Early outcomes with a single-sided access endovascular stent
Michael Hofmann, Felice Pecoraro, David Planer, Thomas Pfammatter, Gilbert Puippe, Dominique Bettex, Frank J Veith, Mario Lachat, Lyubov Chaykovska, FIM and PIVOTAL trialists, Ralf Kolvenbach, Jan Brunkwall, Gioacchino Coppi, Roberto Chiesa, Roberto Silingardi, Enrico Vecchiati, Franco Nessi, Marc Van Sambeek, Lazar Davidovic, Djordje Radak, Michael Hofmann, Felice Pecoraro, David Planer, Thomas Pfammatter, Gilbert Puippe, Dominique Bettex, Frank J Veith, Mario Lachat, Lyubov Chaykovska, FIM and PIVOTAL trialists, Ralf Kolvenbach, Jan Brunkwall, Gioacchino Coppi, Roberto Chiesa, Roberto Silingardi, Enrico Vecchiati, Franco Nessi, Marc Van Sambeek, Lazar Davidovic, Djordje Radak
Abstract
Objective: The objective of this study was to report the 1-year follow-up study results of the new Horizon stent graft (Endospan, Herzliya, Israel) from two different prospective consecutive trials. The Horizon abdominal aortic aneurysm stent graft system is a 14F profile system requiring only a single access site. It consists of three modules, introduced separately: base limb (iliac to iliac limb); distal aortic limb; and proximal aortic limb with a bare suprarenal crown and active fixation.
Methods: Data from the first in man (FIM) clinical study with 10 patients enrolled and the pivotal study with 30 patients were analyzed. Outcomes measured were freedom from major adverse events (MAEs) including all-cause mortality, myocardial infarction, renal failure, respiratory failure, paraplegia, stroke, bowel ischemia, and procedural blood loss ≥1000 mL. Performance end points included successful delivery and deployment of the device, freedom from aneurysm growth ≥5 mm, type I or type III endoleak, stent graft occlusion, conversion to open surgery, rupture, and stent graft migration.
Results: In the FIM study, one conversion to open surgery with >1000 mL of blood loss was registered perioperatively. In the pivotal study, no perioperative MAE was registered. Overall, at 1-year follow-up, two deaths and one aneurysm growth unrelated to endoleak were registered.
Conclusions: The results of both the FIM and pivotal studies demonstrated that 39 of 40 procedures were successful for delivery and deployment of the Horizon stent graft. No MAE was registered during the follow-up. The primary safety and performance end points were met in both studies.
Trial registration: ClinicalTrials.gov NCT02087501.
Copyright © 2018 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.
Source: PubMed