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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 -
Heart, Lung & Circulation Mar 2018Prosthetic valve endocarditis is the most severe form of infective endocarditis. This study assessed the risks and challenges of surgery for aortic prosthetic valve...
BACKGROUND
Prosthetic valve endocarditis is the most severe form of infective endocarditis. This study assessed the risks and challenges of surgery for aortic prosthetic valve endocarditis.
METHODS
In total, 116 consecutive patients (98 males, age 65.2±12.7years), who underwent redo-surgery for active aortic prosthetic valve endocarditis between 2000 and 2014, were reviewed. Cox regression analysis was used to identify factors for aortic root destructions as well as for morbidity and mortality. Median follow-up was 3.8 years (0-13.9 years).
RESULTS
Aortic root destructions (42 limited and 29 multiple lesions) were associated with early prosthetic valve endocarditis and delayed diagnosis (≥14 d), but not with mortality. There were 16 (13.8%) early (≤30 d) and 32 (27.6%) late (>30 days) deaths. Survival at 1, 5, and 10 years was 72±4.3%, 56±5.4%, and 46±6.4%, respectively. The cumulative incidence of death, reinfection, and reoperation was 19.0% at 30days and 36.2% at 1year. Delayed diagnosis, concomitant procedures, and EuroSCORE II >20% were predictors for early mortality and need for mechanical circulatory support, age >70years, and critical preoperative state were predictors for late mortality. In their absence, survival at 10 years was 70±8.4%. Reinfections and reoperations occurred more frequently if ≥1 risk factor for endocarditis and aortic root destructions were present. At 10 years, freedom from reinfection and reoperation was 89±4.2% and 91±4.0%.
CONCLUSIONS
The risks of death, reinfection, and reoperation are significant within the first year after surgery for aortic prosthetic valve endocarditis. Early diagnosis and aortic root destructions are the most important challenges, but advanced age, critical preoperative state, and the need for mechanical circulatory support determine long-term survival.
Topics: Adult; Aged; Aged, 80 and over; Aortic Valve; Endocarditis, Bacterial; Female; Germany; Heart Valve Prosthesis; Humans; Incidence; Male; Middle Aged; Postoperative Complications; Prosthesis-Related Infections; Reoperation; Retrospective Studies; Risk Assessment; Risk Factors; Survival Rate
PubMed: 28764880
DOI: 10.1016/j.hlc.2017.05.143 -
Medicina (Kaunas, Lithuania) Nov 2022Developing a prosthetic heart valve that combines the advantageous hemodynamic properties of its biological counterpart with the longevity of mechanical prostheses has...
Developing a prosthetic heart valve that combines the advantageous hemodynamic properties of its biological counterpart with the longevity of mechanical prostheses has been a major challenge for heart valve development. Anatomically inspired artificial polymeric heart valves have the potential to combine these beneficial properties, and innovations in 3D printing have given us the opportunity to rapidly test silicone prototypes of new designs to further the understanding of biophysical properties of artificial heart valves. TRISKELION is a promising prototype that we have developed, tested, and further improved in our institution. Materials and STL files of our prototypes were designed with FreeCad 0.19.2 and 3D printed with an Agilista 3200W (Keyence, Osaka, Japan) using silicones of Shore hardness 35 or 65. Depending on the valve type, the support structures were printed in AR-M2 plastics. The prototypes were then tested using a hemodynamic pulse duplicator (HKP 2.0) simulating an aortic valve cycle at 70 bpm with 70 mL stroke volume (cardiac output 4.9 L/min). Valve opening cycles were visualized with a high-speed camera (Phantom Miro C320). The resulting values led to further improvements of the prototype (TRISKELION) and were compared to a standard bioprosthesis (Edwards Perimount 23 mm) and a mechanical valve (Bileaflet valve, St. Jude Medical). : We improved the silicone prototype with currently used biological and mechanical valves measured in our setup as benchmarks. The regurgitation fractions were 22.26% ± 4.34% (TRISKELION) compared to 8.55% ± 0.22% (biological) and 13.23% ± 0.79% (mechanical). The mean systolic pressure gradient was 9.93 ± 3.22 mmHg (TRISKELION), 8.18 ± 0.65 mmHg (biological), and 10.15 ± 0.16 mmHg (mechanical). The cardiac output per minute was at 3.80 ± 0.21 L/min (TRISKELION), 4.46 ± 0.01 L/min (biological), and 4.21 ± 0.05 L/min (mechanical). The development of a heart valve with a central structure proves to be a promising concept. It offers another principle to address the problem of longevity in currently used heart valves. Using 3D printing to develop new prototypes provides a fast, effective, and accurate way to deepen understanding of its physical properties and requirements. This opens the door for translating and combining results into modern prototypes using highly biocompatible polymers, internal structures, and advanced valve layouts.
Topics: Humans; Heart Valves; Printing, Three-Dimensional; Polymers; Heart Valve Prosthesis; Silicones
PubMed: 36422234
DOI: 10.3390/medicina58111695 -
The Journal of Thoracic and... Jun 2022The optimal selection of prosthetic heart valve for dialysis-dependent patients remains controversial. We investigated the comparative effectiveness and safety of... (Meta-Analysis)
Meta-Analysis
OBJECTIVE
The optimal selection of prosthetic heart valve for dialysis-dependent patients remains controversial. We investigated the comparative effectiveness and safety of mechanical prosthesis (MP) and bioprosthesis (BP) for these patients.
METHODS
After the systematic review, we included studies that involved patients on dialysis undergoing aortic valve replacement or mitral valve replacement (MVR) and reported comparative outcomes of MP and BP. Meta-analysis was performed using random-effects model. We conducted a subgroup analysis based on the valve position and postoperative international normalized ratio (INR), which was extracted from either tables or methods of each study. A meta-regression was used to examine the effects of study-level covariates.
RESULTS
We included 24 retrospective studies without randomized-controlled trials, involving 10,164 participants (MP = 6934, BP = 3230). Patients undergoing aortic valve replacement with MP exhibited a better long-term survival effectiveness (hazard ratio, 0.64; 95% confidence interval [CI], 0.47-0.86). Conversely, studies including MVR demonstrated little difference in survival (hazard ratio, 0.90; 95% CI, 0.73-1.12). A meta-regression revealed that age had little effect on long-term survival difference between MP and BP (β = -0.0135, P = .433). MP had a significantly greater bleeding risk than did BP when INR was above 2.5 (incidence rate ratio, 10.58; 95% CI, 2.02-55.41). However, when INR was below 2.5, bleeding events were comparable (incidence rate ratio, 1.73; 95% CI, 0.78-3.82). The structural valve deterioration rate was significantly lower in MP (risk ratio, 0.24; 95% CI, 0.14-0.44).
CONCLUSIONS
MP is a reasonable choice for dialysis-dependent patients without additional thromboembolic risk requiring aortic valve replacement, for its better long-term survival, durability, and noninferior bleeding risk compared with BP. Conversely, BP might be an appropriate selection for patients with MVR, given its similar survival rate and lower bleeding risk. Although our meta-regression demonstrates little influence of age on long-term survival difference between MP and BP, further studies stratifying patients based on age cut-off are mandatory.
Topics: Aortic Valve; Bioprosthesis; Heart Valve Prosthesis; Heart Valve Prosthesis Implantation; Humans; Renal Dialysis; Retrospective Studies
PubMed: 32778466
DOI: 10.1016/j.jtcvs.2020.05.101 -
Medicina (Kaunas, Lithuania) May 2023: To evaluate the early and long-term results of surgical treatment of isolated mitral native and prosthetic valve infective endocarditis. : All patients undergoing...
: To evaluate the early and long-term results of surgical treatment of isolated mitral native and prosthetic valve infective endocarditis. : All patients undergoing mitral valve repair or replacement for infective endocarditis at our institution between January 2001 and December 2021 were included in the study. The preoperative and postoperative characteristics and mortality of patients were retrospectively reviewed. A total of 130 patients, 85 males and 45 females, with a median age of 61 ± 14 years, underwent surgery for isolated mitral valve endocarditis during the study period. There were 111 (85%) native and 19 (15%) prosthetic valve endocarditis cases. Fifty-one (39%) patients died during the follow-up, and the overall mean patient survival time was 11.8 ± 0.9 years. The mean survival time was better in patients with mitral native valve endocarditis compared to patients with prosthetic valve endocarditis (12.3 ± 0.9 years vs. 8 ± 1.4 years; = 0.1), but the difference was not statistically significant. Patients who underwent mitral valve repair had a better survival rate compared to patients who had mitral valve replacement (14.8 ± 1.6 vs. 11.3 ± 1 years; = 0.06); however, the difference was not statistically significant. Patients who underwent mitral valve replacement with a mechanical prosthesis had a significantly better survival rate compared to patients who received a biological prosthesis (15.6 ± 1.6 vs. 8.2 ± 0.8 years; < 0.001). Patients aged ≤60 years had significantly better survival compared to patients aged >60 years (17.1 ± 1.1 vs. 8.2 ± 0.9; < 0.001). Multivariate analysis showed that the patient's age >60 years at the time of surgery was an independent risk factor for mortality, while mitral valve repair was a protective factor. Eight (7%) patients required reintervention. Freedom from reintervention was significantly higher in patients with mitral native valve endocarditis compared to patients with prosthetic valve endocarditis (19.3 ± 0.5 vs. 11.5 ± 1.7 years; = 0.04). : Surgery for mitral valve endocarditis is associated with considerable morbidity and mortality. The patient's age at the time of surgery represents an independent risk factor for mortality. Mitral valve repair should be the preferred choice whenever possible in suitable patients affected by infective endocarditis.
Topics: Male; Female; Humans; Middle Aged; Aged; Endocarditis, Bacterial; Mitral Valve; Retrospective Studies; Treatment Outcome; Heart Valve Prosthesis Implantation; Heart Valve Prosthesis; Endocarditis
PubMed: 37374264
DOI: 10.3390/medicina59061060 -
Annales de Cardiologie Et D'angeiologie Oct 2020Mechanical valve malfunction due to thrombosis is an important and life-threatening complication in patients with prosthetic valves. Our study was performed to determine... (Comparative Study)
Comparative Study Observational Study
Mechanical valve malfunction due to thrombosis is an important and life-threatening complication in patients with prosthetic valves. Our study was performed to determine the prevalence of thrombophilia genes among patients with acute thrombosis of the mechanical pulmonary valves despite acceptable anticoagulation levels. In this cross-sectional comparative study thirthy two consecutive patients with acute thrombosis of pulmonary mechanical valve who had international normalized ratio (INR) levels for prothrombin time of at least 2 at the time of presentation and in the preceding three months were enrolled and the prevalence rates of thrombophilia factor genes among them was assessed. The results showed that 24 patients (75%) had thrombophilia gene mutations. The affected patients had mutations in one gene in 37.5% of cases, two genes in 31.3%, and three genes in 6.3%. Prevalence rate of Factor V Leiden (FVL), prothrombin (PTH), Plasminogen activator inhibitor-1 (PAI-I), Methylenetetrahydrofolate Reductase (MTHFR), and endothelial protein C receptor (EPCR) gene mutations was 3.1%, 6.3%, 50%, 37.5%, and 25%, respectively. In our study the prevalence of thrombophilia factor gene mutations of patients with acute thrombosis of pulmonary valve was higher than that reported in the general population.
Topics: Adult; Cross-Sectional Studies; Factor V; Female; Heart Valve Prosthesis; Humans; International Normalized Ratio; Male; Methylenetetrahydrofolate Reductase (NADPH2); Plasminogen Activator Inhibitor 1; Prosthesis Failure; Prothrombin Time; Pulmonary Valve; Receptors, Immunologic; Thrombophilia
PubMed: 32773136
DOI: 10.1016/j.ancard.2020.07.003 -
Heart (British Cardiac Society) Mar 2019The first aortic valve prosthesis, implanted more than 50 years ago, was a mechanical prosthesis (ball-and-cage design). Over the ensuing decades, tissue prostheses and... (Review)
Review
The first aortic valve prosthesis, implanted more than 50 years ago, was a mechanical prosthesis (ball-and-cage design). Over the ensuing decades, tissue prostheses and new mechanical designs were introduced to mitigate the need for anticoagulation with its associated side effects. Tissue and mechanical heart valve prostheses were compared in two head-to-head randomised control trials. Both of these confirmed that mechanical prostheses were durable but patients suffered anticoagulant-related bleeds. Patients who received a tissue prosthesis were more likely to suffer prosthetic dysfunction and require reoperation. This trend was stronger in younger patients. Since the publication of those two trials, several large retrospective studies using data from meta-analyses of published papers or registries have failed to show a survival advantage of either prostheses when implanted in the aortic position in younger patients. This equipoise has been reflected in the heart valve disease guidelines published by European and US societies. In recent years, the primacy of patient choice, the rapid increase in life expectancy of populations, the increased incidence of atrial fibrillation with requirement for anticoagulation, the advent of transcatheter techniques to treat degenerating tissue valves as well as advances in anticoagulant therapy and in new tissue and to a lesser extent mechanical prosthetic design continue to influence choice of aortic valve prosthesis in younger patients undergoing aortic valve replacement.
Topics: Aortic Valve; Bioprosthesis; Heart Valve Diseases; Heart Valve Prosthesis; Heart Valve Prosthesis Implantation; Humans
PubMed: 30846523
DOI: 10.1136/heartjnl-2018-313516 -
European Journal of Obstetrics,... Sep 2019Women with prosthetic heart valves are at higher risk for adverse outcomes during pregnancy. The rates of achieved pregnancy, regardless of the pregnancy outcome, are...
BACKGROUND
Women with prosthetic heart valves are at higher risk for adverse outcomes during pregnancy. The rates of achieved pregnancy, regardless of the pregnancy outcome, are largely unknown in this group of women.
OBJECTIVE
To determine the rate of pregnancy in women with prior heart valve replacement, and compare that to women without known heart disease.
STUDY DESIGN
A retrospective matched population-based cohort study was done between April 1994 and March 2017, in Ontario, Canada, where universal health care is available. Administrative healthcare databases were used to identify study participants, exposures and outcomes. Each woman of child-bearing age who had a bioprosthetic or mechanical mitral or aortic valve replacement (valve replacement group) was matched to four women without heart disease (community comparison group) -- by age, year of cohort entry, any recent prior pregnancy, geographic area of residence and income level. Starting after the date of cohort entry (defined as the date valve replacement date in the valve replacement group), participants were assessed for a recognized pregnancy, namely, a livebirth, stillbirth, miscarriage or induced abortion. Hazard ratios (HR) and 95% confidence intervals (CI) were further adjusted for age, immigrant status and comorbid medical conditions.
RESULTS
1596 women with a valve replacement were matched with 6378 women in the community comparison group. After a median (interquartile range, IQR) duration of follow-up of 3.1 (1.0-5.6) and 2.7 (1.0-6.0) years, respectively, 98 women in the valve replacement group achieved a recognized pregnancy (0.63 per 100 person-years), compared to 607 women in the community comparison group (0.88 per 100 person-years) - an adjusted HR of 0.72 (95% CI 0.57-0.89). Within the valve replacement group, those with a mechanical valve were less likely to achieve a recognized pregnancy than those with a bioprosthetic valve (adjusted HR 0.57, 95% CI 0.38-0.87).
CONCLUSION
Women who undergo aortic or mitral valve replacement are less likely to achieve a pregnancy than matched counterparts without heart disease. This information, and the reasons for why this is so, can inform decisions about the timing of valve replacement and pregnancy planning.
Topics: Adult; Databases, Factual; Female; Heart Valve Prosthesis; Heart Valve Prosthesis Implantation; Humans; Live Birth; Middle Aged; Pregnancy; Pregnancy Outcome; Pregnancy Rate; Retrospective Studies
PubMed: 31299524
DOI: 10.1016/j.ejogrb.2019.06.038 -
Journal of Cardiac Surgery Apr 2022The incidence of prosthetic tricuspid valve (TV) thrombosis is the highest among heart valves. It can lead to high morbidity and mortality without proper treatment. In...
BACKGROUND
The incidence of prosthetic tricuspid valve (TV) thrombosis is the highest among heart valves. It can lead to high morbidity and mortality without proper treatment. In this study, we sought to report the management and clinical outcomes of patients with mechanical TV thrombosis.
METHODS
The current study was conducted in Rajaei Heart Center on 42 patients with mechanical TV thrombosis from 2006 to 2017. The baseline characteristics and the rates of adverse events during the follow-up period were assessed.
RESULTS
A total of 67 episodes of mechanical TV thrombosis in 42 patients were observed. The mean age of patients was 45.5 ± 14.3 years (19-77), and overall two-thirds were female. Thrombolytic therapy was used in 41 (61.1%), anticoagulant intensification in 16 (23.9%), and surgery as the first approach in 10 (14.9%) episodes; subsequently, surgery as the final approach was implemented in 20 (29.8%) episodes. In-hospital mortality occurred in two (2.98%) patients. The rates of freedom from recurrent thrombosis were 84%, 61%, and 21% at the end of 1, 4, and 10 years, respectively. Survival rates and freedom from chronic valve dysfunction were 93%, 82%, and 75% after 1, 4, and 10 years.
CONCLUSIONS
The results of the present study showed that recurrent thrombosis requiring intervention is a major complication of mechanical TV, which underscores individual-approached therapy and close follow-up.
Topics: Adult; Aged; Female; Follow-Up Studies; Heart Valve Prosthesis; Heart Valve Prosthesis Implantation; Humans; Male; Middle Aged; Thrombolytic Therapy; Thrombosis; Treatment Outcome; Tricuspid Valve; Young Adult
PubMed: 35072279
DOI: 10.1111/jocs.16209 -
The Annals of Thoracic Surgery Dec 2022Surgical treatment for prosthetic valve endocarditis remains a challenge. Rapid deployment valves have emerged as an option in the redo setting for infective...
Surgical treatment for prosthetic valve endocarditis remains a challenge. Rapid deployment valves have emerged as an option in the redo setting for infective endocarditis and in patients with a small or calcified aortic root. This report presents 3 patients with prosthetic valve endocarditis who underwent redo aortic valve replacement with the Perceval (LivaNova) prosthesis using the valve-in-valve technique. Hemodynamic performance of the prostheses was excellent during the perioperative period and at follow-up.
Topics: Humans; Heart Valve Prosthesis; Aortic Valve; Endocarditis, Bacterial; Bioprosthesis; Heart Valve Prosthesis Implantation; Prosthesis Design; Endocarditis; Treatment Outcome
PubMed: 35257677
DOI: 10.1016/j.athoracsur.2022.02.037