No reimbursement policy and implantable loop recorders in the real world setting
Authors: Maria Boszko M B , Patryk Pindlowski P P , Jakub Kosma Rokici J K R , Marcin Michalak M M , Marcin Grabowski M G 
Published: October 2024

Abstract

Background
Prolonged heart rhythm evaluation is indicated in patients with suspected arrhythmias. Routine electrocardiographic Holter monitoring is often associated with poor adherence and may lead to little to no clinically relevant findings. Implantable loop recorders (ILRs) are small, subcutaneous cardiac devices providing semi-continuous electrocardiographic recording. Despite strong evidence supporting their effectiveness, ILRs are yet to be fully reimbursed by the National Health Fund- the public insurer in Poland.

Purpose
We aimed to investigate the feasibility, as well as the diagnostic yield of ILRs in a real world setting of a tertiary cardiovascular center.

Methods
We retrospectively analyzed data of consecutive patients admitted for ILR implantation between March 2013 nad November 2023. Hospitalization and procedural costs were covered by the clinic's statutory and hospital funds and not by the National Health Fund, the public payer. All patients were remotely monitored for device follow-up. Baseline demographic characteristics, as well as data regarding observation period, clinical outcomes and safety were collected.

Results
Data for 51 ILR implants in 50 patients was assessed. Insertion success rate was 100% on first attempt with no complications. Mean age was 54,43 ±18,56 years old. 52,94% of patients were female. Coronary artery disease was present in 21,57% patients, hypertension in 50,98%, diabetes in 13,73%. The indications for ILR implantation were unexplained syncope (n= 42; 82,35%), palpitations (n= 16; 31,37%), ischemic stroke of unknown origin (n= 6; 11,76%), monitoring of ventricular arrhythmia (n= 2; 3,92%). Mean time between occurrence of first symptoms and ILR implantation was 80,86 ±112,95 months. Mean monitoring period was 1067,62 ±668,89 days. 23 (45,1%) patients had an actionable event detected. Mean time to clinical outcome was 190,34 ±514,85 days. Based on the obtained recordings, in 13 (25,49%) patients a cardiac electronic device was implanted and 6 (11,76%) underwent an electrophysiological procedure. Time to intervention was 435,17 ± 542,9 days and 338,8 ± 273,44 days, respectively. ILR prompted medication modification in 14 (27,45%) patients. Antiarrhythmic drugs were modified in 6 (11,76%) patients. Oral anticoagulation was initiated in 3 (5,88%) patients. Mean time to any pharmacotherapy modification was 654,68 ± 604,32 days. Skin infections occurred in 2 patients, leading to early device removal.

Conclusions
This is the first study to present a comprehensive evaluation of ILR patients in Poland, along with a substantial observation period. We report a high prevalence of treatable cardiac conditions in patients with previous unsuccessful diagnostic work up. In the light of the upcoming favourable changes in governmental healthcare policy, demonstrating evidence supporting ILR application in everyday clinical practice is crucial for advocating their wider utilization and reimbursement.