139-05: His Optimised Pacing Evaluated for Heart Failure “HOPE-HF” Trial: Rationale, Design and Endpoints

Introduction: Cardiac resynchronisation therapy is an important treatment for heart failure, yet, it is only applicable to patients with left bundle branch block. PR prolongation is associated with increased mortality in heart failure regardless of QRS duration. We have previously demonstrated that AV optimised temporary His pacing improves acute haemodynamic function in patients with heart failure, narrow QRS and prolonged PR interval. The acute haemodynamic effect of optimising AV delay with His pacing is approximately 60% of the effect size observed when conventional CRT is initiated in patients with heart failure, sinus rhythm and LBBB. In this study we will assess whether this acute improvement is translated into improvements in exercise capacity when permanent AV optimised His bundle pacing is delivered to patients with left ventricular dysfunction, PR prolongation and narrow QRS complexes or right bundle branch block. Methods: HOPE-HF is a multi-centre double-blinded cross-over study, we aim to recruit 160 patients. Patients are randomised to six month treatment periods in the following two states (1) No pacing (2) AV optimised His-bundle pacing. Permanent pacing leads are positioned in the right atrium and on the His bundle in order to achieve His-bundle capture. For those without an ICD indication, a second ventricular lead is implanted in the coronary sinus; otherwise an ICD lead is positioned in the right ventricle. AV delay optimisation is performed using beat by-beat non-invasive systolic blood pressure. The primary outcome is change in exercise capacity, measured objectively using peak oxygen uptake. Secondary endpoints are change in ejection fraction, quality of life scores and B-type Natriuretic Peptide. Summary of Results: AV delay optimisation with direct His bundle pacing, appears to be a promising therapy in this population. This study will answer whether the acute improvements observed translate into longer term benefits. Conclusions: If His AV optimised pacing delivers long-term clinical benefits to this cohort it would open up a new therapeutic option to this symptomatic population currently not indicated for device therapy.