Worldwide results from the RESTORE II on elective endografting of thoracic aneurysms and dissections

Zipfel, Burkhart; Zaefferer, Patricio; Riambau, Vicenç; Szeberin, Zoltán; Weigang, Ernst; Menéndez, Marcelo; Funovics, Martin; Hamady, Mohamad; Rousseau, Hervé; Marine, L; Kiskinis, Dimitrios; Bonneville, J. F.; Kratimenos, Theodoros; Nano, Giovanni; Kato, Masaaki; Gasparini, Daniele; Teebken, Omke E.; Mangialardi, Nicola; Coppi, Gioacchino; Hoksbergen, Arjan W.J.; Heijmen, Robin H.

doi:10.1016/j.jvs.2015.12.032

Cited by 22 publications

(6 citation statements)

References 19 publications

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“…The RESTORE registries evaluated the use of Bolton Medical’s RELAY thoracic stent-graft. 18,19 The rate of aortic arch involvement (44% landing zone 0 to 2), technical success (97.7%), and type I endoleak (3.9%) in RESTORE I was comparable to our cohort. 18 Similar results were reported in RESTORE II.…”

Section: Discussionsupporting

confidence: 68%

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One-Year Results From the SURPASS Observational Registry of the CTAG Stent-Graft With the Active Control System

et al. 2020

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Purpose: To report the outcomes from the observational SURPASS registry, which was created to assess the performance of the Conformable TAG (CTAG) stent-graft with the Active Control System (ACS) in patients undergoing thoracic endovascular aortic repair (TEVAR) in a real-world setting. Materials and Methods: The SURPASS registry ( ClinicalTrials.gov; identifier NCT03286400) was an observational, prospective, single-arm, post-market, international study that enrolled patients undergoing TEVAR using the CTAG with ACS for both acute and chronic thoracic aortic disease between October 2017 and July 2018. The CTAG with ACS features 2-stage deployment of the stent-graft and an optional angulation mechanism that modifies only the proximal end of the stent-graft. During the observation period, 127 patients (mean age 67.1±12.1 years, range 27–86; 92 men) were enrolled and treated for an array of aortic pathologies, including chronic and acute lesions and 4 ruptured descending thoracic aneurysms. The primary outcome of this study was technical success; secondary outcomes were clinical success and major adverse events at 30 days and 12 months. The numbers of 2-stage device deployments and applications of the angulation mechanism were recorded, along with the reasons for use. Results: Technical success of the TEVAR was 97.6% owing to unintentional partial coverage of supra-aortic branches in 3 cases (the vessels were patent on imaging). The stent-graft was repositioned at its intermediate diameter in 79 patients (62.2%), and the angulation feature was applied in 64 cases (50.4%), mainly to improve proximal wall apposition and orthogonality in the aorta. The desired effect was achieved in 60 cases (93.8%). There was no device compression, bird-beak configuration, fracture, or graft occlusion. The 30-day and 12-month clinical success rates were 97.6% and 92.9%, respectively. There were 3 aorta-related deaths at 30 days and a further 3 at 12 months. Fatalities were due to a retrograde type A dissection (0.8%), paraplegia, bowel ischemia, sepsis in the setting of a mycotic aneurysm, aneurysm rupture post aortoesophageal fistula, and multiorgan dysfunction syndrome. Three endoleaks (2 type Ia and 1 type III) required reintervention. Conclusion: In the SURPASS registry, the use of the CTAG device with ACS showed promising outcomes despite the challenging pathologies. The new delivery system enables a controlled staged delivery with in situ adjustments during positioning, facilitating the treatment of complex aortic disease.

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Section: Discussionsupporting

confidence: 68%

“…18 Similar results were reported in RESTORE II. 19 Migration rates were low at 2.6% and 2.3% for RESTORE I and II, respectively.…”

Section: Discussionmentioning

confidence: 88%

One-Year Results From the SURPASS Observational Registry of the CTAG Stent-Graft With the Active Control System

et al. 2020

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“…1,2 Nonetheless, endovascular management may still be demanding in many settings, such as in acute arch angulation, that may result in malalignment at the concavity of the aortic arch, risking the so-called birdbeak effect and hence endoleak (EL), and in the case of aortic arch branch involvement at the proximal landing zone (LZ; preferably at least 2 cm long) that may result in inadvertent (partial) obstruction when deployment is not precise. 3,4 These anatomic characteristics are often encountered, for example, in type B aortic dissection patients.…”

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confidence: 99%

The GORE TAG conformable thoracic stent graft with the new ACTIVE CONTROL deployment system

Mariani

Weijde

Smith

et al. 2019

Journal of Vascular Surgery

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“…The scalloped stent-graft is a customized version of the RELAY Plus stent-graft (Bolton Medical), which is a widely available Conformité Européenne–marked device. 18 Although the dimensions of the custom-made Relay scalloped stent-grafts vary, the basic structure and materials used for these devices are the same as in the standard Relay Plus and Relay NBS Plus stent-grafts. They are all composed of a series of self-expanding nitinol springs, stacked in tubular configuration, and sutured to low porosity vascular polyester graft material.…”

Section: Methodsmentioning

confidence: 99%

Results From a Nationwide Registry on Scalloped Thoracic Stent-Grafts for Short Landing Zones

Weijde

Bakker

Tielliu³

et al. 2016

J Endovasc Ther

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Worldwide results from the RESTORE II on elective endografting of thoracic aneurysms and dissections

Abstract: The worldwide results of the RESTORE II registry show the safety and effectiveness of RELAY and RELAY NBS stent grafts for elective endovascular thoracic aortic repair. Compared with the RESTORE registry, the device presents a lower rate of perioperative complications.

Cited by 22 publications

References 19 publications

One-Year Results From the SURPASS Observational Registry of the CTAG Stent-Graft With the Active Control System

One-Year Results From the SURPASS Observational Registry of the CTAG Stent-Graft With the Active Control System

The GORE TAG conformable thoracic stent graft with the new ACTIVE CONTROL deployment system

Results From a Nationwide Registry on Scalloped Thoracic Stent-Grafts for Short Landing Zones

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