ObjectivesDabigatran 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.MethodsWe 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.ResultsThe 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.ConclusionsThe use of dabigatran appears to be similar to warfarin in preventing the formation of intracardiac thrombus.Trial RegistrationClinicaltrials.gov NCT01868243.
This article describes the development and operation of the Integrated Regional STEMI Network in Salvador, Bahia, Brazil, and defines its basic components. Moreover, we present a preliminary STEMI registry, including patients' demographics, clinical, interval times, and primary reperfusion © 2012 American Heart Association, Inc. Background-Regionalized integrated networks for ST-segment-elevation myocardial infarction (STEMI) care have been proposed as a step forward in overcoming real-world obstacles, but data are lacking on its performance in developing countries. We describe an integrated regional STEMI network in Salvador, Bahia, Brazil.Methods and Results-The network was created in 2009. It was coordinated by the prehospital emergency medical service and encompassed the public emergency system (prehospital mobile units, community-based emergency units, general hospitals, and cardiology reference centers). The 12-lead ECGs are interpreted via telemedicine. This network operates as follows: The Telemedicine Center sends each ECG suggestive of STEMI to a Regional STEMI Alert Team, which, together with emergency medical services, offers support for thrombolysis or immediate transfer for primary percutaneous coronary intervention. In 14 months, there were 433 suspected victims, of which in 287 (76.5%) the STEMI could be confirmed (age, 62.1±12.5 years; 63.4% men). Most of them were self-transported. The median pain-to-admission time was 180 minutes (interquartile range, 90-473 minutes), and the median admission-to-ECG time was 159.5 minutes (interquartile range, 83.5-340 minutes). The median interval time between the ECG and the telemedicine report was 31 minutes (interquartile range, 21-44 minutes). For those who sought medical attention and had an ECG performed within 12 hours after symptoms onset (n=119), the reperfusion rate was 75.6% (34.4% by thrombolysis and 65.6% by primary percutaneous coronary intervention).Conclusions-Regional STEMI networks may be feasible in developing countries. Preliminary results showed this network to be effective, achieving primary reperfusion rates comparable with those reported internationally despite the obstacles faced.(Circ Cardiovasc Qual Outcomes. 2013;6:9-17.)
Aims Cardiac resynchronization therapy (CRT) in appropriately selected patients with heart failure improves symptoms and survival. It is necessary to correctly identify patients who will benefit most from this therapy. We aimed to assess the predictive power of the multidisciplinary team's clinical judgement in the short‐term death after CRT implantation. Methods and results Patients with heart failure and referred for the first CRT implant were prospectively included. Prior to implantation, all patients underwent a systematic assessment with a team composed of social work, nurse, psychologist, nutritionist, and clinical cardiologist. Based on this assessment, patients could be contraindicated to CRT or referred to the procedure as favourable or unfavourable. All patients should complete 12 months of follow‐up; 172 patients were referred for CRT, 21 (12.2%) were contraindicated after the multidisciplinary team evaluation, 71 (47%) referred to CRT as non‐favourable implants, and 80 (53%) as favourable implants. All‐cause mortality occurred in only 2 (2.5%) patients in the favourable group and in 30 (42.3%) in the non‐favourable group, P < 0.001 (log rank). Among the 20 variables used as possible predictors of worse prognosis by the multidisciplinary team, four were independently associated with mortality in the follow‐up after the multivariate analysis: 1 year MAGGIC score between 40% and 49%, relative risk (RR) 5.0, 95% confidence interval (CI) 1.3–18.6, P = 0.016; poor pharmacological adherence, RR 4.9, 95% CI 1.6–15.6, P = 0.007; glomerular filtration rate <35 mL/min/1.73 m2, RR 3.0, 95% CI 1.1–8.5, P = 0.041; and right ventricular dysfunction, RR 2.6, 95% CI 1.2–5.7, P = 0.018. Conclusions The clinical judgement before the CRT implantation performed by a multidisciplinary team through the analysis of clinical and psychosocial variables is a strong predictor of short‐term mortality.
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