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Background: Left ventricular (LV) unloading via the percutaneous micro-axial Impella pump is increasingly used in patients with anterior ST-segment elevation myocardial infarction (STEMI) and overt cardiogenic shock. In this context, the evolution of cardiac function and dimensions beyond hospital discharge remains uncertain. We aimed to characterize echocardiographic changes over time in patients with acute anterior STEMI treated with an Impella device. Methods: From an ongoing prospective registry, consecutive patients with acute anterior STEMI managed with an Impella device were extracted. Transthoracic echocardiography was performed at index hospitalization and at first outpatient follow-up. Predictors of response, defined as a ≥ 10% absolute increase in left ventricular ejection fraction (LVEF) at follow-up, were sought. Results: A total of 66 patients (89.4% male, aged 64.3 ± 11.6 years) with anterior STEMI were treated with an Impella device in the first 24 hours of hospitalization, from 2014 to 2022. In-hospital mortality was 24%. Major bleeding and vascular complications requiring surgery occurred in 24% and 11% of patients, respectively. At baseline, mean LVEF was 34% ±12%. At follow-up, survivors showed a significant increase in LVEF (P < 0.0001), whereas LV dimensions, diastolic parameters, and measures of right ventricular dimension and function remained stable. Overall, 28 patients had a ≥ 10% absolute increase in LVEF at follow-up. Baseline creatinine was the only significant predictor of response at univariate analysis. Conclusions: Among patients with anterior STEMI requiring mechanical hemodynamic support with an Impella device, the majority of survivors showed a sustained increase in LV function, without evidence of adverse remodelling. This signal warrants further investigation in dedicated trials.
Contexte: La décharge du ventricule gauche (VG) à l'aide de la pompe microaxiale percutanée Impella est de plus en plus employée chez les patients qui présentent un infarctus du myocarde avec élévation du segment ST (STEMI) et un choc cardiogénique manifeste. Dans ce contexte, l'évolution de la fonction et des dimensions cardiaques après le congé de l'hôpital demeure incertaine. Nous avons cherché à caractériser les variations des paramètres échocardiographiques au fil du temps chez les patients ayant subi un STEMI antérieur aigu traités au moyen d'un dispositif Impella. Méthodologie: À partir d'un registre prospectif actif, nous avons extrait les dossiers de patients consécutifs ayant subi un STEMI antérieur aigu et pris en charge au moyen d'un dispositif Impella. Une échocardiographie transthoracique a été effectuée durant l'hospitalisation de référence puis à la première visite de suivi ambulatoire. Les facteurs prédictifs de la réponse, définis comme une augmentation absolue ≥ 10 % de la fraction d'éjection ventriculaire gauche (FEVG) au moment du suivi, ont été recherchés. Résultats: Au total, 66 patients (89,4 % d'hommes, âgés de 64,3 ± 11,6 ans) ayant subi un STEMI antérieur ont été traités au moyen d'un dispositif Impella pendant les 24 premières heures de l'hospitalisation, entre 2014 et 2022. Le taux de mortalité hospitalière était de 24 %. Des hémorragies majeures et des complications vasculaires ayant nécessité une intervention chirurgicale sont survenues chez 24 % et 11 % des patients, respectivement. Au début de l'étude, la FEVG moyenne était de 34 % ± 12 %. Lors du suivi, les survivants affichaient une augmentation significative de la FEVG (p < 0,0001), alors que les dimensions du VG, les paramètres diastoliques et les mesures de la taille et de la fonction du ventricule droit étaient demeurés stables. Globalement, 28 patients affichaient une augmentation absolue de la FEVG ≥ 10 % lors du suivi. D'après l'analyse univariée, la créatininémie initiale était le seul facteur prédictif important de la réponse. Conclusions: Parmi les patients ayant subi un STEMI antérieur nécessitant un support mécanique hémodynamique au moyen d'un dispositif Impella, une augmentation durable de la fonction ventriculaire gauche, sans signe de remodelage indésirable, a été observée chez la majorité des survivants. Ce signal justifie une évaluation plus approfondie dans le cadre d'essais cliniques conçus à cet effet.
RESUMO
BACKGROUND: The BALLET study was an open-label, multicenter, expanded access study designed to allow treatment with everolimus plus exemestane in postmenopausal women with hormone receptor-positive metastatic breast cancer progressed following prior endocrine therapy. A post hoc analysis to evaluate if previous chemotherapy in the metastatic setting affects the safety profile of the combination regimen of everolimus and exemestane was conducted on the Italian subset, as it represented the major part of the patients enrolled (54%). PATIENTS AND METHODS: One thousand one hundred and fifty-one Italian patients were included in the present post hoc analysis, which focused on two sets of patients: patients who never received chemotherapy in the metastatic setting (36.1%) and patients who received at least one chemotherapy treatment in the metastatic setting (63.9%). RESULTS: One thousand one hundred and sixteen patients (97.0%) prematurely discontinued the study drug, and the main reasons reported were disease progression (39.1%), local reimbursement of everolimus (31.1%), and adverse events (AEs) (16.1%). The median duration of study treatment exposure was 139.5 days for exemestane and 135.0 days for everolimus. At least one AE was experienced by 92.5% of patients. The incidence of everolimus-related AEs was higher (83.9%) when compared with those that occurred with exemestane (29.1%), and the most commonly reported everolimus-related AE was stomatitis (51.3%). However, no significant difference in terms of safety related to the combination occurred between patients without and with chemotherapy in the metastatic setting. CONCLUSION: Real-life data of the Italian patients BALLET-related cohort were an adequate setting to state that previous chemotherapy did not affect the safety profile of the combination regimen of everolimus and exemestane. IMPLICATIONS FOR PRACTICE: With the advent of new targeted agents for advanced or metastatic breast cancer, multiple lines of therapy may be possible, and components of the combined regimens can overlap from one line to another. Thus, it is important to assess even the potential of cumulative and additive toxic effects among the drugs. Previous chemotherapy did not affect the safety profile of the combination regimen of everolimus and exemestane. The continuous monitoring of the safety signals of this drug combination from general clinical practice is important, in particular for stomatitis.
