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

Abstract

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.

Structural Heart Valve Disease in the Era of Change and Innovation: The Crosstalk between Medical Sciences and Engineering

“…The use of computational biomodeling with FEA in the field of cardiovascular science has emerged as an essential method to obtain valuable data about complicated real-world structures that otherwise would be impracticable to squarely determine [ 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 ]. Since the 1980s, this new scenario has mainly been driven by the emergence of percutaneous coronary intervention with novel options for the treatment of coronary heart disease.…”

“…In contrast, computational biomodeling using FEA investigation has not followed a similar evolutionary course since its inception as a method of investigating cardiovascular disease, lacking a true affirmation underpinned by gradual and steady progression while revisiting previous evidence that emerged in the early 1990s [ 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 ]. For this reason, and given the progress made in the field of coronary heart disease and in the treatment of structural heart disease, a dynamic transformation in the trajectory of the well-planned use of bioengineering and its investigation methods would be desirable to identify a new field of interest, which provides an additional stimulus for cardiologists, heart surgeons, and trainees.…”

“…We are convinced that the time has come to affirm the central role of bioengineering applied to medical sciences. Therefore, with regard to the use of methods based on the geometric algorithmic prediction of the stress and deformation coefficients in intricate structures, cardiologists, cardiac surgeons, and trainees must perceive the paradigm shift as an advantage, to be faced without prejudice, and consider it a fundamental step in the advancement of cardiological science and as a relevant opportunity [ 20 , 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 ]. In fact, thus far, FEA has been perceived with distrust in the field of cardiology and cardiac surgery, thus exerting little influence on clinical practice.…”

“…We are confident that bioengineering will have a role as an ideal partner in the improvement of new transcatheter platforms for structural heart diseases, even in cardiac surgery, besides the widely established advances in the cardiological scenario. Similarly, a crucial role will be played by the use of artificial intelligence in diagnostic imaging and procedural planning [ 30 , 31 , 32 , 33 , 34 , 35 , 36 ].…”

“…Studies that address the concerns about bulky calcifications characterizing valve stenosis or pathoanatomic phenomena of mitral annular disjunction should be a priority for bioengineering, so that the ongoing paradigm shift which supports the new procedures using transcatheter approaches can be definitively affirmed and supported by scientific planning. We hope that the recent acceleration and the injection of current intellectual resources [ 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 ] might be sustained over the coming years to enhance device quality and provide tailored options for patients suffering from structural heart disease.…”