Initial Clinical Experience With the Zenith Alpha Stent-Graft

Torsello, Giovanni; Austermann, Martin; Aken, Hugo K. Van; Torsello, Giovanni; Panuccio, Giuseppe

doi:10.1177/1526602815573239

Cited by 9 publications

(14 citation statements)

References 29 publications

(43 reference statements)

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“…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: 68%

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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: 88%

Section: Discussionsupporting

confidence: 68%

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

et al. 2020

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“…In our experience, the Zenith Alpha stent-graft could be implanted where previous attempts with other grafts had failed. 6 The rate of percutaneous access was markedly higher in our study compared to the TX-2 study (86.4% vs 2.5%). Moreover, the proportion of female patients was greater in our study (43.2% vs 28.1%).…”

Section: Discussioncontrasting

confidence: 61%

“…In patients with aortic aneurysms, narrow and calcified access vessels can lead to greater morbidity or even to treatment failure in standard-profile stent-grafts. 6 Moreover, compared with EVAR, the proportion of young, female, and Asian patients requiring TEVAR is greater. 3 As these patients have smaller access vessels, 4 this subgroup of patients is subjected to a higher incidence of access vessel complications and thus greater morbidity.…”

Section: Discussionmentioning

confidence: 99%

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Long-term Results of Thoracic Endovascular Aortic Repair Using a Low-Profile Stent-Graft

et al. 2020

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Purpose To evaluate the long-term results associated with the Zenith Alpha thoracic stent-graft, which was designed to address challenging access vessel anatomy. Materials and Methods A retrospective analysis was conducted of 44 consecutive patients (mean age 72.5±8.3 years; 25 men) treated in a single center between August 2010 and October 2014 with a minimum follow-up of 5 years in survivors. The Zenith Alpha thoracic stent-graft was used to treat thoracic aortic aneurysms (n=37), thoracoabdominal aortic aneurysm (n=5), or penetrating aortic ulcer (n=2). Ten patients (23%) were American Society of Anesthesiologists class IV, and 9 (20%) had nonelective procedures. Access vessel anatomy was demanding (mean minimum diameter 5.4 mm, tortuosity index 1.3). The primary endpoint at 5 years was ongoing clinical success (freedom from aneurysm-/procedure-related death, secondary intervention, type I or III endoleak, infection, thrombosis, aneurysm expansion, rupture, or conversion). Secondary endpoints were freedom from all-cause mortality, device migration, stent fractures, fabric erosions, endoleaks, neurological events, and access vessel complications. Results The ongoing clinical success was 84% (37 of 44 patients) owing to 4 aneurysm-related deaths (9%), 3 type I or III endoleaks (1 in a deceased patient), and 1 aneurysm expansion without detectable endoleak. There were 3 access vessel complications (7%), and no postoperative neurological events. Migration was observed in 2 cases (5%). There were no stent fractures or fabric tears. Conclusion Despite the alterations in stent-graft design and material to reduce profile, the Zenith Alpha thoracic stent-graft showed favorable long-term results even in multimorbid patients with demanding iliac anatomy.

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Thoracic Endovascular Aortic Repair

Torsello¹

2018

Endovascular Treatment of Aortic Aneurysms

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Initial Clinical Experience With the Zenith Alpha Stent-Graft

Abstract: The new Zenith Alpha appears to be equally as safe and efficacious as the Zenith TX-2 while being used in patients with demanding access vessel morphology.

Cited by 9 publications

References 29 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

Long-term Results of Thoracic Endovascular Aortic Repair Using a Low-Profile Stent-Graft

Thoracic Endovascular Aortic Repair

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