PURPOSE The purpose of this study was to explore the possible structural and material property features that may facilitate complete glottal closure in an otherwise isotropic physical vocal fold model. METHOD Seven vocal fold models with different structural features were used in this study. An isotropic model was used as the baseline model, and other models were modified from the baseline model by either embedding fibers aligned along the anterior-posterior direction in the body or cover layer, adding a stiffer outer layer simulating the epithelium layer, or a combination of the 2 features. Phonation tests were performed with both aerodynamic and acoustic measurements and high-speed imaging of vocal fold vibration. RESULTS Compared with the isotropic one-layer model, the presence of a stiffer epithelium layer led to complete glottal closure along the anterior-posterior direction and strong excitation of high-order harmonics in the resulting acoustic spectra. Similar improvements were observed with fibers embedded in the cover layer, but to a lesser degree. The presence of fibers in the body layer did not yield noticeable improvements in glottal closure or harmonic excitation. CONCLUSION This study shows that the presence of collagen and elastin fibers and the epithelium layer may play a critical role in achieving complete glottal closure.

Objectives/hypothesis

The voice effects following laser cordectomy for early glottic cancer are poorly described. We investigated the voice outcomes of subligamentous cordectomy of progressive anterior-posterior extent of excision.

Study design

Physical phonatory modeling.

Methods

The influence of vocal fold surgical defects and corresponding scar was experimentally investigated using a self-oscillating physical model of the vocal folds and compared with the baseline model without defects or scar.

Results

Results showed that increasing anterior-posterior extent of resection increased phonation threshold pressure and flow rate and reduced excitation of high-order harmonics, resulting in a more breathy and rough voice production. However, it was found that voice production was improved with the placement of scar, which increased both excitation of high-order harmonics and the harmonic-to-noise ratio.

Conclusions

Although large anterior-posterior surgical resections resulted in progressive impact on vocal measures, a limited excision of the vocal fold cover surprisingly demonstrated minimal voice changes. Further investigations are required to define the acceptable extent of surgical resection that may result in optimal voice outcomes.

Background

Equipoise of transcatheter aortic valve replacement with surgical aortic valve replacement in intermediate-risk patients has been demonstrated. As transcatheter aortic valve replacement usage expands, questions regarding long-term durability become paramount. Valve design impacts durability with regions of increased leaflet stress being vulnerable to early failure. However, transcatheter aortic valve (TAV) leaflet stresses are unknown. The objective of this study was to determine stent and leaflet stresses of second-generation balloon-expandable TAV.

Methods

Commercial 29-mm Edwards Sapien XT (Edwards Lifesciences, Irvine, CA) valves underwent high-resolution microcomputed tomography scanning to develop precise three-dimensional geometric mesh. Compressed and uncompressed TAVs were modeled under systemic pressure using finite element software. Material properties of stent were based on cobalt-chromium, whereas those for leaflets were obtained from surgical bioprostheses.

Results

Maximum and minimum principal stresses on uncompressed Sapien XT TAV were 1.63 MPa and -0.36 MPa on leaflets and 93.3 MPa and -105.6 MPa on stent at diastolic pressure. Peak leaflet stress was observed at commissural tips where leaflets connected to the stent. For compressed TAV to 26 mm, maximum and minimum principal stresses were 1.55 MPa and -0.63 MPa on leaflets and 526.1 MPa and -902.2 MPa on stent at diastolic pressure. Peak leaflet stress was located at similar position and also along the suture line with the Dacron (C. R. Bard, Haverhill, PA).

Conclusions

Stress analysis of two extreme deployed geometries of 29-mm Edwards Sapien XT using exact geometry from high-resolution scans demonstrated that peak stresses for TAV leaflets were present at commissural tips where leaflets were attached. These regions would be mostly likely to initiate degeneration.

Objective

Transcatheter aortic valve replacement is established therapy for high-risk and inoperable patients with severe aortic stenosis, but questions remain regarding long-term durability. Valve design influences durability. Increased leaflet stresses in surgical bioprostheses have been correlated with degeneration; however, transcatheter valve leaflet stresses are unknown. From 2007 to 2014, a majority of US patients received first-generation balloon-expandable transcatheter valves. Our goal was to determine stent and leaflet stresses in this valve design using finite element analyses.

Methods

A 26-mm Sapien Transcatheter Heart Valve (Edwards Lifesciences, Inc, Irvine, Calif) underwent high-resolution microcomputed tomography scanning to develop precise 3-dimensional geometry of the leaflets, the stent, and the polyethylene terephthalate elements. The stent was modeled using 3-dimensional elements and the leaflets were modeled using shell elements. Stent material properties were based on stainless steel, whereas those for leaflets were obtained from surgical bioprostheses. Noncylindrical Sapien valve geometry was also simulated. Pressure loading to 80 mm Hg and 120 mm Hg was performed using ABAQUS finite element software (Dassault Systèmes, Waltham, Mass).

Results

At 80 mm Hg, maximum principal stresses on Sapien leaflets were 1.31 megaspascals (MPa). Peak leaflet stress was observed at commissural tips where leaflets connected to the stent. Maximum principal stresses for the stent were 188.91 MPa and located at stent tips where leaflet commissures were attached. Noncylindrical geometry increased peak principal leaflet stresses by 16%.

Conclusions

Using exact geometry from high-resolution scans, the 26-mm Sapien Transcatheter Heart Valve showed that peak stresses for both stent and leaflets were present at commissural tips where leaflets were attached. These regions would be prone to leaflet degeneration. Understanding stresses in first-generation transcatheter valves allows comparison to future designs for relative durability.

Objectives

Transcatheter aortic valve replacement (TAVR) is established therapy for severe aortic stenosis patients with intermediate-, high- and prohibitive-risk for surgery. A significant challenge when expanding TAVR to low-risk and younger patients is the unknown long-term durability. High leaflet stresses have been associated with surgical bioprosthetic valve degeneration. In this study, we examined the impact of changes in valve design across 3 generations of same-sized TAVR devices on stent and leaflet stresses.

Methods

The 26-mm Edwards SAPIEN, 23, 26 and 29 mm SAPIEN XT (XT) and 26 mm SAPIEN 3 (S3) (n = 1 each) underwent micro-computed tomography (micro-CT) scanning. Dynamic finite element computational simulations of 23-26 mm SAPIEN, 23-29 mm XT and 23-29 mm S3 were performed with physiological loading and micro-CT or scaled geometries.

Results

Peak stresses were concentrated in the commissure area and along the bottom of the suture, representing areas most likely to develop structural valve degeneration across TAVR generations. Latest-generation S3 showed greatest 99th percentile principal stress on commissural leaflets for 26 and 29 mm, and increased stresses over XT for 23 mm. Percentage of higher stress areas within the leaflets steadily increased across generations, 3.8%, 3.9% and 5.7%, respectively, for 26 mm SAPIEN, XT and S3 with similar trend for 29-mm valves.

Conclusions

Using computational simulations based on high-fidelity modelling of balloon-expandable TAVRs, our study demonstrated that maximum stress areas existed in similar leaflet locations across SAPIEN generations, while the latest model S3 had the highest magnitude for both 26- and 29-mm valves. S3 also had the largest area of higher stresses than other generations, which would be prone to degeneration. Our study coupled with future long-term clinical outcomes >10 years will provide insight on biomechanics of TAVR degeneration.

Background

Finite element analysis (FEA) can be used to determine ascending thoracic aortic aneurysm (aTAA) wall stress as a potential biomechanical predictor of dissection. FEA is dependent upon zero-pressure three-dimensional geometry, patient-specific material properties, wall thickness, and hemodynamic loading conditions. Unfortunately, determining material properties on unoperated patients using non-invasive means is challenging; and we have previously demonstrated significant material property differences among aTAA patients. Our study objective was to determine the impact of patient-specific material properties on aTAA wall stress. Using FEA, we investigated if patient-specific wall stress could be reasonably predicted using population-averaged material properties, which would greatly simplify dissection prediction.

Methods

ATAA patients (n=15) with both computed tomography (CT) imaging and surgical aTAA specimens were recruited. Patient-specific aTAA CT geometries were meshed and pre-stress geometries determined as previously described. Patient-specific material properties were derived from biaxial stretch testing of aTAA tissue and incorporated into a fiber-enforced hyper-elastic model, while group-averaged material properties were estimated using mean values of each parameter. Population-averaged material properties were also calculated from literature and studied. Wall stress distribution and its magnitude were determined using LS-DYNA FEA software. Peak and averaged stresses and stress distributions were compared between patient-specific and both group- and population-averaged material property models.

Results

Patient-specific material properties had minimal influence on either peak or averaged wall stress compared to use of group- or population-averaged material properties. Stress distribution was also nearly superimposed among models with patient-specific vs. group- or population-averaged material properties and provided similar prediction of sites most prone to rupture.

Conclusions

FEA using population-averaged material properties likely provides reliable stress prediction to indicate sites most prone to rupture. Population-averaged material properties may be reliably used in computational models to assess wall stress and significantly simplify risk prediction of aTAA dissection.

Background

Pulmonary autograft dilatation after Ross operation often necessitates reoperation. To understand autograft remodeling, a biomechanical understanding of human autografts after exposure to systemic pressure is required. We previously developed an ex vivo human pulmonary autograft finite element (FE) model to predict wall stress after exposure to systemic pressure. However, autograft material properties vary significantly among individuals. Our study aim was to quantify range of wall stress changes in a human autograft after Ross operation prior to remodeling based upon normal variation in human autograft mechanical properties.

Methods

A normal human autograft FE model was loaded to pulmonary and systemic arterial pressures. Stress-strain data of normal human autografts (n=24) were incorporated into an Ogden hyper-elastic model to describe autograft mechanical behavior. Autograft wall stresses at pulmonary vs. systemic pressures were examined. Autograft volume-based stress analysis was performed, based on percentage of autograft element volume exceeding 1 standard deviation (SD) above group mean stress at systemic systole.

Results

Mean first principal wall stresses (FPS) at systole of systemic versus pulmonary pressures were 129.29±17.47kPa versus 24.42±3.85kPa (p<0.001) at the annulus, 187.53±20.06kPa versus 35.98±2.15kPa at sinuses (p<0.001), and 268.68±23.40kPa versus 50.15±5.90kPa (p<0.001) at sinotubuluar junction (STJ). The percentage of autograft element volume that exceeded one SD above the group mean was 14.3±5.6% for FPS and 12.6±10.1% for second principal stresses.

Conclusion

We quantified normal human autograft biomechanical responses to systemic pressure based on patient-specific material properties. Regions of peak stresses were observed in autograft sinuses and STJ regions, which corresponded clinically to locations of autograft dilation. Our results provide valuable information on predicting variations in patient-specific ex vivo FE models when population-based material properties are used in settings where patient-specific properties are unknown.

Objectives

Transcatheter aortic valve replacement has proven successful in treating intermediate-risk, high-risk, and inoperable patients with severe aortic stenosis. Third-generation, balloon-expandable transcatheter aortic valves were developed with an outer sealing skirt to reduce paravalvular leakage. As transcatheter aortic valve replacement use expands, long-term durability questions remain. Valve design influences durability, where regions of increased leaflet stress are vulnerable to early degeneration. However, third-generation transcatheter aortic valve stresses are unknown. Our goals were to determine the stent and leaflet stresses of third-generation, balloon-expandable transcatheter aortic valves.

Methods

The commercial 26-mm Edwards SAPIEN 3 valve (Edwards Lifesciences, Inc, Irvine, Calif) underwent high-resolution micro-computed tomography scanning to develop a precise 3-dimensional geometric mesh of the stent and valve. Leaflet material properties were obtained from surgical bioprostheses, and stent material properties were based on cobalt-chromium. Simulations of systemic pressure loading were performed, and stress was calculated using finite element analyses.

Results

At diastole, maximum and minimum principal stresses on transcatheter aortic valve leaflets were 2.7 MPa and -0.47 MPa, respectively. Peak leaflet stresses were observed at upper leaflet commissures, at their connection to the stent. Maximum and minimum principal stresses for the stent were 38.2 MPa and -44.4 MPa, respectively, at 80 mm Hg and were located just below the commissural stent.

Conclusions

Stress analysis of the 26-mm SAPIEN 3 valve using exact geometry from high-resolution scans demonstrated that peak stresses for both transcatheter aortic valve stent and leaflets were present at commissural tips where leaflets were attached. These regions would be most likely to initiate degeneration. The Dacron skirt had minimal effect on stresses on leaflets and stent.

Aims

As indications for transcatheter aortic valve replacement (TAVR) continue to expand towards younger and lower-risk patients, durability becomes an increasingly important question. Durability decreases as leaflet stresses increase, but the impact of transcatheter heart valve (THV) size on stress is unknown. Patient annulus sizes can fall within "grey zones" between 2 TAVR sizes. Our aim was to examine the impact of balloon-expandable THV size on leaflet stresses.

Methods and results

SapienXT 23mm, 26mm, and 29mm sizes (Edwards Lifesciences, Inc) underwent micro-computed tomography scanning to create THV computational models then loaded to systemic pressure using finite element software. THV leaflet maximum principal stresses were 1.69MPa (23mm), 1.70MPa (26mm), and 2.12MPa (29mm) at mean arterial pressure. For intermediate annulus sizes, undersizing the larger THV yielded lower leaflet stresses than oversizing the smaller THV.

Conclusions

Increasing THV size yielded greater leaflet maximum principal stresses, which could suggest a relationship between THV size and long-term durability.. For annulus "grey zones" sizes, undersizing the larger THV resulted in lower leaflet stresses than oversizing the smaller THV. These results may influence optimal device sizing, as THV durability remains an important, unanswered question.

Background

Guidelines for sinus of Valsalva (SOV)-thoracic aortic aneurysms in Marfan syndrome recommend size-based criteria for elective surgical repair. Biomechanics may provide a better prediction of dissection risk than diameter. Our aim was to determine magnitudes of wall stress in the aortic root of Marfan patients using finite element analyses.

Methods

Forty-six Marfan patients underwent patient-specific 3-dimensional SOV-thoracic aortic aneurysm geometry reconstruction using imaging data. Finite element analyses were performed to determine wall stress distributions at SOV, sinotubular junction (STJ), and ascending aorta (AscAo) at systole.

Results

Peak circumferential stresses were 432.8 ± 111 kPa, 408.1 ± 88.3 kPa, and 321.9 ± 83.8 kPa at the SOV, STJ, and AscAo, respectively, with significant differences between SOV and AscAo (P < 3.08E-07), and STJ and AscAo (P < 2.26E-06). Peak longitudinal wall stresses were 352 ± 73.9 kPa, 277.5 ± 89.5 kPa, and 200.6 ± 81 kPa at SOV, STJ, and AscAo, respectively, with significant differences between SOV and STJ (P < 6.01E-06), SOV and AscAo (P < 9.79E-13), and STJ and AscAo (P < 3.34E-07). Diameter was not correlated to wall stresses. Comparison of wall stresses in aneurysm <5 cm vs ≥5 cm and <4.5 cm vs ≥4.5 cm showed no significant differences in wall stresses in the circumferential or longitudinal direction.

Conclusions

Peak wall stresses in Marfan SOV- thoracic aortic aneurysm were greatest in SOV than STJ than AscAo. Diameter was poorly correlated to peak stresses such that current guidelines with 5 cm cutoff had significant overlap in peak stresses in patients with <5 cm vs ≥5 cm. Use of patient-specific Marfan aneurysm models may identify patients with high wall stresses and small aneurysms who could benefit from earlier surgical repair to prevent aortic dissection.