Patient-specific modeling of biomechanical interaction in transcatheter aortic valve deployment

The objective of this study was to develop a patient-specific computational model to quantify the biomechanical interaction between the transcatheter aortic valve (TAV) stent and the stenotic aortic valve during TAV intervention. Finite element models of a patient-specific stenotic aortic valve were reconstructed from multi-slice computed tomography (MSCT) scans, and TAV stent deployment into the aortic root was simulated. Three initial aortic root geometries of this patient were analyzed: (a) aortic root geometry directly reconstructed from MSCT scans, (b) aortic root geometry at the rapid right ventricle pacing phase, and (c) aortic root geometry with surrounding myocardial tissue. The simulation results demonstrated that stress, strain, and contact forces of the aortic root model directly reconstructed from MSCT scans were significantly lower than those of the model at the rapid ventricular pacing phase. Moreover, the presence of surrounding myocardium slightly increased the mechanical responses. Peak stresses and strains were observed around the calcified regions in the leaflets, suggesting the calcified leaflets helped secure the stent in position. In addition, these elevated stresses induced during TAV stent deployment indicated a possibility of tissue tearing and breakdown of calcium deposits, which might lead to an increased risk of stroke. The potential of paravalvular leak and occlusion of coronary ostia can be evaluated from simulated post-deployment aortic root geometries. The developed computational models could be a valuable tool for pre-operative planning of TAV intervention and facilitate next generation TAV device design.     

Patient-specific simulation of a stentless aortic valve implant: the impact of fibres on leaflet performance

In some cases of aortic valve leaflet disease, the implant of a stentless biological prosthesis represents an excellent option for aortic valve replacement (AVR). In particular, if compared with the implant of mechanical valves, it provides a more physiological haemodynamic performance and a reduced thrombogeneticity, avoiding the use of anticoagulants. The clinical outcomes of AVR are strongly dependent on an appropriate choice of both prosthesis size and replacement technique, which is, at present, strictly related to surgeon's experience and skill. This represents the motivation for patient-specific finite element analysis able to virtually reproduce stentless valve implantation. With the aim of performing reliable patient-specific simulations, we remark that, on the one hand, it is not well established in the literature whether bioprosthetic leaflet tissue is isotropic or anisotropic; on the other hand, it is of fundamental importance to incorporate an accurate material model to realistically predict post-operative performance. Within this framework, using a novel computational methodology to simulate stentless valve implantation, we test the impact of using different material models on both the stress pattern and post-operative coaptation parameters (i.e. coaptation area, length and height). As expected, the simulation results suggest that the material properties of the valve leaflets affect significantly the post-operative prosthesis performance.     

Patient-specific simulation of stent-graft deployment in type B aortic dissection: model development and validation

Thoracic endovascular aortic repair (TEVAR) has been accepted as the mainstream treatment for type B aortic dissection, but post-TEVAR biomechanical-related complications are still a major drawback. Unfortunately, the stent-graft (SG) configuration after implantation and biomechanical interactions between the SG and local aorta are usually unknown prior to a TEVAR procedure. The ability to obtain such information via personalised computational simulation would greatly assist clinicians in pre-surgical planning. In this study, a virtual SG deployment simulation framework was developed for the treatment for a complicated aortic dissection case. It incorporates patient-specific anatomical information based on pre-TEVAR CT angiographic images, details of the SG design and the mechanical properties of the stent wire, graft and dissected aorta. Hyperelastic material parameters for the aortic wall were determined based on uniaxial tensile testing performed on aortic tissue samples taken from type B aortic dissection patients. Pre-stress conditions of the aortic wall and the action of blood pressure were also accounted for. The simulated post-TEVAR configuration was compared with follow-up CT scans, demonstrating good agreement with mean deviations of 5.8% in local open area and 4.6 mm in stent strut position. Deployment of the SG increased the maximum principal stress by 24.30 kPa in the narrowed true lumen but reduced the stress by 31.38 kPa in the entry tear region where there was an aneurysmal expansion. Comparisons of simulation results with different levels of model complexity suggested that pre-stress of the aortic wall and blood pressure inside the SG should be included in order to accurately predict the deformation of the deployed SG.

     

Bundle-branch reentry ventricular tachycardia after transcatheter aortic valve replacement

An 83-year-old male suffering from severe symptomatic aortic valve stenosis received an implant of a biological aortic prosthesis through the femoral artery without complications. Seven days after dischargement he experienced a syncope. The patient was wearing an ECG holter monitor that day, which showed a wide QRS complex tachycardia of 300 beats per minute. The electrophysiological study revealed a bundle-branch reentry ventricular tachycardia as the cause of the syncope. Radio-frequency was applied on the right-bundle branch. Twelve months later, the patient has remained asymptomatic.     

Better survival after transcatheter aortic valve replacement by process improvements

ObjectiveThe aim of this study is to assess the effects on procedural, 30-day, and 1‑year all-cause mortality by a newly introduced quality improvement strategy in patients after transcatheter aortic valve replacement (TAVR).MethodsIn October 2015, a coherent set of quality improving interventions with respect to patient geriatric screening, general diagnostic examination and safety of the procedure was implemented at a single centre in the Netherlands. Patients undergoing TAVR in 2013–2018 were included for retrospective analysis. Mortality was assessed in the pre-quality improvement strategy cohort (January 2013 to October 2015; cohort A) and in the post-quality improvement strategy cohort (November 2015 to December 2018; cohort B). Logistic regression analysis was used to estimate the influence of patient and procedural characteristics on the results of the quality improvement strategy in terms of procedural, 30-day, and 1‑year all-cause mortality.ResultsIn total, 806 patients were analysed with 274 patients in cohort A and 532 patients in cohort B. After introduction of the quality improvement strategy, procedural (4.4% to 1.3%, p < 0.01), 30-day (8.4% to 2.7%, p < 0.01) and 1‑year (16.4% to 8.5%, p < 0.01) all-cause mortality significantly decreased. Multivariate regression analysis showed that the quality improvement strategy also significantly reduced 30-day (odds ratio [OR] 0.19, 95% confidence interval [CI] 0.09–0.42) and 1‑year (OR 0.38, 95% CI 0.24–0.61) all-cause mortality if corrected for patient characteristics.ConclusionStructural meetings on evaluation of outcomes highlight potential areas for improvement and subsequent outcome-based quality improvement initiatives can result in lower procedural, 30-day, and 1‑year all-cause mortality.Electronic supplementary materialThe online version of this article (10.1007/s12471-020-01526-7) contains supplementary material, which is available to authorized users.     

The impact of imperfect frame deployment and rotational orientation on stress within the prosthetic leaflets during transcatheter aortic valve implantation

TAVI devices are manufactured with cylindrical frames. However, the frames are rarely cylindrical post-deployment since deformation due to localised under expansion can be induced by calcified material on the native valve leaflets exerting irregular forces upon the frame. Consequently, the leaflets within a deformed TAVI device may undergo elevated stress during operation, which may lead to premature device failure.Using computational analysis a complete TAVI device model was simulated undergoing deployment into an aortic root model derived from CT data for a patient with severe calcific aortic stenosis, followed by a pressure simulated cardiac cycle. The complete analysis was performed eight times, each with the device at a different rotational orientation relative to the native valve, with an increment spacing of 15°.The TAVI device frames consistently featured significant distortions associated with bulky calcified material at the base of the non-coronary sinus. It was found that the average von Mises stress in the prosthetic valves was only increased in one of the cases relative to an idealised device. However, the maximum von Mises stress in the prosthetic valves was elevated in the majority of the cases.Furthermore, it was found that there were preferable orientations to deploy the prosthetic device, in this case, when the prosthetic leaflets were aligned with the native leaflets. As device orientation deviated from this orientation, the stresses in the valve increased because the distance between the prosthetic commissures decreased. This potentially could represent a sufficient increase in stress to induce variation in device lifespan.     

Report on outcomes of valve-in-valve transcatheter aortic valve implantation and redo surgical aortic valve replacement in the Netherlands

Netherlands Heart Journal - We sought to investigate real-world outcomes of patients with degenerated biological aortic valve prostheses who had undergone valve-in-valve transcatheter aortic valve...     

Undiagnosed hypertrophic obstructive cardiomyopathy during transcatheter aortic valve replacement: a case report

Background

Transcatheter aortic valve replacement is indicated for severe symptomatic aortic stenosis in patients who have a very high or prohibitive surgical risk as assessed pre-procedurally by the Society of Thoracic Surgery Risk Score, EuroSCORE (II), frailty testing, and other predictors. When combined with another left ventricular outflow tract obstruction, careful consideration must be taken prior to proceeding with transcatheter aortic valve replacement because an additional masked left ventricular outflow tract pathology can lead to challenging hemodynamics in the peri-deployment phase, as reported in this case.

Case presentation

A 56-year-old Caucasian man with multiple comorbidities and severe aortic stenosis underwent transcatheter aortic valve replacement under monitored anesthesia care. During the deployment phase, he developed dyspnea that progressed to pulmonary edema requiring emergent conversion to general anesthesia, orotracheal intubation, acute respiratory distress syndrome-type ventilation, and vasopressor medications. Intraoperative transesophageal echocardiography was performed and hypertrophic obstructive cardiomyopathy with systolic anterior motion of the mitral valve was discovered as an underlying pathology, undetected on preoperative imaging. After treatment with beta blockers, fluid resuscitation, and alpha-1 agonists, he stabilized and was eventually discharged from our hospital without any lasting sequelae.

Conclusions

Patients with aortic stenosis most often develop symmetric hypertrophy; however, a small subset has asymmetric septal hypertrophy leading to left ventricular outflow tract obstruction. In cases of severe aortic stenosis, however, evidence of left ventricular outflow tract obstruction via both symptoms and echocardiographic findings may be minimized due to extremely high afterload on the left ventricle. Diagnosing a left ventricular outflow tract obstruction as the cause of hemodynamic instability during transcatheter aortic valve replacement, in the absence of abnormal findings on echocardiogram preoperatively, requires a high index of clinical suspicion. The management of acute onset left ventricular outflow tract obstruction intraoperatively consists primarily of medical therapy, including rate control, adequate volume resuscitation, and avoidance of inotropes. With persistently elevated gradients, interventional treatments may be considered.

     

Multislice spiral computed tomography in the planning of transcatheter aortic valve replacement

Surgical treatment for aortic valve (AV) pathology is an urgent and important problem of modern medicine. The prevalence of valve disease is great and remains steadily high in the population. Due to a large number of patients who cannot undergo open AV surgery, alternative hybrid treatments are recently being actively improved. Multislice spiral computed tomography (MSCT) is mandatory prior to transcatheter AV replacement as the examination results determine if a hybrid treatment can be performed and the access is transfemoral or transapical. MSCT provides the data necessary to determine the sizes and types of AV prostheses. The application of the current systems of 320-640 spiral tomographs will further improve MSCT as the method of choice in examining patients before transcatheter AV replacement.     

Simulated elliptical bioprosthetic valve deformation: Implications for asymmetric transcatheter valve deployment

The asymmetric, elliptical shape of a transcatheter aortic valve (TAV), after implantation into a calcified aortic root, has been clinically observed. However, the impact of elliptical TAV configuration on TAV leaflet stress and strain distribution and valve regurgitation is largely unknown. In this study, we developed computational models of elliptical TAVs based on a thin pericardial bioprosthetic valve model recently developed. Finite element and computational fluid dynamics simulations were performed to investigate TAV leaflet structural deformation and central backflow leakage, and compared with those of a nominal symmetric TAV. From the results, we found that for a distorted TAV with an elliptical eccentricity of 0.68, the peak stress increased significantly by 143% compared with the nominal circular TAV. When the eccentricity of an elliptical TAV was larger than 0.5, a central backflow leakage was likely to occur. Also, deployment of a TAV with a major calcified region perpendicular to leaflet coaptation line was likely to cause a larger valve leakage. In conclusion, the computational models of elliptical TAVs developed in this study could improve our understanding of the biomechanics involved in a TAV with an elliptical configuration and facilitate optimal design of next-generation TAV devices.     

Incidence and outcome of prosthetic valve endocarditis after transcatheter aortic valve replacement in the Netherlands

Background

Transcatheter aortic valve replacement (TAVR) is increasingly being used as an alternative to conventional surgical valve replacement. Prosthetic valve endocarditis (PVE) is a rare but feared complication after TAVR, with reported first-year incidences varying from 0.57 to 3.1%. This study was performed to gain insight into the incidence and outcome of PVE after TAVR in the Netherlands.

Methods

A multicentre retrospective registry study was performed. All patients who underwent TAVR in the period 2010–2017 were screened for the diagnosis of infective endocarditis in the insurance database and checked for the presence of PVE before analysis of general characteristics, PVE parameters and outcome.

Results

A total of 3968 patients who underwent TAVR were screened for PVE. During a median follow-up of 33.5 months (interquartile range (IQR) 22.8–45.8), 16 patients suffered from PVE (0.4%), with a median time to onset of 177 days (IQR 67.8–721.3). First-year incidence was 0.24%, and the overall incidence rate was 0.14 events per 1000 person-years. Overall mortality during follow-up in our study was 31%, of which 25% occurred in hospital. All patients were treated conservatively with intravenous antibiotics alone, and none underwent a re-intervention. Other complications of PVE occurred in 5 patients (31%) and included aortic abscess (2), decompensated heart failure (2) and cerebral embolisation (1).

Conclusion

PVE in patients receiving TAVR is a relatively rare complication and has a high mortality rate.

     

Mortality after transcatheter versus surgical aortic valve replacement: an updated meta-analysis of randomised trials

To determine whether transcatheter aortic valve implantation (TAVI) improves early (30-day) and midterm (1-year) mortality compared with surgical aortic va     

Population-specific material properties of the implantation site for transcatheter aortic valve replacement finite element simulations

Patient-specific computational models are an established tool to support device development and test under clinically relevant boundary conditions. Potentially, such models could be used to aid the clinical decision-making process for percutaneous valve selection; however, their adoption in clinical practice is still limited to individual cases. To be fully informative, they should include patient-specific data on both anatomy and mechanics of the implantation site. In this work, fourteen patient-specific computational models for transcatheter aortic valve replacement (TAVR) with balloon-expandable Sapien XT devices were retrospectively developed to tune the material parameters of the implantation site mechanical model for the average TAVR population.Pre-procedural computed tomography (CT) images were post-processed to create the 3D patient-specific anatomy of the implantation site. Balloon valvuloplasty and device deployment were simulated with finite element (FE) analysis. Valve leaflets and aortic root were modelled as linear elastic materials, while calcification as elastoplastic. Material properties were initially selected from literature; then, a statistical analysis was designed to investigate the effect of each implantation site material parameter on the implanted stent diameter and thus identify the combination of material parameters for TAVR patients.These numerical models were validated against clinical data. The comparison between stent diameters measured from post-procedural fluoroscopy images and final computational results showed a mean difference of 2.5 ± 3.9%. Moreover, the numerical model detected the presence of paravalvular leakage (PVL) in 79% of cases, as assessed by post-TAVR echocardiographic examination.The final aim was to increase accuracy and reliability of such computational tools for prospective clinical applications.     

Assessment of the MANTA closure device in transfemoral transcatheter aortic valve replacement: a single-centre observational study

Objectives

The present study aims to evaluate the efficacy and safety of the MANTA vascular closure device (VCD) (Teleflex, Morrisville, NC, USA) in transfemoral transcatheter aortic valve replacement (TF-TAVR).

Background

To close the femoral artery in TF-TAVR a VCD is the treatment of choice. Data involving suture-based VCDs have been extensive. Although scarce, results on the MANTA device are promising. There is no consensus yet as to whether the MANTA device is associated with fewer access-site-related vascular/bleeding complications when compared to suture-based VCDs.

Methods

In this prospective single-arm study, performed at a single centre, a total of 73 patients eligible for TF-TAVR were included and consecutively treated with the MANTA device.

Results

Access-site-related vascular complications were seen in 13.7% of patients treated with the MANTA device. In this group of patients only minor vascular complications were observed. Access-site-related bleeding complications were rare (6.8%), and device failure was seen in 13.7% of the patients.

Conclusions

This single-centre study confirms that use of the MANTA device in TF-TAVR is feasible with an acceptable rate of access-site-related complications and no major vascular complications.

     

Surgical treatment of transcatheter aortic valve infective endocarditis

Netherlands Heart Journal - There is growing interest in infections occurring after transcatheter aortic valve implantation (TAVI). The incidence, and clinical and anatomical features suggest many...     

A case study on implantation strategies to mitigate coronary obstruction in a patient receiving transcatheter aortic valve replacement

Coronary obstruction is a life threatening complication during and post-transcatheter aortic valve replacement (TAVR). The objective of this preliminary work is to investigate the mechanisms underlying coronary obstruction in a patient after TAVR, in whom coronary obstruction was confirmed in addition to highlighting the importance of pre-procedural planning. The aortic root of an 80-year old male patient with coronary obstruction during TAVR–where a 29 mm SAPIEN 3 was deployed-was segmented from Computed Tomography scans and 3D-printed with compliant material. Flow and pressure data were acquired in this 3D-printed model in-vitro using a pulse duplicator under physiological conditions for the cases: a 29 mm SAPIEN 3, a 26 mm SAPIEN 3 expanded with a 29 mm balloon, and a 31 mm Medtronic-CoreValve deployed annularly, supra and sub-annularly respectively. Only the CoreValve in sub-annular axial position and the 29 mm SAPIEN 3 yielded pressure gradients (PG) lower than 10 mmHg (6.76 ± 0.52 and 5.72 ± 0.13 mmHg respectively) while the 26 mm SAPIEN 3, CoreValve in normal and supra-annular positions yielded higher PGs (15.5 ± 0.48, 12.2 ± 0.15 and 10.8 ± 0.24 mmHg respectively). 29 mm SAPIEN 3 implantation yielded an FFR value of 45.7 ± 0.6%. However, 31 mm CoreValve in any of the three different annular positions yielded FFR values going from 89.6 ± 1.1% in supra-annular position to 98.3 ± 1.1% in sub-annular position. Implantation with a 26 mm SAPIEN 3 expanded with a 29 mm balloon also yielded an FFR of 92.1 ± 1.2%. Coronary obstruction in this patient could have been prevented through usage of different valve types and/or through usage of a different combination of valve size-balloon sizes.