Key result
Endotak Reliance defibrillator leads drive ~96% of reported lead calcifications in MAUDE database.
Why the study?
Endotak Reliance defibrillation leads may be prone to calcification affecting shocking and pacing electrodes, but comparative data with other leads were lacking.
Do Endotak Reliance defibrillation leads have a higher incidence of calcification compared to other defibrillation leads?
Observational (n=113)
Do Endotak Reliance defibrillation leads have a higher incidence of calcification compared to other defibrillation leads?
Endotak Reliance defibrillation leads appear uniquely prone to shocking coil and distal pacing electrode calcification, which can cause high impedances and potentially compromise defibrillation and pacing therapy.
Answers are grounded in this paper and cite their sources.
Endotak Reliance leads show disproportionate calcification in MAUDE reports; hypothesis-generating and should not change practice pending prospective study.
PURPOSE: We 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. METHODS: We 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. RESULTS: The 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. CONCLUSION: Endotak 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.
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Hauser et al. (2019) conducted an observational in Defibrillation lead calcification (n=113). Endotak Reliance defibrillation leads vs. Other defibrillation leads (Sprint Fidelis, Sprint Quattro Secure, Riata, Durata) was evaluated on Number of calcified defibrillation leads identified in the MAUDE database. Endotak Reliance defibrillation leads accounted for 109 of 113 calcified leads identified in the FDA MAUDE database and were the only leads to exhibit shocking coil calcification.
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