Objective: In recent years, manufacturers have developed new stent grafts with lower profiles to increase the endovascular aneurysm repair applicability. As reported by the current European Society for Vascular Surgery guidelines, long-term evaluation of such low-profile platforms is strongly recommended. This study aims to report outcomes beyond 5 years from a multicenter registry, including a real-world cohort of patients electively treated with low-profile stent grafts. Methods: A retrospective data collection of patients who had undergone elective implantation of low-profile endograft ≤16 Fr. (Zenith LP, Ovation, Incraft) was performed in nine centers. The primary endpoint was a long-term primary clinical success. Secondary endpoints were survival rate, freedom from abdominal aortic aneurysm (AAA)-related death, freedom from type I to III endoleak, limb patency, and freedom from all reinterventions. The Kaplan-Meier curves were stratified for investigative devices. A multivariate analysis evaluated predictors of primary clinical success and reintervention rate. Results: A total of 619 patients were enrolled (Ovation, n = 373; Incraft, n = 111; and Zenith LP, n = 135), with a mean follow-up of 56.8 ± 22.8 months. The overall primary and the secondary clinical success rate at 8 years was 72.1% and 93.8%, respectively. At 8 years, overall survival was 53.2%, freedom from AAA-related death was 94.4%, freedom from reintervention was 74%, freedom from type I/III endoleak was 86.9%, and limb patency was 90.4%. A significantly worse primary clinical success of the Zenith LP was recorded as dependent on more limb-related events. No differences between platforms were registered in the rate of AAA-related deaths, open conversion, sac enlargement, and type I/III endoleaks (P =.26). Multivariate analysis identified iliac tortuosity (hazard ratio, 2.053) and Zenith LP (hazard ratio, 3.818) as significant independent predictors of clinical failure and reintervention. Conclusions: Low-profile stent grafts have acceptable long-term outcomes. Overall survival and AAA-related death were in line with those reported for traditional devices. Long-term surveillance and reintervention, when necessary, remain crucial to guarantee durability.
de Donato, G., Pasqui, E., Nano, G., Lenti, M., Mangialardi, N., Speziale, F., et al. (2022). Long-term results of treatment of infrarenal aortic aneurysms with low-profile stent grafts in a multicenter registry. JOURNAL OF VASCULAR SURGERY, 75(4), 1242-1252.e2 [10.1016/j.jvs.2021.09.036].
Long-term results of treatment of infrarenal aortic aneurysms with low-profile stent grafts in a multicenter registry
de Donato G.;Pasqui E.;Palasciano G.;Galzerano G.;Ferraro G.
2022-01-01
Abstract
Objective: In recent years, manufacturers have developed new stent grafts with lower profiles to increase the endovascular aneurysm repair applicability. As reported by the current European Society for Vascular Surgery guidelines, long-term evaluation of such low-profile platforms is strongly recommended. This study aims to report outcomes beyond 5 years from a multicenter registry, including a real-world cohort of patients electively treated with low-profile stent grafts. Methods: A retrospective data collection of patients who had undergone elective implantation of low-profile endograft ≤16 Fr. (Zenith LP, Ovation, Incraft) was performed in nine centers. The primary endpoint was a long-term primary clinical success. Secondary endpoints were survival rate, freedom from abdominal aortic aneurysm (AAA)-related death, freedom from type I to III endoleak, limb patency, and freedom from all reinterventions. The Kaplan-Meier curves were stratified for investigative devices. A multivariate analysis evaluated predictors of primary clinical success and reintervention rate. Results: A total of 619 patients were enrolled (Ovation, n = 373; Incraft, n = 111; and Zenith LP, n = 135), with a mean follow-up of 56.8 ± 22.8 months. The overall primary and the secondary clinical success rate at 8 years was 72.1% and 93.8%, respectively. At 8 years, overall survival was 53.2%, freedom from AAA-related death was 94.4%, freedom from reintervention was 74%, freedom from type I/III endoleak was 86.9%, and limb patency was 90.4%. A significantly worse primary clinical success of the Zenith LP was recorded as dependent on more limb-related events. No differences between platforms were registered in the rate of AAA-related deaths, open conversion, sac enlargement, and type I/III endoleaks (P =.26). Multivariate analysis identified iliac tortuosity (hazard ratio, 2.053) and Zenith LP (hazard ratio, 3.818) as significant independent predictors of clinical failure and reintervention. Conclusions: Low-profile stent grafts have acceptable long-term outcomes. Overall survival and AAA-related death were in line with those reported for traditional devices. Long-term surveillance and reintervention, when necessary, remain crucial to guarantee durability.File | Dimensione | Formato | |
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https://hdl.handle.net/11365/1241415