Abstract
PurposeWe have reported the calcification of Endotak defibrillation leads that required replacement. The aim of this study was to assess calcified Endotak Reliance leads in the Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database and compare them to calcified Sprint Fidelis, Sprint Quattro Secure, Riata, and Durata leads in MAUDE.MethodsWe searched the MAUDE database from 2008 to 2019 for defibrillation lead calcification using the terms “calcium,” “calcification,” and “calcified”. Included were explanted leads whose manufacturers found calcium on the shocking and/or pacing electrode.ResultsThe MAUDE search identified 113 calcified defibrillation leads that qualified for the study, including 109 Endotak Reliance leads, 1 Sprint Quattro Secure lead, 2 Durata leads, 1 Riata ST lead, and no Sprint Fidelis lead. The sign of calcification was a gradual increase in shocking or pacing impedance. Average implant time was 7.4 ± 3.1 (range: 1.3–16.5) years. Only Endotak Reliance leads had shocking coil calcification (n = 72; 66.0%) and five (6.9%) of these failed defibrillation threshold (DFT) testing. Distal pacing electrode calcification affected 55 (50.4%) Endotak Reliance leads. The four other leads had pacing ring electrode calcification only.ConclusionEndotak Reliance defibrillation leads appear prone to shocking coil and/or distal pacing electrode calcification. High impedances may compromise defibrillation and pacing therapy. Patients who have these leads should be monitored; those exhibiting high shocking impedances should be considered for DFT testing. Lead replacement should be considered for pacemaker-dependent patients whose leads exhibit progressively high impedances.
Highlights
Calcification of tissue surrounding a defibrillation lead may complicate extraction, but calcification of a shocking coil or pacing electrode may increase impedance, limit current flow, and potentially compromise effective therapy [1]
A gradual rise in impedance was the cardinal sign of shocking coil and distal pacing electrode calcification
The results of this study suggest that Endotak Reliance defibrillation leads are prone to shocking coil and distal pacing electrode calcification that may result in high impedances and potential failure to defibrillate or pace
Summary
Calcification of tissue surrounding a defibrillation lead may complicate extraction, but calcification of a shocking coil or pacing electrode may increase impedance, limit current flow, and potentially compromise effective therapy [1]. We reported the calcification of Endotak Reliance (Boston Scientific, St. Paul, MN) high-voltage (HV) defibrillation leads that required replacement [2, 3]. The aim of this study was to assess all clinical events associated with confirmed Endotak Reliance lead calcification as described by the manufacturer in reports publicly available in the Food and Drug Administration’s (FDA) Manufacturers and User Facility Device Experience (MAUDE) database. These results were compared to similar data for Sprint Fidelis and Sprint Quattro Secure (Medtronic Inc., Minneapolis, MN) and Riata and Durata (Abbott/St. Jude Medical, Sylmar, CA) HV defibrillation leads
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