Søren Zöga Diederichsen1, Ketil Jørgen Haugan2, Søren Højberg3, Anders Gaarsdal Holst4, Lars Køber5, Kenneth Bruun Pedersen6, Claus Graff7, Derk Krieger8, Axel Brandes6, Jesper Hastrup Svendsen9. 1. Department of Cardiology, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, 2100 Copenhagen, Denmark. Electronic address: Soeren.Zoega.Diederichsen@regionh.dk. 2. Department of Cardiology, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, 2100 Copenhagen, Denmark; Department of Cardiology, Zealand University Hospital, Sygehusvej 10, 4000 Roskilde, Roskilde, Denmark. 3. Department of Cardiology, Bispebjerg Hospital, Copenhagen University Hospital, Bispebjerg Bakke 23, 2400 Bispebjerg, Denmark. 4. Department of Cardiology, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, 2100 Copenhagen, Denmark; The Danish National Research Foundation Centre for Cardiac Arrhythmia, Blegdamsvej 3, 2200 Copenhagen, Denmark. 5. Department of Cardiology, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, 2100 Copenhagen, Denmark; Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Blegdamsvej 3B, 2200 København N, Copenhagen, Denmark. 6. Department of Cardiology, Odense University Hospital, and Department of Clinical Research, University of Southern Denmark, Sdr. Boulevard 29, 5000 Odense, Denmark. 7. Department of Health Science and Technology, Aalborg University, Fredrik Bajers Vej 7 D2, 9220 Aalborg, Denmark. 8. University Hospital Zurich, Rämistrasse 100, 8091 Zürich, Switzerland, & Mediclinic City Hospital, Building #37, Dubai Health Care City, Dubai, United Arabic Emirates. 9. Department of Cardiology, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, 2100 Copenhagen, Denmark; The Danish National Research Foundation Centre for Cardiac Arrhythmia, Blegdamsvej 3, 2200 Copenhagen, Denmark; Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Blegdamsvej 3B, 2200 Copenhagen, Denmark.
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 anICM, 753 (53%) in a procedure room and 667 (47%) in an electrophysiology laboratory. During a median follow-up of 499days, 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.
RCT Entities:
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 499days, 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.
Authors: Benedict M Wiles; Caroline A Illingworth; Michael Lg Couzins; Paul R Roberts; Stephen P Harden Journal: Br J Radiol Date: 2018-02-01 Impact factor: 3.039
Authors: Prashanthan Sanders; Christopher Piorkowski; Johannes A Kragten; Grahame K Goode; Satish R Raj; Trang Dinh; M Rizwan Sohail; Rishi Anand; Angel Moya-Mitjans; Noreli Franco; Kurt Stromberg; John D Rogers Journal: BMC Cardiovasc Disord Date: 2019-05-31 Impact factor: 2.298
Authors: Thomas Deneke; Pilar Cabanas; Daniel Hofer; Thomas Gaspar; Bertrand Pierre; Giovanni Bisignani; Rajeev Kumar Pathak; Victor Manuel Sanfins; Eimo Martens; Jacques Mansourati; Antonio Berruezo-Sanchez; Marcus Wiemer; Andreas Hain; Thomas Pezawas; Beate Wenzel; Dennis Lau Journal: Heart Rhythm O2 Date: 2022-01-30