Early Experience with the New Ovation Alto Stent Graft in Endovascular Abdominal Aortic Aneurysm Repair

Donato, Gianmarco de; Pasqui, Edoardo; Panzano, Claudia; Galzerano, G; Cappelli, Alessandro; Palasciano, Giancarlo

doi:10.1016/j.ejvsvf.2021.11.003

Cited by 14 publications

(8 citation statements)

References 9 publications

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“…The mean contrast agent volume used was 172 mL, which was similar to that (180 mL) reported by Holden and Lyden [ 6 ]. The results obtained at the 1-month follow-up in a study by de Donato et al [ 9 ] correspond with those obtained in the present study, including a clinical success rate of 100% with no AAA-related mortalities. Type I or III endoleaks, polymer leakage, endograft migration, and sac expansion were not observed.…”

Section: Discussionsupporting

confidence: 91%

Endovascular Juxtarenal Aortic Aneurysm Repair Using the ALTO Abdominal Stent Graft System: The First Case Series

Efthymiou

Tsimpoukis

Papatsirou

et al. 2022

Vasc Specialist Int

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The ALTO abdominal stent graft system (Endologix Inc., Irvine, CA, USA) is a latest-generation polymer-based device used to treat patients with abdominal aortic aneurysms. The present study describes the first case series of patients with abdominal aortic aneurysms, including two patients with juxtarenal aneurysms, treated using the ALTO stent graft system. Six males were treated using the ALTO device at a single public center. All procedures were uneventful, and the dosimetric results recorded in terms of kerma-area product and fluoroscopy time were similar to those reported in previous studies. At the 1-month follow-up, computed tomography angiography showed no evidence of endoleak, device migration, thrombosis, or structural graft failure. This clinical series demonstrates that the use of the ALTO stent graft system is associated with promising patient outcomes. Lifelong postoperative imaging surveillance may highlight possible late failures and suggest potential graft improvements.

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Section: Discussionsupporting

confidence: 91%

Endovascular Juxtarenal Aortic Aneurysm Repair Using the ALTO Abdominal Stent Graft System: The First Case Series

Efthymiou

Tsimpoukis

Papatsirou

et al. 2022

Vasc Specialist Int

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“…A cohort study of 11 patients who underwent EVAR using Alto ( 47 ) reported the device's great potential in early outcomes, as it achieved 100% clinical success (no type I/III endoleak, sac enlargement, stent graft migration, polymer leakage, AAA related mortality, or secondary intervention) at 1- and 6-month follow-up.…”

Section: Resultsmentioning

confidence: 99%

“…Freedom from secondary interventions was 97.3%, while one patient had a type 1A endoleak and received ballooning and bare metal stent placement for intervention on postoperative day 48, which successfully treated the endoleak. Another patient had a device infection and was converted to A cohort study of 11 patients who underwent EVAR using Alto (47) reported the device's great potential in early outcomes, as it achieved 100% clinical success (no type I/III endoleak, sac enlargement, stent graft migration, polymer leakage, AAA related mortality, or secondary intervention) at 1-and 6month follow-up.…”

Section: Altomentioning

confidence: 99%

Endografts for the treatment of abdominal aortic aneurysms with a hostile neck anatomy: A systematic review

2022

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BackgroundEndovascular aortic repair (EVAR) of abdominal aortic aneurysms (AAAs) has emerged as a better alternative to conventional open surgery for AAAs. The purpose of the review is to define the improvement in the clinical management of the patient with hostile neck AAAs due to the introduction of new endografts while giving a thorough description of their instructions for use (IFUs), main characteristics and part sizing, reporting their outcomes from clinical studies and categorizing their usability.MethodsA MEDLINE search was conducted using keyword-specific combinations. Clinical studies were searched via the clinicaltrials.gov website. Relevant articles' references were also hand-searched.ResultsWe retrieved 640 records describing Alto, Ovation iX, Treovance, Aorfix, Anaconda, Conformable, and Endurant II/IIs endografts. Aortic necks >60° can be managed with Anaconda, Aorfix, and Conformable, which can treat up to 90° necks requiring ≥15 mm (Anaconda ≥20 mm), and Treovance, which is eligible for necks ≤75° with ≥15 mm length. Ovation's innovation of combining polymer-filled O-rings with integral anchors can treat conical necked AAAs giving Ovation iX and Alto an advantage. Short-necked AAAs can be treated with Alto, eligible for necks as short as 7 mm, and Endurant II, which can treat ≥10 mm necks or 4 mm if used in conjunction with the EndoAnchors system, respectively. Alto and Conformable report a 100% technical success rate, absence of AAA-related death, migration, ruptures, and limb occlusion during follow-up. Endurant II and Ovation iX report >99% technical success rate and are almost free from the AAA mortality rate, ruptures, migration, and limb occlusion, while Ovation iX has a high rate of sac dilation (15.5%) in a 5-year follow-up. Anaconda is slightly better than Aorfix and Treovance, which are related to the lowest technical success rates, 98.3%, 96.3%, and 96%, respectively. Aorfix has the highest AAA mortality rate, 4% in a 60 month follow-up.ConclusionMost new generation endografts described have comparable results. They broaden the eligibility of patients for EVAR due to their unique technical characteristics described. There is a lack of comparative studies for newer endografts and postmarket clinical studies with long-term results concerning the most recently approved devices described, Alto and Conformable.

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“…Recently, another initial experience [ 25 ] confirmed the early technical and clinical success of the new Ovation Alto stent graft.…”

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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Early Experience with the New Ovation Alto Stent Graft in Endovascular Abdominal Aortic Aneurysm Repair

Cited by 14 publications

References 9 publications

Endovascular Juxtarenal Aortic Aneurysm Repair Using the ALTO Abdominal Stent Graft System: The First Case Series

Endovascular Juxtarenal Aortic Aneurysm Repair Using the ALTO Abdominal Stent Graft System: The First Case Series

Endografts for the treatment of abdominal aortic aneurysms with a hostile neck anatomy: A systematic review

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

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