Early trends in leadless pacemaker implantation: Evaluating nationwide in-hospital outcomes

Background: Single-chamber leadless intracardiac pacemaker (LICP) implantation was approved in 2016 in the United States. However, little is known regarding trends in real-world utilization and complication rates.

Objective: The purpose of this study was to assess nationwide demographics, trends, and outcomes among hospitalizations with LICP implantation in the United States.

Methods: Using the National Inpatient Sample, we identified all hospitalizations with LICP or transvenous pacemaker implantation as a comparator between 2017 and 2019. We evaluated baseline patient characteristics, admitting diagnoses, procedural complications, lengths of stay, discharge dispositions, and all-cause mortality.

Results: The majority of LICP recipients were elderly (75.4 ± 12.8 years), male (55.2%), and White (76.8%) compared to Black (9.8%), or Hispanic (7.3%). Between 2017 and 2019, the average age increased along with the prevalence of heart failure, atrial fibrillation, and malignancy among recipients. Most hospitalizations were emergent (84.5%). Between 2017 and 2019, pooled procedural complications decreased significantly (10.8% vs 7.9%; P <.001), primarily due to declining infection and device retrieval rates. In-hospital mortality also decreased significantly (8.2% vs 4.2%; P <.001). History of cardiogenic shock or cardiac device infection was associated with the greatest mortality or complication risk. Compared to transvenous pacemaker, LICP implantation was associated with lower complication rates (8.6% vs 11.2%) but greater mortality (5.2% vs 1.3%; P <.001).

Conclusion: Nationwide LICP implantations were performed in patients of increasing age, comorbidities, and acuity of illness. In-hospital mortality and procedure-related complications declined in the first 3 years after approval of LICP implantation and may reflect improving operator experience. Increased mortality compared with transvenous pacemaker implant remains a concern.