97 research outputs found

    Echocardiographic Evidence for Valvular Toxicity of Benfluorex: A Double-Blind Randomised Trial in Patients with Type 2 Diabetes Mellitus

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    OBJECTIVES: REGULATE trial was designed to compare the efficacy and safety of benfluorex versus pioglitazone in type 2 diabetes mellitus (DM) patients. METHODS: Double-blind, parallel-group, international, randomised, non-inferiority trial. More than half of the 196 participating centres were primary care centres. Patients eligible had type 2 DM uncontrolled on sulfonylurea. 846 were randomised. They received study treatment for 1 year. 423 patients were allocated to benfluorex (150 to 450 mg/day) and 423 were allocated to pioglitazone (30 to 45 mg/day). Primary efficacy criterion was HbA(1c). Safety assessment included blinded echocardiographic evaluation of cardiac and valvular status. RESULTS: At baseline, patients were 59.1 ± 10.5 years old with HbA1c 8.3 ± 0.8%, and DM duration 7.1 ± 6.0 years. During the study, mean HbA1c significantly decreased in both groups (benfluorex: from 8.30 ± 0.80 to 7.77 ± 1.31 versus pioglitazone: from 8.30 ± 0.80 to 7.45 ± 1.30%). The last HbA1c value was significantly lower with pioglitazone than with benfluorex (p<0.001) and non-inferiority of benfluorex was not confirmed (p = 0.19). Among the 615 patients with assessable paired echocardiography (310 benfluorex, 305 pioglitazone), 314 (51%) had at least one morphological valvular abnormality and 515 (84%) at least one functional valvular abnormality at baseline. Emergent morphological abnormalities occurred in 8 patients with benfluorex versus 4 with pioglitazone (OR 1.99), 95% CI (0.59 to 6.69). Emergent regurgitation (new or increased by one grade or more) occurred more frequently with benfluorex (82 patients, 27%) than with pioglitazone (33 patients, 11%) (OR 2.97), 95% CI (1.91 to 4.63) and were mainly rated grade 1; grade 2 (mild) was detected in 2 patients with benfluorex and 3 with pioglitazone. There was no moderate or severe regurgitation. CONCLUSION: After 1 year of exposure, our results show a 2.97 fold increase in the incidence of valvular regurgitation with benfluorex and provide evidence for the valvular toxicity of this drug

    Effect of Cyclosporine on Left Ventricular Remodeling After Reperfused Myocardial Infarction

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    ObjectivesThis study examined the effect of a single dose of cyclosporine administered at the time of reperfusion on left ventricular (LV) remodeling and function by cardiac magnetic resonance 5 days and 6 months after myocardial infarction.BackgroundIn a human study, administration of cyclosporine at the time of acute reperfusion was associated with a smaller infarct size.MethodsTwenty-eight patients of the original cyclosporine study had an acute (at 5 days) and a follow-up (at 6 months) cardiac magnetic resonance study to determine LV volumes, mass, ejection fraction, myocardial wall thickness in infarcted and remote noninfarcted myocardium, and infarct size.ResultsThere was a persistent reduction in infarct size at 6 months in the cyclosporine group compared with the control group of patients (29 ± 15 g vs. 38 ± 14 g; p = 0.04). There was a significant reduction of LV end-systolic volume (and a trend for LV end-diastolic volume; p = 0.07) in the cyclosporine group compared with the control group, both at 5 days and 6 months after infarction. There was no significant difference between the 2 groups in either global LV mass or regional wall thickness of the remote noninfarcted myocardium at 5 days or 6 months. Attenuation of LV dilation and improvement of LV ejection fraction by cyclosporine at 6 months were correlated with infarct size reduction.ConclusionsCyclosporine used at the moment of acute myocardial infarction reperfusion persistently reduces infarct size and does not have a detrimental effect on LV remodeling. These results are preliminary and must be supported by further studies. (Ciclosporin A and Acute Myocardial Infarction; NCT00403728

    Impact of cardiac resynchronization therapy optimization inside a heart failure programme : a real‐world experience

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    Aims: This study sought to describe and evaluate the impact of a routine in‐hospital cardiac resynchronization therapy (CRT) programme, including comprehensive heart failure (HF) evaluation and systematic echo‐guided CRT optimization. Methods and results: CRT implanted patients were referred for optimization programme at 3 to 12 months from implantation. The program included clinical and biological status, standardized screening for potential cause of CRT non‐response and systematic echo‐guided atrioventricular and interventricular delays (AVd and VVd) optimization. Initial CRT‐response and improvement at 6 months post‐optimization were assessed with a clinical composite score (CCS). Major HF events were tracked during 1 year after optimization. A total of 227 patients were referred for CRT optimization and enrolled (71 ± 11 years old, 77% male, LVEF 30.6 ± 7.9%), of whom 111 (48.9%) were classified as initial non‐responders. Left ventricular lead dislodgement was noted in 4 patients (1.8%), and loss or ≤90% biventricular capture in 22 (9.7%), mostly due to arrhythmias. Of the 196 patients (86%) who could undergo echo‐guided CRT optimization, 71 (36.2%) required VVd modification and 50/144 (34.7%) AVd modification. At 6 months post‐optimization, 34.3% of the initial non‐responders were improved according to the CCS, but neither AVd nor VVd echo‐guided modification was significantly associated with CCS‐improvement. After one‐year follow‐up, initial non‐responders maintained a higher rate of major HF events than initial responders, with no significant difference between AVd/VVd modified or not. Conclusions: Our study supports the necessity of a close, comprehensive and multidisciplinary follow‐up of CRT patients, without arguing for routine use of echo‐guided CRT optimization

    Patent Foramen Ovale Closure or Anticoagulation vs. Antiplatelets after Stroke

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    BACKGROUND Trials of patent foramen ovale (PFO) closure to prevent recurrent stroke have been inconclusive. We investigated whether patients with cryptogenic stroke and echocardiographic features representing risk of stroke would benefit from PFO closure or anticoagulation, as compared with antiplatelet therapy. METHODS In a multicenter, randomized, open-label trial, we assigned, in a 1:1:1 ratio, patients 16 to 60 years of age who had had a recent stroke attributed to PFO, with an associated atrial septal aneurysm or large interatrial shunt, to transcatheter PFO closure plus long-term antiplatelet therapy (PFO closure group), antiplatelet therapy alone (antiplatelet-only group), or oral anticoagulation (anticoagulation group) (randomization group 1). Patients with contraindications to anticoagulants or to PFO closure were randomly assigned to the alternative noncontraindicated treatment or to antiplatelet therapy (randomization groups 2 and 3). The primary outcome was occurrence of stroke. The comparison of PFO closure plus antiplatelet therapy with antiplatelet therapy alone was performed with combined data from randomization groups 1 and 2, and the comparison of oral anticoagulation with antiplatelet therapy alone was performed with combined data from randomization groups 1 and 3. RESULTS A total of 663 patients underwent randomization and were followed for a mean (+/- SD) of 5.3 +/- 2.0 years. In the analysis of randomization groups 1 and 2, no stroke occurred among the 238 patients in the PFO closure group, whereas stroke occurred in 14 of the 235 patients in the antiplatelet-only group (hazard ratio, 0.03; 95% confidence interval, 0 to 0.26; P&lt;0.001). Procedural complications from PFO closure occurred in 14 patients (5.9%). The rate of atrial fibrillation was higher in the PFO closure group than in the antiplatelet-only group (4.6% vs. 0.9%, P = 0.02). The number of serious adverse events did not differ significantly between the treatment groups (P = 0.56). In the analysis of randomization groups 1 and 3, stroke occurred in 3 of 187 patients assigned to oral anticoagulants and in 7 of 174 patients assigned to antiplatelet therapy alone. CONCLUSIONS Among patients who had had a recent cryptogenic stroke attributed to PFO with an associated atrial septal aneurysm or large interatrial shunt, the rate of stroke recurrence was lower among those assigned to PFO closure combined with antiplatelet therapy than among those assigned to antiplatelet therapy alone. PFO closure was associated with an increased risk of atrial fibrillation

    Right-to-left shunt with hypoxemia in pulmonary hypertension

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    <p>Abstract</p> <p>Background</p> <p>Hypoxemia is common in pulmonary hypertension (PH) and may be partly related to ventilation/perfusion mismatch, low diffusion capacity, low cardiac output, and/or right-to-left (RL) shunting.</p> <p>Methods</p> <p>To determine whether true RL shunting causing hypoxemia is caused by intracardiac shunting, as classically considered, a retrospective single center study was conducted in consecutive patients with precapillary PH, with hypoxemia at rest (PaO<sub>2 </sub>< 10 kPa), shunt fraction (Qs/Qt) greater than 5%, elevated alveolar-arterial difference of PO<sub>2 </sub>(AaPO<sub>2</sub>), and with transthoracic contrast echocardiography performed within 3 months.</p> <p>Results</p> <p>Among 263 patients with precapillary PH, 34 patients were included: pulmonary arterial hypertension, 21%; PH associated with lung disease, 47% (chronic obstructive pulmonary disease, 23%; interstitial lung disease, 9%; other, 15%); chronic thromboembolic PH, 26%; miscellaneous causes, 6%. Mean pulmonary artery pressure, cardiac index, and pulmonary vascular resistance were 45.8 ± 10.8 mmHg, 2.2 ± 0.6 L/min/m<sup>2</sup>, and 469 ± 275 dyn.s.cm<sup>-5</sup>, respectively. PaO<sub>2 </sub>in room air was 6.8 ± 1.3 kPa. Qs/Qt was 10.2 ± 4.2%. AaPO<sub>2 </sub>under 100% oxygen was 32.5 ± 12.4 kPa. Positive contrast was present at transthoracic contrast echocardiography in 6/34 (18%) of patients, including only 4/34 (12%) with intracardiac RL shunting. Qs/Qt did not correlate with hemodynamic parameters. Patients' characteristics did not differ according to the result of contrast echocardiography.</p> <p>Conclusion</p> <p>When present in patients with precapillary PH, RL shunting is usually not related to reopening of patent <it>foramen ovale</it>, whatever the etiology of PH.</p

    Facteurs pronostiques de l'insuffisance cardiaque (intérêt du Doppler tissulaire myocardique dans les cardiomyopathies dilatées non ischémiques)

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    ROUEN-BU Médecine-Pharmacie (765402102) / SudocPARIS-BIUM (751062103) / SudocSudocFranceF

    Analyse quantitative de l'extension transmurale de la nécrose myocardique par Doppler tissulaire myocardique (comparaison avec l'imagerie par résonance magnétique nucléaire et la tomoscintigraphie myocardique)

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    Parmi les facteurs pronostiques d'un infarctus, l'identification de myocarde viable est un paramètre crucial. C'est dire l'importance des méthodes en permettant la détection. Les outils validés sont les méthodes isotopiques (scintigraphie myocardique monophotonique et par émission de positons ), l'échocardiographie sous perfusion de dobutamine et l'imagerie par résonance magnétique. Cependant, la faible disponibilité de certains équipements justifient le développement d'outils non invasifs de quantification de la fonction myocardique régionale, aisément accessibles au lit du malade, fiables et reproductibles. Récemment, L'équipe du CHU de Rouen avait évalué la précision du Doppler + Tissulaire myocardique (DTI) dans la quantification de l'extension transmurale de la nécrose en confrontant les données échographiques et histologiques dans un modèle j expérimental de nécrose myocardique clique. Le DTT avait permis de différencier I une nécrose transmurale d'une nécrose non transmurale. Dans notre étude chez 30 patients à l'aide de la comparaison de référence de la fonction et de la perfusion myocardique évaluées à la scintigraphie myocardique et à l'IRM cardiaque, nous constatons que le strain myocardique en DTI permet de discriminer en présence d'une paroi hypokinétique ou akinétique une nécrose myocardique transmurale d'une nécrose myocardique non transmurale. Son avantage est son innocuité et son faible coût. Elle peut être réalisée au lit du patient. Notre étude est la première réalisée à la phase précoce d'un infarctus du myocardeROUEN-BU Médecine-Pharmacie (765402102) / SudocPARIS-BIUM (751062103) / SudocSudocFranceF

    Apport de l'échocardiographie speckle-tracking 3-dimensions dans la prédiction du remodelage ventriculaire gauche post-infarctus

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    Objectif: Le but de cette étude est de préciser l'intérêt des paramètres obtenus en échocardiographie speckle-tràcking et notamment de l'area strain, pour prédire une amélioration de la fonction systolique et le remodelage du ventricule gauche à 6 mois d'une nécrose myocardique. Méthodes : 45 patients (84.4% hommes, 58.1 ans) admis en USIC pour primoinfarctus ont été examinés par échocardiographie 3D. Les strains globaux et segmentaires 3D ont été mesurés, associés aux paramètres habituels d'échocardiographie. A 6 mois de suivi, l'amélioration de la fonction systolique globale était définie par une augmentation de plus de 5% de la fraction d'éjection. Le remodelage myocardique était défini par une augmentation de plus de 15% du volume télé-diastolique du ventricule gauche. Résultats : Il existait une amélioration significative de tous les paramètres échographiques à 6 mois avec une augmentation de la fraction d'éjection (59+/-3% vs. 50+/-3%, p<0.0001), des VTDVG 3D (110+/-15ml vs. 91+/-7ml, p<0.0001). Le WMSI avait diminué à 6 mois (1.4+/-0. fvs. 1.6+/-0.1, p<0.0001). L'amélioration était précoce avec une augmentation significative à 30 jours de la FEVG, WMSI, GAS, 3D GLS. La moitié de la population a présenté un remodelage ventriculaire gauche à 6 mois, préférentiellement ceux dont la fraction d'éjection initiale était plus altérée (46+/-4% vs. 53+/-4%, p=0.02). Le GAS initial était également significativement plus bas dans le groupe remodeleur (-30.4+/-3.9% vs. -35.4+/-3.5%, p=0.05). Le paramètre échographique le plus prédictif du remodelage ventriculaire gauche était la FEVG avec une sensibilité de 57%, et une spécificité de 91% pour un seuil à 46% (AUC=0.7 [0.54-0.85]. Seul le GAS avait une valeur prédictive équivalente avec une aire sous la courbe de 0.67 [0.48-0.81]. Conclusion : Notre étude corrobore les travaux actuels sur l'intérêt et la fiabilité de du 3D speckle-tracking dans l'évaluation des dommages myocardiques après un infarctus. Nous n'avons cependant pas mis en évidence de supériorité de cette technique par rapport aux paramètres habituels pour la prédiction du remodelage et de l'amélioration de la fonction systolique ventriculaire gauche. Une étude sur une plus grande cohorte serait nécessaire pour valider nos résultats.LYON1-BU Santé (693882101) / SudocSudocFranceF
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