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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
Massimo Stefano Silvetti, Vincenzo Pazzano, Irma Battipaglia, Corrado Di Mambro, Camilla Calvieri, Fabio Anselmo Saputo, Letizia Verticelli, Adriano Carotti, Sergio Torcinaro, Fabrizio Drago
AIMS: Young patients with operated complex congenital heart defects (CHD) often develop sinus node dysfunction (SND) requiring permanent pacing with rate-responsive function. Activity-driven sensors cannot account for non-movement stress and cannot modulate heart rate physiologically. Closed Loop Stimulation (CLS, Biotronik, Berlin, Germany) is a physiological rate-responsive pacemaker based on the indirect measure of ventricular contractility. No data are available on the effects of such pacing strategy in young patients...
June 6, 2018: Pacing and Clinical Electrophysiology: PACE
David Naguib, Betül Knoop, Lisa Dannenberg, Eva Liebsch, Martin Pöhl, Carolin Helten, Athena Assadi-Schmidt, Malte Kelm, Tobias Zeus, Amin Polzin
OBJECTIVE: In-stent restenosis (ISR) is a feared complication after coronary stent implantation. Drug-coated balloon (DCB) is being promoted as a treatment option for ISR. However, the benefit-risk ratio of DCB length has not been investigated. Longer DCBs release more anti-proliferative drug to the vessel wall; however, they are associated with a higher lesion length and vessel injury. HYPOTHESIS: DCB length is associated with clinical outcome. METHODS: We analyzed 286 consecutive Pantera Lux (Biotronik, active component Paclitaxel) DCB-treated patients between April 2009 and June 2012...
June 2018: Anatolian Journal of Cardiology
Lars Jakobsen, Evald H Christiansen, Michael Maeng, Steen D Kristensen, Hans E Bøtker, Christian J Terkelsen, Morten Madsen, Bent Raungaard, Svend E Jensen, Martin K Christensen, Henrik Steen Hansen, Lisette O Jensen
BACKGROUND: The Combo stent (OrbusNeich, Hoevelaken, the Netherlands) combining an abluminal, bioabsorbable polymer eluting sirolimus with a luminal CD34+ antibody to capture endothelial progenitor cells has been developed to further improve safety and efficacy of coronary interventions. We have designed a large-scale registry-based randomized clinical trial to compare the Combo stent to the Orsiro stent (Biotronik, Bülach, Switzerland) in patients undergoing percutaneous coronary intervention...
May 5, 2018: American Heart Journal
Malene Söth-Hansen, Christoffer Tobias Witt, Mathis Rasmussen, Jens Kristensen, Christian Gerdes, Jens Cosedis Nielsen
BACKGROUND: Remote monitoring (RM) is an established technology integrated into routine follow-up of patients with implantable cardioverter-defibrillator (ICD). Current RM systems differ according to transmission frequency and alert definition. OBJECTIVE: We aimed to compare time difference between detection and acknowledgement of clinically relevant events between four RM systems. METHODS: We analyzed time delay between detection of ventricular arrhythmic and technical events by the ICD and acknowledgement by hospital staff in 1...
May 24, 2018: Heart Rhythm: the Official Journal of the Heart Rhythm Society
Thierry Lefèvre, Michael Haude, Franz-Josef Neumann, Karl Stangl, Carsten Skurk, Ton Slagboom, Manel Sabaté, Javier Goicolea, Paul Barragan, Stéphane Cook, Jean-Christophe Macia, Stephan Windecker
OBJECTIVES: The authors aimed to compare long-term data of an ultrathin cobalt-chromium stent with passive silicon carbide coating and an active biodegradable polymer that releases sirolimus (O-SES) (Orsiro, BIOTRONIK, Bülach, Switzerland) with the durable polymer-based Xience Prime everolimus-eluting stent (X-EES) (Abbott Vascular, Santa Clara, California). BACKGROUND: Biodegradable polymer stents have been developed aiming to overcome long-term detrimental effects of durable polymer stents, ultimately leaving a bare-metal stent in the vessel...
May 28, 2018: JACC. Cardiovascular Interventions
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
Andrzej Ząbek, Barbara Małecka, Ewa Nowosielska-Ząbek, Maciej Dębski, Krzysztof Boczar, Jacek Lelakowski
The electrocardiogram (ECG) interpretation in patients with implantable cardioverter defibrillator (ICD) is often a puzzling problem. The difficulty of the device function evaluation further increases in the presence of unfamiliar timing cycles and additional functions. Authors present a special function of a Biotronik ICD devices called the thoracic impedance monitoring, and demonstrate its behavior in a patient with sinus rhythm, ventricular ectopic beats, and ventricular tachycardia episode. This report shows unexceptional occurrence of tricky ECG finding in patient with Biotronik ICD...
April 25, 2018: Annals of Noninvasive Electrocardiology
Gerhard Hindricks, Niraj Varma, Salem Kacet, Thorsten Lewalter, Peter Søgaard, Laurence Guédon-Moreau, Jochen Proff, Thomas A Gerds, Stefan D Anker, Christian Torp-Pedersen
Aims: Remote monitoring of implantable cardioverter-defibrillators may improve clinical outcome. A recent meta-analysis of three randomized controlled trials (TRUST, ECOST, IN-TIME) using a specific remote monitoring system with daily transmissions [Biotronik Home Monitoring (HM)] demonstrated improved survival. We performed a patient-level analysis to verify this result with appropriate time-to-event statistics and to investigate further clinical endpoints. Methods and results: Individual data of the TRUST, ECOST, and IN-TIME patients were pooled to calculate absolute risks of endpoints at 1-year follow-up for HM vs...
June 7, 2017: European Heart Journal
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
Roope Männikkö, Leonie Wong, David J Tester, Michael G Thor, Richa Sud, Dimitri M Kullmann, Mary G Sweeney, Costin Leu, Sanjay M Sisodiya, David R FitzPatrick, Margaret J Evans, Iona J M Jeffrey, Jacob Tfelt-Hansen, Marta C Cohen, Peter J Fleming, Amie Jaye, Michael A Simpson, Michael J Ackerman, Michael G Hanna, Elijah R Behr, Emma Matthews
BACKGROUND: Sudden infant death syndrome (SIDS) is the leading cause of post-neonatal infant death in high-income countries. Central respiratory system dysfunction seems to contribute to these deaths. Excitation that drives contraction of skeletal respiratory muscles is controlled by the sodium channel NaV1.4, which is encoded by the gene SCN4A. Variants in NaV1.4 that directly alter skeletal muscle excitability can cause myotonia, periodic paralysis, congenital myopathy, and myasthenic syndrome...
April 14, 2018: Lancet
Estelle Torbey, Charles J Love
BACKGROUND: The Biotronik DX lead is an attractive option due to its floating atrial bipole and its noninferiority compared to dual-chamber defibrillators. METHODS: We describe the case of atrial undersensing by the DX lead resulting in failure of the device to appropriately treat a slow ventricular tachycardia. CONCLUSION: This case underlies the importance of understanding the limitations to each lead technology as well as the underlying assumptions inherent to detection enhancement algorithms...
March 23, 2018: Pacing and Clinical Electrophysiology: PACE
Nassir F Marrouche, Johannes Brachmann, Dietrich Andresen, Jürgen Siebels, Lucas Boersma, Luc Jordaens, Béla Merkely, Evgeny Pokushalov, Prashanthan Sanders, Jochen Proff, Heribert Schunkert, Hildegard Christ, Jürgen Vogt, Dietmar Bänsch
BACKGROUND: Mortality and morbidity are higher among patients with atrial fibrillation and heart failure than among those with heart failure alone. Catheter ablation for atrial fibrillation has been proposed as a means of improving outcomes among patients with heart failure who are otherwise receiving appropriate treatment. METHODS: We randomly assigned patients with symptomatic paroxysmal or persistent atrial fibrillation who did not have a response to antiarrhythmic drugs, had unacceptable side effects, or were unwilling to take these drugs to undergo either catheter ablation (179 patients) or medical therapy (rate or rhythm control) (184 patients) for atrial fibrillation in addition to guidelines-based therapy for heart failure...
February 1, 2018: New England Journal of Medicine
Wolfram Schmidt, Peter Lanzer, Peter Behrens, Christoph Brandt-Wunderlich, Alper Öner, Hüseyin Ince, Klaus-Peter Schmitz, Niels Grabow
BACKGROUND: Drug-eluting stents (DES) compared to bare metal stents (BMS) have shown superior clinical performance, but are considered less suitable in complex cases. Most studies do not distinguish between DES and BMS with respect to their mechanical performance. The objective was to obtain mechanical parameters for direct comparison of BMS and DES. METHODS: In vitro bench tests evaluated crimped stent profiles, crossability in stenosis models, elastic recoil, bending stiffness (crimped and expanded), and scaffolding properties...
January 8, 2018: European Journal of Medical Research
Alexander Wressnegger, Alexandra Kaider, Martin A Funovics
BACKGROUND: Self-expanding nitinol stents must be oversized at least by a minimal amount to ensure contact with the vessel wall and prevent migration. Once the stent is deployed it exerts a continuous force upon the vascular wall, termed chronic outward force (COF). Animal studies have found an increased neointimal hyperplasia in stents with high oversizing and thus high COF. Data about correlation between COF and neointimal hyperplasia in humans are currently lacking. The objective of the BIOFLEX-COF trial is to prospectively investigate differences in formation of intimal hyperplasia at 1 and 2 years after implantation of nitinol stents with high versus low COF in de novo femoropopliteal occlusive arterial lesions...
December 14, 2017: Trials
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
Juan F Iglesias, Olivier Muller, Serge Zaugg, Marco Roffi, David J Kurz, André Vuilliomenet, Daniel Weilenmann, Christoph Kaiser, Maxime Tapponnier, Dik Heg, Marco Valgimigli, Eric Eeckhout, Peter Jüni, Stephan Windecker, Thomas Pilgrim
AIMS: A novel ultrathin-strut biodegradable polymer sirolimus-eluting stent (Orsiro™, Biotronik, Bülach, Switzerland; BP-SES) was shown to be superior to a thin-strut durable polymer everolimus-eluting stent (Xience™ Xpedition/Alpine, Abbott Vascular, Santa Clara, USA; DP-EES) with respect to the primary endpoint of target lesion failure (TLF) at 12 months in the prespecified subgroup of patients with ST-segment elevation myocardial infarction (STEMI) included in the BIOSCIENCE trial...
December 5, 2017: EuroIntervention
S Serge Barold, Andreas Kucher
Biotronik devices used for cardiac resynchronization therapy (CRT) combined with defibrillation function (CRT-D) are capable of left ventricular (LV) sensing. Under certain circumstances, LV sensing may cause loss of CRT. The third generation of the Biotronik i-family CRT-Ds enables the recording of event-triggered tracings of the electrogram particularly those involving "CRT pacing interrupt" episodes. We report three cases of a sudden "CRT pacing interrupt" initiated by an atrial premature complex...
March 2018: Journal of Electrocardiology
Sze-Yuan Ooi, Ben Ng, Suresh Singarayar, Kevin Hellestrand, Peter Illes, Uwais Mohamed, Shakeeb Razak, Rukshen Weerasooriya
BACKGROUND: The BioMonitor 2 Pilot Study assessed the implantation procedure, the sensing amplitude and the remote monitoring transmission success rate of the second generation implantable cardiac monitor, the BioMonitor 2 (Biotronik, Berlin, Germany). METHODS: This was a prospective, multi-centre, single-arm, non-randomised study involving seven operators in five sites across Australia. Data were collected at implantation, during clinic visits at 1 week and 1 month post-implantation, and through wireless remote monitoring...
October 6, 2017: Heart, Lung & Circulation
Claudio Rapetto, Massimo Leoncini
Drug-eluting stents (DES) have reached a high safety and efficacy profile, becoming the best option for percutaneous coronary interventions (PCI) based revascularization. However, despite their optimal performance, a few concerns remain regarding their use, mainly due to permanent caging of the vessels and its consequences, first of all late stent thrombosis (ST). Bioresorbable scaffolds (BRS) aim to overcome these issues. The results achieved in randomized controlled trials (RCT) by the first generation of poly-L-lactic acid (PLLA) based scaffolds were promising at 1 year, but the first long term reports (albeit flawed by non-optimal implantation technique) have been disappointing, showing, for instance, an increased risk of ST and target vessel myocardial infarction (TV-MI)...
August 2017: Journal of Thoracic Disease
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