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Prosthetic heart valve rct

Nelleke M Korteland, Yunus Ahmed, David R Koolbergen, Marjan Brouwer, Frederiek de Heer, Jolanda Kluin, Eline F Bruggemans, Robert J M Klautz, Anne M Stiggelbout, Jeroen J J Bucx, Jolien W Roos-Hesselink, Peter Polak, Thanasie Markou, Inge van den Broek, Rene Ligthart, Ad J J C Bogers, Johanna J M Takkenberg
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)...
February 2017: Circulation. Cardiovascular Quality and Outcomes
Mustafa Ozan Gürsoy, Macit Kalçık, Mahmut Yesin, Süleyman Karakoyun, Emrah Bayam, Sabahattin Gündüz, Mehmet Özkan
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...
December 2016: Anatolian Journal of Cardiology
Simone A Huygens, Mostafa M Mokhles, Milad Hanif, Jos A Bekkers, Ad J J C Bogers, Maureen P M H Rutten-van Mölken, Johanna J M Takkenberg
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...
October 2016: European Journal of Cardio-thoracic Surgery
Ahmed Hassouna, Hemat Allam
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...
June 2014: Interactive Cardiovascular and Thoracic Surgery
Maria Bonou, Konstantinos Lampropoulos, John Barbetseas
Prosthetic valve thrombosis is a potentially life-threatening complication associated with high morbidity and mortality. Transthorasic and transoesophageal echocardiography play an important role to the diagnosis and provides incremental information about the optimal treatment strategy, while fluoroscopy and cardiac computed tomography may be of added value. Guidelines differ on whether surgical treatment or fibrinolysis should be the treatment of choice for the management of left-sided prosthetic valve thrombosis and these uncertainties underline the need for further prospective randomized controlled trials...
June 2012: European Heart Journal. Acute Cardiovascular Care
David R Massel, Stephen H Little
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...
July 9, 2013: Cochrane Database of Systematic Reviews
Ming Ta Michael Lee, Teri E Klein
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...
June 2013: Journal of Human Genetics
Ganesan Karthikeyan, Nagendra Boopathy Senguttuvan, Jo Joseph, Niveditha Devasenapathy, Vinay K Bahl, Balram Airan
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...
June 2013: European Heart Journal
Dinesh Chandra, Anubhav Gupta, Vijay Grover, Vijay Kumar Gupta
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...
April 2013: Interactive Cardiovascular and Thoracic Surgery
M J Dayer, J B Chambers, B Prendergast, J A T Sandoe, M H Thornhill
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...
March 2013: QJM: Monthly Journal of the Association of Physicians
Parag Barwad, Amol Raheja, Raghunandan Venkat, Shyam S Kothari, Vinay Bahl, Ganesan Karthikeyan
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...
October 1, 2012: American Journal of Cardiovascular Drugs: Drugs, Devices, and Other Interventions
John Pepper, Davy Cheng, Rex Stanbridge, Francis D Ferdinand, W R Eric Jamieson, Paul Stelzer, Geoffrey Berg, Guido Sani, Janet Martin
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...
March 2009: Innovations: Technology and Techniques in Cardiothoracic and Vascular Surgery
F Maisano, O Alfieri, G La Canna
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...
May 2011: Annales Françaises D'anesthèsie et de Rèanimation
Ganesan Karthikeyan, Navin Mathew, Ravi S Math, Niveditha Devasenapathy, Shyam S Kothari, Vinay K Bahl
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...
August 2011: Journal of Thrombosis and Thrombolysis
L Linkins, M O'Donnell, J A Julian, C Kearon
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...
October 2010: Journal of Thrombosis and Haemostasis: JTH
Remy R Coeytaux, John W Williams, Rebecca N Gray, Andrew Wang
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...
September 7, 2010: Annals of Internal Medicine
Shahbudin H Rahimtoola
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...
June 1, 2010: Journal of the American College of Cardiology
Cihan Cevik, Cemil Izgi, Weeranun Dechyapirom, Kenneth Nugent
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...
March 2010: Journal of Heart Valve Disease
Peter H Stone
No abstract text is available yet for this article.
November 10, 2009: Journal of the American College of Cardiology
Ganesan Karthikeyan, Ravi S Math, Navin Mathew, Bhima Shankar, Mani Kalaivani, Sandeep Singh, Vinay K Bahl, Jack Hirsh, John W Eikelboom
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...
September 22, 2009: Circulation
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