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

Mariani, Carlo; Weijde, Emma van der; Smith, Tim J.; Smeenk, Hans G.; Vos, Jan Albert; Heijmen, Robin H.

doi:10.1016/j.jvs.2018.11.015

Cited by 11 publications

(8 citation statements)

References 13 publications

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“…Finally, retrograde dissection is a devastating complication of TEVAR and the incidence is low overall, but more common as total TEVAR numbers increase. Like Mariani et al, we observed no retrograde dissection [24]. In comparison, other TEVAR studies have reported incidences of 1-2.3% [7,20,22].…”

Section: Plos Onesupporting

confidence: 77%

“…TEVAR outcomes are determined in part by stent-graft deployment accuracy and apposition. As experience with TEVAR grows, so too does the sophistication with which we measure outcomes as well sensitivity to variability in pathology, anatomy and use; the Gore cTAG with an active control deployment system demonstrated 100% accuracy in 20 patients with landing zone �3 and aortic arch types I (n = 1), II (n = 10), and III (n = 9) [24]. The previous generation RelayPlus NBS demonstrated accurate deployment in the aortic arch in 78 patients with a wide variety of thoracic pathologies involving arch zones 2 (44%) and 3 (54%): aortic arch type…”

Section: Discussionmentioning

confidence: 99%

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Early results of a low-profile stent-graft for thoracic endovascular aortic repair

et al. 2020

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Purpose To assess outcomes of a low-profile thoracic stent-graft in the treatment of thoracic aortic pathologies. Methods A retrospective analysis of all consecutive patients with aortic thoracic pathologies treated with the RelayPro device in two university hospitals between October 2018 and July 2019. Results 23 patients (65% men; mean age 63.4 ± 15 years) were treated. Pathologies included aortic dissections (n = 10), 5 residual type A (22%) and 5 type B (22%), 6 degenerative aortic aneurysms (26%), 4 penetrating aortic ulcers (17%), and aortic erosion, intramural hematoma and aortic rupture (n = 1 and 4% in each case). Two cases (9%) were emergent and two urgent. Proximal landing was achieved in zones 0 (4%), 1 (4%), 2 (43%), and 3 (26%). Five grafts were frozen elephant trunk extensions. Technical success was 100% with accurate device deployment in the intended landing zone of the aortic arch in all 23 patients and with no Ia/III endoleaks and three (13%) type II endoleaks. Apposition was adequate in 96%. Two patients had post-implantation syndromes (one fever, one leukocytosis). Mean follow-up was 11.6 ± 3.7 months (range, 2–16) with no other complications, secondary interventions or conversions to open surgery. There was no 30-day mortality and no aortic-related mortality; all-cause mortality was 4% during follow-up. Conclusion A 3–4 French reduced profile in the current generation of stent-grafts facilitates TEVAR particularly in patients with smaller vessels access. Early safety and effectiveness outcomes are favorable, even in endpoints such as deployment accuracy and apposition which may be surrogates for longer-term clinical success and durability.

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Section: Plos Onesupporting

confidence: 77%

Section: Discussionmentioning

confidence: 99%

Early results of a low-profile stent-graft for thoracic endovascular aortic repair

et al. 2020

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“…Accordingly, no bird-beak configuration was observed in the current cohort, and the rate of type Ia endoleak was low even though half of the endografts were implanted in zones 0 to 2. Mariani et al 12 reported the early results of the CTAG in 30 patients; they achieved a 100% technical success rate without type Ia endoleak, bird-beak configuration, or retrograde aortic arch dissection. The Conformable GORE TAG Endoprosthesis European Registry for thoracic arch pathologies found a comparable technical success of 92% and a low (4%) endoleak rate.…”

Section: Discussionmentioning

confidence: 99%

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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“…26,27 This has been reported to reduce rates of EL-Ia, at least in “suitable” TAA with sufficient PLZ. 28,29 On the other hand, justified doubt remains regarding the durability of oIFU–LZ as FU is usually limited, especially in real-world studies.…”

Section: Discussionmentioning

confidence: 99%

Outcomes of thoracic endovascular aortic repair in thoracic aortic aneurysm and penetrating aortic ulcer using the Conformable Gore TAG within and outside the instructions for use

et al. 2020

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Objective To describe the outcome of thoracic endovascular aortic repair (TEVAR) in thoracic aortic aneurysm and penetrating aortic ulcer with respect to instructions for use status. Methods Between October 2009 and September 2017, a total of 532 patients underwent TEVAR; of which 195 have been treated using the Conformable GORE® TAG® thoracic endoprosthesis (CTAG). Fifty-six patients of this cohort underwent TEVAR for thoracic aortic aneurysm/penetrating aortic ulcer using the CTAG. Depending on the preoperative computed tomography angiography findings, patients were classified as inside or outside the device’s instructions for use. All inside instruction for use patients underwent postoperative reclassification regarding the instructions for use status. Study endpoints included TEVAR-related reintervention, exclusion of the pathology (endoleak type I/III), TEVAR-related mortality, and graft-related serious adverse events. The median duration of follow-up was 29.7 months (range: 0–109.4 months). Results Of the 56 patients, 17 were primarily classified as outside instruction for use, and in additional 13 patients, TEVAR was performed outside instruction for use, leading to 30 outside instruction for use patients (53.6%). Twenty-six patients (46.4%) were treated inside instruction for use. Reintervention-free survival was lower in outside instruction for use patients ( P = 0.016) with a hazard ratio of 9.74 (confidence interval 1.2–80.2; P = 0.034) for TEVAR-related reintervention. With respect to endoleak type I/III, relevant difference was detected between inside/outside instruction for use status ( P = 0.012). The serious adverse event rate was 30.4%, mainly in outside instruction for use patients ( P = 0.004). Logistic regression analysis indicated an association between graft-related serious adverse event/instructions for use status (odds ratio 6.11; confidence interval 1.6–30.06; P = 0.012). In-hospital death was seen more frequently in outside instruction for use patients ( P = 0.12) as was procedure-related death (log-rank test: P = 0.21). Conclusion TEVAR for thoracic aortic aneurysm/penetrating aortic ulcer is frequently performed outside instruction for use despite preoperative inside instruction for use eligibility, leading to important consequences for technical/clinical outcome. Instructions for use adherence in TEVAR should be of interest for further large-scale studies.

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

Cited by 11 publications

References 13 publications

Early results of a low-profile stent-graft for thoracic endovascular aortic repair

Early results of a low-profile stent-graft for thoracic endovascular aortic repair

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

Outcomes of thoracic endovascular aortic repair in thoracic aortic aneurysm and penetrating aortic ulcer using the Conformable Gore TAG within and outside the instructions for use

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