New-generation miniaturized insertable cardiac monitor with a long sensing vector: Insertion procedure, sensing performance, and home monitoring transmission success in a real-world population - Université de Bretagne Occidentale Accéder directement au contenu
Article Dans Une Revue Heart Rhythm O2 Année : 2022

New-generation miniaturized insertable cardiac monitor with a long sensing vector: Insertion procedure, sensing performance, and home monitoring transmission success in a real-world population

Thomas Deneke
  • Fonction : Auteur
Pilar Cabanas
  • Fonction : Auteur
Thomas Gaspar
  • Fonction : Auteur
Giovanni Bisignani
  • Fonction : Auteur
Victor Manuel Sanfins
  • Fonction : Auteur
Eimo Martens
  • Fonction : Auteur
Marcus Wiemer
  • Fonction : Auteur
Andreas Hain
  • Fonction : Auteur
Thomas Pezawas
  • Fonction : Auteur
Beate Wenzel
Dennis Lau
  • Fonction : Auteur

Résumé

Background: Insertable cardiac monitors (ICMs) require an invasive procedure and are used for purely diagnostic purposes. Therefore, simplicity of the insertion procedure, low complication rate, long-term patient acceptance, sensing quality, and reliable remote monitoring are of great importance. Objective: To evaluate a novel ICM (BIOMONITOR III) regarding all these aspects. Methods: BIOMONITOR III has a miniaturized profile, long sensing vector (≈70 mm), a fast insertion tool for pocket formation and ICM placement in 1 step, and daily automatic Home Monitoring (HM) function. We evaluated the insertion procedure, complication rate, patient acceptance, sensing quality, and HM performance in 653 patients with BIOMONITOR III inserted for any ICM indication within 2 ongoing studies involving 51 sites in 11 countries. Results: The median time from skin incision to wound closure was 4.0 minutes (interquartile range, 2.3-6.2 minutes). Median follow-up period was 274 days (interquartile range, 175-342 days). Serious adverse device-related events occurred in 6 patients (0.9%). No deep infections were reported in 334 patients without antibiotic prophylaxis. The wearing comfort was good or excellent in ≈95%. The mean R-wave amplitude (0.73 mV) and HM transmission rate (≈94% of days) were stable over 1.5 years. R-wave amplitudes were larger (mean 0.80 vs 0.62 mV, P < .001) and noise burden was lower (median 3.7 vs 14.5 minutes/day, P < .001) for ICM insertions parallel to the heart's long axis (54.2%) vs parasternal (41.3%). A gross visibility of P waves was 95.1%. Conclusion: The study demonstrated fast insertion times, low complication rate, high patient acceptance, and favorable long-term sensing and HM performance of the ICM.
Fichier principal
Vignette du fichier
New Generation Miniiaturized Insertable Cardiac Monitor.pdf (456.89 Ko) Télécharger le fichier
Origine Accord explicite pour ce dépôt
Licence

Dates et versions

hal-04244648 , version 1 (17-10-2023)

Licence

Identifiants

Citer

Thomas Deneke, Pilar Cabanas, Daniel Hofer, Thomas Gaspar, Bertrand Pierre, et al.. New-generation miniaturized insertable cardiac monitor with a long sensing vector: Insertion procedure, sensing performance, and home monitoring transmission success in a real-world population. Heart Rhythm O2, 2022, 3 (2), pp.152-159. ⟨10.1016/j.hroo.2022.01.010⟩. ⟨hal-04244648⟩
21 Consultations
13 Téléchargements

Altmetric

Partager

Gmail Mastodon Facebook X LinkedIn More