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Journal of the American College of... Nov 2013Obstructive thrombosed prosthetic heart valve (OTPHV) is a serious complication of heart valve replacement. There are no generally accepted criteria for management of... (Review)
Review
Obstructive thrombosed prosthetic heart valve (OTPHV) is a serious complication of heart valve replacement. There are no generally accepted criteria for management of these patients. Therefore, in September 2012, a literature survey of studies published after 1995 was performed to analyze the data regarding clinical outcomes of patients with OTPHV treated with thrombolytic agents and with surgery since 1996. The search yielded appropriate and relevant studies, which included 17 studies comprising 756 patients who had received thrombolytic therapy and 13 studies comprising 662 patients who had received surgery. The data on these 2 groups was analyzed in detail relating to frequency of use of the diagnostic studies, baseline patient data, and on the rate of complete success, outcomes, and complications of the therapy they had received, and the limitations of the studies. We have then developed a strategy for therapy of OTPHV.
Topics: Echocardiography, Transesophageal; Fibrinolytic Agents; Heart Valve Diseases; Heart Valve Prosthesis; Humans; Mitral Valve; Prosthesis Failure; Thrombolytic Therapy; Thrombosis
PubMed: 23994405
DOI: 10.1016/j.jacc.2013.07.075 -
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 -
Journal of the American College of... Apr 2019Prosthetic heart valve interventions continue to evolve with new innovations in surgical and transcatheter technologies. We compared the recommendations from the 2017... (Comparative Study)
Comparative Study Review
Prosthetic heart valve interventions continue to evolve with new innovations in surgical and transcatheter technologies. We compared the recommendations from the 2017 American College of Cardiology/American Heart Association guidelines for management of patients with prosthetic heart valves with the 2017 European Society of Cardiology guidelines. The 2 documents differed regarding recommendations for follow-up imaging, the choice of biological versus mechanical prosthesis, bridging therapies, role of aspirin, use of fibrinolytic therapy for prosthetic valve thrombosis, and management of paravalvular regurgitation. This review highlights the differences between the 2 guidelines, summarizes new evidence, and offers recommendations for the management of patients with prosthetic heart valves in these areas of controversy.
Topics: Aftercare; Bioprosthesis; Fibrinolytic Agents; Heart Valve Prosthesis; Humans; Postoperative Complications; Practice Guidelines as Topic; Thrombosis
PubMed: 30947924
DOI: 10.1016/j.jacc.2019.01.038 -
JACC. Cardiovascular Interventions Feb 2015The aim of this review is to describe the incidence, features, predisposing factors, and outcomes of prosthetic valve endocarditis (PVE) after transcatheter valve... (Review)
Review
OBJECTIVES
The aim of this review is to describe the incidence, features, predisposing factors, and outcomes of prosthetic valve endocarditis (PVE) after transcatheter valve replacement (TVR).
BACKGROUND
Very few data exist on PVE after TVR.
METHODS
Studies published between 2000 and 2013 regarding PVE in patients with transcatheter aortic valve replacement (TAVR) or transcatheter pulmonary valve replacement (TPVR) were identified through a systematic electronic search.
RESULTS
A total of 28 publications describing 60 patients (32 TAVRs, 28 TPVRs) were identified. Most TAVR patients (66% male, 80 ± 7 years of age) had a very high-risk profile (mean logistic EuroSCORE: 30.4 ± 14.0%). In TPVR patients (90% male, 19 ± 6 years of age), PVE was more frequent in the stenotic conduit/valve (61%). The median time between TVR and infective endocarditis was 5 months (interquartile range: 2 to 9 months). Typical microorganisms were mostly found with a higher incidence of enterococci after TAVR (34.4%), and Staphylococcus aureus after TPVR (29.4%). As many as 60% of the TAVR-PVE patients were managed medically despite related complications such as local extension, embolism, and heart failure in more than 50% of patients. The valve explantation rate was 57% and 23% in balloon- and self-expandable valves, respectively. In-hospital mortality for TAVR-PVE was 34.4%. Most TPVR-PVE patients (75%) were managed surgically, and in-hospital mortality was 7.1%.
CONCLUSIONS
Most cases of PVE post-TVR involved male patients, with a very high-risk profile (TAVR) or underlying stenotic conduit/valve (TPVR). Typical, but different, microorganisms of PVE were involved in one-half of the TAVR and TPVR cases. Most TPVR-PVE patients were managed surgically as opposed to TAVR patients, and the mortality rate was high, especially in the TAVR cohort.
Topics: Endocarditis; Heart Valve Prosthesis; Heart Valve Prosthesis Implantation; Humans; Incidence; Pulmonary Valve; Risk Factors; Transcatheter Aortic Valve Replacement
PubMed: 25700757
DOI: 10.1016/j.jcin.2014.09.013 -
Journal of the American Heart... May 2023Background Guidelines for choice of prosthetic heart valve in people of reproductive age are not well established. Although biologic heart valves (BHVs) have risk of...
Background Guidelines for choice of prosthetic heart valve in people of reproductive age are not well established. Although biologic heart valves (BHVs) have risk of deterioration, mechanical heart valves (MHVs) require lifelong anticoagulation. This study aimed to characterize the association of prosthetic valve type with maternal and fetal outcomes in pregnant patients. Methods and Results Using the 2008 to 2019 National Inpatient Sample, we identified all adult patients hospitalized for delivery with prior heart valve implantation. Multivariable regressions were used to analyze the primary outcome, major adverse cardiovascular events, and secondary outcomes, including maternal and fetal complications, length of stay, and costs. Among 39 871 862 birth hospitalizations, 4152 had MHVs and 874 had BHVs. Age, comorbidities, and cesarean birth rates were similar between patients with MHVs and BHVs. The presence of a prosthetic valve was associated with over 22-fold increase in likelihood of major adverse cardiovascular events (MHV: adjusted odds ratio, 22.1 [95% CI, 17.3-28.2]; BHV: adjusted odds ratio, 22.5 [95% CI, 13.9-36.5]) as well as increased duration of stay and hospitalization costs. However, patients with MHVs and BHVs had no significant difference in the odds of any maternal outcome, including major adverse cardiovascular events, hypertensive disease of pregnancy, and ante/postpartum hemorrhage. Similarly, fetal complications were more likely in patients with valve prostheses, including a 4-fold increase in odds of stillbirth, but remained comparable between MHVs and BHVs. Conclusions Patients hospitalized for delivery with prior valve replacement carry substantial risk of adverse maternal and fetal events, regardless of valve type. Our findings reveal comparable outcomes between MHVs and BHVs.
Topics: Pregnancy; Adult; Female; Humans; Heart Valves; Heart Valve Prosthesis; Prenatal Care; Parturition; Cardiovascular Diseases; Bioprosthesis
PubMed: 37183876
DOI: 10.1161/JAHA.122.028653 -
Science Translational Medicine Feb 2020Congenital heart valve disease has life-threatening consequences that warrant early valve replacement; however, the development of a growth-accommodating prosthetic...
Congenital heart valve disease has life-threatening consequences that warrant early valve replacement; however, the development of a growth-accommodating prosthetic valve has remained elusive. Thousands of children continue to face multiple high-risk open-heart operations to replace valves that they have outgrown. Here, we demonstrate a biomimetic prosthetic valve that is geometrically adaptable to accommodate somatic growth and structural asymmetries within the heart. Inspired by the human venous valve, whose geometry is optimized to preserve functionality across a wide range of constantly varying volume loads and diameters, our balloon-expandable synthetic bileaflet valve analog exhibits similar adaptability to dimensional and shape changes. Benchtop and acute in vivo experiments validated design functionality, and in vivo survival studies in growing sheep demonstrated that mechanical valve expansion accommodated growth. As illustrated in this work, dynamic size adaptability with preservation of unidirectional flow in prosthetic valves thus offers a paradigm shift in the treatment of heart valve disease.
Topics: Cardiac Surgical Procedures; Heart Valve Prosthesis; Heart Valves; Prosthesis Design
PubMed: 32075944
DOI: 10.1126/scitranslmed.aay4006 -
The Journal of Thoracic and... Apr 2022
Topics: Heart Valve Prosthesis; Humans; Mitral Valve
PubMed: 34535269
DOI: 10.1016/j.jtcvs.2021.08.060 -
Journal of the American College of... Jun 2010In the last 7 years, more data have reconfirmed that patients' comorbid conditions are very important factors determining patient outcomes. Prosthetic heart valves... (Review)
Review
In the last 7 years, more data have reconfirmed that patients' comorbid conditions are very important factors determining patient outcomes. Prosthetic heart valves (PHVs) that require aortic root replacement in the absence of aortic root disease are associated with poorer outcomes. For the vast majority of patients, the choice of PHV is between a mechanical valve and a stented bioprosthesis. The choice is largely dependent upon the age of the patient at the time of PHV implantation and on which complication the patient wants to avoid: specifically, anticoagulation therapy and its complications with the mechanical valve, and structural valve deterioration with a bioprosthesis. Data on the pros and cons of the choices and exceptions to the rules are discussed, and a new algorithm is developed.
Topics: Age Factors; Aged; Aged, 80 and over; Animals; Bioprosthesis; Disease Models, Animal; Female; Heart Valve Diseases; Heart Valve Prosthesis; Heart Valve Prosthesis Implantation; Humans; Male; Middle Aged; Patient Selection; Postoperative Complications; Prognosis; Prosthesis Design; Prosthesis Failure; Randomized Controlled Trials as Topic; Rats; Risk Assessment; Severity of Illness Index; Survival Analysis; Treatment Outcome
PubMed: 20510209
DOI: 10.1016/j.jacc.2009.10.085 -
BJOG : An International Journal of... Oct 2015Historically, pregnancies among women with prosthetic heart valves have been associated with an increased incidence of adverse outcomes. (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Historically, pregnancies among women with prosthetic heart valves have been associated with an increased incidence of adverse outcomes.
OBJECTIVES
Systematic review to assess risk of adverse pregnancy outcomes among women with a prosthetic heart valve(s) over the last 20 years.
SEARCH STRATEGY
Electronic literature search of Medline, The Cochrane Library, Cumulative Index to Nursing and Allied Health Literature and Embase to find recent studies.
SELECTION CRITERIA
Studies of pregnant women with heart valve prostheses including trials, cohort studies and unselected case series.
DATA COLLECTION AND ANALYSIS
Primary analysis calculated absolute risks and 95% confidence intervals (CI) for pregnancy outcomes using a random effects model. The Freeman-Tukey transformation was utilised in secondary analysis due to the large number of individual study outcomes with zero events.
MAIN RESULTS
Eleven studies capturing 499 pregnancies among women with heart valve prostheses, including 256 mechanical and 59 bioprosthetic, were eligible for inclusion. Pooled estimate of maternal mortality was 1.2/100 pregnancies (95% CI 0.5-2.2), for mechanical valves subgroup 1.8/100 (95% CI 0.5-3.7) and bioprosthetic subgroup 0.7/100 (95% CI 0.1-4.5), overall pregnancy loss 20.8/100 pregnancies (95% CI 9.5-35.1), perinatal mortality 5.0/100 births (95%CI 1.8-9.8) and thromboembolism 9.3/100 pregnancies (95% CI 4.0-16.5).
CONCLUSIONS
Women with heart valve prostheses experienced higher rates of adverse outcomes than expected in a general obstetric population; however, lower than previously reported. Women with bioprostheses had significantly fewer thromboembolic events compared to women with mechanical valves. Women should be counselled pre-pregnancy about risk of maternal death and pregnancy loss. Vigilant surveillance by a multidisciplinary team throughout the perinatal period remains warranted for these women and their infants.
TWEETABLE ABSTRACT
Metaanalysis suggests improvement in #pregnancy outcomes among women with #heartvalveprostheses.
Topics: Bioprosthesis; Female; Fetal Death; Fetal Mortality; Heart Valve Prosthesis; Humans; Infant, Newborn; Maternal Mortality; Perinatal Mortality; Pregnancy; Pregnancy Complications, Cardiovascular; Pregnancy Outcome; Thromboembolism
PubMed: 26119028
DOI: 10.1111/1471-0528.13491