Interim efficacy analysis of the phase 2 dose de-escalation trial of stereotactic arrhythmia radioablation for ventricular tachycardia (StAR-VT)
Notice bibliographique
Résumé
Abstract Background Cardiac radioablation (CRA) for refractory ventricular tachycardia (VT) was introduced in 2017 following the success of the ENCORE-VT trial (1). The current standard of care radiation therapy dose is 25 Gy in 1 fraction, however, the optimal therapeutic dose is being explored. Previous studies have shown fibrosis, reduced bipolar voltage, and scar formation in areas treated with radioablation at doses above 15 Gy. A study suggest that CRA upregulates connexin-43 and sodium channel, NaV1.5, thereby enhancing conduction velocity through cellular reprogramming, even at lower doses (2). Aim In this interim analysis of a single institution, phase 2, dose de-escalation clinical trial, we report the early efficacy in managing refractory ventricular tachycardia. Methods Eligible patients with ischemic or non-ischemic cardiomyopathy experiencing recurrent, monomorphic VT unresponsive to standard medical therapy were offered participation in the study. Patients unable to undergo or contraindicated to invasive electrophysiology study were included if their arrhythmic substrate could be identified non-invasively. Exclusion criteria included prior thoracic radiation therapy, active connective tissue disease, or interstitial pulmonary fibrosis. The CRA workflow is summarised in Figure A. Implantable defibrillators were programmed at the physician’s discretion, with an anti-tachycardia pacing (ATP) zone set, typically set 20 msec slower than the documented arrhythmia. Following treatment, a 6-week blanking period was allowed. During this blanking period, arrhythmia events were tracked but were not included in the efficacy analysis. Follow-ups, including device interrogation, were conducted at 6 weeks, 3 and 6 months. Results Five patients (4 males [80%], mean age 77 ± 3.2 years) have received CRA of 20 Gy in 1 fraction. The median left ventricular ejection fraction was 25% (range 19%-35%). Four patients had an ischemic substrate, and one had a non-ischemic substrate (valvular disease). The average planning target volume was 187.5 ml (IQR 95.9–209.3 ml). After a median follow-up of 6 months, four patients remained stable, and one patient died (secondary to septic shock). Two patients had recurrent VT, one of which presented as a VT storm within the 6-week blanking period but subsequently stabilised. The total VT burden, defined as any sustained VT episodes requiring ICD therapies (both ATP and/or shocks), decreased significantly from 14 episodes to 1 (p = 0.042; Graph A). Episodes requiring an ICD shock reduced from 6 to 0, while those requiring ATP decreased from 14 to 1. VT storm events decreased from 3 to 0. Conclusion This interim analysis demonstrates that a 20 Gy dose effectively reduces VT burden. Preliminary efficacy results for a single 20 Gy dose of CRA are promising; however, data remain too limited for definitive conclusions.Figure A:Workflow for CRA Graph A:6-month ventricular arrhythmia
Récupéré en direct depuis OpenAlex et désinversé. Les résumés ne sont pas conservés dans cette base de données : les index inversés représentent 8,6 Go des 9,3 Go de texte de la base, et le serveur dispose de 13 Go libres.
Comment cette classification a été obtenuedéplier
Prédiction distillée sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Apprise à partir de 10 348 étiquettes directes de Codex et de 10 348 étiquettes directes de Gemma. Le mode candidate est l'union des têtes enseignantes seuillées; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont ni des étiquettes humaines ni des étiquettes directes de modèles de pointe.
Scores Codex et Gemma par catégorie
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,000 | 0,000 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,000 | 0,001 |
| Bibliométrie | 0,000 | 0,001 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,000 | 0,000 |
| Science ouverte | 0,000 | 0,000 |
| Intégrité de la recherche | 0,000 | 0,000 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,000 | 0,000 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule tête enseignante, pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».