Cardiovascular implantable electronic device lead safety: Harnessing real-world remote monitoring data for medical device evaluation

Background

Current methods to identify cardiovascular implantable electronic device lead failure include postapproval studies, which may be limited in scope, participant numbers, and attrition; studies relying on administrative codes, which lack specificity; and voluntary adverse event reporting, which cannot determine incidence or attribution to the lead.

Objective

The purpose of this study was to determine whether adjudicated remote monitoring (RM) data can address these limitations and augment lead safety evaluation.

Methods

Among 48,191 actively monitored patients with a cardiovascular implantable electronic device, we identified RM transmissions signifying incident lead abnormalities and, separately, identified all leads abandoned or extracted between April 1, 2019, and April 1, 2021. We queried electronic health record and Medicare fee-for-service claims data to determine whether patients had administrative codes for lead failure. We verified lead failure through manual electronic health record review.

Results

Of the 48,191 patients, 1170 (2.4%) had incident lead abnormalities detected by RM. Of these, 409 patients had administrative codes for lead failure, and 233 of these 409 patients (57.0%) had structural lead failure verified through chart review. Of the 761 patients without administrative codes, 167 (21.9%) had structural lead failure verified through chart review. Thus, 400 patients with RM transmissions suggestive of lead abnormalities (34.2%) had structural lead failure. In addition, 200 patients without preceding abnormal RM transmissions had leads abandoned or extracted for structural failure, making the total lead failure cohort 600 patients (66.7% with RM abnormalities, 33.3% without). Patients with isolated right atrial or left ventricular lead failure were less likely to have lead replacement and administrative codes reflective of lead failure.

Conclusion

RM may strengthen real-world assessment of lead failure, particularly for leads where patients do not undergo replacement.

Introduction

Cardiovascular implantable electronic devices (CIEDs) play a central role in the care of patients with heart rhythm disorders.1, 2, 3 However, lead failure is an important complication that can result in inadequate pacing and/or inappropriate shocks (for high-energy leads), with clinical consequences such as sudden cardiac death and complications from reoperation.⁴

Over the past 15 years, multiple lead model recalls have been classified as Class 1 recalls by the Food and Drug Administration (FDA), which means there is “a reasonable probability that the…product will cause serious adverse health consequences or death.”⁵ Two examples are the 2007 Medtronic Sprint Fidelis and 2010 Riata/Riata ST implantable cardioverter-defibrillator (ICD) lead recalls. Multiple publications have estimated that approximately 1 in 4 ICD leads have mechanical complications at 10-year follow-up, although these findings are influenced because of the inclusion of recalled leads.6, 7, 8

FDA uses multiple mechanisms to identify lead failure and ensure patient safety. First, 5-year postapproval studies have been mandated for novel or significantly modified leads for approximately the past 15 years since the Sprint Fidelis recall; however, these studies have historically been limited by scope, small participant numbers, slow enrollment, attrition, and high cost. Second, the Manufacturer and User Facility Device Experience (MAUDE) collects reports of device malfunction but cannot determine incidence or prevalence due to spontaneous reporting, attribution to the device, or the role of the device-associated adverse event in clinical outcomes.⁹ Third, manufacturers of CIED systems are required to publicly report performance, including leads. However, these reports are derived from the postapproval studies and adverse event reports with the same aforementioned limitations as well as returned product analyses, which may be limited since not all failed leads are removed and returned.

The 21st Century Cures Act of 2016 and FDA’s 2017 guidance document “Use of real-world evidence to support regulatory decision-making for medical devices,” in combination with advances in the availability of large electronic data sets, have fueled interest in leveraging real-world data (RWD) for postmarket device evaluations.^10,11 ElectroPhysiology Predictable And SuStainable Implementation Of National Cardiovascular Registries is a collaborative initiative of the FDA, CIED manufacturers, the Heart Rhythm Society, and academics to leverage existing RWD to retrospectively identify lead failure among patients with a CIED.^12,13 ElectroPhysiology Predictable And SuStainable Implementation Of National Cardiovascular Registries is primarily leveraging manufacturer registration and tracking databases linked to Medicare fee-for-service claims data to conduct safety evaluations. It is unknown whether remote monitoring (RM) performed in clinical care can strengthen these approaches to lead failure detection by identifying lead failure that may not have otherwise been detected and the specific chamber affected to provide accurate ongoing postmarket safety evaluation.

Since medical claims data are designed for billing purposes, they often lack granular clinical details available in electronic health records (EHRs), such as characterization of nonprocedural clinical interventions for lead failure (ie, those that may not be reflected in diagnosis or procedure codes) and distinguishing structural vs functional lead failure. Additionally, most CIEDs have multiple leads, which are indistinguishable in claims.

To address these limitations, we sought to determine whether RM data could be used to identify lead failure and how it compared with administrative codes for lead failure via manual EHR review. We also sought to evaluate the rates of clinical actions taken for lead failure identified via RM, stratified by lead type and location. For these objectives, we leveraged the Veterans Affairs National Cardiac Device Surveillance Program (VANCDSP), which follows more than 50,000 veterans with a CIED from all 4 major manufacturers through RM, with more than 250,000 transmissions reviewed annually.