Hoda Hatoum

On the Mechanics of Transcatheter Aortic Valve Replacement.

Transcatheter aortic valves (TAVs) represent the latest advances in prosthetic heart valve technology. TAVs are truly transformational as they bring the benefit of heart valve replacement to patients that would otherwise not be operated on. Nevertheless, like any new device technology, the high expectations are dampened with growing concerns arising from frequent complications that develop in patients, indicating that the technology is far from being mature. Some of the most common complications that plague current TAV devices include malpositioning, crimp-induced leaflet damage, paravalvular leak, thrombosis, conduction abnormalities and prosthesis-patient mismatch. In this article, we provide an in-depth review of the current state-of-the-art pertaining the mechanics of TAVs while highlighting various studies guiding clinicians, regulatory agencies, and next-generation device designers.

Aortic sinus flow stasis likely in valve-in-valve transcatheter aortic valve implantation

Objective: Valve‐in‐valve procedures using transcatheter aortic valves are increasingly performed to treat degenerated bioprosthetic surgical aortic valves because they are less invasive than redo aortic valve replacement. The objective of this study is to quantify the changes in aortic sinus blood flow dynamics before and after a valve‐in‐valve procedure to gain insight into mechanisms for clinical and subclinical thrombosis of leaflets. Methods: A detailed description of the sinus hemodynamics for valve‐in‐valve implantation was performed in vitro. A Medtronic Hancock II (Medtronic Inc, Minneapolis, Minn) porcine bioprosthesis was modeled as a surgical aortic valve, and Medtronic CoreValve and Edwards Sapien (Edwards Lifesciences, Irvine, Calif) valves were used as the transcatheter aortic valves. High‐resolution particle image velocimetry was used to compare the flow patterns from these 2 valves within both the left coronary and noncoronary sinuses in vitro. Results: Velocity and vorticity within the surgical valve sinuses reached peak values of 0.7 m/s and 1000 s−1, with a 70% decrease in peak fluid shear stress near the aortic side of the leaflet in the noncoronary sinus. With the introduction of transcatheter aortic valves, peak velocity and vorticity were reduced to approximately 0.4 m/s and 550 s−1 and 0.58 m/s and 653 s−1 without coronary flow and 0.60 m/s and 631 s−1 and 0.81 m/s and 669 s−1 with coronary flow for the CoreValve and Sapien valve‐in‐valve implantations, respectively. Peak shear stress was approximately 38% higher along the aortic side of the coronary versus noncoronary transcatheter aortic valve leaflet. Conclusions: Decreased flow and shear stress in valve‐in‐valve procedures indicate a higher risk of leaflet thrombosis secondary to flow stasis, perhaps more so in the noncoronary sinus.

An In-Vitro Evaluation of Turbulence after Transcatheter Aortic Valve Implantation

Background This study aimed at assessment of post‐transcatheter aortic valve (TAV) replacement hemodynamics and turbulence when a same‐size SAPIEN 3 (Edwards Lifesciences Corp, Irvine, Calif) and Medtronic Evolut (Minneapolis, Minn) were implanted in a rigid aortic root with physiological dimensions and in a representative root with calcific leaflets obtained from patient computed tomography scans. Methods TAV hemodynamics were studied by placing a SAPIEN 3 26‐mm and an Evolut 26‐mm in rigid aortic roots and representative root with calcific leaflets under physiological conditions. Hemodynamics were assessed using high‐fidelity particle image velocimetry and high‐speed imaging. Transvalvular pressure gradients (PGs), pinwheeling indices, and Reynolds shear stress (RSS) were calculated. Results (1) PGs obtained with the Evolut and the SAPIEN 3 were comparable among the different models (10.5 ± 0.15 mm Hg vs 7.76 ± 0.083 mm Hg in the rigid model along with 13.9 ± 0.19 mm Hg vs 5.0 ± 0.09 mm Hg in representative root with calcific leaflets obtained from patient computed tomography scans respectively); (2) more pinwheeling was found in the SAPIEN 3 than the Evolut (0.231 ± 0.057 vs 0.201 ± 0.05 in the representative root with calcific leaflets and 0.366 ± 0.067 vs 0.122 ± 0.045 in the rigid model); (3) higher rates of RSS were found in the Evolut (161.27 ± 3.45 vs 122.84 ± 1.76 Pa in representative root with calcific leaflets and 337.22 ± 7.05 vs 157.91 ± 1.80 Pa in rigid models). More lateral fluctuations were found in representative root with calcific leaflets. Conclusions (1) Comparable PGs were found among the TAVs in different models; (2) pinwheeling indices were found to be different between both TAVs; (3) turbulence patterns among both TAVs translated according to RSS were different. Rigid aortic models yield more conservative estimates of turbulence; (4) both TAVs exhibit peak maximal RSS that exceeds platelet activation 100 Pa threshold limit.

Impact of patient-specific morphologies on sinus flow stasis in transcatheter aortic valve replacement: An in vitro study

Objective The goal of this study is to evaluate how sinus flow patterns after transcatheter aortic valve replacement in realistic representative patient roots vary. Sinus flow can affect transcatheter aortic valve operation and likely leaflet thrombosis occurrence due to stasis and poor washout. How the interaction between transcatheter aortic valve and representative patient aortic roots affects sinus hemodynamics is important to establish for future individualization of transcatheter aortic valve replacement therapy. Methods Two representative patient aortic roots were selected, segmented and 3‐dimensional printed followed by deployment of Medtronic CoreValve (Medtronic Inc, Irvine, Calif) and Edwards SAPIEN (Edwards Lifesciences, Irvine Calif) transcatheter aortic valves. Sinus hemodynamics were assessed in vitro using high spatio‐temporal resolution particle‐image‐velocimetry. Detailed sinus vortex tracking, shear stress probability density functions, and sinus washout were evaluated and assessed as a function of valve type and representative patient morphology as independent case studies. Results Peak velocity in the sinus with SAPIEN valve was approximately 3 times higher than with CoreValve for both models (0.30 ± 0.02 m/s and 0.34 ± 0.041 m/s vs 0.13 ± 0.01 m/s and 0.10 ± 0.02 m/s) (P < .01). Between representative patient models, vorticity magnitudes were significantly different (75 ± 1.1 s−1, 77 ± 3.2 s−1, 109 ± 2.3 s−1, and 250 ± 4.1 s−1) (P < .01) regardless of valve type. Sinus blood washout characteristic as a function of cardiac cycles was strongly both patient related and valve specific. Fluid dynamics favored shear stresses and washout characteristics due to a smaller sinus and sinotubular junction, further amplified by the SAPIEN valve. Conclusions Sinus flow dynamics are highly sensitive to aortic root characteristics and transcatheter aortic valve aortic root interaction. Differences in sinus‐flow washout and stasis regions between representative patient models may be reflected in different risks of leaflet thrombosis or valve degeneration.

Effect of severe bioprosthetic valve tissue ingrowth and inflow calcification on valve-in-valve performance

While in vivo studies clearly demonstrate that supra-annular Valve-in-Valve (ViV) implantation provides the highest probability for optimal post-ViV pressure gradients (PG), there is still no physical insight into explaining anomalies where some supra-annular ViV implantations yield high pressure gradients while some sub-annular implantations yield low pressure gradients. The aim of this study is to explain how severe tissue ingrowth and calcification (TIC) in a surgical aortic valve (SAV) can be one physical mechanism leading to anomalous ViV performance characteristic. The ViV hemodynamic performance was evaluated as a function of axial positioning -9.8, -6.2, 0, and +6 mm in SAVs with and without TIC. Effective orifice area (EOA) and PG were compared. Leaflet high-speed imaging and particle image velocimetry were performed to elucidate flutter and forward jet characteristics. ViV without TIC showed significantly lower PG and greater EOA (p < 0.01). EOA and PG improve with supra-annular deployment (p < 0.01) while for ViV with TIC, EOA and PG worsen as the deployment varies from -9.8 mm to 0 mm (p < 0.01) only to recover at + 6 mm (p < 0.01). Separated jet flow at the TIC site, and consequently induced stronger TAV leaflet fluttering highlight the dynamic compromising nature of TIC on jet width and performance reduction. We conclude that the inflow TIC greatly influence ViV performance due to dynamic effects that results in a real anomalous performance characteristic different than that seen in most ViV in vivo. Further in vivo studies are needed to evaluate ViV outcomes in the presence of severe TIC in SAVs.

Stented valve dynamic behavior induced by polyester fiber leaflet material in transcatheter aortic valve devices

OBJECTIVE This study aims at assessing the global dynamic behavior, elastic deformability, closing energy and turbulence of rigid versus deformable stented (RS vs DS) valve systems with deformable and rigid textile materials (DT vs RT) through studying the stent-valve interaction compared to a bioprosthetic material in transcatheter aortic valves (TAV). METHODS Three 19 mm stented textile TAV designs (RS-DT, RS-RT and DS-RT) with different stent and leaflet properties were tested and compared with a control bioprosthetic TAV (RS-DB) in a left heart simulator flow loop under physiological pressure and flow. Particle Image Velocimetry and high speed imaging were performed. Pressure gradients (PG), leakage fractions (LF), Pinwheeling indices (PI), closing energy (E) and Reynolds shear stresses (RSS) were calculated. RESULTS (a) PGs and LFs were 11.86 ± 0.51 mmHg, 11.70 ± 0.34%; 8.84 ± 0.40 mmHg, 29.80 ± 0.76%; 11.59 ± 0.12 mmHg, 14.23 ± 1.64%; and 7.05 ± 0.09 mmHg, 12.08 ± 0.45% % for RS-DB, RS-DT, RS-RT and DS-RT respectively. (b) PIs were 15.79 ± 2.34%, 4.36 ± 0.84%, 2.47 ± 0.51% and 2.03 ± 0.33% for RS-DB, RS-DT, RS-RT and DS-RT respectively. (c) E is lowest for DS-RT (0.0010 ± 0.0002 J) followed by RS-RT (0.0017 ± 0.0002 J), RS-DB (0.0023 ± 0.0004 J) and highest with RS-DT (0.0036 ± 0.0007 J). (d) At peak systole lowest RSS was obtained with RS-DT (87.82 ± 0.58 Pa) and highest with DS-RT (122.98 ± 1.87 Pa). CONCLUSION PGs, LFs, PIs and E were improved with DS-RT compared to other textile TAVs and RS-DB. Despite achieving more RSS than the rest of TAVs, DS-RT still falls within the same range of RSS produced by the other 2 valves and control exceeding the threshold for platelet activation.