Clinical trial NCT01819662: Optimised Pacing Program
Official title: Stratified Management of Patients With Pacemakers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Pacemaker Complication
Congestive Heart Failure
Keywords: Pacemaker, heart failure, hospitalisation
Lead sponsor: University of Leeds
Sponsor class: OTHER
Collaborators: name: National Institute for Health Research, United Kingdom
First posted: 2013-03-27
Enrollment: 1793
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Permanent pacemakers are a common treatment for slow heart beats. In the UK 300,000 people have a pacemaker, and each year another 36,000 receive them. All of these patients are usually seen yearly to have their device checked. However, pacemaker technology is now very reliable, batteries last well over 5 years, and many patients require their pacemaker only occasionally as a back-up. Each visit costs around £200 such that pacemaker follow-up cost the NHS around £50million per year. Most visits involve checking the battery and the leads which, in the absence of symptoms might be unnecessary.

Pacemaker patients are at risk of developing other problems including heart failure which puts them at higher risk of hospitalisation and death. For those under follow-up, no mechanism exists to identify whether they might have heart failure, and for those receiving new implants, it is unclear which will go on to develop heart failure. Also, whether optimal heart failure treatment with a multidisciplinary team reduces the chances that they will be hospitalised is also unproven.

Our study therefore has three main aims: 1) based on pacing indications and patient factors, to identify which patients are likely to develop complications and therefore which patients could be seen less frequently; 2) to validate and refine a simple risk score to help identify which patients in pacing clinic should undergo screening for heart failure; and 3) to establish whether such screening and subsequent optimisation of those with heart failure is clinically and cost-effective for reducing hospitalisation and death.

Detailed description: 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;

1. 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;
2. 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;
3. 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?

Eligibility criteria: Inclusion Criteria:

* Pacemaker implantation

Exclusion Criteria:

* Dementia, unwilling to fill in quality of life questionnaires, unwilling to sign consent form

Primary outcomes:
measure: Combined hospitalisation and mortality
timeFrame: 3 years
Secondary outcomes:
measure: Predictors of complications from pacemaker implantation
timeFrame: 3 years
Other outcomes:
measure: Predictors of cardiac dysfunction in pacemaker patients
timeFrame: 1-3 years
Locations:
city: Bradford
country: United Kingdom
facility: Bradford Hospitals NHS Foundation Trust
state: Yorkshire
city: Harrogate
country: United Kingdom
facility: Harrogate Hospital Foundation Trust
state: Yorkshire
city: Leeds
country: United Kingdom
facility: Leeds General Infirmary
Study officials:
affiliation: University of Leeds
name: Klaus K Witte, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Paton MF, Gierula J, Jamil HA, Lowry JE, Byrom R, Gillott RG, Chumun H, Cubbon RM, Cairns DA, Stocken DD, Kearney MT, Witte KK. Optimising pacemaker therapy and medical therapy in pacemaker patients for heart failure: protocol for the OPT-PACE randomised controlled trial. BMJ Open. 2019 Jul 17;9(7):e028613. doi: 10.1136/bmjopen-2018-028613.