Primary endpoints of the biventricular pacing after cardiac surgery trial.

BACKGROUND: This study sought to determine whether optimized biventricular pacing increases cardiac index in patients at risk of left ventricular dysfunction after cardiopulmonary bypass. Procedures included coronary artery bypass, aortic or mitral surgery and combinations. This trial was approved by the Columbia University Institutional Review Board and was conducted under an Investigational Device Exemption.
METHODS: Screening of 6,346 patients yielded 47 endpoints. With informed consent, 61 patients were randomized to pacing or control groups. Atrioventricular and interventricular delays were optimized 1 (phase I), 2 (phase II), and 12 to 24 hours (phase III) after bypass in all patients. Cardiac index was measured by thermal dilution in triplicate. A 2-sample t test assessed differences between groups and subgroups.
RESULTS: Cardiac index was 12% higher (2.83±0.16 [standard error of the mean] vs 2.52±0.13 liters/minute/square meter) in the paced group, less than predicted and not statistically significant (p=0.14). However, when aortic and aortic-mitral surgery groups were combined, cardiac index increased 29% in the paced group (2.90±0.19, n=14) versus controls (2.24±0.15, n=11) (p=0.0138). Using a linear mixed effects model, t-test revealed that mean arterial pressure increased with pacing versus no pacing at all optimization points (phase I 79.2±1.7 vs 74.5±1.6 mm Hg, p=0.008; phase II 75.9±1.5 vs 73.6±1.8, p=0.006; phase III 81.9±2.8 vs 79.5±2.7, p=0.002).
CONCLUSIONS: Cardiac index did not increase significantly overall but increased 29% after aortic valve surgery. Mean arterial pressure increased with pacing at 3 time points. Additional studies are needed to distinguish rate from resynchronization effects, emphasize atrioventricular delay optimization, and examine clinical benefits of temporary postoperative pacing.

RCT Entities:   Population Interventions Outcomes