Abstract
BackgroundEchocardiographic optimization of pacemaker settings is the current standard of care for patients treated with cardiac resynchronization therapy. However, the process requires considerable time of expert staff. The BRAVO study is a non-inferiority trial comparing echocardiographic optimization of atrioventricular (AV) and interventricular (VV) delay with an alternative method using non-invasive blood pressure monitoring that can be automated to consume less staff resources.Methods/DesignBRAVO is a multi-centre, randomized, cross-over, non-inferiority trial of 400 patients with a previously implanted cardiac resynchronization device. Patients are randomly allocated to six months in each arm. In the echocardiographic arm, AV delay is optimized using the iterative method and VV delay by maximizing LVOT VTI. In the haemodynamic arm AV and VV delay are optimized using non-invasive blood pressure measured using finger photoplethysmography. At the end of each six month arm, patients undergo the primary outcome measure of objective exercise capacity, quantified as peak oxygen uptake (VO2) on a cardiopulmonary exercise test. Secondary outcome measures are echocardiographic measurement of left ventricular remodelling, quality of life score and N-terminal pro B-type Natriuretic Peptide (NT-pro BNP). The study is scheduled to complete recruitment in December 2013 and to complete follow up in December 2014.DiscussionIf exercise capacity is non-inferior with haemodynamic optimization compared with echocardiographic optimization, it would be proof of concept that haemodynamic optimization is an acceptable alternative which has the potential to be more easily implemented.Trial registrationClinicaltrials.gov NCT01258829
Highlights
Echocardiographic optimization of pacemaker settings is the current standard of care for patients treated with cardiac resynchronization therapy
If exercise capacity is non-inferior with haemodynamic optimization compared with echocardiographic optimization, it would be proof of concept that haemodynamic optimization is an acceptable alternative which has the potential to be more implemented
Onset of biventricular pacing results in immediate improvements in cardiac function which is manifest as an improvement in haemodynamic parameters [1,2,3] including increased peak rate of rise of intraventricular pressure, [4] an increase in stroke volume [5], and higher systemic arterial blood pressure [4,6]
Summary
If exercise capacity is non-inferior with haemodynamic optimization compared with echocardiographic optimization, it would be proof of concept that haemodynamic optimization is an acceptable alternative which has the potential to be more implemented. We already know that it is much more capable of being automated, and consumes less expert time. This would allow more patients to have their resynchronisation devices optimised and allow them to reap maximum benefit from their devices. Authors’ contributions ZIW was involved in conception and design of the study, and analysis of the data. SMAS is involved in recruitment, data collection, and analysis. KM is involved in recruitment, data collection, and analysis. EC is involved in coordinating the study recruitment, and data analysis. AK was involved in design of the study, recruitment, and data collection. DPF was involved in the conception and design of the study, and analysis of the data. All authors contributed to the drafting of the manuscript, and read and approved the final manuscript
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