Abstract 20549: Patient-Specific CT Image-Based Engineering Analysis of Transcatheter Aortic Valve Replacement - Implications for Aortic Root Rupture

Circulation ◽  
2014 ◽  
Vol 130 (suppl_2) ◽  
Author(s):  
Qian Wang ◽  
Caitlin Martin ◽  
Susheel Kodali ◽  
Jonathon Leipsic ◽  
Philipp Blanke ◽  
...  
Keyword(s):  
Aortic Valve ◽  
Aortic Valve Replacement ◽  
Clinical Outcomes ◽  
Valve Replacement ◽  
Aortic Root ◽  
Transcatheter Aortic Valve Replacement ◽  
Aortic Rupture ◽  
Blind Study ◽  
Patient Specific ◽  
Transcatheter Aortic Valve

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.

scholarly journals Bioengineering Case Study to Evaluate Complications of Adverse Anatomy of Aortic Root in Transcatheter Aortic Valve Replacement: Combining Biomechanical Modelling with CT Imaging

2020 ◽  
Vol 7 (4) ◽  
pp. 121
Author(s):  
Cristiano Spadaccio ◽  
Laura Mazzocchi ◽  
Irina Timofeva ◽  
Laurent Macron ◽  
Carlo Nicola De Cecco ◽  
...  
Keyword(s):  
Aortic Valve ◽  
Aortic Valve Replacement ◽  
Valve Replacement ◽  
Aortic Root ◽  
Transcatheter Aortic Valve Replacement ◽  
Specific Treatment ◽  
Patient Specific ◽  
Transcatheter Aortic Valve ◽  
Biomechanical Modelling ◽  
Stent Deformation

Gated computed tomography (CT) might not adequately predict occurrence of post-implantation transcatheter aortic valve replacement (TAVR) complications in hostile aortic root as it would require a more complex integration of morphological, functional and hemodynamical parameters. We used a computational framework based on finite element analysis (FEA) to simulate patient-specific implantation. Application of biomechanical modelling using FEA to gated-CT was able to demonstrate the relation of the device with voluminous calcification, its consequent misalignment and a significant stent deformation. Use of FEA and other advanced computed predictive modelling techniques as an adjunct to CT scan could improve our understanding of TAVR, potentially predict complications and fate of the devices after implantation and inform patient-specific treatment.

Abstract 381: Clinical Outcomes Following Transcatheter Aortic Valve Replacement Among US Hospitals

2015 ◽  
Vol 8 (suppl_2) ◽  
Author(s):  
Fenton McCarthy ◽  
Katherine M McDermott ◽  
Vinay Kini ◽  
Dale Kobrin ◽  
Nimesh D Desai ◽  
...  
Keyword(s):  
Clinical Trials ◽  
High Risk ◽  
Aortic Valve ◽  
Aortic Valve Replacement ◽  
Clinical Outcomes ◽  
Valve Replacement ◽  
Transcatheter Aortic Valve Replacement ◽  
Mortality Rates ◽  
Transcatheter Aortic Valve ◽  
Cardiovascular Interventions

Background: Transcatheter Aortic Valve Replacement (TAVR) demonstrated excellent outcomes in clinical trials of inoperable/high-risk patients. Subsequent approval by the Food and Drug Administration and National Coverage Determination by the Centers for Medicare and Medicaid Services established unique volume requirements for institutions and physicians to perform TAVR. Diffusion of prior cardiovascular interventions has involved less stringent policies and exhibited significant institutional variation in clinical outcomes. Our objective is to compare risk-standardized procedural outcomes across US hospitals performing TAVR to identify hospitals with outlying post-procedure mortality rates. Methods: All Medicare fee-for-service beneficiaries who underwent TAVR between January 1, 2011 and November 30, 2012 were identified. Thirty-day risk-standardized mortality rates (RSMR) were calculated using the Hospital Compare statistical method, a well-validated hierarchical generalized linear model. Results: Claims were examined from 5044 patients undergoing TAVR at 199 hospitals, with a crude 30-day mortality rate of 5.97%. RSMRs modeled using patient-level predictors varied from 4.5 % to 9.0 % (Figure 1). One hospital had a RSMR statistically lower than the national mean (4.5%, P<0.05), and two hospitals had RSMRs statistically higher than the national mean (8.5% and 6.9%, P<0.05). Conclusions: Clinical outcomes among TAVR hospitals in high-risk/inoperable patients demonstrated very little variability, few outliers, and excellent outcomes comparable to pre-approval clinical trials. This may be the result of the unique policy and regulatory environment governing the CMS coverage determination for TAVR institutions. As TAVR disseminates to additional hospitals and other new cardiovascular interventions are inevitably introduced, risk-standardized outcome comparisons across hospitals may facilitate ongoing surveillance to ensure high quality outcomes at all active centers.

Real-World Experience With the SAPIEN 3 Ultra Transcatheter Heart Valve: A Propensity-Matched Analysis From the United States

2021 ◽  
Vol 14 (9) ◽  
Author(s):  
Tamim M. Nazif ◽  
Thomas J. Cahill ◽  
David Daniels ◽  
James M. McCabe ◽  
Mark Reisman ◽  
...  
Keyword(s):  
Aortic Valve ◽  
Aortic Valve Replacement ◽  
Clinical Outcomes ◽  
Valve Replacement ◽  
Heart Valve ◽  
Transcatheter Aortic Valve Replacement ◽  
Transcatheter Aortic Valve ◽  
Transcatheter Heart Valve ◽  
Sapien 3 ◽  
Transcatheter Valve

Background: Paravalvular regurgitation (PVR) after transcatheter aortic valve replacement is associated with adverse clinical outcomes. The SAPIEN 3 Ultra (Ultra) is a new generation balloon-expandable transcatheter heart valve with a modified external skirt that is designed to reduce PVR, but reports of clinical and echocardiographic outcomes are limited. The aim of this study was to compare short-term outcomes of patients undergoing transcatheter aortic valve replacement with the Ultra and the original SAPIEN 3 (S3) transcatheter heart valve in a large national registry. Methods: Data from The Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry was used to compare patients who underwent elective, transfemoral transcatheter aortic valve replacement with the Ultra or S3 transcatheter heart valve. Clinical and echocardiographic outcomes were analyzed in a propensity-matched cohort at discharge and 30 days. Results: Patients who underwent transcatheter aortic valve replacement with Ultra (N=1324) from January 2019 to February 2020 were propensity score–matched with patients treated with S3 (N=32 982) during the same period, resulting in 1324 matched pairs. There was no difference in the rate of device success between patients treated with Ultra and S3 (97.1% versus 98.0%, P =0.11). At hospital discharge, PVR was significantly reduced with Ultra compared with S3, with mild PVR in 9.0% versus 13.9% and moderate or greater PVR in 0.1% versus 0.4% (overall P <0.01). At 30 days, there were no differences between Ultra and S3 recipients in the rates of all-cause mortality or stroke (1.8% versus 2.8%, P =0.10), major vascular complications (1.1% versus 1.0%, P =0.84), or permanent pacemaker implantation (6.4% versus 6.2%, P =0.81). Conclusions: In this propensity-matched analysis from the Transcatheter Valve Therapy Registry, the Ultra transcatheter heart valve was associated with similar procedural and 30-day clinical outcomes, but reduced incidence of PVR, compared with S3. The clinical benefit of less PVR should be evaluated in longer-term studies.

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