Long-term follow-up results of the pacing to avoid cardiac enlargement (PACE) trial

Abstract

Aims: We report the results of long-term follow-up of the Pacing to Avoid Cardiac Enlargement (PACE) trial, a prospective, double-blinded, randomized, multicentre study that confirmed the superiority of biventricular (BiV) pacing compared with right ventricular apical (RVA) pacing in prevention of LV adverse remodelling and deterioration of systolic function at 1 and 2 years.

Methods and results: Patients with bradycardia and preserved LVEF were randomized to receive RVA (n = 88) or BiV pacing (n = 89). Co-primary endpoints were LV end-systolic volume (LVESV) and LVEF measured by echocardiography. There were 149 patients who had extended follow-up, with a mean duration of 4.8 ± 1.5 years (2.5-7.8 years). The primary endpoint analyses were performed in 146 patients (74 in the RVA group and 72 in the BiV group). In the RVA pacing group, the LVEF decreased while the LVESV increased progressively at follow-up, but remained unchanged in the BiV pacing group. The differences in LVEF between the RVA and BiV groups were -6.3, -9.2, and -10.7% at 1-year, 2-year, and long-term follow-up, respectively (all P < 0.001). The corresponding differences in LVESV were +7.4, +9.9, and +13.1 mL, respectively (all P < 0.001). The deleterious effects of RVA pacing consistently occurred in all the pre-defined subgroups. Furthermore, patients with RVA pacing had a significantly higher prevalence of heart failure hospitalization than the BiV group (23.9% vs. 14.6%, log-rank χ² = 7.55, P = 0.006).

Conclusion: Left ventricular adverse remodelling and deterioration of systolic function continued at long-term follow-up in patients with RVA pacing; this deterioration was prevented by the use of BiV pacing. Also, heart failure hospitalization was more prevalent in the RVA pacing group.

Keywords: Bradycardia; Left ventricular remodelling; Long-term follow-up; Pacing.