Complications after implantation of a new-generation insertable cardiac monitor: Results from the LOOP study

Søren Zöga Diederichsen; Ketil Jørgen Haugan; Søren Højberg; Anders Gaarsdal Holst; Lars Køber; Kenneth Bruun Pedersen; Claus Graff; Derk Krieger; Axel Brandes; Jesper Hastrup Svendsen

doi:10.1016/j.ijcard.2017.03.144

Complications after implantation of a new-generation insertable cardiac monitor: Results from the LOOP study

Søren Zöga Diederichsen^*, Ketil Jørgen Haugan, Søren Højberg, Anders Gaarsdal Holst, Lars Køber, Kenneth Bruun Pedersen, Claus Graff, Derk Krieger, Axel Brandes, Jesper Hastrup Svendsen

^*Corresponding author for this work

Department of Clinical Medicine

10 Citations (Scopus)

Abstract

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.

Original language	English
Journal	International Journal of Cardiology
Volume	241
Pages (from-to)	229-234
Number of pages	6
ISSN	0167-5273
DOIs	https://doi.org/10.1016/j.ijcard.2017.03.144
Publication status	Published - Aug 2017

Keywords

Cardiac arrhythmias
Insertable cardiac monitor
Minimally invasive surgical procedures
Operating rooms
Postoperative complications
Remote sensing technology

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10.1016/j.ijcard.2017.03.144

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@article{0fb69c583a924d17a5032fc453d37885,

title = "Complications after implantation of a new-generation insertable cardiac monitor: Results from the LOOP study",

abstract = "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{\texttrademark} 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{\texttrademark} ICM can be inserted with a very low risk of complications, both in the traditional electrophysiology laboratory setting and in an outpatient procedure room.",

keywords = "Cardiac arrhythmias, Insertable cardiac monitor, Minimally invasive surgical procedures, Operating rooms, Postoperative complications, Remote sensing technology",

author = "Diederichsen, {S{\o}ren Z{\"o}ga} and Haugan, {Ketil J{\o}rgen} and S{\o}ren H{\o}jberg and Holst, {Anders Gaarsdal} and Lars K{\o}ber and Pedersen, {Kenneth Bruun} and Claus Graff and Derk Krieger and Axel Brandes and Svendsen, {Jesper Hastrup}",

year = "2017",

month = aug,

doi = "10.1016/j.ijcard.2017.03.144",

language = "English",

volume = "241",

pages = "229--234",

journal = "International Journal of Cardiology",

issn = "0167-5273",

publisher = "Elsevier Ireland Ltd",

}

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

SN - 0167-5273

VL - 241

SP - 229

EP - 234

JO - International Journal of Cardiology

JF - International Journal of Cardiology

ER -

Complications after implantation of a new-generation insertable cardiac monitor: Results from the LOOP study

Abstract

Keywords

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