Assessment of Paravalvular Leak Severity and Thrombogenic Potential in Transcatheter Bicuspid Aortic Valve Replacements Using Patient-Specific Computational Modeling

Author(s):  
Salwa B. Anam ◽  
Brandon J. Kovarovic ◽  
Ram P. Ghosh ◽  
Matteo Bianchi ◽  
Ashraf Hamdan ◽  
...  
2018 ◽  
Vol 140 (10) ◽  
Author(s):  
Wenbin Mao ◽  
Qian Wang ◽  
Susheel Kodali ◽  
Wei Sun

Paravalvular leak (PVL) is a relatively frequent complication after transcatheter aortic valve replacement (TAVR) with increased mortality. Currently, there is no effective method to pre-operatively predict and prevent PVL. In this study, we developed a computational model to predict the severity of PVL after TAVR. Nonlinear finite element (FE) method was used to simulate a self-expandable CoreValve deployment into a patient-specific aortic root, specified with human material properties of aortic tissues. Subsequently, computational fluid dynamics (CFD) simulations were performed using the post-TAVR geometries from the FE simulation, and a parametric investigation of the impact of the transcatheter aortic valve (TAV) skirt shape, TAV orientation, and deployment height on PVL was conducted. The predicted PVL was in good agreement with the echocardiography data. Due to the scallop shape of CoreValve skirt, the difference of PVL due to TAV orientation can be as large as 40%. Although the stent thickness is small compared to the aortic annulus size, we found that inappropriate modeling of it can lead to an underestimation of PVL up to 10 ml/beat. Moreover, the deployment height could significantly alter the extent and the distribution of regurgitant jets, which results in a change of leaking volume up to 70%. Further investigation in a large cohort of patients is warranted to verify the accuracy of our model. This study demonstrated that a rigorously developed patient-specific computational model can provide useful insights into underlying mechanisms causing PVL and potentially assist in pre-operative planning for TAVR to minimize PVL.


Author(s):  
Giorgia M. Bosi ◽  
Claudio Capelli ◽  
Robin Chung ◽  
Michael Mullen ◽  
Andrew M. Taylor ◽  
...  

In the past decade, Transcatheter Aortic Valve Replacement (TAVI) has been shown to be a feasible, less invasive option to open heart surgery for aortic valve replacement; however, TAVI is indicated only in patients with severe, symptomatic, aortic stenosis and who are considered at high or prohibitive risk for conventional surgery [1]. To date, two different TAVI devices are available on the market — the balloon-expandable Edwards-Sapien® Valve (Edwards Lifesciences, CA, USA) and the self-expandable CoreValve ReValving System® (Medtronic, MN, USA) — with many other devices currently under development and clinical trials. The procedural success rate has been >90% in all studies [1], but vascular complications, electrical conduction abnormalities and paravalvular leak — 65–89% of cases, the majority being trivial to mild, with 0 to 26% moderate and 0 to 10% severe — still remain major safety concerns. In particular, a negative influence of moderate to severe paravalvular leak on survival rates has recently been demonstrated [2].


2021 ◽  
Vol 23 (Supplement_G) ◽  
Author(s):  
Gianmarco Iannopollo ◽  
Vittorio Romano ◽  
Nicola Buzzatti ◽  
Marco Ancona ◽  
Luca Ferri ◽  
...  

Abstract Aims Transcatheter Aortic Valve Replacement (TAVR) in patients with bicuspid aortic valve (BAV) still represents a challenge due to the peculiar anatomy and the lack of consensus for the optimal CT scan sizing method for prosthesis selection. Recent evidences have shown that transcatheter heart valve (THV) anchoring in BAV patients might occur at the raphe-level, known as the LIRA (Level of Implantation at the RAphe) plane. Furthermore, a novel supra-annular sizing method based on the measurement of the perimeter at the raphe-level (LIRA-method) was shown to be safe and effective in 20 consecutive BAV patients with severe aortic stenosis. The purpose of this study was to confirm the safety and the efficacy of the LIRA method in a larger study population. Methods and results the LIRA plane method was applied to all consecutive patients with raphe-type BAV disease between November 2018 to September 2021 in our centre. We prospectively sized TAVI prosthesis according to the manufacture recommendations on the basis of baseline CT scan perimeters at the LIRA plane. Post-procedural device success, defined according to Valve Academic Research Consortium-2 (VARC-2) criteria, was evaluated in the overall cohort. Forty-four patients were identified as having a raphe-type BAV disease at pre-TAVI CT scans. Mean patient age was 80 ± 6.2 years and 74% were males; median Society of Thoracic Surgeons (STS) predicted risk of mortality score was 4.3 (3.0–6.5). Three different BAV anatomies (36 patients with BAV type 1 with calcific raphe, 5 patients with BAV type 1 with fibrotic raphe, and 3 patients with BAV type 2) were implanted with different types of TAVI prostheses (6 Acurate Neo 2,16 Acurate Neo, 21 Core Valve Evolut R/Pro , 1 Lotus) sized prospectively according to the LIRA plane method. In all patients, there was a significant discrepancy between LIRA and virtual basal ring (VBR) measurements with LIRA plane perimeter smaller than VBR perimeter (mean perimeter LIRA 73.1 ± 8.3 mm vs. mean perimeter VBR 81.5 ± 6.6 mm; P < 0.001). The prostheses were sized according to the manufacture recommendations on the basis of the LIRA plane perimeter (diameter prosthesis implanted/diameter prosthesis according to LIRA plane = 1) (DPI/DP LIRA = 1) and significantly downsized according to the VBR perimeter (DPI/DP VBR 0.89; P < 0.001). The median prosthesis size was 25 mm (23–27). Pre-dilatation was frequently performed (86%) with a median balloon size of 20 mm (18–22), whereas post-dilatation was applied in 27% of the cases with a median balloon size of 23 mm (20–26). The LIRA plane method appeared to be highly successful (100% VARC-2 device success) with no procedural mortality, no valve migration, residual trivial/mild paravalvular leak with no cases of moderate-severe regurgitation and low transprosthetic gradient (residual mean gradient of 8.3 ± 3.5 mmHg) with no cases of mean gradient >20 mmHg pre-discharge. The rate of new pacemaker implantation was 9%. Conclusions Supra-annular sizing according to the LIRA plane method confirmed to be safe with a high device success in a larger study population. The application of the LIRA plane method might optimize TAVI prosthesis sizing in patients with raphe-type BAV disease.


Author(s):  
V. Govindarajan ◽  
H. S. Udaykumar ◽  
S. Vigmostad ◽  
M. M. Levack ◽  
J. H. Gorman ◽  
...  

Congenital Bicuspid Aortic Valve (BAV) is a valvular anomaly where a patient is born with a valve with two leaflets instead of a normal tri-leaflet valve. It has also been reported that BAVs are prone to progressive calcification and also other complications such as ascending aortic dilatation, dissection and rupture [1]. The geometrical variations with the BAV may be a factor in altering the deformation and stresses on the leaflets resulting in calcification of the leaflets earlier than with normal tri-leaflet aortic valves. Altered flow patterns past BAV into the ascending aorta can also be anticipated. Analysis of flow dynamics during the opening phase, and the resultant fluid forces on the aortic root could improve our understanding of aortic aneurysms and dissections observed in patients with BAV [2]. In this study, the valvular deformation and the flow across a patient-specific BAV and root are simulated using the method of fluid structural interaction analysis. The patient-specific geometry is obtained employing 3D ultrasound images segmented as point cloud data and surfaces are constructed with commercial software GAMBIT using NURBS based connectivity. The opening phase of the valve is simulated under flow with physiological Reynolds number and with realistic material properties for the leaflets and the aortic root. Such an analysis on the dynamics of BAV with patient-specific geometry may be a useful tool in stratifying BAV patients that may be at risk in developing valvular and ascending aortic pathology.


2020 ◽  
Vol 32 (1) ◽  
pp. 20-28
Author(s):  
Riccardo Gorla ◽  
Matteo Casenghi ◽  
Alice Finotello ◽  
Federico De Marco ◽  
Simone Morganti ◽  
...  

Abstract OBJECTIVES To compare device success and paravalvular leak rates of 3 new-generation transcatheter aortic valve replacement devices in patients with bicuspid aortic valve stenosis and to test their biomechanical performance in a computer-based simulation model of aortic root with increasing ellipticity. METHODS This retrospective multicentre study included 56 bicuspid aortic valve patients undergoing transcatheter aortic valve replacement with new-generation devices: Lotus/Lotus Edge (N = 15; 27%), Evolut-R (N = 20; 36%) and ACURATE neo (N = 21; 37%). Three virtual simulation models of aortic root with increasing index of eccentricity (0–0.25–0.5) were implemented. Stress distribution, stent–root contact area and paravalvular orifice area were computed. RESULTS Device success was achieved in 43/56 patients (77%) with comparable rates among Lotus (87%), Evolut-R (60%) and ACURATE neo (86%; P = 0.085). Moderate paravalvular leak rate was significantly lower in the Lotus group as compared to Evolut-R group (0% vs 30%; P = 0.027) and comparable to the ACURATE neo group (0% vs 10%; P = 0.33). By index of eccentricity = 0.5, Lotus showed a uniform and symmetric pattern of stress distribution with absent paravalvular orifice area, ACURATE neo showed a mild asymmetry with small paravalvular orifice area (1.1 mm2), whereas a severely asymmetric pattern was evident with Evolut-R, resulting in a large paravalvular orifice area (12.0 mm2). CONCLUSIONS Transcatheter aortic valve replacement in bicuspid aortic valve patients with new-generation devices showed comparable device success rates. Lotus showed moderate paravalvular leak rate comparable to that of ACURATE neo and significantly lower than Evolut-R. On simulation, Lotus and ACURATE neo showed optimal adaptability to elliptic anatomies as compared to Evolut-R.


2021 ◽  
Vol 8 ◽  
Author(s):  
Xianbao Liu ◽  
Jiaqi Fan ◽  
Peter Mortier ◽  
Yuxin He ◽  
Qifeng Zhu ◽  
...  

Background: Patient-specific computer simulation of transcatheter aortic valve replacement (TAVR) can provide unique insights in device-patient interaction.Aims: This study was to compare transcatheter aortic valve sealing behavior in patients with bicuspid aortic valves (BAV) and tricuspid aortic valves (TAV) through patient-specific computational modeling.Methods: Patient-specific computer simulation was retrospectively performed with FEops HEARTguide for TAVR patients. Simulation output was compared with postprocedural computed tomography and echocardiography to validate the accuracy. Skirt malapposition was defined by a distance larger than 1 mm based on the predicted device-patient interaction by quantifying the distance between the transcatheter heart valve (THV) skirt and the surrounding anatomical regions.Results: In total, 43 patients were included in the study. Predicted and observed THV frame deformation showed good correlation (R2 ≥ 0.90) for all analyzed measurements (maximum diameter, minimum diameter, area, and perimeter). The amount of predicted THV skirt malapposition was strongly linked with the echocardiographic grading of paravalvular leakage (PVL). More THV skirt malapposition was observed for BAV cases when compared to TAV cases (22.7 vs. 15.5%, p < 0.05). A detailed analysis of skirt malapposition showed a higher degree of malapposition in the interleaflet triangles section for BAV cases as compared to TAV patients (11.1 vs. 5.8%, p < 0.05).Conclusions: Patient-specific computer simulation of TAVR can accurately predict the behavior of the Venus A-valve. BAV patients are associated with more malapposition of the THV skirt as compared to TAV patients, and this is mainly driven by more malapposition in the interleaflet triangle region.


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