Predicting pacemaker-related LVSD
Research type
Research Study
Full title
Predicting pacemaker-related left ventricular systolic dysfunction
IRAS ID
309289
Contact name
Maria Paton
Contact email
Sponsor organisation
University of Leeds
Duration of Study in the UK
2 years, 5 months, 31 days
Research summary
Implantable pacemakers consist of a battery and one or two leads to the heart and prevent slow heart beats by delivering an electrical pulse ‘on demand’ to the heart when necessary. I have shown that since a pacemaker- beat is not normal, people with pacemakers, and especially those who need pacemaker-beats most of the time, and those with a previous heart attack, have a higher risk of developing progressive heart muscle weakness or heart failure which causes breathlessness and fatigue, hospitalisations and shortens life expectancy. I also proved that this can be avoided in some by programming the pacemaker to reduce the amount of pacemaker- beats. This is impossible in people who have persistently slow heart beats who rely on their pacemaker to stimulate nearly all of their heart beats, meaning they are more at risk of heart failure. A more complex pacemaker system could help these people but there are no easy options. We could:
1. Implant a standard pacemaker, monitor people for heart failure and ‘upgrade’ the pacemaker to a more complex system in a second operation.
2. Implant a more complex system at the first operation.Neither option is ideal. Although the first targets only those who develop heart failure, symptoms often develop late after heart function deteriorates, the deterioration is often irreversible, and requires a second procedure. The second option may prevent heart failure altogether, but is not available in all hospitals, is a more difficult procedure, is more expensive, devices have shorter battery lives, and is not necessary in those patients who will not develop heart failure. This problem would not exist if, before the first implantation, there was a simple test, available in all hospitals, to inform us which patients are likely to develop heart failure.
A new way to assess heart contraction using cardiac ultrasound may be able to do this. This study will investigate whether these ultrasound measurements, recorded before pacemaker implantation, identify people more likely to develop heart failure and could therefore guide better device selection from the outset. The study will involve inviting 248 people to have an ultrasound scan before pacemaker implantation, immediately afterwards, 6 weeks and 6 months later to coincide with pacemaker appointments, to assess how the heart’s contraction changes over time and whether deteriorating function can be predicted at the pre-implant scan.
REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
22/EE/0080
Date of REC Opinion
25 Apr 2022
REC opinion
Favourable Opinion