Abstract:Objective: The Valiant Navion stent graft system (Medtronic, Santa Rosa, Calif) is a new iteration of a thoracic endograft for the treatment of descending thoracic aortic aneurysms. Herein, the 30-day primary safety and efficacy outcomes and secondary end points are presented.
Methods:The Valiant EVO global clinical trial is a prospective, nonrandomized, single-arm trial. Patient enrollment occurred from April 2016 to October 2017. The primary end point was defined as access and/or deployment failure and/or a … Show more
“…These results are favorable and/or comparable to what has been reported so far with other latest-generation or low-profile devices. There was no 30-day mortality as compared to 2.3%, 9% and 10% reported by other authors [20,22,23]. We saw no aortic rupture or stent fractures, again in line with the low incidences reported to date (1% and 1.1% for rupture and 0.9% for fracture) [20][21][22].…”
Section: Plos Onesupporting
confidence: 88%
“…There were no adjunctive techniques in this series despite a mean access vessel diameter of 7.7 ± 1.32 mm (range 0.5-1); compared with 9.1 (6-13) mm previously reported with RelayPro [10]. Most patients had severe iliac and aortic tortuosity but there was no vessel-access related complication in this series, confirming a generally low incidence with all the low-profile devices reported so far: 3% [23], 5.7% [20], 6% [10] and 7% [22].…”
Section: Discussionsupporting
confidence: 72%
“…Almost 90% of implants were percutaneous in a later study of 70 patients treated with the Zenith Alpha and 22.3 ± 15.9 months follow-up: 6% required balloon dilation of the iliac arteries, 4% required iliofemoral conduit: 4% had access vessel complications [19]. In 87 patients (40% female) treated with the Valiant Navion, 51% were accessed percutaneously, four patients required iliac stenting and there was no access or deployment failure [20]. In a European multicenter registry of 100 patients treated with a Gore cTAG (18-24F), iliac conduits were needed in 5% of patients [22].…”
Section: Discussionmentioning
confidence: 99%
“…Much progress to lower profile stent-grafts has already been made and the Cook Medical Zenith Alpha and Medtronic Valiant Navion (both 18-22/23F outer diameter) have demonstrated encouraging early and midterm results [19,20]. In a prospective study of 110 patients (42% women, 38% Asian) treated with the Zenith Alpha, mean access vessel diameter was 6.7 ±1.6 mm and 36% of implants were percutaneous [21].…”
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.
“…These results are favorable and/or comparable to what has been reported so far with other latest-generation or low-profile devices. There was no 30-day mortality as compared to 2.3%, 9% and 10% reported by other authors [20,22,23]. We saw no aortic rupture or stent fractures, again in line with the low incidences reported to date (1% and 1.1% for rupture and 0.9% for fracture) [20][21][22].…”
Section: Plos Onesupporting
confidence: 88%
“…There were no adjunctive techniques in this series despite a mean access vessel diameter of 7.7 ± 1.32 mm (range 0.5-1); compared with 9.1 (6-13) mm previously reported with RelayPro [10]. Most patients had severe iliac and aortic tortuosity but there was no vessel-access related complication in this series, confirming a generally low incidence with all the low-profile devices reported so far: 3% [23], 5.7% [20], 6% [10] and 7% [22].…”
Section: Discussionsupporting
confidence: 72%
“…Almost 90% of implants were percutaneous in a later study of 70 patients treated with the Zenith Alpha and 22.3 ± 15.9 months follow-up: 6% required balloon dilation of the iliac arteries, 4% required iliofemoral conduit: 4% had access vessel complications [19]. In 87 patients (40% female) treated with the Valiant Navion, 51% were accessed percutaneously, four patients required iliac stenting and there was no access or deployment failure [20]. In a European multicenter registry of 100 patients treated with a Gore cTAG (18-24F), iliac conduits were needed in 5% of patients [22].…”
Section: Discussionmentioning
confidence: 99%
“…Much progress to lower profile stent-grafts has already been made and the Cook Medical Zenith Alpha and Medtronic Valiant Navion (both 18-22/23F outer diameter) have demonstrated encouraging early and midterm results [19,20]. In a prospective study of 110 patients (42% women, 38% Asian) treated with the Zenith Alpha, mean access vessel diameter was 6.7 ±1.6 mm and 36% of implants were percutaneous [21].…”
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.
“…However, the anatomy of the included patients was not particularly demanding in terms of landing zone, tortuosity, or calcification. 16 In a midterm evaluation of a single-center experience of 70 patients treated with Cook's Zenith Alpha thoracic stentgraft, ongoing clinical success was 87.1% at a mean followup of 22.3 months. 17 However, there is no information on the exact localization of the aortic pathologies.…”
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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