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 been proposed as an alternative to conventional BVP for HFrEF. 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 bi-ventricular CRT pacemaker (CRT-P). The primary objectives were to determine CSP non-inferiority to CRT-P in 30-day acute complications and reinterventions, and in 12-month heart failure hospitalizations (HFH). Secondary outcomes included all-cause mortality, all-cause mortality + HFH, and reinterventions at 12 months. RESULTS: The study cohort included 2207 CSP and 5693 CRT-P de novo patients. CSP was non-inferior to CRT-P on 30-day complications and reinterventions (adjusted [adj.] odds ratio [OR] 0.92, P = .379; OR ≥1.5 1-sided P < .001) and on 12-month HFH (adj. hazard ratio [HR] 0.89, P = .161; HR ≥1.5 1-sided P < .001). CSP patients had lower all-cause mortality (adj. HR 0.72, P < .001) and all-cause mortality + HFH (adj. HR 0.82, P = .003) than CRT-P patients. There were no differences in reintervention rates between CSP and CRT-P. 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.