PMID- 26412309
OWN - NLM
STAT- MEDLINE
DCOM- 20170110
LR  - 20220409
IS  - 1540-8159 (Electronic)
IS  - 0147-8389 (Linking)
VI  - 38
IP  - 12
DP  - 2015 Dec
TI  - Safety Profile of a Miniaturized Insertable Cardiac Monitor: Results from Two 
      Prospective Trials.
PG  - 1464-9
LID - 10.1111/pace.12752 [doi]
AB  - 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.
CI  - (c) 2015 The Authors. Pacing and Clinical Electrophysiology published by Wiley 
      Periodicals, Inc.
FAU - Mittal, Suneet
AU  - Mittal S
AD  - Electrophysiology Laboratory, The Valley Hospital, Valley Health System, 
      Ridgewood, New Jersey.
FAU - Sanders, Prashanthan
AU  - Sanders P
AD  - Centre for Heart Rhythm Disorders, South Australian Health and Medical Research 
      Institute, University of Adelaide and Royal Adelaide Hospital, Adelaide, 
      Australia.
FAU - Pokushalov, Evgeny
AU  - Pokushalov E
AD  - Arrhythmia Department, State Research Institute of Circulation Pathology, 
      Novosibirsk, Russia.
FAU - Dekker, Lukas
AU  - Dekker L
AD  - Department of Cardiology, Catharina Hospital, Eindhoven, the Netherlands.
FAU - Kereiakes, Dean
AU  - Kereiakes D
AD  - The Carl and Edyth Lindner Center for Research and Education, The Christ 
      Hospital, Cincinnati, Ohio.
FAU - Schloss, Edward J
AU  - Schloss EJ
AD  - The Carl and Edyth Lindner Center for Research and Education, The Christ 
      Hospital, Cincinnati, Ohio.
FAU - Pouliot, Erika
AU  - Pouliot E
AD  - Departments of Statistics and Clinical Research, Medtronic, Inc, Mounds View, 
      Minnesota.
FAU - Franco, Noreli
AU  - Franco N
AD  - Departments of Statistics and Clinical Research, Medtronic, Inc, Mounds View, 
      Minnesota.
FAU - Zhong, Yan
AU  - Zhong Y
AD  - Departments of Statistics and Clinical Research, Medtronic, Inc, Mounds View, 
      Minnesota.
FAU - DI Bacco, Marco
AU  - DI Bacco M
AD  - Department of Clinical Research, Medtronic Bakken Research Center BV, Maastricht, 
      the Netherlands.
FAU - Purerfellner, Helmut
AU  - Purerfellner H
AD  - Department of Cardiology, Elisabethinen University Teaching Hospital, Linz, 
      Austria.
LA  - eng
PT  - Controlled Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
DEP - 20151020
PL  - United States
TA  - Pacing Clin Electrophysiol
JT  - Pacing and clinical electrophysiology : PACE
JID - 7803944
SB  - IM
MH  - Electrocardiography, Ambulatory/*statistics & numerical data
MH  - Equipment Design
MH  - Equipment Failure Analysis
MH  - Equipment Safety/statistics & numerical data
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Miniaturization
MH  - Pain, Postoperative/*epidemiology
MH  - Prospective Studies
MH  - Prostheses and Implants/*statistics & numerical data
MH  - Prosthesis Implantation/*statistics & numerical data
MH  - Prosthesis-Related Infections/*epidemiology
MH  - Surgical Wound Infection/*epidemiology
OTO - NOTNLM
OT  - adverse events
OT  - arrhythmia monitoring
OT  - insertable cardiac monitor
OT  - safety
EDAT- 2015/09/29 06:00
MHDA- 2017/01/11 06:00
CRDT- 2015/09/29 06:00
PHST- 2015/06/30 00:00 [received]
PHST- 2015/08/17 00:00 [revised]
PHST- 2015/09/20 00:00 [accepted]
PHST- 2015/09/29 06:00 [entrez]
PHST- 2015/09/29 06:00 [pubmed]
PHST- 2017/01/11 06:00 [medline]
AID - 10.1111/pace.12752 [doi]
PST - ppublish
SO  - Pacing Clin Electrophysiol. 2015 Dec;38(12):1464-9. doi: 10.1111/pace.12752. Epub 
      2015 Oct 20.