TY - JOUR
T1 - One-Year Single-Center Results of the Multilayer Flow Modulator Stents for the Treatment of Type B Aortic Dissection
AU - Costache, Victor S.
AU - Meekel, Jorn P.
AU - Costache, Andreea
AU - Melnic, Tatiana
AU - Bucurenciu, Cristian
AU - Chitic, Anca
AU - Candea, Gabriela
AU - Solomon, Crina
AU - Yeung, Kak K.
N1 - Funding Information: The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This work was supported by the Competitiveness Operational Programme 2014–2020, financed by the European Regional Development Fund, and by the Romanian Government under the project “Next generation computer aided research in cardiovascular disease management–NextCARDIO,” project code: COP P_37_701. Publisher Copyright: © The Author(s) 2020. Copyright: Copyright 2021 Elsevier B.V., All rights reserved.
PY - 2021/2
Y1 - 2021/2
N2 - Purpose: To report a single-center series of patients with type B aortic dissection treated with the Multilayer Flow Modulator (MFM). Materials and Methods: Over a 36-month period, 23 patients (median age 53 years; 20 men) with complicated type B aortic dissections (2 acute, 5 subacute, and 16 chronic) were treated with the MFM. Primary endpoints of rupture or dissection-related death, overall mortality, and reintervention were evaluated using the Kaplan-Meier method; estimates for freedom from the endpoints are reported with the 95% confidence interval (CI). Secondary outcomes included technical success, adverse events, and aortic remodeling. Clinical and imaging data were collected preoperatively, directly postoperatively, and annually to 36 months for analysis using computational fluid dynamics (CFD). Results: Initial technical success was 91.3%. The estimates of the endpoints at 12 months were 100% for freedom from rupture or aortic-related death, 95.7% for freedom from overall mortality, and 91.3% for freedom from reintervention. No device-related neurological or systemic complications occurred, and no additional reinterventions were needed during follow-up. A total of 144 branches overstented by the MFM remained patent. Morphologic analysis of the aortic dissection showed progressive true lumen volume increase (75.9%, p<0.001) with concomitant false lumen volume decrease (42.8%, p<0.001); the CFD analyses showed increased laminar flow. Conclusion: In the current series, the MFM provided a safe and feasible treatment option for complicated acute, subacute, and chronic type B aortic dissections, with high technical success, low mortality, and active aortic remodeling. Further studies should elucidate the long-term safety of the MFM and its effectiveness in a larger patient cohort.
AB - Purpose: To report a single-center series of patients with type B aortic dissection treated with the Multilayer Flow Modulator (MFM). Materials and Methods: Over a 36-month period, 23 patients (median age 53 years; 20 men) with complicated type B aortic dissections (2 acute, 5 subacute, and 16 chronic) were treated with the MFM. Primary endpoints of rupture or dissection-related death, overall mortality, and reintervention were evaluated using the Kaplan-Meier method; estimates for freedom from the endpoints are reported with the 95% confidence interval (CI). Secondary outcomes included technical success, adverse events, and aortic remodeling. Clinical and imaging data were collected preoperatively, directly postoperatively, and annually to 36 months for analysis using computational fluid dynamics (CFD). Results: Initial technical success was 91.3%. The estimates of the endpoints at 12 months were 100% for freedom from rupture or aortic-related death, 95.7% for freedom from overall mortality, and 91.3% for freedom from reintervention. No device-related neurological or systemic complications occurred, and no additional reinterventions were needed during follow-up. A total of 144 branches overstented by the MFM remained patent. Morphologic analysis of the aortic dissection showed progressive true lumen volume increase (75.9%, p<0.001) with concomitant false lumen volume decrease (42.8%, p<0.001); the CFD analyses showed increased laminar flow. Conclusion: In the current series, the MFM provided a safe and feasible treatment option for complicated acute, subacute, and chronic type B aortic dissections, with high technical success, low mortality, and active aortic remodeling. Further studies should elucidate the long-term safety of the MFM and its effectiveness in a larger patient cohort.
KW - acute complicated dissection
KW - aortic remodeling
KW - false lumen
KW - lumen volume
KW - multilayer stent
KW - true lumen
KW - type B aortic dissection
UR - http://www.scopus.com/inward/record.url?scp=85090139357&partnerID=8YFLogxK
U2 - https://doi.org/10.1177/1526602820950720
DO - https://doi.org/10.1177/1526602820950720
M3 - Article
C2 - 32873130
SN - 1526-6028
VL - 28
SP - 20
EP - 31
JO - Journal of endovascular therapy
JF - Journal of endovascular therapy
IS - 1
ER -