Periodic Reporting for period 1 - STOPSTORM (A PROSPECTIVE EUROPEAN VALIDATION COHORT FOR STEREOTACTIC THERAPY OF RE-ENTRANT TACHYCARDIA)
Période du rapport: 2021-05-01 au 2022-10-31
A novel and promising treatment for refractory Ventricular Tachycardia (VT) patients (after failed ablation) is the delivery of single fraction high-dose radiotherapy. This non-invasive modality is known in cancer treatment as extracranial Stereotactic Ablative Radiotherapy (SAbR), and in analogy has been coined STereotactic Arrhythmia Radioablation (STAR) for cardiac indications. To move STAR from single centres into wider clinical practice, more clinical and technical data for higher patient numbers are needed, especially in the light of recent evidence from a small series of patients indicating that results might not always be durable, due to several reasons. Clinical standardisation requires a concerted Europe-wide effort to reach consensus on STAR treatment. In this interdisciplinary framework, both radiation oncologists/physicists and cardiac electrophysiologists will work closely together to clinically validate and optimise STAR. Therefore this STOPSTORM project is started. The STOPSTORM project consortium comprises 31 clinical/research institutes and is divided into nine work-packages centred around a comprehensive STAR registry with accompanying quality assurance projects. The consortium started off with preparations to implement a European registry infrastructure for collecting STAR data from all patients treated non-invasively for refractory VT. This first period of the project, focus was on legal and logistical aligning. Next, we captured current STAR practice in Europe that showed significant variance, which will serve as baseline for the main goal: future standardisation and harmonisation within the STOPSTORM project using the newly established guidelines, workflows and audits for STAR as the fruits of STOPSTORM project.
For the observational validation cohort (WP1), the major prerequisites have been achieved: regulatory approval for the registry and individual beneficiaries as well as the development of the eCRF and implementation of the database structure. Although these haven been slightly delayed and some deliverables needed to be postponed, these now lay the ground for a successful start in data collection for further analysis. The preparative part for standardisation of target delineation (WP2) has been completed. All benchmark documents containing recommendations for substrate definition, delineation and data transfer have been created. An interactive workshop has been held to transfer this knowledge to the different partners. The prospective registry (WP3) preparation is ongoing in all centres being Members of the Consortium but the advancement of the work varies considerably from one site to another. In most sites, the participation in the STOPSTORM registry has been accepted by local IRBs and these sites provided also national versions of patient information brochures and informed consent forms. The recruitment process to the prospective cohort has started and the first prospective patient data have been entered into the database. The enrolment rate is lower than planned (also due to covid19) but as subsequent national trials are initialized we expect the number of patients enrolled to the prospective cohort to grow faster. The collaboration among STOPSTORM partners will be crucial to develop and implement the research protocol on patient and healthcare professionals' experiences. In WP4 (Quality assurance of clinical structure delineation, treatment planning, and treatment delivery), we successfully performed STOPSTORM partner centre credentialing with dedicated audit and review workflows for STAR; comprehensive surveys on the STAR patterns-of-practise in Europe; multi-centre multi-platform benchmark studies for contouring and treatment planning; and treatment unit quality audits for STAR. Within those successful tasks and subtasks, we established treatment quality guidelines that are based on international recommendations for STAR and a credentialing and audit committee that will review all STAR cases using a dedicated central treatment review guideline with newly developed software for joined electrophysiology-radiotherapy data presentation. The Ethics and regulations WPs (WP6 and WP9) will continue working on both ethical and legal issues about the registry and prospective data collection. The dissemination framework for STOPSTORM (WP7) was established in the first eighteen months of the project. This included the website, logo, and social media platforms, along with both a data management and dissemination and exploitation plan. In addition, the consortium developed a 3-minute animation video to explain the project concept. The STOPSTORM partners were also active in dissemination and communication efforts, including press releases, project videos, presentations at virtual, global scientific conferences, and the publishing of peer-reviewed publications. The project management structure and consortium guidelines were established and distributed to the consortium via the PM Handbook (WP8) by Month 6. The project management strategy has thus far been sufficient to maintain lines of communication between partners and to ensure that any potential issues are addressed early and proactively.
The project builds on a close collaboration between radiation oncologists and electrophysiologists: medical specialists that normally do not have close encounters due to non-overlapping patient populations. Raising the collaboration to a European level sparked a great enthusiasm in the collaborators, intensifying local, national and international progress in the field. As side effect from the project, electrophysiologists started to exchange knowledge on the standard procedures, increasing effectivity in some cases. Radiation oncologists saw the same positive effects from collaboration and bench marking of their departments. At the end of the project, electrophysiology and radiotherapy will have become better as parts, but also as collaborative treatments.