Abstract 2649: Cost-Effectiveness Analysis Of Implantable Loop Recorder In The Diagnostic Management Of Patients With Unexplained Palpitations
Background. In subjects with palpitations that remain unexplained after initial evaluation (history, physical examination, 12-lead ECG), conventional diagnostic strategy (CDS) includes Holter recording, external ambulatory ECG recorders (ER), and electrophysiological study (EPS). The aim of our multicentre, prospective, randomized study was to compare the cost-effectiveness ratio of implantable loop recorders (ILR) and CDS in patients with unexplained palpitations.
Methods. We studied 50 consecutive patients without severe structural heart disease (SHD) (ejection fraction >35%), and with infrequent (≤ 1 episode per month), sustained (>1 minute), and clinically significant palpitations remained unexplained after initial evaluation. Patients were randomized either to CDS (n=24) or to ILR implantation (Reveal Plus®, Medtronic) (n=26) with 1-year monitoring. Full hospital costs of each investigation were calculated. The costs included in the analysis were: staff involved; equipment and disposables used; utilisation of the electrophysiology room (including overheads); removal procedure in the case of ILR strategy.
Results. A diagnosis was obtained in 5 patients in CDS group, and in 19 subjects in ILR group (21% vs 73%, p<0.001). No deaths or significant adverse events were observed during the study. The mean cost per patient was significantly higher (€2,233 ± €265 vs €1,410 ± €1,389, p=0.001), while the mean cost per diagnosis was significantly lower (€3,056 ± € 363 vs € 6,768 ± € 6,672 , p = 0.012) in ILR group than in CDS group. The incremental cost-effectiveness ratio for ILR strategy was low (€1,576) in relation to the costs of further investigations and acute events management, which are necessary when the diagnoses are fewer. Sensitivity analysis showed that the mean cost per diagnosis remained significantly lower in ILR group, except for EPS 50 %. These data confirm that EPS constituted the main driver of cost in CDS, and that it is not cost-effective in patients without SHD.
Conclusions. In subjects without severe SHD and with infrequent palpitations, ILR is a safe and more cost-effective diagnostic approach than CDS, and it may be a useful primary strategy in the evaluation of these patients.