Clinical Results and Aortic Remodeling After Endovascular Treatment for Complicated Type B Aortic Dissection With the “Fabulous” Stent System

Abstract

ObjectiveTo report the clinical outcomes and aortic remodeling after the implantation of a self-developed, biomechanically optimized, two-stage thoracic stent system named Fabulous.BackgroundGiven the efficacy of the PETTICOAT concept, the benefits of Fabulous and the behavior of remodeling in different segments need further investigation.MethodsThis is a prospective and multicenter study. From 2017 to 2019, 145 patients (mean age, 56.6 years; 88.3% male) from 14 centers were included in this cohort. The clinical results and core laboratory results were from a central electronic data capture system. Computed tomographic angiography was performed preoperatively, 1 month, 6 months and yearly thereafter and was used for volumetric analysis by 3mensio (Bilthoven, The Netherlands). After the 1-year follow-up, 97.2 and 87.6% of the clinical and imaging results of the eligible patients were available.ResultsBoth stent grafts and bare stents were successfully delivered in place in 100% of the patients. The 30-day mortality and 1-year freedom from all-cause mortality were 2.1 and 96.6%, respectively. The incidence of entry flow was 11.7% at 30 days and 6.2% at 365 days. No cases of stent-induced new entry (SINE) or reintervention were observed. After the 1-year follow-up, the true lumen/overall volume ratio reached 88%. The following subdivided segment volume changes were recorded: stent graft segment TL +56%; FL −92%, bare stent segment TL +32%; FL −75%, and there were no significant changes in the visceral segment.ConclusionsThese outcomes indicated that there were favorable clinical benefits of Fabulous stent system. This device achieved a low short-term mortality and a low incidence of reintervention. In addition, patients undergoing Fabulous stent system implantation showed remodeling both on descending aorta and on the distal aorta. The volume changes in the TL and FL varied in the different segments. The long-term follow-up is still ongoing.

Unraveling the Enigma of Aortic Dissection: From Genetics to Innovative Therapies

“…Bioresorbable stent grafts composed of biocompatible materials offer the potential for tissue regeneration and remodeling in patients with AD. These devices gradually degrade over time, allowing for physiological adaptation of the aorta and reducing the risk of long-term complications such as stent graft migration or infection [ 38 , 39 ]. Advancements in endovascular techniques allow for improved and minimally invasive management of branch vessel involvement in dissections, ensuring adequate blood flow to vital organs.…”

Application of "Fabulous" stent system to improve aortic remodeling after TEVAR for type B aortic dissection

“…All patients enrolled provided written informed consent. The "Fabulous" stent system group was a prospective single-arm study conducted at multicenter between December 2017 and October 2019 comprised of 134 type B aortic dissection (TBAD) patients, [ 3 ] and 159 TBAD patients receiving standard TEVAR from multicenter during the same period were included in control group. Two groups have the consistent inclusion and exclusion criteria, and Inverse Probability Treatment Weighting (IPTW) was used to balance baseline characteristics and analyze the outcomes [Supplementary Table 1, http://links.lww.com/CM9/B504 ].…”