|
1
|
Freedman RA, Curtis AB, Delgado SM, Lee LY. Externalized Conductors and Electrical Dysfunction in Transvenous Ventricular Leads: Results of the Cardiac Lead Assessment Study. Heart Rhythm O2 2022; 3:160-168. [PMID: 35496462 PMCID: PMC9043361 DOI: 10.1016/j.hroo.2022.01.007] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/25/2022] Open
Abstract
Background The Cardiac Lead Assessment Study (CLAS) was a large prospective, multicenter, international postmarket surveillance study conducted at 45 sites. Objective The purpose of CLAS was to examine the prevalence and incidence of externalized conductors and electrical dysfunction in subjects with selected St. Jude Medical defibrillator and left ventricular leads. Methods Cinefluoroscopy was used to determine the presence of externalized conductors at enrollment and at 12-, 24-, and 36-month follow-up visits. Lead electrical measurements were collected systematically. Results The study enrolled 2216 subjects with a total of 2847 study leads. The prevalence of externalized conductors through 36 months for Riata leads was 30.9%, Riata ST leads 12.6%, Durata leads 0.5%, and QuickSite/QuickFlex leads 4.7%. The prevalence of electrical dysfunction through 36 months for Riata was 4.0%, Riata ST 3.3%, Durata 2.4%, and QuickSite/QuickFlex 0.3%. In Riata and Riata ST leads with externalized conductors, there was a low risk of electrical dysfunction. None of the Durata or QuickSite/QuickFlex leads with externalized conductors developed electrical dysfunction. There was no evidence of an electrical short in a high-voltage shocking circuit leading to failed shock. Conclusion A high prevalence of externalized conductors was found in Riata and Riata ST defibrillator leads, with a higher risk of externalization for 8F Riata leads than for 7F Riata ST leads. The 98% reduction in prevalence of externalized conductors in Durata leads compared to Riata/Riata ST leads confirms that the design improvements culminating in Durata leads significantly improved abrasion resistance and durability.
Collapse
|
|
2
|
De Maria E, Borghi A, Bonetti L, Fontana PL, Cappelli S. Riata silicone defibrillation lead with normal electrical measures at routine ambulatory check: The role of high-voltage shock testing. World J Cardiol 2016; 8:657-666. [PMID: 27957252 PMCID: PMC5124724 DOI: 10.4330/wjc.v8.i11.657] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/02/2016] [Revised: 07/21/2016] [Accepted: 09/21/2016] [Indexed: 02/06/2023] Open
Abstract
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. Three patients (20%) failed the test. One patient with externalized conductors showed a sudden drop of high-voltage impedance (< 10 Ohm) after a 25 J R-wave-synchronized shock. Two other patients with externalized conductors, undergoing defibrillation testing, showed a short-circuit during shock delivery and the implantable cardioverter defibrillator was unable to interrupt VF. CONCLUSION In Riata™ leads the delivery of a low current during routine measurement of high-voltage impedance may not reveal a small short circuit, that can only be evident by attempting to deliver a true shock, either for spontaneous arrhythmias or in the context of a shock testing.
Collapse
Affiliation(s)
- Elia De Maria
- Elia De Maria, Ambra Borghi, Lorenzo Bonetti, Pier Luigi Fontana, Stefano Cappelli, Cardiology Unit, Ramazzini Hospital, 41012 Carpi (Modena), Italy
| | - Ambra Borghi
- Elia De Maria, Ambra Borghi, Lorenzo Bonetti, Pier Luigi Fontana, Stefano Cappelli, Cardiology Unit, Ramazzini Hospital, 41012 Carpi (Modena), Italy
| | - Lorenzo Bonetti
- Elia De Maria, Ambra Borghi, Lorenzo Bonetti, Pier Luigi Fontana, Stefano Cappelli, Cardiology Unit, Ramazzini Hospital, 41012 Carpi (Modena), Italy
| | - Pier Luigi Fontana
- Elia De Maria, Ambra Borghi, Lorenzo Bonetti, Pier Luigi Fontana, Stefano Cappelli, Cardiology Unit, Ramazzini Hospital, 41012 Carpi (Modena), Italy
| | - Stefano Cappelli
- Elia De Maria, Ambra Borghi, Lorenzo Bonetti, Pier Luigi Fontana, Stefano Cappelli, Cardiology Unit, Ramazzini Hospital, 41012 Carpi (Modena), Italy
| |
Collapse
|
|
3
|
Phan K, Kabunga P, Kilborn MJ, Sy RW. Defibrillator Threshold Testing at Generator Replacement: Is it Time to Abandon the Practice? PACING AND CLINICAL ELECTROPHYSIOLOGY: PACE 2015; 38:777-81. [PMID: 25790073 DOI: 10.1111/pace.12630] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Track Full Text] [Subscribe] [Scholar Register] [Received: 10/17/2014] [Revised: 02/09/2015] [Accepted: 03/12/2015] [Indexed: 01/29/2023]
Affiliation(s)
- Kevin Phan
- Sydney Medical School, University of Sydney, Sydney, Australia
| | - Peter Kabunga
- Department of Cardiology, Royal Prince Alfred Hospital, Sydney, Australia
| | - Michael J Kilborn
- Sydney Medical School, University of Sydney, Sydney, Australia.,Department of Cardiology, Royal Prince Alfred Hospital, Sydney, Australia
| | - Raymond W Sy
- Sydney Medical School, University of Sydney, Sydney, Australia.,Department of Cardiology, Royal Prince Alfred Hospital, Sydney, Australia
| |
Collapse
|
|
4
|
Parkash R, Tung S, Champagne J, Healey JS, Thibault B, Cameron D, Tang A, Connors S, Beardsall M, Mangat I, Ayala-Paredes F, Toal S, Exner D, Yee R, Krahn AD. Insight into the mechanism of failure of the Riata lead under advisory. Heart Rhythm 2014; 12:574-579. [PMID: 25485777 DOI: 10.1016/j.hrthm.2014.12.002] [Citation(s) in RCA: 14] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Key Words] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/31/2014] [Indexed: 12/29/2022]
Abstract
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. These data were correlated with the clinical presentation of patients just before lead removal from service. RESULTS As of May 1, 2013, there were 263 returned Riata leads in Canada. Of these, 43 (16.8%) were found to have insulation abrasion that was due to either lead-can or lead-other device interaction (70%) or inside-out abrasion (27.9%). The predilection of lead-to-can abrasion was seen in the Riata 7-F leads (84.2% vs 58.4%; P = .07), while inside-out abrasion was more common in the Riata 8-F leads (37.5% vs 15.8%; P = .12). Electrical abnormalities were frequent (20 of 31 [65.4%]) and most often due to electrical noise (45.2%), although inappropriate shocks were present (25.8%). Death occurred in 1 of 43 (2.3%) of those patients with an insulation defect in the lead-can abrasion group. CONCLUSION Lead-can abrasion is the most common form of insulation defect in the Riata group of leads under advisory. Management of this group of leads under advisory should not neglect the issue of lead-can abrasion, in addition to detection of cable externalization.
Collapse
Affiliation(s)
- Ratika Parkash
- QEII Health Sciences Center, Halifax, Nova Scotia, Canada.
| | - Stanley Tung
- St. Paul's Hospital, Vancouver, British Columbia, Canada
| | - Jean Champagne
- Quebec Heart Institute, Laval Hospital, Quebec City, Quebec, Canada
| | | | | | | | - Anthony Tang
- London Health Sciences Center, London, Ontario, Canada
| | - Sean Connors
- Memorial University Health Sciences Center, St John's Newfoundland, Canada
| | | | | | | | - Satish Toal
- Saint John Regional Hospital, Saint John, New Brunswick, Canada
| | - Derek Exner
- Libin Cardiovascular Institute, Calgary, Alberta, Canada
| | - Raymond Yee
- London Health Sciences Center, London, Ontario, Canada
| | - Andrew D Krahn
- University of British Columbia, Vancouver, British Columbia, Canada
| |
Collapse
|
|
5
|
Steinberg C, Sarrazin JF, Philippon F, Champagne J, Bouchard MA, Molin F, Nault I, Blier L, O'Hara G. Longitudinal follow-up of Riata leads reveals high annual incidence of new conductor externalization and electrical failure. J Interv Card Electrophysiol 2014; 41:217-22. [PMID: 25399242 DOI: 10.1007/s10840-014-9951-6] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/17/2014] [Accepted: 09/10/2014] [Indexed: 01/17/2023]
Abstract
BACKGROUND AND PURPOSE Riata(TM) defibrillation leads are susceptible to conductor externalization. The point prevalence of insulation defect in Riata(TM) leads is up to 33 %, but prospective data concerning incidence of new lead abnormalities are lacking. The purpose of our study was to determine the annual incidence of new conductor externalizations and electrical lead failure. METHODS A prospective observational study was conducted at a single tertiary center. One hundred forty-one patients were followed over 12 months. A posterior-anterior (PA)/lateral chest x-ray (CXR) with zooming was performed at baseline and at 12 months to screen for conductor externalization. Electrical abnormalities and clinical outcome were also assessed. RESULTS The overall incidence of new insulation defects was 8.5 % at 12 months. High-risk leads for new conductor externalization were lead models 1580, 1582, and 1590 with an annual rate of 11.9, 11.1, and 10 %, respectively. New conductor externalizations were three times more common in 8 Fr leads compared to 7 Fr leads. The overall incidence of new electrical dysfunction was 6.4 % at 12 months. Electrical dysfunction was significantly higher in abnormal leads (25 % [3/12], 4.7 % [6/129]; p = 0.03) and mostly driven by high ventricular pacing thresholds. There was no difference in inappropriate shock or failure of high-voltage therapy. CONCLUSION The annual incidence of new insulation defects in Riata(TM) leads is much higher than previously reported. Lead models 1580, 1582, and 1590 are at highest risk for new conductor externalization. Electrical dysfunction in Riata(TM) leads is also much higher than reported and is associated with conductor externalization.
Collapse
Affiliation(s)
- Christian Steinberg
- Institut universitaire de cardiologie et pneumologie de Québec (IUCPQ), Division of electrophysiology, 2725, chemin Sainte-Foy, Quebec, QC, G1V 4G5, Canada,
| | | | | | | | | | | | | | | | | |
Collapse
|
|
6
|
Maytin M, Wilkoff BL, Brunner M, Cronin E, Love CJ, Grazia Bongiorni M, Segreti L, Carrillo RG, Garisto JD, Kutalek S, Subzposh F, Fischer A, Coffey JO, Gangireddy SR, Saba S, Mittal S, Arshad A, O’Keefe RM, Henrikson CA, Belott P, John RM, Epstein LM. Multicenter experience with extraction of the Riata/Riata ST ICD lead. Heart Rhythm 2014; 11:1613-8. [DOI: 10.1016/j.hrthm.2014.05.014] [Citation(s) in RCA: 32] [Impact Index Per Article: 2.9] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/30/2014] [Indexed: 12/21/2022]
|
|
7
|
Shock-induced failure of a Riata lead with normal electrical lead parameters and a normal fluoroscopic appearance: A case report. J Arrhythm 2014. [DOI: 10.1016/j.joa.2013.07.006] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/21/2022] Open
|
|
8
|
GOLDSTEIN MATTHEWA, BADRI MARWAN, KOCOVIC DUSAN, KOWEY PETERR. Electrical Failure of an ICD Lead due to a Presumed Insulation Defect Only Diagnosed by a Maximum Output Shock. PACING AND CLINICAL ELECTROPHYSIOLOGY: PACE 2013; 36:1068-71. [DOI: 10.1111/pace.12187] [Citation(s) in RCA: 21] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Track Full Text] [Subscribe] [Scholar Register] [Received: 04/09/2013] [Revised: 04/23/2013] [Accepted: 04/23/2013] [Indexed: 11/30/2022]
Affiliation(s)
- MATTHEW A. GOLDSTEIN
- Lankenau Medical Center and Institute for Medical Research; Main Line Health System; Wynnewood Pennsylvania
| | - MARWAN BADRI
- Lankenau Medical Center and Institute for Medical Research; Main Line Health System; Wynnewood Pennsylvania
| | - DUSAN KOCOVIC
- Lankenau Medical Center and Institute for Medical Research; Main Line Health System; Wynnewood Pennsylvania
| | - PETER R. KOWEY
- Lankenau Medical Center and Institute for Medical Research; Main Line Health System; Wynnewood Pennsylvania
- Jefferson Medical College; Philadelphia Pennsylvania
| |
Collapse
|
|
9
|
Nationwide Fluoroscopic Screening of Recalled Riata Defibrillator Leads in Denmark. Heart Rhythm 2013; 10:821-7. [DOI: 10.1016/j.hrthm.2013.02.010] [Citation(s) in RCA: 20] [Impact Index Per Article: 1.7] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/04/2013] [Indexed: 11/20/2022]
|