Perimount Magna Research Articles

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...

Trifecta Versus Perimount Magna Ease Aortic Valve Prostheses

Recent surgical bovine pericardial prostheses are widely used despite limited data on their long-term durability. This is a comparative analysis of the outcome of the Trifecta (Abbott, Abbott Park, IL) and Perimount Magna Ease (Edwards, Lifesciences Corp, Irvine, CA) bioprostheses from the FinnValve registry, a Finnish nationwide database including patients with aortic stenosis who underwent transcatheter or surgical aortic valve replacement with a bioprosthesis between 2008 and2017. Overall 2216 patients (mean age, 74.1 ± 6.7 years; age <65 years, 8.9%; mean follow-up, 3.8 ± 2.1 years) received the Trifecta (851 patients) or the Perimount Magna Ease (1365 patients) bioprostheses. The rates of late mortality and prosthetic valve endocarditis were comparable in the study cohorts. At 7 years the Trifecta cohort had a significantly higher risk of repeat aortic valve replacement for structural valve failure (3.3% vs 0%; adjusted subdistribution hazard ratio, 2.224; 95% confidence interval, 1.044-4.737), repeat aortic valve replacement for any cause (3.6% vs 0.4%; adjusted subdistribution hazard ratio, 3.210; 95% confidence interval, 1.286-8.013), and repeat aortic valve replacement and/or prosthetic valve endocarditis (4.1% vs 0.9%; adjusted subdistribution hazard ratio, 3.210; 95% confidence interval, 1.286-8.013) compared with the Perimount Magna Ease cohort. Among 772 propensity score-matched pairs, at 7 years the Trifecta cohort had a higher risk of repeat aortic valve replacement for structural valve failure (5.7% vs 0%, P= .009). The Trifecta aortic bioprosthesis is associated with a higher occurrence of repeat aortic valve replacement for structural valve failure compared with the Perimount Magna Ease bioprosthesis. Further comparative studies with echocardiographic data on structural valve deterioration and longer follow-up are needed to confirm these findings.

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

Comparison of Survival of Transfemoral Transcatheter Aortic Valve Implantation Versus Surgical Aortic Valve Replacement for Aortic Stenosis in Low-Risk Patients Without Coronary Artery Disease

Increasing data support transcatheter aortic valve implantation (TAVI) as a valid option over surgical aortic valve replacement (SAVR) in the treatment for severe aortic stenosis (AS) also in patients with low operative risk. However, limited data exist on the outcome of TAVI and SAVR in low-risk patients without coronary artery disease (CAD). The FinnValve registry included data on 6463 patients who underwent TAVI or SAVR with bioprosthesis between 2008 and 2017. Herein, we evaluated the outcome of low operative risk as defined by STS-PROM score <3% and absence of CAD, previous stroke and other relevant co-morbidities. Only patients who underwent TAVI with third-generation prostheses and SAVR with Perimount Magna Ease or Trifecta prostheses were included in this analysis. The primary endpoints were 30-day and 3-year all-cause mortality. Overall, 1,006 patients (175 TAVI patients and 831 SAVR patients) met the inclusion criteria of this analysis. Propensity score matching resulted in 140 pairs with similar baseline characteristics. Among these matched pairs, 30-day mortality was 2.1% in both TAVI and SAVR cohorts (p = 1.00) and 3-year mortality was 17.0% after TAVI and 14.6% after SAVR (p = 0.805). Lower rates of bleeding and atrial fibrillation, and shorter hospital stay were observed after TAVI. The need of new permanent pacemaker implantation and the incidence of early stroke did not differ between groups. In conclusion, TAVI using third-generation prostheses achieved similar early and mid-term survival compared with SAVR in low-risk patients without CAD.

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.

PRIMARY CARDIAC ANGIOSARCOMA INVADING BIOPROSTHETIC MITRAL VALVE

SESSION TITLE: Tuesday Medical Student/Resident Case Report Posters SESSION TYPE: Med Student/Res Case Rep Postr PRESENTED ON: 10/22/2019 01:00 PM - 02:00 PM INTRODUCTION: Primary cardiac tumors have an occurrence rate of 0.0001% - 0.03% on large autopsy series. The angiosarcoma variety are locally aggressive, however there are no previous reports of invasion of a bioprosthetic mitral valve. This may be partially due to the predisposition of malignant cardiac tumors to be right sided. CASE PRESENTATION: We present a 52-year-old female with a past medical history of rheumatic heart disease that came to the hospital for worsening shortness of breath and chest pain. She had undergone a surgical mitral valve replacement 5 years prior. To evaluate for possible endocarditis a trans-esophageal echocardiogram was performed which showed a large mass overlying the mitral annulus and significant bioprosthetic stenosis. This mass protruded across the mitral valve and extended into the left atrial appendage. During removal of the compromised bioprosthetic mitral valve a significant amount of foreign material was noted in and around the valve and a large tumor-like mass involving part of the interatrial septum was resected. A 27 mm Perimount Magna Mitral Ease valve was seated in the supra-annular position. The interatrial septum was reconstructed using a 2 cm bovine pericardium patch. Initial pathology of the mass revealed foci of high-grade malignant neoplasm, organizing thrombi and mesenchymal tissue. Final pathology was consistent with a high-grade epithelioid angiosarcoma. This patient is currently undergoing chemotherapy and radiation therapy. DISCUSSION: Overall survival of patients with primary cardiac angiosarcoma is approximately 1 year. Patients that undergo surgical resection of the tumor have a greater survival than those treated with chemotherapy and radiation alone. Surgical resection is technically difficult due to proximity to important vascular structures. Improvement in overall survival rates has been difficult due to the rarity of the condition. CONCLUSIONS: Primary cardiac angiosarcoma is a rare condition with very poor outcomes. Surgical resection is the cornerstone of treatment, however survival is poor regardless. Reference #1: Lam KY, Dickens P, Chan AC. Tumors of the heart. A 20-year experience with a review of 12,485 consecutive autopsies. Arch Pathol Lab Med. 1993;117(10):1027-31. Reference #2: Patel SD, Peterson A, Bartczak A, et al. Primary cardiac angiosarcoma - a review. Med Sci Monit. 2014;20:103-9. Published 2014 Jan 23. https://doi.org/10.12659/MSM.889875 Reference #3: Look hong NJ, Pandalai PK, Hornick JL, et al. Cardiac angiosarcoma management and outcomes: 20-year single-institution experience. Ann Surg Oncol. 2012;19(8):2707-15. DISCLOSURES: No relevant relationships by Raul Alonso, source=Web Response No relevant relationships by Daryoosh Derakhshan, source=Web Response No relevant relationships by Christopher Foth, source=Web Response No relevant relationships by Marc Iskandar, source=Web Response No relevant relationships by Vy Nguyen, source=Web Response No relevant relationships by Josue Rizo, source=Web Response

Mitroflow and Perimount Magna 10 years outcomes a direct propensity match analysis to assess reintervention rates and long follow‐up mortality

Biological valves are the most commonly used prostheses for aortic valve replacement (AVR) surgery in the UK. The aim of this retrospective observational study was to compare 10-year outcomes of Perimount Magna and Mitroflow bioprosthesis implanted in a single center. The medical records of patients undergoing AVR in Liverpool Heart and Chest Hospital between 1999 and 2014 were examined. All data were collected retrospectively, and a propensity match analysis was performed with a ratio 3:1 to analyze 10-year outcomes. The primary outcomes were all-cause mortality rates and aortic valve reintervention rates. A total of 2608 patients were included; Mitroflow bioprosthesis was used in 352 patients while Perimount Magna was used in 2256 patients. Median (interquartile range [IQR]) follow-up for the entire data set was 6.95 (4.99, 9.69) years. After 10 years, the all-cause mortality rate was higher in Mitroflow cohort 34.8% vs 14.7% (P < .001). A higher rate of aortic valve reintervention was observed in the Mitroflow cohort (4.7% vs 1%, P < .001). There were significant differences in survival and reintervention-free survival rate between the two groups considered. The implant of the Perimount Magna valve seems to have a better short-term and long-term outcome over Mitroflow valve. Such results require larger studies to be validated.

Hemodynamic performance and clinical outcome of pericardial Perimount Magna and Porcine Hancock-II valves in aortic position.

We investigated hospital and midterm outcome of patients operated for an aortic valve replacement (AVR) with a pericardial Perimount or a Porcine Hancock-II valve. We analyzed 353 patients with Perimount Magna (n = 189) or Hancock-II valves (n = 164). Echocardiographic data, hospital outcome, and follow-up were collected and compared. The role of the type of valve on perioperative and midterm outcome was investigated. Mean age was 75.3 ± 6.8 and 74.3 ± 7.1 years (P = .17) for Perimount and Hancock-II group, respectively. Fifty-four Perimount (28.6%) and 24 patients with Hancock-II (14.6%) required urgent procedures (P = .002), including six type-A dissections and five endocarditis. EuroSCORE-II was 3.1 ± 2.7% (Perimount) and 2.7 ± 2.2% (Hancock-II). Combined procedures were performed in 115 Perimount (60.8%) and 71 patients with Hancock (43.3%); redo procedures counted for 1% and 2.4%, respectively (P = .42). Mean valve size was 23.2 ± 1.8 mm for pericardial and 23.6 ± 1.9 mm for porcine valves (P = .08). Hospital mortality (6.3% vs 2.4%; P = .05), kidney failure (11.6% vs 9.8%; P = .73), and new pacemaker implantation rates (6.3% vs 3.0%; P = .21) were higher in the Perimount group reflecting the fact that more urgent, combined, and critical procedures were implanted with a Perimount Magna. Overall, 51 patients died over 60 months (34 Perimount, 17 Hancock), corresponding to a mortality of 5.3 per 100-persons year (95% confidence interval [CI]: 3.8-7.4) and 3.0 (95% CI: 1.8-4.8), respectively. Survival at 5 years was 76% (95% CI: 68-82) and 83% (95% CI: 74-89) in the Perimount and Hancock groups (log-rank test; P = .099). We confirm a good clinical outcome of patients with AVR with modern pericardial or a porcine bioprosthesis. Despite better hemodynamic, the Perimount does not improve the midterm clinical outcome compared with the porcine valve.

Pulmonary versus aortic pressure behavior of a bovine pericardial valve

BackgroundThe Carpentier Edwards Perimount Magna Ease aortic valvular prosthesis (Edwards Lifesciences, Irvine, Calif) has been among the most frequently and successfully used tissue prosthetic cardiac valves. Furthermore, this prosthesis has been used off-label in the pulmonary position. Until now, there has been a paucity of data regarding the functioning of tissue prosthetic valves under pulmonary conditions. MethodsUsing a pulse duplicator, hydrodynamic characteristics of a 21-mm and 25-mm Magna Ease valve were evaluated. Among parameters evaluated were leakage orifice area, closing time (ie, time required to close), and leakage duration. This procedure was performed under different pulmonic pressure conditions (15/5 mm Hg, 28/11 mm Hg, 73/32 mm Hg) and normal aortic pressure (120/80 mm Hg) as a reference. Moving images were obtained using a Phantom MIRO M320S high-speed camera (Vision Research Inc, Wayne, NJ) at 600 frames per second and used to analyze valve area in closed position. ResultsUnder normal pulmonic conditions (28/11 mm Hg) the leakage orifice area was 0.020 ± 0.012 mm2 for the 21-mm valve and 0.054 ± 0.041 mm2 for the 25-mm valve (P = .03). Hydrodynamic characteristics of the valves differed between pulmonary and aortic testing condition. Valve closing volumes were significantly lower under pulmonary hypotension and normal pulmonary conditions than under normal aortic conditions (P < .05). ConclusionsUnder normal pulmonary pressure conditions, the hydrodynamic characteristics of Magna Ease valves are significantly different compared with aortic conditions. Further research is needed to determine whether these results are associated with prosthetic valve failure.

Trends in isolated aortic valve replacement in middle‑aged patients over the last 10 years: epidemiology, risk factors, valve pathology, valve types, and outcomes.

Valve prosthesis selection in aortic valve replacement (AVR) is particularly difficult in middle‑aged patients (60-70 years old). We described changes in trends and outcomes of AVR in middle‑aged patients over the last 10 years, based on the real‑life single‑center data from the Polish National Registry. A total of 4912 consecutive adult patients who underwent any type of isolated aortic valve surgery between 2006 to 2016 were included. The main outcome measures were changes in the number of procedures, characteristics, surgical details, and in‑hospital mortality. Out of all 4912 AVR procedures performed, 1531 patients (31.2%) were between 60 and 70 years of age. The share of aortic valve prosthesis in the overall number of replacements changed between 2006 and 2016 for mechanical valves (MV) from 98.3% to 15.2% and for biological valves (BV) from 0% to 81.8% (P <0.001 for both comparisons). In the BV group, stented valves were implanted in 92.6%. The most common MV was the St. Jude Medical Mechanical Heart Valve (St. Jude Medical, Saint Paul, Minnesota, United States) and most common BV was the Carpentier‑Edwards Perimount Magna (Edwards Lifesciences, Irvine, California, United States). The most common prosthesis size was 23 mm. There were no significant differences in body mass index and comorbidities between the patients with MV and BV. The overall in‑hospital mortality was 3.46% (3.33% in the MV group and 3.69% in the BV group; P = 0.85). In the last 10 years, one‑third of aortic valve replacements were performed in patients between 60 and 70 years of age. We observed rapidly changing trends in the type of implanted valve prostheses.

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...

An in vitro comparison of flow dynamics of the Magna Ease and the Trifecta prostheses

Objectives: We aimed to compare the in vitro flow dynamics of the Perimount Magna Ease™ (PME) and the Trifecta™ (TF) bioprostheses.Material and methods: A new flow chamber was designed to compare the flow patterns of the PME (Edwards Lifesciences, Irvine, CA, USA) and the TF (SJM, St. Paul, MN, USA) aortic valve prostheses. This new channel offered the possibility of 2D-particle-image-velocimetry (2D-PIV) to completely evaluate the flow field downstream from the aortic valve to the middle of the aortic arch. Maximum average velocities, vorticity, shear strength, maximum orifice diameters and jet flow diameters were analyzed. Valve sizes of 21, 23 and 25 mm were evaluated.Results: Average velocity values, shear strength and vorticities were smaller in the flow field of the TF (maximum average velocity: 0.81 ± 0.03m/s, PME 23 mm vs. 0.7 ± 0.02m/s TF 23 mm, P < .001) under pulsatile flow conditions (70 Hz, 70 mL stroke volume). The evaluation of the upper orifice area revealed bigger maximum diameters during the peak flow phase for the TF, but more leaflet-flutter.Conclusions: Our flow chamber allowed a precise and highly sensitive characterization and comparison of complex fluid dynamics of different aortic valve prostheses. Both the Trifecta™ and the Perimount Magna Ease™ showed a good performance on a high level.

Erratum to: Hemodynamic Results and Mid-term Follow-up of 850 19 to 23 mm Perimount Magna Ease Valves.

Erratum to: Hemodynamic Results and Mid-term Follow-up of 850 19 to 23 mm Perimount Magna Ease Valves.

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.

Transprosthetic Cuff Leakage of a Bovine Pericardial Aortic Bioprosthesis

The Carpentier-Edwards PERIMOUNT Magna aortic heart valve is the most frequently implanted bioprosthesis. However, the existence of transvalvular cuff leakage necessitating a second cross clamp has been recently reported. The aim of this study is to seek the mechanism, occurrence rate, and influence of cuff leakage on the clinical course. Between September 2012 and August 2018, 754 consecutive patients underwent aortic valve replacement using a Magna aortic prosthesis at a single cardiovascular center. The overall mean patient age was 75 (69-80) years, and the percentage of female gender was 45.5% (343/754). The etiology included aortic stenosis in 506 patients (67.1%) and aortic insufficiency in 248 patients (32.9%). The implanted valve size was 19 mm, 21 mm, 23 mm, 25 mm, and 27 mm in 125 (16.6%), 243 (32.2%), 228 (30.2%), 130 (17.2%), and 28 (3.7%) patients, respectively. The incidence of cuff leakage was 1.59% (12/754). The origin was left-right commissure in all cases, and the jet passed toward the anterior mitral leaflet. In 9 patients (75%), cuff leakage faded completely within 3 months after surgery. Additionally, residual leak was not associated with hemolysis and cardiac events in all cases. Transvalvular cuff leakage should be perceived as a benign leakage. Nonperivalvular oblique jet from the left-right commissure toward the anterior mitral leaflet in transgastric long-axis view is likely to be cuff leakage, and follow-up with protamine administration for mild leak is suggested as the first-line choice of treatment rather than a second aortic clamp.

ОТДАЛЕННЫЕ РЕЗУЛЬТАТЫ ИСПОЛЬЗОВАНИЯ БИОЛОГИЧЕСКИХ ПРОТЕЗОВ У ПАЦИЕНТОВ C ПОРОКАМИ АОРТАЛЬНОГО КЛАПАНА

Background: This article presents hospital and long-term (1 year after the intervention) results of aortic valve replacement with biological valves of different size in patients with critical aortic valve stenosis. Objective: To evaluate hemodynamic parameters on the implanted biological aortic valve prostheses depending on the size, as well as to study left ventricular (LV) remodeling after surgery for aortic valve stenosis in the early and late periods. Material and methods: The study included 171 patients who were performed isolated or combined with the correction of concomitant pathology (coronary bypass surgery, mitral valve plasty, tricuspid valve plasty) aortic valve replacement with biological prostheses with landing sizes of 19-25 mm. Carprotier-Edwards PERIMOUNT, Carpentier-Edwards PERIMOUNT MAGNA, Medtronic Mosaic, St.Jude Medical Epic and TLPB Labcor bioprostheses were used for prosthetics. Results: The prosthesis-patient mismatch (PPM) phenomenon of a moderate (effective hole area index (iEHA) less than 0.85 cm2/m2) and severe degree (iEHA less than 0.65 cm2/m2) was observed in patients with implanted bioprostheses size 19 and 21. When PPM occurred, the peak and average transprosthetic gradients were lower than on the affected valve prior to surgery. The occurrence of PPM did not lead to complete remodeling of the left ventricle in the long-term period. Conclusions: In patients with implanted biological prostheses size 23 and 25 the prosthesis-patient mismatch phenomenon was not observed in the hospital and long-term period; a reverse left ventricular remodeling was detected in the long-term. The analysis showed that when using biological prostheses of standard sizes 19 and 21 iEHA in most cases was less than 0.85 cm2/m2. In these groups, it can be argued about the presence of a patient-prosthesis mismatch of varying severity.

A Non-Invasive Material Characterization Framework for Bioprosthetic Heart Valves.

Computational modeling and simulation has become more common in design and development of bioprosthetic heart valves. To have a reliable computational model, considering accurate mechanical properties of biological soft tissue is one of the most important steps. The goal of this study was to present a non-invasive material characterization framework to determine mechanical propertied of soft tissue employed in bioprosthetic heart valves. Using integrated experimental methods (i.e., digital image correlation measurements and hemodynamic testing in a pulse duplicator system) and numerical methods (i.e., finite element modeling and optimization), three-dimensional anisotropic mechanical properties of leaflets used in two commercially available transcatheter aortic valves (i.e., Edwards SAPIEN 3 and Medtronic CoreValve) were characterized and compared to that of a commonly used and well-examined surgical bioprosthesis (i.e., Carpentier-Edwards PERIMOUNT Magna aortic heart valve). The results of the simulations showed that the highest stress value during one cardiac cycle was at the peak of systole in the three bioprostheses. In addition, in the diastole, the peak of maximum in-plane principal stress was 0.98, 0.96, and 2.95MPa for the PERIMOUNT Magna, CoreValve, and SAPIEN 3, respectively. Considering leaflet stress distributions, there might be a difference in the long-term durability of different TAV models.