Interventricular Septal Hematoma Complicating Left Branch Bundle Lead Implantation: Treatment by Covered Stent

We present a female patient with heart failure with reduced ejection fraction who underwent left bundle branch cardiac resynchronization therapy. Left bundle branch lead implantation was complicated with septal branch perforation causing an iatrogenic coronary fistula complicated by septal hematoma formation and development of shock. Occlusion by covered stents was successfully achieved

Safety and Efficacy of Low-dose Domperidone for Treating Nausea and Vomiting Due to Acute Gastroenteritis in Children

This study was conducted based on a request from the European Medicines Agency to generate robust data on domperidone efficacy in children in the relief of symptoms of nausea and vomiting by assessing the effect of a low-dose and short treatment duration.The study was funded by the marketing authorization holders of medicinal products containing domperidone that are part of the consortium, Domperidone PAES Collaboration Group, constituting Janssen Research & Development, Research and Development, Pierre Fabre for Pierre Fabre Médicament SAS, and Esteve Pharmaceuticals, S.A.Medicin

Frontline bortezomib, rituximab, cyclophosphamide, doxorubicin, and prednisone (VR-CAP) versus rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in transplantation-ineligible patients with newly diagnosed mantle cell lymphoma: final overall survival results of a randomised, open-label, phase 3 study

In the LYM-3002 study, the efficacy and safety of frontline bortezomib plus rituximab, cyclophosphamide, doxorubicin, and prednisone (VR-CAP) and rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) were compared in transplant-ineligible patients with untreated, newly diagnosed, mantle cell lymphoma. We report the final overall survival and safety outcomes for patients in the long-term follow-up phase after the primary progression-free-survival endpoint was met.LYM-3002 was a randomised, open-label, phase 3 study done at 128 clinical centres in 28 countries in Asia, Europe, North America, and South America. Adult patients with confirmed stage II-IV previously untreated mantle cell lymphoma, Eastern Cooperative Oncology Group performance status score of 2 or less, who were ineligible for bone marrow transplantation, were randomly assigned (1:1) to receive six or eight 21-day cycles of VR-CAP (intravenous rituximab 375 mg/m2, cyclophosphamide 750 mg/m2, doxorubicin 50 mg/m2, and bortezomib 1·3 mg/m2, plus oral prednisone 100 mg/m2) or R-CHOP (intravenous vincristine 1·4 mg/m2 [2 mg maximum], rituximab 375 mg/m2, cyclophosphamide 750 mg/m2, and doxorubicin 50 mg/m2, plus oral prednisone 100 mg/m2). Randomisation was done according to a computer-generated randomisation schedule prepared by the sponsor; permuted blocks central randomisation was used (block size of 4), and was stratified by International Prognostic Index score and disease stage at diagnosis. The primary endpoint of this final analysis was overall survival, which was analysed in the intention-to-treat population. This study is registered with ClinicalTrials.gov, number NCT00722137, and is closed to new participants with follow-up completed.Between May 22, 2008, and Dec 5, 2011, 487 patients were enrolled and randomly assigned. 268 patients (140 in the VR-CAP group and 128 in the R-CHOP group) were included in the follow-up analysis, which included patients with data available after the primary analysis clinical cutoff date of Dec 2, 2013. After median follow-up of 82·0 months (IQR 74·1-94·2), median overall survival was significantly longer in the VR-CAP group than in the R-CHOP group (90·7 months [95% CI 71·4 to not estimable] vs 55·7 months [47·2 to 68·9]; hazard ratio 0·66 [95% CI 0·51-0·85]; p=0·001). Three new adverse events were reported since the primary analysis cutoff (one each of grade 4 lung adenocarcinoma and grade 4 gastric cancer in the VR-CAP group, and one case of grade 2 pneumonia in the R-CHOP group). 103 (42%) of 243 patients in the VR-CAP group, and 138 (57%) of 244 in the R-CHOP group died; the most common cause of death was progressive disease.Compared with R-CHOP, VR-CAP was associated with significantly longer survival, and had a manageable and expected safety profile. Our results support further assessment of VR-CAP in patients with previously untreated mantle cell lymphoma.Janssen Research & Development

El Rol del Médico en la industria farmacéutica de investigación

Las Jornadas Académicas de Salud 2023 promueven la actualización de los profesionales de la salud de diversas especialidades, enfatizando la atención interprofesional centrada en el paciente.Appiani, Carlos Alberto. Vice President, Head of Established Products at The Janssen Pharmaceutical Companies en Johnson & Johnso

A proposal for a semantic change in the current diagnostic criteria of Parkinson’s disease Psychosis

Psychosis may emerge as part of Parkinson’s disease (PD) process but is also associated with PD treatment. When the NINDS-NIMH criteria were applied to a cross-sectional PD cohort, the prevalence of PD psychosis in PD patients reached 60% [1].The most frequent symptoms in PD-associated psychosis (PDAP) are related to sensory perception areas, especially hallucinations. Graham et al. [2], reported that 70% of their patients with hallucinations had retained insight. This seems a contradiction because psychosis is a mental disorder characterized by symptoms, such as delusions or hallucinations that indicate an impaired contact with reality [3]. If we adhere to this definition, which is in fact the common and accepted one, those patients who retained insight about abnormal sensory perceptive phenomena should not be diagnosed as “psychotic”. Moreover, Fénelon and Alves reviewed the epidemiology of psychosis across different centers worldwide, showing that although psychosis could be diagnosed at that point of time, visual hallucinations were not always present for diagnosis: other features were taken into account to make this diagnosis for example the presence of delusions or illusions [4].</p

Comparison of efficacy from two different dosing regimens of bortezomib: an exposure--response analysis

Bortezomib is a first-in-class proteasome inhibitor, approved for the treatment of multiple myeloma. The originally approved dosing schedule of bortezomib results in significant toxicities that require dose interruptions and discontinuations. Consequentially, less frequent dosing has been explored to optimise bortezomib’s benefit–risk profile. Here, we performed exposure–response analysis to compare the efficacy of the original bortezomib dosing regimen with less frequent dosing of bortezomib over nine 6-week treatment cycles using data from the VISTA clinical trial and the control arm of the ALCYONE clinical trial. The relationship between cumulative bortezomib dose and clinical response was evaluated with a univariate logit model. The median cumulative bortezomib dose was higher in ALCYONE versus VISTA (42·2 vs. 38·5 mg/m2) and ALCYONE patients stayed on treatment longer (mean: 7·2 vs. 5·8 cycles). For all endpoints and regimens, probability of clinical response correlated with cumulative bortezomib dose. Similar to results observed for VISTA, overall survival was longer in ALCYONE patients with ≥ 39·0 versus &amp;lt; 39·0 mg/m2 cumulative dose (hazard ratio, 0·119; P &amp;lt; 0·0001). Less frequent bortezomib dosing results in comparable efficacy, and a higher cumulative dose than the originally approved bortezomib dosing schedule, which may be in part be due to reduced toxicity and fewer dose reductions/interruptions. © 2020 British Society for Haematology and John Wiley &amp; Sons Lt

Echocardiogram by apical-subcostal protocol in prone position during invasive mechanical ventilation in cardiovascular intensive care unit

Abstract Aims To evaluate the feasibility of a transthoracic echocardiogram using an apical-subcostal protocol in invasive mechanical ventilation (IMV) and prone position. Methods Prospective study of adults who required a prone position during IMV. A pillow was placed only under the left hemithorax in the prone position to elevate and ease the apical and subcostal windows. A critical care cardiologist (prone group) acquired and evaluated the images using the apical-subcostal protocol. Besides, we used ambulatory echocardiograms performed as a comparative group (supine group). Results 86 patients were included, 43 in the prone and 43 in the supine. In the prone group, the indication to perform an echocardiogram was hemodynamic monitoring. All patients were ventilated with protective parameters, and the mean end-expiratory pressure was 10.6 cmH2O. The protocol was performed entirely in 42 of 43 patients in the prone group because one patient did not have any acoustic window. In the 43 patients in the prone group analyzed and compared to the supine group, global biventricular function was assessed in 97.7% (p = 1.0), severe heart valve disease in 88.4% (p = 0.055), ruled out of the presence of pulmonary hypertension in 76.7% (p = 0.80), pericardial effusion in 93% (p = 0.12), and volume status by inferior vena cava in 93% (p = 0.48). Comparing prone versus supine position, a statistical difference was found when evaluating the left ventricle apical 2-chamber view (65.1 versus 100%, p < 0.01) and its segmental function (53.4 versus 100%, p < 0.01). Conclusion The echocardiogram using an apical-subcostal protocol is feasible in patients in the IMV and prone position. Graphical Abstrac

Interventricular Septal Hematoma Complicating Left Branch Bundle Lead Implantation

We present a female patient with heart failure with reduced ejection fraction who underwent left bundle branch cardiac resynchronization therapy. Left bundle branch lead implantation was complicated with septal branch perforation causing an iatrogenic coronary fistula complicated by septal hematoma formation and development of shock. Occlusion by covered stents was successfully achieved. (Level of Difficulty: Advanced.