Conectar
by Giacinto Angelo Sgarro, Paride Vasco, Domenico Santoro, Luca Grilli, Marco Giglio, Natale Daniele Brunetti, Luigi Traetta, Giuseppe Cibelli, Anna Antonia Valenzano
Sudden Cardiac Death (SCD) is a critical and unexpected condition that occurs due to cardiac causes within one hour of the onset of acute cardiovascular symptoms or twenty-four hours in unwitnessed cases. Despite advancements in cardiovascular medicine, practical methods for predicting SCD are still lacking, and there are no standardized systems to identify individuals at risk, especially in seemingly healthy populations such as athletes. In this study, we employed hierarchical clustering and principal component analysis (PCA) on data from 711 competitive athletes, revealing distinct patterns and cluster distributions in PCA space. Specifically, Clustering revealed characteristic feature combinations associated with increased SCD risk in athletes. Notably, certain clusters shared traits, including participation in Class C sports, sinus tachycardia, ventricular pre-excitation, personal or family history of heart disease, T-wave inversions, and prolonged QTc intervals. PCA helped visualize these patterns in distinct spatial regions, highlighting underlying structures and aiding intuitive risk interpretation. These results enable scientists to derive cluster metrics that serve as reference points for classifying new individuals and visually representing risk patterns in a clear graphical format. These findings establish a foundation for predictive tools that, with additional clinical validation, could aid in the prevention of SCD. The dataset used in this study, along with the clustering and PCA results, is available to the scientific community in an open format, together with the necessary tools and scripts to enable independent experimentation and further analysis.Despite the known haemostatic action of emicizumab (Hemlibra) in haemophilia A patients, its role in the prevention and control of bleeding in high-demand haemostatic situations, such as major surgery, remains to be determined. Patients receiving regular emicizumab prophylaxis often require concomitant factor VIII (FVIII) therapy during major surgery to prevent uncontrolled bleeding and to promote postoperative healing. However, there are limited prospective surgical data relating to concomitant FVIII and emicizumab use. Simoctocog alfa (Nuwiq) is a B-domain deleted recombinant FVIII produced in a human cell line without chemical modification or protein fusion with proven efficacy as surgical prophylaxis in adult and paediatric patients. The Nuwiq for Perioperative management Of patients With haemophilia A on Emicizumab Regular prophylaxis (NuPOWER) study aims to examine perioperative efficacy and safety of simoctocog alfa in haemophilia A patients on emicizumab prophylaxis undergoing major surgery.
NuPOWER is a prospective, open-label, single-arm, multicentre study that will be conducted at approximately 15 centres worldwide. Up to 28 male patients ≥12 years with severe haemophilia A and no FVIII inhibitors will be recruited. All patients must be receiving regular emicizumab prophylaxis and scheduled to undergo a major surgical procedure during which concomitant simoctocog alfa will be administered. The primary endpoint is the overall haemostatic efficacy of simoctocog alfa, adjudicated by an independent data monitoring committee using a pre-defined algorithm, and will consider intraoperative and postoperative efficacy assessments by the surgeon and investigator, respectively. Secondary endpoints include intraoperative haemostatic efficacy, postoperative haemostatic efficacy, number of allogeneic blood products transfused, perioperative FVIII plasma levels (as measured by FVIII activity) and thrombin generation, and safety parameters. In the era of non-factor therapy, NuPOWER will generate valuable prospective data on concomitant use of simoctocog alfa and emicizumab prophylaxis in patients with severe haemophilia A undergoing major surgery.
Ethical approval has been received from institutional review boards/independent ethics committees, and the study will be conducted in compliance with the Declaration of Helsinki. This work will be disseminated by publication of peer-reviewed manuscripts and presentations at scientific meetings.
CT EU 2022-502060-21-00; NCT05935358.
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