This randomized trial enrolled 43 patients with cardiac resynchronization therapy (CRT) and long-standing persistent atrial fibrillation resulting in low biventricular performance. Participants were assigned to rhythm control strategies involving external electrical cardioversion or rate control strategies utilizing atrioventricular node ablation if necessary. The primary outcome assessed 12-month biventricular performance, with secondary outcomes including left ventricular ejection fraction (LVEF), peak oxygen consumption, quality of life, and safety endpoints.
At 12 months, biventricular performance was 99% [95% CI 97.3-99.8] in the rhythm control group versus 98% [94.0-99.0] in the rate control group (P = 0.14). LVEF increased significantly only in the rhythm control group, with a mean difference of 4.1 (± 7.3) and a P value of 0.018. Sinus rhythm was maintained in 38% of patients after 12 months, and the EC success rate was 58%.
No differences were observed between groups regarding peak oxygen consumption, quality of life, or clinical and safety endpoints. Adverse events, serious adverse events, discontinuations, and tolerability were not reported in the study. The study noted that no randomized trials comparing strategies to maintain high biventricular performance existed prior to this investigation.
The restoration of sinus rhythm led to improved left ventricular ejection fraction in CRT patients with long-standing AF. However, the small sample size and lack of reported safety data limit the generalizability of these findings to broader clinical practice.
View Original Abstract ↓
BACKGROUND: Atrial fibrillation (AF) is common in cardiac resynchronization therapy (CRT) recipients. It is a marker of impaired CRT response mainly mediated by the reduction of effectively captured biventricular paced beats (BiVp). There are no randomized trials comparing strategies to maintain high BiVp percentage.
OBJECTIVE: To compare the efficacy of rhythm vs rate control strategies in CRT recipients with long-standing persistent AF.
METHODS: We performed a randomized trial including CRT recipients with persistent AF resulting in low BiVp%. All patients received amiodarone, the rhythm control group received external electrical cardioversion (EC), and the rate control group received atrioventricular node ablation, if needed. The primary end-point was 12-month BiVp% (NCT).
RESULTS: 43 patients were included in the analysis. The mean age was 68.4 (SD: ± 8.3) years and the mean BiVp% 82.4% ± 9.7%. AF lasted 25 ± 19 months. The mean baseline left ventricular ejection fraction (LVEF), left atrium area, and the maximal oxygen uptake (VO2max) were: 30 ± 8%, 33 ± 7 cm, and 14 ± 5 mL/(kg*min), respectively. The EC success rate was 58%. 38% patients remained in sinus rhythm (SR) after 12 months. BiVp% increased similarly in both arms reaching 99% [95% CI 97.3-99.8] and 98% [94.0-99.0], P = 0.14 in rhythm and rate control groups, respectively. LVEF raised significantly only in the rhythm control group (ΔLVEF 4.1 (± 7.3), P = 0,018) which was driven by the patients who maintained SR. No differences in VO2max, QoL, clinical and safety end-points were observed.
CONCLUSION: Despite comparable BiVp% in both groups, only restoration of SR led to improved left ventricular ejection fraction in CRT patients with long-standing AF.
TRIAL REGISTRATION: NCT01850277 registered on 22/04/2013.