Carpentier-Edwards Perimount Magna Research Articles

The Measurement of Bovine Pericardium Density and Its Implications on Leaflet Stress Distribution in Bioprosthetic Heart Valves.

Bioprosthetic Heart Valves (BHVs) are widely used in clinical practice, showing promising outcomes. Computational modeling offers a valuable tool for quantitatively characterizing BHVs. To ensure the accuracy of computational models, it is crucial to consider precise leaflet properties, including mechanical properties and density. Bovine pericardium (BP) serves as a common material for BHV leaflets. Previous computational studies often assume BP density to approximate that of water or blood. Given that BP leaflets undergo various treatments, such as tissue fixation and anti-calcification, this study aims to measure the density of BP used in BHVs and assess its impact on leaflet stress distribution. Eight square BP samples were laser cut from Edwards BP patches and their density was determined. Specimen weight was measured using an A&D Analytical Balance, while volume was assessed through high-resolution imaging. Additionally, finite element models resembling a BHV, like the Carpentier-Edwards PERIMOUNT Magna, were constructed in ABAQUS. The average density of the BP samples was found to be 1,410kg/m3. During the acceleration phase of a cardiac cycle, the maximum stress reached 1.89MPa for a density of 1,410kg/m3 and 2.47MPa for a density of 1,000kg/m3 (a 30.7% difference). In the deceleration phase, the maximum stress reached 713kPa and 669kPa, respectively. Leaflet stress distribution and motion in BHVs are influenced by density variations. Establishing an accurate density value for BHV leaflets is imperative for enhancing the computational models, which can ultimately contribute to improved BHV design and outcomes.

Budget impact analysis of a bovine pericardial aortic bioprosthesis versus mechanical aortic valve replacement in adult patients with aortic stenosis in Romania

AimsAn analysis of the budget impact of using a bovine pericardial aortic bioprosthesis (BPAB) or a mechanical valve (MV) in aortic stenosis (AS) patients in Romania.Materials and methodsA decision-tree with a partitioned survival model was used to predict the financial outcomes of using either a BPAB (the Carpentier-Edwards Perimount Magna Ease Valve) or MV in aortic valve replacement (AVR) procedure over a 5-year period. The budget impact of various resource consumption including disabling strokes, reoperations, minor thromboembolic events, major bleeding, endocarditis, anticoagulation treatment and monitoring, and echocardiogram assessments were compared for both types of valves. One-way sensitivity analyses (OWSA) were conducted on the input costs and probabilities.ResultsThe use of BPAB compared to MV approaches budget neutrality due to incremental savings year-on-year. The initial surgical procedure and reoperation costs for BPAB are offset by savings in acenocoumarol use, disabling strokes, major bleeding, minor thromboembolic events, and anticoagulation complications. The cost of the initial procedure per patient is 460 euros higher for a BPAB due to the higher valve acquisition cost, although this is partially offset by a shorter hospital stay. The OWSA shows that the total procedure costs, including the hospital stay, are the primary cost drivers in the model.LimitationsResults are limited by cost data aggregation in the DRG system, exclusion of costs for consumables and capital equipment use, possible underestimation of outpatient complication costs, age-related variations of event rates, and valve durability.ConclusionsAdopting BPAB as a treatment option for AS patients in Romania can lead to cost savings and long-term economic benefits. By mitigating procedure costs and increasing anticoagulation treatment costs, BPAB offers a budget-neutral option that can help healthcare providers, policymakers, and patients alike manage the growing burden of AS in Romania.

Rapid deployment versus its conventional counterpart in aortic valve replacement: comparison of early hemodynamic outcomes.

Edwards Intuity is designed for rapid deployment based on the structure of Magna Ease. This study was conducted to compare early hemodynamic performance between the two valves. Patients who underwent aortic valve replacement (AVR) using Edwards Intuity or Carpentier-Edwards PERIMOUNT Magna Ease in our institution from June 2016 to July 2021 were enrolled. Intuity valve was used in 215 patients, and Magna Ease valve was used in 198 patients, respectively. Early postoperative echocardiographic data were available in 99.0% (409/413) of the patients. The transvalvular mean pressure gradient, effective orifice area, and effective orifice area index were compared between the valves stratified by prosthesis size. There were no differences in the proportion of female patients or body surface area between the groups. Mean pressure gradient on early postoperative echocardiography was significantly lower in Intuity valve than Magna Ease valve for 19, 21, 23, and 25 mm valves (15.5±5.0 vs. 20.8±9.1 mmHg, P=0.004; 12.7±4.2 vs. 15.6±5.3 mmHg, P=0.001; 11.5±3.3 vs. 13.4±5.8 mmHg, P=0.034; and 9.9±3.1 vs. 12.3±4.0 mmHg, P=0.029; respectively). Effective orifice area was larger in Intuity valve than Magna Ease valve for 19 mm valve (1.45±0.38 vs. 1.19±0.28 cm2, P=0.002), and effective orifice area index was also larger in Intuity valve than Magna Ease valve for 19 mm valve (0.96±0.26 vs. 0.80±0.20 cm2/m2, P=0.005). Early clinical outcomes, including operative mortality and postoperative complications, demonstrated no significant differences between the groups. Edwards Intuity demonstrated superior early hemodynamic performance compared with Magna Ease in a size-by-size comparison, and this superiority was more definite for small prostheses.

Postoperative complications for the new Chinese and imported bioprosthetic surgical valves replacement

This study assessed structural valve degeneration (SVD) clinical difference of BalMedic and Edward bioprosthetic valves in Zhuzhou areas, Hunan province, China, in the past 6 years. From August 2016 to August 2022, Chinese bioprosthetic valves were implanted in 77 patients while imported valves were implanted in 64 patients, to compare their postoperative SVD. Results showed that, 4 patients (9.1%) underwent SVD after surgery for Chinese mitral valve replacement (MVR) group. In addition, 2 patients (6.3%) underwent SVD after procedure for the imported MVR group. Both of them showed no statistically significant difference (p > 0.05). As for the Chinese AVR group, 3 patients (9.1%) underwent SVD after operation, and in contrast, as for the imported AVR group, 4 patients (12.5%) underwent SVD after surgery. Therefore, the short-term follow-up study in Zhuzhou area indicates good durability and efficiency of SVD, compared with its counterparts from Carpentier-Edwards PERIMOUNT Magna Ease, between mitral valve group and aortic valve group, (p>0.05)

Durability of a bovine pericardial aortic bioprosthesis based on Valve Academic Research Consortium-3 echocardiographic criteria

ObjectivesThe Carpentier-Edwards Perimount Magna Ease (Edwards Lifesciences) pericardial bioprosthesis has demonstrated satisfying hemodynamics at midterm follow-up, but its durability remains unclear. We report our 10-year experience with this third-generation valve implanted in the aortic position, with particular attention to structural valve deterioration. MethodsFrom 2007 to 2016 at our center, 338 patients underwent aortic valve replacement using the Perimount Magna Ease pericardial bioprosthesis. Patients were prospectively followed (mean 6.6 ± 2.6 years) with clinical evaluation and yearly echocardiography. Follow-up was 98% complete (7 patients lost) for a total of 2238 valve-years. Bioprosthesis structural valve deterioration was determined by strict echocardiographic assessment based on the Valve Academic Research Consortium 3 criteria. ResultsOverall operative mortality was 1.2%. Actuarial survival including early deaths averaged 80.9% ± 2.2% and 66.7% ± 4.4% after 5 and 10 years of follow-up, respectively. Actuarial freedom from explantation due to structural valve deterioration at 5 and 10 years was 99.6% ± 0.4% and 88.8% ± 5.0%, respectively, and actuarial freedom of structural valve deterioration at 5 and 10 years was 98.5% ± 0.7% and 44.0% ± 6.4%, respectively. More precisely, actuarial freedom of structural valve deterioration stage 3 was 99.6% ± 0.4% at 5 years and 88.3% ± 5.0% at 10 years, whereas freedom of structural valve deterioration stage 2/3 was 98.5% ± 0.7% and 60.9% ± 7.0%, respectively. ConclusionsWith a low rate of explantation due to structural valve deterioration events at 10 years, and particularly a low rate of moderate or severe structural valve deterioration based on echocardiographic Valve Academic Research Consortium 3 criteria, the Carpentier-Edwards Perimount Magna Ease pericardial bioprosthesis remains a reliable choice for a tissue valve in the aortic position. Video Abstract [Display omitted]

Iatrogenic Aortic Stenosis During a Case of Aortic Paravalvular Leak Closure

We report the case of a 70-year-old male patient with prior aortic valve replacement (AVR) using a Carpentier-Edwards PERIMOUNT Magna Ease pericardial bioprosthesis 19 mm valve for severe aortic stenosis. He presented to our institution 2 ​years later with severe hemolytic anemia requiring regular blood transfusions and pulmonary edema hospitalizations.

In vitro four-dimensional flow magnetic resonance analysis of the effect of pericardial valve design on aortic flow

We investigated the effect of the design of bioprosthetic pericardial valves on the downstream fluid flow pattern through four-dimensional flow magnetic resonance imaging (4D Flow). A dedicated in vitro test bench, including a paradigmatic aortic root phantom, was used to compare, under steady flow conditions, three commercially used pericardial bioprostheses (TrifectaTM, Carpentier-Edwards PERIMOUNT Magna, Crown PRT®), selecting the two smallest and comparable valve sizes. In-house 4D Flow post-processing provided the downstream flow pattern of velocity, the velocity profile at vena contracta, its effective orifice area (EOA) and the corresponding hydraulic diameter (DH). Trifecta reported the lowest peak of velocity for both the tested sizes, with vena contracta position being the most proximal to the free margin of leaflets. Conversely, in both Crown and Magna, jet flow continued to increase its downstream velocity, resulting in a farther position of vena contracta. EOA shape was trilobal for Magna, triangular for Crown and circular for Trifecta, the last one maximising EOA. The percentage of nominal luminal area effectively exploited by the flow was largely above 80% in Trifecta, below 75% in Crown and below 70% in Magna. Hence, the design of pericardial bioprostheses directly impacts on the downstream flow field pattern and its fluid dynamic performance.

Structural valve degeneration of bioprosthetic aortic valves: A network meta-analysis

ObjectiveTo compare the rate of structural valve degeneration (SVD) following surgical aortic valve replacement associated with the Trifecta (TF) valve (St Jude Medical) versus other bioprosthetic valves. MethodsA systematic literature search was conducted for studies comparing durability of the TF prosthesis to other valve types, including Perimount (Edwards Lifesciences), Carpentier-Edwards Perimount Magna Ease (ME) (Edwards Lifesciences), and Mitroflow (LivaNova USA) after surgical aortic valve replacement. Random effect pairwise and network meta-analyses were performed to compare the incident rate ratio of the composite primary outcome of SVD or reintervention due to SVD. ResultsTen studies with 31,029 patients were included, of whom 6832 received TF, 19,023 received Perimount, 3514 received ME, and 713 received Mitroflow. When compared with TF, ME was associated with lower rates of SVD or reintervention for SVD (incident rate ratio, 0.13; 95% CI, 0.02-0.92; P = .04). Similarly, at network meta-analysis, when compared with TF, only ME was associated with significantly lower rates of SVD or reintervention for SVD (incident rate ratio, 0.13; 95% CI, 0.02-0.97). ME (incident rate ratio, 0.18; 95% CI, 0.07-0.47) and PM (incident rate ratio, 0.34; 95% CI, 0.12-0.98) were associated with significantly lower rate of all-cause reintervention when compared with TF. No differences in the other secondary outcomes were found. ConclusionsThe TF valve is associated with significantly higher rates of SVD or reintervention for SVD than the ME valve, but not the Mitroflow valve. The TF valve was also associated with higher rates of all-cause reintervention than ME and Perimount valves. The underlying mechanism(s) of these findings warrant further investigation.

Serial echocardiographic evaluation of the Perimount Magna Ease prosthesis.

BackgroundThe Carpentier-Edwards Perimount Magna Ease prosthesis (PME) represents the latest generation of stented bioprostheses used for surgical aortic valve replacement (SAVR). The aim of our study was to evaluate the long-term clinical outcome and hemodynamic performance of the prosthesis with a focus on the incidence and course of structural valve deterioration (SVD) by serial echocardiographic examinations.MethodsSAVR with the PME was performed in 58 consecutive patients between 2007 and 2008. Transthoracic echocardiography was performed preoperatively, at discharge and annually during a 10-year follow-up at the German Heart Center Munich.ResultsMean age at surgery was 62±14 years. At discharge (n=57), the overall mean pressure gradient (MPG) and effective orifice area (EOA) were 15.8±4.1 mmHg and 1.8±0.4 cm2, respectively. Moderate patient-prosthesis mismatch (PPM) was present in 18 patients (32%) and severe PPM in 6 patients (11%) at discharge. Ten years following SAVR (n=33), the overall MPG was 16.6±7.3 mmHg and EOA was 1.3±0.4 cm2.Thirty-day and late mortality was 2% (n=1) and 21% (n=12), respectively. Survival at 1, 5, and 10 years was 94.7%±3.3%, 91.1%±4.1%, and 77.3%±5.9%, respectively. Freedom from reoperation at 10 years was 88.8%±4.7%. Ten years after PME implantation the cumulative incidence of any SVD, severe SVD, and bioprosthetic valve failure (BVF) was 25%±6%, 14%±5%, and 16%±5%, respectively.ConclusionsThe PME shows an excellent hemodynamic performance over the course of 10 years with development of clinically relevant SVD as late as 6 years post implant, and a 10-year incidence of severe SVD of 14%.

M01 Carpentier-Edwards Perimount Magna Ease Aortic Valve Bioprosthesis: A Single Centre Review of Intermediate Term Durability

The Carpentier-Edwards Perimount Magna Ease bioprosthetic aortic valve (Edwards Lifesciences, Irvine, CA) is a low profile version of the earlier Perimount valve that uses the ThermaFix process to enhance calcium removal with a view to improve durability of the prosthesis. The Magna ease valve has been in use for the past 10 years with but its long term durability has not been verified. We sought to assess the durability of this valve.

Hemodynamic Performance of Pericardial Bioprostheses in the Aortic Position.

BackgroundThis study was conducted to evaluate the hemodynamic performance and the incidence of prosthesis-patient mismatch (PPM) after aortic valve replacement (AVR) using bovine pericardial valves (Carpentier-Edwards Perimount Magana and Magna Ease).MethodsIn total, 216 patients (mean age, 70.0±10.5 years) who underwent AVR using stented bovine pericardial valves and had follow-up echocardiography between 3 months and 2 years (mean, 12.0±6.6 months) after surgery were enrolled. The implanted valve sizes were 19, 21, 23, and 25 mm in 32, 56, 99, and 29 patients, respectively.ResultsOn follow-up echocardiography, the mean transvalvular pressure gradients for the 19-mm, 21-mm, 23-mm, and 25-mm valves were 13.3±4.4, 12.6±4.2, 10.5±3.9, and 10.2± 3.7 mm Hg, respectively. The effective orifice area (EOA) was 1.25±0.26, 1.54±0.31, 1.81±0.41, and 1.87±0.33 cm2, respectively. These values were smaller than those suggested by the manufacturer for the corresponding sizes. No patients had PPM, when based on the reference EOA. However, moderate (EOA index ≤0.85 cm2/m2) and severe (EOA index ≤0.65 cm2/m2) PPM was present in 56 patients (11.8%) and 9 patients (1.9%), respectively, when using the measured values.ConclusionCarpentier-Edwards Perimount Magna and Magna Ease bovine pericardial valves showed satisfactory hemodynamic performance with low rates of PPM, although the reference EOA could overestimate the true EOA for individual patients.

Mid-term follow-up after aortic valve replacement with the Carpentier Edwards Magna Ease prosthesis

BackgroundApproximately 250,000 heart valve operations are performed annually worldwide. An intensive research and development effort has led to progressively more advanced heart valve prostheses. The Carpentier-Edwards Perimount Magna Ease (CEPME) prosthesis represents the latest iteration of the Edwards Perimount series of aortic tissue valves. The current study aims to evaluate the midterm performance of this bioprosthesis.MethodsFive hundred and eighteen patients with aortic stenosis underwent aortic valve replacement with the CEPME valve at Papworth Hospital between August 2008 and November 2011. After a minimum of 3 years from the index operation, eligible patients were retrospectively and consecutively recruited to participate. Recruitment was closed after 100 eligible patients had completed all study assessments. Investigations at follow-up included echocardiography, and NYHA status. Primary endpoints included valve performance measures.ResultsThe mean age was 72 years, 64% were male and median follow-up was 5.1 years. NYHA status had improved in 66% of patients. The average postoperative peak and mean pressure gradients decreased by 51.2 mmHg (64.5%) and 31.8 mmHg (59.4%), with a significant improvement in NYHA status. The frequency of moderate aortic regurgitation was 3%. There was no evidence for structural valve deterioration.ConclusionsThe CEPME has excellent mid-term durability. Its use effectively improves haemodynamics and functional capacity.

Preliminary Experience with Edwards INSPIRIS RESILIA® Compared with Carpentier-Edwards PERIMOUNT MAGNA EASE® for Aortic Valve Replacement: A Propensity-score Matched Pilot Study

Objective: PERIMOUNT MAGNA aortic valve (PM) has demonstrated optimal hemodynamic performance with excellent durability at 20 years of follow-up. INSPIRIS RESILIA (IR) has the potential to reduce s...

4D Flow MRI hemodynamic benchmarking of surgical bioprosthetic valves

PurposeWe exploited 4-dimensional flow magnetic resonance imaging (4D Flow), combined with a standardized in vitro setting, to establish a comprehensive benchmark for the systematic hemodynamic comparison of surgical aortic bioprosthetic valves (BPVs). Materials and methods4D Flow analysis was performed on two small sizes of three commercialized pericardial BPVs (Trifecta™ GT, Carpentier-Edwards PERIMOUNT Magna and Crown PRT®). Each BPV was tested over a clinically pertinent range of continuous flow rates within an in vitro MRI-compatible system, equipped with pressure transducers. In-house 4D Flow post-processing of the post-valvular velocity field included the quantification of BPV effective orifice area (EOA), transvalvular pressure gradients (TPG), kinetic energy and viscous energy dissipation. ResultsThe 4D Flow technique effectively captured the 3-dimensional flow pattern of each device. Trifecta exhibited the lowest range of velocity and kinetic energy, maximized EOA (p < 0.0001) and minimized TPGs (p ≤ 0.015) if compared with Magna and Crown, these reporting minor EOA difference s (p ≥ 0.042) and similar TPGs (p ≥ 0.25). 4D Flow TPGs estimations strongly correlated against ground-truth data from pressure transducers; viscous energy dissipation proved to be inversely proportional to the fluid jet penetration. ConclusionThe proposed 4D Flow analysis pinpointed consistent hemodynamic differences among BPVs, highlighting the not negligible effect of device size on the fluidynamic outcomes. The efficacy of non-invasive 4D Flow MRI protocol could shed light on how standardize the comparison among devices in relation to their actual hemodynamic performances and improve current criteria for their selection.

Late clinical outcomes of aortic valve replacement with Carpentier-Edwards pericardial valves.

The present study aimed to compare the long-term clinical and hemodynamic outcomes of aortic valve replacement using Carpentier-Edwards Perimount (Perimount) or Perimount Magna (Magna) valves. We enrolled 430 patients who underwent aortic valve replacements with Perimount (n=58) or Magna (n=372) valves [1998-2013]. Multivariable and inverse probability of treatment weight (IPTW) analyses were performed. Before IPTW analysis, the overall 8-year survival rate differed significantly between the groups [Perimount 90%±4% vs. Magna 76%±4%; P=0.02; hazard ratio (HR): 0.37 for the Perimount group; 95% confidence interval (CI): 0.17-0.83]. Multivariable analysis of the overall survival identified Perimount valve use as a protective factor (P=0.009; HR: 0.32; 95% CI: 0.14-0.75). Independent risk factors of overall survival were older age, male sex, higher preoperative left ventricular mass index, lower ejection fraction, lower aortic valve pressure gradient, and lower haemoglobin. After applying IPTW, overall survival was again found to be significantly longer in the Perimount group (P=0.04; HR: 0.43; 95% CI: 0.20-0.93). Event-free survival was also better in the Perimount group (P=0.006; HR: 0.38; 95% CI: 0.19-0.75). However, the Magna group had significantly lower aortic valve pressure gradients at one year and five years postoperative. Although Magna use led to decreased aortic valve pressure gradients at follow-up, overall and event-free survival rates were significantly better with use of the Perimount valve. Additional and larger studies are needed to confirm these results.

An in vitro comparison of internally versus externally mounted leaflets in surgical aortic bioprostheses.

To improve haemodynamic performance, design modifications of prosthetic valves have been proposed with each new generation of valves. These different designs also impact the amount of mechanical wear, because mechanical stresses are distributed differently. Because long-term evidence for new prosthetic valves is lacking, this in vitro study compared hydrodynamic performance and durability among 3 currently available bioprosthetic valves with internally (IMLV) or externally mounted leaflets (EMLV). Prostheses of the internally mounted Medtronic Avalus and Carpentier-Edwards Perimount Magna Ease valves were compared to prostheses of the externally mounted Abbott Trifecta valve. For each labelled size (e.g. 19, 21 and 23) of the 3 types, 3 valves underwent accelerated wear testing for up to 600 million cycles, corresponding to ∼15 years of simulated wear. The valves underwent hydrodynamic testing and visual inspection. EMLV had the largest effective orifice area and lowest pressure gradient for each labelled size at baseline and 600 million cycles; the effective orifice area and the pressure gradient were equivalent for the 2 types of IMLV. Five of 9 EMLVs had at least 1 hole or tear in the leaflet tissue around the stent posts, which resulted in severe regurgitation at 500 million cycles in 2 cases. All IMLVs were intact at 600 million cycles with minimal tissue wear. EMLV showed superior hydrodynamic performance but inferior mechanical durability compared to IMLV after 600 million cycles of testing. The primary failures were because of significant mechanical abrasion in the commissural region, which may warrant close monitoring of EMLV during long-term follow-up.

Invited Commentary

Invited Commentary

A geometry optimization framework for transcatheter heart valve leaflet design

Transcatheter aortic valve replacement (TAVR) is an established treatment for patients with severe symptomatic aortic stenosis. It is known and recognized that leaflet geometry has a key role in structural and hemodynamic performance of bioprosthetic heart valves. Excessive mechanical stress on the leaflets will lead to accelerated tissue degeneration and diminished long-term valve durability. The goal of this study was to develop an automatic optimization framework by means of commercially available software packages to reduce maximum stress value of transcatheter aortic valve (TAV) leaflets. Leaflet design was parameterized by 2 s-order non-uniform rational B-splines (NURBS) curves and particle swarm optimization method was used to examine the optimization design space. Optimized leaflet geometry for 23-mm and 26-mm TAVs were obtained under dynamic physiological loading condition. Leaflet stress distributions of the optimized TAV geometries were compared with two commercially available bioprostheses (i) Carpentier-Edwards PERIMOUNT Magna surgical bioprosthesis and (ii) Edwards SAPIEN 3 transcatheter heart valve. A considerable reduction in the maximum in-plane principal stress was observed in the optimized TAV geometries compared to the commercially available bioprostheses. The optimization results underline the opportunity to improve leaflet design in the next generation of TAVs to potentially increase long-term durability of transcatheter heart valves.

Detailed Stress Analysis of Edwards-SAPIEN and Medtronic CoreValve Devices. Is Leaflet Stress Comparable to Surgical Carpentier-Edwards PERIMOUNT Magna Bioprosthesis?

Objective: Transcatheter aortic valves (TAVs) are prone to structural valve deterioration resulting in limited long-term durability. However, data regarding long-term durability of TAVs are limited...

Spatiotemporal Complexity of the Aortic Sinus Vortex as a Function of Leaflet Calcification.

Several studies have shown the variation of aortic sinus structures' hemodynamics with different flow and geometric characteristics. They have also correlated aortic sinus hemodynamics with the progression and evolution of calcific aortic valve disease (CAVD). This study aims at visualizing aortic sinus fluid structure variations as functions of different leaflet calcification degrees and assessing their potential relationship with CAVD. A degenerated 23mm Carpentier-Edwards Perimount Magna valve extracted from a redo-surgery patient was implanted in an aortic root model and tested in a pulse duplicator left heart simulator. The valve has 3 leaflets with 3 different levels of calcium distribution: mild, moderate and severe. High-speed imaging and particle image velocimetry were performed to assess sinus vortices, leaflet tip position and velocity along with shear stress. Results have shown that (a) aortic sinus vortices initiation, entrapment and evolution varied with different calcified leaflet exposure; (b) higher velocities in the sinus were calculated with the mildly calcified leaflet compared to the moderately and severely calcified ones; (c) during systole, the mildly calcified leaflet sinus case shows the most spread-out and higher ranges of shear stress probabilities and highest magnitudes going from (- 1.5 to + 1.8Pa) compared with (- 1.0 to + 1.0Pa) for moderately and severely calcified leaflets. The higher the calcification degree the lower the shear stress range and likelihoods of having higher shear stress. This holds in diastole as well. This study shows the impact of calcification on the aortic sinus flow structures.