Browsing by Subject "Heart Valve Prosthesis"

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    An evaluation of patient self-testing competency of prothrombin time for managing anticoagulation: pre-randomization results of VA Cooperative Study #481--The Home INR Study (THINRS).
    (Journal of thrombosis and thrombolysis, 2010-10) Dolor, Rowena J; Ruybalid, R Lynne; Uyeda, Lauren; Edson, Robert G; Phibbs, Ciaran; Vertrees, Julia E; Shih, Mei-Chiung; Jacobson, Alan K; Matchar, David B; THINRS Site Investigators
    Prior studies suggest patient self-testing (PST) of prothrombin time (PT) can improve the quality of anticoagulation (AC) and reduce complications (e.g., bleeding and thromboembolic events). "The Home INR Study" (THINRS) compared AC management with frequent PST using a home monitoring device to high-quality AC management (HQACM) with clinic-based monitoring on major health outcomes. A key clinical and policy question is whether and which patients can successfully use such devices. We report the results of Part 1 of THINRS in which patients and caregivers were evaluated for their ability to perform PST. Study-eligible patients (n = 3643) were trained to use the home monitoring device and evaluated after 2-4 weeks for PST competency. Information about demographics, medical history, warfarin use, medications, plus measures of numeracy, literacy, cognition, dexterity, and satisfaction with AC were collected. Approximately 80% (2931 of 3643) of patients trained on PST demonstrated competency; of these, 8% (238) required caregiver assistance. Testers who were not competent to perform PST had higher numbers of practice attempts, higher cuvette wastage, and were less able to perform a fingerstick or obtain blood for the cuvette in a timely fashion. Factors associated with failure to pass PST training included increased age, previous stroke history, poor cognition, and poor manual dexterity. A majority of patients were able to perform PST. Successful home monitoring of PT with a PST device required adequate levels of cognition and manual dexterity. Training a caregiver modestly increased the proportion of patients who can perform PST.
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    Effect of home testing of international normalized ratio on clinical events.
    (The New England journal of medicine, 2010-10) Matchar, David B; Jacobson, Alan; Dolor, Rowena; Edson, Robert; Uyeda, Lauren; Phibbs, Ciaran S; Vertrees, Julia E; Shih, Mei-Chiung; Holodniy, Mark; Lavori, Philip; THINRS Executive Committee and Site Investigators

    Background

    Warfarin anticoagulation reduces thromboembolic complications in patients with atrial fibrillation or mechanical heart valves, but effective management is complex, and the international normalized ratio (INR) is often outside the target range. As compared with venous plasma testing, point-of-care INR measuring devices allow greater testing frequency and patient involvement and may improve clinical outcomes.

    Methods

    We randomly assigned 2922 patients who were taking warfarin because of mechanical heart valves or atrial fibrillation and who were competent in the use of point-of-care INR devices to either weekly self-testing at home or monthly high-quality testing in a clinic. The primary end point was the time to a first major event (stroke, major bleeding episode, or death).

    Results

    The patients were followed for 2.0 to 4.75 years, for a total of 8730 patient-years of follow-up. The time to the first primary event was not significantly longer in the self-testing group than in the clinic-testing group (hazard ratio, 0.88; 95% confidence interval, 0.75 to 1.04; P=0.14). The two groups had similar rates of clinical outcomes except that the self-testing group reported more minor bleeding episodes. Over the entire follow-up period, the self-testing group had a small but significant improvement in the percentage of time during which the INR was within the target range (absolute difference between groups, 3.8 percentage points; P<0.001). At 2 years of follow-up, the self-testing group also had a small but significant improvement in patient satisfaction with anticoagulation therapy (P=0.002) and quality of life (P<0.001).

    Conclusions

    As compared with monthly high-quality clinic testing, weekly self-testing did not delay the time to a first stroke, major bleeding episode, or death to the extent suggested by prior studies. These results do not support the superiority of self-testing over clinic testing in reducing the risk of stroke, major bleeding episode, and death among patients taking warfarin therapy. (Funded by the Department of Veterans Affairs Cooperative Studies Program; ClinicalTrials.gov number, NCT00032591.).
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    Transcatheter Valve Replacement for Right-sided Valve Disease in Congenital Heart Patients.
    (Progress in cardiovascular diseases, 2018-09-17) Gales, Jordan; Krasuski, Richard A; Fleming, Gregory A
    Pulmonary and/or tricuspid valve dysfunction is common among individuals with congenital heart disease, and surgical intervention often carries prohibitive risks. Transcatheter valve replacement (TVR) of the right-sided cardiac valves has become a viable treatment option over the past two decades, while continued technological development aims to broaden its applicability to an even larger portion of those with repaired congenital heart disease. To date, two transcatheter valves have been approved for use in patients with dysfunctional right ventricular to pulmonary artery conduits as well as those with failing pulmonic bioprosthetic valves, and are also used off-label in the "native" RVOT and within surgically repaired/replaced but failing tricuspid valves. TVR has demonstrated comparable safety and short-term outcomes to that of surgical valve replacement. This article aims to review current available devices, focusing on their safety, efficacy and on and off label usage, while briefly describing some of the emerging devices and novel procedural techniques that will likely lead to significant expansion of transcatheter treatment of right sided valve disease in the future.
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    Using a Regent Aortic Valve in a Small Annulus Mitral Position Is a Viable Option.
    (The Annals of thoracic surgery, 2018-04) Barac, Yaron D; Zwischenberger, Brittany; Schroder, Jacob N; Daneshmand, Mani A; Haney, John C; Gaca, Jeffrey G; Wang, Andrew; Milano, Carmelo A; Glower, Donald D
    BACKGROUND:Outcome of mitral valve replacement in extreme scenarios of small mitral annulus with the use of the Regent mechanical aortic valve is not well documented. METHODS:Records were examined in 31 consecutive patients who underwent mitral valve replacement with the use of the aortic Regent valve because of a small mitral annulus. RESULTS:Mean age was 60 ± 14 years. Mitral stenosis or mitral annulus calcification was present in 30 of 31 patients (97%). Concurrent procedures were performed in 17 of 31 patients (55%). Median valve size was 23 mm. Mean mitral gradient coming out of the operating room was 4.2 ± 1.5 mm Hg and at follow-up echocardiogram performed at a median of 32 months after the procedure was 5.8 ± 2.4 mm Hg. CONCLUSIONS:A Regent aortic mechanical valve can be a viable option with a larger orifice area than the regular mechanical mitral valve in a problematic situation of a small mitral valve annulus. Moreover, the pressure gradients over the valve are acceptable intraoperatively and over time.