Mechanical versus bioprosthetic valves in chronic dialysis: a systematic review and meta-analysis.
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ABSTRACT: Background
Many patients with end-stage kidney disease (ESKD) have valvular heart disease requiring surgery. The optimal prosthetic valve is not established in this population. We performed a systematic review and meta-analysis to assess outcomes of patients with dialysis-dependent ESKD who received mechanical or bioprosthetic valves.Methods
We searched Cochrane Central, Medline and Embase from inception to January 2020. We performed screening, full-text assessment, risk of bias and data collection, independently and in duplicate. Data were pooled using a random-effects model.Results
We identified 28 observational studies (n = 9857 patients, including 6680 with mechanical valves and 3717 with bioprosthetic valves) with a median follow-up of 3.45 years. Twenty-two studies were at high risk of bias and 1 was at critical risk of bias from confounding. Certainty in evidence was very low for all outcomes except bleeding. Mechanical valves were associated with reduced mortality at 30 days (relative risk [RR] 0.79, 95% confidence interval [CI] 0.65-0.97, I 2 = 0, absolute effect 27 fewer deaths per 1000) and at 6 or more years (mean 9.7 yr, RR 0.83, 95% CI 0.72-0.96, I 2 = 79%, absolute effect 145 fewer deaths per 1000), but increased bleeding (incidence rate ratio [IRR] 2.46, 95% CI 1.41-4.27, I 2 = 59%, absolute effect 91 more events per 1000) and stroke (IRR 1.63, 95% CI 1.21-2.20, I 2 = 0%, absolute effect 25 more events per 1000).Conclusion
Mechanical valves were associated with reduced mortality, but increased rate of bleeding and stroke. Given very low certainty for evidence of mortality and stroke outcomes, patients and clinicians may choose prosthetic valves based on factors such as bleeding risk and valve longevity.Study registration
PROSPERO no. CRD42017081863.
SUBMITTER: Kim KS
PROVIDER: S-EPMC9293484 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BackgroundMechanical prostheses and bioprosthetic prostheses have their own advantages and disadvantages. Mechanical ones are recommended for younger patients (<50 years old), and bioprosthetic ones are recommended for older patients (>70 years old). There is still debate regarding which kind of prosthesis is better for middle-aged patients (50 to 70 years old) receiving aortic valve replacement (AVR). To solve this problem, we conducted this meta-analysis. Given that only one randomized controlled trial (RCT) study was included, we conducted a subgroup analysis of RCT and propensity score matching (PSM) retrospective studies to reduce the bias.MethodsWe systematically searched articles related to clinical outcomes of mechanical and bioprosthetic prostheses in middle-aged patients receiving AVR in the PubMed, Cochrane Library, and China National Knowledge Infrastructure (CNKI) databases. The published date was up to 1 October 2022. Studies were excluded if not only middle-aged patients were included, or if they lacked direct comparisons between mechanical and bioprosthetic prostheses.ResultsIn total, 22 studies with 32,298 patients were included in the final analysis. The results show that patients aged between 50 and 70 receiving AVR with mechanical prostheses achieved better long-term survival and fewer reoperations and valve-related events but suffered more with bleeding events. No significant difference could be found in terms of early mortality and long-term cardiac death. The same results could be observed in the subgroup analysis of RCT and PSM retrospective studies.ConclusionBoth mechanical and bioprosthetic prostheses are beneficial to middle-aged patients undertaking AVR procedures. However, mechanical prostheses show better clinical outcomes in long-term survival and comorbidities. Individual recommendation is still necessary.
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Project description:Background The Ross operation appears to restore normal survival in young and middle-aged adults with aortic valve disease. However, there are limited data comparing it with conventional aortic valve replacement. Herein, we compared outcomes of the Ross procedure with mechanical and bioprosthetic aortic valve replacement (M-AVR and B-AVR, respectively). Methods and Results MEDLINE and EMBASE were searched through March 2022 to identify randomized controlled trials and propensity score-matched studies that investigated outcomes of patients aged ≥16 years undergoing the Ross procedure, M-AVR, or B-AVR. The systematic literature search identified 2 randomized controlled trials and 8 propensity score-matched studies involving a total of 4812 patients (Ross: n=1991; M-AVR: n=2019; and B-AVR: n=802). All-cause mortality was significantly lower in the Ross procedure group compared with M-AVR (hazard ratio [HR] [95% CI], 0.58 [0.35-0.97]; P=0.035) and B-AVR (HR [95% CI], 0.32 [0.18-0.59]; P<0.001) groups. The reintervention rate was lower after the Ross procedure and M-AVR compared with B-AVR, whereas it was higher after the Ross procedure compared with M-AVR. Major bleeding rate was lower after the Ross procedure compared with M-AVR. Long-term stroke rate was lower following the Ross procedure compared with M-AVR and B-AVR. The rate of endocarditis was also lower after the Ross procedure compared with B-AVR. Conclusions Improved long-term outcomes of the Ross procedure are demonstrated compared with conventional M-AVR and B-AVR options. These results highlight a need to enhance the recognition of the Ross procedure and revisit current guidelines on the optimal valve substitute for young and middle-aged patients.
| S-EPMC9973571 | biostudies-literature
Project description:AimsTo review maternal and foetal outcomes in women with mechanical heart valves (MHVs) treated with vitamin-K antagonists (VKAs), first-trimester heparin followed by VKAs (sequential treatment), low molecular weight heparin (LMWH) and unfractionated heparin (UFH) during pregnancy, in order to inform practice.Methods and resultsMedline, Embase and Central were searched from inception until February 2016. Two reviewers independently screened 1786 titles, reviewed 110 full-texts and extracted data and assessed risk-of-bias from 46 articles. Pooled incidence (95% confidence intervals) was calculated for maternal and foetal outcomes. Included studies had a moderate or high risk-of-bias. With VKAs, sequential treatment and LMWH, maternal mortality occurred in 0.9% (0.4-1.4), 2.0% (0.8-3.1) and 2.9% (0.2-5.7), thromboembolic complications in 2.7% (1.4-4.0), 5.8% (3.8-7.7) and 8.7% (3.9-13.4), livebirths in 64.5% (48.8-80.2), 79.9% (74.3-85.6) and 92.0% (86.1-98.0) and anticoagulant-related foetal/neonatal adverse events (embryopathy or foetopathy) in 2.0% (0.3-3.7), 1.4% (0.3-2.5) and 0%, respectively. When UFH is used throughout pregnancy, 11.2% (2.8-19.6) suffered thromboembolic complications. Foetal loss and adverse events occurred with first-trimester warfarin doses ≤ 5 mg/day, although there were more livebirths [83.6% (75.8-91.4) vs. 43.9% (32.8-55.0)] and fewer foetal anomalies [2.3% (0.7-4.0) vs. 12.4% (3.3-21.6)] with lower doses than with warfarin > 5 mg/day.ConclusionsVKAs are associated with fewest maternal complications but also with fewest livebirths. Sequential treatment does not eliminate anticoagulant-related foetal/neonatal adverse events. LMWH is associated with the highest number of livebirths. The safety of UFH throughout pregnancy and first-trimester warfarin ≤ 5 mg/day remains unconfirmed.
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Project description:ObjectiveSurgery remains the primary form of treatment for infective endocarditis (IE). However, it is not clear what type of prosthetic valve provides a better prognosis. We conducted a meta-analysis to compare the prognosis of infective endocarditis treated with biological valves to cases treated with mechanical valves.MethodsPubmed, Embase and Cochrane databases were searched from January 1960 to November 2016.Randomized controlled trials, retrospective cohorts and prospective studies comparing outcomes between biological valve and mechanical valve management for infective endocarditis were analyzed. The Newcastle-Ottawa Scale(NOS) was used to evaluate the quality of the literature and extracted data, and Stata 12.0 software was used for the meta-analysis.ResultsA total of 11 publications were included; 10,754 cases were selected, involving 6776 cases of biological valves and 3,978 cases of mechanical valves. The all-cause mortality risk of the biological valve group was higher than that of the mechanical valve group (HR = 1.22, 95% CI 1.03 to 1.44, P = 0.023), as was early mortality (RR = 1.21, 95% CI 1.02 to 1.43, P = 0.033). The recurrence of endocarditis (HR = 1.75, 95% CI 1.26 to 2.42, P = 0.001), as well as the risk of reoperation (HR = 1.79, 95% CI 1.15 to 2.80, P = 0.010) were more likely to occur in the biological valve group. The incidence of postoperative embolism was less in the biological valve group than in the mechanical valve group, but this difference was not statistically significant (RR = 0.90, 95% CI 0.76 to 1.07, P = 0.245). For patients with prosthetic valve endocarditis (PVE), there was no significant difference in survival rates between the biological valve group and the mechanical valve group (HR = 0.91, 95% CI 0.68 to 1.21, P = 0.520).ConclusionThe results of our meta-analysis suggest that mechanical valves can provide a significantly better prognosis in patients with infective endocarditis. There were significant differences in the clinical features of patients receiving a biological valve compared to patients receiving a mechanical valve. A large, multicenter retrospective study included in our meta-analysis suggested that any mortality risk of the biological valve group was significant higher than that of the mechanical valve group. However, the risk was no different after risk was adjusted. So, we thought the reason for this result may be related to the characteristics of the patient rather than valve dysfunction. It is still necessary to future randomized studies to verify this conclusion.
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Project description:BackgroundValve replacement surgery is the definitive management strategy for patients with severe valvular disease. However, valvular conduits currently in clinical use are associated with significant limitations. Tissue-engineered (decellularized) heart valves are alternative prostheses that have demonstrated promising early results. The purpose of this systematic review and meta-analysis is to perform robust evaluation of the clinical performance of decellularized heart valves implanted in either outflow tract position, in comparison with standard tissue conduits.MethodsSystematic searches were conducted in the PubMed, Scopus, and Web of Science databases for articles in which outcomes between decellularized heart valves surgically implanted within either outflow tract position of human subjects and standard tissue conduits were compared. Primary endpoints included postoperative mortality and reoperation rates. Meta-analysis was performed using a random-effects model via the Mantel-Haenszel method.ResultsSeventeen articles were identified, of which 16 were included in the meta-analysis. In total, 1418 patients underwent outflow tract reconstructions with decellularized heart valves and 2725 patients received standard tissue conduits. Decellularized heart valves were produced from human pulmonary valves and implanted within the right ventricular outflow tract in all cases. Lower postoperative mortality (4.7% vs. 6.1%; RR 0.94, 95% CI: 0.60-1.47; P = 0.77) and reoperation rates (4.8% vs. 7.4%; RR 0.55, 95% CI: 0.36-0.84; P = 0.0057) were observed in patients with decellularized heart valves, although only reoperation rates were statistically significant. There was no statistically significant heterogeneity between the analyzed articles (I2 = 31%, P = 0.13 and I2 = 33%, P = 0.10 respectively).ConclusionsDecellularized heart valves implanted within the right ventricular outflow tract have demonstrated significantly lower reoperation rates when compared to standard tissue conduits. However, in order to allow for more accurate conclusions about the clinical performance of decellularized heart valves to be made, there need to be more high-quality studies with greater consistency in the reporting of clinical outcomes.
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Project description:BACKGROUND:Transcatheter aortic valve-in-valve (VIV) procedure is a safe alternative to conventional reoperation for bioprosthetic dysfunction. Balloon-expandable valve (BEV) and self-expanding valve (SEV) are the 2 major types of devices used. Evidence regarding the comparison of the 2 valves remains scarce. METHODS:A systematic review and meta-analysis was conducted to compare the outcomes of BEV and SEV in transcatheter VIV for aortic bioprostheses dysfunction. A computerized search of Medline, PubMed, Embase, and Cochrane databases was performed. English-language journal articles reporting SEV or BEV outcomes of at least 10 patients were included. RESULTS:In total, 27 studies were included, with 2,269 and 1,671 patients in the BEV and SEV groups, respectively. Rates of 30-day mortality and stroke did not differ significantly between the 2 groups. However, BEV was associated with significantly lower rates of postprocedural permanent pacemaker implantation (3.8% vs. 12%; P < 0.001). Regarding echocardiographic parameters, SEV was associated with larger postprocedural effective orifice area at 30 days (1.53 cm2 vs. 1.23 cm2; P < 0.001) and 1 year (1.55 cm2 vs. 1.22 cm2; P < 0.001). CONCLUSIONS:For patients who underwent transcatheter aortic VIV, SEV was associated with larger postprocedural effective orifice area but higher rates of permanent pacemaker implantation. These findings provide valuable information for optimizing device selection for transcatheter aortic VIV.
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Project description:BackgroundHome-based peritoneal dialysis (PD) is an alternative to facility-based hemodialysis and has lower costs and greater freedom for patients with kidney failure. For a patient to undergo PD, a safe and reliable method of accessing the peritoneum is needed. However, different catheter insertion techniques may affect patient health outcomes.ObjectiveTo compare the risk of infectious and mechanical complications between surgical (open and laparoscopic) PD catheter insertion and percutaneous catheter insertion.DesignSystematic review and meta-analysis.SettingWe searched for observational studies and randomized controlled trials (RCTs) in CENTRAL, EMBASE, MEDLINE, PubMed, and SCOPUS from inception until June 2018. Data were extracted by 2 independent reviewers based on a preformed template.PatientsAdult (aged 18+) patients with kidney failure who underwent a PD catheter insertion procedure.MeasurementsWe analyzed leak, malfunction, and bleed as early complications (occurring within 1 month of catheter insertion). Infectious complications (exit-site infections, tunnel infections, and peritonitis) were presented as both early complications and with the longest duration of follow-up.MethodsRandom effects meta-analyses with the generic inverse variance method to estimate pooled rate ratios and 95% confidence intervals. We quantified heterogeneity by using the I2 statistic for inconsistency and assessed heterogeneity using the χ2 test. Sensitivity analysis was performed by removing studies at high risk of bias as measured with the Newcastle-Ottawa Scale and the Cochrane Risk of Bias tool.ResultsTwenty-four studies (22 observational, 2 RCTs) with 3108 patients and 3777 catheter insertions were selected. Data from 2 studies were unable to be extracted and were qualitatively assessed. In the remaining 22 studies, percutaneous insertion was associated with a lower risk of both exit-site infections (risk ratio [RR] = 0.36, 95% confidence interval [CI] = 0.24-0.53, I2 = 0%) and peritonitis (RR = 0.52, 95% CI = 0.36-0.77, I2 = 3%) within 1 month of the procedure. There was no difference in mechanical complication rates between the 2 techniques.LimitationsLack of consistency in the time periods for the various outcomes reported, risk of bias concerns with respect to population comparability, and the inability to analyze individual component causes of primary nonfunction (catheter obstruction, catheter migration, and leak).ConclusionsOur meta-analysis suggests differences in early infectious complications in favor of percutaneous insertion and no significant differences in mechanical complications compared with surgical insertion. These findings have implications on the direction of PD programs in terms of maximizing operating room resources.
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Project description: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.
| S-EPMC10227312 | biostudies-literature
Project description:BackgroundPatients on chronic dialysis are at increased risk of postoperative mortality following elective surgery compared to patients with normal kidney function, but morbidity outcomes are less often reported. This study ascertains the excess odds of postoperative cardiovascular and infection related morbidity outcomes for patients on chronic dialysis.MethodsSystematic searches were performed using MEDLINE, Embase and the Cochrane Library to identify relevant studies published from inception to January 2020. Eligible studies reported postoperative morbidity outcomes in chronic dialysis and non-dialysis patients undergoing major non-transplant surgery. Risk of bias was assessed using the Newcastle-Ottawa Scale and the certainty of evidence was summarised using GRADE. Random effects meta-analyses were performed to derive summary odds estimates. Meta-regression and sensitivity analyses were performed to explore heterogeneity.ResultsForty-nine studies involving 10,513,934 patients with normal kidney function and 43,092 patients receiving chronic dialysis were included. Patients on chronic dialysis had increased unadjusted odds of postoperative cardiovascular and infectious complications within each surgical discipline. However, the excess odds of cardiovascular complications was attenuated when odds ratios were adjusted for age and comorbidities; myocardial infarction (general surgery, OR 1.83 95% 1.29-2.36) and stroke (general surgery, OR 0.95, 95%CI 0.84-1.06). The excess odds of infectious complications remained substantially higher for patients on chronic dialysis, particularly sepsis (general surgery, OR 2.42, 95%CI 2.12-2.72).ConclusionPatients on chronic dialysis are at increased odds of both cardiovascular and infectious complications following elective surgery, with the excess odds of cardiovascular complications attributable to being on dialysis being highest among younger patients without comorbidities. However, further research is needed to better inform perioperative risk assessment.
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Project description:INTRODUCTION:Pregnancy in patients with mechanical heart valves (MHVs) is associated with high maternal complications and fetal complications.Anticoagulation treatments serve to decrease their venous clotting risk. Although some anticoagulation regimens have been used for patients during pregnancy with MHVs, no one is definitively superior among different regimens in recent studies. For a better understanding of the clinical treatment which anticoagulation regimen is more effective and safer during the pregnancy in patients with MHVs, a Bayesian network meta-analysis is necessary. METHODS AND ANALYSIS:This protocol has been reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols. Related studies until April 2019 will be searched in the following databases: PubMed, Embase,SinoMed and the using the OVID interface to search for evidence-based medicine reviews. A clinical trial registry (www.ClinicalTrials.gov) was also searched for unpublished trials. Both experimental studies (randomised clinical trials) and observational studies (cohort studies, case-control studies and case series studies) will be included in this study. Quality assessment will be conducted using Cochrane Collaboration's tool or Newcastle-Ottawa Scale based on their study designs. The primary outcomes of interest will be the frequencies of serious maternal and fetal events. The additional outcomes of interest will be adverse maternal events, mode of delivery and adverse fetal events. Pairwise and network meta-analysis will be conducted using R (V.3.4.4, R Foundation for Statistical Computing, Vienna, Austria) and Stata (V.14, StataCorp). The ranking probabilities will be estimated at each possible rank for each anticoagulation regimen using the surface under the cumulative ranking curve. Statistical inconsistency assessment, subgroup analysis, sensitivity analysis and publication bias assessment will be performed. ETHICS AND DISSEMINATION:Either ethics approval or patient consent is not necessary, because this study will be based on literature. The results of this study will be published in a peer-reviewed journal. PROSPERO REGISTRATION NUMBER:CRD42019130659.
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