BACKGROUND: In recent years, 2 popular implantable cardioverter-defibrillator (ICD) leads have undergone a class I recall by the Food and Drug Administration (FDA): the Sprint Fidelis and the Riata leads. OBJECTIVE: To examine the failure rates of these 2 leads with respect to their date of FDA recall. METHODS: All patients implanted with a Sprint Fidelis, Riata, or Sprint Quattro lead at our institution were included. Kaplan-Meier failure-free survival curves were constructed with and without censoring at the dates of announcement of the FDA recall for each lead. RESULTS: A total of 2270 patients (623 Sprint Fidelis, 627 Riata, and 1020 Sprint Quattro) were included. The failure-free survival of the Sprint Quattro lead was significantly better than that of the Riata lead (P <.0001), which in turn was better than that of the Sprint Fidelis lead (P = .0214). After censoring events at the time of the FDA recall for each lead, the failure-free survival of the Sprint Quattro lead continued to be superior to that of the Riata (P <.0001) and Sprint Fidelis (P = .0124) leads but the difference between the Riata and Sprint Fidelis leads was eliminated (P = .123). CONCLUSIONS: In this study, a comparative analysis of the failure-free survival of 2 recalled leads demonstrates discrepancies in the timing of the recall despite comparable failure-free survival patterns leading to the recall. The causes of these discrepancies are unclear and raise questions regarding the consistency of postmarketing surveillance and manufacturers' reporting of malfunctions of medical devices.
BACKGROUND: In recent years, 2 popular implantable cardioverter-defibrillator (ICD) leads have undergone a class I recall by the Food and Drug Administration (FDA): the Sprint Fidelis and the Riata leads. OBJECTIVE: To examine the failure rates of these 2 leads with respect to their date of FDA recall. METHODS: All patients implanted with a Sprint Fidelis, Riata, or Sprint Quattro lead at our institution were included. Kaplan-Meier failure-free survival curves were constructed with and without censoring at the dates of announcement of the FDA recall for each lead. RESULTS: A total of 2270 patients (623 Sprint Fidelis, 627 Riata, and 1020 Sprint Quattro) were included. The failure-free survival of the Sprint Quattro lead was significantly better than that of the Riata lead (P <.0001), which in turn was better than that of the Sprint Fidelis lead (P = .0214). After censoring events at the time of the FDA recall for each lead, the failure-free survival of the Sprint Quattro lead continued to be superior to that of the Riata (P <.0001) and Sprint Fidelis (P = .0124) leads but the difference between the Riata and Sprint Fidelis leads was eliminated (P = .123). CONCLUSIONS: In this study, a comparative analysis of the failure-free survival of 2 recalled leads demonstrates discrepancies in the timing of the recall despite comparable failure-free survival patterns leading to the recall. The causes of these discrepancies are unclear and raise questions regarding the consistency of postmarketing surveillance and manufacturers' reporting of malfunctions of medical devices.
Authors: John A Cairns; Jeff S Healey; Andrew E Epstein; Ellison Themeles; Kumar Balasubramanian; Stuart J Connolly Journal: Heart Rhythm O2 Date: 2021-12-01