Navigating Pacemaker and ICD Safety in Clinical Practice - 2025 Quality Summit Presentation (Non-CE)-Navigating Pacemaker and ICD Safety in Clinical Practice

Video Transcription

Video Summary

Dr. Sanket Dhruva discusses the critical issue of recalls for pacemakers and implantable cardioverter-defibrillators (ICDs), highlighting their implications for patient care and quality management. These life-saving devices, implanted for long-term use, are sometimes subject to FDA-classified recalls, especially class 1 recalls involving serious health risks or death. Unlike consumer recalls, these devices cannot simply be removed and replaced; often, risk mitigation strategies such as reprogramming or monitoring are recommended rather than immediate explantation. Examples include recalls due to lead fractures (Medtronic Sprint Fidelis) or generator malfunctions (Medtronic short circuit detection issues), which pose challenges in balancing risks of device failure versus procedural complications from replacements.<br /><br />Dr. Dhruva emphasizes the role of the National Cardiovascular Data Registry (NCDR) and the Electrophysiology Device Implant (EPDI) registry in tracking affected devices and facilitating patient identification and management. Shared decision-making is crucial for tailoring interventions to individual patient needs and risks, including transparent communication about device recalls and potential outcomes. Remote monitoring and firmware updates also play key roles in maintaining patient safety. Despite the complexities, the goal remains delivering high-quality, safe care through comprehensive protocols and leveraging registry data to improve recall management and patient outcomes.

Keywords

public reporting

cardiovascular healthcare

National Cardiovascular Data Registry

healthcare quality measurement

transparency

accountability

risk aversion

clinical registries

hospital rankings

transcatheter aortic valve replacement

pacemaker recalls

implantable cardioverter-defibrillators

FDA class 1 recalls

risk mitigation strategies

lead fractures

device failure risks

shared decision-making

remote monitoring