OPT-paceStratified Pacemaker Patient Management: Predicting Complications and Optimizing Heart Failure Therapy

Permanent pacemaker implantation is a safe, life-prolonging and cost-effective treatment for bradycardia. An estimated 300,000 people in the UK have a pacemaker and there are 36,000 new implants per year. Complications from pacemaker implantation occur in 5-15% of patients, mostly in the first six weeks. After six months new problems are very rare. Clinic follow-up of patients with a PPM usually occurs at six weeks, three months and then annually to monitor battery performance. Reprogramming is rarely required, and batteries reliably last at least five years. The tariff for pacemaker follow-up is £200 costing the National Health Service (NHS) £50 million per year. The commonest and most under-recognised long-term complication of pacemaker implantation is pacemaker-related chronic heart failure (CHF) due to left ventricular systolic dysfunction, seen in up to 50% of patients. Published data examining the incidence and associations of pacemaker-related cardiac dysfunction consist of retrospective cross-sectional analyses or data taken from other studies rather than a-priori planned analyses. Our unique pilot data in almost 500 patients show that cardiac dysfunction is present in 40% of all pacemaker patients and confirm previous suggestions that it is more common in patients with an underlying predisposition, for example cardiovascular co-morbidities (including diabetes mellitus), with high rates of pacing and atrial fibrillation. Our data also demonstrate that patients with cardiac dysfunction and a pacemaker are not usually taking optimal medical therapy for their heart failure and suffer a 13% annual combined heart failure hospitalisation or death rate (compared to 6% in pacemaker patients without cardiac dysfunction, and ~8% in patients with CHF attending the Leeds Integrated Heart Failure Service). However, since patients with pacemakers were often excluded from the large studies of medical (and device) therapy of CHF, it is unclear whether optimisation of medical (and pacemaker) therapy in patients with pacemaker-related cardiac dysfunction can reduce mortality and hospitalisation. Pilot data from our clinic in 25 patients with a pacemaker and CHF, show that optimised medical therapy can lead to similar improvements in cardiac function as in CHF patients without a pacemaker. The present project therefore includes three distinct, but closely related, work packages which will answer three questions; in patients receiving their first pacemaker, which clinical and pacing variables predict short, medium and long-term complications and is it therefore feasible, safe and cost-effective to individualise follow-up intervals; can we confirm and validate our previous observation that a model consisting of simple clinical and pacing variables identifies pacemaker patients at higher risk for cardiac dysfunction during a pacemaker-follow-up appointment and; does applying our risk model with subsequent optimisation of medication and pacemaker programming within a multidisciplinary heart failure service in those with heart failure lead to cost effective and clinically relevant reductions in mortality and hospitalisation?