperative, perioperative, and postoperative results in patients treated by the Alto stent graft (Endologix Inc.) for elective AAA repair in a multicentric consecutive experience. Methods All consecutive eligible patients submitted to endovascular aneurysm repair (EVAR) by Alto Endovascular AAA implantation will be included in this analysis. Patients will be submitted to EVAR procedures based on their own preferences, anatomical features, and operators experience. An estimated number of 300 patients submitted to EVAR with Alto stent graft should be enrolled. It is estimated that the inclusion period will be 24 months. The follow-up period is set to be 5 years. Full data sets and cross-sectional images of contrast-enhanced computed tomography scan performed before EVAR, at the first postoperative month, at 24 or 36 months, and at 5-year follow-up interval will be reported in the central database for a centralized core laboratory review of morphological changes. The primary endpoint of the study is to evaluate the technical and clinical success of EVAR with the Alto stent graft in short- (90-day), mid- (1-year), and long-term (5-year) follow-up periods. The following secondary endpoints will be also addressed: operative time; intraoperative radiation exposure; contrast medium usage; AAA sac shrinkage at 12-month and 5-year follow-up; any potential role of patients’ baseline characteristics, valuated on preoperative computed tomography angiographic study, and of device configuration (number of component) in the primary endpoint. Results The study is currently in the recruitment phase and the final patient is expected to be treated by the end of 2023 and then followed up for 5 years. A total of 300 patients will be recruited. Analyses will focus on primary and secondary endpoints. Updated results will be shared at 1- and 3-5-year follow-ups. Conclusions The results from this registry study could validate the safety and effectiveness of the new design of the Ovation Alto Stent Graft. The technical modifications to the endograft could allow for accommodation of a more comprehensive range of anatomies on-label. Trial Registration ClinicalTrials.gov NCT05234892; https://clinicaltrials.gov/ct2/show/NCT05234892 International Registered Report Identifier (IRRID) PRR1-10.2196/36995

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“…Challenging anatomies, vessel calcification and thrombosis, iliac vessel tortuosity and complex aortic neck have represented during time some important issues that technological development and research have faced, in order to increase the feasibility and durability of EVAR [43,44]. Ultimately, neck enlargement and type I and II EL are the drawbacks of traditional EVAR devices, which have justified the search for different technologies to seal the aneurysms based on polymers' use [45][46][47][48].…”

Section: Concept Of Traditional Endovascular Aneurysm Repairmentioning

confidence: 99%

The Polymer-Based Technology in the Endovascular Treatment of Abdominal Aortic Aneurysms

et al. 2021

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An abdominal aortic aneurysm (AAA) is a dilatation of the abdominal aorta that progressively grows until it ruptures. Treatment is typically recommended when the diameter is more than 5 cm. The EVAR (Endovascular aneurysm repair) is a minimally invasive procedure that involves the placement of an expandable stent graft within the aorta to treat aortic disease without operating directly on the aorta. For years, stent grafts’ essential design was based on metallic stent frames to support the fabric. More recently, a polymer-based technology has been proposed as an alternative method to seal AAA. This review underlines the two platforms that are based on a polymer technology: (1) the polymer-filled endobags, also known as Endovascular Aneurysm Sealing (EVAS) with Nellix stent graft; and (2) the O-ring EVAR polymer-based proximal neck sealing device, also known as an Ovation stent graft. Polymer characteristics for this particular aim, clinical applications, and durability results are hereby summarized and commented critically. The technique of inflating endobags filled with polymer to exclude the aneurysmal sac was not successful due to the lack of an adequate proximal fixation. The platform that used polymer to create a circumferential sealing of the aneurysmal neck has proven safe and effective.

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

Cited by 5 publications

References 31 publications

Is Evar Feasible in Challenging Aortic Neck Anatomies? A Technical Review and Ethical Discussion

Is Evar Feasible in Challenging Aortic Neck Anatomies? A Technical Review and Ethical Discussion

Endovascular Abdominal Aortic Aneurysm Repair With Ovation Alto Stent Graft: Protocol for the ALTAIR (ALTo endogrAft Italian Registry) Study

The Polymer-Based Technology in the Endovascular Treatment of Abdominal Aortic Aneurysms

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