New generation cardioverter‐defibrillator lead with a floating atrial sensing dipole: Long‐term performance
Objectives The study aim is to present the long‐term performance of a new generation implantable cardioverter defibrillator (ICD) electrode with floating atrial dipole (Linox S DX, Biotronik, Berlin, Germany). Background The single ICD electrode with a floating dipole in the atrial chamber was intro...
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Published in | Pacing and clinical electrophysiology Vol. 41; no. 2; pp. 128 - 135 |
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Main Authors | , , , , , , , |
Format | Journal Article |
Language | English |
Published |
United States
Wiley Subscription Services, Inc
01.02.2018
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Subjects | |
Online Access | Get full text |
ISSN | 0147-8389 1540-8159 1540-8159 |
DOI | 10.1111/pace.13256 |
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Abstract | Objectives
The study aim is to present the long‐term performance of a new generation implantable cardioverter defibrillator (ICD) electrode with floating atrial dipole (Linox S DX, Biotronik, Berlin, Germany).
Background
The single ICD electrode with a floating dipole in the atrial chamber was introduced about 15 years ago to overcome risk of inappropriate shock.
Methods
After implantation, internal electrocardiogram data were prospectively collected via telemonitoring (Home Monitoring, Biotronik).
Results
A total of 93 patients (81.5% male, 18.5% female; 58.9 ± 12.3 years) were implanted with a single–chamber ICD using the Linox S DX. Patients were followed up for a median of 693 days (33–2,460 days). At time of implantation average p‐wave value was 3.5 ± 1.7 mV and remained stable throughout follow‐up with an average value of 3.7 ± 1 mV (P = 0.2). A total of 460 arrhythmic episodes were recorded and 185 (40.2%) were incorrectly stratified by the device software. Seven patients (7.5%) experienced inappropriate ICD therapy. In three patients, VT episodes were not detected and remained untreated.
Conclusions
Although the Linox S DX lead presents a satisfactory long‐term stability of the atrial sensing, many of the messages sent to the device during follow‐up were incorrectly classified by the ICD software. As a result, inappropriate therapy occurred with a rate similar to that observed with dual‐chamber ICDs, but some malignant arrhythmias remained undiagnosed and untreated while occurring.
Results in larger prospective cohorts should be analyzed and software improvements of the device should be suggested to overcome these potential drawbacks. |
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AbstractList | The study aim is to present the long-term performance of a new generation implantable cardioverter defibrillator (ICD) electrode with floating atrial dipole (Linox S DX, Biotronik, Berlin, Germany).
The single ICD electrode with a floating dipole in the atrial chamber was introduced about 15 years ago to overcome risk of inappropriate shock.
After implantation, internal electrocardiogram data were prospectively collected via telemonitoring (Home Monitoring, Biotronik).
A total of 93 patients (81.5% male, 18.5% female; 58.9 ± 12.3 years) were implanted with a single-chamber ICD using the Linox S DX. Patients were followed up for a median of 693 days (33-2,460 days). At time of implantation average p-wave value was 3.5 ± 1.7 mV and remained stable throughout follow-up with an average value of 3.7 ± 1 mV (P = 0.2). A total of 460 arrhythmic episodes were recorded and 185 (40.2%) were incorrectly stratified by the device software. Seven patients (7.5%) experienced inappropriate ICD therapy. In three patients, VT episodes were not detected and remained untreated.
Although the Linox S DX lead presents a satisfactory long-term stability of the atrial sensing, many of the messages sent to the device during follow-up were incorrectly classified by the ICD software. As a result, inappropriate therapy occurred with a rate similar to that observed with dual-chamber ICDs, but some malignant arrhythmias remained undiagnosed and untreated while occurring. Results in larger prospective cohorts should be analyzed and software improvements of the device should be suggested to overcome these potential drawbacks. Objectives The study aim is to present the long-term performance of a new generation implantable cardioverter defibrillator (ICD) electrode with floating atrial dipole (Linox S DX, Biotronik, Berlin, Germany). Background The single ICD electrode with a floating dipole in the atrial chamber was introduced about 15 years ago to overcome risk of inappropriate shock. Methods After implantation, internal electrocardiogram data were prospectively collected via telemonitoring (Home Monitoring, Biotronik). Results A total of 93 patients (81.5% male, 18.5% female; 58.9 ± 12.3 years) were implanted with a single-chamber ICD using the Linox S DX. Patients were followed up for a median of 693 days (33-2,460 days). At time of implantation average p-wave value was 3.5 ± 1.7 mV and remained stable throughout follow-up with an average value of 3.7 ± 1 mV (P = 0.2). A total of 460 arrhythmic episodes were recorded and 185 (40.2%) were incorrectly stratified by the device software. Seven patients (7.5%) experienced inappropriate ICD therapy. In three patients, VT episodes were not detected and remained untreated. Conclusions Although the Linox S DX lead presents a satisfactory long-term stability of the atrial sensing, many of the messages sent to the device during follow-up were incorrectly classified by the ICD software. As a result, inappropriate therapy occurred with a rate similar to that observed with dual-chamber ICDs, but some malignant arrhythmias remained undiagnosed and untreated while occurring. Results in larger prospective cohorts should be analyzed and software improvements of the device should be suggested to overcome these potential drawbacks. Objectives The study aim is to present the long‐term performance of a new generation implantable cardioverter defibrillator (ICD) electrode with floating atrial dipole (Linox S DX, Biotronik, Berlin, Germany). Background The single ICD electrode with a floating dipole in the atrial chamber was introduced about 15 years ago to overcome risk of inappropriate shock. Methods After implantation, internal electrocardiogram data were prospectively collected via telemonitoring (Home Monitoring, Biotronik). Results A total of 93 patients (81.5% male, 18.5% female; 58.9 ± 12.3 years) were implanted with a single–chamber ICD using the Linox S DX. Patients were followed up for a median of 693 days (33–2,460 days). At time of implantation average p‐wave value was 3.5 ± 1.7 mV and remained stable throughout follow‐up with an average value of 3.7 ± 1 mV (P = 0.2). A total of 460 arrhythmic episodes were recorded and 185 (40.2%) were incorrectly stratified by the device software. Seven patients (7.5%) experienced inappropriate ICD therapy. In three patients, VT episodes were not detected and remained untreated. Conclusions Although the Linox S DX lead presents a satisfactory long‐term stability of the atrial sensing, many of the messages sent to the device during follow‐up were incorrectly classified by the ICD software. As a result, inappropriate therapy occurred with a rate similar to that observed with dual‐chamber ICDs, but some malignant arrhythmias remained undiagnosed and untreated while occurring. Results in larger prospective cohorts should be analyzed and software improvements of the device should be suggested to overcome these potential drawbacks. The study aim is to present the long-term performance of a new generation implantable cardioverter defibrillator (ICD) electrode with floating atrial dipole (Linox S DX, Biotronik, Berlin, Germany).OBJECTIVESThe study aim is to present the long-term performance of a new generation implantable cardioverter defibrillator (ICD) electrode with floating atrial dipole (Linox S DX, Biotronik, Berlin, Germany).The single ICD electrode with a floating dipole in the atrial chamber was introduced about 15 years ago to overcome risk of inappropriate shock.BACKGROUNDThe single ICD electrode with a floating dipole in the atrial chamber was introduced about 15 years ago to overcome risk of inappropriate shock.After implantation, internal electrocardiogram data were prospectively collected via telemonitoring (Home Monitoring, Biotronik).METHODSAfter implantation, internal electrocardiogram data were prospectively collected via telemonitoring (Home Monitoring, Biotronik).A total of 93 patients (81.5% male, 18.5% female; 58.9 ± 12.3 years) were implanted with a single-chamber ICD using the Linox S DX. Patients were followed up for a median of 693 days (33-2,460 days). At time of implantation average p-wave value was 3.5 ± 1.7 mV and remained stable throughout follow-up with an average value of 3.7 ± 1 mV (P = 0.2). A total of 460 arrhythmic episodes were recorded and 185 (40.2%) were incorrectly stratified by the device software. Seven patients (7.5%) experienced inappropriate ICD therapy. In three patients, VT episodes were not detected and remained untreated.RESULTSA total of 93 patients (81.5% male, 18.5% female; 58.9 ± 12.3 years) were implanted with a single-chamber ICD using the Linox S DX. Patients were followed up for a median of 693 days (33-2,460 days). At time of implantation average p-wave value was 3.5 ± 1.7 mV and remained stable throughout follow-up with an average value of 3.7 ± 1 mV (P = 0.2). A total of 460 arrhythmic episodes were recorded and 185 (40.2%) were incorrectly stratified by the device software. Seven patients (7.5%) experienced inappropriate ICD therapy. In three patients, VT episodes were not detected and remained untreated.Although the Linox S DX lead presents a satisfactory long-term stability of the atrial sensing, many of the messages sent to the device during follow-up were incorrectly classified by the ICD software. As a result, inappropriate therapy occurred with a rate similar to that observed with dual-chamber ICDs, but some malignant arrhythmias remained undiagnosed and untreated while occurring. Results in larger prospective cohorts should be analyzed and software improvements of the device should be suggested to overcome these potential drawbacks.CONCLUSIONSAlthough the Linox S DX lead presents a satisfactory long-term stability of the atrial sensing, many of the messages sent to the device during follow-up were incorrectly classified by the ICD software. As a result, inappropriate therapy occurred with a rate similar to that observed with dual-chamber ICDs, but some malignant arrhythmias remained undiagnosed and untreated while occurring. Results in larger prospective cohorts should be analyzed and software improvements of the device should be suggested to overcome these potential drawbacks. |
Author | Caglayan, Evren Safak, Erdal Ince, Hüseyin Kaplan, Hilmi D´Ancona, Giuseppe Öner, Alper Ortak, Jasmin Kische, Stephan |
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Cites_doi | 10.1016/j.ijcard.2016.08.105 10.1056/NEJMoa1608029 10.1111/pace.12171 10.1161/CIRCULATIONAHA.110.940148 10.1056/NEJMoa043399 10.1111/pace.12967 10.1016/j.jacc.2011.04.039 10.1161/CIRCEP.110.958397 10.1111/j.1540-8159.2012.03452.x 10.1023/A:1023921322671 10.1046/j.1540-8167.2001.00143.x 10.1056/NEJMoa071098 10.1056/NEJM199912163412503 10.1111/j.1540-8159.2007.00681.x 10.1046/j.1460-9592.2003.00299.x 10.1161/CIRCULATIONAHA.105.594531 10.1046/j.1460-9592.2001.01489.x |
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Notes | Erdal Safak and Giuseppe D´Ancona contributed equally to this study. Funding Disclosure: None. ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 14 content type line 23 |
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SubjectTerms | Cardiovascular diseases Computer programs Defibrillators Defibrillators, Implantable - trends EKG Electrodes Electrodes, Implanted Equipment Design Equipment Failure Analysis Female Humans ICD atrial dipole floating inappropriate therapy Male Middle Aged Prospective Studies Software Treatment Outcome |
Title | New generation cardioverter‐defibrillator lead with a floating atrial sensing dipole: Long‐term performance |
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