ROGERIO DE SOUZA

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Departamento de Cardio-Pneumologia, Faculdade de Medicina - Docente
Instituto do Coração, Hospital das Clínicas, Faculdade de Medicina - Médico
LIM/09 - Laboratório de Pneumologia, Hospital das Clínicas, Faculdade de Medicina - Líder

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Assunto: survival ×

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Agora exibindo 1 - 10 de 22
  • article 27 Citação(ões) na Scopus
    Schistosomiasis and pulmonary hypertension
    (2011) DOS, Caio Julio Cesar; FERNANDES, Santos; JARDIM, Carlos Viana Poyares; HOVNANIAN, Andre; HOETTE, Susana; MORINAGA, Luciana Kato; SOUZA, Rogerio
    Expert Rev. Respir. Med. 5(5), 675-681 (2011) Schistosomiasis is one of the most prevalent chronic infectious diseases in the world. One of its most severe complications, pulmonary hypertension, occurs in up to 5% of patients with hepatosplenic schistosomiasis. The prevalence of schistosomiasis is so overwhelming that schistosomiasis-associated pulmonary hypertension (Sch-PH) may be the most prevalent cause of pulmonary hypertension around the world. Multiple pathways have been described as potential mechanisms of disease in Sch-PH, such as egg embolism, inflammatory disease or pulmonary blood overflow. The possible physiopathological mechanisms will be discussed in this article, as well the disease's clinical course and response to the treatment available.
  • article 9 Citação(ões) na Scopus
    Integrating Data From Randomized Controlled Trials and Observational Studies to Assess Survival in Rare Diseases Insights From Pulmonary Arterial Hypertension
    (2019) TORBICKI, Adam; BACCHI, Marisa; DELCROIX, Marion; FARBER, Harrison W.; GHOFRANI, Hossein-Ardeschir; HENNESSY, Brian; JANSA, Pavel; MEHTA, Sanjay; PERCHENET, Loic; PULIDO, Tomas; ROSENBERG, Daniel; RUBIN, Lewis J.; SASTRY, B. K. S.; SIMONNEAU, Gerald; SITBON, Olivier; SOUZA, Rogerio; WEI, Lee-Jen; CHANNICK, Richard; BENZA, Raymond
    BACKGROUND: Conducting randomized controlled trials to investigate survival in a rare disease like pulmonary arterial hypertension has considerable ethical and logistical constraints. In many studies, such as the Study with an Endothelin Receptor Antagonist in Pulmonary Arterial Hypertension to Improve Clinical Outcome (SERAPHIN) randomized controlled trial, evaluating survival is further complicated by bias introduced by allowing active therapy among placebo-treated patients who clinically deteriorate. METHODS AND RESULTS: SERAPHIN enrolled and followed patients in the same time frame as the US Registry to Evaluate Early And Long-term PAH Disease Management, providing an opportunity to compare observed survival for SERAPHIN patients with predicted survival had they received real-world treatment as in the Registry to Evaluate Early And Long-term PAH Disease Management. From the Registry to Evaluate Early And Long-term PAH Disease Management (N= 3515), 734 patients who met SERAPHIN eligibility criteria were selected and their data used to build a prediction model for time to death up to 3 years based on 10 baseline prognostic variables. The model was used to predict a survival curve for each of the 742 SERAPHIN patients via their baseline variables. The average of these predicted survival curves was compared with observed survival of the placebo (n= 250) and macitentan 10 mg (n= 242) groups using a log-rank test and Cox proportional hazard model. Observed mortality risk for patients randomized to placebo, 62% of whom were taking background pulmonary arterial hypertension therapy, tended to be lower than that predicted for all SERAPHIN patients (16% lower; P= 0.259). The observed placebo survival curve closely approximated the predicted survival curve for the first 15 months. Beyond that time, observed risk of mortality decreased compared with predicted mortality, potentially reflecting the impact of crossover of patients in the placebo group to active therapy. Over 3 years, risk of mortality observed with macitentan 10 mg was 35% lower than predicted mortality (P= 0.010). CONCLUSIONS: These analyses show that, in a rare disease, real-world observational data can complement randomized controlled trial data to overcome some challenges associated with assessing survival in the setting of a randomized controlled trial.
  • article 6 Citação(ões) na Scopus
    Comparação de dois modelos experimentais de hipertensão pulmonar
    (2012) POLONIO, Igor Bastos; ACENCIO, Milena Marques Pagliarelli; PAZETTI, Rogerio; ALMEIDA, Francine Maria de; CANZIAN, Mauro; SILVA, Barbara Soares da; PEREIRA, Karina Aparecida Bonifacio; SOUZA, Rogerio de
    Objective: To compare two models of pulmonary hypertension (monocrotaline and monocrotaline+pneumonectomy) regarding hemodynamic severity, structure of pulmonary arteries, inflammatory markers (IL-1 and PDGF), and 45-day survival. Methods: We used 80 Sprague-Dawley rats in two study protocols: structural analysis; and survival analysis. The rats were divided into four groups: control; monocrotaline (M), pneumonectomy (P), and monocrotaline+pneumonectomy (M+P). In the structural analysis protocol, 40 rats (10/group) were catheterized for the determination of hemodynamic variables, followed by euthanasia for the removal of heart and lung tissue. The right ventricle (RV) was dissected from the interventricular septum (IS), and the ratio between RV weight and the weight of the left ventricle (LV) plus IS (RV/LV+IS) was taken as the index of RV hypertrophy. In lung tissues, we performed histological analyses, as well as using ELISA to determine IL-1 and PDGF levels. In the survival protocol, 40 animals (10/group) were followed for 45 days. Results: The M and M+P rats developed pulmonary hypertension, whereas the control and P rats did not. The RV/LV+IS ratio was significantly higher in M+P rats than in M rats, as well as being significantly higher in M and M+P rats than in control and P rats. There were no significant differences between the M and M+P rats regarding the area of the medial layer of the pulmonary arteries; IL-1 and PDGF levels; or survival. Conclusions: On the basis of our results, we cannot conclude that the monocrotaline+pneumonectomy model is superior to the monocrotaline model.
  • article 13 Citação(ões) na Scopus
    Pulmonary artery enlargement in schistosomiasis associated pulmonary arterial hypertension
    (2015) HOETTE, Susana; FIGUEIREDO, Claudia; DIAS, Bruno; ALVES- JR., Jose Leonidas; GAVILANES, Francisca; PRADA, Luis Felipe; JASINOWODOLINSKI, Dany; MORINAGA, Luciana Tamie Kato; JARDIM, Carlos; FERNANDES, Caio Julio Cesar; SOUZA, Rogerio
    Background: Schistosomiasis associated pulmonary arterial hypertension (Sch-PAH) might represent the most prevalent form of PAH worldwide. In Sch-PAH, the presence of aneurismal dilation of the pulmonary artery has been described, although it is still a matter of debate whether on average the pulmonary artery is more enlarged in Sc-PAH than IPAH. Methods: We retrospectively evaluated patients with IPAH (n = 25) and Sch-PAH (n = 22) who underwent computed tomography pulmonary angiogram and right heart catheterization. Results: Sch-PAH patients were older and presented less severe hemodynamic profiles. Main pulmonary artery diameter (MPAD) was greater in Sch-PAH than IPAH (4.5 +/- 1.8 vs 3.7 +/- 1.1 cm, p = 0.018). For the same level of mean pulmonary artery pressure, the MPAD in Sch-PAH was 0.89 cm larger than in IPAH (Covariance model p = 0.02). Conclusion: This study demonstrated that pulmonary artery enlargement is more pronounced in Sch-PAH than IPAH, independently of mean pulmonary artery pressure level, suggesting that this is more likely a feature of Sch-PAH.
  • article 64 Citação(ões) na Scopus
    Cardiac Magnetic Resonance Imaging: What Can It Add to Our Knowledge of the Right Ventricle in Pulmonary Arterial Hypertension?
    (2012) VONK-NOORDEGRAAF, Anton; SOUZA, Rogerio
    Pulmonary arterial hypertension (PAH) is a disease of the pulmonary vasculature characterized by vasoconstriction and vascular remodeling leading to a progressive increase in pulmonary vascular resistance (PVR). It is becoming increasingly recognized that it is the response of the right ventricle (RV) to the increased afterload resulting from this increase in PVR that is the most important determinant of patient outcome. A range of hemodynamic, structural, and functional measures associated with the RV have been found to have prognostic importance in PAH and, therefore, have potential value as parameters for the evaluation and follow-up of patients. If such measures are to be used clinically, there is a need for simple, reproducible, accurate, easy-to-use, and noninvasive methods to assess them. Cardiac magnetic resonance imaging (CMRI) is regarded as the ""gold standard"" method for assessment of the RV, the complex structure of which makes accurate assessment by 2-dimensional methods, such as echocardiography, challenging. However, the majority of data concerning the use of CMRI in PAH have come from studies evaluating a variety of different measures and using different techniques and protocols, and there is a clear need for the development of standardized methodology if CMRI is to be established in the routine assessment of patients with PAH. Should such standards be developed, it seems likely that CMRI will become an important method for the noninvasive assessment and monitoring of patients with PAH.
  • article 39 Citação(ões) na Scopus
    Incident and prevalent cohorts with pulmonary arterial hypertension: insight from SERAPHIN
    (2015) SIMONNEAU, Gerald; CHANNICK, Richard N.; DELCROIX, Marion; GALIE, Nazzareno; GHOFRANI, Hossein-Ardeschir; JANSA, Pavel; BRUN, Franck-Olivier Le; MEHTA, Sanjay; PERCHENET, Loic; PULIDO, Tomas; SASTRY, B. K. S.; SITBON, Olivier; SOUZA, Rogerio; TORBICKI, Adam; RUBIN, Lewis J.
    In SERAPHIN, a long-term, randomised, controlled trial (NCT00660179) in pulmonary arterial hypertension (PAH), macitentan significantly reduced the risk of morbidity/mortality and PAH-related death/hospitalisation. We evaluated disease progression and the effect of macitentan in treatment-nave incident and prevalent cohorts. Patients allocated to placebo, or macitentan 3 mg or 10 mg were classified by time from diagnosis to enrolment as incident (<= 6 months; n=110) or prevalent (>6 months; n=157). The risk of morbidity/mortality and PAH-related death/hospitalisation was determined using Cox regression. The risk of morbidity/mortality (Kaplan-Meier estimates at month 12: 54.4% versus 26.7%; p=0.006) and PAH-related death/hospitalisation (Kaplan-Meier estimates at month 12: 47.3% versus 19.9%; p=0.006) were significantly higher for incident versus prevalent patients receiving placebo, respectively. There was no significant difference in the risk of all-cause death between incident and prevalent cohorts (p=0.587). Macitentan 10 mg significantly reduced the risk of morbidity/mortality and PAH-related death/hospitalisation versus placebo in incident and prevalent cohorts. Incident patients had a higher risk for PAH progression compared with prevalent patients but not a higher risk of death. Macitentan delayed disease progression in both incident and prevalent PAH patients.
  • article 77 Citação(ões) na Scopus
    Pulmonary Arterial Hypertension-Related Morbidity Is Prognostic for Mortality
    (2018) MCLAUGHLIN, Vallerie V.; HOEPER, Marius M.; CHANNICK, Richard N.; CHIN, Kelly M.; DELCROIX, Marion; GAINE, Sean; GHOFRANI, Hossein-Ardeschir; JANSA, Pavel; LANG, Irene M.; MEHTA, Sanjay; PULIDO, Tomas; SASTRY, B. K. S.; SIMONNEAU, Gerald; SITBON, Olivier; SOUZA, Rogerio; TORBICKI, Adam; TAPSON, Victor F.; PERCHENET, Loic; PREISS, Ralph; VERWEIJ, Pierre; RUBIN, Lewis J.; GALIE, Nazzareno
    BACKGROUND Registry data suggest that disease progression in pulmonary arterial hypertension (PAH) is indicative of poor prognosis. However, the prognostic relevance of PAH-related morbidity has not been formally evaluated in randomized controlled trials. OBJECTIVES The purpose of these analyses was to assess the impact of morbidity events on the risk of subsequent mortality using the landmark method and data from the SERAPHIN and GRIPHON studies. METHODS For each study, the risk of all-cause death up to the end of the study was assessed from the landmark time point (months 3, 6, and 12) according to whether a patient had experienced a primary endpoint morbidity event before the landmark. Each analysis was conducted using data from all patients who were available for survival follow-up at the landmark. RESULTS In the SERAPHIN study, on the basis of the 3-month landmark time point, patients who experienced a morbidity event before month 3 had an increased risk of death compared with patients who did not (hazard ratio [HR]: 3.39; 95% confidence interval [CI]: 1.94 to 5.92). In the GRIPHON study, on the basis of the 3-month landmark time point, there was also an increased risk with a HR of 4.48; (95% CI: 2.98 to 6.73). Analyses based on 6-month and 12-month landmarks also showed increased risk in patients who experienced morbidity events, albeit with a reduced HR. CONCLUSIONS These results demonstrate the prognostic relevance of PAH-related morbidity as defined in the SERAPHIN and GRIPHON studies, highlighting the importance of preventing disease progression in patients with PAH and supporting the clinical relevance of SERAPHIN and GRIPHON morbidity events. (Study of Macitentan [ACT-064992] on Morbidity and Mortality in Patients With Symptomatic Pulmonary Arterial Hypertension [SERAPHIN]; NCT00660179; Selexipag [ACT-293987] in Pulmonary Arterial Hypertension [GRIPHON]; (c) 2018 The Authors.
  • article 2178 Citação(ões) na Scopus
    Updated Clinical Classification of Pulmonary Hypertension
    (2013) SIMONNEAU, Gerald; GATZOULIS, Michael A.; ADATIA, Ian; CELERMAJER, David; DENTON, Chris; GHOFRANI, Ardeschir; SANCHEZ, Miguel Angel Gomez; KUMAR, R. Krishna; LANDZBERG, Michael; MACHADO, Roberto F.; OLSCHEWSKI, Horst; ROBBINS, Ivan M.; SOUZA, Rogiero
    In 1998, a clinical classification of pulmonary hypertension (PH) was established, categorizing PH into groups which share similar pathological and hemodynamic characteristics and therapeutic approaches. During the 5th World Symposium held in Nice, France, in 2013, the consensus was reached to maintain the general scheme of previous clinical classifications. However, modifications and updates especially for Group 1 patients (pulmonary arterial hypertension [PAH]) were proposed. The main change was to withdraw persistent pulmonary hypertension of the newborn (PPHN) from Group 1 because this entity carries more differences than similarities with other PAH subgroups. In the current classification, PPHN is now designated number 1. Pulmonary hypertension associated with chronic hemolytic anemia has been moved from Group 1 PAH to Group 5, unclear/multifactorial mechanism. In addition, it was decided to add specific items related to pediatric pulmonary hypertension in order to create a comprehensive, common classification for both adults and children. Therefore, congenital or acquired left-heart inflow/outflow obstructive lesions and congenital cardiomyopathies have been added to Group 2, and segmental pulmonary hypertension has been added to Group 5. Last, there were no changes for Groups 2, 3, and 4. (C) 2013 by the American College of Cardiology Foundation
  • article 202 Citação(ões) na Scopus
    Pulmonary hypertension diagnosed by right heart catheterisation in sickle cell disease
    (2012) FONSECA, G. H. H.; SOUZA, R.; SALEMI, V. M. C.; JARDIM, C. V. P.; GUALANDRO, S. F. M.
    Recent studies have recognised the importance of pulmonary hypertension (PH) in sickle cell disease (SCD). The aim of this study was to determine the prevalence and prognostic impact of PH and its features in patients with SCD. 80 patients with SCD underwent baseline clinical evaluation, laboratory testing, 6-min walk tests (6MWTs) and echocardiography. Patients with a peak tricuspid regurgitant jet velocity (TRV) of >= 2.5 m.s(-1) were further evaluated through right heart catheterisation (RHC) to assure the diagnosis of PH. Our study evidenced a 40% prevalence of patients with elevated TRV at echocardiography. RHC (performed in 25 out of 32 patients) confirmed PH in 10% (95% CI 3.4-16.5%) of all patients, with a prevalence of post-capillary PH of 6.25% (95% CI 0.95-11.55%) and pre-capillary PH of 3.75% (95% CI -0.4-7.9%). Patients with PH were older, had worse performance in 6MWTs, and more pronounced anaemia, haemolysis and renal dysfunction. Survival was shorter in patients with PH. Our study reinforced the use of echocardiography as a screening tool for PH in SCD and the mandatory role of RHC for proper diagnosis. Our findings confirmed the prognostic significance of PH in SCD as its association to pronounced haemolytic profile.
  • article 56 Citação(ões) na Scopus
    Effect of Macitentan on Hospitalizations: Results From the SERAPH IN Trial
    (2015) CHANNICK, Richard N.; DELCROIX, Marion; GHOFRANI, Hossein-Ardeschir; HUNSCHE, Elke; JANSA, Pavel; BRUN, Franck-Olivier Le; MEHTA, Sanjay; PULIDO, Tomas; RUBIN, Lewis J.; SASTRY, B. K. S.; SIMONNEAU, Gerald; SITBON, Olivier; SOUZA, Rogerio; TORBICKI, Adam; GALIE, Nazzareno
    OBJECTIVES This study sought to evaluate the effect of macitentan on hospitalization of patients with symptomatic pulmonary arterial hypertension (PAH). BACKGROUND PAH is a progressive, life-threatening disease often requiring hospitalization. METHODS In the multicenter, double-blind, randomized, event-driven, phase III SERAPHIN (Study with an Endothelin Receptor Antagonist in Pulmonary arterial Hypertension to Improve cliNical outcome) trial, patients with symptomatic PAH were randomized (1:1:1) to receive placebo or 3 mg or 10 mg of macitentan. Effects of macitentan on the risk, rate, and number of hospital days for all-cause and PAH-related hospitalizations were compared with those for placebo. Risk and causes of hospitalizations unrelated to PAH were investigated. RESULTS Of 742 randomized patients, 250 received placebo, 250 received 3 mg of macitentan, and 242 received 10 mg of macitentan; the overall median duration of treatment was 115 weeks. Risk of all-cause hospitalization was reduced by 18.9% (p = 0.1208) and 32.3% (p = 0.0051) in the macitentan 3-mg and 10-mg arm, respectively. Rates of all-cause hospitalizations and numbers of hospital days were reduced by 20.5% (p = 0.0378) and 30.6% (p = 0.0278), respectively, with 3 mg of macitentan and by 33.1% (p = 0.0005) and 31.0% (p = 0.0336), respectively, with 10 mg of macitentan. Risk of PAH-related hospitalizations were reduced by 42.7% (p = 0.0015) and 51.6% (p < 0.0001) in the macitentan 3-mg and 10-mg arms, respectively. Rate of PAN-related hospitalizations and numbers of hospital days were reduced by 44.5% (p = 0.0004) and 53.3% (p = 0.0001), respectively, with 3 mg of macitentan, and reduced by 49.8% (p < 0.0001) and 52.3% (p = 0.0003), respectively, with 10 mg of macitentan. Risk of non-PAH-related hospitalization was similar between treatment arms. CONCLUSIONS Macitentan 10 mg significantly reduced the risk and rate of all-cause hospitalization, which was driven by reductions in the risk and rate of PAH-related hospitalization. (Study of Macitentan [ACT-064992] on Morbidity and Mortality in Patients With Symptomatic Pulmonary Arterial Hypertension; NCT:00660179) (C) 2015 by the American College of Cardiology Foundation.