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This study assessed the clinical utility and feasibility of concomitant of combined left atrial appendage (LAA) closure and positioning of miniaturized pacemaker (Micra TPS). All consecutive patients who underwent VVI-PM implant from November 2015 to October 2016 were considered. VVI-PM implant was conducted either using transvenous approach or by positioning Micra TPS. In selected patients with concomitant contraindication to OAC, Micra TPS was combined with LAA occlusion ("combined approach"), performed in general anesthesia and guided by multimodality imaging; procedural and follow-up data of these specific patients were registered. Sixty patients were treated with VVI-PM implant. Six patients (10.0%) presented OAC contraindication, of which 4 (6.7%) were eligible for the "combined procedure"; 2 of 4 of these patients presented chronic hemodialysis-dependent renal failure. The combined approach was successful in all 4 patients without intra- or periprocedural complications. No adverse events linked to the combined approach occurred during mid-term follow-up (7.5, interquartile range 5.0 to 7.9 months). In conclusion, VVI-PM indication and concomitant contraindication to OAC is not uncommon; in selected patients, combined LAA closure and positioning of Micra TPS may be a feasible therapeutic option.

This report describes the 12-month outcomes of the a prospective, multicenter, nonrandomized post-approval study of the MitraClip therapy in Europe (ACCESS-EU postapproval study of MitraClip therapy) with respect to preprocedural left ventricular ejection fraction (LVEF). Transcatheter deployment of the MitraClip device may be considered for patients who are not suitable for conventional surgery. A total of 567 patients with significant mitral regurgitation (MR) underwent MitraClip therapy. Of those, 393 had functional MR (FMR) and were subdivided by preprocedural LVEF (A: 10% to 20%, B:20% to 30%, C:30% to 40%, D:40%). Procedural safety and efficacy and treatment outcomes including MR grade, New York Heart Association (NYHA) functional class, 6-minute walk test, and the Minnesota Living with Heart Failure Questionnaire were analyzed at baseline, 30 days, and 12 months. Baseline mean logistic EuroSCORE was 25 ± 19; 87% of patients were in NYHA classes III or IV (A: 96%, B: 83%, C: 90%, D: 86%). There was no incidence of death or stroke intraprocedurally. Eleven patients died within 30 days with no differences among subgroups. Kaplan-Meier survival at 12 months was 81.8% (A: 71%, B: 79%, C: 87%, D: 86%). There was a significant improvement in MR severity at 30 days and 12 months (p0.0001). At 12 months, all subgroups experienced similar improvements in NYHA class, 6-minute walk test, and Minnesota Living with Heart Failure Questionnaire. This real-world registry reports promising results of MitraClip therapy in patients with FMR. In conclusion, the low rates of hospital mortality and adverse events in patients with FMR-even in patients with severely reduced LVEF-provide additional evidence of substantial benefits after MitraClip implantation.

Prevalence of echocardiographically assessed mechanical dyssynchrony and consistency in detection of the latest mechanical left ventricular (LV) contracting region when different echocardiographic methods are used in the same patient remains ill-defined. The objectives of this study were to evaluate (1) the prevalence of intraventricular mechanical dyssynchrony and (2) consistency of latest mechanical LV contraction using a multiparametric approach derived from tissue Doppler imaging (TDI), 3-dimensional (3D) echocardiography, and speckle tracking in patients scheduled for cardiac resynchronization therapy (CRT). In 63 patients with heart failure scheduled for CRT, 2D echocardiography, TDI, 3D echocardiography, and speckle tracking were prospectively collected and analyzed. Prevalence of dyssynchrony was low for some tissue-velocity derived indexes (11%, 13%, and 43%) but wasor=80% for strain derived by TDI, for systolic dyssynchrony index by 3D echocardiography, and for longitudinal and radial strains by speckle tracking. Prevalence of dyssynchrony was 69% for maximum delay between anteroseptal and posterolateral walls by radial strain. Agreement among dyssynchrony indexes was generally low (kappa -0.02). Agreement of each of these echocardiographic indexes in determining, in the same patient with heart failure, the latest LV mechanical contraction site was also low (no site agreement in 77%). In conclusion, in a typical CRT population there is considerable variability among various techniques that assess prevalence of mechanical dyssynchrony and in identification of the latest mechanical LV contracting region.

Definition and validation of the ranges of normal values and agreement among echocardiographic measures of mechanical synchrony in healthy subjects are mostly lacking. The aims of this study were (1) to assess the ranges of normal values for 5 tissue Doppler imaging parameters, real-time 3-dimensional echocardiographic measures, and speckle-tracking measures of mechanical synchrony; (2) to evaluate interinstitutional variability; (3) to compare the ranges of normal values with those reported in previous research; and (4) to analyze the agreement among all parameters in the same healthy subject. Time to peak systolic velocity (Ts), the delay between Ts at the basal septal and lateral segments, peak velocity difference, strain derived by tissue Doppler imaging, Ts derived by tissue synchronization imaging, systolic synchrony index (SSI) derived by real-time 3-dimensional echocardiography, and longitudinal and radial strain derived by speckle tracking were prospectively collected and analyzed at 2 different institutions in 160 consecutive healthy subjects. The ranges of normal values, expressed as means ± 2 SDs, were 30.32 ± 29.36 ms for the SD of Ts, 15.51 ± 99.88 ms for septal-lateral delay, 60.75 ± 81.62 ms for peak velocity difference, 33.07 ± 29.96 ms for tissue synchronization imaging, 34.16 ± 23.26 ms for the SD of strain, 2.74 ± 2.16% for SSI, 28.91 ± 23.02 ms for the SD of longitudinal strain, and 10.4 ± 6.31 ms for radial strain. There was large interinstitutional variability for all parameters. Three-dimensional SSI and radial strain were within the published upper range limit for healthy subjects. Ninety percent of healthy subjects were consistently classified to be synchronous by 1 parameter. With a composite index, more subjects than expected showed dyssynchrony (10% vs 2.5%). In conclusion, 3-dimensional SSI and radial strain were the most reproducible parameters and consistently discriminated normal healthy subjects from the cardiac resynchronization therapy volume responders.

The accuracy of the logistic EuroSCORE (logES), a widely used risk prediction algorithm for cardiac surgery including aortic valve surgery, usually overestimates observed perioperative mortality. Elevated brain natriuretic peptide (BNP) in symptomatic patients with aortic stenosis (AS) is associated with a poor short-term outcome after aortic valve replacement. We aimed to compare BNP with the logES for predicting short- and long-term outcome in symptomatic patients with severe AS undergoing aortic valve replacement. We prospectively studied 144 consecutive patients referred for aortic valve replacement (42% women, 73 +/- 9 years, mean aortic gradient 51 +/- 18 mm Hg, and left ventricular ejection fraction 61 +/- 11%) undergoing either isolated aortic valve replacement (58%) or combined to bypass grafting. Both plasma BNP and logES was estimated before surgery. The median BNP plasma level and logES were 157 pg/ml (interquartile range [IQR] 61 to 440) and 6.6% (IQR 4.2 to 12.2), respectively. The perioperative mortality was 6% and the overall mortality by the end of the study was 13%. Patients with logES >10.1% (upper tertile) had a higher risk of dying over time (hazard ratio [HR] 2.86, p = 0.037), as had patients with BNP >312 pg/ml (HR 9.01, p

The purpose of this study was to determine the feasibility of multislice computed tomography (MSCT) to assess the coronary sinus (CS) and its tributaries in patients who are undergoing cardiac resynchronization therapy and need a left ventricular (LV) lead revision. Preprocedural imaging modality, which may enable delineation of the cardiac venous anatomy in patients who need LV lead replacement, has not yet been evaluated. Ten patients with heart failure with previously implanted cardiac resynchronization therapy devices, who presented with worsening heart failure, were studied with MSCT and tissue Doppler imaging echocardiography before LV lead replacement. MSCT was performed to evaluate patency of the CS and coronary veins, and tissue Doppler imaging echocardiography assessed the region and the magnitude of mechanical dyssynchrony. An excellent concordance in the vein diameter, location, and status between MSCT and angiography was found. Apart from the need to perform a venoplasty in 1 patient and an unsuccessful lead explantation in another patient, all other anatomic issues were correctly predicted by MSCT. CS or vein occlusion were present in 4 patients, and in 3 of them surgical LV lead replacement was performed. Identification of a patent venous system enabling successful transvenous lead implantation was possible in 2 patients. Direct visualization of the proximity of the target vein to the phrenic nerve and the diaphragm guided lead selection and position in 4 patients. In conclusion, MSCT may be used to delineate the coronary venous anatomy in patients in whom LV lead replacement is needed to help strategize whether a transvenous or transthoracic approach may be preferred for LV lead revision.

Patients at risk of coronary heart disease may not achieve recommended low-density lipoprotein (LDL) cholesterol goals on statin monotherapy. This study was designed to investigate the efficacy and safety of rosuvastatin 40 mg alone or in combination with ezetimibe 10 mg in patients at high risk of coronary heart disease. Four hundred sixty-nine patients were randomly assigned to rosuvastatin alone or in combination with ezetimibe for 6 weeks. The primary end point was the percentage of patients achieving the Adult Treatment Panel III (ATP III) LDL cholesterol goal (

Novel high-sensitivity assay can detect very low levels of circulating cardiac troponin (hs-cTnT) in apparently healthy subjects. Within normal range, higher levels are associated with coronary artery disease (CAD) and cardiac abnormalities commonly associated to traditional risk factors (RFs) for CAD. Therefore, we investigated the relation between circulating hs-cTnT and CAD in patients with a spectrum of RF burden aiming to assess the added value of hs-cTnT to identify "outlier" patients with CAD despite a low RF burden. Hs-cTnT was measured in 525 stable patients without previous diagnosis of ischemic heart disease with 0 to 1 RF, excluded diabetes, (low-RF group, n = 263) or ≥2 RFs (multiple-RF group, n = 262) and without CAD (segment involvement score = 0) or diffuse CAD (segment involvement score5) at coronary computed tomography angiography. Outlier patients with diffuse CAD despite low-RF burden had similar extent, severity, and plaque composition than patients with multiple RFs. Overall, hs-cTnT was measurable in 81% of patients with median value of 6.0 ng/L. In both groups, hs-cTnT concentration was higher in patients with CAD than in patients with normal coronary arteries (p0.0001). Hs-cTnT was more accurate to detect patients with CAD in the low-RF group than in the multiple-RF group (p = 0.04). In multivariate analysis, higher level of hs-cTnT (6 ng/L) was independently associated with CAD in low-RF group only. Despite very low circulating concentrations, hs-cTnT may identify with a good accuracy the outlier patients with diffuse CAD despite low-RF burden.

Definition and validation of the ranges of normal values and agreement among echocardiographic measures of mechanical synchrony in healthy subjects are mostly lacking. The aims of this study were (1) to assess the ranges of normal values for 5 tissue Doppler imaging parameters, real-time 3-dimensional echocardiographic measures, and speckle-tracking measures of mechanical synchrony; (2) to evaluate interinstitutional variability; (3) to compare the ranges of normal values with those reported in previous research; and (4) to analyze the agreement among all parameters in the same healthy subject. Time to peak systolic velocity (Ts), the delay between Ts at the basal septal and lateral segments, peak velocity difference, strain derived by tissue Doppler imaging, Ts derived by tissue synchronization imaging, systolic synchrony index (SSI) derived by real-time 3-dimensional echocardiography, and longitudinal and radial strain derived by speckle tracking were prospectively collected and analyzed at 2 different institutions in 160 consecutive healthy subjects. The ranges of normal values, expressed as means +/- 2 SDs, were 30.32 +/- 29.36 ms for the SD of Ts, 15.51 +/- 99.88 ms for septal-lateral delay, 60.75 +/- 81.62 ms for peak velocity difference, 33.07 +/- 29.96 ms for tissue synchronization imaging, 34.16 +/- 23.26 ms for the SD of strain, 2.74 +/- 2.16% for SSI, 28.91 +/- 23.02 ms for the SD of longitudinal strain, and 10.4 +/- 6.31 ms for radial strain. There was large interinstitutional variability for all parameters. Three-dimensional SSI and radial strain were within the published upper range limit for healthy subjects. Ninety percent of healthy subjects were consistently classified to be synchronous by 1 parameter. With a composite index, more subjects than expected showed dyssynchrony (10% vs 2.5%). In conclusion, 3-dimensional SSI and radial strain were the most reproducible parameters and consistently discriminated normal healthy subjects from the cardiac resynchronization therapy volume responders.