scholarly journals Anticoagulation for Prosthetic Valves

Thrombosis ◽  
2013 ◽  
Vol 2013 ◽  
pp. 1-4 ◽  
Author(s):  
Tsuyoshi Kaneko ◽  
Sary F. Aranki
Keyword(s):  
Major Bleeding ◽  
Bleeding Event ◽  
Mechanical Valve ◽  
Large Trial ◽  
Current Guideline ◽  
Prosthetic Valves ◽  
Mechanical Valves ◽  
Frequent Monitoring ◽  
Major Bleeding Episode ◽  
New Generation

Implantation of prosthetic valve requires consideration for anticoagulation. The current guideline recommends warfarin on all mechanical valves. Dabigatran is the new generation anticoagulation medication which is taken orally and does not require frequent monitoring. This drug is approved for treatment for atrial fibrillation and venous thromboembolism, but the latest large trial showed that this drug increases adverse events when used for mechanical valve anticoagulation. On-X valve is the new generation mechanical valve which is considered to require less anticoagulation due to its flow dynamics. The latest study showed that lower anticoagulation level lowers the incidence of bleeding, while the risk of thromboembolism and thrombosis remained the same. Anticoagulation poses dilemma in cases such as pregnancy and major bleeding event. During pregnancy, warfarin can be continued throughout pregnancy and switched to heparin derivative during 6–12 weeks and >36 weeks of gestation. Warfarin can be safely started after 1-2 weeks of discontinuation following major bleeding episode.

Non–Vitamin K Antagonist Oral Anticoagulants in the Treatment of Atrial Fibrillation

2019 ◽  
Vol 70 (1) ◽  
pp. 61-75 ◽  
Author(s):  
Alexander C. Fanaroff ◽  
E. Magnus Ohman
Keyword(s):  
Atrial Fibrillation ◽  
Vitamin K ◽  
Major Bleeding ◽  
Anticoagulant Activity ◽  
Oral Anticoagulants ◽  
Significant Risk ◽  
Vitamin K Antagonist ◽  
Therapeutic Window ◽  
Mechanical Valves ◽  
Frequent Monitoring

Atrial fibrillation (AF) increases a patient's stroke risk four- to five-fold. Anticoagulation with the vitamin K antagonist (VKA) warfarin reduces the risk of stroke by 67%, but warfarin carries a significant risk of major bleeding and has unpredictable pharmacodynamics with a narrow therapeutic window, necessitating frequent monitoring of its anticoagulant effect. The non–vitamin K antagonist oral anticoagulants (NOACs) dabigatran, rivaroxaban, apixaban, and edoxaban provide more predictable anticoagulant activity than warfarin with a lower risk of major bleeding, and each is noninferior to warfarin for the prevention of stroke. All have earned regulatory approval in the past eight years. At least one of the NOACs is approved for use in all patients with AF, except those with mechanical valves and rheumatic mitral valve disease, for whom warfarin remains the only option. Recent clinical trials have shown that antithrombotic regimens including NOACs are safe and effective in patients with AF who need potent antiplatelet therapy.

scholarly journals Supra-Annular Mitral Valve Replacement in Infants with Congenital Mitral Valve Disease

2019 ◽  
Vol 22 (5) ◽  
pp. E315-E316
Author(s):  
Haoyong Yuan ◽  
Zhongshi Wu ◽  
Yifeng Yang ◽  
Can Huang
Keyword(s):  
Mitral Valve ◽  
Valve Replacement ◽  
Mitral Valve Replacement ◽  
Early Death ◽  
Mechanical Valve ◽  
Ptfe Graft ◽  
Prosthetic Valves ◽  
Mechanical Valves ◽  
Neonates And Infants

Mitral valve replacement in infants is rare and causes a relatively high mortality, especially for patients under the age of 1. Supra-annular valve replacement is a viable technique for infants with a small valve annulus. Here, we report two infants who underwent mitral valve replacement via the supra-annular technique. The age and body weight of these babies were 2 months and 3 months and 4.1 kg and 4.7 kg, respectively. Aortic mechanical valves were reversely implanted with a short segment of PTFE graft. The purpose of this strategy was to insert a larger mechanical valve and delay resternotomy. A two-year follow-up exam showed normal ventricular function without mechanical valve-related complications. This method is useful in treating neonates and infants. Although the technique of mitral valve repair has improved over several decades, mitral valve replacement still is necessary at times. In neonates and infants with a small annulus, implantation of commercially available prosthetic valves in the annular position can be a challenge, and an age less than 1 year is a risk factor for early death [Selamet 2008]. Supra-annular mitral valve replacement (SMVR) is an alternative when a traditional annular implantation is not feasible [Sung 2008]. Herein, we report the cases of two patients, who underwent SMVR with a follow-up after two years.

scholarly journals A meta-analysis of the performance of small tissue versus mechanical aortic valve prostheses

2019 ◽  
Vol 56 (3) ◽  
pp. 510-517 ◽  
Author(s):  
Marco Moscarelli ◽  
Khalil Fattouch ◽  
Giuseppe Speziale ◽  
Giuseppe Nasso ◽  
Giuseppe Santarpino ◽  
...  
Keyword(s):  
Left Ventricle ◽  
Adverse Events ◽  
Weighted Mean Difference ◽  
Meta Analysis ◽  
Mechanical Valve ◽  
Left Ventricle Mass ◽  
Prosthetic Valves ◽  
Small Tissue ◽  
Mechanical Valves

Abstract OBJECTIVES Small aortic prosthetic valves have been associated with suboptimal performance due to patient–prosthesis mismatch (PPM). This meta-analysis compared the outcomes of patients with a small root who received tissue versus mechanical aortic valves. METHODS A systematic literature review identified 7 candidate studies; of these, 5 met the meta-analysis criteria. We analysed outcomes for a total of 680 patients (227 tissue valves and 453 mechanical valves) using random effects modelling. Each study was assessed for heterogeneity and quality. The primary end point was mortality at follow-up. Secondary end points included intraoperative and postoperative outcomes, the rate of PPM and left ventricle mass regression and major cardiac and prosthesis-related adverse events at follow-up. RESULTS There was no between-group difference in mortality at follow-up [incidence rate ratio 1, 95% confidence interval (CI) 0.50–2.01; P = 0.99]. The tissue group had a higher rate of PPM (odds ratio 17.19, 95% CI 8.6–25.78; P = 0.002) and significantly less reduction in ventricular mass (weighted mean difference 40.79, 95% CI 4.62–76.96; P = 0.02). There were no significant differences in the incidence of structural valve disease at follow-up compared to that in the mechanical valve group. There was also no between-group difference in aggregated adverse events at follow-up (P = 0.68). CONCLUSIONS Tissue and mechanical valves were associated with similar mortality rates; however, patients receiving tissue valves had a higher rate of PPM and significantly less left ventricle mass regression. These findings indicate that patients receiving small tissue valves may require closer clinical surveillance than those receiving mechanical valves.

scholarly journals Loss of engagement in controlling chronic anticoagulation therapy during Covid-19 stringency measures. A single center experience of disproportioned increase of stuck mechanical valves

2021 ◽  
Author(s):  
Olga Vriz ◽  
Andrea Rossi Zadra ◽  
Abdalla Eltayeb ◽  
Fatima Asiri ◽  
Claudio Pragliola ◽  
...  
Keyword(s):  
Transthoracic Echocardiography ◽  
Warfarin Therapy ◽  
Anticoagulation Therapy ◽  
Mechanical Valve ◽  
Single Center ◽  
Single Center Experience ◽  
Prosthetic Valves ◽  
Mechanical Valves ◽  
Mitral Position ◽  
Target Therapeutic Range

Stuck valve is a very rare and severe complication that occurs in mechanical valve replacement patients with ineffective anticoagulation. However, with COVID-19 restriction measures, it became challenging to regularly assess INR to make sure it falls within the target therapeutic range to prevent this complication. We present a series of 10 patients who either underwent transthoracic echocardiography for a suspected stuck valve or were seen at the outpatient valve clinic with the residual consequences of a stuck valve during the COVID-19 restriction measures in our institute. Stuck prosthetic valves incident has increased significantly during this period, particularly those in the mitral position for which urgent replacement and prolonged hospitalization were necessary. Particularly with the COVID-19 restrictions in place, these cases highlight the need for physicians to be aware of the dramatic increase in the incidence of stuck prosthetic valves in patients on chronic warfarin therapy.

scholarly journals Burden of major gastrointestinal bleeding among oral anticoagulant-treated non-valvular atrial fibrillation patients

2021 ◽  
Vol 14 ◽  
pp. 175628482199735
Author(s):  
Steven Deitelzweig ◽  
Allison Keshishian ◽  
Amiee Kang ◽  
Amol D. Dhamane ◽  
Xuemei Luo ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Major Bleeding ◽  
Oral Anticoagulant ◽  
Proportional Hazards ◽  
Bleeding Event ◽  
Cox Proportional Hazards ◽  
High Rate ◽  
Gi Bleeding ◽  
Increased Risk ◽  
Gi Bleed

Background: Gastrointestinal (GI) bleeding is the most common type of major bleeding associated with oral anticoagulant (OAC) treatment. Patients with major bleeding are at an increased risk of a stroke if an OAC is not reinitiated. Methods: Non-valvular atrial fibrillation (NVAF) patients initiating OACs were identified from the Centers for Medicare and Medicaid Services ( CMS) Medicare data and four US commercial claims databases. Patients who had a major GI bleeding event (hospitalization with primary diagnosis of GI bleeding) while on an OAC were selected. A control cohort of patients without a major GI bleed during OAC treatment was matched to major GI bleeding patients using propensity scores. Stroke/systemic embolism (SE), major bleeding, and mortality (in the CMS population) were examined using Cox proportional hazards models with robust sandwich estimates. Results: A total of 15,888 patients with major GI bleeding and 833,052 patients without major GI bleeding were included in the study. Within 90 days of the major GI bleed, 58% of patients discontinued the initial OAC treatment. Patients with a major GI bleed had a higher risk of stroke/SE [hazard ratio (HR): 1.57, 95% confidence interval (CI): 1.42–1.74], major bleeding (HR: 2.79, 95% CI: 2.64–2.95), and all-cause mortality (HR: 1.29, 95% CI: 1.23–1.36) than patients without a major GI bleed. Conclusion: Patients with a major GI bleed on OAC had a high rate of OAC discontinuation and significantly higher risk of stroke/SE, major bleeding, and mortality after hospital discharge than those without. Effective management strategies are needed for patients with risk factors for major GI bleeding.

Abstract 19672: Comparison of Major-bleeding Risk and Health Care Costs Among Treatment-naïve Non-valvular Atrial Fibrillation Patients Initiating Apixaban, Dabigatran, Rivaroxaban or Warfarin

Circulation ◽  
2015 ◽  
Vol 132 (suppl_3) ◽  
Author(s):  
Alpesh Amin ◽  
Allison Keshishian ◽  
Lin Xie ◽  
Onur Baser ◽  
Kwanza Price ◽  
...  
Keyword(s):  
Health Care ◽  
Health Care Costs ◽  
Major Bleeding ◽  
Bleeding Event ◽  
Bleeding Risk ◽  
Medical Costs ◽  
Medicare Advantage ◽  
Major Bleeding Event ◽  
Treatment Naïve ◽  
Care Costs

Objective: The study aim was to compare major bleeding risk and health care costs after initiating oral anticoagulants (OACs) for treatment-naïve non-valvular atrial fibrillation (NVAF) patients. Methods: Patients in the Medicare advantage population prescribed apixaban, rivaroxaban, dabigatran or warfarin were selected from the Optum Research Database 01JAN2013-31DEC2014. The first OAC prescription date was designated as the index date. Patients were required to have a NVAF diagnosis, continuous health plan enrollment for 6 months and no OAC claims before the index date. Patients were classified into four cohorts based on their index OAC prescription. Major bleeding events, identified by the Cunningham algorithm plus additional bleeding sites, were compared using a Cox proportional hazards model. Health care costs were calculated per patient per month and compared using generalized linear models. Results: The study included 36,260 patients: 3,762 apixaban, 2,677 dabigatran, 8,740 rivaroxaban, and 21,081 warfarin patients. CHA2DS2-VASc score was higher in apixaban patients (4.2) compared to dabigatran and rivaroxaban (both 4.0; p<0.001), but lower than in warfarin patients (4.3; p<0.001). After adjusting for baseline characteristics, apixaban patients were significantly less likely to have a major-bleeding event within one year of treatment initiation compared to rivaroxaban (HR=0.69; 95% CI=0.59-0.81) and warfarin (HR=0.71; 95% CI=0.61-0.82) patients and trended towards numerically lower major bleeding compared to dabigatran patients (HR=0.87; 95% CI=0.72-1.06). Major bleeding-related medical costs were lower in apixaban patients ($53) compared to rivaroxaban ($111) and warfarin ($138) patients (p<0.001) and similar to dabigatran patients ($44, p=0.370). Furthermore, apixaban patients incurred lower all-cause medical costs ($1,646) compared to dabigatran ($1,974, p=0.02), rivaroxaban ($1,909, p=0.002) and warfarin ($2,162, p<0.001) patients. Conclusion: In a large national Medicare advantage population, treatment-naïve NVAF patients treated with apixaban were significantly less likely to have a major-bleeding event compared to those prescribed rivaroxaban or warfarin and had significantly lower medical costs.

scholarly journals Concurrent Treatment of VEGFR Tyrosine Kinase Inhibitors (TKIs) and Factor Xa Inhibitors Is Associated with Increased Bleeding Risks

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 3681-3681
Author(s):  
Sandip Patel ◽  
Tiffany George ◽  
Tzu-Fei Wang ◽  
Sherry Mori Vogt ◽  
Edmund Folefac ◽  
...  
Keyword(s):  
Cancer Patients ◽  
Major Bleeding ◽  
Metastatic Cancer ◽  
Bleeding Event ◽  
Factor Xa ◽  
Factor Xa Inhibitors ◽  
Factor Xa Inhibitor ◽  
Bleeding Events ◽  
Concurrent Treatment ◽  
Clinically Significant

ABSTRACT Background: Some cancer patients with thromboembolism require dual treatment of VEGFR TKIs and factor Xa inhibitors (direct or indirect), which may contribute to increased bleeding risks. However, the safety of such combination treatment has not been well characterized in the literature or national guidelines. Methods: This is a single center retrospective study, where we identified metastatic cancer patients (renal cancer, colorectal cancer, sarcoma, etc) who received concurrent VEGFR TKIs (pazopanib, sunitinib, sorafenib, axitinib, regorafenib, vandetanib, lenvatinib or cabozantinib) and Xa inhibitors (low-molecular weight heparin [LMWH] or direct oral anticoagulants [DOACs] including rivaroxaban or apixaban) at the Ohio State University Medical Center. We assessed bleeding risks of dual therapies vs. factor Xa inhibitors alone, using the same patients as self controls. We reviewed medical charts of all identified patients for clinically significant bleeding events (defined as combined major bleeding and clinically relevant non-major bleeding by the International Society of Thrombosis and Haemostasis criteria). The Cox proportional hazard model was used to compare the differences of time to first clinically significant bleeding event between the groups of concurrent use and anticoagulant use only. Results: A total of 86 patients (26 females and 60 males) were included: 78 Caucasians, 6 African Americans, and 2 others. 81 patients had concurrent TKI and LMWH treatment; 20 patients had concurrent TKI and DOACs; and 85 patients have had been on factor Xa inhibitor alone (LMWH or DOACs) at some point. Some patients had been on both LMWH and DOACs at different time periods. Overall, there were 29 clinically significant bleeding events (including 8 major bleeding) during concurrent treatment and 17 events (4 major bleeding) during factor Xa inhibitor alone over a median follow up of 63 days (52 days for concurrent treatment and 99 days for Xa inhibitor alone). In this self-control study, concurrent treatment was associated with a statistically higher risk of clinically significant bleeding events (HR, 2.84; 95% CI, 1.43-5.64, P &lt; 0.01), which reached 37% patient population in the first 3 months, while the bleeding associated with factor Xa inhibitor alone seemed spaced out at the entire length of anticoagulation (8% by 6 months). Similar trend was found in the analysis of patient group of concurrent TKI and LMWH vs. LMWH alone (HR, 1.96; 95% CI, 0.95-4.02, P = 0.067), although significance was not reached likely due to insufficient power. Sample size was inadequate for meaningful comparison between concurrent VEGFR TKI and DOAC vs. DOAC alone. Conclusions: Concurrent treatment of VEGFR TKI and factor Xa inhibitors is associated with a significantly increased bleeding risks when compared with factor Xa inhibitors alone in patients with metastatic cancer. Disclosures No relevant conflicts of interest to declare.

scholarly journals Duration of Dual Antiplatelet Therapy in Patients With Acute Coronary Syndrome Treated With New Generation Stents: A Meta-Analysis of Randomized Controlled Trials

2021 ◽  
Vol 8 ◽  
Author(s):  
Wen-Jiao Zhang ◽  
Xuan Qiao ◽  
Wen-Fen Guo ◽  
Xi-Ying Liang ◽  
Yan Li ◽  
...  
Keyword(s):  
Acute Coronary Syndrome ◽  
Randomized Controlled Trials ◽  
Major Bleeding ◽  
Meta Analysis ◽  
Cardiovascular Death ◽  
Controlled Trials ◽  
Target Vessel Revascularization ◽  
Coronary Syndrome ◽  
Randomized Controlled ◽  
New Generation

Background and Objective: The optimum duration of dual antiplatelet therapy (DAPT) remains uncertain in patients with acute coronary syndrome treated with new generation stents. This meta-analysis was performed to investigate ischemia and bleeding outcomes with different DAPT strategies.Methods: PubMed, Embase, Cochrane and Web of science from inception to May 27, 2020, were systematically searched. Randomized controlled trials were included to compare short-term (6 months or less) with standard (12 months) DAPT in patients with acute coronary syndrome treated with new generation stents. The primary endpoints were myocardial infarction, definite or probable stent thrombosis and major bleeding. The secondary endpoints included all-cause death, cardiovascular death, stroke, target vessel revascularization and net adverse clinical events. Random effect model and fixed effect model were used to calculate the odds ratio (OR) and 95% confidence interval (CI) of each endpoint.Results: Four randomized controlled trials and seven subgroup analyses of larger randomized controlled trials, including a total of 21,344 patients with acute coronary syndrome, met our inclusion criteria. The shorter DAPT was associated with significantly lower major bleeding compared with the standard DAPT (OR 0.71, 95% CI 0.56–0.90, P = 0.005, I2 = 25%), while without increasing the risk of myocardial infarction (OR 1.18, 0.88–1.58, P = 0.28, I2 = 20%), definite or probable stent thrombosis (OR 1.60, 0.98–2.59, P = 0.06, I2 = 0%). No significantly difference was observed in the risk of all-cause death (OR 0.96, 0.72–1.27, P = 0.76, I2 = 2%), cardiovascular death (OR 0.91, 0.62–1.33, P = 0.62, I2 = 0%), stroke (OR 0.84, 0.54–1.30, P = 0.43, I2 = 0%), target vessel revascularization (OR 1.14, 0.84–1.55, P = 0.41, I2 = 8%), and net adverse clinical events (OR 0.93, 0.80–1.07, P = 0.3, I2 = 18%) between the two groups.Conclusions: In patients with acute coronary syndrome treated with new generation stents, the shorter DAPT leads to a marked reduction in the risk of major bleeding compared with the standard DAPT. This benefit is achieved without increasing the risk of mortality or ischemic outcomes. The study protocol was registered in PROSPERO (CRD42020189871).

scholarly journals Thrombolytic therapy in prosthetic valve thrombosis in the second trimester of pregnancy

2020 ◽  
Vol 7 (5) ◽  
pp. 853
Author(s):  
Santhosh Jadhav ◽  
H. S. Natraj Setty ◽  
Shankar S. ◽  
Phani Teja Mundru ◽  
Yeriswamy M. C. ◽  
...  
Keyword(s):  
Thrombolytic Therapy ◽  
Valve Replacement ◽  
Prosthetic Valve ◽  
Prosthetic Heart Valve ◽  
Mechanical Valve ◽  
Second Trimester ◽  
Prosthetic Valve Thrombosis ◽  
First Line Therapy ◽  
Mechanical Valves ◽  
Valve Thrombosis

Pregnancy with mechanical valves requires anticoagulation, the risk of bleeding and embryopathy associated with oral anticoagulation must be weighed against the risk of valve thrombosis. In the presence of a mechanical valve thrombosis, an appropriate treatment modality must be selected. Prosthetic valve thrombosis during pregnancy requires immediate therapy such as valve replacement, thrombolytic therapy, or surgical thrombectomy. A course of thrombolytic therapy may be considered as a first-line therapy for prosthetic heart valve thrombosis. We describe a primigravida (second trimester) with mitral valve replacement status presenting with acute prosthetic valve thrombosis and treated successfully with intravenous streptokinase.

Long-term clinical outcomes after major bleeding in patients with atrial fibrillation: the Fushimi AF registry

2020 ◽  
Author(s):  
Hisashi Ogawa ◽  
Yoshimori An ◽  
Kenjiro Ishigami ◽  
Syuhei Ikeda ◽  
Kosuke Doi ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Ischaemic Stroke ◽  
Clinical Outcomes ◽  
Major Bleeding ◽  
Bleeding Event ◽  
Community Based ◽  
Increased Risk ◽  
All Cause Mortality

Abstract Aims Oral anticoagulants reduce the risk of ischaemic stroke but may increase the risk of major bleeding in atrial fibrillation (AF) patients. Little is known about the clinical outcomes of patients after a major bleeding event. This study assessed the outcomes of AF patients after major bleeding. Methods and results The Fushimi AF Registry is a community-based prospective survey of the AF patients in Fushimi-ku, Kyoto, Japan. Analyses were performed on 4304 AF patients registered by 81 institutions participating in the Fushimi AF Registry. We investigated the demographics and outcomes of AF patients who experienced major bleeding during follow-up period. During the median follow-up of 1307 days, major bleeding occurred in 297 patients (6.9%). Patients with major bleeding were older than those without (75.6 vs. 73.4 years; P &lt; 0.01). They were more likely to have pre-existing heart failure (33.7% vs. 26.7%; P &lt; 0.01), history of major bleeding (7.7% vs. 4.0%; P &lt; 0.01), and higher mean HAS-BLED score (2.05 vs.1.73; P &lt; 0.01). On landmark analysis, ischaemic stroke or systemic embolism occurred in 17 patients (3.6/100 person-years) after major bleeding and 227 patients (1.7/100 person-years) without major bleeding, with an adjusted hazard ratio (HR) of 1.93 [95% confidence interval (CI), 1.06–3.23; P = 0.03]. All-cause mortality occurred in 97 patients with major bleeding (20.0/100 person-years) and 709 (5.1/100 person-years) patients without major bleeding [HR 2.73 (95% CI, 2.16–3.41; P &lt; 0.01)]. Conclusion In this community-based cohort, major bleeding is associated with increased risk of subsequent all-cause mortality and thromboembolism in the long-term amongst AF patients. Trial registration https://www.umin.ac.jp/ctr/index.htm. Unique identifier: UMIN000005834. (last accessed 22 October 2020)

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