Prosthetic heart valve rct

BACKGROUND: Patients with prosthetic heart valves are at increased risk for valve thrombosis and arterial thromboembolism. Oral anticoagulation alone, or the addition of antiplatelet drugs, has been used to minimise this risk. An important issue is the effectiveness and safety of the latter strategy. OBJECTIVES: This is an update of our previous review; the goal was to create a valid synthesis of all available, methodologically sound data to further assess the safety and efficacy of combined oral anticoagulant and antiplatelet therapy versus oral anticoagulant monotherapy in patients with prosthetic heart valves...

Since the introduction in the 1950s, warfarin has become the commonly used oral anticoagulant for the prevention of thromboembolism in patients with deep vein thrombosis, atrial fibrillation or prosthetic heart valve replacement. Warfarin is highly efficacious; however, achieving the desired anticoagulation is difficult because of its narrow therapeutic window and highly variable dose response among individuals. Bleeding is often associated with overdose of warfarin. There is overwhelming evidence that an individual's warfarin maintenance is associated with clinical factors and genetic variations, most notably polymorphisms in cytochrome P450 2C9 and vitamin K epoxide reductase subunit 1...

AIMS: Left-sided prosthetic valve thrombosis (PVT) occurs frequently in developing countries and causes major morbidity and mortality. Fibrinolytic therapy (FT) is most commonly used as treatment, but increases the risk of stroke and bleeding. Urgent surgery may be more efficacious and cause fewer complications. Our aim was to compare the efficacy and safety of urgent surgery and FT for the treatment of left-sided PVT. METHODS AND RESULTS: We searched EMBASE and MEDLINE for articles which included at least five patients each treated with surgery and FT...

A best evidence topic in cardiac surgery was written according to the structured protocol. The question addressed was about the best time to restart anticoagulation in patients with intracranial bleed with a prosthetic valve in situ. This difficult clinical decision has to balance the risk of thromboembolism during the period that the anticoagulation was reversed and later withheld vs the risk of haematoma expansion or rebleed if the anticoagulation was started early. Altogether, more than 80 papers were found using the reported search, of which 10 represented the best evidence to answer the clinical question...

BACKGROUND: Since the introduction of the National Institute for Health and Clinical Excellence (NICE) guideline (CG064) in 2008 recommending cessation of antibiotic prophylaxis (AP) against infective endocarditis (IE), low level prescribing persists in the UK and is a potential reason why there has been no significant change in the general upward trend in cases of IE. AIM: To undertake a survey of dentists (Ds), cardiologists and cardiothoracic surgeons (C/CTSs) and infection specialists (ISs) to determine why this might be the case...

BACKGROUND: Symptomatic thromboembolic events including stroke occur frequently in patients with mechanical heart valves, particularly among those who are poorly anticoagulated. OBJECTIVE: This study set out to determine the prevalence of silent brain infarction (SBI) in this population. METHODS: This was a post hoc analysis of data from a randomized controlled trial carried out in a tertiary-care academic medical center. The trial included participants from a randomized controlled trial of fibrinolytic therapy (FT) in patients with left-sided prosthetic valve thrombosis (PVT), who had undergone pre-treatment computed tomography (CT) scans of the brain...

OBJECTIVE: : The purpose of this consensus conference was to determine whether stentless bioprosthetic valves improve clinical and resource outcomes compared with stented valves in patients undergoing aortic valve replacement, and to outline evidence-based recommendations for the use of stentless and stented bioprosthetic valves in adult aortic valve replacement. METHODS: : Before the consensus conference, the best available evidence was reviewed in that systematic reviews, randomized trials, and nonrandomized trials were considered in descending order of validity and importance...

Mitral regurgitation (MR) is associated with poor prognosis and high incidence of clinical events if left untreated. To reduce the invasiveness of the surgical approach, different types of trans-catheter procedures are becoming available. The MitraClip procedure (Abbott Vascular Inc. Menlo Park, CA) is yet the only available at the moment. The procedure is used to treat high risk surgical candidates with either functional or degenerative MR. Recent trials have shown that the procedure is safer than surgery, although less effective...

Serious bleeding and embolic events are common after fibrinolytic therapy (FT) for left-sided prosthetic valve thrombosis (PVT), and are believed to occur more frequently with prolonged fibrinolytic infusions. But there is no data from prospective studies examining this contention. Our aim was to determine the timing of adverse events after FT with streptokinase (SK) for left-sided PVT. In a post-hoc analysis involving all 120 participants from a randomized controlled trial of FT for left-sided PVT, we determined the timing of occurrence of a composite of death, major bleeding, embolic stroke, or non-central nervous system systemic embolism, in relation to the duration of SK infusion...

BACKGROUND:  Rate of major bleeding is generally accepted as a good measure of the risks associated with anticoagulant therapy, but this may not be true if the proportion of major bleeds with the most serious consequences differs according to the indication for anticoagulant therapy. OBJECTIVE: To determine whether the indication for long-term oral anticoagulant therapy influences the proportion of major bleeds that are intracranial and fatal. PATIENTS/METHODS:  Two authors abstracted intracranial and fatal bleeds from randomized trials of patients who received anticoagulant therapy for a minimum of 6months for atrial fibrillation, ischemic heart disease, venous thromboembolism, prosthetic heart valves and ischemic stroke...

Surgical aortic valve replacement (SAVR) is the only treatment known to improve symptoms and survival in patients with severe, symptomatic aortic stenosis. Perioperative mortality, however, is high among many patients for whom SAVR may be indicated. Percutaneous heart valve replacement (PHVR) is an emerging, catheter-based technology that allows for implantation of a prosthetic valve without open heart surgery. This review describes the available literature on PHVR for aortic stenosis, which comprised 84 published reports representing 76 distinct studies and 2375 unique patients...

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...

BACKGROUND AND AIM OF THE STUDY: Prosthetic valve thrombosis (PVT) is a serious complication that may cause significant morbidity and mortality. Despite advances in valve technology, patient education and adequate anticoagulation, the risk of PVT persists indefinitely. Certain clinical and prothrombotic states, including atrial fibrillation, insufficient anticoagulation and pregnancy, predispose these patients to develop PVT. The optimal treatment of the condition is controversial, and to date no randomized clinical trials have been conducted to assist in decision making...

No abstract text is available yet for this article.

BACKGROUND: No large prospective studies have evaluated the efficacy of fibrinolytic therapy for left-sided prosthetic valve thrombosis, yet it remains the first line of treatment in developing countries. METHODS AND RESULTS: We performed a randomized controlled trial comparing an accelerated infusion with the conventional infusion of streptokinase in 120 patients with a first episode of left-sided prosthetic valve thrombosis. The primary outcome measure was the occurrence of a complete clinical response, defined as objectively documented complete restoration of valve function in the absence of major complications...

This chapter about antithrombotic therapy in atrial fibrillation (AF) is part of the American College of Chest Physicians Evidence-Based Guidelines Clinical Practice Guidelines (8th Edition). Grade 1 recommendations indicate that most patients would make the same choice and Grade 2 suggests that individual patient's values may lead to different choices (for a full understanding of the grading see Guyatt et al, CHEST 2008; 133[suppl]:123S-131S). Among the key recommendations in this chapter are the following (all vitamin K antagonist [VKA] recommendations have a target international normalized ratio [INR] of 2...

The current Food and Drug Administration (FDA) heart valve guidance document uses an objective performance criteria (OPC) methodology to evaluate the clinical performance of prosthetic heart valves. OPC are essentially historical controls, but they have turned out to be an adequate, and perhaps optimal, study design in this situation. Heart valves have a simple open-and-close mechanism, device effectiveness is easy to document, and the common complications (thromboembolism, thrombosis, bleeding, leak, and infection) are well known and easily detected...

BACKGROUND: In patients receiving chronic oral anticoagulation with vitamin K antagonists (VKAs) it may be necessary to temporarily discontinue VKA therapy to allow surgery or other invasive procedures to be performed, as maintaining treatment may increase the risk of bleeding during the procedure. This, however, creates a clinical dilemma, since discontinuing VKAs may place the patient at risk of thromboembolism. SCOPE: We undertook a systematic narrative review of patients on chronic oral anticoagulation, requiring a periprocedural bridging therapy with heparin during invasive procedures...

PURPOSE OF REVIEW: The aim of this article is to evaluate the findings of clinical trials in cardiac valve surgery and to determine the real impact in standard of care. Also, publications on randomized clinical trials were reviewed as to integrity and validity. Nineteen randomized clinical trials were identified in 11 areas of operative and clinical management. RECENT DEVELOPMENTS: The Veterans Affairs and Edinburgh Heart Valve Trials confirmed the guidelines for indications for bioprostheses and mechanical prostheses...

BACKGROUND AND AIM OF THE STUDY: Different standards for the reporting of morbid events and different follow up techniques have a profound impact on reported morbidity after prosthetic valve replacement. Most studies follow the guidelines of The American Association of Thoracic Surgery (AATS) and The Society of Thoracic Surgeons (STS); the present authors' group has now developed an adapted Karnofsky scale which allows a more precise grading of the severity of morbid events. METHODS: The AATS/STS criteria and the adapted Karnofsky criteria were applied to the database of the German Experience with Low-Intensity Anticoagulation (GELIA) study...