Complications after implantation of a new | 合法醫療器材資訊網

由SZDiederichsen著作·2017·被引用12次—TheRevealLINQ™ICMcanbeinsertedwithaverylowriskof...afterimplantationofanew-generationinsertablecardiacmonitor:Results ...

Background: Insertable cardiac monitors (ICM) are leadless devices utilized in long-term monitoring of the heart rhythm. The implantation procedure of the new-generation ICMs is minimally invasive, but little experience exists regarding complications. We thus aimed to investigate adverse events (AE) according to procedure-related characteristics after implantation of a large number of new-generation ICMs.

Methods: The study population consisted of participants randomized to receive ICM in a multi-center trial. The Reveal LINQ™ ICM was implanted using provided insertion tools, either in an electrophysiology laboratory or outpatient procedure room. If device sensing was insufficient in the first subcutaneous position, one or more repositions were performed. Patients were urged to make contact if they suspected any AE. Furthermore, follow-up for safety endpoints consisted of evaluation of medical recor...