BACKGROUND: Recently, many new approaches have been developed for the treatment of type B aortic dissection (TBAD), among them, endovascular systems have been increasingly used due to lower morbidity and mortality. The MFM self-expandingmultilayer stent (Cardiatis, Belgium) aims at providing extensive structural support of the aortic wall, reopening the true lumen and recentralizing blood flow, while maintaining branch perfusion. The objective of the study was to investigate safety and performance of this multilayer stent in patients with TBAD with malperfusion or high-risk features.
METHODS: In this prospective study approved by applicable Competent Authorities and Ethics Committees, eligible patients who had consented to the study were implanted with ready-to-treat multilayers stents over the length of the aortic dissection. After hospital discharge, patients attended follow-up visits at 1, 6 and 12 months, and annually thereafter. During these follow-ups, clinical evaluations and CT-scans were performed. Following the COVID pandemic, attempts were made to contact all patients for attending follow-up visits in 2022.
RESULTS: 27 patients were enrolled in the study between April 2016 and September 2019. 24 patients meeting study eligibility criteria were treated and 23 (mean age 53 years; 78% male) were discharged from hospital: technical success was 96%, and procedural success was 92%. 18 patients received aortic multilayer stent only, and 5 patients received aortic multilayer stent in combination with grafts or stent grafts. A mean of 2.3 aortic stents were implanted per patient, covering a total of 143 branches including 43 supra-aortic, 59 visceral and 41 renal arteries. Patients attended hospital follow-up visits between August and November 2022. The mean follow-up duration was 55 months (range: 38-76 months). The 5-year overall survival was estimated at 87%. No aortic dissection-related reintervention was required during this period, and there was no device migration, kinking, or loss of integrity documented. No neurological complications, nor symptoms of end-organ ischemia, nor postoperative deterioration in renal function were reported, indicating preserved long-term end-organ perfusion after implantation of the multilayer stent.
CONCLUSIONS: We present here the first long-term outcome data of patients treated with a multilayer stent. The MFM appears to be a safe treatment option for individuals with TBAD, with high procedural success, no aortic dissection-related reintervention and no neurological or ischemic events. These results also show high overall survival and preserved long-term end-organ perfusion in all patients of the study.
