RESUMO
BACKGROUND: Right ventricular (RV) imaging has not a definite role in risk stratification of pulmonary arterial hypertension (PAH) patients. We tested the hypothesis that echocardiography-derived phenotypes, depicting different degrees of RV remodeling and dysfunction, may provide additional prognostic information to current risk stratification tools. METHODS: Consecutive incident PAH patients aged ≥18 years, diagnosed between January 2005 and December 2021, underwent clinical assessment, right heart catheterization, standard echocardiography. Simple echocardiographic variables were combined in order to define a priori four phenotypes representing different degrees of RV dilatation and RV-pulmonary arterial (PA) coupling: Phenotype 1 with mildy dilated right ventricle and preserved RV-PA coupling (n = 152 patients); phenotype 2 with mildly dilated right ventricle and poor RV-PA coupling (n = 143 patients); phenotype 3 with severely dilated right ventricle and preserved RV-PA coupling (n = 201 patients); phenotype 4 with severely dilated right ventricle and poor RV-PA coupling, with or without severe tricuspid regurgitation (n = 519 patients). Risk stratification was based on the European Society of Cardiology/European Respiratory Society (ESC/ERS) 3-strata model and Registry to Evaluate Early and Long-Term PAH disease Management (REVEAL) 2.0 score. RESULTS: These phenotypes were present in all risk groups. Notably, regardless of the ESC/ERS risk stratum assigned to the patient, phenotype 4 was associated with a 2-fold increase of the odds of death (HR 2.1, 95% CI 1.6-2.8, p < 0.001), while phenotype 1 was associated with a 71% reduction in the odds of dying (HR 0.29, 95% CI 0.18-0.47, p < 0.001). CONCLUSIONS: Echocardiography-derived phenotypes describing RV remodeling and dysfunction may provide prognostic information which is independent of and additional to the clinically defined risk in incident PAH patients.
RESUMO
Pulmonary arterial hypertension is a complex pathology whose etiology is still not completely well clarified. The pathogenesis of pulmonary arterial hypertension involves different molecular mechanisms, with endothelial dysfunction playing a central role in disease progression. Both individual genetic predispositions and environmental factors seem to contribute to its onset. To further understand the complex relationship between endothelial and pulmonary hypertension and try to contribute to the development of future therapies, we report a comprehensive and updated review on endothelial function in pulmonary arterial hypertension.
RESUMO
In 2015, the Italian Society of Cardiology and its Working Group on Telemedicine and Informatics issued a position paper on Telecardiology, resuming the most eminent evidence supporting the use of information and communication technology in principal areas of cardiovascular care, ranked by level of evidence. More than 5 years later and after the global shock inflicted by the SARS-CoV-2 pandemic, an update on the topic is warranted. Recent evidence and studies on principal areas of cardiovascular disease will be therefore reported and discussed, with particular focus on telemedicine for cardiovascular care in the COVID-19 context. Novel perspectives and opportunities disclosed by artificial intelligence and its applications in cardiovascular disease will also be discussed. Finally, modalities by which machine learning have realized remote patient monitoring and long-term care in recent years, mainly filtering critical clinical data requiring selective hospital admission, will be provided.
Assuntos
COVID-19 , Cardiologia , Doenças Cardiovasculares , Telemedicina , Humanos , Doenças Cardiovasculares/diagnóstico , Doenças Cardiovasculares/terapia , Inteligência Artificial , SARS-CoV-2 , InformáticaRESUMO
AIMS: Sodium-glucose cotransporter type 2 inhibitors (SGLT-2i) represent a unique class of anti-hyperglycaemic agents for type 2 diabetes mellitus that selectively inhibit renal glucose reabsorption, thereby increasing urinary excretion of glucose. Several studies have demonstrated the cardioprotective effects of SGLT-2i in patients with heart failure (HF), unrelated to its glucosuric effect. It is unclear whether the benefits of SGLT-2i therapy also rely on the improvement of left ventricular (LV) and/or right ventricular (RV) function in patients with HF. This study aimed to evaluate the effect of SGLT-2i on LV and RV function through conventional and advanced echocardiographic parameters with a special focus on RV function in patients with HF. METHODS AND RESULTS: The Biventricular Evaluation of Gliflozins effects In chroNic Heart Failure (BEGIN-HF) study is an international multicentre, prospective study that will evaluate the effect of SGLT-2i on echocardiographic parameters of myocardial function in patients with chronic stable HF across the left ventricular ejection fraction (LVEF) spectrum. Patients with New York Heart Association Class II/III symptoms, estimated glomerular filtration rate > 25 mL/min/1.73 m2 , age > 18 years, and those who were not previously treated with SGLT-2i will be included. All patients will undergo conventional, tissue-derived imaging (TDI), and strain echocardiography in an ambulatory setting, at time of enrolment and after 6 months of SGLT-2i therapy. The primary endpoint is the change in LV function as assessed by conventional, TDI, and myocardial deformation speckle tracking parameters. Secondary outcomes include changes in RV and left atrial function as assessed by conventional and deformation speckle tracking echocardiography. Univariate and multivariate analyses will be performed to identify predictors associated with primary and secondary endpoints. CONCLUSIONS: The BEGIN-HF will determine whether SGLT-2i therapy improves LV and/or RV function by conventional and advanced echocardiography in patients with HF irrespective of LVEF.
Assuntos
Diabetes Mellitus Tipo 2 , Insuficiência Cardíaca , Inibidores do Transportador 2 de Sódio-Glicose , Humanos , Adulto , Pessoa de Meia-Idade , Inibidores do Transportador 2 de Sódio-Glicose/uso terapêutico , Inibidores do Transportador 2 de Sódio-Glicose/farmacologia , Diabetes Mellitus Tipo 2/complicações , Diabetes Mellitus Tipo 2/tratamento farmacológico , Volume Sistólico , Estudos Prospectivos , Função Ventricular Esquerda , Insuficiência Cardíaca/diagnóstico por imagem , Insuficiência Cardíaca/tratamento farmacológico , Doença Crônica , GlucoseRESUMO
INTRODUCTION: The recent Sars-CoV-2 pandemic (COVID-19) has led to growing research to explain the poor clinical prognosis in some patients. While early observational studies highlighted the role of the virus in lung failure, in a second moment thrombosis emerged as a possible explanation of the worse clinical course in some patients. Despite initial difficulties in management of such patients, the constant increase of literature in the field is to date clarifying some questions from clinicians. However, several other questions need answer. EVIDENCE ACQUISITION: We performed systematic research using Embase and PubMed, inserting the keywords and mesh terms relative to the new coronavirus and to VTE: "COVID-19," "SARS," "MERS," "coronavirus," "2019 n-CoV," venous thromboembolism," "pulmonary embolism," "deep vein thrombosis," "thromboembolism," "thrombosis." Boolean operators "AND," "OR," "NOT" were used where appropriate. We found 133 articles of interest but only 20 were selected, providing the most representative information. EVIDENCE SYNTHESIS: A novel disease (COVID-19) due to severe acute respiratory syndrome coronavirus 2 (Sars-CoV-2) infection was responsible for thousands of hospitalizations for severe acute respiratory syndrome, with several cases of thrombotic complications due to excessive inflammation, platelet activation, endothelial dysfunction, and stasis. COVID-19 and hospitalizations for COVID-19 may carry several potential risk factors for thrombosis. Severe coagulation abnormalities may occur in almost all the severe and critical ill COVID-19 cases. CONCLUSIONS: Despite a strong pathophysiological rationale, the evidence in literature is not enough to recommend an aggressive antithrombotic therapy in COVID-19. However, it is our opinion that an early use, even at home at the beginning of the disease, could improve the clinical course.
Assuntos
COVID-19 , Trombose , Tromboembolia Venosa , Humanos , Anticoagulantes/uso terapêutico , COVID-19/complicações , Progressão da Doença , SARS-CoV-2 , Trombose/etiologia , Tromboembolia Venosa/diagnóstico , Tromboembolia Venosa/epidemiologia , Tromboembolia Venosa/etiologiaAssuntos
Síndrome de Brugada , Vacinas contra COVID-19 , COVID-19 , Síndrome de Brugada/diagnóstico , Síndrome de Brugada/epidemiologia , Síndrome de Brugada/terapia , COVID-19/prevenção & controle , Vacinas contra COVID-19/efeitos adversos , Eletrocardiografia , Febre/complicações , Humanos , Incidência , Vacinação/efeitos adversosRESUMO
Psychosomatic syndromes have emerged as an important source of comorbidity in cardiac patients and have been associated with increased risk for adverse outcomes in patients with heart failure (HF). Understanding of the mechanisms underlying this connection is limited, however immune activity represents a possible pathway. While there have been numerous studies connecting immune activity to psychosomatic psychopathology, there is a lack of research on patients with HF. We examined forty-one consecutive outpatients affected by HF. We assessed psychosomatic psychopathology using the Diagnostic Criteria for Psychosomatic Research (DCPR) and the Patient Health Questionnaire-15 (PHQ-15). The Psychosocial Index (PSI) was used for assessing stress and psychosocial dimensions. Depression was evaluated with Beck Depression Inventory-II (BDI-II). Circulating levels of proinflammatory cytokines IL-6 and TNF-alpha were ascertained. Univariate and multivariable regression models were used to test for associations between inflammatory cytokines and psychosomatic psychopathology (i.e., DCPR syndromes, PHQ-15) and psychological dimensions (i.e., BDI-II, PSI). A significant positive correlation was found between IL-6 levels and psychosomatic psychopathology even when controlling for any confounding variables (i.e., Body-mass index (BMI), New York Heart Association (NYHA) class, smoking habits, alcohol consumption, statin use, aspirin use, beta blockers use, age, and gender). In contrast, the associations between TNF-alpha levels were non-significant. These findings can contribute to research in support of a psychoneuroimmune connection between psychosomatic psychopathology and HF. Findings also suggest the possibility that elevated IL-6 levels are more relevant for the pathogenesis of psychosomatic syndromes than for depression in patients with HF.
Assuntos
Insuficiência Cardíaca , Interleucina-6/sangue , Citocinas , Humanos , Transtornos Psicofisiológicos/psicologia , Síndrome , Fator de Necrose Tumoral alfaRESUMO
First recognized in 1990, takotsubo syndrome (TTS) constitutes an acute cardiac condition that mimics acute myocardial infarction commonly in the absence of obstructive coronary artery disease; it is characterized by temporary left ventricular dysfunction, regularly in a circumferential apical, midventricular, or basal distribution. Considering its acute clinical presentation, coronary angiography with left ventriculography constitutes the gold standard diagnostic tool to exclude or confirm TTS. Frequently, TTS is related to severe emotional or physical stress and a subsequent increased adrenergic stimulation affecting cardiac function. Beyond clinical presentation, epidemiology, and novel diagnostic biomarkers, this review draws attention to potential pathophysiological mechanisms for the observed reversible myocardial dysfunction such as sympathetic overdrive-mediated multi-vessel epicardial spasms, microvascular dysfunction, the direct toxicity of catecholamines, lipotoxicity, and inflammation. Considering the long-term prognosis, further experimental and clinical research is indispensable to elucidate further pathophysiological mechanisms underlying TTS before randomized control trials with evidence-based therapeutic management can be performed.
RESUMO
Takotsubo syndrome (TTS) represents a form of acute heart failure featured by reversible left ventricular systolic dysfunction. The management during the acute phase is mainly performed with supportive pharmacological (diuretics, ACE-inhibitors/angiotensin-receptor blockers (ARBs), anticoagulants, antiarrhythmics, non-catecholamine inotropics (levosimendan), and non-pharmacological (mechanical circulatory and respiratory support) therapy, due to the wide clinical presentation and course of the disease. However, there is a gap in evidence and there are no randomized and adequately powered studies on clinical effectiveness of therapeutic approaches. Some evidence supports the use ACE-inhibitors/ARBs at long-term. A tailored approach based on cardiovascular and non-cardiovascular risk factors is strongly suggested for long-term management. The urgent need for evidence-based treatment approaches is also reflected by the prognosis following TTS. The acute phase of the disease can be accompanied by various cardiovascular complications. In addition, long term outcome of TTS patients is also related to non-cardiovascular comorbidities. Physical triggers such as hypoxia and acute neurological disorders in TTS are associated with a poor outcome.
RESUMO
Scientists, medical researchers, and health care workers have mobilized worldwide in response to the outbreak of COVID-19, caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2; SCoV2). Preliminary data have captured a wide range of host responses, symptoms, and lingering problems post-recovery within the human population. These variable clinical manifestations suggest differences in influential factors, such as innate and adaptive host immunity, existing or underlying health conditions, co-morbidities, genetics, and other factors. As COVID-19-related data continue to accumulate from disparate groups, the heterogeneous nature of these datasets poses challenges for efficient extrapolation of meaningful observations, hindering translation of information into clinical applications. Attempts to utilize, analyze, or combine biomarker datasets from multiple sources have shown to be inefficient and complicated, without a unifying resource. As such, there is an urgent need within the research community for the rapid development of an integrated and harmonized COVID-19 Biomarker Knowledgebase. By leveraging data collection and integration methods, backed by a robust data model developed to capture cancer biomarker data we have rapidly crowdsourced the collection and harmonization of COVID-19 biomarkers. Our resource currently has 138 unique biomarkers. We found multiple instances of the same biomarker substance being suggested as multiple biomarker types during our extensive cross-validation and manual curation. As a result, our Knowledgebase currently has 265 biomarker type combinations. Every biomarker entry is made comprehensive by bringing in together ancillary data from multiple sources such as biomarker accessions (canonical UniProtKB accession, PubChem Compound ID, Cell Ontology ID, Protein Ontology ID, NCI Thesaurus Code, and Disease Ontology ID), BEST biomarker category, and specimen type (Uberon Anatomy Ontology) unified with ontology standards. Our preliminary observations show distinct trends in the collated biomarkers. Most biomarkers are related to the immune system (SAA,TNF-â, and IP-10) or coagulopathies (D-dimer, antithrombin, and VWF) and a few have already been established as cancer biomarkers (ACE2, IL-6, IL-4 and IL-2). These trends align with proposed hypotheses of clinical manifestations compounding the complexity of COVID-19 pathobiology. We explore these trends as we put forth a COVID-19 biomarker resource that will help researchers and diagnosticians alike. All biomarker data are freely available from https://data.oncomx.org/covid19 .
RESUMO
Cardiac tumors (CTs) are extremely rare, with an incidence of approximately 0.02% in autopsy series. Primary tumors of the heart are far less common than metastatic tumors. CTs usually present with any possible clinical combination of heart failure, arrhythmias, or embolism. Echocardiography remains the first diagnostic approach when suspecting a CT which, on the other side, frequently appears unexpectedly during an echocardiographic examination. Yet, cardiac tomography and especially magnetic resonance imaging may offer several adjunctive opportunities in the diagnosis of CTs. Early and exact diagnosis is crucial for the following therapy and outcome of CTs.
RESUMO
INTRODUCTION: Several systemic conditions, inflammatory disease, infections and alcoholism, may affect both the heart and the liver. Common conditions, such as the non-alcoholic fatty liver disease (NAFLD), may increase the risk of cardiac dysfunction. Patients with acute decompensated HF (ADHF) may develop acute ischemic hepatitis and, chronic HF patients may develop congestive hepatopathy (CH). EVIDENCE ACQUISITION: Laboratory anomalies of hepatic function may predict the outcome of patients with advanced HF and the evaluation of both cardiac and hepatic function is very important in the management of these patients. In clinically apparent ischemic hepatitis more than 90% of patients have some right-sided HF. There are systemic disorders characterized by the accumulation of metals or by metabolism defects that may affect primarily the liver but also the heart leading to symptomatic hypertrophic cardiomyopathy (HCM). EVIDENCE SYNTHESIS: Abnormal LFTs indicate the mechanism of liver injury: liver congestion or liver ischemia. In AHF, it's important an adequate evaluation of heart and liver function in order to choose the treatment in order to ensure stable hemodynamic as well as optimal liver function. CONCLUSIONS: Measurements of LFTs should be recommended in the early phase of ADHF management. Physicians with interest in HF should be trained in the evaluation of LFTs. It's very important for cardiologists to know the systemic diseases affecting both heart and liver and the first imaging or laboratory findings useful for a diagnosis. it is very important for internists, nephrologists, cardiologists, primary physicians and any physicians with interest in treating HF to recognize such signs and symptoms belong to rare diseases and liver diseases that could be mistaken for HF.
Assuntos
Insuficiência Cardíaca/complicações , Hepatopatias/complicações , Doença Aguda , Doença de Fabry/fisiopatologia , Doença de Depósito de Glicogênio/fisiopatologia , Hemocromatose/fisiopatologia , Hemodinâmica , Hemossiderose/fisiopatologia , Hepatite/complicações , Degeneração Hepatolenticular/fisiopatologia , Humanos , Inflamação , Isquemia/patologia , Testes de Função HepáticaRESUMO
BACKGROUND: Right heart catheterization (RHC) is recommended by guidelines for the diagnosis of pulmonary hypertension, the definition of hemodynamic impairment and responsiveness to drug therapy. However, RHC is an invasive test with associated risk of complications. Noninvasive echocardiographic tools, possibly predictive of pulmonary hypertension at RHC, could be therefore extremely useful. METHODS: Sixty-four consecutive patients with suspected pulmonary hypertension were enrolled in the study and assessed by echocardiography and RHC. Diagnosis of pulmonary hypertension was based on mean pulmonary artery pressure (≥25âmmHg) at RHC. RESULTS: Of 64 consecutive patients enrolled, 77% were diagnosed as having pulmonary hypertension after RHC. On the basis of significant differences between patients with pulmonary hypertension at RHC and those without on echocardiographic assessment, a multiple logistic regression model was constructed to predict the presence of pulmonary hypertension at RHC. The score was calculated using right atrium and ventricular diastolic area, tricuspid regurgitation Vmax, tricuspid regurgitation severity degree and left ventricular ejection fraction. The score area under the curve was therefore 0.786 (Pâ=â0.0001), higher than for tricuspid regurgitation Vmax (Pâ=â0.06). A score value more than 57 was associated with a 93% sensitivity, a 67% specificity, a 91% positive predictive power, a 73% negative predictive power, and an odds ratio 27 (Pâ<â0.001) of pulmonary hypertension at RHC, significant even after correction at multivariable analysis. Accuracy of the prediction model was assessed in a validation cohort with comparable results (Pâ=ân.s.). CONCLUSION: A simple noninvasive echocardiographic score can be useful in predicting the diagnosis of pulmonary hypertension at RHC and may be considered for the selection of patients who should undergo or could avoid RHC.
Assuntos
Pressão Arterial , Cateterismo Cardíaco , Ecocardiografia Doppler em Cores , Ecocardiografia Doppler de Pulso , Insuficiência Cardíaca/complicações , Hipertensão Arterial Pulmonar/diagnóstico por imagem , Artéria Pulmonar/fisiopatologia , Idoso , Feminino , Insuficiência Cardíaca/diagnóstico , Insuficiência Cardíaca/fisiopatologia , Humanos , Itália , Masculino , Pessoa de Meia-Idade , Valor Preditivo dos Testes , Hipertensão Arterial Pulmonar/etiologia , Hipertensão Arterial Pulmonar/fisiopatologia , Sistema de Registros , Reprodutibilidade dos Testes , Fatores de Risco , Função Ventricular Esquerda , Função Ventricular DireitaRESUMO
OBJECTIVES: Treatment of aortic valve stenosis is evolving, indications for transcatheter approach (TAVI) have increased but also surgical valve replacement has changed with the use of minimally invasive approaches. Comparisons between TAVI and surgery have rarely been done with minimally invasive techniques (mini-SAVR) in the surgical arm. Aim of the present study is to compare mini-SAVR and TAVI in a multicenter recent cohort. METHODS: Evaluated were 2904 patients undergone mini-SAVR (2407) or TAVI (497) in 10 different centers in the period 2011-2016. The Heart Team approved treatment for complex cases. The primary outcome is the incidence of 30-day mortality following mini-SAVR and TAVI. Secondary outcomes are the occurrence of major complications following both procedures. Propensity matched comparisons was performed based on multivariable logistic regression model. RESULTS: In the overall population TAVI patients had increased surgical risk (median EuroSCORE II 3.3% vs. 1.7%, pâ¯≤â¯0.001) and 30-day mortality was higher (1.5% and 2.8% in mini-SAVR and TAVI respectively, pâ¯=â¯0.048). Propensity score identified 386 patients per group with similar baseline profile (median EuroSCORE II ~3.0%). There was no difference in 30-day mortality (3.4% in mini-SAVR and 2.3% in TAVI; pâ¯=â¯0.396) and stroke, surgical patients had more blood transfusion, kidney dysfunction and required longer ICU and hospital length of stay while TAVI patients had more permanent pace maker insertion. CONCLUSIONS: Mini-SAVR and TAVI are both safe and effective to treat aortic stenosis in elderly patients with comorbidities. A joint evaluation by the heart-team is essential to direct patients to the proper approach.
RESUMO
BACKGROUND: Transient pacing failure caused by transient increased pacing threshold has been reported in patients with transient left ventricular apical dysfunction (Takotsubo cardiomyopathy [TC]). Normal pacing thresholds usually recover after normalization of systolic dysfunction. HYPOTHESIS: Pacing failure correlates with clinics of TC. METHODS: We report the case of a 76-year-old man with a dual chamber pacemaker, admitted for acute chest pain and dyspnea and final diagnosis of TC. One month after index admission, the patient came back complaining again of chest pain. Unexpectedly, admission electrocardiogram showed ventricular pacing failure and an increased pacing threshold. In the following weeks, pacing threshold gradually recovered with left ventricular ejection fraction and QTc values. RESULTS: Ventricular pacing threshold correlated directly to QTc values and inversely to left ventricular ejection fraction over time (P < 0.05). CONCLUSIONS: This is one of the first cases of delayed transient ventricular pacing failure in a male patient with transient left ventricular apical ballooning, in the presence of spared right ventricular function. Given the possibility of acute transient anomalies in myocardial impedance and pacing failure even in the subacute phase of TC several weeks after clinical onset of transient systolic dysfunction, pacing threshold should be carefully monitored in subjects with TC, both during the acute phase of the disease and in first months of follow-up after discharge. Ventricular pacing threshold correlated directly to QTc values and inversely to left ventricular ejection fraction over time.
Assuntos
Fibrilação Atrial/terapia , Estimulação Cardíaca Artificial/métodos , Síndrome do Nó Sinusal/terapia , Volume Sistólico , Cardiomiopatia de Takotsubo/fisiopatologia , Função Ventricular Esquerda , Potenciais de Ação , Idoso , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/fisiopatologia , Eletrocardiografia , Frequência Cardíaca , Humanos , Masculino , Síndrome do Nó Sinusal/diagnóstico , Síndrome do Nó Sinusal/fisiopatologia , Cardiomiopatia de Takotsubo/diagnóstico , Fatores de Tempo , Falha de Tratamento , Função Ventricular DireitaRESUMO
BACKGROUND: Takotsubo syndrome (TTS), a form of acute transient heart failure, has been associated with severe complications and considerable mortality rates. N-Terminal Pro-B-Type Natriuretic Peptide (NT-proBNP) might serve as a marker to identify high-risk patients but has not yet been investigated regarding prognostic implications in TTS. Aim of this study was to determine the short- and long-term prognostic utility of NT-proBNP in patients with TTS. METHODS: The predictive value of admission NT-proBNP was assessed in an international, multicenter study including 177 consecutive TTS patients. Predefined endpoints were 30-day major adverse cardiac events (MACE) consisting of all-cause death, cardiogenic shock, and pulmonary edema as well as long-term mortality in median 2.3 years after the acute event. RESULTS: Stratification according to median admission NT-proBNP (4511 pg/ml) resulted in significantly higher 30-day MACE [22.5 versus 9.1%; odds ratio (OR) 2.90, 95% confidence interval (CI) 1.20-6.99 p = 0.015] and long-term mortality rates [16.3 versus 9.4%; hazard ratio (HR) 2.72, 95% CI 1.13-6.56 p = 0.021] in patients > median. The best admission NT-proBNP cutoffs to predict 30-day MACE and long-term mortality were determined at 5560 and 8178 pg/ml respectively, with subsequent improved risk stratification for short-term MACE (OR 3.61, 95% CI 1.49-8.72; p = 0.003) and long-term mortality (HR 4.40; 95% CI 1.85-10.44, p < 0.001). Multivariate regression analysis identified admission NT-proBNP as an independent predictor of 30-day MACE (p < 0.001) and long-term mortality (p = 0.012). CONCLUSIONS: Admission NT-proBNP is an independent predictor for short- and long-term adverse events in TTS patients and, therefore, a useful marker for risk stratification immediately at presentation.
Assuntos
Peptídeo Natriurético Encefálico/sangue , Fragmentos de Peptídeos/sangue , Cardiomiopatia de Takotsubo/sangue , Idoso , Idoso de 80 Anos ou mais , Biomarcadores/sangue , Distribuição de Qui-Quadrado , Feminino , Alemanha , Humanos , Itália , Estimativa de Kaplan-Meier , Masculino , Análise Multivariada , Razão de Chances , Admissão do Paciente , Valor Preditivo dos Testes , Prognóstico , Medição de Risco , Fatores de Risco , Cardiomiopatia de Takotsubo/diagnóstico por imagem , Cardiomiopatia de Takotsubo/mortalidade , Cardiomiopatia de Takotsubo/fisiopatologia , Fatores de TempoRESUMO
Background: MITO-8 showed that prolonging platinum-free interval by introducing non-platinum-based chemotherapy (NPBC) does not improve prognosis of patients with partially platinum-sensitive recurrent ovarian cancer. Quality of life (QoL) was a secondary outcome. Patients and methods: Ovarian cancer patients recurring or progressing 6-12 months after previous platinum-based chemotherapy (PBC) were randomized to receive PBC or NPBC as first treatment. QoL was assessed at baseline, third and sixth cycles, with the EORTC C-30 and OV-28 questionnaires. Mean changes and best response were analysed. Progression-free survival, response rate, and toxicity are also reported for proper interpretation of data. All analyses were based on intention-to-treat. Results: Out of the 215 patients, 151 (70.2%) completed baseline questionnaire, balanced between the arms; thereafter, missing rate was higher in the NPBC arm. At mean change analysis, C30 scores were prevalently worse in the NPBC than PBC arm, statistical significance being attained for emotional functioning, global health status/QoL, fatigue, and dyspnoea (effect sizes ranging from 0.30 to 0.51). Conversely, as for OV28 scale, the other chemotherapy side-effects item was significantly worse with PBC at three and six cycles, with a larger effect size (0.70 and 0.54, respectively). At best response analysis, improvement of emotional functioning and pain and worsening of peripheral neuropathy and other chemotherapy side-effects were significantly more frequent in the PBC arm. Progression-free survival (median 9 versus 5 months, P = 0.001) and objective response rate (51.6% versus 19.4%, P = 0.0001) were significantly better with PBC. Allergy, blood cell count, alopecia, nausea, musculoskeletal, and neurological side-effects were more frequent and severe with PBC; hand-foot skin reaction, rash/desquamation, mucositis, and vascular events were more frequent with NPBC. Conclusion: MITO-8 QoL analysis shows that deterioration of some functioning and symptom scales is lower with PBC, with improvement of emotional functioning and pain, despite worsening of toxicity-related items. ClinicalTrials.gov: NCT00657878.