Abstract 16146: A Scoping Review of Adverse Outcomes Associated With Cardiac Resynchronization Therapy Device Implantation: Implications for Informed Consent

Abstract

Background/Objectives: Cardiac Resynchronization Therapy (CRT) is a treatment option for many adults with heart failure with reduced ejection fraction (HFrEF). While the benefits of CRT are well-established, the downstream implications of adverse events are not well-characterized. We sought to better understand the ramifications of CRT-related adverse events on length of hospital stay (LOS) and mortality—information relevant for patients and clinicians to make informed decisions about pursuing CRT. Design: Scoping Review Methods: We conducted an initial PubMed search using terms including “Congestive Heart Failure” or “Heart Failure” and "Cardiac resynchronization" or "Cardiac re-synchronization" or "Biventricular pacing.” We reviewed resulting articles that were written in English, studied CRT devices, and outlined adverse events related to CRT device placement. We separately searched PubMed for additional articles outlining individual adverse events identified using search terms “event name,” “mortality,” and “hospital stay.” We read articles and summarized data regarding the impact of reported adverse events on hospital LOS and mortality. Results: Our search identified 18 full length articles with relevant data. The most common adverse events included device implant failure/non-response, lead dislodgment, coronary sinus dissection, and pocket hematoma. The LOS and mortality rates of each event are shown in Table 1. Of note, LOS for implantation in the ambulatory setting is up to 1 day; LOS for uncomplicated implantation during hospitalization is 4.6 days. Implantation during hospitalization with complication is mean 13.6 days. Conclusion: While absolute risks for adverse events associated with CRT implantation are low, several have important implications on hospital LOS and mortality. These findings warrant inclusion in discussion regarding the risks of CRT when clinicians and patients engage in informed decision making related to CRT.