Implantable cardioverter-defibrillator FDA safety advisories: Impact on patient mortality and morbidity

Abstract

Background A significant proportion of implantable cardioverter-defibrillators (ICDs) have been subject to FDA advisories. The impact of device advisories on mortality or patient care is poorly understood. Although estimated risks of ICD generators under advisory are low, dependency on ICD therapies to prevent sudden death justifies assessment of long-term mortality. Objective To test association of FDA advisory status with long-term mortality. Methods The study was a retrospective, single-center review of clinical outcomes, including device malfunctions, in patients from implantation to either explant or death. Patients with ICDs first implanted at Cleveland Clinic between 8/96-5/04 who became subject to FDA advisories on ICD generators were identified. Mortality was determined using the Social Security Death Index. Results In 1644 consecutive patients receiving first ICD implants, 704 (43%) became subject to an FDA advisory, of which 172 (10.5%) were Class I and 532 (32.3%) were Class II. ICDs were explanted before advisory notifications in 14.0% of Class I and 10.1% of Class II advisories. Among ICDs under advisory, 28 (4.0%) advisory related and 15 non-advisory related malfunctions were documented. Over a median follow-up of 70 months, 814 patients died. Kaplan-Meier 5-year survival was 65.6% overall, and 64.2%, 61.1%, and 69.3% in patients with no, Class I, and Class II advisories, respectively, p=0.17. Conclusions ICD advisories impacted 43% of patients. Advisory-related malfunctions affected 4% within the combined Advisory group. Based on a conservative management strategy ICDs under advisory were not associated with increased mortality over a background of significant disease-related mortality.

2023 HRS/EHRA/APHRS/LAHRS Expert Consensus Statement on Practical Management of the Remote Device Clinic

“…Though there were no major complications attributed to these alerts, the patient burden related to extra visits or procedures did lead to an increased cost burden. Additional studies confirmed the high volume of patients affected, though there continued to be no evidence of associated of increased mortality 174 . Acknowledging these challenges, in 2005 the HRS and the FDA convened a conference on PM and ICD performance.…”

“…Additional studies confirmed the high volume of patients affected, though there continued to be no evidence of associated of increased mortality. 174 Acknowledging these challenges, in 2005 the HRS and the FDA convened a conference on PM and ICD performance. The resulting taskforce called for improved communication from manufacturers to physicians and patients regarding recalls and advisories, and generally more cooperation among industry, the FDA, and the physician community.…”

Health care policy and regulatory implications on medical device innovations: a cardiac rhythm medical device industry perspective

“…The apparent paradox of more advisories despite improving overall performance is consistent with a lower tolerance of malfunctions at multiple levels. Thus, a recent study of 1,644 consecutive ICD implants between 1996 and 2004 revealed that 704 patients(43 %) were part of an advisory, but only 28 of 1,644 patients (1.7 %) actually had an advisory-related device malfunction, and Class I recalls were not associated with increased mortality [17]. Some patients did undergo device replacement (42/1,644, 2.5 %) and hence were harmed, but it should also be considered that ultimately, if the patient does not succumb to comorbidities, that most ICDs need to be replaced and that this is a fractional harm depending on the device age when replaced.…”

Use and Abuse of Internal Cardioverter Defibrillators for Primary Prevention

“…52 Additionally, up to 40 % of leads or generators implanted in patients are affected by FDA safety advisories. 53 54 Device and lead failure often require lead extraction.…”