title: Safety Profile of a Miniaturized Insertable Cardiac Monitor: Results from Two Prospective Trials.
abstract: BACKGROUND
  Insertable cardiac monitors (ICMs) are used to continuously monitor the patient's electrocardiogram. In response to patient activation or based on automated device algorithms, arrhythmia episodes are stored and automatically transmitted daily to the clinician. Thus, ICMs can be used to diagnose arrhythmias in at-risk patients and in those with symptoms potentially attributable to arrhythmias. The ICM described in this report has undergone a dramatic change in size and method of insertion.
  
  
  METHODS
  To evaluate the safety profile of the ICM procedure, we analyzed procedure-related adverse events (AEs) from two separate trials: A controlled, nonrandomized multicenter study (Reveal LINQ(TM) Usability study) and a multicenter registry (Reveal LINQ(TM) Registry) evaluating real-world experience. For the Registry we reported all procedure-related AEs upon occurrence, whereas for the Usability study, we reported events occurring during the first month of follow-up.
  
  
  RESULTS
  The Usability study enrolled 151 patients (age 56.6 ± 12.1 years; male 67%) at 16 centers; during follow-up, an infection was observed in 1.3% patients and a procedure-related serious AE (SAE) in 0.7% patients. The Registry enrolled 122 patients (age 61.0 ± 17.8 years; male 47%) at seven centers; during follow-up, an infection was observed in 1.6% patients and a procedure-related SAE in 1.6% patients.
  
  
  CONCLUSIONS
  The cumulative experience from a controlled clinical trial and a "real-world" registry demonstrate that the new ICM can be inserted with very low incidence of AEs.
authors.affiliation: Electrophysiology Laboratory, The Valley Hospital, Valley Health System, Ridgewood, New Jersey.
authors.forename: Suneet
authors.initials: S
authors.lastname: Mittal
authors.affiliation: Centre for Heart Rhythm Disorders, South Australian Health and Medical Research Institute, University of Adelaide and Royal Adelaide Hospital, Adelaide, Australia.
authors.forename: Prashanthan
authors.initials: P
authors.lastname: Sanders
authors.affiliation: Arrhythmia Department, State Research Institute of Circulation Pathology, Novosibirsk, Russia.
authors.forename: Evgeny
authors.initials: E
authors.lastname: Pokushalov
authors.affiliation: Department of Cardiology, Catharina Hospital, Eindhoven, the Netherlands.
authors.forename: Lukas
authors.initials: L
authors.lastname: Dekker
authors.affiliation: The Carl and Edyth Lindner Center for Research and Education, The Christ Hospital, Cincinnati, Ohio.
authors.forename: Dean
authors.initials: D
authors.lastname: Kereiakes
authors.affiliation: The Carl and Edyth Lindner Center for Research and Education, The Christ Hospital, Cincinnati, Ohio.
authors.forename: Edward J
authors.initials: EJ
authors.lastname: Schloss
authors.affiliation: Departments of Statistics and Clinical Research, Medtronic, Inc, Mounds View, Minnesota.
authors.forename: Erika
authors.initials: E
authors.lastname: Pouliot
authors.affiliation: Departments of Statistics and Clinical Research, Medtronic, Inc, Mounds View, Minnesota.
authors.forename: Noreli
authors.initials: N
authors.lastname: Franco
authors.affiliation: Departments of Statistics and Clinical Research, Medtronic, Inc, Mounds View, Minnesota.
authors.forename: Yan
authors.initials: Y
authors.lastname: Zhong
authors.affiliation: Department of Clinical Research, Medtronic Bakken Research Center BV, Maastricht, the Netherlands.
authors.forename: Marco
authors.initials: M
authors.lastname: DI Bacco
authors.affiliation: Department of Cardiology, Elisabethinen University Teaching Hospital, Linz, Austria.
authors.forename: Helmut
authors.initials: H
authors.lastname: Pürerfellner
mesh_terms: D015716:Electrocardiography, Ambulatory / Q000706:statistics & numerical data*; D004867:Equipment Design; D019544:Equipment Failure Analysis; D004869:Equipment Safety / Q000706:statistics & numerical data; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D008904:Miniaturization; D010149:Postoperative Pain / Q000453:epidemiology*; D011446:Prospective Studies; D019736:Prostheses and Implants / Q000706:statistics & numerical data*; D019919:Prosthesis Implantation / Q000706:statistics & numerical data*; D016459:Prosthesis-Related Infections / Q000453:epidemiology*; D013530:Surgical Wound Infection / Q000453:epidemiology*
keywords: adverse events; arrhythmia monitoring; insertable cardiac monitor; safety