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Trials May 2024The optimal antithrombotic strategy early after aortic valve replacement surgery with a biological valve remains controversial due to lack of high-quality evidence.... (Comparative Study)
Comparative Study
BACKGROUND
The optimal antithrombotic strategy early after aortic valve replacement surgery with a biological valve remains controversial due to lack of high-quality evidence. Either oral anticoagulants or acetylsalicylic acid should be considered for the first 3 months. Hypo-attenuated leaflet thickening on cardiac computed tomography has been associated with latent bioprosthetic valve thrombosis and may be prevented with anticoagulation. We hypothesize that anticoagulation with apixaban is superior to single antiplatelet therapy with acetylsalicylic acid in reducing hypo-attenuated leaflet thickening of bioprosthetic aortic valve prostheses.
METHODS
In this prospective, open-label, randomized trial, patients undergoing isolated aortic valve replacement surgery with rapid deployment bioprosthetic valves will be randomized. The treatment group will receive 5 mg of apixaban twice a day for the first 3 months and 100 mg of acetylsalicylic acid thereafter. The control group will be administered 100 mg of acetylsalicylic acid once a day, indefinitely. After the 3-month treatment period, a contrast-enhanced electrocardiogram-gated cardiac computed tomography will be performed to identify hypo-attenuated leaflet thickening of the bioprosthetic valve. The primary objective of the study is to assess the impact of apixaban on the prevention of hypo-attenuated leaflet thickening at 3 months. The secondary and exploratory endpoints will be clinical outcomes and safety profiles of the two strategies.
DISCUSSION
Antithrombotic therapy after aortic valve replacement is used to prevent valve thrombosis and systemic thromboembolism. Latent bioprosthetic valve thrombosis is a precursor of clinically significant prosthetic valve dysfunction or thromboembolic events. The hallmark feature of latent bioprosthetic valve thrombosis is hypo-attenuated leaflet thickening on cardiac computed tomography. Subclinical leaflet thrombosis occurs frequently in bioprosthetic aortic valves, more commonly in transcatheter than in surgical valves. There is no evidence on the effect of direct oral anticoagulants on the incidence of hypo-attenuated leaflet thickening after surgical aortic valve replacement with rapid deployment bioprostheses.
TRIAL REGISTRATION
ClinicalTrials.gov NCT06184113. Registered on December 28, 2023.
Topics: Adult; Aged; Female; Humans; Male; Middle Aged; Aortic Valve; Aspirin; Bioprosthesis; Factor Xa Inhibitors; Fibrinolytic Agents; Heart Valve Prosthesis; Heart Valve Prosthesis Implantation; Platelet Aggregation Inhibitors; Prospective Studies; Pyrazoles; Pyridones; Randomized Controlled Trials as Topic; Thrombosis; Time Factors; Treatment Outcome
PubMed: 38755709
DOI: 10.1186/s13063-024-08175-w -
Computers in Biology and Medicine Jun 2024Severe aortic valve stenosis can lead to heart failure and aortic valve replacement (AVR) is the primary treatment. However, increasing prevalence of aortic stenosis...
Severe aortic valve stenosis can lead to heart failure and aortic valve replacement (AVR) is the primary treatment. However, increasing prevalence of aortic stenosis cases reveal limitations in current replacement options, necessitating improved prosthetic aortic valves. We investigate flow disturbances downstream of severe aortic stenosis and two bioprosthetic aortic valve (BioAV) designs using advanced energy-based analyses. Three-dimensional high-fidelity fluid-structure interaction simulations have been conducted and a dedicated and novel spectral analysis has been developed to characterise the kinetic energy (KE) carried by eddies in the wavenumber space. In addition, new field quantities, i.e. modal KE anisotropy intensity as well as normalised helicity intensity, are introduced. Spectral analysis shows kinetic energy (KE) decay variations, with the stenotic case aligning with Kolmogorov's theory, while BioAV cases differing. We explore the impact of flow helicity on KE transfer and decay in BioAVs. Probability distributions of modal KE anisotropy unveil flow asymmetries in the stenotic and one BioAV cases. Moreover, an inverse correlation between temporally averaged modal KE anisotropy and normalised instantaneous helicity intensity is noted, with the coefficient of determination varying among the valve configurations. Leaflet dynamics analysis highlights a stronger correlation between flow and biomechanical KE anisotropy in one BioAV due to higher leaflet displacement magnitude. These findings emphasise the role of valve architecture in aortic turbulence as well as its importance for BioAV performance and energy-based design enhancement.
Topics: Humans; Aortic Valve; Models, Cardiovascular; Anisotropy; Heart Valve Prosthesis; Hemodynamics; Aortic Valve Stenosis
PubMed: 38754219
DOI: 10.1016/j.compbiomed.2024.108552 -
JACC. Cardiovascular Interventions May 2024Tetralogy of Fallot (TOF) is the most common form of cyanotic congenital heart disease. Palliative procedures, either surgical or transcatheter, aim to improve oxygen... (Review)
Review
Tetralogy of Fallot (TOF) is the most common form of cyanotic congenital heart disease. Palliative procedures, either surgical or transcatheter, aim to improve oxygen saturation, affording definitive procedures at a later stage. Transcatheter interventions have been used before and after surgical palliative or definitive repair in children and adults. This review aims to provide an overview of the different catheter-based interventions for TOF across all age groups, with an emphasis on palliative interventions, such as patent arterial duct stenting, right ventricular outflow tract stenting, or balloon pulmonary valvuloplasty in infants and children and transcatheter pulmonary valve replacement in adults with repaired TOF, including the available options for a large, dilated native right ventricular outflow tract.
Topics: Humans; Tetralogy of Fallot; Cardiac Catheterization; Infant; Treatment Outcome; Age Factors; Palliative Care; Child, Preschool; Stents; Child; Adult; Heart Valve Prosthesis Implantation; Balloon Valvuloplasty; Adolescent; Infant, Newborn; Young Adult; Cardiac Surgical Procedures; Risk Factors; Female; Pulmonary Valve; Male; Hemodynamics; Middle Aged; Recovery of Function
PubMed: 38749587
DOI: 10.1016/j.jcin.2024.02.009 -
Computers in Biology and Medicine Jun 2024Aortic valve replacement has become an increasing concern due to the rising prevalence of aortic stenosis in an ageing population. Existing replacement options have...
Aortic valve replacement has become an increasing concern due to the rising prevalence of aortic stenosis in an ageing population. Existing replacement options have limitations, necessitating the development of improved prosthetic aortic valves. In this study, flow characteristics during systole in a stenotic aortic valve case are compared with those downstream of two newly designed surgical bioprosthetic aortic valves (BioAVs). To do so, advanced three-dimensional fluid-structure interaction simulations are conducted and dedicated analysis methods to investigate jet flow configuration and vortex dynamics are developed. Our findings reveal that the stenotic case maintains a high jet flow eccentricity due to a fixed orifice geometry, resulting in flow separation and increased vortex stretching and tilting in the commissural low-flow regions. One BioAV design introduces non-axisymmetric leaflet motion, which reduces the maximum jet velocity and forms more vortical structures. The other BioAV design produces a fixed symmetric triangular jet shape due to non-moving leaflets and exhibits favourable vorticity attenuation, revealed by negative temporally and spatially averaged projected vortex stretching values, and significantly reduced drag. Therefore, this study highlights the benefits of custom-designed aortic valves in the context of their replacement through comprehensive and novel flow analyses. The results emphasise the importance of analysing jet flow, vortical structures, momentum balance and vorticity transport for thoroughly evaluating aortic valve performance.
Topics: Humans; Aortic Valve; Models, Cardiovascular; Heart Valve Prosthesis; Hemodynamics; Aortic Valve Stenosis; Blood Flow Velocity; Bioprosthesis
PubMed: 38749328
DOI: 10.1016/j.compbiomed.2024.108526 -
Brazilian Journal of Cardiovascular... May 2024Female, seven years old, referred to our service complaining about congestive heart failure symptoms due to mitral valve regurgitation and atrial septal defect....
CLINICAL DATA
Female, seven years old, referred to our service complaining about congestive heart failure symptoms due to mitral valve regurgitation and atrial septal defect. Technical description: Echocardiographic findings compatible with Barlow's disease and atrial septal defect, ostium secundum type.
OPERATION
She was submitted to mitral valvuloplasty with chordal shortening and prosthetic posterior ring (Gregori-Braile®) along with patch atrioseptoplasty.
COMMENTS
Mitral valve regurgitation is a rare congenital heart disease and Barlow's disease is probably rarer. Mitral valve repair is the treatment of choice.
Topics: Humans; Heart Septal Defects, Atrial; Female; Child; Mitral Valve Insufficiency; Echocardiography; Mitral Valve Prolapse
PubMed: 38748990
DOI: 10.21470/1678-9741-2023-0278 -
Brazilian Journal of Cardiovascular... May 2024Transcatheter mitral valve-in-valve is an alternative to high-risk reoperation on a failing bioprosthesis. It entails specific challenges such as left ventricular...
Transcatheter mitral valve-in-valve is an alternative to high-risk reoperation on a failing bioprosthesis. It entails specific challenges such as left ventricular outflow tract obstruction. We propose a patient-specific augmented imaging based on preoperative planning to assist the procedure. Valve-in-valve simulation was performed to represent the optimal level of implantation and the neo-left ventricular outflow tract. These data were combined with intraoperative images through a real-time 3D/2D registration tool. All data were collected retrospectively on one case (pre and per-procedure imaging). We present for the first time an intraoperative guidance tool in transcatheter mitral valve-in-valve procedure.
Topics: Humans; Heart Valve Prosthesis Implantation; Mitral Valve; Surgery, Computer-Assisted; Heart Valve Prosthesis; Cardiac Catheterization; Bioprosthesis; Retrospective Studies; Mitral Valve Insufficiency; Female; Male
PubMed: 38748975
DOI: 10.21470/1678-9741-2023-0237 -
Brazilian Journal of Cardiovascular... May 2024It is not yet clear whether cardiac surgery by mini-incision (minimally invasive cardiac surgery [MICS]) is overall less painful than the conventional approach by full... (Meta-Analysis)
Meta-Analysis Comparative Study Review
INTRODUCTION
It is not yet clear whether cardiac surgery by mini-incision (minimally invasive cardiac surgery [MICS]) is overall less painful than the conventional approach by full sternotomy (FS). A meta-analysis is necessary to investigate polled results on this topic.
METHODS
PubMed®/MEDLINE, Cochrane CENTRAL, Latin American and Caribbean Health Sciences Literature (or LILACS), and Scientific Electronic Library Online (or SciELO) were searched for all clinical trials, reported until 2022, comparing FS with MICS in coronary artery bypass grafting (CABG), mitral valve surgery (MVS), and aortic valve replacement (AVR), and postoperative pain outcome was analyzed. Main summary measures were the method of standardized mean differences (SMD) with a 95% confidence interval (CI) and P-values (considered statistically significant when < 0.05).
RESULTS
In AVR, the general estimate of postoperative pain effect favored MICS (SMD 0.87 [95% CI 0.04 to 1.71], P=0.04). However, in the sensitivity analysis, there was no difference between the groups (SMD 0.70 [95% CI -0.69 to 2.09], P=0.32). For MVS, it was not possible to perform a meta-analysis with the included studies, because they had different methodologies. In CABG, the general estimate of the effect of postoperative pain did not favor any of the approaches (SMD -0.40 [95% CI -1.07 to 0.26], P=0.23), which was confirmed by sensitivity analysis (SMD -0.02 [95% CI -0.71 to 0.67], P=0.95).
CONCLUSION
MICS was not globally less painful than the FS approach. It seems that postoperative pain is more related to the degree of tissue retraction than to the size of the incision.
Topics: Humans; Sternotomy; Pain, Postoperative; Cardiac Surgical Procedures; Coronary Artery Bypass; Minimally Invasive Surgical Procedures; Heart Valve Prosthesis Implantation
PubMed: 38748974
DOI: 10.21470/1678-9741-2023-0154 -
BMC Cardiovascular Disorders May 2024Prolonged mechanical ventilation (PMV) is a common complication following cardiac surgery linked to unfavorable patient prognosis and increased mortality. This study...
OBJECTIVES
Prolonged mechanical ventilation (PMV) is a common complication following cardiac surgery linked to unfavorable patient prognosis and increased mortality. This study aimed to search for the factors associated with the occurrence of PMV after valve surgery and to develop a risk prediction model.
METHODS
The patient cohort was divided into two groups based on the presence or absence of PMV post-surgery. Comprehensive preoperative and intraoperative clinical data were collected. Univariate and multivariate logistic regression analyses were employed to identify risk factors contributing to the incidence of PMV. Based on the logistic regression results, a clinical nomogram was developed.
RESULTS
The study included 550 patients who underwent valve surgery, among whom 62 (11.27%) developed PMV. Multivariate logistic regression analysis revealed that age (odds ratio [OR] = 1.082, 95% confidence interval [CI] = 1.042-1.125; P < 0.000), current smokers (OR = 1.953, 95% CI = 1.007-3.787; P = 0.047), left atrial internal diameter index (OR = 1.04, 95% CI = 1.002-1.081; P = 0.041), red blood cell count (OR = 0.49, 95% CI = 0.275-0.876; P = 0.016), and aortic clamping time (OR = 1.031, 95% CI = 1.005-1.057; P < 0.017) independently influenced the occurrence of PMV. A nomogram was constructed based on these factors. In addition, a receiver operating characteristic (ROC) curve was plotted, with an area under the curve (AUC) of 0.782 and an accuracy of 0.884.
CONCLUSION
Age, current smokers, left atrial diameter index, red blood cell count, and aortic clamping time are independent risk factors for PMV in patients undergoing valve surgery. Furthermore, the nomogram based on these factors demonstrates the potential for predicting the risk of PMV in patients following valve surgery.
Topics: Humans; Risk Factors; Male; Female; Middle Aged; Respiration, Artificial; Time Factors; Risk Assessment; Nomograms; Aged; Predictive Value of Tests; Retrospective Studies; Treatment Outcome; Cardiac Surgical Procedures; Decision Support Techniques; Adult; Heart Valve Prosthesis Implantation; Heart Valves; Heart Valve Diseases; Age Factors
PubMed: 38745119
DOI: 10.1186/s12872-024-03923-x -
Clinical Cardiology May 2024Paravalvular leak (PVL) is an uncommon complication of prosthetic valve implantation, which can lead to infective endocarditis, heart failure, and hemolytic anemia.... (Review)
Review
Paravalvular leak (PVL) is an uncommon complication of prosthetic valve implantation, which can lead to infective endocarditis, heart failure, and hemolytic anemia. Surgical reintervention of PVLs is associated with high mortality rates. Transcatheter PVL closure (TPVLc) has emerged as an alternative to surgical reoperation. This method provides a high success rate with a low rate of complications. This article reviews the pathogenesis, clinical manifestation, diagnosis, and management of PVL and complications following TPVLc. Besides, we presented a case of a patient with severe PVL following mitral valve replacement, who experienced complete heart block (CHB) during TPVLc. The first TPVLc procedure failed in our patient due to possible AV-node insult during catheterization. After 1 week of persistent CHB, a permanent pacemaker was implanted. The defect was successfully passed using the previous attempt. Considering the advantages of TPVLc, procedure failure should be regarded as a concern. TPVLc should be performed by experienced medical teams in carefully selected patients.
Topics: Humans; Mitral Valve; Cardiac Catheterization; Heart Valve Prosthesis; Heart Valve Prosthesis Implantation; Prosthesis Failure; Mitral Valve Insufficiency; Echocardiography, Transesophageal; Male; Treatment Outcome; Female; Aged; Reoperation
PubMed: 38742736
DOI: 10.1002/clc.24272 -
Journal of the American Heart... May 2024
Topics: Humans; Cardiac Catheterization; Heart Valve Prosthesis Implantation; Mitral Valve; Mitral Valve Annuloplasty; Mitral Valve Insufficiency; Reoperation; Treatment Failure
PubMed: 38742527
DOI: 10.1161/JAHA.124.035033