Safety and performance of a novel defibrillation lead placed in the left bundle branch area: primary results of the LEADR LBBAP clinical trial
Notice bibliographique
Résumé
Abstract Background Right ventricular placement of the OmniaSecure defibrillation lead has demonstrated high defibrillation success, low occurrence of lead-related major complications and high predicted reliability. With the advent of left bundle branch area pacing (LBBAP) as a more physiologic option for therapeutic delivery of pacing, LBBAP has emerged as a potentially more desirable option for pacing in the ICD population. Purpose To understand the safety and performance of the OmniaSecure defibrillation lead when placed in the LBBA in ICD and CRT indicated patients. Methods The Lead Evaluation for Defibrillation and Reliability in LBBAP (LEADR LBBAP) clinical trial is a global, prospective, non-randomized, multi-center study to evaluate the OmniaSecure defibrillation lead in the LBBAP position. Enrolled patients are indicated for de novo implantation of a primary or secondary prevention ICD (LBBAP-ICD) or left bundle branch area pacing-optimized CRT-D (LOT-CRT-D). LOT-CRT-D patients required a coronary sinus lead for LV pacing. At least 300 patients are required for enrollment with a minimum of 150 LOT-CRT-D implant attempts. Per study protocol, LBBAP includes deep septal pacing. The primary efficacy objective is defibrillation efficacy at implant exceeding a pre-specified threshold of 88% in at least 160 patients. The defibrillation protocol aligned to standard of care testing with a maximum of six inductions and troubleshooting and/or lead repositioning in-between. Defibrillation success was defined as termination of first sustained shockable ventricular arrhythmia (SSVA) episode with 18J or 10J safety margin or termination of additional induced SSVA episodes with a 10J safety margin. The primary safety objective is to demonstrate the lead-related major complication rate at 3 months post-implant. Database snapshot was February 12, 2025. Results As of data snapshot, a total of 191 patients met the criteria for LBBAP implant attempt (age: 66.3±12.0 years; 31.0% female). The physician-reported LBBAP implant success per protocol was 95.8% (n=183; n=104 LBBAP-ICD; n=79 LOT-CRT-D). Defibrillation testing was performed in 162 patients with a protocol success rate of 100%. In 98.1% there was no need for repositioning or troubleshooting as the first induced SSVA was successfully treated. During available follow up (116.7±37.4 days; 62 patients with 3-month follow-up), there was one major lead related complication (high RV threshold) 92 days after implant that resulted in replacement with a non-study lead. There were no lead fractures or deaths related to system and/or procedure. Conclusion The LEADR LBBAP clinical trial is the first large clinical trial to prospectively assess the safety and efficacy of a novel defibrillation lead implanted for LBBAP in a large cohort of ICD and CRT-D indicated patients. These results demonstrate procedural-related safety and efficacy of the OmniaSecure lead when placed for LBBAP. Long-term follow-up is ongoing.
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 machine sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Le volet Gemma est une étiquette directe du modèle pour chaque travail de la base, lue sur la notice réduite au titre. Le volet Codex est un classifieur appris des 10 348 étiquettes directes de Codex et calibré sur les taux pondérés de l'échantillon; les champs sans appui suffisant ne portent aucun appel Codex. Le mode candidate est l'union des deux volets; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont pas des étiquettes humaines.
Scores du classifieur distillé par catégorie (deux têtes)
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,004 | 0,003 |
| Méta-épidémiologie (sens strict) | 0,001 | 0,000 |
| Méta-épidémiologie (sens large) | 0,002 | 0,002 |
| Bibliométrie | 0,000 | 0,000 |
| Études des sciences et des technologies | 0,000 | 0,001 |
| Communication savante | 0,002 | 0,001 |
| Science ouverte | 0,001 | 0,000 |
| Intégrité de la recherche | 0,001 | 0,002 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,003 | 0,001 |
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 source (Gemma direct ou Codex distillé), 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 ».