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https://www.readbyqxmd.com/read/28705736/a-worldwide-experience-of-the-management-of-battery-failures-and-chronic-device-retrieval-of-the-nanostim-leadless-pacemaker
#1
Dhanunjaya Lakkireddy, Reinoud Knops, Brett Atwater, Petr Neuzil, John Ip, Elkin Gonzalez, Paul Friedman, Pascal Defaye, Derek Exner, Kazutaka Aonuma, Rahul Doshi, Johannes Sperzel, Vivek Reddy
BACKGROUND: The Nanostim leadless pacemaker (LP) met the primary endpoints in an IDE trial, and was shown to be fully retrievable percutaneously. In October 2016, St Jude Medical, issued a worldwide alert of a battery malfunction that caused lost pacing output and LP communication. OBJECTIVE: The objective here is to report the battery failure mechanism and incidence and the worldwide patient management including device retrieval experiences. METHODS: The affected LP battery is a custom Lithium-Carbon Monofluoride (Li-CFx) cell...
July 10, 2017: Heart Rhythm: the Official Journal of the Heart Rhythm Society
https://www.readbyqxmd.com/read/28674619/on-x-versus-st-jude-medical-regent-mechanical-aortic-valve-prostheses-early-haemodynamics
#2
Robert Xu, Mohammad Rahnavardi, Bradley Pitman, Masoumeh Shirazi, Robert Stuklis, James Edwards, Michael Worthington
OBJECTIVE: We aimed to compare the early haemodynamic data of the On-X and St Jude Medical (SJM) Regent bileaflet mechanical prostheses in the aortic position. METHODS: A retrospective study was performed using data collected prospectively for a national database. Thirty-three patients who had aortic On-X valve (On-X group) and 33 matched patients who had aortic SJM Regent valve (SJM group) were included. The intraoperative and early postoperative data were collected...
2017: Open Heart
https://www.readbyqxmd.com/read/28669505/bioprosthetic-valve-fracture-to-facilitate-transcatheter-valve-in-valve-implantation
#3
Keith B Allen, Adnan K Chhatriwalla, David J Cohen, John T Saxon, Sanjeev Aggarwal, Anthony Hart, Suzanne Baron, J Russell Davis, Alex F Pak, Danny Dvir, A Michael Borkon
BACKGROUND: Valve-in-valve transcatheter aortic valve replacement is less effective in small surgical bioprostheses. We evaluated the feasibility of bioprosthetic valve fracture with a high-pressure balloon to facilitate valve-in-valve transcatheter aortic valve replacement. METHODS: In vitro bench testing on aortic tissue valves was performed on 19-mm and 21-mm Mitroflow (Sorin, Milan, Italy), Magna and Magna Ease (Edwards Lifesciences, Irvine, CA), Trifecta and Biocor Epic (St...
June 29, 2017: Annals of Thoracic Surgery
https://www.readbyqxmd.com/read/28668149/a-novel-technique-for-prosthetic-valve-retrieval-after-transcatheter-aortic-valve-embolization
#4
Francesco Giannini, Neil Ruparelia, Francesca Del Furia, Vittorio Romano, Marco Ancona, Antonio Mangieri, Damiano Regazzoli, Azeem Latib, Cosmo Godino, Francesco Ancona, Luciano Candilio, Richard Jabbour, Antonio Colombo, Matteo Montorfano
Although the rate of procedural complications during transcatheter aortic valve implantation has decreased because of technological advancement and increased operator experience, device embolization remains a rare but potentially fatal complication, even with new generation devices. We report, to our knowledge, the first case of Portico valve (St Jude Medical, Minneapolis, MN) migration despite apparent optimal initial implantation depth, which was retrieved using a novel strategy after failure of a traditional retrieval technique...
July 2017: Canadian Journal of Cardiology
https://www.readbyqxmd.com/read/28667812/utility-of-3d-oct-imaging-with-angiographic-co-registration-in-acute-coronary-syndrome-with-normal-or-near-normal-coronary-arteries
#5
Santiago Jesús Camacho Freire, Javier León Jiménez, Antonio Enrique Gómez Menchero, Jessica Roa Garrido, Rosa Cardenal Piris, José Francisco Díaz Fernández
The OPTIS integrated system (St. Jude Medical) is a new technology allowing the online co-registration of optical coherence tomography (OCT) images with the angiogram in the catheterization laboratory. Additionally, 3D navigation can be performed. This integration of OCT information on an angiographic roadmap could find broad application in the characterization of substrates causing acute coronary syndromes with normal or near-normal coronary arteries. The utility of OCT with co-registration for the guidance of percutaneous coronary intervention could be considerable in the management of patients with acute coronary syndromes...
July 2017: Journal of Invasive Cardiology
https://www.readbyqxmd.com/read/28660476/a%C3%A2-review-of-the-atrial-upper-rate-algorithms-of-st-jude-medical-abbott-cardiac-implantable-electronic-devices-incidence-of-repetitive-nonreentrant-ventriculoatrial-synchrony-rnrvas
#6
REVIEW
S S Barold
This review focuses on the manifestations of the three triggered atrial upper rate functions of St Jude Medical cardiac implantable electronic devices. The occurrence of repetitive nonreentrant ventriculoatrial synchrony (RNRVAS) is also evaluated as a basis for the development of automatic mode switching (AMS) and as a trigger for atrial tachycardia/atrial fibrillation (AT/AF) event recordings. RNRVAS is a common trigger for AMS because all the atrial events or intervals are used to calculate the filtered atrial rate interval (FARI)...
June 28, 2017: Herzschrittmachertherapie & Elektrophysiologie
https://www.readbyqxmd.com/read/28641844/the-in%C3%A2-vivo-morphology-of-post-infarct-ventricular-septal-defect-and-the-implications%C3%A2-for%C3%A2-closure
#7
Mark C K Hamilton, Jonathan C L Rodrigues, Robin P Martin, Nathan E Manghat, Mark S Turner
OBJECTIVES: The aim of this study was to define the dynamic in vivo morphology of post-infarct ventricular septal defect (PIVSD), which has not been previously described in living patients. BACKGROUND: PIVSD is a devastating complication of acute myocardial infarction. METHODS: The anatomic features of PIVSD, as demonstrated by computed tomography or magnetic resonance imaging, were retrospectively reviewed. RESULTS: Thirty-two PIVSDs were assessed, 16 left coronary artery and 16 right coronary artery PIVSDs...
June 26, 2017: JACC. Cardiovascular Interventions
https://www.readbyqxmd.com/read/28610762/early-trifecta-valve-failure-report-of-a-cluster-of-cases-from-a-tertiary-care-referral-center
#8
Ankur Kalra, Hasan Rehman, Mahesh Ramchandani, Colin M Barker, Gerald M Lawrie, Ross M Reul, Michael J Reardon, Neal S Kleiman
BACKGROUND: The Trifecta valve (St Jude Medical, Inc, St Paul, Minn) was approved for commercial use by the US Food and Drug Administration in 2011. Several isolated cases have been reported since then, describing early structural valve deterioration. We report a case series of 8 Trifecta valve failures, describing patients' clinical substrate and management, and the pathologic characteristics of the explanted valves. METHODS: Trifecta valve failure occurred in 7 patients (8 valves) receiving 19-mm (n = 2), 21-mm (n = 3), 23-mm (n = 1), and 25-mm (n = 2) valves...
May 22, 2017: Journal of Thoracic and Cardiovascular Surgery
https://www.readbyqxmd.com/read/28535554/anesthetic-considerations-and-perioperative-management-of-spinal-cord-stimulators-literature-review-and-initial-recommendations
#9
REVIEW
Michael E Harned, Brandon Gish, Allison Zuelzer, Jay S Grider
BACKGROUND: Patients with implanted spinal cord stimulators (SCS) present to the anesthesia care team for management at many different points along the care continuum. Currently, the literature is sparse on the perioperative management. What is available is confusing; monopolar electrocautery is contraindicated but often used, full body magnetic resonance imaging (MRI) is safe with particular systems but with other manufactures only head and specific extremities exams are safe. Moreover, there are anesthetizing locations outside of the operating room where implanted SCS can interact with surrounding medical equipment and pose significant risk to patient and device...
May 2017: Pain Physician
https://www.readbyqxmd.com/read/28533992/ambulatory-heart-failure-monitoring-a-systemic-review
#10
REVIEW
Muhammad A Mangi, Hiba Rehman, Muhammad Rafique, Michael Illovsky
Heart failure (HF) is one of the leading causes of morbidity and mortality and has a large effect on the country's economy. Although there have been major advances in HF monitoring, including more advanced pharmacological management and device-based therapy, HF-related mortality remains high. It is important to monitor HF so that HF-related hospitalization and mortality can be prevented. Due to the lower sensitivity of clinical features and biochemical markers, as well as the failure of telemonitoring in early detection of HF, more advanced techniques have been sought to more accurately predict impending HF, in order to address timely pharmacological management and prevent heart failure hospitalization (HFH)...
April 18, 2017: Curēus
https://www.readbyqxmd.com/read/28515113/force-sensing-catheters-during-pediatric-radiofrequency-ablation-the-federation-study
#11
Aarti S Dalal, Hoang H Nguyen, Tammy Bowman, George F Van Hare, Jennifer N Avari Silva
BACKGROUND: Based on data from studies of atrial fibrillation ablations, optimal parameters for the TactiCath (TC; St. Jude Medical, Inc) force-sensing ablation catheter are a contact force of 20 g and a force-time integral of 400 g·s for the creation of transmural lesions. We aimed to evaluate TC in pediatric and congenital heart disease patients undergoing ablation. METHODS AND RESULTS: Comprehensive chart and case reviews were performed from June 2015 to March 2016...
May 17, 2017: Journal of the American Heart Association
https://www.readbyqxmd.com/read/28511801/intergenerational-differences-in-the-effects-of-transcatheter-closure-of-atrial-septal-defects-on-cardiac-function
#12
Hideki Tashiro, Kenji Suda, Motofumi Iemura, Youzou Teramachi
BACKGROUND: Little is known regarding intergenerational differences in the effects of atrial sepal defect (ASD) closure on the left heart. We therefore analyzed age-related serial changes in the left heart following ASD closure. METHODS: We studied 50 patients with an isolated ASD who underwent successful transcatheter closure using Amplatzer septal occluders (St. Jude Medical, Little Canada, MN, USA) between June 2007 and June 2013. Patients were divided into three age groups: young patients aged ≤17 years; middle-aged patients aged 18-50 years; and older patients aged >50 years...
May 13, 2017: Journal of Cardiology
https://www.readbyqxmd.com/read/28462889/radiofrequency-pulmonary-vein-isolation-in-a-patient-with-dextrocardia-with-situs-inversus-totalis
#13
John Meulet, Geoffrey Trim, Ben Hunt, Kang-Teng Lim, Andrew James, Albert Henry, Wayne Pirihi, Paul Davies, Jason Brabant
BACKGROUND: We present a case report of a 67-year-old male with dextrocardia situs inversus totalis and persistent atrial fibrillation who presented for radiofrequency pulmonary vein isolation. METHODS: Pulmonary vein isolation was performed using the St Jude Medical Ensite NavX 3D mapping system with AccuNav ICE guidance. RESULTS: All pulmonary veins were successfully isolated. The procedure time was 125 mins with a fluoroscopy time of 44...
November 19, 2016: Heart, Lung & Circulation
https://www.readbyqxmd.com/read/28438271/how-does-an-inventor-find-an-investor-or-partner-raising-funds-to-start-a-company
#14
Rudy A Mazzocchi
Rudy Mazzocchi has over 25 years of senior executive management, technology and intellectual property development, and financing experience in the medical-technology/biotechnology industries. He serves currently as cofounder/chief executive officer of ELENZA, Inc, an ophthalmology company that has developed an electro-active, autofocusing, implantable lens; executive chairman of Establishment Labs; executive chairman of LAFORGE Optical; and executive chairman of OptiSTENT, Inc. He served previously as managing director of Accuitive Medical Ventures and The Innovation Factory; cofounder/chief executive officer of Image-Guided NEUROLOGICS, acquired by Medtronic in 2005; and founding chief executive officer of MICROVENA Corporation, which became "eV3," acquired by Covidien...
May 2017: Surgery
https://www.readbyqxmd.com/read/28431058/additional-electrodes-on-the-quartet%C3%A2-lv-lead-provide-more-programmable-pacing-options-than-bipolar-and-tripolar-equivalents
#15
David O'Donnell, Johannes Sperzel, Bernard Thibault, Christopher A Rinaldi, Carlo Pappone, Klaus-Jürgen Gutleben, Christopher Leclercq, Hedi Razavi, Kyungmoo Ryu, Luke C Mcspadden, Avi Fischer, Gery Tomassoni
Aims: The aim of this study was to evaluate any benefits to the number of viable pacing vectors and maximal spatial coverage with quadripolar left ventricular (LV) leads when compared with tripolar and bipolar equivalents in patients receiving cardiac resynchronization therapy (CRT). Methods and Results: A meta-analysis of five previously published clinical trials involving the Quartet™ LV lead (St Jude Medical, St Paul, MN, USA) was performed to evaluate the number of viable pacing vectors defined as capture thresholds ≤2...
April 1, 2017: Europace: European Pacing, Arrhythmias, and Cardiac Electrophysiology
https://www.readbyqxmd.com/read/28413855/frequency-of-pacemaker-malfunction-associated-with-monopolar-electrosurgery-during-pulse-generator-replacement-or-upgrade-surgery
#16
Yun Lin, Daniel P Melby, Balaji Krishnan, Selcuk Adabag, Venkatakrishna Tholakanahalli, Jian-Ming Li
PURPOSE: The aim of this study is to investigate the frequency of electrosurgery-related pacemaker malfunction. METHODS: A retrospective study was conducted to investigate electrosurgery-related pacemaker malfunction in consecutive patients undergoing pulse generator (PG) replacement or upgrade from two large hospitals in Minneapolis, MN between January 2011 and January 2014. The occurrence of this pacemaker malfunction was then studied by using MAUDE database for all four major device vendors...
April 17, 2017: Journal of Interventional Cardiac Electrophysiology: An International Journal of Arrhythmias and Pacing
https://www.readbyqxmd.com/read/28412431/3d-morphological-changes-in-lv-and-rv-during-lvad-ramp-studies
#17
Karima Addetia, Nir Uriel, Francesco Maffessanti, Gabriel Sayer, Sirtaz Adatya, Gene H Kim, Nitasha Sarswat, Savitri Fedson, Diego Medvedofsky, Eric Kruse, Keith Collins, Daniel Rodgers, Takayoshi Ota, Valluvan Jeevanandam, Victor Mor-Avi, Daniel Burkhoff, Roberto M Lang
OBJECTIVES: The purpose of this study was to investigate the differential impact of the 2 most commonly available left ventricular assist device (LVAD) types on the right (RV) and left (LV) ventricles using 3-dimensional (3D) echocardiography-based analysis of ventricular morphology. BACKGROUND: LVADs have emerged as common therapy for advanced heart failure. Recent data suggest that the heart responds differently to speed settings in the 2 main devices available (HeartMate II [HMII], St Jude Medical, Pleasanton, California, and HVAD, HeartWare International, Framingham, Massachusetts)...
April 7, 2017: JACC. Cardiovascular Imaging
https://www.readbyqxmd.com/read/28409845/procedural-success-and-intra-hospital-outcome-related-to-left-atrial-appendage-morphology-in-patients-that-receive-an-interventional-left-atrial-appendage-closure
#18
Christian Fastner, Michael Behnes, Benjamin Sartorius, Annika Wenke, Ibrahim El-Battrawy, Uzair Ansari, Ishar-Singh Gill, Martin Borggrefe, Ibrahim Akin
BACKGROUND: The interventional left atrial appendage (LAA) closure represents an emerging alternative to oral anticoagulation for stroke prevention in certain atrial fibrillation patients. Preliminary results have suggested high procedural success rates and fewer peri-interventional complications; however, there persists an insufficient understanding of the role of many underlying confounding variables (e.g., anatomical characteristics). HYPOTHESIS: It was investigated whether varying LAA morphologies influence procedural success as well as in-hospital outcome...
April 13, 2017: Clinical Cardiology
https://www.readbyqxmd.com/read/28406699/early-morphologic-alterations-in-renal-artery-wall-and-renal-nerves-in-response-to-catheter-based-renal-denervation-procedure-in-sheep-difference-between-single-point-and-multiple-point-ablation-catheters
#19
M Táborský, D Richter, Z Tonar, T Kubíková, A Herman, J Peregrin, L Červenková, Z Husková, L Kopkan
Renal sympathetic hyperactivity is critically involved in hypertension pathophysiology; renal denervation (RDN) presents a novel strategy for treatment of resistant hypertension cases. This study assessed effects of two RDN systems to detect acute intravascular, vascular and peri-vascular changes in the renal artery, and renal nerve alterations, in the sheep. The procedures using a single-point or multi-point ablation catheters, Symplicity Flex(TM), Medtronic versus EnligHTN(TM), St. Jude Medical were compared; the intact contralateral kidneys served as controls...
April 12, 2017: Physiological Research
https://www.readbyqxmd.com/read/28401867/premature-battery-depletion-with-st-jude-medical-icd-and-crt-d-devices-indian-heart-rhythm-society-guidelines-for-physicians
#20
Kartikeya Bhargava, Vanita Arora, Aparna Jaswal, Amit Vora
No abstract text is available yet for this article.
November 2016: Indian Pacing and Electrophysiology Journal
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