scholarly journals CoreValve vs. Sapien 3 Transcatheter Aortic Valve Replacement: A Finite Element Analysis Study

2021 ◽  
Vol 8 (5) ◽  
pp. 52
Author(s):  
Francesco Nappi ◽  
Laura Mazzocchi ◽  
Cristiano Spadaccio ◽  
David Attias ◽  
Irina Timofeva ◽  
...  
Keyword(s):  
Finite Element Analysis ◽  
Finite Element ◽  
Valve Replacement ◽  
Heart Valves ◽  
Preoperative Imaging ◽  
Paravalvular Leak ◽  
Element Analysis ◽  
Transcatheter Aortic Valve ◽  
Transcatheter Heart Valve ◽  
Sapien 3

Aim: to investigate the factors implied in the development of postoperative complications in both self-expandable and balloon-expandable transcatheter heart valves by means of finite element analysis (FEA). Materials and methods: FEA was integrated into CT scans to investigate two cases of postoperative device failure for valve thrombosis after the successful implantation of a CoreValve and a Sapien 3 valve. Data were then compared with two patients who had undergone uncomplicated transcatheter heart valve replacement (TAVR) with the same types of valves. Results: Computational biomechanical modeling showed calcifications persisting after device expansion, not visible on the CT scan. These calcifications determined geometrical distortion and elliptical deformation of the valve predisposing to hemodynamic disturbances and potential thrombosis. Increased regional stress was also identified in correspondence to the areas of distortion with the associated paravalvular leak. Conclusion: the use of FEA as an adjunct to preoperative imaging might assist patient selection and procedure planning as well as help in the detection and prevention of TAVR complications.

scholarly journals A Finite Element Analysis Study from 3D CT to Predict Transcatheter Heart Valve Thrombosis

Diagnostics ◽  
2020 ◽  
Vol 10 (4) ◽  
pp. 183 ◽  
Author(s):  
Francesco Nappi ◽  
Laura Mazzocchi ◽  
Irina Timofeva ◽  
Laurent Macron ◽  
Simone Morganti ◽  
...  
Keyword(s):  
Finite Element Analysis ◽  
Aortic Valve ◽  
Aortic Valve Replacement ◽  
Valve Replacement ◽  
Transcatheter Aortic Valve Replacement ◽  
Element Analysis ◽  
Transcatheter Aortic Valve ◽  
Transcatheter Heart Valve ◽  
Valve Thrombosis ◽  
Heart Valve Thrombosis

Background: Transcatheter aortic valve replacement has proved its safety and effectiveness in intermediate- to high-risk and inoperable patients with severe aortic stenosis. However, despite current guideline recommendations, the use of transcatheter aortic valve replacement (TAVR) to treat severe aortic valve stenosis caused by degenerative leaflet thickening and calcification has not been widely adopted in low-risk patients. This reluctance among both cardiac surgeons and cardiologists could be due to concerns regarding clinical and subclinical valve thrombosis. Stent performance alongside increased aortic root and leaflet stresses in surgical bioprostheses has been correlated with complications such as thrombosis, migration and structural valve degeneration. Materials and Methods: Self-expandable catheter-based aortic valve replacement (Medtronic, Minneapolis, MN, USA), which was received by patients who developed transcatheter heart valve thrombosis, was investigated using high-resolution biomodelling from computed tomography scanning. Calcific blocks were extracted from a 250 CT multi-slice image for precise three-dimensional geometry image reconstruction of the root and leaflets. Results: Distortion of the stent was observed with incomplete cranial and caudal expansion of the device. The incomplete deployment of the stent was evident in the presence of uncrushed refractory bulky calcifications. This resulted in incomplete alignment of the device within the aortic root and potential dislodgment. Conclusion: A Finite Element Analysis (FEA) investigation can anticipate the presence of calcified refractory blocks, the deformation of the prosthetic stent and the development of paravalvular orifice, and it may prevent subclinical and clinical TAVR thrombosis. Here we clearly demonstrate that using exact geometry from high-resolution CT scans in association with FEA allows detection of persistent bulky calcifications that may contribute to thrombus formation after TAVR procedure.

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.

scholarly journals Finite Element Analysis to Study Percutaneous Heart Valves

10.5772/38701 ◽  
2012 ◽  
Author(s):  
Silvia Schievano ◽  
Claudio Capelli ◽  
Daria Cosentino ◽  
Giorgia Bosi ◽  
Andrew Taylor
Keyword(s):  
Finite Element Analysis ◽  
Finite Element ◽  
Heart Valves ◽  
Element Analysis

TTK Chitra tilting disc heart valve model TC2: An assessment of fatigue life and durability

2017 ◽  
Vol 231 (8) ◽  
pp. 758-765 ◽  
Author(s):  
NN Subhash ◽  
Adathala Rajeev ◽  
Sreedharan Sujesh ◽  
CV Muraleedharan
Keyword(s):  
Finite Element Analysis ◽  
Finite Element ◽  
Fatigue Life ◽  
Heart Valve ◽  
Life Prediction ◽  
Heart Valves ◽  
Failure Modes ◽  
Fatigue Life Prediction ◽  
Element Analysis ◽  
Valve Model

Average age group of heart valve replacement in India and most of the Third World countries is below 30 years. Hence, the valve for such patients need to be designed to have a service life of 50 years or more which corresponds to 2000 million cycles of operation. The purpose of this study was to assess the structural performance of the TTK Chitra tilting disc heart valve model TC2 and thereby address its durability. The TC2 model tilting disc heart valves were assessed to evaluate the risks connected with potential structural failure modes. To be more specific, the studies covered the finite element analysis–based fatigue life prediction and accelerated durability testing of the tilting disc heart valves for nine different valve sizes. First, finite element analysis–based fatigue life prediction showed that all nine valve sizes were in the infinite life region. Second, accelerated durability test showed that all nine valve sizes remained functional for 400 million cycles under experimental conditions. The study ensures the continued function of TC2 model tilting disc heart valves over duration in excess of 50 years. The results imply that the TC2 model valve designs are structurally safe, reliable and durable.

scholarly journals Third-Generation Balloon and Self-Expandable Valves for Aortic Stenosis in Large and Extra-Large Aortic Annuli From the TAVR-LARGE Registry

2020 ◽  
Vol 13 (8) ◽  
Author(s):  
Germán Armijo ◽  
Gilbert H.L. Tang ◽  
Nynke Kooistra ◽  
Alfredo Nunes Ferreira-Neto ◽  
Stefan Toggweiler ◽  
...  
Keyword(s):  
Aortic Valve ◽  
Aortic Stenosis ◽  
Aortic Valve Replacement ◽  
Valve Replacement ◽  
Transcatheter Aortic Valve Replacement ◽  
Paravalvular Leak ◽  
Third Generation ◽  
Large Area ◽  
Transcatheter Aortic Valve ◽  
Sapien 3

Background: Currently, 2 third-generation transcatheter valves, 29-mm Sapien-3 and 34-mm Evolut-R (ER), are indicated for large sized aortic annuli. We analyzed short and 1-year performance of these valves in patients with large (area ≥575 mm 2 or perimeter ≥85 mm) and extra-large (≥683 mm 2 or ≥94.2 mm) aortic annuli undergoing transcatheter aortic valve replacement. Methods: A total of 833 patients across 12 centers with symptomatic aortic stenosis and large aortic annuli underwent transcatheter aortic valve replacement with 29-mm Sapien-3 (n=640) or 34-mm ER (n=193). Clinical, anatomic, and procedural characteristics were collected, and Valve Academic Research Consortium-2 outcomes were reported. Results: Median aortic annulus area and perimeter were 617 mm 2 (591–657) and 89.1 mm (87.0–92.1), respectively (704 mm 2 [689–743] and 96.0 mm [94.5–97.9] in the subgroup of 124 patients with extra-large annuli). Overall device success was 94.3% (Sapien-3, 95.8% and ER, 89.3%; P =0.001), with a higher rate of significant paravalvular leak ( P =0.004), second valve implantation ( P =0.013), and valve embolization ( P =0.009) in the ER group. Thirty-day and 1-year mortality was 2.4% and 9.2%, respectively, without differences between groups. Valve hemodynamics were excellent (mean gradient, 8.8±3.6 mm Hg; 3.3% rate of moderate-severe paravalvular leak) in the extra-large annulus, without differences compared with the large annulus group. Conclusions: In patients with large and extra-large aortic annuli, transcatheter aortic valve replacement using 29-mm Sapien-3 and 34-mm ER is safe and feasible. Observed differences in clinical outcomes and hemodynamic performance may guide valve choice in this cohort of patients undergoing transcatheter aortic valve replacement.

scholarly journals Overestimation of Paravalvular Leak With Edwards SAPIEN 3 Transcatheter Aortic Valve Replacement

2015 ◽  
Vol 8 (5) ◽  
pp. e69-e71 ◽  
Author(s):  
Taisei Kobayashi ◽  
Jay Giri ◽  
Prashanth Vallabhajosyula ◽  
Howard C. Herrmann ◽  
Dinesh H. Jagasia
Keyword(s):  
Aortic Valve ◽  
Aortic Valve Replacement ◽  
Valve Replacement ◽  
Transcatheter Aortic Valve Replacement ◽  
Paravalvular Leak ◽  
Transcatheter Aortic Valve ◽  
Edwards Sapien ◽  
Sapien 3

scholarly journals Complementary Role of the Computed Biomodelling through Finite Element Analysis and Computed Tomography for Diagnosis of Transcatheter Heart Valve Thrombosis

2018 ◽  
Vol 2018 ◽  
pp. 1-13 ◽  
Author(s):  
Francesco Nappi ◽  
Laura Mazzocchi ◽  
Sanjeet Singh Avtaar Singh ◽  
Simone Morganti ◽  
Jean-Louis Sablayrolles ◽  
...  
Keyword(s):  
Computed Tomography ◽  
Finite Element Analysis ◽  
Finite Element ◽  
High Risk ◽  
Aortic Valve ◽  
Aortic Valve Stenosis ◽  
Element Analysis ◽  
Transcatheter Heart Valve ◽  
Aortic Valve Implantation ◽  
Valve Implantation

Introduction. The TAVR procedure is associated with a substantial risk of thrombosis. Current guidelines recommend catheter-based aortic valve implantation for prohibitive-high-risk patients with severe aortic valve stenosis but acknowledge that the aetiology and mechanism of thrombosis are unclear.Methods. From 2015 to 2018, 607 patients with severe aortic valve stenosis underwent either self-expandable or balloon-expandable catheter-based aortic valve implantation at our institute. A complementary study was designed to support computed tomography as a predictor of complications using an advanced biomodelling process through finite element analysis (FEA). The primary evaluation of study was the thrombosis of the valve at 12 months.Results. At 12 months, 546 patients had normal valvular function. 61 patients had THVT while 6 showed thrombosis and dislodgement with deterioration to NYHA Class IV requiring rehospitalization. The FEA biomodelling revealed a strong link between solid uncrushed calcifications, delayed dislodgement of TAVR and late thrombosis. We observed an interesting phenomenon of fibrosis/calcification originating at the level of the misplaced valve, which was the primary cause of coronary obstruction.Conclusion. The use of cardiac CT and predictive biomodelling should be integrated into routine practice for the selection of TAVR candidates and as a predictor of negative outcomes given the lack of accurate investigations available. This would assist in effective decision-making and diagnosis especially in a high-risk cohort of patients.

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