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Ratika Parkash, Bernard Thibault, Francois Philippon, Iqwal Mangat, Benoit Coutu, Matthew Bennett, Eugene Crystal, Jeffrey Healey, Atul Verma, Roopinder Sandhu, Douglas Cameron, Felix Ayala-Paredes, Laurence Sterns, Vidal Essebag, Marcio Sturmer, Pablo Nery, George Wells, Andrew Krahn
BACKGROUND: The Riata lead advisory was announced in 2011 and has posed unique management challenges because of cable externalization and insulation abrasion, in some cases leading to sudden loss of defibrillation. OBJECTIVE: The purpose of this study was to provide further data on the rate of electrical failure in a population of patients with a Riata lead under advisory. METHODS: Using the Canadian Registry of Electronic Device Outcomes, prospective follow-up data were collected on 1352 Riata leads under advisory in 17 implantable cardioverter-defibrillator (ICD) implantation centers in Canada...
December 2, 2017: Heart Rhythm: the Official Journal of the Heart Rhythm Society
Antonio Dello Russo, Gaetano Michele Fassini, Sergio Conti, Giulia Vettor, Michela Casella, Fabrizio Tundo, Maurizio Roberto, Francesco Grillo, Francesco Alamanni, Claudio Tondo
Transvenous extraction of Riata lead could be a challenging procedure due to insulation failure and conductor cables' externalization through the eroded outer insulation. In this case, a complete lead extraction was achieved through a combined LASER and femoral approach because of the massive conductors' externalization.
September 2017: Clinical Case Reports
Hye Bin Gwag, Jin Kyung Hwang, Kyoung Min Park, Seung Jung Park, Young Keun On, June Soo Kim
Riata defibrillator leads were recalled due to a high failure rate. This study measured the incidence of externalized conductor (EC) and electrical dysfunction (ED) and sought to determine the predictors of ED with Riata defibrillator leads. We enrolled patients who received Riata® or Riata® ST silicone defibrillator leads at our center between January 2003 and December 2010. The presence of EC was evaluated with chest radiography. The incidence rates were measured at < 3 years, 3-5 years, and > 5 years after lead implantation...
October 2017: Journal of Korean Medical Science
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
Zefferino Palamà, Roberta Trotta, Cosimo Mandurino, Mariangela Pinto, Giovanni Luzzi, Stefano Favale
We report the case of a man affected by polymicrobial endocarditis developed on a St. Jude Medical Riata lead with a malfunction because of the outsourcing of conductors. The patient was treated with antibiotic targeted therapy and showed different bacteria at the blood cultures and then underwent transvenous leads extraction. Vegetations were highlighted on the caval, atrial, and ventricular tracts of the Riata lead, but the cultures were all negative. The externalization of Riata lead may cause the malfunction but it could also promote bacterial colonies and vegetations...
2017: Case Reports in Cardiology
Elia De Maria, Ambra Borghi, Lorenzo Bonetti, Pier Luigi Fontana, Stefano Cappelli
AIM: To describe our experience with shock testing for the evaluation of patients with Riata™ leads. METHODS: Among 51 patients with normal baseline electrical parameters, 20 died during follow-up. Of the remaining 31 patients, 15 underwent the test: In 10 cases a defibrillation testing with ventricular fibrillation (VF) induction and in 5 cases a R-wave-synchronized shock (> 20 J, without inducing VF). The test was performed under sedation with Midazolam. RESULTS: Twelve patients (80%) had a normal behavior during shock testing: In 8 cases induced VF was correctly detected and treated; in 4 cases of R-wave-synchronized shock electrical parameters remained stable and normal...
November 26, 2016: World Journal of Cardiology
Andrew H Voigt, Samir Saba
No abstract text is available yet for this article.
October 2016: Circulation. Arrhythmia and Electrophysiology
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
Julia W Erath, Nadejda Monsefi, Stefan H Hohnloser
No abstract text is available yet for this article.
November 1, 2017: Europace: European Pacing, Arrhythmias, and Cardiac Electrophysiology
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
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
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
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
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
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
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
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
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
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
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
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