Safety and efficacy of conduction system pacing in dual-chamber pacemakers in a CRT-indicated population: primary analysis of the CORE-CPP study

Background Cardiac resynchronization therapy (CRT) with bi-ventricular pacing (BVP) is a well-established therapy in patients with heart failure with reduced ejection fraction (HFrEF). Conduction system pacing (CSP) has emerged as an option that can provide more physiological ventricular activation than conventional right ventricular pacing (RVP). CSP has been associated with better clinical outcomes vs. RVP in patients with a bradycardia indication. CSP has also been proposed as an alternative to conventional BVP for HFrEF, with some studies confirming equivalent outcomes to standard CRT. Objective The purpose of the Characterizing Outcomes and Real-World Experience of Cardiac Physiologic Pacing (CORE-CPP) study was to use real-world evidence to assess the safety and efficacy of CSP with dual-chamber pacemakers in comparison with CRT in patients with an indication for CRT. Methods This study used 2017-2023 Medicare claims data linked to manufacturer device registration data to identify CRT-indicated patients implanted with a dual-chamber pacemaker with a CSP lead or a traditional biventricular CRT pacemaker (CRT-P). The primary objectives were CSP non-inferiority to CRT-P patients in 30-day acute complications and reinterventions, and non-inferiority in 12-month heart failure hospitalizations (HFH). Secondary objectives included all-cause mortality, all-cause mortality + HFH, and reinterventions at 12 months. Device registration data were used to identify CSP lead location and device type, followed by linkage to claims and enrollment to describe patient characteristics and outcomes. A claims-based algorithm was used to approximate the indication for CRT (HF and AV block, HF and Atrial Fibrillation (AF), and HF in sinus rhythm). Results The study cohort included 2,207 CSP and 5,693 CRT-P de novo patients. CSP was non-inferior to CRT-P on the primary safety endpoint of 30-day acute complications and reinterventions (adj. OR 0.92, p=0.379; OR≥1.5 one-sided p<.001) and on the primary efficacy endpoint of 12-month HF hospitalisations (adj. HR 0.89, p=0.161; HR≥1.5 one-sided p<.001 Figure 1). CSP patients had significantly lower all-cause mortality rates (adj. HR 0.72, p<.001 Figure 2A) and all-cause mortality + HF hospitalisation composite rates (adj. HR 0.82, p=0.003 Figure 2B) than CRT-P patients. There were no differences in reintervention rates between CSP and CRT-P (adj. HR 1.04, p=0.798), although reinterventions trended higher in CRT-P patients with His bundle CSP (adj. HR 1.35, p=0.109) compared to LBB area CSP (vs. CRT-P) (adj. HR 0.86, p=0.334). Conclusion In a real-world cohort, CSP via a single ventricular lead was non-inferior to CRT-P therapy in patients indicated for CRT. CSP was associated with lower all-cause mortality and all-cause mortality + HFH.