Global Post-Market Clinical Follow-up of the Treovance Stent-Graft for Endovascular Aneurysm Repair: One-Year Results From the RATIONALE Registry

Uberoi, Raman; Setacci, Carlo; Lescan, Mario; Lorido, Antonio; Murray, David; Szeberin, Zoltán; Zubilewicz, Tomasz; Riambau, Vincent; Chartrungsan, Angsu; Teßarek, J.; Iłżecki, Marek; Gortz, Hartmuth; Thenholt, Matthias; Fattoum, Maher; Buz, Semih; Cao, Piergiorgio; Benevento, Domenico; Palasciano, Giancarlo; Abdallah, Feras F.; Boyle, John; Pujol, S. Llagostera; Esteban, Carlos; Mosquera, Nilo J.; Sanus, E. Aracil; Negreira, Ignacio Iglesias; Raymakers, J.T.; Herwaarden, Joost van; Pitoulias, Georgios A.; Kratimenos, Theodoros; Wahlgren, Carl Magnus; Forssell, Claes; Fulton, Greg; Lönn, Lars; Pedersen, G.; Vergara, Jorge; Silva, Manuel Espindola; Cheng, Swk; Anh, Phan Minh; Calderas, Carlos; Bohan, Patrick

doi:10.1177/1526602818803939

Cited by 13 publications

(6 citation statements)

References 36 publications

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“…In the RATIONALE ( 52 ) (global postmarket registry for the Treovance stent graft 2018) postmarket approval registry evaluated, clinical success (96%), a secondary intervention rate (3.5%), reduction in the aneurysm sac size of 5 mm (40%), absent 30-day mortality, rupture migration of the endograft were accessed. After 1 year of follow-up, 8 (4%) reinterventions were required and 13 (6.4%) patients died, but none of these deaths was aneurysm-related.…”

Section: Resultsmentioning

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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Section: Resultsmentioning

confidence: 99%

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

2022

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“…Recent design modifications have been introduced to overcome limitations regarding proximal neck anatomy and thereby expanding indications [ 24 ]. The current suprarenal fixation platforms, Treovance® (Terumo Aortic, Sunrise, FLA, USA) and Endurant II® (Medtronic Cardiovascular, Santa Rosa, CA, USA) are currently indicated to treat infrarenal necks up to 75° [ 25 , 26 ]. Moreover, the indication is expanded up to 90° with infrarenal platforms as Anaconda® (Terumo Aortic, Glasgow, UK), Aorfix® (Lombard Medical, Didcot, UK) and Conformable C3 device® (WL Gore & Associates, Flagstaff, AZ, USA).…”

Section: Discussionmentioning

confidence: 99%

A meta-analysis of safety and efficacy of endovascular aneurysm repair in aneurysm patients with severe angulated infrarenal neck

et al. 2022

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Objectives A growing number of abdominal aortic aneurysms with severe angulated neck anatomy is treated by endovascular means. However, contradictory early and late outcomes have been reported. Our review and outcome analysis attempted to evaluate the available literature and provide clinicians with a base for clinical implementation and future research. Materials and methods A systematic review of the literature was undertaken to identify the outcomes of endovascular aneurysm repair in patients with severe infrarenal neck angulation (SNA ≥ 60°) vs non-severe neck angulation (NSNA). Outcome measures included perioperative complications, type 1a endoleak, neck-related secondary procedures, stent graft migration, aneurysm rupture, increase (>5mm) in sac diameter, all-cause and aneurysm-related mortality (PROSPERO Nr.: CRD42021233253). Results Six observational studies reporting on 5981 patients (1457 with SNA and 4524 with NSNA) with a weighted mean follow-up period of 1.8 years were included. EVAR in SNA compared with NSNA was associated with a higher rate of type 1a endoleak at 30 days (4.0% vs 1.8%; p< 0.00001), at 1 year (2.8% vs 1.9%; p<0.03), at 2 years (4.9% vs 2.1%; p< 0.0002), at 3 years (5.6% vs 2.6%; p< 0.0001). The rate of neck-related secondary procedures was significantly higher at 1 year (6.6% vs 3.9%; p<0.05) and at 3 years (13.1% vs 9%; p<0.05). Graft migration, aneurysm sack increase, aneurysm rupture and all-cause mortality were not statistically different at mid-term. Conclusions The use of EVAR in severely angulated infrarenal aortic necks is associated with a high rate of early and mid-term complications. However, aortic related and all-causes mortality are not higher compared to patients with NSNA. Therefore, EVAR should be cautiously used in patients with SNA.

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“…In the December 2018 issue of the JEVT , the RATIONALE registry 4 reports 1-year results from 202 patients treated with the Treovance platform. The authors show favorable results, with both technical and clinical success in 96% of patients, 1-year freedom from reintervention of 95.6%, and 1-year freedom from type I/III endoleak of 95.5%.…”

mentioning

confidence: 99%

Favorable Results of the RATIONALE Registry: Are They Comparable?

Georgakarakos

Pitoulias

2018

J Endovasc Ther

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Global Post-Market Clinical Follow-up of the Treovance Stent-Graft for Endovascular Aneurysm Repair: One-Year Results From the RATIONALE Registry

Cited by 13 publications

References 36 publications

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

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

A meta-analysis of safety and efficacy of endovascular aneurysm repair in aneurysm patients with severe angulated infrarenal neck

Favorable Results of the RATIONALE Registry: Are They Comparable?

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