Management of Recalled Pacemakers and Implantable Cardioverter-Defibrillators

Abstract

The decision to replace a device under advisory is determined primarily by the incidence of device malfunction and the likely effects of device failure. This analysis provides a framework for managing recalled devices in the context of device, patient, and institutional characteristics.

To Replace or Not to Replace: A Systematic Approach to Respond to Device Advisories

“…Based on the analysis of the literature on SCD rates in different groups of patients, on the reported data of complications associated with device replacement and information available on device performance (Table 1) and the manufacturers' product performance reports, 17–19 we have used a set of values for the four parameters that influence the risk/benefit profile of device replacement in different settings. Overall, this analysis concurs with previous reports and shows that device replacement may not provide a major survival benefit, and it may even harm patients 2,3,7,8,21 . We have included in our model the procedure‐related mortality (two deaths in 533 replacement procedures = 0.4%) reported in the Canadian report 13 .…”

“…Gould and Krahn showed a range of failure rates for recent “advisory” devices (Table 1), mostly between 0.01 and 0.2 (with one outlier at 2.6%) 13 . There is of course also some unavoidable failure rate associated with the replacement device , as previously pointed out by Amin et al 7 The Δ (delta) is the difference between the two failure rates. In our model, we have assumed a zero failure rate for the new replacement device because this assumption actually makes the NNR more conservative, since it provides the largest delta in failure rate for each occurrence and, therefore, the smallest NNR.…”

New Insights into Predictors of Cardiac Implantable Electronic Device Infection

“…Before a device is replaced, the benefits and risks of device and accessory replacement-including the risk of death due to device failure, the rate of device failure, and the risk of procedure-related death-should be carefully considered. 40 Our study, as did that of Romeyer-Bouchard and colleagues, 18 showed that procedure duration is an independent predictor of infection, which is especially relevant in patients who are candidates for CRT device implantation. Improvements in left ventricular lead design, delivery systems, and over-the-wire technology may substantially shorten procedure time and decrease the likelihood of infection.…”

The Effect of Device Advisories on Implantable Cardioverter-defibrillator Therapy

“…The results from this study suggested that device replacement in the setting of an advisory was not inconsequential and frequently had a greater risk than continued device follow-up [18]. Their findings suggested that the decision to replace a recalled device should be based primarily on the device failure rate, the degree of patient dependency, and the anticipated mortality from device replacement [18]. A similar Markov model by Gula et al [19•] assessed survival rates over a 5-year period; they used initial estimates of risk derived from real data on advisory devices from multiple Canadian implanting centers.…”