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Dabigatran Versus Warfarin After Bioprosthesis Valve Replacement for the Management of Atrial Fibrillation Postoperatively: DAWA Pilot Study
Objectives
Dabigatran is a direct thrombin inhibitor shown to be an effective alternative to warfarin in patients with non-valvular atrial fibrillation (AF). We evaluated the use of dabigatran in patients with bioprosthetic mitral and/or aortic valve replacement and AF.
Methods
We selected 34 and randomized 27 patients in a 1:1 ratio to receive dabigatran or warfarin. The primary endpoint was the presence of a new intracardiac thrombus at 90 days, by transesophageal echocardiogram (TEE). Secondary endpoints included the development of dense spontaneous echo contrast (SEC) and incidence of stroke (ischemic or hemorrhagic), myocardium infarction, valve thrombosis and peripheral embolic events.
Results
The trial was terminated prematurely because of low enrollment. There were 27 patients in total: 15 patients placed in the dabigatran group and 12 in the warfarin group. After 90 days, one patient (8.3 %) in the warfarin group and none in the dabigatran group had developed a new intracardiac thrombus. In the dabigatran group, two patients (13.3 %) developed dense SEC versus one patient (8.3 %) in the warfarin group. In the warfarin group, one patient (8.3 %) presented ischemic stroke, and none did in the dabigatran group. We observed no cases of hemorrhagic stroke, valve thrombosis, embolic events or myocardial infarction in either group throughout the study. However, one patient (6.7 %) in the dabigatran group had a fully recovered transient ischemic attack and one patient in the warfarin group died of heart failure.
Conclusions
The use of dabigatran appears to be similar to warfarin in preventing the formation of intracardiac thrombus.
Trial Registration
Clinicaltrials.gov NCT01868243.
Journal Article
Coronary Angiography after Cardiac Arrest without ST-Segment Elevation
Patients who had cardiac arrest without ST-segment elevation were assigned to undergo either immediate coronary angiography or delayed coronary angiography (after neurologic recovery). All patients underwent PCI if indicated. There was no significant between-group difference in overall survival at 90 days.
Journal Article
Subcutaneous or Transvenous Defibrillator Therapy
Patients with an indication for an implantable cardioverter–defibrillator but no indication for pacing were randomly assigned to a subcutaneous or a transvenous ICD. At 49 months, the subcutaneous ICD was noninferior to the transvenous ICD with respect to device-related complications and inappropriate shocks.
Journal Article
The new American Heart Association cookbook
\"If you want to improve your health or simply maintain it, The New American Heart Association cookbook, Centennial Edition, is for you. This comprehensive resource provides information on grocery shopping strategies, stocking a healthy kitchen, preparing delicious recipes, eating well, meal planning, and much more. This revised edition of the American Heart Association's flagship cookbook offers not only more than 800 recipes-100 of which are all new and 100 refreshed-to satisfy every palate but also provides the most current dietary and lifestyle recommendations. It is the one-stop guide that should be in everyone's kitchen. The new and revised recipes are based on today's flavor profiles; eating preferences, such as Mediterranean and vegetarian; family favorites; and diverse cultural cuisines, as well as popular appliances including the air fryer, slow cooker, and Instant Pot. This edition includes more than 13 categories of scrumptious recipes, including: Mexican Noodle Soup; Korean Cucumber Salad; Seared Jerk Fish with Broiled Asparagus; Sheet Pan Chicken, Sweet Potatoes, and Green Beans; Slow Cooker Pulled Pork Tostadas; Pressure Cooker Five-Spice Beef with Hoisin Sauce; Roasted Vegetable Macaroni and Cheese; Air Fryer Plantains with Lime Crema; Whole-Wheat Sourdough Bread; Mixed Berry Cobbler\"-- Provided by publisher.
BOOK
Antibacterial Envelope to Prevent Cardiac Implantable Device Infection
Infection is a known complication of the placement of cardiac implantable electronic devices. In this randomized, controlled trial involving 6983 patients undergoing cardiac-device placement, an antibacterial envelope was studied to determine infection prevention. The envelope reduced infection by 40%.
Journal Article
The health-related quality of life was not improved by targeting higher hemoglobin in the Normal Hematocrit Trial
The Normal Hematocrit Trial (NHT) was the largest trial of epoetin randomizing 1265 hemodialysis patients with cardiac disease to lower (9–11g/dl) or higher (13–15g/dl) hemoglobin (Hgb), hypothesizing that higher Hgb would reduce mortality, and improve survival and quality of life. The trial was terminated early, and a 1998 publication reported that targeting higher hematocrit levels led to an insignificant increase in the primary end points (death or myocardial infarct), or risk ratio 1.3, 95% confidence interval (CI), 0.9–1.90, but the P-value was not given, and all-cause death risk was not reported. A higher target reportedly did not increase hospitalization rates, but did significantly improve the ‘physical function’ domain of quality of life. Comparing the 1996 Food and Drug Administration (FDA)-filed clinical trial report to the 1998 publication, however, found several discrepancies. Among these, the 1998 article reported interim trial results with only the adjusted CI but did not state that the unadjusted CIs were 99.912th percentile, and despite being a secondary end point, reported only the association of achieved Hgb with higher quality of life score. Randomization to the higher target had actually increased the risk for the primary end point (risk ratio 1.28, 95% CI=1.06–1.56; P=0.0112; 99.92% CI=0.92–1.78), the risk of death (risk ratio 1.27, 95% CI=1.04–1.54), non-access thrombotic events (P=0.041), and hospitalization rate (P=0.04), while ‘physical function’ did not improve (P=0.88). Hence, disclosure of these results in the 1998 publication or access to the FDA-filed report on the NHT in the late 1990s would likely have led to earlier concerns about epoetin safety and greater doubts about its benefits.
Journal Article
Web-Based Mindfulness Intervention in Heart Disease: A Randomized Controlled Trial
Evidence is accumulating that mindfulness training has favorable effects on psychological outcomes, but studies on physiological outcomes are limited. Patients with heart disease have a high incidence of physiological and psychological problems and may benefit from mindfulness training. Our aim was to determine the beneficial physiological and psychological effects of online mindfulness training in patients with heart disease.
The study was a pragmatic randomized controlled single-blind trial. Between June 2012 and April 2014 we randomized 324 patients (mean age 43.2 years, 53.7% male) with heart disease in a 2:1 ratio (n = 215 versus n = 109) to a 12-week online mindfulness training in addition to usual care (UC) compared to UC alone. The primary outcome was exercise capacity measured with the 6 minute walk test (6MWT). Secondary outcomes were other physiological parameters (heart rate, blood pressure, respiratory rate, and NT-proBNP), subjective health status (SF-36), perceived stress (PSS), psychological well-being (HADS), social support (PSSS12) and a composite endpoint (all-cause mortality, heart failure, symptomatic arrhythmia, cardiac surgery, and percutaneous cardiac intervention). Linear mixed models were used to evaluate differences between groups on the repeated outcome measures.
Compared to UC, mindfulness showed a borderline significant improved 6MWT (effect size, meters: 13.2, 95%CI: -0.02; 26.4, p = 0.050). There was also a significant lower heart rate in favor of the mindfulness group (effect size, beats per minute: -2.8, 95%CI: -5.4;-0.2, p = 0.033). No significant differences were seen on other outcomes.
Mindfulness training showed positive effects on the physiological parameters exercise capacity and heart rate and it might therefore be a useful adjunct to current clinical therapy in patients with heart disease.
Dutch Trial Register 3453.
Journal Article