RESUMEN
BACKGROUND: In a prospective epidemiological study of chronic Chagas' disease, several clinical and echocardiographic variables were analyzed as predictors of mortality. METHODS: Among 960 subjects seropositive for Chagas' disease who were examined between June 1981 and June 1992, 283 had echocardiograms. RESULTS: During a mean follow-up period of 48.3 +/- 36.4 months (range, 1-156 months), 108 subjects died. Echocardiographic end-diastolic and -systolic left ventricular internal dimensions, fractional shortening, radius-to-thickness ratio, left ventricular mass, mitral E-point septal separation, and 17 other nonechocardiographic variables were predictors of death on univariate analysis (P < 0.001 for each). On stepwise multiple regression analysis of 215 subjects, significant risk covariates in a Cox model analysis were clinical group (P < 0.0001), M-mode echocardiographic E-point septal separation of 22 mm (P = 0.003), presence of first- or second-degree heart block (P = 0.003), chest radiologic cardiothoracic ratio >/= 0.55 (P = 0.012), presence of electrocardiographic ST segment elevation on precordial leads (P = 0.014), age >/= 56 years (P = 0.028), and presence of right bundle-branch block (P = 0.045). Patients with an apical aneurysm on two-dimensional echocardiography had an increased mortality (Chi-square = 11.5, P < 0.001). CONCLUSIONS: Echocardiography is a valuable tool to assess the risk of death in prospective studies on chronic Chagas' heart disease.
RESUMEN
BACKGROUND: Multiple percutaneous therapies for the treatment of functional and ischemic mitral regurgitation (FMR/IMR) are under development. We previously reported a novel percutaneous technique, the percutaneous septal sinus shortening [PS(3)] System which was effective in ameliorating FMR in an animal model. We herein report results from the first-in-human safety and feasibility pilot study involving the PS(3) System. METHODS AND RESULTS: The primary objective of this first-in-human study was to evaluate the safety and feasibility of acute percutaneous septal-lateral shortening by using the PS(3) System in patients immediately prior to clinically-indicated surgical mitral valve repair. Two patients were enrolled. Patient One had severe aortic insufficiency with moderate functional mitral regurgitation. The PS(3) System reduced the MR grade from 2+ to 1+ with a decrease in the mean septal-lateral systolic (SLS) dimension from 38 to 27 mm (29% reduction). Patient Two had severe ischemic mitral regurgitation in the setting of severe multi-vessel disease and prior infero-posterior infarct. MR grade was reduced from 3+ to 1+ with a decrease in the mean SLS dimension from 36 to 25mm (31% reduction). There were no procedural complications and both patients proceeded to pre-planned cardiac surgery, where the devices were explanted under direct visualization. CONCLUSIONS: The PS(3) System has been safely translated from the preclinical setting to first-in-human implantation. Both patients studied experienced a reduction in MR after device implantation, with significant SLS shortening. Further clinical trials will be needed to assess long-term efficacy and durability.