BackgroundAtrial fibrillation is associated with higher mortality. Identification of causes of death and contemporary risk factors for all‐cause mortality may guide interventions.Methods and ResultsIn the Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF) study, patients with nonvalvular atrial fibrillation were randomized to rivaroxaban or dose‐adjusted warfarin. Cox proportional hazards regression with backward elimination identified factors at randomization that were independently associated with all‐cause mortality in the 14 171 participants in the intention‐to‐treat population. The median age was 73 years, and the mean CHADS 2 score was 3.5. Over 1.9 years of median follow‐up, 1214 (8.6%) patients died. Kaplan–Meier mortality rates were 4.2% at 1 year and 8.9% at 2 years. The majority of classified deaths (1081) were cardiovascular (72%), whereas only 6% were nonhemorrhagic stroke or systemic embolism. No significant difference in all‐cause mortality was observed between the rivaroxaban and warfarin arms (P=0.15). Heart failure (hazard ratio 1.51, 95% CI 1.33–1.70, P<0.0001) and age ≥75 years (hazard ratio 1.69, 95% CI 1.51–1.90, P<0.0001) were associated with higher all‐cause mortality. Multiple additional characteristics were independently associated with higher mortality, with decreasing creatinine clearance, chronic obstructive pulmonary disease, male sex, peripheral vascular disease, and diabetes being among the most strongly associated (model C‐index 0.677).ConclusionsIn a large population of patients anticoagulated for nonvalvular atrial fibrillation, ≈7 in 10 deaths were cardiovascular, whereas <1 in 10 deaths were caused by nonhemorrhagic stroke or systemic embolism. Optimal prevention and treatment of heart failure, renal impairment, chronic obstructive pulmonary disease, and diabetes may improve survival.Clinical Trial Registration URL: https://www.clinicaltrials.gov/. Unique identifier: NCT00403767.
We report our initial experience with transcatheter closure of ventricular septal defects (VSD) using the Rashkind device. Transcatheter closure of 25 VSDs was attempted in 16 patients with a median age of 2 (range 0.1–4) years and a median weight of 11 (range 4.1–19) kg. The location of the VSDs was apical in 14, midmuscular in 8, and anterior muscular in 3. Five patients had complex heart lesions, 10 patients had associated defects, including perimembranous VSD, atrial septal defect, patent ductus arteriosus, and coarctation of aorta. The remaining patient had isolated multiple muscular VSDs. The surgical repair of VSDs was a high‐risk option in all the patients. Of the 25 attempted closures, 22 devices were placed successfully. Nine patients had a single device, four patients had two devices each and one patient had a total of five devices placed. In two patients attempts to close three VSDs were associated with major problems/death. Fourteen patients have been followed up for at least 1 year and all are doing well. Five patients, who otherwise remain asymptomatic, have a trace residual shunt. The fluoroscopy time ranged from 51 to 205 min (median 110) and the procedure time 120 to 300 min (median 200). The transcatheter closure of VSDs acts as a palliation as well as a definitive therapeutic modality in some patients with surgically inaccessible VSDs. Deployment of multiple devices in a patient is feasible. Increased experience may diminish the initial rate of complications. Cathet. Cardiovasc. Intervent. 46:43–48, 1999. © 1999 Wiley‐Liss, Inc.
The results obtained with this new device are encouraging and at least comparable to those of current balloon techniques. Multiple uses after sterilization should markedly decrease the procedural cost, a major advantage in countries with limited resources and high incidence of mitral stenosis.
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