Feasibility of a novel implantable device to provide heart failure therapy and left atrial pressure monitoring in a chronic animal study
Notice bibliographique
Résumé
Abstract Introduction Pulmonary Artery Pressure Monitoring (PAPM) has been shown to reduce rehospitalization in heart failure (HF) patients. Interatrial Shunting Therapy (IST) is in clinical studies for similar purposes. However, current available devices provide either PAPM or IST, but not both in the same device. Purpose A novel implantable device system has been developed to provide IST and Left Atrial Pressure (LAP) monitoring. The system consists of an implant, a delivery system, and an external Monitoring Unit (MU). The MU works with the battery-less MEMS pressure sensor, as part of the implant, to provide the measured LAP to user. The aim of this study is to assess the feasibility of the system and accuracy of measured LAP as compared to the Swan-Ganz measured Pulmonary Capillary Wedge Pressure (PCWP) in a chronic canine study. Methods The implant is designed to integrate the interatrial shunting and LAP sensing. It is designed to be placed on the atrial septum with the fixation by three pairs of nitinol anchors. The device was implanted in 10 healthy dogs (Labrador, 30-35 Kg), with 4 observed for 1 month and 6 for 3 months, all under general anesthesia. Procedure success, safety outcome, shunt patency (via TEE) and pressure accuracy were evaluated. In order to achieve various pressure levels, phenylephrine (0.05-2.00 mg) was injected during implant and at the end of each follow up (FU) before termination. Pressure waveforms of PCWP and LAP from the device sensor were recorded for more than 10 seconds simultaneously by PowerLab (PLC01) and MU respectively. Correlation and agreement between LAP and PCWP from implant and FU were assessed with Pearson’s correlation analysis and Bland-Altman plots. Results The implant was successful in all dogs and the shunt was patent at 1 or 3 months. No device related adverse event was observed during FU periods and gross anatomical findings at termination at 1 or 3 months were all acceptable. Pressure points were obtained at each time for each dog, with a total of 42 pairs of pressure measurements ranging from 0 to 22 mmHg from all dogs. Fig. 1a shows an example of the gross anatomy of encapsulation of the device by a thin layer of endothelium at 3 months. Representative simultaneous waveform recordings, correlation and Bland-Altman plot are shown in Fig.1b-d. The PCWP and LAP measurements correlated well (R²=0.87), with an average difference of 0.33±1.80 mmHg. In the Bland-Altman plot, 40 of 42 pairs fell inside the 95% limit of agreement, indicating good agreement between PCWP measured by Swan-Ganz and LAP by the MEMS pressure sensor of the device. Conclusions This preliminary chronic canine study demonstrated the feasibility of this implantable device and the accuracy of LAP from the MEMS sensor as compared to PCWP. Further studies are warranted. This novel device with interatrial shunting therapy and hemodynamics may provide clinicians with more options for managing HF patients.Fig.1
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 | 0,001 | 0,001 |
| Méta-épidémiologie (sens strict) | 0,001 | 0,000 |
| Méta-épidémiologie (sens large) | 0,001 | 0,001 |
| Bibliométrie | 0,001 | 0,000 |
| Études des sciences et des technologies | 0,000 | 0,001 |
| Communication savante | 0,000 | 0,001 |
| Science ouverte | 0,001 | 0,000 |
| Intégrité de la recherche | 0,001 | 0,001 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,001 | 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 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 ».