Dataset Information

Safety and Use of Anticoagulation After Aortic Valve Replacement With Bioprostheses: A Meta-Analysis.

ABSTRACT: The American College of Cardiology guidelines recommend 3 months of anticoagulation after replacement of the aortic valve with a bioprosthesis. However, there remains great variability in the current clinical practice and conflicting results from clinical studies. To assist clinical decision making, we pooled the existing evidence to assess whether anticoagulation in the setting of a new bioprosthesis was associated with improved outcomes or greater risk of bleeding.We searched the PubMed database from the inception of these databases until April 2015 to identify original studies (observational studies or clinical trials) that assessed anticoagulation with warfarin in comparison with either aspirin or no antiplatelet or anticoagulant therapy. We included the studies if their outcomes included thromboembolism or stroke/transient ischemic attacks and bleeding events. Quality assessment was performed in accordance with the Newland Ottawa Scale, and random effects analysis was used to pool the data from the available studies. I(2) testing was done to assess the heterogeneity of the included studies. After screening through 170 articles, a total of 13 studies (cases=6431; controls=18210) were included in the final analyses. The use of warfarin was associated with a significantly increased risk of overall bleeding (odds ratio, 1.96; 95% confidence interval, 1.25-3.08; P<0.0001) or bleeding risk at 3 months (odds ratio, 1.92; 95% confidence interval, 1.10-3.34; P<0.0001) compared with aspirin or placebo. With regard to composite primary outcome variables (risk of venous thromboembolism, stroke, or transient ischemic attack) at 3 months, no significant difference was seen with warfarin (odds ratio, 1.13; 95% confidence interval, 0.82-1.56; P=0.67). Moreover, anticoagulation was also not shown to improve outcomes at time interval >3 months (odds ratio, 1.12; 95% confidence interval, 0.80-1.58; P=0.79).Contrary to the current guidelines, a meta-analysis of previous studies suggests that anticoagulation in the setting of an aortic bioprosthesis significantly increases bleeding risk without a favorable effect on thromboembolic events. Larger, randomized controlled studies should be performed to further guide this clinical practice.

SUBMITTER: Riaz H

PROVIDER: S-EPMC5124764 | biostudies-literature | 2016 May

REPOSITORIES: biostudies-literature

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Safety and Use of Anticoagulation After Aortic Valve Replacement With Bioprostheses: A Meta-Analysis.

Riaz Haris H Alansari Shehab Ahmad Redha SA Khan Muhammad Shahzeb MS Riaz Talha T Raza Sajjad S Luni Faraz Khan FK Khan Abdur Rahman AR Riaz Irbaz Bin IB Krasuski Richard A RA

Circulation. Cardiovascular quality and outcomes 20160510 3

<h4>Background</h4>The American College of Cardiology guidelines recommend 3 months of anticoagulation after replacement of the aortic valve with a bioprosthesis. However, there remains great variability in the current clinical practice and conflicting results from clinical studies. To assist clinical decision making, we pooled the existing evidence to assess whether anticoagulation in the setting of a new bioprosthesis was associated with improved outcomes or greater risk of bleeding.<h4>Method ...[more]

PMID: 27166205

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Project description:Many observational studies have reported outcomes after surgical aortic valve replacement (AVR), but there are no recent systematic reviews and meta-analyses including all available bioprostheses and allografts. The objective of this study is to provide a comprehensive and up-to-date overview of the outcomes after AVR with bioprostheses and allografts reported in the last 15 years. We conducted a systematic literature review (PROSPERO register: CRD42015017041) of studies published between 2000-15. Inclusion criteria were observational studies or randomized controlled trials reporting on outcomes of AVR with bioprostheses (stented or stentless) or allografts, with or without coronary artery bypass grafting (CABG) or valve repair procedure, with study population size n ≥ 30 and mean follow-up length ≥5 years. Fifty-four bioprosthesis studies and 14 allograft studies were included, encompassing 55 712 and 3872 patients and 349 840 and 32 419 patient-years, respectively. We pooled early mortality risk and linearized occurrence rates of valve-related events, reintervention and late mortality in a random-effects model. Sensitivity, meta-regression and subgroup analyses were performed to investigate the influence of outliers on the pooled estimates and to explore sources of heterogeneity. Funnel plots were used to investigate publication bias. Pooled early mortality risks for bioprostheses and allografts were 4.99% (95% confidence interval [CI], 4.44-5.62) and 5.03% (95% CI, 3.61-7.01), respectively. The late mortality rate was 5.70%/patient-year (95% CI, 4.99-5.62) for bioprostheses and 1.68%/patient-year (95% CI, 1.23-2.28) for allografts. Pooled reintervention rates for bioprostheses and allografts were 0.75%/patient-year (95% CI, 0.61-0.91) and 1.87%/patient-year (95% CI, 1.52-2.31), respectively. There was substantial heterogeneity in most outcomes. Meta-regression analyses identified covariates that could explain the heterogeneity: implantation period, valve type, patient age, gender, pre-intervention New York Heart Association class III/IV, concomitant CABG, study design and follow-up length. There is possible publication bias in all outcomes. This comprehensive systematic review and meta-analysis provides an overview of the outcomes after AVR with bioprostheses and allografts reported during the last 15 years. The results of this study can support patients and doctors in the prosthetic valve choice and can be used in microsimulation models to predict patient outcomes and estimate the cost-effectiveness of AVR with bioprostheses or allografts compared with current and future heart valve prostheses.

Project description:BackgroundStudies assessing outcomes of transcatheter aortic valve replacement (TAVR) in patients with severe aortic valve stenosis (AS) with hemodynamic subtypes have demonstrated mixed results with respect to outcomes and periprocedural complications. This study aimed to assess the outcomes of TAVR in patients across various hemodynamic subtypes of severe AS.MethodsPubMed, Embase, and Cochrane databases were searched through September 2023 to identify all observational studies comparing outcomes of TAVR in patients with paradoxical low flow low gradient (pLFLG), classic LFLG, and high gradient AS (HGAS). The primary outcome was major adverse cardiovascular events (MACE). The secondary outcomes were components of MACE (mortality, myocardial infarction [MI], stroke). A bivariate, influential, and frequentist network meta-analysis model was used to obtain the net odds ratio (OR) with a 95% CI.ResultsA total of 21 studies comprising 17,298 (8742 experimental and 8556 HGAS) patients were included in the quantitative analysis. TAVR was associated with a significant reduction in the mean aortic gradient, and an increase in the mean aortic valve area irrespective of the AS type. Compared with HGAS, TAVR in classic LFLG had a significantly higher (OR, 1.68; 95% CI, 1.04-2.72), while pLFLG (OR, 0.98; 95% CI, 0.72-1.35) had a statistically similar incidence of MACE at a median follow-up of 1-year. TAVR in LFLG also had a significantly higher need for surgery (OR, 3.57; 95% CI, 1.24-10.32), and a greater risk of periprocedural (OR, 2.00; 95% CI, 1.17-3.41), 1-month (OR, 1.69; 95% CI, 1.08-2.64), and 12-month (OR, 1.41; 95% CI, 1.05-1.88) mortality compared with HGAS. The incidence of MI, major bleeding, vascular complications, paravalvular leak, pacemaker implantation, and rehospitalizations was not significantly different between all other types of AS (HGAS vs LFLG, pLFLG).ConclusionsTAVR is an effective strategy in severe AS irrespective of the hemodynamic subtypes. Relatively, pLFLG did not have significantly different risk of periprocedural complications compared with HGAS, while classical LFLG AS had higher risk of MACE, primarily driven by the greater mortality risk.

Project description:Background Transcatheter aortic valve replacement with supra-annular transcatheter heart valves has been adopted in patients with degenerated surgical aortic valves. The next generation self-expanding Evolut PRO valve has not been evaluated in patients with surgical valve failure. Methods and Results Patients undergoing transcatheter aortic valve replacement in degenerated surgical aortic valve procedures using the Evolut R or Evolut PRO transcatheter heart valves in the Society of Thoracic Surgeons and American College of Cardiology Transcatheter Valve Therapy Registry between April 2015 and June 2019 were evaluated. Transcatheter valve performance was evaluated by clinical site echocardiography. In-hospital, 30-day, and 1-year clinical outcomes were based on the Society of Thoracic Surgeons-American College of Cardiology-Transcatheter Valve Therapy registry definitions. Transcatheter aortic valve replacement in degenerated surgical aortic valve was performed in 5897 patients (5061 [85.8%] patients received the Evolut R valve and 836 [14.2%] received the Evolut PRO valve). Thirty-day transcatheter heart valves hemodynamic performance was excellent in both groups (mean gradient: Evolut PRO: 13.8±7.5 mm Hg; Evolut R: 14.5±8.1 mm Hg), while paravalvular regurgitation was significantly different between valve types (P=0.02). Clinical events were low at 30 days (Evolut PRO: for the all-cause mortality, 2.8%, any stroke was 1.8%, new pacemaker implantation, 3.0%: Evolut R:all-cause mortality, 2.5%, any stroke was 2.2%, new pacemaker implantation, 5.3%) and 1 year (Evolut PRO: all-cause mortality, 9.2%; any stroke, 3.1%; Evolut R: all-cause mortality, 9.8%; any stroke, 2.9%). Conclusions Transcatheter aortic valve replacement in degenerated surgical aortic valve with self-expandable supra-annular transcatheter heart valves is associated with excellent clinical outcomes and valve hemodynamics. Additional reductions in residual paravalvular regurgitation were obtained with the next generation Evolut PRO.

Dataset Information

Safety and Use of Anticoagulation After Aortic Valve Replacement With Bioprostheses: A Meta-Analysis.

Publications

Safety and Use of Anticoagulation After Aortic Valve Replacement With Bioprostheses: A Meta-Analysis.

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