scholarly journals Numerical Parametric Study of Paravalvular Leak Following a Transcatheter Aortic Valve Deployment Into a Patient-Specific Aortic Root

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.

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
I Michalowska ◽  
L Kalinczuk ◽  
M Dabrowski ◽  
Z Chmielak ◽  
K Zielinski ◽  
...  

Abstract Introduction Severe annular and valve cusps calcification is frequent among patients treated with transcatheter aortic valve replacement (TAVR). Severe annular calcification increases the risk of paravalvular leak (PVL) and was associated with worse outcomes. Whether it is accompanied by an independent effect of calcifications localized on cusps and whether the impact of cusps/annular calcification depends on supra vs intra-annular valve design is unknown. Purpose To assess the impact of cusps/annular calcifications on occurrence of moderate PVL after successful TAVR with devices of either intra- or supra-annular design. Methods 282 consecutive patients (80.3±7.6 yrs, 63% female) with baseline 384-slice CT scan were successfully treated with TAVR between Jul 2012 and Oct 2017, either with intra-annular or supra-annular devices. Severe annular calcification (clear protrusion) and severe cusps calcification (Rosenhek 4 score) were identified using a Syngo Via. Results 138 (48.9%) patients were treated with intra-annular and 144 (51.15) with supra-annular devices. Whereas severe annular calcification was similar (23.9% vs 20.1%), there was more severe cusps calcification among intra-annular valves (52.9% vs 41.7%, p=0.073). Intra-annular devices were used less frequently among bicuspid aortic valves, were also of smaller diameter, less frequently deployed after pre-dilation, and less frequently post-dilated. Post-procedure mean aortic gradient tended to be higher among intra-annular devices. Moderate PVL was less frequent among intra- vs supra-annular valves (14.5% vs 34.0%, p<0.001). However, PVL occurrence was higher (30.3%) among those (33/138, 23.9%) treated with an intra-annular valve who had severe annular calcification vs 9.5% in pts treated with an intra-annular TAVR who did not have severe annular calcification (p=0.008) unlike in patients treated with a supra-annular valve who had a high frequency of PVL with or without severe annular calcium (37.9% vs 33.0%). After excluding patients with severe annular calcium (n=62, 22%), moderate PVL was similar between those with vs without severe cusp calcification whether treated with intra- or supra-annular valves (11.8% vs 7.4% and 29.3% vs 35.1%, respectively). Combined VARC-2 safety endpoints plus 2-yr mortality occurrence were lower for intra- vs supra-annular devices (30.4% vs 43.8%, p=0.026). Conclusions Moderate PVL after intra-annular TAVR device deployment occurs in 30% of patients with protruding annular calcification. Severe cusps calcification unaccompanied by annular calcium was not associated with PVL occurrence. Higher frequency of moderate PVL (34%) seen after supra-annular valve deployment appears to be related to other parameters rather than presence of severe annular or cusps calcification. Funding Acknowledgement Type of funding source: None


2020 ◽  
Vol 21 (Supplement_1) ◽  
Author(s):  
P Grilo Diogo ◽  
C X Resende ◽  
A Nunes ◽  
P Araujo ◽  
S Torres ◽  
...  

Abstract INTRODUCTION Aortic annular rupture is a potentially catastrophic complication after transcatheter aortic valve implantation (TAVI), with an estimated incidence of 1%. Rupture occurs in the anatomical device landing zone, that extends from the aortic root to the distal left ventricular outflow tract (LVOT). It usually occurs in the context of highly calcified aortic valve and LVOT, implantation of balloon-expandable valves, valve oversizing and overdilation to treat paravalvular leakage. CASE REPORT An 80-year old woman with no past relevant medical history was admitted to our Cardiology Department with decompensated heart failure because of symptomatic severe aortic stenosis, moderate aortic regurgitation and mild left ventricular (LV) dysfunction. She was already in waiting list for TAVI procedure, after being refused for conventional aortic valve replacement due to a "porcelain" aorta. Her pre-operative angiography showed no significant coronary heart disease, and the cardiac computed tomography (cardiac-CT) revealed a severely calcified aortic valve (Agatston score = 4940). An Acurate neo L (27mm) valve was implanted after clinical stabilization with no immediate complications. Because of paravalvular regurgitation, sequential post-dilation was performed with 25mm and 26mm balloons. Post-procedural angiography showed no contrast extravasation (Panel A). In the first hours after the procedure, she was hypotensive with non-specific mild chest discomfort. The EKG showed sinus rhythm with left anterior fascicular block. A transthoracic echocardiogram revealed a moderate pericardial effusion, with no signs of tamponade, and a moderate "paravalvular leak "at the level of the non-coronary cusp to a pulsatile cavity, between the aortic root and the left atrium (Panel B and C). The patient evolved with haemodynamic and electrical stability with no recurrence of chest discomfort. A retrospective cardiac-CT was performed that confirmed the presence of a multilobular cavity below the left coronary artery in continuous with the LVOT, compatible with a contained subannular aortic rupture (Panel E and F), at the level of previous gross calcification in the pre-operative cardiac-CT (Panel D). The case was discussed in Heart Team and a conservative strategy was adopted due to clinical stability and inoperable condition. The patient was discharged at day 28, after CT reavaluation,, that demonstrate similar findings. CONCLUSION We report a rare and potentially fatal complication of TAVI with a self-expandable valve. This clinical case illustrates how balloon post-dilation to treat moderate post-procedural paravalvular regurgitation lead to tearing of a highly calcified aortic annulus. A multi-modality imaging approach, with echocardiography and computer tomography, was essential for full anatomical definition of the subannular rupture, clinical decision-making and for follow-up surveillance. Abstract P1718 Figure. Panel A,B,C,D,E,F.


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 2021 ◽  
pp. 1-9
Author(s):  
Akihiro Nakajima ◽  
Toru Naganuma ◽  
Haruhito Yuki ◽  
Hirokazu Onishi ◽  
Tatsuya Amano ◽  
...  

Objectives. To investigate the relationship between the eccentric calcification of aortic valve and transcatheter heart valve (THV) distortion and the impact of THV distortion on echo parameters and clinical outcomes. Background. The effects of eccentric calcification of the aortic valve on the THV distortion and the relationship between THV distortion and clinical impact were not fully understood. Methods. Patients with symptomatic severe aortic stenosis who were undergoing THV implantation were enrolled. Patients underwent preprocedural, postprocedural multislice computed tomography (MSCT), and follow-up transthoracic echocardiogram (TTE). Delta calcium score (ΔCS) is defined as the difference between the maximum and minimal calcium scores of the three cusps, while valve distortion score (VDS) is defined as the difference between the longest and shortest stent frame, as obtained using MSCT. Patients were divided into two groups according to ΔCS: “noneccentric calcification group” and “eccentric calcification group.” Results. A total of 118 patients were enrolled (59 patients in noneccentric and 59 in eccentric calcification groups). VDS was significantly lower in the noneccentric calcification group than in the eccentric calcification group (1.31 ± 0.82 mm vs. 1.73 ± 0.76 mm, p = 0.004 ). VDS was not associated with the degree of paravalvular leak (PVL) and aortic valvular mean pressure gradient (AVPG) at 30-day and 1-year follow-up TTE and the cumulative rates of all-cause death and rehospitalization at 2-year clinical follow-up. Conclusions. Eccentric valvular calcification was associated with longitudinal THV distortion. However, THV distortion was not associated with PVL, AVPG, and adverse clinical events during midterm follow-up.


Circulation ◽  
2014 ◽  
Vol 130 (suppl_2) ◽  
Author(s):  
Qian Wang ◽  
Caitlin Martin ◽  
Susheel Kodali ◽  
Jonathon Leipsic ◽  
Philipp Blanke ◽  
...  

Introduction: Despite the increased global experience with transcatheter aortic valve replacement (TAVR), there remain major adverse clinical events. One of the most severe complications of TAVR is aortic rupture. Although several clinical risk factors of TAVR-induced rupture have been identified, the mechanisms remain largely unknown. The objective of this study was to use computational models to predict potential aortic rupture in TAVR patients. Methods: Pre-procedural CT scans of TAVR patients were used to reconstruct patient-specific finite element (FE) models, which included the aortic root, aortic leaflets, calcification, mitral-aortic intervalvular fibrosa, anterior mitral leaflet, fibrous trigones, and left ventricle. Stent deployment was simulated in a total of 25 patients to evaluate the potential for aortic rupture. Our research design consisted of two phases: Phase One, which was to develop and calibrate FE modeling techniques by retrospectively analyzing 7 Edwards SAPIEN cases with known results; and Phase Two, which was to implement the modeling methodology developed in Phase One to conduct a blind study of 18 cases from a database of 60 patients consisting of 50% rupture cases. For the blind study, FE simulations were completed by researchers blind to the clinical outcomes, and data analysis was conducted by an independent researcher. Results: Simulations correctly predicted 83% of the rupture cases. The balloon pressure at time of rupture was approximately 3.52 atm and 2.53 atm for SAPIEN 23 and 26 valves, respectively. The average contact force between the stent and native tissue was about 81N. Conclusion: Our analysis of over 18 patients suggested that the TAVR outcome could depend on the patient-specific aortic sinus shape, calcification volume, shape, location, and orientation. These results demonstrate the potential for simulation-based pre-TAVR planning tools to evaluate device performance and improve clinical outcomes.


Author(s):  
Eric Sirois ◽  
Qian Wang ◽  
Susheel Kodali ◽  
Wei Sun

Recently, minimally-invasive transcatheter aortic valve (TAV) replacement has emerged as a viable alternative to traditional open-chest heart valve replacement for high risk patients who otherwise have limited or no treatment options. Although significant experience with TAV procedures has been gained, various adverse effects have been observed after device implantation [1, 2]. One adverse event is the impairment of coronary artery flow. Because the TAV stent pushes the native leaflets towards the sinus of Valsalva during TAV deployment, the flow boundaries in the aortic root are consequently altered. A worst case scenario would be the occlusion of the coronary ostia. Reduced flow to the coronary arteries has also been observed for some patients following TAV intervention [3]. With IRB approval, we recently conducted a dimensional analysis of 3D aortic root geometries, reconstructed from 64-slice CT scans of 95 patients [4]. TAV-relevant dimensions were measured. The spatial distribution of the left coronary ostium was quantified (Fig. 1). In this study, we will construct a patient-specific aortic root model with varied coronary ostium locations as shown in Fig. 1, and perform a combined finite element analysis (FEA) and computational fluid dynamics (CFD) simulation to investigate hemodynamic environment changes that occur following TAV intervention.


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