Florian Stefanov

Stent graft performance in the treatment of abdominal aortic aneurysms: The influence of compliance and geometry

The long-term success of the endovascular procedure for the treatment of Abdominal Aortic Aneurysms (AAAs ) depends on the secure fixation of the proximal end and the geometry of the stent-graft (SG) device. Variations in SG types can affect proximal fixation and SG hemodynamics. Such hemodynamic variations can have a catastrophic effect on the vascular system and may result from a SG/arterial wall compliance mismatch and the sudden decrease in cross-sectional area at the bifurcation, which may result in decreased distal perfusion, increased pressure wave reflection and increased stress at the interface between the stented and non-stented portion of the vessel. To examine this compliance mismatch, a commercial SG device was tested experimentally under a physiological pressure condition in a silicone AAA model based on computed tomography scans. There was a considerable reduction in compliance of 54% and an increase in the pulse wave velocity of 21%, with a significant amount of the forward pressure wave being reflected. To examine the SG geometrical effects, a commercial bifurcated geometry was compared computationally and experimentally with a geometrical taper in the form of a blended section, which provided a smooth transition from the proximal end to both iliac legs. The sudden contraction of commercial SG at the bifurcation region causes flow separation within the iliac legs, which is known to cause SG occlusion and increased proximal pressure. The blended section along the bifurcation region promotes a greater uniformity of the fluid flow field within the distal legs, especially, during the deceleration phase with reduced boundary layer reversal. In order to reduce the foregoing losses, abrupt changes of cross-section should be avoided. Geometrical tapers could lead to improved clinical outcomes for AAA SGs.

In vitro evaluation of the effects of intraluminal thrombus on abdominal aortic aneurysm wall dynamics

The optimum time to treat abdominal aortic aneurysms (AAAs) still remains an uncertain issue. The decision to intervene does not take in account the effects that wall curvature, intraluminal thrombus (ILT) properties and thickness have on rupture. The role of ILT in aneurysm dynamics and rupture has been controversial. In vitro testing of four silicone AAA models incorporating the ILT and aortic bifurcation was studied under physiological conditions. Pressures (P) and diameters (D) were analysed for models with and without ILT at different locations. The diametral strain, compliance and P/D curves were influenced by the presence, elastic stiffness and thickness of the ILT. In this case, the inclusion of ILT reduced the lumen area by 77% that resulted in a 0.5-81% reduction in compliance depending on ILT properties. With an increase in ILT stiffness from 0.05 to 0.2 MPa, the compliance was reduced by 81%. In the region of maximum diameter, there was a reduction of diametral strain and compliance except for the softer ILT which was more compliant throughout the proximal region. The shifting of the maximum diametral strain and compliance to the proximal neck was pronounced by an increase in ILT stiffness, thus creating a possible rupture site.

Endovascular management of chronic symptomatic aortic dissection with the Streamliner Multilayer Flow Modulator: Twelve-month outcomes from the global registry

Objective: Reported are initial 12‐month outcomes of patients with chronic symptomatic aortic dissection managed by the Streamliner Multilayer Flow Modulator (SMFM; Cardiatis, Isnes, Belgium). Primary end points were freedom from rupture‐ and aortic‐related death, and reduction in false lumen index. Secondary end points were patency of great vessels and visceral branches, and freedom of stroke, paraplegia, and renal failure. Methods: Out of 876 SMFM implanted globally, we have knowledge of 542. To date, 312 patients are maintained in the global registry, of which 38 patients were identified as having an aortic dissection (12.2%). Indications included 35 Stanford type B dissections, two Stanford type A and B dissections, and one mycotic Stanford type B dissection. Results: There were no reported ruptures or aortic‐related deaths. All cause survival was 85.3% Twelve‐month freedom from neurologic events was 100%, and there were no incidences of end‐organ ischemia, paraplegia or renal insult. Morphologic analysis exhibited dissection remodeling by a reduction in longitudinal length of the dissected aorta, and false lumen volume. A statistically significant reduction in false lumen index (P = .016) at 12 months, and a borderline significant increase in true lumen volume (P = .053) confirmed dissection remodeling. Conclusions: The SMFM is an option in management of complex pan‐aortic dissection. Results highlight SMFM implantation leads to dissection stabilization with no further aneurysm progression, and no retrograde type A dissection. Thoracic endovascular aneurysm repair by SMFM ensued in freedom from aortic rupture, neurologic stroke, paraplegia and renal failure. Further analysis of the global registry data will inform long‐term outcomes.

Computational fluid analysis of symptomatic chronic type B aortic dissections managed with the Streamliner Multilayer Flow Modulator.

Objective: Managing symptomatic chronic type B aortic dissection (SCTBAD) by the Streamliner Multilayer Flow Modulator (SMFM) stent (Cardiatis, Isnes, Belgium) is akin to provisional structural support to induce complete attachment of the dissection flap, but with the ability of aortic remolding. This study investigated the SMFMs capability to enact healing of SCTBAD. Methods: Clinical data for 12 cases comprising preoperative and postoperative treatment of SCTBAD were obtained from a multicenter database hosted by the Multilayer Flow Modulator Global Registry, Ireland. A biomechanical analysis, by means of computational fluid dynamics modeling, of the hemodynamic effects and branch patency associated with the use of the SMFM was performed for all cases. The mean length of the dissections was 30.23 ± 13.3 cm. There were 30 SMFMs used, which covered 69 aortic branches. Results: At 1‐year follow‐up, the true lumen volume increased from 175.74 ± 98.83 cm3 to 209.87 ± 128.79 cm3; the false lumen decreased from 135.2 ± 92.03 cm3 to 123.19 ± 110.11 cm3. The false lumen index decreased from 0.29 ± 0.13 (preoperatively) to 0.21 ± 0.15 (postoperatively). The primary SMFM treatment of SCTBAD increased carotid perfusion by 35% ± 21% (P = .0216) and suprarenal perfusion by 78% ± 32% (P = .001). The wall pressure distribution blended along the newly enlarged true lumen, whereas the false lumen wall pressure decreased by 6.23% ± 4.81% for the primary group (cases 1–7) and by 3.84% ± 2.59% for the secondary group (cases 8–12). Conclusions: SMFM reduces the false lumen wall pressure through flow modulation. It preserves patency of all branches, minimizing the incidence of short‐term complications. The SMFM is a valuable option in managing primary SCTBAD, without midterm complications.

Hemodynamic variations due to spiral blood flow through four patient‐specific bifurcated stent graft configurations for the treatment of abdominal aortic aneurysms

Endovascular repair is now a recognised procedure for treating abdominal aortic aneurysms. However, post-operative complications such as stent graft migration and thrombus may still occur. To assess these complications numerically, the correct input boundary conditions, which include the full human aorta with associated branching, should be included. Four patient-specific computed tomography scanned bifurcated stent grafts (SGs) were modelled and attached onto a full human aorta, which included the ascending, aortic arch and descending aortas. Two of the SG geometries had a twisted leg configuration, while the other two had conventional nontwisted leg configurations. Computational fluid dynamics was completed for both geometries and the hemodynamics assessed. The complexity of the flow patterns and secondary flows were influenced by the inclusion of the full human aorta at the SG proximal section. During the decelerating phase significant recirculations occurred along the main body of all SG configurations. The inclusion of the full human aorta did not impact the velocity contours within the distal legs and there was no difference in drag forces with the SG containing the full human aorta and those without. A twisted leg configuration further promoted a spiral flow formation along its distal legs.

A computational assessment of the hemodynamic effects of crossed and non-crossed bifurcated stent-graft devices for the treatment of abdominal aortic aneurysms

There are several issues attributed with abdominal aortic aneurysm endovascular repair. The positioning of bifurcated stent-grafts (SG) may affect SG hemodynamics. The hemodynamics and geometrical parameters of crossing or non-crossing graft limbs have not being totally accessed. Eight patient-specific SG devices and four pre-operative cases were computationally simulated, assessing the hemodynamic and geometrical effects for crossed (n= 4) and non-crossed (n= 4) configurations. SGs eliminated the occurrence of significant recirculations within the sac prior treatment. Deans number predicted secondary flow locations with the greatest recirculations occurring at the outlets especially during the deceleration phase. Peak drag force varied from 3.9 to 8.7N, with greatest contribution occurring along the axial and anterior/posterior directions. Average resultant drag force was 20% smaller for the crossed configurations. Maximum drag force orientation varied from 1.4° to 51°. Drag force angle varied from 1° to 5° during one cardiac cycle. 44% to 62% of the resultant force acted along the proximal centerline where SG migration is most likely to occur. The clinicians decision for SG positioning may be a critical parameter, and should be considered prior to surgery. All crossed SG devices had an increased spiral flow effect along the distal legs with reductions in drag forces.

Endovascular management of renal artery aneurysms using the multilayer flow modulator

Objective Our aim was to describe our experience of the Multilayer Flow Modulator (MFM, Cardiatis, Isnes, Belgium) used in the treatment of type III renal artery aneurysms (RAA). Methods This is a single-centre study. 3 patients (2 men and 1 woman; mean age 59 years; range 41–77 years) underwent treatment of a type III renal artery aneurysm using the MFM. The indications were a 23.9 mm type III RAA at the bifurcation of the upper and lower pole vessels, with 4 side branches; a 42.4 mm type III saccular RAA at the renal hilum; and a 23 mm type III RAA at the origin of the artery, supplying the upper pole. Results Patients had a mean follow-up of 27 months, and were assessed by perioperative renal function tests, and repeat postoperative CT scan. There were no immediate postoperative complications or mortality. The first patients aneurysm shrank by 8.6 mm, from 23.9 to 15.3 mm over 19 months, with all 4 side branches remaining patent. The largest aneurysm at 42.4 mm completely thrombosed, while the renal artery remained patent to the kidney. The final patient refused to have any follow-up scans but had no deterioration in renal function below 30 mL/min, and no further symptoms reported. Conclusions The MFM is safe and effective in the management of patients with complex renal artery aneurysms. The MFM can be used to treat branched or distal renal artery aneurysms with exclusion of the aneurysm from the circulation, while successfully preserving the flow to the side branches and kidney. Initial results are promising, however, longer follow-up and a larger cohort are required to prove the effectiveness of this emerging technology.

TCT-810 “The Phantom Streamlinear” as a Therapeutic Option in the Management of Total Body Thoraco-abdominal Aortic Pathology[TAAA]. Early Results.

RESULTS A total of 15 studies (3 prospective studies, 3 observational reviews and 9 case reports) were included. The mean age of patients was 68.85years (þ/-12.34 years), mean aneurysm diameter was 6.67cm ( 1.57cm). Technical success reported in 15 studies was 77.2 %. Aneurysm related survival at one year was 78.7% ( 3.92%). One year all-cause survival was 53.7 % ( 3.94%). There were no reported cases of spinal cord ischemia or renal insult.

Endovascular Repair of a Type III Renal Artery Aneurysm using the MultilayerFlow Modulator: A Clinical Case Report

Background: Our aim was to describe our experience of the multilayer flow modulator (Cardiatis, Isnes, Belgium) used in the treatment of renal artery aneurysms. Case report: A female patient, aged 42 years underwent treatment of a renal artery aneurysm using the multilayer flow modulator. Contrast-enhanced computed tomography revealed a 23.9 mm type III renal artery aneurysm at the bifurcation of the upper and lower pole vessels, with four side branches. Follow up was assessed by postoperative computed tomography scan at 6 and 19 months postoperatively. There were no immediate postoperative complications or mortality. A normal estimated glomerular filtration rate of > 90 ml/min, which was recorded preoperatively, decreased to 77 ml/min on the day of surgery, and returned to > 90 ml/min 1 day postoperatively. The aneurysm initial decreased in size by 23% at 6 months, and by 16% at 19 months. Overall aneurysm shrinkage was 36% (8.6 mm), with all four side-branches remaining patent throughout follow up. Conclusion: The MFM may provide less operative trauma for patients where complex surgical intervention is the only other feasible treatment option. Longer follow-up, a larger sample size, and comparative studies are required to prove the efficacy of this emerging technology.

Innovative Design and Manufacturing Techniques for Patient Specific Abdominal Aortic Aneurysm Flexible Benchtop Models

Abdominal aortic aneurysm (AAA) represents an asymptomatic cardiovascular type of disease, that is diagnosed in elder people over 60 years old. It is characterised by a ballooning of the abdominal aorta, which grows, at different rates in different patients. If left untreated, it will rupture causing severe internal bleeding, which can lead to shock or death [1]. Medical devices such as bifurcated stent grafts (SG) are used for the treatment of this disease. To help improve SG performance, biomedical engineers design benchtop models for testing.© 2013 ASME