Prosthetic heart valve rct

OBJECTIVE(S): To evaluate whether warfarin targeted at an international normalized ratio of 1.8 (range 1.5-2.0) following On-X mechanical aortic valve implant is safe for all patients. METHODS: This prospective, observational clinical registry assessed adverse event rates in adult patients receiving low-dose warfarin (target international normalized ratio 1.8, range 1.5-2.0) plus daily aspirin (75-100 milligrams) during a 5-year period following On-X aortic valve implant...

OBJECTIVES: To assess if warfarin targeted to INR 1.8 (range 1.5-2.0) is safe for all patients with an On-X aortic mechanical valve. METHODS: This prospective, observational registry follows patients receiving warfarin targeted at an INR of 1.8 (range 1.5-2.0) plus daily aspirin (75-100 mg) after On-X aortic valve replacement. The primary end-point is a composite of thromboembolism, valve thrombosis, and major bleeding. Secondary end-points include the individual rates of thromboembolism, valve thrombosis, and major bleeding, as well as the composite in subgroups of home or clinic-monitored INR and risk categorization for thromboembolism...

Background In the absence of randomized controlled trials, reports from nonrandomized studies comparing valve-in-valve implantation (ViV) to redo surgical aortic valve replacement (rAVR) have shown inconsistent results. Methods and Results PubMed/MEDLINE, Google Scholar, and CENTRAL (Cochrane Central Register of Controlled Trials) were searched through December 2021. Meta-Analysis of Observational Studies in Epidemiology guidelines were followed. The protocol was registered at the International Prospective Register of Systematic Reviews...

OBJECTIVE: Most evidence for anticoagulation in aortic bioprosthesis is centered on embolic events, bleeding and reintervention risk. The effect of anticoagulation on haemodynamics has not been previously assessed. Our hypothesis was that patients with early AC after aortic valve replacement with porcine bioprosthesis have better haemodynamics at 1 year of follow-up. METHODS: Prospective, randomized, open label trial conducted at two cardiac surgery centers. All patients undergoing aortic valve replacement with porcine bioprosthesis were consecutively recruited...

Objective: We sought to conduct a systematic review and meta-analysis of clinical adverse events in patients undergoing transcatheter aortic valve replacement (TAVR) with bicuspid aortic valve (BAV) vs. tricuspid aortic valve (TAV) anatomy and the efficacy of balloon-expandable (BE) vs. self-expanding (SE) valves in the BAV population. Comparisons aforementioned will be made stratified into early- and new-generation devices. Differences of prosthetic geometry on CT between patients with BAV and TAV were presented...

Transcatheter aortic valve replacement (TAVR) has already received the green light for high-, intermediate- and low-risk profiles and is an alternative for all patients regardless of age. It is clear that there has been a push towards the use of TAVR in younger and younger patients (<65 years), which has never been formally tested in randomized controlled trials but seems inevitable as TAVR technology makes steady progress. Lifetime management as a concept will set the tone in the field of the structural heart...

New antithrombotic drugs have been developed, new valve types have been designed and minimally invasive transcatheter techniques have emerged, making the choice of antithrombotic therapy after surgical or transcatheter heart valve repair and replacement increasingly complex. Moreover, due to a lack of large randomized controlled trials many recommendations for antithrombotic therapy are based on expert opinion, reflected by divergent recommendations in current guidelines. Therefore, decision-making in clinical practice regarding antithrombotic therapy for prosthetic heart valves is difficult, potentially resulting in sub-optimal patient treatment...

Background There are no clear consensus guidelines on the indications and types of anticoagulation therapies in patients with bio-prosthetic valves either with concomitant atrial fibrillation (AF) or sinus rhythm. In our meta-analysis, we assessed the safety and efficacy of DOACs as compared to the standard treatment with warfarin in patients with AF and bioprosthetic valves. Methods We included randomized controlled trials (RCTs), cohort studies in the English language, and studies reporting patients with valvular heart disease that included bioprosthetic valvular disease...

BACKGROUND: Tricuspid valve replacement (TVR) is seldom performed in cardiac valve surgery, and there currently are no clinical guidelines as to which type of prostheses is better in tricuspid valve position. This meta-analysis was performed to compare the results of mechanical and biological prostheses for TVR. METHODS: We searched the Pubmed, Cochrane, and Embase clinical trial databases to collect all related studies published from January 1, 2000 to July 31, 2020...

Left sided endocarditis (LSE) can include the entirety or portion of mitral and/or aortic valve and the structures in their anatomical contiguity and represent a significant portion of emergency surgical activity. Literature and guidelines on the management of LSE relies mainly on observational studies given the difficulty in designing randomized trials in emergency settings. Heart teams (HT) are often called in to difficult decisions on the most appropriate strategy to adopted in case of LSE. Decision-making should take into account the localization and the extension of the infection, patient preoperative status and comorbidities, presence of a previous valve prosthesis and best timing for surgery...

BACKGROUND: The recent approval of transcatheter aortic valve replacement (TAVR) in patients with low operative risk has paved the way for the introduction of novel and potentially improved technologies. The safety and efficacy of these novel technologies should be investigated in randomized control trials against the contemporary TAVR devices. The objective of the LANDMARK trial is to compare the balloon-expandable Myval transcatheter heart valve (THV) series with contemporary THV (SAPIEN THV and Evolut THV series) series in patients with severe symptomatic native aortic stenosis...

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...

Prosthetic valve thrombosis is a rare and severe complication of the mechanical prosthetic valve. Management can be challenging due to varying clinical presentation, overlapping features of differential diagnosis, and lack of randomized controlled trials on the therapeutic options. In this article, we report the case of a patient with a mechanical prosthetic mitral valve presented with symptoms of heart failure, and an echocardiography showing increased mean pressure gradient across the prosthesis along with a fixed posterior leaflet and a partially restricted anterior leaflet with no visible mass...

BACKGROUND: Transcatheter aortic valve implantation (TAVI) has been approved for the treatment of severe aortic stenosis since 2008 and recent trials have shown that TAVI is at least non-inferior to surgical aortic valve replacement (SAVR) with regards to short-term efficacy and safety in patients across all surgical risk profiles. Prosthetic valve endocarditis of the transcatheter heart valve is a feared complication; data on the risk of infective endocarditis (IE) subsequent to TAVI are now gradually emerging...

INTRODUCTION: International guidelines support the use of low molecular weight heparins for the treatment of thromboembolism and thromboprophylaxis during pregnancy. However, evidence of the benefit and harm associated with specific low molecular weight heparins such as enoxaparin is dated. No current systematic review and meta-analysis describing the safety and efficacy of enoxaparin for thromboembolism and thromboprophylaxis during pregnancy exists. METHODS: PubMed, Embase, and Cochrane databases were searched on August 17, 2018 for clinical trials or observational studies in pregnant women receiving enoxaparin; patients with a prosthetic heart valve were excluded...

BACKGROUND: Anemia is a frequent complication after cardiac surgery especially following reoperation due to previous prosthetic valve failure or multiple valve surgery (including combined coronary artery bypass grafting). This trial explores whether intravenously administered iron isomaltoside 1000 (Monofer®) results in better clinical outcomes in patients undergoing complex heart valve surgery who are expected to receive transfusion. METHODS/DESIGN: In this prospective, single-center, double-blinded, randomized controlled trial, 214 patients undergoing reoperation or multiple valve surgery are randomly allocated to either the iron isomaltoside 1000 (IVFe) or the control group from August 2016 to August 2018...

BACKGROUND: A Dutch online patient decision aid to support prosthetic heart valve selection was recently developed. A multicenter randomized controlled trial was conducted to assess whether use of the patient decision aid results in optimization of shared decision making in prosthetic heart valve selection. METHODS AND RESULTS: In a 5-center randomized controlled trial, patients were allocated to receive either standard preoperative care (control group) or additional access to the patient decision aid (intervention group)...

Prosthetic valve thrombosis is one of the major causes of primary valve failure, which can be life-threatening. Multimodality imaging is necessary for determination of leaflet immobilization, cause of underlying pathology (thrombus versus pannus or both), and whether thrombolytic therapy attempt in the patient would be successful or surgery is needed. Current guidelines for the management of prosthetic valve thrombosis lack definitive class I recommendations due to lack of randomized controlled trials, and usually leave the choice of treatment to the clinician's experience...

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...

The continuation of warfarin throughout pregnancy in patients with a mechanical valve prosthesis is a valid anticoagulation regimen, provided that warfarin dose does not exceed 5 mg/day. Two decades after being introduced, the efficacy and safety of this regimen merit evaluation. We performed a systematic review for cases published between January 1991 and January 2013. We compiled our prospective data on 55 pregnancies and calculated pooled estimates (95% confidence interval) of adverse foetal and maternal outcomes...