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https://www.readbyqxmd.com/read/27733497/don-t-just-do-something-stand-there-unraveling-the-complexities-of-riata
#1
Andrew H Voigt, Samir Saba
No abstract text is available yet for this article.
October 2016: Circulation. Arrhythmia and Electrophysiology
https://www.readbyqxmd.com/read/27733493/canadian-registry-of-implantable-electronic-device-outcomes-surveillance-of-the-riata-lead-under-advisory
#2
Ratika Parkash, Bernard Thibault, Iqwal Mangat, Benoit Coutu, Matthew Bennett, Jeffrey Healey, Atul Verma, Francois Philippon, Roopinder Sandhu, Douglas Cameron, Felix Ayala-Paredes, Laurence Sterns, Vidal Essebag, Teresa Kus, Pablo Nery, Elizabeth Stephenson, Raymond Yee, Derek Exner, Satish Toal, David Birnie, George Wells, Andrew Krahn
BACKGROUND: The Riata lead under advisory has posed a unique clinical scenario where inside-out abrasion results in externalization of conductor cables, with a higher risk of electrical failure. We developed a comprehensive registry to assist with clinical management of this lead. METHODS AND RESULTS: This Canadian registry reports the findings of 3763 (74.2% of all Riata leads in Canada) Riata leads under advisory, with a mean follow-up time of 8.9±1.5 years. The overall electrical failure rate was 5...
October 2016: Circulation. Arrhythmia and Electrophysiology
https://www.readbyqxmd.com/read/27733461/complete-tear-off-of-a-riata-dual-coil-lead-tip
#3
Julia W Erath, Nadejda Monsefi, Stefan H Hohnloser
No abstract text is available yet for this article.
October 12, 2016: Europace: European Pacing, Arrhythmias, and Cardiac Electrophysiology
https://www.readbyqxmd.com/read/26762730/long-term-performance-of-the-riata-st-implantable-cardioverter-defibrillator-lead
#4
MULTICENTER STUDY
Erwin Ströker, Carlo de Asmundis, Philippe Vanduynhoven, Katrien De Vadder, Philip De Vusser, Wilfried Mullens, Gian-Battista Chierchia, Pedro Brugada, Jens Czapla, Mark La Meir, Francis Wellens, Hugo Van Herendael, Maximo Rivero-Ayerza
Riata and Riata ST implantable cardioverter-defibrillator leads are prone to structural and electrical failure (EF). Our objective was to evaluate Riata/ST lead performance over a long-term follow-up. Of 184 patients having undergone Riata/ST and Riata ST Optim lead implantation from September 2003 to June 2008, 154 patients were evaluated for EF and radiographic conductor externalization (CE). Survival analysis for EF was performed for Riata/ST leads, both for failure-free lead survival and cumulative hazard...
March 1, 2016: American Journal of Cardiology
https://www.readbyqxmd.com/read/26331700/a-new-riata-lead-complication-spontaneous-lead-tip-embolization
#5
Pierre-Louis Nadeau, François Philippon, Jean-François Sarrazin, Jean Champagne
No abstract text is available yet for this article.
February 2016: Journal of Cardiovascular Electrophysiology
https://www.readbyqxmd.com/read/26293817/sudden-and-fatal-malfunction-of-a-durata-defibrillator-lead-due-to-external-insulation-failure
#6
Anand D Shah, David S Hirsh, Jonathan J Langberg
Defibrillator lead malfunction can be a disastrous complication, leading to loss of protection from sudden cardiac death in a high-risk patient population. Recognition of lead-specific risk for failure can assist in development of focused screening or surveillance, as in the case of the Riata lead (St. Jude Medical, St. Paul, MN, USA) or the Sprint Fidelis lead (Medtronic Inc., Minneapolis, MN, USA). A case of defibrillation failure secondary to a Durata lead insulation failure is presented. A brief review of the literature and current St...
January 2016: Pacing and Clinical Electrophysiology: PACE
https://www.readbyqxmd.com/read/26285670/pulse-generator-exchange-does-not-accelerate-the-rate-of-electrical-failure-in-a-recalled-small-caliber-icd-lead
#7
Joshua D Lovelock, Ajay Premkumar, Mathew R Levy, Andenet Mengistu, Michael H Hoskins, Mikhael F El-Chami, Michael S Lloyd, Angel R Leon, Jonathan J Langberg, David B Delurgio
BACKGROUND: St. Jude Riata/Riata ST defibrillator leads (St. Jude Medical, Sylmar, CA, USA) were recalled by the Food and Drug Administration in 2011 for an increased rate of failure. More than 227,000 leads were implanted and at least 79,000 patients still have active Riata leads. Studies have examined clinical predictors of lead failure in Riata leads, but none have addressed the effect of implantable cardioverter defibrillator (ICD) generator exchange on lead failure. The purpose of this study is to assess the effect of ICD generator exchange on the rate of electrical failure in the Riata lead at 1 year...
December 2015: Pacing and Clinical Electrophysiology: PACE
https://www.readbyqxmd.com/read/26218183/predictive-factors-of-lead-failure-in-patients-implanted-with-cardiac-devices
#8
Yoshiyasu Aizawa, Masachika Negishi, Shin Kashimura, Kazuaki Nakajima, Akira Kunitomi, Yoshinori Katsumata, Takahiko Nishiyama, Takehiro Kimura, Nobuhiro Nishiyama, Kotaro Fukumoto, Yoko Tanimoto, Shun Kohsaka, Seiji Takatsuki, Keiichi Fukuda
INTRODUCTION: Lead failures (LFs) are one of the most common complications in patients implanted with cardiovascular implantable electronic devices. LFs often cause serious secondary complications such as inappropriate ICD shocks or asystole. This study aimed to identify the clinical factors associated with the occurrence of LFs. METHODS: A total of 735 consecutive device implantations (mean age 67±15years, males 64%) performed at a single university hospital setting from 1997 to 2014 were included...
November 15, 2015: International Journal of Cardiology
https://www.readbyqxmd.com/read/26165944/user-reported-abrasion-related-lead-failure-is-more-common-with-durata-compared-to-other-implantable-cardiac-defibrillator-leads
#9
COMPARATIVE STUDY
Anand D Shah, David S Hirsh, Jonathan J Langberg
BACKGROUND: Following increased rates of inside-out abrasion with the St Jude Medical Riata lead, the Durata implantable cardiac defibrillator (ICD) lead was introduced with modifications intended to increase abrasion resistance. Recent case reports have described insulation failures of the Durata. OBJECTIVE: To determine if increased rates of abrasion-related failure are present with the Durata lead. METHODS: The Food and Drug Administration Manufacturer and User Facility Device Experience database was queried for reports of insulation failure of the Durata lead from 2014...
December 2015: Heart Rhythm: the Official Journal of the Heart Rhythm Society
https://www.readbyqxmd.com/read/26054484/what-did-we-learn-from-riata%C3%A2
#10
Avi Fischer, C Jenney
The Riata™ 8 French (Fr) and Riata ST™ 7 Fr families of silicone leads have experienced a specific form of insulation abrasion characterized by externalization of conductor cables outside the lead body. Design differences between the 8 Fr and 7 Fr leads make conductor externalization less likely in the smaller diameter lead. The Riata Lead Evaluation Study (RLES) reported on the prevalence of externalized conductors (EC) in patients implanted with Riata™ and Riata ST™ silicone leads and provided details on the incidence of electrical abnormalities in Riata™ and Riata ST™ leads with and without EC...
June 2015: Herzschrittmachertherapie & Elektrophysiologie
https://www.readbyqxmd.com/read/26036679/-icd-leads
#11
REVIEW
Carsten W Israel, Mohamed Karim Sheta
Implantable cardioverter-defibrillator (ICD) leads have to fulfill particular requirements: safe pacing and sensing, detection, and termination of ventricular tachyarrhythmias, if necessary by (multiple) high-energy shocks. At the same time, their implantation has to be simple, they need to provide excellent long-term stability and they must be completely and safely extractable. Numerous technical developments have enabled currently available ICD leads to fulfill these expectations to a high extent. However, some changes of lead design, materials, and manufacturing processes have led to increased lead failure, especially in two lead models (Medtronic Sprint Fidelis®, St...
June 2015: Herzschrittmachertherapie & Elektrophysiologie
https://www.readbyqxmd.com/read/26028656/a-comparative-study-of-defibrillator-leads-at-a-large-volume-implanting-hospital-results-from-the-pacemaker-and-implantable-defibrillator-leads-survival-study-paidless
#12
Todd J Cohen, Wilbur J Asheld, Joseph Germano, Shahidul Islam, Dhimesh Patel
OBJECTIVES: The purpose of the study was to examine survival in the implantable defibrillator subset of implanted leads at a large-volume implanting hospital. BACKGROUND: Implantable lead survival has been the subject of many multicenter studies over the past decade. Fewer large implanting volume single-hospital studies have examined defibrillator lead failure as it relates to patient survival and lead construction. METHODS: This investigator-initiated retrospective study examined defibrillator lead failure in those who underwent implantation of a defibrillator between February 1, 1996 and December 31, 2011...
June 2015: Journal of Invasive Cardiology
https://www.readbyqxmd.com/read/26025935/transvenous-implantable-cardioverter-defibrillator-lead-reliability-implications-for-postmarket-surveillance
#13
Daniel B Kramer, Laura A Hatfield, Deepa McGriff, Christopher R Ellis, Melanie T Gura, Michelle Samuel, Linda Kallinen Retel, Robert G Hauser
BACKGROUND: As implantable cardioverter-defibrillator technology evolves, clinicians and patients need reliable performance data on current transvenous implantable cardioverter-defibrillator systems. In addition, real-world reliability data could inform postmarket surveillance strategies directed by regulators and manufacturers. METHODS AND RESULTS: We evaluated Medtronic Sprint Quattro, Boston Scientific Endotak, and St Jude Medical Durata and Riata ST Optim leads implanted by participating center physicians between January 1, 2006 and September 1, 2012...
June 2015: Journal of the American Heart Association
https://www.readbyqxmd.com/read/25998139/cable-externalization-and-electrical-failure-of-the-riata-family-of-implantable-cardioverter-defibrillator-leads-a-systematic-review-and-meta-analysis
#14
REVIEW
Emily P Zeitler, Sean D Pokorney, Ke Zhou, Robert K Lewis, Ruth Ann Greenfield, James P Daubert, David B Matchar, Jonathan P Piccini
BACKGROUND: The Riata class of defibrillator leads were placed under US Food and Drug Association (FDA) advisory as of November 2011 because of high rates of cable externalization (CE) and electrical failure (EF). The overall rates of these complications remain unknown. OBJECTIVE: The purpose of this study was to systematically search the literature for rates of Riata lead failure and to perform a meta-analysis to estimate failure rates. METHODS: We conducted a meta-analysis of observational studies examining the rates of EF, CE, and the interaction of the two...
June 2015: Heart Rhythm: the Official Journal of the Heart Rhythm Society
https://www.readbyqxmd.com/read/25998138/outcomes-of-sprint-fidelis-and-riata-lead-extraction-data-from-2-high-volume-centers
#15
COMPARATIVE STUDY
Mikhael F El-Chami, Faisal M Merchant, Mathew Levy, Mian Bilal Alam, Rohit Rattan, Michael H Hoskins, Jonathan J Langberg, David Delurgio, Michael S Lloyd, Angel R Leon, Samir Saba
BACKGROUND: The Sprint Fidelis (SF) and the Riata (RT) implantable cardioverter-defibrillator leads have been recalled for premature failure. OBJECTIVE: Data on SF and RT extractions are limited; therefore, we performed a pooled analysis to compare the safety and efficacy of lead extraction for the SF and RT lead families. METHODS: We retrospectively reviewed consecutive patients undergoing transvenous extraction of SF and RT leads at Emory University and the University of Pittsburgh Medical Center from January 2007 to October 2013...
June 2015: Heart Rhythm: the Official Journal of the Heart Rhythm Society
https://www.readbyqxmd.com/read/25884090/managing-patients-with-advisory-defibrillator-leads-what-can-we-learn-from-published-data
#16
F A Bracke, B M van Gelder
Defibrillator lead advisories stir a lot of emotions, both with patients and physicians, and this may influence lead management. We reviewed the literature for a more evidence-based approach to this issue.From the complications of two of the current advisory leads, the Medtronic Sprint Fidelis and St. Jude Riata leads, and the consequences of possible interventions, we can conclude that a restrained approach to premature replacement is appropriate. It may be opportune to replace the leads during a scheduled generator replacement in case of a higher electrical failure rate, in order to prevent future premature interventions...
April 2015: Netherlands Heart Journal
https://www.readbyqxmd.com/read/25571482/icd-lead-failure-detection-through-high-frequency-impedance
#17
Daniel T Kollmann, Charles D Swerdlow, Mark W Kroll, Gregory J Seifert, Patrick A Lichter
Abrasion-induced insulation breach is a common failure mode of silicone-body, transvenous, implantable cardioverter defibrillator leads. It is caused either by external compression or internal motion of conducting cables. The present method of monitoring lead integrity measures low frequency conductor impedance. It cannot detect insulation failures until both the silicone lead body and inner fluoropolymer insulation have been breached completely, exposing conductors directly to blood or tissue. Thus the first clinical presentation may be either failure to deliver a life-saving shock or painful, inappropriate shocks in normal rhythm...
2014: Conference Proceedings: Annual International Conference of the IEEE Engineering in Medicine and Biology Society
https://www.readbyqxmd.com/read/25499627/transvenous-extraction-profile-of-riata-leads-procedural-outcomes-and-technical-complexity-of-mechanical-removal
#18
COMPARATIVE STUDY
Maria Grazia Bongiorni, Andrea Di Cori, Luca Segreti, Giulio Zucchelli, Stefano Viani, Luca Paperini, Raffaele De Lucia, Dianora Levorato, Adriano Boem, Ezio Soldati
BACKGROUND: Riata (RT) and Sprint Fidelis (SF) leads were recalled by the United States Food and Drug Administration because of an increased rate of failure mainly due to conductor fracture or insulation abrasion. According to lead design and type of failure, extraction complexity may be different, potentially affecting procedural outcomes and indications. OBJECTIVE: The purpose of this study was to assess the extraction profile of RT leads with and without cable externalization in comparison to SF leads...
March 2015: Heart Rhythm: the Official Journal of the Heart Rhythm Society
https://www.readbyqxmd.com/read/25485777/insight-into-the-mechanism-of-failure-of-the-riata-lead-under-advisory
#19
Ratika Parkash, Stanley Tung, Jean Champagne, Jeffrey S Healey, Bernard Thibault, Douglas Cameron, Anthony Tang, Sean Connors, Marianne Beardsall, Iqwal Mangat, Felix Ayala-Paredes, Satish Toal, Derek Exner, Raymond Yee, Andrew D Krahn
BACKGROUND: Cable externalization and insulation abrasion are known to occur with the St Jude Medical Riata leads under advisory. The distribution of these abnormalities and how they relate to clinical presentation have not been well described. OBJECTIVE: In this study, we sought to determine the relationship between structural lead failure and clinical presentation by using the analysis of returned Riata products in Canada. METHODS: The analyses of returned Riata products in Canada were obtained from St Jude Medical, Sylmar, CA...
March 2015: Heart Rhythm: the Official Journal of the Heart Rhythm Society
https://www.readbyqxmd.com/read/25479754/cost-of-a-recall-of-a-single-center-experience-managing-the-riata-defibrillator-lead
#20
Sarah Hussain, Liza Moorman, J Randall Moorman, John P DiMarco, Rohit Malhotra, Andrew Darby, Kenneth Bilchick, J Michael Mangrum, John D Ferguson, Pamela K Mason
Riata and Riata ST defibrillator leads (St. Jude Medical, Sylmar, California) were recalled in 2011 due to increased risk of insulation failure leading to externalized cables. Fluoroscopic screening can identify insulation failure, although the relation between mechanical failure and electrical failure is unclear. At the time of the recall, the University of Virginia developed a screening program, including fluoroscopic evaluation, education sessions, device interrogation, and remote monitoring for patients with this defibrillator lead...
January 15, 2015: American Journal of Cardiology
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