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https://www.readbyqxmd.com/read/29237489/self-expanding-nitinol-stents-of-high-versus-low-chronic-outward-force-in-de-novo-femoropopliteal-occlusive-arterial-lesions-bioflex-cof-trial-study-protocol-for-a-randomized-controlled-trial
#1
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
https://www.readbyqxmd.com/read/29222869/new-generation-cardioverter-defibrillator-lead-with-a-floating-atrial-sensing-dipole-long-term-performance
#2
Erdal Safak, Giuseppe D Ancona, Hilmi Kaplan, Evren Caglayan, Stephan Kische, Alper Öner, Hüseyin Ince, Jasmin Ortak
OBJECTIVES: 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). 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 implant, internal ECG data were prospectively collected via tele-monitoring (Home Monitoring, Biotronik)...
December 9, 2017: Pacing and Clinical Electrophysiology: PACE
https://www.readbyqxmd.com/read/29205157/a-comparison-of-an-ultrathin-strut-biodegradable-polymer-sirolimus-eluting-stent-with-a-durable-polymer-everolimus-eluting-stent-for-patients-with-acute-stsegment-elevation-myocardial-infarction-undergoing-primary-percutaneous-coronary-intervention-rationale
#3
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
https://www.readbyqxmd.com/read/29162282/interruption-of-cardiac-resynchronization-therapy-by-atrial-premature-complexes
#4
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. This was caused by realignment of the LV timing cycles induced by the APCs whereupon LV pacing was inhibited and a self-perpetuating desynchronization process was initiated...
October 21, 2017: Journal of Electrocardiology
https://www.readbyqxmd.com/read/29054505/biomonitor-2-pilot-study-early-experience-with-implantation-of-the-biotronik-biomonitor-2-implantable-cardiac-monitor
#5
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
https://www.readbyqxmd.com/read/28894596/magmaris-a-new-generation-metallic-sirolimus-eluting-fully-bioresorbable-scaffold-present-status-and-future-perspectives
#6
REVIEW
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
https://www.readbyqxmd.com/read/28889769/orsiro-cobalt-chromium-sirolimus-eluting-stent-present-and-future-perspectives
#7
Juan F Iglesias, Marco Roffi, Sophie Degrauwe, Gioel Gabrio Secco, Adel Aminian, Stephan Windecker, Thomas Pilgrim
New-generation drug-eluting stents (DES) represent the current standard of care in patients undergoing percutaneous coronary intervention (PCI). Biodegradable polymer DES (BP-DES) were recently developed to overcome current limitations of newer-generation durable polymer DES (DP-DES) attributed to sustained inflammatory responses induced by permanent polymers. The Orsiro DES (Biotronik AG, Bülach, Switzerland) is a novel thin-strut cobalt-chromium sirolimus-eluting stent with biodegradable polymer that features some of the latest developments in DES technology...
September 19, 2017: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/28851504/ultrathin-bioresorbable-polymer-sirolimus-eluting-stents-versus-thin-durable-polymer-everolimus-eluting-stents-in-patients-undergoing-coronary-revascularisation-bioflow-v-a-randomised-trial
#8
David E Kandzari, Laura Mauri, Jacques J Koolen, Joseph M Massaro, Gheorghe Doros, Hector M Garcia-Garcia, Johan Bennett, Ariel Roguin, Elie G Gharib, Donald E Cutlip, Ron Waksman
BACKGROUND: The development of coronary drug-eluting stents has included use of new metal alloys, changes in stent architecture, and use of bioresorbable polymers. Whether these advancements improve clinical safety and efficacy has not been shown in previous randomised trials. We aimed to examine the clinical outcomes of a bioresorbable polymer sirolimus-eluting stent compared with a durable polymer everolimus-eluting stent in a broad patient population undergoing percutaneous coronary intervention...
October 21, 2017: Lancet
https://www.readbyqxmd.com/read/28819983/an-evaluation-of-the-effectiveness-of-a-risk-based-monitoring-approach-implemented-with-clinical-trials-involving-implantable-cardiac-medical-devices
#9
Christopher A Diani, Angie Rock, Phil Moll
Background Risk-based monitoring is a concept endorsed by the Food and Drug Administration to improve clinical trial data quality by focusing monitoring efforts on critical data elements and higher risk investigator sites. BIOTRONIK approached this by implementing a comprehensive strategy that assesses risk and data quality through a combination of operational controls and data surveillance. This publication demonstrates the effectiveness of a data-driven risk assessment methodology when used in conjunction with a tailored monitoring plan...
August 1, 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/28741575/the-drug-eluting-absorbable-magnesium-vascular-scaffold-in-complex-coronary-bifurcations-insights-from-an-in-vivo-multimodality-imaging-study
#10
Johan Bennett, Maarten Vanhaverbeke, Nina Vanden Driessche, Nick Hiltrop, Tom Adriaenssens, Walter Desmet, Peter Sinnaeve, Christophe Dubois
AIMS: This acute in-vivo study sought to provide insights regarding the feasibility of performing complex bifurcation stenting with Magmaris magnesium-alloy bioresorbable scaffolds (Biotronik,Bulach, Switzerland). METHODS AND RESULTS: Twenty-five New-Zealand-White rabbits underwent stenting of non-diseased aorto-iliac bifurcations with Magmaris using provisional (PS,n=5), culotte (n=6), modified-T (n=6), or T-and-protrusion (TAP,n=8) stenting techniques. Angiography, optical coherence tomography and micro-computed tomography were performed...
July 25, 2017: EuroIntervention
https://www.readbyqxmd.com/read/28715316/virtual-humans-for-implantable-device-safety-assessment-in-mri-mitigating-magnetic-resonance-imaging-hazards-for-implanted-medical-devices
#11
James E Brown, Rui Qiang, Paul J Stadnik, Larry J Stotts, Jeffrey A Von Arx
Magnetic resonance imaging (MRI) is the preferred modality for soft tissue imaging because of its nonionizing radiation and lack of contrast agent. Due to interactions between the MR system and active implantable medical devices (AIMDs), patients with implants such as pacemakers are generally denied access to MRI, which presents a detriment to that population. It has been estimated that 50-75% of patients with a cardiac device were denied access to MRI scanning and, moreover, that 17% of pacemaker patients need an MRI within 12 months of implantation [1]...
July 2017: IEEE Pulse
https://www.readbyqxmd.com/read/28670989/-sudden-cardiac-death-due-to-sarcoidosis-case-report
#12
István Sejben, Zoltán Som, Gábor Cserni
Sarcoidosis is a systemic granulomatous disease of unknown aetiology, which is characterized by bilateral hilar lymphadenopathy and pulmonary disease. Clinically detected cardiac involvement occurs in 5% of sarcoid patients, although cardiac manifestations are discovered in 25% of the cases at autopsy. Sarcoid heart disease frequently causes atrioventricular block. The authors present the case of a 44-year-old man with bradycardia. On admission, second degree Mobitz II, then third degree atrioventricular block was diagnosed...
July 2017: Orvosi Hetilap
https://www.readbyqxmd.com/read/28640075/maximum-voltage-gradient-technique-for-optimization-of-ablation-for-typical-atrial-flutter-with-zero-fluoroscopy-approach
#13
MULTICENTER STUDY
Karol Deutsch, Janusz Śledź, Mariusz Mazij, Bartosz Ludwik, Michał Labus, Dariusz Karbarz, Bernadetta Pasicka, Michał Chrabąszcz, Arkadiusz Śledź, Monika Klank-Szafran, Laura Vitali-Sendoz, Tomasz Kameczura, Jerzy Śpikowski, Piotr Stec, Marek Ujda, Sebastian Stec
Radiofrequency catheter ablation (RFCA) is an established effective method for the treatment of typical cavo-tricuspid isthmus (CTI)-dependent atrial flutter (AFL). The introduction of 3-dimensional electro-anatomic systems enables RFCA without fluoroscopy (No-X-Ray [NXR]). The aim of this study was to evaluate the feasibility and effectiveness of CTI RFCA during implementation of the NXR approach and the maximum voltage-guided (MVG) technique for ablation of AFL.Data were obtained from prospective standardized multicenter ablation registry...
June 2017: Medicine (Baltimore)
https://www.readbyqxmd.com/read/28593660/inhibition-of-left-ventricular-stimulation-due-to-left-ventricular-lead-failure-and-the-left-ventricular-t-wave-protection-algorithm-in-patient-with-cardiac-resynchronization-therapy-and-pacemaker-dependency
#14
Andrzej Ząbek, Barbara Małecka, Maciej Dębski, Krzysztof Boczar, Jacek Lelakowski
The electrocardiogram (ECG) interpretation in patients with cardiac resynchronization therapy (CRT) is often a perplexing problem. The difficulty in the device evaluation increases in the presence of unfamiliar timing cycles and a lead dysfunction. Authors describe a special function of a Biotronik CRT devices called the left ventricle T-wave protection (LVTP), and demonstrate its behavior in a patient with left ventricular (LV) lead failure. This report shows that sometimes it might be difficult to understand the loss of resynchronization in 12-lead ECG when LVTP feature is on, and a malfunction of left ventricular lead sensing occurs...
June 8, 2017: Annals of Noninvasive Electrocardiology
https://www.readbyqxmd.com/read/28502870/comparison-of-longevity-and-clinical-outcomes-of-implantable-cardioverter-defibrillator-leads-among-manufacturers
#15
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
https://www.readbyqxmd.com/read/28491761/use-of-biotronik-closed-loop-pacemaker-to-treat-recurrent-syncope-in-pediatric-patient-with-dysautonomia
#16
Jennfier Shortland, Orhan Uzun, Deirdre Wilson, Graham A Stuart, Mark A Walsh
No abstract text is available yet for this article.
January 2017: HeartRhythm Case Reports
https://www.readbyqxmd.com/read/28255544/externalized-conductors-and-insulation-failure-in-biotronik-defibrillator-leads-history-repeating-or-a-false-alarm
#17
REVIEW
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
https://www.readbyqxmd.com/read/28220938/performance-of-the-new-biomonitor-2-af-insertable-cardiac-monitoring-system-can-better-be-worse
#18
Philipp Lacour, Phi Long Dang, Martin Huemer, Abdul Shokor Parwani, Philipp Attanasio, Burkert Pieske, Leif-Hendrik Boldt, Wilhelm Haverkamp, Florian Blaschke
BACKGROUND: Implantable loop recorders (ILR) are valuable tools for the investigation of patients with suspected arrhythmias. The BioMonitor 2-AF is a novel insertable ILR with enhanced atrial fibrillation (AF) detection algorithm and remote monitoring capability. OBJECTIVE: The objective of this first-in-human study with the BioMonitor 2-AF was to analyze course of P-wave sensing performance and R-wave amplitude, prevalence of false and correctly sensed and classified episodes, and effectiveness of remote monitoring...
May 2017: Pacing and Clinical Electrophysiology: PACE
https://www.readbyqxmd.com/read/28108202/evaluation-of-coronary-flow-conditions-in-complex-coronary-artery-bifurcations-stenting-using-computational-fluid-dynamics-impact-of-final-proximal-optimization-technique-on-different-double-stent-techniques
#19
Gianluca Rigatelli, Marco Zuin, Fabio Dell'Avvocata, Dobrin Vassilev, Ramesh Daggubati, Thach Nguyen, Nguyen Van Viet Thang, Nicolas Foin
BACKGROUND/PURPOSE: Computational fluid dynamics (CFD) have been recently adopted in many fields of cardiovascular medicine and in interventional cardiology. Using CFD analysis we compared the use of different PCI procedures, with and without the utilization of a proximal optimization technique (POT), on a complex coronary artery bifurcation. METHODS/MATERIALS: For the analysis, we considered a hypothetic model of a left anterior descending artery-diagonal Medina 1,1,1 bifurcation type with a diameter of the proximal main branch (MB) and the side branch (SB) set at 3...
June 2017: Cardiovascular Revascularization Medicine: Including Molecular Interventions
https://www.readbyqxmd.com/read/27969804/tct-448-biotronik-safety-and-clinical-performance-of-the-drug-eluting-orsiro-stent-in-the-treatment-of-subjects-with-single-de-novo-coronary-artery-lesions-ii-bioflow-ii-4-year-clinical-results
#20
Ton Slagboom, Michael Haude, Thierry Lefevre, Salim Hayek, Karl Stangl, Franz-Josef Neumann, Rafaelruiz Salmeron, Manel Sabate, Gert Richardt, Bela Merkely, Javier Goicolea, Johannes Bilger, Paul Barragan, Ron Waksman, Stephan Windecker
No abstract text is available yet for this article.
November 1, 2016: Journal of the American College of Cardiology
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