Personalised reprogramming to prevent progressive pacemaker-related left ventricular dysfunction: A phase II randomised, controlled clinical trial

Abstract

Background: Pacemakers are widely utilised to treat bradycardia, but right ventricular (RV) pacing is associated with heightened risk of left ventricular (LV) systolic dysfunction and heart failure. We aimed to compare personalised pacemaker reprogramming to avoid RV pacing with usual care on echocardiographic and patient-orientated outcomes.

Methods: A prospective phase II randomised, double-blind, parallel-group trial in 100 patients with a pacemaker implanted for indications other than third degree heart block for ≥2 years. Personalised pacemaker reprogramming was guided by a published protocol. Primary outcome was change in LV ejection fraction on echocardiography after 6 months. Secondary outcomes included LV remodeling, quality of life, and battery longevity.

Results: Clinical and pacemaker variables were similar between groups. The mean age (SD) of participants was 76 (+/-9) years and 71% were male. Nine patients withdrew due to concurrent illness, leaving 91 patients in the intention-to-treat analysis. At 6 months, personalised programming compared to usual care, reduced RV pacing (-6.5±1.8% versus -0.21±1.7%; p<0.01), improved LV function (LV ejection fraction +3.09% [95% confidence interval (CI) 0.48 to 5.70%; p = 0.02]) and LV dimensions (LV end systolic volume indexed to body surface area -2.99mL/m2 [95% CI -5.69 to -0.29; p = 0.03]). Intervention also preserved battery longevity by approximately 5 months (+0.38 years [95% CI 0.14 to 0.62; p<0.01)) with no evidence of an effect on quality of life (+0.19, [95% CI -0.25 to 0.62; p = 0.402]).

Conclusions: Personalised programming in patients with pacemakers for bradycardia can improve LV function and size, extend battery longevity, and is safe and acceptable to patients.

Trial registration: ClinicalTrials.gov identifier: NCT03627585.

Conflict of interest statement

MFP received a NIHR fellowship for the submitted work and discloses payments for developing and delivering unrelated educational presentations for Abbott, JG holds a NIHR fellowship outside of this work has been paid for developing and delivering educational presentations for Abbott, RMC held a BHF intermediate fellowship, MTK holds a BHF chair, and KKW held a NIHR clinician scientist award parallel to but outside of this work and discloses payment for unrelated educational presentations with Medtronic, Abbott, and Microport. KKW, MTK and RMC have also received unconditional research support in the form of an educational grant from Medtronic UK to the University of Leeds towards a PhD fellowship for clinicians and allied health professionals and KKW provides mentorship and education to trainee clinicians across Europe and the Middle East through an unconditional grant from Abbott. This does not alter our adherence to PLOS ONE policies on sharing data and materials.

Figures

Fig 1. CONSORT participation flow diagram.

Patient enrolment, randomisation, and disposition.

Fig 2. Pacemaker reprogramming protocol and its results.

Simple adjustments to pacemaker programming in addition to manufacturer-specific algorithms can reduce RV pacing, improve LV function and dimensions, lengthen battery longevity with no loss to patient quality of life.

Fig 3. Primary and secondary outcomes by allocation.

Mean change and standard deviation in LV diastolic and systolic volume index, left ventricular ejection fraction and minimum device longevity following 6 months of usual care programming versus personalised programming.