Continuous right ventricular (RV) pacing demonstrates harm in patients with normal left ventricular (LV) function as well as in patients with cardiomyopathy and clinical heart failure. However, little is known about RV pacing in patients with advanced heart failure treated with an implantable left ventricular assist device (LVAD). The univentricular support provided by contemporary continuous flow LVAD's has improved outcomes for many advanced heart failure patients, yet the incidence of RV failure in the early post-operative period following implantation is associated with significantly reduced survival and increased length of stay. Acute LVAD unloading of the left ventricle has adverse effects on RV shape and size that contribute to post-operative RV failure. By promoting RV synchrony, RV overdrive pacing may counteract these adverse mechanical alterations, improving RV systolic function and ultimately LVAD function. The investigators will recruit all patients referred for an implantable, continuous flow LVAD at Duke University Medical Center who have an existing implantable dual-chamber cardioverter-defibrillator. Patients will be prospectively randomized into two cohorts to compare continuous right ventricular pacing vs. native ventricular conduction at equivalent heart rates. Multiple clinical outcomes will be examined over a two week period post-operatively including invasive hemodynamics, vasoactive medication use, end-organ function, RV function by Echocardiography as well as patient symptoms and functional status.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
3
Pacing parameters set to AAI 90
Pacing parameters set to DDD 90-100
Duke University Medical Center
Durham, North Carolina, United States
Length of Hospitalization
To determine whether continuous RV pacing reduces ICU length of stay (number of days) and overall hospital length of stay (number of days) post-LVAD implantation.
Time frame: 14 days
Post-operative Need for Hemodynamic / Respiratory Support
To determine whether continuous RV pacing reduces the need for inotropic / vasoactive agents, mechanical ventilation, or other circulatory support in the early post-operative period. Measured by the number of hemodynamic and respiratory support interventions and duration of those interventions.
Time frame: 14 days
Right Ventricular Function
To determine whether continuous RV pacing improves invasive and non-invasive measures of RV function in the early period post-LVAD implantation. Measured by Pulmonary Artery catheter measures of intra-cardiac pressures and cardiac output in the ICU setting and by qualitative and quantitative Echocardiographic measures of RV function during the hospital course.
Time frame: 14 days
Functional Capacity and Symptoms
To determine whether continuous RV pacing improves functional capacity and symptoms as measured by six minute walk test and symptoms questionnaires in the early post-LVAD implantation period.
Time frame: 14 days
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