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Objectives Patients with congenital heart disease frequently require surgical or percutaneous interventional valve replacement after initial congenital heart defect (CHD) repair. In some of these patients, simultaneous replacement of both semilunar valves is necessary, resulting in increased procedural complexity, morbidity, and mortality. In this study, we analyze the outcomes of simultaneous aortic and pulmonary valve replacements following multiple surgical interventions for CHD. Methods This was a retrospective study of 24 patients who after initial repair of CHD underwent single-stage aortic and pulmonary valve replacement at our institution between 2003 and 2021. Results The mean age of the patients was 28 ± 13 years; the mean time since the last surgery was 15 ± 11 years. Decellularized valved homografts (DVHs) were used in nine patients, and mechanical valves were implanted in seven others. In eight patients, DVHs, biological, and mechanical valves were implanted in various combinations. The mean cardiopulmonary bypass time was 303 ± 104 minutes, and aortic cross-clamp time was 152 ± 73 minutes. Two patients died at 12 and 16 days postoperatively. At a maximum follow-up time of 17 years (mean 7 ± 5 years), 95% of the surviving patients were categorized as New York Heart Association heart failure class I. Conclusion Single-stage aortic and pulmonary valve replacement after initial repair of CHD remains challenging with substantial perioperative mortality (8.3%). Nevertheless, long-term survival and clinical status at the latest follow-up were excellent. The valve type had no relevant impact on the postoperative course. The selection of the valves for implantation should take into account operation-specific factors—in particular reoperability—as well as the patients' wishes. [ABSTRACT FROM AUTHOR]

Background: Paravalvular leak (PVL) is a recognized and challenging complication after surgical or transcatheter valve replacement. The transcatheter closure of PVL has become the first-line treatment in clinical practice when the procedure is not contraindicated. Transcatheter PVL closure rests on a complex procedure and complications still occur in approximately 9% of patients. Case Report: We describe the case of a delayed mechanical prosthetic leaflet impingement after transcatheter closure of a paravalvular leak associated with a Valsalva pseudoaneurysm that required an urgent surgery. Conclusion: Aorta–left ventricle communication could be a relative contraindication to be assessed on a case-by-case basis, but transcatheter closure does not preclude subsequent attempt for surgical repair and outcome. [ABSTRACT FROM AUTHOR]

Resumen: Introducción y objetivos: En los pacientes que presentan anomalías en las válvulas cardiacas la cirugía que se prefiere siempre es la plastia; sin embargo, existen casos en los cuales el reemplazo valvular es la única opción. El objetivo de este estudio es valorar los resultados a corto y largo plazo de pacientes pediátricos que requirieron reemplazo valvular.Material y métodos Previo consentimiento informado firmado por los padres o el tutor legal, se ingresaron los datos de los pacientes menores de 18 años de edad que fueron sometidos a reemplazo valvular entre 2012 y 2020,. Resultados: Se ingresaron 13 pacientes, de los cuales el 84,6% corresponden al género masculino, la media de edad fue de 9 años, el peso medio fue de 29 kg, la válvula más afectada fue la mitral, con el 61,5%, seguida de la aórtica, con el 23,1%. En el 61,5% la presentación corresponde a la doble lesión valvular. En cuanto a la etiología, la más frecuente fue la congénita, con el 84,6%; la prótesis más utilizada fue la St. Jude Medical® número 23, la media de tiempo de circulación extracorpórea fue de 115 min y el de pinzamiento aórtico fue de 75 min; el promedio de seguimiento fue 23 meses. Conclusiones: El reemplazo valvular en la etapa pediátrica siempre es un procedimiento que se intenta postergar el mayor tiempo posible; sin embargo, no es factible en muchas ocasiones y conlleva un alto riesgo tanto quirúrgico como de complicaciones. En nuestra experiencia, los resultados son satisfactorios; sin embargo, nuestra muestra son pacientes mayores de 5 años. Abstract: Introduction and objectives: In paediatric patients with heart valve abnormalities plasty is always preferred; however, there are cases in which valve replacement is the only option. The objective of this study is to assess the short- and long-term results of paediatric patients who required valve replacement. Material and methods: With prior informed consent signed by the patient's parents or legal guardian, the data of patients under 18 years of age who underwent valve replacement were entered from the period between 2012 and 2020. Results: Thirteen patients were admitted of whom 84.6% were male, the mean age was 9 years, the mean weight was 29 kg, the most affected valve was the mitral valve in 61.5%, followed by the aortic valve at 23.1%. In 61.5% presentation was a double valve lesion. In terms of the aetiology; the most frequent aetiology was congenital in 84.6%; the most widely used prosthesis was St. Jude Medical® number 23. The mean time for extracorporeal surgery was 115 min and the mean time for aortic clamping was 75 min. Follow-up was 23 months. Conclusions: valve replacement in the paediatric stage is always a procedure that we should attempt to postpone as long as possible, as it carries a high risk both in surgery and in complications, however this is often not feasible. Although our sample is not in children under 5 years of age, the results are good.

Background: Prosthetic valve endocarditis (PVE) is a feared complication after heart valve surgery. Studies on differences in bacteriology in various types of PVE are limited. Objectives: This study aimed to investigate the microbiology of PVE depending on the type of prosthetic valve and timing of diagnosis. Methods: A retrospective study based on the Swedish Registry on Infective Endocarditis focusing on PVE was conducted. The cohort was divided into mechanical and bioprosthetic valves; into endocarditis localization in the aortic, mitral, or tricuspid valve; and into early and late PVE. The microbiology in these groups was compared. Predictors of Staphylococcus aureus as the cause of PVE were examined by multivariable logistic regression. Results: A total of 780 episodes of PVE in 749 patients were compared regarding the distribution of causative microbiological agents. The most common agents included alpha‐hemolytic streptococci (29%), S. aureus (22%), enterococci (14%), coagulase‐negative staphylococci (CoNS) (12%), and Cutibacterium acnes (6%). S. aureus was more commonly found on mechanical valves compared to bioprosthetic ones (36% vs. 17%, p < 0.001) whereas alpha‐hemolytic streptococci, enterococci, and CoNS were more common on bioprosthetic valves. There were no significant differences in the microbiology of PVE affecting mitral or aortic valves or in cases of early and late PVE. Predictors for S. aureus as the cause of PVE were end‐stage renal disease, intravenous drug use, mechanical valve, and tricuspid localization of endocarditis. Conclusions: The type of prosthetic heart valve is associated with the causative pathogen. Patients with mechanical valves are more likely to have PVE caused by S. aureus. [ABSTRACT FROM AUTHOR]

Background and Objectives: Friable or infected tissue remains a challenge in surgical aortic valve replacement. We recently described the "Caput medusae" method, in which circumferential tourniquets temporarily secure the prosthesis and are then gently knotted. Tourniquets have been shown to develop significantly less force than knots. The current study investigates the critical threshold forces for tissue damage to the aortic annulus. Materials and Methods: In 14 fresh porcine hearts, the aortic valve leaflets were removed and several pledgeted sutures were placed along the annulus at defined locations. The hearts were mounted in a self-constructed device. Incremental traction force was applied to every suture and continuously recorded. The movement of each Teflon pledget was filmed with a high-speed camera. Forces at the moment of pledget "cut-in" as well as complete "tear-out" were determined from the recordings. Results: The average threshold force was determined 9.31 ± 6.04 N for cut-in and 20.41 ± 10.02 N for tear-out. Detailed analysis showed that the right coronary region had lower threshold forces than the other regions (4.77 ± 3.28 N (range, 1.67–12.75 N) vs. 10.67 ± 6.04 N (1.62–26.00 N) for cut-in and 10.67 ± 4.04 N (5.40–18.64 N) vs. 23.33 ± 9.42 N (9.22–51.23 N) for tear-out). The findings are discussed in conjunction with the knot and tourniquet forces from our previous study. Conclusions: Even in healthy tissue, moderate forces can reach a critical level at which a Teflon pledget will cut into the annulus, while a complete tear-out is unlikely. The right coronary portion is more susceptible to damage than the remaining regions. When compared to previous data, forces during manual knotting may exceed the critical cut-in level, while rubber tourniquets may provide a higher safety margin against tissue rupture. [ABSTRACT FROM AUTHOR]

Background and Aims of Study: Transcatheter mitral valve implantation (TMVI) is a promising and minimally invasive treatment for high‐risk mitral regurgitation. We aimed to investigate the feasibility of a novel self‐expanding valved stent for TMVI via apical access. Methods: We designed a novel self‐expanding mitral valve stent system consisting of an atrial flange and saddle‐shaped ventricular body connected by two opposing anchors and two opposing extensions. During valve deployment, each anchor was controlled by a recurrent string. TMVI was performed in 10 pigs using the valve prosthesis through apical access to verify technical feasibility. Echocardiography and ventricular angiography were used to assess hemodynamic data and valve function. Surviving pigs were killed 4 weeks later to confirm stent deployment. Results: Ten animals underwent TMVI using the novel mitral valve stent. Optimal valve deployment and accurate anatomical adjustments were obtained in nine animals. Implantation failed in one case, and the animal died 1 day later due to stent mismatch. After stent implantation, the hemodynamic parameters of the other animals were stable, and valve function was normal. The mean pressure across the mitral valve and left ventricular outflow tract were 2.98 ± 0.91 mmHg and 3.42 ± 0.66 mmHg, respectively. Macroscopic evaluation confirmed the stable and secure positioning of the stents. No obvious valve displacement, embolism, or paravalvular leakage was observed 4 weeks postvalve implantation. Conclusions: This study demonstrated that the novel mitral valve is technically feasible in animals. However, the long‐term feasibility and durability of this valved stent must be improved and verified. [ABSTRACT FROM AUTHOR]

Abstract Background Objective assessment of prosthetic paravalvular leak (PVL) is complex and challenging even in transesophageal echocardiography (TEE). Our aim was to assess the value of cardiovascular magnetic resonance (CMR) in quantifying PVL in aortic (AVR) or mitral valve (MVR) replacement. Methods Thirty-one patients (62 ± 15.1 years, 63% males) with a preliminary diagnosis of significant PVL (AVR, n-23; MVR, n = 8) were recruited. The TEE PVL grading was based on the semi-quantitative (SQ) TEE according to the VARC II PVL classification (%PVL: mild 30%). Non-contrast CMR studies were acquired at 1.5 T with a quantitative approach (phase-contrast velocity encoded imaging). The CMR PVL severity was classified according to regurgitant fraction (RF: (1) mild ≤ 20%, (2) moderate 21%–39%, or (3) severe ≥ 40%). Results All patients revealed symptoms of heart failure (71%: New York Heart Association [NYHA] II; 91%: N-terminal pro-B-type natriuretic peptide [NT-proBNP] > 150 pg/ml) and typical cardiovascular disease risk factors. The SQ-TEE results revealed several categories: (1) mild (n = 5; 16%), (2) moderate (n = 21; 67%), and (3) severe (n = 5; 16%) PVL. However, CMR PVL RF reclassified the severity of PVL: (1) mild to moderate (in 80%), (2) moderate to severe (in 47%), and (3) severe to moderate (in 40%). The receiver operating characteristic analysis showed that SQ-TEE and CMR PVL-vol and -RF predicted the upper tertile of NT-proBNP (> 2000 pg/ml) with the best sensitivity for CMR parameters. Conclusion The SQ-TEE showed moderate agreement with CMR and underestimated a considerable number of AVR or MVR-PVL.

Objective: We looked for a correlation between the surgically measured mitral valve size and the cardiac dimensions (left ventricle internal diameter, left atrial size, aorta size, and body surface area) measured by preoperative and intraoperative echocardiography. We also assessed to see if we could predict the mitral prosthesis size based on the correlation data obtained. Methods: The hospital records of 180 patients who underwent mitral valve replacement (MVR) with TTK Chitra valve between January 2008 and December 2012 at our hospital, were studied. The correlation between surgically measured mitral annulus size to left ventricular internal diameter systolic (LVIDS) and diastolic (LVIDD), left atrial size (linear measurement), and aorta size on echocardiography and body surface area was calculated using Pearson correlation coefficient. Mean LVIDS was calculated for each valve prosthesis size separately and the correlation was studied. Results: The correlation between mitral valve prosthesis size and left ventricular internal diameter (systolic) showed a Pearson coefficient of 3.3 with significance at the level 0.01. Mitral valve size and left atrial size showed a correlation coefficient of 2.7 with significance at the level 0.01. The correlation coefficient for mitral valve size with left ventricular internal diameter diastolic, aorta and body surface area were 2.5, 1.9, and 1.8, respectively. There was a gradual increase in the mean LVIDS with increase in the prosthetic valve size. Box plot and scatter plot showed linear correlation between valve size and mean LVIDS.

This case report describes an initially stabilized transcatheter heart valve that embolized in the ascending aorta, leading to a postprocedural acute type A aortic dissection. [ABSTRACT FROM AUTHOR]

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Open in new tab Download slide Open in new tab Download slide OBJECTIVES The aim of this study was to identify the predictors of death and of reintervention after mitral valve replacement (MVR) in children. METHODS A single-centre retrospective study was performed including 115 patients under the age of 18 undergoing MVR between 1982 and 2019. For all patients, the ratio of prosthetic valve size (diameter in mm) to weight (kg) at surgery was calculated and long-term result was assessed. The primary outcome was freedom from mitral valve (MV) re-replacement. The composite secondary outcome was freedom from death or transplant. RESULTS Fifty-four patients had a previous surgical attempt to MV repair. The median age at surgery was 5.5 years (interquartile range 1.21–9.87). Death/transplant-free survival was 77 ± 4% at 5 years and 72 ± 5% at 10 years. Univariate analysis showed a size/weight ratio higher than 2 and age <2 years as significant risk factors for death or transplant. Freedom from MV re-replacement at 5 and 10 years was 90 ± 3% and 72 ± 6%, respectively. Biological prosthesis implanted at first replacement (P  = 0.007) and size/weight ratio higher than 2 (P  = 0.048) were predictors of reoperation. Significant upsizing (P  < 0.0001) of mitral prosthesis was observed at re-replacement. CONCLUSIONS MVR is a viable strategy in children with unrepairable MV disease. Mortality can be predicted based on size/weight ratio and age <2 years. MV re-replacement can be performed with low morbidity and mortality and a larger-size prosthesis can often be placed at the time of redo. [ABSTRACT FROM AUTHOR]

Objective: We looked for a correlation between the surgically measured mitral valve size and the cardiac dimensions (left ventricle internal diameter, left atrial size, aorta size, and body surface area) measured by preoperative and intraoperative echocardiography. We also assessed to see if we could predict the mitral prosthesis size based on the correlation data obtained.Methods: The hospital records of 180 patients who underwent mitral valve replacement (MVR) with TTK Chitra valve between January 2008 and December 2012 at our hospital, were studied. The correlation between surgically measured mitral annulus size to left ventricular internal diameter systolic (LVIDS) and diastolic (LVIDD), left atrial size (linear measurement), and aorta size on echocardiography and body surface area was calculated using Pearson correlation coefficient. Mean LVIDS was calculated for each valve prosthesis size separately and the correlation was studied.Results: The correlation between mitral valve prosthesis size and left ventricular internal diameter (systolic) showed a Pearson coefficient of 3.3 with significance at the level 0.01. Mitral valve size and left atrial size showed a correlation coefficient of 2.7 with significance at the level 0.01. The correlation coefficient for mitral valve size with left ventricular internal diameter diastolic, aorta and body surface area were 2.5, 1.9, and 1.8, respectively. There was a gradual increase in the mean LVIDS with increase in the prosthetic valve size. Box plot and scatter plot showed linear correlation between valve size and mean LVIDS. [ABSTRACT FROM AUTHOR]

Background and Objectives: Friable or infected tissue remains a challenge in surgical aortic valve replacement. We recently described the “Caput medusae” method, in which circumferential tourniquets temporarily secure the prosthesis and are then gently knotted. Tourniquets have been shown to develop significantly less force than knots. The current study investigates the critical threshold forces for tissue damage to the aortic annulus. Materials and Methods: In 14 fresh porcine hearts, the aortic valve leaflets were removed and several pledgeted sutures were placed along the annulus at defined locations. The hearts were mounted in a self-constructed device. Incremental traction force was applied to every suture and continuously recorded. The movement of each Teflon pledget was filmed with a high-speed camera. Forces at the moment of pledget “cut-in” as well as complete “tear-out” were determined from the recordings. Results: The average threshold force was determined 9.31 ± 6.04 N for cut-in and 20.41 ± 10.02 N for tear-out. Detailed analysis showed that the right coronary region had lower threshold forces than the other regions (4.77 ± 3.28 N (range, 1.67–12.75 N) vs. 10.67 ± 6.04 N (1.62–26.00 N) for cut-in and 10.67 ± 4.04 N (5.40–18.64 N) vs. 23.33 ± 9.42 N (9.22–51.23 N) for tear-out). The findings are discussed in conjunction with the knot and tourniquet forces from our previous study. Conclusions: Even in healthy tissue, moderate forces can reach a critical level at which a Teflon pledget will cut into the annulus, while a complete tear-out is unlikely. The right coronary portion is more susceptible to damage than the remaining regions. When compared to previous data, forces during manual knotting may exceed the critical cut-in level, while rubber tourniquets may provide a higher safety margin against tissue rupture.

Heart valve replacement is a very effective method to treat severe valvular stenosis or valvular insufficiency. The valve can be divided into the mechanical valve and biological valve according to the main materials of the valve leaflets. The former has good durability, but the patients need to take anticoagulants all their lives, otherwise, thrombosis will occur; the latter has good blood compatibility, and only 3–6 months of postoperative anticoagulation is required, but its durability is lower than the former. Compared with a traditional valve used materials, the fabric composite valve leaflets have both mechanical valve and biological valve advantages, i.e. it can have both good blood compatibility and excellent fatigue resistance. This material is comprised of the internal fabric layer and bilateral external polyurethane layers jointed with adhesive, and it can adjust the flexibility, wear-resistance and fatigue resistance of the valve leaflet through adjusting the thickness of the outer polyurethane protective layer, the weaving method, the fiber diameter and the surface density of the inner ultra-high molecular weight polyethylene (UHMWPE) fabric. In this article, we tested the long-term durability of a fabric composite with its property close to the valve leaflet made of bovine pericardium, to evaluate the material performance loss under long-term fatigue and the wear degree of this material with different polyurethane layer thicknesses. As many as two hundred million cycles of fatigue test and the hydrodynamic performance test before and after the fatigue test proved that the material could withstand a service life of at least five years without structural failure or functional degradation. According to the SEM images after the experiment, it can be predicted that this material can achieve a longer fatigue life.

Background: Objective assessment of prosthetic paravalvular leak (PVL) is complex and challenging even in transesophageal echocardiography (TEE). Our aim was to assess the value of cardiovascular magnetic resonance (CMR) in quantifying PVL in aortic (AVR) or mitral valve (MVR) replacement. Methods: Thirty-one patients (62 ± 15.1 years, 63% males) with a preliminary diagnosis of significant PVL (AVR, n-23; MVR, n = 8) were recruited. The TEE PVL grading was based on the semi-quantitative (SQ) TEE according to the VARC II PVL classification (%PVL: mild < 10%; moderate 10%–30%; severe > 30%). Non-contrast CMR studies were acquired at 1.5 T with a quantitative approach (phase-contrast velocity encoded imaging). The CMR PVL severity was classified according to regurgitant fraction (RF: (1) mild ≤ 20%, (2) moderate 21%–39%, or (3) severe ≥ 40%). Results: All patients revealed symptoms of heart failure (71%: New York Heart Association [NYHA] II; 91%: N-terminal pro-B-type natriuretic peptide [NT-proBNP] > 150 pg/ml) and typical cardiovascular disease risk factors. The SQ-TEE results revealed several categories: (1) mild (n = 5; 16%), (2) moderate (n = 21; 67%), and (3) severe (n = 5; 16%) PVL. However, CMR PVL RF reclassified the severity of PVL: (1) mild to moderate (in 80%), (2) moderate to severe (in 47%), and (3) severe to moderate (in 40%). The receiver operating characteristic analysis showed that SQ-TEE and CMR PVL-vol and -RF predicted the upper tertile of NT-proBNP (> 2000 pg/ml) with the best sensitivity for CMR parameters. Conclusion: The SQ-TEE showed moderate agreement with CMR and underestimated a considerable number of AVR or MVR-PVL. [ABSTRACT FROM AUTHOR]

Background: Valvular heart diseases are common worldwide and are associated with a high rate of mortality and morbidity. Surgical valve replacement is the most important treatment for valvular diseases. One of the most important complications of this treatment is prosthetic valve malfunction which requires rapid diagnosis and treatment. In this study, we examined the etiologies, treatment strategies, and treatment outcomes in a series of patients with prosthetic valve malfunction. Patients and Methods: In this cross-sectional, analytic-descriptive study, 63 cases in 52 patients with prosthetic valve malfunction were included. Their coagulation status, demographic, and clinical information was collected in a questionnaire. Patients treatment and their outcomes or rehospitalization rate was recorded as well. Data were analyzed using SPSS 20 software. Results: In our study population, average age was 49.98±14.31, and 53.9% of patients were women. Among 63 cases, 57 of them had mechanical valve malfunction and 6 of them had biological valve malfunction. All cases of mechanical valve malfunction were caused by thrombosis. Surgery was the most common treatment strategy and was associated with excellent outcomes compared with other strategies (p=0.002). In this study, we observed acceptable outcomes for thrombolytic therapy. Conclusion: Thrombosis was the most frequent cause of prosthetic valve malfunction in this study, which seems to be due to inadequate anticoagulant therapy. It can be concluded that educating and following patients for their accurate coagulation status is necessary for decreasing prosthetic valve malfunction. We also found surgical treatment to be significantly better than other treatments. [ABSTRACT FROM AUTHOR]

This work presents a structural computational simulation of a polymeric aortic valve prosthesis, made with a hyperelastic material (Styrene-Ethylene/Propylene-Styrene). The valve has a suture ring, three pillars placed at 120° and three leaflets. The analysis is based on a modification over previous designs consisting in a fillet concave surface to avoid stress concentration at the junctions between leaflets and pillars. Three shapes were simulated. The first one was used to validate the computational method by comparison of the results with a recent paper. The second shape was designed to show that a fillet or "rounding" can be beneficial to the stress leaflet reduction. The third shape was also designed to show that the reduction of leaflet thickness and intercommissural distance between leaflets at the pillar junctions improves the valve opening and closure. The use of fillet with a 0.5 mm radius, reduced 26.5% the maximum Von Mises stresses for the second shape and 33.9% for the third shape. Additionally, for the latter, the opening area was not affected for the high stiffness due to fillet. The results -mainly for the third shape-are promising and give rise to future studies: further shape optimization, analysis for other materials and valve simulation under pathological loads. [Display omitted] [ABSTRACT FROM AUTHOR]

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Coronary artery embolism (CE) should be considered as a nonatherosclerotic cause of acute myocardial infarction (AMI), especially in patients with conditions favouring the formation of intracardiac thrombi. The main aetiologies of CE have changed in recent decades. Currently, atrial fibrillation is the most common cause. Most studies on CE infarcts are case reports with small numbers of patients. There are still no clear guidelines for the management in embolic myocardial infarction. Depending on the aetiology, the treatment needs to be tailored individually. As long-term outcomes indicate, patients with CE causing AMI are at high-risk and therefore require close follow-up.

This article presents an analysis of the impact of the transcatheter prosthesis frame design features on the results of its implantation in the aortic root model. In this paper we analyzed the various approaches to the design of such structures, as well as modifications in order to improve their functional characteristics during the implantation. As a general method for obtaining the results of interaction of the objects was used finite element method with nonlinear materials description and analysis of the main parameters: the stress-strain state, radial and friction forces.

This paper presents the analysis of dependences between frame basic cell geometry parameters and function via finite element analysis. The simplified models of frame cell with varied strut width, thickness and quantity in a circle was researched to evaluate radial forces, maximum stress and strain, permanent residual strain and pinching load forces. The outcomes of this study might help in the development of new artificial heart valves and during the analysis of existing in-clinical TAVI prostheses.

Transcatheter Mitral Valve Replacement (TMVR) is currently under clinical investigation as a viable treatment option for mitral regurgitation (MR). Therefore, it is important to outline the key functional requirements of a TMVR prosthesis in order to provide an overall approach to assessing mitral valve replacement devices utilizing a combination of in vitro and preclinical methods. This article provides a review of the mitral valve disease as well as general considerations and guidance for developing a TMVR device based on International Industry Standards. Specific details pertaining to the mitral valve apparatus, morphology of mitral valve disease, assessment of specific patient population as well as hazard analysis to evaluate and develop a TMVR device to treat a specific patient population have been included. The details contained within this report are not all inclusive or explicate for every technology being developed but rather thought of as a general guide on how a TMVR technology could be developed in alignment with International Industry Standards. Key learnings from the Transcatheter Aortic Valve Replacement (TAVR) experience has also been considered and taken into account when outlining this general guidance for TMVR. Key learning points from the TAVR development experience included the following: quantification of acceptable levels of paravalvular leak, valve migration potential using various anchoring methods and overall implant frame failure modes when treating the native aortic valve. It should be noted that TAVR is over a decade further along in development and clinical experience compared to TMVR. These key learnings from the early experience with TAVR should be considered with all transcatheter development projects. [ABSTRACT FROM AUTHOR]

Aims We compared thromboembolic (TE) and bleeding risks in patients with atrial fibrillation (AF) according to the new ‘Evaluated Heartvalves, Rheumatic or Artificial’ (EHRA) valve classification. Methods Patients were divided into 3 categories: (i) EHRA type 1 corresponds to the previous ‘valvular’ AF patients, with either rheumatic mitral valve stenosis or mechanical prosthetic heart valves; (ii) EHRA type 2 includes AF patients with other valvular heart disease (VHD) and valve bioprosthesis or repair; and (iii) ‘non-VHD controls’ i.e. all AF patients with neither VHD nor post-surgical valve disease. Results Among 8962 AF patients seen between 2000 and 2010, 357 (4%) were EHRA type 1, 1754 (20%) were EHRA type 2 and 6851 (76%) non-VHD controls. EHRA type 2 patients were older and had a higher CHA 2 DS 2 -VASc and HAS-BLED scores than either type 1 and non-VHD patients. After a mean follow-up of 1264 ± 1160 days, the occurrence of TE events was higher in EHRA type 2 than non-VHD patients (HR (95%CI): 1.30 1.09–1.54), p  = 0.003; also, p  = 0.31 for type 1 vs 2, p  = 0.68 for type 1 vs non-VHD controls). The rate of major BARC bleeding events for AF patients was higher in either EHRA type 1 (HR (95%CI): 3.16(2.11–4.72), p  < 0.0001) or type 2 (HR (95%CI): 2.19(1.69–2.84), p  < 0.0001) compared to non-VHD controls. Conclusion The EHRA valve classification of AF patients with VHD appears useful in categorizing these patients, in terms of TE and bleeding risks. This classification can be used in clinical practice for appropriate choices of oral anticoagulation therapy and follow-up. [ABSTRACT FROM AUTHOR]

Aim. To study different ways of development and combinational abilities of pathological changes common for bicuspid aortic valvulopathy. Material and methods. Totally 207 patients included, who had during previous 5 years been operated for progression of inherited aortic valve defect. The age varied from 17 to 75 years (median 49,6±0,9 y.), men to women — 3:1. Comorbidities included rheumatic fever in 33 (15,9%) patients and infectious endocarditis in the past in 45 (21,7%). In 111 (53,6%) patients aortic stenosis dominated and distension of ascending aorta — in 82 (39,6%) patients.Results. For most of patients mechanical prostheses were used and only for 12 — biological; 13 patients underwent valvulopastic or no any operation. One third of patients (31,9%) required a prosthesis of ascending aorta. Combinations of additional procedures (as aortic valve plastic or prosthesis, tricuspid plastic, left atrium plastic, septal defects sewing, coronary bypass grafting) were not unusual — in 57. In-hospital mortality reached 2,9%.Conclusion. Bicuspid aortic valve is a specific kind of valvulopathy, commonly combined with aortopathy. The development of this pathology is probably inherited. Clinical picture of the defect develops during time and its exacerbation might be accelerated by rheumathic fever and infectious endocarditis. Surgical treatment is effective.

The steady increase in the number of patients with diseased aortic valves demands the development of effective aortic valve replacement procedures. Engineering and technology offer various manufactured alternatives, but none can exactly match the natural human valve. In addition to the experts of heart valve tissue engineering, many researchers focus on specific aspects of the manufacturing of artificial valves. The aim of this study was to benefit such manufacturing processes. From the contributor's perspective, it is vital to gain comprehensive knowledge before embarking on this project. The perfect/optimal shape of the valve is the fundamental aspect that needs to be considered by all participants. It is noteworthy that the geometry not only limits the functionality of the structure but also determines the choice of material and engineering methods. In this study, we attempt to determine if current knowledge is sufficient to reach consensus on the issue of the optimum shape of the valve. Here, we not only provide a brief overview of traditional literature but also include the opinions of experts. This innovative way of scientific communication is unprecedented in scientific literature, and we hope that both professionals and contributors will find this study useful. [ABSTRACT FROM AUTHOR]

An observational, descriptive and cross-sectional study of 51 patients with valve prosthesis was carried out. They were admitted to the Cardiology Center of "Saturnino Lora Torres" Teaching Clinical Surgical Provincial Hospital due to valve thrombosis or bleeding episodes, from January, 2012 to December, 2014, with the purpose of estimating the variations in the International Standard Ratio values and their association with these events. The chi-square test was carried out. Those patients affected with valve thrombosis (60.4%) and International Standard Ratio under 2.5 were predominant; while the latter in bleedings was over 3.5. The patients with more than one associated risk factor presented higher quantity of thrombosis episodes; events that had less incidence when warfarin and aspirin were included in the treatment. [ABSTRACT FROM AUTHOR]

Background: Cardiovascular Magnetic Resonance is often used to evaluate patients after heart valve replacement. This study systematically analyses the influence of heart valve prostheses on phase contrast measurements in a phantom trial. Methods: Two biological and one mechanical aortic valve prostheses were integrated in a flow phantom. B0 maps and phase contrast measurements were acquired at a 1.5 T MR scanner using conventional gradient-echo sequences in predefined distances to the prostheses. Results were compared to measurements with a synthetic metal-free aortic valve. Results: The flow results at the level of the prosthesis differed significantly from the reference flow acquired before the level of the prosthesis. The maximum flow miscalculation was 154 ml/s for one of the biological prostheses and 140 ml/s for the mechanical prosthesis. Measurements with the synthetic aortic valve did not show significant deviations. Flow values measured approximately 20 mm distal to the level of the prosthesis agreed with the reference flow for all tested all prostheses. Conclusions: The tested heart valve prostheses lead to a significant deviation of the measured flow rates compared to a reference. A distance of 20 mm was effective in our setting to avoid this influence. [ABSTRACT FROM AUTHOR]

Background and objective Surgery for valvular heart disease by valve replacement procedures has become one of the most frequently performed cardiac operations to improve the quality of life (QoL). Its long-term outcomes are assessed using the quality-of-life index (QLI). This study aimed to evaluate the QoL in patients who received valve prostheses after surgery for valvular heart diseases at King Abdulaziz University in Jeddah from 2010 to 2023. Methods This was a descriptive cross-sectional study of 59 patients aged 18 years or older who underwent surgical mitral and aortic valve replacement, involving either mechanical or tissue valves, from January 2010 to May 2023 They were selected using a non-probability convenient sampling technique. Their medical records were reviewed and the participants were interviewed via phone using the World Health Organization Quality of Life-BREF (WHOQOL-BREF) questionnaire, which was used to measure the QoL of patients (https://neurotoolkit.com/whoqol-bref/). Results The study found that the QoL of the participants varied across different domains. The psychological domain had the highest mean score of 79.76, while the physical domain had the lowest mean score of 61.5. The other domains, - social, environmental, and spiritual - had mean scores of 68.05, 69.9, and 73.25, respectively. There was a statistically significant association between the QoL and nationality and chronic diseases. However, the duration after surgery and the type of valve did not significantly correlate with the QoL in the different domains. Conclusion Based on our findings, heart valve replacement improves the QoL of patients. Healthcare organizations and providers should aim to improve the management of chronic diseases to optimize outcomes., Competing Interests: The authors have declared that no competing interests exist., (Copyright © 2023, Al-Ebrahim et al.)

Objectives: Surgical supra-annular aortic valvar tissue prostheses are labelled in an inconsistent and confusing manner. If the replaced valve is too small for a given patient, the risk of patient-prosthesis mismatch is increased, which is associated with the risk of morbidity and mortality. The labelled diameter (LD) of these valves should coincide with the inflow orifice diameter (IOD). Therefore, our goal was to measure all relevant IODs., Methods: Valvar design was assessed in terms of the intended position of the valve in relation to the patient's annulus. The IODs of all available supra-annular aortic valvar prostheses were measured using a conical gauge. The IODs were compared to the LDs. We searched for instructions for use, websites, packing boxes and regulatory institutions involved in the process., Results: Eight valve models from 4 manufacturers were included. None of these valves were clearly labelled as supra-annular on the packing box, although for 3, the supra-annular label could be found in the written specifications. All valves had an IOD smaller than their LD, with a median difference of 15% (range: 4%-25%). The departure from LD differed per valve model and valve size., Conclusions: Valve packages should be labelled accurately and clearly so that surgeons can make a well-informed choice. Currently essential information is missing because the intended position in relation to the annulus is not consistently marked on the packing boxes, and valve sizes are labelled incorrectly. We propose a change for the better: relabel all valves according to their true IOD in a structured manner., (© The Author(s) 2023. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery.)