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Journal of the American Heart... Jan 2024Whether a bovine or porcine aortic valve bioprosthesis carries a higher risk of endocarditis after aortic valve replacement is unknown. The aim of this study was to...
BACKGROUND
Whether a bovine or porcine aortic valve bioprosthesis carries a higher risk of endocarditis after aortic valve replacement is unknown. The aim of this study was to compare the risk of prosthetic endocarditis in patients undergoing aortic valve replacement with a bovine versus porcine bioprosthesis.
METHODS AND RESULTS
This nationwide, population-based cohort study included all patients who underwent surgical aortic valve replacement with a bovine or porcine bioprosthesis in Sweden from 1997 to 2018. Regression standardization was used to account for intergroup differences. The primary outcome was prosthetic valve endocarditis, and the secondary outcomes were all-cause mortality and early prosthetic valve endocarditis. During a maximum follow-up time of 22 years, we included 21 022 patients, 16 603 with a bovine valve prosthesis and 4419 with a porcine valve prosthesis. The mean age was 73 years, and 61% of the patients were men. In total, 910 patients were hospitalized for infective endocarditis: 690 (4.2%) in the bovine group and 220 (5.0%) in the porcine group. The adjusted cumulative incidence of prosthetic valve endocarditis at 15 years was 9.5% (95% CI, 6.2%-14.4%) in the bovine group and 2.8% (95% CI, 1.4%-5.6%) in the porcine group. The absolute risk difference between the groups at 15 years was 6.7% (95% CI, 0.8%-12.5%).
CONCLUSIONS
The risk of endocarditis was higher in patients who received a bovine compared with a porcine valve prosthesis after surgical aortic valve replacement. This association should be considered in patients undergoing both surgical and transcatheter aortic valve replacement.
Topics: Male; Humans; Animals; Cattle; Swine; Aged; Female; Aortic Valve; Heart Valve Prosthesis; Bioprosthesis; Endocarditis, Bacterial; Cohort Studies; Endocarditis; Heart Valve Prosthesis Implantation
PubMed: 38156596
DOI: 10.1161/JAHA.123.031387 -
Biomaterials Science Apr 2024The sole effective treatment for most patients with heart valve disease is valve replacement by implantation of mechanical or biological prostheses. However, mechanical...
The sole effective treatment for most patients with heart valve disease is valve replacement by implantation of mechanical or biological prostheses. However, mechanical valves represent high risk of thromboembolism, and biological prostheses are prone to early degeneration. In this work, we aim to determine the potential of novel environmentally-friendly non-isocyanate polyurethanes (NIPUs) for manufacturing synthetic prosthetic heart valves. Polyhydroxyurethane (PHU) NIPUs are synthesized an isocyanate-free route, tested , and used to produce aortic valves. PHU elastomers reinforced with a polyester mesh show mechanical properties similar to native valve leaflets. These NIPUs do not cause hemolysis. Interestingly, both platelet adhesion and contact activation-induced coagulation are strongly reduced on NIPU surfaces, indicating low thrombogenicity. Fibroblasts and endothelial cells maintain normal growth and shape after indirect contact with NIPUs. Fluid-structure interaction (FSI) allows modeling of the ideal valve design, with minimal shear stress on the leaflets. Injection-molded valves are tested in a pulse duplicator and show ISO-compliant hydrodynamic performance, comparable to clinically-used bioprostheses. Poly(tetrahydrofuran) (PTHF)-NIPU patches do not show any evidence of calcification over a period of 8 weeks. NIPUs are promising sustainable biomaterials for the manufacturing of improved prosthetic valves with low thrombogenicity.
Topics: Humans; Polyurethanes; Isocyanates; Endothelial Cells; Heart Valve Prosthesis; Aortic Valve
PubMed: 38487997
DOI: 10.1039/d3bm01911j -
The Journal of Thoracic and... Oct 2019Intraoperative surgical prosthetic heart valve (SHV) choice is a key determinant of successful surgery and positive postoperative outcomes. Currently, many controversies... (Review)
Review
Characteristics of surgical prosthetic heart valves and problems around labeling: A document from the European Association for Cardio-Thoracic Surgery (EACTS)-The Society of Thoracic Surgeons (STS)-American Association for Thoracic Surgery (AATS) Valve Labelling Task Force.
Intraoperative surgical prosthetic heart valve (SHV) choice is a key determinant of successful surgery and positive postoperative outcomes. Currently, many controversies exist around the sizing and labeling of SHVs rendering the comparison of different valves difficult. To explore solutions, an expert Valve Labelling Task Force was jointly initiated by the European Association for Cardio-Thoracic Surgery (EACTS), The Society of Thoracic Surgeons (STS) and the American Association for Thoracic Surgery (AATS). The EACTS-STS-AATS Valve Labelling Task Force, comprising cardiac surgeons, cardiologists, engineers, regulators and representatives from the International Organization for Standardization (ISO), and major valve manufacturers, held its first in-person meeting in February 2018 in Paris, France. This article was derived from the meeting's discussions. The Task Force identified the following areas for improvement and clarification: reporting of physical dimensions and characteristics of SHVs determining and labeling of SHV size, in vivo and in vitro testing, and reporting of SHV hemodynamic performance and thrombogenicity. Furthermore, a thorough understanding of the regulatory background and the role of the applicable ISO standards, together with close cooperation between all stakeholders (including regulatory and standard- setting bodies), is necessary to improve the current situation. Cardiac surgeons should be provided with appropriate information to allow for optimal SHV choice. This first article from the EACTS-STS-AATS Valve Labelling Task Force summarizes the background of SHV sizing and labeling and identifies the most important elements where further standardization is necessary.
Topics: Bioprosthesis; Cardiology; Clinical Decision-Making; Consensus; Consumer Product Safety; Equipment Failure Analysis; Heart Valve Prosthesis; Heart Valve Prosthesis Implantation; Humans; Patient Selection; Product Labeling; Prosthesis Design; Prosthesis Failure; Societies, Medical
PubMed: 31084981
DOI: 10.1016/j.jtcvs.2019.04.001 -
European Journal of Cardio-thoracic... Jun 2019Intraoperative surgical prosthetic heart valve (SHV) choice is a key determinant of successful surgery and positive postoperative outcomes. Currently, many controversies... (Review)
Review
Characteristics of surgical prosthetic heart valves and problems around labelling: a document from the European Association for Cardio-Thoracic Surgery (EACTS)-The Society of Thoracic Surgeons (STS)-American Association for Thoracic Surgery (AATS) Valve Labelling Task Force.
Intraoperative surgical prosthetic heart valve (SHV) choice is a key determinant of successful surgery and positive postoperative outcomes. Currently, many controversies exist around the sizing and labelling of SHVs rendering the comparison of different valves difficult. To explore solutions, an expert Valve Labelling Task Force was jointly initiated by the European Association for Cardio-Thoracic Surgery (EACTS), The Society of Thoracic Surgeons (STS) and the American Association for Thoracic Surgery (AATS). The EACTS-STS-AATS Valve Labelling Task Force, comprising cardiac surgeons, cardiologists, engineers, regulators and representatives from the International Organization for Standardization (ISO) and major valve manufacturers, held its first in-person meeting in February 2018 in Paris, France. This article was derived from the meeting's discussions. The Task Force identified the following areas for improvement and clarification: reporting of physical dimensions and characteristics of SHVs determining and labelling of SHV size, in vivo and in vitro testing and reporting of SHV haemodynamic performance and thrombogenicity. Furthermore, a thorough understanding of the regulatory background and the role of the applicable ISO standards, together with close cooperation between all stakeholders (including regulatory and standard-setting bodies), is necessary to improve the current situation. Cardiac surgeons should be provided with appropriate information to allow for optimal SHV choice. This first article from the EACTS-STS-AATS Valve Labelling Task Force summarizes the background of SHV sizing and labelling and identifies the most important elements where further standardization is necessary.
Topics: Europe; Heart Valve Diseases; Heart Valve Prosthesis; Heart Valve Prosthesis Implantation; Humans; Product Labeling; Prosthesis Design; Societies, Medical; Thoracic Surgery; United States
PubMed: 31075173
DOI: 10.1093/ejcts/ezz034 -
Cardiology 2020After aortic valve replacement (AVR), suspected prosthetic valve dysfunction (mechanical or biological) may arise based on echocardiographic transvalvular velocities and...
BACKGROUND
After aortic valve replacement (AVR), suspected prosthetic valve dysfunction (mechanical or biological) may arise based on echocardiographic transvalvular velocities and gradients, leading to reoperative surgical intervention being considered. Our experience has found that 4-dimensional (space and time) image reconstruction of ECG-gated computed tomography, termed cine-CT, may be helpful in such cases. We review and illustrate our experience.
METHODS
Twenty-seven AVR patients operated previously by a single surgeon (who performs >100 AVRs/year) were referred for repeat evaluation of suspected aortic stenosis (AS) based on elevated transvalvular velocities and gradients. The patients were fully evaluated by cine-CT.
RESULTS
In all but 2 cases, the cine-CT strikingly and visually confirmed normal leaflet function and excursion, with no valve thrombosis, restriction by pannus, or obstruction by clot. In only 2 cases did cine-CT reveal decreased mechanical valve leaflet excursion. Repeat surgery was required in only 1 case while all other patients continued clinically without cardiac events.
CONCLUSIONS
Echocardiography is an extraordinarily useful tool for the evaluation of prosthetic valve function. Increased pressure recovery beyond the valve and other factors may occasionally lead to exaggerated gradients. Cine-CT is emerging as an extremely valuable tool for further evaluation of suspected prosthetic valve AS. Our experience has been extremely helpful, as is shown in the dramatically reassuring images.
Topics: Adult; Aged; Aortic Valve; Aortic Valve Stenosis; Echocardiography, Doppler; Female; Heart Valve Prosthesis; Heart Valve Prosthesis Implantation; Humans; Imaging, Three-Dimensional; Male; Middle Aged; Reoperation; Sensitivity and Specificity; Tomography, X-Ray Computed; Young Adult
PubMed: 32454507
DOI: 10.1159/000507182 -
Gaceta Medica de Mexico 2023Heart valve replacement surgery with mechanical or biological prostheses entails a risk of thromboembolism and bleeding complications.
BACKGROUND
Heart valve replacement surgery with mechanical or biological prostheses entails a risk of thromboembolism and bleeding complications.
OBJECTIVE
To determine the complications related to complementary anticoagulation therapy and the probability of risk.
METHODS
One-hundred and sixty-three patients who underwent heart valve replacement between 2002 and 2016 with either mechanical or biological prostheses, and who received vitamin K antagonists after hospital discharge, were studied. Anticoagulation therapy was categorized into optimal and non-optimal according to INR values prior to the development of complications. Patients with comorbidities and other risk factors for thrombosis and/or bleeding were excluded.
RESULTS
In total, 68.7 % of patients received mechanical prostheses, and 31.3 %, biological prostheses (p ≤ 0.001); 25.2 % experienced the complications that motivated the study (p ≤ 0.001), which were hemorrhagic in 48.8 %, thromboembolic in 26.8 %, and of both types in 24.4 % (relative risk = 4.229). Among the patients with complications, 95.1 % received mechanical prostheses, and 4.9 %, biological (p = 0.005); non-optimal INR was identified in 49.7 % (p ≤ 0.001).
CONCLUSIONS
Given the high risk of thromboembolic and hemorrhagic complications, valve prostheses must be carefully chosen, and care priorities should include prevention and follow-up, especially in those patients who require anticoagulation therapy.
Topics: Humans; Tertiary Care Centers; Thromboembolism; Heart Valve Prosthesis; Anticoagulants; Hemorrhage; Heart Valves; Heart Valve Prosthesis Implantation
PubMed: 37494706
DOI: 10.24875/GMM.M23000772 -
Heart, Lung & Circulation Jan 2024Prosthetic valve endocarditis (PVE) is the most severe form of infective endocarditis associated with a high mortality rate. Whether PVE affects biological and... (Observational Study)
Observational Study
AIMS
Prosthetic valve endocarditis (PVE) is the most severe form of infective endocarditis associated with a high mortality rate. Whether PVE affects biological and mechanical aortic valves to the same extent remains controversial. This study aimed to compare the incidence of re-intervention because of PVE between bioprosthetic and mechanical valves.
METHODS
Patients undergoing isolated surgical aortic valve replacement (AVR) or combined AVR in a single cardiac surgery centre between January 1998 and December 2019 were analysed. All patients who underwent re-intervention because of PVE were identified. The primary endpoint was the rate of explants. Freedom from re-intervention and variables associated with re-intervention were analysed using Cox regression analysis including correction for competing risk.
RESULTS
During the study period, 5,983 aortic valve prostheses were implanted, including 3,620 biological (60.5%) and 2,363 mechanical (39.5%) prostheses. The overall mean follow-up period was 7.3±5.3 years (median, 6.5; IQR 2.9-11.2 years). The rate of re-intervention for PVE in the biological group was 1.5% (n=54) compared with 1.7% (n=40) in the mechanical group (p=0.541). Cox regression analysis revealed that younger age (HR 0.960, 95% CI 0.942-0.979; p<0.001), male sex (HR 2.362, 95% CI 1.384-4.033; p=0.002), higher creatinine (HR 1.002, 95% CI 0.999-1.004; p=0.057), and biological valve prosthesis (HR 2.073, 95% CI 1.258-3.414; p=0.004) were associated with re-intervention for PVE. After correction for competing risk of death, biological valve prosthesis was significantly associated with a higher rate of re-intervention for PVE (HR 2.011, 95% CI 1.177-3.437; p=0.011).
CONCLUSIONS
According to this single-centre, observational, retrospective cohort study, AVR using biological prosthesis is associated with re-intervention for PVE compared to mechanical prosthesis. Further investigations are needed to verify these findings.
Topics: Humans; Male; Aortic Valve; Heart Valve Prosthesis; Endocarditis, Bacterial; Retrospective Studies; Heart Valve Prosthesis Implantation; Endocarditis
PubMed: 38158265
DOI: 10.1016/j.hlc.2023.11.024 -
Journal of Echocardiography Dec 2015Echocardiographic evaluation of prosthetic valves is similar in many respects to evaluation of native valve disease. However, there are some important differences....
Echocardiographic evaluation of prosthetic valves is similar in many respects to evaluation of native valve disease. However, there are some important differences. First, there are several types of prosthetic valves with different fluid dynamics for each basic design and differing flow velocities for each valve size. Second, the mechanisms of valve dysfunction are somewhat different from those for native valve disease. Third, the technical aspects of imaging artificial devices, specifically the problem of acoustic shadowing, significantly affect the diagnostic approach when prosthetic valve dysfunction is suspected. Fourth, transcatheter aortic valve implantation (TAVI) has rapidly expanded in recent years. Echocardiography plays an essential role in identifying patients suitable for TAVI and providing intra-procedural monitoring, and is the modality for post-procedure follow-up. Both an understanding of the basic approach to echocardiographic evaluation and detailed knowledge of the specific flow dynamics for the size and type of prosthesis in an individual patient are needed for appropriate patient management.
Topics: Aortic Valve; Aortic Valve Stenosis; Cardiac Catheterization; Echocardiography; Heart Valve Prosthesis; Heart Valve Prosthesis Implantation; Heart Valves; Humans; Prosthesis Design; Transcatheter Aortic Valve Replacement
PubMed: 26286254
DOI: 10.1007/s12574-015-0261-5 -
BMJ Case Reports Nov 2023In this case, we present a rare cause of prosthetic valve endocarditis. A man in his 80s presented to the emergency department with fever and diarrhoea. The patient...
In this case, we present a rare cause of prosthetic valve endocarditis. A man in his 80s presented to the emergency department with fever and diarrhoea. The patient underwent a transcatheter aortic valve replacement 17 years earlier. A negative PCR result in faeces for and positive blood cultures with gave rise to the suspicion of an intravascular infection, which was confirmed with a positron emission tomography. Due to the low prevalence of endocarditis, there is no consensus on the most effective treatment. Guidelines recommend early surgery and long-term antimicrobial treatment in endocarditis with Gram-negative bacteria. In this case, surgery was not deemed feasible given the patient his advanced age and multiple comorbidities. Despite treatment with intravenous antibiotics, the patient succumbed to progression of endocarditis 37 days after admission.
Topics: Male; Humans; Endocarditis, Bacterial; Salmonella enteritidis; Heart Valve Prosthesis; Tomography, X-Ray Computed; Endocarditis; Aortic Valve
PubMed: 38011951
DOI: 10.1136/bcr-2023-256540 -
General Thoracic and Cardiovascular... Jun 2020We examined the outcomes following mitral valve replacement with bileaflet mechanical prosthetic valve in children and identified the predictors for mortality and...
OBJECTIVES
We examined the outcomes following mitral valve replacement with bileaflet mechanical prosthetic valve in children and identified the predictors for mortality and reoperation.
METHODS
Medical records from 49 children who underwent mitral valve replacement between 1982 and 2015 were reviewed retrospectively. Median age and body weight at initial mitral valve replacement were 2.4 years and 9.7 kg, respectively. The median follow-up was 13 years. Surgical results and predictors for mortality and reoperation were investigated.
RESULTS
There was no operative mortality; eight late deaths occurred. The actuarial survival rates were 89.5%, 84.2%, and 80.7% at 5, 10, and 15 years, respectively, after initial mitral valve replacement. The actuarial freedom rates from related complications were 89.5%, 78.3%, and 70.7% at 5, 10, and 15 years, respectively. Nineteen patients required 1st re-mitral valve replacement at a median of 5.9 years; six of these 19 required 2nd re-mitral valve replacement at a median of 8.9 years after 1st re-MVR. The actuarial freedom rates from re-mitral valve replacement were 86.0%, 56.8%, and 44.2% at 5, 10, and 15 years, respectively. No predictor for death was determined; however, the predictor for re-mitral valve replacement was initial valve diameter less than 19 mm.
CONCLUSIONS
Survival outcomes among children after mitral valve replacement with bileaflet mechanical prosthetic valve in biventricular heart were satisfactory. However, complications, including re-mitral valve replacement, were frequent and the predictor was of a small prosthesis size.
Topics: Adolescent; Child; Child, Preschool; Female; Follow-Up Studies; Heart Valve Prosthesis; Heart Valve Prosthesis Implantation; Humans; Infant; Male; Mitral Valve; Mitral Valve Insufficiency; Mitral Valve Stenosis; Postoperative Complications; Prosthesis Design; Reoperation; Retrospective Studies; Survival Rate
PubMed: 31659705
DOI: 10.1007/s11748-019-01236-x