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Diego Pérez Díez, José Manuel Rubín, David Calvo Cuervo, Daniel García Iglesias, César Morís De La Tassa
BACKGROUND AND OBJECTIVES: Early failure of Biotronik Linox and Linox Smart leads has been reported in numerous recent publications. The aim of this study was to assess the performance of this lead compared with that of 2 other contemporary leads. METHODS: We conducted an ambispective study of all consecutive first implantations of defibrillator leads carried out in our center: Endotak (Boston Scientific, model 148, 158)(n = 173), Sprint Quattro (Medtronic, model 6644, 6947)(n = 145) and Linox Smart (Biotronik, model SD 65/16)(n = 120)...
June 12, 2018: Pacing and Clinical Electrophysiology: PACE
Nicholas A McKeag, Rebecca L Noad, Kyle Ashfield, Carol M Wilson, David J McEneaney, Michael J D Roberts
INTRODUCTION: Insulation failure leading to conductor externalization (CE) of a Linox (Biotronik, Berlin, Germany) implantable cardioverter defibrillator (ICD) lead has recently been reported. The aim of this study was to assess prospectively all Linox family ICD leads implanted at our center for evidence of CE or an electrical abnormality. METHODS: All patients with a Linox family ICD lead implanted at our center, between November 2007 and March 2015, were identified and all living patients were invited to attend for fluoroscopic screening and electrical assessment of the lead...
May 5, 2018: Advances in Therapy
Vanessa Weberndörfer, Tobias Nyffenegger, Ian Russi, Miriam Brinkert, Benjamin Berte, Stefan Toggweiler, Richard Kobza
PURPOSE: Early lead failure has recently been reported in ICD patients with Linox SD leads. We aimed to compare the long-term performance of the following lead model Linox Smart SD with other contemporary high-voltage leads. METHODS: All patients receiving high-voltage leads at our center between November 2009 and May 2017 were retrospectively analyzed. Lead failure was defined as the occurrence of one or more of the following: non-physiological high-rate episodes, low- or high-voltage impedance anomalies, undersensing, or non-capture...
May 1, 2018: Journal of Interventional Cardiac Electrophysiology: An International Journal of Arrhythmias and Pacing
Matthew O'Connor, Darren Hooks, Matthew Webber, Bijia Shi, Stephanie Morrison, Scott Harding, Peter Larsen
INTRODUCTION: ICD lead failure is a potential source of significant morbidity and mortality. This study investigates the survival rates of Sprint Quattro, Endotak Reliance, and Linox ICD leads. METHODS AND RESULTS: A retrospective cohort study of all patients with an ICD implanted between January 2007 and December 2012 from the Wellington Hospital region, New Zealand, a tertiary referral center. Lead and patient details were established by review of clinical notes and the PaceArt Optima database...
April 14, 2018: Journal of Cardiovascular Electrophysiology
Erdal Safak, Giuseppe D Ancona, Hilmi Kaplan, Evren Caglayan, Stephan Kische, Alper Öner, Hüseyin Ince, Jasmin Ortak
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)...
February 2018: Pacing and Clinical Electrophysiology: PACE
Mohammed Shurrab, Amir Janmohamed, Jean-François Sarrazin, Felix Ayala-Paredes, Marcio Sturmer, Randall Williams, Satish Toal, Chris Lane, Kevin E Thorpe, Jeff S Healey, Eugene Crystal
PURPOSE: Atrial fibrillation (AF) is the most common cardiac dysrhythmia. Appropriate detection of AF and early initiation of oral anticoagulation therapy are critical to reduce the risk of stroke. Patients with implantable cardioverter defibrillators (ICD) are at high risk of developing AF. The purpose of the Dx-AF study is to demonstrate that a novel single-lead VDD-ICD system (Linox smart S DX) will facilitate adequate recognition of sub-clinical AF and ultimately stroke prevention with a comparable safety profile in comparison to VVI-ICD...
October 2017: Journal of Interventional Cardiac Electrophysiology: An International Journal of Arrhythmias and Pacing
Satoshi Kawada, Nobuhiro Nishii, Yoshimasa Morimoto, Akihito Miyoshi, Motomi Tachibana, Hiroyasu Sugiyama, Koji Nakagawa, Atsuyuki Watanabe, Hiroshi Morita, Hiroshi Ito
BACKGROUND: An early failure of the Biotronik Linox S/SD implantable cardioverter-defibrillator (ICD) lead has been reported. We have also experienced several cases with early failure of Linox leads. OBJECTIVE: Our aim was to assess the longevity of Linox S/SD (Biotronik, Berlin, Germany) compared with Sprint Fidelis (Medtronic, Minneapolis, MN), Sprint Quattro (Medtronic), and Endotak Reliance (Boston Scientific, Natick, Massachusetts) leads. METHODS: We retrospectively reviewed patients who had undergone implantation of Linox S/SD (n = 90), Sprint Fidelis (n = 37), Sprint Quattro (n = 27), or Endotak Reliance (n = 50) leads between June 2000 and December 2013 at our hospital...
October 2017: Heart Rhythm: the Official Journal of the Heart Rhythm Society
Elia De Maria, Ambra Borghi, Lorenzo Bonetti, Pier Luigi Fontana, Stefano Cappelli
Conductor externalization and insulation failure are frequent complications with the recalled St. Jude Medical Riata implantable cardioverter-defibrillator (ICD) leads. Conductor externalization is a "unique" failure mechanism: Cables externalize through the insulation ("inside-out" abrasion) and appear outside the lead body. Recently, single reports described a similar failure also for Biotronik leads. Moreover, some studies reported a high rate of electrical dysfunction (not only insulation failure) with Biotronik Linox leads and a reduced survival rate in comparison with the competitors...
February 16, 2017: World Journal of Clinical Cases
Nicole E Worden, Musab Alqasrawi, Alexander Mazur
BACKGROUND: Available atrial electrograms in implantable cardioverter defibrillators (ICDs) improve arrhythmia diagnosis, allow monitoring for atrial fibrillation, and may reduce the risk of inappropriate therapies. A recently introduced ICD system using a single-lead with floating atrial electrodes provides diagnostic capability of a dual-chamber system without placing an additional lead. Data on long-term clinical performance of this system are limited. METHODS: We retrospectively analyzed data from 35 consecutive patients implanted with Biotronik VR-T DX devices and Linox(Smart) DX leads...
December 2016: Pacing and Clinical Electrophysiology: PACE
Marcin Michalak, Andrzej Cacko, Agnieszka Kapłon-Cieślicka, Monika Budnik, Przemysław Stolarz, Grzegorz Opolski, Marcin Grabowski
BACKGROUND: Single-lead for implantable cardioverter-defibrillator (ICD) with floating atrial sensing dipole is a new diagnostic tool with the potential advantage in terms of arrhythmia discrimination. We sought to determine whether right heart size and dipole position influence atrial sensing. METHODS: Atrial sensing (AS) amplitude was measured during implantation (PP, periprocedural), predischarge (IHFU, in-hospital follow-up) and 3-6 months after the procedure (AFU, ambulatory follow-up)...
2017: Cardiology Journal
Sophie C H van Malderen, Tamas Szili-Torok, Sing C Yap, Sanne E Hoeks, Felix Zijlstra, Dominic A M J Theuns
BACKGROUND: After the introduction of the Biotronik Linox S/SD high-voltage lead, several cases of early failure have been observed. OBJECTIVE: The purpose of this article was to assess the performance of the Linox S/SD lead in comparison to 2 other contemporary leads. METHODS: We used the prospective Erasmus MC ICD registry to identify all implanted Linox S/SD (n = 408), Durata (St. Jude Medical, model 7122) (n = 340), and Endotak Reliance (Boston Scientific, models 0155, 0138, and 0158) (n = 343) leads...
December 2016: Heart Rhythm: the Official Journal of the Heart Rhythm Society
H Elfarra, R Moosdorf, L Rybinski, W Grimm
No abstract text is available yet for this article.
September 2016: Herzschrittmachertherapie & Elektrophysiologie
Eric D Good, Ivan Cakulev, Michael V Orlov, David Hirsh, John Simeles, Kelly Mohr, Phil Moll, Heather Bloom
INTRODUCTION: Expert consensus holds that post-market, systematic surveillance of ICD leads is essential to ensure confirmation of adequate lead performance. GALAXY (NCT00836589) and CELESTIAL (NCT00810264) are ongoing multicenter, prospective, non-randomized registries conducted to confirm the long-term safety and reliability of Biotronik leads. METHODS AND RESULTS: ICD and CRT-D patients are followed for Linox and Linox(smart) ICD lead performance and safety for 5 years post-implant...
June 2016: Journal of Cardiovascular Electrophysiology
Hamdi Elfarra, Rainer Moosdorf, Leszek Rybinski, Wolfram Grimm
In this article the case of a patient who received a total of 35 inappropriate defibrillator shocks due to insulation failure with externalized conductor of a Biotronik Linox® lead is described. The implanted defibrillator was immediately inactivated and the failed lead was extracted using a laser sheath system.
March 2016: Herzschrittmachertherapie & Elektrophysiologie
Christian Steinberg, Gareth J Padfield, Edna Hahn, Sheila Flavelle, Cheryl McILROY, Otto VAN Bremen, John A Yeung-Lai-Wah, Charles R Kerr, Marc W Deyell, Stanley K Tung, Jason G Andrade, Matthew T Bennett, Jamil G Bashir, Andrew D Krahn, Santabhanu Chakrabarti
INTRODUCTION: Medtronic's Lead Integrity Alert (LIA) software algorithm is useful for detecting abnormal parameters across various ICD-lead families. However, its utility in the assessment of the Biotronik Linox™ family of high-voltage (HV) leads is unknown. METHODS: We conducted a retrospective cohort study to assess the performance of the LIA algorithm to detect abnormalities and lead failure in Linox ICD-leads. All LIA-enabled Medtronic devices connected to an active Linox lead were included...
December 2015: Journal of Cardiovascular Electrophysiology
Tobias Reichlin, Michael Kühne, Christian Sticherling
No abstract text is available yet for this article.
May 2016: Europace: European Pacing, Arrhythmias, and Cardiac Electrophysiology
Andrew J Howe, Nicholas A McKeag, Carol M Wilson, Kyle P Ashfield, Michael J Roberts
Implantable cardioverter defibrillator (ICD) lead insulation failure and conductor externalization have been increasingly reported. The 7.8F silicon-insulated Linox SD and Linox S ICD leads (Biotronik, Berlin, Germany) were released in 2006 and 2007, respectively, with an estimated 85,000 implantations worldwide. A 39-year-old female suffered an out-of-hospital ventricular fibrillation (VF) arrest with successful resuscitation. An ICD was implanted utilizing a single coil active fixation Linox(Smart) S lead (Biotronik, Berlin, Germany)...
June 2015: Journal of Cardiovascular Electrophysiology
Gareth J Padfield, Christian Steinberg, Shahzad S Karim, Stanley Tung, Matthew T Bennett, John P Le Maitre, Jamil Bashir
INTRODUCTION: The Linox and Durata implantable cardioverter defibrillator (ICD) leads were introduced to British Columbia (BC) in 2008. We determined their performance and the potential risk factors for lead failure in a large population-based patient registry. METHODS AND RESULTS: We used the BC Cardiac Registry, a mandatory Governmental database of ICD implants, to identify all recipients of Linox and Durata leads in BC between October 2008 and April 2012, and those subsequently undergoing reoperation...
March 2015: Journal of Cardiovascular Electrophysiology
Matteo Iori, Daniele Giacopelli, Fabio Quartieri, Nicola Bottoni, Antonio Manari
BACKGROUND: The concept of a single-lead dual-chamber implantable cardioverter defibrillator (ICD) with floating sensing atrial dipole has been proven safe and functional. We report a single-center experience with this ICD system; the major focus of the work is on the recorded atrial activation and its stability on a medium term follow-up. METHODS: Thirteen patients received a DX ICD (BIOTRONIK SE & Co, Berlin, Germany) with the Linox Smart S DX(ProMRI) ICD lead; the implantation data were reported...
October 2014: Pacing and Clinical Electrophysiology: PACE
Joseph A Manfredi, Steven M Smithgall, Charles M Kircher, Mary A Lollis
A 53-year-old man with a dual-chamber implantable cardioverter-defibrillator presented to the electrophysiology (EP) lab for an EP study in evaluation of supraventricular tachycardia despite medical therapy. Fluoroscopic imaging during placement of diagnostic catheters demonstrated insulation failure with an externalized conductor on the right ventricular defibrillator lead just distal to the proximal defibrillator coil. Device interrogation revealed normal pacing, and shock impedances, normal sensing, and stable pacing thresholds...
April 2014: Journal of Cardiovascular Electrophysiology
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