Sensing and detection performance of the novel, small-diameter omniasecure defibrillation lead: leadr trial analysis
Notice bibliographique
Résumé
Abstract Introduction The Lead EvaluAtion for Defibrillation and Reliability (LEADR) trial evaluated the small-diameter (4.7Fr), integrated bipolar OmniaSecure defibrillation lead. The trial exceeded primary safety and efficacy endpoint thresholds, demonstrating favorable performance and zero fractures through ~12 mo; patients remain in ongoing follow-up. Purpose To report on chronic electrical performance of the OmniaSecure lead through midterm follow-up of the LEADR trial. Methods Patients with indication for de novo ICD/CRT-D were implanted with the OmniaSecure lead in standard RV locations and followed at prespecified intervals along with CareLink. Results As reported, a total of 643 patients were implanted with the OmniaSecure lead; the lead continues to show favorable safety, efficacy, and reliability with zero fractures through midterm follow-up (18.2 ± 5.5 mo). Electrical measurements (Pacing capture threshold, pacing impedance, and R-wave amplitude) were chronically stable through follow-up; average R-wave amplitudes were >10mV throughout (Figure 1). Nineteen patients had reports of P-wave oversensing (PWOS), however there were zero inappropriate shocks due to PWOS. Among those with associated adverse events, 3 resulted in system modification and 1 in reprogramming. The remaining 15 patients had instances of PWOS noted by physicians via monitoring that were not associated with an adverse event; resolved via repositioning at implant (1) and reprogramming (14). Thirty-eight patients had reports of T-wave oversensing (TWOS). Among these, 1 patient had a system modification and 3 patients had reprogramming after inappropriate shock after which no further IAS was reported. The remaining 34 patients had instances of TWOS noted by physicians at device checks that were not associated with an adverse event; 1 resulted in unsuccessful implant and 1 had no action taken for lack of clinical concern, the others were resolved via repositioning at implant (1) and reprogramming (31). Additionally, 1 patient reported both TWOS and PWOS; both resolved via reprogramming with no further reports of TWOS/PWOS. During induced VF sensing at implant, 98% (119/122) of patients showed appropriate detection at the least sensitive setting (1.2mV) and the remaining were successful at more sensitive settings. There were 670 ambulatory VT/VF episodes appropriately treated in 94 patients, all of which were successfully detected across a variety of programmed sensitivities (Table 1) with no reported undersensing. Conclusion Chronic sensing performance of the OmniaSecure defibrillation lead demonstrated R-wave stability with a low rate of PWOS and TWOS, predominantly resolved by reprogramming RV sensitivity. Furthermore, VT/VF detection was successful in all patients and was not impacted when reprogrammed to less sensitive settings. The OmniaSecure lead shows a robustness of sensing and detection performance and programmability.Figure 1:Chronic electrical stability o Table 1:Proportion of successfully trea
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 | 0,000 |
| 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 ».