Miniaturized Reveal LINQ insertable cardiac monitoring system: First-in-human experience

H. Pürerfellner; P. Sanders; E. Pokushalov; M. Di Bacco; T. Bergemann; L.R.C. Dekker; Reveal LINQ Usability Study Investigators

doi:10.1016/j.hrthm.2015.02.030

Miniaturized Reveal LINQ insertable cardiac monitoring system: First-in-human experience

H. Pürerfellner, P. Sanders, E. Pokushalov, M. Di Bacco, T. Bergemann, L.R.C. Dekker, Reveal LINQ Usability Study Investigators

Research output: Contribution to journal › Article › Academic › peer-review

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Abstract

BACKGROUND: The Reveal LINQ is a miniaturized insertable cardiac monitor (ICM) with wireless telemetry for remote monitoring of patients with suspected arrhythmias.

OBJECTIVE: The primary objective of this study was to evaluate the functionality of the Reveal LINQ system by measuring R-wave sensing and data transmission.

METHODS: The Reveal LINQ Usability Study was a nonrandomized, prospective, multicenter trial. The study enrolled 30 patients with any indication for an ICM. Data were collected at baseline, implantation, and 1-month follow-up visits and through daily wireless transmissions.

RESULTS: Thirty patients were enrolled and had a Reveal LINQ device implanted. The mean age was 55 ± 15 years. All patients had successful implantation of the ICM in one of the recommended locations. Ease of implantation procedure was rated as easy or very easy for 90% of implantations. R-wave amplitudes were 0.584 ± 0.325 mV at implantation and 0.596 ± 0.336 mV at 1 month (P = .8). Automatic transmissions were successful 79.5% (69.5%-86.9%) of the time. Transmission failures that caused a delay in data transfer occurred because of incomplete data reception or patients being out of range in 45% and 42% of instances, respectively. For all patients, transmission failures were followed by successful automated or manual transmission of information on a subsequent day. The devices stored 217 arrhythmic episodes during 30 days of follow-up, identified as atrial fibrillation (n = 111), asystole (n = 95), bradycardia (n = 4), fast ventricular tachycardia (n = 1), and ventricular tachycardia ( n = 6). No serious procedure- or system-related adverse events occurred during the 1-month follow-up period.

CONCLUSION: The miniaturized Reveal LINQ ICM supports arrhythmia detection and monitoring, achieving adequate sensing performance without safety issues.

CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01965899.

Original language	English
Pages (from-to)	1113-1119
Journal	Heart Rhythm
Volume	12
Issue number	6
DOIs	https://doi.org/10.1016/j.hrthm.2015.02.030
Publication status	Published - Jun 2015

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title = "Miniaturized Reveal LINQ insertable cardiac monitoring system: First-in-human experience",

abstract = "BACKGROUND: The Reveal LINQ is a miniaturized insertable cardiac monitor (ICM) with wireless telemetry for remote monitoring of patients with suspected arrhythmias.OBJECTIVE: The primary objective of this study was to evaluate the functionality of the Reveal LINQ system by measuring R-wave sensing and data transmission.METHODS: The Reveal LINQ Usability Study was a nonrandomized, prospective, multicenter trial. The study enrolled 30 patients with any indication for an ICM. Data were collected at baseline, implantation, and 1-month follow-up visits and through daily wireless transmissions.RESULTS: Thirty patients were enrolled and had a Reveal LINQ device implanted. The mean age was 55 ± 15 years. All patients had successful implantation of the ICM in one of the recommended locations. Ease of implantation procedure was rated as easy or very easy for 90% of implantations. R-wave amplitudes were 0.584 ± 0.325 mV at implantation and 0.596 ± 0.336 mV at 1 month (P = .8). Automatic transmissions were successful 79.5% (69.5%-86.9%) of the time. Transmission failures that caused a delay in data transfer occurred because of incomplete data reception or patients being out of range in 45% and 42% of instances, respectively. For all patients, transmission failures were followed by successful automated or manual transmission of information on a subsequent day. The devices stored 217 arrhythmic episodes during 30 days of follow-up, identified as atrial fibrillation (n = 111), asystole (n = 95), bradycardia (n = 4), fast ventricular tachycardia (n = 1), and ventricular tachycardia ( n = 6). No serious procedure- or system-related adverse events occurred during the 1-month follow-up period.CONCLUSION: The miniaturized Reveal LINQ ICM supports arrhythmia detection and monitoring, achieving adequate sensing performance without safety issues.CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01965899.",

author = "H. P{\"u}rerfellner and P. Sanders and E. Pokushalov and {Di Bacco}, M. and T. Bergemann and L.R.C. Dekker and {Reveal LINQ Usability Study Investigators}",

year = "2015",

month = jun,

doi = "10.1016/j.hrthm.2015.02.030",

language = "English",

volume = "12",

pages = "1113--1119",

journal = "Heart Rhythm",

issn = "1547-5271",

publisher = "Elsevier",

number = "6",

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T1 - Miniaturized Reveal LINQ insertable cardiac monitoring system

T2 - First-in-human experience

AU - Pürerfellner, H.

AU - Sanders, P.

AU - Pokushalov, E.

AU - Di Bacco, M.

AU - Bergemann, T.

AU - Dekker, L.R.C.

AU - Reveal LINQ Usability Study Investigators

PY - 2015/6

Y1 - 2015/6

N2 - BACKGROUND: The Reveal LINQ is a miniaturized insertable cardiac monitor (ICM) with wireless telemetry for remote monitoring of patients with suspected arrhythmias.OBJECTIVE: The primary objective of this study was to evaluate the functionality of the Reveal LINQ system by measuring R-wave sensing and data transmission.METHODS: The Reveal LINQ Usability Study was a nonrandomized, prospective, multicenter trial. The study enrolled 30 patients with any indication for an ICM. Data were collected at baseline, implantation, and 1-month follow-up visits and through daily wireless transmissions.RESULTS: Thirty patients were enrolled and had a Reveal LINQ device implanted. The mean age was 55 ± 15 years. All patients had successful implantation of the ICM in one of the recommended locations. Ease of implantation procedure was rated as easy or very easy for 90% of implantations. R-wave amplitudes were 0.584 ± 0.325 mV at implantation and 0.596 ± 0.336 mV at 1 month (P = .8). Automatic transmissions were successful 79.5% (69.5%-86.9%) of the time. Transmission failures that caused a delay in data transfer occurred because of incomplete data reception or patients being out of range in 45% and 42% of instances, respectively. For all patients, transmission failures were followed by successful automated or manual transmission of information on a subsequent day. The devices stored 217 arrhythmic episodes during 30 days of follow-up, identified as atrial fibrillation (n = 111), asystole (n = 95), bradycardia (n = 4), fast ventricular tachycardia (n = 1), and ventricular tachycardia ( n = 6). No serious procedure- or system-related adverse events occurred during the 1-month follow-up period.CONCLUSION: The miniaturized Reveal LINQ ICM supports arrhythmia detection and monitoring, achieving adequate sensing performance without safety issues.CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01965899.

AB - BACKGROUND: The Reveal LINQ is a miniaturized insertable cardiac monitor (ICM) with wireless telemetry for remote monitoring of patients with suspected arrhythmias.OBJECTIVE: The primary objective of this study was to evaluate the functionality of the Reveal LINQ system by measuring R-wave sensing and data transmission.METHODS: The Reveal LINQ Usability Study was a nonrandomized, prospective, multicenter trial. The study enrolled 30 patients with any indication for an ICM. Data were collected at baseline, implantation, and 1-month follow-up visits and through daily wireless transmissions.RESULTS: Thirty patients were enrolled and had a Reveal LINQ device implanted. The mean age was 55 ± 15 years. All patients had successful implantation of the ICM in one of the recommended locations. Ease of implantation procedure was rated as easy or very easy for 90% of implantations. R-wave amplitudes were 0.584 ± 0.325 mV at implantation and 0.596 ± 0.336 mV at 1 month (P = .8). Automatic transmissions were successful 79.5% (69.5%-86.9%) of the time. Transmission failures that caused a delay in data transfer occurred because of incomplete data reception or patients being out of range in 45% and 42% of instances, respectively. For all patients, transmission failures were followed by successful automated or manual transmission of information on a subsequent day. The devices stored 217 arrhythmic episodes during 30 days of follow-up, identified as atrial fibrillation (n = 111), asystole (n = 95), bradycardia (n = 4), fast ventricular tachycardia (n = 1), and ventricular tachycardia ( n = 6). No serious procedure- or system-related adverse events occurred during the 1-month follow-up period.CONCLUSION: The miniaturized Reveal LINQ ICM supports arrhythmia detection and monitoring, achieving adequate sensing performance without safety issues.CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01965899.

U2 - 10.1016/j.hrthm.2015.02.030

DO - 10.1016/j.hrthm.2015.02.030

M3 - Article

C2 - 25728756

SN - 1547-5271

VL - 12

SP - 1113

EP - 1119

JO - Heart Rhythm

JF - Heart Rhythm

IS - 6

ER -

Miniaturized Reveal LINQ insertable cardiac monitoring system: First-in-human experience

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