• Je něco špatně v tomto záznamu ?

Clinical evaluation of a small implantable cardiac monitor with a long sensing vector

C. Piorkowski, M. Busch, G. Nölker, J. Schmitt, FX. Roithinger, G. Young, M. Táborský, G. Herrmann, D. Schmitz,

. 2019 ; 42 (7) : 1038-1046. [pub] 20190605

Jazyk angličtina Země Spojené státy americké

Typ dokumentu hodnotící studie, časopisecké články, multicentrická studie

Perzistentní odkaz   https://www.medvik.cz/link/bmc20025810

INTRODUCTION: We conducted this study to show the safety and efficacy of a new implantable cardiac monitor (ICM), the BioMonitor 2 (Biotronik SE & Co. KG; Berlin, Germany), and to describe the arrhythmia detection performance. METHODS: The BioMonitor 2 has an extended sensing vector and is implanted close to the heart. It can transmit up to six subcutaneous electrocardiogram strips by Home Monitoring each day. We enrolled 92 patients with a standard device indication for an ICM in a single-arm, multicenter prospective trial. Patients were followed for 3 months, and 48-h Holter recordings were used to evaluate the arrhythmia detection performance. RESULTS: One patient withdrew consent and in one patient, the implantation failed. Two study device-related serious adverse events were reported, satisfying the primary safety hypothesis. Implantations took 7.4 ± 4.4 min from skin cut to suture. At 1 week, the R-wave amplitude was 0.75 ± 0.53 mV. In the 82 patients with completed Holter recordings, all patients with arrhythmias were correctly identified. False positive detections of arrhythmia were mostly irregular rhythms wrongly detected as atrial fibrillation (episode-based positive predictive value 72.5%). Daily Home Monitoring transmission was 94.9% successful. CONCLUSION: Safety and efficacy of the new device has been demonstrated. The detected R-wave amplitudes are large, leading to a low level of inappropriate detections due to over- or undersensing.

Citace poskytuje Crossref.org

000      
00000naa a2200000 a 4500
001      
bmc20025810
003      
CZ-PrNML
005      
20201222155439.0
007      
ta
008      
201125s2019 xxu f 000 0|eng||
009      
AR
024    7_
$a 10.1111/pace.13728 $2 doi
035    __
$a (PubMed)31119745
040    __
$a ABA008 $b cze $d ABA008 $e AACR2
041    0_
$a eng
044    __
$a xxu
100    1_
$a Piorkowski, Christopher $u Department of Invasive Electrophysiology, Heart Center Dresden, Dresden, Germany.
245    10
$a Clinical evaluation of a small implantable cardiac monitor with a long sensing vector / $c C. Piorkowski, M. Busch, G. Nölker, J. Schmitt, FX. Roithinger, G. Young, M. Táborský, G. Herrmann, D. Schmitz,
520    9_
$a INTRODUCTION: We conducted this study to show the safety and efficacy of a new implantable cardiac monitor (ICM), the BioMonitor 2 (Biotronik SE & Co. KG; Berlin, Germany), and to describe the arrhythmia detection performance. METHODS: The BioMonitor 2 has an extended sensing vector and is implanted close to the heart. It can transmit up to six subcutaneous electrocardiogram strips by Home Monitoring each day. We enrolled 92 patients with a standard device indication for an ICM in a single-arm, multicenter prospective trial. Patients were followed for 3 months, and 48-h Holter recordings were used to evaluate the arrhythmia detection performance. RESULTS: One patient withdrew consent and in one patient, the implantation failed. Two study device-related serious adverse events were reported, satisfying the primary safety hypothesis. Implantations took 7.4 ± 4.4 min from skin cut to suture. At 1 week, the R-wave amplitude was 0.75 ± 0.53 mV. In the 82 patients with completed Holter recordings, all patients with arrhythmias were correctly identified. False positive detections of arrhythmia were mostly irregular rhythms wrongly detected as atrial fibrillation (episode-based positive predictive value 72.5%). Daily Home Monitoring transmission was 94.9% successful. CONCLUSION: Safety and efficacy of the new device has been demonstrated. The detected R-wave amplitudes are large, leading to a low level of inappropriate detections due to over- or undersensing.
650    _2
$a srdeční arytmie $x diagnóza $7 D001145
650    _2
$a elektrokardiografie ambulantní $x přístrojové vybavení $7 D015716
650    _2
$a design vybavení $7 D004867
650    _2
$a ženské pohlaví $7 D005260
650    _2
$a lidé $7 D006801
650    _2
$a mužské pohlaví $7 D008297
650    _2
$a lidé středního věku $7 D008875
650    _2
$a prospektivní studie $7 D011446
655    _2
$a hodnotící studie $7 D023362
655    _2
$a časopisecké články $7 D016428
655    _2
$a multicentrická studie $7 D016448
700    1_
$a Busch, Mathias $u Department of Internal Medicine B, Greifswald University Hospital, Greifswald, Germany.
700    1_
$a Nölker, Georg $u Clinic for Cardiology, Herz- und Diabeteszentrum NRW, Ruhr-Universität Bochum, Bad Oeynhausen, Germany.
700    1_
$a Schmitt, Jörn $u Department of Cardiology, University Hospital Giessen, Giessen, Germany.
700    1_
$a Roithinger, Franz Xaver $u Department of Inner Medicine, Landesklinikum Mödling, Mödling, Austria.
700    1_
$a Young, Glenn $u Department of Cardiology, St. Andrew's Hospital, Adelaide, South Australia, Australia.
700    1_
$a Táborský, Miloš $u Department of Internal Medicine-Cardiology, University Hospital Olomouc, Olomouc, Czech Republic.
700    1_
$a Herrmann, Gundula $u Center of Clinical Research, Biotronik SE & Co. KG, Berlin, Germany.
700    1_
$a Schmitz, Dietmar $u Clinic for Cardiology and Angiology, St. Elisabeth Hospital Essen, Essen, Germany.
773    0_
$w MED00003671 $t Pacing and clinical electrophysiology : PACE $x 1540-8159 $g Roč. 42, č. 7 (2019), s. 1038-1046
856    41
$u https://pubmed.ncbi.nlm.nih.gov/31119745 $y Pubmed
910    __
$a ABA008 $b sig $c sign $y a $z 0
990    __
$a 20201125 $b ABA008
991    __
$a 20201222155435 $b ABA008
999    __
$a ok $b bmc $g 1599955 $s 1116496
BAS    __
$a 3
BAS    __
$a PreBMC
BMC    __
$a 2019 $b 42 $c 7 $d 1038-1046 $e 20190605 $i 1540-8159 $m Pacing and clinical electrophysiology $n Pacing Clin Electrophysiol $x MED00003671
LZP    __
$a Pubmed-20201125

Najít záznam

Citační ukazatele

    Možnosti archivace