One-Year Single-Center Results of the Multilayer Flow Modulator Stents for the Treatment of Type B Aortic Dissection.

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.

Geometric Analysis of Type B Aortic Dissections Shows Aortic Remodeling After Intervention Using Multilayer Stents.

Recently, multilayer stents for type B aortic dissections (TBAD) have been proposed to decrease false lumen flow, increase and streamline true lumen flow, and retain branch vessel patency. We aimed to provide a protocol with standardized techniques to investigate aortic remodeling of TBAD by multilayer flow modulators (MFM) in static geometric and hemodynamic analyses. Combining existing literature and new insights, a standardized protocol was designed. Using pre- and postoperative CT scans, geometric models were constructed, lumen dimensions were calculated, computational fluid dynamics (CFD) models were composed, and velocity and pressures were calculated. Sixteen TBAD cases treated with MFM were included for analysis. For each case, aortic remodeling was analyzed using post-processing medical imaging software. After 3D models were created, geometrical anatomical measurements were performed, and meshes for finite element analysis were generated. MFM cases were compared pre- and postoperatively; true lumen volumes increased (p < 0.001), false lumen volumes decreased (p = 0.001), true lumen diameter at the plane of maximum compression (PMC) increased (p < 0.001), and false lumen index decreased (p = 0.008). True lumen flow was streamlined, and the overall fluid velocity and pressures decreased (p < 0.001 and p = 0.006, respectively). This protocol provided a standardized method to evaluate the effects of MFM treatments in TBAD on geometric analyses, PMC, and CFD outcomes.

Aortic Remodeling After Total Endovascular Aortic Repair With Multilayer Stents: Computational Fluid Dynamics Analysis of Aortic Remodeling Over 3 Years of Follow-up.

PURPOSE: To report Multilayer Flow Modulator (MFM) implantation from the sinotubular junction to the distal infrarenal aorta in the treatment of type B aortic dissection (TBAD) and demonstrate aortic remodeling using computational fluid dynamics (CFD) analysis over the course of 3-year follow-up. CASE REPORT: A hypertensive patient with complicated TBAD required thoracic endovascular aortic repair due to severe thoracic pain associated with rapid progression of the false lumen aneurysm toward the distal aortic arch. Under general anesthesia, 2 aortic multilayer stents were placed over a 0.035-inch stiff guidewire in the compressed true lumen. The aorta was covered with 2 MFM stents between the sinotubular junction and the distal infrarenal aorta. Serial computed tomography scans showed progressive remodeling of the entire dissected aortic wall, with an excellent result at 24 months. Morphological and CFD vascular analysis confirmed the aortic remodeling, with a false lumen index drop from a preoperative 4.04 to 0.01 at 36 months. CONCLUSION: Endovascular aortic repair with multilayer stents is a promising treatment for complicated TBAD due to the unique ability of these devices to stabilize the entire aortic wall without compromising the flow in the major aortic side branches.