Trends in adoption of extravascular devices compared to conventional devices: real-world data from the Netherlands Heart Registration

FUNDING ACKNOWLEDGEMENTS: Type of funding sources: None. INTRODUCTION: Extravascular devices (EVD), such as the subcutaneous ICD (S-ICD) and leadless pacemaker (LP), have been developed to circumvent pocket- and lead-related device complications. Knowledge on trends in adoption of these devices among patient categories and hospital types is mainly derived from industry-initiated studies or selected populations. PURPOSE: To assess the real-world nationwide trends in adoption of EVDs in the Netherlands. METHODS: Using real-world data registered at the Netherlands Heart Registration from 72 Dutch device-implanting hospitals, all consecutive patients were included with an EVD implantation (de novo or replacement) from 2012-2020. To describe the relative adoption of EVDs, all consecutive patients with a single-chamber conventional ICD or pacemaker were also included (pacemakers from 2014, the first LP registration). Trends in EVD adoption are described for different patient (age, gender, and BMI) and hospital (tertiles of device-implanting volume and implanting center [general , intervention, or thorax]) characteristics. Differences in adoption were tested using Chi-square and Fisher’s exact tests. RESULTS: From 2012-2020, 2862 S-ICDs and 15806 single-chamber conventional ICDs were implanted, while from 2014-2020, 785 LPs and 16530 single-chamber conventional pacemakers were implanted. S-ICD use among single-chamber ICD recipients increased from 7% to 22% and LP use among single-chamber pacemaker recipients increased from 1% to 8%, although utilization has levelled off in recent years (Fig. 1). The relative use of S-ICDs was largest in patients aged 10-30 years and declined with higher age (p<0.001); LP use ranged between 0 and 6% among age groups, with no specific preference at older age (p=0.002)(Fig. 2A). S-ICDs were used more in female than male ICD recipients (p=0.005); LPs more in male than female pacemaker recipients (p=0.002)(Fig. 2B). EVD utilization was largest in patients with a BMI <25 kg/m2 (S-ICDs p<0.001; LPs p=0.02)(Fig. 2C). EVDs were mostly implanted in high-volume centers (S-ICDs p=0.03; LPs p<0.001). S-ICDs were implanted mostly in thorax centers (p<0.001); LPs in thorax centers only. CONCLUSIONS: Although EVDs have been adopted early in the Netherlands, their utilization has levelled off in recent years, possibly driven by higher cost, battery issues, or the COVID-19 pandemic. Utilization of S-ICDs is highest among younger patients while utilization of LPs was not specifically high in certain age groups. The effects of gender and BMI were smaller. EVDs were mainly implanted in high-volume thorax centers. [Figure: see text] [Figure: see text]