Comparative Trial of the Effects of Left Ventricular and Biventricular Pacing on Indices of Cardiac Function and Clinical Course of Patients With Heart Failure: Rationale and Design of the READAPT Randomized Trial

Abstract

Nonresponse to cardiac resynchronization therapy (CRT) has been related with right ventricular dysfunction. Ventriculoarterial coupling (VAC) assesses energy efficiency of the failing heart and stroke work maximization for a given contractility, for both systemic and pulmonary circulations. Preferential left ventricular pacing (pLVP) can overcome iatrogenic right ventricular dysfunction by achieving left ventricle resynchronization and by allowing for intrinsic activation of the right side, with ramifications extending beyond cardiac output and atrial fibrillation occurrence. In the present article, we detail the design of a single-center randomized clinical trial to evaluate the effects of a pLVP algorithm. More specifically, following randomization of 220 CRT-eligible patients to standard biventricular pacing and pLVP, their clinical course will be followed for 12 months, through echocardiography to study indices of systolic and diastolic function of ventricles, left and right side VAC to evaluate efficiency, and cardiopulmonary exercise test to objectively document improvements in functional status, as well as a self-reported quality of life questionnaire. Device programming will be based on echocardiography-evaluated maximization of stroke volume and subsequent interventricular and atrioventricular delay adjustments delegated to the device. Findings of this trial may provide evidence for alternative programming of the devices, linking pLVP to improved clinical outcomes.