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https://www.readbyqxmd.com/read/28894596/magmaris-a-new-generation-metallic-sirolimus-eluting-fully-bioresorbable-scaffold-present-status-and-future-perspectives
#1
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
#2
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
#3
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...
August 26, 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
#4
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
#5
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
#6
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
#7
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
#8
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
#9
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
#10
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
#11
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
#12
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
#13
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
#14
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
#15
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
https://www.readbyqxmd.com/read/27909501/-two-for-the-price-of-one-a-single-lead-implantable-cardioverter-defibrillator-system-with-a-floating-atrial-dipole
#16
REVIEW
Nicole E Worden, Musab Alqasrawi, Siva M Krothapalli, Alexander Mazur
In patients known to be a high risk for sudden cardiac arrest, implantable cardioverter defibrillators (ICD) are a proven therapy to reduce risk of death. However, in patients without conventional indications for pacing, the optimal strategy for type of device, dual- versus single-chamber, remains debatable. The benefit of prophylactic pacing in this category of patients has never been documented. Although available atrial electrograms in a dual chamber system improve interpretation of stored arrhythmia events, allow monitoring of atrial fibrillation and may potentially reduce the risk of inappropriate shocks by enhancing automated arrhythmia discrimination, the use of dual-chamber ICDs has a number of disadvantages...
April 2016: Journal of Atrial Fibrillation
https://www.readbyqxmd.com/read/27892602/the-analog-blanking-period-of-implantable-cardiac-rhythm-devices
#17
S Serge Barold, Andreas Kucher
BACKGROUND: Analog blanking periods (BPs) that hold down the display of electrograms (EGMs) in cardiac rhythm devices have received much less attention than the well-known digital BPs which do not influence the EGM display. In Biotronik devices (Biotronik GmbH, Berlin, Germany), when a paced event initiates an analog BP in one chamber (right atrium, right ventricle [RV], or left ventricle [LV]), an identical cross-chamber analog BP starts in the other two chambers. METHODS: All clinical observations were recorded from patients with Biotronik devices...
February 2017: Pacing and Clinical Electrophysiology: PACE
https://www.readbyqxmd.com/read/27848030/-implantable-loop-recorder-biomonitor%C3%A2-2-biotronik
#18
REVIEW
Thorsten Lewalter, Clemens Jilek
The implantable loop recorder BioMonitor 2 is available with an emphasis on syncope and one on detection of atrial tachycardias. The BioMonitor 2 can be easily implanted. The BioMonitor 2 pilot study showed a high and over time stable signal and the telemetric performance was above average.
December 2016: Herzschrittmachertherapie & Elektrophysiologie
https://www.readbyqxmd.com/read/27823996/evaluation-of-safety-and-efficacy-of-qinming8631-dr-implantable-cardiac-pacemaker-in-chinese-patients-a-prospective-multicenter-randomized-controlled-trial-of-the-first-domestically-developed-pacemaker-of-china
#19
RANDOMIZED CONTROLLED TRIAL
Mei-Xiang Xiang, Dong-Qi Wang, Jing Xu, Zheng Zhang, Jian-Xin Hu, Dong-Mei Wang, Xiang Gu, He-Ping Liu, Tao Guo, Xiang-Jun Yang, Feng Ling, Jia-Feng Lin, Shang-Lang Cai, Guo-Bin Zhu, Jian-An Wang
BACKGROUND: High cost of imported pacemakers is a main obstacle for Chinese patients suffering from bradyarrhythmia, and a domestically developed pacemaker will help lower the burden. This study aimed to evaluate the safety and efficacy of Qinming8631 DR (Qinming Medical, Baoji, China), the first domestically developed dual-chamber pacemaker of China, compared with a commercially available pacemaker Talos DR (Biotronik, Berlin, Germany) in Chinese patients. METHODS: A prospective randomized trial was conducted at 14 centers in China...
November 20, 2016: Chinese Medical Journal
https://www.readbyqxmd.com/read/27806902/very-thin-strut-biodegradable-polymer-everolimus-eluting-and-sirolimus-eluting-stents-versus-durable-polymer-zotarolimus-eluting-stents-in-allcomers-with-coronary-artery-disease-bio-resort-a-three-arm-randomised-non-inferiority-trial
#20
RANDOMIZED CONTROLLED TRIAL
Clemens von Birgelen, Marlies M Kok, Liefke C van der Heijden, Peter W Danse, Carl E Schotborgh, Martijn Scholte, R Melvyn Tjon Joe Gin, Samer Somi, K G van Houwelingen, M G Stoel, Frits H A F de Man, J Hans W Louwerenburg, Marc Hartmann, Paolo Zocca, Gerard C M Linssen, Job van der Palen, Carine J M Doggen, Marije M Löwik
BACKGROUND: In patients with coronary artery disease, treated with durable polymer-coated drug-eluting stents, the life-long presence of the polymer might delay arterial healing. Novel very thin strut biodegradable polymer stents, which leave only a bare metal stent after polymer resorption, might improve long-term outcome. We investigated in allcomers the safety and efficacy of three stents eluting either everolimus, sirolimus, or zotarolimus, often clinically used but never compared, of which the biodegradable polymer everolimus-eluting stent was never before assessed in allcomers...
November 26, 2016: Lancet
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