BACKGROUND Guidelines recommend nonstatin lipid-lowering agents in patients at very high risk for major adverse cardiovascular events (MACE) if low-density lipoprotein cholesterol (LDL-C) remains ≥70 mg/dL on maximum tolerated statin treatment. It is uncertain if this approach benefits patients with LDL-C near 70 mg/dL. Lipoprotein(a) levels may influence residual risk. OBJECTIVES In a post hoc analysis of the ODYSSEY Outcomes (Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab) trial, the authors evaluated the benefit of adding the proprotein subtilisin/kexin type 9 inhibitor alirocumab to optimized statin treatment in patients with LDL-C levels near 70 mg/dL. Effects were evaluated according to concurrent lipoprotein(a) levels. METHODS ODYSSEY Outcomes compared alirocumab with placebo in 18,924 patients with recent acute coronary syndromes receiving optimized statin treatment. In 4,351 patients (23.0%), screening or randomization LDL-C was <70 mg/dL (median 69.4 mg/dL; interquartile range: 64.3–74.0 mg/dL); in 14,573 patients (77.0%), both determinations were ≥70 mg/dL (median 94.0 mg/dL; interquartile range: 83.2–111.0 mg/dL). RESULTS In the lower LDL-C subgroup, MACE rates were 4.2 and 3.1 per 100 patient-years among placebo-treated patients with baseline lipoprotein(a) greater than or less than or equal to the median (13.7 mg/dL). Corresponding adjusted treatment hazard ratios were 0.68 (95% confidence interval [Cl]: 0.52–0.90) and 1.11 (95% Cl: 0.83–1.49), with treatment-lipoprotein(a) interaction on MACE ( P interaction = 0.017). In the higher LDL-C subgroup, MACE rates were 4.7 and 3.8 per 100 patient-years among placebo-treated patients with lipoprotein(a) >13.7 mg/dL or ≤13.7 mg/dL; corresponding adjusted treatment hazard ratios were 0.82 (95% Cl: 0.72–0.92) and 0.89 (95% Cl: 0.75–1.06), with P interaction = 0.43. CONCLUSIONS In patients with recent acute coronary syndromes and LDL-C near 70 mg/dL on optimized statin therapy, proprotein subtilisin/kexin type 9 inhibition provides incremental clinical benefit only when lipoprotein(a) concentration is at least mildly elevated. (ODYSSEY Outcomes: Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab; NCT01663402 )
Bifocal RIGHT ventricular stimulation (BRIGHT) is an ongoing, randomized, single-blind, crossover study of atrial synchronized bi-right ventricular (RV) pacing in patients in New York Heart Association heart failure functional class III, a left ventricular ejection fraction <35%, left bundle branch block and QRS complexes >/=120 ms. This analysis compared the electrical and handling characteristics, and the complications of pacing at the RV apex (Ap) with passive, versus RV outflow tract (OT) with active fixation leads. A mean of 1.6 +/- 0.9 and 2.2 +/- 2.0 attempts were needed to position the Ap and OT leads, respectively (ns). R-wave amplitudes at Ap versus OT were 23 +/- 13 mV versus 14 +/- 8 mV (n = 36, P < 0.001). R-wave amplitudes at the Ap remained stable between implant and M7. R-wave amplitudes at the OT could not be measured after implantation. In two patients, atrioventricular block occurred during active fixation at the OT. Conduction recovered spontaneously within 4 months. Ventricular fibrillation was induced in one patient during manipulation of an Ap lead in the RV. Marked differences were found between leads positioned in the OT versus Ap, partly related to the difference in lead design. Mean R-wave amplitude was higher at the Ap that at the OT. Ease and success rate of lead implant was similar in both positions.
Bifocal RV pacing in patients with a classic indication for CRT shows improvement in all parameters.
pseudobipolar (LV tip -right ventricle (RV) ring or RV distal coil) and extended pseudobipolar (LV ring -RV ring or RV distal coil) configurations. In pacemaker devices, we also evaluated: unipolar (LV distal electrode -can) and extended unipolar (LV proximal electrode -can) pacing configurations. For each configuration we tested the LV pacing threshold, the diaphragmatic capture threshold and the pacing impedance. Results: we included 19 consecutive patients with advanced heart failure and left bundle branch block, they were 18 men, mean EF=23,14-8,2%, QRS=176,44-33,2 ms, NYHA=2,84-0,7, 47,4% with ischaemic and 31,6% with dilated cardiomyopathy. Twelve patients received an ICD resynchronization device. All leads are implanted in posterolateral vein. No failures of implant have been observed. Nominal bipolar pacing was not optimal in any patient. In ICD patients, the optimal pacing configuration was pseudobipolar in 9 and extended pseudobipolar in 3. In pacemaker patients, the optimal configuration was unipolar in 3, pseudobipolar in 2 and extended pseudobipolar in 2. The optimal pacing threshold was lower than the nominal bipolar (1,24-0,8 vs 2,34-1,6; p<0,001), reducing this parameter from 0,2 to 3V. One patient presented diaphragmatic stimulation that was resolved changing the left lead to pseudobipolar pacing, achieving safety margin enough between left ventricle and diaphragmatic capture thresholds. Conclusions: new configurations of pacing through left ventricle lead improved implant pacing parameters, avoiding in some cases the need to reposition. Generally, the optimal results were obtained with a pseudobipolar configuration. Background: cardiac resynchronization therapy (CRT) has shown to reverse left ventricular (LV) remodeling in patients with congestive heart failure (CHF), but its relationship with clinical response has not been assessed. The objective of this study was to analyze if patients who improve clinically have greater LV remodeling than those who do not respond (NR). Methods and results: forty-eight consecutive patients with end-stage CHF, left bundle branch block and LV ejection fraction (EF < 35%) treated with CRT were included. Echo-Doppler scans were taken just before and immediately after the implantation of the pacemaker, and at 6 month follow-up. We compared LV diameters, volumes and ejection fraction (EF) (obtained by M mode and Simpson's method). We considered responders those patients who improved by 10% or more in the 6 minutes walking test, did not die or need a heart transplantation during follow-up. Nine out of 48 patients (19%) did not respond to CRT. There were no differences in baseline LV dimensions between responders and NR. At follow-up, LV volumes and diameters decreased significantly in responders, but did not change in NR (graph Background: pacing and sensing parameters have been described in a general pacemaker population, but not in patients who received a pacemaker in the RV outflow tract (OT) for cardiac resynchronisation therapy (CRT). This study describes the ...
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