TY - JOUR
T1 - Complications after implantation of a new-generation insertable cardiac monitor
T2 - Results from the LOOP study
AU - Diederichsen, Søren Zöga
AU - Haugan, Ketil Jørgen
AU - Højberg, Søren
AU - Holst, Anders Gaarsdal
AU - Køber, Lars
AU - Pedersen, Kenneth Bruun
AU - Graff, Claus
AU - Krieger, Derk
AU - Brandes, Axel
AU - Svendsen, Jesper Hastrup
PY - 2017/8
Y1 - 2017/8
N2 - 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 records and planned study visits. Results 1420 patients received an ICM, 753 (53%) in a procedure room and 667 (47%) in an electrophysiology laboratory. During a median follow-up of 499 days, 9 (0.63%) and 15 (1.13%) patients experienced AEs with and without need for device explantation, respectively. In the 38 patients requiring device repositioning, more AEs requiring explantation were seen (3 (7.9%) vs. 6 (0.4%), p = 0.001). Patients undergoing implantation in a procedure room had more infections (12 (1.6%) vs. 1 (0.1%), p = 0.004), though no significant difference was reached in AEs requiring explantation (7 (0.9%) vs. 2 (0.3%), p = 0.19). Conclusion The Reveal LINQ™ ICM can be inserted with a very low risk of complications, both in the traditional electrophysiology laboratory setting and in an outpatient procedure room.
AB - 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 records and planned study visits. Results 1420 patients received an ICM, 753 (53%) in a procedure room and 667 (47%) in an electrophysiology laboratory. During a median follow-up of 499 days, 9 (0.63%) and 15 (1.13%) patients experienced AEs with and without need for device explantation, respectively. In the 38 patients requiring device repositioning, more AEs requiring explantation were seen (3 (7.9%) vs. 6 (0.4%), p = 0.001). Patients undergoing implantation in a procedure room had more infections (12 (1.6%) vs. 1 (0.1%), p = 0.004), though no significant difference was reached in AEs requiring explantation (7 (0.9%) vs. 2 (0.3%), p = 0.19). Conclusion The Reveal LINQ™ ICM can be inserted with a very low risk of complications, both in the traditional electrophysiology laboratory setting and in an outpatient procedure room.
KW - Cardiac arrhythmias
KW - Insertable cardiac monitor
KW - Minimally invasive surgical procedures
KW - Operating rooms
KW - Postoperative complications
KW - Remote sensing technology
U2 - 10.1016/j.ijcard.2017.03.144
DO - 10.1016/j.ijcard.2017.03.144
M3 - Journal article
C2 - 28457562
AN - SCOPUS:85018187701
VL - 241
SP - 229
EP - 234
JO - International Journal of Cardiology
JF - International Journal of Cardiology
SN - 0167-5273
ER -